Belco Formula User Manual

Formula
Formula plus
Formula 2000
Formula 2000 plus
SW. 5.8
USER MANUAL
IB5331228ENG Rev. 01
SW 5.8
INDEX
Expressions used in the manual iii
Glossary Iv
Section 1
1.1 INTRODUCTION (Ed. 11/09)
1.2 WARNINGS, CAUTIONS AND SAFETY NOTES (Ed. 11/09)
Section 2
2.1 DESCRIPTION OF MACHINE AND COMPONENTS – STANDARD NON-THERAPY
MODELS (Ed. 11/09)
2.2 DESCRIPTION OF MACHINE AND COMPONENTS – STANDARD THERAPY MODEL
(Ed. 11/09)
2.3 DESCRIPTION OF MACHINE AND COMPONENTS – OPTIONS AND ACCESSORIES
(Ed. 11/09)
2.4 FORMULA DOMUS (HOME CARE SYSTEM) - VERSION FOR HOME HAEMODIALYSIS
(Ed. 11/09)
2.5 OPERATOR INTERFACE (Ed. 06/09)
2.6 CONFIGURATION (Ed. 06/09)
2.7 DISPOSABLE MATERIALS AND ACCESSORIES (Ed. 06/09)
2.8 TECHNICAL CHARACTERISTICS (Ed. 11/09)
Section 3
3.1 START-UP, TEST, RINSE (Ed. 06/09)
3.2 DIALYSIS FLUID PREPARATION (Ed. 06/09)
3.3 PREPARATION OF TREATMENT (Ed. 06/09)
3.4 HEPARIN (Ed. 06/09)
3.5 INITIATING DIALYSIS AND TREATMENT PROCESS (Ed. 06/09)
3.6 DISCONNECTING PATIENT (Ed. 06/09)
Section 4
4.1 DOUBLE NEEDLE HAEMODIALYSIS – DN (Ed. 11/09)
4.2 SINGLE NEEDLE/SINGLE PUMP HAEMODIALYSIS – SNsp (Ed. 11/09)
4.3 SINGLE NEEDLE/DOUBLE PUMP HAEMODIALYSIS – SNdp (Ed. 11/09)
Section 5
5.1 ONLINE HAEMODIAFILTRATION (HDF PRE, HDF POST ) (Ed. 11/09)
Section 6
6.1 OPERATION DURING HAEMODIAFILTRATION WITH INFUSION OF DIALYSIS
FLUID (PHF PRE, PHF POST) (Ed. 06/09)
ENG - Ed. 11/09 IB5331228ENG rev.01 Index - i of vii
SW 5.8
Section 7
7.1 HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REINFUSION
(HFR) (Ed. 06/09)
Section 8
8.1 PROFILES (ed. 12/07)
8.2 PROFILER (Ed. 06/09)
8.3 FORMULA PLUS SENSORS (Ed. 11/09)
8.4 OTHER FUNCTIONS (Ed. 12/07)
Section 9
9.1 DISINFECTION/CLEANING (Ed. 11/09)
9.2 WEEKLY DISINFECTION/CLEANING (Ed. 05/08)
9.3 PERIODIC CLEANING AND MAINTENANCE (Ed. 06/09)
9.4 MANAGEMENT OF ULTRAFILTERS AND MULTIPURE FILTER (Ed. 05/08)
9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA MACHINE USED IN ON-
LINE HAEMODIAFILTRATION TREATMENT (Ed. 12/07)
Section 10
10.1 ALARMS AND WARNINGS - GENERAL (Ed. 06/09)
10.2 ALARMS AND WARNINGS - DIALYSATE SECTION (Ed. 06/09)
10.3 ALARMS AND WARNINGS - BLOOD SECTION (Ed. 06/09)
Section 11
11.1 PROBLEM SOLVING (Ed. 06/09)
ii of vii –Index IB5331228ENG rev.01 ENG - Ed. 11/09

SW 5.8
EXPRESSIONS USED IN THE MANUAL
WARNING
Warns the operator not to take any particular action or carry out a procedure able to cause
potential risks which, if ignored, may produce serious injury to the patient and/or the user.
CAUTION
Refers to operating procedures and conditions which, if not applied, may have adverse
effects on the patient or the machine.
NOTE
Refers to important operating procedures and conditions.
This manual constitutes an integral and essential part of the machine.
The manufacturer reserves the right to perform any eventual modifications to the user manual and
the equipment without notice obligation. Should typographic mistakes or errors of other kind be
noticed, the corrections will be included in the next versions/editions of the manual.
Reserved property - Forbidden reproduction without the prior written permission of the
manufacturer –
The manufacturer protects its rights on the drawings and the images to law terms.
ENG - Ed. 11/09 IB5331228ENG rev.01 Index - iii of vii

SW 5.8
GLOSSARY
These terms are defined as they apply to haemodialysis and to the formula® single patient delivery
system. The definitions are not intended to be comprehensive.
DN Identifies double needle dialysis.
SNsp Identifies single needle dialysis with a single pump.
SNdp Identifies single needle dialysis with double pump.
HDF This refers to standard haemodiafiltration treatment (replacement

solution is a sterile solution supplied in bags).
HDF OnLine This refers to the following on-line haemodiafiltration treatments

(replacement solution is an ultrapure solution generated for
ultrafiltration from dialysis solution prepared by the machine): HDF
PRE, HDF POST, MID-HDF
HDF PRE This refers to pre-dilution on-line haemodiafiltration treatment with

High-Flux standard dialysers (see Disposable materials chapter)
HDF POST This refers to post-dilution on-line haemodiafiltration treatment with

High-Flux standard dialysers (see Disposable materials chapter)
MID-HDF This refers to mid-dilution on-line haemodiafiltration treatment with

OLPure dialysers (see Disposable materials chapter).
PHF This refers to on-line haemodiafiltration treatments PHF PRE and PHF
POST carried out using PHF double chamber dialysers (see Disposable
materials chapter).
(Replacement solution is an ultrapure solution generated for
ultrafiltration from the dialysis solution prepared by the machine)
PHF PRE This refers to pre-dilution on-line haemodiafiltration treatment with

PHF dual-chamber dialysers (see Disposable materials chapter).
PHF POST This refers to post-dilution on-line haemodiafiltration treatment with

PHF dual-chamber dialysers (see Disposable materials chapter).
HFR Refers to haemodiafiltration treatment with endogenous reinfusion of

ultrafiltrate.
Class I equipment EN 60601-1 classification.

Equipment in which protection against electrical shock does not rely
on basic insulation only, but which includes an additional safety
precaution in that means are provided for the connection of the
equipment to the protective earth conductor in the fixed wiring of the
installation in such a way that accessible metal parts can not become
live in the event of a failure of the basic insulation.
iv of vii –Index IB5331228ENG rev.01 ENG - Ed. 11/09

SW 5.8
Applied part Type B Applied part in conformity with the requirements specified in EN
60601-1, which provides a degree of protection against electrical risks
with particular reference to permissible leakage currents.
Applied part Type BF Applied part in conformity with the requirements specified in EN
60601-1, which provides a higher degree of protection against
electrical risks with respect to that provided by applied parts type B.
By-pass Device to deviate dialysis fluid away from the dialyser to the drain.
Dialysis fluid Solution which is intended to exchange solutes and/or water with
blood during haemodialysis. It is also defined as dialysing solution or
dialysis fluid.
Electroclamp Device to automatically clamp the blood lines, i.e. in case of an alarm.
Arterial phase or arterial In single needle, it indicates the phase in which blood is drawn from
cycle (AP) the patient with the pump running and the clamp closed.
Venous phase or venous In single needle, it indicates the phase in which blood is returned to
cycle (VP) the patient with the pump stopped and the clamp open.
Arterial pressure The pressure measured in the extracorporeal circuit between the
patient and the arterial blood pump.
Switching pressure Pressure used to define when the venous phase ends and the arterial
phase starts and to indicate possible problems arising during such
phases.
Ultrafiltration pressure Pressure measured on the dialysate at dialyser outlet before the UF
pump.
Transmembrane pressure The hydrostatic pressure difference inside the dialyser across the
membrane from the blood to the dialysate side.
Venous pressure The pressure measured in the extracorporeal circuit between the outlet
of the dialyser and the return to the patient.
Stroke Blood volume moved during the cycle in Single Needle .
Single needle, single Emergency treatment carried out in the event of vascular access
pump treatment problems using a single drawing point, a Y line and a single blood
pump.
Ultrafiltration The process of fluid removal from the patient’s blood across the
dialyser.
Isolated ultrafiltration Ultrafiltration without dialysing fluid. Fluid removal is carried out
without changing the solute composition of the blood.
Accessory MDD 93/42 classification.

An article which, whilst not being a device, is intended specifically by
its manufacturer to be used together with a device to enable it to be
ENG - Ed. 11/09 IB5331228ENG rev.01 Index - v of vii
SW 5.8
used in accordance with the use of the device intended by the

manufacturer of the device.
Maintenance Any operation for maintaining the efficiency of the machine. Also, from
the "maintenance" menu, the user can access rinsing, descaling,
disinfection and ultrafilter and bacterial microfilter control functions.
Rinsing Physical process that uses water to remove deposits eventually present
in the fluid pathway.
Descaling Process that removes inorganic deposits commonly left by the saline
solutions circulating in the fluid pathway of the dialysis machine.
Disinfection Chemical or physical process which has effect on living micro-

organisms, but with possibility of survival of some vegetative forms
(spores).
Disinfection/cleaning In both the instructions for use and on the user interface, this term
indicates a generic machine “cleaning” process which may consist of
disinfection, descaling or rinsing.
vi of vii –Index IB5331228ENG rev.01 ENG - Ed. 11/09

SW 5.8
ENG - Ed. 11/09 IB5331228ENG rev.01 Index - vii of vii

1.1 INTRODUCTION
GENERAL
NAME
formula

For convenience, if not otherwise specified, the name formula will be used to indicate
the models formula, formula 2000, formula plus, formula 2000 plus, and formula Therapy.
INTENDED USE
Haemodialysis and haemodiafiltration delivery system for the acetate or bicarbonate
dialysis treatment of patients suffering from chronic renal failure.
It may be used both in hospitals and at home.
CAUTION
Information and assistance given to the patient during dialytic therapy
therapy in home
dialysis must take place under the management and supervision of the
physician
physician prescribing the treatment. The
The manufacturer does not undertake any
responsibility for teaching the patient how to use formula
. Responsibility lies
exclusively with
with the physician in charge.
LIMITATION OF USE
The formula delivery system is not designed, commercialised or intended for use
different from that specified. Furthermore, it must not be used outside the
specifications and operating values indicated by the manufacturer.
The formula delivery system is not designed to dialyse infants.
COLLATERAL EFFECTS
Dialysis therapy may cause hypotension, nausea, vomiting and cramping in some
patients.
CONTRAINDICATIONS
Hyperpotassemia (only with haemodialysis concentrates containing potassium)
Hypopotassemia (only with haemodialysis concentrates not containing potassium)
Uncontrollable coagulation anomalies.
ENG – Ed. 11/09 chap. 1.1 - Introduction - 1 of 14

HAEMODIALYSIS
Haemodialysis is a method of blood purification that is able to eliminate the toxic

substances and excess water that accumulate in the body in the event of renal failure.
Haemodialysis consists of the treatment of a patient’s blood by extracorporeal
circulation, through a device made up of semi-permeable capillary fibres (dialyser) and
a solution with an electrolytic content similar to plasma water which runs outside the
fibres.
The porosity of the membrane of which the fibres are made up allows water molecules
and low molecular weight solutes to travel from the blood compartment to the dialysis
fluid compartment, while the larger solutes such as protein and blood cells remain
inside the blood compartment.
Solutes are typically transported through the membrane via two different mechanisms:
diffusion and convection
HAEMODIAFILTRATION
Haemodiafiltration
Haemodiafiltration is a haemodialysis technique that uses a dialyser, both for its
diffusive properties and for its high convection capacity, with a plasma water removal
that exceeds the weight loss rate, thus necessitating reinfusion with a physiological
solution.
The infusion methods, filter types and physiological solution used distinguish certain
haemodiafiltration methods implemented into the formula machine.
This manual gives descriptions on:

o Standard haemodiafiltration,
haemodiafiltration for treatments in which the replacement solution
consists of a sterile solution supplied in bags.
Standard haemodiafiltration implemented into the formula machine is indicated
by the letters HDF.
HDF
o On line haemodiafiltration,
haemodiafiltration for treatments in which the replacement solution
consists of an ultrapure solution derived by ultrafiltration from dialysis solution
prepared by the machine.
HDF Online treatments available on the formula machine are indicated by the
letters: HDF PRE,
PRE HDF POST,
POST MID-
MID-HDF,
HDF PHF PRE,
PRE PHF POST.
POST
o Haemodiafiltration with endogenous reinfusion
reinfusion,
usion for treatments in which the
replacement solution consists of an ultrapure solution derived by ultrafiltration
from plasma water from the patient.
Haemodiafiltration treatment with endogenous reinfusion implemented into the
formula machine is indicated by the letters HFR.
HFR
Refer to the relevant chapters for descriptions and use of the aforementioned methods.
See the table in this chapter, below, for the availability of treatments according to the
formula model used.
2 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

HAEMODIAFILTRATION - INDICATIONS
INDICATIONS
Haemodiafiltration treatments are indicated for patients who have haemodynamic
stability problems and when molecules of medium- to high molecular weight have to
be removed.
ON-
ON-LINE HAEMODIAFILTRATION – CONTRAINDICATIONS
Online haemodiafiltration treatments (HDF PRE, HDF POST, PHF PRE, PHF POST, MID-
HDF) are not recommended in areas where the quality of water entering the machine is
not under strict control by the dialysis centre and does not conform to the regulations
in force.
WARNING
• Chemical substances
substances potentially toxic for infusion, present in the deionised
water distribution network or in concentrate solutions are not detectable by
formula.
• It is the responsibility of the dialysis centre to use water suitable for
infusion.
• To avoid potentially dangerous
dangerous situations, carefully read the directions on
the device packaging.
• Check that the device packaging, which ensures their sterility, is not
damaged and that the sterilization validity date has not expired.
• Always ensure that disposable devices are installed properly using aseptic
techniques.
• Only use not pyrogenic concentrate solutions, qualitatively in compliance
with the monographs of the European Pharmacopoeia.
• The concentrate solutions to be used for preparation of dialysis fluid must
be intact,
intact, opened only at the moment of use. Once opened, they must be
used for one treatment only within 24 hours.
• Before starting an on-
on-line haemodiafiltration session, take a dialysis fluid
sample and check that it is free from any residual chemical agents.
• Before
Before and during on- on-line haemodiafiltration treatment, check the exact
mixture of the concentrates with water.
• Always run a disinfection cycle before and after each on- on-line
haemodiafiltration treatment session. The manufacturer declines any
responsibility for patient safety in the event of failure to carry out proper
disinfection.
• Regularly change the Multipure and Forclean filters to ensure the maximum
purification of the liquid used.
• The Qinf value must be selected taking into consideration the dilution
mode;
mode; in POST dilution (PHF POST) in particular, a careful evaluation of the
set value is necessary. Refer to the literature and the clinical scene of the
patient to avoid potentially dangerous conditions.

HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE
REINFUSION
REINFUSION (HFR) - INDICATIONS
Haemodiafiltration with on-line endogenous reinfusion of ultrafiltrate (HFR) is
indicated for patients who may, on the one hand, enjoy the benefits derived from a
haemodiafiltration technique (cardiovascular stability, efficiency of removal of
molecules of medium- to high molecular weight) and, on the other hand, save
nutritional and hormonal components. This technique is hence indicated for elderly
patients and patients at risk of developing a malnutrition picture of both Type I (from
reduced protein-calorie intake) and Type II (on the basis of chronic inflammation).
HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE

REINFUSION (HFR) - CONTRAINDICATIONS
The disposables utilised in HFR treatment, if properly used, do not have
contraindications. Nevertheless, the HFR technique with the SELECTA PLUS cartridge
(cartridge containing charcoal) is not indicated for patients undergoing a therapy with
ACE inhibitors or sartanes (angiotensin II receptor antagonists). The SELECTA PLUS
cartridge has been associated with an increase in contact phase activation in patients
treated with ACE inhibitors or sartanes. Therefore, it is unadvisable to use the SELECTA
PLUS cartridge for such patients or patients who have already shown a certain
hypersensitivity.
The HFR treatment uses an adsorbent cartridge to regenerate the ultrafiltrate and
hence adsorption can also occur in the case of medication. This adsorption may
directly or indirectly cause side effects, particularly in sensitive patients.

MAIN FEATURES
The formula dialysis system is produced in the following models:
• formula (single pump)
• formula 2000 (double pump)
• formula plus (single pump)
• formula 2000 plus (double pump)
• formula Therapy (double pump)
The basic model, formula, is equipped with a single pump and can be used to carry
out standard dialysis treatment (double needle haemodialysis) and emergency
treatment (single needle haemodialysis).
In comparison to the basic model, formula 2000 is equipped with a second pump for
infusion in the haemodiafiltration treatments and some sensors necessary for
monitoring the infusion circuit.
formula plus/ formula 2000 plus are “enriched” with innovative and advanced sensors
(conductivity sensor, hematocrit measuring sensor, heart rate meter, ultrafilter
recognition sensor, sphygmomanometer) able to control the progress of dialysis and
its dose, monitor the patient and prevent any complications from arising.
formula Therapy introduces, based on the formula 2000 plus, a double filtration of the
dialysis solution, in order to produce a replacement solution in on-line
haemodiafiltration treatments.
The formula dialysis system is able to operate in different treatment modes,

subdivided according to the preparation of the dialysis solution and to extracorporeal
circulation and the treatment of infusion solutions.
As regards the preparation of dialysis solution:

• treatments with acetate concentrate
• treatments with liquid bicarbonate concentrate
• treatments with bicarbonate concentrate powder
• treatments with acetate-free concentrate (Lympha)
As regards the extracorporeal circulation system and the treatment of infusion

solutions:
• Double Needle Haemodialysis
• Single Needle Haemodialysis with single pump (SNsp)
• Sequential haemodialysis with isolated ultrafiltration
• Haemodiafiltration (HDF) with scale accessory
• Haemodialysis with extracorporeal circulation with single needle/double pump
(SNdp)
• Haemodiafiltration with endogenous ultrafiltrate reinfusion (HFR)
• On-line Haemodiafiltration with the infusion of dialysis fluid (PHF PRE, PHF
POST, HDF PRE, HDF POST, MID-HDF).

TABLE OF TREATMENTS/MODELS
X indicates that the treatment shown at the start of the row can be carried out using
the model indicated at the top of the column.
formula formula plus formula formula 2000 formula

2000: plus Therapy
DN X X X X X
SNsp X X X X X
SNdp X X X
HDF X X
HFR X X X
PHF PRE X X X
PHF POST X X X
HDF PRE X
HDF POST X
MID-HDF X
Additionally, formula is manufactured into a configuration specifically suited for use in

the home environment as the display, keyboard and flow regulators can be positioned
at various heights from the floor with variable inclinations.
formula has an electronic multiprocessor architecture composed of control and

protection microprocessors which control functioning of all the
actuators/detectors/transducers, and a Personal Computer which supervises all the
operating functions and facilitates operator/machine interaction making the
management approach to dialysis immediate and safe.
The PC architecture of formula allows using high-level software; the operator can
communicate with the machine in a flexible and simple manner. Guide messages on
the display make all the operating functions easy for the operator to understand. The
significant data to manage the dialysis session are highlighted on one single display
page on the operator interface, both in numeric terms and with ideograms to facilitate
reading.
The hydraulic circuit has been optimised in volume, and is rigorously single-
single-pass in
any operating state. For ultrafiltration control a Coriolis flowmeter is used, able to
measure the mass of fluids which flow through the circuit without interrupting dialysis.
Ultrafiltration accuracy is independent of UF pressure.
Use of the Multipure antibacterial filter, placed on the water inlet of the machine, and
of the ultrafilter for endotoxin removal, placed on the dialysate inlet, allows preparing
a dialysing solution of high microbiological quality, and improves biocompatibility of
the haemodialytic treatment administered by formula.
The hydraulic circuit is completely disinfectable.

Short, automatic, high-flow rinsing cycles guarantee removal by mechanical means of
any salt or biofilm deposits before disinfection.

The vertical structure (monolithic type) of formula makes the external surfaces easy to
clean, and thanks to the side panels which can be opened and rotated by 180º, access
to the internal components is improved thus facilitating maintenance/repair
operations.
formula has four rotating wheels of which the front two can be locked individually,
allowing safe transport and positioning in any operating environment.
formula optimises the consumption of:

• electric energy:
energy it is equipped with a high-efficiency heat exchanger which allows
increasing the inlet water temperature by conduction, recovering part of the heat
emitted by the dialysis fluid running to the drain with the consequent reduction in
machine energy requirements.
• concentrates
concentrates:
tes both during the patient waiting phase and during dialysis with
isolated ultrafiltration, formula reduces the dialysis fluid flow to a minimum level.
• feedwater: in all standby phases during rinsing, formula reduces the inlet water
flow to a minimum.
SAFETY PHILOSOPHY
formula has a multiprocessor architecture and guarantees the safety of the patient
even in single fault condition (first failure proof IEC 513).
The self-tests, run automatically when switching on and at the beginning of each
dialysis session, allow checking proper functioning of the components. Any failure
recognized during the tests prevents starting of the treatment.
The operator interface is structured in such a way that the operator has to confirm any
commands twice and thus ensures that the actual intended action is carried out.
formula immediately transmits every alarm condition to the operator giving him a
visual, optical and acoustic warning:
• visual: messages and/or ideograms on screen in bright red
• optical: red flashing light located at the highest point of the I.V. pole
• acoustic: warning signal of different intensity according to a scale of priorities.
Direct access keys allow the operator to manage the alarm condition.
formula combines technological innovations with tradition, maintaining a rapidly

accessible potentiometer knob for blood pump control: any critical condition can be
controlled by simply setting the blood flow to zero by turning the knob.
formula is equipped with non-invasive measuring transducers, free of stasis points

and not subject to contamination because the dialysing fluid flows across them at high
speed. The transducers are fitted with auto-diagnostic systems which check
functioning before each treatment and do not require any particular calibration except
in the maintenance phase.
formula warns the operator of some faults which may affect the efficiency of the
dialysis treatment:
• dialysate flow lower than an adequate threshold
• incorrect connection between patient and machine

• presence of electrically conductive substances in the machine's water system which
could produce unsuitable conductivity levels for the set treatment
• incorrect completion of the disinfection programs.

SYMBOLS ON THE MACHINE
The following symbols are found on the machine or the identification tag:
Applied part TYPE B

(ref. EN 60601-1
Applied part TYPE BF

(ref. EN 60601-1)
Defibrillation-proof type BF applied part (ref. EN 60601-1)
IPX1 Protection against dripping water with vertical drop
Year of manufacture
Alternate current power supply
Off (not powered)
On (powered)
WARNING. Consult the manual.
Protection ground
Equipotentiality
DRAIN
Water inlet
Remote alarm

Socket for auxiliary keyboard
Connectors for serial ports
Conformity with Directive 93/42/EEC relative to Medical Devices.

Notifying body: TÜV SÜD Product Service - Munich (Germany)
Connector for Pulsar
Connector for Hemox
This symbol indicates the compulsory separation of electrical and

electronic equipment for disposal (see Disposal).
MANUFACTURER RESPONSIBILITY
The manufacturer is responsible for the safety, reliability and proper functioning of
formula only if the electrical system of the dialysis room is in conformity with the
regulations in force, if the machine is used in accordance with the instructions in the
user manual and if any maintenance operation is carried out by authorized technical
staff.
Proper functioning of formula is guaranteed only if the machine is used and

maintained in accordance with the instructions supplied by the manufacturer. The
manufacturer declines any liability following incorrect or improper use of the machine,
as well as in case of errors on the part of the Haemodialysis Centre staff.
All maintenance and repair procedures and periodic inspections must be carried out
exclusively by qualified technicians authorised by the manufacturer in accordance with
the specifications in the technical manual.
BELLCO is a company whose quality system is certified in accordance with EN ISO
13485: 2003.
formula has been designed and manufactured in compliance with National, European
and International regulations applicable to the safety of electro-medical equipment:
EN 60601-
60601-1 Medical electrical equipment.
Part 1: General requirements for safety
EN 60601-
60601-1-2 Medical electrical equipment.
Part 1: General requirements for safety - Collateral standards:
Electromagnetic compatibility – Requirements and tests

EN 60601-
Part 1: General requirements for safety.
4. Collateral standard: Programmable electrical medical systems
EN 60601-
Part 2-16: Particular requirements for the safety of haemodialysis,
haemofiltration and haemodiafiltration equipment
EN 60601-
Part 2: Particular requirements for safety, including essential
performance, of automatic cycling non-invasive blood pressure
monitoring equipment.
EN ISO 14971 Medical devices
Application of risk management to medical devices (ISO
14971:2000)
formula carries the CE marking in compliance with the European Directive

93/42/EEC of 14 June 1993 relative to Medical Devices.
Notifying Body: TÜV SÜD Product Service - Munich (D), number 0123.
The CE marking printed in this manual is valid only if the machine related to it carries
the same marking.
Contact the manufacturer (or your local representative) for additional information.
To contact
contact After-
After-Sales Service:
ph: ++39 0535 29271 (Italy)

ph: ++39 0535 29402 (International)
Fax: ++39 0535 29400
e-mail: service@bellco.net Local Representative

EQUIPMENT DISPOSAL
IMPORTANT
The guidelines herein indicated are addressed only to the Member States which
accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and
Electronic
Electronic Equipment (WEEE). These measures comply with the European
Directive and the national laws transposing the Directive in the Member States.
In order to safeguard, protect and improve the quality of the environment as well as
the human health, at the end of its lifetime the dialysis equipment must be treated as
special waste and must be collected separately, in compliance with the current national
regulations.
Illicit disposal of WEEE (Waste Electrical and Electronic Equipment) is punished with
pecuniary endorsements.
The manufacturer shall be responsible for the take-back and disposal of the
equipment and undertakes to treat it according to the modalities of reuse, recycling,
treatment and other forms of recovery of the WEEE as foreseen by the law.
At the time of purchase of a new equipment, the customer may demand the
manufacturer the take-back and disposal of the historical WEEE (placed on the marked
before 13 August 2005), as long as the new equipment is of equivalent type (meeting
the criteria of equivalence indicated in the Directive 2002/96/EC),
In compliance with the Directive 2002/96/EC, the equipment to be disposed of must

be delivered to the manufacturer opportunely disinfected and accompanied by a
declaration which states that the equipment is NOT infected. The disinfection and the
declaration (signed by a person officially designed ) must be executed by the hospital.
The manufacturer will not take back equipment from the hospital which have not been
previously disinfected and are not accompanied by declarations adequately edited and
signed.

PRODUCT CODE
The product code, described below, is a 9-character alphanumerical code:
I B F X M X 7 0 0
The first two characters (IB) are identical for all equipment and identify the product.
The third character (alphabetic) identifies the machine:

F: formula or formula 2000
The fourth and fifth characters (alphanumeric)) identify the model:

XM: formula (single pump)
XB: formula 2000 (double pump)
PM: formula Plus (single pump)
PB: formula 2000 Plus (double pump)
TB: formula Therapy (double pump)
The sixth character (alphanumeric) identifies the version:

X: standard system
D: formula Domus (Home Care System)
The seventh character (numeric) indicates the pre-set voltage.

2: 110 Vac
3: 115 Vac
4: 120 Vac
6: 220 Vac
7: 230 Vac
8: 240 Vac
The eighth and ninth characters (numeric) are digits included between 00 and 99. They
identify the option devices mounted on the machine.
Formula , Formula Plus, Formula 2000 and Formula

Formula 2000 Plus models
CODE Sphygmo Double Perforated

clamp cartridge
00
01 x
02 x
03 x
10 x x
20 x x
30 x x
40 x x x

Formula Therapy model
CODE Sphygmo Natrium Double Perforated

clamp cartridge
00 x x
01 x x x
02 x x x
30 x x x x

1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES
WARNINGS
Carefully read the instructions contained in this manual before starting the
machine for the first time. Non-Non-conform use, application of procedures
different from those indicated, or the use of accessory
accessory devices not provided for
may present a risk to the patient and/or the machine.
Haemodialysis treatments must be carried out under supervision of the

medical staff responsible for administration of the treatment.
 may only be used by persons who have acquired adequate knowledge

formula
of haemodialysis and who have been suitably trained for proper use of the
machine and the risks connected with such use.
Check the quality of the haemodialysis water used so that when mixed with the
concentrates, no potentially
potentially dangerous conditions for the patient are created.
The operator must pay careful attention to all the alarm conditions and follow
the instructions, the warnings and the notes contained in this manual. If
formula does not function as described in the
the manual, it must not be used
until its operating conditions have been restored.
There are no parts of the machine which may be repaired by the operator.
Periodic maintenance is to be carried out every 3000 hours of operation or
every 12 months.
The machines
machines are not disinfected before shipment. Always carry out a
disinfection cycle after installation, before use.
The blood circuits must be sterile and pyrogen-

pyrogen-free. Check that the packaging
is undamaged and open it using aseptic techniques. To prevent any possibility
of contamination, the sterile sets must be used immediately.
Once the disposable material is installed, check there are no bends or kinks in
the lines.
Disposable material should be treated as special waste and disposed of

according to statutory
statutory laws and regulations. Do not re-
re-sterilize. When handling
disposable material, adopt the necessary and adequate precautions to prevent
any exposure to or transmission of infecting agents, HIV and hepatitis viruses.
When the machine is no longer going to to be used, it must also be treated as
special refuse and disposed of according to statutory laws and regulations.
ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 1 of 4
The temperature of the liquid circulating in the tubes during the heat
disinfection cycles is extremely high. Do not touch the tubes and the
connectors until the disinfection cycle has ended.
During dialysis pay careful attention to inverse ultrafiltration (signalled by a

specific alarm), as this situation can be dangerous for the patient. Accurately
verify the patient’
patient’s weight.
During dialysis
dialysis pay careful attention to eventual leakage of fluids from the
equipment, as this situation can be dangerous for the patient. Accurately verify
the patient’
patient’s weight.
Some of the alarms can be disabled by pressing the key to allow the
operator to resolve
resolve the situations which generated the alarm. The operator
must pay very careful attention and is responsible for monitoring the disabled
parameters. The repeated silencing of alarms due to an unknown cause can be
dangerous for the patient.
If the I.
I.V. pole
pole is fitted with both hooks and scale, in HDF hang the
infusion fluid bags only on the scale hooks to prevent weight loss errors.
 is 10 kg,
The maximum load that may be applied to the IV pole of formula
while to the I.
I.V. pole of formula
 2000 is 16 kg.
kg.
To transport or to move the machine, the IV pole and scale hooks must be
unloaded.
 must always be installed by technicians authorised by the

formula
manufacturer or by technical staff of the dialysis centre, who are adequately
trained and authorised. If not, the manufacturer declines all responsibility
regarding safety and reliability of the machine.
The electrical system of the haemodialysis rooms must be in conformity with

the relevant regulations; therefore, have the earthing and the good condition
of the power outlet checked before installing the machine. Specific regulations
of different countries, as well as any changes to national regulations, must be
taken into account.
Ensure compliance with current regulations concerning drain-

drain-traps and point
point-
to-
to-point distance to the drain.
 single patient delivery system is a continuous operation machine,

The formula
and is not suitable for use with inflammable anaesthetic mixtures containing
air, oxygen or nitrous oxide.
2 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09
When connecting the machine to the
the mains, only use the power cable provided
and do not use extensions or adapters for plugs.
Do not connect external machines to the auxiliary socket (if present).

present). The
connector for an external keyboard may only be used by technicians or
personnel authorised
authorised by the manufacturer.
The power supply voltage on the mains outlet at the dialysis centre must be
identical to that indicated on the machine identification plate.
Do not remove labels or written information from the machine panels.
Before use, the mac

machine
hine must be configured. The first configuration must be
performed only by technicians authorised by the manufacturer.
CAUTIONS
During transport and storage the machine must be kept in its original
packaging. Should the period of transport or storage be longer than 15 weeks,
refer to the ambient data relative to functioning.
When unpacking, check that there are no signs of external damage which may
compromise proper functioning of the machine.
cannot
Take all the necessary precautions so that the machine cann ot fall or is not
placed in an unstable position during ordinary use or transport. In case of
falling or other mechanical stress, have a preventive inspection carried out by
qualified technicians.
On all models, before moving the machine, the IV pole hooks,

hooks, scale hooks and
concentrate bag holder must be completely unloaded.
On DOMUS versions, the instrument table must also completely empty before
moving the machine.
Do not step on the container-

container-tray base.
Use the bag hook only for the physiological solution

solution bags.
Use of mobile telephones near formula  or other devices emitting

electromagnetic waves may cause bad functioning of the machine.
After each dialysis disinfect the concentrate intake tubes.

Do not exchange the concentrate with the disinfectant tubes and with those of
other dialysis machines.
ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 3 of 4
NOTES
This manual provides the necessary instructions for safe and proper
functioning of formula
. It must not be understood as guide for administration
of dialytic therapy.
Keep this manual in a readily

readily accessible place for rapid consultation by both
the operator and the authorised maintenance technician.
The operator must regularly clean the machine. Refer to the chapter “Cleaning
and Maintenance”. Before carrying out any cleaning or preventive maintenance
maintenance
operation, make sure that the machine is off.
The formula
 technical manual is handed out following a specific course on the
machine, or is available on request for authorized technical staff.
NOTES FOR USING THE SCALE FORMULA 2000
The FORMULA 2000 SCALE accessory may be used only on formula  2000 and
 2000 plus models in standard and domus versions; installation must be
formula
carried out by a qualified technician authorised by the manufacturer.
The FORMULA 2000 SCALE accessory does not come as standard with
compatible models.
The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is
not required for any of the other treatments.
4 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09
2.1 DESCRIPTION OF MACHINE AND COMPONENTS –
STANDARD NON-
NON-THERAPY MODELS
FRONT VIEW
26
25
22
24
23
8
5
9
10 4
7
6
3
ENG – Ed. 11/09 chap. 2.1 - Description of machine and components - 1 of 6

FRONT PANEL: DESCRIPTION
Pivoting wheels
1 To easily move the machine. The front wheels are fitted with a braking system. It
is recommended to lock the wheels during treatment.
Container base
2 To house the containers of the concentrate solutions and chemicals used for
disinfection/cleaning.
Disinfectant connector (yellow)
3
Acetate/acid concentrate connector (white/red)
4
Bicarbonate concentrate
concentrate connector (blue)
5
Powder bicarbonate cartridge supports
6
Allow the use of the powder bicarbonate cartridge.
Powder bicarbonate cartridge connector
7
Dialyser fluid outlet connector (red)

8
To connect the dialysis fluid tube to the dialyser outlet.
Dialyser inlet connector for dialysis fluid (blue)
9
To connect the dialysis fluid tube to the dialyser inlet.
Dialysis fluid drawing connector
10
Electric safety clamp

11 To close the blood line interrupting the blood flow to the patient during an alarm
condition.
Air detector
12
To detect foam or air bubbles in the venous line. Ultrasound device.
Blood detector
13
To detect presence of the line and blood in the arterial line. Infrared-ray device.
Heparin pump
To administer heparin. 20, 30 and 50 cc syringes can be used. The syringe
14 capacity is set by the operator, while the internal diameter is fixed by the
technician during configuration. When the blood pump stops, also the heparin
pump interrupts infusion.
Heparin syringe positioning
positioning keys
15 To push the heparin syringe plunger up or down or to automatically load the
pump segments.
Arterial pump flow regulator
16 To change the blood flow. Turn the knob clockwise to increase flow, anticlockwise
to decrease it. Set to zero to stop the pump.
2 of 6 - chap. 2.1 – Description of machine and components ENG – Ed. 11/09

31b
20
21
31 19
18 17
16
27
14
30
15
29
13
28
11
12
23b
34
32
33

Arterial pump
17 To move blood through the extracorporeal circuit. The pump stops when the
cover is opened. In case of power failure, the pump may be manually moved by
turning the cranking handle.
Level detector
18
Optical device to measure the level in the venous chamber.
19 Luer-
Luer-lock connector to measure the arterial pressure (red)
(red)
20 Luer-
Luer-lock connector to measure the venous pressure (blue)
21 Clips to fix the blood lines
Display
22
Colour display.
23 I.V. pole
23b I.V. pole hooks
24 Expansion chamber support
Scale Formula 2000 (optional)
25 To be used only in haemodiafiltration (HDF) for bags containing infusion liquid.
Maximum load: 16 Kg.
Alarm lamp (red)
26
To indicate an alarm or warning condition by flashing.
Fixing clips
27 To fix the switching chamber in Single Needle with Double Pump (SNdp) or the
infusion chamber.
Blood/infusion/ultrafiltration pump (formula 2000)
28 To move blood in single needle with double pump. In haemodiafiltration
treatments it permits the handling of infusion liquid. The pump stops when the
turning the cranking handle. The pump is bidirectional.
Infusion/ultrafiltration pump flow regulator (formula 2000)
29 To change the infusion/ultrafiltration flow. Turn the knob clockwise to increase
flow, anticlockwise to decrease it. Set to zero to stop the pump.
30 End Infusion detector (formula 2000)

Ultrasound device which detects the absence of infusion liquid during
31 Luer-
Luer-lock connector for infusion pressure measurement (formula 2000)
2000)
31b Blood leakage detector (formula 2000)
32 Natrium (formula plus) (accessory)
33 Hemox (formula plus) (accessory)
34 Additional pressure transducers:

 2000: luer-lock connectors for prefilter arterial pressure transducers
- formula
and haemofilter ultrafiltration (in HFR) / auxiliary pressure (other treatments) .
: luer-lock connector for the prefilter arterial pressure transducer.
- formula

REAR PANEL
19
4
1
5
2
6
7 3
9
8
10
12
11
13
20
14
15
18
16
17
Fig. 5

REAR PANEL: DESCRIPTION
1 Cooling fans
2 Main switch
3 Hour counter
4 Acoustic warning indicator
5 Battery label
Only present on machines equipped with battery.
6 Identification plate
Indicates the serial number and the mains voltage (V).
7 Connector for external keyboard
Only for technicians authorised by the manufacturer.
8 Connector for heart rate meter - Pulsar
9 Connector for hematocrit and oxygen saturation measuring system -
Hemox
10 Connector for serial communication RS 232
232 C
Available for connecting data acquisition systems with formula protocol.
11 Tube winding supports
To be used to wind the inlet and drain tubes.
12 Cable winding supports
To be used to wind the power cable.
13 Forclean support and protection cover cover
Ultrafilter for dialysis fluid. The protection cover is purposely arranged to avoid
contact with the ultrafilter connecting tubes.
Pay extreme attention because the temperature of the liquid

circulating in the tubes during certain disinfection/cleaning cycles is
very high.
14 Multipure filter support
Water inlet antibacterial filter.
15 Auxiliary socket for external machine power supply (if present)
To connect external machines or accessories. At present, no connection is
available. Do not remove the cap from its housing.
16 Power cable
To be connected to the mains; it must be inserted in a suitable wall socket.
17 Drain connector
18 Water inlet connector
19 Sphygmomanometer - Sphygmo
20 Equipotentiality (if present)

THERAPY MODEL,
MODEL, STANDARD VERSION
FRONT VIEW
26
23b
23
22
24
8
5
9
10 4
3
7

FRONT PANEL: DESCRIPTION
Pivoting wheels
1 To easily move the machine. The front wheels are fitted with a braking system. It
is recommended to lock the wheels during treatment.
Container base
2 To house the containers of the concentrate solutions and chemicals used for
Disinfectant connector (yellow)
3
Acetate/acid concentrate connector (white/red)
4
Bicarbonate concentrate connector (blue)
5
Powder bicarbonate cartridge supports
6
Allow the use of the powder bicarbonate cartridge.
Bicarbonate cartridge perforator unit
7
Dialyser fluid outlet connector (red)

8
To connect the dialysis fluid tube to the dialyser outlet.
Dialyser inlet connector for dialysis fluid (blue)
9
To connect the dialysis fluid tube to the dialyser inlet.
Dialysis fluid drawing connector
10
Electric safety clamp

11 To close the blood line interrupting the blood flow to the patient during an alarm
condition.
Air detector
12
To detect foam or air bubbles in the venous line. Ultrasound device.
Blood detector
13
To detect presence of the line and blood in the arterial line. Infrared-ray device.
Heparin pump
To administer heparin. 20, 30 and 50 cc syringes can be used. The syringe
14 capacity is set by the operator, while the internal diameter is fixed by the
technician during configuration. When the blood pump stops, also the heparin
pump interrupts infusion.
Heparin syringe
syringe positioning keys
15 To push the heparin syringe plunger up or down or to automatically load the
pump segments. (see the chapter “PREPARATION OF THE TREATMENT”.
To change the blood flow. Turn the knob clockwise to increase flow, anticlockwise
16 to decrease it. Set to zero to stop the pump.
It allows the automatic opening of the clamp (see the chapter “PREPARATION OF
THE TREATMENT”).

31b
20
21
31 19
18 17
16
27
14
30 25
29 15
13
28
12 11
34
32
33

Arterial pump
17 To move blood through the extracorporeal circuit. The pump stops when the
turning the cranking handle.
Level gauge
18
Optical device to measure the level in the venous chamber.
19 Luer-
Luer-lock connector to measure the arterial pressure (red)
20 Luer-
Luer-lock connector to measure the venous pressure (blue)
21 Clips to fix the blood lines
lines
Display
22
Colour display.
23 I.V. pole
23b I.V. pole hooks
24 Expansion chamber support
25 Infusion connector
Device for connecting infusion line in on-line treatments
WARNING!
Opening of the cover must be done only in system ready mode or after
after
having set the priming.
Do not under any circumstances open the cover if rinsing or
disinfection/cleaning is being performed.
Alarm lamp (red)
26
To indicate an alarm or warning condition by flashing.
Fixing clips
27 To fix the switching chamber in Single Needle with Double Pump (SNdp) or the
infusion chamber.
Blood/infusion/ultrafiltration pump
28 To move blood in single needle with double pump. In haemodiafiltration
treatments it permits the handling of infusion liquid. The pump stops when the
turning the cranking handle. The pump is bidirectional.
Infusion/ultrafiltration pump flow regulator
End-
30 End -infusion detector
Ultrasound device which detects the absence of infusion liquid during
31 Pressure transducer
31b Blood leak detector
32 Natrium
Natrium sensor
33 Hemox sensor (optional)
34 Additional pressure transducers:
luer-lock connectors for prefilter arterial pressure transducers and haemofilter
ultrafiltration (in HFR) / auxiliary pressure (other treatments) .

REAR PANEL
17
4
1
5
2
6
3
7
9
8
10
11
12
18
13
16
14
15

REAR PANEL: DESCRIPTION
1 Cooling fans
2 Main switch
3 Hour counter
4 Acoustic warning indicator
5 Battery label
Only present on machines equipped with battery.
6 Identification plate
Indicates the serial number and the mains voltage (V).
7 Connector for external keyboard
Only for technicians authorised by the manufacturer.
8 Connector for heart rate meter - Pulsar
9 Connector for hematocrit and oxygen saturation measuring system -
Hemox
10 Connector for serial communication RS 232 C
Available for connecting data acquisition systems with formula protocol.
11 Additional hydraulic protection cover
12 Support for Forclean ultrafilters, Forclean ultrafilters and protective
covers.
Ultrafilter for dialysis fluid. The protection cover is purposely set-up to avoid
contact with the ultrafilter connecting tubes.
Pay careful attention since the temperature of the liquid circulating

in the tubes during certain disinfection/descaling cycles is very high.
13 Support for Multipure Filter and Multipure Filter
Water inlet antibacterial filter.
14 Power cable
To be connected to the mains; it must be inserted in a suitable wall socket.
15 Drain connector
16 Water inlet connector
17 Sphygmomanometer
Sphygmomanometer - Sphygmo
18 Equipotentiality (if present)

OPTIONS AND ACCESSORIES
OPTIONS
Single Clamp vs. Double Clamp
SINGLE CLAMP
VENOUS
CLAMP
ARTERIAL TUBE
GUIDE CLIP
DOUBLE CLAMP
ARTERIAL
CLAMP
VENOUS CLAMP
WARNING
Do not introduce the fingers between the clamps during functioning.

BIDRY VS. PERFORATION
PERFORATION SYSTEM
Bidry Cartridge
BIDRY CARTRIDGE
CONNECTOR
BIDRY CARTRIDGE
SUPPORT HOOKS
Perforation System
PERFORATION SYSTEM
NOTE
The expression “perforation system” also extends to cases where the powder
bicarbonate cartridge used does not require a connection by perforation.
In the machine operator interface the term “bidry” generally refers to the
powder bicarbonate cartridge irrespective of the connection system (with
hooks or by perforation).

I.V. POLE SUPPORT
1 Dialyser holder
To hold the dialyser to the IV pole.
2 Lines fixing clips
To hold the blood lines firmly to the dialyser.
3 Fixing clip
To fix the dialyser to the holder
4 Concentrate bags holder
Holding device for positioning of the concentrate bags during treatment.
5 Bag hook
Support device for hanging the bags of physiological solution.

WARNING
The concentrate bags holder is suitable for the positioning of two bags,
and has a maximum load capacity of 13 kg.
To transport or move all formula
formula equipment models, the holder must be left
empty.
formula
The holder cannot be installed on the right I.V. pole of the formula  Domus
version.
The holder cannot be installed at a height above the ultrafiltration/venous
pump flow regulator.
WARNING
The bag hook has a maximum capacity
capacity of 5 kg.

ONBOARD DISINFECTANT
The onboard disinfectant kit has been designed so that the chemical agent can be
drawn directly from the container placed at the rear of the machine. The advantages
offered by installing the kit are the following:
- the container of the chemical agent remains closed and hence no unpleasant fumes
are emitted into the environment
- the machine can more easily be moved with the container housed in its rack.
The kit can be installed on all formula machines. The kit must be installed by
technicians authorised by the manufacturer.
The rack can house 5-6-litre containers and has a load-carrying capacity of maximum
15 kg.
WARNING
Do not use the container rack in a manner or for uses different from that
indicated.
Always check the quantity and the type of chemical agent in the container
before starting the disinfection/cleaning.
Do not mix chemical agents with a different composition.
For other safety information, consult the chapter concerning disinfection.

INSTRUMENT TABLE
The instrument table has been designed to hold all those devices normally used in the
dialysis room, for example, tubes, dialysers, syringes, clamps.
The table is divided into two compartments, a deeper one to house the more bulky
items, and the other larger but less deep for smaller items.
The table can be installed on all the formula  machines. The kit must be installed by
technicians authorised by the manufacturer.
CAUTION
Small bags can be placed on the table, however, it has a maximum load-
load-
carrying capacity of 5 kg.
Do not use the table in a manner or for uses different from that indicated.
During haemodiafiltration do not place the bags containing the infusion fluid
on the table.
To transport or move the formula
formula Domus equipment,
equipment, the instruments table
must be left empty.
The instrument table must regularly be cleaned with a cloth moistened in a neutral
detergent. Use the products indicated in the chapter "Routine Cleaning and
Maintenance" of this user manual.
The retaining screws can be loosened and the table lifted upwards and removed so that
the top cover of the machine can also be cleaned.

2.4. FORMULA DOMUS (HOME CARE SYSTEM) - VERSION FOR
HOME HAEMODIALYSIS
HAEMODIALYSIS
formula Domus Home Care System is particularly suited for use in the home
environment as the display, keyboard and flow regulators can be positioned at
different heights from the floor with variable inclinations.
WARNING
Carefully read the instructions contained in this user manual before starting
the equipment for the first time. Non-
Non-conform use, application of procedures
different from those indicated, or the use of accessory devices not provided for
may present a risk to the patient and/or the machine.
This chapter includes only specific information related to formula  Domus,,
therefore anything which is not expressly mentioned in this chapter remains
unchanged relative to the information
information contained in the formula
 user manual.
Information and assistance given to the patient during dialytic therapy in home
dialysis must take place under the management and supervision of the
physician prescribing the treatment. The manufacturer does not undertake any
responsibility for teaching the patient how to use formula
. Responsibility lies
exclusively with the physician in charge.
ENG – Ed. 11/09 chap. 2.4 - Formula Domus (Home Care System) - 1 of 6
FRONT VIEW
Display
1 Colour display with tilting capability, held by the monitor arm.
Functions
Indicate the functions which can be activated depending on the machine
2 operating status. Refer to the description in the dedicated chapter in the user
manual.
3 To change the blood flow. Turn the knob clockwise to increase flow,
anticlockwise to decrease it. Set to zero to stop the pump.
Infusion/ultrafiltration pump flow regulator (formula  2000))
Monitor arm
5
Right side I.V. pole

6 To support the monitor arm.
2 of 6 – chap. 2.4 - Formula Domus (Home Care System) ENG – Ed. 11/09
ADJUSTING THE DISPLAY
To adjust the display to the most comfortable viewing angle, proceed as indicated in
fig. 1 for the monitor arm version with locking pin knob and to fig. 2 for the monitor
arm version without locking pin knob.
fig.1 fig.2
(1) (2) (3) (4)
(3) (2) (1)

(1)
(1) monitor arm
(2) locking pin knob (1) monitor arm
(3) vertical adjustment clamp (2) vertical adjustment clamp
(4) friction system (3) friction system
• Loosen the screw of the friction system • Loosen the screw of the friction system
clamp. clamp.
• Loosen the screw of the vertical • Loosen the screw of the vertical
adjustment clamp. adjustment clamp.
• Adjust the arm to the most comfortable • Adjust the arm to the most
height. Exert pressure on the clamp not comfortable height. Exert pressure on
on the arm, in order to prevent the clamp not on the arm, in order to
jamming while moving up or down. prevent jamming while moving up or
• Tighten the screw of the vertical down.
adjustment clamp. • Tighten the screw of the vertical
• Hold the display with one hand and adjustment clamp.
with the other hand pull the locking pin • Hold the display with one hand and
knob outward. with the other hand pull the arm
• Adjust to the height and angle needed, outward.
then release the locking pin knob. • Adjust to the height and angle needed,
• Again holding the display with one then release the arm.
hand move it down until the arm locks • Tighten the screw of the friction
into place. system clamp enough to allow the arm
• Tighten the screw of the friction system to swivel.
clamp enough to allow the arm to
swivel.
WARNINGS
WARNINGS
To avoid possible harm to the patient, do not perform monitor adjustment

during dialysis treatment, but only when the patient is disconnected from the
equipment.
The sole function of the monitor arm is to support the display. Therefore:
• Do not use monitor, arm or cable management tube to support bags or any
other object or weight.
• Do not lean on and pull the monitor and/or arm when you get up from the
bed or the armchair.
• Never push or pull directly on monitor and/or arm to transport or move the
equipment.
The manufacturer does not undertake any responsibility for possible damages
when these directions are not followed, such as the machine falling over when
leaning on the monitor or arm.
Take care not to spill any liquids above the display.
Take care not to rotate the flow regulators accidentally during dialysis.
Do not install the concentrate bags

bags holder on the right IV pole.
To move or transport the home haemodialysis system, proceed as follows

(refer to fig. 3):
• lower the monitor arm along the the right-
right-side I.V. pole to the lowest position
above surface.
• fold the monitor arm in vertical position.
• place the display in front of the machine facing onward.
To transport or move the equipment, proceed as follows:

• push the machine from the back.
• leave the instruments table empty, if there is one.
one.
• unload the IV pole hooks and scale.
scale.
• unload the concentrate bags holder.
holder.
MONITOR ARM WITH LOCKING PIN KNOB MONITOR ARM WITHOUT LOCKING PIN KNOB
fig.3
2.5 OPERATOR INTERFACE
GENERAL
The operator interface consists of a graphic display, a keyboard to the right of the
monitor and a series of keys/icons (below the display) to enable specific functions.
It is divided into functional areas in which the operating status is shown, both of the
dialysis fluid preparation and of the extracorporeal circuit section.
The use of ideograms allows graphically reproducing the progress of the main
dialysis variables.
The on-line guide makes operation easier for the user; the alarm messages and/or
warnings displayed on differentiated colour bars help identify the situation and
correct it.
12 13 14
lun 08:00
1
15 2
11 3
10 4
9 8 7 6 5
ENG – Ed. 06/09 chap. 2.5 – Operator Interface - 1 of 28

Help on line
1
Side keys
2
To activate the corresponding functions.
Enter key
3
To confirm the selection made.
Arrow keys
4
To increase or decrease the values of the selected parameters. The horizontal
keys act on the horizontal graphic tools, whereas the vertical keys act on the
vertical graphic tools.
Key to silence the acoustic warning signal
5
To silence the acoustic tone. The silencing period is 2 min. in dialysis and 5
min. in priming.
Key to temporarily disable the alarms
6
Allows an alarm to be silenced. The silencing period is 2 min. in dialysis and 5
min. in priming.
Key to stop the blood pumps
7 To stop the blood pumps. Consequently, the clamp automatically closes and
the min. and max. pressure thresholds are recalculated.
Bypass key
8
To isolate the dialyser from the dialysate circuit. Active during dialysis only.
9 Keys to regulate the level in the venous drip chamber
Power key
Turns on the monitor when the main switch is in the ON position (“I”).
10 Orange LED = indicates that the machine can be turned on.
Green LED = indicates that the machine is powered.
Red LED = indicates that the mains power supply has been interrupted.
This key may not be used to turn off the machine.
Flashing orange LED = the back-up battery is functioning.
Bar to display operating instructions and alarm messages
During the operating phases, it displays the message to the operator. It is
normally grey.
The bar changes colour depending on the operating conditions. It turns
11 - red if an alarm occurs
- orange if a warning occurs
- yellow if the key has been pressed.

Dialysate section status bar
12 Indicates the machine operating status relative to the dialysate fluid section.
Blood section status bar
13 Indicates the machine operating status relative to the extracorporeal circuit
section.
Clock/Heparin icon
14 Indicates the day of the week and the time expressed in hours and minutes.
In dialysis, it turns into the syringe heparin icon which indicates the status of
the heparin program.
Functions
15 Indicate the functions which can be activated depending on the machine
operating status. To activate, press the corresponding key on the keyboard on
the side.
2 of 28 - chap. 2.5 – Operator Interface ENG – Ed. 06/09

NOTE
The LED next to the keys and indicates:

• LED off = function inactive,
• LED on = function active.

• LED off = function inactive,
• LED on permanently = function active,
• LED flashing = function activata
activatable.
table.
The interface management philosophy is based on the display of windows connected

according to a simplified “tree” structure with a “main menu” and few “submenus”,
which show the functions dedicated for that operative condition.
This means that some functions may be present or absent in relation to the
machine status or the selected menu.
Each function is activated through the key next to the function.

During dialysis only one window is displayed in which all the variables concerned are
shown.
BICARBONATO- PREP. DIALISI AD lun 08:00
modifica
trattamento
modifica
parametri
BICARBONATO- PREP. DIALISI AD lun 08:00
ritorna
BICARBONATO- PREP. DIALISI AD 08:00

inizia ematico ritorna
stacco
dialisato
ricalcolo
incorso
infusione
eparina
capacità
siringa
ok
Main menu
Menù principale First
1°sottomenù 2°sottomenù
Second
submenu

ON-
ON-LINE HELP
The on-line help aids the operator to solve problems and provides information
relating to the machine data. The machine operates regardless of the on-line help
window being present.
The on-line help is active in any treatment mode, as well as in rinsing and
maintenance. to access on-line help.
The on-line help is based on priority criteria, i.e. in relation to the machine state
(alarms/warnings present) or profile activation. When is pressed, the

information can be viewed in the order here below indicated:
• Once to view the blood section alarm window
• Twice to view the dialysate section alarm window
• Three times to view the profile window (if enabled)
• Four times to view the on-line help window with the general information.
Failing one or more of the above conditions, the next priority information is
displayed. For example, if there are no alarms and the profiles are not enabled, the
key needs to be pressed only once to view the on-line help window with the
general information.
The on-line help window remains open for about 30 sec.; it disappears when is
pressed again or if 30 sec. have elapsed or if the machine state has changed.
In case of alarms or warnings, the on-line help window provides information relating
to the active alarm or warning. The information may be on one or more pages. Use
the and keys to move from one page to the previous or next.
On-line help cannot be activated if a measurement with the sphygmomanometer

(Sphygmo) is in progress.

The on-line help window with general information contains a series of function keys
which in their turn activate further data windows:
parameters To view the data of the treatment in progress. When the patient
dialysis is disconnected, the data remains stored until the next
treatment, i.e. until the beginning of dialysate preparation and
blood line priming for the next treatment.
parameters to view information on maintenance: last disinfection/cleaning

mainten. carried out, weekly programming, Multipure and Forclean
filters operating hours.
parameters To view a further menu which allows access to the

config. configuration data.
layout Function not active at present.

blood lines
layout Function not active at present.

dial. side
machine Function that may be accessed only by technicians authorised

parameters by the manufacturer.
To return to the previous menu.

return

GRAPHIC TOOLS AND MODIFICATION
MODIFICATION OF RELEVANT
RELEVANT
PARAMETERS
The graphic tools displayed during each machine operating phase are immediate
and thus allow the operator to read and monitor the main parameters during the
entire treatment and to interpret the alarm conditions.
Some parameters can only be set during configuration and cannot be modified by
the operator.
Other parameters may be modified, even during dialysis, by entering the menu
see/mod.
parameters
.
Selection and modification procedure
The selection and/or modification procedure is similar for all the parameters.
blood dialysate
• or
total
cond.
• Select the desired parameter (e.g. ). The graphic tool is
highlighted in light blue to indicate that the parameter may be modified.
• Use the arrow keys below the screen to set the new value. The horizontal keys
act on the horizontal graphic tools, whereas the vertical keys act on the
vertical graphic tools.
• to confirm and make the settings operative both on the dialysate

and blood side.
return
• to return to the main menu and cancel all changes made:
the current settings remain active.
Tool colours
The background of the graphic tools can take on different colours according to the
machine status or the mode of use of the variable displayed:
• Red colour: the equipment is in a state of alarm due to the value taken by the
variable being displayed.
• Orange colour: the variable being displayed is at the limit of the set or
acceptable range.
• Green colour: the variable being displayed holds a value that is automatically
set by the equipment.
• Light blue colour: the variable being displayed can be modified.
• White colour: in all other cases.

DIALYSIS FLUID SECTION
TEMPERATURE
The tool indicates:

- the alarm limits for the dialysis fluid temperature (graduated scale)
- the current value (mobile index)
All the values are expressed in °C.
To modify the temperature value set,
see/mod. dialysate other temperature

parameters parameters
The mobile index indicates the value set, the window indicates the
current value.
Press or to obtain the new value (intervals of 0.5°C) and
confirm with .
When the modification has been acquired, the display returns to the
main menu.
BICARBONATE CONDUCTIVITY
During dialysis the tool indicates the conductivity read

by the partial conductivity probe (first step) (in mS/cm).
To modify the conductivity value set,
see/mod. dialysate bic.

parameters cond.
3.1
COND The mobile index shows the value set, the ends of the
BIC
2.4 3.6 scale show the min. and max. settable values with
reference to the concentrates used (3-5 mS/cm).

Use the or key to obtain the new value and confirm with .
When the modification has been acquired, the display returns to the main menu.
TOTAL CONDUCTIVITY
During dialysis the tool indicates the dialysis fluid

conductivity read by the probe at the machine outlet
(in mS/cm).
To modify the conductivity value set,
see/mod. dialysate total

parameters cond.
.
The mobile index indicates the value set, the ends of

14.0
COND
the scale show the min. and max. settable values
TOT 12.1 15.7
(mS/cm).
UF/RATE
UF/RATE
During dialysis the tool indicates the UF set (set
independently or obtained from the ratio between
the weight to lose and the treatment time ) (in kg/h)
.
To modify the UF value set,
see/mod. dialysate uf
parameters rate
The mobile index indicates the value set, the ends of

1.00
the scale show the min. and max. values set in
UF/h
0.10 4. 00 configuration (kg/h).
During dialysis the instrument becomes orange if:

- - the UF setting corresponds to the extreme pre-set values
- the UF value does not correspond to the ratio between weight loss and treatment
time settings.

PATIENT WEIGHT LOSS
Peso kg
4.00
2.67
The graduated scale indicates the weight loss set (or weight to
lose), the mobile index displays the weight lost (in kg).
1.33
0.00
To modify the total weight loss set,
see/mod. dialysate weight

parameters loss
.
Peso kg
16.00
The graduated scale indicates the max. settable total weight loss
6.66 (16.0 kg), the mobile index indicates the total weight loss set,
the window indicates the current value.
3.33 Press the keys or to obtain the new value and then
confirm with .
0.00 When the modification has been acquired, the display returns to
the main menu.
NOTE
Check that the UF/h value obtained is coherent with the modified values set.

TREATMENT TIME
During dialysis the tool indicates:

- the total duration of the treatment (4:00) in hh:mm
- the time elapsed from the start of treatment (the circled
tool colors clockwise) or
4:00 00:00
- the countdown time to the end of the treatment (the
circled tool empties counterclockwise)
The displayed value depends on the value set in
configuration.
The treatment time is expressed in hh:mm.
The flashing circle indicates that the ultrafiltration program is

running.
To modify the treatment time set,
see/mod. dialysate treat.

parameters time
01:00
The tool indicates:
10:00 00:00
the max. treatment time (10:00) in hh:mm
- the time set for the treatment in progress (04:00 hh:mm),
inside the tool,
- the treatment time performed or the residual treatment
time (in hh:mm).
The displayed value depends on the value set in
configuration.
Use the or key to obtain the new value and
confirm with . When the modification has been acquired,

the display returns to the main menu.
NOTE
It is not possible to set a treatment time less than the time already reached.
Check that the UF/h value obtained is coherent with the modified values set.
see/mod. dialysate
parameters
During dialysis and to display the totalized treatment
time below the tool.
01:00

ULTRAFILTRATION or TMP PRESSURE
P_UF mmHg
During dialysis the tool indicates the ultrafiltration pressure
200 (P_UF in mmHg)) or the transmembrane pressure (TMP in
mmHg), ), depending on the set configuration.
The mobile index indicates the current value, the ends of the
scale indicate the min. and max. alarm thresholds (fixed during
configuration, not modifiable during treatment).
The thresholds of the max (H) and min (L) alarms are displayed,
- as well.
These thresholds are automatically calculated on the basis of the
average ultrafiltration pressure (or TMP) ± the set range value
-300 (settable between 30 and 300 mmHg).
To modify this value:
see/mod. dialysate other

range
TMP/P_UF
.
Use the or key to obtain the new value and confirm
with .
The transmembrane pressure is obtained from the following

relation:
Single Needle:
Needle
TMP = (Max Switch. P + Min. Switch. P) /2 – (Pd out + 30 mmHg)
Other treatments:
TMP = Pv – (Pd out + 30 mmHg)
where:
VP = venous pressure
Pd out = dialysate pressure measured at the dialyser outlet
Switch. Pres. = switching pressure in single needle
30 mmHg = load loss of the dialysate compartment.
In the event of alarm with bypass: TMP = 0
To recalculate the min. and max. ultrafiltration pressure (or TMP) alarm thresholds,

see/mod. see other recalcul.
parameters parameters TMP/P_UF on
.
NOTE
The recalculation of the average ultrafiltration pressure (or TMP) is also
enabled when:
- the ultrafiltration time is modified (even by changing the weight loss or the
treatment time)
- isolated ultrafiltration is enabled (or disabled)
- minimum ultrafiltration is enabled (or disabled)
- an infusion bolus is enabled (or ends)
- the TMP (or P_UF) range is modified
- the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST,POST,
MID-
MID-HDF, HDF) manually or automatically with variation of the infusion
flow.
flow.
- the or or key is pressed.
AVERAGE
AVERAGE TMP AND WORKING TMP
If automatic control of the infusion flow is

enabled in online-haemodiafiltration, the tool
displays the average TMP measured and the
working TMP set for automatic control.
The average TMP is obtained from the following relations:
Treatment Formula for TMP calculation
HDF PRE Pfilt + Pv

HDF POST TMP = − (Pdout + 30 )
MID HDF 2
(P − ∆Pe ) + Pv
TMP = − (Pdout + 30 )
filt
PHF PRE
2
Pfilt + (Pv + ∆Pe )
PHF POST TMP = − (Pdout + 30 )
2
where Pfilt indicates the prefilter arterial pressure, Pv the venous pressure, Pdout the
dialysate measured at the dialyser outlet and ∆Pe the pressure drop on the blood
filter of the dual chamber filter (20 mmHg).
To modify the working TMP:
see/mod. blood set

parameters TMP
.
Press the or keys to set the new value and then confirm with .

DIALYSIS FLUID FLOW
The dialysis fluid flow is measured on the haemodialysis water before mixing with
the concentrates. Its value, which does not appear on the main page during dialysis,
may be displayed and/or modified by activating the following functions:
see/mod. dialysate other flow

.
The tool indicates:

Flow • the selectable flows in the boxes (ml/min)
• the current flow at the far right (ml/min)
(502)
• the set flow (blue box)
Use the or key to obtain the new value and confirm with . The
reading of the flow rate just set requires at least 1 min. When the modification has
been acquired, the display returns to the main menu.
NOTE
Initially, the dialysis fluid is prepared at a minimum flow.
As soon as blood is detected, the flow rate rate automatically adjusts to the set
value.
NOTE
For treatments with OnLine Haemodiafiltration: HDF PRE, HDF POST,
MID-
MID-HDF, PHF PRE, PHF POST.
POST.
If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to
the dialyser does not correspond
correspond to the set value, but is equal to the set
value minus the infusion flow.
If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at
less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value;
if, however, the infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser
is equal to the maximum value (800 ml/min) minus the infusion flow.
If the dialysis fluid flow is set at 300 ml/min, the inlet flow to the dialyser
coincides with the set value.
INFUSION BOLUS
BOLUS
Boluses of dialysis fluid can be infused at any time in a dialysis session, during
To infuse a bolus,
see/mod. dialysate other Infusion

parameters parameters bolus

and set the amount to be infused with the or keys.
The total amount of boluses infused during treatment is displayed on the monitor,
on the first page.
NOTE
When an infusion bolus is enabled, any Kt/V measurement in progress
will be aborted.

BLOOD SECTION
BLOOD FLOW
The graphic tool indicates the blood flow set (settable

between 20 and 700 ml/min).
To modify this value, turn the flow regulator

- clockwise to increase,
- anticlockwise to decrease.
In the case of an increase in blood flow or when there is a re-start after the pumps
are stopped, the flow is gradually increased (ramp trend) to the set value.
To display also the real blood flow,
see/mod. see other

The graphic tool indicates the set and the real blood
flows. The latter may differ from the set flow for the
following reasons:
• the machine status does not allow the operator
to set the arterial pump flow (i.e. priming phase
in HFR).
• the flow is recalculated on the basis of the
measured arterial pressure, when pressure is
below –100 mmHg.

INFUSION FLOW
The graphic tool indicates the infusion flow set (settable
Qinf 3.00 kg/h between 0 and 8 l/h in HDF and HFR, between 0 and 21
kg/hr in On Line Haemodiafiltration).
To change the value, turn the blue flow regulator
- anticlockwise to decrease.
In HFR, the graphic tool displays the UF/infusion flow set

(settable between 0 and 8 L/hr). If automatic control of
the UF/infusion (HFR Evolution) flow is enabled, the tool
background is green and the displayed value is that
automatically set by the machine.
In online haemodiafiltration, if automatic control of the
infusion flow based on the TMP is enabled, the tool
background is green and the value displayed is that set
automatically by the machine.
see/mod. blood
parameters
to display the tool
with the maximum and minimum limits of automatic
infusion flow setting.
VENOUS PRESSURE
The graduated scale indicates the absolute min. and max. limits
(not
not modifiable by the operator)
operator relative to the out-of-range
alarm.
For the limit values refer to the Chapter “TECHNICAL

CHARACTERISTICS”.
The mobile index indicates the actual pressure read in the venous
drip chamber (mmHg).

The max. (H) and min. (L) alarm thresholds are displayed in
dialysis and in reinfusion only in DN, HDF, HDF PRE, HDF POST,
MID-HDF, PHF PRE, PHF POST, HFR.
These values are automatically calculated on the basis of the

mean venous pressure (Pvm) ± the pressure value set during
configuration (between 50 and 150 mmHg).
ARTERIAL PRESSURE
The graduated scale indicates the min. and max. limits relative
to the out-of-range alarm, not modifiable by the operator.
operator.

CHARACTERISTICS”.
The mobile index indicates the pressure read before the

arterial pump (mmHg).
Pa mmHg
200
The max. (H) and min. (L) alarm thresholds are displayed only
during dialysis.
-150 These thresholds are automatically calculated on the basis of

the mean arterial pressure (PAm) ± the pressure value set
during configuration (between 50 and 250 mmHg).
-300
To recalculate the min. and max. alarm thresholds of the venous/arterial pressure,
see/mod. recalcul.
blood
parameters on
.
NOTE
Recalculation of the mean arterial and venous pressure is activated also
when
- the blood flow is modified or
- an infusion bolus is enabled (or ends) or
- the or key is pressed.

PREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSURE
To display the prefilter arterial pressure and the auxiliary pressure,
see/mod. see other

The graphic tool indicates the prefilter arterial

pressure (left) and the auxiliary pressure (right).
In HFR, the prefilter arterial pressure (Pfilt) and blood filter transmembrane pressure
(TMPH) are visualized:
The tool displays the prefilter arterial pressure next to

the hemofilter transmembrane pressure. The latter is
calculated as difference between the prefilter arterial
pressure and the ultrafiltration pressure (before the
infusion pump).
SWITCHING PRESSURE
PRESSURE (in Single Needle)
The graduated scale gives the min. and max. limits in relation
to the out of range alarm, not modifiable by the operator,
which are different depending on whether the equipment is in
priming, dialysis or reinfusion.

CHARACTERISTICS”.
The mobile index indicates the pressure read in the venous

drip chamber (mmHg).
The max. and min. alarm thresholds (modifiable by the

operator) are displayed only during dialysis in single
needle single pump (SNsp).
see/mod. blood
parameters
max min
switch. p. switch. p.
or
Then use or key to obtain the new value and
confirm with .
The switching pressure ranges are :
max: +200 / +400 mmHg min: +10 / +200
mmHg
END PRIMING
The tool indicates the stop priming and end priming values (in litres). Both values
are set during configuration of the machine.
End priming = total volume of fluid to use for priming.

Stop priming = volume of fluid to be circulated in the blood lines before the pump
stops.
- End priming (3.00) is indicated (in litres) on

1.50
End the graduated scale.
Priming 2.00
- Inside the tool the quantity of physiological
0.00 3.00 solution which still needs to be circulated
(2.00) is indicated.
- The mobile index indicates the stop priming
value (in litres), obtained from the difference
between the end priming and stop priming
set. (1.50).
- If the stop priming has not been set, the
mobile index is set to 0.
To modify the stop priming and/or end priming values set,
see/mod. blood stop priming

parameters priming volume
or
The upper mobile index indicates the stop priming

(StopP) value (in l) set.
End
Priming
The lower mobile index indicates the end priming
(VolP) value (in l) set.
The graduated scale indicates the min. (0.00) and

max. value (7.00) which can be set (in L).
Use the or keys to obtain the new value and confirm with .
NOTE
The Stop Priming and/or End Priming values may be modified provided that
the new value set is not less than the total remaining physiological solution.
The Stop Priming may not be greater than the End Priming value.
NOTE
Following a treatment change, if the treatment selected is an online or an
HFR treatment, the total priming volume is reset.

BLOOD VOLUME
The volume of blood treated, i.e. the volume circulating in the arterial line (in L) is
displayed on the second page.
To display it,
see/mod. see other

.
Counting starts only when blood is detected

(therefore not in priming).
In Single Needle the volume of treated blood depends on the set stroke volume.
STROKE (ONLY IN SINGLE NEEDLE)

In priming and dialysis it indicates the blood
volume circulated during the cycle (ml).
The setting range is fixed during configuration:
Minimum (10 - 50 ml)
Maximum (30 - 100 ml).
The operating values can however be modified by
the operator provided the allowed range is not
exceeded.
To change the set stroke,
see/mod. blood stroke

parameters
The mobile index indicates the stroke value (in

ml) set.
The graduated scale indicates the min. (10) and
max. value (50) set during configuration (in ml).
Use the or keys to obtain the new value and confirm with .

QBM (ONLY IN SINGLE NEEDLE)
Indicates the mean blood flow during the whole
cycle (ml/min).
Such blood flow is obtained by the following

relation :
Qb x art. phase duration. / (art. phase duration. +

ven. phase duration).
In single needle with double pump, the tool has a
green background to indicate that this flow is
regulated by the equipment following an
optimization algorithm.
ARTERIAL PRESSURE DISPLAY IN SINGLE-

SINGLE-NEEDLE WITH DOUBLE PUMP
In Single Needle with double pump, if the double clamp is present, the arterial
pressure is displayed on the first page in place of the switching pressure.
see/mod. blood
parameters
to view/modify the switching pressure.
see/mod. see other

to view:
- the real-time measured switching pressure,
- the instantaneous arterial pressure
ARTERIAL PRESSURE DISPLAY IN SINGLE NEEDLE WITH SINGLE PUMP

In Single Needle with single pump, if the double clamp is present, the arterial
pressure is displayed next to the switching pressure on the first page.
see/mod. see other

to view the instantaneous pressure with the tool
LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in SINGLE

NEEDLE WITH DOUBLE PUMP)
The lower switching pressure threshold makes it possible to manage the blood
pressure in the dialyser, to improve its effectiveness using transmembrane pressure.
Therefore the min. switching pressure set by the operator is not actually the
minimum switching pressure, but the threshold needed for the algorithm to detect
when the automatic switching pressure reduction mechanism must stop.
The range set is +100 / -100 mmHg.
It is advisable to set a value between + 10 and +50 mmHg.
To set the min switch. p. value:
see/mod. blood min

parameters switch. p.
In Single Needle with double pump the upper switching pressure threshold is
automatically set by the machine starting with an initial value of +450mmHg
(+200mmHg as long as the dialysate connectors are NOT connected to the dialyser)
which is progressively decreased of 20 mmHg each cycle until reaching a value
corresponding to the minimum switching pressure + the equivalent pressure of the
set stroke. This operation requires a certain number of cycles before reaching
normal operation.
UPPER VENOUS PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH
DOUBLE PUMP
This is the maximum venous pressure value allowed during treatment.

The range set is +100 / +400 mmHg.
To set the max venous pressure value:
see/mod. blood max

parameters switch. p.
ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD FLOW (QbV)

In Single Needle Double Pump the arterial flow regulator (red knob) regulates the
delivery of both the arterial and venous pumps. Therefore the blue flow regulator is
not used.
In priming the delivery of the venous pump is equal to 1.1 of the delivery set for the
arterial pump (so if QbA is set at 300 ml/min, QbV will be 330 ml/min).
In dialysis on the contrary , the delivery of the venous pump can be between 1.1 and
1.5 of the delivery set for the arterial pump. The speed of the venous pump
gradually increases until the threshold set for upper venous pressure (max ven. p.)
has been reached: this means that the delivery of the venous pump will
automatically regulate so that the average blood flow (Qbm) is optimised in
conformity with the set max. venous pressure.
The arterial blood flow is displayed on the screen during

priming and dialysis: the set range is
20 - 700 ml/min during priming and dialysis
20 - 250 ml/min during rinseback
To display the venous blood flow:
see/mod. see other

.
The tool indicating the venous blood flow in ml/min is displayed on the right

NOTE
The delivery of the venous pump cannot exceed 1.5 times the delivery of the
arterial pump and cannot exceed the indicated limits.
Data for expected blood flow recirculation in the extracorporeal circuit are available
upon request.
EFFICIENCY (in SINGLE NEEDLE)

Efficiency is calculated as follows:
efficiency = number of venous pump revs

number of arterial pump revs
The range of allowed efficiency values is set during configuration and can be
changed during treatment; when this range is exceeded, a warning is generated.
To modify the range:
see/mod. blood efficiency

parameters max
or
see/mod. blood efficiency

parameters min
or to obtain the new value and then confirm with .
Efficiency is an excellent indication of the negative suction pressure. Because the

actual delivery of a pump starts to decrease when the negative suction pressure falls
below a certain limit (based on the type of pump and the section), the ratio between
the venous pump revs and arterial pump revs provides a good approximate
indication of the negative inlet pressure (e.g. setting a minimum efficiency equal to
0.7, the warning is generated for negative suction pressures of approximately -400
mmHg).
Efficiency is displayed on a specific instrument during dialysis
To display it,

see/mod. see other
.
VOLUME OF LIQUID INFUSED

The volume of infused fluid (in kg) in haemodiafiltration treatments (HDR, HFR,
OnLine HDF, PHF) is displayed on the second page.
To display it,
see/mod. see other

.
Tool displayed in patient rinseback with ultrapure dialysis

fluid. Counting starts when going into rinseback.
Tool displayed in the other cases. Counting starts only

when blood is detected (therefore not in priming).
SCALE WEIGHT
The graphic tool indicates the weight of the bags hanged
on the scale in HDF (kg).
INFUSION PRESSURE
The infusion fluid pressure (in mmHg) during haemodiafiltration treatments is
displayed on the second page.
To display it,
see/mod. see other

Pinf Qinf
mmHg ml/min

GRAPHIC PARAMETER DISPLAY
DISPLAY
The graphic display of the time trend of the parameters measured is the same for all
the sensors. By way of example, the graph displayed with the Natrium sensor on
Formula Therapy is explained.
sensors Applications cond/temp

blood/UF
.
COND/TEMP BLOOD/UF
COND/TEMP BLOOD/UF
Indicated at the bottom right of the screen are the conductivity and temperature
data of the blood and the ultrafiltrate read in real-time. The function keys of the
menu on the side allow displaying the graph of the time trend of this data.
display BC
to view the blood conductivity graph.
COND/TEMP BLOOD/UF

display BT
Now to display the blood temperature graph, as well.
COND/TEMP BLOOD/UF
The graph is the Cartesian type in two dimensions: the time axis (in minutes) is
represented horizontally and the selected parameter vertically (e.g. blood
temperature and blood conductivity).
A maximum of two parameters can be displayed simultaneously, each curve with its
own scale. These curves are plotted by points.
The red vertical bars identify the beginning and end of dialysis.
The graph shows the data of the dialysis in progress or the one just concluded and
is reset only when a new dialysis is set.
The grid facilitates data reading (the time axis is divided into 60 min. intervals,
significant values are indicated on the other axis).
zoom
The function key allows enlarging the graph displayed, more specifically
the graph related to the dialysis time included between the red vertical bars.
Press the and keys to act on the vertical scale and the and keys
for the horizontal one.

SCREENSAVER MODE
Through the screensaver mode, formula® provides the possibility of performing
dialysis with the screen blackened so as not to disturb patients undergoing dialysis
at night.
This mode must be enabled in the Service configuration, where the time is set after
which - when there are no alarms and no keys are pressed - the screen is
automatically blackened.
The screen automatically lights up again
• if an alarm occurs,
• if any key is pressed
• if a flow regulator is adjusted.
To enable the screensaver mode:
see/mod. see other enable

parameters parameters screensaver
.
To disable the screensaver mode:
see/mod. see other disable

parameters parameters screensaver
.

2.6 CONFIGURATION
Configuration is a phase in the machine installation procedure. It is carried out by technicians
authorised by the manufacturer in order to fix the operating parameters in accordance with the
hardware characteristics of the machine and the habits of the dialysis centre.
These parameters will be displayed as default values during the machine operating phases:
some may be modified before and during treatment, others can be modified only by re-
executing the configuration.
Configuration is divided into three levels of which only one is accessible by the operator/user,
while the others are available only to authorized technical staff.
The configuration procedure described here below can thus be carried out by the operator/user
and customised according to prescriptions given by the responsible physician and the
requirements of the dialysis centre.
NOTE
The configuration menu can be accessed only when the machine is turned on.
HOW TO CARRY OUT CONFIGURATION
• Turn on the machine with the main switch.
• Wait until the LED next to the key on the front panel turns orange.
• Press and wait for three white asterisks (***) to appear at the bottom right of the
screen.
• In sequence press the keys . If the sequence is not respected, the

configuration menu cannot be accessed.
• The parameters are displayed on pages which can only be consulted only in one direction (it
is not possible to return to the previous page unless first completing the configuration and
then turning the machine off and on again).
• Use the or key to scroll from one parameter to the next; use the or
key to modify the parameter selected.
• When the settings have been made, press . The following window appears:
WILL YOU CONFIRM DATA?

(ENTER = YES)
• Again press to confirm and pass to the next page.
• Press to cancel confirmation.

• In case of a power failure, the parameters confirmed up to that moment will have been
stored; to set the remaining parameters, the configuration menu must be re-accessed.
ENG – Ed. 06/09 ch. 2.6 - Configuration - 1 of 12
Page 1
ALARMS, WARNINGS RANGE PRE-SET

AND DEFAULT VALUES VALUES
Treatments selectable by DN DN-SNsp - specifies the type of treatment that
the user SNsp SNdp SNdp may be used.
HDF PHF HFR
Priming volume (l) 1.0 ÷ 7.0 2.0 specifies the total volume that can
be utilized for priming.
Stop priming volume 0.0 ÷ 4.0 0.0 specifies the volume of priming
(l) fluid that has circulated before the
blood pump stops.
When set to 0, the pump stop is
cancelled and the priming liquid
circulates in the blood lines until
the priming volume is reached.
Vol. priming HFR (l) 3.0 + vol. stop 4.0 If HFR Cartridge = SELECTA PLUS
priming ÷ 7.0
has been set in Service
Configuration.
Specifies the priming volume
automatically set by the machine
for HFR Selecta Plus.
1.3 + vol. stop 2.0 If HFR Cartridge = SELECTA or
priming ÷ 7.0
HFR Cartridge = BOTH has been
set in Service Configuration.
Specifies the priming volume
for HFR Selecta .
Vol. stop priming HFR (l) 1.0 ÷ (vol. 1.0 If HFR Cartridge = SELECTA PLUS
priming –3.0)
has been set in Service
Configuration.
Specifies the stop priming volume
for HFR Selecta Plus.
0.7 ÷ (vol. 0.7 If HFR Cartridge = SELECTA or
priming –1.3)
HFR Cartridge = BOTH has been
Specifies the stop priming volume
for HFR Selecta .
Qb priming HFR 0 ÷ 200 200 If HFR Cartridge = SELECTA PLUS
(ml/min) has been set in Service
Configuration.
Specifies the arterial pump flow
rate, automatically set by the
machine, during HFR Selecta Plus
priming.
Qb priming HFR 0 ÷ 200 100 If HFR Cartridge = SELECTA or
(ml/min) HFR Cartridge = BOTH has been
2 of 12 – ch. 2.6 - Configuration ENG - Ed. 06/09
Specifies the arterial pump flow
rate, automatically set by the
machine, during HFR Selecta
priming.
Qinf LV (ml/min) 10 ÷ 100 10 specifies the infusion flow rate
automatically set in HFR by the
machine, when the relative
automatic control is active.
Patient’s connecting 30 ÷ 180 90 specifies the time elapsing between
time (sec) the detection of blood and the
activation of the dialysis alarm
limits.
FF Max (%) 1 ÷ 40 22 in HFR specifies the threshold
filtration fraction value for the
automatic control of the infusion
flow.
Additional pump stop ON/OFF OFF specifies the additional arterial

during patient’s pump stop as soon as the blood
connection level is detected in the venous drip
chamber:
ON: pump stop active
OFF: pump stop not active
TMPH Max (mmHg) 0 ÷ 400 200 in HFR specifies the max.
hemofilter transmembrane pressure
for the automatic control of the
infusion flow.
Alarm range: PV 50 ÷ 150 120 specifies the venous pressure alarm
(mmHg) threshold with respect to its mean
value.
Alarm range : PA 50 ÷ 250 150 specifies the arterial pressure alarm
(mmHg) threshold with respect to its mean
value.
PA alarm: max (mmHg) 100 ÷ 300 200 specifies the maximal arterial
pressure alarm value.
PA alarm : min (mmHg) -100 ÷ -350 -300 specifies the minimum arterial
pressure alarm value.
Heparin pump normal 20/30/50 30 specifies the capacity of the heparin
syringe.
Heparin pump diameter 18.0 ÷ 30.0 20.0 specifies the diameter of the
20 cc (mm) heparin syringe for each of the
syringes that may be used.
Heparin pump diameter 18.0 ÷ 30.0 23.9
30 cc (mm)
Heparin pump diameter 18.0 ÷ 30.0 26.8
50 cc (mm)
Normal heparin pump 0 ÷ 10 0 specifies the heparin pump infusion
speed (cc/hr) flow rate.
Normal heparin pump 0 ÷ 120 0 specifies the pre-switching off time
prestop (min) of the heparin pump.
Automatic heparin bolus 0 ÷ 25 0.0 specifies the quantity of heparin
(cc) automatically infused as soon as
blood is recognized.
Pre-set values refer to the values that have been set prior to storing the machine.
Page 2

UF pressure neg. UF or neg. UF Indicates the pressure to be utilized to
measurement TMP monitor the correct use of the dialyser.
Min TMP/backfiltration 0 ÷ -300 -60 For double needle or single needle

alarm (mmHg) treatments.
Max TMP alarm (mmHg) 200 ÷400 200 For double needle or single needle
treatments.
Min TMP alarm/backfiltr. 0 ÷ -300 -100 For haemodiafiltration treatments
HFLUX (mmHg) (HDF, PHF, HFR).
Max TMP alarm 200 ÷400 300 For haemodiafiltration treatments
Min. neg. UF alarm -200 ÷-400 -300 For double needle or single needle
(mmHg) treatments.
Max. neg. UF alarm 200 ÷ 400 200 For double needle or single needle
(mmHg) treatments.
Neg. UF alarm min -200 ÷-400 -300 For haemodiafiltration treatments
Neg. UF alarm max 200 ÷ 400 200 For haemodiafiltration treatments
Min settable WLR (kg/hr) 0.1 ÷ 0.5 0.1 Defines the minimum value of hourly
ultrafiltration that can be set.
Max. settable WLR (kg/hr) 0.5 ÷4.0 2.5 Defines the maximum value of hourly
ultrafiltration that can be set.
Dialyser rinsing UF value 0.1 ÷ 1.5 0.5 Defines the ultrafiltration rate when
(kg/hr) rinsing the dialyser.
Acoustic min. UF warning ON/OFF OFF Defines the time elapsing between an
deadened acoustic tone and the following
ON = acoustic tone every 2 min.
OFF = acoustic tone every 20 sec.

Page 3
ALARMS, WARNINGS AND RANGE PRE-SET VALUES

DEFAULT VALUES
Dialysate type (DN/SN) Bic + STD A. Conc/ Bic+STD A. Conc
Bid+STD A. Conc/Acet/
Bic+Lympha/Bid+Lympha
Dialysate type : HDF Bic + STD A. Conc/ Bic+STD A. Conc
Dialysate type : PHF Bic + STD A. Conc/ Bic+STD A. Conc
Dialysate type : HFR Bic + STD A. Conc/ Bic+STD A. Conc
Treatment type DN/SNsp/SNdp/ HDF/ DN
PHF/HFR
Dialysate flow (ml/min) 300/500/800 500
Treatment time (hr:min) 0:00 ÷10:00 0
Total weight (kg) 0 ÷ 10 0
Weight loss (kg/hr) 0.1 ÷ 4.0 * 0.1

* The range depends on the WRL min.
and max. values defined in page 2.
Max. systolic pressure (mmHg) 0-300 300
Min. systolic pressure (mmHg) 0-300 0
Max. diastolic pressure (mmHg) 0-200 200
Min. diastolic pressure (mmHg) 0-200 0
Total conductivity (mS/cm) 12.1 ÷ 15.7 14
Bicarbonate conductivity (mS/cm) 2.4 ÷ 3.6 3.1

4 ÷6
Dialysate temperature (°C) 35 ÷39 37.5
Time countdown ON/OFF OFF

Page 4

Water inlet conductivity 0 ÷ 1.0 0.2 defines the conductivity alarm value
alarm (mS/cm) referring to the use of inappropriate
0 = no alarm haemodialysis water.
Filter replacement warning 0 / 400 200 defines the number of hours after
time Forclean (hr) which the filter must be replaced (refer
0 = no filter to the instructions for use of the
Forclean filter)
filter replacement warning 0 / 600 600 defines the number of hours after
time Multipure (hr) which the filter must be replaced (refer
0 = no filter to the instructions for use of the
Multipure filter).
Acoustic alarms in ON / OFF ON identifies the acoustic tones associated

rinseback ON-OFF with priming and rinseback alarms.
ON = alarms active, OFF = alarms
inactive
Acoustic alarms in priming ON / OFF ON ON-OFF= only some alarms are
ON-OFF inactive
Arterial and venous pump 3 ÷12 5 defines the single needle rpm out of
out of range alarm range alarm threshold.
(SNsp / SNdp)
(rpm)
Normal value 200 ÷400 250 defines the maximum switching
max. SWITCHING pressure value programmed in single
PRESSURE (SNsp) needle single pump mode.
(mmHg)
Normal value 10 ÷ 200 30 defines the minimum switching
min. SWITCHING pressure value programmed in single
PRESSURE (SNsp) needle single pump mode.
(mmHg)
Min. STROKE 10 ÷ 20 10 defines the minimum stroke which can
(SNsp/ SNdp) be set for each cycle in single needle
(cc) mode.
Max STROKE 30 ÷ 100 50 defines the maximum stroke which can
(SNsp/ SNdp) be set for each cycle in single needle
(cc) mode.
STROKE normal value 10 ÷50 10 defines the STROKE default value in
(SNsp/ SNdp) single needle mode.
(cc)

Page 5

Max. VENOUS PRESSURE +100 ÷ +450 + 350 identifies the maximum venous
(SNdp) pressure value which can be set in
(mmHg) single needle double pump.
Min. SWITCHING -100 ÷ +100 + 30 identifies the lowest minimum
PRESSURE (SNdp) switching pressure value which can
(mmHg) be set in single needle double pump.
Max. efficiency 1.1 ÷ 2.0 1.2 identifies the higher value of the
(SNdp) efficiency alarm in single needle
double pump.
Min. efficiency 0.0 ÷ 0.9 0.7 identifies the lower value of the
(SNdp) efficiency alarm in single needle
double pump.
Date identifies the date used by the
equipment computer (dd, mm, yyyy).
Time identifies the time used by the
equipment computer (hh, mm, ss).
Page 6
DISINFECTION/CLEANING RANGE PRE-SET

SETTINGS VALUES
Disinfection/cleaning icon ON / OFF ON Indicates the activation of the icon for
available in rinsing disinfected/cleaned machine during
pre-dialysis rinse.
USER CHEM. FULL disinf. 6 ÷ 30 30 Identifies the dilution ratio for the
setting chemical-full disinfection/cleaning with
Dilution ratio 1: USER agent.
USER CHEM. FULL disinf. 23 ÷ 33 33 Identifies the duration of the post-
setting disinfection rinsing for the chemical-
Rinsing (min) full disinfection/cleaning with USER
agent.
USER CHEM. FULL disinf. 0.0 ÷ 20.0 20.0 Identifies the conductivity lower value
setting of the DISINFECTION warning for the
Min conductivity chemical-full disinfection/cleaning with
(mS/cm) USER agent.
USER CHEM. FULL disinf. 0.0 ÷ 20.0 0.0 Identifies the conductivity upper value
Max conductivity chemical-full disinfection/cleaning with
(mS/cm) USER agent.
USER CHEM. STD disinf. 6 ÷ 30 30 Identifies the dilution ratio for the
setting chemical std. disinfection/cleaning
Dilution ratio 1: with USER agent.
USER CHEM. STD disinf. 7 ÷ 11 7 Identifies the contact time of the
setting chemical agent in the chemical std.
contact (min) disinfection/cleaning with USER agent.

USER CHEM. STD disinf. 25 ÷ 30 30 Identifies the duration of the post-
setting disinfection/cleaning rinsing for the
rinsing (min) chemical std. disinfection/cleaning
with USER agent.
USER CHEM. STD disinf. 0.0 ÷ 20.0 20.0 Identifies the conductivity lower value
Min conductivity (mS/cm) chemical std. disinfection/cleaning
with USER agent.
USER CHEM. STD disinf. 0.0 ÷ 20.0 0.0 Identifies the conductivity upper value
Max conductivity (mS/cm) chemical std. disinfection/cleaning
with USER agent.
USER CHEM. HEAT disinf. 6 ÷ 30 30 Identifies the dilution ratio for the
setting chemical-heat disinfection/cleaning
Dilution ratio 1: with USER agent.
USER CHEM. HEAT disinf. 15 ÷ 20 20 Identifies the contact time in the
setting chemical-heat disinfection/cleaning
contact (min) with USER agent.
USER CHEM. HEAT disinf. 0.0 ÷ 20.0 20.0 Identifies the conductivity lower value
Min conductivity (mS/cm) chemical-heat disinfection/cleaning
with USER agent.
USER CHEM. HEAT disinf. 0.0 ÷ 20.0 0.0 Identifies the conductivity upper value
Max conductivity (mS/cm) chemical-heat disinfection/cleaning
cycle with USER agent.

Page 7
CHEMICAL STD. DISINFECTION/CLEANING SETTING
Contact time Contact time Rinse time Rinse time

RANGE Pre-set value RANGE Pre-set value (min)
(min) (min) (min)
HYPOCHLORITE 7 or 11 7 25 or 30 25
PERESAL 7 or 11 7 25 or 30 25
AMUCHINA 6 or 10 6 25 or 30 25
ACETIC ACID 6 or 10 6 25 or 30 25
TIUTOL 7 or 11 7 25 or 30 25
INSTRUNET 6 or 10 6 25 or 30 25
PURISTERIL 7 or 11 7 25 or 30 25
OXAGAL 6 or 10 6 25 or 30 25
RENAXID 7 or 11 7 25 or 30 25
RANGE Pre-set value

Default HYPOCHLORITE, PERESAL, AMUCHINA, ACETIC ACID, TIUTOL, AMUCHINA
agent INSTRUNET, PURISTERIL, OXAGAL, RENAXID , USER
Page 8
CHEMICAL FULL DISINFECTION/CLEANING SETTING
Rinse time Rinse time

RANGE (min) Pre-set values (min)
HYPOCHLORITE 23 or 33 23
PERESAL 23 or 33 23
AMUCHINA 23 or 33 23
DIALOX 23 or 33 23
TIUTOL 23 or 33 23
INSTRUNET 23 or 33 23
OXAGAL 23 or 33 23
RENAXID 23 or 33 23
RANGE Pre-set value

Default agent HYPOCHLORITE, PERESAL, AMUCHINA, DIALOX, TIUTOL, AMUCHINA
INSTRUNET, OXAGAL, RENAXID ,USER
Default dwell 0:00 ÷ 80:00 12:00
time (h: min)
Dwell time can be set only for Dialox, Oxagal and centralized disinfection.

Page 9
HEAT DISINFECTION/CLEANING SETTING
Contact time Contact time Heating time Heating time

RANGE Value RANGE Value
(min) pre-set (min) pre-set
(min) (min)
Heat 15 or 20 15
Chemical Heat 15 or 20 15
Page 10
WEEKLY DISINFECTION SETTING
Types of Start Duration Rinsing Shut down

disinf./cleaning h : min (min) g : h : min g : h : min
Event
Monday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Tuesday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Wednesday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Thursday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Friday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Saturday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Sunday absent / type -- - - / N.W. -- -
ENABLED
DISABLED
Should the set parameters be not congruent with the settings of the previous or next days, the
whole line of the table is coloured in red in order to warn the operator about incorrect settings.

Ex:
Monday he. wsh.w.i.t 7:00 20 mo 8:00 DISABLED
Tuesday st. DIALOX 18:00 13 we 7:50 DISABLED

Wednesday st. 8:00 32 -- DISABLED
HYPOCHLORITE
Saturday he. wsh.w.i.t 2:00 45 su 1:00 su 2:00

Sunday he. dis.w.i.t. 2:00 21 do 3:00 DISABLED
The start of Wednesday disinfection/cleaning is not congruent with the start of the rinsing of the
previous day.
The beginning of Sunday disinfection/cleaning coincides with the end of Saturday
Remember that between the end of a disinfection/cleaning and the beginning of the next at least
20 minutes must elapse.

Explanations of the abbreviations used for setting the weekly disinfection.
TYPE OF DISINFECTION/CLEANING ABBREVIATION
ABSENT ABSENT
Standard chemical disinfection with HYPOCHLORITE st. HYPOCHLORITE
Standard chemical disinfection with AMUCHINA st. AMUCHINA
Standard chemical disinfection with PERESAL st. PERESAL
Standard chemical disinfection with ACETIC st. ACETIC A.
Standard chemical disinfection with TIUTOL st. TIUTOL
Standard chemical disinfection with INSTRUNET st. INSTRUNET
Standard chemical disinfection with PURISTERIL st. PURISTERIL
Standard chemical disinfection with OXAGAL st. OXAGAL
Standard chemical disinfection with RENAXID st. RENAXID
Standard chemical disinfection with USER disinfectant st. USER
Chemical-full disinfection with HYPOCHLORITE fu. HYPOCHLORITE
Chemical-full disinfection with AMUCHINA fu. AMUCHINA
Chemical-full disinfection with PERESAL fu. PERESAL
Chemical-full disinfection with DIALOX fu. DIALOX
Chemical-full disinfection with TIUTOL fu. TIUTOL
Chemical-full disinfection with INSTRUNET fu. INSTRUNET
Chemical-full disinfection with OXAGAL fu. OXAGAL
Chemical-full disinfection with RENAXID fu. RENAXID
Chemical-full disinfection with USER disinfectant fu. USER
Heat disinfection heat
Chemical-heat disinfection with CITRIC ACID ch.he.CITRIC A.
Chemical-heat disinfection with USER disinfectant ch.he.USER
Centralized chemical disinfection ce.ch.
Centralized heat washing he. wsh.w.i.t.
Centralized heat disinfection he. dis. w.i.t.
MACHINE POWER ON POWER ON
Centralized chemical special disinfection ch. w.i.t.sp.
Centralized heat washing special h. w.i.t.sp.
Centralized heat special disinfection h.d. w.i.t.sp.
For the profile configuration pages, refer to chapter “PROFILES”.
When settings have been completed, the following message appears:
FORMULA IS READY
TO BE SWITCHED OFF.

2.7 DISPOSABLE MATERIALS AND ACCESSORIES
DIALY
DIALYZERS
The hollow-fibre dialysers must conform to the harmonized standard EN 1283.
Some dialysers that can be used with formula and manufactured by Bellco are listed
herein as a reference. Other equivalent dialysers suitable for the intended use,
produced by Bellco or having the same functional and mechanical characteristics, can
be used.
Low Flux and High Flux Hollow Fibre Dialyser
Code Model Ster.

PhyltherTM LF 11 G Gamma
PhyltherTM LF 11 SD Steam
ENG – Ed. 06/09 chap. 2.7 – Disposable Materials and Accessories - 1 of 10

Code Model Ster.
IBP4247 PhyltherTM HF 11 G Gamma
IBP4246 PhyltherTM HF 11 SD Steam
Code Model Ster.

IBP 4123 BLS512G Gamma
IBP 4127 BLS512SD Steam
2 of 10 - chap. 2.7 - Disposable Materials and Accessories ENG – Ed. 06/09

Code Model Ster.

OLpur SERIES DIALYZERS for MID-
MID-HDF
IB0958079 OLpur MD190 radiation

IB0958105 OLpur MD220 radiation
Manufacturer: Nephros Inc. New York, NY 10032 USA

BLOOD AND INFUSION LINES
The blood and infusion lines to use with formula must have characteristics comparable
with the blood lines manufactured by Bellco and specifically dedicated for this dialysis
machine.
Some codes of the lines manufactured by Bellco and suitable for the use with formula
are given herein as a reference. Other equivalent codes produced by Bellco or other
devices, with the same functional and mechanical characteristics, from another
manufacturer can be used.
ETO Sterilization
Arterial line for double needle and single needle (single pump and IB0354410
double pump) for formula and formula 2000.
Venous line for double needle and single needle (single pump) for IB0432610
formula and formula 2000.
Infusion line for HDF for formula 2000. IB0487110
Combipack (arterial and venous line in the same packaging) for IB0681700
BETA Sterilization
double pump) for formula and formula 2000.
double pump) for formula and formula 2000 with spike for saline bags.
Venous line for double needle and single needle (single pump) for IB0432640
formula, formula 2000 and formula plus.
Venous line for HDF for formula 2000. IB0432740
Venous line for single needle (double pump) for formula 2000. IB0432840
Infusion line in HFR for formula 2000. IB0434020
Infusion line in PHF for formula 2000 IB0434120
Combipack (arterial and venous line in the same packaging) for IB0691500
Arterial line including Natrium and Hemox for formula plus and IB0428440
formula 2000 plus.
Arterial line including Hemox for formula plus and formula 2000 plus IB0428540
Infusion line including Natrium for formula 2000 plus. IB0434720

formula plus/ formula 2000 plus can however be used with the blood and infusion lines
dedicated to formula / formula 2000.
Therapy formula can use the lines dedicated for formula 2000 / formula 2000 plus as far as
blood lines (artery and vein), infusion lines for HFR, and Kit for HFR are concerned.
Infusion lines for PHF (PHF PRE, PHF POST) and HDF OnLine (HDF PRE, HDF POST, MID-
HDF) are as follows:
Infusion line for PHF for formula Therapy. IB0434920
Infusion line for HDF ONLINE for formula Therapy. IB0435020
T-set for dilution IB0560900
KITS FOR SPECIFIC TREATMENTS

Some complete kits for specific treatments available with formula are given herein as a
reference, including the different devices composing the kits, manufactured by Bellco.
KIT PHF
KIT PHF including BL690 – IB 0567600 (PHF DIALYSER 0719)

Arterial line IB 0357040
Venous line IB 0432640
Infusion line IB 0434120
Infusion set IB 0550920
Manometer protection set IB 0556700
PHF dialyser IBP 4100
KIT PHF including BL690 – IB 0567610 (PHF DIALYSER 0714)
Infusion set IB 0550920
Manometer protection set IB 0556700
PHF dialyser IBP 4105

KIT HFR
KIT HFR including BL640 - IB0568822 (DIALYSER

DIALYSER SG30 PLUS)
Dialyser SG30 PLUS IBP 4117
Selecta Cartridge IBP 1503
KIT HFR including BL640 – IB 0568823 (DIALYSER SG40 PLUS))

KIT HFR AEQUILIBRIUM including BL640 - IB0568828 (DIALYSER

DIALYSER SG30 PLUS)
KIT HFR AEQUILIBRIUM including BL640 – IB 0568829 (DIALYSER SG40 PLUS))


DIALYSER HFR13)
Dialyser HFR 13 IBP 4282

DIALYSER HFR17)

KIT HFR AEQUILIBRIUM including BL640 - IB0568838 (DIALYSER
DIALYSER HFR13)
KIT HFR AEQUILIBRIUM including BL640 – IB 0568839 (DIALYSER HFR 17))

KIT HFR AEQUILIBRIUM

AEQUILIBRIUM HEMOX BL640 - IB0568840 (DIALYSER
DIALYSER HFR13)
including IB 0428540
Hemox arterial line IB 0432640
Infusion line IBP 4282
Selecta Cartridge
KIT HFR AEQUILIBRIUM HEMOX BL640 – IB 0568841 (DIALYSER HFR 17))

including IB 0428540
Hemox arterial line IB 0432640
Infusion line IBP 4283
Selecta Cartridge

CONCENTRATES
The concentrate saline solutions are identified by the dilution ratio to which they must
be used. For “dilution ratio” it is meant the water quantity which must be added to the
concentrate unit.
Based on different conductivity configurations (partial conductivity), formula has to be
used with appropriate concentrate solutions.
3 mS System
Basic solution for bicarbonate dialysis dilution 1:28.57
Acid solution for bicarbonate dialysis dilution 1:35
3 mS System with powder bicarbonate
Herein some bicarbonate cartridge types are listed:
BIDRY – Powder bicarbonate cartridge Code BSCART003

from 750 g, - water down to obtain a solution close to saturation at approx. 37°C
BIDRY – Powder bicarbonate cartridge Code BSCART009

SOLUCART PLUS – powder bicarbonate cartridge Code BSCART002

SOLUCART PLUS – powder bicarbonate cartridge Code BSCART018

Acid solution for bicarbonate dialysis dilution 1:35 or 1:45 (various

formulas)
To be used with Bidry or Solucart Plus
LYMPHA kit Acetate free (bicarbonate powder cartridge and concentrate acid solution in
bag) dilution 1:45 (various formulas)
5 mS System
System
Basic solution for bicarbonate dialysis dilution 1:20.13
Acid solution for bicarbonate dialysis dilution 1:36.83
In configuration mode different dilution ratios can be set. Further details can be given
on request.

WATER INLET FILTER
MULTIPURE Code IB5092200
Water inlet for bacterial microfilter.
ACCESSORI
ACCESSORIES
FORCLEAN PLUS Code IB0958500
Hollow-fibre Medisulfone® ultrafilter for dialysis fluid, ETO sterilized.
FORCLEAN I Code IB0958600

Hollow-fiber Medisulfone® ultrafilter for dialysis fluid, ETO sterilized, equipped with
transponder.
SCALE FORMULA 2000 Code IB7097000

Scale for HDF
SPHYGMO FORMULA Code IB7097050

Sphygmomanometer
NATRIUM FORMULA Plus Code IB7097060

Blood temperature and conductivity sensor
HEMOX
HEMOX FORMULA Plus Code IB7097070
Hematocrit and oxygen saturation measuring system
PULSAR FORMULA Plus Code IB7097080

Heart rate meter

2.8 TECHNICAL CHARACTERISTICS
DIMENSIONS AND WEIGHT

WEIGHT
Height, depth, width 1740 x 755 x 500 mm
Standard model
Height, depth, width
Domus model 1740 x 800 x 1000 mm - max.-
(with monitor arm)
Weight (formula) 85 kg
Weight (formula 2000) 89 kg
Weight (formula plus) 85.5 kg
Weight (formula 2000) 89.5 kg
Weight (formula Domus) 94 kg
Weight (formula 2000 Domus) 98 kg
Weight (formula plus Domus) 94.5 kg
Weight (formula plus Domus) 98.5 kg
Weight (formula Therapy) 91 kg
Weight (formula Therapy Domus) 100 kg
MAX. APPLICABLE WEIGHT

WEIGHT
I.V. pole hooks 10 Kg
Scale hooks 16 kg
Bag hooks 5 Kg
Instrument table 5 Kg
Concentrate bags holder 13 Kg
Onboard disinfectant container rack 15 Kg
WARNING
The maximum load that can be applied to to the I.V. pole on the single pump
models (formula
(formula, formula
formula plus) is 10 kg, and 16 kg for double pump models.
AMBIENT AND STORAGE CONDITIONS

Operation:
Temperature +10ºC to +40ºC
Relative humidity 0-95% non-condensing
Pressure atmospheric
Storage and transport (without liquids)

Temperature -19ºC to +70ºC
Relative humidity 0-95% non-condensing
Pressure atmospheric
If the period of transport or storage exceeds 15 weeks, refer to the ambient operating
conditions (see above).
In case of battery-equipped formula machines, if the transportation and/or storage

period exceeds one month, it is recommended to contact After-Sales Service
Department for battery removal.
ENG – Ed. 11/09 chap. 2.8 – Technical characteristics - 1 of 22

Bellco
HAEMODIALYSIS WATER REQUIREMENTS

The water used for haemodialysis treatments with formula must meet the requirements
as specified by the National or European Pharmacopoeia, and the American AAMI
standards for haemodialysis systems. In particular, the European Pharmacopoeia and the
American AAMI standards suggest the following values:
European Pharmacopoeia IV Ed. AAMI

WQD,1998
Pollutant Maximum level suggested Maximum level suggested

Calcium 2.0 mg/l (0.10 mEq/l) 2 mg/l (0.1 mEq/l)
Magnesium 2.0 mg/l (0.165 mEq/l) 4 mg/l (0.3 mEq/l)
Sodium 50 mg/l (2.17 mEq/l) 70 mg/l (3.0 mEq/l)
Potassium 2.0 mg/l (0.05 mEq/l) 8 mg/l (0.2 mEq/l)
Fluoride 0.20 mg/l 0.2 mg/l
Chlorine 0.10 mg/l 0.5 mg/l
Chloramine 0.1 mg/l
Chloride 50 mg/l
Nitrate (N) 2.0 mg/l 2.0 mg/l
Sulphate 50 mg/l 100.0 mg/l
Copper, Barium and Zinc 0.10 mg/l (Zinc) 0.1 mg/l each
Aluminium 0.010 mg/l 0.01 mg/l
Arsenic, Lead, Silver 0.005 mg/l each
Cadmium 0.001 mg/l
Chromium 0.014 mg/l
Selenium 0.09 mg/l
Ammonium 0.20 mg/l
Heavy metals 0.10 mg/l (Lead)
Mercury 0.001 mg/l 0.0002 mg/l
Endotoxin 0.25 I.U. /ml
Bacterial level 100 CFU /ml 200 CFU /ml
WARNING
The user is responsible for evaluating the quality of the water supplied so that when
mixed with the concentrates no potentially
potentially dangerous conditions for the patient are
created.
suitable for dialysis treatments in conformity

WATER with
AAMI standards or European Pharmacopoeia.
Temperature (min-max) 5ºC ÷ 32ºC
If the kit for centralized disinfection/cleaning

is installed:
5ºC ÷ 32ºC in dialysis
2 of 22 - chap. 2.8 - Technical characteristics ENG – Ed. 11/09

5ºC ÷ 94ºC in rinsing and
disinfection/cleaning
Input pressure (min-max) 0.9 ÷ 4.0 bar

If the kit for centralized disinfection/cleaning is
installed:
0.9 ÷ 7.5 bar
Flow (minimum inlet) 1000 ml/min
DRAIN at atmospheric pressure to prevent siphon

effects.
Height of drain from ground max 800 mm
Flow 60 l/h max.
Temperature • 60 °C max (during chemical-heat descaling)

• 15° C (in dialysis)
If the kit for centralized disinfection/cleaning is

installed:
• 94 °C max (during chemical-heat descaling)
• 15° C (in dialysis)
ELECTRICAL DATA
Nominal voltage 220V~, 230V~, 240V~ ±10%

110V~, 115V~, 120V~ ±10%
Nominal frequency 50 / 60 Hz (220V~,230V~,240V~)

60 Hz (110V~,115V~,120V~)
Average power absorbed during
dialysis (Tin water = 17.5°C, 1.0 kW
Tdialysate = 37.5°C,
Troom = 20°C,
Dialysate Flow = 800 ml/min)
Max. absorption 8A ( 220V~, 230V~, 240V~ )
16 A ( 110V~, 115V~, 120V~ )
Power cable with Schuko moulded plug

( 220V~, 230V~, 240V~ )
with NEMA 5-20 moulded plug
( 110V~, 115V~, 120V~ )

Bellco
Potential equalization WARNING

For treatment of patients with central
venous catheter, it is necessary to:
• connect the equipment to a potential
equalizer.
• If other devices are are connected to the
patient or located in the area that can be
reached by the patient, it is necessary to
check that all leakage currents of these
devices are within the limits for type CF
applied parts.
parts.
Leakage current to earth < 0.5 mA
Leakage current to patient < 0.1 mA

in conformity with EN 60601-1, CEI EN 60601-
1 and IEC 60601-1.
Type of protection against direct and Class I
indirect contacts
Applied part Type B
Degree of protection against ingress IPX1

of water
Electromagnetic compatibility In conformity with EN 60601-1-2
Power failure The system is able to maintain the current

dialysis parameters in memory for a minimum
of 2 minutes.
An acoustic alarm intervenes which cannot be
silenced. When the power is restored, the
system automatically restarts from the same
values.
Battery operation Lead battery 12V 7.2Ah

BLOOD SECTION
BLOOD FLOW
in double needle and in 20 - 700 ml/min
haemodiafiltration treatments
In single needle (instantaneous) 20 -700 ml/min
During rinseback (initial phase) 20 -250 ml/min
During rinseback (final phase) 20 -180 ml/min
Resolution 10 ml/min
Accuracy (*) ± 10 % for inlet pressure above -250 mmHg
and any outlet pressure in the working range
NOTE
NOTE
An alarm is generated when the blood pump stops.
INFUSION FLOW
in HDF 0.5 – 8 kg/h
in PHF PRE, PHF POST, HDF PRE, HDF 0.5 – 21 kg/h
POST, MID-HDF
in HFR 0.5 – 8 l/h
Resolution 0.1 l/h

Accuracy (*) ± 10 %
(*) Accuracy with the blood lines indicated in the Disposable materials chapter.
VENOUS
VENOUS PRESSURE
Type Pressure transducer (part of protective system)
Reading -400 to +800 mmHg
Resolution 5 mmHg
Accuracy ± 20 mmHg, ± 3% of actual value
Alarms:
- during dialysis (min/max) + 10 mmHg ÷ 450 mmHg
- during priming and -150 mmHg ÷ +300 mmHg
- In rinseback SNsp and SNdp
(min/max)
- in reinfusion DN, HDF, HDF PRE, -150 mmHg / +450 mmHg
HDF POST, MID-HDF, PHF PRE, PHF
POST, HFR
Alarm thresholds (during dialysis and 50 to 150 mmHg, configurable intervals,
reinfusion DN, HDF, HDF PRE, HDF calculated with respect to average value.
POST, MID-HDF, PHF PRE, PHF POST,
HFR )
ARTERIAL PRESSURE
Resolution 5 mmHg
Bellco
Alarms:
- during dialysis (max) 100 ÷ 300 mmHg, configurable
(min) - 350 ÷ -100 mmHg, configurable
- during priming and rinseback - 300 / + 200 mmHg
(min/max)
- in on-line reinfusion (min/max) - 300 / + 700 mmHg
Alarm thresholds (during dialysis) 50 to 250 mmHg, configurable intervals,
calculated with respect to average value.
PRE-
PRE-FILTER ARTERIAL PRESSURE
PRESSURE
Resolution 5 mmHg
Alarms:
- during dialysis (min/max) + 20 mmHg / + 770 mmHg
- during priming and rinseback Not available
(min/max)
Alarm thresholds (during dialysis) Not available
INFUSION PRESSURE (ONLY

(ONLY IN HFR, HDF PRE, HDF POST, MID-
MID-HDF, PHF PRE, PHF
POST)
Resolution 5 mmHg
Alarms:
Therapy model
- in on-line priming and in on-line -200 mmHg ÷ +770 mmHg
rinseback, (HDF PRE, HDF POST,
MID-HDF, PHF PRE, PHF POST)
(min/max)
- in priming with bags, rinseback + 20 mmHg ÷ +770 mmHg
with bags, rinseback with air and
during dialysis (min/max)
other models
- in on-line priming and during +20 mmHg / +770 mmHg
dialysis (min/max)
- in priming with bags and in on- -200 mmHg / +770 mmHg
line rinseback (PHF) (min/max)
HEMOFILTER ULTRAFILTRATION
ULTRAFILTRATION PRESSURE (ONLY
(ONLY IN HFR)
Resolution 5 mmHg

HEMOFILTER TRANSMEMBRANE
TRANSMEMBRANE PRESSURE (ONLY IN HFR)
Hemofilter TMP Pre-filter arterial press.
- Hemofilter UF press.
Alarms:
- during dialysis (min/max) - 100 to +300 mmHg
- during priming and rinseback Not available
(min/max)
Alarm thresholds (during dialysis) Not available
VENOUS SWITCHING PRESSURE

PRESSURE IN SINGLE-
SINGLE-PUMP SINGLE NEEDLE
Setting range:
- min +10 ÷ +200 mmHg
- max +200 ÷ +400 mmHg
Resolution 5 mmHg
VENOUS SWITCHING PRESSURE

PRESSURE IN DOUBLE-
DOUBLE-PUMP SINGLE NEEDLE
Setting range:
- min -100 ÷ +100 mmHg
Resolution 5 mmHg
HEPARIN PUMP (WITH SYRINGE)

SYRINGE)
Syringe capacity 20, 30, 50 cc
Syringe internal diameter 18 - 30 mm (increments of 0.1 mm)

(configurable)
Infusion flow 0.1 -10 ml/h (increments of 0.1 ml/h)
Accuracy ± 2% (if internal diameter is correctly set during
configuration)
Max operating pressure 900 mmHg
AIR/END
AIR/END INFUSION DETECTOR
Type ultrasound
Sensitivity bubbles ≥ 100Ol
BLOOD DETECTOR FOR END

END PRIMING
Type infrared rays
BLOOD LEAK DETECTOR ON THE BLOOD

BLOOD FILTER
Type optical - green
DRIP CHAMBER LEVEL GAUGE

GAUGE
Type infrared rays

Bellco
DIALYSIS FLUID SECTION
DIALYSIS FLUID
Temperature:
Type PT100 (part of protective system)
Setting 35ºC to 39ºC (increments of 0.5°C)
Reading 25ºC to 50ºC
Resolution 0.1°C
Accuracy ± 0.5°C
Alarms (min/max) 34 / 40ºC
Powder bicarbonate cartridge

filling pressure (only with kit for
filling the powder bicarbonate
cartridge under positive pressure)
Max. 2.5 bar
Concentrate inlet pressure

pressure (only
with installed kit for concentrate
centralised distribution)
Max. 3 bar
UF Pressure
Reading - 625 ÷ +625 mmHg
Resolution 5 mmHg
Alarms: (configurable) min. -200 ÷ -400 mmHg (increments of 10 mmHg)
max +200 ÷ +400 mmHg (increments of 10 mmHg)
Alarm thresholds (during dialysis) 30 to 300 mmHg, configurable intervals, calculated

with respect to average value.
TMP :
In double needle, HDF, HFR, PHF VP – (Pdo + 30 mmHg)
PRE, PHF POST, MID-
MID-HDF, HDF
PRE, HDF POST
In single needle Min switch P. + max switch P. – (Pdo +30 mmHg)
2
where:
VP = venous pressure
Pdo = dialysate pressure measured at dialyser
outlet
Switch P. = switching pressure in single needle
30 mmHg = load loss of the dialysate compartment.

Reading within the configured alarm limits
Resolution 5 mmHg
Alarms: (configurable) min -300 ÷ 0 mmHg (increments of 10 mmHg)
max +200 ÷ +400 mmHg (increments of 10 mmHg)
Alarm thresholds (during dialysis) from 30 to 300 mmHg, settable intervals,
calculated against the average value.
AVERAGE TMP:
In on-
on-line haemodiafiltration
with automatic control of the
infusion flow enabled
in HDF PRE, HDF POST, MID-
MID-HDF Pfilt + Pv – (Pdo + 30 mmHg)
2
in PHF PRE (Pfilt – 20 mmHg)+ Pv – (Pdo + 30 mmHg)
2
in PHF POST Pfilt + (Pv + 20 mmHg) – (Pdo + 30 mmHg)
2
where:
Pv = venous pressure
Pdo = dialysate pressure at the dialyser outlet
Pfilt = prefilter arterial pressure
30 mmHg = dialysate compartment pressure drop
20 mmHg = blood filter pressure drop
Resolution 5 mmHg
MAXIMUM TMP:
In double needle
needle,, HDF, PHF Pfilt – Pdo
POST, HDF PRE, HDF POST
in HFR, PHF PRE (Pfilt – 20 mmHg) – Pdo
in MID-
MID-HDF Pfilt + Pv – (Pdo + 30 mmHg)
2
where:
Pfilt = prefilter arterial pressure
Pdo = dialysate pressure at the dialyser outlet
20 mmHg = blood filter pressure drop
Resolution 5 mmHg
Signalling (max. only) +600 mmHg
FLOW RATE:
Setting 300, 500, 800 ml/min
Reading 200 to 1000 ml/min
Resolution 1 ml/min
Accuracy ± 10 %
CONDUCTIVITY
Final solution
Bellco
Type Conductivity sensor (part of protective system)

Setting 12.1 ÷ 15.7 mS/cm (increments of 0.1 mS/cm
Reading 11.5 ÷ 16.5 mS/cm
Resolution 0.1 mS/cm
Accuracy: 0.1 mS/cm
Alarm limits on value set ± 5%
Basic section during bicarbonate dialysis

Type Conductivity sensor
Setting (3 mS/cm) 2.4 ÷ 3.6 mS/cm (increments of 0.1 mS/cm)
Setting (5 mS/cm) 4.0 ÷ 6.0 mS/cm (increments of 0.1 mS/cm)
Reading 2 ÷ 8 mS/cm
Accuracy: 0.1 mS/cm
Alarm limits on value set ± 5%
ULTRAFILTRATION
Ultrafiltration control continuous flow single-pass differential flowmeter
Accuracy ± 1 g/min, ± 1% of total ultrafiltrate
SCALE (only
(only in HDF with bags):
Accuracy ± 0.3% of total infused fluid
WEIGHT LOSS
Programmable weight loss 0.1 to 4.0 Kg/h
Accuracy:
- In double needle, single needle, ± 1 g/min ± 1% weight loss
HFR, PHF PRE, PHF POST, HDF PRE,
HDF POST, MID-HDF
- in HDF with bags ± 1 g/min ± 1% weight loss ± 1.3% of the total
infused fluid
BLOOD LEAK DETECTOR

Type infrared ray optical (part of protective system)
Sensitivity 0.5 ml/min blood, hematocrit 25 %

DISINFECTION/CLEANING
CHEMICAL DISINFECTION/CLEANING
DISINFECTION/CLEANING (NOT PRESENT
PRESENT ON THE THERAPY MODEL):
MODEL):
Chemical agents - Hypochlorite >7%
- Amuchina
- Peresal
- Acetic Acid (10%) (descaling agent)
- Tiutol
- Instrunet
- Puristeril
- Oxagal
- Renaxid
- User Agent
Dilution ratio 1:30 Hypochlorite, Peresal, Tiutol, Puristeril , Renaxid
1:6 Amuchina, Acetic Acid, Instrunet, Oxagal
1:6 - 1:30 (settable during configuration), User Agent
Contact time settable during configuration
Hypochlorite, Peresal,Tiutol, Puristeril , Renaxid = 7 or
11 min.
Amuchina, Acetic Acid, Instrunet, Oxagal = 6 or 10 min.
Consumption (cc) ∼ 90 (dilution ratio 1:30, contact time 7 min)
∼ 120 (dilution ratio 1:30, contact time 11 min)

Water temperature in circuit 38°C ∼
Dwell time None
Rinsing time settable during configuration

- 25 or 30 minutes if contact time is 6/7 min.
- 30 min. if contact time is 10/11 min.
Total duration 32 or 37 or 41 min. for Hypochlorite, Peresal,Tiutol,

Puristeril, Renaxid.
31 or 36 or 40 min. for Amuchina, Acetic Acid,

Instrunet, Oxagal

Bellco
CHEMICAL-
CHEMICAL-FULL DISINFECTION/CLEANING
Chemical agents Therapy Model:
- Amuchina
- Oxagal
- User Agent
Other Models:
- Hypochlorite >7%
- Amuchina
- Peresal
- Tiutol
- Dialox
- Instrunet
- Oxagal
- Renaxid
- User Agent
Dilution ratio 1:30 Hypochlorite, Peresal, Tiutol, Renaxid
1:6 Amuchina, Instrunet, Oxagal, Dialox
Consumption (cc) ∼ 45 (dilution ratio 1:30)
∼ 166 (dilution ratio 1:6)
∼ 250 (dwelling - dilution ratio 1:6)
Intake + contact time Therapy Model:
(minutes) 11 (14 with OXAGAL + dwelling)
Other models:
8 (12 with DIALOX/OXAGAL + dwelling)
Dwell time max 80 hours only with DIALOX and OXAGAL
Rinsing time (minutes) settable during configuration

Therapy Model:
- 23 ÷ 33 (AMUCHINA)
- 42 ÷ 52 (OXAGAL)
Other Models:
- 23 or 33
Total duration (minutes) Therapy Model:

- 34 ÷ 44 (AMUCHINA)
- 53 ÷ 63 (OXAGAL)
- 56 ÷ 66 (OXAGAL + dwelling)
Other Models:
31 or 41 (35 or 45 with DIALOX /OXAGAL+ dwell)

COLD DESCALING (PRESENT
(PRESENT ONLY ON THE THERAPY
THERAPY MODEL):
Descaling agents Acetic Acid (10%) (descaling agent)
User descaling agent
Dilution ratio 1:6 Acetic acid 10%
Consumption (cc) ∼ 166
Intake + contact time 11 (ACETIC A.)
(minutes)
Rinsing time (minutes) settable during configuration
28 ÷ 38 min (ACETIC A.)
Dwell time none

Total duration (minutes) 39 ÷ 49 (ACETIC A.)
HOT DESCALING:
Descaling agents Citric acid 12% , descaling agent
User descaling agent
Dilution ratio 1:6 Citric acid 12%
Consumption (cc) ∼ 166
Average temperature in 50°C ∼
circuit
Contact time (minutes) Therapy Model:

13
Other Models:
13
Heating time + intake Therapy Model:

(minutes) Phase not foreseen
Other Models:_
settable during configuration 15 or 20 min.
Rinsing time (minutes) Therapy Model:

23 ÷ 33 min
Other Models:
23
Dwell time None

36 ÷ 46
Other Models:
51 or 56

Bellco
HEAT DISINFECTION:
Chemical agents none
Average temperature in 85°C ∼
circuit
Pre-heating time (minutes) Therapy Model:
8
Other Models:
8
Contact time (minutes) 15 or 20 (settable during configuration)

Cooling time (minutes) Therapy Model:
16
Other Models:
15

31 or 36
Other Models:
30 or 35
RINSING automatic when turning on and after each dialysis

Water temperature 37.5°C ∼
Flow 750 ml/min
Life cycle 3 min.

NATRIUM TECHNICAL CHARACTERISTICS
Temperature (blood and ultrafiltrate):
Operating principle Thermal resistance and thermal conduction
Reading 25 – 50 °C
Resolution 0.1°C
Accuracy ± 0.5°C
Conductivity (blood and ultrafilt

ultrafiltrate):
rate):
Operating principle Electromagnetic induction
Reading 0 – 25 mS/cm
Accuracy ± 0.1 mS/cm
Interfacing with disposable The reader interfaces with the disposable

conductivity probe inserted in the blood line.
Patient safety The applied part is galvanically isolated from all live
parts of the equipment.
The conductivity and temperature measurements do
not affect the behaviour of the equipment, except in
the Aequilibrium application.
HEMOX TECHNICAL CHARACTERISTICS
Operating principle Optical absorbance at three different wavelengths

Hematocrit
Reading 15 ÷ 50 %
Resolution 0.1 %
Accuracy ±5%
Oxygen saturation
Reading 40 ÷ 100%
Resolution 0.1 %
Accuracy ±5%
Percent volume loss

(derived quantity)
quantity)
Resolution 0.1 %
Accuracy ± 2.5 %
Dimensions 51 x 72 x 45 mm
Interfacing with disposable The reader interfaces with the disposable cuvette
built in the blood line.
Bellco
Patient safety The device is not an applied part.

The hematocrit and oxygen saturation
measurements do not affect unit performance.
PULSAR TECHNICAL CHARACTERISTICS
Operating principle Reading of the pulses emitted by commercial

electrocardiographic bands.
Heart rate
Operating range 0 – 250 bpm
Resolution 1 bpm
Accuracy ± 1 bpm
Patient safety The chest band is battery-powered and completely

isolated from the equipment.
The receiver does not constitute a part applied to
the patient.
The heart rate measurements do not affect the
operation of the equipment.
The measurement can directly be checked on the
wrist clock supplied with the equipment.
LECTOR TECHNICAL CHARACTERISTICS
Operating principle Transponder system
Reading Ultrafilter recognition code (10 characters)
Wavelength 125 KHz
Patient safety The system guarantees, if properly configured,

recognition of depletion of the ultrafilter eliminating
the risk of errors by the operators.

SPHYGMOMANOMETER TECHNICAL CHARACTERISTICS
Operating principle Oscillometric method
Pressure measurement Systolic: 40 - 260 mmHg
Diastolic: 20 - 200 mmHg
Heart rate 40 - 200 beats per minute
Accuracy (pressure measurement) ± 3 mmHg between 0 and 300 mmHg in

operating conditions between 0° and 50°C.
Accuracy (heart rate) ±2% or ±3 beats per minute whichever is

greater
Inflation automatic
Cuff: suitable for adult patients only

Plus code 4941270 Arm circumference 310 - 400 mm
**This cuff is supplied with the

sphygmomanometer
Small code 4941275 Arm circumference 230 - 330 mm
Large code 4941280 Arm circumference 380 - 500 mm
Patient safety The operating software assures that:

- max. cuff inflation time is limited to 50
seconds;
- duration of blood pressure reading is
limited to 130 seconds.
Additional redundant safety circuitry
oversees normal operation and will override
to abort a reading if:
- cuff pressure exceeds 300 mmHg at any
time;
- the cuff has been inflated for 180
seconds.
Defibrillation-proof type BF applied part
(ref. EN 60601-1)

Bellco
Kt/V TECHNICAL CHARACTERISTICS
Operating principle Conductometric Method
Dialysance Measurement Max: 700 ml/min.
Resolution 1 ml/min
Accuracy + 10%
Alarms Refer to the chapter on alarms

MATERIALS
BODY
BAYDUR and polystyrene, self extinguishing.
MATERIALS IN CONTACT WITH DIALYSIS FLUID

Metallic materials:
Stainless steel AISI 316 (UNI X5CrNiMo1712)
Titanium grade 5 (6AL4V ASTM B348)
Stainless steel UHB 904L/R 840
Stainless steel AISI 302
Stainless steel AISI 316 L(UNI X2CrNiMo1712)
Ceramic materials:
Pure alumina 99.7% Al2O3 (ceramic)
Plastic materials:
Polypropylene PP (Moplen)
Polyoxymethylene POM (Delrin)
Vinylidene polyfluoride PVDF (Kynar)
Polycarbonate PC (Makrolon)
Polyetherimide PEI (Ultem)
Polytetrafluoroethylene PTFE (virgin Teflon)
Polysulfone PSU (Udel)
Polyarylether PEEK (Victrex)
Polyphenylsulfide PPS (Ryton R4)
Glass:
Borosilicated glass 3.3 DIN-ISO 3585 (Duran)
Elastomeric materials:
Silicone VMQ-FG
Silicone VMQ-FG + fabric
Fluorosilicone MVSQ
Ethylene-propylene-diene EPDM
Silicone VMQ-FG (silopren LSR)
Silicone VMQ-FG (elastosil LR)
Medical silicone, Si (raumed)
Silicone, red, SI
Tubes:
Polyvinylchloride PVC+fabric (Raufilam)
Silicone VMQ-FG
Silicone VMQ-FG + fabric
Medical silicone, Si (raumed)
Lubricants:
Medical silicone spray
Ethanol, colourless
Threadlockers:
Anaerobic adhesive, monocomponent (Sichel 100 M SP)

Bellco
REQUIREMENTS OF THE STANDARD IEC 60601-

60601-1-2:2001
The FORMULA dialysis machine is suitable for use in the specified electromagnetic
environment. The purchaser or user of FORMULA should assure that it is used in an
electromagnetic environment as described below:
Emissions test Compliance Electromagnetic Environment
Radiated and conducted RF Class B The device FORMULA is suitable for use in
emissions domestic establishments and in
establishments directly connected to the
CISPR 11 low voltage power supplies network which
supplies buildings used for domestic
purposes.
Group 1 The device FORMULA uses RF energy only
for its internal function. Therefore, the RF
emission is very low and not likely to cause
interference in nearby electronic equipment.
Harmonic emissions Complies The device FORMULA is suitable for use in
establishments directly connected to a
EN 61000-3-2 public low voltage power supply network.
Voltage fluctuations/ Flicker Complies The device FORMULA is suitable for use in
emissions establishments directly connected to a
public low voltage power supply network.
EN 61000-3-3
The FORMULA dialysis machine is suitable for use in the specified electromagnetic
environment. The purchaser or user of FORMULA should assure that it is used in an
electromagnetic environment as described below:
Immunity test Test level Compliance Electromagnetic Environment
magnetic field EN level
60601-
60601-1-2
Electrostatic ±6 kV contact EN 60601-1- Residential
discharge (ESD) ±8 kV air 2 Test level
EN 61000-4-2
Radiated RF Non-life supporting Residential
EN 61000-4-3 equipment
3 V/m
80 MHz to 2.5 GHz EN 60601-1-
2 Test level
Non-life supporting
equipment
Conducted RF 3V
EN 61000-4-6 150 kHz to 80 MHz
EN 60601-1-
2 Test level
Electrical fast ±2 kV for power EN 60601-1- Residential
transient/burst supply lines 2 Test level
EN 61000-4-4
±1 kV for
input/output
lines>3m
Surge ±1 kV differential EN 60601-1- Residential
EN 61000-4-5 mode 2 Test level
±2 kV common
mode
Voltage dips, short 0% Un for 0.5 cycles EN 60601-1- Residential
interruptions and 40% Un for 5 cycles 2 Test level
voltage variations 70% Un for 25
on power supply cycles
input lines 0% Un per 5 s
EN 61000-4-11
Power frequency 3 A/m EN 60601-1- Residential
(50/60 Hz) 2 Test level
EN 61000-4-8
Recommended Separation Distance for non-

non-LIFE SUPPORTING EQUIPMENT
RF Source Typical Rated Power Distance

(W) (m)
Microcellular phone CT1, CT2, CT3 0,01 0,4
DECT cellular phone, wireless
information technology equipment 0,25 2
(modem, LAN)
Cellular phone, hand-held (USA) 0,6 3
Cellular phone, hand-held (e.g. GSM 2 6
and NMT, Europe; DECS 1800) 8 11
Walkie-talkie (rescue, police, fire,
5 9
maintenance)
Cellular phone 16 16
Mobile radio (rescue, police, fire) 100 40
For transmitters using frequencies below 800 MHz, the DISTANCE can be estimated
using Equation A:
d =4 P
For transmitters using frequencies between 800 MHz and 2,5 GHz, the DISTANCE can
be estimated using Equation B:
d = 2,3 P
where P is the rated power of the transmitter in Watt (W) according to the transmitter
manufacturer.

3.1 START-UP, TEST, RINSE
PRELIMINARY CONDITIONS
• The machine must be connected to a haemodialysis water source and the tap must be open.
• The power cable must be connected to the mains socket.
• The water drain line must be positioned in the drain.
• The machine must be off.
• The patient must be disconnected from the blood lines and the dialyser.
• The consumption materials must be available.
NOTE
Ensure that the national regulations concerning drain-traps and the point-to-point
distance to the drain are respected.
ELECTRICAL AND HYDRAULIC CONNECTION

1. Position the machine in a suitable place and block the wheels.
2. Connect the water inlet tube to the water supply of the dialysis room.
3. Insert the special tube in the drain. The drain must be at atmospheric pressure to prevent
siphon effects (max. height: 800 mm). Check that the tubes are not squashed or occluded.
4. Connect the power cable directly to the mains outlet.
5. Open the haemodialysis water delivery tap.
6. Switch on the main switch on the rear panel of the machine.
7. Wait until the LED next to the key on the front panel comes on (orange).
8. If required, it is possible to enter machine configuration following the instructions given in the
dedicated chapter of this manual.
POWER ON
Turn on the machine using the main switch located at the rear.
Wait until the LED next to the key on the front panel comes on (orange).
Press the key . The LED turns green.
WARNING
Check that the alarm indicator turns on and the acoustic warning indicator emits a signal.
ENG – Ed. 06/09 chap. 3.1 – Start-up, Test, Rinse - 1 of 4

After a few seconds the screen comes
on, and the formula® logo appears with
the software release.
In this phase, the equipment performs
the initial autodiagnostic tests.
Upon conclusion of the initial tests, a rinsing phase which lasts a few minutes (not modifiable by
the operator) starts. Simultaneously the autodiagnostic tests begin on both the dialysis fluid side
and the blood side.
When the blood tests are successfully completed, WAIT appears on the blood status bar of the
select
priming
screen. The function key appears. At this point it is possible to start installing the
blood lines.
During the tests the following functions keys are available:
switch off To switch off the machine.
select
priming To prime the blood lines.
special
treatment To change the haemodiafiltration treatment set in configuration (refer to the
chapter " Preparation of Treatment ").
filter To replace the Forclean and/or Multipure filters (refer to Chapter “Management
management of ultrafilters and Multipure filter).
disinfection/ To program disinfection, descaling, centralized disinfection/cleaning,

cleaning programmed disinfection/cleaning.
To access the sensor menu (see the Chapter “FORMULA PLUS SENSORS”).
sensors
A positive outcome of the dialysate tests is indicated by the message SYSTEM READY and the word
RINSING on the top left side. The dialysis system is ready to be programmed.
select
dialysis
The function key appears.
2 of 4 – chap. 3.1 – Start-up, Test, Rinse ENG - Ed. 06/09
The machine reverts to a low-consumption rinsing condition.
The rinsing time is indicated by the circular tool on the left of the screen (mm: sec).
During the above described phases the following icons may be present on the screen:
“Disinfection/cleaning performed icon”: for meaning and management, refer

to the “Disinfection/cleaning” chapter.
or
indicates that a disinfection/cleaning has been programmed.

To check the program set, and if necessary to modify it,
disinfection/ weekly
cleaning disinf./clean.
indicates that a disinfection/cleaning has not been programmed.
Indicate that the internal battery is installed.

Red icon = the battery test did not have a positive outcome and therefore the
machine will not be able to operate if there is a power fail.
Green icon = the battery is operating
AUTOMATIC TURNING ON
formula® has the possibility to automatically turn on, at the time set by the operator, to run the
tests and enter the SYSTEM READY state.
This performance has to be set during configuration, i.e. the parameters POWER ON and START
TIME are to be set (in the weekly setting page).
Automatic turning on can also be set from the keyboard of the display.
disinfection/ weekly
•
• Select the desired day.
• In the next menu, set POWER ON in the field TYPE, set the desired time for automatic turning
on in the field START TIME.
ok
• to confirm.
Always check that the main switch located at the rear of the machine is in the ON position (I).
ENG – Ed. 06/09 chap. 3.1 – Start-up, Test, Rinse - 3 of 4

4 of 4 – chap. 3.1 – Start-up, Test, Rinse ENG - Ed. 06/09
3.2 DIALYSIS FLUID PREPARATION
DIALYSATE PREPARATION WITH LIQUID/ POWDER BICARBONATE

or ACETATE
WARNING
It is recommended to use concentrate solutions suitable to the type and
duration of the treatment in terms of composition and quantity. Consequently,
check the technical specifications of the concentrate solutions in the labels on
the containers and/or
and/or bags (composition, quantity/volumes, dilution ratio, and
so on.).
The most suitable concentrate solution must be determined by the physician
responsible for the treatment.
Check that the dialysis system is configured for the type of concentrate used (3
(3
or 5 mS/cm). Use of wrong concentrates represents a risk for the patient.
Do not use concentrate solutions whose container was previously opened or
looks damaged.
The sodium bicarbonate powder cartridge makes it possible to prepare the dialysis
fluid for dialysis treatment.
All formula® models are equipped for the use of a powder bicarbonate cartridge,
according to two alternative options: cartridge with luer lock connection (Bidry), or
perforated cartridge.
WARNING
The powder bicarbonate cartridge may only be used with machines set for
partial conductivity to 3mS/cm.
Use the powder bicarbonate cartridge only after having carefully read the
instructions for use provided with the cartridge.
The powder bicarbonate cartridge must be used with acid concentrate suitable
for use with pure sodium bicarbonate solution and appropriate for 1:35 or
1:45 dilution ratios.
Check the expiry date and integrity of the powder bicarbonate cartridge and its
protective
protective wrapping.
Use the powder bicarbonate cartridge only once and for a single treatment. Do
not keep it and use for another treatment.
Do not administer dialysis solutions obtained parenterally.
Make sure that the piercing connectors are not unplugged during rinse and
disinfection/cleaning modes; if during such phases the piercing connectors are
not plugged correctly on the mobile bypass, it is possible to have alarms, a not
circuit.
corrected disinfection/cleaning or an insufficient rinse of the hydraulic circu it.
ENG – Ed. 06/09 chap. 3.2 – Dialysis Fluid Preparation - 1 of 8

The upper piercing connector can contain a permanent magnet, therefore it
must be handled with caution by individuals with pacemakers.
NOTE
• Check that the quantity of concentrate used is sufficient to complete the
therapy, so as to avoid exhaustion of the containers/bags and their
consequent replacement during treatment.
• If containers are used, for proper mixing, check that the concentrate
aspiration lines are properly inserted in the containers of concentrate saline
saline
solutions.
• Check that the powder bicarbonate cartridge connectors
connectors areare properly
positioned on the machine.
• Check that the set conductivity allows reaching the correct composition of
the dialysis fluid obtained with the concentrates used.
• Frequently check the level of contaminants in the dialysis liquid.
• If a certain type of concentrate solution is used for the first time, it is
suggested to draw a sample of dialysis fluid before the treatment and to
check its correct composition.
select
dialysis
.
The following window will appear.
bicarbonate + bicarbonate+
conc A STD lympha
or to set dialysis with liquid bicarbonate or standard
acid concentrate or Lympha (acetate-free solution).
acetate
to set an acetate dialysis.
2 of 8 – chap. 3.2 – Dialysis Fluid Preparation ENG - Ed. 06/09
bidry + bidry +
conc A STD lympha
or to set dialysis with powder bicarbonate or standard
acid concentrate or Lympha (acetate-free solution).
Select the desired dialysis fluid with the relevant function key.
Should two different dialysing fluids be associated to the same function key, press the
bicarbonate+
conc A STD
key once (e.g. ) to select a dialysis fluid type, press twice to select the
bicarbonate+
lympha
alternative dialysis fluid type, (i.e. ).
ok
to confirm.
NOTE
select
dialysis
allows setting the treatment both in the blood and the dialysate
compartments.
In all models of the formula device, with the exception of the formula
Therapy, priming of the extracorporeal circuit can be performed with the use
of bags of physiological solution before/during/after the preparation of the
dialysate.
In the formula Therapy model, this is true with the exception
exception of HDF PRE, HDF
POST, MID-
MID-HDF, PHF PRE, PHF POST treatments, where priming can be
performed only after preparing the dialysate.
PARAMETER SETTING
Set the dialysis fluid parameters as described in the chapter Operator Interface –
Dialysing Solution Section; the settable parameters are the following:
• Bicarbonate Conductivity
• Total Conductivity
• Temperature
• Dialysis Fluid Flow

CONCENTRATE SOLUTIONS CONNECTION
If liquid concentrates in containers are used, open the containers, insert the cannulas
and connect the concentrate connectors:
Bicarbonate dialysis: connect the blue connector to the bicarbonate concentrate

container, connect the white/red connector to the acid concentrate container.
Acetate dialysis: Connect the white/red connector to the acetate concentrate.
If liquid concentrates in bags are used, attach the concentrate connectors to the proper
connector and refer to the instruction sheets of the bags.
Bicarbonate dialysis with containers Acetate dialysis with containers
BIC AC
If the powder bicarbonate cartridge is used, proceed with its connection.

BIDRY CARTRIDGE INSTALLATION
• Mount the cartridge on its support hooks with the blue connector at the top right.
• Connect the transparent connector of the cartridge to the Bidry connector of the
machine.
• Insert the other end of the cartridge (blue connector) in the Luer connector on the
block.
• Check that the clamps on the cartridge inlet and outlet lines are open.
• Connect the white/red connector to the acid concentrate.

PERFORATED CARTRIDGE INSTALLATION
• Completely rotate the locking bracket so as to release the upper piercing connector
(Fig.1).
• Disconnect the upper piercing connector from the mobile bypass.
• Lift the mobile bypass (Fig.2).
• Place the lower cartridge end into the lower piercing connector.
• Secure the upper piercing connector on the upper cartridge end and insert it into
upper clip support (Fig.3).
• Connect the white/red connector to the acid concentrate.
Fig.1
Fig.3
Fig.2

CHANGING THE CONCENTRATE TYPE
To change the concentrate type during the treatment, proceed as follows:
modify
treatment
.
Select the treatment type (acetate, bicarbonate + standard acid concentrate,

bicarbonate + Lympha, bidry + standard acid concentrate, bidry + Lympha ).
ok
.
If the dialysate type has been changed, the following dialogue window will appear: Ex:
Dialysate: BIDRY+LYMPHA
Do you confirm?
yes
to confirm.
return
to return to the previous menu.
WARNING
Connect the concentrate connectors according to the selected treatment (refer
to the previous paragraphs).
The CONCENTRATE CONNECTORS alarm indicates that one of the connectors
has been wrongly
wrongly positioned.
The CONCENTRATE ERROR alarm indicates that concentrates different from
those selected are being used or air has been aspirated from one of the
connectors.
NOTE
If the Profiler application is active, the type of concentrate solution cannot be
changed without first disabling the Profiler.
CONNECTION TO THE DIALYSER
• When the led indicator of the key lights up and the BYPASS warning appears,
disconnect the blue Hansen connector from the machine and connect it to the
dialysis fluid inlet connector of the dialyser.
• Disconnect the red Hansen connector from the machine and connect it to the
dialysate outlet connector of the dialyser.
• again to fill the dialyser.

• When the message BIC. appears in the top left side. (/BIDRY/ACETATE) + STD A.
CONC. (/LYMPHA) – STAND-BY, the dialysate is ready.
• In this phase , provided that blood has not yet been detected, the function Dialyser
Rinse on may be activated, which allows performing ultrafiltration to remove any
substances, e.g. glycerine, from the dialyser.
dialyser dialyser
rinse on rinse off
• . The function key turns into .
Ultrafiltration carried out corresponds to the value set at configuration (default
value = 0,5 kg/h).
• This function is temporarily interrupted any time an alarm triggers but restarts as
soon as the alarm is cleared. It is automatically disabled when blood has been
detected.
NOTE
Ultrafiltration
Ultrafiltration carried out during the Dialyser Rinse function does
does not affect the
programmed ultrafiltration during dialysis.
• The dialysis fluid flow sets to the programmed value only when blood is detected.
During dialysis fluid preparation, the flow is automatically set to a minimum value.
SETTING THE ULTRAFILTRATION PROGRAM
WARNING
The dialysis parameters must be adapted to the patient, therefore, the
ultrafiltration program must be carried out under supervision of the physician
prescribing the treatment.
Set the ultrafiltration parameters as described in the chapter Operator Interface –

Dialysing Solution Section; the settable parameters are the following:
• Weight Loss
• Treatment time
• Hourly Ultrafiltration
• Ultrafiltration/transmembrane pressure thresholds
Hourly UF may be set as single parameter or is obtained from the weight loss –
treatment time ratio.
Refer to the Operator Interface chapter for the individual parameter settings.
When the settings have been made, the relevant tool displays the UF/h value.
uf
on
.
uf
set
The function appears to indicate that the program has been enabled.
The program will start just a few seconds after detecting blood in the arterial line.
In case heparin should be administered, follow the instructions in Chapter “Heparin”.

3.3 PREPARATION OF THE TREATMENT
TREATMENT SELECTION
special
treatment
In the rinsing phase, the function is enabled, which allows to modify the
configured haemodiafiltration (HDF/HDF OnLine, HFR, PHF) treatment already set.
On formula2000 machines not configured for haemodiafiltration treatments, the choice

of the blood treatments is the following:
double
needle
s. needle
(s. pump)
s. needle
(d. pump)
only if the presence of the second pump has been configured.
If, however, the machine is configured to perform a haemodiafiltration treatment, the

combination of the functions keys allows selecting from 4 or more treatment modes:
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
hdf
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
phf pre phf post
or
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
hfr hfr
Selecta Selecta Plus
or
ENG – Ed. 06/09 chap. 3.3 – Preparation of treatment - 1 of 6

or, only for the Therapy model
double
needle
s. needle s. needle
(s. pump) (d. pump)
or
mid-hdf hdf pre hdf post
or or
Select the desired treatment with the relevant function key.
Should two treatments be associated to the same function key, press the key once (e.g.
s. needle
(s. pump)
) to select the treatment, press twice or more to select the alternative
s. needle
(d. pump)
treatment or treatments (i.e. ).
return
to cancel and return to the previous menu, or
ok
to confirm selection.
NOTE
cancel
priming
Press to cancel priming and return to the rinsing phase.
NOTE
In case of
of an error in the selection of a haemodiafiltration treatment, you can –
cancel
priming
only in priming – change this selection using or, if priming can no
longer be cancelled using the following procedure:
modify
treatment
double
needle
ok
modify
treatment
2 of 6 - chap. 3.3 – Preparation of treatment ENG - Ed. 06/09

mid-hdf hdf pre hdf post phf pre phf post
or or or or
hfr hfr
Selecta Selecta Plus
or
ok
totalized
The moment the new treatment is confirmed, the total ized priming volume is
set to zero.
NOTE
see/mod.
parameters
To modify the stop priming or end priming volumes, press and
blood stop priming
priming volume
and respectively select
select or .
Refer to chapter on disposable devices for the list of disposable devices to use for the
selected treatment.
BLOOD LINE INSTALLATION
WARNING
• The use of specific blood lines is recommended (see (see the chapter concerning
disposable devices). The alarms and performance can be influenced by the
use of inappropriate blood lines, for example, the air detection alarm.
• Use only lines with blood catcher for the connection to the pressure
transducers.
• During
During dialysis, if blood or any other fluid comes into contact with the blood
catcher, and fluid passage through the membrane is detected or suspected,
proceed as follows:
- replace the line as indicated in the instructions given by the manufacturer;
- Contact
Contact the authorized After-
After-Sales Service to verify and sanitize the internal
measurement set;
- DO NOT USE the machine for further treatments before it has been checked
and disinfected.
• To avoid potentially dangerous conditions, carefully read the instructions
instructions on
the packaging of the blood lines.
• Check that the line packaging, which ensures their sterility, is not damaged
and that the sterilization validity date has not expired.
• Ensure that installation is carried out properly using aseptic techniques.
General information on several operating procedures is given here below.

For the assembly sequence, refer to the chapter on the selected treatment.
select
priming
After setting up the blood lines, to start priming.
For the priming sequence, refer to the chapter on the selected treatment.
treatment
SEMIAUTOMATIC LOADING OF THE PUMP SEGMENT
Semiautomatic loading of the pump segment makes it easier for the operator to mount
the pump segment inside the pump body.
Semiautomatic loading of the pump segment must be activated separately for each
pump. It can be carried out in Rinsing, Priming and Rinseback modes (when the
message EMPTYING appears).
Manual operation of the heparin pump plunger can not be done simultaneously with
the pump segment loading. Thus pressing the keys and for positioning the
heparin syringe as well as opening the pump covers, the following functions can be
activated in a mutually exclusive way:
• Automatic operation of the arterial pump: open the cover of the arterial pump and
press .
• Automatic operation of the venous pump (or infusion pump): open the cover of the
venous pump (or infusion) and press .

• Automatic operation of the heparin pump plunger: close both pump covers and
press or .
To carry out the semiautomatic loading of the pump segment:
• Open the cover of the pump where the segment is to be mounted.

• Position the pump segment in the lower guide-set if it is the arterial pump, in the
left guide-set if it is the venous or infusion pump.
• Press down the key for the arterial pump, instead press for the venous or
infusion pump and rotate the pump until completing insertion of the segment.
• If the pump stops rotating (it cannot perform more than one revolution each time),
release the key. Then press it again.
NOTE
To avoid crushing injuries be careful not to inadvertently insert your fingers
inside the pump while it is rotating.

AUTOMATIC OPENING OF THE CLAMP
To facilitate the installation of the blood lines, an automatic clamp opening procedure
may be used (of both clamps in the case of a machine equipped with a double clamp).
To open the clamp,

• open the cover of the arterial pump,
• set the blood pump flow to the max value with the flow regulator.
To close the clamp, close the cover of the arterial pump and/or lower the blood pump
flow rate.
The automatic clamp opening procedure may be activated in all operation phases
except during initial blood tests and dialysis.
INSTALLING THE DIALYSER
WARNING
The use of the dialyzers described in the chapter on single-
single-use devices is
recommended. If different dialysers are used, check that the specifications and
instructions for use of the dialysers are compatible with use on formula
.
The dialyser inlet/outlet connectors must be in conformity with ISO 8637 and
EN 1283 standards.
Install the dialyser in its support and carefully read the instructions on the packaging
related to use of the filter.
MOUNTING THE PRIMING SOLUTION BAGS
Hang the bags containing the physiological solution for priming from the hooks of the
stand (max. 10 kg).
Do not hang the bags of priming solution from the scale hooks: use only the
relevant support on the I.V. pole.

3.4 HEPARIN
WARNING
Heparin may only be administered under supervision of a physician.
SYRINGE INSTALLATION
1. Prepare a syringe with the required quantity of heparin.
2. Push the syringe plunger to the bottom using the key next to the heparin
pump.
3. Mount the syringe in the support.
4. Fix the syringe turning the retaining screw (located in the lower part) clockwise.
5. Connect the syringe to the arterial line.
NOTE
Do not unwind the tubing segment of the heparin infusion line.
ENG – Ed. 06/09 chap. 3.4 - Heparin - 1 of 6

SYRINGE CAPACITY SETTING/MODIFICATION
SETTING/MODIFICATION
This may be carried out both during priming and dialysis:
see/mod. heparin syringe

parameters capacity
The graphic tool indicates the syringe capacity

value currently set (on the right).
Use the or key to set the new value and to confirm.
HEPARIN INFUSION SETTING/MODIFICATION

It may be carried out both during priming and dialysis:
see/mod. heparin heparin

parameters infusion
The tool indicates the heparin infusion value

currently set (on the left).
HEPARIN PRE-
PRE-STOP
STOP SETTING/MODIFICATION
Provision has been made in the machine configuration for a heparin pre-stop value,
that is, how long (min) before the end of dialysis the heparin pump interrupts
infusion.
This value may be modified during both priming and dialysis:
see/mod. heparin heparin

parameters pre-stop
The tool indicates the pre-stop value currently set

(on the left). The max. settable value is 120
minutes.
2 of 6 – chap. 3.4 - Heparin ENG – Ed. 06/09

DISPLAY OF TOTAL HEPARIN
HEPARIN INFUSED
In dialysis the total value of the heparin infused can be viewed.
see/mod. heparin
parameters
.
The graphic tool indicates the set heparin

infusion on the left, and the total heparin infused
on the right.
WARNING
The total value of heparin infused only takes the set program into account
and does not consider any heparin infused manually by pressing the and
keys on the front panel.
panel.

ACTIVATION OF THE HEPARIN
HEPARIN PROGRAM
The heparin program status is clear to the operator by the syringe icon on the right
top of the screen. The icon colour is associated to a different meaning.
Indicates that the program has not been previously set.

Warning: NO HEPARIN SETTING
Indicates that the heparin pump is momentarily stopped

because of an alarm of the blood side.
grey background
Indicates that heparin is being administered.

white background
Indicates that the heparin program was set but not activated.
heparin
on
red background Warning: HEPARIN OFF

Also indicates that the pre-stop value has been reached. The
heparin pump is off.
Indicates that the heparin user profile is active and that heparin
is being administered.
green background
Indicates that the heparin user profile is active, that heparin is

being administered but the infusion value was set to the max.
orange background allowed value.
If the heparin program has not been activated, when blood has been detected in the
arterial line, the warning NO HEPARIN SETTING appears. This condition is true if the
heparin flow rate set in configuration mode is different from 0.
Set the heparin infusion value and start the program.

heparin
off
To stop the heparin infusion at any time, .
When the pre-stop time has been reached, if you want to continue infusing, it is
necessary to decrease the pre-stop time or increase the dialysis time.
heparin
on
.

FILLING THE SYRINGE DURING TREATMENT
heparin
off
1. .
2. Clamp the heparin infusion line.
3. Unscrew the retaining screw and remove the syringe from the support.
4. Fill the syringe with the required quantity of heparin.
5. Move the plunger to the end of its travel with the key .
6. Mount the syringe as previously described.
7. Remove the clamp from the heparin infusion line.
heparin
on
8.
HEPARIN BOLUSES
BOLUSES
Two types of heparin boluses can be carried out.
At the beginning of the patient connection phase, the machine can deliver a bolus in
an amount that can be set during configuration (with the Automatic Heparin Bolus
(cc) parameter) and modified during priming. To modify this value:
see/mod. heparin
parameters
.
heparin
bolus
The function key allows the bolus amount to be set, which will then be
activated when blood is detected.
To enable this function, set and activate the heparin program during priming.
Manual boli can be administered during the patient’s connection and dialysis
see/mod.
parameters
phases, provided the heparin program is active.
heparin heparin
bolus
. The function allows to set the size of the bolus
which starts after confirmation .

Both these functions are not available if a heparin profile is active .

3.5 INITIATING DIALYSIS AND TREATMENT PROCESS
PATIENT CONNECTION AND START OF TREATMENT
For patient connection and starting treatment, refer to the chapter on the selected
treatment.
The following functions keys are available during dialysis:
WARNING
modify
treatment If changing the treatment, check that all the parameters are
congruent with the treatment selected and modify them if
necessary.
necessary.
see/mod.
parameters Displays and modifies the treatment parameters.
heparin Enables the heparin program (see Chapter « Heparin »).

on The function is available only if the heparin infusion value has been
set.
Interrupts the UF program in progress, activating a minimum UF of
0.1 kg/h. The treatment time continues to advance.
uf
on
uf To restart the UF program, press . When the UF program is
off see/mod.
parameters
reactivated, a window warns the user to check in the and
dialysate
menu that the ultrafiltration parameters are as desired.
ENG – Ed. 06/09 chap. 3.5 - Initiating dialysis and treatment process – 1 of 4
isolated uf
on Activates isolated UF.
sensors
Allows access to the sensor menu and the Kt/V application.
rinseback
Enables the restitution of blood to the patient.
sphygmo
measure Enables sphygmomanometer measurement.
PASSING TO THE SINGLE NEEDLE SINGLE PUMP
During dialysis, it is possible to pass from any treatment mode to Single Needle with
single pump.
NOTE
In the Therapy model, if an on- on-line haemodiafiltration
haemodiafiltration (HDF OnLine, PHF)
treatment is being performed, the treatment change to Single Needle does not
allow a return to the previous treatment.
Single Needle Dialysis with Single Pump must be considered as an

emergency treatment.
modify s.needle
treatment (s.pump)
•
ok
• to confirm.
• The message DIALYSIS SNsp appears on the top right bar, the blood pump stops
and the alarm message PUMP OFF is displayed.
• Disconnect the line for arterial pressure measurement and clamp it.
• Set the blood flow to the desired value.
• Set the switching pressures and the stroke :

see/mod. blood switch p. stroke
parameters
and
• Suggested values: min. switch. p. = 50 mmHg

max. switch. p. = 350 –400 mmHg
stroke = 20 ml
• to restart the blood pump.
2 of 4 - chap. 3.5 - Initiating dialysis and treatment process ENG - Ed. 06/09
DIALYSIS WITH ISOLATED UF
Dialysis with isolated UF may be carried out at the beginning, during or at the end of a
dialysis session for a maximum time of 60 minutes, provided that the UF program has
been activated and no alarms are present.
isolated uf
on
.
The message BIC. (BIDRY/ACETATE) + STD A. CONC. - ISOLATED appears at the top
left of the screen.
To set an isolated UF different from the ultrafiltration in progress,
see/mod. dialysate
parameters
and
and then enter the menus UF/Hour or Weight Loss and Treatment Time to modify the
parameters and obtain the new isolated UF value.
During isolated UF the dialysis fluid flow automatically turns to a minimum value and
will be reset to the set value as soon as isolated UF has been completed.
isolated uf
off
to at any time stop isolated UF.
Isolated UF is interrupted each time:

• an alarm occurs,
• the keys and have been pressed.
Isolated UF is disabled when:

• the UF program has ended (message END UF)
• an hour of isolated UF has been run.
rinseback
• the function key has been pressed.
NOTE
If the ultrafiltration parameters have been modified during haemodialysis with
isolated UF, when running conventional dialysis the UF value must be checked
and modified if necessary, since the machine keeps the ultrafiltration with
which isolated UF has been run in memory.
The total duration
duration of the treatment includes the isolated UF time.
Ultrafiltration is not affected by isolated UF.
ENG – Ed. 06/09 chap. 3.5 - Initiating dialysis and treatment process – 3 of 4
ULTRAFILTRATION SYSTEM TEST
At 30 minute intervals, the equipment runs a self-test of the ultrafiltration system.

While the test is running, the message bar displays the word SELF-TEST.
NOTE
If a haemodiafiltration treatment is being performed, with the exception of
HFR, the infusion pump is at rest during the test.
In online haemodiafiltration, before the test the infusion pump gradually
decelerates until
until it stops in correspondence to the test; when exiting the test,
the infusion pump gradually accelerates up to the value set.
4 of 4 - chap. 3.5 - Initiating dialysis and treatment process ENG - Ed. 06/09
3.6 PATIENT RINSEBACK
PATIENT RINSEBACK
WARNING
During patient rinseback some machine protections are not active.
Check the rinseback procedure with extreme care to prevent passage of air bubbles into
the vein.
To interrupt the treatment or when the treatment time has ended (the UF END message appears),
rinseback
.
A message appears requesting to confirm

rinseback.
no
to cancel the
operation, or
yes
to confirm.
NOTE
When rinseback has started, you may not return to dialysis.
Rinseback to the patient of the blood in the extracorporeal lines performed without the help of
physiological saline solution is termed Rinseback with air (the Technical configuration setting is
Rinseback with physiological saline solution = OFF): it is accomplished by disconnecting the
arterial line from the patient and leaving the connector in free air.
Rinseback to the patient of the blood in the extracorporeal lines performed with the help of
physiological saline solution is termed Rinseback with physiological saline solution (the Technical
configuration setting is Rinseback with physiological saline solution = ON): it is accomplished by
disconnecting the arterial line from the patient and connecting it to a bag of physiological saline
solution or, in online treatments, to the infusion line, leaving the connector in free air.
ENG – Ed. 06/09 chap. 3.6 – Disconnecting patient - 1 of 4

Rinseback is divided into two phases:
• Rinseback I: this consists in the progressive emptying of the blood lines, in sequence: arterial
line, dialyser, venous line to the venous drip chamber;
• Rinseback II: this consists of the emptying of the last section of the venous line, beyond the
drip chamber.
Passing from phase one to phase two occurs following a different procedure depending on the type
of rinseback:
Rinseback with air

- the arterial line does not contain any more blood (this situation is assessed by the blood
detector)
- the drip chamber is emptied or blood mixed with physiological saline solution is presence (this
situation is assessed by the level detector)
- air is present in the return line for at least 2 sec (as assessed by the air detector)
Rinseback with physiological solution

- the arterial line does not contain any more blood (this situation is assessed by the blood
detector)
- the drip chamber is emptied or blood mixed with physiological saline solution is presence (this
situation is assessed by the level detector)
In the transition dialysis-rinseback, there is a stop of extracorporeal circulation, with an automatic

initial reduction of blood flow settable by the operator.
Arterial pump rotation is continuous.
In the transition from rinseback I to rinseback II, there is a stop of extracorporeal circulation, with a
further automatic reduction of blood flow settable by the operator.
Rotation of the arterial pump varies according to the type of rinseback:

Rinseback with air:
the arterial pump makes a complete turn and then stops; press to restart the pump every
time it stops, that is to say after each turn, and complete rinseback.
Rinseback with physiological solution:

the arterial pump continues its motion continuously.
WARNING
If you have set rinseback with air, the AIR DETECTED alarm is not active. Therefore carry
out patient rinseback with extreme care to prevent passage of air bubbles into the vein.
If you have set rinseback with physiological solution (or online rinseback), check with
care the quantity of physiological saline solution (or ultrapure dialysis fluid) infused to the
patient to prevent weight loss errors.
For the operating sequence, refer to the chapter on the selected treatment.
2 of 4 – chap. 3.6 – Disconnecting patient ENG - Ed. 06/09

The following functions keys are available during patient rinseback:
rinsing rinsing yes

and confirm ( ) to start a few minute
rinsing cycle during which the self-diagnostic tests are performed.
Then the machine reverts to a low-consumption rinsing condition and waits
for operator’s intervention.
early early yes

disinf./clean. disinf./clean.
and confirm ( ) to start a short high
flux rinsing phase (90 sec. at 800 ml/min) at the end of which only the
disinfection/cleaning program is allowed.
Dialysis will be enabled only after the self-test phase, at the end of
dialyser The function is available when the message EMPTYING appears on the top
drain on right bar. Press the key to empty the dialyser again.
bidry The function is available only in case of bicarbonate cartridge dialysis.

drain on Press the key to empty the cartridge.
For dialysis with the Bidry cartridge, disconnect the cartridge blue connector
and check that the clamps are open.
When using a pierceable bicarbonate cartridge, remove the upper piercing
connector from the upper clip support and disconnect it from the cartridge.
bidry
drain on
Keep the cartridge in the lower piercing connector. .
Wait for the cartridge to empty and then remove it. Re-close the mobile
bypass over the lower piercing connector. Re-close the upper piercing
connector over the mobile bypass and lock it with the locking bracket.
ENG – Ed. 06/09 chap. 3.6 – Disconnecting patient - 3 of 4

4 of 4 – chap. 3.6 – Disconnecting patient ENG - Ed. 06/09
4.1 DOUBLE NEEDLE HAEMODIALYSIS - DN
Refer to chapter on disposable materials for the list of disposable devices to use for the
selected treatment.
Refer to the chapter Preparation of Treatment for general information.
ARTERIAL
ARTERIAL LINE ASSEMBLY
• Fix the expansion chamber in the relevant support (1).
• Connect the Luer connector of the blood catcher (if present on the arterial
expansion chamber) to the prefilter arterial pressure gauge (1b) (red).
• Open the cover of the arterial pump.
• Lift the folding drive handle of the pump.
• Fix the arterial pump segment inlet in the lower set guide . (For semi-automatic
loading of the pump segment, refer to the relevant paragraph in the Treatment
preparation chapter).
• Turn the pump anti-clockwise and fit the segment.
• Fasten the other end of the segment in the upper guide set.
• Fold the drive handle back into the pump block and close the cover.
• Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3)
next to the electric safety clamp. If the arterial electric safety clamp (double clamp)
(3b) is present, insert the arterial line following the instructions described in the
paragraph “Automatic opening of the clamp” in the Treatment preparation chapter.
• Connect the Luer-lock connector of the blood catcher (at pump inlet) to the
pressure gauge (4) (red).
• Connect the red line connector to the blood inflow connector of the dialyser.
• Fasten the line in the relevant clip on the dialyser holder.
• Fix the line in the relevant clip (5) (red side).
• Connect the heparin syringe (see Chapter “Heparin”)
ENG – Ed. 11/09 chap. 4.1 – DN Haemodialysis - 1 of 8

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2 of 8 - chap. 4.1 – DN Haemodialysis ENG - Ed. 11/09

VENOUS LINE ASSEMBLY
• Insert the venous drip chamber into its support (1), positioning it approximately
halfway. The internal filter must remain below the support.
• Insert the venous line into the air detector (2).
• Insert the line into the electric safety clamp pressing the lever downward and
accurately position the tube in the fastening clip. (For semi-automatic opening of
the clamp, refer to the corresponding paragraph in the chapter Treatment
Preparation).
• Attach the blue connector to the blue blood outlet connector of the dialyser.
• Connect the Luer-lock connector of the blood catcher to the venous pressure gauge
(4)(blue).
• Fasten the line in the relevant clip (3) (blue side).
• Hang the priming fluid collection bag on the hook of the stand.

PRIMING BLOOD LINES
• Start the blood pump ( ).

• Vent air from the venous drip chamber..
• Set the blood pump flow with the flow regulator.
• Fill the arterial expansion chamber up to 1/3 its volume.
• Fill the venous drip chamber up to 2/3 its volume and close it.
• If there are alarms, and .

• As soon as the level has been reached in the venous drip chamber, the electric
safety clamp opens and line priming ends.
• To change the bag or bottle of physiological solution, stop the blood pump by
pressing .
• Once replaced, reactivate the pump.
• The machine stops 0.2 l before the Stop Priming value is reached. (If the stop
priming is = 0,
0 the equipment continues to operate).
• If recirculation is desired, connect together the venous and the arterial line.
to continue.
• The machine stops again 0.4 litres before the End Priming value is reached and
after every 0.2 litres circulated, until blood is detected in the arterial line.
• Dialysate preparation is independent of blood line priming until the dialyser
connectors are connected to the dialyser (see the chapter concerning dialysate
preparation).

• to stop the blood pump.
• to bypass the dialyser.

• Connect the arterial line to the patient in accordance with the procedure used at the
centre.
• Re-activate the blood pump and completely prime the lines with blood.
• to stop the blood pump again and connect the venous line to the
patient.
• and check that the clamps on the pressure measurement lines and the
main line are open.
• Regulate the blood flow to the desired value by turning the flow regulator.
• to connect the dialyser to the dialysis fluid.

• As soon as blood in the arterial line is detected, the message CONNECT appears on
the top right bar (blood section). Blood circulates to prime the venous blood line
and the dialyser. As soon as blood is detected in the venous drip chamber, if the
relevant parameter was set in configuration, an additional pump stop is performed;
if not, wait until the message DIALYSIS appears. The left status bar will read BIC.
(ACETATE/BIDRY) + STD A. CONC. (LYMPHA) - PROG.
• If the heparin program has not been set yet, then the message NO HEPARIN
SETTING appears.
• The alarm thresholds of the arterial (Pa) and venous pressure (Pv) automatically
switch to the values set for dialysis. The machine automatically sets the max. and
min. (H/L) pressure values.
• If the UF program has not activated yet, a pertinent message appears.
• During dialysis the instrument indicating the UF setting becomes orange if:
- the UF setting corresponds to the extreme pre-set values
- the UF value does not correspond to the ratio between weight loss and
treatment time settings.
• At any time during the dialysis session, it is possible to view and modify the pre-set
parameters (temperature, conductivity, dialysis fluid flow, treatment time, UF/hr,
see/mod.
parameters
weight loss) and follow the instructions in the Operator
Interface chapter.
see/mod. dialysate
parameters
• During the dialysis, if and selected, the total
running treatment time is shown beneath the treatment time instrument.
• The volume of treated blood is displayed on the second page of the screen:
see/mod. see other
and , refer to the “blood volume” tool, Operator
Interface chapter,
• In case of alarms, refer to the dedicated chapter.

PATIENT RINSEBACK
Refer to the Disconnecting Patient chapter for general information.
RINSEBACK with air
• After confirming the Rinseback command, the equipment activates the transition to
the Rinseback I phase (see the general chapter on patient rinseback): the blood
pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is
interrupted.
• Disconnect the arterial line from the patient and let it free.
• Reactivate the pump ( ) to start blood rinseback.

• If necessary, adjust the blood flow using the flow regulator.
• The venous and arterial pressure alarms absolute thresholds are set automatically.
• Upon transition to the Rinseback II phase (see the general chapter on patient
rinseback), the blood pump stops (PUMP STOP message) and the electric safety
clamp is closed.
• to infuse any blood present in the venous line. The arterial pump
rotates only one time before coming to a stop.
WARNING
If rinseback is performed with air, the AIR DETECTED alarm is not active during
emptying (Rinseback II). Therefore carry out patient rinseback with extreme
care to prevent passage of air bubbles into the vein.
• Set the arterial flow regulator to zero or .

• Disconnect the venous line from the patient.
• Disconnect the blue dialyser connector and insert it in its housing on the machine.
The Filter Emptying procedure will be performed automatically.
• Turn the dialyser and wait until it empties out completely.
• Disconnect the red dialyser connector and insert it in its housing on the machine.
• If the perforated cartridge is present, perform the emptying procedure (see the
Chapter “PATIENT RINSEBACK”).
• Remove disposable accessories.
• Position the concentrate connectors in their housings on the machine.

RINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTION
WARNING
In Rinseback with physio
physiological
ysiological saline solution, check with care the quantity of
physiological saline solution infused to the patient to prevent weight loss
errors.
• For information on displaying and modifying parameters, refer to the Operator

Interface chapter.
interrupted.
• Disconnect the arterial line from the patient and connect the physiological saline
solution bag.

rinseback), the equipment stops the blood pump (PUMP STOP message) and closes
the electric safety clamp.
• to infuse any blood-saline solution in the venous line

• The arterial pump performs continuous rotation with a reduced flow. If necessary,
adjust the blood flow using the flow regulator.

• If the sodium bicarbonate powder cartridge is present, perform the emptying
procedure (see the Chapter “PATIENT RINSEBACK”).

4.2 SINGLE NEEDLE SINGLE PUMP HAEMODIALYSIS - SNsp
selected treatment.


loading of the pump segment, refer to the relevant paragraph in the chapter
PREPARATION OF TREATMENT).
paragraph “Automatic opening of the clamp” in the chapter PREPARATION OF
TREATMENT.
• Connect the red connector of the line to the dialyser blood inlet connector.
• Connect the heparin syringe (see Chapter “Heparin”).
ENG – Ed. 11/09 chap. 4.2 – SNsp Haemodialysis - 1 of 8

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2 of 8 - 4.2 – SNsp Haemodialysis ENG - Ed. 11/09

accurately position the tube in the fastening clip. (For automatic opening of the
clamp, refer to the relevant paragraph in the chapter PREPARATION OF
TREATMENT).
• Connect the Luer-lock connector of the blood catcher to the venous pressure gauge
(4)(blue).
• Fasten the line in the relevant clip (3) (blue side).
• Hang the priming fluid collection bag on the hook of the stand.

PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH SINGLE
PUMP (SNsp)

• Set the blood pump flow with the flow regulator.
• Fill the arterial expansion chamber up to 1/3.
• Fill the venous drip chamber up to its level (2/3) and close it.
• In case of alarms, press and .

• The blood pump goes on running until the level in the venous drip chamber has
been reached, or the first pump cycling has occurred.
pressing . Once replaced, reactivate the pump.

• Suggested values for the switching pressures:
max. switch p.= 350 – 400 mmHg min. switch p. = 50 mmHg
• If the alarm “abnormal switching pressure” intervenes after the first pump switching
and the blood lines are still empty, . To prime the blood lines more
rapidly, it is suggested to cancel priming, to open the venous drip chamber and to
select the treatment again.
NOTE
cancel
priming
Priming can be cancelled with until dialysate preparation has
begun.
If dialysate preparation has begun, it is recommended to change treatments,
going to Double Needle.
When priming is over, change the treatment again and return to Single Needle
Dialysis.
• During the entire priming phase, the pump cycling depends on the switching
pressure values set. The stroke is not used.
priming is = 0,
• If recirculation is desired, inter-connect the venous line and the arterial line.
to continue.
• The machine stops again 0.4 l before the End priming value is reached and after
every 0.2 litres circulated until blood is detected in the arterial line.
• Start dialysis fluid preparation as already described for Double Needle Dialysis.
• Set the stroke value (refer to the chapter “Description of the equipment and its
components”). Suggested value: 20 ml/min.


centre.
patient,
main line are open.

if not wait until the message DIALYSIS appears. The left status bar will read BIC.
(ACETATE/BIDRY) + STD A. CONC. (LYMPHA)- PROG. If the heparin program has not
been set yet, then the message NO HEPARIN SETTING appears.
• The absolute thresholds of the arterial (Pa, in the case of double clamp equipment)
and venous pressure alarms (Pc) switch automatically to the values set for dialysis.
The machine automatically sets the max. and min. (H/L) pressure values.
• At any time during the dialysis session, it is possible to view and modify the pre-set
parameters (temperature, conductivity, dialysis fluid flow, treatment time, UF/hr,
see/mod.
parameters
weight loss) and follow the instructions in the Operator
Interface chapter.
see/mod. dialysate
parameters
• During the dialysis, if and are selected, the total running
treatment time is shown beneath the treatment time instrument.
see/mod. see other
and refer to the “blood volume” tool, Operator
Interface chapter.

• The alarm thresholds of the switching pressures automatically switch to the values
set for the dialysis. Pump cycling depends on the set stroke volume.
• The tool Qbm indicates the mean blood flow given by the following formula:
Qbm = Qb x art. phase duration / ( art. phase duration + ven. phase
duration)
PATIENT RINSEBACK
RINSEBACK WITH AIR
interrupted.

• The venous and arterial pressure alarms absolute thresholds are set automatically
(if the double clamp is present).
rinseback), the blood pump stops (PUMP STOP message) and the electric safety
clamp is closed.
• Press to infuse any blood present in the venous line. The arterial pump rotates
only one time before coming to a stop.
WARNING
If rinseback is performed with air, the AIR DETECTED alarm is not active during
emptying (Rinseback II). Therefore carry out patient rinseback with extreme

• If the perforation cartridge is present, perform the emptying procedure (see the

WARNING
In Rinseback with physiological saline solution, check with care the quantity of
physiological saline solution infused
infused to the patient to prevent weight loss
errors.

Interface chapter.
interrupted.
solution bag.

• The venous and arterial pressure alarms absolute thresholds are set automatically
(if the double clamp is present).
rinseback), the equipment stops the blood pump (PUMP STOP message) and closes
the electric safety clamp.
• Press to infuse any blood-saline solution in the venous line

• The arterial pump performs continuous rotation with a reduced flow. If necessary,
adjust the blood flow using the flow regulator.
• Set the arterial flow regulator to zero or press .


4.3 SINGLE NEEDLE DOUBLE PUMP HAEMODIALYSIS - SNdp
selected treatment.

loading of the pump segment, refer to the relevant paragraph in the chapter
PREPARATION OF TREATMENT).
paragraph “Automatic opening of the clamp” in the chapter PREPARATION OF
TREATMENT.
pressure gauge (4) (red). (Do not perform this operation in Single Needle with
Single Pump)
• Connect the red line connector to the blood inflow connector of the dialyser.
ENG – Ed. 11/09 chap. 4.3 – SNdp Haemodialysis 1 of 10

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2 of 10 - chap. 4.3 – SNdp Haemodialysis ENG - Ed. 11/09

• Insert the switching chamber into the clip (1).
• Open the cover of the venous pump.
• Insert the switching chamber outlet line in the infusion end detector (2).
• Fasten the inlet of the venous pump segment in the left set guide (follow the
direction of the blue arrow). (For semi-automatic loading of the pump segment,
refer to the relevant paragraph in the chapter PREPARATION OF THE TREATMENT).
• Fasten the other end of the pump segment in the right guide set.
accurately position the tube in the fastening clip. (For automatic opening of the
clamp, refer to the corresponding paragraph in the chapter PREPARATION OF
TREATMENT).
• Attach the blue connector leading to the switching chamber to the blue blood outlet
connector of the dialyser.
• Connect the Luer-lock connector of the blood catcher for measuring the venous
pressure (in the drip chamber) to the venous pressure gauge (blue) (5).
• Connect the Luer-lock connector of the blood catcher for measuring the switching
pressure (on the switching chamber) to the switching pressure/infusion gauge (6).
6
1
5
1
1 3
1
2
1
4
1

PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH DOUBLE
PUMP (SNdp)

• Vent the venous drip chamber and the switching chamber..
• Set the blood pump flow with the red flow regulator.
• Fill the arterial expansion chamber up to 1/3.
• Fill the switching chamber up to its level (1/3) and close it.
• In case of alarms, press and .

• After reaching the switching pressure of 50 mmHg, the venous pump begins to
operate together with the arterial pump. The venous pump speed is regulated
automatically by the equipment on the basis of the set value (with red flow
regulator) and the measured switching pressure.
• Fill the venous drip chamber up to its level (2/3) and close it.
• As soon as the level has been reached in the venous drip chamber, the electric
safety clamp opens and line priming ends.

priming is = 0,
to continue.
• Start dialysis fluid preparation.

Single Needle Double Pump operation involves alternation of two phases:
Arterial phase
Blood is drawn from the patient with the arterial pump operating, the venous pump off
and the clamp closed. The phase ends when a certain value above the switching
pressure is reached.
Venous phase
The blood is returned to the patient with the arterial pump off, the venous pump
operating and the clamp open. The phase ends when a certain value of venous pump
revolutions is reached which corresponds to the set stroke volume.
These two phases are referred to as CYCLE.

CYCLE
Single Needle Double Pump operation can only be performed on formula 2000 or
formula Therapy machines, that is machines equipped with two blood pumps.
Single Needle Double Pump run by formula 2000 is a “PRESSURE-STROKE” single needle.
“Pressure” refers to the switching pressure measured downstream from the dialyser,
“stroke” refers to the volume of blood pumped in a cycle.
The Single Needle Double Pump dialysis run by formula 2000 is a highly automatic
treatment aimed at optimising parameters.
The user only needs to move only the arterial pump flow regulator since the venous
return speed is managed by the equipment.
The system has two adapting algorithms which automate, respectively.

a) Maximum switching pressure
b) Venous blood pump speed
If the blood pump stops due to an alarm or stop arterial pump condition, the treatment
continues in the arterial phase.
Single Needle Double Pump operation is active when SNdp appear in the machine
configuration at «treatment type». Some of the parameters require particular values to
allow correct operation of the dialysis machine. Refer to the “Configuration” chapter
to set these parameters.

centre.
patient,

main line are open.

if not wait until the message DIALYSIS appears. The left status bar will read BIC.
(ACETATE/BIDRY) + STD A. CONC. (LYMPHA) - PROG.
SETTING appears.
- - the UF setting corresponds to the extreme pre-set values
- - the UF value does not correspond to the ratio between weight loss and
• The preset parameters (temperature, conductivity, dialysate flow, treatment time,
UF/h, weight loss) can be set at any time during the dialysis treatment session.
see/mod.
parameters
and follow the indications shown in chap. Operator Interface.
see/mod. dialysate
parameters
treatment time is shown beneath the treatment time instrument.
see/mod. see other
and refer to the “blood volume” tool, Operator
Interface chapter.
• Set the min switch. p. value (Pc) which is the lower switching pressure threshold. It
is advisable to set a value between 10 and 50 mmHg to prevent draining the drip
chambers.
• Set the max ven. p. value which is the maximum venous pressure threshold. Pay
careful attention when setting the value because it is an operating pressure and not
an alarm threshold.
• Set the stroke volume which is the amount of blood pumped during each cycle.
• To optimise the treatment performance, it is advisable to keep the drip chamber
level (located before and after the dialyser) between 1/3 and 2/3 during each cycle.
In particular, avoid letting the drip chambers become too full when the blood flow
is high, to prevent sudden changes in pressure.
• The transmembrane pressure is calculated as follows:
TMP = P. switch. Average – P.UF average –30 mmHg
where:
P.switch. average is the average value of switching pressure during a cycle
P.UF average is the average value of ultrafiltration pressure during a
cycle.
30 mmHg pressure loss in dialysate compartment
NOTE
If you need to change to SNsp or DN, remove the venous segment and:
modify s. needle double
treatment (s. pump) needle
or

PATIENT RINSEBACK
If formula was configured for rinseback in Double Needle (the Service configuration
setting is Rins. in SNdp = OFF):
• The message “DISCONNECT THE VENOUS PUMP SEGMENT, WHEN THE PUMPS STOP”
is displayed.
• Remove the venous pump segment while both pumps are stopped and the clamp is
closed.
• Patient rinseback continues as in Double Needle operation. The venous pump
remains stopped, only the arterial pump operates.
If formula® is configured for rinseback in Single Needle (the Service configuration

setting is SNdp Rinseback = ON), rinseback is performed with the two pumps working
at the same time. In this case, extraction of the venous segment is not necessary and
the venous pump speed is automatically regulated by the equipment based on the
arterial flow and the measured switching pressure.
RINSEBACK WITH AIR
pump stops (the pumps stop) (PUMP STOP message), the dialyser is isolated,
ultrafiltration is interrupted.
• Reactivate the pump (pumps) ( ) to begin the rinseback phase.

rinseback), the blood pump stops (the blood pumps stop) (PUMP STOP message)
and the electric safety clamp is closed.
• to infuse any blood present in the venous line. The arterial pump
rotates only one time before coming to a stop.
WARNING
If rinseback with air is performed, the AIR DETECTED alarm is not active during
emptying (Rinseback II). Therefore
Therefore carry out patient rinseback with extreme

• If the piercing cartridge is present, perform the emptying procedure (see the
WARNING
In Rinseback with physiological saline solution, check with care the quantity of
physiological saline solution infused to the patient to prevent weight loss
errors.

Interface chapter.
the Rinseback I phase (see the general chapter on patient rinseback): the pump
stops (the pumps stop) (PUMP STOP message), the dialyser is isolated, ultrafiltration
is interrupted.
solution bag.
• Reactivate the pump (pumps) ( ) to begin the rinseback phase.

rinseback), the equipment stops the pump (pumps) (PUMP STOP message) and
closes the electric safety clamp.
• to infuse any blood-saline solution eventually present in the venous

line.
• The arterial pump performs (The pumps perform) continuous rotation with a
reduced flow. If necessary, adjust the blood flow using the flow regulator.


5.1 HAEMODIAFILTRATION WITH BAGS - HDF

• Connect the Luer connector of the blood catcher to the prefilter arterial pressure
gauge (1b) (red).
loading of the pump segment, refer to the relevant paragraph in the
PREPARATION OF TREATMENT chapter).
• Accurately insert the arterial line in the blood detector (2) and in the fixing clip
(3) next to the electric safety clamp. If the arterial electric safety clamp (double
clamp) (3b) is present, insert the arterial line following the instructions described
in the paragraph “Automatic opening of the clamp” in the PREPARATION OF
TREATMENT chapter.
• Connect the red connector of the line to the blood inlet connector of the dialyser.
ENG – Ed. 11/09 chap. 5.1 – Haemodiafiltration with bags - HDF - 1 of 10

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VENOUS/INFUSION LINE ASSEMBLY

• Insert the infusion drip chamber into the relevant clip (1).
• Insert the outlet line from the infusion drip chamber in the end infusion detector
(2).
• Open the infusion pump cover.
2 of 10 - chap. 5.1 – Haemodiafiltration with bags – HDF ENG – Ed. 11/09
• Fasten the inlet of the infusion pump segment in the left guide set (follow the
direction of the blue arrow). (For semi-automatic loading of the pump segment,
refer to the relevant paragraph in the PREPARATION OF TREATMENT chapter ).
• Fit the pump segment, rotating the pump anticlockwise.
• Fasten the other end of the pump segment in the right guide set.
• Fold the drive handle back into the pump and close the cover.
• Insert the line into the electroclamp (5), pressing the lever downwards and
accurately position the tube into the fastening chip (For automatic opening of the
clamp, refer to the relevant paragraph in the Preparation of treatment chapter).
• Connect the luer-lock connector of the blood catcher to the venous pressure
detector (blue) (6).
• Fasten the line from the dialyser into the relevant clip (blue) (7).
• Hang the priming liquid collection bag on its support on the stand (8).
• Hang the infusion bags on the scale hooks (9).
• Connect the bags to the infusion line and open the clamps positioned on the
line.

9
1
8
1
7 6
1
3
1 1
2
1
4
1
5
1
PATIENT CONNECTION AND

AND START OF TREATMENT
Haemodiafiltration treatment (HDF) is a haemodialysis technique that removes high
quantities of plasmatic water by means of high permeability membranes and
partially reintegrates the ultrafiltrate infusing replacement solutions taken from
sterile bags.
Haemodiafiltration treatment (HDF) is possible only on formula® 2000 equipment,
i.e. equipment furnished with the scale Formula 2000.

• Connect the arterial line to the patient in accordance with the procedure used at
the centre.
• As soon as blood in the arterial line is detected, the message CONNECT appears
on the top right bar (blood section).
• Blood circulates to prime the venous blood line and the dialyser. As soon as
blood is detected in the venous drip chamber, if the relevant parameter was set
in configuration, an additional pump stop is performed; if not, wait until the
message DIALYSIS appears. In the left status bar the message BIC.
(ACETATE/BIDRY) + STD A. CONC. (LYMPHA) - PROG. appears.
patient.
• and check that the clamps on the pressure measurement lines and
the main line are open.

SETTING appears.
switch to the values set for dialysis. The machine automatically sets the max.
and min. (H/L) pressure values.
- the UF setting corresponds to the extreme pre-set values;
• The preset parameters (temperature, conductivity, dialysis fluid flow, treatment
time, UF/h, weight loss) can be set at any time during the dialysis treatment
see/mod.
parameters
session. and follow the indications shown in chap. “Operator
Interface”.
see/mod. dialysate
parameters
treatment time is shown beneath the treatment time tool.
see/mod. see other
and refer to the “blood volume” tool,
Operator Interface chapter.
• Ultrafiltration must be set without taking account of the infusion, since formula
automatically adjusts hourly ultrafiltration.
• The treatment is indicated with the letters HDF in the status bar on the upper
right of the display.
• If the infusion flow has not been set, a warning appears.
• At any moment during the dialysis session it is possible to display and change
the infusion flow. The total amount infused is displayed on the second page of
see/mod. see other
the screen. .

• During treatment the ultrafiltration program is active only if the infusion pump is
in operation and vice versa, with the exception of isolated UF dialysis during
which the infusion pump is off.
The following functions keys are available during dialysis:
modify
treatment Changes the selected treatment or the concentrate type.
see/mod.
parameters Displays and modifies the treatment parameters.
heparin Enables the heparin program (see Chapter « Heparin »).

on
The function is available only if the heparin infusion value has been
set.
Interrupts the UF program in progress, activating a minimum UF of

0.1 kg/h. The treatment time continues to advance.
uf uf
off on
To restart the UF program, press . When the UF
program is reactivated, a window warns the user to check in the
see/mod. dialysate
parameters
and menu that the ultrafiltration
parameters are as desired.
isolated uf
on Activates isolated UF.
sensors To access the sensor menu and the Kt/V application
rinseback Enables the restitution of blood to the patient.
sphygmo
measure Enables sphygmomanometer measurement.

PATIENT RINSEBACK
WARNING
During the patient rinseback phase some machine protections are not active.
Check the rinseback procedure with extreme care to prevent passage of air
bubbles
bubbles into the vein.
In HDF during blood rinseback, the UF/infusion pump remains still.
To interrupt the treatment or when the treatment time has ended (the END UF
rinseback
warning message appears), .
A message appears requesting to
confirm rinseback.
no
to cancel the
operation, or
yes
to confirm.
NOTE
When rinseback has started, you may not return to dialysis.
• The blood pump stops (PUMP OFF warning), the dialyser is bypassed,
ultrafiltration is interrupted and the blood flow is automatically reduced.
• If necessary, regulate the blood flow with the flow regulator (it can be set
between 20 and 250 ml/min).
• If Rinseback with air is accomplished (the Service configuration setting is

Rinseback with physiological saline solution = OFF), disconnect the arterial line
from the patient and leave the connector in free air.
• If Rinseback with physiological saline solution is accomplished (the Service

configuration setting is Rinseback with physiological saline solution = ON),
disconnect the arterial line from the patient and connect it to a bag of
physiological saline solution
• Reactivate the pump to start blood rinseback.

• The absolute alarm thresholds of the venous and arterial pressure automatically
set to the following values:
-150 +450 mmHg venous pressure

-300 +200 mmHg arterial pressure
• When all the following conditions are fulfilled, that is:

Rinseback with air
- the arterial line does not contain any more blood,
- air is detected in the venous line for at least 2 sec,
- the emptying of the venous drip chamber, or blood is mixed with the
physiological solution
Rinseback with physiological saline solution

- the emptying of the venous drip chamber, or blood is mixed with the
physiological solution
the blood pump stops, the electroclamp closes and the blood flow value
automatically decreases.
• If necessary, regulate the blood flow with the arterial flow regulator to between
20 and 180 ml/min.
• Complete rinseback but note that:

- rinseback with air:
air the arterial pump makes a complete turn and then stops;
to restart the pump every time it stops, that is to say after each turn,
and complete rinseback.
- rinseback with physiological saline solution: the arterial pump goes on running
without interruption after each turn.
WARNING
If you have set rinseback with air, the AIR DETECTED alarm is not active
during emptying. Therefore carry out patient rinseback with extreme care to
prevent passage
passage of air bubbles into the vein.
If you have set rinseback with physiological solution, check with care the
quantity of physiological saline solution infused to the patient to prevent
weight loss errors.
• Set to zero the arterial flow regulator or .

• Disconnect the blue dialyser connector and insert it in its housing on the
machine.

rinsing rinsing yes

and confirm ( ) to start a few
minute rinsing cycle during which the self-diagnostics tests are
performed.
Then formula reverts to a low-consumption rinsing condition and
waits for operator’s intervention.
early early yes

disinf./clean. disinf./clean.
and confirm ( ) to start a
short, high flux rinsing phase (800 ml/min) at the end of which
only the disinfection/cleaning program is allowed.
the disinfection/cleaning program.
dialyser The function is available when the message EMPTYING appears on

drain on dialyser
drain on
the top right bar. Press to empty the dialyser again.
bidry The function is available only in case of bicarbonate cartridge

drain on dialysis (also see the Chapter “PATIENT RINSEBACK”).
Press the key to empty the cartridge. Disconnect the blue
cartridge connector and check that the clamps are open.
When using a pierceable bicarbonate cartridge, remove the upper
piercing connector from the upper clip support and disconnect it
from the cartridge. Keep the cartridge in the lower piercing
bidry
drain on
connector. . Wait for the cartridge to empty
and then remove it.
Re-close the mobile bypass over the lower piercing connector.
Re-close the upper piercing connector over the mobile bypass and
lock it with the locking bracket.
• Remove the disposable accessories and discard them.


6.1 OPERATION DURING HA
HAEMODIAFILTRATION WITH
INFUSION OF DIALYSIS FLUID (PHF PRE, PHF POST)
POST)
INDICATIONS
Haemodiafiltration with infusion of dialysis fluid (PHF – Paired Haemodiafiltration) is
indicated for patients who have hemodynamic stability problems and when
molecules of medium- to high molecular weight have to be removed.
CONTRAINDICATIONS
Haemodiafiltration with infusion of dialysis fluid (PHF) is not indicated where the
quality of the haemodialysis supply water is not strictly controlled and does not
comply with the relevant standards.
DESCRIPTION
Haemodiafiltration with infusion of dialysis fluid (PHF) is a technique that involves
the infusion of liquid prepared directly by the equipment and derived from the
dialysis fluid. It is an on-line technique that enables optimisation of high flow rate
treatments since it allows the use of high exchange volumes, without the need to
manage a large number of bags.
The treatment utilises a double chamber dialyser which enables the separation of
the dialysis process from the infusate filtration process.
The disposable polyethersulfone dialyser is 100% tested during the production
process. Before dialysis the dialyser is also subject to an automatic, patented on-line
fibre integrity test, with inversion of the infusion pump for a period of time
sufficient for the blood detector (BLD), located on the line, to detect a possible
leakage of blood from the fibres.
PHF treatment may be executed only on formula 2000 machines, i.e. machines
equipped with infusion pump.
WARNING
• Chemical substances potentially toxic for infusion, present in the
deionised water distribution network or in concentrate solutions are not
detectable by formula®.
• It is the responsibility of the dialysis centre to use water suitable for
infusion.
infusion.
• To avoid potentially dangerous situations, carefully read the directions on
• Check that the packaging of the disposable material, which ensures their
sterility, is not damaged and that the sterilisation validity date has not
expired.
expired.
• Ensure that the installation is carried out properly using aseptic
techniques.
• Only use not pyrogenic concentrate solutions, qualitatively in compliance
with the monographs of the European Pharmacopoeia.
• The concentrate solutions to be used for preparation
preparation of dialysis fluid
ENG – Ed. 06/09 ch. 8.1 - Operation during PHF - 1 of 20
must be intact, opened only at the moment of use. Once opened, they
must be used for one treatment only within 24 hours.
• Before carrying out a PHF dialysis, take a sample of dialysis fluid and
check for the absence of disinfectant agents.
• Before and during PHF treatment, check the exact mixture of the
concentrates with water.
• Before and at the end of each PHF treatment always run a disinfection
program. The manufacturer declines any responsibility for patient safety
in the event of failure to carry out proper disinfection.
• Regularly change the Multipure and Forclean filters to ensure the
maximum apyrogenicity of the liquid used.
• The Qinf value must be chosen taking into consideration the dilution
mode, in particular in POST dilution (PHF POST) a careful evaluation of the
set value is necessary. Refer to the literature and the clinical scene of the
patient to avoid potentially dangerous conditions.
During PHF treatment, in addition to the parameters displayed in Double Needle, the
following tools are present:
INFUSION FLOW
The tool displays the infusion flow set (settable between
0 and 21 kg/h).
To modify this value, turn the infusion pump blue flow regulator
- anti-clockwise to decrease.
NOTE
If a dialysis
dialysis fluid flow of 800 ml/min is set, the flow that is actually sent to
the dialyser will not correspond to the set value, but will be equal to the set
value less the infusion flow.
If the dialysis fluid flow of 500 ml/min. and an infusion flow less than 18
kg/h are set, the flow entering the dialyser will coincide with the set flow. If
the infusion flow is greater than 18 kg/h, then the flow entering the dialyser
will be equal to the maximum flow (800 ml/min) less the infusion flow.
If a dialysis fluid flow
flow of 300 ml/min is set, the flow entering the dialyser will
coincide with the set flow.
OTHER PARAMETERS
In the second page of the display the following parameters are displayed :
- infused fluid volume (in kg); the tool starts calculating only when blood is
detected (thus not during priming)
- infusion fluid pressure.
see/mod. see other
To display these parameters, .
2 of 20 - ch. 6.1 - Operation during PHF ENG – Ed. 06/09
INSTALLATION OF DISPOSABLE
DISPOSABLE MATERIALS
Refer to chapter ”Disposable Materials and accessories” for the disposables to use in
PHF treatment.
DIALYSER
WARNING
PHF treatment may only be carried out with PHF dialysers (see chapter
Disposable Materials and accessories)
accessories).
The dialyser inlet/outlet connectors conform to ISO 8637 and EN 1283
standards.
Install the double chamber PHF dialyser in its support and carefully read the
instructions on the packaging related to the direction of the blood flow, depending
on the dilution mode chosen.
To perform PHF treatment in PRE-DILUTION mode (PHF PRE), install

the dialyser with the filtration chamber upwards.
To perform PHF in POST-DILUTION mode (PHF POST), install the

dialyser with the filtration chamber downwards.

LINES
WARNING
• Use
Use of specific lines is recommended (see chapter Disposable Materials
and accessories)
accessories). Alarms and performance may be affected if
inappropriate lines are used, i.e. air detector alarm or ultrafiltration
accuracy.
• Use only lines with blood catcher for the connection

connection to the pressure
transducers.
• During dialysis, if blood or any other fluid comes into contact with the
blood catcher, and fluid passage through the membrane is detected or
suspected, proceed as follows:
- replace the line as indicated in the instructions
instructions given by the manufacturer;
- contact authorized technicians to verify and disinfect the internal

measurement set;
- DO NOT USE the machine for further treatments before it has been
checked and disinfected.

INFUSION LINE
The procedure described below
below is for both pre-
pre-dilution (PHF PRE) and post
dilution (PHF POST) modes. Pictures are provided relative only to predilution
mode (PHF-
(PHF-PRE).
- Connect the yellow end (1) of the infusion line to the inlet of the filtration section
of the double chamber dialyser.
- Position the drip chamber in the appropriate right side clip (2).
- Open the infusion pump cover and fasten the initial blue connector of the
infusion pump segment in the left guide set of the infusion pump head (follow
the direction of the blue arrow). (For the semi-automatic loading of the pump
segment, refer to the relevant paragraph in the PREPARATION OF TREATMENT
chapter).
- Load the pump segment, rotating the pump anticlockwise.
- Fasten the other end of the pump segment in the right guide set.
- Fold the drive handle back into the pump and close the cover of the infusion
pump.
- Insert a segment of the pre-pump line into the infusion end detector (3).
- Connect the luer connector of the blood catcher to the infusion pressure
transducer (4).
- Insert the segment of the line in proximity of the yellow end into the blood leak
detector block (BLD) (green) (5).
- Insert the PHF sampling connector (7) into the dialysate inlet port (blue) of the
dialyser.
WARNING
Do not clamp
clamp the pressure measurement line.
line.
5
1
6 2

ARTERI
ARTERIAL LINE
The procedure described below is for both pre-pre-dilution (PHF PRE) and post
dilution (PHF POST) modes.
Pictures are provided relative only to predilution mode (PHF-
(PHF-PRE).
- Fix the expansion chamber into the relevant support (1).

- Connect the Luer connector of the blood catcher to the prefilter arterial pressure
gauge (1b, red).
- Open the cover of the arterial pump.
- Lift the folding drive handle of the pump.
- Fasten the inlet of the arterial segment in the lower guide set (follow the
direction of the red arrow). (For semi-automatic loading of the pump segment,
refer to the relevant paragraph in the Preparation of Treatment chapter).
- Load the pump segment, rotating the pump anticlockwise.
- Fasten the other end of the pump segment in the right guide set.
- Fold the drive handle back into the pump and close the cover.
- Accurately insert the arterial line in the blood detector (2) and in the fixing clip
(3) next to the electroclamp. If the arterial electric safety clamp (double clamp)
paragraph “Automatic opening of the clamp” in the Preparation of Treatment
chapter.
- Connect the Luer-lock connector of the blood catcher (at pump inlet) to the
pressure meter(red) (4).
- Connect the red connector of the line to the blood inlet connector of the dual
chamber dialyser according to the dilution mode chosen (pre- or post-dilution).
- Fasten the line in the relevant clip on the dialyser holder.
- Fasten the line into the relevant clip (red) (5).
- Connect the heparin syringe (see chapter on Heparin).

When priming is executed with BAGS OF When priming is executed with ultrapure
PHYSIOLOGICAL SOLUTION (PHF Self DIALYSIS FLUID (PHF Self Priming = ON
Priming = OFF was set during service was set during service configuration),
configuration), Connect the arterial line to sampling point
- Hang the bag of physiological on the venous line.
solution on the support on the I.V.
pole.
Connect the arterial line to the bag of
physiological solution.
1b

VENOUS LINE
The procedure described below is for both pre-pre-dilution (PHF PRE) and post
dilution (PHF POST) modes.
Pictures are provided relative only to predilution mode (PHF-
(PHF-PRE).
- Insert the venous drip chamber into its support (1), positioning it approximately
- Insert the venous line into the air detector (2).
- Insert the line into the electroclamp and carefully position the tube in the
fastening clip. (For semi-automatic opening of the clamp, refer to the
corresponding paragraph in the chapter Preparation of Treatment).
- Connect the blue connector to the dialyser blood outlet connector (blue),
according to the dilution mode chosen (pre- or post-dilution).
- Connect the Luer connector of the blood catcher to the venous pressure meter(3)
(blue).
- Fasten the line into the relevant clip (blue) (4).
- Hang the priming liquid collection bag on its support on the I.V. pole.
3
4

PRIMING BLOOD LINES
select
priming
To activate blood line priming .
return
to cancel and return to the previous menu, or
phf pre phf post

or to select the PHF treatment with the desired
dilution mode and
ok
to confirm.
NOTE
The LED next to keys and indicates:
LED off = function inactive,
LED on = function active.
The LED next to keys and indicates:

indicates
LED off = function inactive,
LED on permanently = function active,
LED flashing = function activata
activatable.
table.
NOTE
cancel
priming
to cancel priming and return to the rinsing phase.
WARNING
as,, in this
Do not set a priming volume greater than or equal to 20 litres as
case,
case, the machine will not take into account the priming
priming mode set in the
configuration and will only allow the lines to be primed with bags of
physiological solution.
solution.
It is advisable to place the dialyser in dialysis mode, that is to say with the arterial
line upwards. In particular, if carrying out a PHF PRE, it may be helpful to turn the
dialyser after adjusting the level in the venous expansion chamber; the dialyser
must then be re-set to dialysis mode to complete the priming.
There are different modes for line priming if using BAGS OF PHYSIOLOGICAL SALINE
SOLUTION (PHF Self Priming = OFF set during Technical configuration) or with
ultrapure DIALYSATE FLUID (PHF Self Priming = ON).
The two different methods are described below.

PRIMING WITH BAGS OF PHYSIOLOGICAL SOLUTION
SOLUTION
• Set the equipment to conductivity (refer to the chapter “Dialysis fluid
preparation”) and connect the dialysis fluid connectors to the dialyser via the PHF
sampling connector (7). The BLUE Hansen connector must be connected to the
PHF sampling connector and not directly to the dialyser.
• Set infusion pump flow to 0 using the blue flow regulator.
• Start the blood pump (press ).

• Fill the arterial expansion chamber up to 1/3 and adjust the level.
• Adjust the level (up to 2/3) in the venous drip chamber .
• If there are alarms, refer to the ALARMS chapter for the use of the and
keys.
• As soon as the venous drip chamber level had been reached, the electric safety
clamp opens.
dialyser
rinse on
• to carry out an ultrafiltration and remove any substances, e.g.
glycerine, from the dialyser.
• After the passage of approximately 1 litre of physiological saline solution, check
that no air flows from the venous outlet. If the priming of the blood lines is
carried out in post-dilution mode, rotate the double chamber filter so as the
arterial line is facing upwards.
• Adjust blood flow to 200 ml/min.
• Start the infusion pump by adjusting the blue flow regulator and set a flow
different from 0 (e.g. the infusion value of the treatment): initially the pump will
turn clockwise at a speed of 60 cc/min for 1 to 3 minutes, subsequently it will
stop for the entire duration of priming.

priming is = 0,
Press to continue.
• formula® stops again 0.4 l before the End priming value is reached.
NOTE
see/mod.
parameters
blood stop priming
priming volume
and respectively select or .
• .
• The blood pump stops after every 0.2 litres circulated, until blood is detected in
the arterial line.
• Priming terminates when the sensor on the arterial line detects blood.
• Disconnect the venous line from the collection bag and connect it to the patient.
WARNING
This operation must absolutely be done in order to avoid uncontrolled
weight loss in the patient.

PRIMING WITH ULTRAPURE
ULTRAPURE DIALYSATE FLUID
• Set the equipment to conductivity (refer to the chapter “Dialysis fluid

preparation”)
• Connect the dialysis fluid connectors to the dialyser via the PHF sampling
connector (7). The BLUE Hansen connector must be connected to the PHF
sampling connector and not directly to the dialyser.
• Set priming without heparin to 2 litres or priming with heparin to 3.6 litres with
first stop to 1,6 litres.
• Set blood and infusion flows. As flows in the first priming phase are automatic,
blood (Qb) and infusion flows (Qinf) are to be set to any flow other than zero (i.e.
in accordance to dialysis prescription).
• ; initially only the infusion pump will turn.

• Maintain the dialyser with the arterial line facing upwards (filtration chamber
upwards in PHF-PRE and downwards in PHF-POST) and wait until the dialysate
compartment is filled up.
• Adjust the level in the drip chamber of the infusion line.
• Open the drip chamber of the arterial line and fill it up.
• Turn the dialyser with the venous line upwards (filtration chamber downwards in
PHF-PRE and upwards in PHF-POST).
• Adjust the level in the venous drip chamber up to 2/3. If this operation is
delayed, an arterial or venous pressure alarm could intervene. After venting air
from the drip chambers the alarms can be overridden.
• As soon as the level has been reached in the venous drip chamber, the
electroclamp opens and the arterial pump also starts. The blood flow is set with
the arterial pump flow regulator; the infusion flow (Qinf) is automatically set by
the machine. Check and adjust, if necessary, the levels in the drip chambers.
• Automatic recalculation of the arterial and venous pressures is carried out
throughout priming.
• If priming is executed with heparin, perform a heparin bolus at the first stop and
then continue priming upon conclusion.
• On completion of line rinsing, set the dialyser with the arterial line upwards
again (filtration chamber upwards in PHF-PRE and downwards in PHF-POST).
• formula® stops 0.2 litres before the Stop Priming value is reached. (If the stop
priming is = 0, the equipment continues to operate).
• formula® stops again 0.4 l before the End priming value is reached and after
every 0.2 litres circulated, until blood is detected in the arterial line.
NOTE
see/mod.
parameters
blood stop priming
priming volume

• Before connecting the patient and starting the treatment, disconnect the arterial
line from the sampling point of the venous line (after closing it with a clamp) and
connect it to the patient.
WARNING
Close the sampling point on the venous line by clamping
clamping the tube and fitting
the safety cap.
• Priming ends when the sensor on the arterial line detects blood.
WARNING
When connecting the patient, it is necessary to check that formula® switches
to CONNECT or DIALYSIS (blood section status bar message). Lack of
detection of blood by the blood detector (with resulting stay in priming) can
determine the infusion of ultrapure dialysis fluid to the patient. (also see the
Alarms chapter 10.3:
10.3: BLOOD LEVEL ALARM).
DIALYSIS FLUID PREPARATION,

PREPARATION, SETTING OF UF
UF PROGRAM AND
OPERATION DURING PHF
For the dialysis fluid preparation, the setting of the ultrafiltration program, the
execution and change of the treatment, refers to the descriptions in the
corresponding chapters of the user manual.
The only differences are as follows:
• Ultrafiltration must be set without taking account of the infusion, since formula
automatically adapts hourly ultrafiltration.
• The treatment is indicated with the letters PHF-PRE or PHF-POST in the status
bar at the top right side of the display.
• If the infusion flow has not been set, the relevant warning appears.
• At any moment during the dialysis session it is possible to display and modify
the infusion flow. The total amount infused is shown on the second page of the
see/mod. see other
display. .
• The infusion pump operates only if the blood pump is active and no alarms of
the dialysate compartment are active.
• During treatment the ultrafiltration programme is active only if the infusion
pump is in operation and vice versa, with the exception of isolated UF dialysis
during which the infusion pump is off.
WARNING
In case of leaks of infusion liquid
liquid into the environment, check the patient
weight, immediately interrupt the PHF treatment and continue in Double
Needle.

INFUSION FLOW ADJUSTMENT
ADJUSTMENT
If the Press. Transd. Kit parameter is set to a value below 2 in Technical
configuration, the infusion flow is set by means of the infusion flow regulator.
Otherwise, when entering dialysis, automatic adjustment of the infusion flow is
enabled. This mechanism automatically adjusts the infusion flow value based on the
average TMP measured by the machine and the working TMP set by the user. In
particular, the infusion flow is automatically adjusted by the machine so that the
average TMP is maintained within a range of ± 10 mmHg around the working TMP
set.
The average TMP is obtained from the following relations:
Treatment Formula for TMP calculation

(P − ∆Pe ) + Pv
TMP = − (Pdout + 30 )
filt
PHF PRE
2
Pfilt + (Pv + ∆Pe )
PHF POST TMP = − (Pdout + 30 )
2
where Pfilt is the prefilter arterial pressure, Pv the venous pressure, Pdout the
dialysate pressure measured at the dialyser outlet, and ∆Pe the pressure drop on the
blood filter of the dual chamber filter (20 mmHg).
To modify the working TMP:
see/mod. blood set

parameters TMP
.
Press the or keys to set the new value and then confirm with .
If the working TMP is not set, the application uses a default value of 250 mmHg in
PHF PRE and 200 mmHg in PHF POST.
The moment the control is activated, Qinf goes to a prefixed value which depends
on the treatment selected (see table below) . Subsequently, Qinf is automatically
changed to within minimum and maximum thresholds which again depend on the
treatment (see table).
Treatment Minimum Qinf Maximum Qinf

(kg/h) (kg/h)
PHF PRE 2 21
PHF POST 1 10
It is therefore possible that during a treatment, although not being around the set
working TMP, Qinf is not changed since it coincides with one of the maximum and
minimum limits.
To view the Qinf tool with these limits:
see/mod. blood
parameters

Automatic infusion flow adjustment can be disabled at any time during dialysis:
see/mod. blood disable
parameters auto Qinf
or re-enabled:
see/mod. blood enable

parameters auto Qinf
If automatic adjustment is disabled, the infusion flow is set by means of the infusion
flow regulator.
PHF DIALYSER INTEGRITY

INTEGRITY TEST
At the beginning of each PHF treatment, a test to check the integrity of the
membrane of the convective section of the PHF dialyser is automatically carried out.
During this test, which lasts max. 3 minutes, the infusion pump turns clockwise,
thus permitting removal of ultrafiltrate from the PHF dialyser. The blood leak sensor
checks the extracted ultrafiltrate for any potential presence of blood. In the case of a
negative result, the infusion pump re-starts turning anticlockwise to start the
infusion.
If, however, the presence of blood is detected, the “Haemofilter Test failed” (yellow
window) alarm is displayed which indicates a rupture of the membrane in the
convective section of the PHF dialyser.
Check the dialyser and the line and proceed in one of the following ways:
repeat To repeat the PHF dialyser test.

filter test
NOTE
The PHF dialyser test may be performed at any point
during treatment even if no alarm situation exists.
see/mod. filter repeat
parameters management filter test
test test .
change To allow substitution of PHF dialyser and infusion line.

filter
test Activating this function enables the following conditions:
- stop of the infusion pump
- dialysis time interrupted
- dialyser bypass
Once replaced, the PHF dialyser test is automatically re-run.
NOTE
In case of rupture of the PHF dialyse
dialyser,
r, it is always
necessary to substitute both the dialyser and infusion
line.

If, in addition to the PHF dialyser, the blood lines need
also to be replaced, it is advisable to disconnect the
patient and prime again the whole blood circuit.
To continue the treatment regardless of a negative result of

continue
the PHF dialyser test.
WARNING
It is sole and full responsibility of the operator
continuing the treatment despite the failed test .
rinseback
To begin the rinseback procedure.
INFUSION BOLUSES
Boluses of dialysis fluid can be infused at any time during dialysis.
To infuse a bolus,
see/mod. see other infusion

dialysate
parameters parameters bolus
and set the amount to be infused (between 0 and 500 ml).
The bolus will not be subtracted by the ultrafiltration program, so the actual
weight loss at the end of dialysis is given by the total weight loss set less the
sum of the boluses infused during treatment.
During infusion of the bolus, the dialysis fluid is infused at a flow rate that may vary
between 3 and 12 kg/h in relation to the blood flow.
Infusion of the bolus can be stopped by resetting the value to the volume infused up
to that moment.
The total amount of boluses infused during treatment is also displayed.

PATIENT RINSEBACK (WITH PHYSIOLOGICAL SOLUTION OR
AIR)
This rinseback mode is available in PHF treatment both in POST-DILUTION (PHF-
POST) and PRE-DILUTION (PHF PRE), provided that in Service configuration the
parameter Rinseback Online was set to OFF (Rins. Online PHFpre = OFF). (check the
Technical configuration parameters in the help on line).
During patient rinseback the infusion pump is off. Please refer to the relevant
chapter in the user manual.
PATIENT RINSEBACK WITH ULTRAPURE DIALYSIS FLUID

This rinseback mode is available only in PRE-DILUTION (PHF PRE) PHF treatment
provided that in Service configuration the parameter Rinseback Online was set to ON
(Rins. Online PHFpre = ON). (Check the Technical configuration parameters in the
help on line).
WARNING
During patient rinseback some machine protections are not active.
Check the rinseback procedure with extreme care to prevent passage of air
bubbles into the vein.
To interrupt the treatment or when the dialysis time has ended (the END UF warning
rinseback
appears), .
A message appears requesting to confirm rinseback.

no
to cancel the operation, or
yes
to confirm.
NOTE
When rinseback has started, you are not allowed to return to dialysis.
• The blood pump stops (PUMP OFF warning), the dialyser is bypassed,
ultrafiltration is interrupted and the blood flow is automatically reduced.
• Reactivate the pump to start blood rinseback.
• The absolute alarm thresholds of the venous and arterial pressure automatically
set to the following values:
-150 +300 mmHg venous pressure
-300 +200 mmHg arterial pressure
• About 25 sec. later the blood pump stops and dialysis fluid is infused by the
infusion pump. The infusion flow rate, automatically set at 10 kg/h, is displayed
with a negative value in the hourly UF tool on the monitor.
• The arterial pressure alarm is disabled and the alarm thresholds of the infusion
pressure alarm are automatically set to -200 ÷ +770 mmHg .
• The total dialysis fluid infused during the rinseback procedure (VTot. Inf.)
together with the infusion pressure (Pinf) are displayed by the dedicated tool on
the monitor.
WARNING
Pay careful attention to the amount of dialysis fluid infused to the patient to
prevent weight loss errors.
At any moment reinfusion of dialysis fluid to the patient can be interrupted
by setting the infusion flow regulator to zero or pressing .
• When all the following conditions are fulfilled, that is:

- the emptying of the venous drip chamber, or blood is mixed with ultrapure
dialysis fluid
the blood pump stops (PUMP OFF warning), the electroclamp closes and the infusion
flow value is automatically reduced.
• Restart the pump to complete rinseback but pay attention because the infusion
pump goes on running without interruption.
• Set the infusion flow regulator to zero or .

• .
machine.
rinsing rinsing yes

and confirm ( ) to start a few
minute rinsing cycle during which the self-diagnostic tests are
performed.
Then the machine reverts to a low-consumption rinsing condition
and waits for operator’s intervention.

early early
disinf./clean. yes
disinf./clean.
and confirm ( ) to start a
short high flux rinsing phase (90 sec. at 800 ml/min) at the end
of which only the disinfection/cleaning program is allowed.
dialyser The function is available when the message EMPTYING appears

drain on on the top right bar. Press the key to empty the dialyser again.
WARNING
dialyser
drain on
(or ) before removing the BLUE Hansen
connector from the dialyser.
bidry The function is available only in case of bicarbonate cartridge

drain on dialysis (also see the Chapter “PATIENT RINSEBACK”).
Press the key to empty the cartridge. Disconnect the blue
cartridge connector and check that the clamps are open.
When using a pierceable bicarbonate cartridge, remove the upper

piercing connector from the upper clip support and disconnect it
from the cartridge. Keep the cartridge in the lower piercing
bidry
drain on
connector. . Wait for the cartridge to empty
and then remove it. Re-close the mobile bypass over the lower
piercing connector. Re-close the upper piercing connector over
the mobile bypass and lock it with the locking bracket.
WARNING
dialyser bidry
drain on drain on
Once the or key functions have been pressed, the
dialyser is bypassed and it is impossible to continue rinseback infusing
ultrapure dialysis
dialysis fluid.
• Remove the disposable accessories and discard them.


7.1 HAEMODIAFILTRATION WITH ENDOGENOUS
REINFUSION OF ULTRAFILTRATE (HFR)
DESCRIPTION
Haemodiafiltration with on-line reinfusion to the patient of his/her own ultrafiltrate
(HFR) utilises a double chamber dialyser that enables separation of the diffusive and
convective processes. The ultrafiltrate obtained from the convective section of the
dialyser crosses an adsorbent cartridge containing both insoluble synthetic styrene
resin and uncovered active carbon (SELECTA PLUS) or only resin (SELECTA). These
materials are immobilised inside the cartridge by means of disc filters.
This treatment may be carried out only on formula 2000 machines, i.e. machines
equipped with UF/infusion pump.
INSTALLATION OF DISPOSABLE
DISPOSABLE MATERIALS
Refer to chapter on Disposable materials for use in HFR treatment.
DIALYSER
Install the dialyser in its support and carefully read the instructions on the
packaging related to use of the filter.
WARNING
HFR treatment may be carried out only with HFR dialysers and SELECTA or
SELECTA PLUS adsorbent cartridges.
ADSORBENT CARTRIDGE
The adsorbent cartridge is to be mounted on the relevant support hooked onto the
stand.
BLOOD AND INFUSION LINES
WARNING
• To avoid potentially dangerous situations, carefully read the directions on
• Check that the device packaging, which ensures their sterility, is not
damaged and that the sterilization validity date has not expired.
• Ensure that installation is carried out properly using aseptic techniques.
• It is recommended to use the specific lines (see Disposable materials
chapter). Alarms and performance may be affected if inappropriate lines
are used.
• Use only lines with blood catcher for the connection to the pressure
transducers.
• During dialysis, if blood or any other fluid comes into contact with the
blood catcher, and fluid passage through the membrane is detected or
suspected, proceed as follows:
- replace the line as indicated in the instructions given by the manufacturer;
ENG – Ed. 06/09 chap. 7.1 - Haemodiafiltration HFR - 1 of 18

- contact
contact the authorised Technical Services to check and disinfect the
internal measuring set;
- DO NOT USE the machine for further treatments before it has been
checked and disinfected.
2 of 18 - chap. 7.1 – Haemodiafiltration HFR ENG – Ed. 06/09

ARTERIAL LINE
- Fix the expansion chamber in the relevant support (1).
- Connect the Luer connector of the blood catcher (if present on the arterial
- Open the cover of the arterial pump.
- Fasten the inlet of the arterial segment in the lower guide set (follow the
direction of the screen-printed red arrow). (For semi-automatic loading of the
pump segment, refer to the relevant paragraph in the chapter PREPARATION OF
TREATMENT).
- Turn the pump anti-clockwise and fit the segment.
- Fasten the other end of the segment in the upper guide set.
- Fold the drive handle back into the pump block and close the cover.
- Accurately insert the arterial line into the blood detector (2) and the fixing clip
(3) next to the electric safety clamp. If the arterial electric clamp (double clamp)
is fitted, insert the arterial line following the instructions in the paragraph
“Automatic opening of the clamp” in the chapter PREPARATION OF TREATMENT.
- Connect the Luer-lock connector of the blood catcher (at pump inlet) to the
- Connect the red line connector to the blood inflow connector of the HFR dialyser.
- Fasten the line in the clip on the dialyser holder.
- Fasten the line in the clip (red) (5).
- Connect the heparin syringe (see chapter “Heparin”).

1b

VENOUS LINE
- Insert the venous drip chamber into its support (1), positioning it approximately
- Insert the venous line into the air detector (2).
- Insert the line into the electroclamp pressing the lever downward and accurately
position the tube in the fastening clip. (For automatic opening of the
electroclamp, refer to the relevant paragraph in the chapter “PREPARATION OF
TREATMENT”).
- Attach the connector (blue) to the blood outlet connector (blue) of the HFR
dialyser.
- Connect the Luer-lock connector of the blood catcher to the venous pressure
gauge (blue) (3).
- Fasten the line in the relevant clip (blue) (4).
- Hang the priming liquid collection bag on its support on the stand.
3
4

ULTRAFILTRATION/INFUSION
ULTRAFILTRATION/INFUSION LINE
- Position the adsorbent cartridge (1) in its support on the stand below the HFR
dialyser and the infusion line drip chamber.
WARNING
The cartridge has to be positioned with the inlet facing upwards (refer to
the instructions on the label).
Should air bubbles form inside the cartridge, they must be removed
during rinsing. Air may cause excessive pressure loss.
- Connect the yellow terminal of the ultrafiltrate circulation line (2) to the outlet of
the convective section of the HFR dialyser and the other terminal (3) to the inlet
of the adsorbent cartridge.
- Clamp the section of line between the first deaeration filter and the cartridge.
- Connect the section of line connected to the priming liquid collection bag to the
outlet of the adsorbent cartridge (4) .
- Hang the priming liquid collection bag on its support on the stand (5).
WARNING
• If using a Selecta cartridge, disconnect the end section of the line leading
from the adsorbent cartridge from the collection bag and connect it to
the infusion point of the dialyser (10), then proceed with the next steps.
• If using a Selecta Plus cartridge, proceed with the next steps.
- Position the drip chamber in the right-hand side clip (6).

- Open the UF/infusion pump cover.
- Lift the folding drive handle of the infusion head.
- Fasten the initial connection of the infusion pump segment (tube leading from
the dialyser) in the left guide set of the infusion pump head (follow the direction
of the screen-printed blue arrow). (For semi-automatic loading of the pump
segment, see chapter Preparation of Treatment).
- Make the segment stick to the inner wall of the head by simultaneously turning
the rotor (anticlockwise).
- Insert a segment of the pre-pump line into the end-of-infusion detector (7).
- Connect the transparent Luer connector of the blood catcher (tube on the drip
chamber) to the infusion pressure transducer (8).
- Only after selecting priming, connect the Luer connector of the blood catcher (if
present on the UF/infusion line) to the UF/infusion pressure transducer (8b)
(yellow).
- Insert the segment of line between the drip chamber and the deaeration filter
into the blood leak detector (BLD) block (green) (9).
- Prepare the physiological solution for priming. It is suggested to use a heparin
solution of 5000 IU/l (if necessary, use the Y-connector to join two bags).

NOTE
see/mod.
parameters
blood stop priming
priming volume
WARNING
• Be extremely careful
careful when connecting the cartridge, in particular when
removing the protective caps, to prevent spilling filling liquid. Follow the
instructions for direction of flow shown on the label.
• Replace the cartridge if the internal liquid runs out or in the event of
excessive air.
• Do not clamp the pressure measurement line.
Infusion line assembly with Infusion line assembly with

SELECTA cartridge SELECTA
SELECTA PLUS cartridge

SELECTING LINE PRIMING
PRIMING
select
priming
To activate blood line priming .
return
to cancel and return to the previous menu.
There are various options to select the treatment depending on the cartridge to be
used:
hfr
Selecta
to select HFR treatment with use of the SELECTA cartridge. This
function is the only one available if the following is set during service configuration:
HFR cartridge = SELECTA
hfr
Selecta Plus
to select HFR treatment with use of the SELECTA PLUS cartridge.
This function is the only one available if the following is set during service
configuration:
HFR cartridge = SELECTA PLUS
If, however, configuring:
HFR cartridge = BOTH
the two functions are both available, and are associated with the same button.
ok
Only in this case, when pressing to confirm, the following dialogue
window appears:
HFR cartridge: SELECTA

Do you confirm?
or:
HFR cartridge
cartridge:: SELECTA PLUS
Do you confirm?
return
to cancel and return to the previous menu
ok
to confirm.

NOTE
cancel
priming
to cancel priming and return to the rinsing phase.
NOTE
If configuring:
HFR cartridge = BOTH
the configured values for HFR Priming QB, HFR Priming Vol. and HFR Stop
Priming Vol. refer to line priming with Selecta cartridge. In the case of line
priming with Selecta Plus cartridge, these respectively assume the following
default values: 200 ml/min, 4 l and 1 l.
It is however possible to modify the stop priming and end priming volumes
see/mod. blood stop
parameters priming
and and respectively select or
priming
volume
LINE PRIMING WITH SELECTA

SELECTA PLUS CARTRIDGE
• Position the HFR dialyser with the arterial inlet facing down.
• Start the blood pump ( ). The infusion pump stays off.

• It is suggested to prime the dialyser with flows not exceeding 100 ml/min.
• Fill the arterial expansion chamber up to 1/3 and connect the Luer connector of
the blood catcher (if present on the arterial expansion chamber) to the prefilter
arterial pressure gauge (red).
• Fill the venous drip chamber up to 2/3.
electroclamp opens and line priming ends.
• After the first stop (i.e. 0.2 litres before the HFR STOP PRIMING VOL. has been
reached), check that no air flows from the venous outlet and turn the HFR
dialyser so that the arterial inlet faces upwards.
• Check that the UF/infusion pump is not set to 0. . The blood pump
will automatically operate at a rate of 90 ml/min and the UF/infusion pump at a
rate of 60 ml/min for 1 to 3 minutes. Unclamp as soon as the priming fluid
reaches the first deaeration filter and the level in the infusion drip chamber is
about 1/3.
• After the initial 1-3 min and for the entire duration of the remaining priming
volume, the blood flow is automatically set to the HFR PRIMING Qb value
(displayed via the Eff. Qb tool) and the UF/infusion flow is automatically set to
2/3 of the blood flow.
• In this phase the infusion pump stops whenever the blood pump stops.
WARNING
Priming of the infusion line should be carried
carried out correctly in order to
replace all the fluid contained in the adsorbent cartridge.
The cartridge must be rinsed with at least two litres of saline solution.
If changing the treatment mode during HFR priming (e.g. switching from
HFR to DN and then back to HFR), the totalized priming volume will be reset.
reset.

• The machine stops 0.2 l before the Stop Priming value is reached.
• formula stops again 0.4 l before the End priming value is reached and after
• Priming in any case ends when the sensor on the arterial line detects blood.
• On completion of rinsing, set the UF/infusion flow regulator to zero and connect
the terminal section of the line leading from the adsorbent cartridge to the
dialyser infusion point (10).
It is absolutely essential that the latter operation be carried out in order to

avoid uncontrolled patient weight loss.
LINE PRIMING WITH SELECTA

SELECTA CARTRIDGE
• Position the dialyser with the arterial inlet facing down.
• Start the blood pump ( ). In this phase the blood flow is automatically
set to the configured HFR Priming Qb value. The infusion pump stays off.
• Fill the arterial expansion chamber up to 1/3 and connect the Luer connector of
the blood catcher (if present on the arterial expansion chamber) to the prefilter
arterial pressure gauge (red).
• Fill the venous drip chamber up to 2/3.
electroclamp opens and line priming ends.
• After the first stop (i.e. 0.2 litres before the HFR STOP PRIMING VOL. set during
configuration has been reached), check that no air flows from the venous outlet
and turn the HFR dialyser so that the arterial inlet faces upwards.
• Check that the UF/infusion pump is not set to 0. . The blood pump
will automatically operate at a rate of 90 ml/min and the UF/infusion pump at a
rate of 60 ml/min for 1 to 3 minutes. Unclamp as soon as the priming fluid
reaches the first deaeration filter and the level in the infusion drip chamber is
about 1/3.

• After the initial 1-3 min and for the entire duration of the remaining priming
volume, the blood flow is automatically set to 150 ml/min (displayed via the Eff.
Qb tool) and the UF/infusion flow is automatically set to 133 ml/min.
• In this phase the infusion pump stops whenever the blood pump stops.
WARNING
Priming of the infusion line should be carried out correctly in order to
replace all the fluid contained in the adsorbent cartridge.
The cartridge must be rinsed with at least two litres of saline solution.
If changing the treatment mode during HFR priming (e.g. switching from
HFR to DN and then back to HFR), the totalized priming volume will be reset.

• Priming in any case ends when the sensor on the arterial line detects blood.

For preparation of the dialysis fluid, setting the ultrafiltration program and changing
treatment mode, refer to the descriptions in the corresponding chapters of the user
manual.
• to bypass the HFR dialyser.

• Connect the arterial line to the patient in accordance with the procedure used at
the centre.
patient,
• and check that the clamps on the pressure measurement lines and
the main line are open.
• to connect the HFR dialyser to the dialysis fluid.

• As soon as blood in the arterial line is detected, the message CONNECT appears
on the top right bar (blood section). Blood circulates to prime the venous blood
line and the HFR dialyser. As soon as blood is detected in the venous drip
chamber, if the relevant parameter was set in configuration, an additional pump
stop is performed; if not, wait until the message DIALYSIS appears. In the left
status bar appears the message BIC. (/BIDRY/ACETATE) + STD A. CONC.
(LYMPHA) - PROG.
SETTING appears.
• The preset parameters (temperature, conductivity, dialysate flow, treatment time,
UF/h, weight loss) can be set at any time during the dialysis treatment session.
see/mod.
parameters
and follow the indications shown in chap. Operator Interface.
see/mod. dialysate
parameters
• During the dialysis, if and are selected, the total
running treatment time is shown beneath the treatment time instrument.

see/mod. see other
and and refer to the “blood volume” instrument in
chap. Operator Interface.
OPERATING IN HFR
• Ultrafiltration must be set without taking account of infusion.
• The treatment is indicated with the letters HFR shown in the top status bar on the
display.
• If the UF/infusion flow has not been set (= 0), the NO INFUSION FLOW warning
appears. NULLO.
• At any moment during the dialysis session the UF/infusion flow can be displayed.
The total UF/infused amount is shown on the second page of the display.
see/mod. see other
.
• The UF/infusion pump operates only if the blood pump is active.
• The dialyser bypass and UF/infusion pump are independent of each other, i.e.
1. the UF/infusion pump operates even when the weight loss program is inactive.
2. the weight loss program continues even if the UF/infusion pump has stopped due
to an alarm in the UF/infusion section.
WARNING
In case of leaks of UF/infusion liquid into the environment, check the patient
weight, immediately interrupt the HFR treatment and continue in Double
Needle.
To enable the Aequilibrium application (also in Isonatric mode) in HFR, see the
Chapter “PROFILER”.
ADJUSTING THE UF/INFUSION

UF/INFUSION FLOW
If the parameter Kit Press. Transd. is set to zero during service configuration, the
UF/infusion flow is set by means of the UF/infusion flow regulator.
Otherwise, the automatic UF/infusion flow adjustment is enabled when entering HFR
dialysis.
This mechanism determines the optimal value of the UF/infusion flow on the basis
of the hematocrit of the patient (if the Hemox sensor is present), the
transmembrane pressure measured on the hemofilter and the control parameters
(Qinf
Qinf LV, FF max, TMPH max) max set during configuration (refer to the chapter
“Configuration”). The UF/infusion flow rate is initially set to the configured value so
as to guarantee optimal linear velocity (Qinf LV).
LV
This flow rate decreases if the transmembrane pressure measured on the hemofilter
exceeds the threshold set in configuration (TMPH
TMPH max)
max and/or if the fraction of
filtration exceeds the maximum configured threshold (FFFF max).
max In any case, the
automatic adjustment mechanism does not reduce the UF/infusion flow to below 1
l/h.
When automatic UF/infusion flow adjustment is enabled, the Qinf tool has a green
background.
Automatic flow adjustment can be disabled during dialysis:

see/mod. blood Auto Qinf
parameters on
or re-enabled:
see/mod. blood Auto Qinf

parameters on
Should automatic flow adjustment be disabled, the UF/infusion flow is set by means
of the UF/infusion flow regulator.
PATIENT RINSEBACK
Refer to the Patient Rinseback chapter for general information.
NOTE
During rinseback with air, the infusion pump remains still.
PATIENT RINSEBACK WITH AIR
• After confirming the Rinseback command, the equipment activates the transition
to the Rinseback I phase (see the general chapter on patient rinseback): the
blood pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is
interrupted.

• The venous and arterial pressure alarms absolute thresholds are set
automatically.
rinseback), the blood pump stops (PUMP STOP message) and the electroclamp is
closed.
• Press to infuse any blood present in the venous line. The arterial
pump rotates only one time before coming to a stop.

WARNING
If rinseback is performed with air, the AIR DETECTED alarm is not active
during emptying (Rinseback II). Therefore carry out patient rinseback with
extreme care to prevent passage of air bubbles into the vein.

machine. The Filter Emptying procedure will be performed automatically.
• If the bicarbonate powder cartridge is present, perform the emptying procedure
(see the Chapter “PATIENT RINSEBACK”).

RINSEBACK WITH PHYSIOLOGICAL
PHYSIOLOGICAL SALINE SOLUTION
SOLUTION
WARNING
In Rinseback with physiological saline solution, check with care the quantity
of physiological saline solution infused to the patient to prevent weight loss
errors.

Interface chapter.
• After confirming the Rinseback command, the equipment activates the transition
to the Rinseback I phase (see the general chapter on patient rinseback): the
blood pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is
interrupted.
solution bag.

• The venous and arterial pressure alarms absolute thresholds are set
automatically.
rinseback), the equipment stops the blood pump (PUMP STOP message) and
closes the electroclamp.
• to infuse any blood-saline solution in the venous line

• The arterial pump performs continuous rotation with a reduced flow. If
necessary, adjust the blood flow using the flow regulator.

machine. The Filter Emptying procedure will be performed automatically.
procedure (see the Chapter “PATIENT RINSEBACK”)

8.1 PROFILES
INDICATIONS
Dialysis is generally performed using constant values for dialysis parameters, which are set at
the beginning of the treatment and are changed throughout the session only further to eventual
problems.
The profiling feature represents a different approach to the dialysis treatment: it enables the
physician to appropriately change some parameters during the dialysis session and therefore to
execute patient tailored treatments.
THE PROFILES
The profiles are curves defining the variations to which certain parameters are subjected during
dialysis in order to make treatment more tolerable.
The profiles can be divided into:
STANDARD PROFILES : profiles with qualitative predefined characteristics, which are easy for
the operator to use and require , when used, the input of very few parameters.
To use these profiles, the following parameters are to be set during service configuration (by
technical or authorized personnel)
PROFILES = STD
Profiled parameters:
1. Hourly weight loss rate
2. Total conductivity
USER PROFILES: profiles that are entirely defined by the user in configuration mode.
To use both standard and user profiles, the following parameters are to be set in configuration:
PROFILES = SPE
Profiled parameters:
1. Hourly weight loss rate
2. Sequential dialysis (hourly weight loss + isolated dialysis)
3. Total conductivity
4. Partial conductivity
5. Heparin (continuous infusion + Boluses)
NOTE
The user profiles are extremely versatile, as they allow the user to create a profile with
no limitations and to associate weight loss rate profiles with both total and partial
conductivity profiles, as well as with heparin (both by continuous infusion and by
bolus) and isolated dialysis.
However, due to this versatility, their definition in configuration mode and their
subsequent use in dialysis is not such a simple process, and if incorrectly used, they
may cause serious harm to the patient.
ENG – Ed. 12/07 chap. 8.1 - Profiles - 1 of 26

The USER PROFILES are therefore for “skilled” users only, and those interested in their
use should contact the Marketing Department and/or Post Sales Department to obtain
further information and, if necessary, suitable training.
WARNINGS
These profiles are only to be used by adequately trained medical staff.
Before using the profiles, check that the profiling parameters have been correctly
configured during installation of formula ®.
The setting of the profile parameters in configuration can only be done by Technicians
authorized by the manufacturer or by medical staff. Adequacy of these parameters for
dialysis is the sole responsibility of the medical staff.
The setting of the profiling parameters is not subject to any special controls by
formula® (which merely guarantees that the profiles will be carried out as they have
been configured and set by the operator), to allow the greatest possible level of
versatility. However, it is consequently recommended that the medical staff of the
dialysis unit manage these parameters with extreme care, to avoid dialysis that is
inadequate or even harmful for the patient.
The use of profiles, the association of a weight loss rate profile to a specific total
conductivity profile rather than to constant total conductivity of the dialysing fluid,
substitution or cancellation of a profile during treatment, may all, if incorrectly used,
cause serious injury to the patient; the machine is obviously unable to evaluate
whether or not the above options are suitable (as they depend on the patient and
his/her specific clinical characteristics), and the medical staff of the dialysis unit is
therefore solely responsible for case-by-case evaluation of how and when to use the
profiles.
It is recommended that great attention is paid to the warning message VERIFY

PROFILE, as it indicates that the machine is not able to follow the selected profiles
completely; if you do not adjust the set parameters so as to make the warning
message disappear, but merely press to override it, this means that the expected
total weight loss and/or amount of electrolytes to be exchanged will not be obtained.
Whenever you set or modify the dialysis parameters, you are recommended to use the
on-line HELP function to consult the profile tables, and check that the values displayed
are the ones you require.
2 of 26 – chap. 8.1 - Profiles ENG – Ed. 12/07

STANDARD PROFILES
formula® allows seven types of standard profiles, each of which can be independently applied
to weight loss rate (kg/h) and total conductivity (mS/cm), so as to combine different types of
profiles for the two parameters. The standard profiles available on formula®are the following:
LINEAR PROFILE
The profiled parameter varies according to a LINEAR rule over the time. The user has to set the
desired starting value.
Start value
WARNING
The total treatment time is divided into 15 min intervals in which the parameter value
is constant.
PARABOLIC PROFILE
The profiled parameter varies according to a PARABOLIC rule over the time. The user has to set
the desired max. value and the instant in which the max. value is to be reached.
Max value
TMAX T
WARNING
is constant.

CUBIC PROFILE
The profiled parameter varies according to a CUBIC rule over the time. The user has to set the
starting value, the maximum value and the instant in which the max. value is to be reached.
Max value
Start value
TMAX T
WARNING
is constant.
EXPONENTIAL PROFILE
The profiled parameter varies according to an EXPONENTIAL rule over the time. The user has to
set the desired starting value.
Start value
WARNING
is constant.

STEPPED PROFILE
The treatment time is divided into 4 phases of equal duration: during each phase the profiled
parameter corresponds to the percentage set for that phase.
WARNING
The total treatment time is split into 4 phases each lasting 15 min. (the fourth phase
may have a different duration than the other three).
SQUARE WAVE PROFILE

Dialysis is carried out in a succession of cycles.
Each cycle is made up of 2 phases: in the first phase the profiled value depends on the dialysis
parameters; in the second phase it takes on the constant value set by the user. Phase time can
be set by the user.
Set value
T1
T2
T
WARNING
is constant.
Depending on the configured and set times, the phases of the last cycle may be
different from the set values.

REVERSE SQUARE WAVE PROFILE
Dialysis is carried out in a succession of cycles.
Each cycle is made up of 2 phases: in the first phase the parameter corresponds to the value set
by the user; in the second phase it depends on the dialysis parameters. Phase time can be set
by the user.
Set value
T1
T2
T
WARNING
is constant.
Depending on the configured and set times, the phases of the last cycle may be
different from the set values.

SETTING THE STANDARD PROFILE
To set the standard profile to be used for dialysis, proceed as follows:
see/mod. profiles Standard
parameters profiles
The following windows will appear:
As it can be noticed, it is possible to separately select the UF and TC profiles to combine and
activate. To do this, press UF profile type and TC profile type and then use the keys or
to select the desired profile. It is also possible to activate only one of the two profiles by
selecting no profile for the other one.
ok
to confirm and to access the pages for parameter settings. If a UF profile
has been activated, the first window to be displayed is that pertaining to the weight loss rate.
Here below the window of the UF cubic profile is given as an example:

To return to the main page.
return
treatment To set the duration of the treatment (hh:mm).

time
weight To set the total weight loss (Kg).

loss
starting To set the UF value (Kg/h) in the first quarter of an hour.

UF
To set the max. UF value (Kg/h) of the profile.

UF Max
To set the instant in which the UF has to reach the max. set value (UF Max).
Tmax
Tmax changes every quarter of an hour and the maximum UF value is kept
unchanged for the whole following quarter.
The table displayed below the graphic tools shows the calculated and discrete profile in
numerical pattern, with the values to use during dialysis.
The menus of the other profiles are similar to that shown; here below only the parameters,
which differ from those already explained, are indicated.
STEPPED PROFILE
1st To set the weight loss percentage in the first quarter of the dialysis session.
step
2nd To set the weight loss percentage in the second quarter of the dialysis
step session.
3rd To set the weight loss percentage in the third quarter of the dialysis session.
step
4th To set the weight loss percentage in the last quarter of the dialysis session.
step

SQUARE WAVE PROFILE
UF To set the UF value in the second phase of the wave.

2nd sector
1st To set the duration of the first phase of the wave.

phase
2nd To set the duration of the second phase of the wave.

phase
REVERSE SQUARE WAVE PROFILE
UF To set the UF value in the first phase of the wave.

1st sector
1st To set the duration of the first phase of the wave.

phase
2nd To set the duration of the second phase of the wave.

phase
Press OK to confirm and to display the profile graph; should it not meet the user requirements,
return to the setting parameter page by pressing return:
The next window pertains to total conductivity profile settings (if this has been selected ); the
menus are analogous to those described for ultrafiltration, simply refer to total conductivity
rather than to weight loss rate.

WARNING
If an UF profile has already been set, the treatment duration cannot be modified in the
window of the TC profile parameters.
Once confirmed also the total conductivity profile, the window of the treatment parameters is
shown, in which the parameters not previously set can now be selected (i.e. partial
conductivity).
At this point it is recommended to press and display the on-line HELP for the selected
profile, and then press or to check that the values indicated in the displayed tables
are the ones required.
NOTE
The tables show the weight loss rate in kg/h and the total conductivity in mS/cm every
15-minute intervals.
During dialysis with profiles, according to the type of treatment, one of the following messages
will be displayed in the top left bar of the screen:
BIC+STD. A. CONC. - PROF. instead of BIC+STD. A. CONC. - PROG.
BIC + LYMPHA – PROF. instead of BIC + LYMPHA – PROG.
ACETATE - PROF. instead of ACETATE - PROG.
BIDRY+STD. A. CONC. - PROF. instead of BIDRY+STD. A. CONC. - PROG.

BIDRY + LYMPHA – PROF. instead of BIDRY+ LYMPHA – PROG.
During dialysis the tools for weight loss rate and total conductivity may be displayed with a
background of one of the following colours:
text field (left hand side of the tool):
- GREY not profiled variable
- GREEN profiled variable
- ORANGE profiled variable, but with value limited to max. or min. allowed
number field (right hand side of the tool):

- WHITE active, not profiled variable
- RED light
- GREEN active, profiled variable
- ORANGE variable with value limited to max. or min. allowed, but not in alarm mode

CHANGING THE STANDARD PROFILE
Once the profile is active, it can be changed at any moment during the treatment by pressing
see/mod. profiles standard modify

parameters profiles profile
Thus doing it is possible to recall all the windows for profile setting (see par. SETTING THE
STANDARD PROFILE) and modify the type and/or the parameters.
WARNING
Carry out this procedure also when the treatment time, the total weight loss and the
total conductivity are to be modified, as changing these parameters requires that the
profile is recalculated and then reconfirmed by the user.
Therefore, if the profile is active, modification of the a.m. parameters cannot be carried
out by pressing
see/mod. dialysate
parameters
SAVING A STANDARD PROFILE AS A USER PROFILE

If during Service configuration the following parameter has been set:
Profiles = SPE
the standard profile in progress can be saved as a user profile, thus allowing the user to recall it
in the next dialysis sessions without having to reset it up.
By pressing:
see/mod. profiles Save

parameters Profile
the following screen will open:

Identifier To select, using the keys or , the position in which to save the
current profile inside the profile file.
If the position is already occupied, the fields show the name of the profile
stored in that position, which can anyway be overwritten.
Profile
name To set the name of the profile to save. Use the keys or to move
on the character to be modified, use the keys or to change the

selected character .
WARNING
The first three characters identified as "{s}" are fixed and allow to distinguish the user
profiles, created by saving some standard profiles, from the others. Such distinction is
required as such profiles, which can be recalled as the other user profiles, do not allow
to modify the treatment duration (such limitation allows to keep the curve of the
profile unchanged).
Therefore the treatment duration will correspond to the value set in the standard
profile.
CANCELLING THE STANDARD PROFILE

It is possible, even during dialysis, to cancel an active standard profile and to continue treatment
without using profiles.
To cancel the profile, proceed as follows:
see/mod. profiles
parameters
The following menu will appear:
Cancel To cancel only the weight loss profile and to continue dialysis with a
UF profile constant weight loss rate.
Cancel To cancel only the total conductivity profile and to continue dialysis with a
TC profile constant total conductivity.
Cancel To cancell all the active profiles and to continue dialysis with constant
profile weight loss rate and conductivity.
Once cancelling the profile is confirmed, the modification page of the dialysis parameters is
automatically displayed. This page allows to set the constant values of the parameters no longer
profiled.

IMPORTANT
Carefully check that:
1. The constant weight loss rate and total conductivity used after cancelling the profile
are the ones desired.
2. Interruption of the profile in progress - with consequent use of those constant
hourly weight loss and total conductivity values until the end of dialysis - is
compatible with the adequacy of the dialysis in progress and the specific clinical
needs of the patient treated.

USER PROFILES
User profiles can be divided into:
NORMAL
It allows free profiling of weight loss rate, sequential dialysis (weight loss rate + isolated
dialysis), total and partial conductivity, heparin (continuous flow + boluses).
LINEAR
It allows profiling of weight loss rate and total conductivity in linear mode, while heparin
(continuous flow + boluses) is profiled freely, as in the NORMAL profile.
STEPPED
It allows profiling of weight loss rate and total conductivity in stepped mode, while heparin
SQUARE WAVE
It allows profiling of weight loss rate and total conductivity in square wave mode, while heparin
For every user profile there are parameters set in configuration (accessible to the nurse), which
define the qualitative feature, as well as parameters set during dialysis, which determine the
quantitative feature. According to the values given to these parameters, the system calculates
the correct setting for the profiled parameter.
The vectors which define the user profiles are stored in files; this allows the storage of up to
100 different profiles, each with an identifying name and number, which can be freely
associated with a patient name or a particular curve shape.
The setting of the data in configuration refers to a 4-hour standard dialysis with weight loss of 4
kg and total conductivity of 14.0 mS/cm; the treatment time is the leading profiling parameter
which is the temporal variable for the calculation of the parameter trends. The values set in
dialysis are correlated to those set in configuration; it is obvious that not all the set values are
compatible with the chosen profile, but this is also true, for example, for the simple setting of
the weight loss rate program.
The considerations above apply to each of the profiled parameters: the machine guarantees that
the set value does not exceed the range but it cannot assure that the result is always the one
wished by the operator; therefore the profiled value undergoes a limitation before the profiling
function takes place.

CONFIGURATION OF USER PROFILES
The user profiles are set in configuration, starting from the page shown on the following screen
(see chapter Configuration to set configuration parameters):
In this page first of all it is possible to select the profile identification number; if this number
corresponds to an existing profile, the name and type are shown. The profile type and name can
now be changed. Once confirmed, the pages of the profiling parameters, which depend on the
selected profile, will be accessed.
NORMAL PROFILE – hourly weight loss rate
In this page you can set the desired weight loss rate (in kg/h), for every 15-minute interval, in a
theoretical standard 4-hour dialysis; it therefore sets the qualitative trend of the weight loss
rate curve. Furthermore you can set the Treat. time and total weight loss rate (also called
“simulation variables”) to display – in the BLUE table – the profile that would be effectively
carried out if just those values of treatment duration and total weight loss had been input (refer
to the par. RESULTING CURVE AND SIMULATION VARIABLES). This rule applies to all of the
remaining pages.
NORMAL PROFILE – sequential dialysis (1)
This page is analogous to the weight loss rate page, but the resulting table is used for the
sequential dialysis profile, in which dialysis and isolated dialysis alternate following the outline
set in the successive page.
NORMAL PROFILE – sequential dialysis (2)
In this page you can select, for each 15-minute interval, if the UF value, already set in the
previous page, is to be carried out in standard dialysis mode (DIA) or isolated dialysis mode
(ISO).
NORMAL PROFILE – total conductivity
In this page, analogous to the weight loss rate page, you can set the desired total conductivity
(mS/cm), for every 15-minute interval, in a theoretical 4-hour standard dialysis.
NORMAL PROFILE – partial conductivity

In this page, analogous to the weight loss rate page, you can set the desired partial conductivity
(mS/cm), for every 15-minute interval, in a theoretical 4-hour standard dialysis.
NORMAL PROFILE – heparin infusion

In this page, analogous to the weight loss rate page, you can set the heparin infusion rate (in
cc/h), for a theoretical 4-hour standard dialysis.

NORMAL PROFILE – heparin boluses
In this page, for every 15-minute interval of a 4-hour standard dialysis, you can set the amount
of heparin to administer at the beginning of each quarter of an hour.
WARNING
The NORMAL user profile, whose name starts with “{s}”, results from a standard
profile saved during dialysis. The configuration of these profiles is quite similar to the
configuration of a NORMAL user profile, except for the following:
1. the pages of sequential dialysis are not present;
2. the pages of weight loss rate and total conductivity simply display the stored data
(eventually simulating variation of weight loss rate or total conductivity): it is not
allowed to modify these tables as for any NORMAL profile.
Let’ s now go through the settings of linear, stepped and square wave profiles. For all these
profiles the pages pertaining to sequential dialysis and partial conductivity are not present, while
those pertaining to infusion and heparin boluses are quite similar to a NORMAL profile page.
Therefore the only pages not yet described are those of weight loss rate and total conductivity.
LINEAR PROFILE – hourly weight loss rate
SETTING 'LINEAR' RANGE

PROFILE
Starting weight loss rate 0.1 ÷ 2.5 The weight loss rate at the beginning of dialysis
(Kg/hr) depends on the set total weight loss and treatment
time; then, every 15 min the weight loss will vary
by:
(Starting weight loss rateconfigured -
Final weight loss rateconfigured) / 16
CAUTION: The starting and final values of

weight loss rate DO NOT correspond to the
values of beginning and end dialysis; these
values are only used for the qualitative
definition of the profile.
Final weight loss rate 0.1 ÷ 2.5
(kg/hr)

LINEAR PROFILE – total conductivity
SETTING 'LINEAR' RANGE

PROFILE
Starting total 12.1 ÷ 15.7 The total conductivity at the beginning of dialysis
conductivity (mS/cm) depends on the set total conductivity and treatment
Final total conductivity 12.1 ÷ 15.7 time; then, every 15 min the total conductivity will vary
(mS/cm) by:
(Starting total conductivityconfigured – Final total
conductivityconfigured) / 16.
CAUTION: The starting and final values of total

conductivity DO NOT correspond to the values of
beginning and end dialysis; these values are only
used for the qualitative definition of the profile.
STEPPED PROFILE – hourly weight loss rate
SETTING RANGE
'STEPPED' PROFILE
Weight Loss: first phase (%) 0 ÷ 100 The treatment time is divided into 4 phases of equal
Weight Loss: Second phase duration: during each phase there is a weight loss
0 ÷ 100
(%) rate corresponding to the percentage configured for
Weight Loss: Third phase that phase.
0 ÷ 100
(%)
Weight Loss: Fourth phase In practice, the total weight loss set for dialysis is
0 ÷ 100
(%) achieved in four phases, during each of which a
percentage of the total weight loss is extracted
equivalent to the one set for that phase .
CAUTION: The total treatment time is split into

4 phases each lasting 15 min. (the fourth phase
may have a different duration than the other
three).

STEPPED PROFILE – total conductivity
SETTING RANGE
'STEPPED' PROFILE
Total conductivity: first 0 ÷ 100 The treatment time is divided into 4 phases of equal
phase (%) duration: during each phase a total conductivity
Total conductivity: Second 0 ÷ 100 corresponding to the percentage configured for that
phase (%) phase is set.
Total conductivity: Third 0 ÷ 100
phase (%) CAUTION: The total treatment time is split into
Total conductivity: Fourth 0 ÷ 100 4 phases each lasting 15 min. (the fourth phase
phase (%) may have a different duration than the other
three).
SQUARE WAVE PROFILE – hourly weight loss rate
SETTING RANGE
'SQUARE WAVE' PROFILE
Weight loss rate: second 0.1 ÷ 2.5 Dialysis is carried out in a succession of cycles.
phase (kg/hr) Each cycle is made up of 2 phases:
Cycle duration : first phase 0 ÷ 600 • the first phase is carried out with a weight loss
(min) rate which depends on the set total weight loss
Cycle duration : second 0 ÷ 600 and treatment time.
phase (min) • the second phase is carried out with a weight loss
rate equal to the value specified in configuration.
CAUTION: Depending on the configured and set

times, the phases of the last cycle may be
different from the configured values.
SQUARE WAVE PROFILE – total conductivity
SETTING RANGE
'SQUARE WAVE' PROFILE
Total conductivity: second 0.1 ÷ 2.5 Dialysis is carried out in a succession of cycles.
phase (mS/cm) Each cycle is made up of 2 phases:
Cycle duration : first phase 0 ÷ 600 • the first phase is carried out with a total
(min) conductivity which depends on the set total mean
Cycle duration : second 0 ÷ 600 conductivity and treatment time.
phase (min) • the second phase is carried out with a total
conductivity value equal to the value specified in
configuration.
CAUTION: Depending on the configured and set

times, the phases of the last cycle may be
different from the configured values.

RESULTING PROFILE AND SIMULATION VARIABLES
In the user profile configuration pages, the RESULTING PROFILE of the profiled parameters is
displayed by way of example.
The resulting profile is a table displaying the values which the profiled parameters would
assume during the treatment, provided dialysis is carried out with parameter values equal to
that of simulation variables.
In other words, if after configuring the linear profile parameters:
Starting weight loss rate (kg/h)
Final weight loss rate (kg/hr)
the following values are set:
Treatment time (min) = 180
Total weight loss (kg) = 3.0
read at intervals of 15 min, the table will show the weight loss rate values during a hypothetical
dialysis of 3 kg in 3 hours, carried out with a linear profile.
The residual and total values are displayed along with the resulting profile.
The duration of dialysis may not be an entire multiple of 15 min; the residual is the remainder
(expressed in minutes) after dividing the treatment time by 15.
The totals constitute the weight loss rate, the mean conductivity (total or partial) and the
administered heparin achieved by the profile.
WARNING
The values indicated in the table, as well as those for the residual and totals are merely
an example; when the profile is used for dialysis, it is suitably and automatically
adapted to the parameters specified for that particular dialysis, and will therefore have
different values from those shown as an example in the table that is displayed during
configuration.
THE "RED" FIELDS

The resulting profile has an important function in checking and controlling the profiling
parameters while they are being configured.
The choice of profiling parameters may NOT match the parameter setting, in which case, the
corresponding fields in the tables displayed using HELP are coloured RED.
The RED fields thus indicate those values that, according to the profile configured and the
simulation variables, would be outside the limits set by formula®; these values are not
acceptable, and are therefore automatically reset to the minimum value (or to the maximum
value, accordingly) that will be accepted by formula®.
Example:
If, on the basis of the weight loss rate profile and simulation variables, the first 15 min would
give a weight loss rate of 3.0 kg/h, this value would be displayed as 2.5 kg/h (the maximum
value allowed) on a RED ground.
Even during dialysis with parameters that are the same as the simulation parameters, the weight
loss rate would be limited automatically to 2.5 kg/h, and in this way the total weight loss set
would not be obtained.
NOTE
Whether or not the fields turn RED will obviously depend on the values selected for
the simulation variables.
It is therefore recommended, during configuration, to set the simulation variables to
typical dialysis values, or in any case to values as close as possible to those to be used
during dialysis.
In this way it is eventually possible to modify the profiling parameters, so as to avoid

the presence of RED fields; this will enable the profiles to be performed in the way in
which they are configured.

RECALLING THE USER PROFILE
To recall a configured user profile, proceed as follows:
see/mod. profiles user

parameters profiles
Thus a menu is accessed which allows the operator to choose the desired user profile. After
confirming the profile type, the following window will appear:

return
To enable UF profiling. This function is available as alternative to

Ufr profile
seq. Ufr
profile
seq. Ufr To enable the sequential UF program.

profile
Ufr profile
This function is available as alternative to .
tot. cond. To enable total conductivity profiling.
profile
par. cond. To enable partial conductivity profiling.

profile
Profile To select the desired profile among the ones stored of the same type.
name
cancel To cancel the profile, when it is active.

profile

After confirming the profile, the dialysis parameter modification page is automatically displayed.
The highlighted BLUE keys correspond to the parameters involved in the selected profile.
Now proceed by setting time, weight and conductivity parameters adequate to the patient and
to the selected profile, then confirm.
A page is accessed which allows the operator to set heparin profiling according to the profile
selected with the function key.
NOTE
At any moment during the treatment it is possible to enable or disable heparin
profiling by pressing either:
see/mod. heparin use

parameters profile
or:
see/mod. heparin profile

parameters off
After confirming also the heparin page, press to display the on-line HELP for the selected
profile, and or to check that the values indicated in the tables are the ones you
require.
NOTE
The tables show the weight loss rate in kg/h and the total conductivity in mS/cm every
15-minute intervals.
During dialysis with profiles, according to the type of treatment, one of the following messages
will be displayed in the top left bar of the screen:
BIC+STD. A. CONC. - PROF. instead of BIC+STD. A. CONC. - PROG.
BIC + LYMPHA – PROF. instead of BIC + LYMPHA – PROG.
ACETATE - PROF. instead of ACETATE - PROG.
BIDRY+STD. A. CONC. - PROF. instead of BIDRY+STD. A. CONC. - PROG.

BIDRY + LYMPHA – PROF. instead of BIDRY+ LYMPHA – PROG.
During dialysis the tools for weight loss rate, partial and total conductivity may be displayed
with a background of one of the following colours:
text field (left hand side of the tool):

- GREY not profiled variable
- GREEN profiled variable
- ORANGE profiled variable, but with value limited to max. or min. allowed
number field (right hand side of the tool):

- WHITE active, not profiled variable
- RED light
- GREEN active, profiled variable
- ORANGE variable with value limited to max. or min. allowed, but not in alarm mode
The heparin program status is indicated by a syringe icon at the top right of the monitor, as
described in chap. Heparin.
USER PROFILES: CHANGE DIALYSIS PARAMETERS
It is always possible, even during dialysis with user profiles, to modify any of the dialysis
see/mod.
parameters
parameters. To do this, .
After the modification has been made, press to display the on-line HELP for the selected
profile, and or to check that the values indicated in the tables displayed are the ones
you require.
CANCELLING THE USER PROFILE

It is possible, even during dialysis, to cancel a user profile and to continue treatment without
using profiles.
To cancel the profile, proceed as follows:

see/mod. profiles cancel
parameters profile
• .
• when cancelling profile is confirmed, the dialysis parameters modification page is
automatically displayed
• dialysis continues with constant parameters equal to the values set.
IMPORTANT
1. the constant values used after cancelling the profile are the ones desired.
2. interruption of the current profile with the consequent use of constant values up to
the treatment end is compatible with the dialysis adequacy and the specific clinical
demands of the patient.

CHANGING THE USER PROFILE
It is possible, even during dialysis, to change the type of user profile (i.e. to change from a
linear to a stepped profile).
To change the profile, first cancel the current profile and then select the new one (refer to
previous paragraphs).
WARNING
It is recommended NOT to change the profile during treatment, even if allowed, as the
trend of the profiled parameters might not be sufficiently clear to the operator.
Carefully check the on-line help table to ensure that the profiled parameters take on
the desired values.
'VERIFY PROFILE' WARNING MESSAGE

The settings for dialysis time, weight and total conductivity parameters may NOT be entirely
congruent with the type of profile selected (standard or user); if this is the case, the
corresponding fields in the tables displayed using HELP are coloured RED.
The RED fields thus indicate those values that, according to the selected profile and the set
parameters, would be outside the limits allowed by formula®; these values are not acceptable,
and are therefore reset automatically to the minimum value (or to the maximum value,
accordingly) that will be accepted by formula®.
IMPORTANT
If, while setting and/or modifying the dialysis parameters, the warning message VERIFY
PROFILE is displayed, terminate the modification and press or to check

see/mod.
parameters
which of the fields in the table are RED. Then press again and adjust the
settings until the warning message VERIFY PROFILE disappears.
If, after checking which fields have turned red, you want to maintain the set values anyway,
press to override the VERIFY PROFILE warning ( this message will reappear every time
you modify a parameter and can be overridden each time by pressing ).
IMPORTANT
The presence of RED fields in the tables displayed using HELP means that during
treatment the profile will not always follow the curve foreseen, but that there will be
intervals of 15 min during which the profiled parameters will be restricted, according
to the situation, either to the minimum value allowed or to the maximum value
allowed.
In the above conditions the operator must bear in mind that the expected total values
will not be achieved (weight loss and/or conductivity and/or heparin).

DISPLAYING THE PROFILE
After confirming the profile (standard or user), the parameters may be graphically displayed:
see/mod. profiles profile

parameters graphs
.
This sequence allows the operator to enter the relevant menu and select the profiled parameter
to be displayed in graphic form.
Or, to display the information in numeric form:
see/mod. profiles profile

parameters tables
.
This sequence allows the operator to enter the relevant menu and select the profiled parameter
to be displayed in numeric form.
END UF
If a dialysis with profiles is performed, the profile is NOT cancelled when the END UF is
signalled.
WARNING
To continue dialysis after the END UF message has appeared, it is recommended to
cancel the profile and go on with constant weight loss rate and total conductivity,
otherwise the trend of the profiled parameters might not be sufficiently clear to the
operator.
To continue with the profile active, carefully check the on-line help table to ensure that
the profiled parameters take on the desired values.

8.2 PROFILER
INDICATIONS
Thanks to Profiler, formula allows the operator to exploit a new profiling method
based on the use of a mathematical model of the kinetics of the body fluids and the
main solutes, such as sodium and urea. It is possible to generate profiles of sodium
concentrate in the dialysis fluid and ultrafiltration profiles, which reduce the
incidence of low blood pressure and disequilibrium syndrome based on certain input
parameters.
The application strategy is based on a priori processing of patient tailored profiles
which can be displayed in both numerical and graphic time form.
The aim is to compensate the high loss in plasmatic osmolarity during the first two
hours of dialysis (at maximum diffusion) by increasing the sodium concentration of
the dialysis liquid (reduced sodium removal) and subsequently completing the
necessary removal of sodium during the second half of the session (at minimum
diffusion) by reducing the sodium concentration of the dialysis fluid (increased
sodium removal).
In the modelling application panorama Profiler stands out for its capability of
reconciling the descriptive complexity of a mathematical model with the ease of use
required in clinical practice.
SETTING THE PROFILES
Profiler setting is accessed via the function keys of the operator interface.
see/mod. profiles Profiler/

parameters Aequilibrium
.
ENG – Ed. 06/09 chap. - Profiler - 1 of 10

Thus a menu is accessed which allows the operator to set various parameters:
Profile To select the patient name, i.e. the data already stored for that
name profile. This data serves as initial values for the current profiling.
modify This allows the operator to enter a screen from which to change the
name saved profile name.
enable In HFR only, this allows enabling automatic recalculation of the total
Aequilibrium conductivity profile based on the ultrafiltrate conductivity reading
taken from the Natrium sensor.
enable In HFR only, this allows enabling the Aequilibrium application in

Isonatric Isonatric mode, consisting of automatic recalculation of the total
conductivity profile in order to reach a final patient sodium
concentration equal to the initial sodium concentration obtained
from the Natrium sensor.
ok
When the settings have been made, to confirm the data set and
enter the Profiler parameter edit menu.
This type of menu is displayed in a sequence and allows to modify the preset values
for the selected patient.
Dialysis parameter menu 1

return
treatment To set the duration (min) of the dialysis treatment.

duration
To set the dialysis fluid flow (ml/min).

flow
To set the dialysis fluid temperature (°C).

temperature
To set the patient blood flow (ml/min) to be maintained during

Qb
dialysis.
weight To set the patient weight (kg) at the end of dialysis.

end
weight To set the patient weight loss (kg).

loss
2 of 10 – chap. 8.2 - Profiler ENG – Ed. 06/09

Dialysis parameter menu 2
To return to dialysis parameter 1 menu.

return
To select the type of dialyser used.

filter
acid To select the type of acid concentrate used.

concentrate
tot cond To set the maximum total conductivity level attainable by that
max profile.
tot cond To set the minimum total conductivity level attainable by that
min profile.
bicarbonate To set the 1st step conductivity level (bicarbonate conductivity)

cond.
Patient parameter menu
To return to dialysis parameter 2 menu.

return
[Urea]pl To set the concentration of plasmatic urea (g/l) at the beginning of

start dialysis.
[Na]pl To set the concentration of plasmatic sodium (mEq/l) at the

start beginning of dialysis. The presence of this button and the
corresponding instrument depends on the Configuration Service
setting (Profiler parameter).
removal To set the sodium removal (mEq) or the concentration of plasmatic

Na sodium (mEq/l) to be achieved at the end of treatment. The
possibility of setting one or the other parameter depends on the
Service Configuration settings (Profiler parameter). Characteristic
[Na]pl end/
character. [Na]pl means the value to be set if isonatric dialysis is enabled
(characteristic patient sodium concentration level).
max uf
To set the maximum ultrafiltration value (kg/h).
save profile To overwrite the data previously stored with the new data set for
data the selected profile. Overwriting requires an additional confirmation
profilo
by the operator through a dialogue window.

ok
Once the required settings have been made, to calculate and
display the total conductivity and UF profiles.
Confirm both profiles to activate profiling.
WARNING
 is unable to evaluate the adequacy of the profile set (which
formula
depends on the patient and his/her specific clinical characteristics). The
operator is hence solely responsible for setting and confirming the profiles.
WARNING
The Profiler is not available in PHF PRE, PHF POST, HDF and HDF OnLine
treatments.
If the profiles are not confirmed, the profile display menu is exited to return to the
parameter edit menu to allow the operator to modify the parameters and relaunch
the profile calculation or to quit the edit menu.
If the profile calculation fails due to failed compliance with some mathematical
constraints, the operator will be instructed which parameters to modify for proper
execution of the calculation to then continue with the display/confirmation of the
profiles.

AEQUILIBRIUM
During HFR dialysis and when using a Natrium sensor, the Aequilibrium application
can be enabled within the first five minutes of treatment:
see/mod. Profiler/ enable

profiles
parameters Aequilibrium Aequilibrium
This application consists of automatic recalculation of the total conductivity profile,

carried out after the first fifteen minutes of dialysis. The recalculation is generated if
the patient’s plasma sodium concentration (taken from the Natrium reading) should
differ from the level set by the model based on the initial sodium concentration
setting.
If the Natrium sensor does not read any sodium concentration measurement within
the first five minutes of treatment, the warning “SODIUM CONCENTRATION NOT
DETECTED” is generated (see the chapter on alarms). In this case, check that the
probe is properly inserted in the sensor.
If the profile recalculation should fail due to any mathematical errors, the display
will read "AEQUIL./ISONA. NOT AVAIL.” and the system will continue to run in the
original profile set (see the chapter on alarms). However, the operator may interrupt
profiling at any moment using the "Profiler Off” function described in the next
chapter.
As the recalculation is performed after the first fifteen minutes of dialysis, the
Aequilibrium application can be disabled in this period:
see/mod. Profiler/ disable

profiles
parameters Aequilibrium Aequilibrium
WARNING
Using the following key sequence:
see/mod. profiles Profile
parameters graphs
or:
parameters tables
the active profile can be displayed in graphic or numeric form at any time. If
this is not requested by the user, it can be cancelled.
see/mod. profiles Profiler/ cancel
parameters Aequilibrium profile

ISONATRIC DIALYSIS
The isonatric dialysis application is a particular operating mode of the Aequilibrium
application, available if the Profiler parameter has been set to 4 or 6 during Service
Configuration. In this mode, the patient’s initial concentration of plasmatic sodium
obtained from the Natrium sensor during the first fifteen minutes of dialysis is also
used as the final sodium concentration setting at the time of recalculation. That way,
a total conductivity profile is achieved, which, in line with the aims of the
Aequilibrium strategy, allows at the end of dialysis obtaining a concentration of
plasmatic sodium equal to the initial concentration.
If the Natrium sensor does not read any sodium concentration measurement within
the first five minutes of treatment, the warning “SODIUM CONCENTRATION NOT
DETECTED” is generated (see the chapter on alarms). In this case, check that the
probe is properly inserted in the sensor.
If the profile recalculation should fail due to any mathematical errors, the display
will read "AEQUIL/ISONA NOT AVAIL.” and the system will continue to run in the
original profile set (see the chapter on alarms). However, the operator may interrupt
profiling at any moment using the "Profiler Off” function described in the next
chapter.
During HFR dialysis and when using a Natrium sensor, the Isonatric application can
be enabled within the first five minutes of treatment:
see/mod. Profiler/ enable

profiles
parameters Aequilibrium isonatric
The setting parameters have the same meaning as for Aequilibrium, the only
difference is the “[Na]pl end/character.” key which in the case of isonatric dialysis is
for the characteristic sodium of the patient and is used to identify the level of
sodium concentration in the patient.
Like for Aequilibrium, given that the recalculation is performed after the first fifteen
minutes of dialysis, the isonatric application can be disabled in this period:
see/mod. Profiler/ disable

profiles
parameters Aequilibrium Isonatric
WARNING
Using the following key sequence:
parameters graphs
or:
parameters tables
the active profile can be displayed in graphic or numeric form at any time. If
this is not requested by the user, it can be cancelled.

DEACTIVATING PROFILER
PROFILER
During treatment, the total conductivity and hourly ultrafiltration profiles set with
Profiler can be cancelled to continue normally without profiles.
To deactivate Profiler, proceed as follows:

When deactivation of the profile is confirmed, the dialysis parameter edit page is
automatically displayed, where the constant values of the no longer profiled
magnitudes can be set.
WARNING
1. The constant hourly weight loss and total
total conductivity values applied after
deactivating the profile are those desired.
2. Interruption
Interruption of the profile in progress - with consequent use of those
constant hourly weight loss and total conductivity values until the end of
dialysis - is compatible
compatible with the adequacy of the dialysis in progress and the
specific clinical needs of the patient treated.
NOTE
If the Profiler parameter was set to 3 or 4 during Service Configuration,
changing the treatment from HFR to DN when dialysis is inin progress will
result in cancellation of any running profile.

PARAMETER DISPLAY
The total conductivity and ultrafiltration profiles for the dialysis in process can be
displayed in graphic form at any time.

parameters graphs
The profiles are displayed as follows:
To view the values set for the profiled dialysis in progress an additional menu is
available, accessed by selecting the functions below:
see/mod. profiles Profiler/

parameters Aequilibrium

To exit the display menu and return to the main menu.
return
save profile To overwrite the data previously stored with the new data set for
data the selected profile. Overwriting requires an additional confirmation
profilo
by the operator through a dialogue window.
modify This allows the operator to enter a screen from which to change the
name saved profile name.
enable In HFR only, this will launch an application to automatically

Aequilibrium recalculate the total conductivity profile based on the ultrafiltrate
conductivity reading taken from the Natrium sensor.
enable In HFR only, this allows enabling the Aequilibrium application in

Isonatric Isonatric mode, consisting of automatic recalculation of the total
conductivity profile in order to reach a final patient sodium
concentration equal to the initial sodium concentration obtained
from the Natrium sensor.
display Function not active.

output
cancel To cancel the profiling in progress. A dialogue window will ask the
profile operator to reconfirm the cancellation.
The “Remov. [Na] calc” tool allows displaying the sodium removal achieved by means
of the calculated profile and corresponding to the final sodium set. If Aequilibrium
(also in Isonatric mode) is active, this value is displayed only after the recalculation
performed after the first fifteen minutes of dialysis (otherwise it is zero). If setting
sodium removal, the tool displayed instead of “Remov. [Na] calc” is “[Na] end calc”
which performs the same functions relating to the final sodium.
The “[Na] start calc” tool allows displaying the patient’s initial plasmatic
concentration recalculated by the Aequilibrium application (also in Isonatric mode)
after the first fifteen minutes of dialysis. In all other cases it is zero.

8.3 FORMULA PLUS SENSORS
GENERAL AND WARNINGS

The formula dialysis machine is equipped with some sensors able to control the
progress of dialysis and its dose, monitor the patient and prevent any complications
from arising.
The sensors that may be implemented on models formula plus/ formula 2000 plus
(referred to as formula plus in the next chapter) are the following:
SENSOR NAME
Sphygmomanometer Sphygmo
Blood temperature and conductivity sensor

Natrium
Ultrafiltrate conductivity and temperature sensor
Hematocrit and oxygen saturation measuring system Hemox

Heart rate meter (only for 220-240 Vac power supply Pulsar
machines)
WARNING
Carefully read the instructions contained in this chapter before using the
sensors. Non-
Non-conform use, application
application of procedures different from those
indicated or use of accessory devices not provided for may determine
improper functioning and give rise to incorrect and/or unreliable
measurements.
CONTRAINDICATIONS
The sensors usable on formula plus are not designed, marketed or intended for use
different from that specified. Moreover, they must not be used outside the
specifications and the operating values indicated by the manufacturer.
SENSOR TEST
The formula plus sensor test refers to the conductivity sensor (Natrium) and the
hematocrit measuring system (Hemox). The test starts automatically as soon as the
tests on the blood side have been completed and the system enters into the
STANDBY state.
In the event that the test result is negative, the following warning appears:
FORMULA+ SENSORS TEST.
ENG – Ed. 11/09 chap. 8.3 - Formula plus sensors- 1 of 24

INSTALLATION
ARTERIAL LINE (FOR HEMOX

HEMOX AND NATRIUM)
- Fix the expansion chamber (1) in the relevant support.
- Open the cover of the arterial pump (2).

- Fasten the inlet of the arterial segment (3) in the lower guide set (follow the
direction of the screen-printed red arrow). (For semi-automatic pump loading of
the pump segment, see chap. Preparation of Treatment).
- Turn the pump anti-clockwise and fit the segment.
- Fasten the other end of the segment in the upper guide set.
- Fold the drive handle back into the pump block and close the cover.
- Accurately insert the arterial line into the blood detector (4) and the fixing clip
(5) next to the electric safety clamp. If using the arterial electric safety clamp
(double clamp), insert the arterial line.
6
2
- Connect the Luer-lock connector (at pump inlet) to the pressure gauge (6) (red).
- Connect the red line connector to the blood inflow connector of the dialyser.
- Open the cover of the Natrium sensor (7) turning the unlocking lever to the right.
2 of 24 – chap. 8.3 - Formula plus sensors ENG – Ed. 11/09

- If present, insert the arterial probe (8), positioned on the outlet tube from the
expansion chamber, into the Natrium sensor on the left-hand side (red arrow).
The blood flow must run upward.
- Close the cover of the Natrium sensor.

- If present, insert the cuvette (9) on the inlet tube to the expansion chamber into
the Hemox sensor. Exert a light pressure on the ends of the cuvette and check
correct positioning in its seat.
10
- Fasten the line in the clip (red) (10).

- Connect the heparin syringe (see chapter on Heparin).

ULTRAFILTRATION/INFUSION
ULTRAFILTRATION/INFUSION LINE
LINE (FOR NATRIUM IN HFR)
HFR)
- Position the adsorbent cartridge in its support on the IV pole below the dual-
chamber dialyser and the infusion line drip chamber.
WARNING
The cartridge has to be positioned with the inlet facing upwards (refer to
the instructions on the label).
Should air bubbles form inside the cartridge, they must be removed
during rinsing. Air may cause excessive pressure loss.
- Connect the yellow terminal of the ultrafiltration line (1) to the outlet of the
convective section of the dialyser, and the other terminal to the inlet of the
adsorbent cartridge.
- Clamp the section of line between the first deaeration filter and the cartridge.
- Connect the section of the line connected to the priming liquid collection bag to
the outlet of the adsorbent cartridge.
- Hang the priming liquid collection bag on its support on the stand.
WARNING
• If using a Selecta cartridge, disconnect the end section of the line leading
from the adsorbent cartridge from the collection bag and connect
connect it to
the infusion point of the dialyser (1), then proceed with the next steps.
• If using a Selecta Plus cartridge, proceed with the next steps.
- Position the drip chamber in the right-hand side clip (2).

6
- Open the UF/infusion pump cover.

- Lift the folding drive handle of the infusion head.
- Fasten the initial connection of the infusion pump segment (tube leading from
the dialyser) in the left guide set of the infusion pump head (follow the direction
of the screen-printed blue arrow). (For semi-automatic pump loading of the
pump segment, see the chapter "Preparation of Treatment ").
- Make the segment stick to the inner wall of the head by simultaneously turning
the rotor (anticlockwise).
- Insert a segment of the pre-pump line into the end-of-infusion detector (3).
- Connect the tube on the drip chamber to the infusion pressure transducer (4).
- Insert the segment of line between the drip chamber and the deaeration filter (5)
into the blood leak detector (BLD) block (6).
- Open the cover of the Natrium sensor turning the unlocking lever to the right.
- If present, insert the ultrafiltrate probe (7) into the Natrium sensor on the right
(the ultrafiltrate flow must follow the direction of the green arrow).
- Close the cover of the Natrium sensor.
- Prepare the physiological solution for priming. It is suggested to use a
heparinoid solution of 5000 IU/l (if necessary, use the Y-connector to join two
bags).
- To prime the blood lines, refer to the dedicated chapter in the user manual.
WARNING
• Be extremely careful
careful when connecting the cartridge, in particular when
removing the protective caps, to prevent spilling filling liquid. Follow the
instructions for direction of flow shown on the label.
• Replace the cartridge if the internal liquid runs out or in the eve event
nt of
excessive air.
• Do not clamp the pressure measurement line.

7

FEATURES
Sphygmo is an automatic non-invasive arterial pressure measuring system with the
possibility to display the mean arterial pressure, the systolic pressure, the diastolic
pressure and the heart rate.
Sphygmo, which uses the principle of oscillometric measurement, is composed of a

special card installed and connected behind the display, inside the case. The card is
connected to a rubber tube at the end of which a cuff is attached.
The system allows making measurements on demand of the operator as well as

automatically at programmable time intervals. It also allows storing the readings so
that they are available whenever the operator requires. All the measurements made
are displayed in both numerical and graphic form with the additional possibility of
crossing the values measured by Sphygmo with the values read by the other sensors
of the machine.
On the basis of clinical needs, thresholds can be set on the arterial pressure values
which, if exceeded, generate a warning for the operator.
The system can be used on adult patients of different build but not on infants.
PRECAUTIONS FOR USE

To obtain an accurate arterial pressure measurement, it is necessary that:
• the size of the cuff is suited to the diameter of the patient’s arm,
• the cuff is accurately positioned.
An inadequate size or an incorrect attachment of the cuff may result in incorrect
measurements.
The pressure measurement can be affected by the patient’s position and his
physiological conditions. The patient must therefore be relaxed and in a comfortable
position.
WARNING
Sphygmo can be used on adult patients only.
Avoid compressure or restriction of pressure tubes.
Check (for example examining
examining the involved arm) for possible prolonged
impairment of the circulation of the patient.
Thanks to its insulating material, Sphygmo “applied part” part” (type BF) is
discharge..
protected against effects of defibrillator discharge
In case of accidental wetting of the cuff cuff or the connections, dry them
immediately in order to prevent dampness from entering the measuring
system.
system.
OPERATION
Wrap the cuff around the upper arm of the patient (at the same level as the heart) in
such a way that the arrow pointing to the artery is aligned with the brachial artery as
shown in the figure. Ensure that the tube connected to the cuff is not compressed,
squashed or damaged.
To enter the main Sphygmo page:
sensors
Sphygmo
At the bottom right of the display a box appears with the data of the last three
measurements made.
A menu is also accessed activating the following functions:
To return to the main menu.

return
To activate the arterial pressure measurement. The cuff automatically

starts inflating to a pressure higher than the arterial pressure. (If the
measure
key is pressed while measuring is in progress, the process is
interrupted immediately).
On the right of the display a box appears indicating “MEASURE IN
PROG.”
At the end of the measurement the following values are displayed in

the box:
• Systolic pressure (maximum), Sys.
• Diastolic pressure (minimum), Dia.
• Mean arterial pressure (MAP)
• Heart rate (number of beats a minute)
Should the pressure measurement result negative, an error code or a

message appears in the box.
The main causes for an error may be:
• Cuff positioned incorrectly
• Air tube disconnected from cuff
• Patient movement during measurement
Check which of the above has caused the error and then

measure
to repeat the measurement.
auto BP To automatically activate pressure measurement at variable time

on intervals. To set the time interval between one automatic pressure
measurement and the next,
see/mod. measure
parameters interval
.
The minimum interval settable is 5 minutes.
Automatic measurements are disabled when rinseback starts.
see/mod. MAX SYS MIN SYS

parameters threshold threshold
or to set, respectively, the maximum
or minimum systolic pressure thresholds for setting off the alarm
signal.
MAX DIA MIN DIA
threshold threshold
or to set, respectively, the maximum
or minimum diastolic pressure thresholds for setting off the alarm
signal.
ok
Use the and keys to set and press to confirm.
These thresholds can be preset during configuration (see the Chapter
“CONFIGURATION”).
warning
on
to activate the warning
warning
off
to deactivate the warning
ok
to confirm.
To enable a submenu where the functions related to the variables
display
measured appear. Pressing any one of these functions activates the
graph associated with it. For the graphs, refer to the related
description.
open To view a table containing the data of the last measurements made
table for a maximum of 16 measurements. The data displayed for each
measurement are: time and duration of the treatment in which the
measurement was carried out, systolic and diastolic pressure, MAP,
heart rate.
To confirm the parameters set.
ok
When the measurement has been completed, do not immediately remove the cuff,
but leave it on the arm for a few seconds to allow complete deflation. After removing
the cuff, fold it, wind the tube and place it on the holder provided on the rear of the
dialysis machine.
In the priming, dialysis and rinseback states, pressure measurement can be
sphygmo
measure
activated by means of the function on the main page near the key.
interrupt
measure
When measurement is active, the key is present in the same position,
which allows interrupting the measurement. If an automatic sphygmomanometer
sphygmo
measure
measuring program is enabled, the key turns green; also in this case,
interrupt
measure
when measurement is active, to interrupt the measurement.

FEATURES
Thanks to Pulsar, formula plus can continuously measure the heartbeat during all the
dialytic treatment phases. The technology used exploits radio waves in such a way
as not to tie the patient to the equipment and leave him free in his/her movements.
Pulsar is composed of a low-frequency transmitter inserted in a band fitted around

the chest of the patient. The chest band is personal, easy to use and can be worn at
any time as it is activated automatically. Before use moisten the electrode areas on
the back with gel for electrocardiographs. Fit the band around the check, check that
the Polar logo is in a central, upright position and the wet electrode areas are firmly
against the skin.
In addition to the transmitter there is also a receiver connected to the dialysis
machine, which must be positioned on the patient’s bed.
The system reads the depolarisation signal of the cardiac muscle in such a way as
not to be affected by the variation in peripheral vascularization and the position of
the vascular access.
The Pulsar outputs, similar to the other sensors of formula plus, are displayed in
numerical form as far as the instantaneous value is concerned and in graphic form
for the time trend.
Depending on the clinical requirements and the patient, the minimum and maximum
heart rate values can be set, on the basis of which the operator is alerted.
INDICATIONS
Measuring the heart rate is important as it supplies fundamental information to
understand the patient’s compensation capacity under haemodynamic stress due to
ultrafiltration induced by the machine control of the patient weight loss.
The information relating to the heart rate together with the hematocrit measurement
provide an indication of the refilling capacity (transfer of water from the intracellular
to the extracellular compartment).
WARNING
Pulsar is a system composed of a receiver specially designed and connected
to a thoracic transmitter (chest band) of the heart rate meter manufactured
Polar. Carefully read the user manual of the Polar heart rate meter
by Polar
before using the Pulsar system.
 transmitter. Use
Polar
The system has been designed to function with the Polar
of transmitters different from the one specified is not allowed.
The receiver must be positioned on the patient’s bed within a range of 50
cm from the chest band and oriented in such a way that the longest side is
parallel to the chest band.
The Polar heart rate meter is equipped with a receiver (wrist clock) which
may only be used as additional receiver to check, before the dialysis
dialysis
treatment, correspondence of the measurements with the data displayed by
formula
 plus.
OPERATION
sensors Pulsar
To display the heart rate measurement, .
At the bottom of the monitor a window opens displaying the heart rate value in real-
time.
A menu is also accessed activating the following functions:

return
see/mod. MAX. HR MIN. HR

or to set the maximum or minimum
heart rate thresholds generating alarm signalling. Use the and
keys to set parameters.
warning
on
to activate or deactivate alarm signalling.
ok
to confirm the parameters set.
To view the heart rate time trend.

display HR

FEATURES
Thanks to Hemox, formula plus can continuously supply the absolute measurement
of hematocrit and oxygen saturation. This is made possible by a disposable probe
integrated in the arterial bloodline and a reader (fixed on the stand) which makes
optical absorbance measurements at three different wavelengths and does not
require initial calibration.
The qualities of the system are the non-invasive measurement, the absolute sterility
and the ease of use for the operator. In fact, the personnel do not have to perform
any extra operations to install the dedicated line. Knowing the hematocrit value
moreover allows supplying the percentage volume loss during dialysis.
The operator interface allows, as for the other formula plus sensors, displaying the
data in both numerical and graphic form. It is also possible to set customised
thresholds on the hematocrit, saturation and percentage volume loss values, which
generate a warning for the operator if they are exceeded.
INDICATIONS
The hematocrit measurement is of fundamental importance to understand the state
of water accumulation in the patient (in the intradialytic interval) and to monitor its
variation during treatment. This variation is closely tied to the quantity of water
extracted from the extracellular compartment as well as the rate of water transfer
from the intracellular to the extracellular compartment.
Of course, the process is governed not only by movements of volumes of water but
also by the concentrations of sodium in the dialysing fluid and in the extracellular
and intracellular compartments.
Moreover, as already mentioned for Pulsar, the hematocrit and heart rate data
provides a valid support to the clinic to understand the haemodynamic state of the
patient, the refilling capacity and the need to modify the dialysis fluid parameters
which, together with ultrafiltration modulation, can improve the haemodynamic
state of the patient preventing possible hypotensive states.
The information relating to oxygen saturation is important as the contact of the
patient’s tissues (blood) with foreign bodies (blood lines and dialyser) may induce
hypoxaemia. This parameter is related to the biocompatibility of the disposable
materials and the dialysing fluid.
OPERATION
To view the hematocrit and oxygen saturation measurement, proceed as follows:

sensors Hemox
At the bottom of the monitor a window opens displaying in real-time the

hematocrit, oxygen saturation and percentage volume loss data. A menu is also
accessed activating the following functions:

return
see/mod. MAX. HCT MIN. HCT MAX. SO2 MIN. SO2

parameters threshold threshold threshold threshold
/ or / or
VL%
threshold
to set the threshold to generate alarm signalling. Use the
and keys to set parameters.
warning
on
to activate or deactivate alarm signalling.
ok
to confirm the parameters set.
To view the hematocrit time trend.

display HCT
To view the oxygen saturation time trend.

display SO2
To view the percentage volume loss time trend.

display VL%

FEATURES
Direct and continuous measurement of blood and ultrafiltrate conductivity is made
possible on formula plus thanks to the use of two disposable probes and a reading
system able to measure not only the conductivity but also the temperature of the
fluids flowing across the probes.
To measure the fluid resistivity, this system, defined as Natrium, makes use of
electromagnetic coupling, galvanically isolating the probe from the rest of the
circuit. The temperature measurement occurs via the probe by thermal contact with
the fluid.
The probe on the arterial line measures conductivity in all haemodialysis treatments,
while the probe on the ultrafiltrate line is present only in HFR, where ultrafiltrate is
available. In this case, the patient’s plasma sodium concentration level is also given,
which may be increased by the ultrafiltrate conductivity.
The non-invasive measurement, ease of use and complete safety for the patient (no
direct electrical contact) constitute the strengths of this sensor.
The operator interface allows, as for the other formula plus sensors, displaying the
data in both numerical and graphic form.

OPERATION
To view the plasma sodium concentration:
sensors Natrium
At the bottom of the monitor, a window opens displaying real-time data for plasma
sodium concentration:
display [Na]
for graphic display
To view other readings, proceed as follows:
sensors applications cond/temp

blood/uf
At the bottom of the monitor a window opens displaying the data in real-time of:
display BC
- Blood conductivity for graphic display
display CUF
- Ultrafiltrate conductivity for graphic display
display BT
- Blood temperature for graphic display
display UFT
- Ultrafiltrate temperature for graphic display
return
to return to the main menu.

THERMAL BALANCE
sensors applications thermal

balance
Via the Natrium sensor formula plus is able to continuously, directly and non-
invasively monitor the blood temperature at the dialyser inlet during all treatments
and the ultrafiltrate temperature during HFR. Through the “Thermal balance”
application, this data can be compared with the dialysis fluid temperature (in real-
time and graphic form) thus allowing evaluation of the correct thermal balance in
the course of treatment.
A menu is accessed activating the following functions:

return
To view the blood temperature in graphic form.

display BT
To view the dialysis fluid temperature in graphic form.

display DT
To view the ultrafiltrate temperature in graphic form.

display UFT
NOTE
The Thermal Balance application is disabled if the Natrium sensor is not
installed.

CARDIUM
sensors applications cardium
Cardium is the formula plus application which, integrating the Sphygmo and Pulsar
measurements, allows interactive control of the heart rate and arterial pressure.
The advantages of this integration are:

• The possibility of automatic activation of the sphygmomanometer in the event
that the values measured by Pulsar exceed given thresholds.
• Display, on the same graph, of the heart rate measured by Pulsar and the
pressure measurements obtained with Sphygmo in order to immediately
understand the state the patient is in.
A menu is accessed activating the following functions:

return
see/mod. MAX HR MIN HR

/ to set the thresholds on the
absolute value of the heart rate.
%
threshold
to set the thresholds on the percentage value with
respect to the basal value of the heart rate .
derivative
threshold
to set the thresholds on the heart rate variation.
The derivative thresholds are calculated as the difference between
the mean values/minute measured in two consecutive minutes.
Use the and keys to set parameters.

ok
to confirm.
Cardium To enable the Cardium application after the setting of the thresholds.
on

display
description.

Automatic disabling of the set arterial pressure measurements is allowed at any
Cardium
off
time. .
Only manual arterial pressure measurements can be made in the 5 minutes

following each activation of Cardium. In this way, the patient is not excessively
exposed to stress.
NOTE
The Cardium application is disabled if the Pulsar or Sphygmo sensor is not
installed.

KT/V
The Kt/V application has the function of measuring certain dialysis efficiency
parameters (Clearance, Kt, Kt/V) during dialysis.
The measurement method involves generating conductivity steps in the dialysate
solution entering the filter; the method uses a 1mS/cm step to alternate upward and
downward steps, in successive measurements, in order to balance the flow of
sodium from and to the patient. This alternation is absent if the set total
conductivity is greater than 14.7mS/cm (downward steps only) or less than
13.5mS/cm (upward steps only).
In regard to timing, the measurement process may be performed automatically,
during dialysis, every 15 or 30 minutes (depending on the "Kt/V Level" parameter
set in Service Configuration); in any case (i.e. without automatic measurement),
measurements may be taken manually at any time during the dialysis.
The total measurement time varies according to flow, i.e. the lower the dialysis flow,
the longer it takes for the modified conductivity liquid used to reach the dialyser;
throughout the measurement process, the message "Kt/V" will appear on the status
bar, advising the operator that the measurement is in process.
Both automatic and manual measurements may only be taken in conditions in which
they can be activated.
More specifically, for automatic measurements, each one can only be taken provided
the following conditions are met:
• The system is not in alarm or isolated UF

• The measurement will not overlap the T0 test of the UF system
• The measurement will not overlap a total conductivity variation (for example,
due to execution of a profile).
• The system is not in a “change filter” state
• An infusion bolus is not in progress.
If any of these conditions are not met, the measurement is automatically postponed
until it can be taken correctly.
The same conditions apply for manual measurements; in this case, however, failure
to satisfy the conditions would not postpone the measurement, but would disable
the button to activate it (“measurement”).
During measurement, the following checks are carried out:
• If an alarm sounds for the closure of the bypass or if the machine switches to
isolated UF, the measurement is interrupted and cancelled.
• The total conductivity cannot be changed.
• The dialysis flow cannot be changed.
• If performing an infusion bolus the measurement is interrupted and
cancelled.
• The measurement can always be interrupted and cancelled by pressing
interrupt
measure
The key sequence

sensors applications Kt/V
brings up the application menu and a window showing a breakdown of the

measurement data:

return
Allows manual measurement to be started.

measure
interrupt
measure
When measurement is active, the key is set to the same
position, which allows the measurement to be interrupted.
see/mod. To access the application parameter setting menu.

parameters

display
description.
In regard to the window, given below are the meanings for the sizes shown.
K The instant clearance shown with the last measurement
Kt The instant Kt taken with the last measurement, where K is the

clearance and t is the treatment time elapsed
Kt prev Predicted Kt at end of treatment
Kt/V The instant Kt/V taken with the last measurement, where V is the
patient distribution volume, to be entered by the operator
Kt/V prev Predicted Kt/V at end of treatment.

T to goal
goal Remaining minutes of dialysis required to reach the desired Kt/V set
Kt/V by the user via the “view/edit parameters” page
see/mod.
parameters
to enter the following menu:

return
distribution To enter the menu for setting the distribution volume, which can
volume also be selected from a list of stored data.
goal To set the desired Kt/V at end of treatment.

Kt/V
min To set the minimum acceptable Kt/V at end of treatment.

Kt/V
min To set the minimum acceptable clearance for each measurement

Clearance (expressed in % blood flow).
meas. To set the system to carry out automatic Kt/V measurements, setting
int. (min) the delay between one automatic measurement and the next (0 =
only manual measurements).
warning To enable alerts associated with set parameters (see chapter on

on alarms and indicators)

To confirm changes, saving the new settings to file
ok
distribution
volume
to enter the distribution volume setting menu, also using a
database of saved settings.

return
distribution To set the distribution volume setting.

volume
To open a previously saved setting.

name
Select the desired data using either button or .
modify To rename saved setting.

name
Use keys and to select the box to be changed, and keys
or to select the new alphanumeric code to be attributed to

the box.
To confirm changes, saving the new settings to file

ok
To set a distribution volume without associating it to a name, simply select the two
horizontal bars (“- -“) in the name box.
display
to view graphs for the measurements taken, graphs “Kt” and
“Kt/V” show the values taken with a continuous line and those set with a
discontinuous line. However, the “Clearance” graph shows only the measured values.

8.4 OTHER FUNCTIONS
SERIAL CONNECTION
Thanks to a dedicated interface it is possible to connect with formula by means of a RS
232C serial connection for the acquisition of the system data.
Connection is performed thanks to a Formula protocol. The serial connection kit (if not
fitted) can be installed upon request, but only by technicians authorised by the
manufacturer.
The serial connection does not alter the functioning of formula. No specific indication
of its presence is given to the user, even during data transmission.
CAUTION
 may only be connected to equipment which comply with CEI EN
formula
60950 or EN 60601-
60601-1 standards, provided that they are properly grounded.
The connection must be in conformity with the requirements included in EN
60601-
60601-1-1 standard.
It must be connected using cables that comply with the RS 232C serial
connection ( ± 12V, 1W).
The use of non-
non-conform cables and equipment which do not comply with the
specifications may damage the interface.
If the connector is not used (refer to
to chapter 2.1, back panel), do not remove
the cover.
BACK-
BACK-UP BATTERY
The back-up battery makes it possible to continue extra-corporeal circulation of the
blood if the power fails while waiting for it to be restored, or to return the blood to the
patient without having to manually rotate the pump. The installation of the back-up
battery is performed only on request.
The battery must be activated during configuration of the machine by authorised

personnel. Once activated, the battery is tested every time the machine is switched on.
If a red icon appears on the display during the rinsing phase, it indicates
that the battery test did not have a positive outcome and therefore the
machine will not be able to operate if there is a power fail.
If a green icon appears, it indicates that the battery is operating and the
machine will be able to withstand a power fail for approximately 5
minutes.
The overall duration of the battery depends on its preservation, on the operating
conditions of formula and on the charge condition of the battery.
ENG – Ed. 12/07 cap. 8.4 – Other functions - 1 of 4

The battery activates in PATIENT CONNECTION, DIALYSIS and RINSEBACK phases
allowing only the extracorporeal circuit to operate.
In the other operating conditions, that is RINSING, DISINFECTION and DESCALING, if
there is a power fail, the machine switches off. Only 5 sec. after the power is restored it
switches back on and starts from where it was interrupted.
Battery operation is indicated by a flashing orange LED next to the ON key. An alarm
signal also goes on (BATTERY) with a visual and acoustic signal warning the operator
that the battery is activated.
If there is a power fail during dialysis or in any other machine condition where blood is
present in the blood lines, a circular instrument is displayed on the left side of the
display which indicates the charge of the battery.
The arc of the instrument is divided into

two sectors:
- the green sector indicates the battery
is charged.
- the red sector indicates a low battery
charge.
When the circular crown is only coloured
in the red part, the machine can operate
autonomously for approximately 2 min.
before switching off.
When the battery is empty, formula® enters offline mode, yet it is still able to save
operating data for at least 2 mins. Once the mains power is restored, the machine
restarts but, if it should go offline again within a short period of time, the battery
backup power will not be guaranteed.
CAUTION
The battery employed is a lead-lead-type battery and recharges during

 operation; any maintenance/interventions
formula maintenance/interventions on the battery should be
performed exclusively by technicians authorised by the manufacturer.
Do not use the battery in room temperatures over 40 °C.
Never remove the plug from the socket if the main rear switch is on.
If the battery leaks,

leaks, turn off the machine and immediately contact the
authorised technicians.
In case the equipment is not used for long periods (longer than one month) it
is recommended to contact the authorised technicians to remove the battery.
At the end of its life-

life-cycle the battery should not be disposed of with regular
waste but given to authorised disposal services (contact the manufacturer or
the authorised technicians).
2 of 4 - chap. 8.4 – Other functions ENG – Ed. 12/07
PERFORATED POWDER BICARBONATE CARTRIDGE: FILLING
UNDER PRESSURE
The perforated sodium bicarbonate cartridge allows the preparation of dialysis fluid for
dialysis treatment.
This cartridge can only be used on machines equipped with a support which permits
perforation of the cartridge.
The equipment can be modified by expert and qualified technical personnel to keep
the cartridges in pressure during the use.
The procedure of use of the cartridge described in the user’s manual does not change,
but it is recommended to follow the warnings given below.
WARNING
Do not disconnect the upper perforation connector
connector in any machine
conditions (particularly during disinfection/cleaning), except for
connecting the concentrate containers after selecting dialysis mode.
To replace the cartridge during treatment, see chapter Problem solving.
ENG – Ed. 12/07 cap. 8.4 – Other functions - 3 of 4

4 of 4 - chap. 8.4 – Other functions ENG – Ed. 12/07
9. 1 DISINFECTION/CLEANING
GENERAL
The actions necessary to “clean" the haemodialysis equipment must take in account
some characteristics, among which the fact that they manage, during every session,
more than 100 litres of dialysis fluid composed of saline solutions, bicarbonates and
organic substances that may contain bacterial colonies and endotoxins.
In such sense, a total action on the machines consists in using chemical or physical
agents which are able to remove scaling and saline accumulation, to prevent and/or
to remove organic substances and biofilms and to be effective against bacteria, virus
and endotoxins.
To this aim, formula is provided with automatic rinsing and disinfection/cleaning
cycles where chemical solutions, according to prefixed dilution ratios, or high
temperature water come into contact with the hydraulic circuit for periods of time,
such as to guarantee removal of substances and bacterial formations (biofilms).
These terms are defined as they apply to formula:
RINSING: physical process that uses water to remove eventual deposits from the
fluid pathway.
DESCALING:
DESCALING process to remove eventual inorganic deposits normally left by the
solutions used in the fluid pathway of haemodialysis monitors.
DISINFECTION:
DISINFECTION chemical or physical process which has effect on living
microorganisms, however with possibility of survival of some vegetative forms
(spore).
DISINFECTION/CLEANING:
DISINFECTION/CLEANING in the user manual as well as in user interface this
procedure generally indicates the process of "cleaning" the machine, that may
consists in a disinfection, descaling or rinsing cycle.
All disinfecting/cleaning cycles occur rigorously in single-pass and are followed by

high-flow rinsing which guarantees removal of any traces of chemical agents and
deposits.
The chemical agents may be harmful to the materials used for the fluid pathway and
may also contain additives which generate foam or which are difficult to remove.
To this aim, the chemical agents listed in this manual have been tested on formula
and are compatible with the materials of the machine, provided that they are used in
accordance with the specifications indicated.
WARNING
As the haemodialysis delivery system is a medical device, the accessories
used with it must comply with the MDD European Directive and therefore, if
it is the case, be in their turn CE marked Medical Devices. In the specific case
of the products used for disinfection, the Medical Devices used must belong
to Class IIa.
ENG – Ed. 11/09 ch. 9.1 – Disinfection/cleaning - 1 of 16

The maximum dwell times of the disinfectants have been defined and tested in such
a way as not to damage the internal parts of the fluid pathway and cause
malfunctioning of the machine.
A disinfection protocol is available on request from Marketing Department.
NOTE
The test procedure used to verify the disinfection
disinfection efficacy is available on
demand.
demand.
WARNING AND CAUTIONS
The chemical agents may be toxic. Take the necessary precautions before
use. Follow the instructions and warnings printed on the package labels and
safety sheets.
It is recommended to disinfect
disinfect the machine after each dialysis session. The
disinfectant action must be combined with the use of a descaling agent on
alternate days. Descaling must be performed before disinfection, not after.
The manufacturer will not guarantee the machine disinfection
disinfection or descaling,
nor the rinse efficacy, when using the USER disinfection/cleaning program.
program.
If the machine is not used for a certain period of time, even short (24h), run
a disinfection cycle before carrying out a dialysis treatment.
The temperature of the the liquid circulating in the tubes during heat
disinfection/cleaning is extremely high. Do not disconnect the connectors,
and do not touch the tubes and the Forclean ultrafilter until the
disinfection/cleaning cycle has been completed.
After each disinfection/cleaning
disinfection/cleaning cycle and in any case before dialysing the
patient, the operator must ensure that there are no residues of chemical
agent in the machine or in the dialysis fluid. Draw a dialysis fluid sample
(through the special connector on the dialyser line)
line) and run specific control
tests for the chemical agent used. Follow the indications recommended by
the manufacturer of the chemical agent.
Do not mix different disinfecting /descaling solutions.
Do not turn off the machine leaving the disinfecting or the descaling agent
inside the circuit, except in the case where dwell time has been
programmed.
The tube marked yellow (provided with the machine) must be used only for
the container of the disinfecting/descaling agent.
Always disinfect the concentrate aspiration
aspiration tubes.
Do not use the chemical agent AMUSAFE any longer.
CAUTION
A disinfection/descaling in progress can never be cancelled nor can the
chemical agent or the selected type be modified.
2 of 16 - ch. 9.1 – Disinfection/cleaning ENG – Ed. 11/09

formula provides for the following disinfection/cleaning programs:
• Chemical standard
• Chemical-full (this cycle involves the whole fluid pathway, including the heating
tank)
• Chemical-heat
• Heat (inlet water is heated to 98°C in the heating container, guaranteeing an
average temperature of 85°C in the fluid pathway, without recirculation, for 15-
20 minutes).
• Centralized disinfection/cleaning with the possibility to intake the chemical
agent or hot water directly from the dialysis centre water distribution system.
REMEMBER:
• Each time a disinfection/cleaning program is entered, the parameters set during
configuration are displayed.
• If disinfection/cleaning is interrupted by turning off the machine with the main
rear switch, when it is turned on again, the program runs the tests and then
restarts from the point of interruption.
formula carries out a triple control: conductimetric, volumetric and thermal, in order
to guarantee proper conduction of the disinfection/cleaning method selected. In
case of faults, the equipment warns the user.
ICON OF DISINFECTED/CLEANED
DISINFECTED/CLEANED MACHINE
If the parameter “Disinfection/cleaning icon available in rinsing” has been set to ON

during configuration, the icon changes according to the following criteria:
Once the program STD. DISINFECTION/CLEANING, or COMPLETE FULL

DISINFECTION/CLEANING, or CHEMICAL HEAT DISINFECTION/CLEANING, or
CHEMICAL HEAT DESCALING, or HEAT DISINFECTION or CENTRALIZED HEAT
DISINFECTION/ HEAT SPECIAL has been run, the icon indicates that the
program has been successfully completed. On the contrary, if the icon

appears, it means that the program has not been performed correctly.
WARNING
It is responsibility of the user to run a new dialysis treatment only when the
icon is present and the program run was not a simple descaling but a
disinfection performed with
with a suitable agent.
In case of centralized programs (CHEMICAL/CHEMICAL SPECIAL and HEAT
WASHING/HEAT WASHING SPECIAL), the icons and do not refer to the

program just completed. This means that the displayed icon will remain as it was
before the program.
To know the date and type of the last performed disinfection/cleaning, enter the
parameters
disinf./clean.
help on line and press the key .

STANDARD CHEMICAL DISINFECTION/CLEANING
In standard chemical disinfection/cleaning a specific chemical solution is aspirated
and circulated through the fluid pathway, between the concentrate aspiration point
and the drain with the exception of the heating tank.
PARAMETERS OF STD. CHEMICAL

CHEMICAL DISINFECTION/CLEANING
DISINFECTION
Chemical Dilution Consumptio

Consumptio Contact time Rinsing time Total duration
agents n (cc) (min) (min) (min)
(configurable) (configurable)
Sodium 1:30 ∼ 90 7 25 or 30 32 or 37
hypochlorite ∼ 120 11 30 41
>7%
Peresal 1:30 ∼ 90 7 25 or 30 32 or 37
∼ 120 11 30 41
Amuchina 1:6 ∼ 250 6 25 or 30 31 or 36
∼ 400 10 30 41
Tiutol 1:30 ∼ 90 7 25 or 30 32 or 37
∼ 120 11 30 41
Instrunet 1:6 ∼ 250 6 25 or 30 31 or 36
∼ 400 10 30 40
Puristeril 1:30 ∼ 90 7 25 or 30 32 or 37
∼ 120 11 30 41
Oxagal 1:6 ∼ 250 6 25 or 30 31 or 36
∼ 400 10 30 40
Renaxid 1:30 ∼ 90 7 25 or 30 32 or 37
∼ 120 11 30 41
WARNING
“>7% Sodium hypochlorite”
hypochlorite” is any Medical Device whose composition is
based on sodium hypochlorite with >7% concentration.
concentration.
DESCALING
Acetic acid 1:6 ∼ 250 6 25 or 30 31 or 36

10% ∼ 400 10 30 40
WARNING
“10%Acetic acid” is any suitable solution made of acetic acid with 10%
concentration.

USER PROGRAM
User According to the preset values
WARNING
If the USER program has been selected, the user must check that a Medical
Device
Devic e is being used. The manufacturer will not guarantee machine
disinfection or descaling, nor rinse efficacy.
CHEMICAL FULL DISINFECTION/CLEANING

In chemical full disinfection/cleaning a specific chemical solution is aspirated,
circulated and eventually dwelt inside the entire fluid pathway, including the heating
tank, but with the exception of the water inlet section.
Dwell of the chemical agent is allowed only if DIALOX or OXAGAL are used.
PARAMETERS OF CHEMICAL
CHEMICAL-
AL-FULL DISINFECTION/CLEANING
Chemical Dilution Consumptio Intake + Dwell time Rinsing time Total

agents
agents n (cc) Contact time configurable configurable time
(min) (h) (min) (min)
Sodium 1:30 ∼ 45 8 - 23 or 33 31 or 41
hypochlorite
>7%
Peresal 1:30 ∼ 45 8 - 23 or 33 31 or 41
Amuchina 1:6 ∼ 180 8 - 23 or 33 31 or 41
Dialox 1:6 ∼ 180 8 23 or 33 31 or 41

+ dwell ∼ 250 12 80 max. 23 or 33 35 or 45
time + dwell
time
Oxagal 1:6 ∼ 180 8 80 max. 23 or 33 31 or 41
+ dwell
time
Instrunet 1:6 ∼ 180 8 - 23 or 33 31 or 41
Renaxid 1:30 ∼ 45 8 - 23 or 33 31 or 41
WARNING
“>7% Sodium hypochlorite” is any Medical Device whose composition
composition is
based on sodium hypochlorite with >7% concentration.
concentration.

USER PROGRAM
WARNING
If the USER program has been selected, the the user must check that a Medical
Device is being used. The manufacturer will not guarantee machine
disinfection or descaling, nor rinse efficacy.
CHEMICAL HEAT DISINFECTION/CLEANING

Chemical heat disinfection/cleaning combines the properties of heat with the
characteristics of a specific chemical agent delivered through the entire fluid
pathway but with the exception of the water inlet section.
PARAMETERS OF CHEMICAL
CHEMICAL-
AL-HEAT DISINFECTION/CLEANING
Chemical Dilution Consumption Heating./ Contact Rinsing Total

agents (cc) aspir.. time
aspir time time duration
(min) (min) (min)
(min)
configurable
Citric 1:6 ∼ 180 15 or 20 3 23 51 or 56

acid 12%
WARNING
“Citric acid 12%” is any suitable solution made of critic acid with
12%.concentration.
12%.concentration.
If the USER program has been selected, the user must check that a Medical
Device is being used. The manufacturer will not however guarantee the
machine disinfection or descaling, nor the rinse efficacy.
Pay attention in selecting the chemical

chemical agent: it must be compatible with
high temperatures.
If chemical heat descaling is programmed in error and citric acid or user

chemical agent are unavailable, use water only. Wait for the program to end
and then select a new descaling cycle.

HEAT DISINFECTION
In heat disinfection hot water (temperature greater than 85°C) is circulated through
the fluid pathway, with the exception of the water inlet section. The advantage of
this program is to combine the gaseous activity due to steam with the efficiency of
heat.
KIT FOR INCOMING HOT WATER

The kit for incoming hot water allows formula to draw in hot water for heat
disinfection up to 94 °C max. If necessary, contact the authorized technical staff to
check if the kit is installed on the dialysis machine.
Hot water is allowed to be drawn in only when the machine is not in dialysis mode.
WARNING
 builds in all the necessary alarm systems to prevent the dialysis
formula
treatment be executed if the temperature of the incoming water is superior
than 40°C.
The manufacturer does not undertake any responsibility for possible

damages caused by use of water to temperatures higher than 94°
94°C and/or
pressure superior than 7.5 bars.
The manufacturer does not undertake any responsibility for possible

damages caused by incorrect connection of formula  to the water
distribution plant, whether for the materials used, or for the lengths of the
pipes, or for height of the drain from ground.
CENTRALISED DISINFECTION/CLEANING
Centralised disinfection/cleaning entails circulating a chemical agent or water in the
fluid pathway of the machine at the same time as the dialysis centre water
distribution system is being disinfected.
formula provides for the following centralized disinfection/cleaning programs:

• chemical
• heat washing
• heat disinfection
• chemical special
• heat washing special
• heat disinfection special
The “special” programs were suitably designed for those dialysis centres in which
the machine receives water to a temperature superior than 50°C at start-up.

Dwell of the chemical agent may be set for every program of centralized
Before carrying out centralised disinfection/cleaning, remove the MULTIPURE filter

to avoid damaging it (for further information, please contact Post Sales Department).
To remove the Multipure filter, follow the directions described in the chapter
“Management of ultrafilters and Multipure filter” of this user manual.
When the program is over, reposition the MULTIPURE filter.
CENTRALIZED CHEMICAL/CHEMICAL
CHEMICAL/CHEMICAL SPECIAL
SPECIAL
The machine receives a solution of water and chemical agent from the dialysis
centre water distribution system. The water inlet tubes are flushed with flows at
300 ml/min.
The chemical agents used in the centralised chemical programs and their
concentrations are not controlled by the machine; the operator must ensure that the
chemical agents used and their concentrations correspond to those indicated for the
chemical full disinfection/cleaning.
The effectiveness of the following rinsing cycle is only guaranteed if the rinse times
established for each type of chemical agent are observed and if the water used
contains no chemical agents. However, it is operator’s responsibility to verify
conformity of the water used for rinsing.
CENTRALIZED HEAT WASHING/HEAT

WASHING/HEAT WASHING SPECIAL
SPECIAL
The machine receives hot water from the dialysis centre water distribution system.
The water inlet tubes are flushed with flows at 300 ml/min.
WARNING
The programs CENTRALIZED CHEMICAL/CHEMICAL SPECIALS and HEAT
WASHING/HEAT WASHING
WASHING SPECIAL are ADDITIONAL procedures and DO NOT
substitute machine disinfection.
Therefore, it is recommended to execute another disinfecting cycle by
selecting one of those available on formula
.
CENTRALIZED HEAT DISINFECTION/HEAT

DISINFECTION/HEAT DISINFECTION
DISINFECTION
SPECIAL
SPECIAL
The machine receives hot water from the dialysis centre water distribution system.
Water is later warmed to 90-95°C inside the machine.

MANUAL SETTING
disinfection/ manual
from the main menu.
The following window appears:
Select the type of disinfection/cleaning desired with the relevant function key.

DISINFECTING/CLEANING
DISINFECTING/CLEANING PROCEDURE
Each time a disinfection/cleaning program is entered (Chemical standard, Chemical
Full, Chemical Heat, Heat, Centralized), the selection is automatically set on the
parameters fixed during configuration.
If the parameters are not the ones desired, modify them by selecting them one at a
time. The function and the field of the parameter selected turn light blue. Grey
fields indicate parameters which may not be set.
Use the and keys to make the changes.

water inlet
tube
For instance, after pressing , the following window will appear:
disinf./clean. Indicates the type of disinfection/cleaning selected.

type
To select the chemical agent or the type of centralized

agent
start To display the starting time of the program.

time
disinf./clean. In centralized disinfection/cleaning – chemical and heat washing:

time sets the duration of the aspiration of the chemical agent or hot
water from the plant.
If NO WATER is selected, the aspiration phase ends when the NO
WATER alarm message appears and remains at least 1 minute on
the display.
In all other programs: displays the total duration of the program.

rinsing Not available in the disinfection/cleaning program which does not
time allow dwell of chemical agent.
In full-chemical and centralized disinfection/cleaning: sets

automatic machine switching on after dwell of the chemical agent.
Should the machine be switched on before the set time, then the
following window is displayed:
Dwelling
Dwelling phase.
Ensure there are no chemical agents and
control temperature in the water supply
system"
Press 'OK' to anticipate rinsing.
In chemical full disinfection with DIALOX or OXAGAL, this field may

be left void (digit - -).
Rinsing will start immediately after aspiration of the chemical agent,
without dwell.
This field may be left void also in centralized disinfection/cleaning

(digit - -).
In such condition, the machine will remain on after aspiration of the

chemical agent and will wait for a confirmation from the operator.
When the aspiration phase is completed, a window displays the

message:
Ensure there are no chemical agents

and control temperature in the water supply
system
and then
press 'continue' to start rinsing
automatic To set automatic machine turning off at the end of

off disinfection/cleaning (enabled/disabled).
The time for machine turn off can be set only in centralized
This setting allows the operator to extend the minimum rinsing
time.
ok
Once the desired parameters have been set, to start
Check if the container of the chemical agent has already been connected, provided it
is required for the selected program.
return
to cancel the operations executed and return to the main menu.
The following data will appear on the display:
type of disinfection/cleaning
chemical agent selected
water temperature reached in the

container
duration of the disinfection/cleaning:

yellow sector =aspiration /heating
time
blue sector = rinsing/cooling time
In this phase the following functions are active:
second To set a second disinfection/cleaning which will start when the one
disinf./clean. in progress has ended.
The procedure is identical to that previously described:

• Select the type of disinfection/cleaning.
• Set the parameters if different from the default values.
• Connect the container of the chemical agent (perform this
operation only after the agent used for the first
disinfection/cleaning has completely been aspirated – the second
sector of the circle is blue) .
ok
• .
• The second disinfection/cleaning will start as soon as the one in
progress has ended; it may be cancelled on the condition that
intake of the chemical agent has not started. To cancel,
cancel 2nd
disinf./clean.
.
NOTE
Dwell time of the chemical agent cannot be set for the second
disinfection/cleaning if priming of the blood lines has started.
select To prime the blood lines.

priming
enable To enable the automatic off function if not previously done.

switch off The message « Automatic OFF » warns the operator that the
function has been activated.
Switching off is ignored in the following cases:
• when a second disinfection/cleaning has been programmed. If
the machine is to be switched off after the second
disinfection/cleaning, the machine switches off as a consequence
of the second setting.
• when priming of the blood lines has been set.
When the second disinfection/cleaning or priming is cancelled,

automatic off is reset.
If the disinfection/cleaning program is not completed successfully,

the programmed “automatic off” remains active: the machine
switches off, but when it is switched on again, the operator is
warned that disinfection/cleaning has not been carried out (the icon
appears).
To enable the sensor menu.

sensors
USER CHEMICAL
CHEMICAL AGENT
As “USER chemical agent” it is meant the use of a different agent from those listed
for any type of disinfection/cleaning.
For a correct use of the USER chemical agent:
- during configuration set appropriate operation parameters (dilution ratio, rinse
time, minimum and maximum conductivity)
- check that no residues of chemical agent are present in the machine or in the
dialysis fluid before dialysing the patient.
The use of the USER chemical agent can be activated/deactivated during the
machine configuration carried out by technicians authorized by the manufacturer.

USING THE ULTRAFILTERS
ULTRAFILTERS FORCLEAN
Guidelines for the disinfection/cleaning cycles and the chemical agents tested to be
used with the new ultrafilters FORCLEAN:
PROGRAM CHEMICAL
CHEMICAL DILUTION TEMP. QUANTITY MINIMUM
AGENT (°C) ASPIRATED DURATION
(ml) (min)
(in the
container)
HYPOCHLOR.
CHEMICAL >7% 1 : 30 90
AMUCHINA 1: 6 250
PERESAL 1 : 30 90
OXAGAL 1:6 38 250 31
TIUTOL 1: 30 90
HD INSTRUNET 1:6 250
RENAXID 1: 30 90
PURISTERIL 1: 30 90
Acetic Acid 10% 1:6 250

(descaling)
CHEMICAL FULL HYPOCHLOR.

>7% 1 : 30 45
AMUCHINA 1:6 166
PERESAL 1 : 30 45
OXAGAL 1:6 38 180 31
TIUTOL 1 : 30 45
HD INSTRUNET 1:6 166
RENAXID 1 : 30 45
DIALOX 1:6 166
DWELL TIME DIALOX 1:6 38 250 35 + 80 h

OXAGAL 1:6 38 250 35 + 80 h
HEAT NONE - 98 - 30
CHEMICAL HEAT CITRIC ACID 1:6 98 166 51

12%
descaling

9. 2 WEEKLY DISINFECTION/CLEANING
GENERAL
Weekly disinfection/cleaning allows programming a disinfection/cleaning for each
day of the week. The parameters are set in the configuration menu and are
repeated week after week, unless modified by the operator.
The weekly disinfection/cleaning cycles are identical to those of manual

disinfection/cleaning (Chemical std., Chemical-full, Chemical-Heat, Heat,
Centralized), use the same chemical agents, aspiration times, etc.
Refer to the instructions included in chapter 9.1 for further details.
This icon reminds the operator that at least one disinfection/cleaning

has been programmed for the week.
This icon indicates that no disinfection/cleaning has been programmed.
It is recommended to set the daily disinfection/cleaning far from the normal dialysis
session.
Once the weekly program has been set, every day the machine automatically
switches on 10 minutes before the time fixed for the disinfection/cleaning program
and runs the initial tests.
The operator is prompted whether he/she intends to cancel the

disinfection/cleaning procedure.
yes
to cancel the procedure or wait for the tests to be completed
and the start of disinfection/cleaning.
Only in the special programs of centralized disinfection/cleaning (chemical special,
heat washing special, heat disinfection special) the machine switches on at the fixed
time and does not run any tests.
The essential conditions for automatic switching ON of the machine are the
following:
- the power cable must be connected to the power outlet.
- the main switch must be in the on position “I”.
- the machine is connected to a haemodialysis water source, the distribution plant
is working and the tap is open.
- the yellow connector is connected to the disinfectant intake tube placed in the
tank of the disinfecting agent.
No modification can be made in the 10 minutes prior the start of the programmed
disinfection/cleaning. Any modification becomes definitive, if the parameters are
changed in the configuration of the machine. On the contrary, the modification will
be valid only that day.
ENG – Ed. 05/08 ch. 9.2 - Weekly disinfection/cleaning - 1 of 4
DISINFECTING/CLEANING
DISINFECTING/CLEANING PROCEDURE
disinfection/
cleaning
To enter the weekly disinfection/cleaning program, and
weekly
disinf./clean.
in the main menu.
ok
Select the desired day with the or key and to
confirm.
Each time the daily disinfection/cleaning program is entered, the selection is
automatically set on the parameters fixed during configuration.
If the parameters are not the desired ones, modify them by selecting them one at a
time. The function and the field of the parameter selected turn light blue.
Use the and keys to make the changes.
disinf./clean. Indicates the type of disinfection/cleaning selected.

type
Selects the chemical agent or the type of centralized

agent
start Sets the starting time of disinfection/cleaning.

time
disinf./clean. In centralized disinfection/cleaning – chemical and heat washing:

time sets the duration of the aspiration of the chemical agent or hot
water from the distribution plant.
If NO WATER is selected, the aspiration phase ends when the NO
WATER alarm message appears and remains at least 1 minute on
the display.
2 of 4 – ch. 9.2 - Weekly disinfection/cleaning ENG – Ed. 05/08

In all other programs different from centralized
disinfection/cleaning: displays the total duration of the program.
rinsing Not available in the disinfection/cleaning cycles in which dwell of
time the chemical agent is not allowed.
In full-chemical and centralized disinfection/cleaning: sets the

automatic machine switching on after dwell of chemical agent.
Should the machine be switched on before the set time, then the
following message is displayed:
Dwelling phase.
Ensure there are no chemical agents and
system"
Press 'OK' to anticipate rinsing.
In chemical full disinfection/cleaning with DIALOX or OXAGAL, this

field may be left void (digit - -).
Rinsing will start immediately after aspiration of the chemical agent,
without dwell.
This field may be left void also in centralized disinfection/cleaning

(digit - -). In such condition, the machine will remain on after
aspiration of the chemical agent and will wait for a confirmation
from the operator.
When the aspiration phase is completed, a window displays the

message:
Ensure there are no chemical agents

and control
system
and then
press 'continue' to start rinsing
automatic Sets automatic switching off at the end of disinfection/cleaning

off (enabled/disabled).
Switching off time can be set only in centralized

This setting allows the operator to extend the minimum rinsing
time.
ENG – Ed. 05/08 ch. 9.2 - Weekly disinfection/cleaning - 3 of 4

CANCELLING THE PROGRAMMED
PROGRAMMED DISINFECTION/CLEANING
To permanently cancel the disinfection/cleaning programmed for a certain

day (e.g. Mondays) the machine configuration must be modified (see chapter
“Configuration”).
There are conditions where the disinfection/cleaning programmed for a certain day
is automatically cancelled, and others where the operator can intervene to cancel it.
Disinfection/cleaning is automatically cancelled:

• if the tests fail after automatic switching on;
• if the machine is in dialysis or disinfection/cleaning 10 minutes before the set
time.
To cancel disinfection/cleaning:
yes
- when the window with the specific prompt appears (i.e. 10
minutes before the start of the program);
weekly
disinf./clean.
- by setting the starting time to “--:--”. To do this, .
The disinfection/cleaning will be cancelled for that day (e.g. Monday), but the
following Monday will be repeated with the configuration values.
4 of 4 – ch. 9.2 - Weekly disinfection/cleaning ENG – Ed. 05/08

9.3 ROUTINE CLEANING
CLEANING AND MAINTENANCE
CLEANING
NOTE
The operator may not carry out any cleaning or maintenance operation
different from those listed. The side panels which allow access to the
electronic components may only be opened by technicians authorized
authorized by the
manufacturer. Refer to the technical manual.
Before any maintenance operation, disconnect the power supply by pulling out
the plug or turning off the main switch. The hands must be dry when touching
the switch or live parts.
UNITIZED BODY
The dust which deposits on the external panels and on the screen can be removed with
a cloth or soft brush. Any deposits of salt, blood, etc. can be removed with a cloth
moistened in a neutral detergent. Never spray detergents directly onto the machine
surface or onto components to be cleaned.
A certain number of detergents/disinfectants commonly used in dialysis centres have

been tested and did not cause any alteration or damage to the keyboards and panels of
the machine. These products are therefore recommended.
• ANTISAPRIL Amuchina
• CITROSIL Manetti - Roberts
• Ethyl ALCOHOL
• QUATHOEX B. Braun
• MELSEPT SPRAY B. Braun
• HYGIEN SPRAY B. Braun
In case of using different products, contact the manufacturer to check compatibility.
CAUTION
Any liquid spilled
spilled on the machine must be removed immediately to prevent
penetration into the machine damaging the components.
Do not use chemical products containing benzene, acetone, toluene, xylene,

iodine or similar solvents. These solutions damage the polyurethane a and
nd
polystyrene panels.
ENG – Ed. 06/09 chap. 9.3 - Routine Cleaning and Maintenance - 1 of 4

BLOOD PUMPS
• Open the pump cover.
• Pull the drive handle outwards.
• Turn the rotor until finding the unhooking point.
• Remove the rotor from the shaft.
• Clean the cover, the pump cup and the rotor rollers with a cloth moistened in
disinfectant (see above).
ROUTINE MAINTENANCE
MAINTENANCE (by the authorized technician)
Routine maintenance must be carried out every 3000 hours of operation or every 12
months by personnel or technicians authorized by the manufacturer. Refer to the
technical manual for more tips.
REPLACING THE ISOPRENE PLUG IN THE FORMULA PIERCEABLE

SAMPLING VALVE
Use the isoprene plug only in the formula pierceable sampling valve.
The isoprene plug must periodically be replaced since the successive perforations with
the needle damage it and compromise its integrity over time.
The plug must be replaced every 6 perforations by paramedical or technical staff.
For replacement follow the procedure below:

1. Turn off formula
2. Unscrew the valve cap.
3. Remove the worn isoprene plug and discard it in a container for hospital waste.
4. Insert a new isoprene plug in the valve cap taking care to insert it properly (the plug
is a small cylinder which is pressure-fitted into the cylindrical housing of the cap).
5. Screw on the valve cap until it fits against the valve body.
6. Turn on formula and run a disinfection program.
WARNINGS
The following human errors:
errors:
- improper insertion of the plug in the valve cap
cap
- cap not or not fully screwed down onto the valve body
- number of perforations exceeding
exceeding that permitted (max. 6)
- failure
failure to execute
execute disinfection after replacing
replacing the plug
may cause:
cause:
- the dialysis fluid to leak out with a consequent error in patient weight loss
- the chemical agent or hot water to leak out during the disinfection/cleaning
cycle
- bacterial contamination of the hydraulic circuit.
Before starting a treatment or a disinfection/cleaning

disinfection/cleaning cycle,
cycle, always check that
no fluid leaks
leaks from the sampling valve.
valve.
2 of 4 – chap. 9.3 – Routine Cleaning and Maintenance ENG – Ed. 06/09

Destroy the used plugs taking the appropriate measures for potentially
contaminated material.
material.
When handling the sampling valve and plugs, take the necessary and
appropriate precautions to prevent any exposure to or transmission of
infectious agents, HIV virus and hepatitis.
hepatitis.
ORDINARY MAINTENANCE (by the operator)

DESCALING
To prevent scaling resulting from the delayed precipitation of calcium carbonates, it is
advisable to clean the hydraulic circuit with acetic acid at least twice a week. Descaling
with acetic and citric acid is included in the heat and cold descaling program,
respectively.
MACHINE DISCONNECTION
Before removing the machine from the dialysis room to transfer it to another place or
to store it, perform a rinsing cycle and then carry out the following operations:
switch off
.
CAUTION
Before turning off the machine using the main switch on the back, wait for the
automatic power off controlled from the operator interface.
The machine must never be turned off directly at the main rear switch.
A message appears asking for

confirmation that you want to turn off.
yes
to confirm.
To drain the water from the hydraulic

circuit
drain
on
• Wait for the machine to turn off automatically and set the main rear switch to the
“O” (OFF) position.
• Disconnect the mains cable and the equipotential cable (if present) from the power
outlet.
• Close the water delivery tube and disconnect the water inlet tube.
• Disconnect the drain tube.
ENG – Ed. 06/09 chap. 9.3 - Routine Cleaning and Maintenance - 3 of 4
• Remove the wheel block.
• Move the machine by pushing it from behind.
4 of 4 – chap. 9.3 – Routine Cleaning and Maintenance ENG – Ed. 06/09

9.4 MANAGEMENT OF ULTRAFILTERS AND MULTIPURE
FILTER
formula® is equipped with filters which operate simultaneously to prevent bacterial
contamination and to prevent pyrogenic substances from entering the dialysate.
The FORCLEAN ultrafilter is an apyrogenic ultrafilter in Medisulfone placed after the

dialysis fluid preparation point and before the dialyser. By filtering the dialysis fluid,
the filters retain bacteria and adsorb endotoxins emerging from concentrated solutions
and/or from inside the machine. This ultrafilter is disinfected with the machine.
The ultrafilter is manufactured in two models Forclean Plus and Forclean I.
The FORCLEAN I ultrafilter is equipped with a transponder which, by means of the

Lector system, allows the machine to identify the ultrafilter (code) and the actual run
time.
NOTE
The Therapy model is equipped with two Forclean ultrafilters in sequence,
which must be checked for integrity before each treatment.
WARNING
The FORCLEAN ultrafilter must be replaced after a maximum number of
dialysis hours as indicated in the instructions for use of the ultrafilter.
ultrafilter.
On the formula® therapy model, both FORCLEAN filters must be changed at the
same time.
When the ultrafilter is installed on a machine for the first time, installation
must be done by technicians authorized by the manufacturer, since the
machine has to be reconfigured.
ENG – Ed. 05/08 chap. 9.4 – Management of ultrafilters and Multipure - 1 of 4

LECTOR: FORCLEAN I RECOGNITION DEVICE
Lector consists of a reader system built into the filter support which recognises the
FORCLEAN I ultrafilter fitted into the formula® plus and formula® therapy machines.
formula, taking account of the hours of treatment, advises the operator that it needs
to be replaced 20 hours before it expires.
Lector has different levels of safety on the basis of which the operator is informed – by
means of warnings and/or alarms and/or dialogue windows - on the state of use of the
ultrafilter and on any restrictions in the selection of dialysis treatments in the presence
of unsuitable ultrafiltrate.
These levels may only be set by techincians authorized by the manufacturer on the
basis of the requirements of the dialysis centre.
If activated, Lector runs a recognition test of the installed Forclean I ultrafilter during
the machine tests. This recognition test is automatically repeated each time the
replace FORCLEAN
FORCLEAN check
function has been activated or, after an alarm, when the
function key has been pressed.
Lector recognises each time the ultrafilter is replaced, stores the new code recognised
and, through the dialogue window, prompts the operator to start the automatic
filter replace
management FORCLEAN
priming/spilling sequence of the ultrafilter. and .
Counting of the hours elapsed since the last ultrafilter replacement is reset only if this
procedure is performed.
In the dialogue window two additional parameters are displayed:
- time of use of the recognized code (i.e. of the ultrafilter installed)

replace
FORCLEAN
- time elapsed since the key was last pressed.
2 of 4 – chap. 9.4 - Management of ultrafilters and Multipure ENG – Ed. 05/08

REPLACING ULTRAFILTERS (by the operator)
For Therapy models:
1. Switch off the machine with the main switch on the rear panel.
2. Open the protective cover.
3. Remove the six Hansen connectors.
4. Unfasten the elastic band around the FORCLEAN I ultrafilter and remove the
ultrafilters.
5. Place the new Forclean ultrafilter into the fixing clips.
6. Tie the elastic clip again.
7. Reattach the filter connectors, checking the colour code and the assembly tag on the
back of the machine, and ensure none of the tubes are bended or squashed.
8. Using the clip provided, attach the second ultrafilter to the first.
9. Attach the filter connectors, checking the colour code and the assembly tag on the
back of the machine, and ensure none of the tubes are bent or squashed.
10. Replace the protective cover, making sure none of the tubes are bent or
squashed.
11. Switch on the machine.
filter replace
maintenance management FORCLEAN
12. . The automatic filter
priming/spilling sequence will be started and the dialysis hour counter reset.
13. Always perform a disinfection before using the formula machine for a dialysis
treatment.
For the other models:
2. Remove the protective cover.
3. Detach the elastic clip holding the ultrafilter.
4. Disconnect the three connectors from the ultrafilter and remove it.
5. Mount the new ultrafilter in the fixing clips.
6. Tie the elastic clip again.
7. Reconnect the connectors to the filter, taking care not to bend or squash the tubes.
8. Replace the protective cover.
filter replace
management FORCLEAN
10. . The automatic filter priming/spilling
sequence will be started and the dialysis hour counter reset.
ENG – Ed. 05/08 chap. 9.4 – Management of ultrafilters and Multipure - 3 of 4
treatment.
MULTIPURE FILTER
The MULTIPURE filter, positioned after the water supply inlet and accessible from the
back of the machine, is a bacterial microfilter designed to remove endotoxins. It thus
prevents the microbiological contamination of the machine.
WARNING
The Multipure filter must be replaced after 600 hours of operation.
NOTE
The operator is warned when the filter needs to be replaced by the message
“REPLACE MULTIPURE” .
REPLACING MULTIPURE FILTER (by the operator)

2. Close the haemodialysis water delivery tap.
3. Unscrew the wing screw to remove the filter retaining band.
4. Disconnect the two quick couplings and remove the filter from its housing.
5. Mount the new filter.
6. Reconnect the two quick couplings.
7. Refit the filter retaining bar.
8. Open the water delivery tap.
9. Open the upper valve of the filter to bleed the air.
11. For Therapy models:

models
filter replace
maintenance management MULTIPURE
to reset the dialysis
hour counter.
For the other models:
filter replace
management MULTIPURE
to reset the dialysis hour counter.
treatment.
4 of 4 – chap. 9.4 - Management of ultrafilters and Multipure ENG – Ed. 05/08

9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA
MACHINES PERFORMING ONLINE HAEMODIAFILTRATION
TREATMENT
All dialysis treatments, and particularly on-line techniques with dialysis fluid
infusion, may only be performed using a properly sanitised machine.
Dialysis fluid is filtered through three levels of cold filtering positioned in sequence,
characterised by adsorbent, microfilter surfaces with different properties: a
Multipure microfilter at the water inlet, a Forclean double (formula Therapy model
only) or single (all other models) ultrafilter for dialysate and, for PHF only, a PHF
filter chamber for dialysis fluid infused through backfiltration. Below follows a
description of the disinfection procedures for formula 2000. These procedures have
to be carried out by the nursing and/or technical staff of the dialysis centre in order
to prepare the equipment to perform PHF treatment.
WARNING
The manufacturer declines all responsibility for any harm to the patient
caused by failed or improper use of these disinfection/cleaning
disinfection/cleaning procedures.
Furthermore, the manufacturer does not guarantee proper disinfection of
formula for On Line Haemodifiltration treatments if chemical agents and/or
disinfection/cleaning procedures different from those described are used.
START-
TART-UP DISINFECTION PROCEDURE
PROCEDURE FOR FORMULA
MACHINES USED FOR ON ONLINE
LINE HAEMODIAFILTRATION
HAEMODIAFILTRATION
TREATMENT
WARNING
This procedure must be used in the following cases:
• first installation of the machine.
• each time online HDF treatment is performed on machines that have
have been
used for other treatments.
• performing online HDF treatment using machines not disinfected
following the recommended “maintenance“ disinfection procedure.
• performing online HDF treatment using machines that have remained
inactive or off for a long time.
Proceed as follows:
1. perform a DISINFECTION from the machine water intake using a suitable device
(to be used only by personnel authorised by the manufacturer).
2. perform a descaling procedure by selecting HEAT DESCALING with citric acid.
3. perform a disinfection by selecting FULL CHEMICAL DISINFECTION with Oxagal
with DWELL TIME, until used for PHF (pre/post) or HDF (pre/post/mid) dialysis
treatment.
ENG – Ed. 12/07 chap. 9.5 – Sanitation for online HDF - 1 of 2

“MAINTENANCE” SANITATION
SANITATION FOR FORMULA MACHINES
MACHINES USED
FOR ONLINE HAEMODIAFILTRATION
HAEMODIAFILTRATION TREATMENT
WARNING
This procedure must be performed on all formula® machines used regularly
for online haemodiafiltration.
If use is:
• not continuous (periods of inactivity),
• not governed by the “maintenance”
maintenance” disinfection procedure described
below,
the “start-
“start-up” disinfection procedure above described must be carried out
preliminarily.
The machine must be sanitized regularly following a specific protocol.

This protocol must be chosen and supervised by the physician. Responsibility lies
exclusively with the physician in charge.
charge.
The manufacturer recommends performing dwell time during night night-
-time hours and
two citric acid descaling cycles per week (activated by selecting heat descaling with
citric acid).
Here below a protocol example is given.
SANITIZATION PROTOCOL EXAMPLE FOR

FOR PHF OR HDF ON-
ON-LINE
After 1st dialysis After 2nd dialysis After 3rd dialysis and
night
Monday free free Descal. (citric a.)
+
Dwell with Oxagal
Tuesday free free Dwell with Oxagal
Wednesday free free Dwell with Oxagal
Thursday free free Dwell with Oxagal
Friday free free Dwell with Oxagal
Saturday free free Descal. (citric a.)

+
Dwell with Oxagal
Sunday Dwell with Oxagal
Descaling with citric acid can be performed on Mondays and Saturdays, it can be
done in the evening, before using OXAGAL. In case of only two dialysis sessions per
day, do not take into consideration the first column.
2 of 2 – chap. 9.5 - Sanitation for online HDFOnLine ENG – Ed. 12/07

10.1 ALARMS AND WARNINGS - GENERAL
The alarms and warnings for the operator are indicated by messages displayed on
the bar at the bottom of the screen, on the right those relative to the blood section,
on the left those relative to the dialysate section.
This bar, which normally is grey, turns
- red when an alarm occurs,
- orange when a warning is signalled,
- yellow if the alarm has been disabled temporarily.
If the parameter in alarm condition is displayed on the screen,

the relevant graphic tool turns red.
Each alarm/warning is characterised by visual and acoustic signalling.

The visual signalling (red indicator on I.V. pole) continues flashing for the entire
duration of the alarm.
Acoustic warning signals have different intensity and time intervals according to a
scale of priorities.
An active alarm covers any warning present relative to the same section (the orange
bar turns red).
A warning in one of the two sections (blood or dialysate) is highlighted in red if an
alarm occurs on the other section.
In the event of an alarm/warning indicator, the following buttons can be used:
To silence the alarm sound for 5 minutes in priming and 2 minutes in

dialysis.
Where allowed, this key permits to temporarily override the alarm (5 min.
during priming and 2 min. during dialysis), thus allowing to restart the
machine and remove the cause of the alarm. The machine permanently
monitors the parameters connected with the alarm condition.
In some conditions the key is used to cancel a warning or an alarm.
ENG – Ed. 06/09 chap. 10.1 – Alarms and warnings - General - 1 of 8

NOTE
• LED off = the function is inactive.
• LED on permanently = the function is active
• LED flashing = the function is activata
activatable.
Alarms/indicators are described in the following chapters, subdivided into a

dialysate section and a blood section.
For each alarm and warning the following are indicated:

- Machine operating status
- Alarm message
- Effects produced (pump stop, electroclamp closure,...).
- Cause of the alarm
- Action to take
In the alarm description if the symbol appears, it means that the acoustic
alarm can be silenced with the relevant key.
Likewise, if the symbol appears, it means that the alarm can be temporarily
overridden.
ALARMS SILENCED DURING

DURING PRIMING AND RINSEBACK
RINSEBACK
In configuration mode it is possible to set formula (ACOUSTIC ALARMS IN
RINSEBACK: OFF, ACOUSTIC ALARMS IN PRIMING: OFF) in order to automatically
silence some alarms during priming and/or disconnection:
PRIMING
PUMP OFF
BICARB. CONDUCTIVITY
TOTAL CONDUCTIVITY
PATIENT RINSEBACK
END UF
EMPTYING
All alarms (except the AIR DETECTED alarm if rinseback with physiological solution
was configured )
2 of 8 – chap. 10.1 – Alarms and warnings – General ENG – Ed. 06/09

LIST OF ALARMS - WARNINGS
The table below allows you to have quick consultation of the alarms/warnings
displayed by the formula.
The table indicates the alarm/warning message, the denomination and the chapter
of the user manual in which the operator can read the relevant information.
WARNING MESSAGE ALARM CHAPTER

Error 0 alarm chap. 10.1
DIALYSATE SIDE
BICARB. CONDUCTIVITY Partial conductivity alarm chap. 10.2
TOTAL CONDUCTIVITY Total conductivity alarm chap. 10.2
CONCENTRATE CONNECTORS Concentrate connector alarm chap. 10.2
DIALYSER CONNECTORS Dialyser connector alarm chap. 10.2
DISINFECTANT CONNECTOR Disinfectant connector alarm chap. 10.2
INFUSION CONNECTOR Infusion connector alarm chap. 10.2
CONCENTRATE ERROR Concentrate error alarm chap. 10.2
HYDRAULIC Hydraulic alarm chap. 10.2
NO WATER No water alarm chap. 10.2
TMP OUT OF RANGE Transmembrane pressure alarm chap. 10.2
(absolute limit)
P_UF OUT OF RANGE Ultrafiltration pressure alarm (absolute chap. 10.2
limit)
TMP MINMAX Transmembrane pressure alarm chap. 10.2
(relative limit)
P_UF MINMAX Ultrafiltration pressure alarm (relative chap. 10.2
limit)
BIDRY NOT FILLED Bidry not filled alarm chap. 10.2
TEMPERATURE Temperature alarm chap. 10.2
REVERSE UF Reverse ultrafiltration alarm chap. 10.2
BLUE CON. Blue connector alarm chap. 10.2
BATTERY Battery alarm chap. 10.2
UF TEST FAILED Ultrafiltration system test alarm chap.10.2
REPLACE FORCLEAN Replace Forclean alarm chap. 10.2
FORCLEAN ABSENT Missing Forclean alarm chap. 10.2
DIALYSATE INFUSION Incorrect dialysate infusion alarm chap. 10.2
START [Na] Initial [Na] with Aequilibrium alarm chap. 10.2
TECHNICAL ALARM XXX:XXX Dialysate technical alarm code xxx:xxx Chap. 10.2
HYDRAULIC XXX Hydraulic alarm code xxx Chap. 10.2

BLOOD SIDE
CLAMP OPEN Open clamp alarm chap. 10.3
BLD BLD alarm chap. 10.3
ART. PUMP COVER Arterial pump cover alarm chap. 10.3
HEPARIN RUN OUT End heparin alarm chap. 10.3
ARTERIAL PUMP REVOL. Arterial pump revolution alarm chap. 10.3
WRONG ART. LINE Arterial line set up alarm chap. 10.3
BLOOD LEVEL Blood level alarm chap. 10.3
PA MINMAX Min/max arterial pressure alarm chap. 10.3
PA OUT OF RANGE Arterial pressure out of range alarm chap. 10.3
FILTER INLET PRESSURE Dialyser inlet arterial pressure out of chap. 10.3
range alarm
PUMP OFF Pump off alarm chap. 10.3
ABNORMAL COMM. PRESSURE Abnormal switching pressure alarm chap. 10.3
HEPARIN INFUSION Incorrect heparin infusion alarm chap. 10.3
AIR DETECTED Air detection alarm chap. 10.3
PV MINMAX Min/max venous pressure alarm chap. 10.3
PV OUT OF RANGE Venous pressure out of range alarm chap. 10.3
ARTERIAL PHASE TIMEOUT Arterial phase timeout alarm chap. 10.3
VENOUS PHASE TIMEOUT Arterial phase time alarm chap. 10.3
BLOOD VOLUME Venous phase time alarm chap. 10.3
END INFUSION End infusion alarm chap. 10.3
EXCESSIVE LOAD Excessive load alarm chap. 10.3
LOAD INSUFFICIENT Insufficient load alarm chap. 10.3
LOAD MODIFIED Modified load alarm chap. 10.3
LOAD UNSTABLE Unstable load alarm chap. 10.3
LOAD ABNORMAL Abnormal load alarm chap. 10.3
INFUSION ERROR Infusion error alarm chap. 10.3
EXCESSIVE INFUSION Excessive infusion alarm chap. 10.3
INSUFFICIENT INFUSION Insufficient infusion alarm chap. 10.3
INVERSE INFUSION Inverse infusion alarm chap. 10.3
INFUSION PUMP COVER Infusion pump cover alarm chap. 10.3
INF. PUMP ROTATION No. Infusion pump revolution alarm chap. 10.3
MAX. VEN. P. Maximum venous pressure alarm chap. 10.3
VEN. PUMP COVER Venous pump cover alarm chap. 10.3
V. PUMP ROTATION No. Venous pump revolution alarm chap. 10.3
EXTRACT V. PUMP SEGMENT Venous segment alarm chap. 10.3
INF. PRESS. OUT OF RANGE Infusion pressure out of range alarm chap. 10.3
HFR LINE PRIME TIMEOUT HFR line prime timeout alarm chap. 10.3
WRONG HFR LINE INSERTION Incorrect infusion line insertion alarm chap. 10.3
BLOOD DET. IN INF. LINE Blood detected in infusion line alarm chap. 10.3
INADEQUATE FLOWS UF/infusion flow too high alarm chap. 10.3

TMPH OUT OF RANGE Transmembrane pressure HFR out of chap. 10.3
range alarm
WRONG INF. LINE INSERTION Incorrect infusion line insertion alarm chap. 10.3
INF. LINE TEST TIMEOUT Infusion line priming timeout/PHF chap. 10.3
filter test alarm
TECHNICAL ALARM XXX:XXX Blood side technical alarm Chap 10.3
WARNING MESSAGE WARNING CHAPTER

DIALYSATE SIDE
WATER UNSUITABLE Unsuitable water warning chap. 10.2
BACKFILTRATION Backfiltration warning chap. 10.2
BYPASS Dialyser bypass warning chap. 10.2
DISINFECTION (not Therapy Disinfection (not Therapy model) or chap. 10.2
maintenance (Therapy model)
model) or
procedure not completed warning
MAINTENANCE (Therapy
model)
END UF End UF warning chap. 10.2
PUMP REVOLUTIONS Concentrate pump revolution warning chap. 10.2
DISINFECTANT NOT INTAKEN No disinfectant/descaling agent intake chap. 10.2
alert
INFUSION CONNECTOR Infusion connector warning chap. 10.2
TESTING TEMP. INSUF. Testing temperature insufficient chap. 10.2
warning
SYSTEM READY System ready warning chap. 10.2
MINIMAL UF Minimum UF warning chap. 10.2
UF NOT ACTIVATED UF not activated warning chap. 10.2
UF NOT PROGRAMMED UF not programmed warning chap. 10.2
WAITING FOR RINSING Waiting for rinsing warning chap. 10.2
TMP MAX. Maximum TMP out of range warning chap. 10.2
VERIFY PROFILE Incorrect profile warning chap. 10.2
AEQUIL/ISONA NOT AVAIL. Aequilibrium or Isonatric indicator chap. 10.2
unavailable warning
REPLACE MULTIPURE Warning: replace Multipure warning chap. 10.2
REPLACE FORCLEAN Replace Forclean warning chap. 10.2
FORCLEAN ABSENT Missing Forclean warning chap. 10.2
BLOOD SIDE
HEPARIN OFF Heparin not active warning chap. 10.3
NO HEPARIN SETTING Heparin not set warning chap. 10.3
FLOW SET TO ZERO Zero blood flow warning chap. 10.3
INADEQUATE BLOOD FLOW Blood flow inadequate warning chap. 10.3
MODIFY ARTERIAL FLOW Arterial flow modification warning chap. 10.3
BLOOD DETECTED Blood detection warning chap. 10.3
ART./ FILTER INLET PRESS. Arterial pressure/prefilter warning chap. 10.3
BLOOD LINE EMPTYING Line emptying warning chap. 10.3
ERROR: LINE PRESSURE Infusion line pressure warning chap. 10.3
Kt/V MIN OUT OF RANGE Kt/V min out of range warning chap. 10.3
Kt/V GOAL OUT OF RANGE Kt/V goal out of range warning chap. 10.3
K MIN OUT OF RANGE Clearance out of range warning chap. 10.3
ERROR: BLD BLD detector line error warning chap. 10.3
NO INFUSION FLOW No infusion flow warning chap. 10.3
INCOMPL. INF. LINE PRIMING Uncompleted HFR line priming warning chap. 10.3
EFFICIENCY Efficiency warning chap. 10.3
COMM. PRESSURE Switching pressure warning chap. 10.3
ERROR: WEIGHT ON SCALE Weight on scale warning chap. 10.3
INCOMPL. HFR LINE PRIMING Uncompleted HFR line priming warning chap. 10.3
SPHYGMO ERROR Sphygmo measurement error warning chap. 10.3
SYSTOLIC OUT OF RANGE Warning: systolic pressure out of range chap. 10.3
DIASTOLIC OUT OF RANGE Warning: diastolic pressure out of chap. 10.3
range
HR OUT OF RANGE Warning: heart rate out of range chap. 10.3
HCT OUT OF RANGE Warning: hematocrit out of range chap. 10.3
SO2 OUT OF RANGE Warning: oxygen saturation out of chap. 10.3

range
VL% OUT OF RANGE Warning: percent volume loss out of chap. 10.3
range
CARDIUM HR OUT OF RANGE Cardium warning: heart rate out of the chap. 10.3
absolute range
CARDIUM HR % OUT OF Cardium warning: heart rate out of the chap. 10.3
percent range
RANGE
CARDIUM HR DER. OUT OF Cardium warning: heart rate out of the chap. 10.3
derivative range
RANGE
TEST SENSORS FORMULA + Warning: Formula Plus test sensor chap. 10.3
failed
SODIUM CONCENTRATION Sodium concentration not detected Chap. 10.3
warning
NOT DETECTED

MACHINE ERROR
ERROR 0 ALARM during all operational phases
RED/BLUE ALARM WINDOW
Effects Causes
- Clamp closure after an alarm was not detected
Visual warning by the machine, as the clamp was been opened
Acoustic warning manually.
- The blood pump has been forced while off.
Blood pump stop
- Internal machine problem.
Clamp closure
Dialyser bypass - A condition dangerous to the patient has been
Dialysis/ rinsing/ disinfection detected.
time interrupted - At turning on, the water tap has remained
closed.
Suggested actions
- Note down the error code.
- Press the power key (green LED) for at least 5
seconds. If ERROR 0 does not disappear,
switch off the machine using the main switch
in the rear panel and contact After-Sales
Service.
- Open the water tap.

10.2 ALARMS AND WARNINGS – DIALYSATE SECTION
ALARMS
PARTIAL CONDUCTIVITY ALARM during dialysis
MESSAGE: BICARB. CONDUCTIVITY
Causes
- The bicarbonate concentrate conductivity is
outside the set values (+/-5%) or is outside
Effects the permitted limits.
- The bicarbonate concentrate is not aspirated
Visual warning properly.
Acoustic warning - The bicarbonate concentrate container is
empty.
dialyser bypass - Unsuitable concentrate solutions have been
dialysis time interrupted used.
- Air in the circuit.
- The machine has just entered the preparation
phase.
- Air from the bicarbonate powder cartridge.
- Variation of the dialysate flow rate.
Suggested actions
- Check suitability of the bicarbonate
concentrate and its proper aspiration.
- Remove the air from the concentrate suction
tubes.
- Seal the concentrate connectors on the
cannulas of the containers.
ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 1 of 18
TOTAL CONDUCTIVITY ALARM during dialysis
MESSAGE: TOTAL CONDUCTIVITY
Causes
- The dialysis fluid conductivity is outside the set
values (+/- 5%) or is outside the permitted limits.
Effects - The concentrate containers are empty or the
concentrate is not aspirated properly.
Visual warning - Unsuitable concentrate solutions have been used.
Acoustic warning - Air in the circuit.
- The machine has just entered the preparation
dialyser bypass phase.
dialysis time interrupted
Suggested actions
- Check suitability of the concentrates and their
intake.
- Remove the air from the concentrate suction tubes.
CONCENTRATE CONNECTOR ALARM

during dialysis, rinsing and disinfection/cleaning
MESSAGE: CONCENTRATE CONNECTORS
Causes
- The concentrate connectors are not properly
Effects inserted in the block or their position is not in
conformance with the operating phase the machine
Visual warning is in.
Acoustic warning - The bracket has not been closed correctly.
- The upper piercing connector has not been properly
dialyser bypass closed.
Dialysis/rinsing/disinfection
time interrupted Suggested actions
- Check the position of the concentrate connectors
and change it if necessary.
- Make sure the upper piercing connector and the
locking bracket are in the correct position.
2 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09
DIALYSER CONNECTORS ALARM
during dialysis, rinsing and disinfection/cleaning
Message: DIALYSER CONNECTORS
Causes
- The dialyser connectors are not properly
Effects inserted in the block or their position is not in
Visual warning conformity with the machine operating phase.
Acoustic warning
Suggested actions
dialyser bypass - Check and, if necessary, correct the position of
Dialysis/rinsing/disinfection time the dialyser connectors.
interrupted
DISINFECTANT CONNECTOR ALARM during dialysis and

Message: DISINFECTANT CONNECTOR
Causes
- The disinfectant connector is not properly
Effects inserted in the block or its position is not in
conformity with the machine operating phase.
Visual warning
Acoustic warning Suggested actions
- Check and, if necessary, correct the position of
dialyser bypass the disinfectant connector.
Dialysis/disinfection time
interrupted
INFUSION CONNECTOR ALARM during cleaning, dialysis and

Message: INFUSION CONNECTOR
Causes
- The infusion connector cover is not closed
Effects properly or its position is not in conformity with
the machine operating phase.
Visual warning
- Check the position of the infusion connector
dialyser bypass cover.
Dialysis/disinfection time
interrupted
CONCENTRATE ERROR ALARM during dialysis
Message: CONCENTRATE ERROR
Causes
- Unsuitable concentrate solutions have been
used.
Effects - The cannulas of the containers have been
inverted.
Visual warning - The concentrate pumps turn outside the preset
Acoustic warning speed.
- The water inlet flow is incorrect.
dialyser bypass
dialysis time interrupted Suggested actions
- Check the connection and the type of
concentrates used.
HYDRAULIC ALARM during dialysis, rinsing and disinfection/cleaning
Message: HYDRAULIC
Causes
- Excessive pressure measured in the hydraulic
circuit.
Effects
Suggested actions
Visual warning - Check possible occlusions of the drain tube.
Acoustic warning - Check possible occlusions of the dialyser
connection tubes.
dialyser bypass - Check if the Forclean ultrafilter is installed
Dialysis/ rinsing/ disinfection time correctly.
interrupted - Check the proper connection of the powder
bicarbonate cartridge or the position of the
Bidry connector.
If the HYDRAULIC alarm is followed by a number, refer to the HYDRAULIC ALARM: XXX
hereinafter.
NO WATER ALARM during dialysis, rinsing and disinfection/cleaning
Message: NO WATER
Causes
- The water supply pressure is too low.
- No water supply to machine inlet.
Effects
Visual warning Suggested actions
Acoustic warning - Check that the water tap is open.
- Check that the machine water supply pressure
dialyser bypass is correct and that the inlet tube is not
Dialysis/rinsing/disinfection time squashed or clogged.
interrupted
TRANSMEMBRANE PRESSURE OUT OF ABSOLUTE RANGE ALARM during
dialysis
Message: TMP OUT OF RANGE
Causes
- The transmembrane pressure has exceeded the
absolute maximum or minimum value set
Effects during configuration.

Acoustic warning - Check that the ultrafiltration set is in
accordance with the type of filter being used.
dialyser bypass
ULTRAFILTRATION PRESSURE
PRESSURE OUT OF ABSOLUTE RANGE ALARM during
dialysis
Message: P_UF OUT OF RANGE
Causes
- The dialyser outlet pressure has exceeded the
absolute minimum or maximum value set
Effects during configuration.

Acoustic warning - Check that the ultrafiltration set is in
accordance with the type of filter being used.
dialyser bypass - Check that the dialyser connection tubes are
dialysis time interrupted not occluded.
TRANSMEMBRANE PRESSURE MIN / MAX ALARM during dialysis
Message: TMP MINMAX
Causes
- The transmembrane pressure exceeds the
operating thresholds.
Effects
Suggested actions
Visual warning - Check that the ultrafiltration set is in
Acoustic warning accordance with the type of filter being used.
- Check for leakage and obstructions.
dialyser bypass - Check the alarm range set.
MIN./MAX. ULTRAFILTRATION PRESSURE ALARM during dialysis
Message: P_UF MINMAX
Causes
- The dialyser outlet pressure exceeds the
operating thresholds.
Effects
Suggested actions
Visual warning - Check that the ultrafiltration set is in
Acoustic warning accordance with the type of filter being used.
- Check that the dialyser connection tubes are
dialyser bypass not occluded.
dialysis time interrupted - Check for leakage and obstructions.
- Check the alarm range set.
BIDRY NOT FILLED ALARM during dialysis
Message: BIDRY NOT FILLED
Causes
- The Bidry cartridge has not been filled correctly.
The most common causes are:
Effects 1. the clamps on the cartridge lines are closed,
2. the cartridge is not connected properly,
Visual warning 3. the cartridge is broken.
Acoustic warning
Suggested actions
dialyser bypass - Check the cartridge connections and possible
dialysis time interrupted obstructions in the lines. Repeat filling.
- Check that the cartridge is undamaged and
replace it if necessary.
TEMPERATURE ALARM during dialysis
Message: TEMPERATURE
Causes
- The dialysis fluid temperature is outside the
34 - 40 °C range.
Effects
Acoustic warning - Wait for the temperature to spontaneously
return within the permitted range.
dialyser bypass
REVERSE ULTRAFILTRATION ALARM during dialysis
Message: REVERSE UF
Causes
- Reverse filtration detected by reading of the
differential flowmeter.
Effects
Suggested actions
Visual warning - Check that the drain tube or the dialyser tubes
Acoustic warning are not occluded.
- Check that air is not present in the circuit.
dialyser bypass - Check the patient's precise weight since reverse
dialysis time interrupted ultrafiltration may be dangerous.
BLUE CONNECTOR ALARM during dialysis
MESSAGE: BLUE CON.
Causes
- The blue dialyser connector is not connected to
the machine while the filter is being drained.
Effects
Suggested actions
Visual warning - Connect the blue dialyser connector to the
Acoustic warning machine.
dialyser bypass
BATTERY ALARM during priming and dialysis
MESSAGE: BATTERY
Causes
- During the connection phase in priming or
during dialysis treatment, there is a mains
power shortage and the machine has switched
Effects
to the auxiliary battery power.
Visual warning
- The machine will run for the entire life cycle of
Flashing orange led close to the the battery during dialysis (refer to the
corresponding paragraph in chapter 8.4 ("Other
key functions")).
- Wait for the mains power supply to reconnect.
- Disconnect the patient if the mains power is
not restored.
ULTRAFILTRATION SYSTEM TEST FAILURE ALARM during dialysis
Message: UF TEST FAILED
Causes
- The ultrafiltration system may have a failure.
Effects - Possible damage to Forclean(s).
- Possible presence of air in the hydraulic circuit.
Visual warning - Possible leak in the hydraulic circuit.
Acoustic warning
Suggested actions
dialyser bypass - Check the integrity of the Forclean(s).
dialysis time interrupted repeat
test
- Press and eventually perform a filling
of the cartridge.
REPLACE ULTRAFILTER FORCLEAN ALARM during rinsing

rinsing
MESSAGE: REPLACE FORCLEAN
Causes
- A number of hours equal to the maximum
configured has passed since the ultrafilter(s)
Effects was(were) last replaced.
- The Forclean ultrafilter(s) has(have) totalled a
Visual warning
number of hours of dialysis exceeding the
Acoustic warning
maximum configured.
Rinse time interrupted
Unable to select treatments. Suggested actions
- Press to cancel the alert and replace the

dialyser bypass
ultrafilter(s).
MISSING FORCLEAN ALARM during rinsing
MESSAGE: FORCLEAN ABSENT
Causes
- "Forclean I” ultrafilter not detected.
- Incorrect installation of “Forclean i” ultrafilter.
Effects

Acoustic warning - Insert the ultrafilter in its holder.
Rinse time interrupted - Check positioning of the ultrafilter.
Unable to select treatments.
- Press to cancel the warning.
dialyser bypass
INCORRECT DIALYSATE INFUSION ALARM
in priming, dialysis and rinseback of on-
on-line haemodiafiltration treatments
MESSAGE: DIALYSATE INFUSION
Causes
- During priming:
Effects Priming is not carried out at the established
infusion flow rate.
Visual warning
Acoustic warning - During dialysis:
The bolus is not infused at a flow rate consistent
infusion pump stop with the set Qb value.
dialyser bypass
dialysis time interrupted - In Rinseback with ultrapure dialysis fluid:
Reinfusion is not carried out at the established
infusion flow rate.
Suggested actions
- During priming:
Increase the value set for Qinf.
During dialysis:
- Check the value set for Qb.
- Check the value set for Qinf.
START [Na] WITH AEQUILIBRIUM ALARM

in HFR dialysis with Profiler and Aequilibrium enabled
MESSAGE: START [NA]
Causes
- The sodium concentration measured by Natrium
shows a difference of at least 3mEq/L against the
Effects initial concentration set.
Visual warning
Suggested actions
Acoustic warning
- Press “yes” to enable the profile recount, or "no"
to continue with the profiling in progress.
DIALYSATE TECHNICAL ALARM CODE XXX:XXX in all machine
states
MESSAGE: TECHNICAL ALARM XXX:XXX
Causes
- Signal conformity tests on the dialysate side
Effects failed .

Acoustic warning
- If possible, press to clear the alarm.
Dialyser bypass - If the alarm persists, note down the alarm code
Rinsing/dialysis time XXX:XXX and contact After-sales Service.
interrupted
HYDRAULIC ALARM XXX in dialysis, rinsing and

MESSAGE: HYDRAULIC XXX
Causes
- Bypass state not conform with machine state .
Effects
Suggested actions
Visual warning
Acoustic warning - If possible, press to clear the alarm.
- If the alarm persists, note down the alarm code
Dialyser bypass XXX and contact After-sales Service.
Rinsing/dialysis time
interrupted
WARNINGS
UNSUITABLE WATER WARNING during rinsing
Message: WATER UNSUITABLE
Causes
- The inlet water conductivity is higher than the
permitted limit.
Effects - Dialysis liquid is left inside the machine during
post-dialysis rinsing.
Visual warning
- Check the water distribution system.
- Wait for rinsing end. The warning disappears
automatically.
BACKFILTRATION WARNING during dialysis
MESSAGE: BACKFILTRATION
Causes
- The TMP value has exceeded the threshold set
in configuration.
Effects
Suggested actions
Visual warning - Change the blood flow and/or dialysis fluid flow
Acoustic warning and, if necessary, reset the ultrafiltration
program.
- Check that the UF program is in accordance
with the dialyser being used.
DIALYSER BYPASS WARNING during priming and dialysis
MESSAGE: BYPASS
Effects Causes
Acoustic warning - The key has been pressed.

Visual warning
Suggested actions
dialyser bypass
dialysis time interrupted - Press again to disable the function.
WARNING
The acoustic warning is
disabled during filter change.
DISINFECTION WARNING (not Therapy model) or
MAINTENANCE WARNING (Therapy model) during disinfection/cleaning
Message: DISINFECTION (not Therapy model) or
Message: MAINTENANCE (Therapy model)
Causes
- Disinfection/cleaning not completed correctly
since the machine could not detect the
Effects disinfectant or descaler within a set time period.
- The disinfectant or descaler uptaken does not
Visual warning match that selected.
Acoustic warning - The suitable temperature for heat disinfection
has not been reached.
Suggested actions
- Check that the disinfectant or descaler used
matches that selected.
- Check that the concentration of the disinfectant
or descaler is correct.
- Restart the disinfection or descaling process.
END UF WARNING during dialysis
MESSAGE: END UF
Effects Causes
- The UF program time has run out.
Suggested actions
- Re-set a new ultrafiltration program or
Visual warning
Acoustic warning
disconnect the patient.
dialyser bypass
CONCENTRATE
CONCENTRATE PUMP REVOLUTIONS during rinse and disinfection/cleaning
MESSAGE: PUMP REVOLUTIONS
Causes
- The concentrate pumps are locked.
Effects Suggested actions

- Wait and eventually contact After-Sales Service.
Visual warning
Acoustic warning
Rinsing/ disinfection time

interrupted
DISINFECTANT/DESCALER NOT UPTAKEN WARNING in disinfection/cleaning
MESSAGE: DISINFECTANT NOT INTAKEN
Causes
- The disinfectant or descaler has not been drawn
correctly.
Effects
Suggested actions
Visual warning - Check that there is disinfectant or descaler in
Acoustic warning the container.
- Check that there is no air in the
disinfectant/descaler suction tube.
- Check that the disinfectant/descaler suction
tube is not clogged or squashed.
- Contact After-Sales Service .
INFUSION CONNECTOR WARNING (Therapy model only) during rinsing
Message: INFUSION CONNECTOR
Causes
- Infusion connector window not closed correctly
Effects or not in correct position for the operational
phase of the machine.
Visual warning
- Check the position of the infusion connector
dialyser bypass window.
Rinsing time interrupted
TESTING TEMPERATURE INSUFFICIENT WARNING during rinsing
MESSAGE: TESTING TEMP. INSUF.
Causes
- The perfect temperature for execution of the
autodiagnostic tests has not been reached.
Effects
Suggested actions
Visual warning - Contact After-Sales Service .
Acoustic warning
SYSTEM READY WARNING during rinsing
Message: SYSTEM READY
Causes
- The tests have been completed successfully.

- The system is ready to be programmed.
Acoustic warning
Visual warning
MINIMUM UF WARNING during dialysis
MESSAGE: MINIMAL UF
Effects Causes
- The ultrafiltration program has been
Acoustic warning deactivated
(the time delay between one alert
and the next can be either 20 Suggested actions
seconds or 2 minutes depending - Activate or re-activate the ultrafiltration
on the parameter set during uf
configuration for acoustic on
minimum UF alert) program with the function key .
Minimum UF
UF NOT ACTIVATED WARNING during

during dialysis
MESSAGE: UF NOT ACTIVATED
Effects Causes
- The ultrafiltration program has been set but not
Acoustic warning enabled.
Minimum UF
Suggested actions
uf
on
- Press .
UF NOT PROGRAMMED WARNING during dialysis
MESSAGE: UF NOT PROGRAMMED
Effects Causes
- The ultrafiltration program has not been set.
Acoustic warning
Minimum UF Suggested actions
- Set and activate the ultrafiltration program.
WAITING FOR RINSING WARNING during centralised disinfection
MESSAGE: WAITING FOR RINSING
Effects Causes
- The machine is waiting for the start of the
Visual warning rinsing phase during centralised disinfection.
Acoustic warning
Suggested actions
- The machine automatically restarts as soon as
the waiting for rinsing time set in configuration
has elapsed.
- If the time set is = 0, manually activate rinsing:
continue
press .
MAXIMUM TRANSMEMBRANE PRESSURE OUT OF RANGE WARNING

during dialysis DN, HFR, HDF and online haemodiafiltration
Message: TMP MAX.
Causes
- The maximum TMP measured on the dialyser
has exceeded the permitted limit.
Effects - Possible dialyser clogging.
- Blood flow and/or hourly UF and/or infusion
Visual warning flow too high.
Acoustic warning
Suggested actions
- Check the condition of the dialyser.
- Reduce the blood flow.
- Reduce the hourly UF.
- Reduce the infusion flow
INCORRECT
INCORRECT PROFILE WARNING during dialysis with profiles
MESSAGE: VERIFY PROFILE
Causes
- The resulting profile differs from the
programmed one because some parameters are
Effects out of the settable range.
Visual warning
Suggested actions
Acoustic warning
- Check the set values and the rusulting profile.
- Refer to the par. “Verify profile warning
message” in the chap. “Profiles”.
AEQUILIBRIUM/ISONATRIC
AEQUILIBRIUM/ISONATRIC NOT AVAILABLE WARNING
in HFR dialysis with Profiler and Aequilibrium or Isonatric enabled
MESSAGE: AEQUIL
AEQUIL/ISONA
IL/ISONA NOT AVAIL.
Causes
- The ultrafilter temperature and/or conductivity
levels measured by Natrium prevent the
Effects
automatic total conductivity profile recount.
Visual warning
REPLACE MULTIPURE WARNING during rinsing
MESSAGE: REPLACE MULTIPURE
Causes
- At least 580 hours have passed since the last
replacement of the filter.
Effects
Suggested actions
Acoustic warning
Window appears showing
filter at the end of the following dialysis or
information on the filter status.
within the deadline of 600 hours.
REPLACE FORCLEAN WARNING during rinsing
rinsing
MESSAGE: REPLACE FORCLEAN
Causes
- Less than 20 hours remaining until reaching the
maximum number of hours configured since
Effects the last replacement of the ultrafilter(s).
- The ultrafilter(s) has(have) totalled at least a
Acoustic warning
number of hours of dialysis equal to 20 hours
less than the maximum number of hours
Window appears showing
configured.
information on the filter status.
Suggested actions

ultrafilter(s) at the end of the following dialysis
or within the deadline of the maximum number
of hours configured.
MISSING FORCLEAN ALERT WARNING during rinsing
MESSAGE: FORCLEAN ABSENT
Causes
- "Forclean i” ultrafilter not detected.
- Incorrect installation of “Forclean i” ultrafilter.
Effects
Suggested actions
Acoustic warning
- Insert the ultrafilter into its holder.
- Check positioning of ultrafilter.
10.3 ALARMS AND WARNINGS – BLOOD SECTION
ALARMS
CLAMP OPEN ALARM during dialysis
MESSAGE: CLAMP OPEN
Causes
Causes
Effects - The clamp was open during an alarm.

Continuous acoustic warning - Release the clamp.
- Check for mechanical obstructions
Blood pump stop
BLD ALARM during dialysis
MESSAGE: BLD
Causes
- Dialyser membrane broken.
- Air in the detecting device.
Effects
Suggested actions
Visual warning - Check for blood leaks at the dialyser outlet, or
Acoustic warning air intake by the dialyser connectors.
- If necessary, replace the dialyser.
Blood pump stop
dialyser bypass
Clamp closure
ARTERIAL PUMP COVER ALARM during priming and dialysis
MESSAGE: ART. PUMP COVER
Causes
- The arterial pump cover is open or not properly
Effects closed.
Visual warning
- Close the cover.
Blood pump stop
Dialyser bypass
Clamp closure
Dialysis time interrupted
ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 1 of 30
END HEPARIN ALARM during dialysis
MESSAGE: HEPARIN RUN OUT
Causes
- The syringe plunger has reached the end of
travel.
Effects
Suggested actions
Visual warning - Check that there is heparin in the syringe and if
Acoustic warning not, refill it.
ARTERIAL PUMP ROTATION ALARM during priming and dialysis
MESSAGE: ARTERIAL PUMP REVOL.
Causes
- The arterial pump rotation speed is not
coherent with the blood flow set (the blood flow
Effects is too low or flow changes have been done
Visual warning abruptly.
Acoustic warning
Suggested actions
Blood pump stop - Set a flow greater than 30 ml/min.
Dialyser bypass - Make sure the line and pump segment are
Clamp closure installed correctly.
Dialysis time interrupted - Contact After-Sales Service.
ARTERIAL LINE SET-

SET-UP ALARM during priming and dialysis
MESSAGE: WRONG ART. LINE
Causes
- The arterial line has not been installed properly.

Visual warning - Position arterial line in blood line detector.
Acoustic warning
Blood pump stop

Clamp closure
Dialyser bypass
2 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09
BLOOD LEVEL ALARM during priming and dialysis
MESSAGE: BLOOD LEVEL
Causes
- Possible presence of foam in the venous drip
chamber.
Effects - The level in the venous drip chamber has
Visual warning lowered.
Acoustic warning - No blood has been detected.
Blood pump stop Suggested actions

Dialyser bypass - Restore the level using the relevant regulator.
Clamp closure - Complete priming of the line.
During priming, once at least one litre of priming
volume has been circulated, an alarm intervenes
together with the following warning notice:
After the patient has been connected, check

that the machine is in CONNECT or DIALYSIS
mode. Check that the arterial line is\n correctly
positioned in the blood detector
This notice is to remind the user that the level

alarm can be triggered by the presence of blood in
the venous expansion chamber due to a lack of
blood detected by the sensor installed. In this
situation, before continuing, the user must check
that the arterial line is correctly inserted and that
the machine status has changed to CONNECT or
DIALYSIS (shown on the blood section status bar).
ARTERIAL PRESSURE OUT OF RANGE ALARM during dialysis
Message: PA MINMAX
Causes
- The arterial pressure is outside the maximum
and minimum operating thresholds.
Effects
Acoustic warning
Blood pump stop - Press to restart the pump and recalculate
Dialyser bypass the average venous pressure.
Clamp closure - Check that there are no obstructions along the
Dialysis time interrupted arterial line and the needle is not disconnected.
ARTERIAL PRESSURE OUT OF ABSOLUTE RANGE ALARM during priming and
dialysis
MESSAGE: PA OUT OF RANGE
Causes
- The arterial pressure is outside the absolute
operating values.
Effects - When using machines with a double clamp, for non
Visual warning single needle treatments, the arterial line must be
Acoustic warning inserted into the arterial clamp.
Blood pump stop - Presence of closed clamps along the line.
dialyser bypass
Clamp closure Suggested actions
dialysis time interrupted - Check that the blood flow is not too high with
respect to the fistula capacity.
- Remove the line from the arterial clamp or any
klemmers present.
DIALYSER INLET ARTERIAL PRESSURE OUT OF RANGE ALARM during dialysis
Message: FILTER
FILTER INLET PRESSURE
Causes
- The dialyser inlet pressure is outside the operating
thresholds:
Effects if p<+20 mmHg, or if p>+770 mmHg
Visual warning
- Check for dialyser obstruction.
Blood pump stop
Dialyser bypass - Press to restart the pump.
Clamp closure
PUMP OFF ALARM during priming and dialysis
Message: PUMP OFF
Causes
- The key has been pressed.
Effects - The stop/end priming volume set has been
reached.
Visual warning - The patient is being disconnected.
Acoustic warning
Dialyser bypass - Check which of the above conditions has caused the
Clamp closure pump to lock.
- Press again to restart.
ABNORMAL SWITCHING PRESSURE ALARM
during priming and dialysis SNsp and SNdp
Message: ABNORMAL COMM. PRESSURE
Causes
- In SNsp, air is in the blood circuit.
- In SNdp, the switching pressure has an irregular
Effects trend (it increases during the arterial phase and
Visual warning decreases during the venous phase).
Acoustic warning
Dialyser bypass - In SNsp, vent air out of the circuit.
Clamp closure - In SNdp, make sure that line for measuring the
Dialysis time interrupted switching pressure is not obstructed.
- In SNdp, make sure the blood catcher is not
wet.
- In SNdp, make sure that the blood line is not
obstructed and that the dialyser is not clotted.
- In SNdp, make sure air is not being sucked in
and no blood is leaking.
- In SNdp, make sure the level in the drip
chambers is not too low.
HEPARIN INFUSION ALARM during dialysis
MESSAGE : HEPARIN INFUSION
Causes
- The heparin pump drive does not correspond to
the set programmed.
Effects
Suggested actions
Visual warning - Check for any mechanical obstructions which
Acoustic warning prevent heparin pump functioning.
- Check functioning of the heparin pump using
Stop heparin infusion the manual drive buttons.
- Press and re-enable the heparin if wishing

to reactivate its infusion.
AIR DETECTION ALARM during dialysis
Message: AIR DETECTED
Causes
- The venous line is not properly positioned in
the air detector.
Effects - The detector situated on the venous line has
Visual warning detected an air bubble greater than 100 µl.
Acoustic warning
Suggested actions
Blood pump stop
DO NOT REMOVE THE LINE FROM THE
Dialyser bypass
ELECTROCLAMP.
Clamp closure
- Accurately position the venous line.
- Identify the source of the air bubble. If air
bubbles are detected in the venous line, remove
them in the following way:
a) Clamp the dialyser outlet tube.
b) Clamp also the electroclamp outlet tube.
c) Insert a syringe at the access point of the
venous drip chamber, open the clamp on the
tube and release the pressure in the drip
chamber.
d) Remove the clamp previously placed from the
electroclamp outlet tube.
e) Manually open the electroclamp and
simultaneously aspirate with the syringe. The
negative pressure in the drip chamber will
aspirate the air until it is completely removed.
f) If the key has been pressed as a
consequence of an alarm, do not force the
clamp to pprevent
revent the machine from blocking.
g) Remove the clamp previously placed on the
dialyser outlet tube.
h) Close the clamp on the venous drip chamber
and remove the syringe.
i) Press to restart.
VENOUS PRESSURE OUT OF RANGE ALARM during dialysis
MESSAGE: PV MINMAX
Causes
- The venous pressure is outside the maximum
and minimum operating threshold.
Effects
Acoustic warning
Blood pump stop - Press to restart the pump and recalculate
Dialyser bypass the average venous pressure.
Clamp closure - Check if there are any obstructions along the
Dialysis time interrupted venous line and, if necessary, remove them.
VENOUS PRESSURE OUT OF ABS. RANGE ALARM during priming and dialysis
MESSAGE: PV OUT OF RANGE
Causes
- The venous pressure is outside the absolute
operating values.
Effects - During dialysis, the venous pressure is below a
set limit ( + 10 mmHg).
Visual warning
Acoustic warning
Suggested actions
Blood pump stop - Check if there are any obstructions along the
Dialyser bypass venous line.
Clamp closure - Check that the needle of the venous line has not
Dialysis time interrupted detached from the fistula.
- Return the pressure within the permitted range
by adjusting the level in the venous drip
chamber.
- Return the venous pressure above the +10
mmHg limit and press .
ARTERIAL PHASE TIMEOUT ALARM during priming and dialysis SNsp
and SNdp
Message: ARTERIAL PHASE TIMEOUT
Causes
- In priming, the blood pump cycling has not been
carried out within the max. allowed time.
Effects - In dialysis, the blood pump has performed a
number of revolutions greater than the set limit
Visual warning before switching.
Acoustic warning
Suggested actions
Blood pump stop - Make sure the line for measuring the switching
dialyser bypass pressure is not obstructed
Clamp closure - Make sure the blood catcher is not wet.
dialysis time interrupted - Make sure no air is being sucked into the blood
circuit or that blood is leaking.
- In SNdp, make sure the level in the drip chambers
is not too low.
- In SNdp, make sure the needle is inserted correctly
into the vein and that there are no suction
problems.
- In SNdp, make sure that the Time Out alarm value
set in configuration is compatible with the set
stroke (e.g. with a stroke equal to 40 ml, the time
out alarm needs to be configured at least 40/10
+2 =6, where 10 is the delivery per revolution (in
ml.) of the arterial pump.
INFUSION TIMEOUT ALARM during priming and SNsp and SNdp dialysis
Message: VENOUS PHASE TIMEOUT
Causes
- The venous phase has exceeded the max. allowed
time.
Effects - In SNdp, the venous pump revolutions have
exceeded the maximum value set in configuration.
Visual warning
Acoustic warning
Suggested actions
- In SNsp, check if there are any obstructions along
Blood pump stop
Dialyser bypass
the switching pressure measurement line, or there
Clamp closure
is no air in the blood circuit, or the blood catcher
is not wet.
- In SNsp, check if there are any obstructions along
the venous line.
- In SNdp, make sure that the Out of Range alarm
value set in configuration is compatible with the
set stroke (e.g. with a stroke equal to 40 ml, the
time out alarm needs to be configured at least
40/10 +2 = 6, where 10 is the delivery per
revolution (in ml.) of the venous pump.
- Contact After-Sales Service .
BLOOD VOLUME ALARM during dialysis in SNsp and SNdp
Message: BLOOD VOLUME
Causes
- In SNsp, during the arterial phase (the pump is
running) the switching pressure has exceeded the
Effects max. threshold before the stroke.
- During the venous phase the switching pressure fell
Visual warning below the set minimum threshold.
Acoustic warning
Suggested actions
Blood pump stop - In SNsp, decrease the level in the expansion
dialyser bypass chamber and the venous drip chamber.
Clamp closure - In SNsp, increase the max. switching pressure
dialysis time interrupted value.
- In SNdp, make sure that the stroke set is suitable
for the line being used and if necessary decrease it.
- In SNdp, reduce the levels in the drip chambers.
END INFUSION ALARM durin
dur ing
ing priming, dialysis and rinseback in online PHF
and online HDF (Therapy model)
model) – in HFR priming and dialysis
dialysis
MESSAGE: END INFUSION
Causes
- Air has been detected by the infusion end detector
along the line.
Effects
Suggested actions
Visual warning - During HFR and ON-LINE HDF, check that the line
Acoustic warning used is the correct one for the selected treatment.
- During HFR and ON-LINE HDF, check the integrity of
infusion pump stop the infusion line and that it is correctly fitted.
during on-line
- During HFR and ON-LINE HDF, check that the
haemodiafiltration: dialyser
dialyser is not packed, in which case reduce the
bypass and dialysis time
interrupted infusion flow or replace the dialyser.
- Press to restart.
EXCESSIVE LOAD ALARM during HDF dialysis
MESSAGE: LOAD EXCESSIVE
Causes
- A load heavier than 16 kg has been hung from the
scale.
Effects
Suggested actions
Visual warning - Remove a bag of infusion liquid so that the load is
Acoustic warning lighter than 16 kg.
infusion pump stop - Press to restart.

dialyser bypass
INSUFFICIENT LOAD ALARM during HDF priming and dialysis
MESSAGE: LOAD INSUFFICIENT
Causes
- The load suspended from the scale is less than 0.3
Effects kg (bags are nearly empty).

Acoustic warning
- Add a new bag and press to restart.
infusion pump stop DO NOT REMOVE THE EMPTY BAGS.
dialyser bypass
MODIFIED LOAD ALARM during HDF dialysis
MESSAGE: LOAD MODIFIED
Cause
- An increase or reduction in the load on the balance
Effects greater than 1 kg has been detected.
Visual warning Azioni suggerite

Acoustic warning - Check that all bags have been properly connected.

dialyser bypass
UNSTABLE LOAD ALARM during HDF

dialysis
MESSAGE: LOAD UNSTABLE
Causes
- Unstable scale reading has been detected.
Effects
Suggested actions
Visual warning - Check that the bags hanging from the scale are not
Acoustic warning swinging or being knocked continuously.

dialyser bypass
ABNORMAL LOAD ALARM during HDF dialysis
MESSAGE: LOAD ABNORMAL
Causes
- An increase or reduction of the load on the scale of
Effects between 0.2 and 1 kg has been detected.

Acoustic warning - Do not add or remove loads lighter than 1 kg.
- Leave empty bags hanging on the scale.
infusion pump stop
dialyser bypass - Press to restart.
INFUSION ERROR ALARM during HDF dialysis
MESSAGE: INFUSION ERROR
Causes
- An infusion error greater than 0.3 kg has been
Effects detected.

Acoustic warning - Check for possible leaks or obstructions along the
infusion line and verify effective patient weight loss
infusion pump stop using bed scale.
dialyser bypass
dialysis time interrupted - Press to restart. If after a few minutes the alarm
does not clear, complete the treatment in Double
Needle.
EXCESSIVE INFUSION ALARM during HDF dialysis
MESSAGE: EXCESSIVE INFUSION
Causes
- The infusion effected is greater than the value
Effects foreseen for the set interval of time.

Acoustic warning - Check that there are no leaks from the bags. If leaks
are found, complete the treatment in Double Needle.
infusion pump stop - Check that the klemmers on the infusion line are not
dialyser bypass closed.
- Press to restart.
INSUFFICIENT INFUSION ALARM during HDF dialysis
MESSAGE: INSUFFICIENT INFUSION
Causes
- The infusion effected is less than the value foreseen
Effects for the set interval of time.

Acoustic warning - Check that there are no obstructions on the infusion
line and that the pump segment is not crushed.
Infusion pump stop - Check that the klemmers on the infusion line are not
Dialyser bypass closed.
- Press to restart.
INVERSE INFUSION ALARM during HDF dialysis
MESSAGE: INVERSE INFUSION
Causes
Causes
- The scale has detected an increase in weight of the
Effects bags due to probable reverse infusion.

Acoustic warning - Check that the infusion pump segment is not
blocked or installed in the wrong way.
infusion pump stop
dialyser bypass - Press to restart.
INFUSION PUMP COVER ALARM

during priming, dialysis and rinseback of haemodiafiltration
treatments
MESSAGE: INFUSION PUMP COVER
Causes
- The infusion pump cover is open or not properly
closed.
Effects

Acoustic warning - Close the cover.
infusion pump stop

dialyser bypass
INFUSION PUMP ROTATION ALARM during priming and dialysis
MESSAGE: INF. PUMP ROTATION NO.
Causes
- The speed of rotation of the infusion pump does
not match the set infusion flow.
Effects
Acoustic warning - Make sure the line and pump segment are installed
correctly.
infusion pump stop - Contact After-Sales Service.
dialyser bypass
MAXIMUM VENOUS PRESSURE ALARM during SNdp dialysis
MESSAGE: MAX. VEN. P.
Causes
- During the venous phase the venous pressure has
exceeded the set maximum threshold.
Effects
Acoustic warning - Reduce the pump speed using the red flow
regulator.
pumps stopped
dialyser bypass
Clamp closure
VENOUS PUMP COVER ALARM during SNdp priming and dialysis
MESSAGE: VEN. PUMP COVER
Causes
- The venous pump cover is open or incorrectly
closed.
Effects
Acoustic warning - Close the cover.
pumps stopped
dialyser bypass
Clamp closure
VENOUS PUMP ROTATION ALARM during SNdp priming and dialysis
MESSAGE: V. PUMP ROTATION NO.
Causes
- The rotation speed of the venous pump does not
match the set blood flow.
Effects
Acoustic warning - Make sure the line and pump segment are installed
correctly.
pumps stopped - Contact After-Sales Service.
dialyser bypass
Clamp closure
VENOUS SEGMENT ALARM during SNdp rinseback
MESSAGE: EXTRACT V. PUMP SEGMENT
Causes
- The switching pressure has exceeded the max. or
min. operating limits (-200, +300 mmHg).
Effects
Acoustic warning - Remove the venous pump segment from its seat to
correctly carry out the rinseback procedure.
pumps stopped
dialyser bypass
Clamp closure
INFUSION PRESSURE OUT OF RANGE

during priming, dialysis and rinseback in online PHF and online
HDF (Therapy) – during HFR priming and dialy
dialysis
sis
MESSAGE: INF. PRESS. OUT OF RANGE
Causes
- Pressure out of range detected by the infusion
Effects pressure transducer.

Acoustic warning - Check that the line is the correct type for the
treatment carried out.
infusion pump stop - Check that the line has been correctly installed, in
during on-line particular that it is not clamped and the infusion
haemodiafiltration: dialyser pump segment has not been installed the wrong way
bypass and dialysis time round.
interrupted - Check that the blood catcher on the line is not
clogged.
- Check that the infusion line is intact. If not, check
the patient weight and suspend the treatment.
- During HFR, check for any adsorbent cartridge
damage and then continue with Double Needle.
- If none of the above conditions are present, reduce
the infusion flow.
ALARM: HFR LINE PRIME TIMEOUT during HFR priming
MESSAGE: HFR LINE PRIME TIMEOUT
Causes
- The UF/infusion line has not been properly
Effects primed.

Acoustic warning - Check that the line is correctly installed, in
particular that it is correctly inserted in the end
stop UF/infusion pump
infusion detector. Subsequently press .
ALARM: HFR LINE INCORRECTLY INSERTED during HFR priming
MESSAGE: WRONG HFR LINE INSERTION
Causes
- The UF/infusion line is incorrectly inserted.
Effects
Suggested actions
Visual warning - Check that the line inserted in the blood leak
Acoustic warning detector is the UF/infusion line required for HFR
treatment.
stop UF/infusion pump - Check that the line is correctly installed, in
particular check that it is correctly inserted in
the blood leak detector. Subsequently press
ALARM: BLOOD DETECTED IN INFUSION LINE during HFR dialysis
MESSAGE: BLOOD DET. IN INF. LINE
Causes
- A rupture of the haemofilter has probably
occurred.
Effects
Suggested actions
Visual warning - Remove any residual air bubbles from the blood
Acoustic warning leak detector.
- Check that the line inserted in the blood leak
Stop UF/infusion pump detector is the UF/infusion line required for HFR
Blood pump stop treatment.
Dialysis time interrupted - Check that the line has been correctly installed,
Dialyser bypass in particular check that the UF/infusion pump
segment has not been installed the wrong way
round.
- Check for possible rupture of the haemofilter
(convective section). In case of rupture, continue
the treatment in Double Needle.
ALARM: UF/INFUSION FLOW TOO HIGH in HFR dialysis
MESSAGE: INADEQUATE FLOWS
Causes
- Air in the UF/infusion line.

Visual warning - Reduce the infusion flow.
Acoustic warning - If the problem persists, further reduce the
UF/infusion pump stop infusion flow and possibly stop the UF/infusion
pump for a few minutes.
- Remove any residual microbubbles from the end
infusion sensor.
ALARM: TRANSMEMBRANE PRESSURE HFR OUT OF RANGE in HFR dialysis
MESSAGE: TMPH OUT OF RANGE
Causes
- The transmembrane pressure measured on the
hemofilter is outside the operating thresholds.
Visual warning - Check if the hemofilter has clogged.
Acoustic warning
UF/infusion pump stop - Press to restart the pump.
ALARM: HFR LINE INCORRECTLY INSERTED (not Therapy model)
in PHF priming
MESSAGE: WRONG INF. LINE INSERTION
Causes
- The infusion line is incorrectly inserted.
Effects
Suggested actions
Visual warning - Check that the line inserted into the blood leak
Acoustic warning detector is the infusion line required by PHF
treatment.
Infusion pump stop - Check that the line is correctly installed, in
particular check that it is correctly inserted in
the blood leak detector. Subsequently
INCORRECT DIALYSATE INFUSION ALARM

in PHF priming and dialysis and in rinseback with ultrapure dialysis fluid
MESSAGE: DIALYSATE INFUSION
Causes
- During priming:
Effects Priming is not carried out at the established
infusion flow rate.
Visual warning
Acoustic warning - During dialysis:
The infusion bolus is not produced at a flow
Infusion pump stop level that matches the set Qb.
Dialyser bypass
- In Rinseback with ultrapure dialysis fluid:
Reinfusion is not carried out at the established
infusion flow rate.
Suggested actions
- During priming:
Increase the value set for Qinf.
- During dialysis:
Check the value set for Qb.
Check the value set for Qinf.
TIMEOUT FOR INFUSION LINE PRIMING/PHF
PRIMING/PHF FILTER TEST ALARM (non Therapy
models only) during PHF priming and dialysis
MESSAGE: INF. LINE TEST TIMEOUT

TIMEOUT
Causes
- The infusion line has not been properly primed.
Effects
Suggested actions
Visual warning - Check that the line is correctly installed, in particular
Acoustic warning that it is correctly inserted in the end infusion
Infusion pump stop detector. Subsequently press .

Dialyser bypass
BLOOD SIDE TECHNICAL ALARM CODE XXX:XXX in all machine

states
MESSAGE: TECHNICAL ALARM XXX:XXX
Causes
- Signal conformity tests on the blood side failed .
Effects
Suggested actions
Visual warning
Acoustic warning - If possible, press to clear the alarm.
- If the alarm persists, note down the alarm code
Blood pump stop XXX:XXX and contact After-sales Service.
Rinsing/dialysis time
interrupted
Dialyser bypass
WARNINGS
HEPARIN NOT ACTIVE WARNING during dialysis
Message: HEPARIN OFF
Causes
- The heparin program has not been activated.
- The pre-stop heparin value has been reached.
Effects
Suggested actions
Visual warning
heparin
Acoustic warning on
- Press .
- Reduce the pre-stop time or increase the
duration of the treatment.
HEPARIN NOT SET WARNING during dialysis
Message: NO HEPARIN SETTING
Causes
- The heparin program has not been set.

- Set the heparin infusion flow rate.
Visual warning
Acoustic warning
BLOOD FLOW SET TO ZERO ALERT during priming and dialysis
MESSAGE: FLOW SET TO ZERO
Causes
- Blood flow is set to zero.

- Set the flow rate to a value different from 0 by
Visual warning using the arterial pump flow regulator.
Acoustic warning
Blood pump stop

Dialyser bypass
Clamp closure
BLOOD FLOW INADEQUATE WARNING during priming and dialysis
MESSAGE: INADEQUATE BLOOD FLOW
Causes
- The arterial pressure is less than – 250 mmHg
Effects and the blood pump flow rate might not be
congruent with the set value.
Visual warning
- Decrease the blood flow using the flow
Intermittent blood pump stop regulator.
MODIFY ARTERIAL FLOW ALERT during priming and

dialysis
MESSAGE: MODIFY ARTERIAL FLOW
Causes
- The blood flow has been changed during
Effects
alarm overriding with the key .
Visual warning
- Reset the blood flow to the original value or
modify it slightly.
BLOOD DETECTION WARNING during dialysis
MESSAGE: BLOOD DETECTED
Causes
- Blood has been detected along the arterial
line, but the dialysate section has not entered
Effects dialysis mode yet.
- The dialyser is not connected.
Visual warning
- Activate preparation of the dialysis fluid.
- Connect the dialyser.
ARTERIAL PRESSURE/PREFILTER
PRESSURE/PREFILTER WARNING during dialysis
MESSAGE: ART. /FILTER INLET PRESS.

PRESS.
Causes
- In Single Needle with single clamp, a pressure has
been detected in the arterial pressure transducer.
Effects - In other treatments, there are no variations detected
in the arterial pressure measurement and/or the
Visual warning prefilter arterial pressure measurement (except SN
Acoustic warning for the latter).
Suggested actions
- Disconnect the arterial pressure measurement line
(Single Needle with Single Clamp).
- Properly insert the blood catcher in the arterial
pressure measurement connector and/or the prefilter
arterial pressure connector and check that the blood
catcher is not clogged (other treatments).
The control of the arterial pressure variation is not

performed
per formed if the blood flow rate is < 100
100 ml/min.
During treatments other than the single needle
type (single clamp), alerts may be disabled by
see/mod. blood disable
parameters PA warning
pressing . To
enable
PA warning
enable it, from the same menu, press .
WARNING
Disabling
Disabling the warning may result in failed
detection of arterial and/or prefilter pressure
measurement problems.
LINE EMPTYING WARNING during rinseback
Message: BLOOD LINE EMPTYING
Causes
Effects - Emptying of the blood lines.

Acoustic warning - Proceed with patient rinseback, carefully paying
attention not to infuse air in blood.
INFUSION LINE PRESSURE WARNING during HDF priming and dialysis
MESSAGE: ERROR : INF. LINE PRESSURE
Causes
Effects - Abnormal pressure detected on the infusion
pressure transducer (not used in HDF).
Visual warning
- Disconnect the line if connected by mistake to the
transducer.
Kt/V MIN OUT OF RANGE WARNING during dialysis
MESSAGE: KT/V MIN OUT OF RANGE
Causes
- The Kt/V measured is less than the minimum set
Kt/V.
Effects
Suggested actions
Visual warning
Acoustic warning - Press to cancel the warning.
- Check the set threshold.
Kt/V GOAL OUT OF RANGE WARNING during dialysis
MESSAGE: KT/V GOAL OUT OF RANGE
Causes
- The time required to reach the desired Kt/V
exceeds the set treatment time by more than 15
min.
Effects

Acoustic warning
CLEARANCE OUT OF RANGE WARNING during dialysis
MESSAGE: K MIN OUT OF RANGE
Causes
- The clearance measured is less than the minimum
set
Effects
Suggested actions
Visual warning
Acoustic warning - Press to cancel the warning.
BLD DETECTOR LINE ERROR WARNING
in PHF priming and dialysis (not Therapy model) and in HFR priming and
dialysis
MESSAGE: ERROR : INF. BLD
Causes
Effects - The BLD has detected the absence of the infusion
line.
Visual warning
- Check that the line used is the infusion line
required for PHF treatment.
- Check that the line is correctly installed, in
particular check that it is correctly inserted in the
blood leak detector.
NO INFUSION FLOW WARNING

during
during priming, dialysis and rinseback of haemodiafiltration
treatments
MESSAGE: NO INFUSION FLOW
Effects Causes
- The infusion flow regulator is at 0.
Visual warning
Acoustic warning in priming Suggested actions
- Set a flow other than 0.
Infusion pump stop
Dialyser bypass
INCOMPLETE INFUSION LINE PRIMING ALERT (not Therapy model)

in PHF dialysis
MESSAGE: INCOMPL. INF. LINE PRIMING
Effects Causes
- Priming of the infusion line has not been
Visual warning completed.
Acoustic warning
Suggested actions
- Check that the line has been correctly installed, in
end infusion detector and the blood leak detector.
EFFICIENCY WARNING during SNdp dialysis
MESSAGE: EFFICIENCY
Causes
- Cycle efficiency is out of range. Practically, due to
an excessive negative suction pressure, the arterial
Effects pump executes a much greater number of
revolutions than the venous pump.
Visual warning
- Make sure there are no suction problems on the
arterial line and if necessary reduce the pump
speed using the red flow regulator.
- Check and, if necessary, adjust the set threshold.
SWITCHING PRESSURE WARNING during SNdp dialysis
MESSAGE: COMM. PRESSURE
Causes
- No variations have been detected in the
measurement of the switching pressure.
Effects
Suggested actions
Visual warning - Connect the line for measuring switching pressure.
Acoustic warning - Make sure the blood catcher is not wet.
The control of the pressure variation is not
performed if the flow rate is < 150 ml/min.
WARNING: WEIGHT ON SCALE

in PHF priming and dialysis (not Therapy model) and in HFR priming and
dialysis
MESSAGE: ERROR : WEIGHT ON SCALE
Causes
Effects - The load hanging on the scale hooks is in excess of
6.0 kg.
Visual warning
- Check that the line used is the infusion line required
for the treatment in progress.
- Check that the line is correctly installed, in particular
check that there are no bags hanging on the scale.
INCOMPLETE HFR LINE PRIMING ALERT in HFR dialysis
MESSAGE: INCOMPL. HFR LINE PRIMING
Effects Causes
- Priming of the UF/infusion line has not been
Visual warning completed. The external BLD has not detected the
Acoustic warning passage of saline solution.
Suggested actions
- Check that the line has been correctly installed, in
end infusion detector and the blood leak detector.
WARNING: SPHYGMO MEASUREMENT ERROR

during rinsing, priming, dialysis, rinseback and
MESSAGE: SPHYGMO ERROR
Causes
- The sphygmomanometer is not connected to the
Effects machine.
Acoustic warning - The sphygmomanometer has not been properly put
Visual warning on the arm.
- The sphygmomanometer has not been properly
deflated between one measurement and the next.
Suggested actions
- Press and repeat the measurement after

eliminating the causes.
WARNING: SYSTOLIC PRESSURE OUT OF RANGE

during rinsing, priming and dialysis
MESSAGE: SYSTOLIC OUT OF RANGE
Causes
- The systolic pressure is outside the thresholds set.
Effects
Visual warning - Check the thresholds set.
WARNING: DIASTOLIC PRESSURE OUT OF RANGE
MESSAGE: DIASTOLIC OUT OF RANGE
Causes
- The diastolic pressure is outside the thresholds
Effects set.
Acoustic warning
- Check the thresholds set.
WARNING: HEART RATE OUT OF RANGE during rinsing, priming and dialysis
MESSAGE: HR OUT OF RANGE
Causes
- The heart rate is outside the thresholds set.
Effects
- The warning is automatically deactivated as soon
as the heart rate returns to within the thresholds
set.
HEMATOCRIT OUT OF RANGE ALERT

ALERT during dialysis
MESSAGE: HCT OUT OF RANGE
Causes
- The hematocrit is outside the thresholds set.
Effects
- The warning is automatically deactivated as soon
as the value measured returns to within the
thresholds set.
WARNING: OXYGEN SATURATION OUT OF RANGE during dialysis
MESSAGE: SO2 OUT OF RANGE
Causes
- The oxygen saturation is outside the
Effects thresholds set.
- The warning is automatically deactivated as
soon as the value measured returns to within
the thresholds set.
WARNING: PERCENT VOLUME LOSS OUT OF RANGE during dialysis
MESSAGE: VL% OUT OF RANGE
Causes
- The percent volume loss is outside the
Effects thresholds set.
Acoustic warning
- Check the thresholds set.
- The warning is automatically deactivated as
soon as the value measured returns to within
the thresholds set.
CARDIUM WARNING: HEART RATE OUT OF THE ABSOLUTE RANGE

MESSAGE: CARDIUM HR OUT OF RANGE
Cause
- The heart rate is outside the absolute
Effects thresholds set for the Cardium application.
Acoustic warning
Automatic pressure measurement - Press to cancel the warning until the next
pressure measurement, during which the
warning is reactivated only if the heart rate has
returned to within the set range.
CARDIUM WARNING: HEART RATE OUT OF THE PERCENT RANGE

MESSAGE: CARDIUM HR % OUT OF RANGE
Causes
- The heart rate is outside the percent thresholds
Effects set for the Cardium application.

Visual warning
Automatic pressure measurement
CARDIUM WARNING: HEART RATE OUT OF THE DERIVATIVE RANGE
MESSAGE: CARDIUM HR DER. OUT OF RANGE
Causes
- The difference between the mean values/minute of
Effects the heart rate is outside the thresholds set.

Visual warning
- Press to cancel the warning until the next
Automatic pressure minute.
measurement
WARNING: FORMULA PLUS TEST SENSOR FAILED during rinsing
MESSAGE: TEST SENSORS FORMULA +
Causes
- The Formula Plus sensor test has failed.

Acoustic warning - Check which sensor has failed the test. Press
Visual warning sensors Natrium Hemox
then and . A
message will be displayed (e.g.: NATRIUM(TEST N.P.)
- Remove the lines from the sensors and repeat the
sensors repeat
test
tests. Press and .
- Press to cancel the warning and enter into

dialysis. The sensor that has failed the test remains
operational but shows the test failed message. The
operator is warned that the measurement of the
sensor may not be correct.
WARNING: SODIUM CONCENTRATION NOT DETECTED in HFR dialysis
MESSAGE: SODIUM CONCENTRATION NOT DETECTED
Causes
- Ultrafiltrate conductivity probe possibly incorrectly
Effects positioned in the seat of the Natrium sensor.
- Ultrafiltrate conductivity probe possibly incorrectly
Acoustic warning positioned in the blood seat of the Natrium sensor
Visual warning (left-hand side) rather than in the dedicated seat
(right-hand side).
If the warning persists, - Natrium sensor reading error.
Aequilibrium activation
has failed Suggested actions
- Check that the ultrafiltrate probe is correctly
positioned in the dedicated seat (right-hand side) of
the Natrium sensor.
- If the warning persists, disable the Aequilibrium
application.
11.1
11.1 PROBLEM SOLVING
This chapter describes some “special” operating procedures and some problems which
can be solved by the operator.
It is recommended to consult this list in the event that the conditions stated below
occur. If in spite of following the instructions, the problem cannot be solved, contact
After-Sales Service.
THE MONITOR REMAINS OFF WHEN TURNING THE MACHINE ON

Likely internal fault. Force a power failure to reset the system. If the problem is not
solved, contact After-Sales Service.
THE MONITOR TURNS OFF DURING TREATMENT

Firstly check that the screensaver has been activated (see chap. Operator Interface). If
this does not solve the issue, there is probably an internal fault. The machine remains
in a safe state for the patient since all the functions remain active. Force a power
failure to reset the system. If the monitor does not come back on within 2 minutes,
carry out manual rinseback of blood to the patient. Subsequently, contact After-Sales
Service.
RESTARTING PROCEDURE
In case of ERROR 0 ALARM (red/blue alarm window) it is possible to restart formula
pushing the power key (green LED) for at least 5 seconds.
This must be considered an emergency procedure to continue the dialysis.
WARNING
If ERROR 0 ALARM does not disappear, switch off formula  using the main
switch in the rear panel and contact After-
After-Sales Service.
TESTS
INITIAL TESTS FAILED
If the haemodialysis water tap is closed, or the first sequence of the tests was not
completed successfully, a full-screen 0 ERROR message will appear.
Turn off the machine with the main switch located at the rear and open the water tap.
Then turn on the machine and repeat the operations already described.
If the machine does not restart, contact Post-Sales Dept.
FAILED TESTS - BLOOD SIDE

A window appears on the right side of the display with the indication of the failed test
and the error code to communicate, if necessary, to the After-Sales Dept.
ENG – Ed. 06/09 chap. 11.1 – Problem solving - 1 of 8

retry
blood tests
to repeat the tests of the blood section.
FAILED TESTS - DIALYSATE SIDE

A window appears on the left side of the display with the indication of the error codes
to communicate, if necessary, to the After-Sales Dept.
retry
hydraulic test
to repeat the tests of the dialysate section.
In this case the following message appears:
Do you want to RETRY

hydraulic tests?
tests?
yes
to confirm.
Before repeating the hydraulic tests, the machine carries out a spilling of a few minutes
in order to remove any residual air in the circuit. This phase is indicated by
AUTOMATIC SPILLING displayed on the top left status bar of the screen.
Upon conclusion of the first test sequence, a rinsing phase which lasts a few minutes
(not modifiable by the operator) starts. Simultaneously the self-diagnostics tests are
performed both on the dialysate and the blood compartment.
When the blood tests are successfully completed, WAIT appears on the top right status
select
priming
bar of the screen. The function key appears. At this point it is possible to
start installing the blood lines.
lines.
THE BLOOD PUMP STOPS

1. An alarm in the blood section has occurred.
Correct the alarm condition. to restart.

2. Blood leaks in the dialysate compartment (BLD alarm)
Wait a few seconds and then .

3. Blood flow is set to zero.
Set the blood flow using the arterial flow regulator.
4. key is pressed.
Disable the key.
2 of 8 - chap. 11.1 – Problem solving ENG – Ed. 06/09

MANUAL RINSEBACK OF THE PATIENT
WARNING
Be extremely careful to prevent dangerous conditions to the patient. When the
machine is turned off, all the protections are deactivated.
1. Turn off the machine with the main switch on the rear panel.
2. Open the blood pump cover.
3. Vent air out of the venous drip chamber with the aid of a syringe.
4. Carefully extract the venous blood line from the clamp.
5. If performing a Double Pump/Single Needle treatment, remove the venous pump
line.
6. Fold the arterial pump handle outwards.
7. Disconnect the arterial line from the patient.
8. Revolve the blood pump anticlockwise until the blood lines are empty and patient’s
rinseback is completed. Be careful not to let air into the patient’s infusion line.
9. Disconnect the venous line from the patient.
DIALYSER REPLACEMENT DURING DIALYSIS
see/mod. hemofilter
parameters management
• and
change
filter
• .
DO YOU WANT TO CHANGE
• The following dialog window appears: THE DIALYSER?
yes
• to continue. In the upper right bar (blood section) FILTER
CHANGE appears and the blood pumps stop.
• The BYPASS message appears. In DN, SNsp, SNdp, HDF and HFR treatments,
pressing automatically activates a minimum ultrafiltration of 0.1kg/h.

• Connect the arterial line to the container of physiological solution.
• .
• Adjust the blood flow to the speed used in the dialysis centre.
• The level alarm is automatically disabled and the absolute alarm thresholds for the
venous and arterial pressures set to priming values.
• The air detector is always enabled.
• Return the blood to the patient. Should the AIR DETECTED alarm intervene, press
and be extremely careful not to infuse air.

• Wait until the dialyser empties (only normal saline should be left), remove and
replace it with a new one.
• Prime the new dialyser, circulating as much normal saline as necessary.
• Connect the arterial line and wait until blood is detected: from this point 90 sec.
will pass before the machine starts dialysis.
• The BYPASS message appears.
• .
• If a BLD alarm intervenes (caused by detection of air), press .
WARNING
The AIR DETECTOR alarm can not be overridden with the key . This may
happen only during the dialyser replacement procedure.
In the event of an alarm or warning during the filter change procedure, press
the key to silence ALL the alarms and warnings for five minutes. In
addition, the BYPASS FILTER
FILTER warning is automatically silenced for the entire
duration of the procedure.
ARTERIAL LINE REPLACEMENT DURING DIALYSIS
(as a result of breakage of the pressure transducer or bending of the tube)
see/mod. hemofilter change

parameters management filter
• .
DO YOU WANT TO CHANGE

• A dialog window with confirmation request appears: THE DIALYSER?
yes
• to continue. In the upper right bar (blood section) FILTER
CHANGE appears and the blood pumps stop.
• Connect the arterial line to the container of physiological solution.
• .
• Set the blood flow to 100 -150 ml/min.
• The level alarm is automatically disabled and the absolute alarm thresholds for the
venous and arterial pressures set to priming values.
• The air detector is always enabled.
• Return blood without completely emptying the venous return line.
• Remove the old blood line and mount the new one.
• Prime the line with physiological solution.
• When priming has been completed, connect the arterial line to the patient and wait
until blood is detected: from this point 90 sec. will pass before the machine starts
dialysis.
• The BYPASS message appears. .
• If a BLD alarm intervenes (caused by detection of air), .

• During the operations mentioned above, in DN, SNsp, SNdp, HDF and HFR
treatments, a minimum ultrafiltration of 0.1kg/h is set automatically.
WARNING
In the event of an alarm or warning during the
the filter change procedure, press
the key to silence ALL the alarms and warnings for five minutes. In
addition, the BYPASS FILTER warning is automatically silenced for the entire
duration of the procedure.
IMPOSSIBLE TO PASS FROM THE REINFUSION PHASE TO THE RINSING PHASE
This condition may happen as follows:
1. Blood in the venous drip chamber or on the end priming detector

Remove the drip chamber from the block and/or any traces of blood from the
end priming cycle sensor.
2. Air Alarm not detected (the line is full of physiological solution or blood)
Remove the line from the air detector. A few seconds later the blood pump will
stop.
3. “HYDRAULIC” alarm
4. “NO WATER” alarm

Wait for the condition to return to normal.
THE
THE VENOUS DRIP CHAMBER IS TOO FULL OR DOES NOT REACH THE LEVEL
To prevent a pressure alarm,
see/mod. blood recalcul.

parameters on
1. .
ok
1. to confirm.
2. Act on the regulator until reaching the desired level.

NO POWER
The machine signals this condition with an intermittent acoustic alarm which cannot be
silenced.
The LED next to the power key turns red.
1. The power cable is not inserted in the mains socket.

Connect the power cable.
2. The wall socket does not deliver power.

Connect the machine to another socket or interrupt dialysis returning blood to
the patient by hand.
3. No power in the whole dialysis centre.

Wait for power to be restored. If necessary, interrupt dialysis returning blood to
the patient by hand.
The machine will turn on automatically when the power is restored; the machine status
remains in memory for a guaranteed time of at least 2 minutes.
If a power failure occurs:

- during disinfection/cleaning, the machine starts from the point at which it was
interrupted;
- during dialysis, when power has been restored, the blood pump remains off with
consequent closure of the bypass. Check that the data has not been altered.
to restart the pump and, if necessary, press .
THE MACHINE IS SWITCHED OFF WITH THE MAIN SWITCH DURING

When the machine is switched on again, the initial tests are re-run, then
disinfection/cleaning continues from the point of interruption.
THE MACHINE IS SWITCHED ON MANUALLY

MANUALLY WHILE THE CHEMICAL AGENT IS
STILL DWELLING
The following message appears: “Press OK to anticipate rinsing”

ok
1. to run the tests and start the rinsing cycle or
2. wait a few minutes until the machine switches off automatically.
PATIENT
PATIENT WEIGHT NOT IN CONFORMITY WITH THE SET PROGRAM
If the weight is not in conformity with that set:
1. Record the patient weight (with scale bed) and the time indicated by the treatment-
time tool on the screen.
2. Carefully check the food and drink consumed by the patient and any objects on the
scale bed.
3. After 30 min. (or an hour) again check the weight. Should the new weight differ from
the theoretical weight by a value greater than +/- 80 g/h (+/- 160 g/h in HDF with
bags), the error can be attributed to the machine.
4. Contact After-Sales Service.
FILLING AND REPLACEMENT OF THE POWDER BICARBONATE CARTRIDGE

see/mod. dialysate
parameters
When using the powder bicarbonate cartridge,
other
parameters
to have the following functions available:
bidry
fill-up
• to fill the cartridge.
change
bidry
• to replace the cartridge during the dialysis session.
To replace the powder bicarbonate (traditional or perforated) cartridge,

proceed as follows:
change
bidry
• . Do you want to CHANGE
the bidry cartridge?
• The following dialog window appears:
bidry change
yes
on
• . The function key appears.
• Proceed with the cartridge replacement.
bidry change
on
• .
• The following dialog window appears: Bidry change

COMPLETED?
yes
• .
• At this point the automatic filling of the cartridge takes place. The function key
bidry
fill-up on
appears.
• Wait until it is completely full and has returned to normal

To fill the powder bicarbonate (traditional or perforated) cartridge, proceed as
follows:
see/mod. other bidry
dialysate
parameters parameters fill-up
• to

start cartridge fill-up.
bidry
fill-up on
• The function key appears.
• Wait until it is completely full and has returned to normal.
THE PATIENT HAS BEEN CONNECTED TO THE BLOOD LINES ALTHOUGH THE
MACHINE IS STILL IN THE DISINFECTION/CLEANING PHASE
The blood pump is off and does not start until disinfection/cleaning has been
completed.
Since more than 10 minutes elapse before starting the treatment (end of
disinfection/cleaning, tests, dialysis fluid preparation), it is advisable to manually
return the blood to the patient.

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ii of vii –Index IB5331228ENG rev.01 ENG - Ed. 11/09

EXPRESSIONS USED IN THE MANUAL

This manual constitutes an integral and essential part of the machine.

ENG - Ed. 11/09 IB5331228ENG rev.01 Index - iii of vii

DN Identifies double needle dialysis.

SNsp Identifies single needle dialysis with a single pump.

SNdp Identifies single needle dialysis with double pump.

HDF This refers to standard haemodiafiltration treatment (replacement

HDF OnLine This refers to the following on-line haemodiafiltration treatments

HDF PRE This refers to pre-dilution on-line haemodiafiltration treatment with

HDF POST This refers to post-dilution on-line haemodiafiltration treatment with

MID-HDF This refers to mid-dilution on-line haemodiafiltration treatment with

PHF PRE This refers to pre-dilution on-line haemodiafiltration treatment with

PHF POST This refers to post-dilution on-line haemodiafiltration treatment with

HFR Refers to haemodiafiltration treatment with endogenous reinfusion of

Class I equipment EN 60601-1 classification.

iv of vii –Index IB5331228ENG rev.01 ENG - Ed. 11/09

Stroke Blood volume moved during the cycle in Single Needle .

Accessory MDD 93/42 classification.

used in accordance with the use of the device intended by the

Disinfection Chemical or physical process which has effect on living micro-

vi of vii –Index IB5331228ENG rev.01 ENG - Ed. 11/09

ENG - Ed. 11/09 IB5331228ENG rev.01 Index - vii of vii

ENG – Ed. 11/09 chap. 1.1 - Introduction - 1 of 14

Haemodialysis is a method of blood purification that is able to eliminate the toxic

This manual gives descriptions on:

2 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

ENG – Ed. 11/09 chap. 1.1 - Introduction - 3 of 14

HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE

4 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

The formula dialysis system is able to operate in different treatment modes,

As regards the preparation of dialysis solution:

As regards the extracorporeal circulation system and the treatment of infusion

ENG – Ed. 11/09 chap. 1.1 - Introduction - 5 of 14

formula formula plus formula formula 2000 formula

Additionally, formula is manufactured into a configuration specifically suited for use in

formula has an electronic multiprocessor architecture composed of control and

The hydraulic circuit is completely disinfectable.

6 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

formula optimises the consumption of:

formula combines technological innovations with tradition, maintaining a rapidly

formula is equipped with non-invasive measuring transducers, free of stasis points

ENG – Ed. 11/09 chap. 1.1 - Introduction - 7 of 14

8 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

Applied part TYPE B

Applied part TYPE BF

Defibrillation-proof type BF applied part (ref. EN 60601-1)

IPX1 Protection against dripping water with vertical drop

Alternate current power supply

Off (not powered)

WARNING. Consult the manual.

ENG – Ed. 11/09 chap. 1.1 - Introduction - 9 of 14

Connectors for serial ports

Conformity with Directive 93/42/EEC relative to Medical Devices.

Connector for Pulsar

Connector for Hemox

This symbol indicates the compulsory separation of electrical and

Proper functioning of formula is guaranteed only if the machine is used and

10 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

formula carries the CE marking in compliance with the European Directive

ph: ++39 0535 29271 (Italy)

ENG – Ed. 11/09 chap. 1.1 - Introduction - 11 of 14

In compliance with the Directive 2002/96/EC, the equipment to be disposed of must