Ehemo

1.1 INTRODUCTION 1.1 INTRODUCTION 1.1 INTRODUCTION 1.
1 INTRODUCTION
GENERAL GENERAL GENERAL GENERAL
NAME NAME NAME 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 INTENDED USE INTENDED USE 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 CAUTION CAUTION CAUTION

Information and assistance given to the patient during dialytic t Information and assistance
given to the patient during dialytic t Information and assistance given to the patient during
dialytic t Information and assistance given to the patient during dialytic therapy in home
herapy in home herapy in home herapy in home dialysis must take place under the
management and supervision of the dialysis must take place under the management and
supervision of the dialysis must take place under the management and supervision of the
dialysis must take place under the management and supervision of the physic physic physic
physician prescribing the treatment. T ian prescribing the treatment. T ian prescribing the
treatment. T ian prescribing the treatment. The manufacturer does not undertake any he
manufacturer does not undertake any he manufacturer does not undertake any he
manufacturer does not undertake any responsibility for teaching the patient how to use
responsibility for teaching the patient how to use responsibility for teaching the patient how to
use responsibility for teaching the patient how to use formula . Responsibility lies
Responsibility lies Responsibility lies Responsibility lies exclusively wi exclusively wi exclusively
wi exclusively with the physician in charge. th the physician in charge. th the physician in
charge. th the physician in charge.
LIMITATION OF USE LIMITATION OF USE LIMITATION OF USE 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 COLLATERAL EFFECTS COLLATERAL EFFECTS COLLATERAL EFFECTS
Dialysis therapy may cause hypotension, nausea, vomiting and cramping in some patients.
CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS

Hyperpotassemia (only with haemodialysis concentrates containing potassium)
Hypopotassemia (only with haemodialysis concentrates not containing potassium)
Uncontrollable coagulation anomalies.
2 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

HAEMODIALYSIS HAEMODIALYSIS HAEMODIALYSIS HAEMODIALYSIS
Haemodialysis Haemodialysis 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 HAEMODIAFILTRATION
Haemodiafiltratio Haemodiafiltratio Haemodiafiltratio Haemodiafiltration nn n 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 Standard haemodiafiltration

Standard haemodiafiltration Standard 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 HDF HDF. o On line haemodiafiltration On line haemodiafiltration On line
haemodiafiltration On line 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 HDF PRE HDF PRE HDF PRE, HDF POST HDF POST HDF POST
HDF POST, MID MID MID MID--HDF HDF HDF HDF, PHF PRE PHF PRE PHF PRE PHF PRE, PHF
POST PHF POST PHF POST PHF POST. o Haemodiafiltration with endogenous reinf
Haemodiafiltration with endogenous reinf Haemodiafiltration with endogenous reinf
Haemodiafiltration with endogenous reinfusion usion usion 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 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.
ENG – Ed. 11/09 chap. 1.1 - Introduction - 3 of 14

HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION
-- INDICAT INDICAT INDICAT INDICATIONS IONS IONS IONS
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 OONN ON--LINE HAEMODIAFILTRATION LINE HAEMODIAFILTRATION LINE

HAEMODIAFILTRATION LINE HAEMODIAFILTRATION – –– – CONTRAINDICATIONS
CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS
Online haemodiafiltration treatments (HDF PRE, HDF POST, PHF PRE, PHF POST, MIDHDF) 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 WARNING WARNING WARNING

• Chemical subst Chemical subst Chemical subst Chemical substances potentially toxic for
infusion, present in the deionised ances potentially toxic for infusion, present in the deionised
ances potentially toxic for infusion, present in the deionised ances potentially toxic for
infusion, present in the deionised water distribution network or in concentrate solutions are
not detectable by water distribution network or in concentrate solutions are not detectable by
water distribution network or in concentrate solutions are not detectable by 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 It is the responsibility of the
dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use
water suitable for It is the responsibility of the dialysis centre to use water suitable for
infusion. infusion. infusion. infusion.
• To avoid potentially d To avoid potentially d To avoid potentially d To avoid potentially
dangerous situations, carefully read the directions on angerous situations, carefully read the
directions on angerous situations, carefully read the directions on angerous situations,
carefully read the directions on the device packaging. the device packaging. the device
packaging. the device packaging.
• Check that the device packaging, which ensures their sterility, is not Check that the device
packaging, which ensures their sterility, is not Check that the device packaging, which ensures
their sterility, is not Check that the device packaging, which ensures their sterility, is not
damaged and that the sterilization validity date has not expired. damaged and that the
sterilization validity date has not expired. damaged and that the sterilization validity date has
not expired. damaged and that the sterilization validity date has not expired.
• Always ensure that disposable devices are Always ensure that disposable devices are Always
ensure that disposable devices are Always ensure that disposable devices are installed
properly using aseptic installed properly using aseptic installed properly using aseptic installed
properly using aseptic techniques. techniques. techniques. techniques.
• Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not
pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic
concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate
solutions, qualitatively in compliance with the monographs of the European Pharmacopoeia.
with the monographs of the European Pharmacopoeia. with the monographs of the European
Pharmacopoeia. with the monographs of the European Pharmacopoeia.
• The concentrate solutions to be used for preparation of dialysis fluid must The concentrate
solutions to be used for preparation of dialysis fluid must The concentrate solutions to be used
for preparation of dialysis fluid must The concentrate solutions to be used for preparation of
dialysis fluid must be intact be intact be intact be intact, opened only at the moment of use.
Once opened, they must be , opened only at the moment of use. Once opened, they must be ,
opened only at the moment of use. Once opened, they must be , opened only at the moment
of use. Once opened, they must be used for one treatment only within 24 hours. used for one
treatment only within 24 hours. used for one treatment only within 24 hours. used for one
treatment only within 24 hours.
• Before starting an on Before starting an on Before starting an on Before starting an on--line
haemodiafiltration session, take a dialysis fluid line haemodiafiltration session, take a dialysis
fluid line haemodiafiltration session, take a dialysis fluid line haemodiafiltration session, take a
dialysis fluid sample and check that it is free from any residual chemical agents. sample and
check that it is free from any residual chemical agents. sample and check that it is free from
any residual chemical agents. sample and check that it is free from any residual chemical
agents.
• Befo Befo Befo Before and during on re and during on re and during on re and during on--
line haemodiafiltration treatment, check the exact line haemodiafiltration treatment, check
the exact line haemodiafiltration treatment, check the exact line haemodiafiltration treatment,
check the exact mixture of the concentrates with water. mixture of the concentrates with
water. mixture of the concentrates with water. mixture of the concentrates with water.
• Always run a disinfection cycle before and after each on Always run a disinfection cycle
before and after each on Always run a disinfection cycle before and after each on Always run a
disinfection cycle before and after each on--line line line line haemodiafiltration treatment
session. The manufacturer declines any haemodiafiltration treatment session. The
manufacturer declines any haemodiafiltration treatment session. The manufacturer declines
any haemodiafiltration treatment session. The manufacturer declines any responsibility for
responsibility for responsibility for responsibility for patient safety in the event of failure to
carry out proper patient safety in the event of failure to carry out proper patient safety in the
event of failure to carry out proper patient safety in the event of failure to carry out proper
disinfection. disinfection. disinfection. disinfection.
• Regularly change the Multipure and Forclean filters to ensure the maximum Regularly
change the Multipure and Forclean filters to ensure the maximum Regularly change the
Multipure and Forclean filters to ensure the maximum Regularly change the Multipure and
Forclean filters to ensure the maximum purification of the liquid used. purification of the liquid
used. purification of the liquid used. purification of the liquid used.
• The Qinf value must be selected taking into consideration the dilution The Qinf value must
be selected taking into consideration the dilution The Qinf value must be selected taking into
consideration the dilution The Qinf value must be selected taking into consideration the
dilution mode mode mode mode; in POST dilution (PHF POST) in particular, a careful
evaluation of the ; in POST dilution (PHF POST) in particular, a careful evaluation of the ; in
POST dilution (PHF POST) in particular, a careful evaluation of the ; 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 set value is necessary. Refer to the literature and the clinical scene of the
set value is necessary. Refer to the literature and the clinical scene of the set value is
necessary. Refer to the literature and the clinical scene of the patient to avoid potentially
dangerous conditions. patient to avoid potentially dangerous conditions. patient to avoid
potentially dangerous conditions. patient to avoid potentially dangerous conditions.

HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH
ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE
HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REIN REIN REIN REINFUSION
(HFR) FUSION (HFR) FUSION (HFR) FUSION (HFR) -- INDICATIONS INDICATIONS INDICATIONS
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 HAEMODIAFILTRATION WITH

ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE
HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REINFUSION (HFR) REINFUSION
(HFR) REINFUSION (HFR) REINFUSION (HFR) -- CONTRAINDICATIONS CONTRAINDICATIONS
CONTRAINDICATIONS 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.

M MM MAIN FEATURES AIN FEATURES AIN FEATURES AIN 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 TABLE OF TREATMENTS/MODELS TABLE OF

TREATMENTS/MODELS 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 2000:

formula 2000 plus
formula 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 rigorously single
rigorously single rigorously single--pass pass pass 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 electric energy electric energy
electric 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. •
concentra concentra concentra concentrates tteess tes: both during the patient waiting phase
and during dialysis with isolated ultrafiltration, formula reduces the dialysis fluid flow to a
minimum level. • feedwater: feedwater: feedwater: feedwater: in all standby phases during
rinsing, formula reduces the inlet water flow to a minimum.
SAFETY PHILOSOPHY SAFETY PHILOSOPHY SAFETY PHILOSOPHY 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 SYMBOLS ON THE MACHINE SYMBOLS ON THE MACHINE

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 IPX1 IPX1 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 MANUFACTURER RESPONSIBILITY MANUFACTURER

RESPONSIBILITY 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 EN 60601 EN 60601 EN 60601--1 11 1
Medical electrical equipment. Part 1: General requirements for safety
EN 60601 EN 60601 EN 60601 EN 60601--1 11 1--2 22 2
Medical electrical equipment. Part 1: General requirements for safety - Collateral standards:
Electromagnetic compatibility – Requirements and tests

EN EN EN EN 60601 60601 60601 60601--1 11 1--4 44 4
Medical electrical equipment. Part 1: General requirements for safety. 4. Collateral standard:
Programmable electrical medical systems
EN 60601 EN 60601 EN 60601 EN 60601--2 22 2--16 1166 16
Medical electrical equipment. Part 2-16: Particular requirements for the safety of
haemodialysis, haemofiltration and haemodiafiltration equipment
EN 60601 EN 60601 EN 60601 EN 60601--2 22 2--30 3300 30
Medical electrical equipment. Part 2: Particular requirements for safety, including essential
performance, of automatic cycling non-invasive blood pressure monitoring equipment.
EN EN EN EN ISO 14971 ISO 14971 ISO 14971 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 cont To cont To cont To contact After act After act After act After--Sales Service: Sales
Service: Sales Service: Sales Service:
ph: ++39 0535 29271 (Italy) ph: ++39 0535 29402 (International) Fax: ++39 0535 29400 e-
mail: service@bellco.net
Local Representative Local Representative Local Representative Local Representative
EQUIPMENT DISPOSAL EQUIPMENT DISPOSAL EQUIPMENT DISPOSAL EQUIPMENT DISPOSAL
IMPORTANT IMPORTANT IMPORTANT IMPORTANT

The guidelines herein indicated are addressed only to the Member States which The
guidelines herein indicated are addressed only to the Member States which The guidelines
herein indicated are addressed only to the Member States which 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 accepted Directive 2002/96/EC of 27 January 2003 on
Waste Electrical and accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical
and accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and El EEll
Electronic Equipment (WEEE). ectronic Equipment (WEEE). ectronic Equipment (WEEE).
ectronic Equipment (WEEE). These measures comply with the European These measures
comply with the European These measures comply with the European These measures comply
with the European Directive and the national laws transposing the Directive in the Member
States. Directive and the national laws transposing the Directive in the Member States.
Directive and the national laws transposing the Directive in the Member States. 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 PRODUCT CODE PRODUCT CODE PRODUCT CODE
The product code, described below, is a 9-character alphanumerical code:

IBFXMX700
The first two characters first two characters first two characters first two characters (IB) are
identical for all equipment and identify the product.
The third character (alphabetic) third character (alphabetic) third character (alphabetic) third
character (alphabetic) identifies the machine: F: FF:: F: formula or formula 2000
The fourth fourth fourth fourth and fifth characters fifth characters fifth characters fifth
characters (alphanumeric) )) ) identify the model: XM: XM: XM: XM: formula (single pump)
XB: XB: XB: XB: formula 2000 (double pump) PM: PM: PM: PM: formula Plus (single pump)
PB: PB: PB: PB: formula 2000 Plus (double pump) TB: TB: TB: TB: formula Therapy (double
pump)
The sixth character sixth character sixth character sixth character (alphanumeric) identifies the
version: X: standard system D DD D: formula Domus (Home Care System)
The seventh character seventh character seventh character seventh character (numeric)
indicates the pre-set voltage. 2 22 2: 110 Vac 3 33 3: 115 Vac 4 44 4: 120 Vac 6 66 6: 220 Vac 7
77 7: 230 Vac 8 88 8: 240 Vac
The eighth and ninth characters eighth and ninth characters eighth and ninth characters
eighth and ninth characters (numeric) are digits included between 00 and 99. They identify the
option devices mounted on the machine.
Formula Formula Formula Formula , Formula Plus, , Formula Plus, , Formula Plus, , Formula
Plus, Formula 2000 Formula 2000 Formula 2000 Formula 2000 and Form and Form and Form
and Formula 2000 Plus ula 2000 Plus ula 2000 Plus ula 2000 Plus models models
models models
CODE CODE CODE CODE Sphygmo Sphygmo Sphygmo Sphygmo Double Double Double
Double clamp clamp clamp clamp
Perforated Perforated Perforated Perforated

c cc cartridge artridge artridge artridge
00 0000 00
01 0011 01 x xx x 02 0022 02 x xx x
03 0033 03 x xx x
10 10 10 10 x xx x x xx x 20 2200 20 x xx x x xx x
30 30 30 30 x xx x x xx x 40 40 40 40 x xx x x xx x x xx x

Formula Therapy model Formula Therapy model Formula Therapy model Formula Therapy
model
CODE CODE CODE CODE Sphygmo Sphygmo Sphygmo Sphygmo Natrium Natrium Natrium
Natrium Double Double Double Double clamp clamp clamp clamp
Perforated Perforated Perforated Perforated c cc cartridge artridge artridge artridge
00 0000 00 x xx x x xx x
01 0011 01 x xx x x xx x x xx x
02 0022 02 x xx x x xx x x xx x
30 30 30 30 x xx x x xx x x xx x x xx x
ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 1
of 4
1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES 1. 2 WARNINGS, CAUTIONS AND SAFETY
NOTES 1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES 1. 2 WARNINGS, CAUTIONS AND
SAFETY NOTES
WARNINGS WARNINGS WARNINGS WARNINGS
Carefully read the instructions contained in this manual before starting the Carefully read the
instructions contained in this manual before starting the Carefully read the instructions
contained in this manual before starting the Carefully read the instructions contained in this
manual before starting the machine for the first time. Non machine for the first time. Non
machine for the first time. Non machine for the first time. Non--conform use, application of
procedures conform use, application of procedures conform use, application of procedures
conform use, application of procedures different from those indicated, or the use of accessor
different from those indicated, or the use of accessor different from those indicated, or the
use of accessor different from those indicated, or the use of accessory devices not provided for
y devices not provided for y devices not provided for y devices not provided for may present a
risk to the patient and/or the machine. may present a risk to the patient and/or the machine.
may present a risk to the patient and/or the machine. may present a risk to the patient and/or
the machine.
Haemodialysis treatments must be carried out under supervision of the Haemodialysis
treatments must be carried out under supervision of the Haemodialysis treatments must be
carried out under supervision of the Haemodialysis treatments must be carried out under
supervision of the medical staff responsible for administration of the treatment. medical staff
responsible for administration of the treatment. medical staff responsible for administration of
the treatment. medical staff responsible for administration of the treatment.
formula may only be used by persons who may only be used by persons who may only
be used by persons who may only be used by persons who have acquired adequate knowledge
have acquired adequate knowledge have acquired adequate knowledge have acquired
adequate knowledge of haemodialysis and who have been suitably trained for proper use of
the of haemodialysis and who have been suitably trained for proper use of the of
haemodialysis and who have been suitably trained for proper use of the of haemodialysis and
who have been suitably trained for proper use of the machine and the risks connected with
such use. machine and the risks connected with such use. machine and the risks connected
with such use. machine and the risks connected with such use.
Check the quality of the haemodialysis water used so that when mixed with the Check the
quality of the haemodialysis water used so that when mixed with the Check the quality of the
haemodialysis water used so that when mixed with the Check the quality of the haemodialysis
water used so that when mixed with the concentrates, no poten concentrates, no poten
concentrates, no poten concentrates, no potentially dangerous conditions for the patient are
created. tially dangerous conditions for the patient are created. tially dangerous conditions for
the patient are created. tially dangerous conditions for the patient are created.
The operator must pay careful attention to all the alarm conditions and follow The operator
must pay careful attention to all the alarm conditions and follow The operator must pay
careful attention to all the alarm conditions and follow The operator must pay careful
attention to all the alarm conditions and follow the instructions, the warnings and the notes
contained in this manual. the instructions, the warnings and the notes contained in this
manual. the instructions, the warnings and the notes contained in this manual. the
instructions, the warnings and the notes contained in this manual. If IIff If formula does
not function as described in th does not function as described in th does not function as
described in th does not function as described in the manual, it must not be used e manual, it
must not be used e manual, it must not be used e manual, it must not be used until its
operating conditions have been restored. until its operating conditions have been restored.
until its operating conditions have been restored. until its operating conditions have been
restored.
There are no parts of the machine which may be repaired by the operator. There are no parts
of the machine which may be repaired by the operator. There are no parts of the machine
which may be repaired by the operator. 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 Periodic maintenance is to be carried out every 3000 hours of operation or
Periodic maintenance is to be carried out every 3000 hours of operation or Periodic
maintenance is to be carried out every 3000 hours of operation or every 12 months. every 12
months. every 12 months. every 12 months.
The mach The mach The mach The machines are not disinfected before shipment. Always
carry out a ines are not disinfected before shipment. Always carry out a ines are not
disinfected before shipment. Always carry out a ines are not disinfected before shipment.
Always carry out a disinfection cycle after installation, before use. disinfection cycle after
installation, before use. disinfection cycle after installation, before use. disinfection cycle after
installation, before use.
The blood circuits must be sterile and pyrogen The blood circuits must be sterile and pyrogen
The blood circuits must be sterile and pyrogen The blood circuits must be sterile and pyrogen--
free. Check that the packaging free. Check that the packaging free. Check that the packaging
free. Check that the packaging is undamaged and open it using aseptic techniques. To prevent
any is undamaged and open it using aseptic techniques. To prevent any is undamaged and
open it using aseptic techniques. To prevent any is undamaged and open it using aseptic
techniques. To prevent any possibility possibility possibility possibility of contamination, the
sterile sets must be used immediately. of contamination, the sterile sets must be used
immediately. of contamination, the sterile sets must be used immediately. of contamination,
the sterile sets must be used immediately.
Once the disposable material is installed, check there are no bends or kinks in Once the
disposable material is installed, check there are no bends or kinks in Once the disposable
material is installed, check there are no bends or kinks in Once the disposable material is
installed, check there are no bends or kinks in the lines. the lines. the lines. the lines.
Disposable material should be treated as special waste and disposed of Disposable material
should be treated as special waste and disposed of Disposable material should be treated as
special waste and disposed of Disposable material should be treated as special waste and
disposed of according to statu according to statu according to statu according to statutory laws
and regulations. Do not re tory laws and regulations. Do not re tory laws and regulations. Do
not re tory laws and regulations. Do not re--sterilize. When handling sterilize. When handling
sterilize. When handling sterilize. When handling disposable material, adopt the necessary and
adequate precautions to prevent disposable material, adopt the necessary and adequate
precautions to prevent disposable material, adopt the necessary and adequate precautions to
prevent disposable material, adopt the necessary and adequate precautions to prevent any
exposure to or transmission of infecting agents, HIV and hepatitis viruses. any exposure to or
transmission of infecting agents, HIV and hepatitis viruses. any exposure to or transmission of
infecting agents, HIV and hepatitis viruses. any exposure to or transmission of infecting agents,
HIV and hepatitis viruses.
When the machine is no longer going t When the machine is no longer going t When the
machine is no longer going t When the machine is no longer going to be used, it must also be
treated as o be used, it must also be treated as o be used, it must also be treated as o be used,
it must also be treated as special refuse and disposed of according to statutory laws and
regulations. special refuse and disposed of according to statutory laws and regulations. special
refuse and disposed of according to statutory laws and regulations. special refuse and
disposed of according to statutory laws and regulations.
2 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09
The temperature of the liquid circulating in the tubes during the heat The temperature of the
liquid circulating in the tubes during the heat The temperature of the liquid circulating in the
tubes during the heat The temperature of the liquid circulating in the tubes during the heat
disinfection cycles is extremely high. Do not touch the tubes and the disinfection cycles is
extremely high. Do not touch the tubes and the disinfection cycles is extremely high. Do not
touch the tubes and the disinfection cycles is extremely high. Do not touch the tubes and the
connectors until the disinfection cycle has ended. connectors until the disinfection cycle has
ended. connectors until the disinfection cycle has ended. connectors until the disinfection
cycle has ended.
During dialysis pay careful attention to inverse ultrafiltration (signalled by a During dialysis pay
careful attention to inverse ultrafiltration (signalled by a During dialysis pay careful attention
to inverse ultrafiltration (signalled by a During dialysis pay careful attention to inverse
ultrafiltration (signalled by a specific alarm), as this situation can be dangerous for the patient.
specific alarm), as this situation can be dangerous for the patient. specific alarm), as this
situation can be dangerous for the patient. specific alarm), as this situation can be dangerous
for the patient. Accurately Accurately Accurately Accurately verify the patient verify the
patient verify the patient verify the patient’ ’’ ’s weight. s weight. s weight. s weight.
During dialys During dialys During dialys During dialysis pay careful attention to eventual
leakage of fluids from the is pay careful attention to eventual leakage of fluids from the is pay
careful attention to eventual leakage of fluids from the is pay careful attention to eventual
leakage of fluids from the equipment, as this situation can be dangerous for the patient.
equipment, as this situation can be dangerous for the patient. equipment, as this situation can
be dangerous for the patient. equipment, as this situation can be dangerous for the patient.
Accurately verify Accurately verify Accurately verify Accurately verify the patient the patient
the patient the patient’ ’’ ’s weight. s weight. s weight. s weight.
Some of the alarms can be disabled by pressing the Some of the alarms can be disabled by
pressing the Some of the alarms can be disabled by pressing the Some of the alarms can be
disabled by pressing the key to allow the key to allow the key to allow the key to allow the
operator to resolv operator to resolv operator to resolv operator to resolve the situations
which generated the alarm. The operator e the situations which generated the alarm. The
operator e the situations which generated the alarm. The operator e the situations which
generated the alarm. The operator must pay very careful attention and is responsible for
monitoring the disabled must pay very careful attention and is responsible for monitoring the
disabled must pay very careful attention and is responsible for monitoring the disabled 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 parameters. The repeated
silencing of alarms due to an unknown cause can be parameters. The repeated silencing of
alarms due to an unknown cause can be parameters. The repeated silencing of alarms due to
an unknown cause can be dangerous for the patient. dangerous for the patient. dangerous for
the patient. dangerous for the patient.
If the I If the I If the I If the I. .. .V VV V. .. . po po po pole is fitted with both hooks and scale, in
HDF hang the le is fitted with both hooks and scale, in HDF hang the le is fitted with both hooks
and scale, in HDF hang the le is fitted with both hooks and scale, in HDF hang the infusion fluid
bags only on the scale hooks to prevent weight loss errors. infusion fluid bags only on the scale
hooks to prevent weight loss errors. infusion fluid bags only on the scale hooks to prevent
weight loss errors. infusion fluid bags only on the scale hooks to prevent weight loss errors.
The maximum load that may be applied to the IV pole of The maximum load that may be
applied to the IV pole of The maximum load that may be applied to the IV pole of The
maximum load that may be applied to the IV pole of formula is 10 kg, is 10 kg, is 10 kg,
is 10 kg, while to the I while to the I while to the I while to the I. .. .V VV V. .. . pole of pole of
pole of pole of formula 2000 is 16 kg is 16 kg is 16 kg is 16 kg. .. .
To transport or to move the machine, the IV pole and scale hooks must be To transport or to
move the machine, the IV pole and scale hooks must be To transport or to move the machine,
the IV pole and scale hooks must be To transport or to move the machine, the IV pole and
scale hooks must be unloaded. unloaded. unloaded. unloaded.
formula must always be installed by technicians authorised by the must always be

installed by technicians authorised by the must always be installed by technicians authorised
by the must always be installed by technicians authorised by the manufacturer or by technical
staff of the dialysis centre, who are adequately manufacturer or by technical staff of the
dialysis centre, who are adequately manufacturer or by technical staff of the dialysis centre,
who are adequately manufacturer or by technical staff of the dialysis centre, who are
adequately trained and authorised. trained and authorised. trained and authorised. trained
and authorised. If not, the manufacturer declines all responsibility If not, the manufacturer
declines all responsibility If not, the manufacturer declines all responsibility If not, the
manufacturer declines all responsibility regarding safety and reliability of the machine.
regarding safety and reliability of the machine. regarding safety and reliability of the machine.
regarding safety and reliability of the machine.
The electrical system of the haemodialysis rooms must be in conformity with The electrical
system of the haemodialysis rooms must be in conformity with The electrical system of the
haemodialysis rooms must be in conformity with The electrical system of the haemodialysis
rooms must be in conformity with the relevant regulations; therefore, have the earthing and
the good condition the relevant regulations; therefore, have the earthing and the good
condition the relevant regulations; therefore, have the earthing and the good condition the
relevant regulations; therefore, have the earthing and the good condition
of the power outlet checked before installing the machine. Specific regulations of the power
outlet checked before installing the machine. Specific regulations of the power outlet checked
before installing the machine. Specific regulations of the power outlet checked before
installing the machine. Specific regulations of different countries, as well as any changes to
national regulations, must be of different countries, as well as any changes to national
regulations, must be of different countries, as well as any changes to national regulations,
must be of different countries, as well as any changes to national regulations, must be taken
into account. taken into account. taken into account. taken into account.
Ensure compliance with current regulations concerning drain Ensure compliance with current
regulations concerning drain Ensure compliance with current regulations concerning drain
Ensure compliance with current regulations concerning drain--traps and poin traps and poin
traps and poin traps and point tt t-to ttoo to--point distance to the drain. point distance to the
drain. point distance to the drain. point distance to the drain.
The The The The formula single patient delivery system is a continuous operation
machine, single patient delivery system is a continuous operation machine, single patient
delivery system is a continuous operation machine, single patient delivery system is a
continuous operation machine, and is not suitable for use with inflammable anaesthetic
mixtures containing and is not suitable for use with inflammable anaesthetic mixtures
containing and is not suitable for use with inflammable anaesthetic mixtures containing and is
not suitable for use with inflammable anaesthetic mixtures containing air, oxygen or nitrous
oxide. air, oxygen or nitrous oxide. air, oxygen or nitrous oxide. air, oxygen or nitrous oxide.
ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 3
of 4
When connecting the machine to th When connecting the machine to th When connecting the
machine to th When connecting the machine to the mains, only use the power cable provided
e mains, only use the power cable provided e mains, only use the power cable provided e
mains, only use the power cable provided and do not use extensions or adapters for plugs. and
do not use extensions or adapters for plugs. and do not use extensions or adapters for plugs.
and do not use extensions or adapters for plugs.
Do not connect external machines to the auxiliary socket Do not connect external machines to
the auxiliary socket Do not connect external machines to the auxiliary socket Do not connect
external machines to the auxiliary socket (if present) (if present) (if present) (if present). .. .
The The The The connector for an external keyboard may only be used by technicians or
connector for an external keyboard may only be used by technicians or connector for an
external keyboard may only be used by technicians or connector for an external keyboard may
only be used by technicians or personnel authoris personnel authoris personnel authoris
personnel authorised by the manufacturer. ed by the manufacturer. ed by the manufacturer.
ed by the manufacturer.
The power supply voltage on the mains outlet at the dialysis centre must be The power supply
voltage on the mains outlet at the dialysis centre must be The power supply voltage on the
mains outlet at the dialysis centre must be The power supply voltage on the mains outlet at
the dialysis centre must be identical to that indicated on the machine identification plate.
identical to that indicated on the machine identification plate. identical to that indicated on
the machine identification plate. identical to that indicated on the machine identification plate.
Do not remove labels or written information from the machine panels. Do not remove labels
or written information from the machine panels. Do not remove labels or written information
from the machine panels. Do not remove labels or written information from the machine
panels.
Before use, the mac Before use, the mac Before use, the mac Before use, the machine must
be configured. The first configuration must be hine must be configured. The first
configuration must be hine must be configured. The first configuration must be hine must be
configured. The first configuration must be performed only by technicians authorised by the
manufacturer. performed only by technicians authorised by the manufacturer. performed only
by technicians authorised by the manufacturer. performed only by technicians authorised by
the manufacturer.
CAUTIONS CAUTIONS CAUTIONS CAUTIONS
During transport and storage the machine must be kept in its original During transport and
storage the machine must be kept in its original During transport and storage the machine
must be kept in its original During transport and storage the machine must be kept in its
original packaging. Should the period of transport or storage be packaging. Should the period
of transport or storage be packaging. Should the period of transport or storage be packaging.
Should the period of transport or storage be longer than 15 weeks, longer than 15 weeks,
longer than 15 weeks, longer than 15 weeks, refer to the ambient data relative to functioning.
refer to the ambient data relative to functioning. refer to the ambient data relative to
functioning. refer to the ambient data relative to functioning.
When unpacking, check that there are no signs of external damage which may When
unpacking, check that there are no signs of external damage which may When unpacking,
check that there are no signs of external damage which may When unpacking, check that there
are no signs of external damage which may compromise proper functioning of the machine.
compromise proper functioning of the machine. compromise proper functioning of the
machine. compromise proper functioning of the machine.
Take all the necessary precautions so that the machine cann Take all the necessary
precautions so that the machine cann Take all the necessary precautions so that the machine
cann Take all the necessary precautions so that the machine cannot fall or is not ot fall or is not
ot fall or is not ot fall or is not placed in an unstable position during ordinary use or transport.
In case of placed in an unstable position during ordinary use or transport. In case of placed in
an unstable position during ordinary use or transport. In case of 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 falling or other mechanical stress, have a preventive
inspection carried out by falling or other mechanical stress, have a preventive inspection
carried out by falling or other mechanical stress, have a preventive inspection carried out by
qualified technicians. qualified technicians. qualified technicians. qualified technicians.
On all models, before moving the machine, the IV pole hook On all models, before moving the
machine, the IV pole hook On all models, before moving the machine, the IV pole hook On all
models, before moving the machine, the IV pole hooks, scale hooks and s, scale hooks and s,
scale hooks and s, scale hooks and concentrate bag concentrate bag concentrate bag
concentrate bag holder holder holder holder must be completely unloaded. must be
completely unloaded. must be completely unloaded. must be completely unloaded.
On DOMUS versions, the instrument table must also completely empty before On DOMUS
versions, the instrument table must also completely empty before On DOMUS versions, the
instrument table must also completely empty before On DOMUS versions, the instrument
table must also completely empty before moving the machine. moving the machine. moving
the machine. moving the machine.
Do not step on the container Do not step on the container Do not step on the container Do
not step on the container--tray base. tray base. tray base. tray base.
Use the bag hook only for the physiological solu Use the bag hook only for the physiological
solu Use the bag hook only for the physiological solu Use the bag hook only for the
physiological solution bags. tion bags. tion bags. tion bags.
Use of mobile telephones near Use of mobile telephones near Use of mobile telephones near
Use of mobile telephones near formula or other devices emitting or other devices
emitting or other devices emitting or other devices emitting electromagnetic waves may
cause bad functioning of the machine. electromagnetic waves may cause bad functioning of
the machine. electromagnetic waves may cause bad functioning of the machine.
electromagnetic waves may cause bad functioning of the machine.
After each dialysis disinfect the concentrate intake tubes. After each dialysis disinfect the
concentrate intake tubes. After each dialysis disinfect the concentrate intake tubes. After each
dialysis disinfect the concentrate intake tubes.
Do not exchange the concentrate with the disinfectant Do not exchange the concentrate with
the disinfectant Do not exchange the concentrate with the disinfectant Do not exchange the
concentrate with the disinfectant tubes and with those of tubes and with those of tubes and
with those of tubes and with those of other dialysis machines. other dialysis machines. other
dialysis machines. other dialysis machines.
4 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09
NOTES NOTES NOTES NOTES
This manual provides the necessary instructions for safe and proper This manual provides the
necessary instructions for safe and proper This manual provides the necessary instructions for
safe and proper This manual provides the necessary instructions for safe and proper
functioning of functioning of functioning of functioning of formula . .. . It must not be
understood as guide for administration It must not be understood as guide for administration
It must not be understood as guide for administration It must not be understood as guide for
administration of dialytic therapy. of dialytic therapy. of dialytic therapy. of dialytic therapy.
Keep this manual in a readi Keep this manual in a readi Keep this manual in a readi Keep this
manual in a readily accessible place for rapid consultation by both ly accessible place for rapid
consultation by both ly accessible place for rapid consultation by both ly accessible place for
rapid consultation by both the operator and the authorised maintenance technician. the
operator and the authorised maintenance technician. the operator and the authorised
maintenance technician. the operator and the authorised maintenance technician.
The operator must regularly clean the machine. Refer to the chapter “Cleaning The operator
must regularly clean the machine. Refer to the chapter “Cleaning The operator must regularly
clean the machine. Refer to the chapter “Cleaning The operator must regularly clean the
machine. Refer to the chapter “Cleaning and Maintenance”. Before carrying out any cleaning
or preventive maint and Maintenance”. Before carrying out any cleaning or preventive maint
and Maintenance”. Before carrying out any cleaning or preventive maint and Maintenance”.
Before carrying out any cleaning or preventive maintenance enance enance enance operation,
make sure that the machine is off. operation, make sure that the machine is off. operation,
make sure that the machine is off. operation, make sure that the machine is off.
The The The The formula technical manual is handed out following a specific course on
the technical manual is handed out following a specific course on the technical manual is
handed out following a specific course on the technical manual is handed out following a
specific course on the machine, or is available on request for authorized technical staff.
machine, or is available on request for authorized technical staff. machine, or is available on
request for authorized technical staff. machine, or is available on request for authorized
technical staff.
NOTES FOR USING THE SCALE FORMULA 2000 NOTES FOR USING THE SCALE FORMULA 2000
NOTES FOR USING THE SCALE FORMULA 2000 NOTES FOR USING THE SCALE FORMULA 2000
The FORMULA The FORMULA The FORMULA The FORMULA 2000 SCALE accessory may be
used only on 2000 SCALE accessory may be used only on 2000 SCALE accessory may be used
only on 2000 SCALE accessory may be used only on formula 2000 and and and and
formula 2000 plus models in standard and domus versions; installation must be models
in standard and domus versions; installation must be models in standard and domus versions;
installation must be models in standard and domus versions; installation must be carried out
by a qualified technician authorised by the manufacturer. carried out by a qualified technician
authorised by the manufacturer. carried out by a qualified technician authorised by the
manufacturer. carried out by a qualified technician authorised by the manufacturer.
The FORMULA 2000 SCALE accessory does not come The FORMULA 2000 SCALE accessory
does not come The FORMULA 2000 SCALE accessory does not come The FORMULA 2000 SCALE
accessory does not come as standard with as standard with as standard with as standard with
compatible models. compatible models. compatible models. compatible models.
The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is The FORMULA
2000 SCALE accessory is required only for HDF treatment; it is The FORMULA 2000 SCALE
accessory is required only for HDF treatment; it is The FORMULA 2000 SCALE accessory is
required only for HDF treatment; it is not required for any of the other treatments. not
required for any of the other treatments. not required for any of the other treatments. not
required for any of the other treatments.
ENG – Ed. 11/09 chap. 2.1 - Description of machine and components - 1

of 6
2.1 DESCRIPTION OF MACHINE AND COMPONENTS 2.1 DESCRIPTION OF MACHINE AND
COMPONENTS 2.1 DESCRIPTION OF MACHINE AND COMPONENTS 2.1 DESCRIPTION OF
MACHINE AND COMPONENTS – –– –
STANDARD STANDARD STANDARD STANDARD NON NON NON NON--THERAPY MODELS
THERAPY MODELS THERAPY MODELS THERAPY MODELS
FRONT VIEW FRONT VIEW FRONT VIEW FRONT VIEW
26
25
24
8
22
4
5
9
6
23
10
7
3
1
2
2 of 6 - chap. 2.1 – Description of machine and components ENG – Ed. 11/09

FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION
FRONT PANEL: DESCRIPTION
1 11 1
Pivoting wheels Pivoting wheels Pivoting wheels Pivoting wheels

To easily move the machine. The front wheels are fitted with a braking system. It is
recommended to lock the wheels during treatment.
2 22 2
Container base Container base Container base Container base

To house the containers of the concentrate solutions and chemicals used for
disinfection/cleaning.
3 33 3
Disinfectant connector (yellow) Disinfectant connector (yellow) Disinfectant connector (yellow)

Disinfectant connector (yellow)
4 44 4
Acetate/acid concentrate connector (white/red) Acetate/acid concentrate connector

(white/red) Acetate/acid concentrate connector (white/red) Acetate/acid concentrate
connector (white/red)
5 55 5
Bicarbonate c Bicarbonate c Bicarbonate c Bicarbonate concentrate connector (blue)

oncentrate connector (blue) oncentrate connector (blue) oncentrate connector (blue)
6 66 6
Powder bicarbonate cartridge supports Powder bicarbonate cartridge supports Powder

bicarbonate cartridge supports Powder bicarbonate cartridge supports
Allow the use of the powder bicarbonate cartridge.
7 77 7
Powder bicarbonate cartridge connector Powder bicarbonate cartridge connector Powder

bicarbonate cartridge connector Powder bicarbonate cartridge connector
8 88 8
Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red) Dialyser fluid outlet
connector (red) Dialyser fluid outlet connector (red) To connect the dialysis fluid tube to the
dialyser outlet.
9 99 9
Dialyser inlet connector for dialysis fluid (blue) Dialyser inlet connector for dialysis fluid (blue)
To connect the dialysis fluid tube to the dialyser inlet.
10 1100 10
Dialysis fluid drawing connector Dialysis fluid drawing connector Dialysis fluid drawing
connector Dialysis fluid drawing connector
11 1111 11
Electric safety Electric safety Electric safety Electric safety clamp clamp clamp clamp
To close the blood line interrupting the blood flow to the patient during an alarm condition.
12 1122 12
Air detector Air detector Air detector Air detector

To detect foam or air bubbles in the venous line. Ultrasound device.
13 1133 13
Blood detector Blood detector Blood detector Blood detector

To detect presence of the line and blood in the arterial line. Infrared-ray device.
14 1144 14
Heparin pump Heparin pump Heparin pump Heparin pump

To administer heparin. 20, 30 and 50 cc syringes can be used. The syringe 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.
15 1155 15
Heparin syringe positioni Heparin syringe positioni Heparin syringe positioni Heparin syringe
positioning keys ng keys ng keys ng keys
To push the heparin syringe plunger up or down or to automatically load the pump segments.
16 1166 16
Arterial pump flow regulator Arterial pump flow regulator Arterial pump flow regulator Arterial
pump flow regulator
To change the blood flow. Turn the knob clockwise to increase flow, anticlockwise to decrease
it. Set to zero to stop the pump.

of 6
33
32
34
12
31
30
18
20
19
14
13
11
31b
27
17
16
29
28
15
21
23b
17 1177 17
Arterial pump Arterial pump Arterial pump Arterial pump
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.
18 1188 18
Level Level Level Level detector detector detector detector

Optical device to measure the level in the venous chamber.
19 1199 19 Luer Luer Luer Luer--lock connector to measure the arterial pressure (red lock
connector to measure the arterial pressure (red lock connector to measure the arterial
pressure (red lock connector to measure the arterial pressure (red) )) )
20 2200 20 Luer Luer Luer Luer--lock connector to measure the venous pressure (blue) lock
connector to measure the venous pressure (blue) lock connector to measure the venous
pressure (blue) lock connector to measure the venous pressure (blue)
21 2211 21 Clips to fix the blood lines Clips to fix the blood lines Clips to fix the blood lines
Clips to fix the blood lines
22 2222 22
Display Display Display Display

Colour display.
23 2233 23 I.V. pole I.V. pole I.V. pole I.V. pole
23b 23b 23b 23b I.V. pole hooks I.V. pole hooks I.V. pole hooks I.V. pole hooks
24 2244 24 Expansion chamber support Expansion chamber support Expansion chamber
support Expansion chamber support
25 2255 25
Scale Formula 2000 (optional) Scale Formula 2000 (optional) Scale Formula 2000 (optional)
Scale Formula 2000 (optional)
To be used only in haemodiafiltration (HDF) for bags containing infusion liquid. Maximum
load: 16 Kg.
26 2266 26
Alarm lamp (red) Alarm lamp (red) Alarm lamp (red) Alarm lamp (red)
To indicate an alarm or warning condition by flashing.
27 2277 27
Fixing clips Fixing clips Fixing clips Fixing clips

To fix the switching chamber in Single Needle with Double Pump (SNdp) or the infusion
chamber.
28 2288 28
Blood/infusion/ultrafiltration pump (formula 2000) Blood/infusion/ultrafiltration pump

(formula 2000) Blood/infusion/ultrafiltration pump (formula 2000)
Blood/infusion/ultrafiltration pump (formula 2000)
To move blood in single needle with double pump. In haemodiafiltration treatments it permits
the handling of infusion liquid. The pump stops when the cover is opened. In case of power
failure, the pump may be manually moved by turning the cranking handle. The pump is
bidirectional.
29 2299 29
Infusion/ultrafiltration pump flow regulator (formula 2000) Infusion/ultrafiltration pump flow
regulator (formula 2000) Infusion/ultrafiltration pump flow regulator (formula 2000)
Infusion/ultrafiltration pump flow regulator (formula 2000)
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 3300 30 End Infusion detector (formula 2000) End Infusion detector (formula 2000) End
Infusion detector (formula 2000) End Infusion detector (formula 2000)
Ultrasound device which detects the absence of infusion liquid during haemodiafiltration
treatments. 31 3311 31 Luer Luer Luer Luer--lock connector for infusion pressure
measurement lock connector for infusion pressure measurement lock connector for infusion
pressure measurement lock connector for infusion pressure measurement (formula 200
(formula 200 (formula 200 (formula 2000) 00)) 0)
31b 31b 31b 31b Blood leakage detector (formula 2000) Blood leakage detector (formula
2000) Blood leakage detector (formula 2000) Blood leakage detector (formula 2000)
32 3322 32 Natrium (formula plus) (accessory) Natrium (formula plus) (accessory) Natrium
(formula plus) (accessory) Natrium (formula plus) (accessory)
33 3333 33 Hemox (formula plus) (accessory) Hemox (formula plus) (accessory) Hemox
(formula plus) (accessory) Hemox (formula plus) (accessory)
34 3344 34 Additional pressure transducers: Additional pressure transducers: Additional

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

of 6
REAR PANEL REAR PANEL REAR PANEL REAR PANEL
Fig. 5 Fig. 5 Fig. 5 Fig. 5
17
18
4
6
8
12
5
7
16
15
14
13
11
10
3
2
1
19
9
20
REAR PANEL: DESCRIPTION REAR PANEL: DESCRIPTION REAR PANEL: DESCRIPTION REAR
PANEL: DESCRIPTION
1 11 1 Cooling fans Cooling fans Cooling fans Cooling fans
2 22 2 Main switch Main switch Main switch Main switch
3 33 3 Hour counter Hour counter Hour counter Hour counter
4 44 4 Acoustic warning indicator Acoustic warning indicator Acoustic warning indicator

Acoustic warning indicator
5 55 5 Battery label Battery label Battery label Battery label

Only present on machines equipped with battery. 6 66 6 Identification plate Identification
plate Identification plate Identification plate
Indicates the serial number and the mains voltage (V). 7 77 7 Connector for external
keyboard Connector for external keyboard Connector for external keyboard Connector for
external keyboard
Only for technicians authorised by the manufacturer. 8 88 8 Connector for heart rate meter
Connector for heart rate meter Connector for heart rate meter Connector for heart rate meter
-- Pulsar Pulsar Pulsar Pulsar
9 99 9 Connector for hematocrit and oxygen saturation measuring system Connector for
hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen
saturation measuring system Connector for hematocrit and oxygen saturation measuring
system --
Hemox Hemox Hemox Hemox
10 1100 10 Connector for serial communication RS 2 Connector for serial communication RS
2 Connector for serial communication RS 2 Connector for serial communication RS 232 C 32 C
32 C 32 C
Available for connecting data acquisition systems with formula protocol. 11 1111 11 Tube
winding supports Tube winding supports Tube winding supports Tube winding supports
To be used to wind the inlet and drain tubes. 12 1122 12 Cable winding supports Cable
winding supports Cable winding supports Cable winding supports
To be used to wind the power cable. 13 1133 13 Forclean support and protection cove
Forclean support and protection cove Forclean support and protection cove Forclean support
and protection cover rr r
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 Pay extreme attention because
the temperature of the liquid Pay extreme attention because the temperature of the liquid
Pay extreme attention because the temperature of the liquid circulating in the tubes during
certain disinfection/cleaning circulating in the tubes during certain disinfection/cleaning
circulating in the tubes during certain disinfection/cleaning circulating in the tubes during
certain disinfection/cleaning cycles is cycles is cycles is cycles is very high. very high. very
high. very high.
14 1144 14 Multipure filter support Multipure filter support Multipure filter support
Multipure filter support Water inlet antibacterial filter. 15 1155 15 Auxiliary socket for
external machine power supply Auxiliary socket for external machine power supply Auxiliary
socket for external machine power supply Auxiliary socket for external machine power supply
(if present) (if present) (if present) (if present)
To connect external machines or accessories. At present, no connection is available. Do not
remove the cap from its housing.
16 1166 16 Power cable Power cable Power cable Power cable
To be connected to the mains; it must be inserted in a suitable wall socket. 17 1177 17 Drain
connector Drain connector Drain connector Drain connector
18 1188 18 Water inlet connector Water inlet connector Water inlet connector Water inlet
connector
19 1199 19 Sphygmomanometer Sphygmomanometer Sphygmomanometer

Sphygmomanometer -- Sphygmo Sphygmo Sphygmo Sphygmo
20 2200 20 Equipotentiality (if present) Equipotentiality (if present) Equipotentiality (if

present) Equipotentiality (if present)
ENG – Ed. 11/09 chap. 2.2 - Description of machine and components -

1 of 6
2.2 DESCRIPTION OF MACHINE AND COMPONENTS 2.2 DESCRIPTION OF MACHINE AND
COMPONENTS 2.2 DESCRIPTION OF MACHINE AND COMPONENTS 2.2 DESCRIPTION OF
MACHINE AND COMPONENTS – –– – THERAPY MODEL THERAPY MODEL THERAPY MODEL
THERAPY MODEL, ,, , STANDARD STANDARD STANDARD STANDARD VERSION VERSION
VERSION VERSION
26
24
8
22
4
5
9
6
23
10
7
3
1
2
23b

FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION
FRONT PANEL: DESCRIPTION
1 11 1
Pivoting wheels Pivoting wheels Pivoting wheels Pivoting wheels

To easily move the machine. The front wheels are fitted with a braking system. It is
recommended to lock the wheels during treatment.
2 22 2
Container base Container base Container base Container base

To house the containers of the concentrate solutions and chemicals used for
3 33 3
Disinfectant connector (yellow) Disinfectant connector (yellow) Disinfectant connector (yellow)

Disinfectant connector (yellow)
4 44 4
Acetate/acid concentrate connector (white/red) Acetate/acid concentrate connector

(white/red) Acetate/acid concentrate connector (white/red) Acetate/acid concentrate
connector (white/red)
5 55 5
Bicarbonate concentrate connector (blue) Bicarbonate concentrate connector (blue)

Bicarbonate concentrate connector (blue) Bicarbonate concentrate connector (blue)
6 66 6
Powder bicarbonate cartridge supports Powder bicarbonate cartridge supports Powder

bicarbonate cartridge supports Powder bicarbonate cartridge supports
Allow the use of the powder bicarbonate cartridge.
7 77 7
Bicarbonate cartridge perforator unit Bicarbonate cartridge perforator unit Bicarbonate

cartridge perforator unit Bicarbonate cartridge perforator unit
8 88 8
Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red) Dialyser fluid outlet
connector (red) Dialyser fluid outlet connector (red) To connect the dialysis fluid tube to the
dialyser outlet.
9 99 9
To connect the dialysis fluid tube to the dialyser inlet.
10 1100 10
Dialysis fluid drawing connector Dialysis fluid drawing connector Dialysis fluid drawing
connector Dialysis fluid drawing connector
11 1111 11
Electric safety Electric safety Electric safety Electric safety clamp clamp clamp clamp
To close the blood line interrupting the blood flow to the patient during an alarm condition.
12 1122 12
Air detector Air detector Air detector Air detector

To detect foam or air bubbles in the venous line. Ultrasound device.
13 1133 13
Blood detector Blood detector Blood detector Blood detector

To detect presence of the line and blood in the arterial line. Infrared-ray device.
14 1144 14
Heparin pump Heparin pump Heparin pump Heparin pump

To administer heparin. 20, 30 and 50 cc syringes can be used. The syringe 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.
15 1155 15
Heparin sy Heparin sy Heparin sy Heparin syringe positioning keys ringe positioning keys ringe
positioning keys ringe positioning keys
To push the heparin syringe plunger up or down or to automatically load the pump segments.
(see the chapter “PREPARATION OF THE TREATMENT”.
16 1166 16
pump flow regulator
it. Set to zero to stop the pump. It allows the automatic opening of the clamp (see the chapter
“PREPARATION OF THE TREATMENT”).

3 of 6
33
32
34
12
31
30
18
20
19
14
11
31b
27
17
16
29
28
15
21
25
13
17 1177 17
Arterial pump Arterial pump Arterial pump Arterial pump
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.
18 1188 18
Level gauge Level gauge Level gauge Level gauge

Optical device to measure the level in the venous chamber.
19 1199 19 Luer Luer Luer Luer--lock connector to measure the arterial pressure (red) lock
connector to measure the arterial pressure (red) lock connector to measure the arterial
pressure (red) lock connector to measure the arterial pressure (red)
20 2200 20 Luer Luer Luer Luer--lock connector to measure the venous pressure (blue) lock
connector to measure the venous pressure (blue) lock connector to measure the venous
pressure (blue) lock connector to measure the venous pressure (blue)
21 2211 21 Clips to fix the blood l Clips to fix the blood l Clips to fix the blood l Clips to fix the
blood lines ines ines ines
22 2222 22

Colour display.
23 2233 23 I.V. pole I.V. pole I.V. pole I.V. pole
23b 23b 23b 23b I.V. pole hooks I.V. pole hooks I.V. pole hooks I.V. pole hooks
24 2244 24 Expansion chamber support Expansion chamber support Expansion chamber
support Expansion chamber support
25 2255 25 Infusion connector Infusion connector Infusion connector Infusion connector
Device for connecting infusion line in on-line treatments WARNING! WARNING! WARNING!
WARNING!
Opening of the cover must be done only in system ready mode or afte Opening of the cover
must be done only in system ready mode or afte Opening of the cover must be done only in
system ready mode or afte Opening of the cover must be done only in system ready mode or
after rr r having set the priming. having set the priming. having set the priming. having set the
priming.
Do not under any circumstances open the cover if rinsing or Do not under any circumstances
open the cover if rinsing or Do not under any circumstances open the cover if rinsing or Do not
under any circumstances open the cover if rinsing or disinfection/cleaning is being performed.
disinfection/cleaning is being performed. disinfection/cleaning is being performed.
disinfection/cleaning is being performed.
26 2266 26
Alarm lamp (red) Alarm lamp (red) Alarm lamp (red) Alarm lamp (red)
To indicate an alarm or warning condition by flashing.
27 2277 27
Fixing clips Fixing clips Fixing clips Fixing clips

To fix the switching chamber in Single Needle with Double Pump (SNdp) or the infusion
chamber.
28 2288 28
Blood/infusion/ultrafiltration pump Blood/infusion/ultrafiltration pump
Blood/infusion/ultrafiltration pump Blood/infusion/ultrafiltration pump
To move blood in single needle with double pump. In haemodiafiltration treatments it permits
the handling of infusion liquid. The pump stops when the cover is opened. In case of power
failure, the pump may be manually moved by turning the cranking handle. The pump is
bidirectional.
29 2299 29
Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator

30 3300 30 End End End End--infusion detector infusion detector infusion detector infusion
detector
Ultrasound device which detects the absence of infusion liquid during haemodiafiltration
treatments. 31 3311 31 Pressure transducer Pressure transducer Pressure transducer
Pressure transducer
31b 31b 31b 31b Blood leak detector Blood leak detector Blood leak detector Blood leak
detector
32 3322 32 Na NNaa Natrium sensor trium sensor trium sensor trium sensor
33 3333 33 Hemox sensor (optional) Hemox sensor (optional) Hemox sensor (optional)
Hemox sensor (optional)
34 3344 34 Additional pressure transducers: Additional pressure transducers: Additional
pressure transducers: Additional pressure transducers:
luer-lock connectors for prefilter arterial pressure transducers and haemofilter ultrafiltration
(in HFR) / auxiliary pressure (other treatments) .

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

REAR PANEL: DESCRIPTION REAR PANEL: DESCRIPTION REAR PANEL: DESCRIPTION REAR
PANEL: DESCRIPTION
1 11 1 Cooling fans Cooling fans Cooling fans Cooling fans
2 22 2 Main switch Main switch Main switch Main switch
3 33 3 Hour counter Hour counter Hour counter Hour counter
4 44 4 Acoustic warning indicator Acoustic warning indicator Acoustic warning indicator

Acoustic warning indicator
5 55 5 Battery label Battery label Battery label Battery label

Only present on machines equipped with battery. 6 66 6 Identification plate Identification
plate Identification plate Identification plate
Indicates the serial number and the mains voltage (V). 7 77 7 Connector for external
keyboard Connector for external keyboard Connector for external keyboard Connector for
external keyboard
Only for technicians authorised by the manufacturer. 8 88 8 Connector for heart rate meter
Connector for heart rate meter Connector for heart rate meter Connector for heart rate meter
-- Pulsar Pulsar Pulsar Pulsar
9 99 9 Connector for hematocrit and oxygen saturation measuring system Connector for
hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen
saturation measuring system Connector for hematocrit and oxygen saturation measuring
system --
Hemox Hemox Hemox Hemox
10 1100 10 Connector for serial communication RS 232 C Connector for serial
communication RS 232 C Connector for serial communication RS 232 C Connector for serial
communication RS 232 C
Available for connecting data acquisition systems with formula protocol. 11 1111 11
Additional hydraulic protection cover Additional hydraulic protection cover Additional
hydraulic protection cover Additional hydraulic protection cover
12 1122 12 Support for Forclean ultrafilters, Forclean ultrafilters and protective Support for
Forclean ultrafilters, Forclean ultrafilters and protective Support for Forclean ultrafilters,
Forclean ultrafilters and protective Support for Forclean ultrafilters, Forclean ultrafilters and
protective covers. covers. covers. 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 Pay careful attention
since the temperature of the liquid circulating Pay careful attention since the temperature of
the liquid circulating Pay careful attention since the temperature of the liquid circulating in the
tubes during certain disinfection/descaling cycles is in the tubes during certain
disinfection/descaling cycles is in the tubes during certain disinfection/descaling cycles is in the
tubes during certain disinfection/descaling cycles is very high. very high. very high. very high.
13 1133 13 Support for Multipure Filter and Multipure Filter Support for Multipure Filter and
Multipure Filter Support for Multipure Filter and Multipure Filter Support for Multipure Filter
and Multipure Filter Water inlet antibacterial filter. 14 1144 14 Power cable Power cable
Power cable Power cable
To be connected to the mains; it must be inserted in a suitable wall socket. 15 1155 15 Drain
connector Drain connector Drain connector Drain connector
16 1166 16 Water inlet connector Water inlet connector Water inlet connector Water inlet
connector
17 1177 17 Sphygmomanome Sphygmomanome Sphygmomanome Sphygmomanometer ter

ter ter -- Sphygmo Sphygmo Sphygmo Sphygmo
18 1188 18 Equipotentiality (if present) Equipotentiality (if present) Equipotentiality (if

present) Equipotentiality (if present)

1 of 6
2.3 DESCRIPTION OF 2.3 DESCRIPTION OF 2.3 DESCRIPTION OF 2.3 DESCRIPTION OF MACHINE
MACHINE MACHINE MACHINE AND COMPONENTS AND COMPONENTS AND COMPONENTS
AND COMPONENTS – –– –
OPTIONS AND ACCESSORIES OPTIONS AND ACCESSORIES OPTIONS AND ACCESSORIES
OPTIONS AND ACCESSORIES
OPTIONS OPTIONS OPTIONS OPTIONS
Single Clamp vs. Double Clamp Single Clamp vs. Double Clamp Single Clamp vs. Double Clamp
Single Clamp vs. Double Clamp
SINGLE CLAMP SINGLE CLAMP SINGLE CLAMP SINGLE CLAMP
DOUBLE CLAMP DOUBLE CLAMP DOUBLE CLAMP DOUBLE CLAMP

Do not introduce the fingers between the clamps during functioning. Do not introduce the
fingers between the clamps during functioning. Do not introduce the fingers between the
clamps during functioning. Do not introduce the fingers between the clamps during
functioning.
ARTERIAL TUBE GUIDE CLIP

ARTERIAL CLAMP
VENOUS CLAMP
VENOUS CLAMP
BIDRY VS. PER BIDRY VS. PER BIDRY VS. PER BIDRY VS. PERFORATION SYSTEM FORATION
SYSTEM FORATION SYSTEM FORATION SYSTEM
Bidry Cartridge Bidry Cartridge Bidry Cartridge Bidry Cartridge
P PP Perforation System erforation System erforation System erforation System
NOTE NOTE NOTE NOTE

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

3 of 6
I II I.V. ..VV.. .V. POLE SUPPORT POLE SUPPORT POLE SUPPORT POLE SUPPORT
1 11 1 Dialyser holder Dialyser holder Dialyser holder Dialyser holder

To hold the dialyser to the IV pole. 2 22 2 Lines fixing clips Lines fixing clips Lines fixing clips
Lines fixing clips
To hold the blood lines firmly to the dialyser. 3 33 3 Fixing clip Fixing clip Fixing clip Fixing clip
To fix the dialyser to the holder 4 44 4 Concentrate bags holder Concentrate bags holder
Concentrate bags holder Concentrate bags holder
Holding device for positioning of the concentrate bags during treatment. 5 55 5 Bag Bag Bag
Bag hook hook hook hook
Support device for hanging the bags of physiological solution.
2
3
1
4
5

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

The bag hook has a maximum capac The bag hook has a maximum capac The bag hook has a
maximum capac The bag hook has a maximum capacity of 5 kg. ity of 5 kg. ity of 5 kg. ity of 5
kg.

5 of 6
ONBOARD DISINFECTANT ONBOARD DISINFECTANT ONBOARD DISINFECTANT 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.

Do not use the container rack in a manner or for uses different from that Do not use the
container rack in a manner or for uses different from that Do not use the container rack in a
manner or for uses different from that Do not use the container rack in a manner or for uses
different from that indicated. indicated. indicated. indicated.
Always check the Always check the Always check the Always check the quantity and the type
of chemical agent in the container quantity and the type of chemical agent in the container
quantity and the type of chemical agent in the container quantity and the type of chemical
agent in the container before starting the disinfection/cleaning. before starting the
disinfection/cleaning. before starting the disinfection/cleaning. before starting the
Do not mix chemical agents with a different composition. Do not mix chemical agents with a
different composition. Do not mix chemical agents with a different composition. Do not mix
chemical agents with a different composition.
For other safety information, consult the chapter concerning disinfection.

INSTRUMENT TABLE INSTRUMENT TABLE INSTRUMENT TABLE 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 CAUTION CAUTION CAUTION

Small bags can be placed on the table, however, it Small bags can be placed on the table,
however, it Small bags can be placed on the table, however, it Small bags can be placed on the
table, however, it has a maximum load has a maximum load has a maximum load has a
maximum load-carrying capacity of 5 kg. carrying capacity of 5 kg. carrying capacity of 5 kg.
carrying capacity of 5 kg.
Do not use the Do not use the Do not use the Do not use the table table table table in a
manner or for uses different from that indicated. in a manner or for uses different from that
indicated. in a manner or for uses different from that indicated. in a manner or for uses
different from that indicated.
During haemodiafiltration do not place the bags containing the infusion fluid During
haemodiafiltration do not place the bags containing the infusion fluid During
haemodiafiltration do not place the bags containing the infusion fluid During
haemodiafiltration do not place the bags containing the infusion fluid on the table. on the
table. on the table. on the table.
To transport or move the formula To transport or move the formula To transport or move the
formula To transport or move the formula Domus eq Domus eq Domus eq Domus
equipment, the instruments table uipment, the instruments table uipment, the instruments
table uipment, the instruments table must be left empty. must be left empty. must be left
empty. 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.
ENG – Ed. 11/09 chap. 2.4 - Formula Domus (Home Care System) -
1 of 6
2.4. FORMULA DOMUS (HOME CARE SYSTEM) 2.4. FORMULA DOMUS (HOME CARE SYSTEM)
2.4. FORMULA DOMUS (HOME CARE SYSTEM) 2.4. FORMULA DOMUS (HOME CARE SYSTEM)
-- VERSION FOR VERSION FOR VERSION FOR VERSION FOR HOME HOME HOME HOME
HAEMO HAEMO HAEMO HAEMODIALYSIS DIALYSIS DIALYSIS DIALYSIS
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.

Carefully read the instructions contained in this user manual before starting Carefully read the
instructions contained in this user manual before starting Carefully read the instructions
contained in this user manual before starting Carefully read the instructions contained in this
user manual before starting the equipment for the first time. the equipment for the first time.
the equipment for the first time. the equipment for the first time. Non Non Non Non--
conform use, application of procedures conform use, application of procedures conform use,
application of procedures conform use, application of procedures different from those
indicated, or the use of accessory devices different from those indicated, or the use of
accessory devices different from those indicated, or the use of accessory devices different
from those indicated, or the use of accessory devices not provided for not provided for not
provided for not provided for may present a risk to the patient and/or the machine. may
present a risk to the patient and/or the machine. may present a risk to the patient and/or the
machine. may present a risk to the patient and/or the machine.
This chapter includes only specific information related to This chapter includes only specific
information related to This chapter includes only specific information related to This chapter
includes only specific information related to formula Domus, ,, , therefore anything
which is not expressly mentioned in this chapter remains therefore anything which is not
expressly mentioned in this chapter remains therefore anything which is not expressly
mentioned in this chapter remains therefore anything which is not expressly mentioned in this
chapter remains unchanged relative to the informa unchanged relative to the informa
unchanged relative to the informa unchanged relative to the information contained in the tion
contained in the tion contained in the tion contained in the formula user user user user
manual. manual. manual. manual.
Information and assistance given to the patient during dialytic therapy in home Information
and assistance given to the patient during dialytic therapy in home Information and assistance
given to the patient during dialytic therapy in home Information and assistance given to the
patient during dialytic therapy in home dialysis must take place under the management and
supervision of the dialysis must take place under the management and supervision of the
dialysis must take place under the management and supervision of the dialysis must take place
under the management and supervision of the physician prescribing the treatment. The
manufacturer does not physician prescribing the treatment. The manufacturer does not
physician prescribing the treatment. The manufacturer does not physician prescribing the
treatment. The manufacturer does not undertake any undertake any undertake any undertake
any responsibility for teaching the patient how to use responsibility for teaching the patient
how to use responsibility for teaching the patient how to use responsibility for teaching the
patient how to use formula . Responsibility lies Responsibility lies Responsibility lies
Responsibility lies exclusively with the physician in charge. exclusively with the physician in
charge. exclusively with the physician in charge. exclusively with the physician in charge.
2 of 6 – chap. 2.4 - Formula Domus (Home Care System) ENG – Ed.

11/09
1
Colour display with tilting capability, held by the monitor arm.
2
Functions Functions Functions Functions
Indicate the functions which can be activated depending on the machine operating status.
Refer to the description in the dedicated chapter in the user manual.
3
pump flow regulator
it. Set to zero to stop the pump.
4
(formula 2000) )) )
5
Monitor arm Monitor arm Monitor arm Monitor arm
6
Right side I.V. pole Right side I.V. pole Right side I.V. pole Right side I.V. pole
To support the monitor arm.
3 of 6
ADJUSTING THE DISPLAY ADJUSTING THE DISPLAY ADJUSTING THE DISPLAY 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
(1) (2) (3) (4) (1) (2) (3) (4) (1) (2) (3) (4) (1) (2)
(3) (4)
(1) monitor arm (2) locking pin knob (3) vertical adjustment clamp (4) friction system
fig.2
(3) (2) (1 (3) (2) (1 (3)
(2) (1 (3) (2) (1) )) )
(1) monitor arm (2) vertical adjustment clamp (3) friction system
• Loosen the screw of the friction system clamp. • Loosen the screw of the vertical adjustment
clamp. • Adjust the arm to the most comfortable height. Exert pressure on the clamp not on
the arm, in order to prevent jamming while moving up or down. • Tighten the screw of the
vertical adjustment clamp. • Hold the display with one hand and with the other hand pull the
locking pin knob outward. • Adjust to the height and angle needed, then release the locking
pin knob. • Again holding the display with one hand move it down until the arm locks into
place. • Tighten the screw of the friction system clamp enough to allow the arm to swivel.
• Loosen the screw of the friction system clamp. • Loosen the screw of the vertical adjustment
clamp. • Adjust the arm to the most comfortable height. Exert pressure on the clamp not on
the arm, in order to prevent jamming while moving up or down. • Tighten the screw of the
vertical adjustment clamp. • Hold the display with one hand and with the other hand pull the
arm outward. • Adjust to the height and angle needed, then release the arm. • Tighten the
screw of the friction system clamp enough to allow the arm to swivel.

11/09
WA WWAA WARNINGS RNINGS RNINGS RNINGS
To avoid possible harm to the patient, do not perform monitor adjustment To avoid possible
harm to the patient, do not perform monitor adjustment To avoid possible harm to the
patient, do not perform monitor adjustment To avoid possible harm to the patient, do not
perform monitor adjustment during dialysis treatment, but only when the patient is
disconnected from the during dialysis treatment, but only when the patient is disconnected
from the during dialysis treatment, but only when the patient is disconnected from the during
dialysis treatment, but only when the patient is disconnected from the equipment. equipment.
equipment. equipment.
The sole function of the monitor arm is to support the display. Therefore: The sole function of
the monitor arm is to support the display. Therefore: The sole function of the monitor arm is
to support the display. Therefore: The sole function of the monitor arm is to support the
display. Therefore:
• Do not use Do not use Do not use Do not use monitor, arm or cable management tube to
support bags or any monitor, arm or cable management tube to support bags or any monitor,
arm or cable management tube to support bags or any monitor, arm or cable management
tube to support bags or any other object or weight. other object or weight. other object or
weight. other object or weight.
• Do not lean on and pull the monitor and/or arm when you get up from the Do not lean on
and pull the monitor and/or arm when you get up from the Do not lean on and pull the
monitor and/or arm when you get up from the Do not lean on and pull the monitor and/or
arm when you get up from the bed or the armchair. bed or the armchair. bed or the armchair.
bed or the armchair.
• Never push or pull directly on monitor and/or arm to transport or move the Never push or
pull directly on monitor and/or arm to transport or move the Never push or pull directly on
monitor and/or arm to transport or move the Never push or pull directly on monitor and/or
arm to transport or move the e ee equipment. quipment. quipment. quipment.
The manufacturer does not undertake any responsibility for possible damages The
manufacturer does not undertake any responsibility for possible damages The manufacturer
does not undertake any responsibility for possible damages The manufacturer does not
undertake any responsibility for possible damages when these directions are not followed,
such as the machine falling over when when these directions are not followed, such as the
machine falling over when when these directions are not followed, such as the machine falling
over when when these directions are not followed, such as the machine falling over when
leaning on the monitor or arm. leaning on the monitor or arm. leaning on the monitor or arm.
leaning on the monitor or arm.
Take care not to spill any liquids above the display. Take care not to spill any liquids above the
display. Take care not to spill any liquids above the display. Take care not to spill any liquids
above the display.
Take Take Take Take care not to rotate the flow regulators accidentally during dialysis. care
not to rotate the flow regulators accidentally during dialysis. care not to rotate the flow
regulators accidentally during dialysis. care not to rotate the flow regulators accidentally
during dialysis.
Do not install the Do not install the Do not install the Do not install the concentrate
concentrate concentrate concentrate bag bag bag bags ss s holder on the right IV pole. holder
on the right IV pole. holder on the right IV pole. holder on the right IV pole.
To move or transport the home haemodialysis system, proceed as follows To move or

transport the home haemodialysis system, proceed as follows To move or transport the home
haemodialysis system, proceed as follows To move or transport the home haemodialysis
system, proceed as follows (refer to fig. (refer to fig. (refer to fig. (refer to fig. 3 33 3): )):: ):
• lower the monitor arm along t lower the monitor arm along t lower the monitor arm along t
lower the monitor arm along the right he right he right he right--side I.V. pole to the lowest
position side I.V. pole to the lowest position side I.V. pole to the lowest position side I.V. pole
to the lowest position above surface. above surface. above surface. above surface.
• fold the monitor arm in vertical position. fold the monitor arm in vertical position. fold the
monitor arm in vertical position. fold the monitor arm in vertical position.
• place the display in front of the machine facing onward. place the display in front of the
machine facing onward. place the display in front of the machine facing onward. place the
display in front of the machine facing onward.
To transport or move the equipment, proceed as follows: To transport or move the

equipment, proceed as follows: To transport or move the equipment, proceed as follows: To
transport or move the equipment, proceed as follows:
• push the machine from the back. push the machine from the back. push the machine from
the back. push the machine from the back.
• leave leave leave leave the instruments table empty, if there is one the instruments table
empty, if there is one the instruments table empty, if there is one the instruments table
empty, if there is one. .. .
• unload the IV pole hooks and scale unload the IV pole hooks and scale unload the IV pole
hooks and scale unload the IV pole hooks and scale. .. .
• unload the concentrate bags holder unload the concentrate bags holder unload the
concentrate bags holder unload the concentrate bags holder. .. .
5 of 6
MONITOR ARM WITH LOCKING PIN KNOB MONITOR ARM WITHOUT LOCKING PIN KNOB
fig.3
11/09
ENG – Ed. 06/09 chap. 2.5 – Operator Interface - 1 of 28

2.5 OPERATOR INTERFACE 2.5 OPERATOR INTERFACE 2.5 OPERATOR INTERFACE 2.5
OPERATOR INTERFACE
GENERAL GENERAL GENERAL 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.
1
2
3
410
56789
11
12 13 14
15
lun08:00
2 of 28 - chap. 2.5 – Operator Interface ENG – Ed. 06/09
1 11 1
Help on line Help on line Help on line Help on line
2 22 2
Side Side Side Side keys keys keys keys

To activate the corresponding functions.
3 33 3
Enter key Enter key Enter key Enter key

To confirm the selection made.
4 44 4
Arrow keys Arrow keys Arrow keys Arrow keys
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.
5 55 5
Key to silence the acoustic warning signal Key to silence the acoustic warning signal Key to
silence the acoustic warning signal Key to silence the acoustic warning signal
To silence the acoustic tone. The silencing period is 2 min. in dialysis and 5 min. in priming.
6 66 6
Key to temporarily disable the alarms Key to temporarily disable the alarms Key to
temporarily disable the alarms Key to temporarily disable the alarms
Allows an alarm to be silenced. The silencing period is 2 min. in dialysis and 5 min. in priming.
7 77 7
Key to stop the blood pumps Key to stop the blood pumps Key to stop the blood pumps Key to
stop the blood pumps
To stop the blood pumps. Consequently, the clamp automatically closes and the min. and
max. pressure thresholds are recalculated.
8 88 8
Bypass key Bypass key Bypass key Bypass key

To isolate the dialyser from the dialysate circuit. Active during dialysis only.
9 99 9 Keys to regulate the level in the venous drip chamber Keys to regulate the level in the
venous drip chamber Keys to regulate the level in the venous drip chamber Keys to regulate
the level in the venous drip chamber
10 1100 10
Power key Power key Power key Power key

Turns on the monitor when the main switch is in the ON position (“I”). 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.
11 1111 11
Bar to display operating instructions and alarm messages Bar to display operating instructions
and alarm messages Bar to display operating instructions and alarm messages 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 - red if an alarm occurs - orange if a warning occurs
-
yellow if the key has been pressed.
12 1122 12
Dialysate section status bar Dialysate section status bar Dialysate section status bar Dialysate
section status bar
Indicates the machine operating status relative to the dialysate fluid section.
13 1133 13
Blood section status bar Blood section status bar Blood section status bar Blood section status
bar
Indicates the machine operating status relative to the extracorporeal circuit section.
14 1144 14
Clock/Heparin icon Clock/Heparin icon Clock/Heparin icon Clock/Heparin icon

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.
15 1155 15
Functions Functions Functions Functions
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.
NOTE NOTE NOTE NOTE
The LED next to the keys The LED next to the keys The LED next to the keys The LED next to the
keys and and and and indicates: indicates: indicates: indicates: • LED off = function
inactive, LED off = function inactive, LED off = function inactive, LED off = function inactive,
• LED on = function active. LED on = function active. LED on = function active. LED on =
function active.
The LED next to the keys The LED next to the keys The LED next to the keys The LED next to the
keys and and and and indicates: indicates: indicates: indicates: • LED off = function
inactive, LED off = function inactive, LED off = function inactive, LED off = function inactive,
• LED on permanently = function active, LED on permanently = function active, LED on
permanently = function active, LED on permanently = function active,
• LED flashing = function activa LED flashing = function activa LED flashing = function activa
LED flashing = function activata ttaa table. ble. ble. ble.
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.
08:00BICARBONATO- PREP. DIALISI AD

ritorna
ok
ricalcolo incorso
infusione eparina
capacità siringa
BICARBONATO- PREP. DIALISI AD
ritorna
ematico
dialisato
lun08:00
lun08:00
BICARBONATO- PREP. DIALISI AD
modifica trattamento
modifica parametri
inizia stacco
Menù principale 1°sottomenù 2°sottomenù Main menu First submenu Second

ON OONN ON--LINE HELP LINE HELP LINE HELP 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 dialysis
To view the data of the treatment in progress. When the patient 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 mainten.
to view information on maintenance: last disinfection/cleaning carried out, weekly

programming, Multipure and Forclean filters operating hours.
parameters config.
To view a further menu which allows access to the configuration data.
layout blood lines
Function not active at present.
layout dial. side
Function not active at present.
machine parameters
Function that may be accessed only by technicians authorised by the manufacturer.
return
To return to the previous menu.

GRAPHIC TOOLS AND MO GRAPHIC TOOLS AND MO GRAPHIC TOOLS AND MO GRAPHIC TOOLS
AND MODIFICATION OF RELEVA DIFICATION OF RELEVA DIFICATION OF RELEVA DIFICATION OF
RELEVANT NT NT NT PARAMETERS PARAMETERS PARAMETERS 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 Selection and modification procedure Selection and
modification procedure Selection and modification procedure
The selection and/or modification procedure is similar for all the parameters.
•
blood
or
dialysate
• Select the desired parameter (e.g.

total cond.
). 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 Tool colours Tool colours 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 DIALYSIS DIALYSIS DIALYSIS FLUID FLUID FLUID FLUID SECTION SECTION SECTION
SECTION
TEMPERATURE TEMPERATURE TEMPERATURE 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. parameters
dialysate
other parameters
temperature
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 BICARBONATE CONDUCTIVITY BICARBONATE CONDUCTIVITY

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. parameters
dialysate
bic. cond.
COND BIC
2.4 3.6
3.1
The mobile index shows the value set, the ends of the 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 TOTAL CONDUCTIVITY TOTAL CONDUCTIVITY 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. parameters
dialysate
total cond.
.
CONDTOT12.115.714.0
The mobile index indicates the value set, the ends of the scale show the min. and max. settable
values (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.
UF/ UF/ UF/ UF/RATE RATE RATE 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. parameters
dialysate
uf rate
UF/h
0.10 4. 0
1.00
0
The mobile index indicates the value set, the ends of the scale show the min. and max. values
set in configuration (kg/h).
Use the or key to obtain the new value and confirm with .
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 PATIENT WEIGHT LOSS PATIENT WEIGHT LOSS PATIENT WEIGHT LOSS
0.00
4.00
1.33
2.67
Peso kg
The graduated scale indicates the weight loss set (or weight to lose), the mobile index displays
the weight lost (in kg).
To modify the total weight loss set,
see/mod. parameters
dialysate
weight loss
.
0.00
16.00
3.33
6.66
Peso kg
The graduated scale indicates the max. settable total weight loss (16.0 kg), the mobile index
indicates the total weight loss set, the window indicates the current value.
Press the keys or to obtain the new value and then
confirm with . When the modification has been acquired, the display returns to the main
menu.
NOTE NOTE NOTE NOTE

Check that the UF/h value obtained is coherent with the modified values set. Check that the
UF/h value obtained is coherent with the modified values set. Check that the UF/h value
obtained is coherent with the modified values set. Check that the UF/h value obtained is
coherent with the modified values set.

TREATMENT TIME TREATMENT TIME TREATMENT TIME TREATMENT TIME
4:00 00:00
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 - 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. parameters
dialysate
treat. time
10:00 00:00
The tool indicates: 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 NOTE NOTE NOTE

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

ULTRAFILTRATION or TMP PRESSURE ULTRAFILTRATION or TMP PRESSURE ULTRAFILTRATION
or TMP PRESSURE ULTRAFILTRATION or TMP PRESSURE
During dialysis the tool indicates the ultrafiltration pressure the ultrafiltration pressure the
ultrafiltration pressure the ultrafiltration pressure (P_UF (P_UF (P_UF (P_UF in mmHg) or the
transmembrane pressure (TMP ) or the transmembrane pressure (TMP ) or the
transmembrane pressure (TMP ) 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 (settable between 30 and 300 mmHg).
To modify this value:
see/mod. parameters
dialysate
other parameters
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 Single Needle Single Needle Single 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,
-300
200
-
P_UF mmHg

see/mod. parameters
see other parameters
recalcul. TMP/P_UF on
.
NOTE NOTE NOTE NOTE

The recalculation of the average ultrafiltration pressure (or TMP) is also The recalculation of
the average ultrafiltration pressure (or TMP) is also The recalculation of the average
ultrafiltration pressure (or TMP) is also The recalculation of the average ultrafiltration pressure
(or TMP) is also enabled when: enabled when: enabled when: enabled when:
-- the ultrafiltration time is modified (even by changing the weight loss or the the
ultrafiltration time is modified (even by changing the weight loss or the the ultrafiltration time
is modified (even by changing the weight loss or the the ultrafiltration time is modified (even
by changing the weight loss or the treatment time) treatment time) treatment time) treatment
time)
-- isolated ultrafiltration is enabled (or disabled) isolated ultrafiltration is enabled (or disabled)
isolated ultrafiltration is enabled (or disabled) isolated ultrafiltration is enabled (or disabled)
-- minimum ultrafiltration is enabled (or disabled) minimum ultrafiltration is enabled (or
disabled) minimum ultrafiltration is enabled (or disabled) minimum ultrafiltration is enabled
(or disabled)
-- an infusion bolus is enabled (or ends) an infusion bolus is enabled (or ends) an infusion
bolus is enabled (or ends) an infusion bolus is enabled (or ends)
-- the TMP (or P_UF) range is modified the TMP (or P_UF) range is modified the TMP (or
P_UF) range is modified the TMP (or P_UF) range is modified
-- the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST the infusion flow is
modified (in PHF PRE, PHF POST, HDF PRE, HDF POST the infusion flow is modified (in PHF PRE,
PHF POST, HDF PRE, HDF POST the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE,
HDF POST, ,, , MID MID MID MID--HDF, HDF) HDF, HDF) HDF, HDF) HDF, HDF) manually or
automatically with variation of the infusion manually or automatically with variation of the
infusion manually or automatically with variation of the infusion manually or automatically
with variation of the infusion flow flow flow flow. .. .
-- the the the the or or or or or or or or key is pressed. key is pressed. key is

pressed. key is pressed.
AVERAG AVERAG AVERAG AVERAGE TMP AND WORKING TMP E TMP AND WORKING TMP E
TMP AND WORKING TMP E 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 Treatment Treatment Treatment Formula for TMP calculation Formula for TMP
calculation Formula for TMP calculation Formula for TMP calculation
HDF PRE HDF POST MID HDF ( ) 30 2 +− + = dout vfilt P PP TMP

PHF PRE
()
( ) 30
2
+−
+∆− = dout vefilt P PPP TMP
PHF POST
()
( ) 30
2
+−
∆++ = dout evfilt P PPP TMP
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. parameters
blood
set TMP
.
Press the or keys to set the new value and then confirm with .

DIALYSIS FLUID FLOW DIALYSIS FLUID FLOW DIALYSIS FLUID FLOW 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. parameters
dialysate
other parameters
flow
.
Flow
The tool indicates: • 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 NOTE NOTE NOTE

Initially, the dialysis fluid is prepared at a minimum flow. Initially, the dialysis fluid is prepared
at a minimum flow. Initially, the dialysis fluid is prepared at a minimum flow. Initially, the
dialysis fluid is prepared at a minimum flow.
As soon as blood is detected, the flow rat As soon as blood is detected, the flow rat As soon as
blood is detected, the flow rat As soon as blood is detected, the flow rate automatically
adjusts to the set e automatically adjusts to the set e automatically adjusts to the set e
automatically adjusts to the set value. value. value. value.
NOTE NOTE NOTE NOTE

F FF For treatments with OnLine Haemodiafiltration: or treatments with OnLine
Haemodiafiltration: or treatments with OnLine Haemodiafiltration: or treatments with OnLine
Haemodiafiltration: HDF PRE, HDF POST, HDF PRE, HDF POST, HDF PRE, HDF POST, HDF PRE,
HDF POST, MID MID MID MID--HDF, PHF PRE, PHF POST HDF, PHF PRE, PHF POST HDF, PHF
PRE, PHF POST HDF, PHF PRE, PHF POST. .. .
If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to If the dialysis fluid
flow is set at 800 ml/min, the flow that is actually sent to If the dialysis fluid flow is set at 800
ml/min, the flow that is actually sent to If the dialysis fluid flow is set at 800 ml/min, the flow
that is actually sent to the dialyser does not corre the dialyser does not corre the dialyser does
not corre the dialyser does not correspond to the set value, but is equal to the set spond to the
set value, but is equal to the set spond to the set value, but is equal to the set spond to the set
value, but is equal to the set value minus the infusion flow. value minus the infusion flow.
value minus the infusion flow. value minus the infusion flow.
If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at If the dialysis fluid
flow is set at 500 ml/min and the infusion flow is set at If the dialysis fluid flow is set at 500
ml/min and the infusion flow is set at 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; less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value; less than
18 kg/hr, the inlet flow to the dialyser coincides with the set value; less than 18 kg/hr, the inlet
flow to the dialyser coincides with the set value; if, however, the if, however, the if, however,
the if, however, the infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser infusion flow
exceeds 18 kg/hr, the inlet flow to the dialyser infusion flow exceeds 18 kg/hr, the inlet flow
to the dialyser 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. is equal to the maximum value (800
ml/min) minus the infusion flow. is equal to the maximum value (800 ml/min) minus the
infusion flow. 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 If the dialysis fluid
flow is set at 300 ml/min, the inlet flow to the dialyser If the dialysis fluid flow is set at 300
ml/min, the inlet flow to the dialyser If the dialysis fluid flow is set at 300 ml/min, the inlet flow
to the dialyser coincides with the set value. coincides with the set value. coincides with the set
value. coincides with the set value.
INFUSION BOL INFUSION BOL INFUSION BOL INFUSION BOLUS UUSS US
Boluses of dialysis fluid can be infused at any time in a dialysis session, during
haemodiafiltration treatments.
To infuse a bolus,
see/mod. parameters
dialysate
other parameters
Infusion 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 NOTE NOTE NOTE

When an infusion bolus is enabled, any Kt/V measurement in progress will be aborted.

BLOOD BLOOD BLOOD BLOOD SECTION SECTION SECTION SECTION
BLOOD FLOW BLOOD FLOW BLOOD FLOW 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. parameters
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 INFUSION FLOW INFUSION FLOW INFUSION FLOW
Qinf 3.00 kg/h
The graphic tool indicates the infusion flow set (settable 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
- clockwise to increase,
- 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. parameters
blood
to display the tool with the maximum and minimum limits of automatic infusion flow setting.
VENOUS PRESSURE VENOUS PRESSURE VENOUS PRESSURE VENOUS PRESSURE

The graduated scale indicates the absolute min. and max. limits (not modifiable by the
operator not modifiable by the operator not modifiable by the operator not modifiable by the
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 ARTERIAL PRESSURE ARTERIAL PRESSURE ARTERIAL PRESSURE
The graduated scale indicates the min. and max. limits relative to the out-of-range alarm, not
modifiable by the operator not modifiable by the operator not modifiable by the operator not
modifiable by the operator. .. .
The mobile index indicates the pressure read before the arterial pump (mmHg).
-300
200
-150
The max. (H) and min. (L) alarm thresholds are displayed only only only only during dialysis.
during dialysis. during dialysis. during dialysis.
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).
To recalculate the min. and max. alarm thresholds of the venous/arterial pressure,
see/mod. parameters
blood
recalcul. on
.
NOTE NOTE NOTE NOTE

Recalculation of the mean arterial and venous pressure is activated also Recalculation of the
mean arterial and venous pressure is activated also Recalculation of the mean arterial and
venous pressure is activated also Recalculation of the mean arterial and venous pressure is
activated also when when when when
-- the blood flow is modified or the blood flow is modified or the blood flow is modified or the
blood flow is modified or
-- an infusion bolus is enabled (or ends) or an infusion bolus is enabled (or ends) or an infusion
bolus is enabled (or ends) or an infusion bolus is enabled (or ends) or
-- the the the the or or or or key is pressed. key is pressed. key is pressed. key is pressed.
Pa mmHg
PREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSURE PREFILTER ARTERIAL

PRESSURE AND AUXILIARY/TMPH PRESSURE PREFILTER ARTERIAL PRESSURE AND
AUXILIARY/TMPH PRESSURE PREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSURE
To display the prefilter arterial pressure and the auxiliary pressure,
see/mod. parameters
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 PRESSUR SWITCHING PRESSUR SWITCHING PRESSUR SWITCHING PRESSURE (in

Single Needle) E (in Single Needle) E (in Single Needle) E (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 not modifiable by the operator not modifiable by the operator not
modifiable by the operator, which are different depending on whether the equipment is in
priming, dialysis or reinfusion.
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 only during dialysis in single only during dialysis in single only during dialysis in
single needle single pump (SNsp). needle single pump (SNsp). needle single pump (SNsp).
needle single pump (SNsp).
see/mod. parameters
blood
max switch. p.
or
min switch. p.
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 END PRIMING END PRIMING 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 End priming End priming End priming = total volume of fluid to use for priming.
Stop priming Stop priming Stop priming Stop priming = volume of fluid to be circulated in the
blood lines before the pump stops.
0.00 3.00
1.50
2.00
End
Priming
- End priming (3.00) is indicated (in litres) on the graduated scale. - Inside the tool the quantity
of physiological 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. parameters
blood
stop priming
or
priming volume
End Priming
The upper mobile index indicates the stop priming (StopP) value (in l) set.
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 . When the modification has
been acquired, the display returns to the main menu.
NOTE NOTE NOTE NOTE

The Stop Priming and/or End Priming values may be modified provided that The Stop Priming
and/or End Priming values may be modified provided that The Stop Priming and/or End
Priming values may be modified provided that 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 new value set is not less than the total remaining physiological
solution. the new value set is not less than the total remaining physiological solution. 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. The Stop Priming may not be
greater than the End Priming value. The Stop Priming may not be greater than the End Priming
value. The Stop Priming may not be greater than the End Priming value.
NOTE NOTE NOTE NOTE

Following a treatment change, if the treatment selected is an online or an Following a
treatment change, if the treatment selected is an online or an Following a treatment change, if
the treatment selected is an online or an Following a treatment change, if the treatment
selected is an online or an HFR treatment, the total priming volume is reset. HFR treatment,
the total priming volume is reset. HFR treatment, the total priming volume is reset. HFR
treatment, the total priming volume is reset.
BLOOD VOLUME BLOOD VOLUME BLOOD VOLUME 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. parameters

.
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) STROKE (ONLY IN SINGLE NEEDLE) STROKE (ONLY IN SINGLE
NEEDLE) 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. parameters
blood
stroke
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) QBM (ONLY IN SINGLE NEEDLE) QBM (ONLY IN SINGLE
NEEDLE) 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 ARTERIAL PRESSURE DISPLAY IN SINGLE ARTERIAL

PRESSURE DISPLAY IN SINGLE ARTERIAL PRESSURE DISPLAY IN SINGLE--NEEDLE WITH DOUBLE
PUMP NEEDLE WITH DOUBLE PUMP NEEDLE WITH DOUBLE PUMP 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. parameters
blood
to view/modify the switching pressure.
see/mod. parameters

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

to view the instantaneous pressure with the tool
.
LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in SINGLE LOWER SWITCHING
PRESSURE THRESHOLD (min. switch. p.) (in SINGLE LOWER SWITCHING PRESSURE THRESHOLD
(min. switch. p.) (in SINGLE LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in
SINGLE NEEDLE WITH DOUBLE PUMP) NEEDLE WITH DOUBLE PUMP) NEEDLE WITH DOUBLE
PUMP) 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. parameters
blood
min 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 UPPER VENOUS
PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH UPPER VENOUS PRESSURE
THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH UPPER VENOUS PRESSURE THRESHOLD
(max ven. p.) in SINGLE NEEDLE WITH DOUBLE PUMP DOUBLE PUMP DOUBLE PUMP 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. parameters
blood
max switch. p.
ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD FLOW (QbV) ARTERIAL BLOOD FLOW
(QbA) AND VENOUS BLOOD FLOW (QbV) ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD
FLOW (QbV) 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. parameters

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

The delivery of the venous pump cannot exceed 1.5 times the delivery of the The delivery of
the venous pump cannot exceed 1.5 times the delivery of the The delivery of the venous pump
cannot exceed 1.5 times the delivery of the The delivery of the venous pump cannot exceed
1.5 times the delivery of the arterial pump and cannot exceed the indicated limits. arterial
pump and cannot exceed the indicated limits. arterial pump and cannot exceed the indicated
limits. 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 (in SINGLE NEEDLE) EFFICIENCY (in SINGLE
NEEDLE) 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. parameters
blood
efficiency max
or
see/mod. parameters
blood
efficiency 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. parameters

.
VOLUME OF LIQUID INFUSED VOLUME OF LIQUID INFUSED VOLUME OF LIQUID INFUSED

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. parameters

.
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 SCALE WEIGHT SCALE WEIGHT SCALE WEIGHT
The graphic tool indicates the weight of the bags hanged on the scale in HDF (kg).
INFUSION PRESSURE INFUSION PRESSURE INFUSION PRESSURE INFUSION PRESSURE

The infusion fluid pressure (in mmHg) during haemodiafiltration treatments is displayed on
the second page.
To display it,
see/mod. parameters
Pinf mmHg
Qinf ml/min

GRAPHIC PARAMETER DI GRAPHIC PARAMETER DI GRAPHIC PARAMETER DI GRAPHIC
PARAMETER DISPLAY SPLAY SPLAY SPLAY
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 .
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
COND/TEMP BLOOD/UF
COND/TEMP BLOOD/UF
Now
display BT
to display the blood temperature graph, as well.
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).
The
zoom
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.
COND/TEMP BLOOD/UF

SCREENSAVER MODE SCREENSAVER MODE SCREENSAVER MODE 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. parameters
enable screensaver
To disable the screensaver mode:
see/mod. parameters
disable screensaver
ENG – Ed. 06/09 ch. 2.6 - Configuration - 1 of 12

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
reexecuting 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:
• 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.
WILL YOU CONFIRM DATA? (ENTER = YES)
2 of 12 – ch. 2.6 - Configuration ENG

- Ed. 06/09
Page 1
ALARMS, WARNINGS AND DEFAULT VALUES

RANGE PRE-SET VALUES
Treatments selectable by the user

DN SNsp SNdp HDF PHF HFR
DN-SNsp - SNdp
specifies the type of treatment that may be used.

Priming volume (l) 1.0 ÷ 7.0 2.0 specifies the total volume that can be utilized for priming. Stop
priming volume (l) 0.0 ÷ 4.0 0.0 specifies the volume of priming 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. 3.0 + vol. stop priming ÷ 7.0
4.0 If HFR Cartridge = SELECTA PLUS has been set in Service Configuration. Specifies the
priming volume automatically set by the machine for HFR Selecta Plus. Vol. priming HFR (l) 1.3
+ vol. stop priming ÷ 7.0
2.0 If HFR Cartridge = SELECTA or HFR Cartridge = BOTH has been set in Service Configuration.
Specifies the priming volume automatically set by the machine for HFR Selecta . 1.0 ÷ (vol.
priming –3.0) 1.0 If HFR Cartridge = SELECTA PLUS has been set in Service Configuration.
Specifies the stop priming volume automatically set by the machine for HFR Selecta Plus. Vol.
stop priming HFR (l) 0.7 ÷ (vol. priming –1.3) 0.7 If HFR Cartridge = SELECTA or HFR Cartridge =
BOTH has been set in Service Configuration. Specifies the stop priming volume automatically
set by the machine for HFR Selecta . Qb priming HFR (ml/min) 0 ÷ 200 200 If HFR Cartridge =
SELECTA PLUS 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 (ml/min) 0 ÷ 200 100 If HFR Cartridge = SELECTA or HFR Cartridge = BOTH has
been set in Service Configuration.

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 time (sec)
30 ÷ 180 90 specifies the time elapsing between 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 during patient’s connection ON/OFF OFF specifies the additional arterial
pump stop as soon as the blood 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 (mmHg) 50 ÷ 150 120 specifies the venous pressure alarm threshold with
respect to its mean value. Alarm range : PA (mmHg) 50 ÷ 250 150 specifies the arterial
pressure alarm 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 20 cc (mm) 18.0 ÷ 30.0
20.0 specifies the diameter of the heparin syringe for each of the syringes that may be used.
Heparin pump diameter 30 cc (mm) 18.0 ÷ 30.0 23.9 Heparin pump diameter 50 cc (mm) 18.0
÷ 30.0 26.8
Normal heparin pump speed (cc/hr) 0 ÷ 10 0 specifies the heparin pump infusion flow rate.
Normal heparin pump prestop (min) 0 ÷ 120 0 specifies the pre-switching off time of the
heparin pump. Automatic heparin bolus 0 ÷ 25 0.0 specifies the quantity of heparin

- Ed. 06/09
(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 measurement
neg. UF or TMP
neg. UF Indicates the pressure to be utilized to monitor the correct use of the dialyser.
Min TMP/backfiltration alarm (mmHg)
0 ÷ -300
-60 For double needle or single needle treatments.

Max TMP alarm (mmHg) 200 ÷400
200 For double needle or single needle treatments.

Min TMP alarm/backfiltr. HFLUX (mmHg)
0 ÷ -300
-100 For haemodiafiltration treatments (HDF, PHF, HFR).

Max TMP alarm HFLUX (mmHg)
200 ÷400
300 For haemodiafiltration treatments (HDF, PHF, HFR).

Min. neg. UF alarm (mmHg)
-200 ÷-400 -300 For double needle or single needle treatments.
Max. neg. UF alarm (mmHg)
200 ÷ 400 200 For double needle or single needle treatments.
Neg. UF alarm min HFLUX (mmHg)
-200 ÷-400 -300 For haemodiafiltration treatments (HDF, PHF, HFR).
Neg. UF alarm max HFLUX (mmHg)
200 ÷ 400 200 For haemodiafiltration treatments (HDF, PHF, HFR). 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 (kg/hr) 0.1 ÷ 1.5 0.5 Defines the ultrafiltration rate when rinsing the dialyser. Acoustic
min. UF warning deadened ON/OFF OFF Defines the time elapsing between an acoustic tone
and the following ON = acoustic tone every 2 min. OFF = acoustic tone every 20 sec.

Page 3

Dialysate type (DN/SN) Bic + STD A. Conc/ Bid+STD A. Conc/Acet/ Bic+Lympha/Bid+Lympha
Bic+STD A. Conc
Dialysate type : HDF Bic + STD A. Conc/ Bid+STD A. Conc/Acet/ Bic+Lympha/Bid+Lympha

Bic+STD A. Conc
Dialysate type : PHF Bic + STD A. Conc/ Bid+STD A. Conc/Acet/ Bic+Lympha/Bid+Lympha
Bic+STD A. Conc
Dialysate type : HFR Bic + STD A. Conc/ Bid+STD A. Conc/Acet/ Bic+Lympha/Bid+Lympha
Bic+STD A. Conc
Treatment type DN/SNsp/SNdp/ HDF/ PHF/HFR
DN
Dialysate flow (ml/min)
300/500/800 500
Treatment time (hr:min) 0:00 ÷10:00 0
Total weight (kg) 0 ÷ 10
Weight loss (kg/hr) 0.1 ÷ 4.0 * * The range depends on the WRL min. and max. values defined
in page 2.
0.1
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 4 ÷6
3.1
Dialysate temperature (°C) 35 ÷39 37.5
Time countdown ON/OFF OFF

- Ed. 06/09
Page 4

Water inlet conductivity alarm (mS/cm) 0 = no alarm

0 ÷ 1.0
0.2 defines the conductivity alarm value referring to the use of inappropriate haemodialysis
water.
Filter replacement warning time Forclean (hr) 0 = no filter
0 / 400 200 defines the number of hours after which the filter must be replaced (refer to the
instructions for use of the Forclean filter)
filter replacement warning time Multipure (hr) 0 = no filter
0 / 600 600 defines the number of hours after which the filter must be replaced (refer to the
instructions for use of the Multipure filter).
Acoustic alarms in rinseback
ON / OFF ON-OFF
ON
Acoustic alarms in priming ON / OFF ON-OFF
ON
identifies the acoustic tones associated with priming and rinseback alarms. ON = alarms
active, OFF = alarms inactive ON-OFF= only some alarms are inactive
Arterial and venous pump out of range alarm (SNsp / SNdp) (rpm)
3 ÷12 5 defines the single needle rpm out of range alarm threshold.
Normal value max. SWITCHING PRESSURE (SNsp) (mmHg)
200 ÷400
250 defines the maximum switching pressure value programmed in single needle single pump
mode.
Normal value min. SWITCHING PRESSURE (SNsp) (mmHg)
10 ÷ 200 30 defines the minimum switching pressure value programmed in single needle
single pump mode.
Min. STROKE (SNsp/ SNdp) (cc)
10 ÷ 20 10 defines the minimum stroke which can be set for each cycle in single needle mode.
Max STROKE (SNsp/ SNdp) (cc)
30 ÷ 100 50 defines the maximum stroke which can be set for each cycle in single needle
mode.
STROKE normal value (SNsp/ SNdp) (cc)
10 ÷50 10 defines the STROKE default value in single needle mode.

Page 5

Max. VENOUS PRESSURE (SNdp) (mmHg)
+100 ÷ +450 + 350 identifies the maximum venous pressure value which can be set in single
needle double pump. Min. SWITCHING PRESSURE (SNdp) (mmHg) -100 ÷ +100 + 30 identifies
the lowest minimum switching pressure value which can be set in single needle double pump.
Max. efficiency (SNdp) 1.1 ÷ 2.0 1.2 identifies the higher value of the efficiency alarm in single
needle double pump. Min. efficiency (SNdp) 0.0 ÷ 0.9 0.7 identifies the lower value of the
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 SETTINGS
Disinfection/cleaning icon available in rinsing

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

- Ed. 06/09
USER CHEM. STD disinf. setting rinsing (min)
25 ÷ 30 30 Identifies the duration of the postdisinfection/cleaning rinsing for the chemical std.
USER CHEM. STD disinf. setting Min conductivity (mS/cm)
chemical std. disinfection/cleaning with USER agent.
USER CHEM. STD disinf. setting Max conductivity (mS/cm)
chemical std. disinfection/cleaning with USER agent.
USER CHEM. HEAT disinf. setting Dilution ratio 1:
6 ÷ 30 30 Identifies the dilution ratio for the chemical-heat disinfection/cleaning with USER
agent.
USER CHEM. HEAT disinf. setting contact (min)
15 ÷ 20 20 Identifies the contact time in the chemical-heat disinfection/cleaning with USER
agent.
USER CHEM. HEAT disinf. setting Min conductivity (mS/cm)
chemical-heat disinfection/cleaning with USER agent.
USER CHEM. HEAT disinf. setting Max conductivity (mS/cm)
chemical-heat disinfection/cleaning cycle with USER agent.

Page 7
CHEMICAL STD. DISINFECTION/CLEANING SETTING
Contact time RANGE (min)

Contact time Pre-set value (min)
Rinse time RANGE (min)
Rinse time Pre-set value (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 agent HYPOCHLORITE, PERESAL, AMUCHINA, ACETIC ACID,
TIUTOL, INSTRUNET, PURISTERIL, OXAGAL, RENAXID , USER AMUCHINA
Page 8
CHEMICAL FULL DISINFECTION/CLEANING SETTING
Rinse time RANGE (min)

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

- Ed. 06/09
Page 9
HEAT DISINFECTION/CLEANING SETTING
Contact time RANGE (min)

Contact time Value pre-set (min)
Heating time RANGE (min)
Heating time Value pre-set (min)
Heat
15 or 20 15
Chemical Heat 15 or 20 15
Page 10
WEEKLY DISINFECTION SETTING
Types of disinf./cleaning
Start h : min
Duration (min) Event
Rinsing g : h : min
Shut down g : h : min
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. HYPOCHLORITE 8:00 32 - - DISABLED
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 disinfection/cleaning. Remember that between the end of a disinfection/cleaning
and the beginning of the next at least 20 minutes must elapse.

- Ed. 06/09
Explanations of the abbreviations used for setting the weekly disinfection.
TYPE OF DISINFECTION/CLEANING A BBREVIATION 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.
ENG – Ed. 06/09 chap. 2.7 – Disposable Materials and Accessories - 1

of 10
2.7 DISPOSABLE MATERIALS AND ACCESSORIES 2.7 DISPOSABLE MATERIALS AND ACCESSORIES
2.7 DISPOSABLE MATERIALS AND ACCESSORIES 2.7 DISPOSABLE MATERIALS AND ACCESSORIES
DIAL DIAL DIAL DIALY YY YZ ZZ ZERS ERS ERS ERS
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 Code Code Code Model Model Model Model Ster. Ster. Ster. Ster.
PhyltherTM LF 11 G Gamma
PhyltherTM LF 11 SD Steam
PhyltherTM LF 13 SD Steam PhyltherTM LF 15 SD Steam PhyltherTM LF 17 SD Steam
PhyltherTM LF 21 SD Steam
2 of 10 - chap. 2.7 - Disposable Materials and Accessories ENG – Ed. 06/09
IBP4247 PhyltherTM HF 11 G Gamma
IBP4246 PhyltherTM HF 11 SD Steam
IBP4244 PhyltherTM HF 13 SD Steam IBP4242 PhyltherTM HF 15 SD Steam IBP4240
PhyltherTM HF 17 SD Steam IBP4248 PhyltherTM HF 20 SD Steam IBP4249 PhyltherTM HF 22
SD Steam
IBP 4123 BLS512G Gamma

IBP 4127 BLS512SD Steam
of 10
IBP 4076 BLS812G Gamma IBP 4077 BLS814G Gamma IBP 4078 BLS816G Gamma IBP 4079
BLS819G Gamma IBP 4088 BLS812SD Steam IBP 4085 BLS814SD Steam IBP 4086 BLS816SD
Steam IBP 4087 BLS819SD Steam IBP 4230 BLS821SD Steam

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

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

of 10
BLOOD AND INFUSION LINES BLOOD AND INFUSION LINES BLOOD AND INFUSION LINES
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 ETO Sterilization ETO Sterilization ETO Sterilization
Arterial line for double needle and single needle (single pump and double pump) for formula
and formula 2000. IB0354410 Venous line for double needle and single needle (single pump)
for formula and formula 2000. IB0432610 Infusion line for HDF for formula 2000. IB0487110
Combipack (arterial and venous line in the same packaging) for formula and formula 2000.
IB0681700
BETA Sterilization BETA Sterilization BETA Sterilization BETA Sterilization

and formula 2000.
IB0354440
and formula 2000 with spike for saline bags.
IB0356240
Venous line for double needle and single needle (single pump) for formula, formula 2000 and
formula plus.
IB0432640
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 formula and formula 2000.
IB0691500
Arterial line including Natrium and Hemox for formula plus and formula 2000 plus.
IB0428440
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, MIDHDF) 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 KITS FOR SPECIFIC TREATMENTS KITS FOR SPECIFIC
TREATMENTS 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 KIT PHF KIT PHF
KIT PHF KIT PHF KIT PHF KIT PHF including Arterial line Venous line Infusion line Infusion set
Manometer protection set PHF dialyser
BL690 BL690 BL690 BL690 – –– – IB 0567600 IB 0567600 IB 0567600 IB 0567600 (PHF
DIALYSER 0719) IB 0357040 IB 0432640 IB 0434120 IB 0550920 IB 0556700 IBP 4100
KIT KIT KIT KIT PHF PHF PHF PHF including Arterial line Venous line Infusion line Infusion set
Manometer protection set PHF dialyser
BL690 BL690 BL690 BL690 – –– – IB 0567610 IB 0567610 IB 0567610 IB 0567610 (PHF
DIALYSER 0714) IB 0357040 IB 0432640 IB 0434120 IB 0550920 IB 0556700 IBP 4105

of 10
KIT HFR KIT HFR KIT HFR KIT HFR
KIT HFR KIT HFR KIT HFR KIT HFR including Arterial line Venous line Infusion line Dialyser
SG30 PLUS Selecta Cartridge
BL640 BL640 BL640 BL640 -- IB0568822 IB0568822 IB0568822 IB0568822 (DIALYSER DIALYSER
DIALYSER DIALYSER SG30 PLUS) IB 0357040 IB 0432640 IB 0434020 IBP 4117 IBP 1503
KIT HFR KIT HFR KIT HFR KIT HFR including Arterial line Venous line Infusion line Dialyser
SG40 PLUS Selecta Cartridge
B BB BL640 L640 L640 L640 – –– – IB 0568823 IB 0568823 IB 0568823 IB 0568823 (DIALYSER
(DIALYSER (DIALYSER (DIALYSER SG40 PLUS) )) )
IB 0357040 IB 0432640 IB 0434020 IBP 4114 IBP 1503
KIT HFR AEQUILIBRIUM KIT HFR AEQUILIBRIUM KIT HFR AEQUILIBRIUM KIT HFR AEQUILIBRIUM
including Arterial line Venous line Infusion line Dialyser SG30 PLUS Selecta Cartridge
DIALYSER DIALYSER SG30 PLUS) IB 0357040 IB 0432640 IB 0434720 IBP 4117 IBP 1503
KIT HFR KIT HFR KIT HFR KIT HFR AEQUILIBRIUM AEQUILIBRIUM AEQUILIBRIUM AEQUILIBRIUM
including Arterial line Venous line Infusion line Dialyser SG40 PLUS Selecta Cartridge
BL640 BL640 BL640 BL640 – –– – IB 0568829 IB 0568829 IB 0568829 IB 0568829 (DIALYSER

(DIALYSER (DIALYSER (DIALYSER SG40 PLUS) )) )
IB 0357040 IB 0432640 IB 0434720 IBP 4114 IBP 1503
KIT HFR KIT HFR KIT HFR KIT HFR including Arterial line Venous line Infusion line Dialyser HFR
13 Selecta Cartridge
DIALYSER DIALYSER HFR13) IB 0357040 IB 0432640 IB 0434020 IBP 4282 IBP 1503
KIT HFR KIT HFR KIT HFR KIT HFR including Arterial line Venous line Infusion line Dialyser HFR
17 Selecta Cartridge

KIT HFR AEQUILIBRIUM KIT HFR AEQUILIBRIUM KIT HFR AEQUILIBRIUM KIT HFR AEQUILIBRIUM
including Arterial line Venous line Infusion line Dialyser HFR 13 Selecta Cartridge
KIT HFR KIT HFR KIT HFR KIT HFR AEQUILIBRIUM AEQUILIBRIUM AEQUILIBRIUM AEQUILIBRIUM
including Arterial line Venous line Infusion line Dialyser HFR 17 Selecta Cartridge

(DIALYSER (DIALYSER (DIALYSER HFR 17) )) )
IB 0357040 IB 0432640 IB 0434720 IBP 4283 IBP 1503
KIT HFR AEQUILIBRIU KIT HFR AEQUILIBRIU KIT HFR AEQUILIBRIU KIT HFR AEQUILIBRIUM
HEMOX M HEMOX M HEMOX M HEMOX including Hemox arterial line Venous line Infusion
line Dialyser HFR 13 Selecta Cartridge
KIT HFR KIT HFR KIT HFR KIT HFR AEQUILIBRIUM HEMOX AEQUILIBRIUM HEMOX
AEQUILIBRIUM HEMOX AEQUILIBRIUM HEMOX including Hemox arterial line Venous line
Infusion line Dialyser HFR 17 Selecta Cartridge

(DIALYSER (DIALYSER (DIALYSER HFR 17) )) )
IB 0428540 IB 0432640 IB 0434720 IBP 4283 IBP 1503

of 10
CONCENTRATES CONCENTRATES CONCENTRATES 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 3 mS System 3 mS System 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 3 mS System with powder bicarbonate 3 mS System

with powder bicarbonate 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 from 950 g, - water down to obtain
a solution close to saturation at approx. 37°C
SOLUCART PLUS – powder bicarbonate cartridge Code BSCART002 from 750 g, - water down
to obtain a solution close to saturation at approx. 37°C
SOLUCART PLUS – powder bicarbonate cartridge Code BSCART018 from 850 g, - water down
to obtain a solution close to saturation at approx. 37°C
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 Sys 5 mS Sys 5 mS Sys 5 mS System tem tem tem
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 WATER INLET FILTER WATER INLET FILTER WATER INLET FILTER
MULTIPURE MULTIPURE MULTIPURE MULTIPURE Code IB5092200 Water inlet for bacterial
microfilter.
ACCESSOR ACCESSOR ACCESSOR ACCESSORI II IES EESS ES
FORCLEAN PLUS FORCLEAN PLUS FORCLEAN PLUS FORCLEAN PLUS Code IB0958500 Hollow-
fibre Medisulfone® ultrafilter for dialysis fluid, ETO sterilized.
FORCLEAN FORCLEAN FORCLEAN FORCLEAN I Code IB0958600 Hollow-fiber Medisulfone®

ultrafilter for dialysis fluid, ETO sterilized, equipped with transponder.
SCALE SCALE SCALE SCALE FORMULA 2000 Code IB7097000

Scale for HDF
SPHYGMO SPHYGMO SPHYGMO SPHYGMO FORMULA Code IB7097050

Sphygmomanometer
NATRIUM NATRIUM NATRIUM NATRIUM FORMULA Plus Code IB7097060

Blood temperature and conductivity sensor
HEM HEM HEM HEMOX OX OX OX FORMULA Plus Code IB7097070

Hematocrit and oxygen saturation measuring system
PULSAR PULSAR PULSAR PULSAR FORMULA Plus Code IB7097080

Heart rate meter
ENG – Ed. 11/09 chap. 2.8 – Technical characteristics - 1 of 22

2.8 TECHNICAL CHARACTERISTICS 2.8 TECHNICAL CHARACTERISTICS 2.8 TECHNICAL
CHARACTERISTICS 2.8 TECHNICAL CHARACTERISTICS
DIMENSIONS AND WEIGH DIMENSIONS AND WEIGH DIMENSIONS AND WEIGH DIMENSIONS
AND WEIGHT TT T
Height, depth, width Standard model
1740 x 755 x 500 mm
Height, depth, width Domus model (with monitor arm)
1740 x 800 x 1000 mm - max.-

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 WEIG MAX. APPLICABLE WEIG MAX. APPLICABLE WEIG MAX. APPLICABLE
WEIGHT HT HT HT
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

The maximum load that can be applied t The maximum load that can be applied t The
maximum load that can be applied t The maximum load that can be applied to the I.V. pole on
the single pump o the I.V. pole on the single pump o the I.V. pole on the single pump o the I.V.
pole on the single pump models (formula models (formula models (formula models (formula
, formula , formula , formula , formula plus) is 10 kg, and 16 kg for double pump
models. plus) is 10 kg, and 16 kg for double pump models. plus) is 10 kg, and 16 kg for double
pump models. plus) is 10 kg, and 16 kg for double pump models.
AMBIENT AND STORAGE AMBIENT AND STORAGE AMBIENT AND STORAGE AMBIENT AND
STORAGE CONDITIONS CONDITIONS CONDITIONS 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.
Bellco
2 of 22 - chap. 2.8 - Technical characteristics ENG – Ed. 11/09
HAEMODIALYSIS HAEMODIALYSIS HAEMODIALYSIS HAEMODIALYSIS WATER REQUIREMENTS

WATER REQUIREMENTS WATER REQUIREMENTS 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 European Pharmacopoeia IV Ed. AAMI European
Pharmacopoeia IV Ed. AAMI European Pharmacopoeia IV Ed. AAMI WQD,1998
WQD,1998 WQD,1998 WQD,1998
Pollutant
Maximum level suggested Maximum level suggested Maximum level suggested Maximum
level suggested
Maximum level suggested Maximum level suggested 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

The user is responsible for evaluating the quality of the water supplied so that when The user
is responsible for evaluating the quality of the water supplied so that when The user is
responsible for evaluating the quality of the water supplied so that when The user is
responsible for evaluating the quality of the water supplied so that when mixed with the
concentrates no p mixed with the concentrates no p mixed with the concentrates no p mixed
with the concentrates no potentially dangerous conditions for the patient are otentially
dangerous conditions for the patient are otentially dangerous conditions for the patient are
otentially dangerous conditions for the patient are created. created. created. created.
WATER WATER WATER WATER
suitable for dialysis treatments in conformity with AAMI standards or European

Pharmacopoeia. Temperature (min-max) 5ºC ÷ 32ºC
If the kit for centralized disinfection/cleaning is installed: 5ºC ÷ 32ºC in dialysis

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 DRAIN DRAIN 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 ELECTRICAL DATA ELECTRICAL DATA 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, Tdialysate = 37.5°C, Troom = 20°C,
Dialysate Flow = 800 ml/min)
1.0 kW
Max. absorption 8 A ( 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

For treatment of patients with central For treatment of patients with central For treatment of
patients with central For treatment of patients with central venous catheter, it is necessary to:
venous catheter, it is necessary to: venous catheter, it is necessary to: venous catheter, it is
necessary to:
• connect the equipment to a potential connect the equipment to a potential connect the
equipment to a potential connect the equipment to a potential equalizer. equalizer. equalizer.
equalizer.
• If other devices a If other devices a If other devices a If other devices are connected to the re
connected to the re connected to the re connected to the patient or located in the area that
can be patient or located in the area that can be patient or located in the area that can be
patient or located in the area that can be reached by the patient, it is necessary to reached by
the patient, it is necessary to reached by the patient, it is necessary to reached by the patient,
it is necessary to check that all leakage currents of these check that all leakage currents of
these check that all leakage currents of these check that all leakage currents of these devices
are within the limits for type CF devices are within the limits for type CF devices are within the
limits for type CF devices are within the limits for type CF applied pa applied pa applied pa
applied parts. rts. rts. rts.
Leakage current to earth
< 0.5 mA
Leakage current to patient < 0.1 mA in conformity with EN 60601-1, CEI EN 606011 and IEC
60601-1. Type of protection against direct and indirect contacts
Class I
Applied part
Type B
Degree of protection against ingress of water
IPX1
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 SECTION BLOOD SECTION BLOOD SECTION
BLOOD FLOW BLOOD FLOW BLOOD FLOW BLOOD FLOW

in double needle and in haemodiafiltration treatments 20 - 700 ml/min 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
NOT NOT NOT NOTE EE E An alarm is generated when the blood pump stops. An alarm is
generated when the blood pump stops. An alarm is generated when the blood pump stops. 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 POST, MID-HDF 0.5
– 21 kg/h 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.
VENO VENO VENO VENOUS PRESSURE US PRESSURE US PRESSURE US 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 - In rinseback SNsp and SNdp (min/max) -150 mmHg
÷ +300 mmHg - in reinfusion DN, HDF, HDF PRE, HDF POST, MID-HDF, PHF PRE, PHF POST, HFR
-150 mmHg / +450 mmHg Alarm thresholds (during dialysis and reinfusion DN, HDF, HDF PRE,
HDF POST, MID-HDF, PHF PRE, PHF POST, HFR ) 50 to 150 mmHg, configurable intervals,
calculated with respect to average value.
ARTERIAL PRESSURE ARTERIAL PRESSURE ARTERIAL PRESSURE ARTERIAL PRESSURE
Type Pressure transducer (part of protective system) Reading -400 to +800 mmHg Resolution
5 mmHg
Bellco
Accuracy ± 20 mmHg, ± 3% of actual value
Alarms: - during dialysis (max) 100 ÷ 300 mmHg, configurable (min) - 350 ÷ -
100 mmHg, configurable - during priming and rinseback (min/max) - 300 / + 200 mmHg - 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 PRE PRE--FILTER ARTERIAL PRES FILTER ARTERIAL PRES FILTER ARTERIAL PRES FILTER
ARTERIAL PRESSURE SURE SURE SURE
Reading -400 to +800 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value
Alarms: - during dialysis (min/max) + 20 mmHg / + 770 mmHg - during priming and rinseback
(min/max) Not available Alarm thresholds (during dialysis) Not available
INFUSION PRESSURE (O INFUSION PRESSURE (O INFUSION PRESSURE (O INFUSION PRESSURE

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

HEMOFILTER TRANSMEMB HEMOFILTER TRANSMEMB HEMOFILTER TRANSMEMB
HEMOFILTER TRANSMEMBRANE PRESSURE (ONLY RANE PRESSURE (ONLY RANE PRESSURE
(ONLY RANE PRESSURE (ONLY IN HFR) IN HFR) IN HFR) IN HFR)
Hemofilter TMP Hemofilter TMP Hemofilter TMP Hemofilter TMP Pre-filter arterial press. -
Hemofilter UF press. Alarms: - during dialysis (min/max) - 100 to +300 mmHg - during priming
and rinseback (min/max) Not available Alarm thresholds (during dialysis) Not available
VENOUS SWITCHING PRE VENOUS SWITCHING PRE VENOUS SWITCHING PRE VENOUS
SWITCHING PRESSURE IN SINGLE SSURE IN SINGLE SSURE IN SINGLE SSURE IN SINGLE--PUMP
SINGLE NEEDLE PUMP SINGLE NEEDLE PUMP SINGLE NEEDLE PUMP SINGLE NEEDLE
Reading -400 to +800 mmHg Setting range: - min +10 ÷ +200 mmHg - max +200 ÷ +400
mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value
VENOUS SWITCHING PRE VENOUS SWITCHING PRE VENOUS SWITCHING PRE VENOUS
SWITCHING PRESSURE IN DOUBLE SSURE IN DOUBLE SSURE IN DOUBLE SSURE IN DOUBLE--
PUMP SINGLE NEEDLE PUMP SINGLE NEEDLE PUMP SINGLE NEEDLE PUMP SINGLE NEEDLE
Reading -400 to +800 mmHg Setting range: - min -100 ÷ +100 mmHg Resolution 5 mmHg
Accuracy ± 10 mmHg, ± 3% of actual value
HEPARIN PUMP (WITH S HEPARIN PUMP (WITH S HEPARIN PUMP (WITH S HEPARIN PUMP
(WITH SYRINGE) YRINGE) YRINGE) YRINGE)
Syringe capacity 20, 30, 50 cc
Syringe internal diameter (configurable)

18 - 30 mm (increments of 0.1 mm)
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 AAIIRR AIR/END INFUSION /END INFUSION /END INFUSION /END INFUSION DETECTOR
DETECTOR DETECTOR DETECTOR
Type ultrasound Sensitivity bubbles ≥ 100Ol
BLOOD DETECTOR FOR E BLOOD DETECTOR FOR E BLOOD DETECTOR FOR E BLOOD DETECTOR
FOR END PRIMING ND PRIMING ND PRIMING ND PRIMING
Type infrared rays
BLOOD LEAK BLOOD LEAK BLOOD LEAK BLOOD LEAK DETECTOR ON THE BLOO DETECTOR ON
THE BLOO DETECTOR ON THE BLOO DETECTOR ON THE BLOOD FILTER D FILTER D FILTER D
FILTER
Type optical - green
DRIP CHAMBER LEVEL G DRIP CHAMBER LEVEL G DRIP CHAMBER LEVEL G DRIP CHAMBER
LEVEL GAUGE AUGE AUGE AUGE
Type infrared rays
Bellco
DIALYSIS FLUID SECTION DIALYSIS FLUID SECTION DIALYSIS FLUID SECTION DIALYSIS FLUID
SECTION
DIALYSIS FLUID DIALYSIS FLUID DIALYSIS FLUID DIALYSIS FLUID
Temperature: Temperature: Temperature: 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 Powder bicarbonate Powder bicarbonate Powder bicarbonate cartridge

cartridge cartridge cartridge filling pressure filling pressure filling pressure filling pressure (only
with kit for filling the powder bicarbonate cartridge under positive pressure)
Max. 2.5 bar
Concentrate inlet pres Concentrate inlet pres Concentrate inlet pres Concentrate inlet
pressure sure sure sure (only with installed kit for concentrate centralised distribution)
Max. 3 bar
UF Pressure UF Pressure UF Pressure UF Pressure Type Pressure transducer (part of protective

system) Reading - 625 ÷ +625 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual
value 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 TMP TMP TMP : :: :
In double needle, HDF, HFR, PHF In double needle, HDF, HFR, PHF In double needle, HDF, HFR,
PHF In double needle, HDF, HFR, PHF PRE, PHF POST, MID PRE, PHF POST, MID PRE, PHF POST,
MID PRE, PHF POST, MID--HDF, HDF HDF, HDF HDF, HDF HDF, HDF PRE, HDF POST PRE, HDF
POST PRE, HDF POST PRE, HDF POST
VP – (Pdo + 30 mmHg)
In IInn In single needle single needle single needle 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: AVERAGE TMP: AVERAGE TMP: AVERAGE TMP:
In on In on In on In on--line haemodiafiltration line haemodiafiltration line haemodiafiltration

line haemodiafiltration with automatic control of the with automatic control of the with
automatic control of the with automatic control of the infusion flow enabled infusion flow
enabled infusion flow enabled infusion flow enabled
in HDF PRE, HDF POST, MID in HDF PRE, HDF POST, MID in HDF PRE, HDF POST, MID in HDF
PRE, HDF POST, MID--HDF HDF HDF HDF Pfilt + Pv – (Pdo + 30 mmHg) 2 in PHF PRE in
PHF PRE in PHF PRE in PHF PRE (Pfilt – 20 mmHg)+ Pv – (Pdo + 30 mmHg) 2 in PHF
POST in PHF POST in PHF POST 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: MAXIMUM TMP: MAXIMUM TMP: MAXIMUM TMP:
In IInn In double needle double needle double needle double needle, ,, , HDF, HDF, HDF, HDF,
PHF PHF PHF PHF POST, HDF PRE, HDF POST POST, HDF PRE, HDF POST POST, HDF PRE, HDF
POST POST, HDF PRE, HDF POST
Pfilt – Pdo
in iinn in HFR, HFR, HFR, HFR, PHF PRE PHF PRE PHF PRE PHF PRE (Pfilt – 20 mmHg) – Pdo
in MID in MID in MID in MID--HDF HDF HDF 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: FLOW RATE: FLOW RATE: FLOW RATE:
Setting 300, 500, 800 ml/min Reading 200 to 1000 ml/min Resolution 1 ml/min Accuracy ± 10
%
CONDUCTIVITY CONDUCTIVITY CONDUCTIVITY 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 Resolution 0.1 mS/cm Accuracy: 0.1 mS/cm Alarm limits on
value set ± 5%
ULTRAFILTRATION ULTRAFILTRATION ULTRAFILTRATION ULTRAFILTRATION
Ultrafiltration control continuous flow single-pass differential flowmeter Accuracy ± 1 g/min, ±

1% of total ultrafiltrate
SCALE ( SCALE ( SCALE ( SCALE (only in HDF with bags): only in HDF with bags): only in HDF with
bags): only in HDF with bags):
Accuracy ± 0.3% of total infused fluid
WEIGHT LOSS WEIGHT LOSS WEIGHT LOSS WEIGHT LOSS Programmable weight loss 0.1 to 4.0
Kg/h Accuracy: - In double needle, single needle, HFR, PHF PRE, PHF POST, HDF PRE, HDF
POST, MID-HDF ± 1 g/min ± 1% weight loss - in HDF with bags ± 1 g/min ± 1% weight loss ±
1.3% of the total infused fluid
BLOOD BLOOD BLOOD BLOOD LEAK DETECTOR LEAK DETECTOR LEAK DETECTOR LEAK
DETECTOR
Type infrared ray optical (part of protective system) Sensitivity 0.5 ml/min blood, hematocrit
25 %

DISINFECTION/CLEANING DISINFECTION/CLEANING DISINFECTION/CLEANING
DISINFECTION/CLEANING
CHEMICAL DISINFECTIO CHEMICAL DISINFECTIO CHEMICAL DISINFECTIO CHEMICAL

DISINFECTION/CLEANING (NOT PRES N/CLEANING (NOT PRES N/CLEANING (NOT PRES
N/CLEANING (NOT PRESENT ON THE THERAPY M ENT ON THE THERAPY M ENT ON THE
THERAPY M ENT ON THE THERAPY MODEL): ODEL): ODEL): ODEL):
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)
∼ 250 (dilution ratio 1:6, contact time 6 min) ∼ 400 (dilution ratio 1:6, contact time 10 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 CHEMICAL CHEMICAL--FULL DISINFECTION/CL FULL DISINFECTION/CL
FULL DISINFECTION/CL FULL DISINFECTION/CLEANING EANING EANING EANING
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 1:6 - 1:30 (settable during configuration), User Agent Consumption (cc) ∼ 45
(dilution ratio 1:30) ∼ 166 (dilution ratio 1:6) ∼ 250 (dwelling - dilution ratio 1:6) Water
temperature in circuit 38°C ∼ Intake + contact time (minutes) Therapy Model: 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 (PRES COLD DESCALING (PRES COLD DESCALING (PRES COLD DESCALING
(PRESENT ONLY ON THE THER ENT ONLY ON THE THER ENT ONLY ON THE THER ENT ONLY ON
THE THERAPY MODEL): APY MODEL): APY MODEL): APY MODEL):
Descaling agents Acetic Acid (10%) (descaling agent) User descaling agent Dilution ratio 1:6
Acetic acid 10% Consumption (cc) ∼ 166 Water temperature in circuit 38°C ∼ Intake +
contact time (minutes) 11 (ACETIC A.)
Rinsing time (minutes) settable during configuration 28 ÷ 38 min (ACETIC A.)
Dwell time none Total duration (minutes) 39 ÷ 49 (ACETIC A.)
HOT DESCALING: HOT DESCALING: HOT DESCALING: HOT DESCALING:

Descaling agents Citric acid 12% , descaling agent User descaling agent Dilution ratio 1:6
Citric acid 12% 1:6 - 1:30 (settable during configuration), User Agent Consumption (cc) ∼ 166
Average temperature in circuit
50°C ∼
Contact time (minutes) Therapy Model: 13
Other Models: 13
Heating time + intake (minutes)

Therapy Model: 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
Total duration (minutes) Therapy Model: 36 ÷ 46
Other Models: 51 or 56
Bellco
HEAT DISINFECTION: HEAT DISINFECTION: HEAT DISINFECTION: HEAT DISINFECTION:
Chemical agents none Average temperature in circuit 85°C ∼ 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
Total duration (minutes) Therapy Model: 31 or 36
Other Models: 30 or 35
RINSING RINSING RINSING RINSING
automatic when turning on and after each dialysis Water temperature 37.5°C ∼ Flow 750
ml/min Life cycle 3 min.
NATRIUM TECHNICAL NATRIUM TECHNICAL NATRIUM TECHNICAL NATRIUM TECHNICAL

CHARACTERISTICS CHARACTERISTICS CHARACTERISTICS CHARACTERISTICS
Temperature (blood and ultrafiltrate): Temperature (blood and ultrafiltrate): Temperature

(blood and ultrafiltrate): Temperature (blood and ultrafiltrate):
Operating principle
Reading
Thermal resistance and thermal conduction
25 – 50 °C
Resolution 0.1°C Accuracy ± 0.5°C Conductivity (blood and ultrafilt Conductivity (blood and
ultrafilt Conductivity (blood and ultrafilt Conductivity (blood and ultrafiltrate): rate): rate):
rate): Operating principle Reading Electromagnetic induction 0 – 25 mS/cm
Resolution
0.1 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 HEMOX TECHNICAL HEMOX TECHNICAL HEMOX TECHNICAL
O OO Operating principle perating principle perating principle perating principle Optical

absorbance at three different wavelengths Hematocrit Hematocrit Hematocrit Hematocrit
Reading 15 ÷ 50 % Resolution 0.1 % Accuracy ± 5 % Oxygen saturation Oxygen saturation
Oxygen saturation Oxygen saturation Reading 40 ÷ 100% Resolution 0.1 % Accuracy ± 5 %
Percent volume loss Percent volume loss Percent volume loss Percent volume loss (derived
quantit (derived quantit (derived quantit (derived quantity) yy)) y) Resolution 0.1 % Accuracy
± 2.5 %
Dimensions
Interfacing with disposable

51 x 72 x 45 mm
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 PULSAR PULSAR PULSAR TECHNICAL TECHNICAL TECHNICAL TECHNICAL

Operating principle Operating principle Operating principle Operating principle
Reading of the pulses emitted by commercial electrocardiographic bands.

Heart rate Heart rate Heart rate 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 LECTOR TECHNICAL CHARACTERISTICS LECTOR

TECHNICAL CHARACTERISTICS LECTOR TECHNICAL CHARACTERISTICS
Operating principle Operating principle Operating principle Operating principle
Transponder system
Reading
Wavelength
Ultrafilter recognition code (10 characters)
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 SPHYGMOMANOMETER SPHYGMOMANOMETER

SPHYGMOMANOMETER TECHNICAL TECHNICAL TECHNICAL TECHNICAL CHARACTERISTICS
CHARACTERISTICS CHARACTERISTICS 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 Plus Plus Plus code 4941270
**This cuff is supplied with the sphygmomanometer

Arm circumference 310 - 400 mm
Small Small Small Small code 4941275 Arm circumference 230 - 330 mm Large Large
Large 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 Kt/V Kt/V Kt/V TECHNICAL CHARACTERISTICS TECHNICAL CHARACTERISTICS TECHNICAL

CHARACTERISTICS 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

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1.1 INTRODUCTION 1.1 INTRODUCTION 1.1 INTRODUCTION 1.

GENERAL GENERAL GENERAL GENERAL

NAME NAME NAME NAME

INTENDED USE INTENDED USE INTENDED USE INTENDED USE

CAUTION CAUTION CAUTION CAUTION

LIMITATION OF USE LIMITATION OF USE LIMITATION OF USE LIMITATION OF USE

COLLATERAL EFFECTS COLLATERAL EFFECTS COLLATERAL EFFECTS COLLATERAL EFFECTS

CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS

2 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

Haemodialysis Haemodialysis Haemodialysis Haemodialysis is a method of blood purification

HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION

Haemodiafiltratio Haemodiafiltratio Haemodiafiltratio Haemodiafiltration nn n is a

This manual gives descriptions on: o Standard haemodiafiltration Standard haemodiafiltration

ENG – Ed. 11/09 chap. 1.1 - Introduction - 3 of 14

ON OONN ON--LINE HAEMODIAFILTRATION LINE HAEMODIAFILTRATION LINE

WARNING WARNING WARNING WARNING

4 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

Haemodiafiltration with on-line endogenous reinfusion of ultrafiltrate (HFR) is indicated for

HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH

ENG – Ed. 11/09 chap. 1.1 - Introduction - 5 of 14

As regards the preparation of dialysis solution: • treatments with acetate concentrate •

6 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

TABLE OF TREATMENTS/MODELS TABLE OF TREATMENTS/MODELS TABLE OF

formula formula plus formula 2000:

formula has an electronic multiprocessor architecture composed of control and protection

ENG – Ed. 11/09 chap. 1.1 - Introduction - 7 of 14

formula combines technological innovations with tradition, maintaining a rapidly accessible

8 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

ENG – Ed. 11/09 chap. 1.1 - Introduction - 9 of 14

SYMBOLS ON THE MACHINE SYMBOLS ON THE MACHINE SYMBOLS ON THE MACHINE

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)

Protection against dripping water with vertical drop

Alternate current power supply

WARNING. Consult the manual.

10 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

Socket for auxiliary keyboard

Connectors for serial ports

Connector for Pulsar

Connector for Hemox

MANUFACTURER RESPONSIBILITY MANUFACTURER RESPONSIBILITY MANUFACTURER

EN 60601 EN 60601 EN 60601 EN 60601--1 11 1

Medical electrical equipment. Part 1: General requirements for safety

EN 60601 EN 60601 EN 60601 EN 60601--1 11 1--2 22 2

ENG – Ed. 11/09 chap. 1.1 - Introduction - 11 of 14

EQUIPMENT DISPOSAL EQUIPMENT DISPOSAL EQUIPMENT DISPOSAL EQUIPMENT DISPOSAL

IMPORTANT IMPORTANT IMPORTANT IMPORTANT

In compliance with the Directive 2002/96/EC, the equipment to be disposed of must be

ENG – Ed. 11/09 chap. 1.1 - Introduction - 13 of 14

The product code, described below, is a 9-character alphanumerical code:

Perforated Perforated Perforated Perforated

14 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

Perforated Perforated Perforated Perforated c cc cartridge artridge artridge artridge

WARNINGS WARNINGS WARNINGS WARNINGS

formula must always be installed by technicians authorised by the must always be

CAUTIONS CAUTIONS CAUTIONS CAUTIONS

ENG – Ed. 11/09 chap. 2.1 - Description of machine and components - 1

FRONT VIEW FRONT VIEW FRONT VIEW FRONT VIEW

2 of 6 - chap. 2.1 – Description of machine and components ENG – Ed. 11/09

Pivoting wheels Pivoting wheels Pivoting wheels Pivoting wheels

Container base Container base Container base Container base

Disinfectant connector (yellow) Disinfectant connector (yellow) Disinfectant connector (yellow)