Fleximag - 110xxxx-Ne-22-01 Instruction and Service Manual

Service and Operation Manual
FlexiMag
Neonatal | Pediatric | Adult
BabyMag
Electronic Lung Ventilator
Neonatal | Pediatric
Revision nº. 4
Software version nº2.n
 Copyright 2012
Magnamed Tecnologia Médica S/A
2
The total or partial reproduction of this work is forbidden in any

way or form, through electronic and/or mechanical means,
including reprographic processes without the company’s
EXPRESSED PERMISSION.
(Law No. 9,610/1,998)
ANVISA Registration no. 80659160003
All rights reserved by

Magnamed Tecnologia Médica S/A.
Rua São Paulino, 221 – Vila Mariana
CEP: 04019-040 – São Paulo – SP – Brasil
Tel/Fax: +55 (11) 5081-4115
E-mail: magnamed@magnamed.com.br
Website: www.magnamed.com.br
CNPJ: 01.298.443/0001-73
State Registration: 149.579.528.111
Technician Responsible: Tatsuo Suzuki
CREA-SP Registration: 0600629049
Legal Responsible: Tatsuo Suzuki
MAGNAMED TECNOLOGIA MÉDICA S/A

3
1. Revision History
Elaborated by: Verified by: Approved by:

Sara Neusa Toru
Date( mm/dd/yyyy) Date( mm/dd/yyyy) Date( mm/dd/yyyy)
01/02/2013 01/16/2013 01/18/2013
REV DESCRIPTION (mm/dd/yyyy)

01 Initial Revision 09/15/2011
General Revision to include all FlexiMag and BabyMag models and for the 02/02/2012
02
Inclusion of alarm detailing
03 Inclusion of reference to European Representative 05/15/2012
Detailed feature description, device images update and accessories listing update 01/02/2013
04
and change of software to version 2.n

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2. Definitions and Care
Warning
• Informs the user of the possibility of lesion, death, or other serious adverse reactions
associated to the use or misuse of the equipment.
Attention
• Informs the user of the possibility of equipment failure associated to use or misuse,
such as the equipment’s malfunction, damages to the equipment, or damages to third
party good, and, indirectly, to patient lesion.
Notes
• Important Information

5
FlexiMag and BabyMag are a family of microprocessed electronic ventilators developed to supply invasive
and noninvasive ventilation support with full ventilation monitoring. These ventilators are destined to patients
with compromised respiratory functions in intensive or semi-intensive therapy. FlexiMag attends neonatal,
pediatric, and adult patients. On the other hand, BabyMag was developed for neonatal and pediatric
patients.
Similar functions between FlexiMag and BabyMag are shown below:
• PLV* – Pressure Limited Ventilation (Assisted);

• CPAP/PS – Continuous Positive Airway Pressure/Pressure Support;
• CPAP/PS + NIV – Non Invasive Ventilation through mask or nasal prong, activated only in CPAP
(described above), with leakage compensation;
• P-SIMV – Pressure-Synchronized Intermittent Mandatory Ventilation with Pressure Controlled
cycle;
• DualPAP** – Ventilation in two CPAP levels (with or without Pressure Support). Through this
modality, adjustment can be made in order to obtain the APRV Airway Pressure Release
Ventilation modality.
• NIV - Non Invasive Ventilation by mask in order to compensate leaks.
Additional modalities, exclusive for FlexiMag:
• VCV – Volume Controlled Ventilation (Assisted);

• PCV – Pressure Controlled Ventilation (Assisted);
• V-SIMV – Volume Controlled Synchronized Intermittent Mandatory Ventilation with Volume
Controlled cycle;
• PRVC - Pressure regulated volume control guaranteed with adjustable rise time
•
* Available for neonatal patients
** In BabyMag this modality is an optional
Basic Features:
• Integration of the whole system in one low volume and weight electronic pneumatic module;
• Electronic flow control system for the patient with the use of digital technology;
• Intelligent and integrated alarm system with all required security systems in national and
international regulations
• Power “backup” system that enables operation of up to 3 hours without electricity;
• Possibility to use the adjusted parameters before turning off the equipment.
• Proximal sensor for all patients (optional item available only for FlexiMag).
• These devices must only be operated by qualified and trained professional. The following important
recommendations and warnings are presented in order to use these products in a safe and efficient
manner.

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Warning
• Whenever the symbol is found, read the instruction manual for further details.
• This manual must be entirely read in order for the correct and secure use of the equipment
and provide maximum security and better resources to patients. Observe all Warnings and
Attentions contained in this manual and on the equipment’s labels.
• This equipment must only be used for the specified purpose in the Intended use (chapter
4.1) together with the appropriate monitoring.
• The equipment must be operated by qualified professionals that must maintain vigilance
during its use, including in volume limited ventilation.
• Explosion Risk – This equipment is not approved for the use of flammable anesthetic
agents.
• The equipment must be adversely affected and suffer interferences with certain
transmission equipment, such as: cellular phones, walkie-talkies, cordless telephones,
pagers, high-frequency surgical equipment (diathermy), defibrillators, short wave therapy,
that may interrupt the equipment’s operation. Do not use these transmission devices near
the Ventilator.
• These devices must not be used during nuclear magnetic resonance (MTR, NMR, NMI)
because they may suffer interferences may cause adverse effects to the patient.
• Avoid harmful substances in the environments because these devices may aspirate the
environment’s air in order to ventilate the patient with concentrations inferior to 100% of O2.
• The applied parts are resistant to defibrillation.
• Before the first use or after each patient’s use, clean the equipment according to chapter 10.
• Turn on the equipment and realize basic verification and adjustment procedures – follow
• The Alarms and Warnings must be promptly attended to in order to maintain the
equipment’s operation and the patient’s security.
• Do not use hoses or antistatic or electrically conductive tubes.
• Verify if the equipment is adjusted correctly before use.
• After the ventilation starts, verify if the ventilator parameters indicated by the monitor
display are adequate.
• Only use MAGNAMED accessories listed in this manual, which were tested and approved
for use together with these equipment. Otherwise, the equipment’s correct operation may
be compromised.
• During the equipment’s prolonged use in patients with excess secretion or in respiratory
circuits by using a heated humidifier, the flow sensor’s condition must be frequently
verified.
• The equipment has an independent power supply and its own battery backup system.
• Connect an AC/DC source converter to a three pin socket NBR 13136:2002 (2P+T);
• Maintain the equipment connected to an power source even when it is turned off in order to
maintain the internal batteries permanently charged;
• Completely recharge the batteries after use or after a long stocking period;
• The battery’s recharge alarm must promptly be attended to. Recharge the battery before the
equipment’s next use because a power outage may interrupt the equipment’s operation.
• In the event the equipment’s battery is used for a prolonged period of time in which the
LOW BATTERY message appears, provide IMMEDIATE connection of the power cord to a
power source. In the event this is not possible, DISCONNECT the patient’s device and
provide adequate ventilator support means.
• The absence of obstruction is extremely important for the correct operation of ventilation
monitoring. Therefore, it must be frequently verified during the patient’s ventilation
realization.

7
• After usage, the respiratory circuit components MUST be disinfected before their next used,
whenever the same are reusable.
• All of the equipment’s parts that came into contact with fluids from the patients must
undergo a high-level disinfection process or sterilization when discarded or be discarded as
potentially infected hospital waste.
• All parts applied to FlexiMag and BabyMag ventilators are made of nontoxic material, are
exempted of latex, do not cause irritation or allergy to the patient (biocompatibility).
• The common use accessories, which are not exclusive to FlexiMag or BabyMag, such as:
masks, respiratory circuits, nebulizers, heated humidifiers, HME filters, among others, must
have an ANVISA registration.
• Never obstruct pressure outlets. The measures pressures in these points are used by the
patient’s ventilation monitoring system.
• Do not use the equipment if a problem cannot be resolved.
• Have a manual ventilation equipment on hand in the event the battery becomes completely
depleted; there is a lack of gases in order for the device to operate; or because of general
failure of the ICU ventilator.
• Always use officially approved oxygen cylinders and pressure redactor valves that attend to
legal government requirements.
• In order for appropriate ventilation, take in account the respiratory circuit’s dead spaces
while adjusting the ventilator, especially for small tidal volumes.
• The ventilator must not be covered or positioned so that the ventilator’s operation or
performance becomes adversely affected.
• When adding components to the respiratory circuit or other components or subsets for the
ventilator’s respiratory system, the pressure gradient may increase through the ventilator’s
respiratory system measured in relation to the patient’s connection port.
Attention
• The ICU’s Ventilator does not issue electromagnetic waves that interfere with the operation of
equipment in its proximity.
• Perform annual periodical maintenance or according to the specified hours of usage,
whichever comes first.
• All of the Ventilator’s service or maintenance can only be realized by a licensed, trained, and
duly authorized technician by MAGNAMED.
• Only use parts, accessories, cables, sensors, filters, heated humidifiers, and respiratory
circuits specified by MAGNAMED. In order to acquire the same, inform the code presented on
the corresponding chapter.

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Notes
• Eliminate the equipment’s removed parts according to the disposal protocol of parts and accessories
of its institution and follow the local governmental recommendations regarding environmental
protection, especially in the event of electronic waste or electronic accessories (for example,
batteries).
• MAGNAMED products’ technical characteristics are subject to alterations without previous warning.
• Pressure units:
1 mbar (milibar) = 1 hPa (hectoPascal) = 1.016 cmH2O (centimeter of water)
In practice, these units are not differentiated and may be used as:
1 mbar = 1 hPa ≈ 1 cmH2O

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3. Table of Contents
1. REVISION HISTORY ................................................................................................... 3
2. DEFINITIONS AND CARE ........................................................................................... 4
3. TABLE OF CONTENTS ............................................................................................... 9
4. DESCRIPTION ........................................................................................................... 11
4.1. INTENDED USE ...................................................................................................... 11
4.2. LABELING .............................................................................................................. 15
4.3. OPERATION PRINCIPLE ........................................................................................... 15
4.4. OTHER CHARACTERISTICS ...................................................................................... 17
5. UNPACKING THE PRODUCT ................................................................................... 18
5.1. INITIAL VERIFICATIONS ........................................................................................... 18
5.2. FLEXIMAG’S RELATION OF COMPONENTS ................................................................ 18
5.3. BABYMAG’S RELATION OF COMPONENTS ................................................................. 21
6. COMPONENT IDENTIFICATION............................................................................... 24
7. PREPARATION FOR USE ........................................................................................ 29
7.1. FLEXIMAG ASSEMBLY – ICU VENTILATOR................................................................ 29
7.2. CONNECTION TO POWER SUPPLY............................................................................ 35
7.3. VERIFICATIONS BEFORE USE .................................................................................. 36
8. USE INSTRUCTIONS ................................................................................................ 45
8.1. ITEMS OF THE VENTILATOR’S MAIN SCREEN: ............................................................ 45
8.2. ALTERATION OF PATIENT CONFIGURATION ON FLEXIMAG ........................................... 56
8.2.1. Patient Configuration Alteration (FlexiMag and BabyMag) ........................... 57
8.2.2. Adjustments that depend on Patient configuration ....................................... 58
8.3. AVAILABLE ALARMS................................................................................................ 59
8.3.1. Alert messages: ........................................................................................... 63
8.3.2. Alarms and Security System – Adjustments: ................................................ 63
8.3.3. Alarm Adjustment ......................................................................................... 65
8.4. MODE CONFIGURATION .......................................................................................... 67
8.5. PARAMETER ADJUSTMENT IN EACH MODALITY .......................................................... 68
9. PROBLEM SOLVING ................................................................................................ 89
10. CLEANING, DISINFECTION, AND STERILIZATION ............................................ 91
10.1. VENTILATOR ...................................................................................................... 91
10.2. CLEANING, DISINFECTION, AND STERILIZATION PROCESSES .................................. 92
11. OPTIONAL PARTS AND ACCESSORIES............................................................. 94
12. PREVENTIVE MAINTENANCE .............................................................................. 98
12.1. VERIFICATIONS .................................................................................................. 98
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12.2. INTERNAL LITHIUM BATTERY ................................................................................ 99

12.3. O2 CONCENTRATION INTERNAL SENSOR .............................................................. 99
12.4. REMITTING PRODUCT TO REPAIR SERVICE ......................................................... 100
13. TECHNICAL SPECIFICATION............................................................................. 101
13.1. CLASSIFICATION ............................................................................................... 101
13.2. STANDARDS ..................................................................................................... 101
13.3. SPECIFICATIONS............................................................................................... 101
13.4. ELECTRICAL CHARACTERISTICS ......................................................................... 102
13.5. CONNECTION TO GAS SUPPLY ........................................................................... 103
13.6. PHYSICAL AND ENVIRONMENTAL SPECIFICATIONS ............................................... 103
13.7. VENTILATION MODALITIES ................................................................................. 103
13.8. VENTILATION PARAMETERS ADJUSTMENT SPECIFICATIONS .................................. 105
13.9. VENTILATION PARAMETERS PRESENTATION SPECIFICATIONS (5)(6) ..................... 107
13.10. SECURITY AND ALARM SYSTEM ......................................................................... 108
13.11. PERFORMANCE SPECIFICATIONS ....................................................................... 109
13.12. MAINTENANCE AND CALIBRATION SPECIFICATIONS: ............................................. 109
13.13. EXPIRATORY BRANCH RESISTANCE SPECIFICATIONS: ......................................... 110
13.14. ELECTRONIC CONTROL BLOCK DIAGRAM ........................................................... 110
13.15. ELECTROMAGNETIC COMPATIBILITY ................................................................... 110
13.16. IRMA CO2 SENSOR (PHASEIN) - OPTIONAL .................................................... 115
13.16.1. Use Instructions ...................................................................................... 115
13.16.2. Sensor Assembly .................................................................................... 115
13.16.3. Sensor Positioning .................................................................................. 117
13.16.4. Sensor Reset Procedure ........................................................................ 117
13.16.5. LED Information ...................................................................................... 118
13.16.6. Sensor Cleaning Procedures .................................................................. 118
13.16.7. Preventive Maintenance ......................................................................... 118
13.16.8. Capnograph’s Technical Specifications .................................................. 120
13.16.9. Capnograph accessories ........................................................................ 122
13.17. OXIMETER (MASIMO) - OPTIONAL ................................................................... 122
13.17.1. Principle of Operation ............................................................................. 122
14. SYMBOLS ............................................................................................................ 127
15. TERMS AND ABBREVIATIONS .......................................................................... 130
16. BIOCOMPATIBILITY DECLARATION ................................................................. 133
17. GUARANTEE ....................................................................................................... 134

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4. Description
4.1. Intended Use
FlexiMag and BabyMag are microprocessed electronic ventilators that were developed to provide invasive
and non-invasive ventilation support with complete ventilation monitoring regarding patients that present
compromised respiratory functions during intensive and semi-intensive therapy. FlexiMag attends neonatal,
pediatric, and adult patients. On the other hand, BabyMag was developed for neonatal and pediatric
patients.
These ventilators may be used for lung ventilation:
• For treatment of patients in the intensive care unit (ICU).

• For post-surgery, in the post-anesthesia care unit (PACU).
• In intrahospital transportation: the patient can be internally transported from one department to
another.
The similar modalities between FlexiMag and BabyMag Ventilators are:
• PLV* – Pressure Limited Ventilation (Assisted);

• CPAP/PS – Continuous Positive Airway Pressure/Pressure Support;
• CPAP/PS + NIV – Non Invasive Ventilation through mask or nasal prong, activated only in CPAP
(described above), with leakage compensation;
• P-SIMV – Pressure-Synchronized Intermittent Mandatory Ventilation with Pressure Controlled
cycle;
• DualPAP** – Ventilation in two CPAP levels (with or without Pressure Support). Through this
modality, adjustment can be made in order to obtain the APRV Airway Pressure Release
Ventilation modality.
• NIV - Non Invasive Ventilation by mask in order to compensate leaks.
Additional modalities, exclusive of FlexiMag:
• VCV – Volume Controlled Ventilation (may be assisted);

• PCV – Pressure Controlled Ventilation (may be assisted);
• V-SIMV – Volume Controlled Synchronized Intermittent Mandatory Ventilation with Volume
Controlled cycle;
• PRVC - Pressure regulated volume control guaranteed with adjustable rise time
* Only available for neonatal patients
** Optional modality

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Other resources that these ventilators provide the ICU:
• Synchronized nebulizer with inspiration and volume compensation.

• Synchronized Tracheal Gas Insufflation (TGI) synchronized with expiration.
• Automatic system for oxygen (100% O2) administration for aspiration procedure
• The equipment can be used even in the absence of one of the gas supply (O2 or Air)
• Quick access function
o Manual Cycle
o Insp Hold (pause)
o Exp Hold (pause)
o Sigh (Optional)
FlexiMag and BabyMag have a graphic interface with a colored, high-resolution, touchscreen display
with one data entry button. Both enable displays in two sizes:
Display Model Description
10.4” 1103040 BABYMAG –10.4 inch Neonatal Electronic Lung Ventilator
1103050 FLEXIMAG – 10.4 inch Neonatal Pediatric Adult Electronic Lung Ventilator
15” 1103360 BABYMAG –15 inch Neonatal Electronic Lung Ventilator
1103760 FLEXIMAG – 15 inch Neonatal Pediatric Adult Electronic Lung Ventilator
The alarms were projected in order to permit fast and easy interaction with the operator. The
equipment’s initial display defines the type of patient to be ventilated. This information guides the control and
alarm parameter adjustments within a safe range.
This ventilator is equipped with an oxygen concentration measurement cell for which the concentration
presentation on the display and alarm limits is activated. Moreover, it has a precise inspiration flow (internal)
and expiration flow (external and distal) measurement system for all types of patients.
Both models have the following adjustable alarms:
• High Pressure
• Low Pressure
• High Respiratory Frequency
• Low Respiratory Frequency
• High PEEP
• Low PEEP
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• Apnea Time
• High Minute Volume
• Low Minute Volume
• High EtCO2*
• Low EtCO2*
• High Inspired CO2*
• High Heart Rate (HR)*
• Low Heart Rate (HR)*
• Low SpO2*
The following descriptions pertain to the alarms related to the equipment and ventilation:
• Low Battery
• Low O2 Pressure
• Low Air Pressure
• Respiratory Circuit Disconnection
• Respiratory Circuit Obstruction
• Without Power Supply
The following descriptions pertain to the alarms related to the external sensors*:
• Capnography Sensor (Optional)

o Attention IRMA adapter
o Restart IRMA
o Substitute IRMA
o CO2 out of scale
o IRMA Read Error
o Calibrate IRMA
• SpO2 Sensor
o Attention SpO2 Sensor (Finger out of Sensor)
o Check SpO2
o Check Plug
o Low Perfusion
o Looking for pulse
o Activating SpO2
o SpO2 demo
*Optional items or alarms
The ventilators also present messages concerning ventilation and the equipment as follows:
• Limited Pressure
• Assisted Cycle generated by Pressure Sensitivity
• Assisted Cycle generated by Flow Sensitivity
• Assisted Cycle generated by Manual key
• Spontaneous Cycle generated by Pressure Sensitivity
• Spontaneous Cycle generated by Flow Sensitivity
• Spontaneous Cycle generated by Manual key
• Synchronizer Window
• Disconnected flow sensor (Sensor OFF)
Both incorporate a ventilation monitor that presents:

• Real-time curves:
o Pressure Curve x Time
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o Pressure Flow x Time

o Volume Curve x Time
o Volume Loop x Pressure
o Flow Loop x Volume
o Instant pressure bar graph
*
o CO2 Curve x Time
*
o SpO2 Curve x Time
*
o PV Curve
• Parameters:
o Maximum Pressure
o Average Pressure
o PEEP
o Intrinsic PEEP (Auto PEEP)
o Plateau Pressure
o Tidal Volume (Exhaled Volume)
o Inhaled Volume
o Minute Volume
o Static Compliance
o Dynamic Compliance
o Airway Resistance
o Inspiratory Time
o Expiratory Time
o I:E Ratio
o Total Respiratory Frequency
o Spontaneous Frequency
o Spontaneous Minute Volume
o Spontaneous Volume
o FiO2
*
o Time constant
o Rapid Shallow Breathing Index (RSBI)*
o Occlusion Pressure P0.1*
* Optional parameters and curves

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4.2. Labeling
The following information is presented on the product’s external label:
Indicates the
ventilator’s
model and
description
ANVISA Registration No.80659160003 UNDETERMINED VALIDITY
Image 1 – Product’s External Label
4.3. Operation Principle
FlexiMag and BabyMag ventilators are comprised by:
1. Ventilator’s electronic, microprocessed control board
o Electronic microprocessed control board that controls active pneumatic components: proportional
valves that control gas flow, relief valve that avoid overpressure, solenoid valves that convert
electric signal in pressure or flows in order to act over other pneumatic components, and an
exhalation valve that realizes pressure expiration and control of the patient’s airways.

16
2. Manifold of integrated pneumatic components:

o The pneumatic manifold is a solid metal part that contains embedded passive and active
pneumatic valves that intercommunicate through internal holes.
3. Pressure regulation valves, gas mixture chamber, proportional valves, solenoid valves,
Venturi tube, vacuum chamber, unidirectional air inlet, pressure relief valve, pilot solenoid
valves.
o The pressure regulation valves regulate air and oxygen pressures to working values of the
internal valves.
o Proportional valves control the flows of each gas according to the electrical current sent by the
electronic control board as follows: one high flow valve to control compressed air, one high flow
valve for oxygen, and one low flow valve to control the flow of oxygen that feed the Venturi tube’s
injector.
o The gas mixture chamber is where the gases that derive from the proportional valves come
together. The same are endowed with unidirectional valves in order to avoid the mixture’s return
to one of the gas branches; avoiding gas “contamination” from one another.
o Solenoid valves are fed with compressed oxygen. One of the valves is used to pilot the
overpressure valve in order to shut off the power supply during excess pressure situations; thus,
relieving airway pressure. The other solenoid valve is used to feed the nebulizer. A third solenoid
valve is used to feed the Venturi tube.
o The Venturi system is available for situations in which compressed air is unavailable. By using an
oxygen cylinder, the patient can be ventilated with a mixture of ambient air and oxygen in
concentrations from 35% of FiO2. In the vacuum chamber, the Venturi captures ambient air by
the ambient air inlet through the unidirectional valve. Every Venturi tube system has an airway
pressure and flow limitation. The adjustable concentration curve has a flow range in which low
concentration values of oxygen can be adjusted. This flow range is narrowed when airway
pressures are elevated. A Venturi system with a reduced nozzle injector orifice was projected for
low flows. The FlexiMag or “Double Venturi System” (Patent required) is used for high flows.
4. Ventilation parameter monitoring system with flow and pressure sensors

o FlexiMag’s ventilation and alarm parameter monitoring system works with two hot wire
anemometer flow sensors. One of the sensors measures the inspiratory flow and an external
sensor at the expiratory valve outlet. The instant difference among flows gives the flow that enters
or leaves the lung. Airway pressure is measured at the ventilator’s outlet. All other parameters are
obtained through calculations.
5. Video touchscreen monitor with a second independent electronic, microprocessed control

board.
o The communication interface board with the user is controlled by a second microprocessor,
which:
realizes touchscreen acquisitions and the rotation and confirmation button in order to obtain
the desired adjustment by the equipment’s operator;

17
communicates itself constantly with the pneumatic control system in order to:
• Obtain monitored parameters, such as: instant pressure, volume, and flow, besides
tidal volume, average, pressure, inspiratory and expiratory periods, frequency values,
etc., and alarm actuation;
• send parameter adjustments concerning ventilation control, alarms, and ventilator
configuration;
• Control the display of screens, adjusted data, or monitored graphic data and visual
alarms.
Controls the execution of audible alarms and actions the high priority LED alarm indicator.
6. Software dedicated (firmware) to the general control of pneumatics, monitoring, graphic

screen presentation, parameter and alarm system parameters;
7. Internal battery that permits operation without power supply for as much as 180 continuous
minutes under normal patient ventilation conditions.
Attention
• Do not remove the battery. Seek authorized service for its substitution or repair.
• The battery’s disposal must obey local applicable legislation.
4.4. Other Characteristics
Optional accessories to this equipment are described in chapter 11. FlexiMag and BabyMag can be used
with:
• Nasal prong for CPAP neonatal and respective respiratory circuit.
-1
• A Limbo respiratory circuit of 6 ft. with maximum resistance of 3.69 mbars/L.s (during inspiration)
-1
and 4.39 mbars/L.s (during expiration).
-1
• Tracheal respiratory circuits with resistance lower than 0.3mbar/L.s .
• Simple adult, pediatric, and neonatal Facial Masks
• HME Elliptic 88x58x28 HME Filter registered by ANVISA
• Masimo disposable sensor
• TGI Kit
• Nebulizer

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5. Unpacking the Product

5.1. Initial Verifications
Item Verification Approved
Verify if the package is intact by looking for dents, wholes, or other damages.
Notes
1 • If the package is damaged, immediately contact the responsible carrier OK NOK
and Magnamed.
• Do not open the package.
2 Carefully open the package observing the box’s indications OK NOK
3 Verify the content OK NOK
5.2. FlexiMag’s Relation of Components

The following items are supplied integrating the device and are exclusive to the same.
Item Code Description QTTY UN Picture or Image
FLEXIMAG - 10.4 INCH

NEONATAL PEDIATRIC
1103050
ADULT ELECTRONICAL
LUNG VENTILATOR
1 01 PC
FLEXIMAG - 15 INCH
NEONATAL PEDIATRIC
1103760
ADULT ELECTRONICAL
LUNG VENTILATOR

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ICU ADULT RESPIRATORY

CIRCUIT WITH STRAIGHT
2 1703038 01 PC
Y AUTOCLAVABLE
COLLECTOR
ARTICULATED ARM FOR

RESPIRATORY CIRCUIT
3 1702667 01 PC
SUPPORT
ARTICULATED ARM
4 3803734 01 PC
SUPPORT
O2 DISS EXTENSION X2
5 3902647 01 PC
10ft.
DISS AIR EXTENSION X2

6 3903114 01 PC
10ft.

20
KIT WITH 5 SPIROQUANT

7 1703938 01 PC
ENVITEC FLOW SENSORS
ENVITEC SENSOR CABLE

8 2803779 WITH REDEL 6 PINS 01 PC
(EXTERNAL) - FLEXIMAG
9 5003782 Assembly Guide 1 PC

10 5003785 Ventilator assembly key 1 PC
11 5003783 Ventilator assembly screw 4 PC
3 WAY ASSEMBLY AC
NETWORK CABLE 5ft. –
12 2802612 01 PC
NEW NBR STANDARD
14136
O2 concentration
measurement cell (galvanic)
1702105 1 PC
kit
13
O2 concentration
1702510 measurement cell (galvanic) 1 PC
set

21
110XXXX-NE-22-
14 Operation Manual 1 PC
RR
5.3. BabyMag’s Relation of Components

The following items are supplied and integrate the device and are of exclusive use of the same.
Item Code Description QTY UN Picture or Image
BABYMAG - 10.4 INCH

1103040 NEONATAL ELECTRONICAL
LUNG VENTILATOR
1 01 PC
BABYMAG - 15 INCH
1103360 NEONATAL ELECTRONICAL
LUNG VENTILATOR
ICU ADULT RESPIRATORY

CIRCUIT WITH STRAIGHT Y
2 1703036 01 PC
90 AUTOCLAVABLE
COLLECTOR
ARTICULATED ARM FOR

RESPIRATO
RY CIRCUIT
3 1702667 SUPPORT 01 PC

22
ARTICULATED ARM
4 3803734 01 PC
SUPPORT
O2 DISS EXTENSION X2
5 3902647 01 PC
10ft.
DISS AIR EXTENSION X2

6 3903114 01 PC
10ft.
KIT WITH 5 SPIROQUANT

7 1703938 01 PC
ENVITEC FLOW SENSORS
ENVITEC SENSOR CABLE

8 2803779 WITH REDEL 6 PINS 01 PC
(EXTERNAL) - FLEXIMAG
9 5003782 Assembly Guide 1 PC

10 5003785 Ventilator assembly key 1 PC
11 5003783 Ventilator assembly screw 4 PC

23
3 WAY ASSEMBLY AC
NETWORK CABLE 5ft. –
12 2802612 01 PC
NEW NBR STANDARD
14136
O2 concentration
measurement cell (galvanic)
13 1702105 1 PC
kit
O2 concentration
1702510 measurement cell (galvanic) 1 PC
set
110XXXX-NE-22-
14 Operation Manual 1 PC
RR

24
6. Component Identification
6.1. FlexiMag / BabyMag’s Frontal View
2
3
4 8
5
6
Image 2 – FlexiMag’s Front View
1 – ALARM INDICATOR LIGHT – RED
The alarm indicator light flashes when there is a high priority alarm condition. In silent mode, this light
remains activated indicating an alarm condition.
2- LCD WITH TOUCHSCREEN
Visual and graphic presentation of touchscreen adjustment parameters, monitored parameters (Volume,
Pressure, Frequency), fast access buttons (Stand-By, Manual, O2 100%, Hold Insp, Hold Exp, Lock) and
access menu to the system. The Graphic Screen’s description is detailed in section 6.2 Identification of
Display Areas.

25
3 - ADJUSTMENT AND CONFIRMATION INDICATOR BUTTON WITH POWER SUPPLY INDICATOR
This button is used for most parts of the adjustments that are realized in the ICU FlexiMag/Babymag
Ventilator. When a parameter is selected, rotating the button clockwise and counterclockwise will alter the
parameter’s value.
The confirmation of the new value occurs by pressing the button or touching the selected parameter again.
Image 3 – Rotation and Confirmation Button
This button also indicates if the equipment is plugged to a power source:
• the button will remain green when the equipment is plugged to a power source
• the button will remain blue when the equipment is working without being plugged to a power source.
Notes
• Select a parameter to be adjusted on the display screen by using the corresponding button.
• The selected button will change colors, permitting the alteration of values or adjustments.
• Adjust the desired value by rotating the button clockwise or counterclockwise.
• In order to confirm, press the button or touch the adjustment parameter again.
• When the button returns to its original color, the adjusted parameter will be activated.
•
Warning
• In the event there is an adjustment confirmation after 10 seconds, the parameter’s value and
the button will return to the previous state.
4-NEBULIZER/TGI
Nebulizer or TGI connection. The adjustments will be available on the CONFIG screen in order to activate
these functions.

26
5- INSPIRATORY LIMB CONNECTOR

For this connection, the ventilator’s respiratory circuit’s inspiratory limb must be employed.
6- EXTERNAL FLOW SENSOR CONNECTION

Power cord outlet that must be connected to the external sensor.
7 – EXPIRATORY LIMB CONNECTOR

In this connection, the expiratory valve and the external sensor must be connected, according to what is
described in item 5 of section 7.1 FlexiMag Assembly – ICU Ventilator.
8- HANDLE
This handle helps with the ventilator’s intrahospital transportation.
9- CASTERS
Casters help with the ventilator’s intrahospital transportation.
6.2. Ventilator’s Rear View
Image 4 – FlexiMag’s Rear View

27
1- LABEL
This label has information pertaining to Magnamed, the Authorized European Representative, ANVISA
registration number, manufacturing month and year and series number.
2- ON/OFF SWITCH
On/Off Switch. This switch starts the equipment’s operation. However, when it is on the off position it is
important to maintain the equipment plugged to a power source in order to continue charging the battery,
whenever necessary.
3- POWER SUPPLY INLET

Ventilator’s power supply inlet of 90 to 240 Vca 50-60hz via power cord that accompanies the ventilator.
This power cord has a 3 pin connector that must be coupled to a duly grounded electrical grid.
Make sure the power cord is secured by its loop.
4- FUSE HOLDER
This compartment carries two fuses (made out of glass – 0.79 in – 1A/250V) for protection against
overcurrent coming from the electrical grid. It has a bayonet system with total fuse expulsion, facilitating
substitution and avoiding electric shocks.
5- COMPRESSED AIR INLET

Connect to medical compressed air. The inlet pressure must be in the 60 to 150 psi (414 to 1034 kPa) range.
Standard DISS connection (ABNT NBR-11906:1992).
6- OXYGEN INLET
Connect oxygen. The inlet pressure must be in the 60 to 150 psi (414 to 1034 kPa) range. Standard DISS
connection (ABNT NBR-11906:1992).

28
7- WATER TRAP WITH COALESCENT FILTER FOR GAS UNDER HIGH PRESSURE
In order to remove accumulated water, press the pin found at the bottom of the collector.
In order to substitute the filter, follow the instructions below:
1. Remove the collector with 2. Unscrew the filter 3. Change the filter and screw
the O-ring a new filter into the
equipment
4. Change the filter and screw a new filter into the equipment
Attention
• Do not expose the filter to materials that are incompatible to polycarbonate
• Substitute the filter whenever it is obstructed so that it will not diminish the equipment’s flow
inlet.
8- INMETRO SEAL

29
7. Preparation for Use

7.1. Assembly – ICU Ventilator
OK Item Assembly Instructions Illustration
Install a diaphragm and an expiratory valve in

adequate conditions according to the presented
image.
1
Warning
• Correctly position the diaphragm and the
expiratory valve in order to avoid the
expiratory limbs obstruction.

30
Adequately connect the flow sensor and follow the

instructions on the right.
2 Warning
• All connections must be realized FIRMLY
in order to avoid leaks.

31

Prepare the patient’s respiratory circuit; firmly
connect the inspiratory limb to the gas mixture flow
source.
Attention
3
• Use the respiratory circuit that is
adequate to the patient.
The expiratory circuit’s limb must be firmly connected

4
to the expiratory valve.
In the event the CO2 Sensor (optional item) is used,

realize the assembly right after the flow sensor
according to what is showed on the figures to the
right.
Connect the airway adapter to the CO2 sensor and,
afterwards, realize a firm connection of the flow
sensor’s set.
5
• Remember that by adding the CO2
sensor, the HME filter will have increased
its resistance and, consequently, its
counter pressure and its dead space.

32

In the event the respiratory circuit with CO2 sensor
and HME filter (Heat and Moisture Exchange),
realize the assembly according to the instructions
presented in the image.
Attention
• Use MAGNAMED specified HME FILTERS.
In the event the respiratory circuit is used for NON

INVASIVE VENTILATION (NIV) with masks, besides
the filter and CO2 sensor, follow the instructions on
the image to the right.
7
Attention
• Use MASKS specified by MAGNAMED.
• Use the adequate MASK for the type of
patient.

INVASIVE VENTILATION (NIV) with the use of mask
and without the filter, follow the assembly on the
8
right.

33

INVASIVE VENTILATION (NIV) without filter.
9

INVASIVE VENTILATION (NIV) with mask and HME
10
filter, follow the assembly to the right.

34
In the event the capnography sensor (CO2) is used,

connect the cable to the right lateral panel according
to what is indicated in the illustration.
11 Attention
• The CAPNOGRAPHY connector has a
BLUE indication.
• Use the acquired CAPNOGRAPH by
MAGNAMED.
Connect the power cord to the equipment.

12

35
Equipment connection to gas network:
• Connect an Air hose in the indicated

connection according to the illustration to the
right.
• Connect an O2 hose to the indicated

connection according to the illustration to the
right.
13
Attention
• Pressures superior to 150 psi (1035 kPa)
can damage the equipment.
• The gas network connected to the
equipment must attend to ABNT NBR
12188 standards.
7.2. Connection to Power Supply

The equipment must be connected to a three-pin grounded electric outlet that attends to ABNT NBR 13534
standard – “Electrical installations in healthcare establishments – Safety requirements”.
The equipment’s internal battery must always be charged and ready for use in an eventual electric grid
failure or for external operations. In that case, a power source should be connected to the electrical grid in
order to charge the battery even when the equipment is turned off.
After prolonged use of the equipment with only the internal battery, the same must be completely recharged
in order to prepare the equipment for the next use.

36
The battery must be completely recharged in the event the equipment remains disconnected from the
electrical grid for over a month.
Warning
• If during prolonged use of a FlexiMag and BabyMag Ventilator with battery a LOW BATTERY
alarm message appears, provide IMMEDIATE connection to the electrical grid power source.
In the event it is not possible, DISCONNECT the equipment from the patient and provide
adequate means of ventilation support.
7.3. Verifications Before Use

The object of this inspection routine is to guide the user during a simple and fast procedure that consists of
testing the equipment before each use, or, at least, at the beginning of each work period, guaranteeing more
reliability.
Warning
• Realize this verification before each procedure. In the event there is a failure during the
verification, DO NOT USE THE DEVICE. Correct the problem or provide technical assistance.
7.3.1. Initial procedures
OK Item Verifications
1 Verify if the equipment is turned off.

Realize a visual inspection concerning the equipment and its components, looking to identify
2
their intactness.
3 Verify if all of the equipment’s components are correctly connected and inserted.
Verify a firm connection to the expiratory valve. It is important to verify the diaphragm’s
4
presence.
5 Verify a firm connection of the external flow sensor to the expiratory valve.
6 Verify a firm connection to the adequate respiratory circuit to the patient to be ventilated.
7 Verify a firm connection between the oxygen gas and air hoses.
8 Verify if the network’s pressure is between 60 and 150 psi (414 to 1035 kPa).

37
OK Item Verifications
Verify a firm connection of the electric cord, when applicable. The FlexiMag/BabyMag
Ventilator may be operated with a battery for up to 180 continuous minutes under normal
patient ventilation conditions.
9 Warning
• If during prolonged use of a FlexiMag and BabyMag Ventilator with battery a
LOW BATTERY alarm message appears, provide IMMEDIATE connection to the
electrical grid power source. In the event it is not possible, DISCONNECT the
equipment from the patient and provide adequate means of ventilator support.
Select the type of patient according to what is described in item 7.3.2 Equipment’s Initial
10
Display.
11 If all items are check marked as OK, the equipment is ready for use.

38
7.3.2. Equipment’s Initial Display
The following screen will be presented when the equipment is turned on:
Select Patient to access ventilation screen: adult Select adjustment to access ventilation screen:
pediatric neonatal standard adjustment, last adjustment
(B)
BabyMag
(A)
FlexiMag
(A) (B)
Image 5 - FlexiMag and BabyMag initial screen
1- PATIENT SELECTION BUTTONS
The type of patient will be defined when the FlexiMag button is selected and will initiate the ventilation
parameters, considering the table below:
Ideal Body Weight lb.

Button Patient Initial Modality
(kg)
7.3.3 NEONATAL 7.3.4 PLV 7.3.5 6.16 lbs. (3.0)

39
7.3.6 PEDIATRIC 7.3.7 PCV 7.3.8 43.56 lbs. (19.8)
7.3.9 ADULTO 7.3.10 VCV 7.3.11 108.9 lbs. (49.5)
LAST ADJUSTMENT LAST ADJUSTMENT LAST ADJUSTMENT
st
BabyMag will start by following the configuration established in previous table’s 1 line.

40
1.1 NORMAL STARTUP SEQUENCE
SEQ Operation 7.3.12 Screen(s)

Turn on the ventilator by using the on/off
switch on the bottom of the equipment.
When selecting the type of patient the

FlexiMag equipment will use (touching the
LCD screen at the patient button’s position),
the ventilator will be initialized in the indicated
modality regarding the table in item 7.3.2.
The last parameters saved when the

equipment was turned off last can be
recovered on both equipments. This save is
automatic.

41

The main screen will be shown according to
the images on the right. The beep will be
silenced during the first two minutes and the
equipment will be on Stand-By.
Fleximag
By selecting the ventilation modality, its

configuration screen will be presented. Please
note that the active modality will remain
selected in the upper right side.
As a respiratory modality is selected on the

left column, the modality’s adjustable
3 parameters will be presented in the white
central area.
In order to modify a parameter, after selecting BabyMag

the modality to be activated:
• Follow the instruction from item 1,

table of section 7.3.4.

42
In order to exit this screen, confirm a modality

by pressing the CONFIRM button or discard
4
the modality’s alteration by pressing the
CANCEL button.
7.3.3. ICU ventilator main functions

SEQ Operation Screen
Ventilation parameter adjustment
Select the button that corresponds to

the parameter that must be adjusted.
The same will remain selected (will
change color) permitting value
alteration using the turn/confirm
button.
1 In order to confirm the adjusted value,

select the corresponding button to the
adjustment parameter again or select
the turn/confirm button.
Button without selection – Selected button – Alteration of
Refer to item 8.1.12. turn and confirm button – Adjustment confirmation –
altered parameter

43
Alarm adjustment
After selecting the ALARM Menu, the

screens on the right hand side will be
presented.
If the capnograph or oximeter is

connected to the equipment, the
alarms that are related to the
connected device will be exhibited.
To alter the alarm, select the

parameter to be altered selecting its
value. Adjust the desired value using
the turn/confirm button and activate Alarm Menu without capnograph or oximeter connected
the adjusted value by pressing the
turn and confirm button or pressing
the parameter once again.
To enable automatic adjustment, the

ventilator must not be on STAND-BY.
Alarm Menu without capnograph connected
Alarm Menu with oximeter connected

44

On the right hand side we find an
indication of the alarm adjustment Parameter
structure.
Superior Limits
Inferior Limits

45
8. Use Instructions
8.1. Items of the Ventilator’s Main Screen:
(B)
(A) BabyMag
FlexiMag
Image 6 - ICU Ventilator Main Screen
Image 6 presents FlexiMag(A) and BabyMag(B) ventilators´ main screen.
On the following image (Image 7), the main screen’s functions will be indicated. Observe that the functions
are the same for both equipments.

46
Image 6 - Main Screen’s function indications
8.1.1. Status area ( item 1)

• Cycling – Representative icon of a lung, which indicates if the equipment is cycling, “inflating” in the
inspiratory phase and “disinflating” in the expiratory phase.
• Patient – The selected patient determine the ventilator´s initial adjustments, the available modes, the
standard mode selected, the parameters and alarms´ standard values, as well as its adjustment
ranges.
• Battery – Battery status, which can vary between the following statuses:
Battery charged and equipment connected to power supply.

47
Battery charging with equipment connected to power supply.
Battery charged and in use. Equipment disconnected from power socket or inoperant power
supply.
Battery with partial charge and in use. Equipment disconnected from power socket or
inopearant power supply.
Battery with minimum charge and in use. Equipment disconnected from power socket or
inoperant power supply. Weak battery alarm can be actioned.
8.1.2 Alarm’s message display area (item 2)
This area shows the alarms. The alarms are classified in high and medium priority. For more details
concerning alarms, refer to section 8.3.1 Alarms in decreasing order of priority:
8.1.3 Alert messages display area (item 3)
This area will show the ventilator’s alerts and messages. For more information concerning these messages,
refer to section 8.3.2 Alert Messages.
8.1.4.Deactivated audible alarm indicator/button (item 4)
This indicator will be exhibited when the audible alarm is deactivated for a maximum of 2 minutes.
8.1.5 Display and mode selection area (item 5)

This area exhibits the configured Modality.
8.1.6.Monitored parameters display area (item 6)

Area that displays graphics or one of the available menus on the equipment.
8.1.7 Monitored parameters display area (item 7)

Basically, there are 19 monitored parameters divided into three pages.

48
In order to alter the shown page, select the page you wish to see on the monitor´s screen or on the monitor´s
activated screen at the left.
This area shows the monitored parameters that are related to the selected page.
The information concerning the parameter is shown in below: Alarm indication for the
parameter
Parameter Alarm’s Superior Limit
Description
Alarm’s Inferior Limit
Parameter unit
Image 7 - Description of the exhibited monitored parameters

49
8.1.8 Quick access functions (item 8)
This area shows the buttons that activate quick access functions.
Button Function Description
Activate or deactivate the stand-by mode. On stand-by, the alarms are

STAND-BY
interrupted and ventilation is paused.
MANUAL CYCLE Manually start the inspiratory cycle.
Maintains 100% of oxygen concentration during 90 seconds after it is

O2 100% selected. This resource may be used for pre and post aspiration
procedures regarding airway secretion.
Permits the realization of inspiration suspension maneuvers used in

INSPIRATORY thorax X-rays.
Inspiration will be prolonged for 5 seconds. After this period, the Cest
HOLD parameter will appear for 5 seconds on the parameters area’s first
position. Then, the superior area to the monitoring area will exhibit the
previously exhibited parameter.
Permits extension maneuvers regarding expiration time (prolonged

EXPIRATORY expiration time).
Expiration will be prolonged for 5 seconds. After this period the PEEPi
HOLD parameter will appear for 5 seconds on the parameters area’s first
position. Then, the superior area to the monitoring area will exhibit the
previously exhibited parameter.

50
Lock or unlock touchscreen. When the commands on the display are

locked, select this button to immediately unlock them.
In order to lock them again, select the button once or wait 30 seconds
without touching the screen.
KEYBOARD Notes
LOCK (LOCK)
• Only adjustment functions will be locked on the ventilator.
It enables navigation on the equipment, parameter
visualization, and alternation between ventilation and
stand-by mode.
8.1.9 Status indication area (item 9)

This area exhibits the Equipment’s Menu options:
• MONITOR MENU – Exhibits a Tab will all monitored parameters.

51
Image 8 – Monitor Menu Display
• GRAPHIC MENU – Configures the presentation of graphics. To alternate between the

displayed graphics, select the area on the graphic.
Image 9 – Graphic Menu Display
Descriptions regarding graphic visualization are shown below:

1. Display of graphics in function of time:
52
a. Pressure x Time
b. Flow x Time
c. Volume x Time
2. Display of loop graphics and graphics in function of time:
a. Loop Volume x Pressure
b. Loop Flow x Volume
c. Pressure x Time
d. Flow x Time
e. Volume x Time
3. Display of graphics in function of time including external sensor graphics (oximeter

or capnograph - optional). This graphic option will only be available when one of the
sensors is connected:
a. Pressure x Time
b. Flow x Time
c. CO2 x Time or SpO2 x Time
4. Display of loop graphics and graphics in function of time including external sensor
graphics (oximeter or capnograph - optional). This graphic option will only be
available when one of the sensors is connected:
a. Loop Volume x Pressure
b. Loop Flow x Volume
c. Pressure x Time
d. Flow x Time
e. CO2 x Time
f. SpO2 x Time

53
• CONFIG MENU – Ventilator´s patient configuration, sensor calibration, and general

preferences.
Options:
o Information concerning equipment´s pressure (regulated) supply
o Information concerning technical assistance (usage time and maintenance)
o Type of patient
o Patient´s height and ideal weight
o Ventilation auxiliators (NIV, NEB, TGI)
o Measurement units
o Language
o Sensor calibration
o Ventilation curve filling
Image 10 – CONFIG Menu Display
• ALARM MENU – Configures the equipment’s alarms. Refer to item 8.4 for more details.

54
Image 11 – Alarm Menu Display
• TREND MENU – Configure tendency graph´s display of up to three parameters.
Time selection
displayed on graph
Selection of up to
three parameters to
be displayed on
graph
Image 12 – Tendency graphics configuration tab

55
On this tab, select the data time to be exhibited and up to three parameters for the trend graph.
- While the equipment recovers the requested data, an hourglass will be displayed with the message bellow
while simultaneously updating the graph with the selected parameters current data at the right hand side:
Image 14 – Data recovery indicating for trend graph assembly (Wait… Loading trend)
- After all the recorded data are displayed on the trend graph, the previous message will no longer be
displayed as from this moment when touching the graph area. The trend graph will be frozen and will display
a cursor in order to scroll down the trend graph and the verification of the presented data:
1 3
4
2
5
Image 13 – Indication of the trend screen´s parts
- Description of the items indicated in Image 15 of the trend graph:

1) Events panel –Indicates the occurrence of Stand-by, Alarms and/or graph adjustments.
2) Cursor – scrolls over the graph making it possible to analyze the points on the graph
3) Indicates the selected time in the trend graphic´s configuration
4) Date and Time of the data of the point where the cursor is located
5) Measured values of selected parameters in the trend graph´s configuration. This value refers to the
point where the cursor is located.
6) Type of patient configured on the cursor´s indication.
56
7) Configured respiratory mode on cursor´s indication.

8) Values of the adjusted parameters on the cursor´s indication.
9) Alarms hat occurred on the cursor´s indication.
- In order to place the cursor over the trend graphs, click on the desired position. The cursor will move to the
closest point from the indicated position. For a more specific cursor position, rotate the turn-confirm button.
8.1.10 Exhibition of adjustable parameters (item 10)

This area will display the active modality’s parameters. 6 parameters at a time will be shown. In order to
display other parameters, turn the turn-confirm button without a selected parameter in order to show those
that are not being displayed.
Image 14 – Modality´s adjustment parameters
In order to choose a parameter, select the desired parameter and the corresponding button will change color
indicating the parameters have been selected; therefore, it may be altered:
Image 15 – Parameter alteration selection
8.2. Alteration of patient configuration on FlexiMag

In order to alter the type of Patient, it is necessary to place the equipment on stand-by on the menu´s
CONFIG option.

57
Image 18 – Alteration of patient type
The patient type selection will define the ventilation configurations according to the following table:
Button Patient Initial Mode Weight
NEONATAL PLV 3,0Kg
PEDIATRIC PCV 19,8Kg
ADULT VCV 49,5Kg
Defining the patient will determine his or her height adjustment limit in order to determine the patient´s ideal
weight. Therefore, the ideal weight is calculated based on a Body Mass Index (BMI) of 22 for adult patients
and 15 for pediatric and neonatal patients.
N O T E S
FOR BabyMag, only Neonatal adjustments are enabled
•
• Warning
• Always USE the respiratory circuit that corresponds to the patient that will be ventilated
8.2.1. Patient Configuration Alteration (FlexiMag and BabyMag)

In order to alter the selected patient’s ideal weight, the “Ventilator Configuration” tab must be selected on the
ventilator’s CONFIG menu.

58
Image 19 - Patient’s height adjustment
Simply adjust the height and Vol/Weight of the patient’s area in order to redefine the parameters that depend
on the patient’s ideal weight. The height adjustment follows the following table:
Height [m]
Ideal Weight
Patient
P[ kg]
Min Max
NEONATAL 0.19 0.63 P <= 5.9
PEDIATRIC 0.64 1.20 6.0 < P <= 21.6
ADULT 1.21 2.50 P >= 32.2
Notes
• For BabyMag, only Neonatal adjustments are enabled
Warning
• Always USE the respiratory circuit that corresponds to the patient that will be ventilated
8.2.2. Adjustments that depend on Patient configuration

The patient’s ideal weight is used in order to calculate the ventilator’s adjustment parameters to promote
better approximation to ventilate the patient. This value is calculated by using the patient’s height value,
considering BMI = 22.
The parameters that are calculated considering weight are:
• Volume – calculated considering the adjusted value in the Vol/Weight parameter (CONFIG Menu,
“Ventilator Configuration” tab).
• Frequency –internal calculation function to the system
• I:E Ratio - 1:2
• Inspiratory Flow – calculated considering the obtained TINS
The following parameters will have the following standard values:
• Maximum Pressure – 15 cmH2O
• PEEP – 5 cmH2O
• Plateau Pressure – 30 % of TINS
• Flow – Square
The following tables present the available modalities for each type of patient:
59
Type of Patient Flow Sensor** Available Modalities
(1)(2) PLV, P-SIMV, CPAP/PS,

NEONATAL NEO
DualPAP
PEDIATRIC(1) INF VCV, PCV, V-SIMV, P-

SIMV, V-SIMV, CPAP/PS,
ADULT(1) ADU PRVC, DualPAP*
(1)
Available for ICU Ventilator - FlexiMag
(2)
Available for ICU Ventilator – BabyMag
* Optional
** Valid for proximal flow sensor
Notes
• The type of patient selection will realize the ventilator’s initial configuration and will enable the
determined ventilation modalities.
• Body Mass Index Formula.
Weight [lb]
BMI = ------------------------
(Height [in])2
8.3. Available Alarms

Warning
• When receiving alarm information, provide prompt attention in order to solution the problem.
• After the situation that needed total silence from the audible alarm has ended, reactivate it for
the patient’s security.
Attention
• There may be danger if different pre-configuration alarms are used for the same equipment or
for similar equipment in one area, such as: an intensive treatment unit or a cardiac surgery
room.
Alarm Classification
HIGH PRIORITY Description
When an internal battery has low battery, adequate ventilator support means must be
LOW BATTERY
provided to the patient.
It means the time elapsed since the last inspiration is superior to the adjusted alarm
APNEA
value to indicate apnea.

60
The oxygen pressure network is below 60psi (414 kPa). This alarm will not be activated if
LOW O2
the O2% parameter is 21% (air) and the air network is working within the required
PRESSURE
specifications.
The oxygen pressure network is below 60psi (414 kPa). This alarm will not be activated if
LOW AIR
the O2% parameter is 100% and the Oxygen network is working within the required
PRESSURE
specifications.
OBSTRUCTION There’s an obstruction in the respiratory circuit that prevents the patient’s total expiration.
There was a disconnection from the respiratory circuit or flow sensor lines, if any, which
DISCONNECTION
prevents the patient’s adequate ventilation.
HIGH MAXIMUM
The reached pressure surpassed the adjusted alarm value as the superior pressure limit
PRESSURE
LOW MAXIMUM
The pressure did not reach the adjusted alarm value as the inferior pressure limit
PRESSURE
HIGH ETCO2 The exhaled CO2 rate surpassed the adjusted alarm value as a superior ETCO2 limit.
LOW ETCO2 The exhaled CO2 rate is below the adjusted alarm value as an inferior ETCO2 limit.
HIGH CO2 I The inhaled CO2 surpassed the adjusted alarm value as a superior CO2i limit.
HIGH FC The patient´s heart rate surpassed the adjusted alarm value as a superior limit.
LOW FC The patient´s heart rate is below the adjusted alarm value as an inferior limit.
LOW SPO2 The O2 saturation rate is below the adjusted alarm value as an inferior SpO2 limit.
LOW PRIORITY Description

The positive pressure at the end of the exhalation (PEEP) surpassed the adjusted alarm
HIGH PEEP
value as its superior limit.
The positive pressure at the end of the exhalation (PEEP) is below the adjusted alarm
LOW PEEP
value as its inferior limit.
HIGH CURRENT The volume given to the patient surpassed the adjusted alarm value as a superior limit of
VOLUME the total volume.
LOW CURRENT The volume given to the patient is below the adjusted alarm value as an inferior limit of
VOLUME the total volume.
HIGH MINUTE The given minute volume to the patient surpassed the adjusted alarm value as its
VOLUME superior limit.

61
LOW MINUTE The given minute volume to the patient is below the adjusted alarm value as its inferior
VOLUME limit.
HIGH FREQUENCY The patient’s breathing rate surpassed the adjusted alarm value as its superior limit.
LOW FREQUENCY The patient’s breathing rate is below the adjusted alarm value as its inferior limit.
HIGH FIO2 The inhaled O2 fraction surpassed the adjusted alarm value as its superior limit.
LOW FIO2 The inhaled O2 fraction is below the adjusted alarm value as its inferior limit.
IRMA This alarm indicates two conditions: or the IRMA sensor is not connected or it must be
ADAPTER substituted.
RESTART IRMA Indicates that the IRMA CO2 sensor must be disconnected or reconnected.
SUBSTITUTE IRMA Indicated that the IRMA CO2 sensor must be substituted
CO2 OUT OF Indicates that the CO2 read is incorrect or imprecise.

SCALE
Indicates the occurrence of one of the situations that prevents the correct IRMA sensor
reading:
IRMA READ
ERROR • The operation’s internal temperature is out of scale
• The operation’s environment pressure is out of scale
CALIBRATE IRMA Indicates the need to offset the IRMA CO2 sensor
WITHOUT POWER It means that there is now electricity from the power supply.
SOURCE
It indicated that the SpO2 sensor is connected to the equipment; however, it is off the
SPO2 SENSOR patient´s finger.
Indicates:
• The oximeter is not connected to the sensor, or;
• The sensor connected is defective, or;
VERIFY SPO2
• Interference detected, or;
• Too much environment light, or;
• Unknown sensor.
VERIFY THE PLUG Indicates the plug is disconnected.
LOW PERFUSION Indicates low perfusion.

SEARCHING FOR
Indicates the oximeter is searching for pulse.
PULSE
ACTIVATING SPO2 Indicates the oximeter is being activated.

62
SPO2 DEMO Indicates the oximeter is generating a demo curve.
The pressure ranges of the audible alarm sound are:

• High priority 64dBA
• Medium priority 62Dba

63
8.3.1. Alert messages:

ALERT Description
When the monitored pressure reaches the adjusted maximum pressure. In this
LIMITED
event, the volume delivered by the ventilator module does not reach the adjusted
PRESSURE
volume due to a pressure limitation.
Indicates that the proximal sensor flow is disconnected. In these conditions, all
monitoring depend from this sensor (VT, MV, Frequency, Vins, Tinsp, I:E, T exp,
FLOW SENSOR
Cest, Cdin, Res, τ , iT, Leakage Volume, Graphic V x Time) WILL NOT be
DISCONNECTED
presented. Ventilation modalities that are controlled by volume and the volumes that
will be delivered by the equipment will have a variation of up to ±10%.
ASSIST. TRIGGER Indicates the occurrence of an assisted trigger generated by an increase in
FLOW inspiratory flow.
ASSIST. TRIGGER Indicates the occurrence of an assisted trigger generated by pressure fall.
PRESSURE
ASSIST. TRIGGER Indicates the occurrence of an assisted trigger manually generated by the operator.
MANUAL
SPONT. TRIGGER Indicates the occurrence of a spontaneous trigger generated by an increase in
FLOW inspiratory flow.
SPONT. TRIGGER Indicates the occurrence of a spontaneous trigger generated by pressure fall.
PRESSURE
SPONT. TRIGGER Indicates the occurrence of a spontaneous trigger manually generated by the
MANUAL operator.
8.3.2. Alarms and Security System – Adjustments:
Warning
• When the ventilator is restarted or when the type of patient is changed, the alarms will
assume the standard values according to the previous table and type of patient.
• Apnea Time can be “RESET”. In this condition there will be no information concerning apnea
condition and will be no backup ventilation in action. The equipment’s operator must be
aware of a DEACTIVATED Apnea Alarm condition (INDICATIVE ON THE DISPLAY).
• The alarm limits automatic adjustment (item 18 of the table above) adjusts the alarms for a
calculated percentage over the monitored value during the ventilation. Therefore, it may only
be adjusted when the ventilator IS NOT on stand-by.

64
(1)
Standard Alarm Values
Item Alarm Adjustment Limit Unit
Neonatal Pediatric Adult
High 30 30 40
1 Maximum Pressure OFF, 0 to 120 cmH2O
Low OFF OFF OFF
High 10 15 20
2 PEEP OFF, 0 to 80 cmH2O
Low OFF OFF OFF
High 50 mL 200 mL 1.0 L

3 Total Volume OFF, 0 to 3000 L or mL
Low OFF OFF OFF
High 2.0 5 10
4 Minute Volume OFF, 0.0 to 99 L
Low OFF OFF OFF
High 80 60 60
5 Breathing Frequency OFF, 0 to 200 min-1
Low 5 5 5
High 80 80 80
6 FiO2 OFF, 21 to 100 %
Low OFF OFF OFF
High 45 45 45
7 EtCO2 OFF, 0 to 80 mmHg
Low 0 0 0
8 Inhaled CO2 OFF, 0 to 80 High 3 3 3 mmHg
High 180 120 120

9 FC OFF, 35 to 250 bpm
Low 80 40 40
10 SpO2 OFF, 30 to 100 Low 0 0 0 %
11 Apnea Time OFF, 5 to 60 High 15 15 15 s
Automatic Limit
12 (2) OFF, 10%, 20%, and 30% OFF N/A
Adjustment
(1)
Any time the equipment is initialized, when the type of patient is changed, or when the battery power
source ends without the ventilator being connected to an electric grid, the alarms will assume the standard
values indicated for each type of patient.
(2)
It may only be applied to alarms that are related to ventilation parameters (Maximum Pressure, Peep,
Minute Volume, and Breathing Rate).

65
8.3.3. Alarm Adjustment

In order to alter the alarms, select the Alarm menu from the main screen. A similar screen will be exhibited
as follows:
• Error! Reference source not found., if the ventilator does not have an oximeter or capnograph
connected;
• Error! Reference source not found., if an oximeter is connected to the ventilator;
• Image 18 , if a capnograph is connected to the ventilator;
•
Alarm’s Superior
Adjustment Limit
Without indication of
External sensor
Alarm’s Inferior alarms
Adjustment Limit
Image 16 - Alarm Menu without capnograph or oximeter connected to the ventilator
Indication of
oximetry
alarms
Image 17 - Alarm Menu with oximeter connected to the ventilator

66
Indication of
capnograh
alarms
Image 18 - Alarm Menu with capnograph connected to the ventilator
In order to alter the alarm value, select the circle with the value that must be altered. This circle will change
color, indicating that the parameter is selected (Image 18). Adjust the value using the turn/confirmation
button. In order to activate the adjusted value, select the value gain or press the turn/confirm button.
Image 19- High Pressure Alarm selected
In order to silence the audible alarms, press the silence button. The audible alarms will remain deactivated
for two minutes or until a new alarm condition occurs. After these conditions, the audible alarm will be
restored again.

67
8.4. Mode Configuration

In order to alter the mode, touch the current mode´s acronym on the screen´s upper right corner. This region
will change color indicating the selected mode change and will display the mode´s configuration screen,
according to Figure 24.
Shows active
mode on
Available ventilator
modes
according to
patient
Display and adjustment area

of all of the selected mode´s
parameters
Image 20 - Indication of the items of the mode´s configuration screen
In order to select a mode, select the desired mode´s tab. All adjustable parameters available for this mode
will be displayed. After adjusting the desired parameters, in order for the selected mode to become active,
it´s necessary to press the CONFIRM button.
In order to cancel the adjustments and remain with the previous adjustments, press the CANCEL button.
Thus, the ventilator will ignore the changed made on this screen and will return to the main screen.

68
8.5. Parameter Adjustment in each Modality

VCV – Volume Controlled Ventilation
Description: Adjusted Parameters:
• VOLUME;
In this modality, the ventilator controls the flow • FREQUENCY;
and cycles the volume; in other words, each • I:E RATIO;
inspiratory cycle, the ventilator delivers the exact • PEEP;
volume to the patient, provided that the pressure • MAXIMUM PRESSURE;
is not limited. The flow waveform will assume • INSP PAUSE (%);
square, descending, sinusoidal, and ascending • FiO2
forms.
• FLOW TRIGGER;
Observation • PRESSURE TRIGGER;
• This ventilation modality is not available • FLOW WAVEFORM;
for NEONATAL patients (weight
informed < 13.2 lbs.).
• Modality available for the FlexiMag
equipment
Image 21 –VCV Curves

69
As soon as all the ventilation parameters are received by the ventilator, the same calculates TINS, TEXP,
TPAUSE, FINS according to the I:E Ratio, Pause, and Frequency; thus, obtaining all ventilation control times.
1 - Ventilation without Inspiratory Pause, after TINS the ventilator cycles for expiration. The inspiratory
pressure reached is a consequence of the delivered volume and resistance and compliance of the patient’s
respiratory circuit.
2 - Ventilation with Inspiratory Pause, after the adjusted volume is delivered the ventilator maintains
interrupted expiration until TINS is completed. Afterwards, the ventilator cycles for expiration. The
characteristic is the pressure plateau formation (the gap between the peak and the plateau depends from the
airway resistance).
3 - If the pressure or flow trigger is activated, the ventilator searches to synchronize the start of the next
inspiration with the patient’s effort, according to the established levels. The information related to what type
of trigger activated the inspiratory cycle is informed in the status and messages area. The patient’s
inspiratory effort detection for synchronization occurs at moment during the expiratory time.
Observation
• When the patient starts to demonstrate the inspiratory effort and the ventilator has activated flow or
pressure triggers the same starts “to assist” the patient. Many times, this situation is referred to as
Controlled Assisted Ventilation.
• In controlled assisted ventilation, the monitored respiratory frequency may be greater than the
adjusted respiratory frequency.
4 - ASCENDING (or accelerated) wave flow.
5 - DESCENDING (or decelerated) wave flow.
6 - Sinusoidal wave flow.
7 - Pressure Limitation Representation. In this situation, the ventilator limits pressure on the adjusted value
and as a consequence of factors, such as: patient’s lung compliance and imposed pressure limit, the
adjusted volume IS NOT DELIVERED. This condition is informed on the messages and status area on the
screen (LIMITED PRESSURE message).
Warning
• By reaching the pressure limit defined on the Maximum Pressure adjustment (LIMITED
PRESSURE message), the Adjusted Volume IS NOT DELIVERED.
• The default values are only an initial reference. Readjusted the ventilation parameters
according to the patient’s needs.

70
PCV – Pressure Controlled Ventilation
In this modality, the ventilator controls the • PRESSURE INSP;

pressure and cycles time; in other words, at • FREQUENCY;
each inspiratory cycle, the ventilator reaches • I:E RATIO;
the adjusted pressure level and remains on this • PEEP;
level until the adjusted inspiratory time • FiO2
elapsed; therefore, the volume is a • FLOW TRIGGER;
consequence of the patient’s lung physiology • PRESSURE TRIGGER;
(compliance and resistance). Normally, by
• RISE TIME.
observing the flow curve, a peak flow can be
seen that decreases as time elapses.
Observation
• This modality is only available for
FlexiMag equipment.
Image 22 – PCV Curves

71
PCV – Pressure Controlled Ventilation
As soon as all of these ventilation parameters are adjusted on the ventilator, the same calculates TINS, TEXP
according to Frequency and I:E Ratio; therefore, obtaining all ventilation control times.
1, 2 - Pressure Controlled Ventilation – The ventilation seeks to reach the adjusted inspiratory pressure in
less time as possible. This is achieved by controlling the inspiratory flow. The Volume delivered to the patient
is a consequence of its respiratory circuit resistance and compliance. The ventilator remains on the adjusted
inspiratory pressure limit during TINS after which it cycles to expiration, maintaining the adjusted PEEP
pressure.
3 - If the pressure or flow trigger is activated, the ventilator seeks to synchronize at the beginning of the next
inspiration with the patient’s effort, according to the established levels. The information of what type of trigger
activated the inspiratory cycle is informed on the screen’s messages and status area. The detection of the
patient’s inspiratory effort in order to synchronize occurs at any moment during the expiratory time.
Observation
• When the patient starts to demonstrate inspiratory effort and the ventilator activates flow or pressure
triggers, the same “assists” the patient. This situation is referred to as Assisted Controlled
Ventilation.
• In an Assisted Controlled Ventilation, the monitored respiratory frequency may be greater than the
4 - The rise time can be adjusted by TRISE TIME, the initial peak flow. Generally, it is less than TRISE TIME = 0
(depending on the patient’s respiratory circuit resistance and compliance).
Warning
• Default values are only an initial reference. Readjust the ventilation parameters according to
the patient’s needs.

72
PLV – Pressure Limited Ventilation
In this modality, the ventilator limits the pressure • INSP PRESSURE;

and cycles on time; in other words, at each • FREQUENCY;
inspiratory cycle, the ventilator reaches the • INSPIRATORY TIME;
adjusted pressure and remains on this level until • PEEP;
the adjusted inspiratory time elapsed. The • FLOW ( );
volume is a consequence of the patient’s lung • FiO2
physiology (compliance and resistance). • FLOW TRIGGER;
Normally, when observing the flow curve, a peak
• PRESSURE TRIGGER;
flow decreases as time goes by.
Observation
• This ventilation modality is only available
for NEONATAL patients informed weight
≤ 13.2 lbs.).
• This modality is available for FlexiMag
and BabyMag equipment.
Image 23 – PLV Curves

73
PLV – Pressure Limited Ventilation
As soon as all ventilation parameters are adjusted on the ventilator, the same calculates TEXP according to
the Frequency and TINS; thus, obtaining all ventilation control times.
1, 2 - Pressure Limited Ventilation – The ventilator seeks to reach the adjusted inspiratory pressure, which
is realized through the expiratory valve’s occlusion. It is important to notice that the pressure’s rise time
depends from the continuous adjusted flow. The Volume delivered to the patient is a consequence of
his/her respiratory circuit’s resistance and compliance. The ventilator remains on the adjusted inspiratory
pressure level during TINS after which it cycles to expiration, maintaining the adjusted PEEP pressure.
3 - If the pressure or flow trigger is activated, the ventilator seeks to synchronize at the beginning of the
next inspiration with the patient’s effort, according to the established levels. The information of what type of
trigger activated the inspiratory cycle is informed on the screen’s messages and status area. The detection
of the patient’s inspiratory effort in order to synchronize occurs at any moment during the expiratory time.
Observation
• When the patient starts to demonstrate inspiratory effort and the ventilator activates flow or
pressure triggers, the same “assists” the patient. This situation is referred to as Assisted
Controlled Ventilation.
• The BASEFLOW is the existing flow during the expiratory phase in order to eliminate the
respiratory circuit’s CO2. Furthermore, it reduces undesirable PEEP. Its minimum value is of 4
-1
L.min . The maximum value has a reset adjusted flow; there will be a continuous flow equal to the
adjusted FLOW during the ventilation.
Warning

74
PRVC – Pressure Regulated Volume Control
In this modality, the ventilator controls the • VOLUME

pressure and cycles on time. In other words, at • INSP PRESSURE;
each inspiratory cycle, the ventilator reaches • FREQUENCY;
the calculated pressures and remains on this • INSPIRATORY TIME
level until the adjusted inspiratory time has • PEEP;
elapsed. This ventilation mode’s objective is to • FLOW;
reach the adjusted volume. • FiO2
• FLOW TRIGGER;
The calculated pressure depends on the
patient’s lung physiology (compliance and
resistance) and is calculated during the three • RISE TIME.
VCV cycles realized at the beginning of this
modality’s ventilation.
Observation
• This modality is only available for
FlexiMag equipment.
Image 24 –PRVC Curves

75
As soon as all ventilation parameters are adjusted on the ventilator, the same calculates TEXP according to
the Frequency and TINSP; thus, obtaining all ventilation controlled times.
1, 2, 3 –Lung compliance evaluation phase. After obtaining the compliance value, the ventilator automatically
adjusts a pressure value in order to reach 60% of the adjusted volume. Then, the ventilator automatically
adjusts the pressure at each three PCV cycles.
4, 5 – Beginning of pressure’s automatic control in order to reach the defined volume.
6 – If pressure and flow sensitivity are active, the ventilator seeks to synchronize at the beginning of the next
inspiration on the patient’s effort according to the configured sensitivity. The patient’s effort “window”
detection to synchronize begins on the last fourth period of the controlled ventilation.
Observation
• When the patient starts to demonstrate inspiratory effort and the ventilator activates flow or pressure
triggers, the same “assists” the patient. This situation is referred to as Assisted Controlled
Ventilation.
7 – Reached Volume
Observation
• Automatic pressure control occurs with PEEP+5cmH2O and PLimit.
Warning
• If the pressure limit is reached before the adjusted Volume, the ventilator will exhibit a
“Pressure Limit” message.

76
V-SIMV – Volume-Synchronized Intermittent Mandatory Ventilation – Controlled Volume Cycle
Adjusted Parameters:
Description:
• VOLUME;
In this modality, the patient can breathe • FREQUENCY;
spontaneously in between controlled cycles with • INSPIRATORY TIME;
or without pressure support. The controlled • PEEP;
cycles are VCV (Controlled Volume). • MAXIMUM PRESSURE;
• PAUSE (%);
Observation • FiO2
• This ventilation modality is not available • ∆PS (Pressure Support – PEEP);
for NEONATAL patients (weight • FLOW TRIGGER;
informed ≤ 13.2 lbs.). • PRESSURE TRIGGER;
• This modality is only available for • WAVEFLOW;
FlexiMag equipment. • FLOW CYCLING (% FLOW);
• RISE TIME.
Image 29 - V-SIMV Curves

77
V-SIMV – Volume-Synchronized Intermittent Mandatory Ventilation – Controlled Volume Cycle
As soon as all ventilation parameters are adjusted on the ventilator, the same calculates the TEXP and FINS
according to Inspiratory Time, Pause, and Frequency; thus, obtaining all ventilation control times.
1 - Represents a VCV (controlled volume) cycle with inspiratory pause;
2 - Represents a spontaneous patient respiration cycle WITHOUT PRESSURE SUPPORT;
3 - Represents a VCV (controlled volume) cycle elapsed from a SIMV Period;
4, 5 - Represents the patient’s spontaneous respiration cycle WITH PRESSURE SUPPORTS, which cycling
occurs by flow when it reaches a value between 25% and 75% of the read peak value. The peak’s flow
percentage in which the cycling from inspiratory phase to expiratory phase occur is programmable. The rise
time (TRISE TIME) also applies to support pressure (refer to PCV).
6 - If the patient realizes inspiratory effort, a window will appear at the end of the SIMV (TSIMV) period in order
to synchronize the controlled ventilation cycle, which is “opened” from 0.75 x(TSIMV). In other words, a
synchronism window opens during the last fourth of the SIMV period during the mandatory ventilation cycle.
The information regarding the type of trigger activated the inspiratory cycle is informed on the screen’s
message and status area.
Observation
• The monitored respiratory frequency may be greater than the adjusted respiratory frequency, since
the patient may breathe spontaneously during mandatory ventilation cycles;
• The pressure support (∆PS) is a value above PEEP and may be adjusted between + 5cmH2O and
PMAX.
Warning

78
P-SIMV – Pressure-Synchronized Intermittent Mandatory Ventilation – Controlled Pressure Cycle
In this modality, the patient can breathe • INSP PRESSURE;

spontaneously between controlled cycles, with • FREQUENCY;
or without the help of pressure support. The • INSPIRATORY TIME;
controlled cycles will be PCV (Pressure • PEEP;
Controlled). • FiO2
• ∆PS (Pressure Support – PEEP);
• FLOW TRIGGER;
Observation • CYCLING FLOW (% FLOW);
• This modality is available for FlexiMag • RISE TIME;
and BabyMag equipment. • FLOW ( - NEONATAL);
Image 25 - P-SIMV Curves

79
P-SIMV – Pressure-Synchronized Intermittent Mandatory Ventilation – Controlled Pressure Cycle
As soon as all ventilation parameters are adjusted on the ventilator, this calculates the TEXP according TINS
and Frequency; thus, obtaining all ventilation controlled time.
1 - Represents a PCV (pressure controlled) cycle during TINS;
2 - Represents a spontaneous respiration cycle WITH PRESSURE SUPPORT;
3 - Represents a PCV (pressure controlled) cycle after SIMV Period;
4, 5 - Represents the patient’s spontaneous respiration cycle WITH PRESSURE SUPPORTS, which cycling
occurs by flow when it reaches a value between 25% and 75% of the read peak value. The peak’s flow
percentage in which the cycling from inspiratory phase to expiratory phase occur is programmable. The rise
time (TRISE TIME) also applies to support pressure (refer to PCV).
6 - If the patient realizes inspiratory effort, a window will appear at the end of the SIMV (TSIMV) period in order
to synchronize the controlled ventilation cycle, which is “opened” from 0.75 x(TSIMV). In other words, a
synchronism window opens during the last fourth of the SIMV period during the mandatory ventilation cycle.
The information regarding what type of trigger activated the inspiratory cycle is informed on the screen’s
message and status area.
Observation
• The monitored respiratory frequency may be greater than the adjusted respiratory frequency, since
the patient may breathe spontaneously during mandatory ventilation cycles;
• The pressure support (∆PS) is a value above PEEP and may be adjusted between + 5cmH2O and
PMAX.
Warning

80
DualPAP – Dual Continuous Positive Airway Pressure

In this modality, the patient breathes • SUPERIOR P.;
spontaneously over two, continuous • SUPERIOR T.;
positive pressure and can be auxiliated by • INFERIOR P.;
a Pressure Support (∆PS). By observing • INFERIOR T.;
the flow curve, a peak flow decreases as • FiO2;
time goes by. • ∆PS (Pressure Support – PEEP);
Cycling occurs by flow, adjustable • FLOW TRIGGER;
between 25% and 75% measures
inspiratory peak flow. Depending on the
• CYCLING FLOW (% FLOW);
results, the APRV – Airway Pressure
Release Ventilation may be obtained. • RISE TIME;
• MAXIMUM PRESSURE
• FLOW( - NEONATAL);
Observation • BACKUP:
• This modality is available for o Back-Up VCV, o Back-Up PLV-
FlexiMag and BabyMag VOLUME NEONATAL
equipment FREQUENCY INSP PRESSURE
FLOW FREQUENCY
PRESSURE LIMIT INSPIRATORY
o Back-Up PCV, TIME
INSP PRESSURE FLOW
FREQUENCY o WITHOUT Back-Up
INSPIRATORY
TIME
RISE TIME
Image 26 – DualPAP Curves

81
DualPAP – Dual Continuous Positive Airway Pressure
As soon as all ventilation parameters are adjusted on the ventilator, the patient breathes spontaneously
determined on ventilation control times.
1 - Represents a spontaneous cycle without pressure support on Inferior P. (Continuous Inferior Airway
Pressure);
2 - Represents a respiration cycle with the help of Pressure Support (above Inferior P.);
3 to 4 – Represents a synchronized transition for Superior P. (Continuous, Superior Airway Pressure);
4 – During Superior Pressure the patient may breathe spontaneously with or without pressure support;
5 – Represents a synchronized transition from Superior P. to Inferior P.
The Inferior P. Superior P. or Superior P. Inferior P. transition levels occur on the fourth final of the
Inferior T. and Superior T., respectively, through the synchronization with the patient’s effort. The
information regarding what type of trigger activated the inspiratory cycle is informed on the screen’s
messages and status area.
Observation
• The monitored respiratory frequency is a result of the patient’s spontaneous respiration.
• Pressure support (∆PS) is a value above Superior P. or Inferior P. and may be adjusted between+
5 cmH2O and PMAX.
• Changes in pressure levels are synchronized.
Warning
• Default values are only an initial reference. Readjust the ventilation parameters according
to the patient’s needs.

82
DualPAP - APRV – Airway Pressure Release Ventilation (Inverted Relation)
Adjusted Parameters:
Description:
• SUPERIOR P.;
This modality permits spontaneous • SUPERIOR T.;
cycles in 2 basal pressure levels • INFERIOR P.;
and may be obtained through • INFERIOR T.;
adequate adjustments on the • FiO2;
DualPAP modality; • ∆PS (Pressure Support – PEEP);
According to the adjustments • FLOW TRIGGER;
made, pressure release is
accomplished on the airways;
• CYCLING FLOW (% FLOW);
therefore, obtaining APRV –
Airway Pressure Release • RISE TIME;
Ventilation • MAXIMUM PRESSURE;
• FLOW(NEONATAL);
• BACK-UP :
o Back-Up VCV, o Back-Up PLV-NEONATAL
VOLUME INSP PRSSUE
FREQUENCY FREQUENCY
Observation FLOW INSPIRATORY TIME
• This modality is available PRESSURE LIMIT FLOW
for FlexiMag and BabyMag o Back-Up PCV, o WITHOUT Back-Up
equipment INSP PRESSURE
FREQUENCY
INSPIRATORY TIME
RISE TIME
Image 27 – APRV Curves

83
DualPAP - APRV – Airway Pressure Release Ventilation (Inverted Relation)
As soon as all ventilation parameters are used on the ventilator, the patient breathes spontaneously
determining ventilation control times.
1 and 2 - Represent spontaneous cycles without pressure support on Superior P. (Superior, Continuous
Airway Pressure);
3 – Represents a transition from Superior P. to Inferior P. (Inferior Continuous Airway Pressure) in a

synchronized manner;
3 to 4 – Represents an Inferior T. time, in which airway pressure release is made;
4 – Represents a transition from Inferior P. to Superior P. in a synchronized manner.
The Superior P. PInferior P. or Inferior P. PSuperior P. transition levels occur on the fourth final of the
Superior T. and Inferior T., respectively, through the synchronization with the patient’s effort. The
information regarding what type of trigger activated the inspiratory cycle is informed on the screen’s
messages and status area.
Observation
iThe monitored respiratory frequency is a result of the patient’s spontaneous respiration.
tPressure support (∆PS) is a value above Superior P. or Inferior P. and may be adjusted between+ 5
cmH2O and PMAX.
• Changes in pressure levels are synchronized.
Warning
• Default values are only an initial reference. Readjust the ventilation parameters according
to the patient’s needs.

84
CPAP/PS – Spontaneous Ventilation with Pressure Support
In this modality, the patient breathes • PEEP;

spontaneously over a continuous positive • FiO2
pressure and is auxiliated in respiration by • CYCLING FLOW (% FLOW);
a Pressure Support (∆PS). When • ∆PS (Pressure Support – PEEP);
observing the curve flow, a peak flow • RISE TIME;
decreases as time goes by. • FLOW TRIGGER;
The cycling occurs by flow, which is • PRESSURE TRIGGER;
adjustable between 25% and 75% of the
• BASE FLOW
measured inspiratory flow.
• BACK-UP :
The Pressure Support (∆PS) value cannot
o Back-Up VCV, o Back-Up PLV-
be adjusted to 0 (ZERO) and at least one
VOLUME NEONATAL
of the means of cycle triggers (pressure or
FREQUENCY INSP PRESSURE
flow) must be active.
FLOW FREQUENCY
PRESSURE LIMIT INSPIRATORY
o Back-Up PCV, TIME
Observation INSP PRESSURE FLOW
• This modality is available for FREQUENCY o WITHOUT Back-Up
FlexiMag and BabyMag INSPIRATORY
equipment TIME
RISE TIME
Image 28 - PSV Curves (CPAP + ∆ASB)

85
1 and 2 - Represents spontaneous cycles with pressure support on ZERO.
3, 4, and 5 - Represents the patient’s spontaneous respiration cycles with pressure support different from
zero. The pressure support’s TRISE TIME can be adjusted in order to mitigate the initial flow. Cycling flow can
be adjusted to a value between a 25% to 75% peak flow.
In the event the patient enters into apnea, the ventilator will present this condition through an alarm on the
screen’s message and alarms area after TAPNEA and will initiate selected back-up ventilation, according to the
programmed configurations and parameters.
Observation
• Pressure support (∆PS) is a value above PEEP and can be adjusted between + 5cmH2O and PMAX.
Warning
• The apnea alarm must be adjusted to a secure value to a patient. On the meantime, the apnea
alarm must be RESET. In this condition, there will be no apnea information or alarm condition
or any back-up ventilation in action. The equipment’s operator must be aware of the
DEACTIVATED (OFF INDICATIVE ON DISPLAY) Apnea Alarm condition.
• If the selected back-up ventilation is WITHOUT BACK-UP, the equipment’s operator must be
aware of this situation (INDICATIVE ON DISPLAY). Refer to description on following image.
Image 29 - CPAP/PS configured WITHOUT BACK-UP

86
1 and 2 – Represents spontaneous cycles.
3 – In the event the patient does not breathe after apnea time (TAPNEA), the ventilator exhibits this condition
on the display with an audible alarm.
Warning
• The apnea alarm must be adjusted to a secure value for the patient.

87
NIV – Non-Invasive Ventilation – with Facial Mask
In this modality, the patient breathes • ∆PS (Pressure Support – PEEP);

spontaneously over a continuous, positive • PEEP ;
pressure and is auxiliated in the respiration by a • O2 CONCENTRATION;
Pressure Support (∆ASB). Normally, a peak • CYCLING FLOW;
flow can be observed on a curve flow, which • PRESSURE TRIGGER;
decreases as time goes by. • FLOW TRIGGER;
The cycling occurs by flow and is adjustable • CYCLING TIME;
between 25% and 75% measured inspiratory
• MAXIMUM PRESSURE
peak flow.
• TIME FOR APNEA (adjustment on alarm screen);
The Pressure Support (∆PS) value must not be
adjusted to 0 (ZERO) and at least one of the • BACKUP:
cycle’s trigger means (pressure or flow) must be o Back-Up VCV, o Back-Up PLV-
active. VOLUME NEONATAL
This modality realizes leakage compensation of FREQUENCY INSP
up to 100% of the patient’s minute volume and FLOW PRESSURE
ignores High Minute Volume, High Current PRESSURE FREQUENCY
Volume, and Verify Sensor alarms. LIMIT INSPIRATORY
The flow trigger is compensated for leakage o Back-Up PCV, TIME
flows of up to 25 L.min-1. INSP FLOW
PRESSURE o WITHOUT Back-Up
FREQUENCY
Observation INSPIRATORY
• This modality is available for FlexiMag TIME
and BabyMag equipment RISE TIME
Image 30 – NIV Curves (PEEP + ∆ASB)

88
NIV – Non-Invasive Ventilation – with Facial Mask
1 and 2 - Represents spontaneous cycles with pressure support on ZERO.

3, 4, and 5 - Represents the patient’s spontaneous respiration cycles with a pressure support different from
zero. The cycling flow may be adjusted to a value between a peak flow of 25% to 75%.
6 - In the event the patient enters apnea, after TAPNEA the ventilator exhibits this condition through an alarm in
its alarms and message screen area.
Observation
• Pressure support (∆PS) is a value above PEEP and may be adjusted between+ 5 cmH2O and PMAX.
• The continuous flow that apparently ‘leaks’ through the expiratory valve is normal and serves in
order to reduce the patient’s ventilation control system response time.
Warning
• Uses an adequate mask for each type of patient in order to avoid excessive leakage.
• There is no back-up ventilation in this modality.

89
9. Problem Solving
This chapter presents principle problems and their possible solutions. Most of them have simple solutions
that may be realized by the equipment’s operator.
Warning
• Do not use the equipment if the problem cannot be solved.
Problem Possible Causes Solutions
1. Request for Technical

Inoperative Ventilator Alarm 1. Electronic Failure
Assistance.
1. Disconnect the respiratory 1. Locate the disconnection and

circuit. connect firmly.
2. Lack of Inspiratory Flow. 2. Verify the existence of an
3. Alteration of Patient’s inspiratory flow and increase it, if
Respiratory Mechanics. necessary.
4. Expiratory valve diaphragm 3. Establishes new parameters for
Disconnection Alarm mounted incorrectly or damaged. ventilatory support.
5. Failure on pressure control 4. Place the diaphragm in the
electronic system. right position or substitute the
diaphragm.
5. Request Technical Assistance.
1. Alteration of Patient’s 1. Establish new ventilatory

Respiratory Mechanics. support parameters.
2. Excessive leakage on 2. Locate leakage and correct it.
Low Pressure Alarm respiratory circuit.
1. Alteration of Patient’s 1. Establish new parameters for

Respiratory Mechanics. ventilatory support.
2. Obstruction of respiratory 2. Remove obstructions.
High Pressure Alarm circuit’s expiratory branch or its
expiratory valve. 3. Remove obstructions or
3. Obstruction of the patient’s aspirate the patient’s airways.
airways.

90
Problem Possible Causes Solutions

1. End of internal battery after 1. Immediately reestablish the
usage without power source. equipment’s connection to a
power source or turn off the
Low Battery Alarm
2. Failure on system’s internal equipment and provide means of
battery, even with power source. ventilation support to the patient.
2. Request Technical Assistance.
1. Disconnection from electric 1. Reestablish the equipment’s
power cord. connection to a power source or
Lack of Power Source Alert use equipment with an internal
2. Failure in power grid. battery for transportation.
2. Reestablish the power grid.

91
10. Cleaning, Disinfection, and Sterilization

This chapter presents the main ways to clean and sterilize the equipment and its components.
Warning
• Before the first use, the equipment and its components must be appropriately cleaned and
sterilized.
Attention
• Magnamed FlexiMag/Babymag ventilator’s removable accessories and components that are
submitted to frequented cleaning and sterilization experience a degradation process and,
therefore, must be substituted for new ones according the presented tables in chapter
14.3.10.
• Magnamed FlexiMag ventilator’s removable accessories and components that present
damages or signs of wear and tear must be substituted, avoiding their usage.
10.1. Ventilator
Establish a cleaning, disinfection, or sterilization routine for FlexiMag/Babymag´s components.
A. The FlexiMag/Babymag´s external parts may be cleaned with a damp and soft cloth, dampened in
an appropriate germicide solution. Make sure that any residues of the cleaning product do not
accumulate on the equipment’s connections. After cleaning, use a clean and soft cloth to dry the
ventilator.
B. The components that contact respiratory gases must be periodically dismounted for cleaning or
sterilization purposes, including: tracheas, flow sensor, and pressure outlet line. Use an appropriate
germicide solution of ethylene oxide.
C. Do not use abrasive cleaning agents.
D. Do not use alcohol to use plastic parts.
E. Do not submerse FlexiMag in any liquid.
Warning
• All Magnamed ventilator’s parts that contact patient fluids (for example: respiratory circuit)
that may be potentially contaminated. They are denominated as semi critical and must
undergo a high-level disinfection process or sterilization before discarding (at the end of their
life cycles) or before undergoing maintenance or repairs.
• In the event of discard: INDICATE as potentially infected hospital waste.

• When sending the FlexiMag Ventilator to maintenance or repair services: CLOSELY observe
the disinfection process.

92
• EQUIPMENTS THAT ARE VISIBLE INFECTED BY PATIENT FLUIDS WILL BE RETURNED

WITHOUT PERFORMING MAINTENANCE OR REPAIR SERVICES.
10.2. Cleaning, Disinfection, and Sterilization Processes
Contaminated
Material
Damp cloth Wash
Sterilize Stock Disinfection
Image 36 - Cleaning, Disinfection, and Sterilization Sequences

(1) Damp Cloth
The cleaning must be realized through mechanical friction with a damp cloth or gauze with a solution of
water and soap.
(2) Washing and Drying
Washing and drying are ALWAYS necessary before any disinfection or sterilization process and must be
done by immersion in a neutral solution of soap and water or with enzymatic detergent in a temperature
between 95oF and 140oF during 5 to 10 minutes. Afterwards, it must undergo mechanical friction in order to
remove residues or organic matter, followed by drying.
(3) Chemical Disinfection by Immersion
Realize a chemical disinfection by immersion in a solution of Glutaraldehyde 2% during 40 minutes.

Completely eliminate chemical residues from the components with distilled and sterilized water. Afterwards,
dry thoroughly in a clean environment.
(4) Chemical Sterilization by Immersion
Realize a chemical sterilization by immersion in a solution of Glutaraldehyde 2% during 12 hours. Completely

eliminate chemical residues from the components with distilled and sterilized water. Afterwards, dry
thoroughly in a clean environment.
(5) Autoclave

93
Realize the sterilization with a configured autoclave according to the recommendation of the autoclave’s
manufacturer.
(6) Ethylene Oxide (ETO)
Realize the sterilization with ethylene oxide according to the recommendations of the chemical product’s
manufacturer.
Description Processes Cycles (Life cycle)
FlexiMag Ventilator –Exterior (1) NA

SILICONE Tube – respiratory circuit’s pressure
(2), (3), (4), (5), (6) 50
sensor
Autoclavable Flow Sensors (2), (3), (4), (5), (6) 50
Sterilizable Flow Sensors (2), (3), (4), (6) 50
PVC Tube (2), (3), (4), (6) 50

(2), (3), (4), (5), (6)
Silicone 50
NA – Does not Apply
Attention
• The non-sterile device packaging system (respiratory circuits, expiratory valves, and
connectors) are projected to maintain these products on an adequate cleaning level in order
to be sterilized before their use and are also projected to minimize microbial contamination.

94
11. Optional Parts and Accessories

Attention
• Always use original parts and accessories in order to guarantee the equipment’s security and
efficiency.
Optional Accessories
Item Code Description QTTY UMI Image
AUTOCLAVABLE ADULT
1 1702653 RESPIRATORY CIRCUIT 3.94 01 PC
FT
AUTOCLAVABLE CHILD
FT
AUTOCLAVABLE NEONATAL
FT
4 1702667 ARTICULATED ARM 01 PC

95
5 5003781 SUPPORT FOR HUMIDIFIER 1 PC
O2 EXTENSION DISS X2 – 9.84

5 3902647 1 PC
FT
AIR EXTENSION DISS X2 – 9.84

6 3903114 1 PC
FT
7 5003353 FLOW SENSOR KIT 1 PC
IRMA CO2 AIRWAY SENSOR

8 2702597 1 PC
WITH 5 WAY CONNECTOR

96
IRMA Adult/Pediatric Airway

9 3902414 Adapter 1 PC
• Box with 25 units
IRMA Neonatal Airway Adapter

10 3903443 1 PC
• Box with 10 units
11 5003112 MASIMO OXIMETRY KIT 01 PC
Esophageal Pressure
12 5003784
Connection
Heated Humidifier with
13 1702665
Adult/Pediatric Reservoir
Humidifier’s Adult/Pediatric
14 1702814
Reservoir
15 1703786 Humidifier’s Neonatal Reservoir
MAGNAMED EXPIRATORY
16 3800248 01 PC
VALVE DIAPHRAGM
AUTOCLAVABLE EXPIRATORY
17 3200251 01 PC
VALVE 22M 15F 30M

97
18 2802612 AC NETWORK CABLE 01 PC
O2 CONCENTRATION
19 1702105 1 PC
MEASUREMENT CELL KIT
PARAMAGNETIC O2
20 1702510 CONCENTRATION 1 PC
MEASUREMENT CJ CELL

98
12. Preventive Maintenance

Warning
• FlexiMag and BabyMag Ventilators are life support equipment. Their maintenance must only
be realized by authorized personnel by MAGNAMED.
• DO NOT USE the equipment if not according to the specifications contained in this operation
manual.
12.1. Verifications
Daily or Previous Verification before Use
• Cleaning equipment;
• Integrity of power source AC/DC converter;
• Operation of alarm systems, including audio;
• CLEAN filters installed;
• LCD;
• Charged battery;
• Touch Screen;
• Panel keys;
• Turn and confirm button;
• Respiratory circuit’s correct installation (including the existence of the expiratory valve’s diaphragm).
Warning
• The equipment’s daily verification must be realized when the patient is disconnected.

99
12.2. Internal Lithium Battery

This battery is responsible for the equipment’s operational maintenance, even in the absence of a power
source. Its duration during normal operation is specified in chapter 13.
Attention
• The battery must be substituted according to technical specifications (chapter 13) in order for
the normal operational capacity to reach approximately 180 minutes.
• The internal battery substitution must be realized by trained and qualified personnel.
• The battery’s discard must follow local legislation.
Warning
• In order to have sufficient battery during a power shortage, it is important for the equipment
to ALWAYS remain connected to a power source.
12.3. O2 Concentration Internal Sensor

FlexiMag and BabyMag equipment have two ways of measuring oxygen concentration.
• Galvanic cell (1702105) – Generates an electrical signal proportional to the oxygen concentration in
the gas mixture ministered to the patient. The intensity of this electric signal is due to chemical
reaction. This form of measurement is consumable and the cell’s duration is of 10,000 hours to
100% O2, according to what is specified by the original manufacturer. In other words, it is superior to
one year of continuous use.
Attention
• The galvanic cell used to measure the oxygen concentration must be substituted
according to the indicated specifications (13).
• The substitution of the oxygen concentration measurement cell must be realized by
trained and qualified personnel.
• The discard of the oxygen concentration measurement cell must follow local
legislation.
• Paramagnetic Cell (1702510) – generates an electrical signal proportional to the concentration of

oxygen in the gas mixture ministered to the patient. The intensity of this electrical signal is due to the
created torque during the cell’s magnetic arrangement. This sensor uses paramagnetic oxygen
susceptibility that distinguishes it from other gases. This form of measurement is not consumable.

100
12.4. Remitting Product to Repair Service

Before sending the products to repair services, they must be cleaned and disinfected according to the
guidelines contained in this manual (chapter 10). The products that present signs of potential hospital
contaminants will be returned without performing repairs in order to be disinfected before undergoing the
repair process.
Warning
• When sending the Ventilator to maintenance or repair services: CLOSELY observe the
disinfection process.
• EQUIPMENTS THAT ARE VISIBLE INFECTED BY PATIENT FLUIDS WILL BE RETURNED
WITHOUT PERFORMING MAINTENANCE OR REPAIR SERVICES.

101
13. Technical Specification

13.1. Classification
Class II Equipment (NBR – IEC – 60601), internally energized, type BF for continuous operation. Splash
proof equipment IPX1.
13.2. Standards
• ISO 5356-1:2004 Anesthetic and respiratory equipment – Conical connectors – Part1: Cones and
sockets
• ABNT NBR 11906:1992 Threaded and quick coupling connections in stations that use centralized
systems with medicinal gas under pressure
• ISO 5359:2000 Low-pressure hose assemblies for use with medical gases
• ABNT NBR IEC60601-1-2:2006 Electro-medical equipment – Part 1-2: General safety prescriptions
– Collateral standard: Electromagnetic compatibility – Prescriptions and tests
• ABNT NBR IEC60601-1:1997 Electro-medical equipment – Part 1 – General safety prescriptions.
• ABNT NBR IEC 60601-2-12:2004 – Electro-medical equipment - Part 2-12: Particular prescriptions
for lung ventilator – ventilators for critical care.
• IEC CISPR 11 Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic
disturbance characteristics – Limits and methods of measurement
13.3. Specifications
The electronic lung ventilator is comprised by the following components:
• Colored Touch Screen LCD:
•
Displa Model Description Pixels
y
10.4” 1103040 BABYMAG – Neonatal

Electronic Lung Ventilator 10.4
inches
800x600
1103050 FLEXIMAG –Neonatal
Pediatric Adult Electronic Lung
Ventilator 10.4 inches
15” 1103360 BABYMAG – Neonatal

Electronic Lung Ventilator 15
inches
1024x768
1103760 FLEXIMAG – Neonatal
Pediatric Adult Electronic Lung
Ventilator 15 inches
• Control Board with:

o Data presentation of display;
o Interface serial RS-232C;

102
o Quick access keys for:

Stand By;
Hold Insp;
Hold Exp;
O2 100%;
MANUAL (Inspiratory Cycle Manual Trigger);
LOCK (Lock Keys, but this one);
o Respiratory circuit pressure read;
o respiratory circuit flow read;
o network pressure read;
o O2 concentration read in ministered gas mixture;
o Smart Battery Charger ;
• Speaker for alarms and alerts;
• High brightness RED LED for prompt alarm identification;
• BICOLOR LED, where Blue indicated the connection to a power source and Green when the equipment
is on without being connected to a power source; in other words, working with the battery;
• External Inlet 100-240 VAC – 50 – 60 Hz;
• On/Off Key;
• Optional O2 cells, galvanic cell or paramagnetic cell ( not consumable );
• One distal flow sensor for all types of patients;
• Respiratory circuit:
o FlexiMag – for adult, pediatric, and neonatal patients
o BabyMag – for neonatal and pediatric patients
13.4. Electrical Characteristics
Item Parameter Specification Tolerance Unit

1 Electrical Network (50/60Hz) (1) 100 to 240 ± 10% VAC
2 Maximum Consumed Power 50 ± 10% VA
(1)
Three (3) pin connector, NBR-14136:2002, where the central pin is the ground pin.
Li-Ion Internal Battery:

1 Internal Li-Ion Battery 11,8VDC 4000 ± 15% mAh
2 Internal Battery’s Autonomy (completely charged 180 ± 15% min
and during normal use)
3 Recharge time until reaching maximum charge 4.0 ± 15% h
(operation module)(1)
(1)
ºC The battery charge must be done at room temperature between 41oF to 95 oF.
• Electromagnetic Compatibility
o Immunity: IEC 60601-1-2
o Emission: CISPR11
o Approvals: ISO/IEC 60601-1
• Class IIb – According to norm CE/93/42/CEE annex IX
• Type of Protection for Respiratory Accessories (Disposable or Reusable): BF Type (Body

Floating)

103
13.5. Connection to Gas Supply

• Air and Oxygen inlet
• Connection standard: NBR 11906
• Gas pressure: 40 to 150 PSI (345 to 1035 Kpa)
• Hoses and Extensions: According to ISO 5359:2000
All materials that comprise the product are compatible to Oxygen, Air, and Compressed Medicinal
Air.
13.6. Physical and Environmental Specifications

1 Dimensions (basic unit)
2 Height 1335 ±5 mm
3 Width 453 ±5 mm
4 Depth (with handle) 542 ±5 mm
5 Weight 18 ± 0,1 Kgf
6 Operation
7 Temperature -14 to 122 --- ºF
8 Barometric Pressure 600 to 1100 --- cmH2O
9 Humidity Relative to Air (without 15 to 95 --- %
condensation)
10 Storage
11 Temperature -4 to 167 --- ºF
12 Barometric Pressure 500 to 1200 --- cmH2O
13 Humidity Relative to Air (without 5 to 95 --- %
condensation)
13.7. Ventilation Modalities
(1)(3)(4)(5) Apnea Modality

Modality Description
(BACKUP)
VCV Volume Controlled Ventilation Does not Apply
PCV Pressure Controlled Ventilation Does not Apply
Time-Cycled Pressure Limited Ventilation for ventilator in

PLV Does not Apply
neonatal configuration (may have assisted cycles)
PRVC Pressure Regulated Volume Control Does not Apply
Volume-Synchronized Intermittent Mandatory Ventilation IMV – Volume-Controlled

V-SIMV + P
with Pressure Support Intermittent Mandatory Ventilation
Pressure-Synchronized Intermittent Mandatory IMV – Pressure-Controlled

P-SIMV + P
Ventilation with Pressure Support Intermittent Mandatory Ventilation

104
Apnea Modality
Modality(1)(3)(4)(5) Description
(BACKUP)
Two-level Positive Airway Pressure with Pressure

DualPAP(2) Time cycling
Support
VCV, PCV (adult and pediatric) /
CPAP/PS Continuous Positive Airway Ventilation PLV (neonatal), OFF.
Programmable by the Operator
Non-Invasive Ventilation with leak compensation by
NIV Does not Apply
Mask
(1)
Non Invasive Ventilation (VNI) by Mask can ONLY be activated for CPAP/PS modality. In this case, there
are leakage compensations.
(2)
The APRV (Airway Pressure Release Ventilation) can be obtained through the DualPAP modality (optional)
with appropriate time and pressure regulation.
(3)
Compliance automatic compensation and small leaks on the respiratory circuit.
(4)
The FlexiMag equipment configured for the Neonatal patient (IBW ≤ 13.2 lbs.) or the BabyMag equipment
will only be available in the following modalities: PLV, P-SIMV, CPAP/PS, and DualPAP(optional).

105
13.8. Ventilation Parameters Adjustment Specifications
Item Parameter Specification Resolution Unit
100 to
1000:10
Adult
1000 to
2500: 50
1 Current Volume 10(1) to 3000 mL
10 to
100:5
Pediatric
100 to
300:10
(2) (3) -1 -1
3 Breathing Rate 0 to 180 1 min min
4 Rise Time 0 to 2.0 0,1 s s
5 Pause 0 to 70 10 % %
6 Inspiratory Pressure 1 to 120 1 cmH2O cmH2O
7 ∆PS 0 to 120 1 cmH2O cmH2O
8 PEEP 0 to 50 1 cmH2O cmH2O
0.0 to -2.0: - 0.2
9 Assisted Sensitivity (Pressure) 0.0 to -20 cmH2O
-2 to -10: - 1
0,0 to 1.0: 0.1
10 Assisted Sensitivity (Flow) 0.0 to 30 L x min-1
1.0 to 30,0: 0.5
11 Cycling Flow in Pressure Support 5 to 80 5% %
12 O2 Concentration 21 to 100 1% % vol
0.05 to 1.00: 0.05
13 Inspiratory Time 0.05 to 30 s
1.0 to 30.0: 0.1
Square,
Descendant or
Decelerated,
14 Inspiratory Flow’s Waveform Ascendant or --- ---
Accelerated,
Sinusoidal or
Sinusoid
15 CPAP 1 to 50 1 cmH2O cmH2O
16 Superior Pressure 1 to 60 1 cmH2O cmH2O
17 Inferior Pressure 0 to 40 1 cmH2O cmH2O
0.20 to 0,70: 0.01
18 Superior Time 0.20 to 59.8 0.70 to 1.00: 0.05 s
1.00 to 59.80: 0.10
0.20 to 0.70: 0.01
19 Inferior Time 0.20 to 59.8 0.70 to 1.00: 0.05 s
1.00 to 59.80: 0.10
20 Ratio 1:599 to 10:1 1:0.1 -

106
Item Parameter Specification Resolution Unit

(4)
OFF;PLV; PCV;
21 Backup --- -
VCV
22 Inspiratory Flow 1 to 40 1 L x min-1 L x min-1
-1 -1
23 Inspiratory Flow 1 to 180 1 L x min L x min
24 Base Flow 1 to 20 1 L x min-1 L x min-1
(5)
25 Height 20 to 250 1 cm
Nebulizer(6) (synchronized with inspiratory -1

26 5 to 8 --- L x min
flow) - 100% Oxygen
(6)
TGI Flow (Tracheal Gas Insufflation) –
100% Oxygen – The flow is activated when
27 the exhaled flow reaches 25% of the 5 to 8 --- L x min-1
maximum exhaled flow peak. The end is
determined by the next inspiratory cycle
(1)
The Current Volume Adjustment for values that are less than 10ml is made through pressure adjustment,
monitoring the current volume on the equipment.
(2)
Only for CPAP/PS modality.
(3)
Value depends on ventilator modality.
(4)
CPAP/PS modality back-up options. By setting it on OFF, the modality will not enter back-up mode when
reaching the apnea limit (configurable on the ALARM tab).
(5)
Depending on the adjusted height and modality and referenced BMI, the equipment will automatically
configure some parameters in order to deliver an adequate volume to the patient. However, after the pre-
adjustment, the operator may individually readjust the parameters according to need.
Attention
• The FlexiMag ventilator attends patients with weight between 1lb. and 550 lbs., while
BabyMag is adequate to patients with weight between 1lb. and 66 lbs.
Weight range for pre-adjustment according to patient (only for FlexiMag):

• 1lb. ≤ IBW ≤ 13.2 lbs. Ventilator in NEONATAL Mode
• 13.2 lbs. < IBW ≤ 48 lbs. Ventilator in PEDIATRIC Mode
• IBW ≥ 70 lbs. Ventilator in ADULT Mode
Weight range for pre-adjustment according to patient (only for BabyMag):

• 1lb. ≤ IBW ≤ 55 lbs. Ventilator in NEONATAL/PEDIATRIC Mode
(6)
The TGI flows and nebulizer cannot be configured simultaneously.

107
13.9. Ventilation Parameters Presentation Specifications (5)(6)

Item Parameter Range Resolution Tolerance(1) Unit
± (1 cmH2O or 2%
1 Instant Measured Pressure -20 to 120 1 cmH2O (2)
read)
± (1 cmH2Oor 2%
2 Maximum Inspiratory Pressure 0 to 120 1 cmH2O
read)
± (0.5 cmH2Oor 2%
3 Average Pressure 0 to 120 0.1 cmH2O
read)
± (1 cmH2Oor 2%
4 Plateau Pressure 0 to 120 1 cmH2O
read)
PEEP ± (1 cmH2Oor 2%
5 -20 to 120 1 cmH2O
read)
Intrinsic PEEP at the end of the ± (1 cmH2Oor 2%
6 -20 to 120 1 cmH2O
exhalation read)
-5.0 to 5.0 0.1
-1
Measured Flow - FlexiMag L x min
-180 to -5
1
5 to 180 ± ( 50mL or 2%
7
read)
-5.9 to 5.0 0.1
Measured Flow - BabyMag L x min-1
-20.0 to -5.0
0.2
5.0 to 20
0 to 999 mL 1 mL
Measured Volume (3) - FlexiMag ± (2,5ml or 5% of
8 1.00 to 3.00 0.01 L
measured value)
Measured Volume (3) - BabyMag 0 to 300 mL 1 mL
± (0.18L or 3% of
Minute Volume (MV) - FlexiMag 0.001 to 99.9 0.001 L
measured value)(4)
9
± (0.18L or 3% of
Minute Volume (MV) - BabyMag 0.001 to 20.0 0.001 L
measured value)(4)
10 Inspiratory Time 0.05 to 60.0 0.01 ± 0.01s s
11 Expiratory Time 0.05 to 60.0 0.01 ± 0.01s s
1:100.0 to
12 I:E Ration 1:0.1 ± 2% ---
100.0:1
-1
± (1min or 1% of
13 Breathing Rate 0 to 200 1 min-1
measured value)
20% of measured cmH2O/L/
0 to 99.9 0.1
14 Airway Resistance – RAW value s
100 to 200 1
± 1 mL. cmH2O-1 or
mL.
0 to 99.9 0.1 10% of measured -1
15 Dynamic Compliance cmH2O
value
100 to 200 1
± 1 mL. cmH2O-1 or
mL.
0 to 99.9 0.1 10% of measured -1
16 Static Compliance cmH2O
value
100 to 200 1
±(1% in volume or
12.0 to 99.9 0.1 %O2
17 FiO2 (Oxygen Concentration) 2% read)
100 to 110 1

108
(1)
When two tolerances are indicated, consider the greater value.
(2)
1 mbar (milibar) = 1 hPa (hectoPascal) = 1.016 cmH2O (water centimeter). In practice, these units
are not differentiated and may be used as:
1 mbar = 1 hPa ≈ 1 cmH2O
(3)
For airway resistances superior to 150 cmH2O/L/s, the monitored expired volume will have its tolerance
altered to ± 10%. In this condition, the measured inspired volume will not undergo alterations.
(4)
Calculated tolerance for 12rpm frequency. Tolerance is calculated according to the volume’s uncertainty
multiplied by frequency.
(5)
All monitored data are considered in ATPD (Ambient, Temperature and Pressure Dry).
(6)
The Ventilator does not generate negative pressures in the expiratory phase.
13.10. Security and Alarm System
• Anti-asphyxiation valve to protect against gas supply failure;

• Security release valve of 100cmH2O – Basic standard for ventilators in order to avoid overpressure
in the respiratory circuit;
• ACTIVE overpressure valve – is activated by detecting obstructions in order to reduce pressure on
the patient’s circuit.
Item Alarm Adjustment Unit

1 Maximum High Pressure OFF; 1 to 120 cmH2O
2 Maximum Low Pressure OFF; 1 to 79 cmH2O
3 High PEEP OFF; 1 to 50 cmH2O
4 PEEP OFF; 1 to 49 cmH2O
5 High Minute Volume OFF; 0.1 to 99.0 L
6 Low Minute Volume OFF; 0.1 to 99.0 L
7 Apnea Alarm Time OFF; 5 to 60 s
-1
8 High Breathing Rate OFF; 0.5 to 200 min
9 Low Breathing Rate OFF; 0.5 to 200 min-1
10 High FiO2 OFF; 21 to 100 %
11 Low FiO2 OFF; 21 to 100 %
12 High Current Volume OFF; 0 to 3000 mL
13 Low Current Volume OFF; 0 to 3000 mL
10 Low SpO2 (optional) OFF; 0 to 100 %
11 High EtCO2 (optional) OFF; 0 to 80 mmHg
12 Low EtCO2 (optional) OFF; 0 to 80 mmHg
13 CO2 inhaled (optional) OFF; 0 to 20 mmHg
• Low Battery
• Low Network Pressure
• Disconnection from Respiratory Circuit
• Respiratory Circuit Obstruction
• Apnea
• No Electric Grid
Alert Messages:
• Limited Pressure
109
• Assisted Cycle generated by Pressure Sensitivity

• Assisted Cycle generated by Flow Sensitivity
• Spontaneous Cycle generated by Pressure Sensitivity
• Spontaneous Cycle generated by Flow Sensitivity
• Assisted Cycle generated by Manual key
• Spontaneous Cycle generated by Manual key
• Synchronism Window
• Sensor OFF
13.11. Performance Specifications

Item Parameter Specification Unit Tolerance
1 Valve Response Time T0..90 5 ms ± 20%
Maximum Flow in Pressure Support FlexiMag 180

-1
2 L.min ± 10%
and Spontaneous Respiration BabyMag 60
Cycled on Time, Constant Volume,
3 Control Principle --- ---
and Controlled Pressure
hours (On)
4 MTBF (Mean Time Between Failure) 5.000 ---
(POH)
13.12. Maintenance and Calibration Specifications:
Item Description Specification Unit Tolerance

1 DIAPRAGM REVISION AND 5.000 or 1 year Hours ± 500
SUBSTITUTION (3800248)
2 O2 CELL (GALVANIC) REVISION 10.000 or 2 years Hours ± 500
AND SUBSTITUTION
3 BATTERY (2702236) REVISION 10.000 or 2 years Hours ± 500
AND SUBSTITUTION
4 Expiratory Valve (3200251)

Autoclavable Cycles:
Fast: 4 minutes @ 276.8°F
220kPa 50 @ Fast
Normal: 20 minutes @ 248°F
96kPa and Cycles ---
Note: The processing time is 100 @ Normal

made after stabilizing the
specified temperature and
pressure
5 Ventilator Revision 1 Year ± 1 month
6 Ventilator Calibration 2 Year ± 1 month
7 Expiration Date UNDETERMINED(1) --- ---
(1)
The expiration date is undetermined when submitted to periodic revisions.

110
13.13. Expiratory Branch Resistance Specifications:

Expiratory Resistance (hPa or cmH2O)
Respiratory Circuit + Flow
Flow Circuit + Flow
Circuit Circuit + Flow Sensor + CO2
L.min-1 Circuit Sensor+ HME
(Code) Sensor Sensor + HME
Filter
Filter
Neonatal 5.0 0.6 1.7
Pediatric 30.0 0.4 3.4 4.1 4.3
Adult 60.0 0.8 1.4 3.1 3.5
Adult 60.0 3.8 4.4 6.1 6.5
Expiratory Resistance Table according to Respiratory Circuit and Added Accessories
13.14. Electronic Control Block Diagram
Image 37 – Electronic Block Diagram
13.15. Electromagnetic Compatibility

The issued alterations or modifications in this equipment that have not been expressly approved by
MAGNAMED can cause EMC problems with this or equipment. Contact MAGNAMED to receive technical
assistance. This equipment was designed and tested in order to obey applicable EMC norms as described
below.
111
Warning
• The use of cellular phones or other equipment that emit radio frequency (RF) close to the
system may cause unexpected or adverse results. Monitor operation in the event of radio
frequency sources nearby.
• The use of other electric equipment on or close to the system may cause interference. Before
patient use, verify if the equipment works normally in the defined configuration.
Manufacturer guidelines and declaration – Electromagnetic emissions
The system is intended to be used in the electromagnetic environment specified below. It is recommended
that the system’s client or user guarantees it is being used in the specified environment.
Emission Tests Compatibility Electromagnetic Environment Guideline
RF Emissions Group 1 The system only uses RF energy for its internal
ABNT NBR IEC CISPR 11 functions. Meanwhile, its RF emissions are very
low; therefore, it is improbable they cause any
interference in nearby electronic equipment.
RF Emissions Class B The system may emit electromagnetic energy in

ABNT NBR IEC CISPR 11 order to perform its destined functions.
Harmonic Emissions Class A Electronic equipment nearby may be affected. It
IEC 61000-3-2 is adequate for all establishments, including:
Emissions due to In accordance domestic establishments and those directly
tension/scintillation linked to a public network of low tension energy.
fluctuation
IEC 61000-3-3
Manufacturer guidelines and declaration – Electromagnetic immunity

The system is intended to be used in the electromagnetic environment specified below. It is recommended
that the system’s client or user guarantees it is being used in the specified environment.
IEC-60601-1-2 Electromagnetic environment
Immunity test In accordance
Test Level guideline
IEC 61000-4-2 – ± 6 kV by contact ± 6 kV by contact Floors bust be made out of wood,

Electrostatic ± 8 kV by air ± 8 kV by air concrete, or ceramic. If floors are
Discharge covered by synthetic material, the
(ESD) relative humidity must be of at least
30%
IEC 61000-4-4 – ± 2 kV on supply ± 2 kV on supply The quality of energy supply must

Fast electric lines lines be of a hospital or typical
transients / Burst commercial environment.
±1 kV on ±1 kV on
input/output lines input/output lines
IEC 61000-4-5 - ± 1 kV line to line ± 1 kV line to line The quality of energy supply must
Surges be of a hospital or typical
±2 kV line to ±2 kV line to commercial environment.
ground ground

112
IEC-60601-1-2 Electromagnetic environment

Immunity test In accordance
Test Level guideline
IEC 61000-4-11 – < 5% UT (> 95% < 5% UT (> 95% The quality of energy supply must
Tension drops, tension drop in UT) tension drop in UT) be of a hospital or typical
short interruptions, by 0.5 cycle by 0.5 cycle commercial environment.
and tension
variations in input 40% UT (60% 40% UT (60%
supply lines tension drop in UT) tension drop in UT)
by 5 cycles by 5 cycles
70% UT (30% 70% UT (30%

tension drop in UT) tension drop in UT)
by 25 cycles by 25 cycles
< 5% UT (> 95 < 5% UT (> 95

tension drop in UT) tension drop in UT)
by 5seconds by 5seconds
Frequency supply 3 A/m 3 A/m Magnetic fields in supply frequency

of magnetic field must be in characteristic levels of a
(50/60 Hz) IEC typical location in a hospital or
61000-4-8 typical commercial environment
Note: UT is the c.a. tension supply before applying to assay level.
Radiated Immunity
ABNT NBR IEC Electromagnetic Environment -

Immunity Assay 60601 Assay In Accordance Recommended distance
Level guidelines
Portable and mobile RF

communication equipment must not
be used close to any part of the
system, including: cords with a
lesser separation distance than the
recommended, calculated from the
applicable equation to the
transmitter frequency.
Conducted RF 3 Vrms (?)1 Vrms (V1) D = 3.5/V1 √P

IEC 61000-4-6 150 kHz to 80
MHz outside ISM
ranges(a)
10 Vrms (?)1 Vrms (V2) D = 12/V2 √P

150 kHz to 80
MHz outside ISM
ranges(a)

113
Radiated RF 10 V/m (?)10 V/m (E1) D = 12/E1 √P 80 MHz to 800 MHz

IEC 61000-4-6
80 MHz to 2.5 D= 23/E1 √P 800 MHz to 2,5 GHz

GHz
Where P is the transmitter’s
maximum power nominal exit in
watts (W), according to the
transmitter’s manufacturer. D is the
recommended distance in meters
(b)
(m) .
The intensity established by the RF
transmitter, as determined through
an electromagnetic inspection on
(c)
site , must not be less than the
conformity level in each frequency
range(d).
(a)
ISM ranges (industrial, scientific, and medical) between 150 kHz to 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
(b)
The conformity levels in ISM range between 150 kHz and 80 MHz and a frequency range of 80 MHz to 2.5
GHz intend to reduce the probability of mobile and portable communication equipment to cause interference
if brought inadvertently to the patient’s environment. For this reason, an additional factor of 10/3 is used to
calculate the recommended separation distance for transmitters in these frequency ranges.
(c)
The intensities of established fields by fixed transmitters, such as: radio base stations, telephone (cellular /
wireless, terrestrial mobile radios, amateur radios, AM and FM transmission radios, and TV transmission
cannot be theoretically previewed with precision. To evaluate the electromagnetic environment due to fixed
RF transmitters, consider an electromagnetic inspection of the location. If the on-site field intensity
measurement in which the system is used surpasses the applicable RF conformity level above, the system
must be observed in order to verify if the operation is Normal. In the event an abnormal performance is
observed, additional procedures may be necessary, such as: system reorientation or replacement.
(d)
The field intensity must be less than [V1] V/m if it is above a frequency range between 150 kHz to 80 MHz.
Recommended distances between the portable and mobile RF communication equipment and the
system
The system is intended to be used in an electromagnetic environment where radiated RF disturbances are
controlled. The system’s client or users may help to prevent electromagnetic interference, maintaining a
minimal distance between portable and mobile RF communication equipment (transmitters) and the system
as recommended below, according to the communication equipment’s maximum output power.
Distance according to the transmitter’s frequency (m)
Transmitter’s 150 kHz to 80 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5
nominal MHz in ISM ranges MHz GHz
maximum out of ISM
power ranges
(W)
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 3,5   12   12   23 
D=  P D=  P D=  P D=  P
V1  V 2   E1   E1 
0.01 0.35 1.2 0.12 0.23
0.1 1.1 3.8 0.38 0.73
1 3.5 23 1.2 2.3
10 11 38 3.8 7.3
100 35 120 12 23
For transmitters with a nominal maximum output power not listed above, the recommended distance D in
meters (m) can be determined by using the applicable equation to the transmitter’s frequency, where P is the
transmitter’s nominal maximum output power in watts (W) according to the transmitter’s manufacturer.
Note 1 In 80 MHz to 800 MHz, the distance for the highest frequency range applies.
Note 2 The ISM (industrial, medical, and scientific) frequency ranges between 150 kHz to 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
Note 3 an additional factor of 10/3 is used to calculate the recommended distance for transmitters in ISM
frequency ranges between 150 kHz and 80 MHz and in the frequency range of 80MHz to 2.5 GHz to reduce
the probability of interference that mobile/portable communication equipment could cause if taken
inadvertedly to patient areas.
Note 4 These guidelines may not be applied to all situations. Electromagnetic propagation is affected by the
absorption and reflection of structures, objects, and people.
Electric Security
The following precautions must be observed when combining these items (non-medical equipment) to the
system.
Warning
• The items do not comply with the requirements stated on IEC 60601-1 standard cannot be
placed less than 5 ft. from the patient.
• All items (electro-medical and non-medical equipment) linked to the system with an
input/output signal cord must receive their power supply from an alternating current that
uses a separate transformer (according to IEC 60989 standard) or dispose of the
additional ground protection conducer.
• The multiple portable sockets with switch used on alternated current power supplies
must comply with IEC 60601-1-1 and may not be installed on the floor. Do not use more
than one multiple socket with portable switch.
• Do not connect the non-medical electrical equipment directly to the alternated current
socket on the wall. Use the AC power source with the appropriate transformer. Otherwise,
leakage current will increase above the accepted levels by IEC 60601-1 under normal and
one flaw conditions. This may cause dangerous electric shock to the patient or operator.

115
• After connecting any equipment to these sockets, submit the system to a complete
leakage current test (according to IEC 60601-1 standard).
• The electro-medical system operator must not touch the non-medical equipment and the
patient at the same time. This may cause dangerous electric shock to the patient or
operator.
13.16. IRMA CO2 Sensor (Phasein) - OPTIONAL

PHASEIN IRMA™ mainstream sensor was developed to monitor respiratory gases in adults, children, and
infants during anesthesia in locations with Intensive Care Units (ICU), Surgical Center, and Emergency
Room.
The IRMA sensor consists of an art state, in a set formed by a single sensor with technology of up to 9 non-
dispersive ultra-red ray channels (“Non-Dispersive Infrared” or “NDIR”) in order to identify gases, a
barometric pressure sensor, an electric tension regulator, and a microprocessor. The unit weight less than
0.88 ounces.
Carbon Dioxide (CO2) concentrations are monitored together with other parameters such as Breathing Rate
(or Respiratory Rhythm – RR), the wave of gases, and concentration of each gas during inspiration and
expiration.
The IRMA airway adapter fits perfectly in the IRMA gases sensor. This equipment uses PHASEIN’s XTP™
window technology. The airway adapter must be positioned between the endotracheal tube and the
respiratory circuit, which permits XTP windows positioned on the sides of the sensor to measure gas
concentrations.
Operating in a continuous, standard, low-intensity electrical tension, the IRMA sensor was designed to meet
portability requirements and low energy consumption, typically below 1 Watt. It was designed to be extremely
easy to integrate with any monitoring device, permitting the visualization of information on gases on real
time.
13.16.1. Use Instructions

The IRMA mainstream sensor was designed to be used connected to a Magnamed FlexiMag/BabyMag
ventilator and to any other monitoring device compatible to this sensor. Its purpose is to monitor gas
concentration value and signal in real time.
The sensor must be connected to the patient’s respiratory circuit in order to monitor inspired and expired
gases during anesthesia, besides patient recovery and respiratory treatment centers. It must be used in
Surgical Centers, Intensive Care Units (ICU), Emergency Rooms, and Patient Rooms. It is indicated for
adult, pediatric, and infant patients.
It must not be used as the only means of monitoring the patient. It must always be used with a vital signs
monitoring equipment. This monitoring must be accompanied by a specialist that is capable of analyzing
patient conditions. The IRMA sensor was developed in order to be used by trained and authorized
healthcare professionals.
13.16.2. Sensor Assembly

The following steps demonstrate how to assemble the gas monitoring sensor:
a) Connect the IRMA sensor cable to the FlexiMag ventilator and connect it to the device;
b) Insert the airway adapter into the IRMA sensor. You will hear a click after the airway adapter is
inserted correctly into the sensor;

116
Image 31 – Airway sensor socket
c) The green LED will indicate that the IRMA sensor is ready for use.
Image 39 - LED indicates if the sensor is ready for use
d) Connect the 0.59 inch adult IRMA airway adapter to the respiratory circuit’s “Y” part;
Image 32 - Airway adapter connection to Respiratory Circuit’s Y part
e) Connect the 0.59 inch adult IRMA airway adapter to the patient’s Endotracheal Tube;

117
Image 41 - Airway adapter connection to the patient’s Endotracheal Tube
f) In the event there is a need to connect a Heat Moisture Exchanger (HME), place it between the
IRMA sensor and the Endotracheal Tube. Placing the Moisture Exchanger in front of the sensor will
protect the airway adapter from secretions and water vapor effects, which eliminates the need of
changed the adapter during use.
Image 33 - Assembly scheme with Moisture Filter
13.16.3. Sensor Positioning

It is extremely important to avoid direct contract between the IRMA sensor and the patient’s body when
connection the IRMA sensor to a pediatric patient’s ventilatory circuit.
In the event it is not possible to avoid, for whichever reason, the sensor’s direct contact to any part of the
child’s body; an isolating material must be placed between the IRMA sensor and the body.
Warning
• The IRMA sensor must not have direct contact with the patient during use.
13.16.4. Sensor Reset Procedure

Warning
• The sensor’s incorrect reset will result in the incorrect reading of the measured values.

118
In order to ensure the high precision of the measured valued by the IRMA sensors, the following reset
recommendations must be followed.
The reset must be done by connecting an airway adapter to the IRMA sensor without connecting them to the
respiratory circuit. When the gas monitoring signals present stable values, press the button in order to start
the reset.
Special care should be taken in order to avoid close respiration to the sensor before or during the reset. The
presence of ambient air (21% of O2 and 0% of CO2) through the airway adapter is of crucial importance for a
successful reset. If the following error message appears: “Necessary recalibration” immediately after the
reset procedure, the procedure must be repeated.
The reset must be executed every time the airway adapter is substituted. It also must be executed when
there’s a base line offset in some of the gas measurements or when the “Exact gas measurements not
determined” error message appears on the screen.
After turning on the sensor or exchanging the airway adapter, wait at least a minute before beginning the
reset procedure in order for the IRMA sensor to warm-up. The green LED on the sensor will be intermittent
for 5 seconds while the reset process is in progress.
13.16.5. LED Information

The following tables show possible colors indicated on the LED present on the sensor and their respective
meanings:
Color (Status) Meaning

Green (constantly on) System OK
Green (intermittent) Reset in Progress
Blue (constantly on) Present Anesthetic Agent
Red (constantly on) Sensor Error
Red (intermittent) Verify the adapter
Table 1: LED colors and their meanings
13.16.6. Sensor Cleaning Procedures

The IRMA sensor may be cleaned with a damp cloth and ethanol or isopropyl alcohol.
13.16.7. Preventive Maintenance

The gas calibration must be verified in regular intervals by a reference instrument.
Attention
• The IRMA sensor’s airway adapters are unsterilized accessories. The autoclavable
procedure may damage these accessories.
• Never sterilize or submerse the IRMA sensor in liquid.
Warning
• The IRMA sensor is intended for exclusive use of trained and authorized professionals
from the medical team;
• The IRMA sensor must not be used with flammable anesthetic agents;
• IRMA airway adapters must not be reused. Reusing a disposable airway adapter may
cause a cross infection;
• Airway adapters must be disposed of according to local regulation regarding medical
waste;
• Do not use an Adult/Pediatric airway adapter in infants, since the adapter adds a dead
space of 6 mL to the patient’s respiratory circuit;
119
• Do not use Pediatric airway adapters in adult patients, since the adapter may add
excessive resistance;
• Measurements may be affected by communication equipment by Radio Frequency or
cellular devices. The user must certify that the sensor will be used in environments
according to the Electromagnetic environment requirements described in this manual;
• Do not connect the airway adapter between the Endotracheal Tube and the respiratory
circuit’s elbow, since this may cause patient secretions to block the adapter’s windows,
causing the sensor’s incorrect operation;
Image 43 - Airway adapter correct and incorrect positioning
• Do not use the airway adapter with measured dose inhalers or with nebulized medication,
since it may affect light transmission within the sensor’s windows;
• The IRMA sensor was designed for an adjunct device in the patient’s monitoration. Its
information must be analyzed together with other measurements and symptoms;
• Incorrect reset may result in wrong measurements;
• Change the airway adapter in the event the adapter presents condensation;
• Only use airway adapters produced by PHASEIN;
• The IRMA sensor must enter direct contact with the patient during use.
Attention
• Never sterilize or submerse the IRMA sensor in liquid;
• Do not apply electrical tension on the sensor’s cord;
• Do not use the IRMA sensor in environments in which specifications are outside the
established limits in Technical Specifications (Temperature, Moisture, etc.)

120
13.16.8. Capnograph’s Technical Specifications
GENERAL:
DESCRIPTION MAINSTREAM MONITORING SENSOR WITH INFRARED TECHNOLOGY.
DIMENSIONS (W X D X H) IRMA CO2: 38 X 37 X 34MM (1,49” X 1,45” X 1,34”)
CORD’S LENGTH 2,50M (± 0.02M)
WEIGHT < 25G (WITHOUT CORD);
< 38G (WITH CORD).
OPERATION TEMPERATURE IRMA CO2: 0 TO 40°C / 32 TO 104°F
STORAGE AND IRMA CO2: -40 TO 75°C / -40 TO 167°F
TRANSPORTATION
TEMPERATURE
OPERATION MOISTURE 10 TO 95% RH, WITHOUT CONDENSATION.
STORAGE AND 5 TO 100% RH, WITH CONDENSATION.(1)
(1)
TRANSPORTATION MOISTURE AFTER BEING IN AN ENVIRONMENT WITH CONDENSATION, THE UNIT MUST BE
STORED FOR OVER 24 HOURS IN AN ENVIRONMENT WITH A MOISTURE EQUIVALENT
TO THE OPERATION MOISTURE.
OPERATIONAL ATMOSPHERIC IRMA CO2: 525 TO 1200cmH2O (525cmH2O CORRESPONDS TO AN ALTITUDE
PRESSURE OF 4572 M OR 15000 FT.).
STORAGE AND 500 TO 1200cmH2O.
TRANSPORTATION
ATMOSPHERIC PRESSURE
MECHANICAL RESISTANCE SUPPORTS REPEATED DROPS OF 3.28 FT. ON A HARD SURFACE.
IN ACCORDANCE WITH THE REQUIREMENTS STATED IN AMBULANCE STANDARD
(EN 1789:2004 – CLAUSE 6.4) AND REQUIREMENTS AGAINST CRASHES AND
VIBRATION (EN ISO 21647:2004 – CLAUSE 21.102, TRANSPORTATION).
POWER SUPPLY IRMA CO2: 4.5 TO 5.5 VDC, MAX 1.0W (POWER MEASURED WITH 5V AND LESS
THAN 350MA DURING 200MS).
SURFACE TEMPERATURE IRMA CO2:
(TEMPERATURE OF 73.4°F) MAX: 41°C / 106°F.
AIRWAY ADAPTER ADULT/PEDIATRIC (DISPOSABLE):
ADDS LESS THAN 0.21 OZ OF DEAD SPACE;
PRESSURE LOSS LESS THAN 0.3CMH20 TO 30LPM.
INFANT (DISPOSABLE):
ADDS LESS THAN 0.04 OZ. OF DEAD SPACE;
PRESSURE LOSS LESS THAN 1.3CMH20 TO 10LPM.
OUTPUTS:
BREATHING DETECTION ADAPTIVE THRESHOLD, MINIMUM OF 1% VOLUME VARIATION IN A CO2
CONCENTRATION.
BREATHING RATE 0 TO 150BPM. A BREATHING RATE IS SHOWN AT EVERY 3 BREATHS. THE
AVERAGE’S VALUE IS UPDATED AT EACH BREATH.
FI AND ET FI AND ET ARE SHOWN AFTER A BREATH. ITS AVERAGES ARE CONSTANTLY
UPDATED.
IRMA CO2: CO2.
WAVEFORMS IRMA CO2: CO2.
DIAGNOSTICS PARAMETERS ATMOSPHERIC PRESSURE, SOFTWARE AND HARDWARE REVISION, SERIAL
NUMBER.
INFORMATION NEW BREATH DETECTION, APNEA, VERIFY ADAPTER, NON-SPECIFIED

121
ACCURACY AND SENSOR ERROR.
CO2 GAS ANALYZER:

SENSOR GAS ANALYZERS WITH 2 TO 9 NDIR CHANNELS (NON-DISPERSIVE INFRARED)
THAT MEASURES BETWEEN 4 A 10µM. ALSO, IT PERFORMS PRESSURE,
TEMPERATURE, AND INTERFERENCE CORRECTION WITHIN THE SPECTRAL
RANGE.
CALIBRATION RESET IS RECOMMENDED EVERY TIME THE AIRWAY ADAPTER IS CHANGED. THE
INFRARED DOS NOT PRESENT ANY SPECIFIC CALIBRATION NEED.
WARM-UP TIME INFORMATION ABOUT THE CONCENTRATION IS ANALYZED AND SENT AT EVERY
10 SECONDS.
TOTAL PRECISION OF MEASUREMENTS: 1 MINUTE.
RISE TIME (10 L/MIN) CO2 ≤ 90MS.
SYSTEM’S TOTAL < 1S.

RESPONSE TIME
MEASUREMENT PRECISION (UNDER STANDARD CONDITIONS):

TYPE OF GAS RANGE (AX+) PRECISION
CO2 0 TO 15 ±(0.2 VOL% + 2% READ)
15 T0 25 NOT SPECIFIED
NOTE: GAS CONCENTRATION IS EXPRESSED IN VOLUME PERCENTAGE UNITS.
MEASUREMENT PRECISION (UNDER ALL CONDITIONS):

TYPE OF GAS PRECISION
CO2 ±(0.3 VOL% + 4% READ)
NOTE 1: THE PRECISION SPECIFICATION IS VALID FOR ANY SPECIFIED ENVIRONMENTAL CONDITION, EXCEPT IN
THE EVENTS EXPRESSED ON THE TABLE BELOW AS “GAS AND VAPOR INTERFERENCE EFFECTS”.
GAS AND VAPOR INTERFERENCE EFFECTS:

GASES OR VAPOR GAS LEVEL CO2
(1 E 2)
N2O 60 VOL% ---
(1)
HAL 4 VOL% ---
(3)
ENF, ISO, SEV 5 VOL% +8% READ MEASUREMENT.
(3)
DES 15 VOL% +12% READ MEASUREMENT.
(3)
XE (XENON) 80 VOL% -10% READ MEASUREMENT.
(3)
HE (HELIUM) 50 VOL% -6% READ MEASUREMENT.
PROPELLANT IT WAS NOT DESIGNED TO USE A PROPELLANT INHALER WITH MEASURED DOSE.
INHALER WITH
MEASURED DOSE
C2H5OH 0.3 VOL% --- (1)
(ETHANOL)
(1)
C3H7OH 0.5 VOL% ---
(ISOPROPANOL)
(1)
CH3COCH3 1 VOL% ---
(ACETONE)
CH4 (METHANE) 3 VOL% --- (1)
CO (CARBON 1 VOL% --- (1)
MONOXIDE)
NO (NITROGEN 0.02 VOL% --- (1)
122
MONOXIDE)
O2 100 VOL% --- (1 E 2)
NOTE 1: NEGLIGIBLE INTERFERENCE. EFFECTS FROM INTERFERENCE DO NOT ALTER THE “PRECISION
MEASUREMENTS (UNDER ALL CONDITIONS” TABLE ABOVE.
NOTE 2: FOR SENSORS THAT ARE NOT MEASURING N2O AND/OR O2, THE CONCENTRATIONS MUST BE MANUALLY
INSERTED BY THE USER.
NOTE 3: INTERFERENCE IN THE INDICATED GAS LEVEL. FOR EXAMPLE, 50 VOL% OF HELIUM TYPICALLY
DIMINISHES THE READ VALUES IN CO2 IN 6%. THIS MEANS THAT IF THE MIXTURE CONTAINS 5.0 VOL% CO2 AND
50% OF HELIUM, THE CO2 CONCENTRATION MEASUREMENT WILL NORMALLY BE CALCULATED AS FOLLOWS: (1 –
0.06) * 5.0 VOL% = 4.7 VOL% CO2.
NOTE 4: IN ACCORDANCE TO THE EM ISO 21647:2004 STANDARD.
13.16.9. Capnograph accessories
MAGNAMED:
DESCRIPTION CODE (MAGNAMED)
IRMA CO2 AIRWAY SENSOR WITH 5 WAY CONNECTOR 2702597
PHASEIN:
DESCRIPTION CATALOG NUMBER (PHASEIN) CODE (MAGNAMED)
IRMA AIRWAY ADAPTER, ADULT / 106220 3902414
PEDIATRIC – BOX: 25 UNITS
ADULT/PEDIATRIC AIRWAY ADAPTER
BOX WITH 25 UNITS
13.17. Oximeter (Masimo) - OPTIONAL

The encapsulated Masimo MS-2040 pulse oximeter is an auto sufficient solution that permits the secure
measurement during movement and low infusion in order to measure: SpO2, heart rate, infusion index, and
PVI. This oximeter is compatible with all of Masimo’s LNCS® sensors.
13.17.1. Principle of Operation

®
A Masimo SET oximeter pulse MS panel is based on three principles:
1. Oxyhemoglobin and deoxyhemoglobin absorption differential from red lights and infrared
(spectrophotometry).
2. The volume of arterial blood in the tissue and the light absorbed in the blood alterations
(plethysmography).
3. Arteriovenous derivation is highly variable and its absorbance fluctuation trough the venous
blood is the greatest noise component during the pulse.
The Masimo SET oximeter pulse MS panel, as well as the traditional dosimetry pulse, determines SpO2 by
the passage of red and infrared light in a capillary bed and alter the measurement during the pulsatile cycle.
Diodes that issue red or infrared light (LED) on the oximeter sensors serve as a light source. The photodiode
serves as a photodetector.
Traditionally, pulse oximetry assumes that all pulses on the red absorbance signal are caused by volume
fluctuation in arterial blood, assuming that the blood flow in the sensor’s region passes entirely by the
capillary bed instead of through an arteriovenous derivation. Traditional pulse oximetry calculates the
pulsatile absorbance ratio (AC) with an absorbance average (DC) in each of wave lengths, 660nm and
950nm:

123
S(660)=AC(660)/DC(660)
S(905)=AC(905)/DC(905)
Therefore, the oximeter calculates the ratio between these two arterial absorbance pulse signals:
R=S(660)/S(905)
The value of R is used to find SpO2 saturation in a verification table made by an oximeter software. The
values on this table are based on human blood studies collected in a co-oximetry laboratory from healthy
adult volunteers in an induced hypoxia study.
The Masimo SET pulse oximeter MS panel assumes that the arteriovenous derivation is highly variable in
the fluctuating absorbance since the venous blood is a noise component during pulsation. The MS panel
decomposes S(660) and S(905) in an arterial sign one more noise component and calculates the arterial
sign’s ratio without noise:
S(660)=S1+N1
S(905)=S2+N2
R= S1/S2
Once again, R is the ratio between two arterial pulsed absorbance signs. Its value is used to find SpO2
saturation in an empirically derived equation in an oximeter software. The values from the empirically derived
equation are based on studies regarding human blood studies collected in a co-oximetry laboratory from
healthy adult volunteers in an induced hypoxia study.
The equations above are combined and a reference noise (N’) is determined:
N’=S(660)-S(950)xR
In the event there is no noise N’=0: then S(660) = S(905) x R, which is the same ratio as the traditional pulse
oximetry.
The equation for the reference noise is based on the R value on the searched valued in order to determine
SpO2. The MS panel software scans all possible R values that correspond to SpO2 values between 1% and
100% and generates an N’ value for each of these R values. The S(660) and S(905) signals are processed
for each possible N’ reference noise for an Adaptive Correlation Cancellation (ACC) that produces a power
outlet versus a possible SpO2 value, as shown in the following image, where R corresponds to SpO2=97%.

124
Discrete Saturation (DST), Output Power Correlative Canceller

The DST curve has two peaks: one of the highest corresponding peaks is selected as the SpO2 value. Every
sequence is repeated every two seconds during the most recent four seconds pertaining to the received
data. Concluding to MS panel’s SpO2 corresponds to the coursed evaluation saturation of the arterial
hemoglobin, which is updated every two seconds.
Warning
• Explosion danger. Do not use the MS pulse oximeter in the presence of flammable
anesthetics or other flammable substances in contamination with the air, oxygen or
nitrous oxide enriched environments.
• The pulse oximeter must not be used as an apnea sensor.
• The heart rate is based in the optic detection of the peripheral pulse flow and, therefore,
cannot detect certain arrhythmias. The pulse oximeter must not be used with an
arrhythmia analysis reposition or substitution based on the ECG.
• A pulse oximeter can be considered a previous alert device. As patient deoxygenation
tendency indicator, blood samples can be analyzed by an oximetry laboratory in order to
complete the understanding of the patient’s condition.
• The pulse oximeter MS panel must only be operated by qualified personnel. This manual,
use instructions, all precaution information and specifications must be read before use.
• Electric shock danger. Do not remove the monitor’s cover. The operator may realize the
maintenance procedures specifically described in this manual. Contact Magnamed’s
technical assistance in order to repair this oximeter.
• As well as in every medical equipment, position the cord over the patient in order to
reduce the possibility of entanglement or strangulation.
• Interfering substances: Carboxyhemoglobin may wrongly increase readings. The increase
level is approximately the same as the present carboxyhemoglobin. Dyes, or any
substance containing due, which alter the artery’s usual pigmentation may cause reading
errors.

125
• Do not use the Masimo sensor during the magnetic resonance imaging (MRI). The
induced current may potentially cause burns. The Oximeter may affect the resonance
image. The resonance unit may affect oximetry measurements.
• In the event fidelity of any measurement does not appear to be reasonable, first, verify all
of the patient’s vital signs by alternative means and verify if the oximeter is working
appropriately.
• The Oximeter can be used during defibrillation; however, the readings may not be
accurate for a short period of time.
® ®
• Before use, carefully read LNOP /LNCS sensors’ use instructions.
• Only use Masimo oximetry sensors to measure SpO2.
• Damages to the cloth may be caused by the incorrect application or use of one of the
® ® ® ®
LNOP /LNCS sensor, for example: by fastening the LNOP /LNCS sensor too tight.
Inspect the sensor’s location as described in the use instructions in order to assure the
skin’s integrity and the sensor’s correct positioning.
• Do not use damaged LNOP®/LNCS® sensors. Do not use LNOP®/LNCS® sensor with
exposed optic components.
• Do not submerse the sensor in water, solvents, or cleaning solution (the sensor and
connectors are not water proof). Do not sterilize by irradiation, vapor, or oxide
sterilization. Refer to cleaning instructions provided in the use instructions of reusable
Masimo LNOP®/LNCS® sensors.
Attention
• Cleaning
o Do not autoclave, sterilize by pressure or gas.
o Use cleaning solutions with moderation. Excess solution may run into the monitor
and cause internal damages to the components.
o Do not use solutions derived by petroleum or acetones, or other abrasive solvents
to clean the oximeter. These substances attack the device’s materials and may
result in its failure.
• Imprecise measures may be caused by:
o Sensor’s incorrect application or use
o Significant level of hemoglobin dysfunction (for example, carboxyhemoglobin or
methemoglobin).
o Intravascular dyes, such as: indocyanine green or methylene blue.
o Exposure to excessive light, as well as surgical lamps (especially those with
xenon light source), bilirubin light, fluorescent light, infrared warming lamps, or
direct sun light (the exposition to excessive lighting may be corrected by covering
the sensor with a dark or opaque material).
o Patient’s excessive movement
o Venous pulsation
o Sensor positioning to an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
• The loss of pulse signal can occur by any of the following situations:
o The sensor is too tight

126
o There is excessive lighting from light sources with a surgical lamp, a bilirubin
lamp, or solar light.
o The blood pressure cuff is inflated at the same extremity of where the SpO2
sensor is positioned.
o The patient hypotension, severe vasoconstriction, severe anemia, or hypothermia.
o There is an arterial occlusion next to the sensor.
o The patient is under cardiac arrest or shock.

127
14. Symbols
SIMBOLOS /
MARCAÇÕES PORTUGUÊS ESPANHOL INGLÊS
CLASS I IPX1 CLASSE I IPX 1 CLASE I IPX 1 CLASS I IPX1

INTERNALLY POWERED ENERG. INTERNAMENTE ENERG. INTERNAMENTE INTERNALLY POWERED
CONTINUOUS OPERATION OPERAÇÃO CONTINUA OPERACIÓN CONTÍNUA CONTINUOUS OPERATION
PACIENTE PACIENTE PATIENT
--- CORRENTE
CONTÍNUA
CORRIENTE
CONTINUA
CONTINUOUS
TIDAL
CORRENTE CORRIENTE ALTERNATING

ALTERNADA (REDE) ALTERNA (RED) CURRENT (POWER)
ENERGIA ELÉTRICA ENERGÍA ELÉCTRICA ELETRIC ENERGY
RECOLHIMENTO DE WASTE - ELECTRICAL AND

RECOGIMIENTO DE EQUIPO ELECTRIC EQUIPMENT SHALL BE
EQUIPAMENTO ELÉTRICO /
ELÉCTRICO ELECTRÓNICO COLLECTED AND RECYCLED IN
ELETRÔNICO FEITO DE FORMA ACCORDANCE WITH DIRECTIVE
HECHO POR SEPARADO
SEPARADA 2002/96/EC
ENTRADA DC ENTRADA DC DC INPUT
LIGA ON ON
DESLIGA OFF OFF
INSP / EXP PAUSA INSPIRATÓRIA/ PAUSA INSPIRATORIA/ INSPIRATORY/

HOLD EXPIRATÓRIA ESPIRATORIA EXPIRATORY PAUSE

128
SIMBOLOS /
MANUAL DISPARO MANUAL GATILLO MANUAL MANUAL TRIGGER
O2 100% 100% OXIGÊNIO 100% OXIGENO OXYGEN 100%
INSP INSPIRATÓRIA INSPIRATORIA INSPIRATORY
EXP EXPIRATÓRIA ESPIRATORIO EXPIRATORY
SERIAL SERIAL SERIAL
IDENTIFICAR OU IDENTIFICAR O ASESORAR TO IDENTIFY OR

ACONSELHAR LIMPEZA LA LIMPIEZA O EL CAMBIO ADVISE CLEANING OR
OU TROCA DE FILTRO DEL FILTRO CHANGINGA FILTER
TRAVAR TECLADO TRABAR TECLADO KEYBOARD LOCK
PAGINA PÁGINA PAGE
ALARME AUDIO ALARMA AUDIO AUDIO ALARM

PAUSADO PAUSADO PAUSED
ALARME ALARMA ALARM
PROTEGIDO CONTRA PROTEGIDO CONTRA

PROTECTED AGAINST
IPX4 RESPINGOS DE
ÁGUA
SALPICADURAS
DE AGUA
WATER SPRAYS
ATENÇIÓN! CONSULTAR
ATENÇÃO! CONSULTAR ATTENTION! SEE
DOCUMENTOS QUE ACCOMPANYING DOCUMENTS
DOCUMENTOS ACOMPANHANTES
ACOMPANAN

129
SIMBOLOS /
PARTE APLICADA PARTE APLICADA TYPE BF

TIPO BF TIPO BF APPLIED PART
EQUIPAMENTO EQUIPO CLASS II

CLASSE II CLASE II EQUIPAMENT
DATA DE FECHA DE MANUFACTURE

FABRICAÇÃO FABRICACIÓN DATE
FABRICANTE FABRICANTE MANUFACTURE
Et CO2 Co 2 CORRENTE Co 2 CORRIENTE END TIDAL CO2
O 2 INLET ENTRADA DE O2 ENTRADA DE O 2 O 2 INLET
O2 OXIGÊNIO OXIGENO OXYGEN
FRÁG IL FRÁG IL FRAG ILE
FACE SUPERIO R LADO SUPERIO R THIS SIDE

NESTA DIREÇÃO EN ESTA DIRECCIÓ N UP
PRO TEG ER CO NTRA PRO TEG ER CO NTRA FEARS

UMIDADE LA HUMIDAD HUMIDITY
S O S TE NIMIE NTO S
Q UA NTIDA DE S EG URA S A FE S TA CKING
n
DE L A CA NTIDA D DE
DE E MP IL HA ME NTO Q UA NTITY
A MO NTA NA R
TEMPERATURE
70ºC
10 ºC
LIMITES DE LIMITES DE
TEMPERATURA TEMPERATURA LIMITS
MANTENHA MANTENER KEEP AWAY

PRO TEG IDO DO SO L PRO TEG IDO DEL SO L FRO M HEAT

130
15. Terms and Abbreviations

Terms and Terms and
Description Description
Abbreviations Abbreviations
ADU Adult I:E T.Insp by TExp Ratio
Backup Adjusts Modality in Apnea IMC/BMI Body Max Index
C.Dyn Dynamic Compliance INF Infant
CO2i ↑ Adjust High inspired CO2 alarm Man Trig Manual Trigger
Compliance Circuit Compliance MV Minute Volume
Cons O2 O2 Consumption NEO Neonatal
C.Stat Static Compliance NIV Non-Invasive Ventilation
Continuous Pressure Airway

CPAP/PS O2 100% O2 flash indication
Ventilation with Pressure Support
Cycl. PS Cycling Percentage Pause Inspiratory Pause
DualPAP CPAP ventilation in two levels PCV Pressure Controlled Ventilation
Airway pressure at the end of

etCO2 Expired CO2 PEEP
Expiration
FiO2 O2 Inspired Fraction PEEPi Intrinsic PEEP
P. Inferior Inferior Pressure DualPAP

Freq Total Respiratory Frequency
modality
F.Base Base Flow P. Insp Inspiratory Pressure Adjustment
PLV
Fspn Spontaneous Frequency Pressure Limited Ventilation

131
Terms and Terms and

Fl Tig
Flow Trigger (Sensitivity) T.Insp Inspiratory Time
F.Trigger
P Mean Mean Pressure P.Max Maximum Pressure in Airways
P.Plat Plateau Pressure T. Inferior Inferior Time in DualPAP Modality
Superior Time in DualPAP

Prede Network Pressure T. Superior
Modality
P. Trig
Pressure Trigger (Sensitivity) Exp Valve Expiratory Valve
P.Trigger
Prox Next Page Leakage Circuit Leakage
Pressure-Synchronized
P-SIMV Intermittent Mandatory VCV Volume Controlled Ventilation
Ventilation
PSV VMspn Spontaneous Volume Minute

Pressure Support Ventilation
Superior Pressure in DualPAP Guaranteed Volume-Pressure

P. Superior V-PCV
Modality Controlled Ventilation
Volume-Synchronized Intermittent
Res Airway Resistance V-SIMV
Mandatory Ventilation
Resistencia Circuit Resistance Vspn Spontaneous Volume
Rise Time Rise Time Vt Adjusted Current Volume
SpO2 Blood’s Oxygen Saturation Vti Inspired Current Volume
T.Exp Expiratory Time Vte Expired Current Volume

132
Terms and Terms and

. Value to be added to PEEP’s

V Current Flow ∆PS pressure in order to obtain
Pressure Support

133
16. Biocompatibility Declaration

We declare under our sole responsibility that all materials used in applied parts (according to the definition of
NBR IEC 60601-1 standard) on Magnamed Ventilator, has been widely used in the medical area over time;
therefore, guaranteeing its biocompatibility.
According to ISO-10993-1 Standard Biological evaluation of medical devices — Part 1: Evaluation and
testing – clause 5 – the ventilator, its parts and accessories are classified as a device without direct or
indirect contact with the patient’s body. Therefore, the ventilator, its parts, and accessories are not included
in this standard’s scope.
Warning
• The common accessories acquired from third parties MUST be registered by ANVISA.

134
17. Guarantee
Manufactured and commercialized products by MAGNAMED TECNOLOGIA MÉDICA S/A. are
guaranteed against material defects and manufacturing throughout Brazilian territory according to the
dispositions below.
The guarantee period comprises 275 days or the equipment and what is stipulated by law for batteries
and accessories, provided they maintain their original characteristics. These terms will be counted from the
first buyer’s acquisition date, contained in MAGNAMED TECNOLOGIA MÉDICA S/A. Sales Receipt.
The guarantee responsibility is limited to substitution, repair, and hand labor regarding the parts that
present defects or that do not attend to the specifications contained in the Product’s Operation Manual.
The guarantee is limited to the product that is used under normal conditions and for its intended use,
and which preventive maintenances and part substitutions, and repair are realized according to the
instructions stated in the Product’s Operation Manual by the manufacturers authorized personnel.
The guarantee does not cover damages caused by the inadequate use or installations, accidents,
inadequate sterilization, service, installation, operation, or alteration realized by non-authorized personnel.
The disruption or absence of seals or guarantee stamps by non-authorized personnel results in the
product’s guarantee loss.
The parts that are subject to normal use of wear and tear, adverse use conditions, undue use, or
accidents that are not covered by guarantee.
Eventual expenses and risks with product transportation are not covered by the guarantee.
There is no expressed or implicit guarantee, besides those exposed above.

135
This product is exclusively intended for use in lung ventilation and must only be operated by
qualified professionals.
Manufacturer / Technical Assistance / Customer Service
Magnamed Tecnologia Médica S/A

Rua São Paulino, 221 – Vila Mariana
CEP: 04019-040 – São Paulo – SP – Brasil
Tel/Fax: +55 (11) 5081-4115
E-mail: magnamed@magnamed.com.br
Website: www.magnamed.com.br
European Representative
OBELIS S/A
BD. Genéral Washis, 53, 1030
Brussels – Belgium
Tel.: +32.2.732.59.54
Fax: +32.2.732.60.03
E-mail: mail@obelis.net
Website: www.obelis.net
Brussels – Belgium
CNPJ: 01.298.443/0001-73 State Inscription: 149.579.528.111
We declare that the information reported on these labels are true and may be proven by available documents
that pertain to the Company.
Technical Responsible: Tatsuo Suzuki

Inscription CREA-SP: 0600629049
Legal Responsible: Tatsuo Suzuki

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The total or partial reproduction of this work is forbidden in any

(Law No. 9,610/1,998)

ANVISA Registration no. 80659160003

All rights reserved by

State Registration: 149.579.528.111

Technician Responsible: Tatsuo Suzuki

CREA-SP Registration: 0600629049

Legal Responsible: Tatsuo Suzuki

MAGNAMED TECNOLOGIA MÉDICA S/A

Elaborated by: Verified by: Approved by:

REV DESCRIPTION (mm/dd/yyyy)

MAGNAMED TECNOLOGIA MÉDICA S/A

2. Definitions and Care

MAGNAMED TECNOLOGIA MÉDICA S/A

Similar functions between FlexiMag and BabyMag are shown below:

• PLV* – Pressure Limited Ventilation (Assisted);

Additional modalities, exclusive for FlexiMag:

• VCV – Volume Controlled Ventilation (Assisted);

** In BabyMag this modality is an optional

MAGNAMED TECNOLOGIA MÉDICA S/A

MAGNAMED TECNOLOGIA MÉDICA S/A

MAGNAMED TECNOLOGIA MÉDICA S/A

1 mbar (milibar) = 1 hPa (hectoPascal) = 1.016 cmH2O (centimeter of water)

1 mbar = 1 hPa ≈ 1 cmH2O

MAGNAMED TECNOLOGIA MÉDICA S/A

12.2. INTERNAL LITHIUM BATTERY ................................................................................ 99

MAGNAMED TECNOLOGIA MÉDICA S/A

These ventilators may be used for lung ventilation:

• For treatment of patients in the intensive care unit (ICU).

The similar modalities between FlexiMag and BabyMag Ventilators are:

• PLV* – Pressure Limited Ventilation (Assisted);

Additional modalities, exclusive of FlexiMag:

• VCV – Volume Controlled Ventilation (may be assisted);

* Only available for neonatal patients

MAGNAMED TECNOLOGIA MÉDICA S/A

Other resources that these ventilators provide the ICU:

• Synchronized nebulizer with inspiration and volume compensation.

Display Model Description

10.4” 1103040 BABYMAG –10.4 inch Neonatal Electronic Lung Ventilator

15” 1103360 BABYMAG –15 inch Neonatal Electronic Lung Ventilator

1103760 FLEXIMAG – 15 inch Neonatal Pediatric Adult Electronic Lung Ventilator

Both models have the following adjustable alarms:

• Capnography Sensor (Optional)

*Optional items or alarms

Both incorporate a ventilation monitor that presents:

o Pressure Flow x Time

* Optional parameters and curves

MAGNAMED TECNOLOGIA MÉDICA S/A

The following information is presented on the product’s external label:

ANVISA Registration No.80659160003 UNDETERMINED VALIDITY

Image 1 – Product’s External Label

4.3. Operation Principle

FlexiMag and BabyMag ventilators are comprised by:

1. Ventilator’s electronic, microprocessed control board

MAGNAMED TECNOLOGIA MÉDICA S/A

2. Manifold of integrated pneumatic components:

4. Ventilation parameter monitoring system with flow and pressure sensors

5. Video touchscreen monitor with a second independent electronic, microprocessed control

MAGNAMED TECNOLOGIA MÉDICA S/A

6. Software dedicated (firmware) to the general control of pneumatics, monitoring, graphic

4.4. Other Characteristics

MAGNAMED TECNOLOGIA MÉDICA S/A