Magnamed Fleximag User manual

Operation Manual
Mechanical Ventilator
Fleximag (display 15”)

MAGNAMED TECNOLOGIA MÉDICA S/A
This operation manual refers to ventilator model FlexiMag 15”, developed and manufactured by
Magnamed Tecnologia Médica S/A.
Revision of this operation manual: n° 13
Registration at ANVISA No. 80659160003
All rights reserved by:
Magnamed Tecnologia Médica S/A

Rua Santa Mônica, 801, 831
06715-865 –Parque Industrial San José -Cotia –SP Brasil
Tel/Fax: [phone]
E-mail: [e-mail]
Website: www.magnamed.com.br
CNPJ: 01.298.443/0002-54
State Inscription: 149.579.528.111
Technical Responsible: Toru Miyagi Kinjo
Inscription CREA-SP: 5061555031
Legal Responsible: Wataru Ueda

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Content
1 SAFETY ANNOTATIONS ............................................................................................................................................ 6
DEFINITIONS .................................................................................................................................................................6
WARNING.....................................................................................................................................................................7
ATTENTION...................................................................................................................................................................9
OBSERVATION ...............................................................................................................................................................9
2 CHARACTERISTICS .................................................................................................................................................. 10
INTENDED USE.............................................................................................................................................................10
FUNCTIONING PRINCIPLE ...............................................................................................................................................10
GENERAL CHARACTERISTICS ...........................................................................................................................................12
SAFETY CHARACTERISTICS ..............................................................................................................................................13
3 UNPACKING THE PRODUCT .................................................................................................................................... 14
INITIAL VERIFICATIONS ..................................................................................................................................................14
RELATION OF COMPONENTS OF FLEXIMAG 15”.................................................................................................................15
4 COMPONENT IDENTIFICATION............................................................................................................................... 18
FRONT VIEW................................................................................................................................................................18
BACK VIEW.................................................................................................................................................................19
5 PREPARATION FOR USE.......................................................................................................................................... 20
ASSEMBLY ..................................................................................................................................................................20
CONNECTION TO POWER SUPPLY ....................................................................................................................................25
VERIFICATIONS BEFORE USE............................................................................................................................................25
6 USE INSTRUCTIONS ................................................................................................................................................ 27
INITIAL SEQUENCE ........................................................................................................................................................27
6.1.1 Patient selection...............................................................................................................................................27
ADJUSTMENT BUTTONS .................................................................................................................................................28
MAIN SCREEN .............................................................................................................................................................29

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6.3.1 Menus and Graphs Area ..................................................................................................................................29
6.3.2 Menus Selections Area .....................................................................................................................................29
6.3.3 Display Area of Alarm Messages......................................................................................................................30
6.3.4 Display Area of Alert Messages........................................................................................................................30
6.3.5 Display Area and Ventilatory Mode Selection..................................................................................................30
6.3.6 Information Area..............................................................................................................................................30
6.3.7 Audible alarm paused button...........................................................................................................................31
6.3.8 Quick Access function area ..............................................................................................................................31
6.3.9 Permanent Monitor Display Area ....................................................................................................................33
6.3.10 Area of adjustable parameters ......................................................................................................................33
SETTING THE VENTILATION .............................................................................................................................................34
6.4.1 Ventilatory modes available ............................................................................................................................34
6.4.2 Ventilatory modes adjust .................................................................................................................................34
6.4.3 Non Invasive Ventilation (NIV) .........................................................................................................................35
AVAILABLE MENUS.......................................................................................................................................................36
6.5.1 GRAPH..............................................................................................................................................................36
6.5.2 MONITOR .........................................................................................................................................................36
6.5.3 CONFIG.............................................................................................................................................................37
6.5.3.1 Auxiliary resources in ventilation .................................................................................................................................37
6.5.3.2 Pressure measurement units .......................................................................................................................................37
6.5.3.3 Language ......................................................................................................................................................................37
6.5.3.4 Patient change..............................................................................................................................................................37
6.5.3.5 Calibration of oxygen sensor (O2cell) ..........................................................................................................................38
6.5.4 ALARM .............................................................................................................................................................39
6.5.5 TREND ..............................................................................................................................................................40
CALIBRATIONS .............................................................................................................................................................41
6.6.1 Distal flow sensor.............................................................................................................................................41

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6.6.2 Exhalation valve ...............................................................................................................................................42
6.6.3 O2cell (only galvanic cell).................................................................................................................................42
7 TROUBLESHOOTING............................................................................................................................................... 43
8 CLEANING, DISINFECTION AND STERILIZATION ...................................................................................................... 45
EQUIPMENT CLEANING..................................................................................................................................................45
8.1.1 External Parts...................................................................................................................................................45
8.1.2 Components .....................................................................................................................................................45
8.1.2.1 Respiratory circuit and exhalation valve ......................................................................................................................45
8.1.2.1.1 Wash .................................................................................................................................................................45
8.1.2.1.2 Rinse..................................................................................................................................................................46
8.1.2.1.3 Drying................................................................................................................................................................46
DISINFECTION..............................................................................................................................................................46
8.2.1 External Parts...................................................................................................................................................46
8.2.2 Respiratory circuit and exhalation valve ..........................................................................................................46
8.2.3 DISTAL flow sensor (Envitec SpiroQuant A+)....................................................................................................46
STERILIZATION .............................................................................................................................................................47
8.3.1 Steam sterilization ...........................................................................................................................................47
IMPORTANT ADVICES ....................................................................................................................................................47
PROCESSING METHODS..................................................................................................................................................49
9 PREVENTIVE MAINTENANCE .................................................................................................................................. 50
VERIFICATIONS ............................................................................................................................................................50
SCHEDULE PREVENTIVE MAINTENANCE ............................................................................................................................51
INTERNAL BATTERIES.....................................................................................................................................................51
WATER COLLECTORS WITH COALESCING FILTER ..................................................................................................................51
O2CELL......................................................................................................................................................................52
10 PIECES AND ACCESSORIES OPTIONAL................................................................................................................... 54
11 TECHNICAL SPECIFICATIONS................................................................................................................................. 56

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EQUIPMENT CLASSIFICATION ........................................................................................................................................56
11.1.1 Risks ...............................................................................................................................................................56
11.1.2 Electrical isolation ..........................................................................................................................................56
11.1.3 Mode of operation .........................................................................................................................................56
11.1.4 Protection against liquid penetration ............................................................................................................56
APPLICABLE STANDARDS ..............................................................................................................................................56
PHYSICAL AND ENVIRONMENTAL SPECIFICATIONS .............................................................................................................57
ELECTRICAL SPECIFICATIONS .........................................................................................................................................58
11.4.1 Power Supply..................................................................................................................................................58
11.4.1.1 External Power Supply AC (power grid) .....................................................................................................................58
11.4.1.1 Internal Power Supply (battery).................................................................................................................................58
11.4.1.1 External Power Supply DC..........................................................................................................................................59
11.4.2 Connectors .....................................................................................................................................................59
PNEUMATIC SPECIFICATIONS ........................................................................................................................................60
11.5.1 Pneumatic Chart ............................................................................................................................................60
11.5.2 Gas inlet connections .....................................................................................................................................60
INTERNAL FLOW TRANSDUCER SPECIFICATIONS................................................................................................................61
DISTAL FLOW SENSOR SPECIFICATIONS...........................................................................................................................62
MASK FOR NON-INVASIVE VENTILATION.........................................................................................................................63
BREATHING CIRCUIT ...................................................................................................................................................63
VENTILATION MODES SPECIFICATIONS...........................................................................................................................64
11.10.1 VCV...............................................................................................................................................................64
11.10.2 PCV...............................................................................................................................................................66
11.10.3 PLV ...............................................................................................................................................................69
11.10.4 PRVC.............................................................................................................................................................71
11.10.5 V-SIMV .........................................................................................................................................................73
11.10.6 P-SIMV..........................................................................................................................................................76

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11.10.7 CPAP/PS .......................................................................................................................................................79
11.10.8 DualPAP .......................................................................................................................................................82
11.10.9 APRV.............................................................................................................................................................85
ADJUSTABLE PARAMETER SPECIFICATIONS ....................................................................................................................87
MONITORED PARAMETER SPECIFICATIONS....................................................................................................................89
SPECIFICATIONS OF ALARM AND SAFETY SYSTEM............................................................................................................90
11.13.1 Specifications of adjustable alarms..............................................................................................................93
11.13.2 Messages of Ventilator Alarm......................................................................................................................94
11.13.3 Messages of Ventilator Alerts ......................................................................................................................97
SPECIFICATIONS OF PERFORMANCE ..............................................................................................................................98
SPECIFICATIONS OF EXPIRATORY LIMB RESISTANCE .........................................................................................................98
SPECIFICATIONS OF MAINTENANCE AND CALIBRATION.....................................................................................................99
ELECTROMAGNETIC COMPATIBILITY .............................................................................................................................99
11.17.1 Manufacturer declaration –Electromagnetics emissions..........................................................................100
11.17.2 Manufacturer declaration –Electromagnetic immunity............................................................................100
11.17.3 Radiated Immunity.....................................................................................................................................101
11.17.4 Electrical safety ..........................................................................................................................................103
12 TECHNICAL SERVICE ........................................................................................................................................... 104
13 SYMBOLOGY ...................................................................................................................................................... 105
SYMBOLS USED IN EQUIPMENT....................................................................................................................................105
SYMBOLS USED ON PACKAGING AND LABELING...............................................................................................................106
14 ABBREVIATIONS AND USED TERMS.................................................................................................................... 107
15 BIOCOMPATIBILITY DECLARATION..................................................................................................................... 109
16 GUARANTEE....................................................................................................................................................... 110
17 TECHNICAL ASSISTANCE ..................................................................................................................................... 111
18 TRAINING........................................................................................................................................................... 112

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1 Safety Annotations
Definitions
•Informs the user of the possibility of lesion, death, or other serious adverse reactions
associated to the use or misuse of the equipment.
•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, and, indirectly, to
patient lesion.
•Important information.

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Warning
•Whenever the symbol is found, read the instruction manual for further details.
•This manual shall be fully and carefully read to that equipment to be used in a correct and
safety manner, providing maximum safety 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
2.1) together with the appropriate monitoring.
•The equipment must be operated by qualified professionals, which must maintain
vigilance during use. Including ventilations limited to volume.
•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.
•This equipment must not be used during an MRI (MTR, NMR, NMI), it could be interfered
with, may cause adverse effects on the patient.
•The applied parts are resistant to defibrillation.
•Before the first use or after each patient’s use, clean the equipment according to chapter
8.
•Turn on the equipment and realize basic verification and adjustment procedures –follow
the instructions, according indicated in chapter 5.
•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.
•Use only MAGNAMED’s accessories listed at this manual, in which they were tested and
approved for jointly using with this equipment. Otherwise, the correct equipment’s

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MAGNAMED TECNOLOGIA MÉDICA S/A
operation may be compromised.
•During the equipment’s prolonged use in patients with excess secretion or in breathing
system 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 power cord to a three pin socket NBR 14136:2002 (2P+T);
•Maintain the equipment connected to a 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 alarm battery recharge must be promptly attended to. Perform your recharge before
the next use of the equipment, because any power outage can stop the operation.
•If after a long period of time using battery, occurs a LOW BATTERY alarm, provide an
IMMEDIATE connection of the power cord to a power supply, I it is not possible, provide
adequate ventilator support means and DISCONNECT the patient from ventilator.
•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.
•After usage, the ventilator breathing system 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 medical waste.
•All parts applied of FlexiMag ventilators are made of nontoxic material, they are exempted
of latex and do not cause irritation or allergy to the patient (biocompatibility).
•The common use accessories, which are not exclusive to FlexiMag, such as: masks,
respiratory circuits, nebulizers, heated humidifiers, HME filters, among others, must
comply with local legal government requirements.
•Do not use the equipment if the problem cannot be solved.
•Have a ventilation manual powered available, to use in the cases of: the battery to be
completely depleted or, there is a lack of gas for the ventilator operation; or general failure
of the ICU ventilator.
•Always use officially approved oxygen cylinders and pressure redactor valves that attend
to local legal government requirements.
•In order for appropriate ventilation, take in account the ventilator breathing system’s dead

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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 ventilator breathing system or other components of
subsets for the ventilator breathing system, the pressure gradient may increase through
the ventilator breathing system measured in relation to the patient’s connection port.
•HME filter, HEPA filter and airway adapter are single use. The reuse of these accessories
may cause cross contamination.
Attention
•The ICU’s ventilator does not emit electromagnetic waves which interfere during the
operation of equipment in their 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 MAGNAMED specified parts, cables, sensors and filters. For purchase, please
inform the codes presented in the corresponding chapter.
Observation
•Eliminate the equipment’s removed parts according to the disposal protocol of parts and
accessories of its institution.
•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.

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2 Characteristics
Intended Use
FlexiMag 15” comprises a family of ventilators developed to
supply invasive and non-invasive ventilatory support to
patients with impairment of respiratory functions in intensive
or semi-intensive care, post-operative care, post-anesthetic
recovery (PAR) or intra-hospital transport.
While FlexiMag model serves neonatal low weight, pediatric
and adult with morbid obesity patients.
Functioning Principle
FlexiMag is electronic and microprocessed lung ventilator,
whose operating principle is based on the integration of the
following modules:
•Pneumatic module (manifold)
•Electronic control module
•Electronic interface module
At the pneumatic module inlet, two valves regulate the
pressure coming from the hospital line or gas cylinders, in
order to assure the proper pressure range to the equipment.
After the pressure regulators valves, there are micro switches
that constantly monitors the gas pressure, to guarantee that
an insufficiency or absence of pressure of one or both gases,
is immediately indicated through a priority alarm.
After the micro switches, proportional flow control valves,
regulate the gas flow in such a way to guarantee that the
volume and oxygen concentration are suitable to each
situation.
After having the respective flows adjusted, the gases are
mixed to allow the measurement of O2 concentration and also
the resultant flow.
The oxygen concentration measurement is made through a
galvanic cell sensor or, optionally, through a paramagnetic cell.
The resultant flow measurement is made through a high
precision internal mass flow sensor, that allow the reading
without the need of calibrations and without pressure and
temperature influence.
The patient exhaled flow is measured by a hot-wire external
sensor, connected to the exhalation valve.
The system pressures are taken through existing points in the
pneumatic module, which are connected to existing
transducers in the electronic control module.
All these flow and pressure measurements are converted into
digital signals by the electronic control module and serve to
feed back the control algorithm continuously, ensuring a
gradual and secure adjust of the respiratory process.
The pneumatic module also comprises safety valves, and the
overpressure valve and the anti-asphyxia valve.
The input and output information are processed by the
electronics module interface. The information entered by the
operator via the touch screen or via button, are translated,
interpreted and sent to the electronic control module for serial
type communication through secure protocols. With this
information the ventilator sets the appropriate parameters to
work in each different situation.
As receives information, the control module also sends to the
interface module. All measured or calculated data is sent, also
via serial, to the interface module. This module process and
displays this information to the operator in a friendly and
intuitive way.

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All risk situations that require operator intervention are
analyzed by the control module and sent to the interface
module that emits then, according to the degree of risk, alarms
or alerts needed.
General Characteristics
•Complete ventilation platform, with low weight and
volume, integrating the pneumatic and electronic
modules.
•Graphical interface with high-resolution color screen
(up to XVGA), touch and single button (spin and
confirm) for data entry.
•Color display of 15 inches.
•Digital technology, with the last generation
embedded processor, applied to the electronic
control system flow and pressure.
•Graphical interface completely intuitive, allowing
operations through the touch screen or spin and
confirm button.
•Recording of all parameters used by the last patient,
allowing the ventilator to shut down without the need
for adjustments when turns it on.
•Reading the regulated gas pressure (O2 and
compressed air).
•No need to use regulator valves for O2 and
compressed air if the gas supply is within the
pressure range specified in this manual.
•Flow and pressure readings in the breathing circuit.
•Precise reading of the O2 concentration in the
mixture of gases delivered through the galvanic cell,
or optionally, non-consumable paramagnetic cell.
•Automatic altitude compensation.
•Single distal flow sensor for all types of patient.
•Complete monitoring of various ventilation
parameters.
•Quick access functions:
oStandby Mode
oMute alarm
o100% O2or O2suction
oCycle for manual breath
oInspiratory pause
oExpiratory pause
•Nebulizer synchronized with the patient's inspiration
and volume compensation and FiO2 by software
that maintains the volume and FiO2 adjusted.
•Tracheal Gas Insufflation synchronized with the
expiration of the patient.
•Automatic weaning feature that when detect a
particular sequence of inspiratory efforts suspends
the backup ventilation and resumes the set
ventilation mode.
•Trend graphs with memorization of events in the last
hours of ventilation (up to 24 hours, depending on
the model).
•BICOLOR LED as connection indicator to electrical
supply; green when equipment is connected and
blue when equipment is being supplied only by
batteries.
•Input port to an electric power supply 100-240 VAC
~ 50-60 Hz.
•Input port to an external source 15 V / 4 A (optional).
•Connectivity with personal computer by means of
standard output RS232.
•Remote assistance and diagnostics - Magnamed
(ARM).
•These equipments shall be operated only by qualified and properly trained professionals for

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their use.
Safety Characteristics
•Anti-asphyxia valve to protect against failures in gas supply.
•Relief valve of 100 hPa, in compliance with basic standard of ventilators, avoiding possible overpressure in the respiratory
circuit.
•Active overpressure valve to detect obstructions is activated to reduce the pressure in the patient circuit.
•The equipment has audiovisual alarms related to both equipment operating condition (technical alarms), as the ventilation
process.
•Backup energy system that allows the equipment to run using batteries for about 3,5 hours
1
.
•Speaker for alarms and alerts.
•High brightness RED LED for prompt alarm identification.
•Possibility of automatic adjustment of alarms.
•Option of autodiagnosys to check alarms, failures detection, leakage measurement, system resistance and compliance.
•Use of the equipment even in case of single gas failure (O2 or compressed air)
1
Depending on battery load and adjusted ventilation parameters

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3 Unpacking the Product
Initial Verifications
•If the packaging is damaged, please immediately report to the carrier responsible and
to MAGNAMED.
Table 1 –Initial Verifications
Stage
Procedure
Approved
1
Verify if the package is intact by looking for holes, or other damages.
OK NOK
2
Carefully open the package observing the box’s indications
OK NOK
3
Check the package contents.
OK NOK

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Relation of Components of FlexiMag 15”
The following items are integral part of equipment and are for exclusive use of it:
Table 2 - Components of FlexiMag
Item
Part Number
Description
Qty
IMU
Image
1
1103760
FLEXIMAG - NEONATAL,
PEDIATRIC, ADULT
ELECTRONIC LUNG
VENTILATOR 15 INCHES
01
PC
2
1703038
RESPIRATORY CIRCUIT
ADULT WITH WATER TRAP
STRAIGHT Y
01
PC
3
1702667
ARTICULATED ARM WITH
SUPPORT FOR
RESPIRATORY CIRCUITS
01
PC
4
3902647
O2 DISS X2 HOSE
01
PC

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Item
Part Number
Description
Qty
IMU
Image
5
3903114
COMPRESSED AIR DISS X2
3M HOSE
01
PC
6
1703938
KIT 5 SENSORS
SPIROQUANT ENVITEC
01
PC
7
2803779
FLOW SENSOR
CONNECTION CABLE
(EXTERNAL)
01
PC
8
3800248
MAGNAMED EXHALATION
VALVE DIAPHRAGM
01
PC
9
3804865
EXHALATION VALVE WITH
STABILIZING RING
01
PC
10
5003782
Assembly Guide
1
PC
-
11
9003608
ALLEN KEY 4 MM
1
PC
-
12
3005934
ALLEN SCREW HEAD
SOCKET M6X25 WITH
SEXTABLE INTERNAL
STAINLESS STEEL
1
PC
-

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Item
Part Number
Description
Qty
IMU
Image
13
2804669
AC POWER CORD MONTED
WITH 3 WAYS 3,0M –NEW
NBR STANDARD 14136
01
PC
14
110XXXX-NE-20-RR
Operation manual
1
PC
15
7006466
QUICK GUIDE - FLEXIMAG
01
PC
-

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4 Component Identification
Front view
Figure 1–Front view (FlexiMag)
1. ALARM INDICATOR LIGHT –RED
2
4
7
8
11
10
9
6
5
3
1

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2. LIQUID CRYSTAL DISPLAY WITH TOUCHSCREEN
3. SPIN AND CONFIRM BUTTON AND NETWORK POWER INDICATOR
4. ARTICULATED ARM
5. NEBULIZER /TGI
6. INSPIRATORY LIMB CONNECTOR
7. EXHALATION VALVE AND DISTAL FLOW SENSOR
8. DISTAL FLOW SENSOR CABLE CONNECTOR
9. CARRYING STRAP
10. PEDESTAL
11. CASTORS WITH BRAKES
Back View
Figure 2 –Back View
1. On/Off Switch
2. Input of Electrical Power
3. Fuse holder
4. Inlet of Compressed Air
5. Inlet of Oxygen
6. Collectors of Water with Coalescing Filter for Gas under High Pressure
7. Inlet for Power External Source
4
5
6
1
2
3
7