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