Magnamed FlexiMag Max 700 User manual

Operations Manual
Electronic Pulmonary Ventilator
FlexiMag Max 700
Fleximag Max 500
Fleximag Max 300

2
This operating manual includes the 3 models of pulmonary ventilators of FlexiMag Max’s family: Fleximag Max
700, Fleximag Max 500 and Fleximag Max 300 developed and manufactured by Magnamed Tecnologia
Medica S / A.
Review of this operation manual: 02
ANVISA Registration nº 80659160005
All rights reserved by:
Magnamed Tecnologia Médica S/A

Rua Santa Mônica, 801, 831
06715-865 –Parque Industrial San José -Cotia –SP Brazil
Tel/Fax: [phone]
E-mail: [e-mail]
Website: www.magnamed.com.br
CNPJ: 01.298.443/0002-54
State registration: 149.579.528.111
Technical Responsible: Toru Miyagi Kinjo
Inscription CREA-SP: 5061555031
Legal Responsible: Wataru Ueda

3
Table of Contents
1 SAFETY NOTES........................................................................................................................................................ 14
1.1 DEFINITIONS ...............................................................................................................................................................14
1.2 WARNING...................................................................................................................................................................15
1.3 ATTENTION.................................................................................................................................................................17
1.4 OBSERVATION .............................................................................................................................................................17
2 FEATURES............................................................................................................................................................... 18
2.1 INTENDED USE.............................................................................................................................................................18
2.2 PRINCIPLE OF OPERATION..............................................................................................................................................18
2.3 GENERAL FEATURES ......................................................................................................................................................20
2.4 TECHNICAL CHARACTERISTICS .........................................................................................................................................21
2.5 SAFETY FEATURES.........................................................................................................................................................22
3 UNPACKING THE PRODUCT .................................................................................................................................... 23
3.1 INITIAL VERIFICATIONS ..................................................................................................................................................23
3.2 LIST OF COMPONENTS...................................................................................................................................................23
3.3 OPTIONAL PARTS AND ACCESSORIES ................................................................................................................................25
4 IDENTIFICATION OF COMPONENTS........................................................................................................................ 27
4.1 FRONT VIEW...............................................................................................................................................................27
4.1.4 Front panel ......................................................................................................................................................28
4.2 BACK VIEW.................................................................................................................................................................29
4.3 VIEW FROM THE BOTTOM OF THE DISPLAY ........................................................................................................................30
5 PREPARATION FOR USE.......................................................................................................................................... 31
5.1 ASSEMBLY ..................................................................................................................................................................31
5.2 ELECTRICAL NETWORK CONNECTION................................................................................................................................41
5.3 VERIFICATION BEFORE USE ............................................................................................................................................42
6 INSTRUCTIONS FOR USE......................................................................................................................................... 44
6.1 INITIAL SEQUENCE........................................................................................................................................................44

4
6.2 RESTRICTED MENU .......................................................................................................................................................47
6.2.1 Restricted menu ...............................................................................................................................................47
6.2.1.1 Patient..........................................................................................................................................................................47
6.2.1.2 Autotest........................................................................................................................................................................47
6.2.1.3 Calibration....................................................................................................................................................................47
6.2.1.4 Status............................................................................................................................................................................48
6.2.1.5 Battery..........................................................................................................................................................................48
6.2.1.6 System..........................................................................................................................................................................48
6.2.1.7 Advanced......................................................................................................................................................................48
6.2.1.8 Ventilation....................................................................................................................................................................48
6.3 MAIN SCREEN.............................................................................................................................................................49
6.3.1 Battery status area ..........................................................................................................................................49
6.3.2 Patient information area..................................................................................................................................49
6.3.2.1 Volume x weight patient definition..............................................................................................................................49
6.3.3 Historical events area.......................................................................................................................................50
6.3.4 Alarm setting area ...........................................................................................................................................50
6.3.5 Mute alarm button...........................................................................................................................................50
6.3.6 Manual cycle button ........................................................................................................................................50
6.3.7 Inspiratory hold button ....................................................................................................................................50
6.3.8 Expiratory hold button .....................................................................................................................................51
6.3.9 O2+button (O2flush) ........................................................................................................................................51
6.3.10 Nebulizer / TGI button....................................................................................................................................51
6.3.11 Graphic freeze button ....................................................................................................................................51
6.3.12 Menu access area ..........................................................................................................................................51
6.3.12.1 Layout.........................................................................................................................................................................51
2 waveforms ........................................................................................................................................................................51
Big numbers.........................................................................................................................................................................51

5
Monitor................................................................................................................................................................................52
3 waveforms ........................................................................................................................................................................52
Lung .....................................................................................................................................................................................52
2 loops .................................................................................................................................................................................52
6.3.12.2 Resources ...................................................................................................................................................................52
6.3.12.2.1 Noninvasive Ventilation (NIV).........................................................................................................................53
6.3.12.2.2 External Auxiliary pressure .............................................................................................................................54
6.3.12.2.3 Tube compensation ........................................................................................................................................54
6.3.12.3 Maneuver...................................................................................................................................................................54
6.3.12.3.1 P0.1 .................................................................................................................................................................55
6.3.12.3.2 Slow Vital Capacity..........................................................................................................................................55
6.3.12.3.3 P/V Flex...........................................................................................................................................................55
6.3.12.3.4 Pi Max .............................................................................................................................................................56
6.3.12.3.5 Gas Trapping Volume......................................................................................................................................56
6.3.12.4 Trend..........................................................................................................................................................................56
6.3.12.5 Calibration..................................................................................................................................................................56
6.3.12.5.1 O2cell (galvanic cell only)................................................................................................................................57
6.3.12.6 Advanced....................................................................................................................................................................57
6.3.13 Lock Button ....................................................................................................................................................57
6.3.14 Stand by button..............................................................................................................................................57
6.3.15 Bargraph or monitored parameters area ......................................................................................................57
6.3.16 Graphics area .................................................................................................................................................57
6.3.17 Ventilation Mode Setting Area.......................................................................................................................58
6.3.17.1 Ventilatory modes available.......................................................................................................................................58
6.3.17.2 Adjusting ventilatory modes ......................................................................................................................................59
6.4 CALIBRATIONS .............................................................................................................................................................60
6.4.1 Distal Flow Sensor ............................................................................................................................................60
6.4.2 Integrated valve ...............................................................................................................................................60

6
6.4.3 O2cell (galvanic cell only).................................................................................................................................60
6.5 AUTOMATIC COMPENSATION OF THE RESPIRATORY CIRCUIT ..................................................................................................61
7 TROUBLESHOOTING............................................................................................................................................... 62
8 CLEANING, DISINFECTION AND STERILIZATION ...................................................................................................... 64
8.1 EXTERNAL PARTS..........................................................................................................................................................64
8.2 COMPONENTS .............................................................................................................................................................64
8.2.1 PROXIMAL flow sensor, silicone line and integrated valve ..............................................................................64
8.2.1.1 Wash ............................................................................................................................................................................64
8.2.1.2 Rinse.............................................................................................................................................................................65
8.2.1.3 Drying...........................................................................................................................................................................65
COMPOSITION OF THE ENZYMATIC DETERGENT.........................................................................................................................65
8.3 DISINFECTION..............................................................................................................................................................65
8.3.1 External Parts...................................................................................................................................................65
8.3.2 Exhalation valve, proximal flow sensor and silicone line .................................................................................66
8.3.3 Distal flow sensor (Envitec SpiroQuant A+)......................................................................................................66
8.3.4 IRMA CO2sensor ..............................................................................................................................................66
8.3.5 Oximetry sensor (oximeter)..............................................................................................................................67
8.4 STERILIZATION .............................................................................................................................................................68
8.4.1 Steam Sterilization ...........................................................................................................................................68
8.5 IMPORTANT ADVICES ....................................................................................................................................................68
8.6 PROCESSING METHODS.................................................................................................................................................70
9 PREVENTIVE MAINTENANCE .................................................................................................................................. 71
9.1 VERIFICATIONS ............................................................................................................................................................71
9.2 PREVENTIVE MAINTENANCE SCHEDULE ............................................................................................................................72
9.3 CONSUMABLE ITEMS.....................................................................................................................................................72
9.4 INTERNAL BATTERIES.....................................................................................................................................................72
9.5 WATER COLLECTORS WITH COALESCING FILTER..................................................................................................................73

7
9.6 MESH FILTER...............................................................................................................................................................74
9.7 O2CONCENTRATION CELL..............................................................................................................................................75
10 TECHNICAL SPECIFICATIONS................................................................................................................................. 77
10.1 CLASSIFICATION .........................................................................................................................................................77
10.1.1 Class I Equipment ...........................................................................................................................................77
10.1.2 Protection class of applied parts....................................................................................................................77
10.1.3 CE –Class IIB ..................................................................................................................................................77
10.1.4 ANVISA –Class III ...........................................................................................................................................77
10.1.5 FDA –Class II ..................................................................................................................................................77
10.2 APPLICABLE STANDARDS..............................................................................................................................................77
10.3 PHYSICAL AND ENVIRONMENTAL SPECIFICATIONS .............................................................................................................78
10.4 ELECTRICAL SPECIFICATIONS .........................................................................................................................................79
10.4.1 Electrical network ..........................................................................................................................................79
10.4.2 Batteries.........................................................................................................................................................80
10.4.3 External DC Power Supply ..............................................................................................................................80
10.4.4 Connectors .....................................................................................................................................................81
10.4.4.1 Protocol used for data communication with external devices...................................................................................82
10.4.5 Gas Inlet Connector........................................................................................................................................83
10.5 PNEUMATIC SPECIFICATIONS ........................................................................................................................................84
10.5.1 Pneumatic layout ...........................................................................................................................................84
10.6 INTERNAL FLOW TRANSDUCER SPECIFICATIONS................................................................................................................85
10.7 DISTAL FLOW SENSOR SPECIFICATIONS...........................................................................................................................86
10.8 PROXIMAL FLOW SENSOR SPECIFICATIONS ......................................................................................................................86
10.9 PRESSURE SENSOR SPECIFICATIONS................................................................................................................................86
10.10 GALVANIC O2CELL SPECIFICATIONS..............................................................................................................................87
10.11 PARAMAGNETIC O2CELL SPECIFICATION .......................................................................................................................88
10.12 VENTILATION MODES SPECIFICATIONS .........................................................................................................................89

8
10.12.1 VCV...............................................................................................................................................................89
10.12.2 PCV...............................................................................................................................................................91
10.12.3 PLV ...............................................................................................................................................................93
10.12.4 PRVC.............................................................................................................................................................95
10.12.5 V-SIMV .........................................................................................................................................................97
10.12.6 P-SIMV........................................................................................................................................................100
10.12.7 CPAP/PS .....................................................................................................................................................103
10.12.8 DualPAP .....................................................................................................................................................106
10.12.9 APRV...........................................................................................................................................................109
10.12.10 MMV ........................................................................................................................................................111
10.12.11 VS .............................................................................................................................................................112
10.12.12 Nasal CPAP...............................................................................................................................................113
10.12.13 NIV ...........................................................................................................................................................113
10.12.14 VG.............................................................................................................................................................114
10.12.15 O2THERAPY..............................................................................................................................................115
10.13 OXYGEN ADJUSTMENT RESPONSE TIME .......................................................................................................................116
10.14 ACCURACY OF SETTINGS...........................................................................................................................................116
10.15 ADJUSTABLE PARAMETER SPECIFICATIONS ..................................................................................................................117
10.16 MONITORED PARAMETER SPECIFICATIONS..................................................................................................................120
10.17 SAFETY SYSTEM SPECIFICATIONS ...............................................................................................................................122
10.18 ALARM SYSTEM SPECIFICATION.................................................................................................................................123
10.18.1 Adjustable alarm specifications .................................................................................................................124
10.18.2 Ventilator alarm messages ........................................................................................................................125
10.18.3 Ventilator Alert Messages..........................................................................................................................128
10.18.4 IRMA CO2 sensor alarm messages..............................................................................................................129
10.18.5 Oximeter Alarm Messages .........................................................................................................................131
10.18.6 Alarm Testing .............................................................................................................................................132

9
10.18.6.1 FiO2alarm...............................................................................................................................................................132
10.18.6.2 Airway pressure alarm ...........................................................................................................................................133
10.18.6.3 Volume alarm.........................................................................................................................................................133
10.18.6.4 No AC power alarm ................................................................................................................................................133
10.18.6.5 Low battery alarm ..................................................................................................................................................133
10.18.6.6 Gas supply failure alarm.........................................................................................................................................133
10.18.6.7 PEEP alarm .............................................................................................................................................................133
10.18.6.8 Disconnection alarm...............................................................................................................................................133
10.18.6.9 Obstruction alarm ..................................................................................................................................................134
10.18.6.10 Minute volume alarm...........................................................................................................................................134
10.18.6.11 Respiratory rate alarm .........................................................................................................................................134
10.18.6.12 Apnea alarm.........................................................................................................................................................134
10.18.6.13 EtCO2alarm..........................................................................................................................................................134
10.18.6.14 ICO2alarm ............................................................................................................................................................135
10.18.6.15 Heart rate alarm...................................................................................................................................................135
10.18.6.16 SpO2alarm............................................................................................................................................................135
10.18.7 Battery test ................................................................................................................................................135
10.19 PERFORMANCE SPECIFICATIONS ................................................................................................................................135
10.20 RESPIRATORY CIRCUIT SPECIFICATIONS.......................................................................................................................136
10.21 MAINTENANCE AND CALIBRATION SPECIFICATIONS .......................................................................................................137
10.22 IRMA CO2SENSOR SPECIFICATIONS .........................................................................................................................137
10.23 OXIMETER SPECIFICATIONS.......................................................................................................................................140
10.24 ELECTROMAGNETIC COMPATIBILITY ...........................................................................................................................141
10.24.1 Guidelines and manufacturer's declaration - Electromagnetic emissions .................................................142
10.24.2 Guidelines and manufacturer's declaration - Electromagnetic immunity..................................................142
10.24.3 Electrical safety ..........................................................................................................................................146
10.25 AUDIBLE ACOUSTIC ENERGY......................................................................................................................................146

10
10.26 MASK TO NON-INVASIVE VENTILATION .......................................................................................................................146
10.27 RESPIRATORY CIRCUIT.............................................................................................................................................147
10.28 HME FILTER .........................................................................................................................................................147
10.29 HEPA FILTER ........................................................................................................................................................148
11 IRMA CO2 SENSOR (OPTIONAL) .......................................................................................................................... 149
11.1 INTENDED USE.........................................................................................................................................................149
11.2 INSTRUCTIONS FOR USE .............................................................................................................................................149
11.2.1 Reset procedure ...........................................................................................................................................150
11.2.2 LED status information.................................................................................................................................151
11.3 PREVENTIVE MAINTENANCE........................................................................................................................................151
11.4 IMPORTANT NOTICES................................................................................................................................................151
12 PULSE OXIMETER (OPTIONAL)............................................................................................................................ 153
12.1 INTENDED USE.........................................................................................................................................................153
12.2 PRINCIPLE OF OPERATION..........................................................................................................................................153
12.3 IMPORTANT NOTICES................................................................................................................................................155
13 TECHNICAL SERVICE ........................................................................................................................................... 157
14 DISCARD............................................................................................................................................................. 158
15 SYMBOLOGY ...................................................................................................................................................... 159
15.1 SYMBOLS USED IN THE EQUIPMENT..............................................................................................................................159
15.2 SYMBOLS USED IN PACKAGING AND LABELING ................................................................................................................160
16 ABBREVIATIONS AND TERMS USED.................................................................................................................... 162
17 BIOCOMPATIBILITY STATEMENT ........................................................................................................................ 164
18 WARRANTY ........................................................................................................................................................ 165
19 TRAINING........................................................................................................................................................... 166
ANNEX I –DIFFERENCES BETWEEN MODELS ........................................................................................................... 167