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Fleximag Max 300
Operation manual
Magnamed Fleximag Max 300 Operation Manual
Electronic pulmonary ventilator
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Contents
Table of Contents
Troubleshooting
Bookmarks
Table of Contents
Table of Contents
Safety Notes
Definitions
Warning
Attention
Observation
Features
Intended Use
Principle of Operation
General Features
Technical Characteristics
Safety Features
Unpacking the Product
Initial Verifications
List of Components
Optional Parts and Accessories
Identification of Components
Front View
Front Panel
Back View
View from the Bottom of the Display
Preparation for Use
Assembly
Electrical Network Connection
Verification before Use
Instructions for Use
Initial Sequence
Restricted Menu
Patient
Autotest
Calibration
Status
Battery
System
Advanced
Ventilation
Main Screen
Battery Status Area
Patient Information Area
Volume X Weight Patient Definition
Historical Events Area
Alarm Setting Area
Mute Alarm Button
Manual Cycle Button
Inspiratory Hold Button
Expiratory Hold Button
O + Button (O Flush)
Nebulizer / TGI Button
Graphic Freeze Button
Menu Access Area
Layout
Waveforms
Big Numbers
Monitor
Waveforms
Lung
Loops
Resources
Noninvasive Ventilation (NIV)
External Auxiliary Pressure
Tube Compensation
Maneuver
P0.1
Slow Vital Capacity
P/V Flex
Pi Max
Gas Trapping Volume
Trend
Calibration
O 2 Cell (Galvanic Cell Only)
Advanced
Lock Button
Stand by Button
Bargraph or Monitored Parameters Area
Graphics Area
Ventilation Mode Setting Area
Ventilatory Modes Available
Adjusting Ventilatory Modes
Calibrations
Distal Flow Sensor
Integrated Valve
O 2 Cell (Galvanic Cell Only)
Automatic Compensation of the Respiratory Circuit
Troubleshooting
Cleaning, Disinfection and Sterilization
External Parts
Components
PROXIMAL Flow Sensor, Silicone Line and Integrated Valve
Wash
Rinse
Drying
Composition of the Enzymatic Detergent
Disinfection
External Parts
Exhalation Valve, Proximal Flow Sensor and Silicone Line
Distal Flow Sensor (Envitec Spiroquant A+)
IRMA CO Sensor
Oximetry Sensor (Oximeter)
Sterilization
Steam Sterilization
Important Advices
Processing Methods
Preventive Maintenance
Verifications
Preventive Maintenance Schedule
Consumable Items
Internal Batteries
Water Collectors with Coalescing Filter
Mesh Filter
O 2 Concentration Cell
Technical Specifications
Classification
Class I Equipment
Protection Class of Applied Parts
CE - Class IIB
ANVISA - Class III
FDA - Class II
Applicable Standards
Physical and Environmental Specifications
Electrical Specifications
Electrical Network
Batteries
External DC Power Supply
Connectors
Protocol Used for Data Communication with External Devices
Gas Inlet Connector
Pneumatic Specifications
Pneumatic Layout
Internal Flow Transducer Specifications
Distal Flow Sensor Specifications
Proximal Flow Sensor Specifications
Pressure Sensor Specifications
Galvanic O 2 Cell Specifications
Paramagnetic Ocell Specification
Ventilation Modes Specifications
VCV
Pcv
Plv
Prvc
V-Simv
P-Simv
Cpap/Ps
Dualpap
Aprv
MMV
Nasal CPAP
Niv
O 2 Therapy
Oxygen Adjustment Response Time
Accuracy of Settings
Adjustable Parameter Specifications
Monitored Parameter Specifications
Safety System Specifications
Alarm System Specification
Adjustable Alarm Specifications
Ventilator Alarm Messages
Ventilator Alert Messages
IRMA CO 2 Sensor Alarm Messages
Oximeter Alarm Messages
Alarm Testing
Fio 2 Alarm
Airway Pressure Alarm
Volume Alarm
No AC Power Alarm
Low Battery Alarm
Gas Supply Failure Alarm
PEEP Alarm
Disconnection Alarm
Obstruction Alarm
Minute Volume Alarm
Respiratory Rate Alarm
Apnea Alarm
Etco 2 Alarm
ICO 2 Alarm
Heart Rate Alarm
Spo 2 Alarm
Battery Test
Performance Specifications
Respiratory Circuit Specifications
Maintenance and Calibration Specifications
Irma Co 2 Sensor Specifications
Oximeter Specifications
Electromagnetic Compatibility
Guidelines and Manufacturer's Declaration - Electromagnetic Emissions
Guidelines and Manufacturer's Declaration - Electromagnetic Immunity
Electrical Safety
Audible Acoustic Energy
Mask to Non Invasive Ventilation
Respiratory Circuit
Hme Filter
Hepa Filter
Irma Co 2 Sensor (Optional)
Intended Use
Instructions for Use
Reset Procedure
LED Status Information
Preventive Maintenance
Important Notices
Pulse Oximeter (Optional)
Intended Use
Principle of Operation
Important Notices
Technical Service
Discard
Symbology
Symbols Used in the Equipment
Symbols Used in Packaging and Labeling
Abbreviations and Terms Used
Biocompatibility Statement
Warranty
Training
Annex I - Differences between Models
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1
Principle of Operation
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Operations Manual
Electronic Pulmonary Ventilator
FlexiMag Max 700
Fleximag Max 500
Fleximag Max 300
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Summarization of Contents
1 Safety Notes
1.1 Definitions
Explains the meaning of symbols used in the manual.
1.2 Warning
Provides critical safety information and precautions.
1.3 Attention
Highlights important points regarding equipment operation and maintenance.
1.4 Observation
Notes about technical specifications and product changes.
7 Troubleshooting
8 Cleaning, Disinfection and Sterilization
8.1 External Parts
Describes the cleaning process for the external surfaces of the ventilator.
8.2 Components
Details cleaning, disinfection, and sterilization procedures for gas-contacting parts.
9 Preventive maintenance
9.1 Verifications
Lists daily checks and verifications required before operating the equipment.
9.2 Preventive Maintenance Schedule
9.3 Consumable items
9.4 Internal Batteries
9.5 Water Collectors with Coalescing Filter
9.6 Mesh filter
9.7 O2 Concentration Cell
10 Technical specifications
10.1 Classification
Classifies the equipment according to medical device standards.
10.2 Applicable Standards
Lists relevant technical and safety standards the equipment adheres to.
10.3 Physical and Environmental Specifications
Specifies physical dimensions, weight, and environmental operating conditions.
10.4 Electrical Specifications
Covers electrical network, battery, and power supply details.
10.4 Electrical Specifications - Details
10.4.1 Electrical network
Details specifications for the electrical network connection.
10.4.2 Batteries
Specifies the characteristics and life of the internal batteries.
10.4.3 External DC Power Supply
Provides specifications for the optional external DC power supply.
10.4.4 Connectors
10.4.5 Gas Inlet Connector
10.5 Pneumatic Specifications
10.5.1 Pneumatic layout
Illustrates the pneumatic diagram of the FlexiMag Max 700 model.
10.6 Internal Flow Transducer Specifications
10.7 Distal Flow Sensor Specifications
10.8 Proximal Flow Sensor Specifications
10.9 Pressure Sensor Specifications
10.10 Galvanic O2 cell specifications
10.11 Paramagnetic O2 cell Specification
10.12 Ventilation Modes Specifications
10.12.1 VCV
Explains Volume Controlled Ventilation (VCV) mode, its parameters, and operation.
10.12.2 PCV
10.12.3 PLV
10.12.4 PRVC
10.12.5 V-SIMV
10.12.6 P-SIMV
10.12.7 CPAP/PS
10.12.8 DualPAP
10.12.9 APRV
10.12.10 MMV
10.12.11 VS
10.12.12 Nasal CPAP
10.12.13 NIV
10.12.14 VG
10.12.15 O2 THERAPY
10.13 Oxygen adjustment response time
10.14 Accuracy of settings
10.15 Adjustable Parameter Specifications
10.16 Monitored Parameter Specifications
10.17 Safety System Specifications
10.18 Alarm System Specification
10.18.1 Adjustable alarm specifications
Lists default and adjustable settings for various alarms across different patient types.
10.18.2 Ventilator alarm messages
10.18.2 Ventilator alarm messages - Medium Priority
10.18.2 Ventilator alarm messages - Low Priority
10.18.3 Ventilator Alert Messages
Lists and describes alert messages displayed by the ventilator.
10.18.4 IRMA CO2 sensor alarm messages - High Priority
10.18.4 IRMA CO2 sensor alarm messages - Medium/Low Priority
10.18.5 Oximeter Alarm Messages - High Priority
10.18.5 Oximeter Alarm Messages - Medium Priority
10.18.5 Oximeter Alarm Messages - Low Priority
10.18.6 Alarm Testing
10.18.6.2 Airway pressure alarm
Details the procedure for testing airway pressure alarms.
10.18.6.3 Volume alarm
Explains how to test volume alarms.
10.18.6.4 No AC power alarm
Describes the test for the "No AC power" alarm.
10.18.6.5 Low battery alarm
Details the test for the low battery alarm.
10.18.6.6 Gas supply failure alarm
Explains how to test the gas supply failure alarm.
10.18.6.7 PEEP alarm
Describes the procedure for testing PEEP alarms.
10.18.6.8 Disconnection alarm
Explains how to test the disconnection alarm.
10.18.6 Alarm Testing - Other Alarms
10.18.6.9 Obstruction alarm
Details the testing procedure for obstruction alarms.
10.18.6.10 Minute volume alarm
Explains how to test minute volume alarms.
10.18.6.11 Respiratory rate alarm
Describes the procedure for testing respiratory rate alarms.
10.18.6.12 Apnea alarm
Explains how to test the apnea alarm.
10.18.6.13 EtCO2 alarm
Details the testing procedure for EtCO2 alarms.
10.18.6 Alarm Testing - CO2, HR, SpO2
10.18.6.14 iCO2 alarm
Explains how to test iCO2 alarms.
10.18.6.15 Heart rate alarm
Describes the procedure for testing heart rate alarms.
10.18.6.16 SpO2 alarm
Explains how to test SpO2 alarms.
10.18.7 Battery test
10.19 Performance Specifications
10.20 Respiratory Circuit Specifications
10.21 Maintenance and Calibration Specifications
10.22 IRMA CO2 Sensor Specifications
10.23 Oximeter specifications
10.24 Electromagnetic Compatibility
10.24.1 Guidelines and manufacturer's declaration - Electromagnetic emissions
Provides guidelines on electromagnetic emissions and their compliance.
10.24.2 Guidelines and manufacturer's declaration - Electromagnetic immunity
Details guidelines for electromagnetic immunity and compliance.
10.24.3 Electrical safety
10.25 Audible acoustic energy
10.26 Mask to non-invasive ventilation
10.27 Respiratory Circuit
10.28 HME Filter
10.29 HEPA Filter
11 IRMA CO2 Sensor (optional)
11.1 Intended Use
Specifies the application and function of the IRMA CO2 sensor.
11.2 Instructions for use
Explains how to connect and use the IRMA CO2 sensor with ventilators.
11.3 Preventive maintenance
11.4 Important Notices
12 Pulse Oximeter (optional)
12.1 Intended Use
Specifies the functionality and measurement capabilities of the pulse oximeter.
12.2 Principle of Operation
Explains the underlying principles of pulse oximetry measurement.
12.3 Important Notices
13 Technical Service
14 Discard
15 Symbology
15.1 Symbols used in the equipment
Defines symbols found on the ventilator itself.
15.2 Symbols used in packaging and labeling
Defines symbols found on the product packaging and labels.
16 Abbreviations and Terms Used
17 Biocompatibility Statement
18 Warranty
19 Training
Annex I – Differences between models
Table of Contents
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