Magnamed Fleximag Max 300 Operation Manual

Magnamed Fleximag Max 300 Operation Manual

Electronic pulmonary ventilator
Table of Contents

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

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Table of Contents
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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.
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.
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.
10.5 Pneumatic Specifications
10.5.1 Pneumatic layout
Illustrates the pneumatic diagram of the FlexiMag Max 700 model.
10.12 Ventilation Modes Specifications
10.12.1 VCV
Explains Volume Controlled Ventilation (VCV) mode, its parameters, and operation.
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 - Low Priority
10.18.3 Ventilator Alert Messages
Lists and describes alert messages displayed by the ventilator.
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.
10.24 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.
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.
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.
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.

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