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Magnamed OxyMag - User Manual

Magnamed OxyMag
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Operation Manual
OxyMag Transport and Emergency Ventilator

Table of Contents

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Summary

Definition and Care

a. Definitions

Explains the meaning of terms like Warning, Caution, and Note.

b. Warning

Provides critical safety instructions and precautions for using the equipment.

c. Caution

Offers important advice and warnings regarding operational parameters and maintenance.

d. Notes

Includes supplementary information and practical advice for users.

1. Description

1.1 Intended Use

Specifies the target patient population and application of the ventilator.

1.2 Optional items compatible with the products

Lists compatible accessories and components for the ventilator.

2. Unpacking the Product

2.1 Initial Checks

Outlines the initial inspection procedures after unpacking the product.

2.2 Parts and Accessories

Lists and describes the essential parts and accessories included with the ventilator.

2.3 Optional accessories that can be purchased for Oxymag

Lists optional accessories available for purchase to enhance ventilator functionality.

2.4 Components of transport ventilator

Identifies and describes the various components of the ventilator's front, side, and back panels.

2.4.1 Protocol used for data communication with external devices

Explains how the ventilator communicates data with external electronic health records.

5. Checks Before Use

5.1 Initial procedures

Guides the user through essential pre-use checks and settings for safe operation.

5.2 Ventilator Settings

Details how to configure ventilator settings based on patient type and clinical needs.

5.2.1 Normal Startup Sequence

Outlines the procedure for starting the ventilator and performing initial setup.

5.2.2 Test Sequence

Details the internal tests to ensure the ventilator is operating correctly before use.

5.2.3 Failure Diagnosis

Provides guidance on identifying and addressing potential faults indicated during testing.

4. Preparation for Use

4.1 Assembling Oxymag - Transport Ventilation

Provides a step-by-step guide for assembling the ventilator for transport use.

4.2 Noninvasive ventilation mask

Explains the assembly and use of non-invasive ventilation masks with the equipment.

4.3 Power Connection

Details how to properly connect the ventilator to a power source for operation and charging.

4.4 Mounting the vertical support

Describes how to install and use the optional vertical support for the ventilator.

6. Capnography Sensor (EtCO2)

6.1 Instructions for Use

Explains how to use the capnography sensor for monitoring respiratory gases.

6.2 Assembling the Sensor

Provides steps for correctly assembling and connecting the capnography sensor.

6.3 Positioning the Sensor

Details the correct placement of the capnography sensor to ensure accurate readings.

6.4 Procedure to Reset the Sensor

Outlines the steps to reset the capnography sensor for optimal performance.

6.5 Information regarding LED

Explains the meaning of different LED colors on the capnography sensor.

6.6 Preventive Maintenance of EtCO2 Sensor

Describes routine maintenance procedures for the capnography sensor.

6.7 Technical Specifications of the Capnography

Lists the technical specifications and operational parameters of the capnography system.

7. Oximeter (Masimo)

7.1 Operation Principle

Explains the underlying principles of how the Masimo pulse oximeter functions.

7.2 Summary of Blood Calibration Test

Summarizes the blood calibration process for validating sensor accuracy.

7.3 Low perfusion test summary

Details the validation of sensor performance under low perfusion conditions.

7.4 Sensor assembly

Guides the user on connecting the oximetry sensor to the ventilator.

7.5 Oximeter specification

Lists the performance specifications and operational parameters of the oximeter.

8. Description of modes

8.1 VCV - Volume Controlled Ventilation

Explains the Volume Controlled Ventilation mode and its parameters.

8.2 PCV - Pressure Controlled Ventilation

Describes Pressure Controlled Ventilation mode and its operational parameters.

8.3 PLV -Limited Pressure Ventilation

Details the Limited Pressure Ventilation mode and its specific settings.

8.4 V-SIMV - Synchronized Intermittent Mandatory Ventilation - Volume Controlled Cycle

Explains the V-SIMV mode with volume control and pressure support.

8.5 P-SIMV - Synchronized Intermittent Mandatory Ventilation - Pressure Controlled Cycle

Describes P-SIMV mode with pressure control and patient effort synchronization.

8.6 CPAP;PSV - Continuous Pressure Ventilation with Pressure Support

Details CPAP/PSV mode for continuous positive airway pressure with support.

8.7 DualPAP - Bi-level Continuous Positive Airway Pressure Ventilation

Explains DualPAP mode for bi-level positive airway pressure with support.

8.8 APRV -Airway Pressure Release Ventilation (mode obtainied with inverted ratio in DUALPAP)

Describes APRV mode, achieved via DualPAP adjustments for pressure release.

9. Alarms Available

9.1 Description of alarm control

Classifies ventilator alarms by priority level (high, medium, low).

9.2 Setting Alarms

Guides on adjusting alarm limits for various parameters on the ventilator.

9.3 Alarm test

Explains procedures for testing the ventilator's alarm functions.

10. Cleanning and Sterilization

10.1 Equipment cleaning

Details the process for cleaning external ventilator surfaces using appropriate detergents.

10.1.2 Respiratory circuit, proximal flow sensor and exhalation valve

Outlines cleaning steps for components in contact with respiratory gases.

10.2 Disinfection

Describes disinfection procedures for external parts and respiratory circuit components.

10.3 Sterilization

Lists components for cleaning and sterilization and provides guidelines for these processes.

10.4 Processing methods

Presents a table summarizing approved processing methods (sterilization, disinfection) for various components.

11. Preventive Maintenance

11.1 Indication of the need for periodic maintenance

Explains the symbol indicating when periodic maintenance is due for the equipment.

11.2 Daily checks and;or prior to use

Lists essential daily checks to ensure the equipment is safe and functional before use.

11.3 Internal Lithium Battery

Discusses the internal battery, its capacity, and charging requirements.

11.4 Internal Sensor of O2 Concentration

Explains the function and replacement of the internal oxygen concentration sensor.

11.5 Replacing the Ambient Air Filter

Provides a step-by-step procedure for replacing the ambient air filter.

11.6 Forwarding the Product to Repair Service

Outlines the procedure for sending the product for maintenance or repair.

12. Disposal

Disposal

Provides guidelines for the proper disposal of the ventilator and its accessories.

13. Turning off the Equipment

Turning off the Equipment

Details the correct procedure for safely turning off the ventilator.

14. Technical Specification

14.1 Classification

Classifies the ventilator according to medical device standards and protection ratings.

14.2 Standards

Lists applicable international and national standards followed in the ventilator's design.

14.3 Specifications

Lists the ventilator's components, control board features, and connectivity options.

14.3.1 Electrical Characteristics

Details electrical specifications, including power supply and internal battery performance.

14.3.2 Connecting to the Oxygen Supply

Explains how to connect the ventilator to an oxygen source, including pressure requirements.

14.3.3 Physical and Environmental Specifications

Lists physical dimensions and operating/storage environmental conditions.

14.3.4 Internal volume of respiratory circuit components

Specifies the internal volumes of various respiratory circuit parts.

14.3.5 Extreme conditions

Warns about operating the ventilator outside specified environmental conditions.

14.3.6 Ventilation Modes

Lists and describes the available ventilation modes and their backup settings.

14.3.7 Setting Specifications of the Ventilation Parameters

Details the adjustable ranges and resolutions for ventilation parameters.

14.3.9 Control accuracy

Provides accuracy specifications for volume, pressure, and PEEP control.

14.3.10 Specifications of the Safety and Alarm System

Details safety features like anti-asphyxia valve and alarm system parameters.

14.3.11 Concentration x Pressure in the breathing circuit curve

Illustrates the relationship between O2 concentration and flow at different pressure levels.

14.3.12 Performance Specifications

Lists performance metrics like maximum flow and MTBF.

14.3.13 Specifications for Maintenance and Calibration

Outlines specifications for component maintenance intervals and calibration.

14.3.14 Mask for Non-Invasive Ventilation

Specifies connection sizes for non-invasive masks.

14.3.15 Breathing Circuit

Provides connection sizes and resistance specifications for breathing circuits.

14.3.16 HME Filter

Specifies connection size and bacterial filtration efficiency for HME filters.

14.3.17 Specifications for Resistance of the Expiratory Limb

Details expiratory resistance values for various breathing circuits and accessories.

14.3.18 Pneumatic diagram

Shows a diagram illustrating the pneumatic flow and components of the ventilator.

14.3.19 Block Diagram of Control Electronics

Illustrates the electronic architecture and signal flow within the ventilator.

14.3.20 Electromagnetic Compatibility

Provides guidelines and statements regarding electromagnetic compatibility of the equipment.

D) Electrical Safety

Lists precautions for safe use of electrical equipment and connections with the system.

14.4 O2 galvanic cell specification

Details the specifications and interference effects of the O2 galvanic cell sensor.

15. Symbols

Symbols

Lists various symbols used in the manual and their meanings in multiple languages.

16. Terms and Abbreviations

Terms and Abbreviations

Provides a glossary of terms and abbreviations used throughout the manual.

17. Statement of Biocompatibility

Statement of Biocompatibility

Asserts the biocompatibility of materials used in the ventilator parts and accessories.

18. Warranty

Warranty

Outlines the warranty terms, period, coverage, and limitations for the equipment.

19. Technical Assistance

Technical Assistance

Provides information on how to contact technical support for maintenance and service.

20. Training

Training

Instructs users on how to request product training from authorized representatives.

Magnamed OxyMag Specifications

General IconGeneral
CategoryMedical Equipment
Tidal Volume Range20 to 2000 mL
Battery LifeUp to 6 hours
Ventilation ModesSIMV, CPAP
FiO2 Range21% to 100%
PEEP0-20 cmH2O
Inspiratory Time0.2 to 5 s
TriggerFlow or Pressure
AlarmsApnea, Disconnection, Low Battery
Display7-inch touchscreen
Power SupplyAC 100-240V, 50/60Hz