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EDAN H100N User Manual

EDAN H100N
130 pages
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EDAN H100N Specifications

General IconGeneral
SpO2Yes
TemperatureOptional
EtCO2Optional
IBPOptional
Display10.4-inch color TFT LCD
Parameters MonitoredSpO2
ECG3/5-lead
BatteryRechargeable lithium-ion battery
ConnectivityUSB
Data StorageYes

Summary

About this User Manual

Statement

Manual's purpose and EDAN's liability disclaimer for product operation and maintenance.

Manufacturer's Responsibility

Manual Terms and Definitions

1 Safety Information

1.1 Warnings

Advises against actions or situations that could result in personal injury or death.

1.2 Cautions

Alerts users to exercise care for safe and effective use of the oximeter.

1.3 Notes

Provides important information that may be overlooked or missed.

1.4 Symbols in the oximeter

Explains common symbols used on the oximeter and their meanings.

2 Introduction

Intended Use of Oximeter

Describes the target patient population and facilities for the H100N Pulse Oximeter.

General Oximeter Introduction

Provides an overview of the oximeter's features, including displayed parameters and modules.

Oximeter Panel Overview

Identifies symbols, controls, displays, and buttons on the oximeter's front and rear panels.

Connecting Sensors and Cables

Explains how to connect the SpO2 sensor, extension cables, and PC connection.

Oximeter Power and Battery

Details the types of batteries used, their installation, and battery life.

Oximeter Accessory List

Lists standard and optional accessories included with or available for the H100N Pulse Oximeter.

3 Oximeter Operation

Powering On the Oximeter

Step-by-step instructions for powering on the oximeter and the POST process.

Oximeter Measurement Modes

Describes the different measurement modes (waveform, numeric) and trend graphs.

Measurement Mode Details

Explains the large numeric and waveform display modes for SpO2, PR, and TEMP.

Displaying Trend Graphs

How to display SpO2 and PR trend graphs using the arrow buttons.

Abnormal Measurement States

Details alarms and displayed information for disconnected or faulty sensors, and abnormal temp.

Oximeter Data Transfer

Procedure for transferring measurement data from the oximeter to a PC.

System Menu Navigation

Navigating the oximeter's system menu to configure settings like mode, alarms, and patient type.

4 Alarm

Alarm Categories and Levels

Classifies alarms into categories (physiological, technical) and levels (high, medium, low).

Alarm Trigger Conditions

Details specific conditions that trigger alarms, including sensor issues and battery status.

5 Performance Considerations

Performance Verification Procedures

Procedures for verifying oximeter performance by qualified personnel before clinical use.

Patient Factors Affecting Performance

Discusses patient conditions affecting oximeter measurements like dysfunctional hemoglobins and anemia.

OxiMax Sensor Performance Issues

Lists factors causing inaccurate measurements with OxiMax sensors, including application and environmental issues.

6 Maintenance

7 Principles of Operation

Pulse Oximetry Measurement Principle

Explains how pulse oximetry uses light absorption to measure SpO2 and PR.

Functional vs. Fractional Saturation

Differentiates between functional and fractional saturation measurements by the oximeter.

Measured vs. Calculated Saturation

Explains potential differences between SpO2 measurements and saturation calculated from blood gas.

8 Warranty and Service Information

Product Warranty Details

Outlines EDAN's product warranty terms, conditions, and exclusions.

Service and Repair Policy

Defines EDAN's policy for product repairs, approvals, and certified personnel.

Appendix I: Device Specifications

Device Classification

Classifies the device by protection type, EMC compliance, ingress protection, and safety standards.

Physical and Environmental Specs

Details the oximeter's size, weight, operating environment, and display characteristics.

Measurement Parameters and Accuracy

Lists measurement ranges, accuracy tolerances for SpO2, PR, and TEMP.

Appendix II: EMC Information

Electromagnetic Emissions Compliance

Specifies compliance with electromagnetic emission standards for the oximeter.

Electromagnetic Immunity Standards

Details the oximeter's immunity to electromagnetic interference from various sources.

Non-Life-Supporting EMC Guidelines

Provides EMC guidance for non-life-supporting equipment, including separation distances.

Recommended Separation Distances

Provides recommended separation distances for RF communications equipment and the oximeter.

Appendix III: Record Table

Appendix IV: Abbreviations

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