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EDAN H10 User Manual

EDAN H10
85 pages
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Questions and Answers:

EDAN H10 Specifications

General IconGeneral
BrandEDAN
ModelH10
CategoryMedical Equipment
LanguageEnglish

Summary

About this Manual

Responsibility of the Manufacturer

Terms Used in this Manual

1 Intended use/Indications for Use

2 Precautions for Use

General Safety and Usage Precautions

Covers usage in MRI/CT, explosive atmospheres, and as an adjunct tool.

Operational and Environmental Safety Notes

Precautions on sensor application, motion, defibrillators, batteries, and reading accuracy.

Physiological and Battery Safety Concerns

Addresses dysfunctional hemoglobins, dyes, battery disposal, and patient conditions.

Battery Mixing and Environmental Factors

Covers battery mixing, fingernail polish, cardiac arrest, and ambient light effects.

Disposal, Patient Safety, and Eye Protection

Details device disposal, patient-connected equipment hazards, and eye safety.

Interconnection, Checks, and Material Compliance

Addresses leakage currents, pre-use checks, and material safety conformity.

Electromagnetic Interference and Handling Safety

Focuses on EMI, cable routing, small parts, and keeping the device away from pets/children.

Battery Maintenance, EMC, and Operation Control

Covers battery corrosion checks, EMC precautions, and prescription device operation.

Equipment Placement and Patient Use Guidelines

Discusses equipment stacking, RF interference, and single-patient use.

Sensor Application and Skin Integrity

Details correct sensor application to prevent skin issues and ensure optical alignment.

Arrhythmia Impact and Maintenance Restrictions

Explains arrhythmia effects on readings and prohibits user maintenance.

Application Site Monitoring and RF Distances

Covers periodic site checks and recommended RF separation distances.

Modification and Operational Limit Warnings

Prohibits unauthorized modification and operating beyond specified parameters.

3 Symbols

4 Installing Batteries

5 Operation Instructions

6 SpO2 Functional Test

7 Assessing the Validity of a SpO2 Reading

8 Installing String

9 Maintenance

Periodic Safety Checks

Recommended safety checks for the oximeter every 24 months.

Cleaning the Oximeter

Procedure for cleaning the device and accessories after patient contact.

Disinfecting the Oximeter

Steps for disinfecting the oximeter and accessories to prevent cross-infection.

10 Accessories

11 Troubleshooting

12 Warranty and Service Policy

12.1 Warranty

Details EDAN's product warranty terms and conditions.

12.2 Service Policy

Outlines procedures for product repair, assistance, and returns.

Appendix I Product Specification

A1.1 Classification

Details the device's protection, operation mode, and safety standards compliance.

A1.2 Specification

Provides technical specifications including size, weight, environment, and battery life.

A1.3 Displayed Parameters Specification

Defines the displayed ranges and accuracy for SpO2 and PR.

Appendix II EMC Information-Guidance and Manufacture's Declaration

A2.1 Electromagnetic Emissions

Information on the device's electromagnetic emissions and compliance levels.

A2.2 Electromagnetic Immunity

Details the device's immunity to electromagnetic disturbances and test levels.

A2.3 Electromagnetic Immunity

Guidance on electromagnetic immunity for RF communications equipment.

A2.4 Recommended Separation Distances

Recommendations for separation distances from RF sources to ensure proper operation.

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