EDAN H10 Bedienungsanleitung

About this Manual

P/N: 01.54.109755

MPN: 01.54.109755015

Release Date: January 2019

Statement

This manual will help you understand the

operation and maintenance of the product

better. It is reminded that the product shall

be used strictly complying with this manual.

User’s operation failing to comply with this

manual may result in malfunction or

accident for which EDAN INSTRUMENTS,

INC. (hereinafter called EDAN) cannot be

held liable.

EDAN owns the copyrights of this manual.

Without prior written consent of EDAN, any

materials contained in this manual shall not

be photocopied, reproduced or translated

into other languages.

Materials protected by the copyright law,

including but not limited to confidential

information such as technical information

and patent information are contained in this

manual, the user shall not disclose such

information to any irrelevant third party.

The user shall understand that nothing in

this manual grants him, expressly or

implicitly, any right or license to use any of

the intellectual properties of EDAN.

EDAN holds the rights to modify, update,

and ultimately explain this manual.

III

Responsibility of the Manufacturer

EDAN only considers itself responsible for

any effect on safety, reliability and

performance of the equipment if:

Assembly operations, extensions,

re-adjustments, modifications or repairs are

carried out by persons authorized by EDAN,

and

The electrical installation of the relevant

room complies with national standards, and

The instrument is used in accordance with

the instructions for use.

EDAN will make available on request

circuit diagrams, component part lists,

descriptions, calibration instructions, or

other information that will assist service

personnel to repair those parts of the

equipment that are designated by EDAN as

repairable by service personnel.

Terms Used in this Manual

This guide is designed to give key concepts

on safety precautions.

WARNING

A WARNING label advises against certain

actions or situations that could result in

personal injury or death.

CAUTION

A CAUTION label advises against actions

or situations that could damage equipment,

produce inaccurate data, or invalidate a

procedure.

NOTE

A NOTE provides useful information

regarding a function or a procedure.

Table of Contents

1 Intended use/Indicationsfor Use.............. 1

2 Precautions for Use ............................... 2

3 Symbols................................................ 15

4 Installing Batteries.............................. 19

5 Operation Instructions

.......................... 22

6 SpO2Functional Test........................... 34

7 Assessing the Validity of a SpO2

Reading ................................................... 35

8 Installing String................................... 39

9 Maintenance ........................................ 40

10 Accessories ......................................... 49

11 Troubleshooting................................. 50

12 Warranty and Service Policy............ 53

12.1 Warranty...................................... 53

12.2 Service Policy.............................. 55

Appendix I Product Specification......... 58

A1.1 Classification .............................. 58

A1.2 Specification............................... 59

A1.2.1 Size and Weight .................. 59

A1.2.2 Environment........................ 59

A1.2.3 Display................................ 60

A1.2.4 Batteries .............................. 60

A1.2.5 Measurement Wavelengths . 61

A1.3 Displayed Parameters Specification

............................................................. 62

Appendix II EMC Information............. 64

A2.1 Electromagnetic Emissions......... 64

A2.2 Electromagnetic Immunity ......... 66

A2.3 Electromagnetic Immunity ......... 68

A2.4 Recommended Separation

Distances ............................................. 76

H10 Finger Oximeter User Manual

- 1 -

1 Intended use/Indications for Use

The device is a small, lightweight, portable

device intended for use in measuring and

displaying functional oxygen saturation of

arterial haemoglobin (%SpO2) and pulse

rate (PR). The oximeters are intended for

use by trained healthcare professionals in

hospital environments. It is intended for

spot-checking of adult and pediatric patient.

H10 Finger Oximeter User Manual

- 2 -

2 Precautions for Use

WARNING

1 Do not use the device in an MRI or

CT environment.

2 Do not use the device in situations

where alarms are required. The

device has no alarms.

3 Explosion hazard: Do not use the

device in an explosive atmosphere.

4 The oximeter is intended only as an

adjunct in patient assessment. It

must be used with other methods of

assessing clinical signs and

symptoms.

H10 Finger Oximeter User Manual

- 3 -

WARNING

5 Do not stretch the adhesive tape

while applying the oximeter sensor.

This may cause inaccurate readings

or skin blisters.

6 Carefully read the manual and

check the device before using it.

7 In some circumstances, the device

may interpret motion as good pulse

quality. Minimize patient motion as

much as possible.

8 The presence of a defibrillator may

affect the performance of the

device.

9 Only recommended batteries can

be used for oximeter.

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