EDAN H100N Bedienungsanleitung

About this Manual

P/N: 01.54.110221-13

Release Date: August 2010

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) can

not 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.

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,

III

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.

Upon request, EDAN may provide, with compensation,

necessary circuit diagrams, and other information to help

qualified technician to maintain and repair some parts,

which EDAN may define as user serviceable.

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 Safety Information .................................................... 1

1.1 Warnings .............................................................. 1

1.2 Cautions...............................................................11

1.3 Notes................................................................... 14

1.4 Symbols in the oximeter..................................... 17

2 Introduction............................................................. 19

2.1 General Introduction........................................... 19

2.2 Panels Introduction............................................. 21

2.3 Connecting Sensor or Cable ............................... 30

2.4 Powered by Battery ............................................ 32

2.5 Accessory List .................................................... 36

3 Oximeter Operation ................................................ 41

3.1 Turning on the Oximeter .................................... 41

3.2 Measurement State ............................................. 43

3.3 System Menu...................................................... 47

3.4 Charging the Ni-MH Battery Package................ 66

3.5 PatientCare Viewer Data Management Software

Introduction .............................................................. 67

4 Alarm........................................................................ 70

4.1 Alarm Categories and Levels ............................. 70

4.2 Alarm Conditions ............................................... 73

5 Performance Considerations.................................. 79

5.1 Performance Verification ................................... 79

5.2 Oximeter Performance Considerations............... 79

5.3 OxiMax Sensor Performance Considerations..... 81

6 Maintenance............................................................. 85

7 Principles of Operation...........................................90

7.1 Pulse Oximetry Measurement ............................ 91

7.2 Functional Versus Fractional Saturation ............ 94

7.3 Measured Versus Calculated Saturation............. 95

8 Warranty and Service Policy.................................. 96

8.1 Warranty............................................................. 96

8.2 Service Policy..................................................... 97

AppendixⅠSpecification ....................................... 100

A1.1 Classification ................................................. 100

VII

A1.2 Specification.................................................. 100

A1.3 Parameters ..................................................... 103

Appendix II EMC Information............................... 105

A2.1 Electromagnetic Emissions - for all

EQUIPMENT and SYSTEMS ............................... 105

A2.2 Electromagnetic Immunity - for all

EQUIPMENT and SYSTEMS ............................... 107

A2.3 Electromagnetic emissions-for EQUIPMENT

and SYSTEMS that are not LIFE-SUPPORTING ..111

A2.4 Recommended Separation Distances..............117

Appendix ⅢRecord Table..................................... 120

Appendix ⅣAbbreviations................................... 121

H100N Pulse Oximeter User Manual Safety Information

- 1 -

1 Safety Information

1.1 Warnings

AWARNING label advises against certain actions or

situations that could result in personal injury or death.

WARNING

1 Avoid explosion hazard. Do not use the

oximeter in the presence of flammable anesthetic

mixtures with air, or with oxygen or nitrous oxide.

2 Chemicals from a broken LCD display panel

are toxic when ingested. Use cautions when the

oximeter has a broken display panel.

3 Routinely monitor the patient to make sure the

oximeter is functioning and the sensor is correctly

placed.

H100N Pulse Oximeter User Manual Safety Information

- 2 -

WARNING

4 Oximetry measurements and pulse signals can

be affected by certain environmental conditions,

sensor application errors, and certain patient

conditions.

5 The use of accessories, sensors, and cables

other than those specified may result in increased

emission of electromagnetic radiation and/or invalid

readings of the oximeter.

6 Failure to cover the sensor site with opaque

material in high ambient light conditions may result

in inaccurate measurements.

7 Do not silence the audio alarm function, or

decrease the audio alarm volume, if patient safety

could be compromised.

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