EDAN H100B Bedienungsanleitung

About this Manual

P/N: 21.54.109000-15

Release Date: Dec 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,

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

III

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............................................................7

1.3 Notes.................................................................9

1.4 Symbols in the Oximeter.................................11

2 Introduction..........................................................14

2.1 General Introduction........................................14

2.2 Panel Introduction...........................................15

2.2.1 Symbols on Screen..................................16

2.2.2 Front Panel Buttons..................................18

2.2.3 Rear Panel ...............................................22

2.3 Connecting Sensor or Cable...........................23

2.4 Powered by Battery.........................................24

2.5 Accessory List.................................................27

3 Oximeter Operation .............................................31

3.1 Turning on the Oximeter .................................31

3.2 Measurement State.........................................32

3.2.1 Measurement Modes................................32

3.2.2 Trend Graph and Trend Table .................33

3.2.3 Abnormal Measurement State .................34

3.2.4 Data Transfer State..................................35

3.3 System Menu..................................................36

3.3.1 System Mode ...........................................38

3.3.2 Patient Type.............................................39

3.3.3 Alarm Volume...........................................39

3.3.4 Pulse Volume...........................................39

3.3.5 Audio Paused (s)......................................40

3.3.6 User Maintain...........................................40

3.3.7 Default Config...........................................41

3.3.8 Sensitivity.................................................42

3.3.9 Alarm System...........................................42

3.3.10 SpO2Alarm setup...................................44

3.3.11 PR Alarm setup......................................46

3.3.12 Patient ID No. Setup...............................47

3.3.13 Data Storage..........................................48

3.3.14 Delete All Data .......................................49

3.3.15 Exit (Return)...........................................50

3.4 Charging the Ni-MH Battery Package.............50

3.5 PatientCare Viewer Data Management Software

Introduction ...........................................................51

4 Alarm.....................................................................52

4.1 Alarm Categories and Levels..........................52

4.2 Alarm Conditions.............................................54

4.2.1 Alarm off Before the First Measurement..54

4.2.2 Alarm for SpO2 Sensor Unconnected......55

4.2.3 Alarm for SpO2 Sensor off.......................55

4.2.4 Alarm for Low Battery...............................55

4.2.5 Higher than Hi Alarm Limit.......................56

4.2.6 Lower than Lo Alarm Limit .......................56

4.2.7 Alarm Silence...........................................57

4.2.8 Turning off Alarm System.........................57

4.2.9 Alarm Priority............................................57

5 Performance Considerations..............................58

5.1 Performance Verification.................................58

5.2 Oximeter Performance Considerations...........58

5.3 Sensor Performance Considerations..............59

6 Maintenance .........................................................63

7 Principles of Operation .......................................66

7.1 Pulse Oximetry Measurement.........................67

7.2 Functional Versus Fractional Saturation.........69

7.3 Measured Versus Calculated Saturation ........70

8 Warranty and Service Policy...............................71

8.1 Warranty..........................................................71

8.2 Service Policy..................................................72

AppendixⅠSpecification........................................74

VII

A1.1 Classification.................................................74

A1.2 Specification .................................................74

A1.2.1 Size and Weight.....................................74

A1.2.2 Environment...........................................74

A1.2.3 Display ...................................................75

A1.2.4 Batteries.................................................75

A1.2.5 Charger Stand........................................76

A1.3 Parameters...................................................76

Appendix II EMC Information.................................78

A2.1 Electromagnetic Emissions - for all

EQUIPMENT and SYSTEMS................................78

A2.2 Electromagnetic Immunity - for all

EQUIPMENT and SYSTEMS................................80

A2.3 Electromagnetic emissions-for EQUIPMENT

and SYSTEMS that are not LIFE-SUPPORTING.83

A2.4 Recommended Separation Distances..........87

Appendix ⅢRecord Table....................................89

Appendix ⅣAbbreviations ..................................90

H100B Pulse Oximeter User Manual

- 1 -

1 Safety Information

1.1 Warnings

Warnings are identified by the WARNING symbol

shown above.

A WARNING 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.

4 Oximetry measurements and pulse signals can

be affected by certain environmental conditions,

H100B Pulse Oximeter User Manual

- 2 -

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.

8 The oximeter is a prescription device to be

operated only by trained personnel. The

oximeter is for attended monitoring only.

9 Dispose of batteries in accordance with local

ordinances and regulations.

10 The oximeter is not defibrillator-proof. However,

it may remain attached to the patient throughout

defibrillation or while an electrosurgical unit is in

use. The measurements may be inaccurate

throughout the defibrillation, or use of an

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