Tecno-gaz H100B Manual de usuario

H1 OOB/H1 OON

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User Manual

�TECNO-GAZ

� industries

About this Manual

P/N: 21.54.110178

MPN: 21.54.110178018

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 the

manufacturer cannot be held liable.

The manufacturer owns the copyrights of this manual.

Without prior written consent of the manufacturer, 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 the manufacturer.

The manufacturer holds the rights to modify, update, and

ultimately explain this manual.

Responsibilityofthe Manufacturer

The manufacturer 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 the manufacturer, and

The electrical installation of the relevant room complies

with national standards, and

The instrument is used in accordance with the

instructions for use.

III

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.............................................................. 14

1.3 Notes................................................................... 16

1.4 Symbols in the Oximeter.................................... 20

2 Introduction............................................................. 24

2.1 General Introduction........................................... 24

2.2 Panel Introduction .............................................. 26

2.2.1 Symbols on Screen...................................... 26

2.2.2 Front Panel Buttons..................................... 29

2.2.3 Rear Panel.................................................... 32

2.3 Connecting Sensor or Cable............................... 33

2.4 Powered by Battery............................................ 35

2.5 Accessory List.................................................... 39

3 Oximeter Operation ................................................ 42

3.1 Turning on the Oximeter .................................... 42

3.2 Measurement Procedure..................................... 43

3.2.1 SpO2 Measurement Procedure..................... 43

3.2.2 TEMP Measurement Procedure................... 46

3.3 Measurement State............................................. 46

3.3.1 Measurement Modes ................................... 46

3.3.2 Trend Graph and Trend Table..................... 47

3.3.3 Abnormal Measurement State..................... 48

3.3.4 Data Transfer State...................................... 49

3.4 System Menu...................................................... 50

3.4.1 System Mode............................................... 53

3.4.2 Patient Type................................................. 53

3.4.3 Alarm Volume............................................. 54

3.4.4 Pulse Volume .............................................. 54

3.4.5 Audio Paused (s) ......................................... 54

3.4.6 User Maintain.............................................. 55

3.4.7 Default Config............................................. 56

3.4.8 Sensitivity.................................................... 58

3.4.9 Alarm System.............................................. 58

3.4.10 SpO2Alarm Setup ..................................... 60

3.4.11 PR Alarm Setup......................................... 62

3.4.12 Temp Alarm Setup .................................... 63

3.4.13 Patient ID No. Setup.................................. 64

3.4.14 Data Storage .............................................. 65

3.4.15 Delete All Data.......................................... 66

3.4.16 Exit (Return).............................................. 67

3.5 Charging the Ni-MH Rechargeable Battery

Package..................................................................... 67

3.6 Oximeter Viewer Data Management Software

Introduction.............................................................. 68

4 Alarm........................................................................ 71

4.1 Alarm Categories and Levels ............................. 71

4.2 Alarm Conditions............................................... 74

4.2.1 Alarm for SpO2Sensor Unconnected.......... 74

4.2.2 Alarm for SpO2Sensor off .......................... 75

4.2.3 Alarm for Abnormal State of Temp Sensor. 75

4.2.4 Alarm for Low Battery................................ 76

4.2.5 Higher than Hi Alarm Limit........................ 76

4.2.6 Lower than Lo Alarm Limit ........................ 77

4.2.7 Alarm Silence.............................................. 77

4.2.8 Turning off Alarm System........................... 78

4.2.9 Alarm Priority.............................................. 78

4.2.10 Alarm Delay .............................................. 78

4.2.11 Testing Alarms .......................................... 79

5 Performance Considerations.................................. 80

5.1 Performance Verification ................................... 80

5.2OximeterPerformanceConsiderations.......................... 80

5.3 SpO2Functional Test.......................................... 85

5.4 Assessing the Validity of a SpO2Reading ......... 85

6 Maintenance............................................................. 88

VII

7 Principles of Operation........................................... 97

7.1 Pulse Oximetry Measurement ............................ 98

7.2 Measured Versus Calculated Saturation........... 100

8 Warranty and Service ........................................... 101

8.1 Warranty........................................................... 101

8.2 Contact information.......................................... 102

Appendix I Specification.......................................... 103

A1.1 Classification................................................. 103

A1.2 Specification.................................................. 103

A1.2.1 Size and Weight...................................... 104

A1.2.2 Function Configuration........................... 104

A1.2.3 Environment ........................................... 104

A1.2.4 Display.................................................... 105

A1.2.5 Batteries.................................................. 105

A1.2.6 Charger Stand......................................... 107

A1.2.7 Data Storage ........................................... 107

A1.3 Parameters ..................................................... 107

Appendix II EMC Information................................111

A2.1 Electromagnetic Emissions.............................111

A2.2 Electromagnetic Immunity.............................112

A2.3 Electromagnetic Immunity.............................117

A2.4 Recommended Separation Distances............. 124

VIII

Appendix III Record Table...................................... 126

Appendix IVAbbreviations..................................... 127

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 Pulse

Oximeter (hereinafter called 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.

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