Tecno-gaz H100B User manual

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User Manual
�TECNO-GAZ
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I
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.

II
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.

IV
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

V
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

VI
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.

Pulse Oximeter User Manual
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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 of covering 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.

Pulse Oximeter User Manual
- 3 -
WARNING
10 The oximeter is not defibrillator-proof. The
measurements may be inaccurate throughout
the defibrillation, or use of an electrosurgical
unit, and shortly thereafter. To avoid shock, the
caregiver should not hold the oximeter while
using a defibrillator on a patient.
11 Disconnect the oximeter and sensor from the
patient throughout magnetic resonance imaging
(MRI) scanning. Induced current could
potentially cause burns.
12 To ensure accurate performance and prevent
device failure, do not subject the oximeter to
extreme moisture, such as direct exposure to
rain. Such exposure may cause inaccurate
performance or device failure.
13 Do not immerse or wet the sensor, as this may
damage the sensor.
14 Do not lift the oximeter by the sensor or extension
cable because the cable could disconnect from the
oximeterand the oximeter maydropon thepatient.

Pulse Oximeter User Manual
- 4 -
WARNING
15 Do not make any clinical judgment based solely
on the oximeter, it is intended only as an
adjunct in patient assessment. It must be used
in conjunction with clinical signs and symptoms.
16 To ensure patient safety, do not place the
oximeter in any position that might cause it to
fall on the patient.
17 As with all medical equipment, carefully route
patient cables to reduce the possibility of
patient entanglement or strangulation. It is
especially important for children.
18 Please avoid inhalation or swallowing of small
parts.
19 Ensure that the speaker is clear of any
obstruction and that the speaker holes are not
covered. Failure of doing so could result in an
inaudible alarm tone.
20 Do not monitor the patient while the battery is
being charged.

Pulse Oximeter User Manual
- 5 -
WARNING
21 Only use sensors and extension cables
permitted by the manufacturer with the oximeter.
Other sensors or extension cables may fail
and/or cause improper monitor performance
and/or minor personal injury.
22 Oximeter readings and pulse signals can be
affected by certain ambient environmental
conditions, sensor application error, and certain
patient conditions. See the appropriate sections
of the manual for specific safety information.
23 Don’t mix new and old batteries together. Don’t
mix rechargeable batteries with alkaline
batteries.
24 Periodically check the battery for corrosion.
Remove the batteries from the oximeter if you
do not expect to use it within one month.
25 Do not use damaged sensor or extension
cables, do not use sensor with exposed optical
components.
26 This equipment is not intended for home usage.

Pulse Oximeter User Manual
- 6 -
WARNING
27 The device enters POST (Power-On-Self-Test)
immediately after power-on to confirm all the
display segments and icons are shown and the
speaker sounds a few seconds tone. If you do
not hear the POST pass tone, it indicates the
alarm system does not work well. Please do not
use the oximeter and contact qualified service
personnel or your local representative of the
manufacturer. Do not use the oximeter if the
POST has not been finished successfully.
28 Before using it, the user should carefully read
the applicable user manual of sensor, including
warnings, cautions and instructions.
29 Before cleaning the oximeter or the sensor,
make sure that the equipment is switched off
and disconnected from the power line.
30 A potential hazard can exist if different alarm
presets are used for the same or similar
equipment in any single area, e.g. an intensive
care unit or cardiac operating room.

Pulse Oximeter User Manual
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WARNING
31 There are no user-serviceable parts inside the
oximeter, the cover should only be removed by
qualified service personnel.
32 Do not spray, pour, spill liquid to the oximeter and
its accessories, connector, switch or opening in
enclosure, as this may damage the oximeter.
33 Do not disassemble batteries, or dispose of them
in fire, or cause them to short circuit. They may
ignite, explode, leak, or cause personal injury.
34 Do not service or maintain the oximeter or any
accessory which is in use with the patient.
35 Do not use the charger stand when the alkaline
battery is depleted or no battery is installed.
36 Incorrect replacement of batteries would result
in unacceptable risk. The batteries shall be
replaced by adequately trained personnel.
37 Operation of the equipment exceeding specified
physiological signal or the operational
specification may cause inaccurate results.

Pulse Oximeter User Manual
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WARNING
38 Patient's weak pulse or disturbed SpO2 signal
may affect measurement and alarm accuracy.
39 The medical electrical equipment needs special
precautions regarding EMC and needs to be
installed and put into service according to the
EMC Information provided in this user manual.
40 Portable and mobile RF communications
equipment can affect medical electrical
equipment; refer to the recommended
separation distances provided in Appendix A2
EMC Information.
41 The use of patient cable and other accessories
not supplied by the manufacturer may result in
increased emissions or decreased immunity of
the equipment.
42 Use only Nellcor-approved OxiMax Sensors
and extension cables with the H100N Pulse
Oximeter. Other sensors or extension cables
may cause improper monitor performance or
minor personal injury.

Pulse Oximeter User Manual
- 9 -
WARNING
43 The oximeter should not be used adjacent to or
stacked with other equipment. If adjacent or
stacked use is necessary, you must check that
normal operation is possible in the necessary
configuration before you start monitoring
patients.
44 Only recommended rechargeable batteries and
charger stand can be used for oximeter.
45 Setting the alarm limits to extreme values can
cause the alarm system useless.
46 The temperature sensor should be disinfected
after each measurement. The probe must not be
sterilized in steam. Only detergents containing
no alcohol can be used for disinfection.
47 The temperature sensor should not be heated
above 100 C (212 ℉). It should only be
subjected to temperatures from 80 C (176 ℉)
to 100 C (212 ℉).
48 Do not place battery in the oximeter with the (+)
and (-) in the wrong way.

Pulse Oximeter User Manual
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WARNING
49 Verification of the temperature module is
necessary as frequently as dictated by your
Hospital Procedures Policy. When you need to
calibrate the temperature measurement, please
contact the manufacturer.
50 Take the TEMP probe and cable carefully. If
you do not use them for a long time, you should
coil up the probe and cable into a loose circle. If
the wire inside the cable is tensely pulled, it
may cause mechanical damage to the probe
and the cable.
51 Do not touch accessible parts of medical or
non-medical electrical equipment in the patient
environment and the patient simultaneously.
52 The simultaneous use of cardiac pacemaker
and other patient-connected equipment may
cause safety hazard.
53 The device should keep away from pets, pests
or children.

Pulse Oximeter User Manual
- 11 -
WARNING
54 Without use of data store function, the data
previously measured will be cleared when the
oximeter is powered off. With use of data store
function, 300-hour SpO2&PR data can be
stored and transmitted to the computer.
55 During monitoring, if the power supply is off, the
oximeter will be off, and only the patient
information and alarm settings can be saved.
After reconnecting the power supply, the user
should turn on the oximeter for monitoring.
56 If several items of medical equipment are
interconnected, pay attention to the sum of the
leakage currents, otherwise it may cause shock
hazard. Consult your service personnel.
57 Before using the device, the equipment, patient
cable and sensors etc. should be checked.
Replacement shall be taken if there is any
evident defect or signs of aging which may
impair the safety or performance.