Accurate Bio-Medical Technology HS10 User manual

HS10A Pulse Oximeter Operator’s Manual HS10A-03-RDP-004 V4.0
Copy Right. Hunan Accurate Bio-Medical Technology Co., Ltd Page 1/ Total 36
HS10
Handheld Pulse Oximeter
OPERATOR’S MANUAL

HS10A Pulse Oximeter Operator’s Manual HS10A-03-RDP-004 V4.0
Copy Right. Hunan Accurate Bio-Medical Technology Co., Ltd Page 2 / Total 36
Product Information
Product Name: Pulse Oximeter
Product Model: HS10A, HS10A-LI
Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.
Address: 6th Floor，Biyang Industrial Zone,Lijiacun Road,Xueshi Street of Yuelu
District,410208 Changsha,Hunan Province, PEOPLE`S REPUBLIC OF CHINA
Tel: [phone]
Fax: [phone]
Software Version：V1.0
EUROPEAN REPRESENTATIVE:
Name：Shanghai International Holding Corp. GmbH (Europe)
ADD:Eiffestrasse 80, 20537 Hamburg，Germany
Tel: [phone] Fax: [phone]
Revision History
This manual has a revision number. This revision number changes whenever the manual is updated due
to software or technical specification change. Contents of this manual are subject to change without prior
notice.
Revision number: 4.0
Release time: 2022-07
© Copyright Hunan Accurate Bio-Medical Technology Co., Ltd. All rights reserved.

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Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use.
Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any
question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently
when needed.
This product is a reusable medical device.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and
terminology as required for monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your pulse
oximeter.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
→ is used to indicate operational procedures.
[ ] is used to enclose screen texts.

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Contents
Contents ........................................................................................................................................................4
1 Safety ......................................................................................................................................................... 7
1.1 Safety Information .......................................................................................................................... 7
1.1.1 Dangers ................................................................................................................................ 7
1.1.2 Warnings .............................................................................................................................. 7
1.1.3 Cautions ............................................................................................................................... 8
1.1.4 Notes .................................................................................................................................... 9
1.2 Equipment Symbols ........................................................................................................................ 9
2 The Basics ................................................................................................................................................11
2.1 Introduction ................................................................................................................................... 11
2.1.1 Intended Use .......................................................................................................................11
2.1.2 Intended Operator .............................................................................................................. 11
2.1.3 Intended Patient Population ............................................................................................... 11
2.1.4 Medical Condition ..............................................................................................................11
2.1.5 Essential Performance ........................................................................................................11
2.1.6 Contraindications ............................................................................................................... 11
2.1.7 Components ........................................................................................................................11
2.1.8 Operator Position ............................................................................................................... 11
2.1.9 Validation ........................................................................................................................... 11
2.2 Main Unit ...................................................................................................................................... 12
2.2.1 Front View ......................................................................................................................... 12
2.2.2 Rear View and Right View ................................................................................................13
2.3 Display Views ............................................................................................................................... 13
2.3.1 SpO2 Area ..........................................................................................................................14
2.3.2 PR Area .............................................................................................................................. 14
2.3.3 Information Area ................................................................................................................14
3 Getting Started ....................................................................................................................................... 15
3.1 Unpacking and Checking ..............................................................................................................15
3.2 Environmental Requirements ....................................................................................................... 15
3.3 Power On the Pulse Oximeter .......................................................................................................15
3.4 Power Off the Pulse Oximeter ...................................................................................................... 15
4 Basic Operations .....................................................................................................................................16
4.1 Adjusting the Pulse Volume ......................................................................................................... 16
4.2 Selecting Patient Type .................................................................................................................. 16

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4.3 Setting Alarm Limit ...................................................................................................................... 16
4.3.1 Setting PR High Alarm Limit ............................................................................................ 16
4.3.2 Setting PR Low Alarm Limit .............................................................................................17
4.3.3 Setting SPO2High Alarm Limit ........................................................................................ 17
4.3.4 Setting SPO2Low Alarm Limit .........................................................................................17
5 Notices ..................................................................................................................................................... 18
5.1 Notice Categories ..........................................................................................................................18
5.2 Notice Levels ................................................................................................................................ 18
5.3 Notice Indicators ........................................................................................................................... 18
5.3.1 Notice Lamp .......................................................................................................................18
5.3.2 Notice Tones ...................................................................................................................... 18
5.3.3 Notice Messages ................................................................................................................ 19
5.4 Notice Tone Configuration ........................................................................................................... 19
5.4.1 Switch ON/OFF Notice Volume ....................................................................................... 19
5.4.2 Pausing the Notice Tones .................................................................................................. 19
5.5 When an Notice Occurs ................................................................................................................ 19
6 Measuring SpO2 .....................................................................................................................................20
6.1 Introduction ................................................................................................................................... 20
6.2 Safety .............................................................................................................................................20
6.3 Applying the Sensor ......................................................................................................................21
6.4 Settings ..........................................................................................................................................21
6.4.1 Setting Patient Type ........................................................................................................... 21
6.4.2 Adjusting the Notice Limits ...............................................................................................21
6.4.3 Setting VOL ....................................................................................................................... 21
6.5 Measurement Limitations ............................................................................................................. 21
7 Battery ..................................................................................................................................................... 22
7.1 Overview .......................................................................................................................................22
7.2 Installing the Batteries .................................................................................................................. 22
7.2.1 Opening the Battery Door ..................................................................................................22
7.2.2 Installing the Alkaline Batteries ........................................................................................ 22
7.2.3 Installing the Lithium Batteries ......................................................................................... 22
7.2.4 Charging the Lithium Batteries ......................................................................................... 23
To charge the lithium battery. .....................................................................................................23
7.3 Checking The Lithium Battery ..................................................................................................... 23
7.4 Disposing Of The Batteries ...........................................................................................................23
8 Maintenance and Cleaning ....................................................................................................................24
8.1 Safety Checks ................................................................................................................................24
8.2 Cleaning ........................................................................................................................................ 24

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8.3 Disinfecting ................................................................................................................................... 25
8.4 Disposal .........................................................................................................................................25
9 Accessories .............................................................................................................................................. 26
A Product Specifications .......................................................................................................................... 26
B EMC ........................................................................................................................................................28
C Factory Defaults .................................................................................................................................... 32
C.1 System Setup ................................................................................................................................ 32
C.2 SpO2 Setup ...................................................................................................................................32
D Notice Messages ..................................................................................................................................... 32
D.1 Physiological Notice Messages ....................................................................................................33
D.2 Technical Notice Messages .......................................................................................................... 33
E SpO2 Sensor Model ............................................................................................................................... 33
E.1 Disposable SpO2 Sensor .............................................................................................................. 33
E.2 Reusable SpO2 Sensor ................................................................................................................. 34
F Symbols and Abbreviations .................................................................................................................. 34
F.1 Units .............................................................................................................................................. 34
F.2 Symbols .........................................................................................................................................35
F.3 Abbreviations ................................................................................................................................ 35

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1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
Indicates a statement that there may be hazards in using different alarm presets for the same or similar devices in any
signal area.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury.
Indicates a warning to the effect that probes and cables are designed for use with specific monitors.
Indicates a warning statement to the effect that the responsible organization or operators needs to verify the compatibility
of the monitor, probe or cables before use, or patient injury can result.
Indicates a warning statement to the effect that misapplication of a probe with excessive pressure for prolonged periods
can induce pressure injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or
product/property damage.
Indicates a statement to the effect that a FUNCTIONAL TESTER cannot be used to access the ACCURACY of a pulse
oximeter probe or a pulse oximeter monitor.
NOTE
Provides application tips or other useful information to ensure that you get the most from your product.
The pulse oximeter is not part of the body or tissue.
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of
this manual.
1.1.2 Warnings
WARNINGS
Before putting the system into operation, verify that the equipment, connecting cables and accessories are in correct
working order and operating condition.
To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids.
Do not open the equipment housings; electric shock hazard may exist. All servicing and future upgrades must be carried
out by the personnel trained and authorized by our company only.
When using the equipment with electrosurgical units (ESU), make sure the personnel is safe.
Do not come into contact with the personnel during defibrillation. Otherwise serious injury or death could result.
Do not rely exclusively on the audible notice system for personnel monitoring. Adjustment of notice volume to a low level

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or off may result in a hazard to the personnel. Remember that notice settings should be customized according to different
or personnel situations and always keeping the personnel under close surveillance is the most reliable way for safe
personnel monitoring.
The physiological data and notice messages displayed on the equipment are for reference only and cannot be directly used
for diagnostic interpretation.
To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess
cabling to avoid risk of entanglement or strangulation by personnel.
No modification of this equipment is allowed.
The maximum temperature that the applied part can achieve is 42.2℃at an environmental temperature of 40℃.
The continuous test time of one part shall not exceed 2 hours, and the test part shall be replaced.
Applied part having contact with the patient for a time “t”, 10 min ≤t≤2 hours.
Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbances is high.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result
in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
1.1.3 Cautions
CAUTIONS
To ensure safety, use only parts and accessories specified in this manual.
At the end of its shelf life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines
regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact us.
Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason
make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements.
Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other
mechanical force.
WARNING
Use only accessories specified in this manual. Using other accessories may cause damage to the pulse oximeter.
Disposable accessories are designed for single-person use only. Reuse of them may cause a risk of contamination and
affect the measurement accuracy
Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.
The SpO2 sensor mentioned in this chapter meet the bio-compatibility requirements and complies with ISO 10993-1, ISO
10993-5 and ISO10993-10 standards.
It should change the measurement part per 2 hours when user continuing using for detecting.
The measured value is best when the pulse rate waveform is smooth and stable after normalization. Data update period:

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≤3 pulse rate cycles, ＜30s.
FUNCTIONAL TESTER cannot be used to assess the ACCURACY of a PULSE OXIMETER .
The nature of Reminder signals is continue to turning on for 1s. And the intervals between Reminder signals is turn on 1
seconds and turn off 4 second. One cycle has 5 seconds.
1.1.4 Notes
NOTES
Put the equipment in a location where you can easily see the screen and access the operating controls.
Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
1.2 Equipment Symbols
Direct Current(DC)(Only for lithium)
Attention: Consult accompanying documents (this manual).
Auxiliary output connector
Notification silence button
Setting button
Power button
Up button
Down button
Manufacturer
Date of manufacture
Serial number
Type BF applied part, defibrillation protected
European community representative

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The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household waste.
Power supply connector (Only for lithium)
Safety Class II equipment (Only for lithium)
Charging indicator light (Only for lithium)