Acare AH-TX Series User manual

AH-TX Series Handheld Pulse Oximeter Instruction Manual
Handheld Pulse Oximeter
Model: AH-TX Series
(AH-TA)
(AH-TB)
Instruction Manual
Issued Date: July. 01, 2019
Ver.1.0

AH-TX Series Handheld Pulse Oximeter Instruction Manual
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Product Information
Product Model: AH-TX Series
Product Name: Handheld pulse oximeter
Manufacturer: Acare Technology Co., Ltd.
After Service Contact Information:
Address: 6F.-3, No.24, Wuquan 2st Rd., Xinzhuang Dist.,
New Taipei City 242, Taiwan
TEL: [phone]
FAX: [phone]
Email: [e-mail]
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: 1.0
Release time: 2018-07
Copyright © 2016 Acare Technology Co., Ltd. All rights reserve.

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CE Mark
EC Representative Name:
COMPAŇIA EUROPEA DE PROSUCTOS MEDICOS, S.L.
(MEDIPRO)
Villapark Business Park, Av Quitapesares 8, Building 8, Villaviciosa de Odon
(Madrid) 28670, Spain
Statement
The manufacturer, Acare, holds the copyright to this manual, and is
entitled to treat it as a proprietary file. This manual is only to be used for
supporting the operation, maintenance and service of the AH-TX product,
and it cannot be resold or republished by any other party.
This manual contains exclusive information protected by copyright laws and
we, Acare, reserve its copyright. No parts of this manual shall be
photocopied, Xeroxed or translated into other languages without written
approval from the manufacturer.
The contents of this manual are subject to amendment without
notification.

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Manufacturer's Responsibility
The manufacturer will be responsible for the safety, reliability and
performance of the instrument under the following circumstances only:
All installation, expansion, readjustment, renovation or repairs of the
instrument are conducted by personnel certified by the manufacturer.
The storage conditions, operating conditions and electrical status of the
instrument conform to the product specification.
The instrument is used in accordance with the user manual.
About this manual
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 of the product, and ensures patient and operator safety.
This manual is based on the maximum potential configuration of the
product, and therefore some contents may not apply to your device. If you
have any questions, 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 referred to when needed.
All illustrations in this manual serve only as examples. They may not
necessarily reflect the setup or data displayed on your product.
Key:
Bold Italic text is used in this manual to quote the referenced
chapter or sections.

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【】is used to signify text as it appears on the product screen.
→ is used to indicate operational procedures.
Warning: Indicates a potential hazard or unsafe practice that, if not
avoided, will result in serious injury.
Caution: Indicates a potential hazard or unsafe practice that, if not
avoided, could result in minor personal injury or product/property
damage.
Note: Provides application tips or other useful information to ensure
that you get the most from your product.
Note: The oximeter is calibrated in the factory before sale, there is
no need to calibrate it during its life cycle.

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Compliance regulations
This product complies with the relevant medical equipment regulations
as follows:
IEC 60601-1 (Edition 3.1)
IEC 60601-1-2 (4th Ed.)
IEC 60601-1-8
ISO 80601-2-61
EN 301489-1
EN 301489-17
FCC Part15B
FCC Part15C
NCC (Taiwan Only)

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Contents
Chapter 1 General Introduction ……………………...…………1
1.1 Intended Use …………………………………………1
1.2 Main Unit ……………………………………………….1
1.2.1 Front & Rear View ……………………………1
1.2.2 Side View ……………………........………2
1.3 Display Views …………………………………………2
1.3.1 Large Numeric Display Mode ………………..3
1.3.2 SpO2 Waveform Display Mode …………. 4
Chapter 2 Safety …………………………………………………6
2.1 Safety Information ………………………………….6
2.2 Explanation of interface Symbols ………………………7
Chapter 3 Basic Operations………………………………………..9
3.1 Unpacking and Checking ……………………..........9
3.2 Getting Started …………………………………………….…9
3.3 Starting the oximeter ……………………………………….10
3.4 General Setup………………………………………........10
3.4.1 Alarm Volume Setup ……………………………........12
3.4.2 Beep Volume Setup ……………………………........12
3.4.3 Key Volume Setup ………………..........................12
3.4.4 Adjust the Screen Brightness …………….……....12
3.4.5 Scan Speed Setup ……………………………........13
3.4.6 Date Setup …………………...............................14

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3.4.7 Time Setup ………………………………………13
3.4.8 Language Setup ……………………………………...13
3.5 Selecting the Work Mode …………………………………13
3.5.1 Continuous Monitoring Mode……………………14
3.5.2 Spot-checking Mode …………………………………15
3.6 Selecting Patient Type ……………………………………....15
3.7 Load Default Configuration ……………………………….16
3.8 Shutting off the Oximeter …………………………………16
Chapter 4 Alarm …………………………………………………….18
4.1 Alarm Categories ……………………………………………..18
4.2 Alarm Levels …………………………………………….18
4.3 Alarm Indicators ……………………………………………..19
4.3.1 Alarm tone ……………………………………….20
4.3.2 Alarm Message ………………………………………20
4.4 Pausing the Alarm Tones …………………………………21
4.5 Shutting off the Alarm Volume …………………………21
Chapter 5 Measuring SpO2 ………………………………………24
5.1 Introduction …………………………………………………….24
5.2 Safety Information ……………………………………….24
5.3 Monitoring Procedure ………………………………………26
5.4 Parameter Display ………………………………………27
5.5 SpO2 Alarm Setup ……………………………………….27
5.5.1 Switching SpO2 Alarm On/Off …………………..27
5.5.2 Setting the Alarm Levels ………………………….28

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5.5.3 Adjusting the Alarm Limit …………………………..28
5.6 HR Alarm Setup ……………………………………………..28
5.6.1 Switching HR Alarm On/Off ……………………28
5.6.2 Setting the Alarm Level …………………………28
5.6.3 Adjusting the Alarm Limit …………………………..28
Chapter 6 Reviewing …………………………………………….29
6.1 Introduction …………………………………………………….29
6.2 Reviewing Screen ……………………………………….29
6.3 Delete Record …………………………………………….29
6.3.1 Delete single data …………………………………30
6.3.2 Export data ………………………………………30
6.3.3 Delete all data ………………………………………32
Chapter 7 Data transmission ……………………………………….33
7.1 Wired transmission ……………………………………….33
7.1.1 USB cable ……………………………………….33
7.2 Wireless transmission (AH-TB only) …………………….33
7.2.1 Bluetooth Low Energy … ……………………….33
Chapter 8 Battery …………………………………………………….35
8.1 Introduction …………………………………………………….35
8.2 Charging Lithium Ion Battery …………………………………36
8.3 Checking the Lithium-Ion Battery ………………………….37
8.4 Disposing of the Batteries…………………………………38

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Chapter 9 Maintenance and Cleaning … ……………………….39
9.1 Introduction …………………………………………………….39
9.2 Maintenance ………………………………………………40
9.3 Cleaning the Oximeter ………………………………………41
9.4 Cleaning SpO2 Probe ………………………………………41
9.5 Disposal …………………………………………………….42
Chapter 10 Accessories of Probe ………………………………..43
Appendix A Product Specifications …………………………44
A.1 Safety Specifications ………………………………………..44
A.2 Physical Specifications ………………………………………44
A.3 Environmental Specifications ………………………….44
A.4 Charging Specifications …………………………………45
A.4.1 AC-DC Adapter ………………………………………..45
A.4.2 Battery Specification ……………………………….45
A.5 Hardware Specifications …………………………………46
A.5.1 Display ……………………………………………..46
A.5.2 Audio Indicating …………………………………46
A.5.3 Button ……………………………………………..46
A.5.4 Sensors ……………………………………………..47
A.6 Specifications …………………………………………….47
A.6.1 Digital SpO2 ………………………………………48
A.6.2 Alarm limit specifications …………………………..48

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Appendix B EMC ………………………………………………….....50
Appendix C Factory Defaults ……………………………………….52
C.1 Alarm Setup ……………………………………………...52
C.2 Alarm Type Setup ………………………………………..52
C.3 System Setup……………………………………………...52
C.4 Work Type Setup ……………………………………………...53
Appendix D Alarm Message………………………………………..54
D.1 Physiological alarm ………………………………………54
D.2 Technical alarm ………………………………………………54

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Chapter 1 General Introduction
1.1 Intended Use
The AH-TX handheld pulse oximeter is intended for continuously monitoring
or spot checking peripheral oxygen saturation (SpO2) and pulse rate (PR) for
adult, pediatric or neonatal patients.
This device can be used in professional institutions or units with health care
capability. This includes outpatient departments, emergency rooms and
departments of internal medicine in hospitals, ordinary departments in
clinics, nursing hospitals and community medical institutions.
1.2 Main Unit
1.2.1 Front & Rear View
1. Display screen
The Display screen is a 4.3 inch TFT LCD with touch
Fig 1-1 Front & rear view of the oximeter

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function. Users can operate all functions through the touch
interface.
2. Speaker
3. Battery case
1.2.2 Side View
1.3 Display Views
1. SpO2 probe connector
2. Charger connector / Data download connector
3. Power button
This device features an automatic display rotation, which allows vertical and
horizontal positioning of the screen, to maximize space utilization and
visibility.
1.3.1 Large Numeric Display Mode
Fig 1-3 Side view of the oximeter

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1. PA: It is show the pulse amplitude, similar the PI.
2. SpO2(%): Display the SpO2 unit.
3. SpO2 parameter area: Current SpO2 value and its high and low alarm
are displayed in this area.
4. Plath bar: Pulse intensity is indicated by the number of stacked blocks
visible.
5. Alarm status area: Alarm status symbols and alarm pause time are
displayed in this area.
6. Menu: Directly after startup, 【Menu】shown here，is the function
controlled by the left hand button. When appropriate, press the left
button to enter 【Menu】.
7. Information: It’s show the manufacturer information.
8. PPG wave: It’s show the PPG waveform while press the symbol.
9. Heart icon: It will flash with the heartbeat.
10. Battery symbol: This symbol indicates the remaining quantity of
Fig 1-4 Big numeric display mode

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electrical charge in the batteries.
11. HR parameter area: Current heart rate (HR) value and its high and low
alarm are displayed in this area.
12. HR(bpm): Display the heart rate unit.
13. System time: Current time is shown in the area.
1.3.2 SpO2 Waveform Display Mode
1. SpO2 parameter area: Current SpO2 value and its upper and lower alarm
are displayed in this area.
2. PPG waveform area: The waveform shown in this area illustrates the
current PPG curve of the patient being monitored.
3. PR parameter area: Current PR value and its upper and lower alarm are
displayed in this area.
Fig 1-5 SpO2 waveform display mode

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Chapter 2 Safety
2.1 Safety Information
Warning:
Explosion hazard: Do not use the oximeter in an environment
with flammable gases.
Do not use the product in the presence of high power appliances
such as high voltage cables, X-ray machines, ultrasound
equipment or defibrillator.
Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and moisture.
The device is not designed for use in a sterile field.
The oximeter should be handled with care so as to avoid it
getting knocked or falling.
Do not use this device during defibrillation.
When the device is in use, ensure that the batteries have
sufficient charge remaining; otherwise start-up abnormalities
may occur or the measurement data may be inaccurate.
Patients must not wear nail varnish while using the pulse
oximeter as this will lead to unreliable SpO2 measurements.
Measurements and pulse signals can be affected by certain
environmental conditions, errors in applying the probe, and
certain patient conditions. See the appropriate sections of this
manual for specific safety information.
The physiological data and alarm messages displayed on the

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monitor are for reference only and cannot be directly used for
diagnostic interpretation.
The use of accessories, probes, and cables other than those
specified may result in increased emission, low anti-disturbance
and/or may lead to the oximeter producing invalid readings. It
is advisable to check the oximeter at least once a month.
Do not use to measure the patient while charging the battery.
The battery should only be replaced by a service technician with
a screwdriver and keep the hands dry.
Inserting a specific type of battery that is not supplied by the
manufacturer or replacement of lithium batteries by
inadequately trained personnel could result damage to device.
Do not open the monitor housings; electric shock hazard may
exist.All servicing and future upgrades must be carried out by
the personnel trained and authorized by manufacturer only.
Caution: In order to obtain accurate results, the oximeter
should be used in a quiet and comfortable environment.
2.2 Explanation of Interface Symbols
Symbol Symbol Note
Alarm volume pause
Menu button
Wave enable/disenable
Home button, back to the main page

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Symbol Symbol Note
Increase/Up button
Decrease/Down button
Back to previous page
Next page
Previous page
Battery indicator
Battery in charge
Bluetooth connection indicator (AH-TB only)
Cancel selection
Conform selection
Information button, show the manufacturer information

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Chapter 3 Basic Operations
3.1 Unpacking and Checking
Open the package. Take out the oximeter and its accessories. The following
parts are provided in the package:
Parts Standard Quantity
SpO2probes √1
User’s manual √1
AC-DC Class II adapter (MPU15-102) √1
3.2 Getting Started
1. Before using the oximeter to take measurements for the first time, carry
out the following checks on the oximeter and all connected modules:
— Check for any mechanical damage;
— Check for correct connection between of all the external cables and
accessories.
2. Make sure that the battery has sufficient power. For the first time use,
you must charge the battery, first, following the instructions given in
the Battery chapter.
Warning:
If the oximeter is mechanically damaged, or if it is not working
properly, do not use it on a patient for any monitoring procedure.
Contact your service personnel.

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To avoid the risk of explosions, do not use the oximeter in the
presence of flammable anesthetics, vapors or liquids.
3.3 Starting the oximeter
Press the power button to turn on the pulse oximeter, the startup screen
appears and show the software version at the bottom right. Enter the main
screen, the alarm indication should light up and system should give a beep.
After starting the oximeter you can change the settings for more convenient
use, as shown in section 3.4. Enter the main screen, the alarm indication
should light up and system should give a beep. After starting the oximeter
you can change the settings for more convenient use, as shown in section 3.4.
3.4 General Setup
Press the menu button to enter【Menu】, then select【System Setup】to
enter the system setup menu shown as follows. You can set parameters for the
following functions: