华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
C a t a l o g u e
Convention ........................................................................................................................................ 5
Charpter1......................................................................................................................................... 6
1.1 Introduction ......................................................................................................................... 6
1.2 Product Registration Information ........................................................................................ 7
1.3 Technical Specifications ...................................................................................................... 7
1.4 Application .......................................................................................................................... 8
Charpter2......................................................................................................................................... 9
Warning & Attention ..................................................................................................................... 9
2.1 Warnings ............................................................................................................................. 9
2.2 Attention ............................................................................................................................ 10
Charper3......................................................................................................................................... 11
Get Ready for Flexible Thermometer ..................................................................................... 11
3.1 Getting Started .................................................................................................................. 11
3.2 Operating Instructions ....................................................................................................... 13
3.3 Normal body temperature ................................................................................................. 14
3.4 Questions & Solutions ...................................................................................................... 14
3.5 Mobile App (TempSense) ................................................................................................. 16
3.5.1 Registration ..................................................................................................... 16
3.5.2 Log in ................................................................................................................. 17
3.5.3 Connection ......................................................................................................... 17
3.5.4 Data display ..................................................................................................... 18
3.5.5 Smart Reminder ................................................................................................. 19
Charper4......................................................................................................................................... 20
4.1 EMC .................................................................................................................................. 20
4.1.1 Illustration .............................................................................................................. 20
4.1.2 Guidance and MANUFACTYURER’S declaration-ELECTROMANETIC
EMISSIONS-for all ME EQUIPMENT and ME SYSTEMS ..................................... 20
4.1.3 Guidance and MANUFACTYURER’S declaration-ELECTROMANETIC
IMMUNITY-for all ME EQUIPMENT and ME SYSTEMS ....................................... 21
4.1.4 Guidance and MANUFACTYURER’S declaration-ELECTROMANETIC
IMMUNITY-for ME EQUIPMENT and ME SYSTEMS that are not
LIFE-SUPPORTING ..................................................................................................... 22
4.1.5 Recommended separation distances between portable and mobile RF
communications equipment and the ME EQUIPMENT or SYSTEM-for ME
EQUIPMENT and ME SYSTEMS are not LIFE-SUPPORTING .................................. 23
Charpter5....................................................................................................................................... 25
5.1 Symbols ............................................................................................................................. 25
5.2 Maintenance & Preservation ............................................................................................. 25
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
5.3 Preservation& transportation ............................................................................................ 26
5.4 Recall ................................................................................................................................ 26
5.5 Declaration ........................................................................................................................ 26
5.6 EU Representative Contract .............................................................................................. 26
Charpter 5 Disclaimer ..................................................................................................................... 27
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
Charpter1
1.1 Introduction
Welcome to Use Flexible Thermometer
Product Name: Flexible Thermometer
Product Model: TS101
Product Composition:“Flexible Thermometer” (called “Thermometer” thereafter） and a
Mobile App (called “TempSense” thereafter）
Flexible Thermometer，a electronic device of measuring the body temperature.
See pictureb1(a)(b):
（a） Thermometer（Front）
（b）Thermometer（Back）
Pic.1 Flexible Thermometer
TempSense，App is compatible with Wireless 2.4G Bluetooth BLE enabled smart devices
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
running Apple operating system iOS 7.1 through 8.1 or Android operating system 4.3 through
4.4.4
See picture 2
Pic.2 Mobile App called TempSense
1.2 Product Registration Information
Manufacturer：Healthwear Technologies (Changzhou) Ltd.
Address: 203#, No.9-4,Taihu East Road, Changzhou, Jiangsu, China
Postcode: 213022
Phone: 0519-69813298
CE marking: XXXXX
1.3 Technical Specifications
Rang of measurement: 25 ~45℃;
Accuracy of measurement: 25 ~45℃,±0.1℃；
Temperature Unit: ˚C or ˚F
Working Voltage：Paper battery 3654,3.0V DC
Memory Function：store up to 24 hours of readings
Signal Transmission：Wireless 2.4G Bluetooth BLE
Valid Transmission: Up to 5 meters
Receiver: Minimum screen size: 4.0 inch（diagonal）; Apple operating system iOS 7.1 through
8.1 or Android operating system 4.3 through 4.4.4.
Normal mode：Continuously measures body temperature every 10 seconds. Up to 24 hours.
Intelligent mode: temperature measurement interval changes according to the use of the app
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
automatically. Up to 48 hours.
Operating Temperature: 5˚C ~ 40 ˚C
Operating Humidity: 15-85%
Measuring mode: Direct mode
1.4 Application
Flexible thermometer TS101 is a single-use battery-operated electronic device with an intended
use of measuring human axillary temperature of adults and children (aged two years old and up)
continuously and transmitting the results via wireless signal. It can be used in hospital and at
home.
Not suitable for ICU or other emergency situations.
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
Charpter2
Warning & Attention
When using this product always follow these basic safety precautions to insure that the patch
accurately reads temperature and to avoid skin irritation. Failure to follow these precautions
could result in inaccurate temperature readings resulting in delay in treatment, or could result
in skin irritation and mild discomfort.
2.1 Warnings
DO NOT use the patch for any other purpose besides measuring human body temperature.
DO NOT place the patch over wounds, sores or abrasions.
DO NOT excessively bend or twist the TesmpSense patch prior to application.
DO NOT use device together with MRI or CT equipment.
DO NOT immerse the patch in water. Patch may be removed for a bath or shower and then
re-applied afterwards.
DO NOT use the patch if it has been damaged or immersed in water.
DO NOT attempt to take apart the patch; there are no user serviceable parts.
DO NOT wear successive patches under the same arm. When removing one patch and
starting another, place the second patch on the other side of the body.
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
2.2 Attention：
Please consult a doctor when the device will use in the children under the age of 2.
A qualified doctor should make the diagnosis of clinical manifestation and symptoms,
with device as a subsidiary tool.
Please check device regularly to make sure that it is in firm contact with the skin.
Otherwise data may be inaccurate.
Careful to use when the alar skin is hurt.
Don’t use out-of-date device.
Please stop using immediately when the skin irritability.
Make sure to keep receiver charged when using it to monitor body temperature for a
long period of time。
Please upgrade APP when necessary.
The device is not sterile.
Store in a safety place where the children and baby can’t touch.
Radio frequency communication equipment may be affect the data reception.
For the most accurate results, make sure the device has been at room temperature for at
least 5 minutes before using it.
To ensure the measuring and monitoring process, we recommend to keep the smart
phone closer (less than 5 meters) to the patch, keep the app running in foreground, and
don’t use this phone to connect with other Bluetooth devices.
To avoid data losing, please do not update any software or operation system of the smart
phone while measuring and monitoring temperature.
If there’s any malfunction of your phone caused by hardware error, virus, other app fault,
or operating system fault, please change to a good phone.
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
Charper3
Get Ready for Flexible Thermometer
3.1 Getting Started
1. App Download（for the first time）
Download and install the TempSense App from Apple AppStore for iPhone or Google
Play Store for Android phone.
Or go to www.healthwear-tech.com, scan QR code to download and install.
Pic. 3 QR Code
2. Long press the key (more than 5 seconds), switches device on.
Pic.4 Press the key
3. Turn on the receiver and Bluetooth, establish a Bluetooth connection with TempSense.
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
Pic.5 Connection
1. Please register an account for the first time
4. Wear the device
Pic.6 Wear
1. Hold arm tight against side for at least 8 mins.
2. Shave armpits in advance. Make sure the area of skin in contact with the sticker is flat and
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
smooth.
3. Please act softly when ripping down the thermometer.
3.2 Operating Instructions
3.2.1 Frequent operations:
a) Turn on the receiver and turn on Bluetooth, making sure the receiver is connected.
b）Long press button 3 seconds to turn on the device.
c) Run mobile APP “TempSense”；(refer to “3.5 Mobile APP” instructions for details);
d）Wear the device.
3.2.2 Measurement and storage:
The device will continue to measure and store body temperature independently if the Bluetooth
connection fails during monitoring. The device will sync with the receiver automatically as soon
as the connection is restored. The device can store 24 hours of data. If you turn on the device
without wearing it and connecting to a receiver, the device will turn itself off automatically after
15minutes.
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
3.3 Normal body temperature
Age
/Years
Celsius
/℃
Fahrenheit
/℉
Normal temperature
can vary by:
Body temperature
can be raised by
2
34.7-37.2
94.6-99.1
-age
-person
-time of day (often
highest in the evening)
-physical activity
-eating
-strong emotions
-menstruation
-taking certain
medication
-being in an
environment with
high temperature or
humidity
-teething in young
children(but no
higher than 37.8 ℃)
-wearing heavy
clothing
3-10
35.9-36.7
96.6-98.0
11-65
35.2-36.9
95.3-98.4
>65
35.6-36.3
96.0-97.4
3.4 Questions & Solutions
Questions
Possible Reasons
Solutions
Device ID is not shown
in app when setting up
the device.
1. Device is not turned on properly.
2. Device is not within the range of
the wireless signal.
1. Press the button long enough
and keep the mobile closer to
the device, and retry.
2. Change to a new patch, and
contact Healthwear
Technologies representatives.
Device ID is shown in
app, but can’t be
connected.
1. The battery of the device might
be too low.
1. Change to a new patch, and
contact Healtwear
Technologies representatives.
App asks for reconnect
to the device.
1. The Bluetooth connection is
broken.
1. Keep the mobile app closer to
the device.
Temperature from the
1. The device is not positioned
1. Confirm the sensors are
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
app is lower than
expected.
properly with the sensors in the
armpit as shown in instructions
for use.
2. The device is exposed to cold
ambient temperatures.
positioned in the armpit as
shown in the instructions for
use.
2. Hold the arm tight against the
body for 10 minutes.
3. Confirm the body temperature
by measuring oral temperature
with a digital thermometer.
Temperatures from the
app is higher than
expected.
1. Device is not working properly.
1. Confirm the body temperature
by measuring oral temperature
with a digital thermometer.
No audible alert is
received from the
smart device when
the device is out of
range or when a
temperature alert is
generated.
1. Smart phone volume might be
muted or set too low.
2. Reminder settings might not set
properly in app.
1. Make sure the smart phone
volume is set an audible level
and is not set to mute.
2. Check the Reminder settings
to ensure the correct threshold
is set.
3. Note that the audible alert may
only sound for a short period.
The visual Reminder remains
active in the app until canceled
by the user.
No Reminder is
received when
temperature measured
by the patch exceeds
the user set Reminder
level.
1. The smart phone might be out of
the range of the patch.
2. App is not running.
1. Make sure the smart phone
running the app is in the range
of the patch.
2. Make sure the app is running.
No Reminder will be
generated if the app is not
running.
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
3.5 Mobile App (TempSense)
Features of mobile APP:
User registration and login.
Member management.
Scan and pair to TempSense.
Receive and store measurement data from TempSense.
Display the latest measurement data and history data in graph view.
High and low temperature Reminder settings.
Low battery indication.
Bluetooth disconnection Reminder.
Measurement unit: Celsius and Fahrenheit degree.
Please use app TempSense version 1.1.0 or later to operate with the patch.
3.5.1 Registration
Click on the App ”TempSense”
Though personal mobile phone or personal email to register
Pic.7 Registration Screen
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
3.5.2 Log in
Log in the App “TempSense”
Follow the instructions to create member information.
Pic.8 Log in
3.5.3 Connection
Turn on the Bluetooth, establish a Bluetooth connection with TempSense
Click “Searching for device”, begin to find the temperature ID
Select the ID
Confirm the connection between Bluetooth and TempSense
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
Pic.10 Display
3.5.5 Smart Reminder
Set High temperature reminder value and Low temperature reminder value
Background display in red and with sound when temperature is beyond set-point of High and
Low temperature
Low battery detection：The app should indicate the battery power level is low.
pic.11 High/low temperature setting
pic.12 High temperature reminder
华健医药科技（常州）有限公司
Healthwear Techonologies (Changzhou) Ltd.
Charper4
4.1 EMC
4.1.1 Illustration
a）Flexible Thermometer need special tips on the electromagnetic compatibility, and according to
the random file for electromagnetic compatibility information for installation and use instructions.
b）Portable and mobile RF communications equipment may affect the Flexible Thermometer.
c) Patients' physiological temperature range of 25-45 ℃.
1. Flexible Thermometer operated beyond the scope of physiological temperature range may
result in inaccurate results.
2. Flexible Thermometer should not be used with other equipment near or overlay, if used must
be close to or stacked, should observe the validation is its use of configuration can run normally.
3. Even if the other equipment conform to the requirements of emission, Flexible Thermometer
may be intervened.
4.1.2 Guidance and MANUFACTYURER’S declaration-ELECTROMANETIC
EMISSIONS-for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
The Flexible Thermometer is intended for use in the electromagnetic environment specified below.
The customer or the user of the Flexible Thermometer should assure that it is used in such an
environment.
Emission test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The Flexible Thermometer uses RF energy
only for its internal function. Therefore,
its RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The Flexible Thermometer is suitable for
use in all establishments, including
domestic establishments and those
Harmonic emissions
Not applicable
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