Healthwear Technologies TS101 User manual

Brand: Healthwear Technologies

Model: TS101

Category: Digital body thermometers

Type: User manual

Healthwear Technologies TS101 is a flexible thermometer that can be used to measure human axillary temperature of adults and children (aged two years old and up) continuously and transmit the results via wireless signal. It has 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. The device can store up to 24 hours of readings. The data can be transmitted to a mobile app called TempSense via wireless 2.4G Bluetooth BLE.

华健医药科技（常州）有限公司

Healthwear Technologies (changzhou) Ltd.

DOCUMENT NUMBER : PCP-FR-416-B

[User Manual]

Flexible Thermometer

TS101

Written by: Date: 2016-6-22

Reviewed by: Date: 2016-6-22

Approved by: Date: 2016-6-22

华健医药科技（常州）有限公司

Healthwear Techonologies (Changzhou) Ltd.

User Manual

Flexible Thermometer

Healthware Technologies

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.

Convention

“Notes”offer important information and explanation;

“Attentions”prompt your device may be damaged;

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

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.9 Connection

1. Make sure ID printing on package consistent with ID searched by Bluetooth

3.5.4 Data display

 View the temperature curve at any time

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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Healthwear Technologies TS101 User manual

Brand: Healthwear Technologies

Model: TS101

Category: Digital body thermometers

Type: User manual

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Healthwear Technologies TS101 User manual

Healthwear Technologies TS101 User manual

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