Healthwear Technologies TS101 User Manual

Flexible thermometer

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DOCUMENT NUMBER : PCP-FR-416-B

User Manual

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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 Technologies (changzhou) Ltd.

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Page 1 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 Technologies (changzhou) Ltd.
Page 2 华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. User Manual Flexible Thermometer Healthware Technologies...
Page 3: Table Of Contents
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 &...
Page 4 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...
Page 5: Convention
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;...
Page 6: Charpter1
Healthwear Techonologies (Changzhou) Ltd. Charpter1 1.1 Introduction Welcome to Use Flexible Thermometer Product Name: Flexible Thermometer Product Model: TS101 “Thermometer” thereafter） and a Product Composition:“Flexible Thermometer” (called Mobile App (called “TempSense” thereafter）  Flexible Thermometer，a electronic device of measuring the body temperature.
Page 7: Product Registration Information
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...
Page 8: Application
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.
Page 9: Charpter2
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.
Page 10: Attention
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. ...
Page 11: Charper3
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.
Page 12 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...
Page 13: Operating Instructions
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”...
Page 14: Normal Body Temperature
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. 3.3 Normal body temperature Celsius Fahrenheit Normal temperature Body temperature /Years /℃ /℉ can vary by: can be raised by -age -physical activity 34.7-37.2 94.6-99.1 -person -eating -time of day (often -strong emotions highest in the evening) -menstruation 3-10 35.9-36.7...
Page 15 华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. lower than properly with the sensors in the positioned in the armpit as expected. armpit as shown in instructions shown in the instructions for for use. use. 2. The device is exposed to cold 2. Hold the arm tight against the ambient temperatures.
Page 16: Mobile App (Tempsense)
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. ...
Page 17: Log In
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 ...
Page 18: Data Display
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...
Page 19: Smart Reminder
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.
Page 20: Charper4
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 ℃.
Page 21: Guidance And Manufactyurer's Declaration-Electromanetic
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. IEC 61000-3-2 directly connected to the public low-voltage power supply network that Voltage fluctuations/flicker Not applicable supplies buildings used for domestic emissions purposes. IEC 61000-3-3 4.1.3 Guidance MANUFACTYURER’S declaration-ELECTROMANETIC IMMUNITY-for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration –...
Page 22: Guidance And Manufactyurer's Declaration-Electromanetic
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. （30% dip in ） for 25 cycle <5% （>95% dip in ） For 5 s Power frequency magnetic fields Power frequency should be at levels (50/60 Hz) 30 A/m 30 A/m characteristic of a typical Magnetic field location in a typical commercial IEC 61000-4-8...
Page 23: 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
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. where p is the maximum output power rating of the transmitter in watts (W) according transmitter manufacturer and d is the recommended separation distance in meters (m) . Field strengths from fixed transmitters as determined electromagnetic site survey , should be less than the compliance level in...
Page 24 华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. Rated maximum Separation distance according to frequency of transmitter output power of transmitter 150kHz~80MHz 80MHz~800MHz 800MHz~2.5GHz d=1.17 d=1.17 d=2.33 0.01 Not applicable 0.12 0.23 Not applicable 0.38 0.73 Not applicable 1.17 2.33 Not applicable 3.70 7.37 Not applicable 11.67...
Page 25: Charpter5
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. Charpter5 5.1 Symbols attention！look up random file Single-use Radiation ROHS No littering IP22 Waterproofing grade 5.2 Maintenance & Preservation  No need for routine maintenance and calibration.  Life time：2 year , single-use\non-sterile.  Battery model： 3654, 3.0V, single-use. ...
Page 26: Preservation& Transportation
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. 5.3 Preservation& transportation  Store at temperatures of -10℃～+60℃, with humidity of 10%-95% and barometric pressure of 700HPa～1060HPa；  In the process of transportation, should avoid fall\rain\snow. 5.4 Recall If any adverse event, we should investigate the reason in time, and complete report of the investigation, analysis and disposal result.
Page 27: Charpter 5 Disclaimer
华健医药科技（常州）有限公司 Healthwear Techonologies (Changzhou) Ltd. Charpter 5 Disclaimer Copyright of this manual belongs to Healthwear Technologies (changzhou) Ltd. Without prior written permission, no company or individual is allowed to reproduce, copy, or translate this manual or any information contained therein...