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MinttiHealth Coola Instructions For Use Manual

Continuous monitoring thermometer

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Instruction For Use
Continuous Monitoring
Thermometer
■ Version:A0
■ No:WI-Coola-0014
■ Release Date: 2018/09/12
Suzhou Melodicare Medical Technology Co., Ltd.
Model: Coola
I

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Summary of Contents for MinttiHealth Coola

  • Page 1 Instruction For Use Continuous Monitoring Thermometer Model: Coola ■ Version:A0 ■ No:WI-Coola-0014 ■ Release Date: 2018/09/12 Suzhou Melodicare Medical Technology Co., Ltd.
  • Page 2: Table Of Contents

    Contents 1.Foreword..................1 2.Product Ddescription..............3 3.Preparation before use..............4 4.Instructions................11 5.Maintenance and Cleaning............24 6. Appendix...................27...
  • Page 3: Foreword

    1. Foreword Thank you for purchasing the Continuous Monitoring Thermometer. In order to use the product safely and correctly, please read the instructions carefully before use. Before use, please check whether the accessories are complete according to the packing list, and check whether there is any breakage and damage to the product appearance and buttons.
  • Page 4 Measurements will become abnormal right after  the sports activities, diet, and bathing. Having a rest before taking the measurement.  Ensuring thermometer measuring under proper  and required conditions. The measuring results should not be based solely  on personal experience but duly constancy with professional physicians Warning Do not use this product in the environment of...
  • Page 5 Children of this product must be under the guardian of adults The electronic thermometer has been ex-factory  calibrated, do not calibrate it by yourself, but contact the  factory for any calibration in need. The equipment or system shall not be used close ...
  • Page 6 ambient temperature, the measurement may not be accurate. Attention The Electronic Thermometer conforms to the  related requirements of electromagnetic compatibility of IEC60601-1-2 standard. Users shall install and use the electromagnetic  compatibility information provided in the accompanied files with the sale of this product Avoid strong magnetic interference sources such ...
  • Page 7: Product Ddescription

    2. Product description 2.1 Product name and model Product Name: Continuous Monitoring Thermometer Product model: Coola 2.2 Expected usage The electronic thermometer is suitable for measuring the body temperature under the armpit 2.3 Indications for Use...
  • Page 8 Side effects: Skin rash or reaction due. Patient Profile: All patients(age: more than 3 months) who meet indications but do not meet contraindications. User profile: There is no specific user identification for the device. It can be used by experts or non-specialists in accordance with the conditions specified in the user manual.
  • Page 9 Description Electronic Thermometer Model Coola Voltage d.c.3.0V(lithium battery CR2016) Temperature Sensor thermistors Measuring Method actual measurement Measuring Position armpit Temperature Display 3-digital display Model Measuring Accuracy lower than 35.3℃±0.3℃; 35.3℃~36.9℃±0.2℃; 37.0℃~39.0℃±0.1℃; 39.1℃~41.0℃±0.2℃; Higher than 41.0℃±0.3℃。 Measuring Range 33℃~45℃ Measuring Time...
  • Page 10 pressure Transit and 50~106kPa storing air pressure Overall Dimension 38mm×38mm×4mm Product life expectancy 3 years Battery life expectancy 5 years Typical usage time 120h Electric Shock internal power supply ,type B Protection application Disinfection as per recommended cleaning by the manufacturer and Sterilization Method Safety Classification Don't use in the presence of a...
  • Page 11: Preparation Before Use

    comprises mainly the control circuit, battery and temperature detector. 3. Preparation before use 3.1 Open box to check Please check the box carefully before unpacking.If you find any damage, please contact the carrier or the company immediately.If the package is complete, unpack the package in the correct way and carefully remove the device and other components from the box.
  • Page 12 would it be possible for users to obtain right measuring figures. Please follow the measuring procedures well (1) log in HTTP: select "download center" to download the corresponding mobile application.。 (2) battery installation or replacement: open the battery compartment of the thermometer and mount the battery onto the compartment door .
  • Page 13 download and install the APP Figure 2 APP download QR code 2) Open the temperature stick app on the phone, enter the login interface, and register an account to set a password...
  • Page 15 3)Click Settings...
  • Page 16 4)Here are the following functions...
  • Page 17 5)Press and hold the button of the temperature sticking device to boot, enter the APP homepage, pull down and bind the temperature sticking device...
  • Page 18 6)Turn on Bluetooth and bind the device...
  • Page 19 7)Set the alarm temperature and select the alarm prompt method...
  • Page 20 8)Clamp the thermometer directly under the armpit, or prepare medical tape to fix the thermometer under the armpit so that the metal temperature sensor points to the armpit. 9)And click to start measurement according to the instructions of the mobile app The measured temperature is as follows: When the measured value is stable, the mobile application will trigger vibration / sound and display “End Measurement”...
  • Page 22 10)View measurement records: ※ Please do not rely on your own experience, but to accept the doctor's advice you have ever, you can view the help 4.2 General Settings for Mobile Applications (1) temperature display unit is ℃, resolution is 0.1℃.
  • Page 23 (2) when the temperature point is stabilized, the measuring mode changes from "measuring" to "measuring ended". (3)Variable Settings: reminder , medicine -taking, parameters , account and about us .etc. (4)Reminder setting: the system default temperature setting at 37.5℃, and users can set optional temperature range between 37.0℃...
  • Page 24: Maintenance And Cleaning

    5. Maintanance and Cleaning 5.1 Cleaning and maintenance Wipe the dirt on the thermometer with a soft dry cloth before and after each use. If the dirt is more serious, please wring and wipe the cloth soaked with water or neutral detergent first, then wipe the dirt on the thermometer with a soft cloth.
  • Page 25 analysis Temp sensor is Position the temp Valued off the center of sensor in the armpit measured armpit during the center with sensor some lower measurement toward armpit and tight clamp The thermometer Do not raise up your is taken out arms often or take during the the thermometer out...
  • Page 26 Indicator Battery Install the battery installation error correctly poor battery Replace battery at once Undiscover Bluetooth signal Shut off the able in the too weak thermometer and add list of the device after devices rebooting 5.4 Warranty Services This thermometer conforms to all of the requirements established in ASTM Standard E 1112.
  • Page 27: Appendix

    1 Guidance and manufacturer´s declaration – electromagnetic emission The model Coola is intended for use in the electromagnetic environment specified below. The customer or the user of the model Coola should assure that it is used in such an environment. Electromagnetic 3 Emissio Complianc environment –...
  • Page 28 the public low-voltage power supply network that supplies buildings used for domestic 61000-3-2 purposes. Voltage fluctuation flicker emissions applicable 61000-3-3...
  • Page 29 Guidance and manufacturer´s declaration – electromagnetic immunity The Model Coola are intended for use in the electromagnetic environment specified below. The customer or the user of the Model Coola should assure that it is used in such an environment. Electromagneti Immuni...
  • Page 30 voltage 135°,180°, variation 225°, 270°, and 315° on power supply 0 % UT input (100 % dip in lines UT ) for 1 cycle at 0° 61000-4- 70 % UT (30 % dip in UT ) for 25/30 cycles at 0° 0 % UT (100 % dip in UT )
  • Page 31 Guidance and manufacturer’s declaration – electromagnetic immunity The Coola is intended for use in the electromagnetic environment specified below. The customer or the user of the Coola should assure that it is used in such an environment. Immunity IEC 60601 Compl...
  • Page 32 manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range...
  • Page 33 The Model Coola is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model Coola can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications...
  • Page 34 1.11 2.22 11.7 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 35 Recommended separation distances between RF wireless communications equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 36 Where P is the 1970 maximum output power rating of the 2450 ransmitter in watts (W) 5240 according to the transmitter manufacturer 5500 and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitter, as determined by electromagnet ic site survey,...
  • Page 37 Share Info Consultant Service LLC Repräsentanzbüro Address: Heerdter Lohweg 83, 40549 Düsseldorf Tel:0049 1767 0057022 Email: eu-rep@share-info.cn; info@share-info.cn; Suzhou Melodicar e Medical Technology Co., Ltd. Room 301, Building F2, No.32 Hongxi road, Suzhou high-tech zone, Jiangsu province, China Email: fay@minttihealth.com www.minttihealth.com...