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1

Copyright Statement

 

The copyright is reserved by Comper Chuangxiang

（

Beijing

）

Technology Co., Ltd, which enjoys 

and retains all the exclusive rights of copyright according to law.  No part of this document may be 

modified, excerpted, reproduced, or otherwise, in any form without prior written permission of the 

company. 

Regarding the contents of this document, the company assumes no express or implied warranties or 

guarantees. The company reserves the power of interpretation for any changes arising from product 

improvement and technological updating. 

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Summary of Contents for IR-FT

Page 1: ...1 21 User Manual of Infrared Forehead Thermometer Model IR FT Comper Chuangxiang Beijing Technology Co Ltd ...

Page 2: ...ions precautions warnings and prompts 10 1 Contraindications 10 2 Precautions 10 3 Warnings 10 8 Maintenance cleaning repair and maintenance period 11 9 List of accessories 12 10 Interpretation on the contents such as figures symbols and abbreviations used by the medical device labels 12 11 Troubleshooting 13 12 Clinical accuracy 14 13 Statement 14 14 Description on the replacement cycle and metho...

Page 3: ...t Beijing Economic Technological Development Area Beijing Address of manufacturing site Room 102 103 F1 Building 4 No 1 Kangding Street Beijing Economic Technological Development Area Beijing Contact information of manufacturer 86 10 57480968 Production date See the labels Batch No Serial No of product See the labels Service life 3 years After sales service unit Comper Chuangxiang Beijing Technolo...

Page 4: ... for intermittent determination of human body temperature in a touch on the center of the forehead as the measurement site on people of all ages This device can be used in clinical hospital and home 4 Structural composition The product is mainly composed of a temperature sensor a housing a circuit board and a battery compartment 5 Name of components As shown in Figure 1 the product is composed of ...

Page 5: ...erature display range 32 0 43 0 89 6 109 4 Maximum allowable error 0 2 0 4 for the range 35 42 95 107 6 0 3 0 5 for the range 32 34 9 89 6 94 8 and 42 1 43 107 8 109 4 Clinical repeatability 0 3 0 5 Temperature unit Display resolution 0 1 0 1 Operating environment Temperature 10 40 50 104 Relative humidity 95 Atmospheric pressure 70 kPa 106 kPa Power supply conditions internal DC power supply D C ...

Page 6: ...ing to the degree of protection against liquid ingress IP22 4 Classification according to the safety degree of the product used in the flammable anesthetic gas mixed with air oxygen or nitrous oxide This equipment shall not be used in the flammable anesthetic gas mixed with air oxygen or nitrous oxide 5 Classification according to the mode of operation Continuous operating equipment 6 Power supply...

Page 7: ...nts e g dry batteries and the hosts reaching the end of service life according to the local laws and regulations Precautions 1 When opening the battery cover to replace the batteries pay attention to the positive and negative poles Dying batteries should be removed immediately Incorrect mounting will cause damage to the product 2 In long period storage please remove the batteries to prevent damage...

Page 8: ...d body temperature judgment Ensure that the temperature measuring probe of Forehead Thermometer is in full contact with the center of forehead Lightly press the Power Temperature Measurement Button The measurement is completed after hearing a long Click sound The LED will display the temperature measurement result The next measurement can be performed after hearing a short Click sound Sleep Wakeup...

Page 9: ...o use 11 In case of forehead sweating or other circumstances that the forehead temperature cannot reflect the body temperature normally for other reasons please measure behind the earlobe 12 When cleaning is required gently wipe the surface of probe with alcohol 13 In case of any problem with the product please contact the company at 010 57480968 Do not try to repair it by yourself 14 Please do no...

Page 10: ...airflow such as air outlet of fan and air conditioner etc Do not use the device outdoors or under strong sunlight Do not hold the front end of thermometer while measuring The measurement site cannot be covered by hair In case of any sweat stain wipe clean with a dry towel before measuring Otherwise it will affect the measurement result The measurement result will be lower after taking cooling meas...

Page 11: ...n at the end of the cleaning step the user should either repeat the relevant previous cleaning steps or safely dispose of the device so that a visibly soiled device is not used again 1 Please clean and maintain the product as follows Step 1 Power off the thermometer by switch Step 2 Examine the thermometer for visual contamination Step 3 Wipe with a soft cloth dipped with 70 isopropyl alcohol unti...

Page 12: ...infection procedures After each use of the product wipe clean the dirt place with a clean soft cloth or wipe clean the surface of product and the probe with a soft cloth soaked with 75 volume ratio ethanol solution 9 List of accessories In case of any inconsistency between the physical object and the following information please contact the manufacturer No Accessory Quantity 1 Forehead Thermometer...

Page 13: ...ited emotion Excited emotion can rise the facial temperature Please make measurement after the measured object gets calm Lower measurement result Body sweating Do not use the product after swimming bathing or sweating after exercise because the skin temperature will drop in such circumstances Wipe off water and wait for 30 min before measuring The probe is dirty Please clean the probe with soft co...

Page 14: ...n s skin color thickness and body part and great changes of ambient temperature the measured body temperature valueswill be different which is quite normal The reason is that the body parts more frequently exposed to the external environment will be more affected by the ambient temperature 13 Statement The product is intended to measure heat radiation from the forehead to display body temperature ...

Page 15: ...orehead Thermometer Therefore during use the product should be kept away from electromagnetic interference resources such as mobile phones and microwave ovens etc See details of guidance and manufacturer s statement in the subsequent Guidance and Manufacturer s Statement Warnings IR FT Infrared Forehead Thermometer shall not be used adjacent to or stacked with other equipment and if adjacent or st...

Page 16: ...d in such an environment Immunity test IEC 60601 Test Level Compliance level Electromagnetic environment Guidance Electrostatic discharge IEC61000 4 2 6 kV contact discharge 8 kV air discharge 6 kV contact discharge 8 kV air discharge Floors shall be wood concrete or ceramic tile If floors are covered with the synthetic material the relative humidity should be at least 30 Electrical fast transient...

Page 17: ...loser to any part of IR FT Infrared Forehead Thermometer including cables than the recommended separation distance The distance shall be calculated according to the formula applicable to the frequency of the transmitter Recommended separation distance d P 2 1 d P 2 1 80 MHz 800 MHz d P 3 2 800 MHz 2 5 GHz where P The maximum rated output power of the transmitter in watts W according to the transmi...

Page 18: ...intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The buyer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the equipment or system according to the maximum rated output power of the communication equipment Maximum rated output power of t...

Page 19: ... following standards IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance ISO 80601 2 56 Medical electrical equipment Part 2 56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ASTM E 1965 98 2016 Standard specification for infrared thermometers for in...

Page 20: ...interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the rece...

Page 21: ... to law No part of this document may be modified excerpted reproduced or otherwise in any form without prior written permission of the company Regarding the contents of this document the company assumes no express or implied warranties or guarantees The company reserves the power of interpretation for any changes arising from product improvement and technological updating ...

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