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15. Standard list

Shenzhen PACOM Medical Instruments Co., Ltd declares that the

PC868 complies with following applicable standards:

EN ��
EN ��

EN ��-�

EN ��-�-�

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EN ��-�

ISO ��-�-��

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EN ISO ��-�

Symbols for use in the labeling of medical devices
Information supplied by the manufacturer with medical
devices
Medical electrical equipment Part �: General requirements
for basic safety and essential performance
Medical electrical equipment -- Part �-�: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and tests

Medical electrical equipment ‒ Part �-��: General
requirements for basic safety and essential performance ‒
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in home
healthcare environment

Clinical thermometers ‒ Part �: Performance of infra-red
ear thermometers (with maximum device)

Medical devices ‒ Application of usability engineering to
medical devices
Biological evaluation of medical devices - Part �: Evaluation
and testing within a risk management process

Medical electrical equipment part �-��: particular
requirements for basic safety and essential performance of
clinical thermometers for body temperature measurement
Medical device software - Software life-cycle processes

Medical electrical equipment ‒ Part�-�: General
requirements for basic safety and essential performance ‒
Collateral standard: Usability

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Содержание PC868

Страница 1: ...Please read this manual before use Body Infrared Thermometer User s Manual ...

Страница 2: ...rinciples All objects above absolute zero temperature emits certain percentage of infrared radiation energy based on its temperature The amount of the radiation energy and the distribution of the wavelength have very closely relationship When human forehead s temperature in 36 37 it emits wavelength 9 13um of infrared radiation Based on this principle according to the relationship between surface ...

Страница 3: ...ld choose the average We recommend that you measure yourself continuously maximum of three in a unit of time and because the temperature of the human will conduct to the thermometer it may aﬀect the accuracy of measurement There is no absolute standard about the temperature of the human so please try to collect the recording of Individual temperature in the usual as a reference for having a fever ...

Страница 4: ...erature in strong electro magnetic interference environment such as microwave high frequency equipment operation environment Do not disassemble repair or modify the unit This thermometer only a personal device please do not user with others Not touch the battery output when measuring The thermometer must be stored according to the technical speciﬁcations The materials ABS of expect contact with pa...

Страница 5: ...e and range description The infrared thermometer has the following measurement mode 1 Forehead temperature measurement mode measure the skin surface of human forehead s temperature accurately take the place of traditional mercury thermometer and electrical thermometer 2 Object temperature measurement mode you can measure the surface temperature of object such as ambient bathwater and milk temperat...

Страница 6: ...ic data hold and auto power save Automatic selection range and display resolution 0 1 0 1 3 colors backlight 2 measurement mode Forehead and surface mode 1 IR sensor 3 Mode selection 5 UP button 7 Measurement Trigger 2 LCD display 4 Down button 6 Mode button 8 Battery cover 6 Overall description 5 ...

Страница 7: ...here are problems LCD will display Err symbol Check if the sensor laser is dirty damaged phenomenon 4 In order to make the accurate measuring result put the thermometer in the measurement environment for 30 minutes 5 Accuracy of unexpected ﬂuctuations in ambient temperature may decrease the measurement results When the thermometer at the same measurement position display at diﬀerent ambient temper...

Страница 8: ...as follows 2 Use 1 Install batteries Instruction for use 1st step Take the temperature of a person using a conventional thermometer you will get 37 5 99 5 for instance 2nd step Take the temperature of the same person using the device keeping the 3 to 5cm distance between the thermometer and forehead take care to remove any obstacle which could alter the measurement hair perspiration If you get 37 ...

Страница 9: ... the forehead when measuring It is normal that there may be temperature difference depending on various skin types and color since different skin type will reflect different voltage of infrared ray Don t use the thermometer outdoors 6 Select object mode for measuring room temperature surface temperature etc TEMPERATURE TAKING HINTS For heat insulated object please don t measure the surface For the...

Страница 10: ...1 DOWN to reduce it by 0 1 0 1 The alarm threshold default value is 38 0 100 4 3 F3 Set difference Press MODE button for 2 seconds the screen display F1 press two times to get F3 select UP to increase the difference by 0 1 0 1 DOWN to reduce it by 0 1 0 1 In the case of seasonal or environmental changes a verification and adjustment should be carried out Note This function is only effective body 4...

Страница 11: ...ut the mode selection button on the right measurement range 0 to 100 32 0 to 212 0 6 3 colors backlight In body mode the device is able to judge whether a fever or not by different color of backlight 32 0 to 37 4 86 0 to 99 3 Green 37 5 to 37 9 99 5 to 100 2 Orange 38 0 to 43 0 100 4 to 109 4 Red In surface mode the backlight always keeps green 7 Data memory Date memory automatically after tempera...

Страница 12: ...ment exceed the 10 40 range will be showing Err 2 If the measured temperature result is 32 0 the LCD will be showing Lo 3 If the measured temperature result is 43 0 the LCD will be showing Hi 4 If the measured temperature result is 38 0 the buzzer will be send out Beep Beep Beep a long one and two short ones 5 We recommend measurement for 3 times to reference and keep the interval between the two ...

Страница 13: ...restore up to 99 sets data the query interface can display memory serial number body mode and recorded tempera ture values Remark The temperature result of surface mode can not be saved And the abnormal body temperature result can not be saved too such as Lo Err or Hi 7 Backlight function The backlight will be according to the diﬀerent measuring temperature to lighting diﬀerent color The detailed ...

Страница 14: ...tery installment and replacement 1 When the quantity of electric charge is not suﬃcient the icon of low battery will appear on the lower part of the screen Though the battery still can be used it would be perfect to replace it 2 When the quantity of electric charge of the battery is lower than the minimal value Lo symbols will be displayed on the screen and battery icon ﬂashes and the sound of Bee...

Страница 15: ...cts have any questions please contact the manufacturer or distributor to handle the case 2 The user must not attempt any repairs to the device or any of its accessories Please contact the retailer for repair 3 Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty 9 Maintenance The thermometer is initially calibrated at the time of manufacture If ...

Страница 16: ...r conditioner Lo Less than In the object measurement mode The measuring distance is too far Have water vapor condenses on the lens Lo Less than The ambient temperature is beyond of range of measurement The sensor or hardware is damaged Lower battery however you can t use it Replace the new battery Keep the thermometer in the room Whose Temperature is for minutes Excluding the possibility of temper...

Страница 17: ... part Mode of operation Measuring range Measuring accuracy At laboratory conditions Infrared Thermometer PC Forehead and object temperature modes d c V pcs AAA battery Within Relative humidity KPa Relative humidity KPa L W H mm Approx g including battery IP Internally powered ME equipment Type BF applied part including the whole unit Continuous operation For forehead temperature For object surface...

Страница 18: ...quirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in home healthcare environment Clinical thermometers Part Performance of infra red ear thermometers with maximum device Medical devices Application of usability engineering to medical devices Biological evaluation of medical devices Part Evalua...

Страница 19: ...ation The manufacturer is Shenzhen PACOM Medical Instruments Co Ltd IP 16 Disposal 17 Normalized symbols Dispose of the device in accordance with the regulation applicable at the place of operation Dispose of at public collection point in the EU countries 2002 96 EC WEEE Directive If you have any queries please refer to the local authorities responsible for waste disposal To protect the environmen...

Страница 20: ...e guarantee after the date of purchase for one year Any damage caused by improper handling shall not be covered by the guarantee Batter and packaging are also excluded from the guarantee All other damage claims excluded A guarantee claim must be submitted with the purchase receipt Please pack your defective instrument well and send with suﬃcient postage to the distributor 18 EMC DECLATION 19 Guara...

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