Maile M-2028 User manual

Infrared Thermometer User ManualMAILEJiangxi Maile Medical Device Co.,Ltd. Before the use, please carefully read the User Manual. Refer to the qualiﬁcation certiﬁcate or the packing box for the production date.Model:M-2028

1. Product Name Infrared thermometer 2. Model M-2028 3. Structure and ComponentsThe Infrared thermometer mainly consists of infrared sensor, LCD display screen, operation buttons, plastic shell, measurement button, battery bunker, circuit component and other parts.

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23456711234567LCD screeninfrared sensorPage down, Memory inquiryPage up, Memory inquiryFunction setting buttonMeasurement buttonBattery bunker4. Application ScopeThe infrared forehead thermometer is to measure the thermal radiation on the forehead to get the bo-dy temperature of someone.5.Main Performance5.1 Temperature display scope: Human body mode 32.0℃ ~ 42.9℃; 5.2 Maximal allowable error: Within the range of 35.0℃ ~ 42.0℃, the maximal allowable error is ±0.2℃, outside (35℃~42℃) ±0.3℃.5.3 Resolution: 0.1℃. -01-

6. Safety Characteristics 6.1 Classiﬁed by electric shock protection type: Int- ernal power class 6.2 Classiﬁed by electric shock protection degree: BF application part 6.3 Classiﬁed by protection degree of liquid inlet: ordinary equipment 6.4 Classiﬁed by the safety when it is mixed with in- ﬂammable anesthetizing gas mixing with air or mixed with anesthetizing gas mixing with : not applicable. 6.5 Classiﬁed by operation mode type: continuous operation 6.6 Rated voltage of the infrared forehead thermo- meter: DC3V (two No. 7 alkaline batteries)6.7 Input power of the equipment: not applicable 6.8 The infrared forehead thermometer doesn't have a part which is able to protect the deﬁbrillation discharge eﬀect. 6.9 The infrared forehead thermometer doesn't have the signal input or signal output. 6.10 The infrared forehead thermometer is a non-per- manent installed equipment.7.Product Characteristics7.1 Able to accurately measure the body temperature without contact. 7.2 Unit can be in ℃ or .℉ Setting method: When the infrared forehead ther- mometer is on, press the button “set” for 3 secon- ds, F1 will be displayed on the screen; press “-” to sele- ct , press “+” to select ℃. ℉7.3 Mode switch-over Setting method: When the infrared forehead ther- mometer is on, press the button “set” to switch over between “human body mode” or “object mode”. 7.4 The range can be selected automatically; the re- solution is 0.1℃ (0.1 ). ℉7.5 The infrared forehead thermometer is able to do self-inspection. Press the measurement button, all values and characters of self-inspection will be shown on the LCD display screen. 7.6 When the battery voltage is lower than d.c.2.0V -02-

±0.2V, low voltage sign will be displayed on the screen. 7.7 LCD display screen with backlight is able to be used in darkness. 7.8 The infrared forehead thermometer is able to me- morize 32 measurement values obtained recently. (When the infrared forehead thermometer is oﬀ, shortly press “+” to get into the memory mode to read the 32 measurement values obtained recen- tly).7.9 The data can be kept automatically. 7.10 The infrared forehead thermometer can be oﬀ automatically within 30s.8.Prohibitions No9.Tips, Warnings and Reminders9.1 Please carefully read this User Manual before the use. 9.2 The infrared forehead thermometer shall be used at a place whose environment temperature is 16℃ ~ 35℃, the best environment temperature is 25℃. 9.3 Do not use the infrared forehead thermometer at a place where the temperature is higher than 50℃ or lower than 0℃. 9.4 Do not get the infrared forehead thermometer c- lose to a electrical object, otherwise, the infrared forehead thermometer will get an electric shock. 9.5 Do not use this product at a place where the hu- midity is higher than 85%. 9.6 Do not get the infrared forehead thermometer close to the electromagnetic (like wireless radio and mobile phone etc.). 9.7 Do not put the infrared forehead thermometer under the strong sun, or close to the furnace. Do not get the infrared forehead thermometer contact with water. 9.8 Do not get the infrared forehead thermometer hit or fallen down. If it is damaged, do not use it. 9.9 The measurement accuracy will be adversely aﬀ- ected by the sweat, hair, hat or scarf on the fore- head. 9.10 The measurement distance shall be 1-10cm.9.11 If the infrared forehead thermometer needs to be cleaned, please clean the surface by alcohol gently. -03-

9.12 If there is a problem, please contact with the distributor but not repair it by yourself. 9.13 Do not measure the body temperature when the environment temperature changes a lot. 9.14 The protective glass outside the crystal frame work is quite signiﬁcant, which is easy to be bro- ken. Please take good care of it. 9.15 The battery which can not be charged shall not be charged and do not throw the batteries into the ﬁre. 9.16 The operator's operations and body state will adversely aﬀect the body temperature ﬁnally ob- tained. 9.17 The infrared forehead thermometer doesn't get the YY0505 test. Please read the “Warning about Electromagnetic Compatibility” in User Manual for information about electromagnetic interferen- ce. 9.18) The dirty and damaged infrared optical compo- nents will adversely aﬀect the measurement accu- racy of the infrared forehead thermometer. 10.Installation and Use Instructions or Drawings10.1 Inspection before using the product Self-inspection at the time of “ON” *Align to the object to be measured and press the button “measure”, all values and characters of self-inspection will be shown on LCD display screen. And the self-inspection interface comes. See Fig. 1, not more than 2 seconds. *After the self-inspection is done, a sound of “ tick-tock” can be heard, which means the “ON” self-inspection is done. Then the temperature of the object being measured is shown on LCD dis- play screen. -04-

10.2 Before using the forehead thermometer, please get the batteries into it. Here below is the way to install the batteries: 10.2.1 Open the battery cover and put the batteries into the slot, with the anode and cathode correctly placed. 10.2.2 If the infrared forehead thermometer is used for the ﬁrst time or a new battery is just put into it, heat it by waiting for 10 minutes. 10.2.3 At the time of low battery, low battery sign will be shown on the display screen, which remin- ds that it is time to change a new battery. Open the cover of the battery bunker and change a new bat- tery. Do correctly place the anode and cathode. If the anode and cathode are not correctly placed, the thermometer might be damaged. 10.2.4 If the infrared forehead thermometer is to be suspended for a long time, please take out the bat- tery, otherwise, service life will be shortened and the battery leakage will damage the thermometer. 10.2.5 No requirement is set to the battery type. Nor- mally, DC 3V battery shall be used (2 pieces of No. 7 alkaline battery). Note: There is an arrow can be seen on the battery bunker cover. Gently push the battery cover along with the direction pointed by the arrow. Once the battery is installed, the thermometer can be used.10.3 Measurement steps10.3.1 Conﬁrm that the measurement mode on the screen is “body temperature mode”. 10.3.2 Get the infrared forehead thermometer right against to the forehead (above the part between the eyebrows). Make sure the infrared forehead thermometer is perpendicular to the forehead and 1-10cm away from it. Press the button “measure- ment” and the temperature will be displayed im- mediately. 10.3.3 When pressing the button “measurement”, the temperature just obtained will be shown on the display screen. When the temperature is normal, the backlight is in green and a smile face can be seen. If it is higher than the normal temperature (the default is 38℃, able to be customized and corrected), the backlight is in red and cry face can be seen. -05-

Note: a. Before measurement, please make sure that there is no sweat, hair, cosmetics and hat covering on the forehead. b. In one day, human's temperature would change from time to time, which also inﬂuences by other external factors, like age, gender and skin color etc. c. Do not measure the body temperature just after the thermometer measures an object whose tem- perature is quite low or quite high. Normally, measure the temperature after 10 minutes. d. After use, please keep the sensor and the detection head inner part clean. 10.4 Settings Diﬀerent settings can be done to the thermometer, like the temperature unit, warning tone, tempera- ture alarm point, compensation of temperature de- viation and so on. After the thermometer is “ON”, shortly press “set” to switch over between the hu- man body temperature and object temperature. P- ress it for 2 seconds to get into the function setting10.4.1 Setting menu: MenuF1F2F3F4Function“+” button“-” buttonTemperature unit℉℃℃Default valueRemark-3℃ ~ + 3℃Temperature alarm pointIncrease 0.1℃Decrease 0.1℃38℃Temperature deviationIncrease 0.1℃Decrease 0.1℃0℃Warning toneOﬀOnOn10.4.2 Set the measuring unit - F1 Press the button “set” for 3 seconds and F1 is dis- played on the screen, as well as the unit “℃”, press “+” to select the unit “” and select the unit℉ “℃”. 10.4.3 Set the temperature alarm point - F2 Press the button “set” for 3 seconds, F1 is disp- layed on the screen; shortly press the button “set” again, F2 is displayed on the screen. Under F2, the temperature increases 0.1℃/0.1oF if the button “+” is pressed for one time. The temperature dec- reases 0.1℃/0.1oF if the button “-” is pressed for one time. The alarm temperature is defaulted as -06-

38℃ (100.4oF).10.4.4 Set temperature deviation - F3 Press the button “set” for 3 seconds, F1 is disp- layed on the screen; shortly press the button “set” for 2 times, F3 is displayed on the screen. Under F3, the temperature increases 0.1℃/0.1oF if the button “+” is pressed for one time. The tempera- ture decreases 0.1℃/0.1oF if the button “-” is pre- ssed for one time. The factory-leaving default is 0℃ (0oF), the temperature correction range is -3℃ ~ + 3℃. If the season or environment changes, the measurement accuracy can be improved by calib- rating the compensation of temperature correction. For example: If the measurement temperature is 36.2℃ while the actual temperature of the object to be measured is 37℃, get into F3 to adjust the deviation, with a rise of 0.8℃. After the setting, the measured temperature can be the same as the actual temperature of the object. 10.4.5 Set the warning tone - F4 Press the button “set” for 3 seconds, F1 is display- ed on the screen; then shortly press the button “set” for 3 times, F4 is displayed on the screen. Under F4, press the button “+” to open the warn- ing tone and press the button “-” to close the war- ning tone. The factory-leaving default for warn- ing tone is “OFF”.10.5 Reference of body temperature 10.5.1 Diﬀerent ranges of normal temperature at diﬀerent ages In one day, human's temperature changes from time to time, which also inﬂuences by external factors, like age, gender, skin color and thickness etc. Please refer to the table here below for the – ormal temperature range at diﬀerent ages.Note: The temperature of female is diﬀerent from the temperature of male. Normally, female tempera-ture is 0.3℃ higher than the male. At the time of ovu-lation, the temperature of female will be increased AgeNormal temperature (℃) Normal temperature () ℉0~2 years old3~10 years old11~65 years old>65 years old36.4 ~ 38.0 36.1 ~ 37.835.9 ~ 37.635.8 ~ 37.5 97.5 ~ 100.497.0 ~ 100.096.6 ~ 99.796.4 ~ 99.5-07-

by 0.3 ~ 0.5 ℃.10.5.2 Clinical deviation10.5.3 Clinical repeatability11. Product Maintenance and Tips11.1 The detection head is the most accurate part of the thermometer, so please take excellent care of it. 11.2 Do not use a cleaning reagent which is corrosi- ve to clean the thermometer. 11.3 Do not immerse the thermometer into water or other liquids. 11.4 The thermometer shall be put at a dry place, keep away from dusts and contaminants, do not put it under direct sun. 11.5 The thermometer must be periodically cleaned, once every month. If necessary, the product can be properly cleaned according to the actual situa- tion, like cleaning it by a soft cloth. If the thermo- meter is very dirty, use a cloth with water or neu- tral detergent (the cloth shall be fully wrung out before use). After that, use a dry cloth. 11.6 If the thermometer is to be suspended for a long time, please get out the battery so that the service life can be lengthened. Otherwise, the battery lea- kage can damage the thermometer. 11.7 The disposal of spent battery shall follow the environmental protection rules set in the local city.11.8 The measurement result is unable to take place of the doctor's diagnosis. 11.9 No special maintenance is needed when using the thermometer. If there is a failure, please con- tact with the distributor or the manufacturer. 11.10 Please follow the local laws and rules when AgeClinical deviation / ℃ Deviation from clinical standard / ℃0~1 years old1~5 years oldOver 5 years old>Clinical deviation: ≤ ±0.2℃, deviation from clinical standard: ≤±0.2℃Forehead Forehead Forehead 0.03560.06400.03960.02270.01330.0038PartAgeClinical repeatability / ℃0~1 years old1~5 years oldOver 5 years oldClinical repeatability: ≤ ±0.3℃Forehead Forehead Forehead 0.02790.05940.0461Part-08-

disposing the wastes, abandonment and residues.12. Product CareThe thermometer is provided with a calibration mo-de (object mode / body mode), which can be used to calibrate the thermometer. During the service life, there is no need to calibrate the thermometer. If the service life is due and the thermometer is still being used, it is necessary to send it back to the manufac-turer for a calibration. If the following problems are encountered when using the thermometer, please ﬁnd out the solution from the maintenance instructions. If the problem cannot be solved, please contact with the after-sales service. 12.1 No value can be shown on LCD display screen: If the thermometer is being used to measure the human temperature, and it is lower than 32℃ or higher than 42.9℃, LCD display screen will not be shown but “Lo” or “Hi”. 12.2 “Hi” is shown on LCD display screen: When “Hi” is shown on LCD display screen, it means that the measurement scope is exceeded. 12.3 “Lo” is shown on LCD display screen: When “Lo” is shown on LCD display screen, it means that the measurement scope is not reached. 12.4 When is shown on the LCD display screen, it means low battery and it is necessary to replace a new battery in time. 12.5 There is no display or the display is abnormal on LCD display screen, please dismantle the bat- tery and re-install it 13 Storage and Transportation Environment ■Environment temperature: -20℃ ~ + 55℃. ■Relative humidity: ≤85% RH. ■Atmospheric pressure: 70kPa ~ 106kPa. The reason displaying “Lo” or “Hi”SuggestionThe temperature is inﬂuenced by hair and sweatThe temperature is inﬂuenced by the air streamThe measurement distance is too farMake sure that the forehead is not covered by anything when mea-suring the temperature Make sure that the air is stable when measuring the temperaturePlease make sure that the measure-ment distance shall not be more than 5cmEnter a room at a high temperature from a place at a low temperaturePlease wait for 10 minutes, only when someone adapts to the environment can the temperature be measured.-09-

■Atmospheric pressure: 70kPa ~ 106kPa. ■At a well-ventilated place where there is no corrosive air, exterior. ■The transportation requirements shall follow th e ones set in the order contract. However, please make sure that during the transportation, there is no severe shock, vibration and rainfall. The thermometer is not resistant to high temperature, high humidity, severe crash impact. 14. Production Time and Warranty period14.1 Production date: see the product qualeﬁed certiﬁcate. 14.2 Production batch: see the product qualeﬁed certiﬁcate.14.3 is 5 years.Warranty period15. Conﬁguration List ■Infrared forehead thermometer: 1 pcs ■User Manual: 1 pcs (including the after-sales warranty card ■Qualiﬁcation certiﬁcate: 1 pcs16. Preventive inspectionThe users can perform the preventive inspection by the following steps. 16.1 Unpacking inspection ●Before unpacking, the user shall inspect that whether the external packing is damaged. If any, please inform the manufacturer and make a re- cord. Then express the thermometer back to the manufacturer for conﬁrmation and further dis- posal. ●After unpacking, the inspection shall be done in accordance with the “conﬁguration list”, if there is any omission, please inform the manufacturer immediately. 16.2 Periodical inspection Inspect the thermometer periodically, normally, once a month. Here below are the inspection items covered in the periodical inspection: ●Inspect that whether the connect components are well connected. ●Whether the operation buttons are able to be operated ﬂexibly. ●Power on the thermometer and run it to see that whether the thermometer can run normally. ●If the thermometer has been suspended for some -10-

time, it is necessary to do periodical inspection. 16.3 Temporary inspection After the product is maintained and accessories are changed, it is mandatory to power on the ther- mometer to check that whether the maintained p- art and accessories are able to run normally. 17. Method to change accessories Battery: If the battery needs to be changed because of low battery, you can go to a store to buy two pie-ces of alkaline battery (DC 3V, No. 7 battery). When changing the battery, please open the battery bunker cover. Then change the battery and do follow the right direction of anode and cathode.18. Explanation about Signs on Medical Equip-ment LabelIconWarningNo protectionUnable to be abandoned as ordinary wasteNot under direct sunDeﬁnitionIconDeﬁnitionRead the User ManualB type application partKeep away from rainfallHandle with careIPX019. Registration Certiﬁcate Number of Medical Equipment Product Jiangxi Medical Registration Certiﬁcate 2020207022420. Production Certiﬁcate Number of Medical Equipment Jiangxi Food and Drug Administration ﬁrearms production No. 2020036021. Registered / Manufacturer Name Jiangxi Maile Medical Device Co.,Ltd.22. Registered / Manufacturer Address Floor 1-3, No.141 Changan Road, Wengang Town, Jinxian County, Nanchang City, Jiangxi Province, China23. Manufacturer's contact information +86 791 8558 655524. After-Sales Service24.1 From the day when this thermometer is bought, one year of maintenance for free will be provided as long as your invoice is well kept. -11-

24.2 It is recommended that the forehead thermome- ter shall be inspected and calibrated once a year, which can ensure the normal functions and accu- rate measurement. 24.3 Maintenance for the failures which are caused by the users will not be provided free, including: a. Vulnerable parts, consumable parts and battery; b. The thermometer suﬀers a failure resulted in by dismantling and modiﬁcation without permission; c. The thermometer suﬀers a failure resulted in by an operation not consistent with the User Manual; d. The thermometer suﬀers a failure resulted in by irrational maintenance; e. The thermometer suﬀers a failure because of care- less fall-down; f. The thermometer suﬀers a failure because of external force; 24.4 Maintenance service not covered in the warranty shall be charged as required. If the user needs to purchase accessories or vulner- able parts from the manufacturer, please contact with the after-sales department. Then change the accessories or vulnerable parts under the instruc- tions given by someone professional. If the user purchases and changes the vulnerable parts or accessories on its own, the manufacturer will not undertake any responsibilities therefrom. 24.5 After-sales department: Jiangxi Maile Medical Device Co.,Ltd. After-sales hotline: +86 791 8558 6555 After-sales address: Floor 1-3, No. 141, Chang'an Road, Wengang Town, Jinxian County, Nanchang City, Jiangxi Province, China 25. EMC WarningsNote:a. l The user shall follow the electromagnetic compa- tible information covered in the attached docu- ments when installing and using the thermometer. b. l Portable and mobile RF communication equip- ment might inﬂuence the performance of infrared forehead thermometer (M-2028), so please avoid the strong electromagnetic interference at the time of use, like mobile phone or micro oven. c. See the attachments for the guidelines and manu- facturer's statements.-12-

Warranty Registration CardProduct nameInfrared thermometer Product modelM-2028Equipment IDPurchase timeUser nameJiangxi Maile Medical Device Co.,Ltd.Address: Floor 1-3, No.141 Changan Road, Wengang Town, Jinxian County, Nanchang City, Jiangxi Province, ChinaPhone：+86 791 8558 6555 Postcode: 331722http://www.maile.coE-mail：support@maile.co When requiring to maintain the equipment, please show the warranty card or the electronic warranty card.TelE-mailContact addressMaintenance recordRemark

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