JOYTECH HEALTHCARE 0003 DIGITAL THERMOMETER User Manual JDMT 7904 008 Z DMT4752 FDA

JOYTECH HEALTHCARE CO., LTD. DIGITAL THERMOMETER JDMT 7904 008 Z DMT4752 FDA

User Manual

* The performance of the device may be degraded should one or more of the following occur: - Operation outside the manufacturer s s tated te mperature a nd h umidity r ange.’ - Storage outside the manufacturer s s tated te mperature a nd h umidity r ange.’ - Mechanical shock (for example, drop test) or degraded sensor.. - Patient temperature is below ambient temperature.* Portable and mobile RF communications can affect the device. The device needs special pre-cautions regarding EMC according to the EMC information provided in the accompany documents.124mmThis digital thermometer provides a quick and highly accurate reading of an individual's body temperature. To better understand its functions and to provide years of dependable results, please read all instructions first.This appliance conforms to the following standards:EN 12470-3 Clinical thermometers —Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device,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,EN 60601-1-11 Medical electrical equipment —Part 1-11: General requirements for basic safety andessential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment and complies with the requirements of EN 60601-1-2(EMC), IEC/EN60601-1(Safety) standards. And the manufacturer is ISO 13485 certified. The digital thermometer is intended to measure the human body’s temperature in regular mode orally, or vagina, and the device is reusable for clinical or home use on people of all ages. PLEASE READ CAREFULLY BEFORE USINGCONTENTSOWNER S M ANUAL’1 Thermometer, 1 Owner s Manual, 1 Storage Case’Model:DMT-4752DIGITAL THERMOMETER PRECAUTIONWarning : Read instructions thoroughly before using digital thermometer.Choking Hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow childrento use this device without parental supervision.Do not use thermometer in ear. Designed use is for readings only.Do not place thermometer battery near extreme heat as it may explode.Note: Use of the probe cover may result in a 0.01℃(0.02℉) discrepancy from actual temperature.Remove battery from the device when not in operation for a long time.The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for theinterpretation of results. Self-diagnosis may lead to the worsening of existing disease conditions.Do not attempt measurements when the thermometer is wet as inaccurate readings may result.Do not bite the thermometer. Doing so may lead to breakage and/or injury.Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.After each use, disinfect the thermometer especially in case the device is used by more than one person.Do not force the thermometer into the rectum. Stop insertion and abort the measurement when pain ispresent. Failure to do so may lead to injury.For children who are two years old or younger, please do not use the devices orally. If the unit has been stored at temperatures over 5℃～40℃(41℉～104℉), leave it in 5℃～40℃(41℉～104℉) ambient temperature for about 15 minutes before using it. oral and vaginal332.96 Figure 2℃/℉ SWITCHABLEWhen finishing measurement or entering into the memory mode, user can change the unit though APP after connecting bluetooth. PRODUCT FUNCTIONS & FEATURESThis product has two parts functions : the first function can be used to measure the temperature of the vagina, this function should be used by women to measure basal body temperature. the second function can be used as a normal thermometer ,used to measure and record body temperature data, this function suitable for most people to use . HOW TO USE THIS PRODUCT1、Please download and install APP before using this product.2、Turn on the phone bluetooth through APP and press the on/off button next to LED digital tube display to turn on the device.The display will briefly shows full segment at current unit mode. Show the last stored temperature. When the LED digital tube display “Lo ”or "Lo " , it means that the thermometer is waiting for measurement.3、Placing thermometer in desired position a） Oral Use: Place thermometer under tongue as indicated by“√”position shown in Figure 2. Close your mouth and breathe evenly through the nose to prevent the measurement from being influenced by inhaled/exhaled air. Normal temperature between 35.70 and 37.30 (96.26 and 99.14 ) b）Vaginal:Place probe tip approximately 1cm (less than 1/2 ") into vaginal. Normal temperature between 36.20 and 37.70 (97.16 and 99.86 ).4、The thermometer will finish measurement with one short beep after 3 minutes. To make sure the accuracy, do not move the thermometer during the measurement. After finishing the measurements, user can connect bluetooth through APP and upload the data. Remark:When using the thermometer at the first time, pls enter the passkey to connect the bluetooth and APP. 5、To prolong battery life, press the On/Off Button to turn unit off after testing is complete. If no action is taken, the unit will automatically shut off after around 30s.*Note:①.②.When connecting the APP via bluetooth, please enter the correct key..When the OLED display “--.-- ” or “--.-- ”,it means that the thermomenter has no memory. .When bluetooth connects to APP, the LED will light up, and when bluetooth disconnects from APP, the LED will go out. ℃ ℉℃ ℃ ℉ ℉℃ ℃ ℉ ℉So that in order to achieve better body temperature measurement result, recommend to at least 30 seconds measurement interval should be maintained.③ ℃ ℉④ TROUBLESHOOTINGProblem SolutionError message The system is not functioning properly.Unload the battery, wait for 1 minute and repowerit. If the message reappears, contact the retailer for service.Temperature taken islower than 32.00°C(89.60°F)Turn off, wait 10 minute and take a new temperature via close contact and sufficient rest.Temperature taken is higher than 43.99°C(111.18°F)Dead battery: Battery icon is flashing, can’t be measurable. Suggest to charge immediately.Turn off, wait 10 minute and take a new temperature via close contact and sufficient rest.LIMITED WARRANTYThe thermometer is guaranteed for one year from the date of purchase. If the thermometer does not function properly due to defective components or poor workmanship, we will repair or replace it free ofcharge. All components are covered by this warranty excluding the battery. The warranty does not cover damages to your thermometer due to improper handling. To obtain warranty service, an original or copy of the sales receipt from the original retailer is required.Disposal of this product and used batteries should be carried out in accordance with the national regulations forthe disposal of electronic products.Document No. JDMT-7904-008Article No.: 001Version: ZDate of Issue: 2018.11JOYTECH HEALTHCARE CO.LTD.No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city, 311100 Zhejiang,ChinaTel:+86-571-81957767Made in ChinaCLEANING AND DISINFECTIONWipe the thermometer with a soft clean cloth.For stubborn stains, wipe the thermometer with a cloth that has been dampened with water or a neutral detergent solution and then wring thoroughly. Finish by wiping with a soft dry cloth.For disinfection, 75% Ethanol or Isopropyl alcohol can be used.Observe the following to prevent damage to the thermometer.-Do not use benzene, thinner, gasoline or other strong solvents to clean the thermometer.-Do not attempt to disinfect the sensing section (tip) of the thermometer by immersing in alcohol or in hot water (water over 50℃(122℉)).-Do not use ultrasonic washing to clean the thermometer.CALIBRATIONThe thermometer is initially calibrated at the time of manufacture. If the thermometer is used according to the use instruction, periodic readjustment is not required. However, we recommend checking calibration every two years or whenever clinical accuracy of the thermometer is in question. Turn on the thermometerand insert into the water bath and then check the laboratory accuracy of thermometer. Please send thecomplete device to the dealers or manufacturer. The above recommendations do not supersede the legal requirements. The user must always comply with legal requirements for the control of the measurement, functionality, and accuracy of the device which are required by the scope of relevant laws, directives or ordinances where the device is used.Warning: The battery cannot be replaced. In order to extend battery life, the batteries should be stored at room temperature, charged to about 30% to 50% of capacity for long time storage. We recommend that batteries be charged about once per half a year to prevent over discharge. The device cannot be used when in charging. When the device need to charge, you must use a class II adapter or class II computer that complies with IEC 60601-1. The charging specification is 5V , 1A. If you use a computer, adapter or other power supply that does not meet the required specifications, it may cause electric shock hazard.Do not open the USB cover when not charging, it may cause electric shock hazard.Figure 1 PRODUCT ILLUSTRATIONOn/Off ButtonLED digital displayProbeSPECIFICATIONS±0.05℃(±0.1℉) during 35.00℃~38.00℃(95.00℉~100.40℉) at18.00℃～28.00℃(64.40℉～82.40℉) ±0.1℃(±0.2℉) for other measuring and ambient operating rangetemperature range One rechargeable 3.7V lithium battery Measure Range:Ambient operating range:Storage and transportationcondition: LED digital tube display , 4 ½ digits.For storing the last 30 measurements.3 measurements per day about 60 times133mm×30mm×22mm(L x W x H)Approx. 48 grams Temperature: ( )5℃～40℃41℉～104℉Relative humidity: 15%~95%RHAtmospheric Pressure : 700hPa ~ 1060hPaTemperature: ( )-20℃~55℃-4℉～131℉Relative humidity: 15%~95%RHAtmospheric Pressure : 700hPa ~ 1060hPaClassification:Type: Digital Thermometer (Not Predictive)Type BFDirect ModeIngress Protection Rating: IP 64Accuracy:Operating mode: Display:Memory:Battery:Battery life:Dimension:Weight:Expected service life: Three years32.00℃－43.99℃(89.60℉-111.18℉)(℃ /℉ chosen by user)SYMBOL EXPLANATION Direct Current Type BF Applied PartBatch CodeManufacturerConsult Accompanying DocumentsStorage and Transportation Temperature Limit: -20℃~55℃(-4℉～131℉)-2 0℃55℃EC REP European Authorized RepresentativeFCC INFORMATIONCaution: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:(*Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. 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 and correct the interference by one or more of the following measures:- Reorient or relocate the receiving antenna. - Increase the distance between the equipment and the receiver. - Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. - Consult the dealer or an experienced radio/TV technician for help. 1)this device may not cause harmful interference, and(2) this device must accept any interference received, including interference that may cause undesired operation.
1Electromagnetic Compatibility InformationThe device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment.Table 1Table 2Guidance and declaration of manufacturer-electromagnetic immunityThe device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.Electromagnetic environmentguidanceCompliancelevelIEC 60601test levelIMMUNITY testN/A10 V/m3 Vrms 150kHz to 80Mhz10 V/m 80MHz to 2.7GhzConductedRF IEC61000-4-6Radiated RFIEC 61000-4-3Table 3Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transm-itter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:Recommended separation distances between portable and mobile RF communications equipment and the deviceThe device is intended for use in an electromagnetic environment in which radiated therefore disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter WTable 4800 MHz to GHz 2.70.010.11101000.120.381.23.80.230.732.37.323Guidance and declaration of manufacturer-electromagnetic emissionsThe device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.Electromagnetic environment-guidanceComplianceEmissions testThe device uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby electronic equipment.Group 1RF emissions CISPR 11The device is suitable for use in all establishments, including domestic establishments and those directlyconnected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Class BRF emissions CISPR 11Harmonic emissionsIEC 61000-3-2 N/AVoltage fluctuations/flicker emissionsIEC 61000-3-3 N/A12Separation distance according to frequency of transmitterm80 MHz to 800 MHzFor 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.NOTE1 At 80 MHz and 800 MHz, the separation distance for the higer frequency range applies.NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.Guidance and declaration of manufacturer-electromagnetic immunityThe device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.Electromagnetic environmentguidanceCompliancelevel124mm254mmIEC 60601 test levelIMMUNITY testFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.± 8 kV contact±2 kV,±4 kV,±8 kV, ±15 kV airElectrostaticdischarge (ESD)IEC 61000-4-2Electrostatictransient/burstIEC 61000-4-4± 2 kV for power supplylines± 1 kV for input/outputlinesN/ASurgeIEC 61000-4-5± 1 kV differentialmode± 2 kV commonmodeN/AVoltage dips, short interrupti-ons and voltagevariations on p-ower supply in-put linesIEC 61000-4-11 < 5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycle70% UT (30% dip in UT) for 25 cycle<5% UT (>95% dip in UT) for 5 secretaryPower frequency(50/60 Hz)magnetic fieldIEC 61000-4-8 Power frequency magnetic fields should be at levels charactertic of a typical location in a typical comme-rcial or hospital environment.N/A± 8 kV contact±2 kV,±4 kV,±8 kV, ±15 kV air30 A/m; 50Hz or 60Hz 30 A/m; 50Hz or 60Hz 380MHz, 27V/m450MHz, 28V/m710MHz,745MHZ,780MHz9V/m810MHz,870MHZ,930MHz28V/m1720MHz,1845MHZ,1970MHz28V/m2450MHz, 28V/m5240MHz,5500MHZ,5785MHz9V/m 380MHz, 27V/m450MHz, 28V/m710MHz,745MHZ,780MHz9V/m810MHz,870MHZ,930MHz28V/m1720MHz,1845MHZ,1970MHz28V/m2450MHz, 28V/m5240MHz,5500MHZ,5785MHz9V/m RF WirelessCommunicationEquipmentIEC 61000-4-3

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