124mm DIGITAL THERMOMETER OWNER S M ANUAL Model:DMT-4735b Warning :
Read instructions thoroughly before using digital thermometer. Choking Hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children to use this device without parental supervision. Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) 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 the interpretation 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 is present. Failure to do so may lead to injury. Do not use thermometer orally after being used rectally. 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 540(41104), leave it in 540
(41104) ambient temperature for about 15 minutes before using it. PLEASE READ CAREFULLY BEFORE USING This digital thermometer provides a quick and highly accurate reading of an individual's body temperature. The digital thermometer is intended to measure the human bodys temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages. To better understand its functions and to provide years of dependable results, please read all instructions first. This appliance conforms to the following standards:
ASTM E1112 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature, 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, IEC 60601-1-11 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment and complies with the requirements of IEC 60601-1-2(EMC), AAMI/ANSI ES60601-1(Safety) standards. And the manufacturer is ISO 13485 certified. CONTENTS 1 Thermometer, 1 Owner s Manual, 1 Storage Case PRODUCT ILLUSTRATION LCD 7 1
. 0 9 3 Figure 1 Probe Figure 1 On/Off Button PRECAUTION
* 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. SYMBOL EXPLANATION Direct Current Type BF Applied Part Consult Accompanying Documents Batch Code Manufacturer Storage and Transportation Temperature Limit: -20~55
(-4 131) 55
-20 IP 27 The first num.2:Protercted against access to hazardous parts with a finger,and the jointed test finger of 12mm ,80 , 80 mm length, shall have adequate clearance from hazardous parts . And protected against solid foreign objects of 12,5 mm and greater. The second number 7:
Protected against water and the test is made by completely immersing the enclosure in water between 0.15m and 1m for about 30 minutes. The water temperature does not differ from that of the equipment by more than 5 K. SPECIFICATIONS Type:
Measure Range:
Accuracy:
Digital Thermometer (Not Predictive) 32.0043.99(89.60-111.18)( / chosen by manufacturer) 0.05(0.1) during 35.50~42.00(95.90~107.60) 0.1(0.2) during T<35.50(95.90) or T>42.00(107.60) Direct Mode Liquid crystal display, 4 1/2 digits For storing the last measured value One 3.0V DC button battery type CR2032 Eight month with 3 measurements per day 13.4cm3.1cm1.6cm (L x W x H) Approx. 26 grams including battery Operating mode:
Display:
Memory:
Battery:
Battery life:
Dimension:
Weight:
Expected service life: Three years Temperature:
Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa Temperature:
Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa IP 27 Type BF Ingress Protection Rating:
Classification:
Storage and transportation condition:
Ambient operating range:
-20~55 -4131 540 41104
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) SWITCHABLE
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Temperature readings are available in Celsius or Fahrenheit(located in the upper right corner of LCD.). With the device off, press and hold the On/Off Button for approx. 3 seconds to change the unit and when the thermometer connected with the APP ,it will synchronize the current unit. The LCD display will briefly shows full segments at current unit mode with beep stone. Then the display shows another unitmode after change. Followed by last stored temperature , the thermometer is now in the testing mode. PRODUCT FUNCTIONS & FEATURES This product has two parts functions : the first function can be used as a basic thermometer for monitoring ovulation cycles and other physiological information, 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 PRODUCT 1.Please download and install APP before using this product. Then register new account use your email account and select your purpose, ovulation monitoring or normal thermometer. 2.Turn on the phone bluetooth through APP and press the on/off button next to LCD display to turn on the device. The display will briefly shows full segment at current unit mode with beep tone. Followed by last stored temperature , and shows 37.00 or 98.60.Then select the device ID by the APP and bind it. While it connected successful , APP will be synchronized with the thermometer.
*Note:
. If the measured temperature is less than 32.00 or 89.60, the LCD will display Lo below the graduation lines without scale bar, if the measured temperature is higher than 43.99 or 111.18, the LCD will display all scale bars with Hi above. When the LCD display ---- , it means that the thermometer is waiting for Bluetooth connection, you only have 30 seconds to connect your thermometer , otherwise it will skip the Bluetooth connection into the normal temperature measurement. Or you can press the on/off button to skip the waiting for Bluetooth connection into the normal temperature immediately. TAKE YOUR TEMPERATURE PART1: For normal thermometer , position thermometer in desired location (mouth, rectum, or armpit.) 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) Rectal Use: Lubricate silver probe tip with petroleum jelly for easy insertion. Gently insert sensor approximately 1cm (less than 1/2 ") into rectum. Normal temperature between 36.20 and 37.70 (97.16 and 99.86). c) Armpit Use: Wipe armpit dry. Place probe in armpit and keep arm pressed firmly at side. From a medical viewpoint, this method will always provide inaccurate readings, and should not be used if precise measurements are required. Normal temperature between 35.20 and 36.70
(95.36 and 98.06). PART2: For basal body temperature ,while wake up in the morning ,open the APP and measurement method reference to above Oral Use WARM TIPS
. When the peak temperature has been reached, the or will stop flashing and the thermometer will sound a series of beeps. The minimum measurement time until the signaling tone (beep) must be maintained without exception. The measurement continues even after the buzzer notification. So that in order to achieve better body temperature measurement result, recommend to keep the probe in mouth and rectum about 2 minutes, or in armpit about 5 minutes regardless of the beep sound and at least 30 seconds measurement interval should be maintained. 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 around10 minutes. Figure 2 TROUBLESHOOTING Error message Problem Solution Temperature taken is lower than 32.00C(89.60F) Temperature taken is higher than 43.99C(111.18F) The system is not functioning properly. Turn off, wait one minute and take a new temperature via close contact and sufficient rest. Turn off, wait one minute and take a new temperature via close contact and sufficient rest. Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service. Dead battery: Battery icon is flashing, cant be measurable. Suggest to replace the battery. BATTERY REPLACEMENT 1. Replace battery when appears in the lower right corner of LCD display. 2. Put a thin board such as a coin on fillister of cover. Turn the battery anti-clockwise until the cover is off
(See Figure 3). 3. Use a non-meteal instrument such as a pen to remove old battery from the battery holder (See Figure 4). Discard battery according to local law. 4. Place a new 5. With a thin pin to turn the cover clockwise until the facing towards (See Figure 6). into the chamber with positive side facing up.(See Figure 5). 3.0V DC CR2032 Figure 3 Figure 4 Figure 5 Figure 6 CALIBRATION The 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 thermometer and insert into the water bath and then check the laboratory accuracy of thermometer. Please send the complete 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. CLEANING AND DISINFECTION Wipe 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. FCC INFORMATION Caution: 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:
( 1 ) this device may not cause harmful interference, and
( 2 ) this device must accept any interference received, including interference that may cause undesired operation.
*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. LIMITED WARRANTY The 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 of charge. 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. JOYTECH HEALTHCARE CO.LTD. No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city
, 311100 Zhejiang,China Tel:+86-571-81957767 Made in China Document No. JDMT-5604-017 Article No.: 005 Version: Z Date of Issue: 2018.06.09 124mm 1 Electromagnetic Compatibility Information The 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 1 Guidance and declaration of manufacturer-electromagnetic emissions The 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. Emissions test Compliance Electromagnetic environment-guidance Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The 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. IMMUNITY test Conducted RF IEC 61000-4-6 IEC 60601 test level 3 Vrms 150 kHz to 80 Mhz Compliance level N/A Radiated RF IEC 61000-
4-3 10 V/m 80 MHz to 2.7 Ghz 10 V/m Electromagnetic environmentguidance Portable 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 Ghz where 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:
The 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF Wireless Communication Equipment IEC 61000-
4-3 RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 N/A N/A Table 2 Guidance and declaration of manufacturer-electromagnetic immunity The 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. 2 5 4 m m 380MHz, 27V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 380MHz, 27V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m IMMUNITY test IEC 60601 test level Electrostatic discharge (ESD) IEC 61000-4-2 Electrostatic transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 2 kV for power supply lines 1 kV for input/output lines 1 kV differential mode 2 kV common mode Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11
< 5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle
<5% UT (>95% dip in UT) for 5 secretary Compliance level 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air Electromagnetic environm entguidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. N/A N/A N/A Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 30 A/m; 50Hz or 60Hz 30 A/m; 50Hz or 60Hz Power frequency magnetic fields should be at levels charactertic of a typical location in a typical comme-
rcial or hospital environment. Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device The 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 W Separation distance according to frequency of transmitter m 80 MHz to 800 MHz 800 MHz to 2.7 GHz 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 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. 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.