JOYTECH DMT-4763p Predictive Digital Thermometer
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.
- 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 41℉～104℉(5℃～40℃), leave it in 41℉～104℉ (5℃～40℃) ambient temperature for about 15 minutes before using it.
- Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
- PORTABLE RF communications equipment (including peripherals such as antenna cables and external antennas)should be used no closer than 30 cm (12 inches) to any part of the [ME
- EQUIPMENT or ME SYSTEM],including cables specified by the MANUFACTURER. Otherwise, degradation of the performance of this equipment could result.
- It is not intended for use in the oxygen rich environment and presence of flammable anesthetic mixture with air, oxygen or nitrous oxide.
- Do not put the thermometer in direct sunlight or with cotton wool, otherwise the accuracy will be affected. ME equipment should not be cleaned and disinfected while in use.
Indications For Use
The digital thermometers are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 years old with adult supervision.
Expected Operator
- The patient is an intended operator. The Applied part is the probe.
- All functions the patient can safely use.
- The patient can replace the batteries.
PLEASE READ CAREFULLY BEFORE USING
The predictive digital thermometer provides a quick and highly accurate reading of an individual’s body temperature. Predictive-read thermometers are quicker than actual read thermometer. Predictive read type thermometers display the temperature results in a short period of time which are equivalent to balance temperature after 5 minutes according to the particular algorithm. Therefore, users only need about 5 seconds to take the temperature readings. Due to measurement sites of predict thermometer are different, the reading time also may be different, but the actual time is usually between 5 and 10 seconds. (See below Figure 1)
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
PRECAUTION
- *The performance of the device may be degraded should one or more of the following occur:
- Operation outside the manufacturer’s stated temperature and humidity range.
- Storage outside the manufacturer’s stated temperature and humidity range.
- 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.
- Do not use the devices in the MR environment.
SYMBOL EXPLANATION
SPECIFICATIONS
| Type: | Digital Thermometer (Predictive) | ||||
| Measure Range: | 89.6℉-111.0℉(32.0℃－43.9℃ )( ℉ /℃ chosen by manufacturer) | ||||
| Accuracy: | ±0.2℉(±0.1℃) during 95.9℉~107.6℉(35.5℃~42.0℃) at 64.4℉~82.4℉ (18℃~28℃ ) ambient operating range
±0.4℉(±0.2℃) for other measuring and ambient operating range |
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| Operating mode: | Adjusted mode: Oral mode/Rectal mode/Underarm mode Direct mode: Bath mode | ||||
| Display: | Liquid crystal display, 3 ½ digits | ||||
| Memory: | The last ten memories | ||||
| Battery: | One 3.0V DC button battery type CR2032 | ||||
| Battery life: | Approx. 200hours of continuous operation or 1 year with 3 measurements per day | ||||
| Dimension: | 14.3cm×2.5cm×1.4cm(L x W x H) | ||||
| Weight: | Approx. 20 grams including battery | ||||
| Expected service life: | Three years | ||||
| Ambient operating range: | Temperature:41℉～104℉ (5℃～40℃) Relative humidity: 15%~95%RH Atmospheric Pressure : 70kPa ~ 106kPa |
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| Storage and transportation condition: | Temperature:-4℉～131℉ (-20℃~55℃) Relative humidity: 15%~95%RHAtmospheric Pressure : 70kPa ~ 106kPa |
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|
Clinical accuracy |
Oral Mode | Rectal Mode | Armpit Mode | ||
| Clinical bias | 0.09℃ | 0.06℃ | 0.07℃ | ||
| Limits of agreement | 0.72℃ | 0.71℃ | 0.71℃ | ||
| Clinical repeatability | 0. 11 | 0. 12 | 0. 12 | ||
| Contraindication: | No contraindications | ||||
| Ingress Protection Rating: | IP 27 | ||||
| Classification: | Type BF | ||||
|
Bluetooth bandwidth information: |
Modulation Mode | GFSK | |||
| Frequency Range | 2402MHz-2480MHz | ||||
| Occupied Bandwidth | 2MHz | ||||
| Transmitting Power | 5dBm | ||||
℉/℃ SWITCHABLE
Temperature readings are available in the Fahrenheit or Celsius scale (℉/℃; located in the upper right corner of LCD.) With the unit off, press and hold the On/Off Button for approximately 3 seconds to change the current setting.
MEMORY MODE
- Power on the thermometer.
- During the last memory displays, press and hold the On/Off button until entering into Memory Mode.
- Press the button again to cycle check the last 10 memories.
- Hold down the on/Off button for 3 seconds or wait for one minute to exit the memory mode.
Bluetooth requirements
- The thermometer requires a bluetooth device with:
* Bluetooth 4.0 *Android 6.0 or later *IOS 10.0 or later. - And works with: . iphone , iPod, iPad . Android Phones and Tablets.
SELECT MODE
- Power on the thermometer.
- During the mode displays, press and hold the On/Off button until mode flashing.
- Press the button again to cycle through the four mode options (see figure 3).
- When the desired mode displays on screen, wait for auto entering into measurement mode.
DIRECTIONS
- Please download and install “JoyHealth” APP from Website or APP Store (Such as Apple Store),before using this product. Then use your email account to register a new account and log in. Selection “thermometer” device, And turn on your phone’s Bluetooth.
- Press the On/Off Button next to LCD display. A tone will sound as the screen shows(See Figure 4) , followed by last recorded temperature. After showing the mode of measurement(See Figure 3), the thermometer will enter into the testing mode(see Figure 5).
- When you see the LCD display “
flashing, it means that the thermometer is waiting for Bluetooth connection, you only have 60 seconds to use the APP to bind the thermometer device, After successful connection, the will stop flashing and continue to be visible. APP will be synchronized with the thermometer. - Position thermometer in desired location (mouth, rectum, or armpit.)
- Oral Mode: Place thermometer under tongue as indicated by ”
position shown in Figure 6. Close your mouth and breathe evenly through the bose to prevent the measurement from being influenced by inhaled/exhaled air. - Rectal Mode: Lubricate silver probe tip with petroleum jelly for easy insertion. Gently insert sensor approximately lcm (less than 1/2 “) into rectum.
- Underarm Mode: 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. - Bath Mode: It will display — and then °F or °C is still flashing(See Figure 5), then place probe tip into bath water.
Note: The accuracy of unit must be tested using water bath in bath mode.
- Oral Mode: Place thermometer under tongue as indicated by ”
- The three dashes (—) will flash sequentially throughout the testing process, and at the same time the
are flashing(See Figure 7). When flashing stops an alarm will beep for approximately 5 the ” seconds. The predictive measured reading will appear on the LCD simultaneously(For example 98.6 OF see Figure 8).The measurement time of the oral/underarm/rectal mode varies with the individual, which are between 5 and 10 seconds.
*Note: The minimum measurement time of Bath Mode until the signaling tone (beep) must be maintained without exception.
*Note :The minimum measurement time of Bath Mode until the signaling tone (beep) must be maintained without exception.
- The thermometer will enter into the Actual Measurement after 3 minutes except Bath Mode, At the same time you can hear ten beeps as a cue (The ”
disappear and the Actual measurement temperature display see Figure 9), users can take the true body temperature at this time. Users can compare the predictive temperature result with true temperature result. 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 inter 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 around 10 minutes.
- Store the thermometer in its protective case.
*Note: Normally the buzzes are ” Bi-Bi-Bi-Bi-” ; Alarm beeps more rapidly when temperature reaches 100.00F(37.80C) or higher ,and the buzzesare ” Bi-Bi-B1 –Bi-Bi-Bi——- Bi-Bi-Bi”
TROUBLESHOOTING
| Error message | Problem | Solution |
| — | Temperature taken is lower than 89.6°F(32.0°C) | Turn off, wait one minute and take a new temperature via close contact and sufficient rest. |
 |
Temperature taken is higher than 111.0°F(43.9°C) | Turn off, wait one minute and take a new temperature via close contact and sufficient rest. |
| Errr | The system is not functioning properly. | Unload the battery, wait for 1 minute and repower it.
If the message reappears, contact the retailer for service. |
 |
The thermometer is moved when measuring. | Do not move, and then repeat measurement. |
| Er2 |
The time of predictive measurement is excess 15 seconds. |
|
| Other Err messages | The thermometer is not functioning properly. | Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service. |
 |
Dead battery: Only battery icon is displayed, can’t be measurable. |
Replace the battery. |
BATTERY REPLACEMENT
- Replace battery when appears in the lower right corner of LCD display.
- Pull battery cover off as shown in Figure 10.
- Gently pull out plastic circuit board with battery chamber approximately I cm (slightly less than 1/2″. )
(See Figure 11) - Use pointed object such as a pen to remove old battery. Discard battery lawfully. Replace with new 3.0 V DC button type CR2032. Be sure battery is installed with polarity facing up. (See Figure 12)
- Slide battery chamber back into place and attach cover.
CLEANING AND DISINFECTION
- Immerse the thermometer probe in distilled water for at least I minute;
- Using a clean, soft cloth to wipe the thermometer down to remove any residue;
- Repeat step I and 2 for three times until no soil is seen with visual inspection after cleaning;
- For thoroughly clean and disinfection, please use method A or B:
Method A(High level disinfection): immerse the thermometer probe in 0.55% OPA(O-Phthaldehyde), such as CIDEX OPA, for at least 12 minutes under temperature at 680F(200C) ;
Method B(Low level disinfection): Using a clean soft cloth dipped in 70% medical alcohol, wipe the probe 3 times, at least one minute for each time. - Repeat step I to 3 to remove OPA residuals;
Note1 : Rectal use is not recommended for home use as OPA will not be readily available outside ofa hospital.
If rectal measurement is necessary, we strongly recommend high level disinfection.
Note2: Please operate according to the manual of OPA for reference.
To prevent damage to the thermometer please note and observe the following:- Do not use benzene, paint thinner, gasoline or other strong solvents to clean the thermometer.
- Do not attempt to disinfect the sensing probe (tip) of the thermometer by immersing in alcohol, OPA or in hot water (water over 122 OF (500C) for long time.
- Do not use ultrasonic washing to clean the thermometer.
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. Please send the complete device to the dealers or manufacturer. ASTM laboratory accuracy requirements in the display range of 98.6 to 102.2 °F (37.0 to 39.0 °C) for electronic thermometers is±0.2°F( ±0.1°C).
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.
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:
- This device may not cause harmful interference, and
- 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.
The device has been evaluated to meet general RF exposure requirement.The device can be used in portable exposure condition without restriction.
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.
The software identifier refers to the Software validation Report document,and the file code is JYRJ201203003 the file version is AO.
Disposal of this product and used batteries should be carried out in accordance with the national regulations forthe disposal of electronic products.
JOY TECH Healthcare co., Ltd.
No. 365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou , Zhejiang 311100 China
Made in China
Document No.: JDMT-8504-014
Article No.: 001
Version: Z
Date of Issue: 2020.06
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
Table 2
Table 3
| Guidance and manufacturer’s declaration – 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 | IEC 60601 test
level |
Compliance
level |
Electromagnetic environmcnt – guidance |
| Conducted RF
IEC 61000-4-6 |
3 Vrms I 50 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz outside !SM bands a |
NIA |
Portable and mobile RF communications equipment should be used no closer to any pan of
the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,” should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol: |
|
Radiated RF |
I0V/m |
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| I0V/m | |||
| !EC 61000-4-3 | |||
| 80 MHz to 2.7 GHz | |||
| NOTE 1 At 80 MlHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
|
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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 RF 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 of transmitter w |
Separation distance according to frequency of transmitter
m |
||
| I 50 kHz to 80 MHz
d=[3.5] P V, |
80 MHz to 800 MHz
d = [3.5] ? E, |
800 MHz to 2.7 GHz
d =[.!. ] P E, |
|
| 0.01 | 0.12 | 0.04 | 007 |
| 0.1 | 0.37 | 0.12 | 0.23 |
| 1.17 | 0.35 | 0.7 | |
| 10 | 3.7 | I.I I | 2.22 |
| 100 | 117 | 3.5 | 7.0 |
| For transmitters rated at a maximum output power not listed above the recommended separation distanced in meters (m) can he 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.
NOTE 1At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected hy absorption and reflection from structures, objects and people. |
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Table 5
WARNINGS’.
- This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone, transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
- The use of accessories and power cord other than those specified, with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.
FAQ
- Q: Can I use this thermometer for self-diagnosis?
A: It is not recommended to use temperature readings for self-diagnosis. Consult a healthcare professional for accurate interpretation of results. - Q: How should I clean the thermometer?
A: After each use, disinfect the thermometer following the cleaning instructions provided in the owner’s manual. - Q: Can I use the thermometer on infants?
A: For children under two years old, it is advised not to use the thermometer orally. Always use under adult supervision.
Documents / Resources
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JOYTECH DMT-4763p Predictive Digital Thermometer [pdf] Owner's Manual DMT-4763p, DMT-4763p Predictive Digital Thermometer, DMT-4763p, Predictive Digital Thermometer, Digital Thermometer, Thermometer |