kinetik DMT-4336 Instant Flexible Digital Thermometer Owner’s Manual

WELLBEING

Instant Flexible
Digital Thermometer

Warning :

| Read instructions thoroughly before using digital thermometer.
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| 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 a thermometer in-ear.  Designed use is for oral, rectal, and armpit (axilla) readings only.
| Do not place the thermometer battery near extreme heat as it may explode.
| Remove the battery from the device when not in operation for a long time.
| Remove the 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 the 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 a 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°F~104°F (5°C~40°C), leave it in 41°F~104°F (5°C~40°C) ambient temperature for about 15 minutes before using it.

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.

Please Read Carefully Before Using

This 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 the 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 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 EN 60601-1-2(EMC), IEC/EN 60601-1(Safety) standards. And the manufacturer is ISO 13485 certified.

Contents

1 Thermometer, 1 Owner’s Manual, 1 Storage Case

Product Illustration

Figure 1

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.
– The patient temperature is below ambient temperature.

• Portable and mobile RF communications can affect the device. The device needs special precautions regarding EMC according to the EMC information provided in the accompanying documents.
• Keep thermometer away from Magnetic Resonance equipment.
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Symbol Explanation

| Direct Current| | Manufacture date
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| Type BF Applied Part| | Manufacturer
****| Read the instructions (actual symbol colors are white on a blue background)| | Storage and Transportation Temperature Limit: -20°C~55°C (-4°F~131°F)
| European Authorized Representative|

Specifications

manufacturer)
Accuracy:| ±0.1°C (±0.2°F) during 35.5°C ~ 42.0°C (95.9°F ~ 107.6°F) at 18°C ~ 28°C (64.4°F ~ 82.4°F) ambient operating range ±0.2°C (±0.4°F) for other measuring and ambient operating range
Operating mode:| Direct Mode
Display:| Liquid crystal display, 3 1/2 digits
Memory:| For storing the last measured value
Battery:| One 1.5V DC. button battery (size LR41 or SR41, UCC 392)
Battery life:| Approx. 200hours of continuous operation or 1 year with 3 measurements per day
Dimension:| 13.1cm x 2.0cm x 1.2cm (L x W x H)
Weight:| Approx. 10 grams including battery
Expected service life:| Three years
Ambient operating range:| Temperature: 5°C ~ 40°C (41°F ~ 104°F) Relative humidity: 15% ~ 95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Storage and transportation condition:| Temperature: -20°C ~ 55°C (-4°F ~ 131°F) Relative humidity: 15% ~ 95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Ingress Protection Rating:| IP 27
Classification:| Type BF

°C/°F Switchable
Temperature readings are available in the Celsius or Fahrenheit scale (°C/°F; located in the upper right corner of LCD.) With the unit off, press and hold the On/Off Button for approximately 2 seconds to change the current setting.

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 manufacturer’s declaration — electromagnetic emission

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
RF emissions| Group 1| The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| 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.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3| Not applicable

Table 2

Guidance and manufacturer’s declaration — electromagnetic immunity

The device is intended for use in the electromagnetic environment speci­ed 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 environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ± 8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air| ± 8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air| Floors should be wood, concrete or ceramic tile. If ‑doors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrostatic transient/burst IEC 61000-4-4| ± 2 kV for power supply lines 100 kHz repetition frequency ± 1 kV for input/output lines| N/A| N/A
Surge IEC 61000-4-5| ± 0.5 kV, ± 1 kV differential mode line-line| N/A| N/A
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11| 0 % UT (100 % dip in UT ) for 0.5 cycles at 0°, 45°, 90°, 135°,180°, 225°, 270°, and 315°
0 % UT (100 % dip in UT) for 1 cycle at 0°
70 % UT (30 % dip in UT ) for 25/30 cycles at 0°
0 % UT (100 % dip in UT) for 250/300 cycle at 0°| N/A| N/A
Power frequency (50/60 Hz) magnetic ­eld IEC 61000-4-8| 30 Aim, 50/60Hz| 30 A/m, 50/60Hz| Power frequency magnetic ­elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a. c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration — electromagnetic immunity

The device is intended for use in the electromagnetic environment speci­ed 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 environment guidance
Conducted RF IEC 61000-4-6| 3 Vrms 150 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz outside ISM bandsa| N/A| 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 separation distance 80MHz to 800MHz
800MHz to 2.7GHz
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 ­xed RF transmitters, as determined by an electromagnetic site survey, a 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 IEC 61000-4-3| 10 V/m
80 MHz to 2.7 GHz| 10 V/m
NOTE 1 At 80 MHz 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.
a. The ISM (industrial, scienti­c and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18, 17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.
c. Field strengths from ­xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to ­xed RF transmitters, an electromagnetic site survey should be considered. If the measured ­eld strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
d. Over the frequency range 150 kHz to 80 MHz, ­eld strengths should be less than 3 V/m.

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 the frequency of transmitter m

150 kHz to 80 MHz

|

80 MHz to 800 MHz

|

800 MHz to 2.7 GHz

0.01| 0.12| 0.04| 0.07
0.1| 0.37| 0.12| 0.23
1| 1.17| 0.35| 0.7
10| 3.7| 1.11| 2.22
100| 11.7| 3.5| 7.0
For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters (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.
NOTE 1 At 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 by absorption and reflection from structures, objects, and people.

Table 5

Recommended separation distances between RF wireless communications equipment

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 RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
Frequency MHz| Maximum Power W| Distance| IEC 60601 Test Level| Compliance Level| Electromagnetic Environment – Guidance
385| 1.8| 0.3| 27| 27| RF wireless 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 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 ­xed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

450| 2| 0.3| 28| 28
710| 0.2| 0.3| 9| 9
745
780
810| 2| 0.3| 28| 28
870
930
1720| 2| 0.3| 28| 28
1845
1970
2450| 2| 0.3| 28| 28
5240| 0.2| 0.3| 9| 9
5500
5785
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

WARNINGS!

• This device should not be used in the vicinity or on top of other electronic equipment such as cell phones, transceivers 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 cords 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.

Directions

1. Press the On/Off Button next to the LCD display. A tone will sound as the screen shows , followed by the last recorded temperature. After showing the self-test temperature, the thermometer is now in testing mode.

2. Position thermometer in the 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.
   b) Rectal Use: Lubricate silver probe tip with petroleum jelly for easy insertion. Gently insert sensor approximately lcm (less than 1/2 “) into the rectum.
   c) Armpit Use: Wipe armpit dry. Place the probe in the armpit and keep the arm pressed firmly at the side.
   From a medical viewpoint, this method will always provide inaccurate readings, and should not be used if precise measurements are required.

3. The degree sign flashes throughout the testing process. When flashing stops an alarm will beep for approximately 10 seconds. The measured reading will appear on the LCD simultaneously. 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 results, recommend to keep the probe in the mouth and rectum for about 2 minutes, or in the armpit for about 5 minutes regardless of the beep sound and at least 30 seconds measurement interval should be maintained.
   *Note: Normally the buzzes are ” Bi-Bi-Bi-Bi-; Alarm beeps more rapidly when the temperature reaches 37.8°C (100°F) or higher, and the buzzes are ” Bi-Bi-Bi Bi-Bi-Bi Bi-Bi-Bi “

4. To prolong battery life, press the On/Off Button to turn the unit off after testing is complete. If no action is taken, the unit will automatically shut off after around 10 minutes.

Troubleshooting

and take a new temperature via close contact and sufficient rest.
| Temperature taken is higher than 42.9°C (109.9°F)| Turn off, wait one minute and take a new temperature via close contact and sufficient rest.
| 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.
| Dead battery: Battery icon is flashing, can’t be measurable.| Replace the battery.

Battery Replacement

1. Replace the battery when “ ” appears in the lower right corner of the LCD display.
2. Pull battery cover off as shown in Figure 3.
3. Gently pull out plastic circuit board with battery chamber approximately 1 cm (slightly less than 1/2″.) (See Figure 4)
4. Use pointed objects such as a pen to remove old batteries. Discard battery lawfully. Replace with new 1.5V DC button type LR41 or SR41, UCC392, or equivalent. Be sure the battery is installed with ” + ” polarity facing up. (See Figure 5)
5. Slide the battery chamber back into place and attach the cover.

Cleaning And Disinfection

1. Immerse the thermometer probe in distilled water for at least 1 minute;

2. Using a clean, soft cloth to wipe the thermometer down to remove any residue;

3. Repeat steps 1 and 2 for three times until no soil is seen with visual inspection after cleaning;

4. For thoroughly cleaning 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 20°C; 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.

5. Repeat steps 1 to 3 to remove OPA residuals;
   Note 1: Rectal use is not recommended for home use as OPA will not be readily available outside of a hospital. If
   rectal measurement is necessary, we strongly recommend high-level disinfection.
   Note 2: 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°F (50°C)) for a 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 user instruction, periodic readjustment is not required. However, we recommend checking calibration every two years or whenever the clinical accuracy of the thermometer is in question. Turn on the thermometer and insert it into the water bath and then check the laboratory accuracy of the 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.

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 for the disposal of electronic products.
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| JOYTECH HEALTHCARE CO. LTD.
No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city, 311100 Zhejiang, China
| Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
0197| The product is in compliance with the requirements of MDD 93/42/EEC, “0197” is the identification number of the notified body.

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