Kinetik DMT-4336 User manual

Owner’s Manual
DMT-4336
Instant Flexible
Digital Thermometer
Kinetik DMT-4336 EN IB 20201203
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°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.
Battery Replacement
1. Replace battery when " " appears in the lower right corner of 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 object such as a pen to remove old battery. Discard battery lawfully. Replace with new 1.5V DC button
type LR41 or SR41, UCC392, or equivalent. Be sure battery is installed with " +" polarity facing up. (See Figure 5)
5. Slide battery chamber back into place and attach cover.
Troubleshooting
Contents
1 Thermometer, 1 Owner’s Manual, 1 Storage Case
Product Illustration
Figure 1
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 rst.
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 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 certied.
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 step 1 and 2 for three times until no soil is seen with visual inspection after cleaning;
4) 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 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 step 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 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 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.
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.
Directions
Precaution
Symbol Explanation
°C/°F Switchable
Specications
Battery CoverProbe
LCD ON/OFF Button
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.
Keep thermometer away from Magnetic Resonance equipment.
*
-
-
-
-
*
*
Type BF Applied Part
Direct Current
European Authorized Representative
Read the instructions (actual symbol
colours are white on a blue background)
Storage and Transportation Temperature
Limit: -20°C~55°C (-4°F~131°F)
Manufacturer
Manufacture date
55°C
-20°C
Type: Digital Thermometer (Not Predictive)
Measure Range: 32.0°C ~ 42.9°C (90.0°F ~ 109.9°F) (°C/°F chosen by 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
Classication: Type BF
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.
Figure 2
1. Press the On/Off Button next to LCD display. A tone will sound as the screen shows , followed by last
recorded temperature. After showing the self-test temperature, the thermometer is now in the testing mode.
2. 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 inuenced 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 rectum.
c) Armpit Use: Wipe armpit dry. Place probe in armpit and keep arm pressed rmly at 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 ashes throughout the testing process. When ashing 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
notication. 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.
4. 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.
Error message Problem Solution
Temperature taken is
lower than 32.0°C (90.0°F)
Temperature taken is
higher than 42.9°C (109.9°F)
The system is not functioning
properly.
Dead battery: Battery icon is
ashing, can't be measurable.
Turn off, wait one minute and take a new temperature
via close contact and sufcient rest.
Turn off, wait one minute and take a new temperature
via close contact and sufcient rest.
Unload the battery, wait for 1 minute and repower it. If
the message reappears, contact the retailer for service.
Replace the battery.
Figure 3 Figure 4 Figure 5
The product is in compliance with the requirements
of MDD 93/42/EEC, "0197" is the identication
number of notify body.
JOYTECH HEALTHCARE CO. LTD.
No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou city, 311100 Zhejiang, China
Disposal of this product and used batteries should be carried out
in accordance with the national regulations forthe disposal of
electronic products.
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany

The device satises the EMC requirements of the international standard IEC 60601-1-2. The requirements
are satised 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
Voltage uctuations /
icker emissions
IEC 61000-3-3
Not applicable
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
Guidance and manufacturer's declaration — electromagnetic emission
The device is intended for use in the electromagnetic environment specied below. The customer or the user of
the device should assure that it is used in such an environment.
Table 2
NOTE: UT is the a. c. mains voltage prior to application of the test level.
Guidance and manufacturer's declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The customer or the user of
the device should assure that it is used in such an environment.
Electromagnetic environment -
guidance
Immunity test IEC 60601
test level
Compliance
level
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 oors 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
N/A N/A
N/A N/A
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV
differential mode
line-line
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 cycle 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°
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.
Table 3
Guidance and manufacturer's declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The customer or the user of
the device should assure that it is used in such an environment.
Electromagnetic environment -
guidance
Immunity test IEC 60601
test level
Compliance
level
Table 4
Recommended separation distances between
portable and mobile RF communications equipment and the device
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6 Vrms 150 kHz to
80 MHz outside
ISM bandsa
10 V/m
80 MHz to 2.7 GHz
N/A
10 V/m
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 metres(m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic site
survey, ashould be less than the compliance
level in each frequency range b
Interference may occur in the vicinity of
equipment marked with the following symbol:
Table 5
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 reection from structures, objects and people.
a. The ISM (industrial, scientic 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.
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.
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 reection from structures, objects and people.
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.
Rated maximum
output of
transmitter
W
Separation distance according to 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
385 1.8 0.3
450 2 0.3
710
0.2 0.3
0.3
0.3
0.3
0.3
27
28
9
28
28
28
9
27
28
9
28
28
28
9
745
2
780
2
810
2
870
0.2
930
1720
1845
1970
2450
5240
5500
5785
7.0
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.
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 specied, 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.
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reection from structures, objects and people.
Frequency
MHz
Electromagnetic
Environment - Guidance
Maximum
Power
W
Distance IEC 60601
Test Level
Compliance
Level
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 ransmitter in
watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m). Field
strengths from xed RF
transmitter, 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: