PROFESSIONAL MEDICAL PRODUCTS
DIGITAL CLINICAL 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.
• Note: Use of the probe cover may result in a 0.1°C 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 5°C~40°C, leave it in 5°C~40°C 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 body’s 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 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/EN60601-1(Safety) standards. And the manufacturer
is ISO 13485 certied.
CONTENTS
1 Thermometer, 1 Owner’s Manual, 1 Storage Case
ON/OFF
Thermometric sensor LCD
Thermometer tip
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.
button
Battery compartment
SYMBOL EXPLANATION
Direct Current Lot number Product code
Caution: read instructions
(warnings) carefully
Authorized representative
in the European community
WEEE disposal
Temperature limit Humidity limit Atmospheric pressure limit
Keep away from sunlight Date of manufacture
Manufacturer
IP22 Covering Protection rate Keep in a cool, dry place
Follow instructions
for use
Medical Device complies
with Directive 93/42/EEC
Type BF applied part
SPECIFICATIONS
Type: Digital Thermometer (Not Predictive)
Measure Range: 32.0°C~42.9°C
Accuracy: ±0.1℃ during 35.5℃~42.0℃ at 18℃~28℃ ambient operating range
Operating mode: Direct Mode
Display: Liquid crystal display, 3 1/2 digits
±0.2℃ for other measuring and ambient operating range
Memory: For storing the last measured value
Battery: One 1.5 V DC. button battery (size LR41or SR41, UCC 392)
Battery life: Approx. 200hours of continuous operation or 1 year with 3 measurements
Dimension: 140mmx24mmx12rnm (L x W x H)
Weight: Approx. 15 grams including battery
Expected service life: Three years
Ambient operating range: Temperature: 5℃~40℃
Storage and transportation
condition:
Ingress Protection Rating: IP22
Classication: Type BF
DIRECTIONS
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 inuenced by inhaled/exhaled air.
Normal temperature between 35.7℃ and 37.3℃.
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 36.2℃ and 37.7℃.
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. Normal temperature between 35.2℃ and 36.7℃.
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 notication. 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.
*Note: Normally the buzzes are“ Bi-Bi-Bi- Bi-”; Alarm beeps more rapidly w hen temperature reaches 37.8℃
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 unit off after testing is complete. If no action is taken, the
unit will automatically shut off after around10 minutes.
per day
Relative humidity: 15%~95%RH
Atmospheric Pressure : 700hPa ~ 1060hPa
Temperature: -20℃~55℃
Relative condition: humidity: 15%~95%RH
Atmospheric Pressure : 700hPa ~ 1060hPa
Figure 2
TROUBLESHOOTING
Error message Problem Solution
Temperature taken is
lower than 32.0°C
Temperature taken is
higher than 42,9°C
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 tempera-
ture via close contact and sufcient rest.
Turn off, wait one minute and take a new tempera-
ture via close contact and sufcient rest.
Unload the battery, wait for 1 minute and repower it.
If the message reappears, contact the retailer
for service.
Replace the battery.
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 than1/2”.) (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.
Figure 3 Figure 4 Figure 5
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, 70% 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℃).
- Do not use ultrasonic washing to clean the thermometer.
Electromagnetic Compatibility Information
The device satises the EMC requirements of the international standard IEC 60601-1-2. The requirements are satised 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 specied 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 CISPR 11 Group 1 The device uses RF energy only for its internal function.
RF emissions CISPR 11 Class B The device is suitable for use in all establishments, including
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
IEC 61000-3-3
Table 2
Guidance and declaration of manufacturer-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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic eld
IEC 61000-4-8
N/A
N/A
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV differential mode
± 2 kV common mode
< 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 sec
3 A/m 3 A/m; Power frequency magnetic elds
Therefore, its emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
level
± 6 kV contact
± 8 kV air
N/A
N/A
N/A
Electromagnetic environment
guidance
Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material, the relative humidity should be at least 30%.
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
Table 3
Guidance and declaration of manufacturer-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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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
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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higer frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reection from structures, objects and people.
test level
3 Vrms
150 kHz to 80 Mhz
3 V/m
80 MHz to 2,5 Ghz
0.01 0.12 0.23
0.1 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
Compliance
level
N/A
3 V/m
Separation distance according to frequency of transmitter m
80 MHz to 800 MHz 800 MHz to 2,5 GHz
d=
Electromagnetic environment-guidance
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
3.5
80 MHz to 800 MHz
√P
d=
1
E
7
800 MHz to 2,5 GHz
√P
d=
1
E
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, 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:
3.5
E
√P
1
d=
7
1
E
√P
Disposal: The product must not be disposed of along with other domestic waste. The users must dispose
of this equipment by bringing it to a specic recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
KD-101 (25564)
YanCheng KellyUnion Import and Export Co., LTD
Room 2509, Building 1, Financial City, No.5,
Shiji Avenue, Chengnan New District,
224005 Yancheng City, Jiangsu, P. R. China
Made in China
Prolinx GmbH
Brehmstr. 56, 40239, Duesseldorf
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M-25564-GB-Rev.2-02.21
-20°C
55°C
95%1060 hPa
15%700 hPa
IP22
0123
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