Kinetik DT-K11B User manual

Battery replacement
The battery is empty and needs replacing when the " "
battery symbol appears on the right of the LCD. Remove
the battery cover and replace it with a battery (preferably
non-mercury) of the same type.
Please note:
The "+ " sign up and "-" sign down.
We advise you to remove the batteries if the device is not
going to be used for a longer period of time.
Product disposal
Please ensure environmental protection. Batteries do not
belong in the domestic waste. Please hand them in at
collection point or the municipal recycle
material centre as special waste.The lithium
battery or fuel cell may lead to excessive
temperatures, re or explosion.
This symbol on products and/or accompanying
documents means that consumed electronic products
must not be mixed with conventional domestic waste.
Take these products to the corresponding collection
points for correct treatment and recycling, where they
will be accepted free of charge. For more information on
the closest collection point, Please enquire with your
local authorities.
Technical data
Type: maximum thermometer
Measurement range: (32.0~42.9)°C/(89.6-109.2)°F
Measurement accuracy:
+/- 0.1°C/0.2°F (35.5°C~42.0°C/95.9°F~107.6°F)
+/- 0.2°C/0.4°F (32.0°C~35.5°C, 42.0°C~42.9°C/
89.6°F~95.9°F, 107.6°F~109.2°F)
Storage/transportation temperature: (-25~55)°C,
≤95%RH
Ambient temperature during use: (5~35)°C, ≤80%RH
Atmospheric pressure: 700~1060hPa
Mode of operation of the clinical thermometer: direct
mode
Transient response time: 10s
Min Scale: 0.1°C/0.1°F
Battery type:
Alkaline manganese battery, type LR41, 1.5V
Service life minimum 100 hours under continuous
operation.
Weight: Approx. 13g
Shelf life: 3 years
Explanation of symbols
Kinetik DT-K11B NZ IB 20210726
Hangzhou Hua'an Medical & HealthInstruments Co., Ltd
Building 2, 1# Fuzhu Nan RD, Wuchang Town,
Yuhang District, Hangzhou, Zhejiang 310023 China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany
E-Mail: [email protected]
Tel.: 049-40-2513175 Fax.: 049-40-255726
Legal requirements and guidelines
This product complies with the European Directive for
Medical Device 93/42/EEC and carries the CE mark, the
device also complies with the specications of below
standard for:
EN 12470-3
EN 60601-1
EN 60601-1-11
EN 60601-1-2
The CE Marking conrms that this is a medical device
with a measuring function in the sense of the medical
device act which has undergone a conformity
assessment procedure. A Notied body conrms that this
product fullls all the appropriate statutory regulations
Calibration check
This thermometer is initially calibrated at the time of
manufacture. If this thermometer is used according to the
operation instruction, periodic re-adjustment is not
required.
The calibration check has to be carried out immediately,
if there are indications that the product does not keep the
dened error limits or the calibration properties could
have been affected by an intervention or by any other
means. Please also observe any national statutory
regulations. The calibration check can be carried out by
the competent authorities or by authorised service
providers. A test instruction for calibration check can be
provided to the relevant authorities and authorised
services providers on request.
Under the arm(axillary)
Placing the thermometer in the armpit provides a
measurement of surface temperature that can uctuate
by around 0.5°C to 1.5°C from rectal temperature
readings in adults. The usual measuring time for this
method is approximately 23 to 29 seconds. It should be
noted, however, that an exact reading cannot be obtained
if, for example, the armpits have been allowed to cool. If
this is the case, we recommend extending the measuring
time by around 5 minutes in order to obtain the most
precise possible reading that corresponds as closely as
possible to the core body temperature.
In the mouth(oral)
There are different heat zones in the mouth. As a general
rule, the oral temperature is 0.3°C to 0.8°C lower than the
rectal temperature. To ensure that reading is as accurate
as possible, place the thermometer tip to the left or right
of the root of the tongue. The thermometer tip must have
constant contact with the tissue during the reading and
be placed under the tongue in one of the two heat
pockets at the back, keep the mouth closed during the
reading and breathe evenly through the nose. Do not eat
or drink anything before the measurement. The usual
measuring time is approximately 15 to 19 seconds.
Note: We strongly recommend the rectal method as the
most accurate method for identifying the basal tempera-
ture and advise you to extend the measuring time by 3
minutes after the beep.
*Note: Normally the buzzes are "Bi-Bi-Bi-Bi-"; Alarm
beeps more rapidly when temperature reaches 37.8°C or
higher, and the buzzes are
"Bi-Bi-Bi-----Bi-Bi-Bi-----Bi-Bi-Bi"
How to change the measuring scale
(only for switchable type)
To switch the display between °C and °F, turn the unit on.
Press and hold the ON/OFF button for 2 seconds, the
display will show another scale.
Cleaning and disinfection
The best way to clean the thermometer tip is by applying
a disinfectant (e.g. 70% medical alcohol) with a damp
cloth. It shall be disinfected before each use. The
Waterproof thermometers can be immersed in liquid or
lukewarm water for through cleaning and disinfection.
Safety precautions
• Do not allow the device to come into contact with hot
water.
• Do not expose to high temperatures or direct sunlight.
• Do not drop the thermometer. It is neither shock-proof
nor impact-resistant.
• Do not modify this device without authorization of
manufacturer.
• Do not clean with thinners, petrol or benzenel. Only
clean with water or specied disinfectant.
• Do not use in ammable agents/oxygen rich
environment.
• The thermometer contains small parts (battery, battery
compartment) which can be swallowed by children. For
this reason, do not leave the thermometer unattended in
the hands of children.
• Avoid bending the Non-Flexible thermometer tip. which
contact patient with stainless steel cover.
• If the ambient temperature is over 35°C, dip the
thermometer tip in cold water for approx. 5 to 10 seconds
prior to measuring the temperature.
• Persistent fever, in particular in children, has to be
treated by a doctor- please get in touch with your doctor!
• Do not use near strong electromagnetic fields, i.e. keep
it away from any radio systems and mobile phones.
Rapid Digital Thermometer
Model: DT-K11B
0197
Congratulations on your purchase of this product. Please
read the instructions carefully before using the thermom-
eter for the rst time, and keep this in a safe place.
This product is intended for the measurement of human
body temperature. This product is for home and hospital
use, operator shall be at least 11 years old and patient
can be operator.
Operating Instructions
Before using, please disinfect the probe at rst. To switch
on, press the ON/OFF button next to the display;
indicating that the thermometer is operational. At the
same time the thermometer runs a self-check test, during
which all the digital segments appear on the LCD. When
the letters "Lo" and a ashing "°C" or "°F" display, the
thermometer is ready. If the ambient temperature is below
32°C or 89.6°F, then "Lo°C" or "Lo°F" will appear on the
LCD and if it is above 42.9°C /109.2°F, then "HI°C" or
"HI°F" will appear on the LCD.
During the reading, the current temperature is displayed
and the "°C" or "°F" symbol ashes. The measurement is
completed when a constant temperature value has been
reached. The temperature value is considered constant
when the temperature rises less than 0.1°C within 4
seconds. As soon as the constant temperature value is
reached, and the "°C" or "°F" symbol will stop ashing.
The highest temperature measured appears on the LCD.
However, please note that this thermometer is a
maximum thermometer, i.e. the displayed temperature
can increase slightly if measurement continues after the
beep. This is particularly the case with axillary
measurements, should a temperature value be recorded
which approximates the core body temperature. In this
instance please note the description under "Methods of
measuring temperature". When the measurement is
completed, please switch the thermometer off by
pressing the ON/OFF button. After the temperature has
been displayed, the thermometer will automatically turn
off after 10 minutes.
Memory function
Switch the thermometer off, then press the ON/OFF
button for about 2 seconds. The last measured value with
"°C" or "°F" will appear automatically on the LCD. This
display is visible as long as the ON/OFF button is held
down. The reading is only over-written when a new
temperature value is recorded.
Methods of measuring temperature
It is important to remember that the body temperature
reading depends on the site where it is measured. For
this reason, the measurement site must always be
specied in order to ensure that a correct temperature
reading is recorded.
In the rectum(rectal)
This is the most accurate method from a medical point of
view, because it comes closest to the core body
temperature. The thermometer tip is inserted carefully
into the rectum for a maximum of 2 cm.
The usual measuring time is approximately 9 to 11
seconds.
Thermometric sensor
Battery compartmentThermometer tip
LCD ON/OFF Button
Battery is empty
Manufactured by
Classication according to the degree of
protection against ingress of water as detailed
in IEC 60529
Read the instructions (actual symbol colours
are white on a blue background)
Product disposal instructions for electronic
devices
The battery in this product complies with the
requirements stated in European Directives
2006/66/EEC
Type BF equipment
Manufacture date
CE conformity marking
Stand by
Lo°C or Lo°F: temperature under 32°C or 89.6°F
HI°C or HI°F: temperature over 42.9°C or 109.2°F
Support
Our manual should provide you with all the information
you need to set up and use this product.
If you have a question, have a look at our Troubleshooting
page!
For further assistance, why not contact our Customer
Care team directly? We’re here to help!
Our Customer Care team are available from 9am-5pm,
Monday to Friday (excluding bank holidays).
We promise to respond to all queries and will ensure to
resolve any issue you may be having.
You can reach us by…
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a
message.
Email:
Phone (UK):
+44 1483 937967
Post (UK):
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ
Phone (NZ):
(09) 801 0627
Post (NZ):
Kinetik Wellbeing NZ
44 John Brian Drive, 0794 Redvale, Albany,
Auckland, NewZealand
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By cmlam at 3:52 pm, Jul 26, 2021

ELECTROMAGNETIC COMPATIBILITY INFORMATION
This device is suitable for home healthcare environment and professional healthcare facility environment.
WARNING: 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.
The essential performance is the digital thermometer can offer the temperature measurement.
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic elds,
near the medical device. This may result in incorrect operation of the unit and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7 m. Verify correct operation of the device in case the distance is
shorter.
Guidance and manufacturer's declaration – electromagnetic immunity
Phenomenon Professional healthcare
facility environment
Home healthcare
facility environment
Basic EMC standard
or test method
The device is suitable for use in the specied electromagnetic environment and it meets
the following immunity test levels. Higher immunity levels may cause the device's essential
performance lost or degraded.
Radiated RF
EM elds
Proximity elds
from RFwireless
communications
equipment
Electrostatic
discharge IEC 61000-4-2 +/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
3V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
10V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
1kHz or 2Hz can be specied by
the manufacturer
See the RF wireless communication equipment
table in "Recommended minimum
separation distances".
30A/m; 50 Hz or 60Hz
NA
For input a.c. power port
d.c. power lines or signal input/output lines whose length exceeding 3m
NA
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. output signal output lines connected directly to outdoor cables
IEC 61000-4-3
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-3
IEC 61000-4-8
Electric fast
transients bursts
Surges
Rated power
frequency
magnetic elds
Guidance and manufacturer's declaration – electromagnetic emissions
Phenomenon Home healthcare environment
Profession healthcare
facility environment
The device is suitable for use in the specied electromagnetic environment and it has
meets the following standard's emission requirements.
Home healthcare
environment
CISPR 11, Group 1,
Class A or B CISPR 11, Group 1, Class B
Harmonic distortion IEC 61000-3-2,
Class A or not applicable NA
NA
Voltage uctuations
and icker
IEC 61000-3-3
or not applicable
Conducted
disturbances
induced by
RF elds
NA
NA
NA
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. all patient-coupled cables
4. SIP/SOP whose maximum cable length ≥ 3m
IEC 61000-4-6
IEC 61000-4-11
IEC 61000-4-11
Voltage dips
Voltage
interruptions
UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
Recommended minimum separation distances
Test frequency
(MHz)
Nowadays, many RF wireless equipments are being used in various healthcare locations
where medical equipment and/or systems are used. When they are used in close proximity
to medical equipment and/or systems, the medical equipment and/or systems' basic safety
and essential performance may be affected. This device has been tested with the immunity
test level in the below table and meet the related requirements of IEC 60601-1-2:2014. The
customer and/or user should help keep a minimum distance between RF wireless commun-
ications equipment and this device as recommended below.
385
450
710
745
780
810
870
930
1720
1845
1970
5500
5240
2450
5785
Band
(MHz)
380-390
430-470
704-787
800-960
1700-1990
5100-5800
2400-2570
Service
TETRA 400
GMRS 460
FRS 460
LTE Band
13, 17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3
4, 25; UMTS
WLAN 802.11
a/n
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Modulation
Pulse
modulation
18Hz
FM ± 5 kHz
deviation
1 kHz sine
Pulse
modulation
217Hz
Pulse
modulation
18Hz
Pulse
modulation
217Hz
Pulse
modulation
217Hz
Maximum
power(W)
1.8
2
0.2
2
2
0.2
2
Distance
(m)
0.3
0.3
0.3
0.3
0.3
0.3
0.3
Immunity
test level
(V/m)
27
28
9
28
28
9
28
Pulse
modulation
217Hz
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