kinetik WELLBEING DT-K11B Rapid Digital Thermometer User Manual
- June 6, 2024
- kinetik WELLBEING
Table of Contents
- kinetik WELLBEING DT-K11B Rapid Digital Thermometer
- Operating Instructions
- Memory function
- Methods of measuring temperature
- Cleaning and disinfection
- Safety precautions
- Product disposal
- Technical data
- Support
- ELECTROMAGNETIC COMPATIBILITY INFORMATION
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
kinetik WELLBEING DT-K11B Rapid Digital Thermometer
Congratulations on your purchase of this product. Please read the instructions
carefully before using the thermom-eter for the first 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 first. 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 flashing “°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 flashes. 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 flashing. 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 specified 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.
Under the arm(axillary)
Placing the thermometer in the armpit provides a measurement of surface
temperature that can fluctuate 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 temperature 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 specified disinfectant.
- Do not use in flammable 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.
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, fire 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
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
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 specifications of
below standard for:
EN 12470-3
EN 60601-1
EN 60601-1-11
EN 60601-1-2
The CE Marking confirms 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 Notified body confirms that this product
fulfills 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 defined 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.
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…
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
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
customercare@kinetikwellbeing.com
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 fields, 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 emissions
The device is suitable for use in the specified electromagnetic environment
and it has meets the following standard’s emission requirements.
Phenomenon| Pr ofession healthcare facility environment|
Home healthcare environment
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
Voltage fluctuations and flicker| IEC 61000-3-3
or not applicable
| NA
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is suitable for use in the specified electromagnetic environment and it meets the following immunity test levels. Higher immunity levels may cause the device’s essential performance lost or degraded.
Phenomenon
| Basic EMC standard or test method| Pr ofessional healthcare
facility environment| Home healthcare facility environment
Electrostatic discharge|
IEC 61000-4-2
| +/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
Radiated RF EM fields
|
IEC 61000-4-3
| 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 specified by the manufacturer
Proximity fields from RFwireless communications equipment|
IEC 61000-4-3
|
See the RF wireless communication equipment table in “Recommended minimum
separation distances”.
Rated power frequency magnetic fields|
IEC 61000-4-8
|
30A/m; 50 Hz or 60Hz
Electric fast transients bursts
|
IEC 61000-4-4
|
NA
For input a.c. power port
d.c. power lines or signal input/output lines whose length exceeding 3m
Surges| IEC 61000-4-5| 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
Conducted disturbances induced by RF fields
| IEC 61000-4-6| 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
Voltage dips| IEC 61000-4-11| NA
Voltage interruptions| IEC 61000-4-11| NA
UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles
at 60Hz
Recommended minimum separation distances
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.
Test frequency (MHz)| Band (MHz)|
Service
|
Modulation
| Maximum power(W)| Distance (m)| Immunity test level (V/m)
385
|
380-390
|
TETRA 400
| Pulse modulation 18Hz|
1.8
|
0.3
|
27
450
|
430-470
| GMRS 460
FRS 460
| FM ± 5 kHz
deviation 1 kHz sine
|
2
|
0.3
|
28
710|
704-787
|
LTE Band 13, 17
|
Pulse modulation 217Hz
|
0.2
|
0.3
|
9
745
780
810|
800-960
| GSM 800/900, TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
|
Pulse modulation 18Hz
|
2
|
0.3
|
28
870
930
1720|
1700-1990
| GSM 1800;
CDMA 1900;
GSM 1900; DECT;
LTE Band 1, 3
4, 25; UMTS
|
Pulse modulation 217Hz
|
2
|
0.3
|
28
1845
1970
2450
|
2400-2570
| Bluetooth, WLAN,
802.11 b/g/n, RFID 2450, LTE Band 7
|
Pulse modulation 217Hz
|
2
|
0.3
|
28
5240| 5100-5800| WLAN 802.11
a/n
| Pulse modulation 217Hz| 0.2| 0.3| 9
5500
5785