kinetik WELLBEING DT-K111D Rapid Flexible tip Digital Thermometer User Manual

Rapid Flexible tip Digital Thermometer
Model: DT-K111D

0197

Congratulations on your purchase of this product. Please read the instructions carefully before using the thermometer for the first time, and keep these in a safe place. This product is intended for the measurement of human body temperature. this product is for home and hospital use, the operator shall be at least 11 years old and the patient can be the operator.

Operating Instructions

Before using, please disinfect the probe at first. To switch on, press the ON/OFF button next to the display; a short beep will sound, 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 “L” and an ashing “°C” or “°F” display, the thermometer is now ready for use. If the ambient temperature is below 32°C or 89.6°F, then “L°C” or “L°F” will appear on the LCD and if it is more than 42°C or 107.6°F, then “H°C” or “H°F” will appear on the LCD. During the reading, the current temperature is displayed continuously, 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, a beep will sound 12 times, 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, the temperature value should 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 shut off automatically after 4 minutes and a beep sound.

Memory function

Switch the thermometer on, a short beep will sound. At the same time, the thermometer runs a self-check test,  during which all the digital segments appear on the LCD. After that, The last reading value with “°C” or “°F” will appear automatically on the LCD for about 2 seconds. 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. Lubricating the thermometer tip with ungluing agents before use. Do not use vaseline. The thermometer tip is inserted carefully into the rectum for a maximum of 13 mm. The usual measuring time is approximately 10 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 that an exact reading won’t be obtained if, for example, the armpit temperature is lower than normal (the armpit temperature has been cooled down). If in this 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 the 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 25 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 1 Minute after the beep.

How to change the measuring unit

Under the power-off state, press the ON/OFF button for 2 seconds, the display will show “b” and the unit in use. Press the ON/OFF button to switch the unit, Then the thermometer will be operational after 3 seconds

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 thorough cleaning and disinfection.

Safety precautions

• The incorrect methods of measuring temperature may lead to inaccurate measurement results.
• 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 the authorization of the manufacturer.
• Do not bend or open the device (except the battery compartment).
• Do not clean with thinners, petrol, or benzene. Only clean with water or disinfectant.
• Do not immerse the Waterproof thermometers underwater 15cm for longer than 30 minutes.
• The thermometer contains small parts (battery, battery this reason, do not leave the thermometer unattended in the hands of children
• Avoid bending the thermometer tip by more than45 degrees.
• If the ambient temperature is over 35°C or 95°F, 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.

ELECTROMAGNETIC COMPATIBILITY INFORMATION

This device is suitable for home healthcare environments and professional healthcare facility environments. 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. The recommendation is to keep a minimum distance of 7 m. Verify the 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 met the following standard’s emission requirements.
Phenomenon| Profession 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| Professional healthcare
facility environment| Home healthcare
facility environment
Electrostatic
discharge| IEC 61000-4-2| 4/- 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 1 kHz 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 wireless 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 81000-4-8| NA
---|---|---
For 1, input ac. power pat:
2.all d.c. power ports connected permanently to cables >3m
3.all patient-coupled cables
4.SIP/SOP whose maximum cable length z 3m
Voltage dips| IEC 61000-4-11| NA
Voltage
interruptions| IEC 81000-4-11| NA
UT: rated voltage(s): Eg. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz

Recommended mini num separation &stances

Nowadays. many RF wifeless equipment is 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 meets the related requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance between RF wireless communications equipment and this device as recommended below.
Test frequency
(MHz/| Band
(MHz)| Service| Modulation| Maximum| Power (W/
Distance
On)| Immunity
test level
pi ing
385| 380-390| TETRA 400| Pau/
moderation
18Hz| 2.| 0.3| 27
450| 430-470| GMRS 460
FRS 480| FM k 5 kHz
deviation
1 kHz sine| 2| 0.3| 28
710| 704-787| LTE Band
13. 17| Rise
modulation
217Hz| 0.2| 0.3| 9
745
780
810| 800-960| GSM 800900. TETRA800. OEN 820. COMA 850. LTE Band 5| Pulse
modjation
12Hz| 2| 0.3| 28
870
930
1720| 1700-1990| GSM 1800
COMA 1900:
GSM 1900.
DECT:
LIE Band 1, 3
4, 25: MATS| Pulse
modulation 217Hz| 2| 0.3| 28
1845
1970
2450| 2400-2570| Bluetooth,
WLAN. 802.11 WO. RRD 24.%. LTE Band 7| Pulse
moddation
217Hz| 2| 0.3| 28
5240| 5100-5800| WLAN 802.11
ern| Pulse
moddation
217Hz| 0.2| 0.3| 9
5500
5785

Battery replacement
The battery is low voltage and needs to replace when the” ” battery symbol appears on the right of The LCD Remove the battery cover. Pull out the inner frame gently, then take out the battery with a toothpick or tweezers, replace the battery of the same type. The electrode of the battery: 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. The backlight of different thermometers will have differences, it may be related to the battery power or the versions of the thermometer, attribute normal phenomenon.

Product disposal

Please ensure environmental protection. Batteries do not belong to domestic waste. Please hand them in at the collection point or the municipal recycle material center 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: (32.0~42.0)°C/(89.6~107.6)°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/89.6°F~95.9°F)
Storage/transportation temperature: (-25~55)°C, ≤95%RH
Ambient temperature during use: (5~35)°C, ≤Min Scale: 0.1°C/0.1°F
Battery type:
Lithium battery, type CR 1632, 3V, service life minimum
100 hours under continuous operation.
Weight: Approx. 19g
Display: Illuminated display
Atmospheric pressure: 700~1060hPa

Explanation of symbols
or Battery is empty
Manufactured by
Type BF equipment
Manufacture date
Product disposal instructions for electronic devices
Read the instructions (actual symbol colors are white on a blue background)
Classification according to the degree of protection against ingress of water as detailed in IEC 60529
The battery in this product complies with the requirements stated in European Directives 2006/66/EEC
CE conformity marking
Stand by

L°C or L°F: temperature under 32°C or 89.6°F
H°C or H°F: temperature over 42°C or 107.6°F

Legal requirements and guidelines
This product complies with the European Directive for Medical Devices 93/42/EEC and carries the CE mark. The device also complies with the specifications of the European Standard EN 12470-3 Clinical thermometers – Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with the maximum device. The CE marking confirms that this is a medical device with a measuring function in the sense of the Medical Devices Act which has undergone a conformity assessment procedure. A Notified Body confirms that this product fulls 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 intervention or by any other means. Please also observe any national statutory regulations. The calibration check can be carried out by competent authorities or by authorized service providers. A test instruction for calibration check can be provided to the relevant authorities and authorized 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 is available from 9 am-5 pm, 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
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Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email: [email protected]

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

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