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
- Battery replacement
Product disposal
Technical data
Support
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Kinetik

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:
[email protected]

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

|