Kinetik Rapid Digital Thermometer

Model: DT-K11B

CE 0197

Manufactured by: Hangzhou Hua'an Medical & Health Instruments Co., Ltd

European Representative: Shanghai International Holding Corp. GmbH (Europe)

Introduction

Congratulations on your purchase of this product. Please read the instructions carefully before using the thermometer 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. The operator shall be at least 11 years old and the patient can be the operator.

Operating Instructions

Before using, please disinfect the probe first. To switch on, press the ON/OFF button next to the display; this indicates 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. 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, 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.

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.

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 15 to 19 seconds.

Axillary (Under the arm)

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.

Note on Beeps: 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. Waterproof thermometers can be immersed in liquid or lukewarm water for thorough cleaning and disinfection.

Safety Precautions

Battery Replacement

The battery is empty and needs replacing when the [battery indicator] 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 a 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 [recycling 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 inquire with your local authorities.

Technical Data

ParameterSpecification
TypeMaximum 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 pressure700~1060hPa
Mode of operationDirect mode
Transient response time10s
Min Scale0.1°C/0.1°F
Battery typeAlkaline manganese battery, type LR41, 1.5V
Service lifeMinimum 100 hours (continuous operation)
WeightApprox. 13g
Shelf life3 years

Explanation of Symbols

Calibration Check

This thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the operation instructions, 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 authorized service providers. A test instruction for calibration check can be provided to the relevant authorities and authorized services providers on request.

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 standards 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.

Electromagnetic Compatibility (EMC) 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's ability to offer 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 meets the following standard's emission requirements.

PhenomenonHome healthcare environmentProfessional healthcare facility environmentHome healthcare environment
Harmonic distortionCISPR 11, Group 1, Class A or BIEC 61000-3-2, Class A or not applicableCISPR 11, Group 1, Class B
Voltage fluctuations and flickerIEC 61000-3-3 or not applicableNANA

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 to be lost or degraded.

PhenomenonBasic EMC standard or test methodProfessional healthcare facility environmentHome healthcare facility environment
Electrostatic dischargeIEC 61000-4-2±8 kV contact, ±15 kV air±2 kV, ±4 kV, ±8 kV air
Radiated RF EM fieldsIEC 61000-4-310 V/m, 80% AM at 1kHz or 2kHz3 V/m, 80% AM at 1kHz or 2kHz
Proximity fields from RF wireless communications equipmentIEC 61000-4-3See the RF wireless communication equipment table in "Recommended minimum separation distances".See the RF wireless communication equipment table in "Recommended minimum separation distances".
Rated power frequency magnetic fieldsIEC 61000-4-830 A/m; 50 Hz or 60Hz30 A/m; 50 Hz or 60Hz
Electric fast transients burstsIEC 61000-4-4NANA
SurgesIEC 61000-4-5NANA

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 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)ServiceModulationMaximum power (W)Distance (m)Immunity test level (V/m)
385380-390TETRA 400Pulse modulation 18Hz1.80.327
450430-470GMRS 460, FRS 460FM ± 5 kHz deviation, 1 kHz sine20.328
710704-787LTE Band 13, 17Pulse modulation 217Hz0.20.39
745
780800-960GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5Pulse modulation 18Hz20.328
810
870
930
17201700-1990GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTSPulse modulation 217Hz20.328
1845
1970
24502400-2570Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7Pulse modulation 217Hz20.328
52405100-5800WLAN 802.11 a/nPulse modulation 217Hz0.20.39
5500
5785

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, please contact our Customer Care team directly. We are here to help!

Our Customer Care team is 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…

Manufacturer Information

Hangzhou Hua'an Medical & Health Instruments 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. Email: shholding@hotmail.com, Tel.: 049-40-2513175, Fax.: 049-40-255726.

请用AI或EPS档案印刷。 PDF文档只供参考,不可用于印刷, 敬请留意。

Models: DT-K11B, Rapid Digital Thermometer

File Info : application/pdf, 2 Pages, 934.11KB

PDF preview unavailable. Download the PDF instead.

Kinetik DT-K11B NZ IB V4 20210726 Approved Adobe PDF library 15.00 Adobe Illustrator(R) 24.0

Related Documents

Preview Kinetik BPx1A Fully Automatic Blood Pressure Monitor User Manual
Comprehensive user manual for the Kinetik BPx1A Fully Automatic Blood Pressure Monitor, covering setup, usage, interpretation of results, troubleshooting, and specifications. Learn how to accurately measure and understand your blood pressure.
Preview Kinetik WBP1 Blood Pressure Monitor Instruction Manual
Comprehensive instruction manual for the Kinetik WBP1 Blood Pressure Monitor, covering setup, usage, measurement tips, data management, troubleshooting, and specifications for accurate home health monitoring.
Preview Kinetik BPx2 Advanced Blood Pressure Monitor X2 Comfort Quick Start Guide
This quick start guide provides essential steps for setting up and using the Kinetik BPx2 Advanced Blood Pressure Monitor X2 Comfort for accurate blood pressure measurements.
Preview Kinetik NB-222C Compressor Nebuliser Quick Start Guide
Comprehensive quick start guide for the Kinetik NB-222C Compressor Nebuliser, covering essential setup, assembly, and usage steps for effective respiratory treatment.
Preview Kinetik Batteries Explained: Deep Cycle vs. Lead Acid for Car Audio
An in-depth explanation of Kinetik's deep cycle car audio batteries, comparing them to standard lead acid batteries and highlighting the benefits of AGM technology for high-performance audio systems.