Digital Clinical thermometer DT-01B
Digital Clinical thermometer DT-01B
Thank you for choosing this instrument from TFA.
1. Before you use this product
•
Please make sure you read the instruction manual carefully.
•
Following and respecting the instructions in your manual will prevent damage to your instrument and loss of
your statutory rights arising from defects due to incorrect use.
•
We shall not be liable for any damage occurring as a result of non-following of these instructions.
•
Likewise, we take no responsibility for any incorrect readings and for any consequences which may result from
them.
•
Please take particular note of the safety advice!
•
Please keep this instruction manual safe for future reference.
2. For your safety
• The unit is suitable exclusively for measuring human body temperature. The product should only be used as
described within this instruction.
• Before each measurement check intactness of tip and display. Use the unit only when intact.
• Unauthorised repairs, modifications or changes to the product are prohibited.
• Operation in strong electromagnetic fields, such as next to a mobile phone, can lead to malfunction. Keep a
minimum distance of 3.3 m from such devices when using this device.
• The minimum measurement time until the beep must be maintained without exception.
• Discuss the measured values with your doctor.
Caution!
Risk of injury:
• The instrument contains small parts that could be swallowed by children. Keep this instrument and the battery
out of reach of children. Use under parental supervision.
• Batteries contain harmful acids and may be hazardous if swallowed. If a battery is swallowed, this can lead to
serious internal burns and death within two hours. If you suspect a battery could have been swallowed or other-
wise caught in the body, seek medical help immediately.
• Batteries must not be thrown into a fire, short-circuited, taken apart or recharged. Risk of explosion!
• Low batteries should be changed as soon as possible to prevent damage caused by leaking.
• Wear chemical-resistant protective gloves and safety glasses when handling leaking batteries.
Important information on product safety!
• Do not place the unit near extreme temperatures, vibration or shock. Do not bend the instrument.
• The instrument is not waterproof. Protect from moisture.
3. Elements and buttons
A:
Battery compartment
B:
ON/OFF button
C:
Display for the temperature
D:
Temperature probe
4. Use
• Disinfect the tip before each use!
• Press the ON/OFF button for switching on and off.
• When switching on a brief beep tone will sound and all LCD segments will light up for a short moment. The
instrument starts a self-test.
• The display shows for about 2 seconds the last measured temperature.
• Lo stays in the display and °C flashes. If the room temperature is higher than 32 ˚C, the room temperature would
be displayed instead of Lo ˚C. The unit is ready for use.
• The actually measured temperature is permanently shown on the display and the symbol °C flashes. The meas-
urement is completed when the temperature rises less than 0.1 °C within 16 seconds.
• If the maximum temperature remains stable, an alarm will sound 10 times and °C is no longer flashing.
a) Normal alarm (beep ... beep ... beep ...), body temperature below 37.8 °C
b) Fever alarm (beep beep beep ... beep beep beep ...), body temperature 37.8 °C or above
• For axillary measurements, the recommended measuring time has to be observed despite the beep tone.
• Remove the thermometer carefully. Press the ON/OFF button to switch off the instrument. The instrument will
turn off automatically after approx. 10 minutes.
4.1 Measurement methods
Rectal measurement:
• This is the safest method of measurement. It is especially good for babies and infants. Gently insert the ther-
mometer tip 1-2 cm into the anus. Minimum measuring time: 1 minute.
Oral measurement:
• Place the temperature tip in one of the two pockets under the tongue, left or right at the root of the tongue.
Close your mouth during the measurement and breathe calmly. This will prevent the measurement results from
being falsified by breathing air. The measured temperature is on average 0.3 to 0.8 degrees C lower than the
rectally measured temperature. Minimum measuring time: 1 min.
Axillary measurement (under the armpit):
• From the medical point of view this method always provides inaccurate values. A deviation from the rectal
measurement of 0.5 to 1.5 degrees C must be expected. Minimum measuring time: 5 min.
5. Care and maintenance
• Clean the instrument after each use with a soft damp cloth. For disinfection please use water-diluted isopropyl
alcohol according to the manufacturer's instructions. Any other cleansing substances or cleansing method can
cause dysfunction or damage to the instrument. Do not immerse in water or sterilize by boiling method, gas or
steam autoclaves.
• Remove the battery if you do not use the product for a long period of time.
• Keep the instrument in its case in a dry place.
5.1 Battery replacement
• Change the battery when the battery symbol
appears on the display.
• Remove the blue cover and slide out the battery compartment.
• Carefully remove the battery with a pointed object and insert a new LR 41 battery. Make sure the polarity is
correct (+ pole above).
• Slide back the battery compartment and replace the blue cover.
6. Troubleshooting
Problem
Solution
No display
➜
Switch on the instrument
➜
Ensure battery polarity is correct (+ pole above)
➜
Change the battery
Incorrect display
➜
Change the battery
➜
Check the correct position of the thermometer
(see: Measurement methods)
If your device fails to work despite these measures contact the supplier from whom you purchased it.
7. Legal basis for placing of the product in the EU market
• The Digital Thermometer DT-01B, Art.-No.15.2015 is a medical device class 2a according the EU Medical Device
Directive 93/42/EWG. The Digital Thermometer meets the requirements of the standards EN 12470-
3:2000+A1:2009, EN 60601-1:2006+A1:2013, EN 60601-1-11:2015, EN 60601-1-2:2015, EN 60601-1-6:2010+A1:2015,
EN ISO 15223-1:2016, EN ISO 10993-1,-5:2009, EN ISO 10993-10:2010, EN ISO 14971:2012
8. Waste disposal
This product has been manufactured using high-grade materials and components which can be recycled and
reused.
Never dispose of empty batteries and rechargeable batteries in household waste.
As a consumer, you are legally required to take them to your retail store or to appropriate collection
sites depending on national or local regulations in order to protect the environment.
The symbols for the heavy metals contained are: Cd=cadmium, Pb=lead, Hg=mercury
This instrument is labelled in accordance with the EU Waste Electrical and Electronic Equipment
Directive (WEEE).
Please do not dispose of this instrument in household waste. The user is obligated to take end-of-life
devices to a designated collection point for the disposal of electrical and electronic equipment, in
order to ensure environmentally-compatible disposal.
9. Specifications
Type:
Maximum thermometer
Measuring range:
32 °C…42.9 °C
Lo °C
Surrounding temperature lower than 32 °C
Hi °C
Surrounding temperature higher than 42.9 °C
Accuracy:
±0,1 °C at 35.5 °C…42.0 °C
±0,2 °C at 32.0 °C…35.5 °C, 42.0 °C…42.9 °C
Resolution:
0.1 °C
Storage and transport conditions:
Temperature -25 °C…+55 °C / humidity:
≤
95 % rH
Ambient conditions during use:
Temperature 5 °C…35 °C / humidity:
≤
80 % rH
Battery:
LR 41 included
IP protection class:
IP22
Housing dimension:
18 x 10 x 130 mm
Weight:
9 g (instrument only)
10. Explanation of symbols
Instruction manual
Art.-No. 15.2015
D
B
A
C
0197
Device complies with protection class BF
Consult instructions for use
Manufacturer: Hangzhou Hua’an Medical & Health Instruments Co., Ltd, Building 2, 1# Fuzhu Nan RD, Wuchang
Town, Yuhang District 310023 Hangzhou, Zhejiang, China
Lot number
EU Representative: Shanghai International Holding Corp. GmbH (Europe), Eiffestrasse 80, 20537 Hamburg, Germany
Importer: TFA Dostmann GmbH & Co.KG, Zum Ottersberg 12, D-97877 Wertheim, Germany
No part of this manual may be reproduced without written consent of TFA Dostmann. The technical data are correct at the time of going
to print and may change without prior notice. The latest technical data and information about this product can be found in our home-
page by simply entering the product number in the search box.
www.tfa-dostmann.de
E-Mail: [email protected]
04/2020D/GB
Made in P.R.C.
0197
Declaration of European conformity, number of the notified body (TÜV Rheinland)
-25°C
+55°C
Storage and transport conditions:
Temperature: -25 °C…+55 °C
Humidity:
≤
95 % rH
Ambient conditions by use:
Temperature: +5 °C…+35 °C
Humidity:
≤
80 % rH
TFA_No_15.2015_Anl_D_GB_04_20 22.04.2020 16:00 Uhr Seite 2