beurer FT 09-1 Clinical Thermometer User Manual

: June 9, 2024
: Beurer

Table of Contents

Signs and symbols
Use
Memory
Changing the battery
Cleaning/Disinfection
Storage/Disposal
Technical data
Warranty / service
References
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FT 09/1
User Manual

Signs and symbols

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and accessories:

| Caution
---|---
| Follow instructions for use
| Type BF applied part
| Disposal in accordance with EC Directive WEEE (Waste Electrical and Electronic Equipment)
| Manufacturer
| Dispose of packaging in an environmentally friendly manner
| Protected against foreign objects equal to or greater than 12.5 mm and against temporary immersion in water.
| Batch designation
Storage/Transport| Permissible storage and transport temperature and humidity
Operating
| Permissible operating temperature and humidity
| This product satisfies the requirements of the applicable European and national directives.

Included in delivery: • Thermometer • Instruction for Use • 1 x 1,5 V LR 41 battery
Important safety information – retain for later use.
In order to make optimum use of all the merits of the clinical thermo meter, you should carefully read the operating instruc-tions before using it, retain the instructions for later use and also keep them accessible for other users.

The thermometer is intended to measure the temperature of the human body.
The thermometer is only designed for the measuring area on the human body stated in the instructions for use.
Children should not use the thermometer without supervision.
Before each use, check the thermometer for signs of damage or wear. Damaged or worn thermometers should not be used.
Always wait for the acoustic signal which indicates the minimum time required for measurement. Discuss the temperature with your family physician.
The thermometer contains sensitive electronic parts. Therefore, protect it from blows, bending, high temperature or direct exposure to sunlight.
Using the thermometer in strong electromagnetic fields such as next to a mobile phone, can cause a malfunction.
When the thermometer is switched on, it carries out a selftest. Therefore the accuracy of measurement need not be tested at regular intervals.
If the temperature is very abnormal, please contact your family doctor promptly
This device meets the requirements of the EU Directive 93/42/EEC concerning medical devices, as well as those of the Medizinproduktegesetz (German Medical Devices Act), the European Standard EN 12470-3: Clinical thermometers – part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device and the European Standard EN60601-1-2 (In accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3 and IEC 61000-4- 8), and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit.

Notes on electromagnetic compatibility

The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
The use of the device may be limited in the presence of electromagnetic disturbances.
This could result in issues such as error messages or the failure of the display/device.
Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation.
If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.
Failure to comply with the above can impair the performance of the device.

Measuring methods:
Temperature measurement in the anus (rectal)
This method of measurement is most reliable and most accurate.
Guide the tip of the thermometer carefully 2 to 3 cm into the anus.
Measurement in the mouth cavity (oral)
For this purpose, guide the tip of the thermometer carefully into one of the heat pouches beneath the tongue, to the left or the right of the root of the tongue.
Measurement of temperature in the armpit (axillary)
This method of measurement is relatively inaccurate. Therefore, it cannot be recommended from a medical point of view.

Mode of measurement| Recommended time required for measurement| Mean divergence to the rectal method
---|---|---
in the anus| until the acoustic signal| –
in the oral cavity| until the acoustic signal| -0.4 °C to -1.5 °C
in the armpit| minimum 5 minutes| -0.7 °C to -2.0 °C

Use

First remove the protective foil from the display. For switching on, briefly press the on/off key. A short acoustic signal will announce that the thermometer is switched on. The thermometer will carry out a self-test for about 2 seconds. During the selftest all segments of the display will appear. Then the reference reading (37 °C) appears. Then the measurement symbol “°C” flashes and “Lo” is shown on the display. The thermometer is now ready for use. During the measurement, the current temperature is displayed continuously, and the “°C” symbol flashes on and off. The measurement is completed when a stable temperature has been reached. When this stage has been reached, an acoustic signal is heard, the “°C” symbol stops flashing and the temperature measured is displayed. As long as the measured temperature is below 32 °C, “Lo °C” will appear. Higher temperatures will be shown directly, e.g. 32,1 °C. By prolonging the length of measurement until after the acoustic signal, more accurate measurements can be obtained. In case the temperature is measured in the armpit, the thermometer should be left in the armpit for the recommended time of measurement, in spite of the acoustic signal. If temperatures over 37,8 °C are measured, a fever alarm sounds (short bleeping tones, 10 seconds long). If temperatures higher than 42,9 °C are measured, the symbol for “Hi °C” will appear. To prolong the life of the battery, please switch off the thermometer by briefly pressing the on/off key after the measurement. Otherwise the thermometer will automatically switch off after 10 minu tes.

Memory

The last measured value will be stored automatically. Press the ON/OFF button to display this value. The thermometer first carries out a self test. Next the last stored measured value is displayed for approx.
2 sec and then the reference value of 37 °C and “Lo” is shown on the display.
The thermometer is ready to take a measurement and the previously stored measurement value is automatically replaced by the new measurement value.

Changing the battery

The clinical thermometer contains a long-lasting alkali-manganese battery (type LR 41, 1.5 V) for approximately 2 years.
The battery needs to be replaced when all digital reading appear flashing on the display screen. Release the battery compartment cover by gently pressing on the catch. Remove the old battery and replace it with a battery of the same type.
The + sign on the battery must point upwards. Then close the battery compartment, making sure that the catch clicks into place.
The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers.
You are legally required to dispose of the batteries.
The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury.
These batteries contain lead (Pb) and mercury (Hg).

Notes on handling batteries

If your skin or eyes come into contact with battery fluid, flush out the affected areas with water and seek medical assistance.
Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.
Observe the plus (+) and minus (-) polarity signs.
If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
Protect the batteries from excessive heat.
Risk of explosion! Never throw batteries into a fire.
Do not charge or short-circuit batteries.
If the device is not to be used for a long period, take the batteries out of the battery compartment.
Use identical or equivalent battery types only.
Always replace all batteries at the same time.
Do not use rechargeable batteries.
Do not disassemble, split or crush the batteries.

Cleaning/Disinfection

The device must be cleaned and disinfected before and after each use. The thermometer is 100 % water-proof. For the purpose of cleaning or disinfection, it can be dipped into water or disinfectant without any difficulties.
Under no circumstances should the thermometer be boiled! Use one of the following disinfectants in accordance with the manufacturer’s instructions.
Other cleaning agents or methods could impair the function of the thermometer or damage it.
Name of the agent: Isopropanol 70 % Pharmacy; Gigasept FF; Lysoformin; Aseptisol.

Storage/Disposal

When you are not using the thermometer, please retain it in the original protective cover.
The accuracy of this thermometer has been carefully checked and developed with regard to a long useful life.
If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.
For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. **** Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.

Technical data

Type	FT 09/1
Range of measurement	32 °C to 42,9 °C
Accuracy of measurement	± 0.1 °C in a water bath with a temperature of 35,5

°C to 42,0 °C
± 0.2 °C in a water bath with a temperature of 32,0 °C to 35,4 °C
± 0.2 °C in a water bath with a temperature of 42,1 °C to 42,9 °C
Ambient temperature| +10 °C – +40 °C, with 30 % to 85 % relative humidity
Storage temperature| -10 °C – +60 °C, with 25 % to 90 % relative humidity

The serial number is located on the device or in the battery compartment.