bosotherm basic Thermometer Instruction Manual

BOSCH + SOHN GERMANY
bosotherm basic

User Instructions

Symbols on the thermometer

	Keep out of reach of children
	Read the instructions carefully before using this device
	Type BF applied part
	Caution
	Medical device
	Model number
	Reference number
	Lot number (YYYY-MM-DD; year-month-day)
	Manufacturer
	Date of manufacture
	CE Marking of Conformity
	Authorized representative in the European Community
	Authorized representative in Switzerland
	Temperature limitation for operating or storage
	Humidity limitation for operating and storage
	Dispose in accordance with waste electrical and electronic equipment(WEEE) directive.
	Importer
	Distributor
	Unique Device Identifier
	Keep away from sunlight
	Single use only
	Patient information website
	Not made with natural rubber latex
	Keep dry
	Dust-tight. Protected against the effects of temporary immersion in water.

Optional accessories

Single use probe cover for hygienic measurement: Micro life probe covers for digital thermometer are available as an accessory. Use probe covers compatible with the device for measurements to avoid cross contamination between measurements and patients. Using a non-compatible probe cover with the device may affect measurement accuracy. Optional probe cover installation: Insert the thermometer thoroughly into the probe cover and remove the probe cover protection layer. After measurement completed, remove used probe cover and dispose it in accordance with applicable local regulations.

Caution: DO NOT re-use the probe cover. The probe cover is intended only for single-use to prevent cross-contamination.
Device installation and setup
A battery is pre-installed in the device. When the low battery symbol «» appears in the display, the battery is flat and needs replacing. Remove the battery compartment cover 3 from the thermometer by using proper instrument. Replace the new battery with the + at the top.

NOTE:
Make sure you have a new battery on hand. For the correct battery type, please refer to „Technical specifications“. Keep the battery away from children/infants.
This document provides important product operation and safety information regarding this device. Please read this document tho roughly before using the device and keep for future reference.

Important Information

Device description:
A digital thermometer is a medical device that utilizes the principles of conductive thermal equivalent between device-body contact and digital signal processing to compute and provide a body temperature measurement.
Intended purposes: The device is intended to measure body temperature.
Intended user: The device is intended to be operated by adults and adolescents with adequate vision, motor functions, and education, capable of understanding the instructions for use and operating general household electrical appliances.
Intended patient:
The intended patients are the general population of all ages.
Intended use environment and conditions:
The device is intended for use in a home healthcare environment (e.g. general household without medically trained personnel) by patients (e.g. for self-measurement) or by a care giver, and in a professional healthcare facility (e.g. physician office).
Indications: This device measures body temperature for indications of:
– Screening for illness and conditions related to high or low body temperature.
Contra-indications:
– The device is not suitable for use on sites with any breached or compromised skin.
– Do not attempt rectal measurements on persons with rectal disorders.

WARNING!
NOTE: Warning items indicate potentially hazardous situations, if not avoided, may result in death, critical or serious injury to the user or patient.
– This device may only be used for the purposes described in this instruction manual. The manufacturer cannot be held liable for damage caused by incorrect use.
– The measurement result of this device is not a medical diagnosis and not intended to substitute consultation and diagnosis by a qualified professional healthcare provider (e.g., physician, pharmacist, or other licensed health-care professionals).
Do not use this device for self-diagnosis or for self-treatment of a medical condition.
Seek advice from a health-care professional immediately if the patient is clearly unwell and/or having physiological or medical symptoms.
– This product contains a button cell battery. A swallowed button cell battery can cause internal chemical burns in as little as two hours and lead to death. Dispose of used batteries immediately. Keep new and used batteries away from children/infants. If you think batteries might have been swallowed or  placed inside any part of the body, seek immediate medical attention.
– Do not attempt to measure temperature of the body sites that are not specified in this instruction.
– Ensure that children do not use the instrument unsupervised; some parts are small enough to be swallowed.
– Do not walk or run when taking temperature.
– For safety reasons (risk of rectal perforation) rectal measurement in children younger than 3 years must be performed only by trained health care personnel (professional user). Use another measure-ment method instead. For rectal fever measurement in small children younger than 3 years, thermometers with a flexible probe are available.
– Professional users must follow the country specific applicable medical devices ordinance.

CAUTION
NOTE: Caution items indicate potentially hazardous situations, if not avoided, may result in minor or negligible injury to the user or patient, or damage to the property or environment.
– If the patient temperature is influenced (e.g. incubator, heating blanket) the measurement result provided by this device shall not be used to determine the presence/absence of fever.
– Use of compatible probe cover, or cleaning and/or disinfection of device is recommended before / after measurement to avoid cross contamination. Refer to «Device maintenance and disposal» section for details.
– Do not bite, chew or bend the device probe excessively.
– Do not use this device if you think it is damaged or notice anything unusual.

Electromagnetic Compatibility Information
– This device is compliant with EN 60601-1-2 Electromagnetic Disturbances standard.
Further documentation in compliance with this EMC standard is available from Micro life on www.microlife.com/electro-magnetic-compatibility.

– Do not use this device close to strong electromagnetic fields and portable radio frequency communication devices (for example microwave oven and mobile devices). Keep a minimum distance of 0.3 m from such devices when using this device.
-This device is not certified to be used in the vicinity of medical equipment including high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) and computerized tomography (CT) instruments.

Adverse events and reporting
Please report any serious incident that has occurred in relation to the device, injury or adverse event to the local competent authority and to the manufacturer or to the european authorised representative (EU REP).
Turning on the thermometer
To turn on the thermometer, press the ON/OFF button ; 1 a short beep signals «thermometer ON». A display test is performed. All segments should be displayed.
Then at an ambient temperature of less than 32 °C, an «L» and a flashing «C» appear at the display field 2. The thermometer is now ready for use.

Function test
Correct functioning of the thermometer is tested automatically each time it is turned on. If a malfunction is detected (measurement inaccuracy), this is indicated by «ERR» on the display, and a measurement becomes impossible. In this case, the thermometer must be replaced.

Storage of Measured Values
If the ON/OFF button 1 is pressed for more than 3 seconds when turning on the thermometer, the automatically stored maximum temperature during the last measurement will be displayed. At the same time, a «M» for memory will appear on the display. About 2 seconds after the button is released, the temperature value disappears and the thermometer is ready for measurement.

Using the thermometer
Choose the preferred measuring method. When taking a measure-ment, the current temperature is continuously displayed and the «C» symbol flashes. If the beep is heard 10 times and the «C» is no longer flashing, the end-temperature has been determined and the thermometer can be read now. To prolong the battery life, turn off the thermometer by briefly pressing the ON/OFF button 1. Otherwise the thermometer will automatically turn off after about 10 minutes.

Measuring methods / Normal body temperature
Wipe the underarm with a dry towel. Place the measuring sensor 4 under the arm into the center of the armpit so the Measuring sensor is touching the skin and position the patient’s arm next to the patient’s body. This ensures that the room air does not affect the reading. Because the axillary takes more time to reach its stable temperature wait at least 5 minutes, regardless of the beep sound.

Do not eat or drink anything hot or cold 10 minutes before the measurement. The mouth should remain closed up to 2 minutes before starting a reading. Position the thermometer in one of the two pockets under the tongue, to the left or right of the root of the tongue. The measuring sensor 4 must be in good contact with the tissue. Close your mouth and breathe evenly through the nose to prevent the measurement from being influenced by inhaled/exhaled air.
If this is not possible due to blocked airways, another method for measuring should be used.
Approx. measuring time: 1 minute

The use of a probe cover and a lubricant is recommended. Carefully insert the measuring sensor 4 of the thermometer 1 to 2 cm into the anal aperture. If you are unsure of this measurement method, you should consult a professional for guidance/training.
Approx. measuring time: 1 minute

Device error and troubleshooting

Device maintenance and disposal

Cleaning and disinfecting
Cleaning the thermometer is recommended before and after use. (Remove the probe cover before cleaning and disinfection, if applicable). To clean and disinfect the thermometer:

1. Select swab or cotton tissue and moisten it with 70% Isopropyl alcohol.
2. Wipe the surface of the device from the end of the thermometer probe 5 towards the measuring sensor 4 on both front and back side thrice per swab. Repeat this step to both clean and disinfect the thermometer (use at least two swabs).
   Caution: Avoid wiping and immersion of the display area to protect it from fading.
3. Dry out the thermometer on a clean paper towel for 1 minute. Check the thermometer is still functionable after cleaning and disinfecting.

NOTE: Consider the application and safety instruction of the disinfectant manufacturer.
Caution: Do not boil, clean in dishwasher or clean in autoclave units.
Other cleaning agents or cleaning methods may cause malfunction or damage to the product and will void the warranty.

Storage
When not in use:
Keep the device and accessories in a dry, cool place away from sunlight, with ambient conditions within the temperature and humidity ranges described in the «Technical specifications» section.
Warning: Storing the device unused for an extended period without removing batteries increases the chance of battery fluid leakage, which may lead to device damage and skin irritation when in contact. If your eye or skin is exposed to battery fluid, wash the  exposed part immediately with ample clean water. Consult a doctor if irritation or discomfort persists.

Calibration and support
The device is calibrated during manufacturing. In general, it is recom-mended to have the device verified by your local designated Micro life device distributor every two years, or after mechanical impact, liquid ingress, and/or device malfunctions. For questions related to device measurement accuracy, please contact your local designated Micro life device distributor.
Caution: Do not attempt to service or calibrate the device and accessories yourself.

Disposal
This device is medical electrical equipment. Dispose this device and batteries in accordance with the Waste Electrical and Electronic Equipment (WEEE) directive and applicable local regulations. Do not dispose of the device and batteries with domestic or commercial waste.
Guarantee 
This unit is under warranty for 2 years from the date of purchase. Please submit the receipt, invoice or delivery note when claiming for warranty. For both, warranty and repair, please send the instrument carefully packed and postage paid either to your authorized dealer or directly to BOSCH + SOHN GMBH U. CO. KG, Bahnhofstr. 64, 72417 Jungingen – Germany
Warranty and repair work must be undertaken by trained and authorised personnel. Do not modify this equipment without authorization of the manufacturer.

Specifications and compliance

Technical specifications

Device name: Digital thermometer
Model number: MT1681
Reference number: 521-0-024
Operating mode: Direct mode
Measurement site: Sublingual, rectal or axillary
Measurement range: 32.0 °C to 43.9 °C Temp. < 32.0 °C: display «L» for low (too low) Temp. > 43.9 °C: display «H» for high (too high)
Measurement accuracy (Laboratory): ± 0.1 °C; 34 °C – 42 °C ± 0.2 °C; 32.0 – 33.9 °C and 42.1 – 43.9 °C
Operating conditions: 10 – 40 °C; 15 – 90 % relative maximum humidity 700 – 1060 hPa Atmospheric pressure
Storage and transport conditions: -20 – +55 °C 15 – 90 % relative maximum humidity 700 – 1060 hPa Atmospheric pressure
Battery: LR41 (1.5V) / SR41 (1.55V)
Battery lifetime: approx. 4500 measurements (using a new battery)
Ingress protection (IP) rating: IP 67:Dust-tight. Protected against the effects of temporary immersion in water.
Dimensions: 122.5 ± 0.5 * 18.2 ± 0.2 * 10.0 ± 0.2mm
Weight: Approx. 10.7 ± 0.5 g (including battery)
Expected service life: 5 years or 10000 measurements

Compliance information
This device complies with the requirements of the Medical Device Regulation (EU)2017/745.
Compliant standards: EN 60601-1; EN 60601-1-2; EN 60601-1-11; EN ISO 80601-2-56
NOTE: Technical alterations reserved.

BOSCH + SOHN GmbH u. Co. KG
Bahnhofstraße 64
72417 Jungingen, Germany
Micro life Corporation
9F, No. 431, RuiGuang Road, NeiHu
Taipei 114, Taiwan, China, www.microlife.com

Micro life UAB
P. Lukšio g. 32
08222 Vilnius, Lithuania, eurep@microlife.lt

Micro life AG
Espenstrasse 139, 9443 Widnau, Switzerland