9.Technical Data

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC.s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation.

Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

This medical device manufactured by OMRON Healthcare conforms to this EN60601-1-2:2001 standard for both immunity and emissions.

Nevertheless, special precautions need to be observed:

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.

Further documentation in accordance with EN60601-1-2:2001 is available at OMRON Healthcare Europe at the address mentioned in this instruction manual.

Documentation is also available at www.omron-healthcare.com.

 

OMRON HEALTHCARE CO., LTD.

 

Manufacturer

24, Yamanouchi Yamanoshita-cho, Ukyo-ku, Kyoto,

 

 

615-0084, Japan

 

 

 

 

 

OMRON HEALTHCARE EUROPE B.V.

 

EU-representative

Kruisweg 577, 2132 NA Hoofddorp, The Netherlands

EC REP

 

www.omron-healthcare.com

 

 

 

 

 

OMRON HEALTHCARE UK LTD.

 

 

Opal Drive

 

 

Fox Milne, Milton Keynes MK15 0DG, United Kingdom

 

Subsidiary

OMRON Medizintechnik Handelsgesellschaft mbH

 

John-Deere-Str. 81a, 68163 Mannheim, Germany

 

 

 

 

www.omron-medizintechnik.de

 

 

 

 

 

OMRON SANTÉ FRANCE SAS

 

 

14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, France

 

 

 

Made in China

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Omron BF400 instruction manual Omron Healthcare Europe B.V