== TypeTypeBB

9.Technical data

Notes:

•Do not use the device where it may be exposed to flammable gas.

•This device fulfils the provisions of the EC directive 93/42/EEC (Medical Device Directive) and the European Standard EN13544-1:2007, Respiratory therapy equipment - Part1: Nebulizing systems and their components.

= Class ll

= Read the instruction manual carefully

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 EN60601-1-2:2007 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 EN60601-1-2:2007 is available at OMRON Healthcare Europe at the address mentioned in this instruction manual.

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