Omron Comp AIR Elite NE-C30 - Инструкция по эксплуатации - Страница 28

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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.

= Type B

= Type B

= 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.

NE-C30_main.book  Page 28  Tuesday, December 13, 2011  12:14 PM