Omron HEM-7221 Instruction Manual page 28

HEM-7221-C1_C_M.book Page 28 Monday, November 22, 2010 1:19 PM
6. Technical Data
• This device fulfils the provisions of EC directive 93/42/EEC (Medical
Device Directive).
• This blood pressure monitor is designed according to the European
Standard EN1060, Noninvasive sphygmomanometers Part 1:
General Requirements and Part 3: Supplementary requirements for
electromechanical blood pressure measuring systems.
• This OMRON product is produced under the strict quality system of
OMRON HEALTHCARE Co. Ltd., Japan. The Core component for
OMRON blood pressure monitors, which is the Pressure Sensor, is
produced in Japan.
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 EN60601-1-2:2007 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
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.
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)
This marking shown on the product or its literature, indicates that it should not be
disposed of, with other household wastes at the end of its working life. To prevent
possible harm to the environment or human health from uncontrolled waste disposal,
please separate this product from other types of
promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this product, or their local
government office, for details of where and how they can return this item for environmentally safe
recycling.
Business users should contact their supplier and check the terms and conditions of the purchase
contract. This product should not be mixed with other commercial wastes for disposal.
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HEALTHCARE conforms to this EN60601-1-2:2007
wastes and recycle it responsibly to