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Elta BM122 User Manual

Page 25

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NOTE

This blood pressure measuring device conforms to European regulations and carries the CE-
Symbol “CE 0197”.

The quality of this device has been proven and conforms to the requirements of the European
Community regulation 93/42/EEC (EN IEC 60601-1 – general safety requirements, EN IEC
60601-1-2:2001 – electromagnetic compatibility; requirements and screening processes) from
July 14, 1993 according to medical appliance’s and service standards as follows:

EN 1060-1:

Non-invasive blood pressure device – general requirements

EN 1060-3:

Non-invasive blood pressure device – additional requirements for electromagnetic
blood pressure appliances.

EN 1060-4:

Non-invasive blood pressure device – screening process to determine the
measurement accuracy of automatic non-invasive blood pressure appliances.

Classifications:
• Device with internal power supply
• BF-type device
• IPXO
• Device is not suitable for use near inflammable anaesthetics mixtures with air or

oxygen or nitrogen.

• Continuous operation with short term charging

Manufacturer:
HEALTH ø LIFE Co., Ltd.

9F, No. 186, Jian Yi Road, Chung Ho City 235, Taipei, Taiwan

Authorized Representative in the European Community:
Innovative business promotion GmbH Botzstr. 6 07743 Jena, Germany

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