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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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