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Specifications are subject to change without prior notice or any obligation on the parts
of the manufacturer. Certain features may require purchase of separate services.
DISPOSAL
Actuation of European directives 2002/95/EC, 2002/96/EC and
2003/108/EC, for reduction in use of dangerous substances in the
electric and electronic device and for garbage disposal. The symbol
applied on the device or its packaging means that at the end of its useful
life the product must not be disposed of with domestic waste.
At the end of devices useful life, the user must deliver it to the able
collecting centers for electric and electronic garbage, or give back to the retailer when
purchasing a new device. Disposing of the product separately prevents possible
negative consequences for the environment and for health, deriving from inadequate
disposal. It also allows the recovery of materials of which it’s made up in order to obtain
an important saving of energy and resources and to avoid negative effects to the
environment and health. In case of abusive disposal of device by the user, will be applied
administrative endorsements in compliance with current standard. The device and its
parts is made with regard to disposal, as appropriate, in accordance with national or
regional regulations.
CERTIFICATIONS
This device complies with the following normative documents:
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices as
amended by Directive 2007/47/EC
EN ISO 13485:2003 /AC: 2009: Medical devices - Quality management
systems – Requirements for regulatory purposes (ISO 13485:2003) Reference
to standards contd.
EN ISO14971:2012: Medical devices - Application of risk management to medical
devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-
1:2006+AC (2010): Medical electrical equipment - Part 1: General requirements for
basic safety and essential Performance
EN1060-3:1997+A1:2005+A2:2009: Non-invasive sphygmomanometers,Part 3:
Supplementary requirements for electromechanical blood pressure measuring systems
EN1060-4:2004: Non-invasive sphygmomanometers. Test procedures to determine
the overall system accuracy of automated non-invasive sphygmomanometers
IEC/EN 60601-1-11: General requirements for basic safety and essential
performance –Collateral Standard: Requirements for medical electrical equipment
and medical electrical systems used in the home healthcare environment
IEC 80601-2-30:2009 (First Edition) for use in conjunction with IEC
60601-1:2005
EN 80601-2-30:2010/ ANSI/AAMI 80601-2-30:2009: Particular requirements
for the basic safety and essential performance of automated non-invasive
sphygmomanometers
EN300328 V1.7.1:2006: Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems; Data transmission equipment operating in
the 2,4 GHz ISM band and using wide band modulation techniques;
