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31
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09260 Issue 1
Vitalograph VitaloJAK - Instructions for Use
are operating normally.
27. For home use subjects: If there are any changes in the
performance of the equipment contact the site study
administrator.
28. In the unlikely event that there is any visible damage to the
battery pack contact Vitalograph 24/7 support immediately.
29. Reprocessing of single use devices is not permitted.
14. CE Notice
Marking by the symbol
indicates compliance of the Vitalograph
Model 7100 VitaloJAK to the Medical Devices Directive of the
European Community.
The VitaloJAK is intended for use in a variety of professional
healthcare and home environments, e.g. primary care, hospital
wards, occupational health centres and private domiciles, except for
near active high frequency surgical equipment and the RF shielded
room of an ME system for magnetic resonance imaging, where the
intensity of electromagnetic disturbance is high. The customer or
the user of the VitaloJAK should assure that it is not used in such
an environment.
The VitaloJAK has been tested in accordance with:
EN 60601-1:2006 + A1:2013 - Medical electrical equipment. General
requirements for basic safety and essential performance
EN 60601-1-2: 2015 - Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements
and tests.
EN 60601-1-11:2015 - Medical electrical equipment – Part 1-11:
General requirements for basic safety and essential performance –
collateral standard: Requirement for medical electrical equipment
and medical electrical systems used in the home healthcare
environment.
Содержание VitaloJAK 7100
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