09220 Issue 2
19Page of 28
ENG
Vitalograph COMPACT - Instructions for Use
Notes:
• All values displayed are expressed as BTPS values.
• Take care not to block the cone with the tongue or teeth. A ‘spitting’ action
or coughing will give false readings.
• Time zero is determined using the back-extrapolated method, from the
steepestpartofthecurve.Theoperatingconditionsspeciedapplytothe
device plus accessories.
• TheowheadandBVFareclassiedastypeBappliedparts.Thedevice
• body or other accessories are not applied parts. An applied part is a part of
the equipment, that in normal use necessarily comes into physical contact
with the subject for equipment or system to perform its function
15. CE Notice
Marking by the symbol indicates compliance of the Vitalograph Model
6600 Compact to the Medical Devices Directive of the European Community.
The Vitalograph Compact is intended for use by trained healthcare
professionals in a variety of professional healthcare environments, e.g. primary
care, hospitals, clinics and mobile clinics including occupational health settings
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 should assure that it is not
used in such an environment.
The Model 6600 Compact has been tested in accordance with:
EN60601-1:2006 + A1:2013 + A2:2021 - Medical electrical equipment. General
requirements for basic safety and essential performance
EN 60601-1-2:2015 + A1:2021 - Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.
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