Vitalograph ALPHA Touch - 14 CE Notice

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ENG
DT_0006 Issue 15
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result in improper operation.
19. Non-medical equipment must be kept outside the subject environment
i.e. any area in which intentional or unintentional contact between the
subject and parts of the system, or some other persons touching part of the
system, can occur.
20. Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the ALPHA Touch, including cables
specied by Vitalograph. Otherwise, degradation of the performance of this
equipment could result.
21. Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
22. The applied part is the Flowhead. This along with the BVF, are the contact
points for the subject during a spirometry session. There are no adverse
effects if the subject comes into contact with any other part of the ALPHA
Touch device.
14. CE Notice
Marking by the symbol indicates compliance of the Vitalograph
Model 6000 ALPHA Touch to the Medical Devices Directive of the European
Community.
The Vitalograph Model 6000 ALPHA Touch is intended for use in a variety of
professional healthcare environments, e.g. primary care, hospital wards and
occupational health centres, 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 ALPHA Touch should assure that it is not used in
such an environment.
The Model 6000 ALPHA Touch has been tested in accordance with:
EN60601-1: 2006 - Medical electrical equipment. General requirements for
basic safety and essential performance
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.