Vitalograph copd-6 4000, Инструкция по эксплуатации

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EMC Standards EN 60601-1-2
QA/GMP standards
EN ISO 13485, FDA 21 CFR
820, CMDR SOR/98-282, JPAL,
MDSAP.
Auto power down time Set to 2 minutes as standard
13. Contraindications, Warnings, Precautions and
Adverse Reactions
1. No modification of this equipment is allowed. Any
unauthorised changes to the device may compromise product
safety and/or data and as such Vitalograph cannot be held
responsible and the device will no longer be supported.
2. The device should be only used under the supervision of a
healthcare professional.
3. The device is not designed as a sterile device. Always follow
the safety guidelines given by the manufacturer of cleaning
and disinfectant chemicals.
4. Vitalograph intends that a new Eco Bacterial Viral Filter (Eco
BVF) be used for every subject to prevent cross contamination.
Using a new Eco BVF provides a significant level of protection
of the subject, the device and the user against the risk of cross
contamination during spirometry manoeuvres. An Eco BVF is
for single use only.
5. Spirometry is a valuable tool that provides important
information to clinicians which is used together with other
physical findings, symptoms, and history to reach a diagnosis
(ATS/ERS 2019). And as such, spirometry may support or
exclude diagnosis, but it cannot make one.
6. Take care not to block the mouthpiece with the tongue or
teeth during testing. A ‘spitting’ action or cough will give false
readings.
7. Subject fatigue may occur during testing depending on the
subject’s characteristics e.g. age, health status. For safety
reasons, testing should be preferably done in the sitting
position, using a chair with arms and without wheels. Subject
can also take a break between tests.