Vitalograph alpha 6000, Инструкция по эксплуатации

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DT_0006 Issue 15
2. The device is not designed as a sterile device. Always follow the safety
guidelines given by the manufacturer of cleaning and disinfectant
chemicals.
3. Vitalograph intends that a new Bacterial Viral Filter (BVF
TM
) be used for
every subject to prevent cross contamination. Using a new BVF provides a
significant level of protection of the subject, the device and the user against
cross contamination during spirometry manoeuvres. A BVF is for single use
only.
4. Spirometry may support or exclude diagnosis, but it cannot make one (ATS/
ERS 2019
3
).
5. The Alpha is marked as ‘Rx Only’ and as such is restricted to sale by, or on
the order of a physician.
6. When using the device ensure that the flowhead connecting tube is not
pinched or trapped as spirometry results may be affected, or a false reading
may be detected.
7. Take care not to block the flowhead with tongue or teeth during testing. A
‘spitting’ action or cough will give false readings.
8. Subject fatigue may occur during spirometry 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 may also take a break between tests. A max
test completed message will appear after eight manoeuvres.
9. All values displayed are expressed as BTPS values.
10. Time zero is determined using the back-extrapolated method, from the
steepest part of the curve.
11. Do not expose the device to liquids.
12. The device should not be used in the presence of flammable liquids or
gases, dust, sand or any other chemical substances.
13. All spirometry standards recommend completing a calibration verification
of lung function measuring devices daily with a 3-L syringe to verify that
the instrument is measuring accurately. The device should never be outside
accuracy limits. A calibration verification should also be completed after
cleaning or disassembling the spirometer for any reason, after adjusting
calibration or if the flowhead or device has been dropped.
14. Service and repairs should be carried out only by the manufacturer or by
Service Agents approved by Vitalograph.
15. Maintenance must not be performed while the device is in use by a subject.
16. The device contains a Lithium coin cell battery and a NiMH main battery
which are not accessible by the user. Any suspected battery faults should
be reported to the manufacturer.
17. The internal NiMH battery is not user accessible or user replaceable. In
the unlikely event that any issues are noted with the power or battery such
as swelling or leaking, stop using the device immediately, do not charge
3 ATS/ERS Standardisation of Spirometry Eur Respir J 2019