09100 Issue 1
29Page of 36
ENG
ALPHA Touch - Instructions for Use
5. Spirometry is a valuable tool that provides important information to
clinicians which is used together with other physical ndings, symptoms,
and history to reach a diagnosis (ATS/ERS 2019).
6. When using the ALPHA Touch ensure that the owhead connecting tube is
not pinched or trapped as spirometry results may appear to be inverted.
7. Take care not to block the mouthpiece 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.
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 ALPHA Touch to liquids with the exception of the
isopropyl alcohol impregnated cloth specied for cleaning.
12. The ALPHA Touch should not be used in the presence of ammable liquids
or gases, dust, sand or any other chemical substances.
13. All spirometry standards recommend checking the accuracy of lung
function measuring devices daily with a 3-L syringe to validate that the
instrument is measuring accurately. The ALPHA Touch should never be
outside accuracy limits. Accuracy should be checked after cleaning or
disassembling the spirometer for any reason, after adjusting calibration or if
the owhead 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 Nickle-metal hydride
(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
the device and contact Vitalograph support. In case of leaking ensure the
electrolyte does not get in the eyes or touch skin. If electrolyte contacts
the eyes ush the area immediately with water for 15 minutes and seek
medical attention. If electrolyte contacts the skin wash the affected area
immediately and seek medical attention. Do not inhale the leaked material,
leave the area immediately and allow the battery to cool and any material to
dissipate.
18. Use of accessories and cables other than those specied or provided by
Vitalograph for this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of the ALPHA Touch and
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