09220 Issue 2
5Page of 28
ENG
Vitalograph COMPACT - Instructions for Use
8. Subject fatigue may occur during RMS or 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. When the Compact device is used a subject fatigue warning will
appear after 8 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 Compact to liquids.
12. TheCompactshouldnotbeusedinthepresenceofammableliquidsor
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 Compact should never be outside
accuracy limits. Accuracy should be checked daily, after cleaning or
disassembling the spirometer for any reason, after adjusting calibration or if
theowheadordevicehasbeendropped.
14. TakecarenottoblocktheMIPMEPpressureventontheowheadduring
testing. This pressure vent is intended to prevent glottal closure and prevent
the use of cheek muscles as indicated in the ATS/ERS Statement on
Respiratory Muscle Testing.
15. The following contraindications apply to MIP/MEP/SNIP testing:
a. Pathological conditions resulting in relatively large pressure swings in the
abdomen or thorax.
b. Aneurisms
c. Uncontrolled hypertension
d. Urinary incontinence
16. If subject cannot form a good seal on the BVF during MIP/MEP test then a
bite-onmouthpieceshouldbettedtotheBVF.
17. Service and repairs should be carried out only by the manufacturer or by
Service Agents approved by Vitalograph.
18. Maintenance must not be performed while the device is in use by a subject.
19. Useofaccessoriesandcablesotherthanthosespeciedorprovidedby
Vitalograph for this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of the Compact and
result in improper operation.
20. 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.
21. Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30