Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
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Page 71 of 78 DT_0006-15
7. 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 subject fatigue
warning will appear after 8 manoeuvres and the maximum number of
allowed manoeuvres in one session is 20.
8. All values displayed are expressed as BTPS values.
9. Time zero is determined using the back-extrapolated method, from the steepest
part of the curve.
10. All spirometry standards recommend checking the accuracy of lung function
measuring devices at least daily with a 3-L syringe to validate that the
instrument is measuring accurately. Spirotrac should never be outside accuracy
limits. Accuracy should also be checked after cleaning or disassembling the
spirometer for any reason, after adjusting calibration or if the flowhead or device
has been dropped.
11. Service and repairs should be carried out only by the manufacturer or by
Service Agents specifically approved by Vitalograph.
12. Maintenance must not be performed while the device is in use by a subject.
13. It is recommended that the PC is fully powered off before connecting the
device.
14. Medical Devices may be affected by cellular telephones and other personal or
household devices not intended for medical facilities. It is recommended that all
equipment used near the Vitalograph product comply with the medical
electromagnetic compatibility standard. High levels of electromagnetic
disturbances could result in the interruption of communications. If interference is
suspected or possible, switching off the offending device is the normal solution,
as is required in aircraft and medical facilities. NON MEDICAL EQUIPMENT
MUST BE KEPT OUTSIDE THE SUBJECT ENVIRONMENT.
15. Use of accessories and cables other than those specified or provided by
Vitalograph for this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of the device and result in
improper operation.
16. 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.
17. 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 device, including cables specified by Vitalograph. Otherwise,
degradation of the performance of this equipment could result.
18. If you connect additional equipment (not produced by Vitalograph) to the USB
interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN
specifications, e.g. EN60950 for data equipment, EN60601 for medical
equipment.
19. Vitalograph commits to providing software that is virus-free. Vitalograph
assumes no liability for the security of customer computer systems. Any
computer connected to the local area network (LAN) or internet is at risk of the
system being compromised. Vitalograph recommends that customers take
appropriate measures to mitigate such risk including installation and
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