Itamar Medical OM2196470 Operation Manual page 7

Itamar Medical Ltd.
10. Itamar Medical Ltd. makes no representation whatsoever, that the act of reading the
Manual renders the reader qualified to operate, test or calibrate the system
11. The tracings and calculations provided by the WatchPAT system are intended as tools for
the competent diagnostician. They are explicitly not to be regarded as a sole incontrovertible
basis for clinical diagnosis.
12. In the event that the system does not operate properly, or if it fails to respond to the
controls in the manner described in this Manual, you should refer to the Troubleshooting
Guide section. If necessary, contact our service office to report the incident, and to receive
further instructions.
13. The step by step instructions should be carefully followed when attaching the unit.
14. The WatchPAT is not indicated for patient with injuries, deformities or abnormalities that
may prevent proper application of the WatchPAT device.
15. The WatchPAT is not indicated for children less than 12 years old.
16. The AHIc was not clinically assessed for patients who are in high altitudes or for patients
using opioids.
17. Patients with sustained* non-sinus cardiac arrhythmias should be considered for sleep
study in a laboratory polysomnograph (PSG) rather than a home sleep testing (HST).
* In the setting of sustained arrhythmia the WatchPAT's automated algorithm might exclude some
periods of time, resulting in a reduced valid sleep time. A minimum valid sleep time of 90 minutes is
required for an automated report generation.
18. The WP1 is not intended to be used as a diagnostic device for any cardiac arrhythmia and
is not intended to replace traditional methods of diagnosis of cardiac arrhythmia. The WP1
arrhythmia function is to be used for informational use only as additional information to the
sleep indices. The arrhythmia output flags patients suspected of having arrhythmias thereby
aiding the physician to decide if further arrhythmia investigation is needed.
a. A suspected arrhythmia flagging in the sleep report does not necessarily imply an
arrhythmia condition is present but rather suggests that further investigation should be
considered.
b. The absence of arrhythmia flagging in the sleep report does not rule out any
arrhythmia.
c. In some patients, in particular those with a high density of premature beats or AFib,
the device may under-detect arrhythmic events (both premature beats and AFib) and/or
misclassify between premature beats and AFib.
WatchPAT™ONE System 6 Operation Manual