User's Manual
12
Precaution
1) The system includes temperature and humidity limitations. If exposed,
patients may experience degradation of adhesive performance causing
the device to slip or fall off during the patient wear duration.
2) The system has a shelf life date. Use of expired device may cause a
degradation of ECG signal quality and/or low battery condition.
3) Do not use the system if package is damaged. Device may not
perform as intended.
4) Safety and effectiveness of the system on pediatric patient (younger
than 18 years old) has not been established.
5) Keep device and packaging away from young children. Contents may
be harmful if swallowed. Patch contains button cell batteries that are
not accessible during normal use but, if exposed, are known choking
hazards and may cause severe tissue injury if ingested.
6) Safety and effectiveness on patients receiving any form of pacing
therapy has not been established. Paced cardiac rhythms may not be
accurately detected and may be incorrectly classified
7) Registration errors may result in limited functionality or erroneous ECG
reporting. Utmost caution should be applied to ensure that patient
registration is accurate and complete.
2.8. Side-Effect
Skin reaction.