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WARNING!
This equipment/system may cause radio interference or may disrupt the
operation or can be disrupted by external nearby equipment.
WARNING!
The housing of the Savvy sensor is not UV resistant which can cause
depigmentation.
WARNING!
As in all ECG measurement procedures that use electrode contact to the skin,
body movements, muscle activities, or lose contact between the electrodes and the skin are
expected to influence the quality of the measurements.
WARNING!
The user must keep the PDA with the SAVVY mobile application in his/her vicinity
during measurements. The Savvy sensor must be kept in the Bluetooth range of the PDA
(approximately 10 meters, but can vary depending on the PDA and the surrounding). In case of
exceeding this distance, the user simply needs to move the equipment within range and the
connection will be automatically re-established.
WARNING!
Savvy is not recommended for use closer than 4 cm from other devices.
WARNING!
Only prescribed charger can be used. Using other chargers can cause
unacceptable risks (related to electrical safety and electromagnetic compatibility).
WARNING!
Mains plug of battery charger is considered as disconnecting device.
3.2.
Precautions
•
If you start to feel itching or any kind of discomfort after longer use of the same electrodes,
fix the Savvy sensor on another recommended position and/or replace the electrodes.
•
The Savvy sensor should be removed prior to external defibrillation or an MRI scan.
•
Make sure that the PDA has enough free storage space (at least 2 GB) for saving the
measurements.
•
Visually check from time to time the quality of the ECG signal.
•
Users of the SAVVY mobile application should be aware that the PDA can represent a weak
spot in the security chain of the system. By an appropriation of the PDA, a potential attacker
could get access to all of the measurements (which can be considered as personal data)
stored there. Make sure to secure your PDA, if necessary, to an adequate level using the
security features of your PDA.
•
See precautions to be taken to prevent adverse events to the Patient and Operator due to
electromagnetic disturbances in table in item 9.6.