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3.
Safety
3.1.
General warnings
WARNING!
The SAVVY medical device is not intended for individuals with potentially life-
threatening arrhythmias or individuals who require inpatient or hospital monitoring.
WARNING!
The user must carefully read the instructions for use in the user’s manual. The
user should be able to operate smart phones or tablets and understand the user’s manual. If
this is not the case, the device should be used only with the assistance of qualified caregivers
who fulfil the above basic requirements.
WARNING!
The SAVVY medical device may not meet its performance specifications if stored
or used outside the specified temperature and humidity ranges.
WARNING!
The SAVVY mobile application may not function properly if not installed on the
recommended PDA running recommended mobile operating system, defined in technical
specifications.
WARNING!
The SAVVY mobile application may stop functioning properly because of
intermittent faults in the PDA, wireless connection or Savvy sensor. See troubleshooting section
for further instructions.
WARNING!
Individuals with known allergies or hypersensitivities to adhesives or hydrogel
(electrode material) should not use the SAVVY medical device.
WARNING!
To minimize skin irritation, do not place the Savvy sensor over broken or
damaged skin.
WARNING!
The Savvy sensor is water resistant and it can be worn while showering, but do
NOT submerge it in water (for example, in a bath or hot tub, or while swimming).
WARNING!
Do not dispose this product as ‘unsorted municipal waste’. Prepare it for reuse
or separate collection as specified by Directive 2002/96/EC of the European Parliament and the
Council of the European Union on Waste Electronic and Electrical Equipment (WEEE).
WARNING!
To protect against electrical shock due to leakage currents, use only SAVVY
charging dock with recommended AC/DC power supply defined in technical specifications.
WARNING!
When the SAVVY sensor is not in use, it shall be placed in the charging dock and
in charging mode in order to ensure that the battery will not be discharged.
WARNING!
Use proper, non-aggressive and biocompatible cleaning agents. It is allowed to
wipe the device with wet cloth.
WARNING!
Measurements obtained by SAVVY equipment/system are intended for use by
healthcare professionals only.