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Appendix C: Device Care and Use
Operational Modes
TL implantable devices are equipped with two operational modes: ON and OFF.
Devices are shipped to you in the OFF mode. The battery in the device is not activated.
When switched to ON, the devices begin to sense and transmit data. The switch to change
between these two modes is in the interior of each device and is therefore not visible. The
switch is magnetically activated.
To switch operational modes:
1.
Power on a PhysioTel®Digital reader
2.
Bring the reader close to the packaged device.
It is important the devices remain in the sterile packages!
3.
Momentarily bring a strong magnet within approximately one inch of the package.
A magnetically activated internal switch is moved. The order of modes is:
Off (You should hear no tone)
On (You should hear a tone)
On-Site Cleaning and Re-sterilization
All new and exchanged devices shipped to an investigator are sterile and ready for
implantation.
Prior to returning TL devices for refurbishment we ask that they are cleaned and sterilized.
For complete and current information on products and techniques approved for use with
DSI devices, visit www.datasci.com
Storage
Storage of New Devices
Carefully examine all devices when they arrive at your facility. Remove the packages
containing the devices from the shipping boxes. Save the shipping boxes to use when
returning used devices for the Device Exchange Program. Inspect each device package for
signs of damage. Using your AM radio on the low frequency setting, turn each device on
and off by scanning a magnet across the device to ensure that none of the devices were
damaged during shipping. Confirm that each device is turned off before storing. Although
each unit is checked just before shipping, the device may have been exposed to stray
magnetic fields during shipment. This can cause the unit to be turned on unintentionally.
New and exchanged units are sterile upon arrival. If the package remains undamaged, this
sterility is warranted according to the information on the package label. Devices in the OFF
mode may lose up to 10% of the battery life within 12 months after the manufacture date.
The devices should be stored in a cool (between 10 and 25 degrees Celsius), dry area
away from exposure to static discharge and magnetic fields. Never expose them to
temperatures above 60 degrees Celsius, as this will void all warranties. It is also important
to store them in an area where they will not be accidentally dropped or have items placed
on top of them. Storage in a refrigerator does not provide significant benefit in terms of
battery life.
