Product Card

9
Precautions
Implantation Procedure
 Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient
comfort, do not implant the pulse generator within 1.25 cm of bone unless you cannot avoid it.
Device Modification
 This device has been tested for compliance to FCC regulations. Changes or modifications of any
kind not expressly approved by Abbott Medical could void the user's authority to operate this
device.
Storage and Handling
 Store the pulse generator at temperatures between 10° and 45°C. Do not subject it to
temperatures below -20° or over 60°C. Storage outside of this range may result in device reset.
 Store the device in a clean area, away from magnets, kits containing magnets, and sources of
electromagnetic interference to avoid device damage.
 Do not implant a device that has been dropped on a hard surface while outside of its intact shelf
package, or from a height of more than 24 inches (61 cm) while within its intact shelf package.
Sterility, integrity, or function cannot be guaranteed under these conditions, and the device should