AB AIM System Bedienungsanleitung Seite 5

Introductory Information
Carefully read all instructions prior to use. Observe all warnings and precautions
noted in these instructions.
Cautions & Warnings
• Batteries may explode if disposed of in fire. To prevent injury or burns, do not allow metal
objects, such as keys or coins, to contact or short circuit the battery terminals.
• Charge the AIM system with the included power adapter and cable only. The included
power adapter is compliant with IEC 60601-1. Other adapters may not meet medical
electronic safety standards, and charging with such adapters may pose a risk of death or
injury.
• To avoid risk of electric shock, the AIM system must only be connected to a supply main
with protective earth. Be sure the power outlet is suitable for the plug and provides the
correct voltage and current that the AIM system is rated.
• Warning: Do not open or attempt to repair the AIM system yourself. If the AIM system is
damaged or malfunctions, please contact Advanced Bionics.
• Keep the AIM system away from liquids. Electric shock may be caused by spilled liquid.
• Stressing the power cord may cause the cord to fray, crack or crimp, which may present a
safety hazard.
• Obtain specialist medical opinion prior to subjecting any patient with a non-Advanced
Bionics active implantable medical device to electrical stimulation.
• Avoid trans-thoracic stimulation.
• Connection to high frequency surgical equipment to the AIM system may result in burns
at the implant electrodes and damage to the headpiece and/or sound processor.
• Do not use microwave/short-wave therapy near the implant.
• Avoid accidental contact between the headpiece or sound processor to any metal part of
the AIM system when fully assembled.
• The AIM System and its components are intended to be used by physicians and audiolo-
gists, or by medical professionals under the direction of a physician or audiologist, experi-
enced with performing the objective measures enabled by the AIM System.
• Only connect the Advanced Bionics' AIM components to the AIM Module. Failure to do so
may cause damage to the AIM Module.
• Avoid fluid contact with the back of the AIM System.
• Do not place AIM System on Patient during surgery.
• The AIM System and its components are MR Unsafe and must not be brought into a
room containing an MRI scanner.
• When using the system intraoperatively, avoid excessive troubleshooting during the case
which may extend surgical time. For example, it may be reasonable to confirm that the
hardware is connected properly, restart the application, and reboot the AIM System if
functionality has not been restored. In the event of loss of function of the AIM System, use
medical judgment to determine whether to abandon using the AIM System and proceed with
the case.
3