4 Safe Handling of the ICS 3000
Safe Handling of the ICS 3000
Intended Use
The ICS 3000 is intended for use by physicians and
trained medical personnel. To use the system,
individuals must have a fundamental medical
understanding of the respective therapy and detailed
knowledge of how the implant functions and the
conditions for its use. The operator should be present
at all times when the ICS 3000 is in use.
Residual risk No risks are associated with the programming system
if it is used correctly and has been serviced and
inspected according to BIOTRONIK specifications. The
risk evaluation by the Risk Management Team has
determined that the residual risk is as low as
reasonably possible.
Safety Instructions
Note: The ECG connection makes electrical contact with the
patient via the electrodes. It is an applied BF-type part
and is defibrillation-proof when the approved patient
cable is used.
Caution! Never simultaneously touch the patient and connector
components that conduct safety extra-low voltage.
Note: When working with the software, maintain minimum
amplitudes or values of physiologic patient signals. If
these values are not met, inaccurate results may be
produced.
WARNING! Do not use the ICS 3000 on the patient in conjunction
with RF-surgical equipment.
WARNING! During diagnosis, therapy or implantation with the
ICS 3000, keep emergency equipment ready: external
defibrillator and external stimulator, devices for
monitoring cardiac activity.
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