User Manual

10 Safety During Use
General Safety Instructions
Technical manual Only use the programmer in accordance with this technical manual.
Risks of improper handling Disregarding the safety instructions can endanger the patient, the staff and the
equipment.
The following dangers may arise in the event of improper use:
• Failure of important device functions
• Personal endangerment due to electrical effects
Changes not permitted Only the manufacturer or a party expressly authorized by BIOTRONIK may perform
corrective maintenance, enhancements or modifications to the device.
Replacement parts and
accessories
To ensure safety compliance, use only original replacement parts and accessories
authorized by BIOTRONIK. Using any other parts voids the manufacturer's liability
for any consequences, guarantee and warranty.
Defects Do not use defective or damaged devices.
Physician supervision The device should only be used under the constant supervision of a physician.
During operation of the device, it is necessary to monitor the patient’s heart rate
and ensure that for each stimulation, the display of events and their results (using
an external ECG monitor) is plausible.
Patient observation Ensure that patients are individually observed over a suitable period of time in
order to monitor the compatibility and effectiveness of parameter combinations.
Emergency equipment Always ensure that in the event of an emergency the following basic equipment is
available:
•Defibrillator
• Intubation set
•Oxygen
•Emergency drugs
For pacemaker-dependent patients, an additional external pacemaker must also
be available.
Life support system Do not use this device as a life support system.
Liquids • Never use a damp or wet device.
• Protect the device from the accidental ingression of fluids (e.g. infusion fluids).
Electrostatic potentials Ensure that electrostatic potentials between medical staff and patients are
balanced. Before handling the device, the electrostatic potential between the
doctor or medical staff and the patient must be balanced by touching the patient at
a point as far away from the leads as possible.
Note: Failure to observe the safety precautions voids all damage claims and
manufacturer liability.