BIOTRONIK Evia HF - Storage and Sterilization; Lead Connection and Evaluation

Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
PAGE 8
Electrocautery Electrocautery should never be performed within 15 cm (6 inches) of an implanted
pulse generator or lead because of the danger of introducing brillatory currents into the heart and/
or damaging the pulse generator. Pacing should be asynchronous and above the patient’s intrinsic
rate to prevent inhibition by interference signals generated by the cautery. When possible, a bipolar
electrocautery system should be used.
For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed
under the buttocks or around the thigh, but not in the thoracic area where the current pathway could
pass through or near the pacing system.
4.2 Storage and Sterilization
Storage (temperature) Recommended storage temperature range is -10° to 45°C (14°-113°F).
Exposure to temperatures outside this range may result in pulse generator malfunction (see
Section 8.1).
Handling Do not drop. If an unpackaged pulse generator is dropped onto a hard surface, return it to
BIOTRONIK (see Section 8.1).
FOR SINGLE USE ONLY Do not resterilize the pulse generator or accessories packaged with the
pulse generator, they are intended for one-time use.
Device Packaging Do not use the device if the packaging is wet, punctured, opened or damaged
because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK.
Storage (magnets) Store the device in a clean area, away from magnets, kits containing magnets,
and sources of electromagnetic interference (EMI) to avoid damage to the device.
Temperature Stabilization Allow the device to reach room temperature before programming or
implanting the device. Temperature extremes may affect the initial device function.
Use Before Date Do not implant the device after the USE BEFORE DATE because the device sterility
and longevity may be compromised.
4.3 Lead Connection and Evaluation
The pulse generator requires atrial and ventricular leads with IS-1 compatible connectors. There are
no requirements specic to the atrial lead. It is required to use a low polarization ventricular lead for
activation of Ventricular Capture Control.
Lead Check The Evia HF / HF-T pulse generators have an automatic lead check feature which may
switch from bipolar to unipolar pacing and sensing without warning. This situation may be inappropriate
for patients with an Implantable Cardioverter Debrillator (ICD).
Lead/pulse Generator Compatibility Because of the numerous available 3.2-mm congurations (e.g.,
the IS-1 and VS-1 standards), lead/pulse generator compatibility should be conrmed with the pulse
generator and/or lead manufacturer prior to the implantation of a pacing system.
IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators
from different manufacturers are assured a basic t. [Reference ISO 5841-3:1992(E)].
Lead Conguration Lead conguration determines proper programming of the pulse generator. Pacing
will not occur with a unipolar lead if the lead conguration is programmed to bipolar (see Section 9).
Setscrew Adjustment Back-off the setscrew(s) prior to insertion of lead connector(s) as failure to do
so may result in damage to the lead(s), and/or difculty connecting lead(s).