BIOTRONIK Evia DR, Technical Manual

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10 Evia Technical Manual
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 5° to 55°C (41°-131°F). Exposure to temperatures
outside this range may result in pulse generator malfunction (see
Section 10.1
).
Handling – Do not drop.
If an unpackaged pulse generator is
dropped onto a hard surface, return it to BIOTRONIK (see
Section 10.1
).
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 specific to
the atrial lead. It is required to use a low polarization ventricular
lead for activation of Ventricular Capture Control.