BIOTRONIK Evity 6 Manuel Technique page 11

• Peel the sealing paper off of the outer blister at the marked position in the direction
indicated by the arrow. The inner blister must not come into contact with persons
who have not sterilized their hands or gloves, nor with non-sterile instruments.
• Use the gripping tab on the inner blister to remove it from the outer blister.
• Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
Note: The device is disabled on delivery and can be implanted immediately after
unpacking without manual activation.
Checking parts
Damage to any of the parts can result in complications or technical failures.
• Check for damage before and after unpacking all parts.
• Replace damaged parts.
Implantation site
In general, the pacemaker is implanted subcutaneously or subpectorally, depending on
the lead configuration as well as the anatomy of the patient.
Overview: Implanting
1 Shape the device pocket and prepare the vein.
2 Implant the leads and perform measurements.
3 Connect device and leads.
4 Insert the device.
The device starts auto-initialization on its own.
5 Guide the fixation suture through the opening in the header and fixate the device
in the prepared device pocket.
6 Close the device pocket.
7 Prior to testing and configuration, wait for the successful completion of
automatic device initialization.
Note: If necessary, the device can also be programmed before or during auto-initial-
ization.
Avoid damage to the header
Set screws must be tightened or loosened with care.
• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screw-
drivers with torque control!
• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
Preventing short circuits in the header
W WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
• Close unused connector ports with blind plugs.
Keeping distance between leads
W WARNING
Inadequate therapy
Insufficient lead spacing or inappropriate lead positioning may lead to far-field
sensing.
• Leads must not contact each other. Position the tip and ring of newly implanted
leads with a sufficient distance from old implanted leads.
Connecting the lead connector to the device
1 Remove stylets and stylet guides.
2 • Connect the unipolar or bipolar IS-1 lead connector for the right ventricle to
RV.
• Connect the unipolar or bipolar IS-1 lead connector atrium to A.
• Connect the unipolar or bipolar IS-1 or the quadripolar IS4 lead connector
for the left ventricle to LV.
3 Push the lead connector into the header without bending the conductor until the
connector tip becomes visible behind the set screw block.
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