Preventing unintentional shock delivery
W WARNING
Shock delivery with activated ICD
There is a risk of unintended shock delivery when handling an activated ICD.
• Deactivate ICD therapy before touching the device during implantation, device
replacement and explantation.
Avoiding damage to the header
There is a blind plug for DF-1 and IS-1 connections in the header. The provided set
screws must be carefully loosened or tightened.
• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screw-
drivers with torque control!
• Do not forcibly pull out the blind plug!
• 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.
• Either leave unused ports closed with the premounted blind plugs, or close them
using the supplied blind plugs.
Ensure that connections are clean
In case of contamination during implantation:
• Clean lead connectors with a sterile cloth.
• Rinse connection only with sterile water.
Connecting the lead connector to the device
1
Disconnect stylets and stylet guides.
2
DF-1/IS-1 connection:
• Connect the DF-1 connector for the right-ventricular shock coil to RV.
• Connect the DF-1 connector for the supraventricular shock coil to SVC. Or
connect a subcutaneous array to SVC.
DF4/IS-1 connection:
• Connect the DF4 connector to RV
3
DF-1/IS-1 connection:
• Connect the bipolar IS-1 lead connector for the atrium to RA.
• Connect the IS-1 lead connector for the right ventricle to RV.
• Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle
to LV.
DF4/IS-1 connection:
• Connect the bipolar IS-1 lead connector for the atrium to RA.
• Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle
to LV.
4
Push the lead connector into the header without twisting or bending the
connector or conductor until the connector tip (on the DF-1 connector) or the
insertion indicator (on the DF4 connector) becomes visible behind the set screw
block. This indicator can vary depending on the manufacturer of the lead used.
5
If you cannot easily plug the lead connector into the connection:
• Use only sterile water as lubricant.
6
If the lead connector cannot be inserted completely, the set screw may be
protruding into the drill hole of the set screw block.
• Use the screwdriver to perpendicularly pierce through the slitted point in
the center of the silicone plug until it reaches the set screw.
• Carefully loosen the set screw without completely unscrewing it, so that it
does not become tilted upon retightening.
7
Turn the set screw clockwise until torque control starts (you will hear a clicking
sound).
8
Carefully withdraw the screwdriver without retracting the set screw.
• In case of IS-1 connections with two set screws, tighten both screws!
• When the screwdriver is withdrawn, the silicone plug automatically seals
the lead connector port safely.
10