BIOTRONIK ICD Series, Техническое руководство

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Implantation
3 Implantation
Implantation3GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T
Implantation Procedure
Having parts ready The following parts that correspond to the requirements of the EC Directive 90/
385/EEC are required:
• BIOTRONIK device with blind plug and screwdriver
• BIOTRONIK leads and lead introducer set
— Single-chamber device: One bipolar ICD lead with 1 or 2 shock coils for the
ventricle
— Dual-chamber device: One bipolar lead for the atrium and one bipolar ICD
lead for the ventricle with 1 or 2 shock coils
— Triple-chamber device: an additional unipolar or bipolar LV lead
• DF-1, DF4 and IS-1 connections are approved. For leads with a different con-
nection or leads from other manufacturers, use adapters approved by BIO-
TRONIK only.
• BIOTRONIK programmer (with integrated SafeSync RF telemetry or with sepa-
rate SafeSync Module) and approved cable
• External multi-channel ECG device
• Keep spare parts for all sterile components.
Keeping an external defi-
brillator ready
In order to be able to respond to unforeseeable emergencies or possible technical
failures of the device:
• Keep an external defibrillator and paddles or patch electrodes ready.
Unpacking the device
• Peel the sealing paper off of the outer blister at the marked position in the
direction indicated by the arrow. The inner blister may not come into contact
with persons who have not sterilized their hands or gloves, nor with non-sterile
instruments.
• Take hold of the inner blister by the gripping tab and take it out of the outer
blister.
• Peel the sealing paper off of the sterile inner blister at the marked position in
the direction indicated by the arrow.
!
!
WARNING
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic
parts could be damaged.
• Use a replacement device.
• Return the damaged device to BIOTRONIK.