8
Sterility
Delivery
The device and the accessories have been gas sterilized. Sterility is guaranteed only if
the plastic container and quality control seal have not been damaged.
Sterile container
The device and accessories are packaged respectively in two separately sealed plastic
containers. The inner plastic container is also sterile on the outside so that it can be
transferred in a sterile state during implantation.
Single use only
The device and the screwdriver are only intended for one-time use.
• Do not use if package is damaged.
• Do not resterilize.
• Do not reuse.
Preparing the Implantation
Keeping an external defibrillator ready
In order to be able to respond to unforeseeable emergencies or possible device tech-
nical issues:
• Keep an external defibrillator ready.
Have parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/EEC
are required:
• Device with screwdriver from BIOTRONIK
• BIOTRONIK leads and lead introducer set
— One unipolar or bipolar lead each for the atrium and for the right ventricle
— One unipolar or bipolar lead each for the left ventricle (coronary sinus lead)
• Adapters approved by BIOTRONIK for leads with different connections or leads
from other manufacturers
• BIOTRONIK programmer and approved cables
• External multi channel ECG device
• Keep spare parts for all sterile components.
Unpacking the device
• Peel off the sealing paper of the outer plastic container at the marked position in
the direction indicated by the arrow. The inner plastic container must not come into
contact with persons who have not sterilized their hands or gloves, or with non-
sterile instruments.
• Use the gripping tab on the inner plastic container to remove it from the outer
plastic container.
• Peel off the sealing paper of the sterile inner plastic container at the marked posi-
tion in the direction indicated by the arrow.
4 Implantation
Implanting
Implantation site
In general, the pacemaker is implanted on the right side subcutaneously or subpec-
torally, depending on the lead configuration as well as the anatomy of the patient.
Sequence
W
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.
• Send the damaged device to BIOTRONIK.
Note:
The device is disabled on delivery and can be implanted immediately after
unpacking without manual activation.
1
Shape the device pocket and prepare the vein.
2
Implant the leads and perform measurements.
3
Connect device and leads.
The device starts auto-initialization on its own.
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