BIOTRONIK ProMRI Estella SR Manual Tecnico página 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 technical
failures of the device:
• Keep an external defibrillator ready.
Having 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
• 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.
en • English
Unpacking the device
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.
• Peel the sealing paper off of the outer blister 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, nor with non-sterile
instruments.
• Use the gripping tab on the inner plastic container to remove it from the outer
plastic container.
• 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.
• Leads may not be shortened.
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