Table des Matières
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387158--G_GA_Lumax540_mul.book Page 6 Friday, February 1, 2013 5:38 PM
Ambient conditions
5°C to 45°C
Storage location
• Devices are not to be stored close to magnets or sources of electromagnetic inter-
ference.
Implantation
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.
Preparing the Implantation
Having the required parts ready
Note: Ensure that sterile spare parts are available for all parts that are to be
implanted.
• Device with blind plug DF-1 and IS-1
• BIOTRONIK ICD leads complying with the requirements of EC Directive 90/385/EEC,
and lead delivery set
• BIOTRONIK programmer complying with the requirements of EC Directive 90/385/
EEC
— ECG cable PK-222
— 2 PK-141 patient cables or 2 PK-67 patient cables, either with patient adapters
PA-2 or PA-4 for connection of the pacing and sensing leads (IS-1) to ICS (dual-
and triple-chamber devices)
— 1 PK-144 patient cable with patient adapter PA-3 for connection of shock coils
(DF-1) to the programmer
• External multi-channel ECG recorder/monitor
• External defibrillator and paddles or adhesive electrodes.
All manuals and user guides at all-guides.com
W WARNING
Non-terminated ventricular arrhythmia
If the ICD does not deliver an adequate therapy, ventricular arrhythmia is not terminated.
• Keep an external defibrillator ready.
Unpacking the device
Proceed as follows:
W WARNING
Inadequate therapy due to previously damaged device
If the unpacked device is dropped on a hard surface during handling, discontinue use
and return it to BIOTRONIK. Use a replacement device.
1 Peel off the sealing paper of the non-sterile outer plastic container at the
2 Take hold of the inner plastic container by the gripping tab and take it out the
3 Peel off the sealing paper of the sterile inner plastic container at the marked
Connecting ICD Leads
Precautionary measures
Note: Use only adapters approved by BIOTRONIK for ICD leads with different connec-
tions. Should you have questions about the compatibility of other manufacturers' ICD
leads, please contact BIOTRONIK.
W WARNING
Short circuit due to open lead connections
Open – and thus not electrolyte-proof – IS-1 or DF-1 connections may cause undes-
ired current flows to the body and penetration of body fluid into the device.
• Close unused DF-1 connections with the blind plug DF-1, unused IS-1 connec-
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marked position in the direction indicated by the arrow.
The inner plastic container may not come into contact with persons who have not
sterilized their hands or gloves, nor with non-sterile instruments.
outer plastic container.
position in the direction indicated by the arrow.
tions with the blind plug IS-1.
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