User Manual
Table Of Contents
- Edora 8
- Table of Contents
- 1 Product Description
- 2 General Safety Instructions
- 3 Implantation
- Implantation Procedure
- Having parts ready
- Keeping an external defibrillator ready
- Unpacking the device
- Checking parts
- Implantation site
- Overview: Implanting
- Avoid damage to the header
- Preventing short circuits in the header
- Keeping distance between leads
- Connecting the lead connector to the device
- Applying the programming head
- Establishing wandless telemetry
- Auto-initialization
- Behavior during auto- initialization
- Precautionary Measures while Programming
- Checking the device system
- Performing standard tests and monitoring the patient
- Do not interrupt wandless telemetry during a treatment
- Cancelling telemetry
- Avoiding critical parameter settings
- Manually setting lead polarity
- Setting sensing
- Setting the sensitivity
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive left ventricular pacing
- If an ICD is implanted at the same time, do not permit unipolar pacing
- Recognizing lead failure
- Consider power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- 5 Technical Data
15
Implantation
Implantation Procedure
3 Implantation
Implantation3417803Technical ManualEdora 8
Implantation Procedure
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
— Single-chamber device: unipolar or bipolar lead for the right ventricle
— Dual-chamber device: one unipolar or bipolar lead each for the atrium and
for the right ventricle
— Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV
lead
• Approved connections are IS-1 and IS4: Use only adapters approved by
BIOTRONIK for leads with diff
erent connections or leads from other
manufacturers.
• BIOTRONIK programmer (with integrated wandless telemetry or with separate
SafeSync Module) and approved cables
• External multi-channel ECG device
• Keep spare parts for all sterile components.
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 and paddles or adhesive electrodes ready.
!
!
WARNING
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic
parts could be damaged.
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 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 blister to remove it from the outer blister.
• 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.
• Use a replacement device.
• Return the damaged device to BIOTRONIK.