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
Note: If necessary, the device can also be programmed before or during auto-
initialization.
16
Implantation
Implantation Procedure
Implantation site
In general, the pacemaker is implanted subcutaneously or subpectorally,
depending on the lead configuration as well as the anatomy of the patient.
Overview: Implanting
Avoid damage to the header
Set screws must be tightened or loosened with care.
• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK
screwdrivers with torque control!
• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
!
!
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
!
!
WARNING
Inadequate therapy
Insufficient lead spacing or inappropriate lead positioning may lead to far-field
sensing.
Preventing short circuits
in the header
Keeping distance
between leads
1 Shape the device pocket and prepare the vein.
2 Implant the leads and perform measurements.
3 Connect device and leads.
4 Insert the device.
The device starts auto-initialization on its own.
5 Guide the fixation suture through the opening in the header and fixate the
device in the prepared device pocket.
6 Close the device pocket.
7 Prior to testing and configuration, wait for the successful completion of
automatic device initialization.
• Close unused connector ports with blind plugs.
• Leads must not contact each other. Position the tip and ring of newly implanted
leads with a sufficient distance from old implanted leads.