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
26
Implantation
Explantation and Device Replacement
Explantation and Device Replacement
Explantation
• Disconnect the leads from the header.
• Remove the device and, if necessary, leads using state-of-the-art technology.
• Explants are biologically contaminated and must be disposed of safely due to
risk of infection.
Device replacement
The following applies to leads from a previous device that are intended for further
use:
• Check the leads prior to connecting to the new device.
If, upon replacing the device, already implanted leads are no longer used but left in
the patient, then an additional uncontrolled current path to the heart can result.
• Isolate unused lead connectors and close unused connector ports.
Basic principles:
• The device must not be resterilized and reused.
Cremation
Devices should not be cremated.
• Explant the device before the cremation of a deceased patient.
Disposal
BIOTRONIK takes back used products for the purpose of environmentally safe
disposal.
• Clean the explant with a solution of at least 1% sodium hypochlorite.
• Rinse with water.
• Fill out explantation form and send to BIOTRONIK together with the cleaned
device.