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
14
General Safety Instructions
Possible Risks
Magnetic resonance imaging
Magnetic resonance imaging must be avoided due to the associated high frequency
fields and magnetic flux density: Damage or destruction of the device system by
strong magnetic interaction and damage to the patient by excessive warming of the
body tissue in the area surrounding the device system.
Under certain conditions and when maintaining mandatory measures to protect the
patient and the device system, magnetic resonance imaging can be performed.
BIOTRONIK devices with the "MR conditional" function bear the identification
ProMRI.
• The ProMRI manual – MR conditional device systems – contains detailed
information on safely conducting an MRI.
— Download the digital manual from the web site:
manuals.biotronik.com
— Order the printed manual at BIOTRONIK.
• Does approval as "MR conditional" apply in your country or region?
Ask for current information at BIOTRONIK.