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
3
Product Description
Intended Medical Use
1 Product Description
Product Description1417803Technical ManualEdora 8
Intended Medical Use
Intended use
Edora is a family of implantable pacemakers that can be implanted for all
bradycardia arrhythmia indications. The primary objective of the therapy consists of
improving patients' symptoms that can be clinically manifested. The implantation of
the pacemaker is a symptomatic therapy with the following objective:
• Compensation of bradycardia by atrial, ventricular, or AV sequential pacing
• Additional triple-chamber features: Resynchronization of ventricular chamber
contraction via biventricular pacing
Diagnosis and therapy forms
The cardiac rhythm is automatically monitored and bradycardia arrhythmias are
treated. All major therapeutic approaches from the field of cardiology and
electrophysiology are unified in this pacemaker family. BIOTRONIK
Home Monitoring
®
enables physicians to perform therapy management at any
time.
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation of a device system.
• Only qualified medical specialists having the special knowledge required for the
proper use of implanted devices are permitted to use them.
• If users do not possess this knowledge, they must be trained accordingly.