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
4
Product Description
Indications
Indications
Guidelines of cardiological
societies
Generally approved differential diagnostic methods, indications, and
recommendations for pacemaker therapy apply to BIOTRONIK devices.
The guidelines provided by cardiology associations offer decisive information:
• We recommend observing the indications published by the German Cardiac
Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung)
and the ESC (European Society of Cardiology).
• This also applies to the guidelines published by the Heart Rhythm Society (HRS),
the American College of Cardiology (ACC), the American Heart Association
(AHA), and other national cardiology associations.
Device types
For the following symptoms/expectations, the following device types are indicated:
Pacing modes
For the following symptomatic, the following pacing modes are indicated:
MR conditional
ProMRI
®
labeled MRI conditional pacemakers are safe for use in the MRI
environment when used in conjunction with a complete MRI conditional pacing
system and according to the instructions given in the ProMRI® manual.
Symptom/expectation SR DR HF
Disorientation due to bradycardia x x x
Presyncope x x x
Benefit from resynchronization of the right and left
ventricles
x
Syncope xxx
Symptom/expectation Pacing mode
Sick sinus syndrome Dual-chamber pacing
Chronic, symptomatic second and third-degree AV block Dual-chamber pacing
Adams-Stokes syndrome Dual-chamber pacing
Symptomatic bilateral bundle branch block when
tachyarrhythmia and other causes have been ruled out
Dual-chamber pacing
• Chronotropic incompetence
• Benefit from increased pacing rate with physical
activity
R mode or CLS
Sinus node dysfunction in the presence of normal AV and
intraventricular conduction
Atrial pacing
Bradycardia in conjunction with the following:
• Normal sinus rhythms with only rare episodes of
AV block or sinus arrest
• Chronic atrial fibrillation
• Severe physical disability
Ventricular pacing