BIOTRONIK Edora 8 SR-T User manual

Edora 8
Pacemaker |
Bradyarrhythmia Therapy |
Cardiac Resynchronization
Therapy
Technical Manual
459754
Revision: Q (2022-05-16)

0123
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification, revision and
improvement.
® All product names in use may be trademarks or
registered trademarks held by BIOTRONIK or the
respective owner.
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin / Germany
Tel [phone]
Fax [phone]
[email protected]
www.biotronik.com

Table of Contents
1
Table of Contents
1 Product Description.................................................................................................... 2
Intended Medical Purpose................................................................................................................ 2
System Overview ............................................................................................................................... 5
Diagnostic and Therapy Functions................................................................................................... 10
2 General Safety Instructions........................................................................................ 12
General Information on Safe Handling of the Device...................................................................... 12
Operating Conditions ........................................................................................................................ 14
Possible Complications .................................................................................................................... 15
Possible Risks................................................................................................................................... 17
3 Implantation ............................................................................................................... 19
Implantation Procedure.................................................................................................................... 19
Precautionary Measures while Programming ................................................................................ 23
Magnet Response ............................................................................................................................. 26
Follow-up .......................................................................................................................................... 27
Patient Information........................................................................................................................... 29
Replacement Indications.................................................................................................................. 30
Explantation and Device Replacement ............................................................................................ 32
4 Parameter .................................................................................................................. 33
Timing................................................................................................................................................ 33
Pacing and Sensing .......................................................................................................................... 36
Rate Adaptation ................................................................................................................................ 39
MRI Program..................................................................................................................................... 40
Preset Programs .............................................................................................................................. 41
Tolerances of Parameter Values...................................................................................................... 43
5 Technical Data ............................................................................................................ 44
Mechanical Characteristics.............................................................................................................. 44
Electrical Characteristics................................................................................................................. 45
Battery Data ...................................................................................................................................... 46
Legend for the Label......................................................................................................................... 48

Product Description
Intended Medical Purpose
2
1 Product Description
Intended Medical Purpose
Intended purpose
An implantable pacemaker is part of an implantable system comprising of a pacemaker and leads to
pace the heart on demand. The function of the system is the ability, first, to sense the intrinsic heart
rhythm/rate and, second, to provide pacing by electrical pulses of low energy when necessary to ensure
a stable heart rate or to support the intrinsic heart rate when needed.
The implantation of a pacemaker is a symptomatic therapy with the following objectives:
• Monitoring the heart rhythm and automatically detecting bradycardia
• Compensation of bradycardia through atrial or ventricular (single-chamber devices), or AV
sequential pacing (dual-chamber and triple-chamber devices)
• Cardiac resynchronization through multisite ventricular pacing (triple-chamber devices)
Diagnosis and therapy forms
The device monitors the heart rhythm and automatically detects and treats bradycardia.
BIOTRONIK Home Monitoring® enables physicians to supervise therapy management at any time.
Intended user group
In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation
and the operating conditions of a device system. Only qualified medical specialists who have this
required special knowledge are permitted to use implantable devices.
If users do not possess this knowledge, they are not entitled to use the device system until they are
trained accordingly.
BIOTRONIK offers user trainings for specific target groups.
Current information on training and education opportunities can be requested from:
[email protected]
Intended clinical benefit
The clinical benefits for the patients inherent to the use of the implantable pacemakers are the
detection of an unphysiological low heart rate (bradycardia) of a patient and, subsequently, the
restoration of a physiological heart rate. The related performance outcome for this clinical benefit is
defined as successful compensation of bradycardia by antibradycardia pacing.
Triple-chamber pacemakers provide the additional clinical benefit to improve the ejection fraction and/
or cardiac output in patients with heart failure and interventricular dyssynchrony. The related
performance outcome for this clinical benefit is defined as successful cardiac resynchronization
through multisite ventricular pacing.

Product Description
Intended Medical Purpose
3
Indications
Single- and dual-chamber pacemakers are indicated to treat symptomatic bradycardia with
antibradycardia pacing.
Triple-chamber pacemakers are indicated for patients
• who suffer from chronic heart failure with reduced left ventricular ejection fraction (LVEF ≤35%)
and dyssynchrony (defined as QRS duration ≥130 ms).
• with heart failure and reduced LVEF (<40%) who have a high-degree atrioventricular (AV) block
with high ventricular pacing demand.
• with chronic heart failure and symptomatic atrial fibrillation with uncontrolled heart rate who are
candidates for AV junctional ablation (irrespective of the QRS duration).
The most common indications for permanent pacemaker implantation are symptomatic sinus node
dysfunction (SND) and symptomatic high-grade AV block.
Beside the most common indications mentioned above the following conditions are included but are not
limited to:
• Chronic bifascicular block
• Neurocardiogenic syncope and hypersensitive carotid sinus syndrome
• Hypertrophic cardiomyopathy
• Pacing to detect and terminate tachycardia
• Patients with congenital heart disease
Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be
considered for dual chamber pacing modes. Dual chamber modes are specifically indicated for
treatment of conduction disorders that require both restoration of heart rate and AV synchrony such as
AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction
disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
Rate-adaptive pacing with pacemakers is indicated for patients exhibiting chronotropic incompetence
and who would benefit from increased pacing rates concurrent with physical activity.
Generally approved differential diagnostic methods, indications, and recommendations for pacemaker
therapy apply to BIOTRONIK devices. See the current guidelines of cardiology associations for
guidance. We recommend observing the indications published by the European Society of Cardiology
(ESC). This also applies to the guidelines published by the Heart Rhythm Society (HRS), the American
College of Cardiology (ACC), the American Heart Association (AHA), the German Cardiac Society
(Deutsche Gesellschaft fur Kardiologie, Herz- und Kreislaufforschung, (DGK)), and other national
cardiology associations.
Depending on the patient’s anatomy, the pacemakers are implanted in the pectoral or abdominal
region.