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.

Product Description
Intended Medical Purpose
4
Intended patient groups
The pacemakers are intended for adults (including immuno-compromised or elderly patients).
The pacemakers are intended for pregnant patients but the need to limit fluoroscopy in pregnant
women may complicate device implantation or the patient should be resorted to another imaging
method.
The pacemakers are intended for children who are suited to bear an implant of the physical dimensions
of a pacemaker device. Significant technical challenges may arise due to the growth of the patient and
the size of the used leads.
The pacemakers are not intended for neonates or infants.
As there are no randomized clinical trials of bradycardia pacing in pediatric or pregnant patients, the
level of evidence for guideline recommendations is consensus based.
Contraindications
• Sepsis
• Transient or reversible AV block/sinus bradycardia
No further contraindications apply to the implantation of multifunctional single-chamber, dual-
chamber, or triple-chamber pacemakers, provided differential diagnostics precedes implantation
according to the current guidelines of cardiology published by the ESC and ACC/AHA/HRS and no
modes or parameter combinations are configured that pose a risk to the patient (i.e., unipolar pacing in
combination with an implantable cardioverter-defibrillator).

Product Description
System Overview
5
System Overview
Device family
This device family consists of single-chamber, dual-chamber, and triple-chamber devices with or
without HomeMonitoring. Not all device types are available in every country.
The following device variants are available:
Device type Variant with HomeMonitoring Variant without HomeMonitoring
Single-chamber Edora8 SR‑T Edora8SR
Dual-chamber Edora8 DR‑T Edora8DR
Triple-chamber Edora8 HF‑T, Edora8 HF‑TQP —
Product identification
Each product is identified by a so-called unique device identification (UDI). It enables products to be
uniquely identified.
The first part of the UDI is the product-specific identifier UDI-DI (Unique Device Identification Device
Identifier), which can be found next to the UDI symbol on the label.
Edora 8
Device type UDI-DI
SR 04035479147839
SR-T 04035479147761
DR 04035479147716
DR-T 04035479147648
HF-T 04035479147570
HF-T QP 04035479147563
In addition, a basic identifier called B-UDI-DI (Basic Unique Device Identification Device Identifier) is
assigned to several products.
The B-UDI-DI is: 4035479BUDI00005PU
Using this B-UDI-DI, it will be possible to search the European Database on Medical Devices
(EUDAMED) for additional information on the product.
Device
The device's housing is made of biocompatible titanium, welded from the outside and is, therefore,
hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing
serves as an antipole in the case of unipolar lead configuration.
Lead connections
BIOTRONIK provides pacemakers with headers for different standardized lead connections:
• IS‑1
• IS‑1/IS4

Product Description
System Overview
6
Note
Suitable leads must comply with the norms:
• A device's IS-1 connector port may only be used for connecting leads with IS-1 connectors
that conform to ISO5841-3.
• A device's IS4 connector port may only be used for connecting leads with IS4 connectors that
conform to ISO27186.
Note
The device and leads have to match.
• Only quadripolar leads may be connected to the IS4 connector port on device typeHFQP with
IS4.
Note
Use only adapters approved by BIOTRONIK for leads with different connections.
• If you have any questions concerning the compatibility of other manufacturers' leads, please
contact BIOTRONIK.
IS-1
The labeling on the device provides information pertaining to the connector port assignment in the
header:
SR DR HF
Connector
port
Lead
connector
Configuration Implantation site Device type
A/RA IS‑1 Unipolar, bipolar Atrium DR, HF
V/RV IS‑1 Unipolar, bipolar Right ventricle SR, DR, HF
LV IS‑1 Unipolar, bipolar Left ventricle HF
IS‑1/IS4
The labeling on the device provides information pertaining to the connector port assignment in the
header:
HFQP
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS‑1 Unipolar, bipolar Atrium HFQP
RV IS‑1 Unipolar, bipolar Right ventricle HFQP
LV IS4 Unipolar, bipolar Left ventricle HFQP

Product Description
System Overview
7
Leads
BIOTRONIK leads are sheathed with biocompatible silicone. They can be flexibly maneuvered, are
stable long-term, and are equipped for active or passive fixation. They are implanted using a lead
introducer set. Some leads are coated with polyurethane, which is known to increase the gliding
properties for the lead. Steroid-eluting leads reduce inflammatory processes. The fractal design of the
leads allows for low pacing thresholds, high pacing impedance, and a low risk of oversensing.
BIOTRONIK provides a series of adapters to connect a variety of already implanted leads to new
devices.
Telemetry
Telemetric communication between the device and the programmer is possible following initialization
either by applying the programming head (PGH) to the device or by using wireless wandless telemetry
in the programmer.
Programmer
The programmer contains an integrated module for wandless telemetry.
ECG, IEGM, markers, and functions are displayed simultaneously on the color display.
The programmer allows for the determination of thresholds and the performance of all tests during an
in-office follow-up. In addition, the permanent program can be changed and sent to the implanted
device.
Furthermore, the programmer is used to set mode and parameter combinations, as well as for the
interrogation and saving of data from the device.
Pacing modes
The pacing mode setting depends on the individual diagnosis:
Device type Pacing modes Standard
SR
• VVI‑CLS
• VVIR, V00R, AAIR, A00R
• VVI, VVT, V00, AAI, AAT, A00
• OFF
VVIR
DR
• VVI-CLS, DDD-CLS
• DDD-ADI, DDDR-ADIR
• DDDR, DDIR, DVIR, D00R, VDDR, VDIR
• VVIR, V00R, AAIR, A00R
• DDD, DDT, DDI, DVI, D00, VDD, VDI
• VVI, VVT, V00, AAI, AAT, A00
• OFF
DDDR
HF (QP)
• VVI-CLS, DDD-CLS
• DDD-ADI, DDDR-ADIR
• DDDR, DDIR, DVIR, D00R, VDDR, VDIR
• VVIR, V00R, AAIR, A00R
• DDD, DDT, DDI, DVI, D00, VDD, VDI
• VVI, VVT, V00, AAI, AAT, A00
• OFF
DDDR

Product Description
System Overview
8
Note
HomeMonitoring is possible in all pacing modes.
The OFF mode only functions temporarily, i.e. during a test.
NBG codes
AAIR or VVIR is the NBG code for the antibradycardia pacing mode of the single-chamber device:
A/V Pacing in the atrium or ventricle
A/V Sensing in the atrium or ventricle
I Pulse inhibition in the atrium and ventricle
R Rate adaptation
DDDR is the NBG code for the antibradycardia pacing mode of the dual-chamber device:
D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
DDDRV is the NBG code for the antibradycardia pacing mode of the triple-chamber device:
D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
V Multisite pacing in both ventricles
BIOTRONIKHomeMonitoring®
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system:
• With HomeMonitoring, diagnostic and therapeutic information as well as technical data of the
device are automatically and wirelessly sent to a transmitter via an antenna in the device header.
The data is encrypted and sent from the transmitter to the BIOTRONIK ServiceCenter via the
cellular phone network.
• The received data is deciphered and evaluated. Each physician can individually set the criteria for
evaluation and the time of notification via e-mail or SMS for each patient.
• A clear overview of the results of this analysis is displayed for the attending physicians on the
protected internet platform HomeMonitoringServiceCenter (HMSC).
• Data transmission from the device is performed with a daily device message.
• Device messages which indicate special events in the patient's heart or in the device are forwarded
with the following regular message.
• A test message can be initiated at any time using the programmer to immediately check the
HomeMonitoring function.