BIOTRONIK Amvia Stellar UDI-DI User manual

Amvia Stellar
Pacemaker | Bradyarrhythmia
Therapy | Cardiac
Resynchronization Therapy
Technical Manual
462977
Revision: A (2022-04-27)

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 About this Technical Manual ...................................................................................... 2
Objective ............................................................................................................................................ 2
Technical manuals............................................................................................................................ 3
Conventions....................................................................................................................................... 4
2 Product Description.................................................................................................... 5
Intended Medical Purpose................................................................................................................ 5
System Overview ............................................................................................................................... 8
Diagnostic and Therapy Functions................................................................................................... 13
3 General Safety Instructions........................................................................................ 16
General Information on Safe Handling of the Device...................................................................... 16
Operating Conditions ........................................................................................................................ 17
Possible Complications .................................................................................................................... 18
Possible Risks................................................................................................................................... 20
4 Implantation ............................................................................................................... 22
Implantation Procedure.................................................................................................................... 22
Precautionary Measures while Programming ................................................................................ 26
Magnet Response ............................................................................................................................. 29
Follow-up .......................................................................................................................................... 30
Patient Information........................................................................................................................... 31
Replacement Indications.................................................................................................................. 32
Explantation and Device Replacement ............................................................................................ 34
5 Parameter .................................................................................................................. 35
Bradycardia/CRT............................................................................................................................... 35
Tachycardia ....................................................................................................................................... 41
Sensing.............................................................................................................................................. 42
HomeMonitoring .............................................................................................................................. 43
Diagnostics........................................................................................................................................ 44
MRI program ..................................................................................................................................... 45
6 Technical Data ............................................................................................................ 46
Mechanical Characteristics.............................................................................................................. 46
Electrical Characteristics................................................................................................................. 47
Battery Data ...................................................................................................................................... 48
International radio certification........................................................................................................ 49
Legend for the Label......................................................................................................................... 51

About this Technical Manual
Objective
2
1 About this Technical Manual
Objective
In this technical manual, you will find information for physicians and medical professionals regarding
the device, the implantation, programming, and follow-up of an implantable pacemaker as well as
information on safe handling of the device.

About this Technical Manual
Technical manuals
3
Technical manuals
Technical manuals are either included in hard copy form in the storage package or available in digital
form on the internet: https://manuals.biotronik.com.
1. Consult all relevant technical manuals.
2. Keep the technical manuals for future reference.
To ensure safe operation, in addition to this technical manual, please also consult the following
manuals:
• Technical manual for the Home Monitoring Service Center
• Technical manuals for the leads
• Technical manuals for the programmer and its accessories
• Technical manuals for the programmer's software
• Technical manuals for cables, adapters, accessories
• "ProMRI – MR conditional device systems" manual

About this Technical Manual
Conventions
4
Conventions
Identification of Safety Warnings
The following symbol draws attention to potential hazards:
Follow all safety warnings indicated by this symbol to avoid possible serious or fatal injury or damage to
the system.
Safety warnings are also indicated by a signal word.
•DANGER: Non-compliance may immediately lead to severe injury or death.
•WARNING: Non-compliance leads to a potentially dangerous situation that can cause severe
injuries or death.
•Caution: Non-compliance leads to a potentially dangerous situation that can cause moderate
injuries.
•Attention: Non-compliance leads to a potentially dangerous situation that can cause minor injuries
and/or material damage.
Typographical Conventions
The following typographical conventions are used in this technical manual:
Instructions
The individual steps of an instruction are numbered. Prerequisites, intermediate results, and results
may be specified.
Prerequisite
• This is a prerequisite.
1. Step
2. Step
Intermediate result
3. Step
Result
This is the result.
Cross references
Cross references are indicated using "see" or "see also".
Highlights
Text that needs to be highlighted is shown in bold.

Product Description
Intended Medical Purpose
5
2 Product Description
Intended Medical Purpose
Intended purpose
Amvia Stellar are implantable pulse generators (IPG: DR-T) also called pacemakers and implantable
cardiac resynchronization pacemakers (CRT-P: HF-T and HF-T QP).
An implantable pacemaker is part of an implantable pacemaker system comprising a pacemaker and
leads. The primary function of the pacemaker is the ability, first, to sense the intrinsic heart rhythm/
rate and, second, to provide pacing by electrical pulses of low energy, as well as to provide
antitachycardia 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:
• Sensing and recording the heart rhythm and automatically detecting bradycardia and atrial
tachyarrhythmia (IPGs and CRT-Ps).
• Compensation of bradycardia through atrial or ventricular, or AV sequential pacing (IPGs and CRT-
Ps).
• Physiological pacing (LBB(A)P or HBP) by stimulating the conducted system (IPGs and CRT-Ps).
• Termination of atrial tachycardia (AT/AF) through antitachycardia pacing (ATP) in the atrium (IPGs
and CRT-Ps).
• Cardiac resynchronization through multisite ventricular pacing or through physiological pacing
(CRT-Ps, e.g. biventricular pacing).
Diagnosis and therapy forms
The device monitors the heart rhythm and automatically detects and treats bradycardia and atrial
tachycardia. BIOTRONIK Home Monitoring® enables physicians to supervise therapy management at
any time.
Intended user group
In addition to having basic medical and cardiological knowledge, the user must be thoroughly familiar
with the operation 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 or physiological pacing. Physiological pacing can prevent ventricular
dyssynchrony and pacing-induced cardiomyophathy.

Product Description
Intended Medical Purpose
6
Atrial therapy provides the additional clinical benefit of terminating atrial stable tachyarrhythmia after
detection. The associated performance outcome for this clinical benefit is defined as successful
termination of atrial tachyarrhythmia using antitachycardia pacing.
Indications
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 sinus node dysfunction
(SND) and symptomatic high-grade atrioventricular (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.
In patients with bradycardia-tachycardia variant of SND programming of atrial ATP may be considered.
Rate-adaptive pacing with pacemakers is indicated for patients exhibiting chronotropic incompetence
and who would benefit from increased pacing rates concurrent with physical activity.
Physiological pacing (e.g. HBP or LBB(A)P) is indicated to maintain or improve the cardiac
hemodynamic function by optimizing the physiological cardiac contraction pattern in particular for
patients with increased pacing demand.
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 für 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.
Intended Patient Group
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. Significant technical challenges may arise due to the growth of the patient and the size
of the used leads.

Product Description
Intended Medical Purpose
7
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
• ATP therapy is contraindicated in patients with an accessory antegrade pathway.
No further contraindications apply to the implantation of multifunctional single-chamber, or dual-
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
8
System Overview
Device family
This device family comprises dual-chamber and triple-chamber devices. Not all device types are
available in every country.
The following device variants are available:
Device type Variants
Dual-chamber Amvia Stellar DR‑T
Triple-chamber Amvia Stellar HF‑T, Amvia Stellar HF‑TQP
Note
Not all device types are approved in every country.
Not all functions and parameters mentioned in this technical manual are featured in every device
type.
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.
In addition, a basic identifier called B-UDI-DI (Basic Unique Device Identification Device Identifier) is
assigned to several products.
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 type UDI-DI B-UDI-DI
Amvia Stellar DR-
T
XXX XXX
Amvia Stellar HF-
T
XXX XXX
Amvia Stellar HF-
T QP
XXX XXX
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
9
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 must match.
• Only quadripolar leads may be connected to the HF-TQP device type with IS4 connector port.
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:
DR HF
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS‑1 Unipolar, bipolar Atrium DR, HF
RV/His IS‑1 Unipolar, bipolar
Right ventricle,
bundle of His, left
bundle branch
DR, HF
LV/RV-Bckp IS‑1 Unipolar, bipolar Left ventricle, right
ventricle HF
IS‑1/IS4
The labeling on the device provides information pertaining to the connector port assignment in the
header:
HF-TQP
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS‑1 Unipolar, bipolar Atrium HF-TQP
RV/His IS‑1 Unipolar, bipolar
Right ventricle,
bundle of His, left
bundle branch
HF-TQP
LV IS4 Unipolar, bipolar Left ventricle HF-TQP

Product Description
System Overview
10
Leads
BIOTRONIK leads are insulated 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
Implantation and follow-ups are performed with the portable BIOTRONIK programmer using PSW
software version 2204.A or higher.
The programmer contains an integrated module for RFtelemetry.
Leadless 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 implanted device.
Pacing modes
Note
The pacing mode that should be programmed depends on the individual diagnosis. The possible
modes that can be programmed specific to each device type are listed in the tables with the order
numbers.
Device type Pacing modes Standard
DR-T
• DDD-CLS, DDI-CLS, VVI-CLS
• DDDR-ADIR, DDD-ADI, VDDR
• DDDR, DDIR, VDIR
• VVIR, AAIR,
• DDD, DDT, DDI, D00, VDD, VDI
• VVI, VVT, V00, AAI
• OFF
DDDR
HF-T (QP)
• DDD-CLS, DDI-CLS, VVI-CLS
• DDDR-ADIR, DDD-ADI, VDDR
• DDDR, DDIR, VDIR
• VVIR, AAIR,
• DDD, DDT, DDI, D00, VDD, VDI
• VVI, VVT, V00, AAI
• OFF
DDDR

Product Description
System Overview
11
Note
HomeMonitoring is possible in all pacing modes.
The OFF mode only functions temporarily, i.e. during a test.
NBG codes
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 physician and clinical
staff 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.

Product Description
System Overview
12
Amvia Stellar order numbers
Amvia Stellar
Not all device types are available in every country:
IS-1 IS-1/IS4
DR-T 460167
HF-T 460166
HF-T QP 460165
Package contents
The storage package includes the following:
• Sterile packaging with implantable device
• Serial number label
• Implant card
• Filling instructions for the implant card
Note
The technical manual pertaining to the device is either included in hard copy form in the storage
package or is available in digital form on the internet: https://manuals.biotronik.com
Note
The warranty booklet for this device is either included in hard copy form in the storage package or
is available in digital form on the internet: https://www.biotronik.com/warranty-booklet
The sterile packaging includes the following:
• Implantable device
• Torque wrench

Product Description
Diagnostic and Therapy Functions
13
Diagnostic and Therapy Functions
General overview
All the systems have extensive features that allow quick diagnosis and delivery of safe therapy for
bradycardia conditions.
• Automatic functions make it easy and fast to implant, configure, and check the pacemaker.
• Auto-initialization after implantation: The device recognizes the implanted leads autonomously and
sets the polarity. The automatic functions of the software are activated after 10min.
Diagnostic functions
• Data from the implantation and the most recent interrogations and follow-ups are recorded as well
as arrhythmia episodes; they are stored together with other data to assess the state of both the
patient and the device at any time.
• Periodic automatic sub-threshold impedance measurements are performed in the device
independent of the pacing pulse in order to check the lead for proper functioning.
• Leadless ECG function: For all device types, far-field derivation can be measured without external
leads between ring electrode and housing.
• Once a telemetry connection has been established during a test procedure in an in-office follow-
up, the leadless ECG and the IEGM are displayed with markers.
Antibradycardia pacing
• Sensing: Pand Rwave amplitudes are measured periodically and fully automatically by the device
to record varying amplitudes. The sensitivity of the atrium and ventricle is also adjusted fully
automatically on a regular basis. The measurement data is averaged and the trend can be
displayed.
• Pacing thresholds: Pacing thresholds are automatically determined by the device: dual-chamber
devices determine the atrial and right ventricular thresholds, and triple-chamber devices
determine the atrial, and right and left ventricular thresholds. Capture control adjusts the pulse
amplitudes in such a way that every change of the pacing threshold results in the patient being
paced at an optimal amplitude. If His-bundle pacing is used, the threshold test is not available for
all leads.
• Timing: Pacing in the atrium is checked particularly carefully in dual- and triple-chamber devices
by an automatic adaptation of the atrial refractory period in order to avoid pacemaker-mediated
tachycardia (Auto PVARP function: automatic post-ventricular atrial refractory period).
• Additional, specialized form of rate adaptation available: Increased demand for cardiac output is
determined via physiological impedance measurement. The measuring principle is based on
contractile changes (inotropy) of the myocardium (CLS function:closed loop stimulation). Rate
adaptation is automatically initialized and optimized in CLS mode. If His-bundle pacing is used with
an RV backup lead, CLS is not available.
• Ventricular pacing suppression: Unnecessary ventricular pacing is minimized by promoting
intrinsic conduction (Vp suppression function). The device can adapt itself to conduction changes.
In the case of intrinsic conduction, the device switches from a DDD(R) to an ADI(R) mode. If His-
bundle pacing is used, ventricular pacing suppression is not available.
• During an in-office follow-up, an automatic test of the AV delay is performed to improve the heart
performance. The AV delays are calculated and the optimum values can be applied. If His-bundle
pacing is used, AV-Opt is not available.

Product Description
Diagnostic and Therapy Functions
14
Physiological pacing
The device enables therapy through physiological stimulation, thereby improving the hemodynamic
function of the heart.
• For His-bundle pacing, a lead can be implanted in the His bundle. In triple-chamber devices, an
additional lead can be implanted in the left ventricle or as backup lead in the right ventricle.
• For left bundle branch pacing (LBBP), a lead can be implanted in the left bundle branch.
The programming of the device is adjusted to the implantation site of the lead.
Antitachycardia pacing
With the atrial ATP function, dual- and triple-chamber devices can treat atrial tachycardias with
antitachycardia pacing (ATP) in case of stable heart rhythms. Two ATP sequences with up to 10 max.
ATP attempts each can be programmed.
Before delivering the therapy, the lead check verifies the correct positioning of the atrial lead.
Depending on the programming, the delivery of the therapy can be repeated after a defined time
interval or when there is a change in the atrial rhythm.
Additionally, a ventricular backup stimulation can be programmed.
If His-bundle pacing is used, ATP is not available.
Cardiac resynchronization therapy
For resynchronization of the ventricles, triple-chamber devices have functions for multisite ventricular
pacing with possible VV delays in either direction.
• Capture Control is also available for the left ventricle with automated tracking of the pacing
threshold or with automatic threshold monitoring (ATM) for trend analysis.
• To avoid the need for repeat surgery in case of a left-sided increase of pacing threshold or
undesired phrenic nerve stimulation, different pacing polarities can be programmed for the left
ventricular lead with a triple‑chamber device. Up to 20vectors are available with the HF-TQP
device type.
• In the HF-TQP device type, the LV Vector Opt test provides a fast measurement of the pacing
threshold, the phrenic nerve pacing threshold, and the pacing impedance. The impact on service
time is also displayed. The measurement results are evaluated automatically so that the optimal
pacing polarity can be set.
• The short RV-LV conduction test also supports the selection.
• An additional diagnostic function with biventricular pacing: Heart rate variability, patient activity,
and thoracic impedance are continuously monitored.
• The effectiveness of resynchronization can possibly be improved if there are intrinsic AV delays:
The CRT AutoAdapt function measures the intracardiac conduction times every minute, sets up the
pacing configuration to BiV or LV (with activated LV capture control), and adapts the AV delay
automatically. If His-bundle pacing is used with an LV lead, CRT AutoAdapt is not available.
Storing programs
There are different therapy programs:
• Parameter settings effective for the most common pacemaker indications are offered in
preconfigured programs (ProgramConsult).
• Up to 3 therapy programs can be stored for individual parameter settings.

Product Description
Diagnostic and Therapy Functions
15
ProMRI devices recognize magnetic resonance imaging scanners
The static magnetic field of an MRI scanner is reliably recognized with the aid of a sensor. The sensor
can be activated after the implantation or during a follow-up using the MRI Guard 24/7 function.
If the patient is in the vicinity of an MRIscanner, the device recognizes the scanner’s static magnetic
field and automatically activates the preset MRIprogram. Reprogramming to the permanent program
occurs automatically when the patient leaves the scanner.
HomeMonitoring functions
• The device automatically sends information to the transmitter once a day. It also sends messages
related to events, which are forwarded to the HomeMonitoring Service Center (HMSC). In addition,
test messages can be initiated using the programmer.
• Important medical information in the device messages include the following:
– Atrial and ventricular arrhythmias
– Parameters relevant to leads in the atrium and ventricle: pacing thresholds, sensing
amplitudes, impedances
– Current statistics
– IEGM OnlineHD with up to 3high-definition channels
• The following remote functions are possible via the HomeMonitoring Service Center:
– A schedule for Home Monitoring-supported follow-ups can be established.
• Current device data can be requested by the HomeMonitoring ServiceCenter using the
QuickCheck function. If the patient is in the vicinity of the CardioMessenger transmitter, the usual
data for a Home Monitoring-supported follow-up is compiled, an IEGM is added, and transmitted.
This process is called interrogation-on-demand and usually runs within a maximum 15 minutes.
• The usual data for a Home Monitoring-supported follow-up is transmitted to the Home Monitoring
Service Center immediately after the implantation using the EarlyCheck function. If capture control
is activated, a threshold test is also carried out.

General Safety Instructions
General Information on Safe Handling of the Device
16
3 General Safety Instructions
General Information on Safe Handling of the Device
Observe notes and follow instructions
WARNING
Risk to patient, risk to physician and interferences of device
Cardiac electrotherapy is subject to specific conditions. From the transport to the storage, in terms
of sterility, concerning technical complications, what requires special care during implantation or
what needs to be observed regarding risky therapies with persons wearing a pacemaker: The
device system is sensitive and must not be damaged, in order not to harm patients.
• It is always necessary to observe and follow all information in this manual, as well as related
technical manuals.
Safety instructions and warnings in this technical manual
This technical manual provides safety-relevant information on several topics:
• On the one hand, there are safety warnings which are of a general nature. In this technical manual,
these are mainly the following topics:
– General information on the safe handling of the product
– Operating conditions
– Possible technical complications
– Possible medical complications
• On the other hand, there are special and general warnings related to implantation, which educate
about actions and provide instructions for safe operation. In this technical manual, these are
mainly the following topics:
– Implantation procedure
– Precautionary measures while programming
– Follow-up
– Patient education
– Replacement indications
– Explantation and device replacement
Summary Report on Safety and Clinical Performance
The technical documentation of a device includes a brief report on safety and clinical performance
(SSCP, Summary of safety and clinical performance). A current summary will be made available
digitally on the internet by the European Commission: https://ec.europa.eu/tools/eudamed
Reporting of serious incidents
Serious incidents relating to the product must be reported to the manufacturer and the competent
authority.
The competent authorities can be found at: https://ec.europa.eu

General Safety Instructions
Operating Conditions
17
Operating Conditions
WARNING
Risk to patient and interferences of device
Cardiac electrotherapy is subject to special operating conditions. If these are not fulfilled, the
functionality of the device may be impaired; if the functionality of the device is impaired, the patient
may be at risk.
• Please observe the following operating conditions.
Care during shipping and storage
No electromagnetic interference should occur in the vicinity of devices.
• Devices are not to be stored close to magnets or sources of electromagnetic interference.
• Note the effects of the storage period; see Battery Data.
Temperature during shipping and storage
Extremely low and extremely high temperatures can both affect the device's battery service time.
• Permissible temperature range: +5ºC to +30ºC
• Short-term permissible temperature range: -10°C to +45°C
Sterile delivery
The device and the torque wrench are delivered gas-sterilized. Sterility is guaranteed only if the blister
and quality control seal are not damaged.
• Check the package for damage.
• Do not use parts from damaged package.
Sterile packaging
The device and torque wrench are each packaged in 2separately sealed blisters. The inner blister is
sterile on the outside so that it can be transferred and remain sterile during implantation.
Single use
The device and torque wrench are intended for single use only.
The device must not be used more than once or resterilized because of the following risks:
• Mechanical and electrical damage to the device, especially damage to the lead connections in the
header
• Improper battery status
• Device-side infection risks
To ensure that the device is in perfect condition and can function properly:
• Do not use the device if the package is damaged.
• The device must not be resterilized or reused.
The torque wrench is also intended for single use only.

General Safety Instructions
Possible Complications
18
Possible Complications
WARNING
Risk to patient and interferences with the device
Cardiac electrotherapy is subject to special complications. They must be considered so that the
functionality of the device is not impaired and, as a result, put the patient at risk.
• Please take all the following safety information carefully into account.
General information on medical complications
Complications for patients and device systems generally recognized among practitioners also apply to
BIOTRONIK devices.
It is impossible to guarantee the efficacy of antiarrhythmia therapy, even if the programs have proven
successful during tests or subsequent electrophysiological studies. In some cases the set parameters
may be ineffective. In particular, it cannot be excluded that tachyarrhythmias could be induced or
accelerated by a therapy attempt, i.e., that long-lasting ventricular flutter or fibrillation occurs.
Primary sources of complication information include current scientific and technological knowledge.
Possible undesired side effects and adverse events
Possible residual risks are:
• Infection in blood circulation, infection of device pocket, peripheral infection by skin lesion
• Ongoing ventricular tachycardia, prolonged anesthesia or sedation, cardiac arrest, syncope in the
presence of the attending physician, acute and serious heart failure, pulmonary embolism, arterial
and venous embolism, acute and chronic toxic or allergic reaction
• Nausea/sickness/slight dizziness, pain, impairment of performance ability
• Muscle twitching, thermal tissue load, mechanical tissue irritation
• Prolonged undesired medical condition, prolonged psychological stress, physician misdiagnoses of
patient medical condition, environmental impairment, repeated invasive intervention
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate range of intrinsic events
so that skeletal myopotentials are usually not sensed. Skeletal myopotentials can nonetheless be
classified as intrinsic events especially with a unipolar configuration and/or very high sensitivity and,
depending on the interference, may cause inhibition or antiarrhythmia therapy.
• Where appropriate, carry out a follow-up and evaluate the sensitivity and the pacing mode.
Nerve and muscle stimulation
A device system consisting of a unipolar lead and an uncoated device may result in undesirable pacing
of the diaphragm in the case of an initial or permanent high setting of the pulse amplitude.
Possible technical failures
Technical failure of a device system cannot be entirely ruled out. Possible causes can include the
following:
• Lead dislodgement, lead fracture
• Insulation defects
• Device component failures
• Battery depletion
• Interrupted telemetry