BIOTRONIK Enitra 6 Series User manual

Enitra 6/8 ProMRI®
Pacemaker | Bradyarrhythmia Therapy | 
Cardiac Resynchronization Therapy
Technical Manual
417801
Revision: B (2016-03-23)
© BIOTRONIK SE & Co. KG
All rights reserved.
Specification subject to modification, revision and improvement.
® All product names in use may be trademarks or registered trademarks held 
by BIOTRONIK or the respective owner.
Index 417801Technical ManualEnitra 6/8
0123 2016
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel [phone]
Fax [phone]
[e-mail]
www.biotronik.com

2 Table of Contents 
Table of Contents
Table of Contents
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Medical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . . 9
General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Precautionary Measures while Programming . . . . . . . . . . . . 18
Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . 26
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Pacing and Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
MRI Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Preset Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tolerances of Parameter Values. . . . . . . . . . . . . . . . . . . . . . . 36
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

3 Product Description 
Intended Medical Use
1 Product Description
Product Description1417801Technical Man ualEnitra 6/8
Intended Medical Use
Intended use Enitra 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.

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

5 Product Description 
Contraindications
Contraindications
Guidelines No contraindications are known for the implantation of multifunctional single-
chamber, dual-chamber, or triple-chamber pacemakers, provided differential
diagnostics precedes implantation according to the appropriate guidelines and no
modes or parameter combinations are configured that pose a risk to the patient.
Pacing modes and parameters The compatibility and effectiveness of parameter combinations must be checked
and, as the case may be, adapted after programming.
Set of facts Contraindicated pacing mode
Additionally implanted ICD Unipolar pacing
Set of facts Inappropriate pacing mode
Chronic atrial tachycardia, chronic atrial
fibrillation or flutter
Atrial-controlled modes (DDD, VDD, AAI)
Poor tolerance of pacing rates above the
basic rate, e.g., angina pectoris
AV conduction disorder Atrial single-chamber pacing
Failing AV conduction
Set of facts Adapt parameters
Slow retrograde conduction after
ventricular pacing: Risk of pacemaker-
mediated tachycardia
• Extend atrial refractory period (ARP)
and/or:
• Shorten AV delay
• Rarely:
Program to DDI, DVI or VVI
Poor tolerance of pacing rates above the
basic rate, e.g., angina pectoris
• Lower atrial upper rate
• Lower maximum sensor rate
• Deploy atrial overdrive pacing

6 Product Description 
System Overview
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 The device's housing is made of biocompatible titanium, welded from the outside
and 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
Note: Suitable leads must comply with the norms:
Note: The device and leads have to match.
Note: Use only adapters approved by BIOTRONIK for leads with different connec-
tions.
IS-1 The device labeling provides information pertaining to the connection assignment:
Device type Variant with
Home Monitoring Variant without Home Monitoring
Single-chamber Enitra 6 SR-T, Enitra 8 SR-T Enitra 6 SR
Dual-chamber Enitra 6 DR-T, Enitra 8 DR-T Enitra 6 DR
Triple-chamber Enitra 8 HF-T, Enitra 8 HF-T QP —
• A device's IS-1 connector port must only be used for connecting leads with an
IS-1 connector that conform to ISO 5841-3.
• A device's IS4 connector port must only be used for connecting leads with an
IS4 connector that conform to ISO 27186.
• Only quadripolar leads must be connected to the IS4 connector on device
type HF QP with IS4.
• If you have any questions concerning the compatibility of other manufacturers'
leads, please contact BIOTRONIK.
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

Note: Home Monitoring is possible in all modes.
The OFF mode only functions temporary, i.e. during a test.
7 Product Description 
System Overview
IS-1/IS4 The device labeling provides information pertaining to the connection assignment:
Leads BIOTRONIK leads are sheathed in 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. Leads
with steroids 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 adapters to connect already implanted leads to new devices.
Telemetry Telemetric communication between the device and the programmer can be carried
out following initialization either by applying the programming head (PGH) to the
device or by using wireless wandless telemetry in the programmer.
Programmer Using the programmer, the pacing thresholds can be determined and all tests can
be performed during implantation and in-office follow-up. In addition to this, the
programmer is used to set mode and parameter combinations, as well as for
interrogation and saving of data from the device. Leadless ECG, IEGM, markers and
functions are displayed simultaneously on the color display.
Modes The mode setting depends on the individual diagnosis:
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
Device type Modes Standard
SR • VVI-CLS(8 series only)
• VVIR, V00R, AAIR, A00R
• VVI, VVT, V00, AAI, AAT, A00
•OFF
VVIR
DR • VVI-CLS; DDD-CLS(8 series only)
• DDD-ADI, DDDR-ADIR (6 and 8 series)
• 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) (8
series)
• 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

8 Product Description 
System Overview
NBG codes AAIR or VVIR is the NBG code for the antibradycardia mode of the single-chamber
device:
DDDR is the NBG code for the antibradycardia mode of the dual-chamber device:
DDDRV is the NBG code for the antibradycardia mode of the triple-chamber device:
BIOTRONIK Home Monitoring
®In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
• With Home Monitoring, diagnostic and therapeutic information and technical
data are automatically sent to a stationary or mobile transmitter via an antenna
in the device header. The data are encrypted and sent from the transmitter to
the BIOTRONIK Service Center via the cellular phone network.
• The received data are deciphered and evaluated. Each physician can set the
criteria for evaluation to be used for each patient and can configure the time of
notification via e-mail, SMS or fax.
• 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 message.
• A test message can be initiated at any time using the programmer to
immediately check the Home Monitoring function.
Order numbers for Enitra The devices can be obtained as follows:
Package contents The storage package includes the following:
• Sterile packaging with device
• Serial number label
• Patient ID card
• Warranty booklet
Note: The technical manual pertaining to the device is either included in hard copy
form in the storage package or in digital form on the internet.
The sterile packaging includes the following:
•Device
• Screwdriver
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
D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
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
Enitra 6 SR 407165 Enitra 8 SR-T 407159
Enitra 6 SR-T 407162 Enitra 8 DR-T 407147
Enitra 6 DR 407153 Enitra 8 HF-T 407142
Enitra 6 DR-T 407150 Enitra 8 HF-T QP 407141

9 Product Description 
Diagnostic and Therapy Functions
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.
Diagnostics functions • Data from the last 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.
• Continuous automatic below-threshold impedance measurements are
performed in the device independent of the pacing pulse in order to check the
lead for proper functioning.
• Once a telemetry connection has been established during a test procedure in an
in-office follow-up, the IEGM is displayed with markers.
Antibradycardia pacing • Sensing: The amplitudes of the P and R waves are measured in the implanted
device fully automatically and permanently to record varying amplitudes. The
sensitivity for the atrium and ventricle is adapted automatically on an ongoing
basis. The measurement data are averaged and the trend can be displayed.
• Pacing thresholds: Pacing thresholds are automatically identified in the device,
in single and dual-chamber devices the right ventricular, in triple-chamber
devices the right and left ventricular pacing 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.
• 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: the
postventricular atrial refractory period is adapted automatically).
• Additional, special form of rate adaptation with devices from the 8 series: An
increased cardiac output requirement is detected using physiological
impedance measurement. The measuring principle is based on contractile
changes (ionotropy) of the myocardium (CLS function: Closed Loop Stimulation).
Rate adaptation is automatically initialized and optimized in CLS mode.
• Ventricular pacing suppression with devices from the 8 series: Unnecessary
ventricular pacing is avoided 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.
• 8 series: In the course of the follow-up, an automatic test of the AV delay is
performed to improve the heart performance. AV delays are calculated; the
optimum values can be applied.

10 Product Description 
Diagnostic and Therapy Functions
Resynchronisation therapy Triple-chamber devices have functions to configure different VV delays in order to
resynchronize the ventricles.
• Capture Control is also available for the left ventricle with automated tracking of
the pacing threshold or automatic threshold monitoring (ATM) for trend
analysis.
• To ensure that no additional surgery is necessary in case of a left-sided increase
of pacing threshold or undesired phrenic nerve stimulation, different pacing
polarities can be set for the left ventricular lead with a triple-chamber device.
Up to 13 vectors can be used with the HF QP device type.
• 8 series: With the QP device type, the LV vector test provides a fast
measurement of the pacing threshold, the phrenic nerve pacing threshold and
the pacing impedance. The relative influence on the 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 supports also the selection.
• An additional diagnostic function with biventricular pacing: Variability of the
heart rate, patient activity, and thoracic impedance are monitored on a continual
basis.
Programs There are two types of therapy programs:
• Default parameters are offered for the most common indications
(ProgramConsult function).
• Individual settings can be saved in 3 individual therapy programs.
ProMRI devices recognize
magnetic resonance imaging
devices
The static magnetic field of magnetic resonance imaging devices is reliably
recognized with the aid of a sensor. This sensor can be activated for a maximum of
14 days using the MRI AutoDetect function during an interrogation.
If the patient comes near a magnetic resonance imaging device within the time set,
the implanted device recognizes the static magnetic field and automatically
activates the preset MRI program. Reprogramming to the permanent program
occurs also automatically after leaving the imaging device.
Home Monitoring functions The device automatically sends information to the transmitter once a day. In
addition to this, test messages can be initiated using the programmer. Important
medical information includes, among others, the following:
• Ongoing atrial and ventricular arrhythmia
• Parameters relevant to leads in the atrium and ventricle: thresholds, sensing
amplitudes, impedances
• Current statistics on bradycardia therapy
• Individually adjustable timing interval for device messages which provide
additional information pertaining to the device messages
• IEGM online HD®with up to 3 high definition channels
• Transmission of these IEGM recordings with device messages

11 General Safety Instructions 
Operating Conditions
2 General Safety Instructions
General Safety Instructions2417801Technical ManualEnitra 6/8
!
!
CAUTION
Safety information
Cardiac electrotherapy is subject to special operating conditions and possible
complications and risks.
Operating Conditions
Technical manuals The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manuals for leads
— Technical manuals for the programmer and its accessories
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
• Technical manuals are either included in hard copy form in the storage package
or in digital form on the internet:
manuals.biotronik.com
• Follow all relevant technical manuals.
• Keep technical manuals for later use.
Care during shipping and
storage
• 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 Extremely low and high temperatures affect the service time of the battery in the
device.
• Permitted for shipping and storage:
–10°C to +45°C
Sterile delivery The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only
if the blister and quality control seal have not been damaged.
Sterile packaging The device and screwdriver are each packaged in 2 separately sealed blisters. The
inner blister is also sterile on the outside so that it can be transferred in a sterile
state during implantation.
Single use only The device and screwdriver are intended for single use only.
• Do not use the device if the package is damaged.
• The device must not be resterilized and reused.
• Please take all precautionary measures carefully into account.

12 General Safety Instructions 
Possible Complications
Possible Complications
General information on
medical complications
Complications for patients and device systems generally recognized among
practitioners also apply to BIOTRONIK devices.
• Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information
include current scientific and technological knowledge.
• It is not possible to guarantee the efficacy of antiarrythmia therapy, even if the
programs have proven successful during tests or subsequent
electrophysiological examinations. In rare cases the set parameters can
become ineffective. In particular it is inevitable that tachyarrhythmias may be
induced.
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.
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
may include the following:
• Lead dislodgement
• Lead fracture
• Insulation defects
• Device component failures
• Battery depletion
Electromagnetic interference
(EMI)
Any device can be sensitive to interference, for example, when external signals are
sensed as intrinsic rhythm.
• BIOTRONIK devices have been designed so that their susceptibility to EMI is
minimal.
• Due to the intensity and variety of EMI, there is no guarantee for safety. It is
generally assumed that EMI produces only minor symptoms in patients - if any.
• Depending on the pacing mode and the type of interference, sources of
interference may lead to pulse inhibition or triggering, an increase in the
sensor-dependent pacing rate or asynchronous pacing.
• Under unfavorable conditions, for example during diagnostic or therapeutic
procedures, interference sources may induce such a high level of energy into
the pacing system that the cardiac tissue surrounding the lead tip is damaged.
Device behavior in case of EMI In the case of electromagnetic interference or undesired myopotentials, the device
paces asynchronously for the duration of the time that the interference rate is
exceeded.
Static magnetic fields The pacemaker switches to magnet response from a field strength > 1.0 mT.

13 General Safety Instructions 
Possible Risks
Possible Risks
Procedures to avoid The following procedures must be avoided as they may cause harm to the patient or
damage the device and, as a result, put the system functionality at risk:
• Therapeutic ultrasound
• Transcutaneous electrical nerve stimulation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
Potentially risky therapeutic
and diagnostic procedures
If electrical current from an external source is conducted through the body for
diagnostic or therapeutic purposes, then the device can be subjected to
interference and the patient placed at risk.
Arrhythmia or ventricular fibrillation can be induced during diathermic procedures
such as electrocautery, HF ablation or HF surgery. For example, damaging
pressure levels may arise during lithotripsy. Influences on the device are not always
immediately clear.
If potentially risky procedures cannot be avoided, the following should be observed
at all times:
• Electrically insulate patients.
• Switch the pacemaker function to asynchronous modes if needed.
• Do not introduce energy near the device system.
• Check the peripheral pulse of the patient.
• Monitor the patient during and after every intervention.
External defibrillation The device is protected against the energy that is normally induced by external
defibrillation. Nevertheless, any implanted device may be damaged by external
defibrillation. Specifically, the current induced in the implanted leads may result in
necrotic tissue formation close to the electrode/tissue interface. As a result,
sensing properties and pacing thresholds may change.
• Place adhesive electrodes anterior-posterior or perpendicular to the axis
formed by the device to the heart at least 10 cm away from the device and from
implanted leads.
Radiation therapy The use of radiation therapy must be avoided due to possible damage to the device
and the resulting impaired functional safety. If this type of therapy is to be used
anyway, prior risk/benefit analysis is absolutely necessary. The complexity of
influencing factors such as different sources of radiation, a variety of devices and
therapy conditions makes it impossible to issue directives that guarantee radiation
therapy without an impact on the device. The EN 45502 standard pertaining to active
implantable medical devices requires the following measures during the
administration of therapeutic ionizing radiation:
• Adhere to instructions for potentially risky therapeutic and diagnostic
procedures.
• Shield device against radiation.
• After applying radiation, double-check the device system to make sure it is
functioning properly.
Note: Please contact BIOTRONIK with questions on the risk/benefit analysis.

14 General Safety Instructions 
Possible Risks
Magnetic resonance imaging Magnetic resonance imaging must be avoided due to the associated high frequency
fields and magnetic flux density: Damage or destruction of the device system by
strong magnetic interaction and damage to the patient by excessive warming of the
body tissue in the area surrounding the device system.
Under certain conditions and when maintaining mandatory measures to protect the
patient and the device system, magnetic resonance imaging can be performed.
BIOTRONIK devices with the "MR conditional" function bear the identification
ProMRI.
• The ProMRI manual – MR conditional device systems – contains detailed
information on safely conducting an MRI.
— Download the digital manual from the web site:
manuals.biotronik.com
— Order the printed manual at BIOTRONIK.
• Does approval as "MR conditional" apply in your country or region? 
Ask for current information at BIOTRONIK.

15 Implantation 
Implantation Procedure
3 Implantation
Implantation3417801Technical ManualEni tra 6/8
Implantation Procedure
Having parts ready The following parts that correspond to the requirements of the 
EC Directive 90/385/EEC are required:
• Device with screwdriver from BIOTRONIK
• BIOTRONIK leads and lead introducer set
— Single-chamber device: unipolar or bipolar lead for the right ventricle
— Dual-chamber device: one unipolar or bipolar lead each for the atrium 
and for the right ventricle
— Triple-chamber device: an additional unipolar, bipolar, or quadripolar 
LV lead
• Approved connections are IS-1 and IS4: Use only adapters approved by
BIOTRONIK for leads with different connections or leads from other
manufacturers.
• BIOTRONIK programmer (with integrated wandless telemetry or with separate
SafeSync Module) and approved cables
• External multi-channel ECG device
• Keep spare parts for all sterile components.
Keeping an external
defibrillator ready
In order to be able to respond to unforeseeable emergencies or possible technical
failures of the device:
• Keep an external defibrillator and paddles or adhesive electrodes ready.
!
!
WARNING
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic
parts could be damaged.
Unpacking the device
• Peel the sealing paper off of the outer blister at the marked position in the
direction indicated by the arrow. The inner blister must not come into contact
with persons who have not sterilized their hands or gloves, nor with non-sterile
instruments.
• Use the gripping tab on the inner blister to remove it from the outer blister.
• Peel the sealing paper off of the sterile inner blister at the marked position in
the direction indicated by the arrow.
Note: The device is disabled on delivery and can be implanted immediately after
unpacking without manual activation.
Checking parts Damage to any of the parts can result in complications or technical failures.
• Check for damage before and after unpacking all parts.
• Replace damaged parts.
• Use a replacement device.
• Return the damaged device to BIOTRONIK.

Note: If necessary, the device can also be programmed before or during auto-
initialization.
16 Implantation 
Implantation Procedure
Implantation site In general, the pacemaker is implanted subcutaneously or subpectorally,
depending on the lead configuration as well as the anatomy of the patient.
Overview: Implanting
Avoid damage to the header Set screws must be tightened or loosened with care.
• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK
screwdrivers with torque control!
• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
!
!
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
!
!
WARNING
Inadequate therapy
Insufficient lead spacing or inappropriate lead positioning may lead to far-field
sensing.
Preventing short circuits
in the header
Keeping distance
between leads
1 Shape the device pocket and prepare the vein.
2 Implant the leads and perform measurements.
3 Connect device and leads.
4 Insert the device.
The device starts auto-initialization on its own.
5 Guide the fixation suture through the opening in the header and fixate the
device in the prepared device pocket.
6 Close the device pocket.
7 Prior to testing and configuration, wait for the successful completion of
automatic device initialization.
• Close unused connector ports with blind plugs.
• Leads must not contact each other. Position the tip and ring of newly implanted
leads with a sufficient distance from old implanted leads.

17 Implantation 
Implantation Procedure
Connecting the lead connector
to the device
Applying the programming
head
The programming head (PGH) features a diagram of the device. This is used to
assist in positioning the head to ensure proper telemetry.
• Make sure the PGH is positioned correctly.
Establishing wandless
telemetry
The programmer must be no less than 20 cm and no more than 3 m from the
device; ideally there should be no hindrances between the patient and the
programmer.
• Switch on wandless telemetry on the programmer.
• Apply the programming head for about 2 s until successful initialization is
displayed on the programmer:
The wandless telemetry symbol is displayed in the navigator and the
signal strength is displayed in the status line.
• Remove the programming head.
Note: After auto-initialization, all parameters are activated as in the standard
program.
Auto-initialization Auto-initialization begins automatically once the first connected lead is sensed.
Auto-initialization is usually terminated 10 minutes after connection of the first
lead. If no other program has been transferred in the meantime, the device
subsequently works with active automatic functions in the factory settings or with
the preset program of the user.
Manual setting of the lead polarity or measurement of lead impedances is not
necessary.
Behavior during auto-
initialization
• During transmission of a permanent program:
Auto-initialization is terminated and the transferred program is active.
• During testing:
Tests cannot be performed during auto-initialization; stop it beforehand. 
Auto-initialization will not be continued upon completion of the test.
1 Remove stylets and stylet guides.
2 • Connect the unipolar or bipolar IS-1 lead connector for the right ventricle
to RV.
• Connect the unipolar or bipolar IS-1 lead connector atrium to A.
• Connect the unipolar or bipolar IS-1 or the quadripolar IS4 lead connector
for the left ventricle to LV.
3 Push the lead connector into the header without bending the conductor until
the connector tip becomes visible behind the set screw block.
4 If the lead connector cannot be inserted completely, the set screw may be
protruding into the drill hole of the set screw block. Carefully loosen the set
screw without completely unscrewing it, so that it does not become tilted
upon retightening.
5 Use the screwdriver to perpendicularly pierce through the slitting in the
center of the silicone plug until it reaches the set screw.
6 Turn the set screw clockwise until the torque control starts (you will hear a
clicking sound).
7 Carefully withdraw the screwdriver without retracting the set screw.
• When the screwdriver is withdrawn, the silicone plug automatically seals
the lead connection safely.

18 Implantation 
Precautionary Measures while Programming
Precautionary Measures while Programming
!
!
CAUTION
Safety information
The programming of device systems requires special precautions.
Checking the device system • After auto-initialization, perform a follow-up to see if the device system is
functioning properly.
• Perform a pacing threshold test to determine the pacing threshold.
Performing standard tests and
monitoring the patient
Critical conditions can occur for the patient even during standard tests due to
inadequate parameter settings or interrupted telemetry.
• Ensure sufficient patient care even during tests.
• After the threshold test, check to determine whether the threshold is clinically
and technically justifiable.
• Continuously monitor the ECG and the patient's condition.
• Cancel testing if necessary.
Do not interrupt wandless
telemetry during a treatment
Disconnecting the SafeSync Module from the programmer can result in
interference with or termination of the SafeSync wandless telemetry.
• Do not disconnect the SafeSync Module from the programmer.
• Do not take the Operation Module off the ICS 3000.
Cancelling telemetry Programmer interference or interrupted telemetry during performance of
temporary programs (follow-up tests) can result in inadequate pacing of the
patient. This is the case if the programmer can no longer be operated due to a
program error or a defective touch screen and therefore the temporary program
cannot be terminated. Under these circumstances, it is helpful to cancel telemetry,
in which case the device automatically switches to the permanent program.
• In the case of telemetry with PGH: lift the programming head by at least 30 cm.
• In the case of wandless telemetry: switch off and reposition the programmer.
• Turn off possible sources of interference.
Avoiding critical parameter
settings
No modes and parameter combinations that pose a risk to the patient should be set.
• Prior to setting rate adaptation, determine the patient's capacity for strain.
• Check compatibility and effectiveness of parameter combinations after making
settings.
Manually setting lead polarity Due to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing)
should only be set if bipolar leads are implanted.
Setting sensing Manually set parameters can be unsafe. For example, unsuitable far-field
protection may impede sensing of intrinsic pulses.
• Use automatic sensitivity control.
Setting the sensitivity A value set to < 2.5 mV/unipolar for device sensitivity may result in noise caused by
electromagnetic fields.
• Therefore, it is recommended that a value of ≥ 2.5 mV/unipolar be set according
to paragraph 28.22.1 of the EN 45502-2-1 standard. Setting sensitivity values
< 2.5 mV/unipolar requires explicit clinical need. Values like this must only be
set and retained with physician supervision.
• Please carefully take all precautionary measures into account.

19 Implantation 
Precautionary Measures while Programming
Preventing device-induced
complications
BIOTRONIK devices are equipped with several functions to prevent device-induced
complications to the greatest extent possible:
• Measure the retrograde conduction time.
• If the function is not yet automatically set: activate PMT protection.
• Set the VA criterion: The aim is to set a VA criterion that is longer than the
longest measured retrograde conduction time.
Preventing conduction of
atrial tachycardia
BIOTRONIK devices are equipped with several functions to prevent conduction of
atrial tachycardia to the ventricle(s):
•SetModeSwitching for indicated patients.
• Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
• Prefer Wenckebach response and avoid 2:1 behavior.
• Set all parameters so as to prevent constant changing between atrial and
ventricular-controlled modes.
Phrenic nerve stimulation that
cannot be terminated
With LV pacing, chronic phrenic nerve stimulation can in rare cases not be
terminated by reprogramming the available left ventricular pacing configurations
or by other measures.
• Possibly set a right ventricular mode both in the permanent program and for
Mode Switching.
Avoiding risks in the case of
exclusive left ventricular
pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing as well as induction of atrial arrhythmia.
• Consider sensing and pacing parameters with reference to loss of therapy.
• Exclusive left ventricular pacing is not recommended for patients who depend
on the device.
• Take possible interruption of automatic Active Capture Control into
consideration.
• In the case of follow-ups and threshold tests, take loss of synchronized
ventricular pacing into consideration.
• Mode Switching does not allow exclusive left ventricular pacing; consider the
consequences when setting Mode Switching parameters.
If an ICD is implanted at the
same time, do not permit
unipolar pacing
If an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is
possible to switch to unipolar pacing after resetting the pacemaker or using the
automatic lead check. As a result, the ICD could falsely inhibit or trigger
tachyarrhythmiatherapy activity.
• Unipolar leads are not permitted in this configuration.
Recognizing lead failure Automatic impedance measurement is always switched on.
• Impedance values that indicate technical failure of a lead are documented in the
event list.

20 Implantation 
Precautionary Measures while Programming
Consider power consumption
and service time
The pacemaker permits programming of high pulse amplitudes with long pulse
widths at high rates to be able to adequately treat even rare diagnoses. In
combination with low lead impedance, this results in a very high level of power
consumption.
• When programming large parameter values, take into account that the
replacement indication ERI will be reached very early because the service time
of the battery may be reduced to less than 1 year.
Home Monitoring: The CardioMessenger should be relatively close to the patient; 
if it is too far away, the device constantly seeks and consumes more power than
necessary.
• Home Monitoring ON reduces the service time by approximately 15% in single-
and dual-chamber devices and by approximately 10% in triple-chamber devices.
Wandless telemetry: 15 minutes of usage reduces the service time by
approximately 7 days.
• Do not establish unnecessary wandless telemetry.
•After5min without input, the device switches to the economy mode.
• Check the battery capacity of the device at regular intervals.