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