BIOTRONIK SE and KG TACHNT2 Implantable Cardioverter Defibrillator User Manual 417635 B GA Inlexa mul

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Document Description	15a_[TACHNT2] UserMan_Inlexa
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Date Submitted	2016-04-11 00:00:00
Date Available	2016-10-08 00:00:00
Creation Date	2015-11-06 18:51:55
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Document Lastmod	2015-11-06 21:12:49
Document Title	417635--B_GA_Inlexa_mul.fm
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Inlexa 3/7
ICD Family • Tachyarrhythmia Therapy • Cardiac Resynchronization Therapy
Technical manual • en
ICD-Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie
Gebrauchsanweisung • de
Familia de DAI • Terapia antitaquiarritmia • Terapia de resincronización cardiaca
Manual técnico • es
Famille des DAI • Traitement de la tachyarythmie • Traitement par resynchronisation cardiaque
Manuel technique • fr
©
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.
0123
0681 2016
16-D-xx
Revision: B (2015-11-06)
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com
417635--B_GA_Inlexa_mul.fm Page 1 Friday, November 6, 2015 8:30 PM
en • English
Product Description
Intended Medical Use
Intended use
Inlexa belongs to a family of implantable cardioverter-defibrillators (ICD). The primary
objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is
capable of treating bradycardia arrhythmias and cardiac resynchronization therapy
with multisite ventricular pacing.
The implantation of an ICD is a symptomatic therapy with the following objectives:
• Termination of spontaneous ventricular fibrillation (VF) through shock delivery
• Termination of spontaneous ventricular tachycardia (VT) through antitachycardia
pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with
shock delivery
• Cardiac resynchronization through multisite ventricular pacing (triple-chamber
devices)
• Compensation of bradycardia through ventricular (single-chamber devices) or 
AV sequential pacing (DX, dual- and triple-chamber devices).
VR-T DX and HF-T/HF-T QP devices types with DX functionality are only indicated
for patients not requiring atrial pacing.
Diagnosis and therapy forms
The device monitors the heart rhythm and automatically detects and treats cardiac
arrest resulting from ventricular tachyarrhythmia. All major therapeutic approaches
from the field of cardiology and electrophysiology are included. 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 and the operation conditions of a device system.
• Only qualified medical specialists having this required special knowledge are
permitted to use implantable devices.
• If users do not possess this knowledge, they must be trained accordingly.
Table of Contents
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Therapeutic and Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Precautionary Measures while Programming . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Bradycardia / CRT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Electrical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
en • English
417635--B_GA_Inlexa_mul.fm Page 2 Friday, November 6, 2015 8:30 PM
Indications
Inlexa can treat life-threatening ventricular arrhythmias with antitachycardia pacing
and defibrillation.
Generally approved differential diagnostics methods, indications, and recommendations for ICD therapy apply to BIOTRONIK devices. See the current guidelines of
cardiology associations for guidance.
We recommend observing the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung, (DGK)) and 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), and other national cardiology associations.
Single-chamber and dual-chamber
Single-chamber and dual-chamber ICDs are indicated for patients with the following
risk:
• Sudden cardiac death caused by ventricular arrhythmias
System Overview
Triple-chamber
Triple-chamber ICDs are indicated for patients with the following risks:
• Sudden cardiac death caused by ventricular arrhythmias
• Congestive heart failure with ventricular asynchrony
Note: Not all functions and parameters mentioned in this technical manual are
featured by each device type of each device family.
Device family
The complete Inlexa 3/7 device family consists of several device types with a DF-1/IS-1
or DF4/IS-1 connection or with DF4/IS-1 or DF4/IS4/IS-1 connection.
• Single-chamber: VR-T and VR-T DX (device type with only a DF-1/IS-1 connection)
• Dual-chamber: DR-T
• Triple-chamber: HF-T and HF-T QP
Note: Not all device types are included in every device family.
Note: Not all device types are available in every country.
Note: Not all device types are approved in every country.
Device
The device's housing is made of biocompatible titanium, welded from outside and thus
hermetically sealed. The ellipsoid shape facilitates implantation in the pectoral muscle
area.
The connections for bipolar pacing and sensing (and unipolar connections for the triplechamber device) as well as for shock delivery are found in the device header.
The housing serves as a potential antipole during shock delivery or in the case of
unipolar lead configuration.
Contraindications
Known contraindications:
• Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
• Such frequent VT or VF that the therapies would cause an unacceptably rapid
depletion of the device batteries
• VT with few or without clinically relevant symptoms
• VT or VF treatable by surgery
• Concomitant diseases that would substantially limit a positive prognosis
• Accelerated intrinsic rhythm
417635--B_GA_Inlexa_mul.fm Page 3 Friday, November 6, 2015 8:30 PM
Lead connectors
BIOTRONIK offers ICDs with headers for different standardized lead connections:
• DF-1/IS-1 and DF-1/IS-1/IS4
• DF4, DF4/IS-1 and DF4/IS-1/IS4
Connector
port
RA
RV
RV
SVC
LV
Note: Suitable leads must comply with the norms:
• A device's DF-1 connector port may only be used for connecting leads with a 
DF-1 connector that conform to ISO 11318.
• A device's IS-1 connector port may only be used for connecting leads with a 
IS-1 connector that conform to ISO 5841-3.
• A device's DF4 connector port may only be used for connecting leads with a 
DF4 connector that conform to ISO 27186.
• A device's IS4 connector port may only be used for connecting leads with a 
IS4 connector that conform to ISO 27186.
en • English
DF-1
SVC
DF-1
RV
IS-1
RA
IS-1
RV
DF-1
SVC
DF-1
RV
IS-1
RA
IS-1
RV
DF-1
SVC
DF-1
RV
Implantation site
Device type
Atrium
Right ventricle
Right ventricle
Superior vena cava
Left ventricle
VR DX, DR, HF
VR, VR DX, DR, HF
VR, VR DX, DR, HF
VR, VR DX, DR, HF
HF
IS4-LLLL
LV
DF-1
SVC
DF-1
RV
DF-1/IS-1
The labeling on each device provides information pertaining to the connector port
assignment in the header.
VR
VR DX
DR
HF
IS-1
RV
Configuration
Bipolar
bipolar
Shock coil
Shock coil
Unipolar, bipolar
DF-1/IS-1/IS4
The labeling on each device provides information pertaining to the connector port
assignment in the header.
HF QP
Note: The device and leads have to match.
• Only DX type leads by BIOTRONIK may be connected to the device type VR DX with
DF-1/IS-1.
• Only quadripolar leads may be connected to the device type HF QP with IS4.
• When working with DX functionality, the device type HF (QP) with DF-1 (7 series)
may be connected to DX type leads by BIOTRONIK.
DF-1
SVC
DF-1
RV
Lead
connector
IS-1
IS-1
DF-1
DF-1
IS-1
IS-1
LV
IS-1
RA
IS-1
RV
IS-1
RA
IS-1
RV
Connector Lead
Configuration
port
connector
Implantation site
Device type
RA
RV
RV
SVC
LV
Atrium
Right ventricle
Right ventricle
Superior vena cava
Left ventricle
HF QP
HF QP
HF QP
HF QP
HF QP
IS-1
IS-1
DF-1
DF-1
IS4
Bipolar
Bipolar
Shock coil
Shock coil
Unipolar, bipolar
417635--B_GA_Inlexa_mul.fm Page 4 Friday, November 6, 2015 8:30 PM
DF4/IS-1
The labeling on each device provides information pertaining to the connector port
assignment in the header.
VR
DR
HF
IS-1
RA
DF4-LLHH
RV
DF4-LLHH
RV
Connector
port
RA
RV
LV
Lead
connector
IS-1
DF4
IS-1
IS-1
RA
Leads
BIOTRONIK leads are sheathed with biocompatible silicone. They can be flexibly
maneuvered, are stable long-term, and are equipped for active or passive fixation. They
are implanted using a lead introducer set. Some leads are coated with polyurethane
which is known to increase the sliding properties for the lead. Leads with steroids
reduce inflammatory processes. The fractal design of the electrodes provides for low
pacing thresholds. 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 radio frequency (RF) telemetry in the programmer. BIOTRONIK calls
this function SafeSync.
Programmer
Implantation and follow-up are performed with BIOTRONIK's portable programmer:
Software PSW as of version 1505.
There are programmers with integrated or external SafeSync Module for RF telemetry.
Leadless ECG, IEGM, markers and functions are displayed simultaneously on the color
display.
The programmer allows you to determine the thresholds and to perform all tests
during an in-office follow-up; in addition, you can change the permanent program and
send it to the implanted device.
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.
IS-1
LV
DF4-LLHH
RV
Configuration
Implantation site
Device type
Bipolar
Bipolar and shock coil
Unipolar, bipolar
Atrium
Right ventricle
Left ventricle
DR, HF
VR, DR, HF
HF
DF4/IS-1/IS4
The labeling on each device provides information pertaining to the connector port
assignment in the header.
HF QP
IS4-LLLL
LV
IS-1
RA
DF4-LLHH
RV
Connector
port
RA
RV
LV
Lead
connector
IS-1
DF4
IS4
Configuration
Implantation site
Device type
Bipolar
Bipolar and shock coil
Unipolar, bipolar
Atrium
Right ventricle
Left ventricle
HF QP
HF QP
HF QP
417635--B_GA_Inlexa_mul.fm Page 5 Friday, November 6, 2015 8:30 PM
DDDR is the NBG code for the antibradycardia mode of the dual-chamber devices:
Modes
Note: Not all functions and parameters mentioned in this technical manual are
featured by each device type of each device family.
The mode setting depends on the individual diagnosis:
Device type
Modes
VR
VVI; VVIR; VOO; OFF
7 series: VVI-CLS
7 series: VR DX
VDD; VDDR; VDI; VDIR; VVI; VVIR; V00; OFF
VVI-CLS
DR, HF (QP)
DDD; DDDR; DDI; DDIR
7 series: DDDR-ADIR; DDD-ADI
VDD; VDDR; VDI; VDIR
VVI; VVIR; AAI; AAIR; VOO; DOO; OFF
7 series: VVI-CLS; DDD-CLS
DDDRV is the NBG code for the antibradycardia mode of the triple-chamber devices:
Ventricular pacing
Sensing in the atrium and ventricle
Pulse inhibition and pulse triggering
Rate adaptation
VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber
device:
VDE is the NBD code for the antitachycardia mode of the dual-chamber and triplechamber devices with atrial therapy:
Shock in the ventricle
Antitachycardia pacing (ATP) in the atrium and ventricle
Detection via IEGM analysis
en • English
Pacing in the atrium and ventricle
Sensing in the atrium and ventricle
Pulse inhibition and pulse triggering
Rate adaptation
Multisite pacing in both ventricles
VDDR is the NBG code for the antibradycardia mode of the single-chamber type DX
device:
NBD and NBG codes
VVE is the NBD code for the antitachycardia mode of the single-chamber, dualchamber, and triple-chamber devices without atrial therapy:
Shock in the ventricle
Antitachycardia pacing (ATP) in the ventricle
Detection via IEGM analysis
Pacing in the atrium and ventricle
Sensing in the atrium and ventricle
Pulse inhibition and pulse triggering
Rate adaptation
Ventricular pacing
Sensing in the ventricle
Pulse inhibition in the ventricle
Rate adaptation
417635--B_GA_Inlexa_mul.fm Page 6 Friday, November 6, 2015 8:30 PM
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 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 heart or in the device are
forwarded immediately.
• A test message can be initiated at any time using the programmer to immediately
check the Home Monitoring function.
Inlexa order numbers
Not all device types are available in every country:
Inlexa 3
DF-1/IS-1
DF4/IS-1
DF-1/IS4/IS-1
VR-T
404703
404704
—
VR-T DX —
—
—
DR-T
404701
404702
—
HF-T
404699
404700
—
HF-T QP —
—
416037
VR-T
VR-T DX
DR-T
HF-T
HF-T QP
Inlexa 7
DF-1/IS-1
404643
404642
404640
404636
—
DF4/IS-1
404644
—
404641
404637
—
DF-1/IS4/IS-1
—
—
—
—
404638
DF4/IS4/IS-1
—
—
—
—
416038
DF4/IS4/IS-1
—
—
—
—
404639
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 container includes the following:
• Device, blind plugs (if applicable)
• Screwdriver
417635--B_GA_Inlexa_mul.fm Page 7 Friday, November 6, 2015 8:30 PM
Therapeutic and Diagnostic Functions
Antibradycardia pacing and CRT
• Rate hystereses, automatic sensor functions, and a night program promote the
patient's intrinsic rhythm, avoid overdrive pacing, and facilitate adaptation of the
device to the individual needs of the patient.
• Both atrial and ventricular thresholds are determined automatically in the device.
For the 7 series, capture control is used to set the pulse amplitudes so that pacing
is performed with the optimum atrial and ventricular amplitude for the patients
with each change of the pacing threshold.
• Setting an upper tracking rate for the atrium prevents unspecific atrial pacing, thus
reducing the risk of pacemaker-mediated tachycardia.
• Positive AV hysteresis functions support intrinsic conduction and thus the natural
contraction sequence. Negative AV hysteresis functions support the cardiac resynchronization therapy by maintaining pacing in stress situations.
• For resynchronization of the ventricles, triple-chamber implants have functions for
multisite pacing with possible VV delays in either direction.
• 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 
12 vectors can be used with the HF QP device type.
• With the HF QP device of the 7 series: Two stimuli can be configured for the left
ventricle with a view to improve the resonchronization of the ventricles. The stimuli
can be delivered sequentially or simultaneously.
• Additional, special form of rate adaptation with devices from the 7 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 7 series: unnecessary
ventricular pacing is avoided by promoting intrinsic conduction (Vp suppression
function). The device can thereby adapt to conduction changes and switch between
an ADI(R) and a DDD(R) mode.
Diagnostic functions
• Data from 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 both the patients' and the device's state at any time.
• To check the lead for proper functioning, an automatic impedance measurement
using subthreshold pacing pulses is performed in the device.
• Leadless ECG function: For all device types, far-field derivation can be measured
without external leads between the right ventricular shock coil and housing, which,
depending on the implantation site, corresponds to ECG derivation II or III
(Einthoven).
• Once a telemetry connection has been established during a test procedure in an inoffice follow-up, the leadless ECG and the IEGM are displayed with markers.
Antitachycardia pacing
• The ICD can treat ventricular tachycardia with antitachycardia pacing (ATP); ATP
can also be delivered in the VF zone (ATP One Shot) when the stability criterion
(monomorphic rapid VTs) is met before shock delivery.
• The ICD can also respond to atrial tachycardia with antitachycardia pacing (ATP) in
case of stable heart rates or with high-rate pacing (HF bursts) in case of unstable
heart rates.
• Depending on the device type, the device program contains not only the ICD
functions but also all pacemaker functions for 1, 2 or 3 chambers. The heart rhythm
is continuously monitored; each arrhythmia is classified according to the heart rate
and the adjustable detection criteria. Depending on the preset values, antibradycardia as well as antitachycardia therapy is inhibited or delivered.
Cardioversion, defibrillation
• The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrillation. Shock polarity and energy can be programmed individually. Shock energies
between 2.0 J and 40 J are possible. Before delivery of the shock, the ICD can be set
to only deliver a shock when ongoing tachyarrhythmia is confirmed; during this
time period the device can identify spontaneous conversion of the tachyarrhythmia
and cancel the charging process if necessary.
• The shock paths can be set between the different shock coils (SVC/RV) and/or the
housing.
en • English
417635--B_GA_Inlexa_mul.fm Page 8 Friday, November 6, 2015 8:30 PM
Storing programs
There are different therapy programs:
• Parameter settings effective for the most common indications in pre-configured
programs (Program Consult).
• For special indications, individual parameter settings can be stored in up to three
therapy programs.
General Safety Instructions
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.
• Reserve technical manuals for later use.
Home Monitoring functions
• The device automatically sends information to the transmitter once a day. It also
sends messages related to events, which are immediately forwarded to the Service
Center. In addition to this, test messages can be initiated using the programmer.
• Appointments for Home Monitoring-supported follow-ups can be scheduled via the
HMSC.
• 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
Care during shipping and storage
• Devices must not be stored or transported close to magnets or sources of electromagnetic interference.
• Note the effects of the storage duration; see Battery Data.
Delivery in shipment mode
The device is delivered in shipment mode to protect the battery; capacitor reforming
required during storage could result in controlled extended charge times of the shock
capacitors.
• The shipment mode is displayed on the programmer after the initial interrogation
(it is deactivated during implantation by the first valid (in-range) measurement of
the pacing impedance).
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
• Permitted for shipping and storage are +5°C to +45°C.
417635--B_GA_Inlexa_mul.fm Page 9 Friday, November 6, 2015 8:30 PM
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 packaged in two 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.
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
Electromagnetic interference (EMI)
Any device can be sensitive to interference if external signals are sensed as intrinsic
rhythm or if measurements prevent rate adaptation.
• 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, if any, in patients.
• 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 therapeutic or diagnostic 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.
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 impossible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological
examinations. In rare cases the set parameters may become ineffective. It is
possible for therapies to induce or accelerate tachycardia and cause sustained
ventricular flutter or fibrillation.
Device behavior in case of EMI
In case of electromagnetic interference, the device switches to asynchronous pacing
for as long as the interference rate is exceeded.
Static magnetic fields
The magnetic sensor in the device detects magnetic fields starting at a magnetic flux
density of approximately 1.5 mT. Magnetic fields below 1 mT do not affect the sensor.
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 recorded. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially at very high
sensing sensitivity and, depending on the interference, may cause inhibition or antiarrhythmia therapy.
In the case of undesired myopotentials, the device switches to asynchronous pacing if
the interference rate is exceeded.
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Possible Risks
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 risky therapy and diagnosis procedures.
• Shield device against radiation.
• After applying radiation, double-check the device system to make sure it is functioning properly.
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:
• Transcutaneous electrical nerve stimulation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
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,
which can place the patient 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. For example, excessive warming of body tissue near
the device system may occur during therapeutic ultrasound. Influences on the device
are not always immediately clear.
If risky procedures cannot be avoided, the following should be observed at all times:
• Electrically insulate the patient.
• Switch off the ICD's detection function; the pacemaker function may remain active,
switch to asynchronous modes if necessary.
• Do not introduce energy near the device system.
• Additionally check the peripheral pulse of the patient.
• Monitor the patient during and after every intervention.
Note: Please contact BIOTRONIK with questions during the risk/benefit analysis.
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.
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.
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Implantation
Unpacking the device
Implantation Procedure
W WARNING
Having parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/EEC
are required:
• BIOTRONIK device with blind plug and screwdriver
• BIOTRONIK leads and lead introducer set
— Single-chamber device: one bipolar ICD lead with 1 or 2 shock coils for the
ventricle
— Dual-chamber device: one bipolar lead for the atrium and one bipolar ICD lead
for the ventricle with 1 or 2 shock coils
— Triple-chamber device: an additional unipolar or bipolar or quadripolar LV lead
• The lead connections DF-1, DF4 as well as IS-1 and IS4 are permitted. Use only
adapters approved by BIOTRONIK for leads with different lead connections or leads
from other manufacturers.
• BIOTRONIK programmer (with integrated SafeSync RF telemetry or with separate
SafeSync Module) and approved cables
• External multi-channel ECG device
• Keep spare parts for all sterile components.
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic parts
could be damaged.
• Use a replacement device.
• Return the damaged device to BIOTRONIK.
• 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!
• Take hold of the inner blister by the gripping tab and take it out of the outer blister.
• Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
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.
• Upon delivery, the tachyarrhythmia therapy function in the ICD is deactivated. 
The ICD must only be implanted in this state.
• Leads must not be shortened.
Keeping an external defibrillator ready
To be able to respond to unforeseeable emergencies or possible technical failures of
the device:
• Keep an external defibrillator and paddles or patch electrodes ready.
Implantation site
• Depending on lead configuration and the patient's anatomy, the ICD is generally
implanted subpectorally on the left side.
Preventing leakage currents
Leakage currents between the tools and the device must be prevented during implantation.
• Electrically insulate the patient.
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Preventing unintentional shock delivery
Overview: Implanting
W WARNING
Shock delivery with activated ICD
There is a risk of unintended shock delivery when handling an activated ICD.
• Deactivate ICD therapy before touching the device during implantation, device
replacement and explantation.
Avoiding damage to the header
Set screws and blind plugs (if applicable) must be tightened or loosened with care.
• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control!
• Do not forcibly pull out the blind plug!
• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
Prepare the vein.
Implant the leads, perform the measurements, and fixate the leads.
Form the device pocket.
Connect the lead connector to the device.
Insert the device.
Guide the fixation suture through the opening in the header and fixate the device
in the prepared device pocket.
Close the device pocket.
Check the device with standard tests.
Connecting the device
The lead connectors are connected to the ports in the header of the device:
1 Remove stylets and stylet guides.
2 Connect lead for defibrillation: DF-1/IS-1 or DF-1/IS4/IS-1
• Connect the DF-1 connector for the right-ventricular shock coil to RV.
• Connect the DF-1 connector for the supraventricular shock coil to SVC. 
(Or connect a subcutaneous array to SVC).
Connect lead for defibrillation (and sensing/pacing): DF4/IS-1 or DF4/IS4/IS-1
• Connect the DF4 connector to RV.
3 Connect lead for sensing/pacing: DF-1/IS-1 or DF-1/IS4/IS-1
• Connect the bipolar IS-1 connector for the atrium to RA.
• Connect the bipolar IS-1 connector for the right ventricle to RV.
• Connect the unipolar or bipolar IS-1 connector for the left ventricle or the
quadripolar IS4 connector for the left ventricle to LV.
Connect lead for sensing/pacing: DF4/IS-1 or DF4/IS4/IS-1
• Connect the bipolar IS-1 connector for the atrium to RA.
• Connect the unipolar or bipolar IS-1 connector for the left ventricle or the
quadripolar IS4 connector for the left ventricle to LV.
Preventing short circuits in the header
W 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.
• Close unused connector ports with blind plugs.
Ensure that connector ports are clean
In case of contamination during implantation:
• Clean lead connectors with a sterile cloth.
• Rinse connector port only with sterile water.
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Establishing RF telemetry
The programmer (or the SafeSync Module) can be no more than 3 m from the device;
ideally there should be no hindrances between the patient and the programmer.
• Switch on RF telemetry on the programmer.
• Apply the programming head for about 2 s until successful initialization is displayed
on the programmer:
The SafeSync symbol is displayed in the navigator and the signal
strength is displayed in the status line.
• Remove the programming head.
Push the lead connector into the header without twisting or bending the
connector or conductor until the connector tip (on the DF-1 connector) or the
insertion indicator (on the DF4 and the IS4 connector) becomes visible behind
the set screw block. This indicator can vary depending on the manufacturer of
the lead used.
If you cannot easily plug the lead connector into the connection:
• Use only sterile water as lubricant.
If the lead connector cannot be inserted completely, the set screw may be
protruding into the drill hole of the set screw block.
• Use the screwdriver to perpendicularly pierce through the slitted point in
the center of the silicone plug until it reaches the set screw.
• Carefully loosen the set screw without completely unscrewing it, so that it
does not become tilted upon retightening.
Turn the set screw clockwise until torque control starts (you will hear a clicking
sound).
Carefully withdraw the screwdriver without retracting the set screw.
• In case of IS-1 connections with 2 set screws, tighten both screws!
• When you withdraw the screwdriver, the silicone plug automatically seals
the access to the screw head safely.
Activating ICD therapy
• Load the software that is suitable for the device type in the programmer.
• Activate ICD therapy.
• Shipment mode is permanently deactivated once the leads have been connected
and initial measurement of the pacing impedance has been performed successfully. The device data are saved.
• Take precautionary measures while programming.
• If the device induces tachycardia while programming ATPs or does not deliver
adequate therapy in the DFT test: use emergency shock or an external defibrillator.
Precautionary Measures while Programming
Keeping distance between leads
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.
W WARNING
Inadequate therapy
When leads are not spaced sufficiently apart or are positioned inappropriately, this
can lead to far-field sensing or insufficient defibrillation.
• The distance between 2 shock coils must be greater than 6 cm.
• Tip and ring electrodes must not have contact with each other.
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.
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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 programming head: lift the PGH by at least 30 cm.
• In the case of RF telemetry: switch off and reposition the programmer.
• Turn off possible sources of interference.
Monitoring the patient when setting asynchronous modes
The asynchronous modes V00 and D00 can only be set if tachyarrhythmia sensing is
deactivated. This would leave the patient without sensing and therefore without ICD
therapy.
• Continually monitor the patient.
• Keep an external defibrillator ready.
Complying with the morphology criteria
To distinguish between ventricular and supraventricular tachyarrhythmia, QRS
complexes, among other aspects, are compared to each other. You can set
a MorphMatch threshold for the purpose of tachyarrhythmia discrimination, usually
a standard value. Settings that differ, that is to say, a higher or lower threshold to
discriminate the individual QRS complexes, may lead to a delayed/inhibited or unnecessary therapy.
• Set deviations from the standard with particular caution.
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 exertion.
• Check compatibility and effectiveness of parameter combinations after making
settings.
• When setting atrial therapies after an AT or AF has been detected, note that no
ventricular tachyarrhythmia can be detected for the duration of atrial therapy
delivery.
Setting sensing
Manually set parameters can be unsafe. For example, unsuitable far-field protection
may impede sensing of intrinsic pulses.
• Note automatic sensitivity control.
Avoiding risks in the case of exclusive LV pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing and ATP therapy, induction of atrial arrhythmias.
• Consider sensing and pacing parameters with reference to loss of therapy.
• Exclusive LV pacing is not recommended for patients who depend on the device.
• Please note that capture control is not available.
• In the case of follow-ups and threshold tests, take loss of synchronized ventricular
pacing into consideration.
• Mode switching and post shock do not permit exclusive LV pacing. Please note the
effects when programming mode switching and the post shock parameters.
Preventing device-induced complications
BIOTRONIK devices feature several functions to prevent device-induced complications
to the greatest extent possible:
• Measure the retrograde conduction time.
• Set PMT protection.
• Set the VA criterion.
Preventing conduction of atrial tachycardia
BIOTRONIK devices feature several functions to prevent conduction of atrial tachycardia to the ventricle(s):
• Set mode switching 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.
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Avoiding AV crosstalk
When pacing using atrial ATP parameters, atrial pacing pulses can either be conducted
into the ventricle or be sensed such that ventricular pacing is prevented.
• Check the settings for the presence of crosstalk.
• If necessary, temporarily set VVI and a rate for backup stimulation so that no
ventricular pulses are prevented.
Note the reduced pulse amplitude due to a battery voltage drop
If the rate and amplitude are set very high and the pulse width is set too long at the
same time, the battery voltage may temporarily drop so low that the actual pulse
amplitude drops well below the selected level.
• Continuously check the pacing efficiency using ECG monitoring.
Observe when inducing short-term cardiac arrest
To permit TAVI (transcatheter aortic valve implantation), the pressure in the heart must
be reduced so that the heart valve can be correctly positioned. Intentional cardiac
arrest by high-rate pacing (rapid pacing) should be brief, must be tolerated by the
patient and can trigger a life-threatening arrhythmia.
• Take all necessary precautionary measures and keep required emergency
equipment ready.
• Continually monitor the patient by ECG.
• Complete the TAVI procedure before high-rate pacing ends. Extend the pacing
duration if necessary.
• Abort the procedure if it is not successfully completed within the maximum pacing
duration so that cardiac arrest can be stopped.
• Reactivate ICD therapy at a clinically indicated point in time when the TAVI process
is completed.
Observing the shock impedance limit
The implanted device could be damaged if the shock impedance is too low.
• The shock impedance must be > 25 Ω.
Preventing recurrence after therapy shock
After a therapy shock, pacing can be performed with a post-shock program if there is
no intrinsic rhythm.
Permanent program
Post-shock program
DDD(R), DDI(R), AAI(R)
DDI
7 series: DDD-ADI(R), DDD-CLS
VDD(R), VDI(R)
VDI
VVI(R) and OFF
VVI
7 series: VVI-CLS
Checking the settings of the DX lead
The triple-chamber device allows for a DX lead to be implanted for the right atrium and
connected to the IS-1 connector of the device.
• DX sensing in the atrium requires a special setting in the programmer which then
has to be transmitted.
• The following post-shock program parameters can be adjusted: Post-shock
duration, basic rate, rate hysteresis, ventricular pacing, LV T-wave protection,
triggering, AV delay (fixed, not dynamic)
• The default settings for the post-shock program are as follows:
A and RV: 7.5 V and 1.5 ms
LV: settings from the permanent program
Phrenic nerve stimulation that cannot be terminated
In rare cases, chronic phrenic nerve stimulation cannot be terminated by reprogramming the available left ventricular pacing configuration or using other measures.
• Set a right ventricular mode both in the permanent program as well as the ATP, in
the post-shock program and for mode switching if need be.
en • English
Checking for electrodes suitable for the shock path
Three different shock paths can be set. Two of these form an electrical path to the
housing of the implanted device.
• For the RV -> SVC shock path, a second shock coil must be available (dual shock
coil).
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.
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Follow-up
Considering power consumption and service time
RF telemetry requires somewhat more power: Consumption during implantation corresponds to approximately 7 days of service time and consumption during a 20-minute
follow-up corresponds to approximately 2 days.
• Do not establish unnecessary RF telemetry.
• After 5 minutes without input, SafeSync switches to the economy mode.
• Check the battery capacity of the device at regular intervals.
Follow-up intervals
Follow-ups must be performed at regular, agreed intervals.
• The first follow-up should be carried out by the physician using the programmer
(in-office follow-up) approximately 3 months after implantation following the lead
ingrowth phase.
• The next in-office follow-up should be carried out once a year and no later than
12 months after the last in-office follow-up.
Follow-up with BIOTRONIK Home Monitoring
Monitoring using the Home Monitoring function does not serve to replace regular inoffice appointments with the physician required for other medical reasons. Follow-up
supported by Home Monitoring can be used to functionally replace in-office follow-up
under the following conditions:
• The patient was informed that the physician must be contacted despite use of the
Home Monitoring function if symptoms worsen or if new symptoms arise.
• Device messages are transmitted regularly.
• The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the device
system are sufficient. If not, an in-office follow-up needs to be carried out.
Possible early detection due to information gained via Home Monitoring may necessitate an additional in-office follow-up. For example, the data may indicate at an early
stage lead problems or a foreseeable end of service time (ERI). Furthermore, the data
could provide indications of previously unrecognized arrhythmias or modification of the
therapy by reprogramming the device.
Follow-up with the programmer
Use the following procedure for in-office follow-up:
1 Record and evaluate the ECG.
2 Interrogate the device.
3 Evaluate the status and automatically measured follow-up data.
4 Check the sensing and pacing functions.
5 Possibly evaluate statistics and IEGM recordings.
6 Manually perform standard tests if necessary.
7 Possibly customize program functions and parameters.
8 Transmit the permanent program to the implanted device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
Note: Multi pole pacing also needs more power, which leads to various lengths of
service time.
Magnet Response
Application of the programming head when ICD therapy is set
If a connected programming head is applied and is communicating with the
programmer and ICD therapy is permanently set, detection and therapy remain intact
except during the diagnostic tests. If ICD therapy is not set as permanent, no therapy is
delivered when the programming head is applied.
Programming head application
When the programming head is applied, time remains for device interrogation and for
manual activation or deactivation of the therapy before the device switches back to the
previously set permanent therapy mode. The same applies to programming head application to establish RF telemetry contact.
Application of a permanent magnet
Applying a permanent magnet interrupts detection and therapy of tachycardia events.
After 8 hours of this type of deactivation, the device automatically reactivates the
therapy functions to prevent accidental permanent deactivation.
• If detection interruptions of longer than 8 hours are required, the magnet has to be
briefly removed from the device. The 8 hour countdown restarts when the magnet
is applied again.
• Use BIOTRONIK magnets: type M-50 permanent magnets.
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Patient Information
Elective Replacement Indication (ERI)
Elective Replacement Indication can be detected by Home Monitoring.
Patient ID card
A patient ID card is included in delivery.
• Provide the patient with the patient ID.
• Request that patients contact the physician in case of uncertainties.
W CAUTION
Temporally limited therapy
If ERI occurs shortly after follow-up and is only detected during the subsequent
follow-up, then the remaining service time can be much less than 3 months.
• Replace device soon.
Prohibitory signs
Premises with prohibitive signs must be avoided.
•
• The device can monitor the heart rhythm for at least 3 more months.
• At least 6 maximum energy shocks can be delivered until EOS occurs.
• The set parameters in the device do not change.
Draw the patient's attention to prohibitory signs.
Possible sources of interference
Electromagnetic interference should be avoided in daily activities. Sources of interference should not be brought into close proximity with the device.
• Draw the patient's attention to special household appliances, security checkpoints,
anti-theft alarm systems, strong electromagnetic fields, cell phones, and transmitters among other things.
• Request patients to do the following:
— Use cell phones on the side of their body that is opposite of the device.
— Keep the cell phone at least 15 cm away from the device both during use and
when stowing.
EOS replacement indication
End of Service can be detected by Home Monitoring.
W WARNING
Patient at risk of death
If EOS replacement indication occurs before replacement of the device, then the
patient is without therapy.
• Replace device immediately.
• Monitor patient constantly until immediate replacement of the device!
Replacement Indications
• VT and VF detection and all therapies are deactivated!
• The antibradycardia function remains active in the VVI mode:
— Ventricular pacing: RV; basic rate 50 bpm; without special pacemaker functions
such as hysteresis, etc.
— Pulse amplitude of 6 V; pulse width of 1.5 ms
— Cycle duration for BIOTRONIK Home Monitoring: 90 days
Possible battery levels
• BOS: Beginning of Service: > 90% charge
• MOS 1: Middle of Service: 90% to 40% residual charge
• MOS 2: Middle of Service: < 40% residual charge
• ERI: Elective Replacement Indication (i.e. RRT: Recommended Replacement Time)
• EOS: End of Service
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Explantation and Device Replacement
Explantation
• Interrogate the device status.
• Deactivate VT and VF therapies prior to explantation.
• Remove the leads from the header. Do not simply cut them loose.
• Use state-of-the-art techniques to remove the device and, if necessary, the leads.
Parameters
Bradycardia / CRT
General ICD therapy
Parameter
ICD therapy
Programs
Note: Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
• Explants are biologically contaminated and must be disposed of safely due to risk of
infection.
Device replacement
If, upon replacing the device, already implanted leads are no longer used but left in the
patient, then an additional uncontrolled current path to the heart can result.
• Deactivate VT and VF therapies prior to device replacement.
• Cap unused lead connectors and plug unused connector ports.
Basic principles:
• The device must not be resterilized and reused.
Range of values
Standard VR DX DR HF
OFF; ON
ON
x x x x
Display standard program; —
x x x x
Display safe program;
Display first interrogated
program; Individual 1, 2, 3;
ProgramConsult
Timing: Basic rate day/night and rate hystereses
Cremation
Devices must not be cremated.
• Explant the device before the cremation of a deceased patient.
Parameter
Basic rate
Range of values
30 ... (5) ... 100 ... (10)
... 160 bpm
Night rate
Night begins
OFF; 30 ... (5) ... 100 bpm
00:00 ... (00:01)
... 23:59 hh:mm
Night ends
Disposal
BIOTRONIK takes back used products for the purpose of environmentally safe disposal.
• Clean the explant with a solution of at least 1% sodium hypochlorite.
• Rinse off with water.
• Fill out explantation form and send to BIOTRONIK together with the cleaned device.
Rate hysteresis
Scan/repetitive
18
OFF; -5 ... (-5) ... -25 ... 
(-20) ... -65 bpm
OFF; ON
Standard
40 bpm
60 bpm
OFF
22:00 
hh:mm
06:00 
hh:mm
OFF
VR DX DR
x x
x x x
x x x
HF
ON
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Timing: AV delay
Parameter
AV dynamics
AV delay (1 or 2) after:
– Pacing
– Sensing
– At rate 1
– At rate 2
Sense compensation
AV hysteresis mode
AV hysteresis (positive)
7 series, CLS modes: 
AV hysteresis (positive)
AV hysteresis (negative)
AV scan and repetitive
(positive)
Timing: Upper rate
Range of values
Standard VR DX DR HF
Low; Medium; High; Fixed; Low
x x x
(Individual)
Parameter
Upper rate
Atrial upper rate
40 ... (5) ... 350 ms
Only for Fixed, also: 15
Either automatic: AV delay
after pacing + sense
compensation
Or: 15; 40 ... (5) ... 350 ms
50 ... (10) ... 130 bpm
60 ... (10) ... 140 bpm
OFF; -5 ... (-5) ... -120 ms
OFF; Positive; Negative;
IRSplus
OFF; Positive; Negative
70; 110; 150; 200 ms
70; 110; 150 ms
10 ... (10) ... 150 ms
OFF; ON
–
–
Timing: Mode switching
Parameter
Intervention rate
Onset criterion
Resolution criterion
Modification of basic rate
Mode
60 bpm
130 bpm
-40 ms
OFF
OFF
70 ms
110 ms
50 ms
ON
After mode switching:
– Rate
– Duration
7 series – Rate stabilization with mode switching
Post-shock basic rate
AV delay post shock
Ventricular post-shock
pacing
en • English
Standard VR DX DR HF
130 bpm
x x x
200 bpm
x x
Range of values
Standard VR DX DR HF
OFF; 120 ... (10) ... 200 bpm 160 bpm
x x x
3 ... (1) ... 8 (out of 8)
x x x
OFF; 5 ... (5) ... 30 bpm
10 bpm
After mode VDD(R): VDI(R) VDIR
After mode DDD(R): DDI(R) DDIR
7 series, after mode DDDCLS, DDD-ADI(R): DDI(R)
OFF; 5 ... (5) ... 50 bpm
1 ... (1) ... 30 min
ON; OFF
10 bpm
1 min
OFF
Timing: Ventricular pacing suppression
The following parameters apply to the 7 series:
Timing: Post-shock pacing
Parameter
Post-shock duration
Range of values
90 ... (10) ... 160 bpm
OFF; 175; 200; 240 bpm
Range of values
OFF; 10 s; 30 s; 1 min;
2 min; 5 min; 10 min
30 ... (5) ... 100 ... (10)
... 160 bpm
50 ... (10) ... 350 ms
RV; BiV
Parameter
Vp suppression
Pacing suppression
after consecutive Vs
Pacing support after 
X-out-of-8 cycles
Standard VR DX DR HF
10 s
x x x x
60 bpm
140 ms
RV
19
Range of values
OFF; ON
1 ... (1) ... 8
Standard VR DX DR HF
OFF
x x
x x
1; 2; 3; 4
417635--B_GA_Inlexa_mul.fm Page 20 Friday, November 6, 2015 8:30 PM
Timing: Ventricular pacing
Parameter
Permanent
Triggering
LV T-wave protection
Maximum trigger rate:
– DDD(R) and VDD(R)
Timing: Refractory periods and blanking periods
Range of values
RV; BiV; LV
OFF; RVs; RVs+PVC
OFF; ON
UTR + 20; 90 ... (10)
... 160 bpm
– DDI(R), VDI(R) and VVI(R) 90 ... (10) ... 160 bpm
Initially paced chamber
RV; LV
VV delay after Vp
0 ... (5) ... 100 ms
Parameter
PVARP
PVARP extension
Blanking RV after atrial
pacing
LV blanking after 
RV pacing
RV blanking after 
LV pacing
Far-field protection
after Vs
Far-field protection
after Vp
Standard VR DX DR HF
BiV
RVs
ON
UTR + 20
130 bpm
LV
0 ms
Timing: Ventricular multi pole pacing
The following parameters apply for devices of the 7 series, HF QP type:
Parameter
Range of values
Standard
Pacing polarity 2nd LV
OFF;
OFF
LV1 tip -> LV2 ring
LV1 tip -> LV4 ring
LV1 tip -> RV coil
LV1 tip -> housing
LV2 ring -> LV1 tip
LV2 ring -> LV4 ring
LV2 ring -> RV coil
LV3 ring -> LV2 ring
LV3 ring -> LV4 ring
LV3 ring -> RV coil
LV4 ring -> LV2 ring
LV4 ring -> RV coil
LV-LV delay
0 ... (5) ... 50 ms
0 ms
Pulse amplitude LV 2nd LV 0.5 ... (0.25) ... 4.0 ... (0.5) 2.5 V
... 6.0; 7.5 V
Pulse width LV 2nd LV
0.4; 0.5 ... (0.25) ... 1.5 ms 0.4 ms
Range of values
AUTO; 175 ... (25) ... 600 ms
OFF; ON
40 ... (10) ... 100 ms
Standard VR DX
225 ms
ON
50 ms
DR
HF
50 ... (10) ... 100 ms
80 ms
OFF; 25 ... (25) ... 225 ms
75 ms
50 ... (25) ... 225 ms
75 ms
Timing: PMT protection
HF QP
Parameter
Range of values
PMT detection/termination OFF; ON
Standard VR DX DR HF
ON
x x x
VA criterion
350 ms
250 ... (10) ... 500 ms
Timing: Rate adaptation via accelerometer
Parameter
Maximum sensor rate
Sensor gain
Sensor threshold
Rate increase
Rate decrease
7 series: Rate fading
20
Range of values
80 ... (10) ... 160 bpm
AUTO; Very low; Low;
Medium; High; Very high
Very low; Low; Medium;
High; Very high
1; 2; 4; 8 bpm/cycle
Standard VR DX DR HF
120 bpm x x x x
Medium x x x x
Medium
2 bpm/
cycle
0.1; 0.2; 0.5; 1.0 bpm/cycle 0.5 bpm/ x
cycle
OFF; ON
OFF
417635--B_GA_Inlexa_mul.fm Page 21 Friday, November 6, 2015 8:30 PM
Timing: Rate adaptation via CLS
The following parameters apply to devices of series 7:
Parameter
Range of values
Maximum sensor rate
80 ... (10) ... 160 bpm
CLS response
Very low; Low; Medium;
High; Very high
CLS resting rate control
OFF; +10 ... (+10) ...
+50 bpm
Vp required
Yes; No
Yes
Pacing: Ventricular capture control
Standard VR DX DR HF
120 bpm x x x x
Medium x x x x
Parameter
Ventricular capture
control RV + LV
Threshold test start
+20 bpm
No
Yes
Minimum amplitude
Safety margin
Pacing: Pulse amplitude and pulse width
Parameter
Pulse amplitude A
Pulse amplitude V/RV
Pulse amplitude LV
Pulse width A
Range of values
0.5 ... (0.25) ... 4.0 ... (0.5)
... 6.0; 7.5 V
0.4; 0.5 ... (0.25) ... 1.5 ms
Standard VR DX DR HF
AUTO
x x
x x x x
0.4 ms
x x
Parameter
Pacing polarity LV
(IS-1)
Sensing polarity LV
(IS-1)
Pacing: Atrial capture control
Threshold test start
Minimum amplitude
Safety margin
en • English
Range of values
3 series: OFF; ATM
7 series: OFF; ATM; ON
with ATT: 
2.5 ... (0.5) ... 5.0 V
with ATM: 3.5 V
0.5 ... (0.25) ... 4.0 V
0.5; 1.0; 1.2 V
Standard
ATM
ON
3.5 V
VR
DX
DR
HF
1.0 ... (0.25) ... 4.0 V
1.0; 1.2 V
1.0 V
1.0 V
Lead configuration LV on IS-1 connection
Pulse width V/RV
Pulse width LV
Parameter
Atrial capture control
Range of values
3 series: OFF; ATM
7 series: OFF; ATM; ON
with ATT: 
2.5 ... (0.5) ... 5.0 V
with ATM: 3.5 V
Standard
ATM
ON
3.5 V
1.0 V
1.0 V
VR DX DR
HF
21
Range of values
LV tip -> LV ring
LV tip -> RV coil
LV ring -> LV tip
LV ring -> RV coil
UNIP
UNIP; BIPL
Standard VR DX DR HF
LV tip -> RV
coil
UNIP
417635--B_GA_Inlexa_mul.fm Page 22 Friday, November 6, 2015 8:30 PM
Tachycardia
Lead configuration LV on IS4 connection
Parameter
Pacing polarity LV
(IS4)
Sensing polarity LV
(IS4)
Range of values
LV1 tip -> LV2 ring
LV1 tip -> LV4 ring
LV1 tip -> RV coil
LV1 tip -> housing
LV2 ring -> LV1 tip
LV2 ring -> LV4 ring
LV2 ring -> RV coil
LV3 ring -> LV2 ring
LV3 ring -> LV4 ring
LV3 ring -> RV coil
LV4 ring -> LV2 ring
LV4 ring -> RV coil
LV1 tip -> LV2 ring
LV1 tip -> housing
LV2 ring -> LV3 ring
LV2 ring -> housing
LV3 ring -> LV4 ring
LV3 ring -> housing
LV4 ring -> housing
Detection
Standard
HF QP
LV1 tip -> LV2 x
ring
Parameter
Interval AT/AF
Interval VT1
Interval VT2
Interval VF
Detection counter VT1
Detection counter VT2
Detection counter VF
Range of values
240 ... 600 ms
OFF; 270 ... (10) ... 600 ms
OFF; 270 ... (10) ... 500 ms
OFF; 240 ... (10) ... 400 ms
10 ... (2) ... 100
10 ... (2) ... 80
6 out-of 8; 8 out-of 12;
10 out-of 14; 12 out-of 16;
16 out-of 20; 18 out-of 24;
20 out-of 26; 22 out-of 30;
24 out-of 30; 30 out-of 40
Redetection counter VT1 10 ... (2) ... 50
Redetection counter VT2 10 ... (2) ... 40
Redetection counter VF
6 out-of 8; 8 out-of 12;
10 out-of 14; 12 out-of 16;
16 out-of 20;
18 out-of 24; 20 out-of 26;
22 out-of 30; 24 out-of 30
SMART detection VT1/VT2 OFF; ON
SMART detection ON:
– Onset VT1/VT2
4 ... (4) ... 32%
– Stability VT1/VT2
8 ... (4) ... 48%
SMART detection OFF:
– Onset VT1/VT2
OFF; 4 ... (4) ... 32%
– Stability VT1/VT2
OFF; 8 ... (4) ... 48 ms
8 ... (4) ... 48%
MorphMatch
OFF; Monitoring; ON
MorphMatch threshold
Low; Std; High
Sustained VT
OFF; 1; 2; 3; 5; 10; 20;
30 min
LV1 tip -> LV2 x
ring
22
Standard VR DX DR HF
300 ms
x x x
OFF
x x x x
300 ms
28
20
18 out of
24
ON
20%
12%
20
14
8 out of  x
12
20%
12%
OFF
Std.
OFF
417635--B_GA_Inlexa_mul.fm Page 23 Friday, November 6, 2015 8:30 PM
Therapy: Atrial therapy
The following parameters apply to devices of series 7:
Parameter
Range of values
Standard VR DX DR
Atrial therapy in the presence of stable atrial flutter:
ATP type
OFF; Burst; Ramp
OFF
Number S1
2 ... (1) ... 10
P-S1 interval
70 ... (5) ... 95%
80%
S1 decrement
5 ... (5) ... 40 ms
10 ms
Backup stimulation
OFF; 70; 90;
OFF
Atrial therapy in the presence of unstable atrial fibrillation:
Therapy
OFF; HF (high frequency) OFF
burst
Rate
10 ... (5) ... 40 Hz
40 Hz
Duration
2 ... (1) ... 10
3s
Backup stimulation
OFF; 70; 90;
OFF
Parameter
R-S1 interval for VT1/VT2
R-S1 interval for VF
7 series: Early ATP
delivery for VF
HF
Therapy: Shock
Parameter
Number of shocks VT1/VT2
Number of shocks VF
1st Shock for VT1/VT2
2nd Shock for VT1/VT2
en • English
Range of values
OFF; 1 ... (1) ... 10
Burst; Ramp
OFF; Burst; Ramp
OFF; ON
1 ... (1) ... 15
VR
DX
DR
HF
5 ... (5) ... 40 ms
Standard
OFF
Burst
Burst
OFF
10 ms
OFF; 5 ... (5) ... 40 ms
OFF
OFF; ON
RV; LV; BiV
ON
RV
Range of values
0; 1; 2; 6; 8
6; 8
OFF; 2 ... (2) ... 20 ... (5)
... 40 J
OFF; 4 ... (2) ... 20 ... (5)
... 40 J
OFF; 4*40 J; 6*40 J
3rd - nth shock for 
VT1/VT2
1st Shock for VF
2 ... (2) ... 20 ... (5) ... 40 J
2nd Shock for VF
4 ... (2) ... 20 ... (5) ... 40 J
3rd - nth shock for VF
4*40 J; 6*40 J
For shock in VT1/VT2 and VF:
– Confirmation
OFF; ON
– Polarity
Normal; inverse;
Normal -> alternating;
7 series: Inverse -> 
alternating
– Shock form
Biphasic; Biphasic 2;
7 series: Biphasic -> 
alternating; biphasic 2 ->
alternating
– Shock path
RV -> housing + SVC
RV -> housing
RV -> SVC
Therapy: Ventricular ATP
Parameter
For VT1/VT2: Attempts
ATP type for VT1/VT2
ATP type for VF
ATP optimization
Number S1 for VT1/VT2
Number S1 for VF
S1 decrement for 
VT1/VT2 and for VF
Scan decrement for 
VT1/VT2
Add S1 for VT1/VT2
Ventricular pacing
Range of values
Standard VR DX DR HF
70 ... (5) ... 85; 88; 90; 95% 80%
x x x x
88%
OFF; ON
OFF
x x x x
23
Standard
40 J
VR
DX
DR
HF
40 J
6*40 J
40 J
40 J
6*40 J
ON
Normal
Biphasic
RV->
ICD+SVC
RV -> ICD
417635--B_GA_Inlexa_mul.fm Page 24 Friday, November 6, 2015 8:30 PM
Sensing
Parameter
Periodic recording
Sensitivity and thresholds
Parameter
Sensing A
Sensing RV
Sensing LV
7 series: DX sensing
Upper threshold RV
Upper threshold LV
Upper threshold
duration RV after detection
Upper threshold
duration RV after pace
Lower threshold RV
T-wave suppression
after pacing
Minimum threshold A
Minimum threshold RV
Minimum threshold LV
Range of values
STD; OFF
STD; TWS; VFS; IND
STD; OFF; IND
ON; OFF
50; 75%
50; 75%
110; 150 ... (50) ... 500 ms
VFS: 110 ms
Standard
STD
STD
STD
OFF
50%
50%
350 ms
VR DX DR HF
x x x
x x x x
x x x x
x x x x
IEGM configuration
Start resting period
Duration of resting
period
AV delay adjusted in
sensing test
7 series: Thoracic
impedance (TI)
400 ms
25; 50%
25%
OFF; ON
OFF
0.2 ... (0.1) ... 2.0 mV
0.5 ... (0.1) ... 2.5 mV
0.5 ... (0.1) ... 2.5 ... (0.5)
... 5.0 mV
0.4 mV
0.8 mV
1.6 mV
Range of values
When Home Monitoring
is deactivated:
OFF; 30 ... (30) ...
180 days
RA, RV, LV
RA, RV, FF
FF; RV; LV
00:00 ... (1:00 AM) ...
23:00 hh:mm
0.5 ... (0.5) ... 12 h
Standard
90 days
VR DX DR HF
x x x x
OFF; 300 ms
300 ms
OFF, ON
OFF
Range of values
OFF; ON
STD; 00:00 ... (1:00 AM)
... 23:00 hh:mm
OFF; ON
Standard
OFF
STD
VR DX DR HF
x x x x
x x x x
ON
RA, RV, LV
2:00 AM
hh:mm
4h
Home Monitoring
Parameter
Home Monitoring
Time of transmission
Diagnostics
The following can be set:
Parameter
Range of values
For AT/AF
OFF; ON
7 series: Extended ON
For SVT
OFF; ON
For nsVT
OFF; ON
Standard
ON
ON
ON
IEGM for therapy
episodes
IEGM for monitoring
episodes
Ongoing atrial episode OFF; 6; 12; 18 h
Configurable in the HMSC:
Transmission date
XX.XX.XXXX
VR DX DR HF
x x x
Cycle duration
24
20 ... (1) ... 366 days
12 h
Follow-up
+ 91 days
91 days
417635--B_GA_Inlexa_mul.fm Page 25 Friday, November 6, 2015 8:30 PM
Technical Data
Factory settings
• Arrhythmia zones VT1, VT2, VF: OFF
• Antibradycardia pacing: OFF
• Home Monitoring: OFF
Mechanical Characteristics
Housing
Devices with header for DF-1 and DF4 connector:
Type
Lead connector W x H x D in mm
VR
VR DX
DR
HF
HF QP
DF-1
DF4
DF-1
DF-1
DF4
DF-1
DF4
DF-1
DF4
65 x 55 x 11
65 x 54 x 11
65 x 55 x 11
65 x 55 x 11
65 x 56 x 11
65 x 58.5 x 11
65 x 56 x 11
65 x 60.5 x 11
65 x 58.5 x 11
Volume [cm3]
33
31
33
33
32
34
33
36
36
Telemetry data for Home Monitoring:
• MISC frequencies: 402 – 405 MHz
• Maximum power of transmission: < 25 µW (–16 dBm)
Mass g
82
81
82
82
82
83
82
86
87
International radio certification
Devices with BIOTRONIK Home Monitoring are equipped with an antenna for wireless
communication.
Telemetry information for Canada:
This device must neither interfere with meteorological and earth resources technology
satellites nor with meteorological stations working in the 400,150 to 406,000 MHZ band,
and it must accept any interference received, including interference that may cause
undesired operation.
• This device will be registered with Industry Canada under the following number:
IC: 4708A-TACHNT2
The code IC in front of the certification/ registration number only indicates that the
technical requirements for Industry Canada are met.
• Telemetry information for the USA:
This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference
to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids
(i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause
undesired operation. This transmitter shall be used only in accordance with the
FCC Rules governing the Medical Device Radiocommunication Service. Analog and
digital voice communications are prohibited. Although this transmitter has been
approved by the Federal Communications Commission, there is no guarantee that it
will not receive interference or that any particular transmission from this transmitter will be free from interference.
This device will be registered with Federal Communications Commission under the
following number:
FCC ID: QRITACHNT2
Materials in contact with body tissue
• Housing: Titanium
• Header: epoxy, polysulfone; DF4 seal: silastic
• Silicone plugs and blind plugs (if applicable): Silopren or silastic
X-ray identification
NK
Electrical Characteristics
Standards
The specifications are made according to EN 45502-2-2:2008.
Measuring conditions
If not indicated otherwise, all specifications refer to the following conditions:
• Ambient temperature: 37ºC ± 2ºC
• Pacing/sensing: 500 Ω ±1%
• Shock: 50 Ω ± 1%
en • English
25
417635--B_GA_Inlexa_mul.fm Page 26 Friday, November 6, 2015 8:30 PM
Telemetry data for Japan:
In accordance with Japanese law, this device has been assigned an identification
number under the "Ordinance concerning certification of conformity with technical
regulations etc. of specified radio equipment", Article 2-1-8.
• R: 202-LSD078
ATP amplitude
A burst was measured at 500 Ω, an amplitude of 7.5 V (tolerance ± 1.5 V), pulse width of
1.5 ms, R-S1 interval of 300 ms and an S1 count of 5:
ATP amplitude Measured minimum Measured maximum Mean value
RA
7.23 V
7.27 V
4.93 V
RV
7.26 V
7.52 V
5.04 V
LV
7.51 V
7.54 V
5.07 V
Pulse form
The pacing pulse has the following form:
Automatic sensitivity control
Measurement of actual values and test signal wave shape: standard triangle. For the
device type VR DX, the programmed atrial sensitivity is intensified by a factor of 4.
Sensitivity
Value
Tolerance
Measured value
A: positive
0.2 mV
0.2 ... 0.5
0.27 mV
A: negative
0.26 mV
DX: A: positive
0.2 mV
0.2 ... 0.52
0.11 mV
(0.05 to 0.13)
DX: A: negative
The pulse amplitude reaches its maximum value at the beginning of the pulse (Ua).
With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the
pacing impedance.
Resistance to interference
• Note on device type VR DX (only devices with a DF-1/IS-1 connection): The EMC
requirements are met as long as atrial sensitivity is set to 1.0 mV (factory settings)
or values ≥ 1.0 mV. Measures must be taken to assure interference-free therapy if
more sensitive values are set.
• Note on device type HF and HF QP: In the case of unipolar sensing, the requirement
for interference voltages of ≤ 0.3 mV (peak to peak) is met.
RV: positive
RV: negative
LV: positive
LV: negative
Common mode rejection ratio
*Devices with a DF-1/IS-1 connection only; ** Information for device type HF also
applies to device type HF QP.
Rate
Common mode rejection ratio
Atrium: DX* Atrium: DR, HF** V right: VR, DR, HF** V left: HF**
16.6 Hz
76 dB
72 dB
58 dB
55 dB
50 Hz
73 dB
72 dB
65 dB
55 dB
60 Hz
75 dB
71 dB
66 dB
62 dB
0.5 mV
0.3 ... 0.7
0.5 mV
0.3 ... 0.7
Shock energy / peak voltage
With shock path: RV to housing + SVC
Shock energy
Tolerance
(Tolerance)
Peak voltage
1 J (0.7 ... 1.18)
90 ... 120 V
20 J (15.9 ... 21.6)
440 ... 480 V
40 J (33.8 ... 41.4)
620 ... 690 V
26
Measured value
Shock energy
0.83 J
17.4 J
36.7 J
0.53 mV
0.57 mV
0.53 mV
Measured value
Peak voltage
98.1 V
462 V
659 V
417635--B_GA_Inlexa_mul.fm Page 27 Friday, November 6, 2015 8:30 PM
Battery Data
Battery characteristics
The following data is provided by the manufacturers:
Manufacturer
GREATBATCH, INC.
Clarence, NY 14031
Battery type
System
Battery ID number shown on
the programmer
Device type
Battery voltage at ERI
Charge time at BOS
Charge time at ERI
Usable capacity until ERI
3 series: VR, DR, HF, HF QP
7 series: VR, VR DX, DR
Usable capacity until ERI:
7 series: HF, HF QP
Usable capacity until EOS
GB 2992
Li/SVO/CFx
Calculation of service times
• The services times have been calculated as follows – in all chambers depending on
the device type:
— Pulse amplitude: 2.5 V
— Pulse width: 0.4 ms
— Pacing impedance: 500 Ω
— Basic rate: 60 bpm
— Home Monitoring: ON, 1 device message each day and 24 IEGM online HD
transmissions per year
— Diagnostic functions and recordings: permanently set
• Capacitor reforming is performed 4 times per year and therefore at least
4 maximum charges for shocks have to be assumed per year even if less than 4 are
delivered.
LITRONIK 
Batterietechnologie GmbH
01796 Pirna, Germany
LiS 3410 RR
LiMnO2
VR, VR DX, DR, HF, HF QP
2.5 V
2.85 V
8s
8s
10 s
10 s
1390 mAh
1390 mAh
1600 mAh
—
1730 mAh
1520 mAh
Calculation of the number of shocks
Calculation of the number of shocks: Service time [in years] x number of shocks per
year
Storage period
The storage period affects the battery service time.
• Devices should be implanted within 19 months between the manufacturing date
and the use by date (indicated on the package).
• If the ICD is implanted shortly before the use by date, the expected service time
may be reduced by up to 17 months.
en • English
27
417635--B_GA_Inlexa_mul.fm Page 28 Friday, November 6, 2015 8:30 PM
Inlexa 3/7 VR-T
Service times with GB 2992 or LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
10.3
8.3
7.0
6.0
5.3
15%
10.1
8.1
6.8
5.9
5.2
50%
9.5
7.8
6.6
5.7
5.0
100%
8.8
7.3
6.2
5.4
4.8
Inlexa 3 HF-T (QP)
Service times with GB 2992 or LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
8.9
7.4
6.3
5.5
4.9
15%
8.3
7.0
6.0
5.2
4.7
50%
7.2
6.1
5.4
4.8
4.3
100%
6.0
5.3
4.7
4.2
3.9
Inlexa 7 VR-T DX
Service times with GB 2992 or LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
9.4
7.7
6.5
5.7
5.0
15%
9.2
7.6
6.4
5.6
4.9
50%
8.7
7.2
6.2
5.4
4.8
100%
8.1
6.8
5.9
5.2
4.6
Inlexa 7 HF-T (QP)
Service times with battery GB 2992 without multipolar pacing:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
10.1
8.4
7.2
6.3
5.5
15%
9.4
7.9
6.8
6.0
5.3
50%
8.2
7.0
6.1
5.5
4.9
100%
6.9
6.0
5.4
4.8
4.4
Inlexa 3/7 DR-T
Service times with GB 2992 or LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
9.4
7.7
6.5
5.7
5.0
15%
9.0
7.4
6.3
5.5
4.9
50%
8.1
6.8
5.9
5.2
4.6
100%
7.1
6.1
5.3
4.7
4.3
Service times with battery GB 2992 with multipolar pacing:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
10.1
8.4
7.2
6.3
5.5
15%
9.2
7.8
6.7
5.9
5.3
50%
7.7
6.6
5.9
5.2
4.7
100%
6.2
5.5
5.0
4.5
4.1
28
417635--B_GA_Inlexa_mul.fm Page 29 Friday, November 6, 2015 8:30 PM
Legend for the Label
TP2
Label on the package
The label icons symbolize the following:
Manufacturing date
Compatibility with telemetry protocol version 2
of BIOTRONIK Home Monitoring
Device:
NBG code and compatible leads
Use by
Example
Storage temperature
Order number
Serial number
Product identification
number
Dangerous voltages!
European approval mark
Contents
Consult the instructions for
use
Factory settings for therapy: OFF
Example
Screwdriver
Examples of the connector allocation:
DF-1/IS-1, DF4/IS-1, DF4/IS4/IS-1
Sterilized with ethylene oxide
Do not resterilize
Bipolar IS-1 connector
Single use only. 
Do not reuse!
Unipolar IS-1 connector
Unipolar DF-1 connector
Do not use if packaging is
damaged
Non-sterile
IS4 connector, DF4 connector
NON
STERILE
Transmitter with non-ionizing radiation at designated
frequency
en • English
29

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