BIOTRONIK Ilesto 5 VR-T, ICD, Ilesto 5 VR-T DX, Ilesto 5 HF-T, Ilesto 7 VR-T Technical Manual

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Ilesto

xxx xxx xxx ICD Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie xxx xxx xxx xxx xxx xxx xxx xxx

Technical Manual

Technická příručka

Brugermanual

Gebrauchsanweisung

Manual técnico

Käyttöohje

Manuel technique

Manuale tecnico di istruzione

Gebruikshandleiding

Instrukcja obsługi

Manual técnico

Bruksanvisning

• en

• cs

• da

• de

• es

• 

• fr

• it

• nl

• pl

• pt

• sv

393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 1 27.09.2012 15:44:48

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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

12-D-xx Revision: B (2012-xx-xx)

® BIOTRONIK Home Monitoring, IEGM-Online HD and SMART Detecton are registered trademarks of BIOTRONIK SE & Co. KG

0123

0681 2012

393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 2 27.09.2012 15:44:48

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Ilesto 5/7 VR-T, VR-T DX, DR-T, HF-T

ICD Family Tachyarrhythmia Therapy Cardiac Resynchronization Therapy

Technical Manual for the Device

Doc. Id.: GA-HW_en--mul_393468-B

Index GA-HW_en--mul_393468-BTechn ical[nbsp ]Manual f or the[nbsp ]DeviceIles to 5/7 VR-T, VR-T DX, DR-T, HF-T

Page 4

Page 5

3 Table of Contents

Table of Contents

Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Therapeutic and Diagnostic Functions. . . . . . . . . . . . . . . . . 11

General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Precautionary Measures while Programming . . . . . . . . . . 21

Magnet Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Explantation and Device Replacement. . . . . . . . . . . . . . . . . 28

Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Bradycardia / CRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . 39

Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Page 6

4 Table of Contents

Page 7

5 Product Description

1 Product Description

Product Description1GA-HW_en--mul_393468-BTechnical[nbs p ]Manual for the[nbsp ]DeviceI lesto 5/7 VR-T, VR-T DX, DR-T , HF-T

Intended Medical Use

Intended use Ilesto 5/7 is part of a familiy of implantable cardioverter-defibrillators (ICDs).

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 (triplechamber devices)

• Compensation of bradycardia through ventricular (single-chamber devices) or AV sequential pacing (DX, dual- and triple-chamber devices)

Diagnosis and therapy

forms

The device monitors the heart rhythm and automatically detects and terminates 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 special knowledge required are permitted to use implantable devices.

• If users do not possess this knowledge, they must be trained accordingly.

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6 Product Description

Indications Ilesto 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 guidelines of cardiology associations for guidance.

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.

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

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

Also indicated for primary prophylaxis in congestive heart failure patients is Ilesto.

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 idioventricular rhythm

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7 Product Description

System Overview

Device family The complete Ilesto 5/7 device familyconsists of several device types with a DF-1/

IS-1 or DF4/IS-1 connection.

Single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection); dual-chamber: DR-T; triple-chamber: HF-T. Not all device types are available 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 triple-chamber 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.

DF-1/IS-1 or DF4/IS-1 BIOTRONIK provides ICDs with headers for different standardized lead connec-

tions: DF-1/IS-1 and DF4/IS-1.

DF-1/IS-1 lead connection The device labeling provides information pertaining to possible lead connections

depending on the device type and pertaining to connection assignment:

Note: The device type DX can only be connected using a DF-1/IS-1 connector.

VR DX DR HF

DF-1

SVC

IS-1

DF-1

SVC

IS-1

DF-1

SVC

IS-1

DF-1

SVC

IS-1

Connector port Lead con-

nector

Configuration Implantation site Device type

RV DF-1 Shock coil Right ventricle VR, DX, DR, HF

SVC DF-1 Shock coil Superior vena cava VR, DX, DR, HF

RA IS-1 Bipolar Atrium DX, DR, HF

(R)V IS-1 Bipolar (Right) ventricle VR, DX, DR, HF

LV IS-1 Unipolar, Bipolar Left ventricle HF

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8 Product Description

DF4/IS-1 lead connection The device labeling provides information pertaining to possible lead connections

depending on the device type and pertaining to connection assignment:

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 radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this function SafeSync

Programmer Implantation and follow-up are performed with BIOTRONIK's portable pro-

grammer. There is one with integrated RF telemetry and one with a separate SafeSync Module. The programmer is used during implantation to transfer the current device program to the device. The pacing thresholds can be determined and all tests can be performed during 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:

VR DR HF

DF4

IS-1

DF4

IS-1

Connector port

Lead connector

Configuration Implantation site Device type

RA IS-1 Bipolar Atrium DR, HF

LV IS-1 Unipolar, Bipolar Left ventricle HF

RV, SVC DF4 Bipolar and shock Right ventricle VR, DR, HF

Note: The device's DF4 connector port may only be used for connecting leads with a DF4 connector that conform to ISO 27186.

Device type Modes

VR VVI; VVIR; V00; OFF

DX VDD; VDDR; VDI; VDIR; VVI; VVIR; V00; OFF

DR, HF DDD; DDDR; DDI; DDIR; VDD; VDDR; VDI; VDIR

VVI; VVIR; AAI; AAIR; V00; D00; OFF

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9 Product Description

NBD and NBG codes VVE is the NBD code for the antitachycardia mode of the single-chamber, dual-

chamber, and triple-chamber devices:

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:

VDDR is the NBG code for the antibradycardia mode of the single-chamber DX device:

VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber device:

V Shock in the ventricle

V Antitachycardia pacing (ATP) in the ventricle

E Detection via IEGM analysis

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

V Ventricular pacing

D Sensing in the atrium and ventricle

D Pulse inhibition and pulse triggering

R Rate adaptation

V Ventricular pacing

V Sensing in the ventricle

I Pulse inhibition in the ventricle

R Rate adaptation

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10 Product Description

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.

Technical manuals The following technical manuals provide information about usage of the device sys-

tems:

• Technical manual for the implant

• Technical manual for the HMSC

• Technical manuals for the programmer and the SafeSync Module

• Technical manual for device programs as online help on the user interface and as a PDF file in the Manual Library at www.BIOTRONIK.com

• Technical manuals for the leads

• Technical manuals for cables, adapters and accessories

Order numbers for

Ilesto with DF-1/IS-1 or

DF4/IS-1 connection

Not all device types are available in all countries:

Scope of delivery The storage package includes the following:

• Sterile container with device

•Serial number label

•Patient ID card

• Warranty booklet

• Technical manual for the implant

The sterile container includes the following:

• Device, blind plug DF-1 (if applicable) and blind plug IS-1 for device type HF

• Screwdriver

Ilesto 5 Ilesto 7

DF-1 DF4 DF-1 DF4

VR-T 383582 383584 383579 383581

VR-T DX 383596 — 390095 —

DR-T 383566 383568 383563 383565

HF-T 383550 383552 383547 383549

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11 Product Description

Therapeutic and Diagnostic Functions

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 patients and the state of the device 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 in-office 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 indicating that this will be effective before shock delivery (monomorphic rapid VTs) is met.

• 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, defibrilla-

tion

• The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrillation. Shock polarity and energy can be programmed individually. Shock energies between 2.0 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.

Antibradycardia pacing and

CRT

• Innovative 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.

• 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 the intrinsic conduction and thus the natural contraction sequence. Negative AV hysteresis functions support the cardiac resynchronization therapy by maintaining pacing in stressful situations.

• For resynchronization of the ventricles, triple-chamber devices have functions for multisite ventricular 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.

• Automatic active capture control is available for the right and left ventricle with automated tracking of the pacing threshold or automatic threshold monitoring (ATM) for trend analysis.

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12 Product Description

Storing programs The parameter settings can be saved in 3 individual therapy programs.

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. This applies to Ilesto 5/7.

• Important medical information in the device messages include the following:

— Atrial and ventricular arrhythmias — Parameters relevant to leads in the atrium and ventricle: pacing thresh-

olds, sensing amplitudes, impedances — Current statistics —IEGM online HD

with up to 3 high definition channels

Page 15

13 General Safety Instructions

2 General Safety Instructions

General Safety Instructions2GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto5/7 VR-T, VR-T DX, DR-T,HF-T

Operating Conditions

Care during shipping and

storage

• Devices are not to 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 loading the device program (it is deactivated during implantation on initial measurement of the pacing impedance).

Temperature Extremely low and high temperatures affect the service time of the battery in the

device.

• Temperatures of 5°C to 45°C are permitted for transport, storage, and use.

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 container 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.

Page 16

14 General Safety Instructions

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.

Skeletal myopotentials Bipolar sensing and control of sensitivity are adapted by the device to the rate

spectrum 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.

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 interfer-

ence (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 sensordependent 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.

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 reed switch in the device closes starting at a field strength of 1.8 mT. The reed

switch opens if the magnetic field falls below 1 mT.

Page 17

15 General Safety Instructions

Possible Risks

Contraindicated proce-

dures

The following procedures are contraindicated as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk:

• Therapeutic ultrasound: Harm to the patient via excess warming of body tissue near the device system

• Transcutaneous electrical nerve stimulation

• Hyperbaric oxygen therapy

• Applied pressures higher than normal pressure

Risky therapeutic and diag-

nostic 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 heat can result during lithotripsy. 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 can remain active. The device may need to be switched to asynchronous modes for this.

• Do not introduce energy near the device system.

• Additionally check the peripheral pulse of the patient.

• Monitor the patient during and after every intervention.

External defibrillation The device is protected against the energy that is normally induced by external defi-

brillation. Nevertheless, any implanted device may be damaged by external defibrillation. Specifically, the current induced in the implanted leads may result in necrotic tissue formation close to the electrode/tissue interface. As a result, sensing properties and pacing thresholds may change.

• Place adhesive electrodes anterior-posterior or perpendicular to the axis formed by the device to the heart at least 10 cm away from the device and from implanted leads.

Radiation therapy The use of radiation therapy is contraindicated 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.

Note: Please contact BIOTRONIK with questions during the risk/benefit analysis.

Page 18

16 General Safety Instructions

Magnetic resonance

imaging

Magnetic resonance imaging (MRI) is contraindicated due to the high frequency fields and the associated magnetic flux density: damage or destruction of the device system by strong magnetic interaction and damage to the patient by excessive warming of the body tissue in the area surrounding the device system.

• Under certain conditions one can perform special measures with magnetic resonance imaging to protect the patient and device.

Page 19

17 Implantation

3 Implantation

Implantation3GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto5/7 VR-T,VR-T DX, DR-T,HF-T

Implantation Procedure

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 LV lead

• DF-1, DF4 and IS-1 connections are approved. For leads with a different connection or leads from other manufacturers, use adapters approved by BIOTRONIK only.

• BIOTRONIK programmer (with integrated SafeSync RF telemetry or with separate SafeSync Module) and approved cable

• External multi-channel ECG device

• Keep spare parts for all sterile components.

Keeping an external defi-

brillator ready

In order to be able to respond to unforeseeable emergencies or possible technical failures of the device:

• Keep an external defibrillator and paddles or patch electrodes ready.

Unpacking the device

• Peel the sealing paper off of the outer blister at the marked position in the direction indicated by the arrow. The inner blister may 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.

WARNING

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.

Page 20

18 Implantation

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.

• The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be connected and implanted in this state.

• Leads may not be shortened.

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.

Preventing unintentional

shock delivery

Avoiding damage to the

header

There is a blind plug for DF-1 and IS-1 connections in the header. The provided set screws must be carefully loosened or tightened.

• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control!

•Do not forcibly pull out the blind plug!

• If lead repositioning is necessary, re-order sterile screwdrivers from BIOTRONIK.

Preventing short circuits in

the header

Ensure that connections are

clean

In case of contamination during implantation:

• Clean lead connectors with a sterile cloth.

• Rinse connection only with sterile water.

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.

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.

• Either leave unused ports closed with the premounted blind plugs, or close them using the supplied blind plugs.

Page 21

19 Implantation

Connecting the lead

connector to the device

Keeping distance between

leads

1 Disconnect stylets and stylet guides.

2 DF-1/IS-1 connection:

• 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.

DF4/IS-1 connection:

• Connect the DF4 connector to RV

3 DF-1/IS-1 connection:

• Connect the bipolar IS-1 lead connector for the atrium to RA.

• Connect the IS-1 lead connector for the right ventricle to RV.

• Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle to LV.

DF4/IS-1 connection:

• Connect the bipolar IS-1 lead connector for the atrium to RA.

• Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle to LV.

4 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 connector) becomes visible behind the set screw block. This indicator can vary depending on the manufacturer of the lead used.

5 If you cannot easily plug the lead connector into the connection:

• Use only sterile water as lubricant.

6 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.

7 Turn the set screw clockwise until torque control starts (you will hear a

clicking sound).

8 Carefully withdraw the screwdriver without retracting the set screw.

• In case of IS-1 connections with two set screws, tighten both screws!

• When the screwdriver is withdrawn, the silicone plug automatically safely seals the lead connector port.

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.

Page 22

20 Implantation

Implanting

Applying the programming

head

The programming head (PGH) features a diagram of the device. This is used to assist in positioning the head to ensure proper telemetry.

• Make sure the PGH is positioned correctly.

Establishing telemetry

contact

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.

Activating ICD therapy • Load the device program 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. 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.

1 Prepare the vein.

2 Implant the leads, perform the measurements, and fixate the leads.

3 Form the device pocket.

4 Connect the lead connector to the device.

5 Insert the device.

6 Guide the fixation suture through the opening in the header and fixate the

device in the prepared device pocket.

7 Close the device pocket.

8 Check the device with standard tests.

Page 23

21 Implantation

Precautionary Measures while Programming

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.

Cancelling telemetry Programmer interference or interrupted telemetry during performance of tempo-

rary 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.

Avoiding critical parameter

settings

No modes and parameter combinations that pose a risk to the patient should be set.

• Prior to setting rate adaptation, determine the patient's capacity for strain.

• Check compatibility and effectiveness of parameter combinations after making settings.

Check for leads suitable for

shock path

Three shock paths can be set, two of which form an electrical path to the device housing.

• A second shock coil (dual shock coil) must be available for the shock path RV >SVC.

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.

Setting sensing Manually set parameters can be unsafe. For example, unsuitable far-field protec-

tion may impede sensing of intrinsic pulses.

• Note automatic sensitivity control.

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.

Page 24

22 Implantation

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.

• Give preference to Wenckebach response and avoid 2:1 behavior.

• Set all parameters so as to prevent constant changing between atrial and ventricular-controlled modes.

Observing the shock imped-

ance 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.

• 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, 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 of the available left ventricular pacing configurations or by other measures.

• As the case may be, set a right ventricular mode both in the permanent program as well as the ATP, in the post-shock program and for mode switching.

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.

• Take non-availability of automatic active capture control into consideration.

• In the case of follow-ups and threshold tests, take loss of synchronized ventricular pacing into consideration.

• Mode switching and post-shock do not allow for exclusive LV pacing. Also take the effects into account when setting the mode switching and post-shock parameters.

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.

Permanent program Post-shock program

DDD, DDI, AAI DDI

VDD, VDI VDI

VVI and OFF VVI

Page 25

23 Implantation

Considering power

consumption and service

time

RF telemetry requires somewhat more power: Consumption during implantation corresponds to approximately 10 days of service time and consumption during a 20-minute follow-up corresponds to approximately 3 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.

Page 26

24 Implantation

Magnet Response

Application of the program-

ming 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 applica-

tion

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.

Page 27

25 Implantation

Follow-up

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 in-office appointments with the physician required for other medical reasons. Follow-up supported by Home Monitoring can be used to functionally replace inoffice 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 has 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 recording.

6 Manually perform standard tests if necessary.

7 Possibly customize program functions and parameters.

8 Transmit the program permanently to the device.

9 Print and document follow-up data (print report).

10 Finish the follow-up for this patient.

Page 28

26 Implantation

Patient Information

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.

Prohibitory signs Places with prohibitory signs must be avoided.

• Draw the patient's attention to prohibitory signs.

Possible sources of inter-

ference

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.

Page 29

27 Implantation

Replacement Indications

Possible battery levels • BOS: Beginning of Service: > 70% charge

• MOS 1: Middle of Service: 70% 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

Elective Replacement Indi-

cation (ERI)

Elective Replacement Indication can be detected by Home Monitoring.

• 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 selected parameters in the device program do not change.

EOS replacement indication End of Service can be detected by Home Monitoring.

• 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 func-

tions such as hysteresis, etc. — Pulse amplitude of 6 V; pulse width of 1.5 ms — Time of transmission for Home Monitoring: 90 days

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.

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!

Page 30

28 Implantation

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.

• 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.

• Insulate connections that are not used.

Basic principles:

• The device must not be resterilized and reused.

Cremation Devices should not be cremated.

• Explant the device before the cremation of a deceased patient.

Disposal BIOTRONIK takes back used products for the purpose of environmentally safe dis-

posal.

• Clean the explant with an at least 1% sodium hypochlorite solution.

• Rinse off with water.

Note: Normal oxidation processes may cause ICD housing discolorations. This is neither a device defect nor does it influence device functionality.

Page 31

29 Parameters

4 Parameters

Parameters4GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto5/7 VR-T,VR-T DX, DR-T, HF-T

Bradycardia / CRT

General ICD therapy

Timing: Basic rate day/

night and rate hystereses

Parameter Range of values Standard

ICD therapy OFF; ON ON xxxx

Programs Display standard program; Display

safe program; Display first interrogated program; Individual 1,2,3

– xxxx

Parameter Range of values Standard

Basic rate 30 ... (5) ... 100 ... (10) ... 160 bpm 40 bpm x x

60 bpm x x

Night rate OFF; 30 ... (5) ... 100bpm OFF xxxx

Begin of night 00:00 ... (00:01) ...23:59hh:mm 06:00 hh:mmxxxx

End of night 22:00 hh:mm

Rate hysteresis OFF

-5 ... (-5) ... -25 ... (-20) ... -65 bpm

OFF xxxx

Scan/repetitive OFF; ON ON xxxx

Page 32

30 Parameters

Timing: AV delay

Timing: Post-shock pacing

Timing: Upper rate

Parameter Range of values Standard

AV dynamics Low; Medium; High; Fixed; (Individual) Low x x x

AV delay (1 or 2) after:

– Pacing 15; 40 ... (5) ... 350 ms – x x x

– Sensing Either automatic: AV delay after pacing

+ sense compensation Or: 40 ... (5) ... 350 ms

–

– At rate 1 50 ... (10) ... 130 bpm 60 bpm

– At rate 2 60 ... (10) ... 140 bpm 130 bpm

Sense compensation OFF

-5 ... (-5) ... -120 ms

-40 ms x x

AV hysteresis mode OFF

Positive; Negative; IRSplus

OFF x x

OFF; Positive; Negative OFF x

AV hysteresis (positive) 70; 110; 150; 200 ms 70 ms x x x

AV hysteresis (negative) 10 ... (10) ... 150 ms 50 ms x x x

AV scan and repetitive (positive) OFF; ON ON x x x

Parameter Range of values Standard

Post shock duration OFF

10s; 30s; 1min; 2min; 5min; 10min

10s xxxx

Post-shock basic rate 30 ... (5) ... 100 ... (10) ...160bpm 60bpm xxxx

AV delay post-shock 50 ... (10) ... 350 ms 140 ms x x

Ventricular post-shock pacing RV; BiV RV x

Parameter Range of values Standard

Upper rate 90 ... (10) ... 160 bpm 130 bpm x x x

Atrial upper rate OFF

175; 200; 240 bpm

200 bpm x x

Page 33

31 Parameters

Timing: Mode switching

Timing: Ventricular pacing

Timing: Refractory periods

and blanking periods

Timing: PMT protection

Parameter Range of values Standard

Intervention rate OFF; 120 ... (10) ... 200 bpm 160 bpm x x x

Onset criterion 3 ... (1) ... 8 (out of 8) 5 x x x

Resolution criterion

Modification of basic rate OFF; 5 ... (5) ... 30 bpm 10 bpm x x x

Mode VDI(R); VDD(R) VDI x x x

DDI(R); DDD(R) DDI x x

After mode switching:

– Rate OFF; 5 ... (5) ... 50 bpm 10 bpm x x x

– Duration 1 ... (1) ... 30 min 1 min

Parameter Range of values Standard

Permanent RV; BiV; LV BiV x

Triggering OFF; RVs; RVs+PVC RVs x

LV T-wave protection OFF; ON ON x

Maximum trigger rate:

– DDD(R) and VDD(R) UTR + 20;

90 ... (10) ... 160 bpm

UTR + 20 x

– DDI(R), VDI(R) and VVI(R) 90 ... (10) ... 160 bpm 130 bpm

Initially paced chamber RV; LV LV x

VV delay after Vp 0 ... (5) ... 100 ms 5 ms x

Parameter Range of values Standard

PVARP AUTO; 175 ... (20) ... 600 ms 225 ms x x x

Blanking after atrial pacing 50 ... (10) ... 100 ms 50 ms x x

LV blanking after RV pacing 80 ms x

RV blanking after LV pacing

Far-field protection after Vs OFF; 25 ... (25) ... 225 ms 75 ms x x x

Far-field protection after Vp 50 ... (25) ... 225 ms 75 ms x x x

Parameter Range of values Standard

PMT detection/termination OFF; ON ON x x x

VA criterion 250 ... (10) ... 500 ms 350 ms x x x

Page 34

32 Parameters

Timing: Rate adaptation via

accelerometer

Pacing: Pulse amplitude

and pulse width

Pacing: Ventricular capture

control

Pacing: atrial capture

control

LV lead configuration

Parameter Range of values Standard

Maximum sensor rate 80 ... (10) ... 160bpm 160bpm xxxx

Sensor gain AUTO

Very low; Low; Medium; High; Very high

Medium xxxx

Sensor threshold Very low; Low; Medium; High;

Very high

Medium xxxx

Rate increase 1; 2; 4; 8bpm/cycle 2bpm xxxx

Rate decrease 0.1; 0.2; 0.5; 1.0bpm/cycle 0.5bpm xxxx

Parameter Range of values Standard

Pulse amplitude A 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.0; 7.5 V 2.5 V x x

Pulse amplitude V/RV xxxx

Pulse amplitude LV x

Pulse width A 0.4; 0.5 ... (0.25) ... 1.5 ms 0.4 ms x x

Pulse width V/RV xxxx

Pulse width LV 0.5 ms x

Parameter Range of values Standard

Capture control OFF; ATM; ON ATM xxxx

Threshold test start 2.5 ... (0.5) ... 5.0 V ATM: 2.5 V

ON: 3.5 V

xxxx

Minimum amplitude 1.0 ... (0.25) ... 4.0 V 1.0 V xxxx

Safety margin 1.0; 1.2 V 1.0 V xxxx

Parameter Range of values Standard

Capture control OFF; ATM ATM x x

Parameter Range of values Standard

LV pacing polarity LV tip -> LV ring;

LV tip -> RV ring; LV ring -> LV tip; LV ring -> RV ring; UNIP

LV tip -> RV ring

LV sensing polarity UNIP; BIPL UNIP x

Page 35

33 Parameters

Tachycardia

Detection

Therapy: ATP

Parameter Range of values Standard

Interval AT/AF 240 ... 600 ms 300 ms x x x

Interval VT1 OFF; 270 ... (10) ... 600ms OFF xxxx

Interval VT2 OFF; 270 ... (10) ... 500 ms

Interval VF OFF; 240 ... (10) ... 400 ms 300 ms

Detection counter VT1 10 ... (2) ... 60 26 xxxx

Detection counter VT2 10 ... (2) ... 40 16

Detection counter VF 6 out of 8; 8 out of 12; 10 out of 12;

12 out of 16; 14 out of 16; 16 out of 20; 18 out of 24; 20 out of 24; 20 out of 24; 22 out of 24; 24 out of 30; 28 out of 30

8 out of 12

Redetection counter VT1 10 ... (2) ... 30 20 xxxx

Redetection counter VT2 14

SMART detection VT1/VT2 OFF; ON ON x x x

SMART detection ON:

– Onset VT1/VT2 4 ... (4) ... 32% 20% x x x

– Stability VT1/VT2 8 ... (4) ... 48% 12%

SMART detection OFF:

– Onset VT1/VT2 OFF; 4 ... (4) ... 32% 20% xxxx

– Stability VT1/VT2 OFF; 8 ... (4) ... 48 ms 24 ms

SustainedVT OFF; 1; 2; 3; 5; 10; 20; 30min OFF xxxx

Forced termination OFF; 1 ... (1) ... 10 min 1 min x x x

Parameter Range of values Standard

ATP type for VT1/VT2 Burst; Ramp OFF xxxx

ATP type for VF OFF; Burst; Ramp Burst xxxx

ATP optimization OFF; ON OFF xxxx

Attempts OFF; 1 ... (1) ... 10 OFF xxxx

Number S1 for VT1/VT2 1 ... (1) ... 10 5 xxxx

Number S1 for VF 8

S1 decrement forVT1/VT2 and forVF 5 ... (5) ... 40ms 10ms xxxx

Scan decrement OFF; 5 ... (5) ... 40ms OFF xxxx

Additional S1 forVT1/VT2 OFF; ON ON xxxx

Ventricular pacing for VT1/VT2 RV; LV; BiV RV x

Ventricular pacing for VF RV

R-S1 intervalfor VT1/VT2 70 ... (5) ... 95% 80% xxxx

R-S1 interval for VF 85%

Page 36

34 Parameters

Therapy: Shock

Parameter Range of values Standard

Number of shocks VT1/VT2 0; 1; 2; 6; 8 8 xxxx

Number of shocks VF 6; 8 8 xxxx

1. Shock for VT1/VT2 OFF 2 ... (2) ... 20 ... (5) ... 40 J

40J xxxx

2. Shock for VT1/VT2 OFF 4 ... (2) ... 20 ... (5) ... 40 J

40J xxxx

3rd-nth shock forVT1/VT2 4*40J; 6*40J 6*40J xxxx

1. Shock for VF OFF 2 ... (2) ... 20 ... (5) ... 40 J

40J xxxx

2. Shock for VF OFF 4 ... (2) ... 20 ... (5) ... 40 J

40J xxxx

3rd-nth Shock forVF 4*40J; 6*40J 6*40J xxxx

For shock in VT1/VT2 and VF:

Confirmation OFF; ON ON xxxx

Polarity Normal; Reverse; Alternating Normal

Waveform Biphasic; Biphasic 2 Biphasig

Shock path RV -> ICD+SVC

RV -> ICD RV -> SVC

RV-> ICD+SVC

xxx

RV -> ICD x

Page 37

35 Parameters

Sensing

Sensitivity and thresholds

Parameter Range of values Standard

Sensing A STD; OFF; IND STD x x x

Sensing RV STD; TWS; VFS; IND STD xxxx

Sensing LV STD; OFF; IND STD x

Upper thresholdRV 50; 75% 50% xxxx

Upper threshold LV 50; 75 % 50% x

Upper threshold duration after detection

110; 150 ... (50) ... 500 ms VFS: 110 ms

350ms xxxx

Upper threshold duration after pacing 400 ms

Lower threshold RV 25; 50% 25% xxxx

T-wave suppression afterpacing OFF; ON OFF xxxx

Minimum threshold A 0.2 ... (0.1) ... 2.0 mv 0.4 mv x x x

Minimum threshold RV 0.5 ... (0.1) ... 2.5mv 0.8mv xxxx

Minimum threshold LV 0.5 ... (0.1) ... 2.5 ... (0.5) ... 5.0 mv 1.6 mv x

Page 38

36 Parameters

Diagnostics

The following can be set:

The following can additionally be set for Ilesto 7:

Parameter Range of values

Standard

For AT/AF OFF; ON

For Ilesto 7: Extended ON

xxxON

For SVT OFF; ON xxxON

Periodic recording When Home Monitoring OFF:

OFF; 30 ... (30) ... 180 days

xxxx90days

IEGM configuration RA, RV, LV

RA, RV, FF FF; RV; LV

xRA, RV, LV

Parameter Range of values

Standard

Start resting period 0:00 ... (1:00) ... 23:00hh:mm xxxx2:00 hh:mm

Duration of resting period 0.5 ... (0.5) ... 12h xxxx4h

AV delay modification in sensing test OFF; 300 ms xxx300ms

Thoracic impedance (TI) OFF, ON xxxxOFF

Page 39

37 Parameters

Home Monitoring

Parameter Range of values Standard

HomeMonitoring OFF; ON OFF xxxx

Time of transmission STD; 00:00 ... (01:00) ... 23:00hh:mm STD xxxx

IEGM for:

– Therapy episodes OFF; ON ON xxxx

– Monitoring episodes

Ongoing atrial episode OFF; 6, 12, 18 h 12 h x x x

Page 40

38 Parameters

Page 41

39 Technical Data

5 Technical Data

Technical Data5GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto5/7 VR-T,VR-TD X, DR-T,HF-T

Mechanical Characteristics

Housing Devices with a DF-1/IS-1 header:

Devices with a DF4/IS-1 header:

Materials in contact with

body tissue

• Housing: Titanium

• Header: Epoxy resin

• Blind plug and silicone plug: Silopren or Silastik; DF4 seal: Silastik

X-ray identification NT

Type Connection W x H x D in mm Volume in

ccm

Mass in g

VR, DX, DR DF-1 65 x 55 x 11 31 80

HF DF-1 65 x 58.5 x 11 33 80

Type Connection W x H x D in mm Volume in

ccm

Mass g

VR DF4 65 x 52 x 11 29.9 80

DR DF4 65 x 56 x 11 31.5 80

HF DF4 65 x 56 x 11 32.5 80

Page 42

40 Technical Data

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: 37 ºC ± 2 °C

• Pacing/sensing: 500 Ω ± 1%

• Shock: 50 Ω ±1%

Factory settings • Arrhythmia zones VT1, VT2, VF: OFF

• Antibradycardia pacing: OFF

• Home Monitoring: OFF

Telemetry data • Nominal carrier frequency: 403.6 MHz

• Maximum power of transmission: < 25 µW (-16 dBm)

International radio certifi-

cation

Devices with BIOTRONIK Home Monitoring® are equipped with an antenna for wireless communication.

Telemetry data for Canada and the USA:

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-TACHNXT The code IC in front of the certification/ registration number only indicates that the technical requirements for Industry Canada are met.

• This device will be registered with Federal Communications Commission under the following number:

FCC ID: QRITACHNXT

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-SMA026

Pulse form The pacing pulse has the following form:

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.

Page 43

41 Technical Data

Resistance to interference • Note on device type 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: In the case of unipolar sensing, the requirement for interference voltages of ≤ 0.3 mV (tip to tip) is met.

Common mode rejection

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:

Automatic sensitivity

setting

Measurement of actual values and test signal wave shape: standard triangle. For the device type DX, the programmed atrial sensitivity is intensified by a factor of 4.

Shock energy / peak voltage With shock path: RV to housing + SVC

Rate Common mode rejection ratio

Atrium: DX* Atrium: DR, HFV right: VR, DR, HFV left: HF

16.6 Hz 58 dB 53 dB 64 dB 66 dB

50 Hz 55 dB 55 dB 64 dB 66 dB

60 Hz 56 dB 56 dB 64 dB 68 dB

* only devices with a DF-1/IS-1 connection.

ATP amplitude Measured

minimum

Measured maximum

Mean value

RV 7.67 V 7.67 V 5.00 V

LV 7.67 V 7.67 V 4.99 V

Sensitivity Value Tolerance Measured value

A: positive 0.2 mV 0.2 ... 0.5 0.24 mV

A: negative 0.24 mV

DX: A: positive 0.2 mV 0.2 ... 0.52

(0.05 to 0.13)

0.05 mV

DX:A:negative 0.05mV

RV: positive 0.5 mV 0.3 ... 0.7 0.48 mV

RV: negative 0.40 mV

LV: positive 0.5 mV 0.3 ... 0.7 0.48 mV

LV: negative 0.56 mV

Shock energy (Tolerance)

Tolerance peak voltage

Measured value Shock energy

Measured value Peak voltage

1 J (0.7 ... 1.18) 90 ... 120 V 0.84 J 100 V

20 J (16.9 ... 20.9) 440 ... 480 V 18.1 J 469 V

40 J (33.8 ... 41.4) 620 ... 690 V 36.9 J 667 V

Page 44

42 Technical Data

Battery Data

Battery characteristics The following data is provided by the manufacturers:

Storage period The storage period affects the battery service time.

• Devices should be implanted within 19 months between the date of manufacture 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 16 months.

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: 60bpm — Home Monitoring: ON, 1 device message each day and 12 transmissions of

an IEGM online HD 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.

Calculation of the number

of shocks

Calculation of the number of shocks: Longevity [in years] x number of shocks per year

Ilesto5VR-T Service times with GB 2992 or LiS 3410 RA battery:

Manufacturer GREATBATCH, INC.

Clarence, NY 14031

LITRONIK GmbH & Co 01796 Pirna, Germany

Battery type GB 2992 LiS 3410 RA

Battery ID number shown on the programmer

Device type VR, (DX), DR, HF

Battery voltage at ERI 2.5 V 2.85 V

Charge time at BOS 8 s 8 s

Charge time at ERI 10 s 10 s

Usable capacity until ERI Ilesto 5: 1390 mAh

Ilesto 7: 1600 mAh

1390 mAh

Usable capacity until EOS 1730 mAh 1520 mAh

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 10.42 8.39 7.01 6.03 5.28

15% 10.14 8.20 6.89 5.93 5.21

50% 9.55 7.81 6.60 5.72 5.05

100% 8.81 7.31 6.24 5.45 4.83

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43 Technical Data

Ilesto 5 VR-T DX Service times with GB 2992 or LiS 3410 RA battery:

Ilesto 5 DR-T Service times with GB 2992 or LiS 3410 RA battery:

Ilesto5HF-T Service times with GB 2992 or LiS 3410 RA battery:

Ilesto7VR-T Service times with GB 2992 battery:

Ilesto 7 VR-T DX Service times with GB 2992 battery:

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 9.48 7.76 6.57 5.70 5.03

15% 9.24 7.61 6.46 5.61 4.96

50% 8.75 7.26 6.21 5.42 4.81

100% 8.12 6.83 5.89 5.17 4.62

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 9.48 7.76 6.57 5.70 5.03

15% 9.02 7.45 6.35 5.53 4.89

50% 8.10 6.81 5.88 5.17 4.61

100% 7.08 6.07 5.32 4.73 4.26

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 8.78 7.29 6.23 5.44 4.82

15% 8.21 6.89 5.94 5.21 4.65

50% 7.14 6.12 5.35 4.76 4.28

100% 6.01 5.27 4.69 4.23 3.85

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 11.78 9.52 7.98 6.87 6.03

15% 11.48 9.32 7.84 6.76 5.95

50% 10.81 8.87 7.52 6.53 5.76

100% 9.99 8.31 7.11 6.21 5.52

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 10.73 8.82 7.48 6.50 5.74

15% 10.48 8.65 7.36 6.40 5.66

50% 9.92 8.26 7.08 6.19 5.50

100% 9.22 7.77 6.71 5.91 5.27

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44 Technical Data

Ilesto 7 DR-T Service times with GB 2992 battery:

Ilesto7HF-T Service times with GB 2992 battery:

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 10.73 8.82 7.48 6.50 5.74

15% 10.22 8.47 7.23 6.31 5.59

50% 9.20 7.76 6.70 5.90 5.27

100% 8.05 6.92 6.07 5.40 4.87

Stimulation

Longevity [in years] at number of shocks per year

4 8 12 16 20

0% 9.96 8.29 7.10 6.20 5.51

15% 9.33 7.85 6.77 5.95 5.31

50% 8.12 6.97 6.11 5.43 4.89

100% 6.85 6.01 5.36 4.83 4.40

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45 Technical Data

Legend for the Label

Label on the package The label icons symbolize the following:

Manufacturing date Use by

Temperature limit Order number

Serial number Product identification

number

Dangerous voltages! CE mark

Contents Follow the instructions

for use

Sterilized with ethylene oxide

Do not resterilize Do not reuse

Do not use if packaging is damaged

Non-sterile

Transmitter with non-ionizing radiation at designated frequency

Example

Device: NBG code and compatible leads

Example

Factory settings for therapy: OFF

Screwdriver

Example of DF-1/IS-1 header

Examples of DF-1/IS-1 or DF4/IS-1 header

STERILIZE

NON

STERILE

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46 Technical Data

Bipolar IS-1 connector

Unipolar IS-1 connector

Unipolar DF-1 connector

DF4 connector