BIOTRONIK SE and KG TACH70 implantable cardioverter defibrillator User Manual

BIOTRONIK SE & Co. KG implantable cardioverter defibrillator

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15_[TACH70] UserMan

Inventra 7

Iperia 5/7

Itrevia 5/7

VR-T, VR-T DX

DR-T

HF-T, HF-T QP

ICD-Families

Tachyarrhythmia Therapy

Cardiac Resynchronization Therapy

Technical Manual Draft

Subject to completion and modification

1 Product Description

Intended Medical Use

Intended use

Inventra/Iperia/Itrevia are parts of a familiy of implantable cardioverter-defibrillators

(ICDs). Primary objective of the therapy is to prevent sudden cardiac death. Further-

more, the device is capable of treating bradycardia arrhythmias and cardiac resynchro-

nization 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)

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.

Indications

Inventra/Iperia/Itrevia can treat life-threatening ventricular arrhythmias with anti-

tachycardia pacing and defibrillation.

Generally approved differential diagnostics methods, indications, and recommenda-

tions 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

Contraindications

Known contraindications:

•

Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, elec-

trolyte 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

System Overview

Device family

This device families consist of several device types with different lead connections:

DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1:

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 and HF-T QP (only devices with a DF4 connection)

All devices include BIOTRONIK Home Monitoring. 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 or DF4/IS4

BIOTRONIK provides ICDs with headers for different standardized lead connections:

DF-1/IS-1, DF4/IS-1 and DF4/IS4.

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.

The device type HF QP can only be connected using a DF4/IS-1 or DF4/IS4 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

IS-1

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:

DF4/IS4/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 func-

tion SafeSync

Connector

port

Lead

connector

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

VR DR HF

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.

DF4-LLHH

IS-1

DF4-LLHH

IS-1

HF QP

Connector

port

Lead

connector

Configuration Implantation site Device type

RA IS-1 Bipolar Atrium HF QP

LV IS4 Unipolar, bipolar Left ventricle HF QP

RV, SVC DF4 Bipolar and shock Right ventricle HF QP

Note:

The device's DF4/IS4 connector port may only be used for connecting leads with

a DF4/IS4 connector that conform to ISO 27186.

DF4-LLHH

IS4-LLLL

IS-1

Programmer

Implantation and follow-up are performed with BIOTRONIK's portable programmer:

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:

NBD and NBG codes

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

chamber, and triple-chamber devices:

VDE is the NBD code for the antitachycardia mode of the 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:

Device type Modes

VR VVI; VVIR; V00; OFF

Series 7: VVI-CLS

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

Series 7: VVI-CLS

DR, HF, QP DDD; DDDR; DDD-ADI; DDDR-ADIR; DDI; DDIR;

VDD; VDDR; VDI; VDIR

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

Series 7: VVI-CLS; DDD-CLS

V Shock in the ventricle

V Antitachycardia pacing (ATP) in the ventricle

E Detection via IEGM analysis

V Shock in the ventricle

D Antitachycardia pacing (ATP) in the atrium and 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

VVentricular pacing

D Sensing in the atrium and ventricle

D Pulse inhibition and pulse triggering

R Rate adaptation

VVentricular pacing

V Sensing in the ventricle

I Pulse inhibition in the ventricle

R Rate adaptation

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 physi-

cians 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.

Order numbers for Iperia with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection

Order numbers for Inventra with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection

Not all device types are available in every country:

Order numbers for Iperia ProMRI with DF-1/IS-1, DF4/IS-1

or DF4/IS4/IS-1 connection

Not all device types are available in every country:

Iperia 5 Iperia 7

DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4

VR-T 393052 393053 — 393035 3393031 —

VR-T DX 393049 — — 393033 — —

DR-T 392415 392420 — 392410 392424 —

HF-T 393028 393026 — 393008 393010 —

HF-T QP — — 402658 — — 401658

Iperia 5 ProMRI Iperia 7 ProMRI

DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4

VR-T 393034 3393051 — 393050 3393030 —

VR-T DX 393048 — — 393032 — —

DR-T 392418 392419 — 392409 392423 —

HF-T 393027 393025 — 393007 393009 —

HF-T QP — — 402656 — — 401657

Order numbers for Itrevia with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection

Not all device types are available in every country:

Order numbers for Itrevia ProMRI with DF-1/IS-1, DF4/IS-1

or DF4/IS4/IS-1 connection

Not all device types are available in every country:

Order numbers for Inventra with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection

Not all device types are available in every country:

Order numbers for Inventra ProMRI with DF-1/IS-1, DF4/IS-1

or DF4/IS4/IS-1 connection

Not all device types are available in every country:

Itrevia 5 Itrevia 7

DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4

VR-T 393058 393059 — 393040 393041 —

VR-T DX 393055 — — 393037 — —

DR-T 392417 392422 — 392412 392426 —

HF-T 393066 393064 — 393014 393016 —

HF-T QP — — 402659 — — 401662

Itrevia 5 ProMRI Itrevia 7 ProMRI

DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4

VR-T 393056 393057 — 393038 393039 —

VR-T DX 393054 — — 393036 — —

DR-T 392416 392421 — 392411 392425 —

HF-T 393065 393063 — 393013 393015 —

HF-T QP — — 402657 — — 401661

Inventra 7

DF-1/IS-1 DF4/IS-1 DF4/IS4

VR-T 399443 399441 —

VR-T DX 399437 — —

DR-T 399431 399429 —

HF-T 399423 399422 —

HF-T QP — — 393012

Inventra 7 ProMRI

DF-1/IS-1 DF4/IS-1 DF4/IS4

VR-T 399442 399440 —

VR-T DX 399436 — —

DR-T 399430 399428 —

HF-T 399419 393020 —

HF-T QP — — 393011

Package contents

The storage package includes the following:

•

Sterile packaging with device

•

Serial number label

•

Patient ID card

•

Warranty booklet

Note:

Technical manuals are available either printed in the storage package or digitally

in the internet.

The sterile container includes the following:

•

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

•

Screwdriver

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.

•

Arial tachycardia can be treated with antitachycardia pacing (atrial ATP) at stable

heart rhythms and with high frequency bursts (HF burst) at instabil heart rhythms.

•

Depending on the device type, the device program contains not only the ICD func-

tions 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, antibrady-

cardia as well as antitachycardia therapy is inhibited or delivered.

Cardioversion, defibrillation

•

The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrilla-

tion. Shock polarity and energy can be programmed individually. Shock energies

between 2.0 and 45 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 adap-

tation of the device to the individual needs of the patient.

•

Thresholds: atrial as well as ventricular pacing thresholds are automatically deter-

mined in the device. 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 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

the pacing threshold or undesired phrenic nerve stimulation, different pacing

polarities can be set for the left ventricular lead with a triple-chamber device. With

the HF-T QP device up to 12 vectors are possible.

•

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.

•

Series 7: additional, special form of rate adaptation: an increased cardiac output

requirement is detected using physiological impedance measurement. The

measuring principle is based on contractile changes (inotropy) of the myocardium

(CLS function: Closed Loop Stimulation). The suitable rate adaptation is automati-

cally initialized and optimized in CLS mode.

•

Ventricular pacing suppression: unnecessary ventricular pacing is avoided by

promoting intrinsic conduction (Vp suppression function). The device can adapt

itself to conduction changes. In the case of intrinsic conduction, the device switches

to a DDD(R)-ADI(R) mode.

Storing programs

There are two types of therapy programs:

— Default parameters are offered for the most common indications (BradyProgram-

Consult function).

— Individual 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.

•

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

2 General Safety Instructions

Operating Conditions

Technical manuals

Folgende Gebrauchsanweisungen informieren über die Anwendung von Implantatsys-

temen:

— Technical manual for the device

— Technical manual for the HMSC

— Technical manuals for the programmer and the SafeSync Module

— Technical manuals for the user interface

— Technical manuals for cables, adapters and accessories

•

Technical manuals are available either printed in the storage package or digitally in

the internet: https://manuals.biotronik.com/manuals/home

•

Consider all relevant technical manuals.

•

Keep technical manuals for further use.

Care during shipping and storage

•

Devices must not be stored or transported close to magnets or sources of electro-

magnetic 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 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 Complications

General information on medical complications

Complications for patients and device systems generally recognized among practitio-

ners 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 antiar-

rhythmia 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 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 gener-

ally 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 proce-

dures, 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.

Possible Risks

Procedures, which must be avoided

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 diag-

nostic 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 or during the application of thera-

peutic ultrasound. 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 defibril-

lation. Nevertheless, any implanted device may be damaged by external defibrillation.

Specifically, the current induced in the implanted leads may result in necrotic tissue

formation close to the electrode/tissue interface. As a result, sensing properties and

pacing thresholds may change.

•

Place adhesive electrodes anterior-posterior or perpendicular to the axis formed

by the device to the heart at least 10 cm away from the device and from implanted

leads.

Radiation therapy

The use of radiation therapy must be avoided due to possible damage to the device and

the resulting impaired functional safety. If this type of therapy is to be used anyway,

prior risk/benefit analysis is absolutely necessary. The complexity of influencing

factors such as different sources of radiation, a variety of devices and therapy condi-

tions 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 thera-

peutic 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 func-

tioning properly.

Magnetic resonance imaging

Magnetic resonance imaging (MRI) must be avoided 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 and when maintaining mandatory measures to protect the

patient and device system, magnetic resonance imaging can be performed. BIOTRONIK

devices with the "MR conditional" function bear the identification ProMRI

•

The ProMRI

manual – MR conditional device systems – contains detailed informa-

tion on safely conducting an MRI.

—

Download the digital manual from the web site:

www.biotronik.com/manuals/manualselection

—

Order the printed manual from BIOTRONIK.

•

Does approval as "MR-Conditional" apply in your country or region? Request

current information from BIOTRONIK.

3 Implantation

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 defibrillator ready

In order to be able to respond to unforeseeable emergencies or possible technical fail-

ures of the device:

•

Keep an external defibrillator and paddles or patch electrodes ready.

Note:

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

Unpacking the device

•

Peel the sealing paper off of the outer blister at the marked position in the direction

indicated by the arrow. The inner blister must not come into contact with persons

who have not sterilized their hands or gloves, nor with non-sterile instruments!

•

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.

•

The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be

connected and implanted in this state.

•

Leads must 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 implanta-

tion.

•

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 screw-

drivers with torque control!

•

Do not forcibly pull out the blind plug!

•

If lead revision 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

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.

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.

Connecting the lead connector to the device

Keeping distance between leads

Implanting

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 or DF4/IS4 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 or DF4/IS4 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.

•

Or: Connect the quadripolar IS4 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 /IS4 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 seals

the lead connector port safely.

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.

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.

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.

Precautionary Measures while Programming

Performing standard tests and monitoring the patient

Critical conditions can occur for the patient even during standard tests due to inade-

quate 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 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 defec-

tive 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.

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).

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 protection

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.

Preventing conduction of atrial tachycardia

BIOTRONIK devices feature several functions to prevent conduction of atrial tachy-

cardia 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 ventric-

ular-controlled modes.

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.

•

The following post-shock program parameters can be adjusted: post-shock dura-

tion, basic rate, rate hysteresis, ventricular pacing, LV-T-wave protection, trig-

gering, 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 reprogram-

ming 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.

Permanent program Post-shock program

DDD, DDD-CLS

DDI, AAI, DDD-ADI

DDI

VDD, VDI VDI

VVI, VVI-CLS and OFF VVI

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 arrhyth-

mias.

•

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 active 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 allow for exclusive LV pacing. Please note

the effects when programming mode switching and the 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.

Considering power consumption and service time

RF telemetry requires somewhat more power: Consumption during implantation corre-

sponds 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.

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 appli-

cation 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.

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 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 necessi-

tate 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:

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 interference

Electromagnetic interference should be avoided in daily activities. Sources of interfer-

ence 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 transmit-

ters 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.

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 Indication (ERI)

Elective Replacement Indication can be detected by Home Monitoring.

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 program permanently to the device.

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

10 Finish the follow-up for this patient.

•

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 functions

such as hysteresis, etc.

—

Pulse amplitude of 6 V; pulse width of 1.5 ms

—

Time of transmission for Home Monitoring: 90 days

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 must 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 disposal.

•

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

•

Rinse off with water.

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!

Note:

Normal oxidation processes may cause ICD housing discolorations. This is

neither a device defect nor does it influence device functionality.

4 Parameters

Bradycardia / CRT

General ICD therapy

Timing: Basic rate day/night and rate hystereses

Timing: AV delay

Timing: Post-shock pacing

Parameter Range of values Standard

ICD therapy OFF; ON ON x x x x

Programs Display standard program; Display safe

program; Display first interrogated

program; Individual 1,2,3

– xxxx

Parameter Range of values Standard

Basic rate N.n. bpm N.n. bpm x x

N.n. bpm x x

Night rate OFF; N.n. bpm OFF x x x x

Night begins N.n. hh:mm N.n. hh:mm x x x x

Night ends N.n. hh:mm

Rate hysteresis OFF; N.n. bpm OFF x x x x

Scan/repetitive OFF; ON ON x x x x

Parameter Range of values Standard

AV dynamics Low; Medium; High; Fixed;

(Individual)

Low x x x

AV delay (1 or 2) after:

– Pacing N.n. ms – x x

– Sensing Either automatic: AV delay after

pacing + sense compensation

Or: N.n. ms

–xxx

– At rate 1 N.n. bpm N.n. bpm

– At rate 2 N.n. bpm N.n. bpm

Sense compensation OFF; N.n. ms N.n. ms x x

AV hysteresis mode OFF; Positive; Negative; IRSplus OFF x x

OFF; Positive; Negative OFF x

AV hysteresis (positive) N.n. ms N.n. ms

CLS

modes:

N.n. ms

xxx

AV hysteresis (negative) N.n. ms N.n. ms x x x

AV scan and repetitive

(positive)

OFF; ON ON x x x

Parameter Range of values Standard

Post-shock duration OFF; N.n. s N.n. s x x x x

Post-shock basic rate N.n. bpm N.n. bpm x x x x

AV delay post-shock N.n. ms N.n. ms x x

Ventricular post-shock

pacing

RV; BiV RV x

Timing: Upper rate

Timing: Mode switching

Timing: Ventricular pacing supression

Timing: Ventricular pacing

Timing: Refractory periods and blanking periods

Timing: PMT protection

Parameter Range of values Standard

Upper rate N.n. bpm N.n. bpm x x x

Atrial upper rate OFF; N.n. bpm N.n. bpm x x

Parameter Range of values Standard

Intervention rate OFF; N.n. bpm N.n. bpm x x x

Onset criterion N.n. N.n. x x x

Resolution criterion

Modification of basic rate OFF; N.n. bpm N.n. bpm x x x

Mode After mode VDD(R): VDI(R) VDI x x x

After mode DDD(R): DDI(R) DDI x x

After mode switching:

– Rate OFF; N.n. bpm N.n. bpm x x x

– Duration N.n. min N.n. min

Parameter Range of values Standard

Vp suppression OFF; ON OFF x x

Pacing suppression [consec-

utive Vs]

N.n. N.n. x x

Pacing support

[out of 8 cycles]

N.n. N.n. x x

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 N.n. bpm UTR +

N.n.

– DDI(R), VDI(R) and VVI(R) N.n. bpm N.n. bpm

Initially paced chamber RV; LV LV x

VV delay after Vp N.n. ms N.n. ms x

Parameter Range of values Standard

PVARP AUTO; N.n. ms N.n. ms x x x

Blanking after atrial pacing N.n. ms N.n. ms x x

LV blanking after RV pacing N.n. ms x

RV blanking after LV pacing

Far-field protection after Vs OFF; N.n. ms N.n. ms x x x

Far-field protection after Vp N.n. ms N.n. ms x x x

Parameter Range of values Standard

PMT detection/termination OFF; ON ON x x x

VA criterion N.n. ms N.n. ms x x x

Timing: Rate adaptation via accelerometer

Timing CLS-Modes: Closed Loop Stimulation

Parameters valid for devices of the series 7:

Pacing: Pulse amplitude and pulse width

Pacing: Ventricular capture control

Pacing: atrial capture control

LV lead configuration with IS-1

Parameter Range of values Standard

Maximum sensor rate N.n. bpm 160 bpm x x x x

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 N.n. bpm/cycle N.n. bpm x x x x

Rate decrease N.n. bpm/cycle N.n. bpm x x x x

Parameter Range of values Standard

Max. CLS rate N.n. bpm N.n. bpm x x x

CLS response Very low; Low; Medium;

High; Very high

Medium xxxx

CLS resting rate control OFF; N.n. bpm STD x

Vp required Yes; No No

Biv modes:

Yes

xxxx

Parameter Range of values Standard

Pulse amplitude A N.n. V N.n. V x x

Pulse amplitude V/RV x x x x

Pulse amplitude LV x

Pulse width A N.n. ms N.n. ms x x

Pulse width V/RV xxxx

Pulse width LV N.n. ms x

Parameter Range of values Standard

Ventricular capture control OFF; ATM; ON ATM x x x x

Threshold test start N.n. V ATM:

N.n.V

ON:

N.n. V

xxxx

Minimum amplitude N.n. V N.n. V x x x x

Safety margin N.n. V N.n. V xxxx

Parameter Range of values Standard

atrial capture control OFF; ATM ATM x x

Parameter Range of values Standard

Pacing polarity LV (IS-1) LV tip -> LV ring;

LV tip -> RV coil;

LV ring -> LV tip;

LV ring -> RV coil;

UNIP

LV tip ->

RV coil

Sensing polarity LV (IS-1) UNIP; BIPL UNIP x

LV lead configuration with IS4

MRI program

Valid for devices with ProMRI

Tachycardia

Detection

Therapy: atrial ATP

Parameter Range of values Standard

HF QP

Pacing polarity LV (IS4) LV1 tip ->LV2 ring

LV1 tip -> LV4 ring

LV1 tip -> RV coil

LV1 tip -> ICD

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

Sensing polarity LV (IS4) LV1 tip -> LV2 ring

LV2 ring -> LV3 ring

LV3 ring -> LV4 ring

LV1 tip -> ICD

LV2 tip -> ICD

LV3 tip -> ICD

LV4 tip -> ICD

LV1 tip ->

LV2 ring

Parameter Range of values Standard

Mode V00; OFF OFF x x

V00; D00; OFF x x

Basic rate N.n. bpm N.n. bpm x x

Ventricular pacing RV; BiV RV x

Parameter Range of values Standard

Interval AT/AF N.n. ms 300 ms x x x

Interval VT1 OFF; N.n.ms OFF x x x x

Interval VT2 OFF; N.n. ms

Interval VF OFF; N.n. ms 300 ms

Detection counter VT1 N.n. N.n. x x x x

Detection counter VT2 N.n. N.n.

Detection counter VF N.n. N.n.

Redetection counter VT1 N.n. N.n. x x x x

Redetection counter VT2 N.n. N.n.

Redetection counter VF N.n. N.n. x x x x

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

SMART detection ON:

– Onset VT1/VT2 N.n.% N.n.% x x x

– Stability VT1/VT2 N.n.% N.n.%

MorphMatch OFF; Monitor; ON OFF x x x x

SMART detection OFF:

– Onset VT1/VT2 OFF; N.n.% N.n.% x x x x

– Stability VT1/VT2 OFF; N.n. ms N.n. ms

Sustained VT OFF; N.n. min OFF x x x x

Forced termination OFF; N.n. min N.n. min x x x

Parameter Range of values Standard

ATP Type OFF; Burst; Ramp OFF x x

Number S1 N.n. N.n. x x

P-S1 interval N.n.% N.n.% x x

Therapy: atrial HF-Burst

Therapy: ATP

Therapy: Shock

Sensing

Sensitivity and thresholds

S1 decrement N.n. ms N.n. ms x x

Backup Stimulation OFF; N.n. bpm x x

Mode OFF; VVI OFF x x

Parameter Range of values Standard

Therapy OFF; HF burst OFF x x

Rate N.n. Hz N.n. Hz x x

Duration N.n. s N.n. s x x

Backup Stimulation OFF; N.n. bpm OFF x x

Mode OFF; V00 OFF x x

Parameter Range of values Standard

Attempts OFF; N.n. OFF x x x x

ATP type for VT1/VT2 Burst; Ramp Burst x x x x

ATP type for VF OFF; Burst; Ramp Burst x x x x

ATP optimization OFF; ON OFF x x x x

Number S1 for VT1/VT2 N.n. N.n. x x x x

Number S1 for VF N.n.

S1 decrement for VT1/VT2 and

for VF

N.n. ms N.n. ms x x x x

Scan decrement OFF; N.n. ms OFF xxxx

Additional S1 for VT1/VT2 OFF; ON ON x x x x

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

Ventricular pacing for VF RV

R-S1 interval for VT1/VT2 N.n.% N.n.% x x x x

R-S1 interval for VF N.n.%

Parameter Range of values Standard

Number of shocks VT1/VT2 N.n. N.n. x x x x

Number of shocks VF N.n. N.n. x x x x

1st Shock for VT1/VT2 OFF; N.n. J N.n. J x x x x

2nd Shock for VT1/VT2 OFF; N.n. J N.n. J x x x x

3rd - nth shock for VT1/VT2 OFF; N.n. J N.n. J x x x x

1st Shock for VF N.n. J N.n.J xxxx

2nd Shock for VF N.n. J N.n. J xxxx

3rd - nth Shock for VF N.n. J N.n. J x x x x

For shock in VT1/VT2 and VF:

– Confirmation OFF; ON ON x x x x

– Polarity Normal; Reverse;

Alternating

Normal

– Shock form Biphasic; Biphasic 2 Biphasic

– Shock path RV -> ICD+SVC

RV -> ICD

RV -> SVC

RV->

ICD+SVC

xxx

RV -> ICD x

Parameter Range of values Standard

Sensing A STD; OFF; IND STD x x x

Sensing RV STD; TWS; VFS; IND STD x x x x

Sensing LV STD; OFF; IND STD x

Upper threshold RV N.n.% N.n.% x x x x

Upper threshold LV N.n.% N.n.% x

Diagnostics

The following can be set:



Home Monitoring

Upper threshold duration

after detection

N.n. ms

VFS: N.n. ms

N.n. ms xxxx

Upper threshold duration

after pacing

N.n. ms

Lower threshold RV N.n.% N.n.% x x x x

T-wave suppression

after pacing

OFF; ON OFF x x x x

Minimum threshold A N.n. mV N.n. mV x x x

Minimum threshold RV N.n. mV N.n. mV x x x x

Minimum threshold LV N.n. mV N.n. mV x

Parameter Range of values Standard

For AT/AF OFF; ON; Advanced ON ON x x x

For SVT OFF; ON ON x x x x

Periodic recording When Home Monitoring OFF:

OFF; N.n. days

N.n. days xxxx

IEGM configuration RA, RV, LV

RA, RV, FF

FF; RV; LV

RA, RV, LV x

Start resting period N.n. hh:mm N.n. hh:mm x x x x

Duration of resting period N.n. h N.n. h x x x x

AV delay modification in

sensing test

OFF; N.n. ms N.n. ms x x x

Thoracic impedance (TI) OFF, ON OFF x x x x

Parameter Range of values Standard

Home Monitoring OFF; ON OFF x x x x

Time of transmission STD; N.n. hh:mm STD x x x x

IEGM for:

– Therapy episodes OFF; ON ON x x x x

– Monitoring episodes

Ongoing atrial episode OFF; N.n. h N.n. h x x x

5 Technical Data

Mechanical Characteristics

Housing

Devices with a DF-1/IS-1, DF4/IS-1 or DF4/IS4 header:

Materials in contact with body tissue

•

Housing: Titanium

•

Header: Epoxy resin

•

Blind plug and silicone plug: Silopren or silastic

DF4 /IS4 seal: Silastic

X-ray identification

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 ± 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 certification

Devices with BIOTRONIK Home Monitoring

are equipped with an antenna for wireless

communication.

Telemetry data 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–TACH70

The code IC in front of the certification/ registration number only indicates that the

technical requirements for Industry Canada are met.

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-SMC010

Telemetry data 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 oper-

ation. This transmitter shall be used only in accordance with the FCC Rules governing

the Medical Device Radiocommunication Service. Analog and digital voice communica-

Type Connector port W x H x D in mm Volume cm

Mass g

VR DF-1 65 x 55 x 12.5 36 86

DF4 65 x 52 x 12.5 34 86

DX DF-1 65 x 55 x 12.5 36 86

—

DR DF-1 65 x 55 x 12.5 36 86

DF4 65 x 56 x 12.5 35 87

HF DF-1 65 x 58.5 x 12.5 37 88

DF4 65 x 56 x 12.5 36 87

HF QP DF4/IS4 65 x 59x 12.5 37 89

tions 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: QRITACH70

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.

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 inter-

ference voltages of ≤ 0.3 mV (tip to tip) is met.

Common mode rejection ratio

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,

V right: VR, DR,

V left: HF

N.n. Hz N.n. dB N.n. dB N.n. dB N.n. dB

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

ATP amplitude Measured

minimum Measured

maximum Mean value

RV N.n. V N.n. V N.n. V

LV N.n. V N.n. V N.n. V

Sensitivity Value Tolerance Measured value

A: positive N.n. mV N.n. N.n. mV

A: negative N.n. mV

DX: A: positive N.n. mV N.n.

(N.n.)

N.n. mV

DX: A: negative N.n. mV

RV: positive N.n. mV N.n. N.n. mV

RV: negative N.n. mV

LV: positive N.n. mV N.n. N.n. mV

LV: negative N.n. mV

Shock energy



(Tolerance) Tolerance peak

voltage Measured value

Shock energy Measured value

Peak voltage

1 J (N.n.) N.n. V N.n. J N.n. V

20 J (N.n.) N.n. V N.n. J N.n. V

45 J (N.n.) N.n. V N.n. J N.n. V

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 N.n. 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 N.n. 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: 60 bpm

—

Home Monitoring: ON, 1 device message each day and 12 IEGM online HD

transmissions per year

—

Diagnostic functions and recordings: permanently set

•

Capacitor reforming is performed N.n. times per year and therefore at least

N.n. maximum charges for shocks have to be assumed per year even if less

than N.n. are delivered.

Calculation of the number of shocks

Calculation of the maximum number of shocks: Service time [in years] x number of

shocks per year

Service times single-chamber

Service times with GB 2992 or LiS 3410 RR battery, subject to change:

Service times dual-chamber

Service times with GB 2992 or LiS 3410 RR battery

(only devices with DF-1/IS-1 connection), subject to change:

Service times triple-chamber

Service times with GB 2992 or LiS 3410 RR battery, subject to change:

Manufacturer GREATBATCH, INC.

Clarence, NY 14031 LITRONIK GmbH & Co

01796 Pirna, Germany

Battery type GB 2992 LiS 3410 RR

Battery ID number shown on the

programmer

3 N.n.

Device type VR, (DX), DR, HF

Battery voltage at ERI 2.5 V N.n. V

Charge time at BOS 10 s N.n. s

Charge time at ERI 12 s N.n. s

Usable capacity until ERI 1590 mAh N.n. mAh

Usable capacity until EOS 1730 mAh N.n. mAh

Pacing

Service time [in years] at number of shocks per year

48121620

0, 15, 50, 100%

N.n. N.n. N.n. N.n. N.n.

Pacing

Service time [in years] at number of shocks per year

48121620

0, 15, 50, 100%

N.n. N.n. N.n. N.n. N.n.

Pacing

Service time [in years] at number of shocks per year

48121620

0, 15, 50, 100%

N.n. N.n. N.n. N.n. N.n.

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 Single use only. Do not re-

use!

Do not use if packaging is

damaged

Non-sterile

Transmitter with non-ionizing radiation at

designated frequency

Label icon on devices

with ProMRI

MR conditional: Patients who have a system

with devices labeled with this symbol on the

packaging can be examined using an MRI

scan under precisely defined conditions.

STERILIZE

NON

STERILE

TP2

Compatibility with telemetry protocol, version 2 of

BIOTRONIK Home Monitoring

Example

Device: NBG code and compatible leads

Example

Factory settings for therapy: OFF

Screwdriver

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

Examples of DF4/IS4/IS-1 header

Bipolar IS-1 connector

Unipolar IS-1 connector

Unipolar DF-1 connector

DF4/IS4 connector

BIOTRONIK SE and KG TACH70 implantable cardioverter defibrillator User Manual

BIOTRONIK SE & Co. KG implantable cardioverter defibrillator

15_[TACH70] UserMan

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