BIOTRONIK SE and KG TACHBORAX implantable cardioverter defibrillator User Manual

BIOTRONIK SE & Co. KG implantable cardioverter defibrillator

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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

Inlexa 1

VR-T, DR-T, HF-T

ICD-Familie | Tachyarrhythmietherapie |

Kardiale Resynchronisationstherapie

Gebrauchsanweisung

420651

Revision: A (2015-12-09)

Technische Änderungen vorbehalten.

® Alle verwendeten Produktnamen können Marken oder eingetragene Marken von

BIOTRONIK oder dem jeweiligen Eigentümer sein.

Index 420651GebrauchsanweisungInlexa 1 VR-T , DR-T, HF-T,

1 Product Description

Product Description1403736Technical Manual

Intended Medical Use

Intended use Inlexa 1 is part of a family of implantable cardioverter-defibrillators (ICDs). The

primary objective of the therapy is to prevent sudden cardiac death. Furthermore,

the device is capable of treating bradycardia arrhythmias and cardiac resynchroni-

zation 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 antitachy-

cardia 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 (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 manage-

ment at any time.

Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar

with the operation and the operation conditions of a device system.

• Only qualified medical specialists having this required special knowledge are

permitted to use implantable devices.

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

Indications Inlexa 1 can treat life-threatening ventricular arrhythmias with antitachycardia

pacing and defibrillation.

Generally approved differential diagnostics methods, indications, and recommen-

dations for ICD therapy apply to BIOTRONIK devices. See the current guidelines of

cardiology associations for guidance.

We recommend observing the indications published by the German Cardiac Society

(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) 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,

electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction

• Such frequent VT or VF that the therapies would cause an unacceptably rapid

depletion of the device batteries

• VT with few or without clinically relevant symptoms

• VT or VF treatable by surgery

• Concomitant diseases that would substantially limit a positive prognosis

• Accelerated intrinsic rhythm

System Overview

Device family The complete Inlexa 1device family consists of several device types with a DF-1/IS-1

connection.

•Single-chamber: VR-T

•Dual-chamber: DR-T

• Triple-chamber: HF-T

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 The labeling on each device provides information pertaining to the connector port

assignment in the header.

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 poly-

urethane 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.

Note: Not all device types are available in every country.

VR DR HF

Connector

port Lead

connector Configuration Implantation site Device type

RA IS-1 Bipolar Atrium DR, HF

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

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

SVC DF-1 Shock coil Superior vena

cava

VR, DR, HF

LV IS-1 Unipolar, bipolar Left ventricle HF

DF-1

SVC

DF-1

IS-1

DF-1

SVC

DF-1 IS-1

IS-1

DF-1

SVC

DF-1 IS-1

IS-1

Telemetry Telemetric communication between the device and the programmer can be carried

out following initialization either by applying the programming head (PGH) to the

device or by using wireless radio frequency (RF) telemetry in the programmer.

BIOTRONIK calls this function SafeSync®.

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

programmer: Programmer software PSW version N.N. and higher

There is a programmer with integrated RF telemetry and one with a separate

SafeSync Module.

Leadless ECG, IEGM, markers and functions are displayed simultaneously on the

color display.

Using the programmer, the pacing thresholds can be determined and all tests can

be performed during in-office follow-up. If necessary, the current software is trans-

ferred to the device during implantation.

In addition to this, the programmer is used to set mode and parameter combina-

tions, as well as for interrogation and saving of data from the device.

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:

DDDR is the NBG code for the antibradycardia mode of the dual-chamber devices:

DDDRV is the NBG code for the antibradycardia mode of the triple-chamber devices:

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

device:

Device type Modes

VR VVI; VVIR; VOO; OFF

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

VDD; VDDR; VDI; VDIR

VVI; VVIR; AAI; AAIR; VOO; DOO; OFF

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

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 trans-

mitter 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 immedi-

ately check the Home Monitoring function.

Inlexa 1order numbers Not all device types are available in every country:

Package contents The storage package includes the following:

• Sterile packaging with device

• Serial number label

• Patient ID card

• Warranty booklet

The sterile container includes the following:

• Device, blind plugs (if applicable)

• Screwdriver

VR-T DR-T HF-T

405797 405796 40579

Note: The technical manual pertaining to the device is either included in hard copy

form in the storage package or in digital form on the internet.

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 both the patients' and the device's state at any time.

• To check the lead for proper functioning, an automatic impedance measure-

ment 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, defibrillation • The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defi-

brillation. Shock polarity and energy can be programmed individually. Shock

energies between 2.0 and 40 J are possible depending on the device family.

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.

• Thresholds: atrial as well as ventricular pacing thresholds are automatically

determined in the device, automatic threshold monitoring (ATM) for trend

analysis.

• Setting an upper tracking rate for the atrium prevents unspecific atrial pacing,

thus reducing the risk of pacemaker-mediated tachycardia.

• Positive AV hysteresis functions support intrinsic conduction and thus the

natural contraction sequence. Negative AV hysteresis functions support the

cardiac resynchronization therapy by maintaining pacing in stress situations.

• For resynchronization of the ventricles, triple-chamber implants have functions

for multisite pacing with possible VV delays in either direction.

• To ensure that no additional surgery is necessary in case of a left-sided increase

of pacing threshold or undesired phrenic nerve stimulation, different pacing

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

Storing programs There are different therapy programs:

• Parameter settings effective for the most common indications in pre-configured

programs (Program Consult).

• For special indications, individual parameter settings can be stored in up to

three therapy programs.

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

General Safety Instructio ns2403736Technical Manual

Operating Conditions

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

systems:

— Technical manual for the device

— Technical manual for the HMSC

— Technical manual for the electrodes

— Technical manuals for the programmer and its accessories

— Technical manuals for the user interface

— Technical manuals for cables, adapters and accessories

• Technical manuals are either included in hard copy form in the storage package

or in digital form on the internet: manuals.biotronik.com

• Follow all relevant technical manuals.

• Reserve technical manuals for later use.

Care during shipping

and storage

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

tromagnetic interference.

• Note the effects of the storage duration; see Battery Data.

Delivery in shipment mode The device is delivered in shipment mode to protect the battery; capacitor reforming

required during storage could result in controlled extended charge times of the

shock capacitors.

• The shipment mode is displayed on the programmer after the initial interroga-

tion (it is deactivated during implantation by the first valid (in-range) measure-

ment 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 practi-

tioners 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 electrophysio-

logical 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 range

of intrinsic events so that skeletal myopotentials are usually not recorded. Skeletal

myopotentials can nonetheless be classified as intrinsic events especially at very

high sensing sensitivity and, depending on the interference, may cause inhibition or

antiarrhythmia therapy.

In the case of undesired myopotentials, the device switches to asynchronous pacing

if the interference rate is exceeded.

Possible technical failures Technical failure of a device system cannot be entirely ruled out. Possible causes

can include the following:

• Lead dislodgement, lead fracture

• Insulation defects

• Device component failures

• Battery depletion

• Interrupted telemetry

Electromagnetic

interference (EMI)

Any device can be sensitive to interference if external signals are sensed as intrinsic

rhythm or if measurements prevent rate adaptation.

• BIOTRONIK devices have been designed so that their susceptibility to EMI is

minimal.

• Due to the intensity and variety of EMI, there is no guarantee for safety. It is

generally assumed that EMI produces only minor symptoms, if any, in patients.

• Depending on the pacing mode and the type of interference, sources of inter-

ference may lead to pulse inhibition or triggering, an increase in the sensor-

dependent pacing rate or asynchronous pacing.

• Under unfavorable conditions, for example during therapeutic or diagnostic

procedures, interference sources may induce such a high level of energy into

the pacing system that the cardiac tissue surrounding the lead tip is damaged.

Device behavior in

case of EMI

In case of electromagnetic interference, the device switches to asynchronous

pacing for as long as the interference rate is exceeded.

Static magnetic fields The magnetic sensor in the device detects magnetic fields starting at a magnetic

flux density of approximately 1.5 mT. Magnetic fields below 1 mT do not affect the

sensor.

Possible Risks

Procedures to avoid The following procedures must be avoided, as they may cause harm to the patient

or damage the device and, as a result, put the system functionality at risk:

• 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. For example, damaging

pressure levels may arise during lithotripsy. For example, excessive warming of

body tissue near the device system may occur during therapeutic ultrasound. Influ-

ences 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 defibril-

lation. Specifically, the current induced in the implanted leads may result in necrotic

tissue formation close to the electrode/tissue interface. As a result, sensing prop-

erties 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 influ-

encing 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 adminis-

tration 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 func-

tioning properly.

Magnetic resonance

imaging

Magnetic resonance imaging must be avoided due to the associated high frequency

fields and magnetic flux density: Damage or destruction of the device system by

strong magnetic interaction and damage to the patient by excessive warming of the

body tissue in the area surrounding the device system.

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

3 Implantation

Implantation3403736Technical M anual

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

• The lead connections DF-1 and IS-1 are permitted. Use only adapters approved

by BIOTRONIK for leads with different lead connections or leads from other

manufacturers.

• BIOTRONIK programmer (with integrated SafeSync RF telemetry or with

separate SafeSync Module) and approved cables

• External multi-channel ECG device

• Keep spare parts for all sterile components.

Keeping an external

defibrillator ready

To be able to respond to unforeseeable emergencies or possible technical failures

of the device:

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

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.

• Upon delivery, the tachyarrhythmia therapy function in the ICD is deactivated.

The ICD must only be implanted in this state.

• Leads must not be shortened.

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.

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

Set screws and blind plugs (if applicable) must be tightened or loosened with care.

• 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 connector ports

are clean

In case of contamination during implantation:

• Clean lead connectors with a sterile cloth.

• Rinse connector port only with sterile water.

Overview: Implanting

Connecting the device The lead connectors are connected to the ports in the header of the device:

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.

• Close unused connector ports with blind plugs.

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.

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.

Keeping distance

between leads

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 software that is suitable for the device type in the programmer.

• Activate ICD therapy.

• Shipment mode is permanently deactivated once the leads have been connected

and initial measurement of the pacing impedance has been performed success-

fully. 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 defibril-

lator.

3 DF-1/IS-1 connection:

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

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

• Connect the unipolar or the bipolar IS-1 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)

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 2 set screws, tighten both screws!

• When you withdraw the screwdriver, the silicone plug automatically seals

the access to the screw head 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.

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

temporary programs (follow-up tests) can result in inadequate pacing of the

patient. This is the case if the programmer can no longer be operated due to a

program error or a defective touch screen and therefore the temporary program

cannot be terminated. Under these circumstances, it is helpful to cancel telemetry,

in which case the device automatically switches to the permanent program.

• In the case of telemetry with programming head: lift the PGH by at least 30 cm.

• In the case of RF telemetry: switch off and reposition the programmer.

• Turn off possible sources of interference.

Avoiding critical

parameter settings

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

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

• Check compatibility and effectiveness of parameter combinations after making

settings.

• When setting atrial therapies after an AT or AF has been detected, note that no

ventricular tachyarrhythmia can be detected for the duration of atrial therapy

delivery.

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 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 complica-

tions 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.

• Prefer Wenckebach response and avoid 2:1 behavior.

• Set all parameters so as to prevent constant changing between atrial and

ventricular-controlled modes.

Note the reduced

pulse amplitude due to a

battery voltage drop

If the rate and amplitude are set very high and the pulse width is set too long at the

same time, the battery voltage may temporarily drop so low that the actual pulse

amplitude drops well below the selected level.

• Continuously check the pacing efficiency using ECG monitoring.

Observe when inducing

short-term cardiac arrest

To permit TAVI (transcatheter aortic valve implantation), the pressure in the heart

must be reduced so that the heart valve can be correctly positioned. Intentional

cardiac arrest by high-rate pacing (rapid pacing) should be brief, must be tolerated

by the patient and can trigger a life-threatening arrhythmia.

• Take all necessary precautionary measures and keep required emergency

equipment ready.

• Continually monitor the patient by ECG.

• Complete the TAVI procedure before high-rate pacing ends. Extend the pacing

duration if necessary.

• Abort the procedure if it is not successfully completed within the maximum

pacing duration so that cardiac arrest can be stopped.

• Reactivate ICD therapy at a clinically indicated point in time when the TAVI

process is completed.

Avoiding AV crosstalk When pacing using atrial ATP parameters, atrial pacing pulses can either be

conducted into the ventricle or be sensed such that ventricular pacing is prevented.

• Check the settings for the presence of crosstalk.

• If necessary, temporarily set VVI and a rate for backup stimulation so that no

ventricular pulses are prevented.

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

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 repro-

gramming 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.

Avoiding risks in the case of

exclusive LV pacing

Lead dislodgement in the case of exclusive left ventricular pacing could pose the

following risks: loss of ventricular pacing and ATP therapy, induction of atrial

arrhythmias.

• Consider sensing and pacing parameters with reference to loss of therapy.

• Exclusive LV pacing is not recommended for patients who depend on the device.

• Please note that capture control is not available.

• In the case of follow-ups and threshold tests, take loss of synchronized ventric-

ular pacing into consideration.

• Mode switching and post shock do not permit exclusive LV pacing. Please note

the effects when programming mode switching and the post shock parameters.

Permanent program Post-shock program

DDD

DDI, AAI

DDI

VDD, VDI VDI

VVI and OFF VVI

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

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.

Magnet Response

Application of the

programming head when

ICD therapy is set

If a connected programming head is applied and is communicating with the

programmer and ICD therapy is permanently set, detection and therapy remain

intact except during the diagnostic tests. If ICD therapy is not set as permanent, no

therapy is delivered when the programming head is applied.

Programming head

application

When the programming head is applied, time remains for device interrogation and

for manual activation or deactivation of the therapy before the device switches back

to the previously set permanent therapy mode. The same applies to programming

head application to establish RF telemetry contact.

Application of a

permanent magnet

Applying a permanent magnet interrupts detection and therapy of tachycardia

events. After 8 hours of this type of deactivation, the device automatically reacti-

vates 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 neces-

sitate 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 modi-

fication of the therapy by reprogramming the device.

Follow-up with the

programmer

Use the following procedure for in-office follow-up:

1 Record and evaluate the ECG.

2 Interrogate the device.

3 Evaluate the status and automatically measured follow-up data.

4 Check the sensing and pacing functions.

5 Possibly evaluate statistics and IEGM recordings.

6 Manually perform standard tests if necessary.

7 Possibly customize program functions and parameters.

8 Transmit the program permanently to the device.

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

10 Finish the follow-up for this patient.

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 Premises with prohibitive 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 inter-

ference should not be brought into close proximity with the device.

• Draw the patient's attention to special household appliances, security check-

points, 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.

Replacement Indications

Possible battery levels • BOS: Beginning of Service: > 90% charge

• MOS 1: Middle of Service: 90% to 40% residual charge

• MOS 2: Middle of Service: < 40% residual charge

• ERI: Elective Replacement Indication (i.e. RRT: Recommended Replacement

Time)

• EOS: End of Service

Elective Replacement

Indication (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 software 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

— Cycle duration for BIOTRONIK 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!

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 connector ports 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 a solution of at least 1% sodium hypochlorite.

• Rinse off with water.

• Fill out explantation form and send to BIOTRONIK together with the cleaned

device.

Note: Normal oxidation processes may cause ICD housing discolorations. This is

neither a device defect nor does it influence device functionality.

4 Parameters

Parameters4403736Technical Manual

Bradycardia / CRT

General ICD therapy

Timing: Basic rate day/night

and rate hystereses

Timing: AV delay

Parameter Range of values Standard VR DR HF

ICD therapy OFF; ON ON x x x

Programs Display standard

program; Display safe

program; Display first

interrogated program;

Individual 1, 2, 3;

Program Consult

— xxx

Parameter Range of values Standard VR DR HF

Basic rate 30 ... (5) ... 100 ... (10)

... 160 bpm

40 bpm x

60 bpm x x

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

Night begins 00:00 ... (00:01)

... 23:59 hh:mm

22:00 hh:

xxx

Night ends 06:00 hh:

Rate hysteresis OFF; -5 ... (-5) ... -25 ...

(-20) ... -65 bpm

OFF xxx

Scan/repetitive OFF; ON ON x x x

Parameter Range of values Standard VR DR HF

AV dynamics Low; Medium; High;

Fixed; (Individual)

Low x x

AV delay (1 or 2) after:

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

– Sensing Either automatic:

AV delay after pacing +

sense compensation

Or: 40 ... (5) ... 350 ms

–xx

– 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

OFF; Positive; Negative OFF x

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

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

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

AV scan and repetitive

(positive)

OFF; ON ON x x

Timing: Post-shock pacing

Timing: Upper rate

Timing: Mode switching

Timing: Ventricular pacing

Parameter Range of values Standard VR DR HF

Post-shock duration OFF; 10 s; 30 s; 1 min;

2 min; 5 min; 10 min

10 s x x x

Post-shock basic rate 30 ... (5) ... 100 ... (10)

... 160 bpm

60 bpm x x x

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 VR DR HF

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

Atrial upper rate OFF; 175; 200; 240 bpm 200 bpm x x

Parameter Range of values Standard VR DR HF

Intervention rate OFF; 120 ... (10) ...

200 bpm

160 bpm x x

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

Resolution criterion

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

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

After mode DDD(R):

DDI(R)

DDIR x x

After mode switching:

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

– Duration 1 ... (1) ... 30 min 1 min

Parameter Range of values Standard VR DR HF

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 0 ms x

Timing: Refractory periods

and blanking periods

Timing: PMT protection

Timing: Rate adaptation via

accelerometer

Pacing: Pulse amplitude

and pulse width

Pacing:

Atrial capture control

Parameter Range of values Standard VR DR HF

PVARP AUTO; 175 ... (25) ...

600 ms

225 ms x x

PVARP extension OFF; ON ON 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

Far-field protection

after Vp

50 ... (25) ... 225 ms 75 ms x x

Parameter Range of values Standard VR DR HF

PMT detection/termina-

tion

OFF; ON ON x x

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

Parameter Range of values Standard VR DR HF

Maximum sensor rate 80 ... (10) ... 160 bpm 120 bpm x x x

Sensor gain AUTO; Very low; Low;

Medium; High; Very high

Mediumxxx

Sensor threshold Very low; Low; Medium;

High; Very high

Mediumxxx

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

cycle

xxx

Rate decrease 0.1; 0.2; 0.5; 1.0 bpm/

cycle

0.5 bpm/

cycle

xxx

Parameter Range of values Standard VR DR HF

Pulse amplitude A 0.5 ... (0.25) ... 4.0 ... (0.5)

... 6.0; 7.5 V

AUTO x x

Pulse amplitude V/RV x x x

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 xxx

Pulse width LV 0.4 ms x

Parameter Range of values Standard VR DR HF

Atrial capture control OFF; ATM ON x x

Threshold test start 2.5 ... (0.5) ... 5.0 V 3.5 V x x

Pacing:

Ventricular capture control

Lead configuration LV

on IS-1 connection

Parameter Range of values Standard VR DR HF

Ventricular capture

control

OFF; ATM ON xxx

Threshold test start 2.5 ... (0.5) ... 5.0 V 3.5 V x x x

Parameter Range of values Standard VR DR HF

Pacing polarity LV

(IS-1)

LV tip -> LV ring

LV tip -> RV shock coil

LV ring -> LV tip

LV ring -> RV shock coil

UNIP

LV tip -> RV

shock coil

Sensing polarity LV

(IS-1)

UNIP; BIPL UNIP x

Tachycardia

Detection Parameter Range of values Standard VR DR HF

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

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

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

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

Detection counter VT1 10 ... (2) ... 100 28 x x x

Detection counter VT2 10 ... (2) ... 80 20

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

10 out-of 14; 12 out-of 16;

16 out-of 20; 18 out-of 24;

20 out-of 26; 22 out-of 30;

24 out-of 30; 30 out-of 40

18 out of

Redetection counter VT1 10 ... (2) ... 50 20 x x x

Redetection counter VT2 10 ... (2) ... 40 14

Redetection counter VF 6 out-of 8; 8 out-of 12;

10 out-of 14; 12 out-of 16;

16 out-of 20;

18 out-of 24; 20 out-of 26;

22 out-of 30; 24 out-of 30

8 out

of 12

xxx

SMART detection VT1/VT2 OFF; ON ON x x

SMART detection ON:

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

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

SMART detection OFF:

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

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

MorphMatch OFF; Monitoring; ON OFF x x x

Sustained VT OFF; 1; 2; 3; 5; 10; 20;

30 min

OFF xxx

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

Therapy: ATP

Therapy: Shock

Parameter Range of values Standard VR DR HF

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

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

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

ATP optimization OFF; ON OFF x x x

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

Number S1 for VF 8

S1 decrement for VT1/VT2

and for VF

5 ... (5) ... 40 ms 10 ms x x x

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

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

Ventricular pacing

for VT1/VT2

RV; LV; BiV RV x

Ventricular pacing for VF RV

R-S1 interval for VT1/VT2 70 ... (5) ... 95% 80% x x x

R-S1 interval for VF 85 %

Parameter Range of values Standard VR DR HF

Number of shocks

VT1/VT2

0; 1; 2; 6; 8 8 x x x

Number of shocks VF 6; 8 8 x x x

1st Shock for VT1/VT2 OFF; 2 ... (2) ... 20 ... (5) ...

40 J

40 J x x x

2nd Shock for VT1/VT2 OFF; 4 ... (2) ... 20 ... (5) ...

40 J

40 J x x x

3rd - nth shock for VT1/

VT2

OFF; 4*40 J; 6*40 J 6*40 J x x x

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

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

3rd - nth shock for VF 4*40 J; 6* 6*40 J x x x

For shock in VT1/VT2 and VF:

– Confirmation OFF; ON ON x x x

– Polarity Normal; Reverse; Alter-

nating

Normal

– Shock form Biphasic; Biphasic 2 Biphasic

– Shock path RV -> ICD+SVC

RV -> ICD

RV -> SVC

RV->

ICD+SVC

xxx

RV -> ICD

Sensing

Sensitivity and thresholds

Diagnostics

The following can be set:

Parameter Range of values Standard VR DR HF

Sensing A STD; OFF STD x x

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

Sensing LV STD; OFF; IND STD x

Upper threshold RV 50; 75% 50% x x x

Upper threshold LV 50; 75% 50% x

Upper threshold duration

after detection

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

VFS: 110 ms

350 ms x x x

Upper threshold duration

after pacing

400 ms

Lower threshold RV 25; 50% 25% x x x

T-wave suppression

after pacing

OFF; ON OFF x x x

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

Minimum threshold RV 0.5 ... (0.1) ... 2.5 mV 0.8 mV x x x

Minimum threshold LV 0.5 ... (0.1) ... 2.5 ... (0.5)

... 5.0 mV

1.6 mV x

Parameter Range of values Standard VR DR HF

For AT/AF OFF; ON ON x x

For SVT OFF; ON ON x x

Periodic recording When Home Monitoring

OFF:

OFF; 30 ... (30) ...

180 days

90 days x x x

IEGM configuration RA, RV, LV

RA, RV, FF

FF; RV; LV

RA, RV, LV x

Start resting period 00:00 ... (1:00 AM) ...

23:00 hh:mm

2:00

AM hh:mm

xxx

Duration of resting

period

0.5 ... (0.5) ... 12 h 4 h x x x

AV delay adjusted in

sensing test

OFF; 300 ms 300 ms x x

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

Home Monitoring

Parameter Range of values Standard VR DR HF

Home Monitoring OFF; ON OFF x x x

Time of transmission STD; 00:00 ... (1:00 AM)

... 23:00 hh:mm

STD xxx

IEGM for therapy

episodes

OFF; ON ON x x x

IEGM for monitoring

episodes

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

Transmission date XX.XX.XXXX Follow-up

+ 91 days

xxx

Cycle duration 20 ... (1) ... 366 days 91 days x x x

5Technical Data

Technical Data5403736Technical M anual

Mechanical Characteristics

Housing Devices with header for DF-1 connector:

Materials in contact with

body tissue

• Housing: Titanium

• Header: Epoxy resin

• Silicone plugs and blind plugs (if applicable): Silopren or silastic

X-ray identification HK

Type Lead

connector W x H x D in mm Volume cm3Mass g

VR DF-1 69 x 55 x 12,5 38 71

DR DF-1 69 x 55 x 12,5 39 71

HF DF-1 69 x 58.5 x 12,5 40 73

Electrical Characteristics

Standards The specifications are made according to EN 45502-2-2:2008.

Measuring conditions If not indicated otherwise, all specifications refer to the following conditions:

• Ambient temperature: 37ºC ± 2ºC

• Pacing/sensing: 500 Ω ±1%

• Shock: 50 Ω ±1%

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

• Antibradycardia pacing: OFF

• Home Monitoring: OFF

Telemetry data • MICS frequencies: 402-405 MHz

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

International

radio certificationDevices with BIOTRONIK Home Monitoring® are equipped with an antenna for

wireless communication.

Telemetry information for Canada:

This device must neither interfere with meteorological and earth resources tech-

nology 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-TACHBORAX

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

the technical requirements for Industry Canada are met.

Telemetry information for the USA:

This transmitter is authorized by rule under the Medical Device Radiocommunica-

tion 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 Meteoro-

logical Satellite, or the Earth Exploration Satellite Services and must accept inter-

ference that may be caused by such stations, including interference that may cause

undesired operation. This transmitter shall be used only in accordance with the FCC

Rules governing the Medical Device Radiocommunication Service. Analog and

digital voice communications are prohibited. Although this transmitter has been

approved by the Federal Communications Commission, there is no guarantee that

it will not receive interference or that any particular transmission from this trans-

mitter will be free from interference.

This device will be registered with Federal Communications Commission under the

following number:

FCC ID: QRITACHBORAX

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-SMD021

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.

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 control

Measurement of actual values and test signal wave shape: standard triangle.

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

Rate Common mode rejection ratio

Atrium: DR, HF V right: VR, DR, HF V left: HF

16.6 Hz 72 dB 59 dB 57 dB

50 Hz 73 dB 66 dB 57 dB

60 Hz 71 dB 66 dB 62 dB

ATP amplitude Measured minimum Measured maximum Mean value

RA 7.57 V 7.49 V 5.1 V

RV 7.54 V 7.49 V 5.1 V

LV 7.55 V 7.51 V 5.1 V

Sensitivity Value Tolerance Measured value

A: positive 0.2 mV 0.2 ... 0.5 0.23 mV

A: negative 0.24 mV

RV: positive 0.5 mV 0.3 ... 0.7 0.55 mV

RV: negative 0.58 mV

LV: positive 0.5 mV 0.3 ... 0.7 0.52 mV

LV: negative

Shock energy

(Tolerance) Tolerance

Peak voltage Measured value

Shock energy Measured value

Peak voltage

1 J (0.7 ... 1.18) 100 ... 140 V 0.89 J 125,0 V

20 J (15.9 ... 21.6) 500 ... 550 V 16,62 J 530,4 V

40 J (32.0 ... 43.2) 710 ... 790 V 33,84 J 750,9 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 19 months between the manufacturing date

and the use by date (indicated on the package).

• If the ICD is implanted shortly before the use by date, the expected service time

may be reduced by up to 17 months.

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 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: Service time [in years] x number of shocks per

year

Inlexa 1 VR-T Service times with LiS 3410 RR battery:

Manufacturer LITRONIK Batterietechnologie GmbH & Co

01796 Pirna, Germany

Battery type LiS 3410 RR

System LiMnO2

Battery ID number

shown on the programmer

Device type VR-T, DR-T, HF-T

Battery voltage at ERI 2.85 V

Charge time at BOS 8 s

Charge time at ERI 10 s

Usable capacity until ERI:

VR, DR, HF

1390 mAh

Usable capacity until EOS 1520 mAh

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

48121620

0% 10.3 8.3 7.0 6.0 5.3

15% 10.1 8.1 6.8 5.9 5.2

50% 9.5 7.8 6.6 5.7 5.0

100% 8.8 7.3 6.2 5.4 4.8

Inlexa 1 DR-T Service times with LiS 3410 RR battery:

Inlexa 1 HF-T Service times with LiS 3410 RR battery:

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

48121620

0% 9.4 7.7 6.5 5.7 5.0

15% 9.0 7.4 6.3 5.5 4.9

50% 8.1 6.8 5.9 5.2 4.6

100% 7.1 6.1 5.3 4.7 4.3

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

48121620

0% 8.9 7.4 6.3 5.5 4.9

15% 8.3 7.0 6.0 5.2 4.7

50% 7.2 6.1 5.4 4.8 4.3

100% 6.0 5.3 4.7 4.2 3.9

Legend for the Label

Label on the package The label icons symbolize the following:

Manufacturing date Use by

Storage temperature 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 reuse!

Do not use if packaging is

damaged

Non-sterile

Transmitter with non-ionizing radiation at designated

frequency

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

Example of lead connection: DF-1/IS-1

STERILIZE

NON

STERILE

BIOTRONIK SE and KG TACHBORAX implantable cardioverter defibrillator User Manual

BIOTRONIK SE & Co. KG implantable cardioverter defibrillator

15_TACHBorax UserMan

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