BIOTRONIK SE and KG TACH70 implantable cardioverter defibrillator User Manual
BIOTRONIK SE & Co. KG implantable cardioverter defibrillator
15_[TACH70] UserMan
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1
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.
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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
RV
DF-1
SVC
IS-1
RV
DF-1
RV
DF-1
SVC
IS-1
RA
IS-1
RV
DF-1
RV
DF-1
SVC
IS-1
RA
IS-1
RV
DF-1
RV
DF-1
SVC IS-1
RA
IS-1
RV
IS-1
LV
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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
RV
DF4-LLHH
RV
IS-1
RA
DF4-LLHH
RV
IS-1
RA
IS-1
LV
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
RV
IS4-LLLL
RA
IS-1
LV
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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
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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
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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
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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.
8
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
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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.
10
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.
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11
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.
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12
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.
W
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.
W
WARNING
Shock delivery with activated ICD
There is a risk of unintended shock delivery when handling an activated ICD.
•
Deactivate ICD therapy before touching the device during implantation, device
replacement and explantation.
W
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
•
Either leave unused ports closed with the premounted blind plugs, or close them
using the supplied blind plugs.
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13
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.
W
WARNING
Inadequate therapy
When leads are not spaced sufficiently apart or are positioned inappropriately, this
can lead to far-field sensing or insufficient defibrillation.
•
The distance between 2 shock coils must be greater than 6 cm.
•
Tip and ring electrodes must not have contact with each other.
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.
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14
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.
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15
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
16
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.
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17
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.
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18
•
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.
W
CAUTION
Temporally limited therapy
If ERI occurs shortly after follow-up and is only detected during the subsequent
follow-up, then the remaining service time can be much less than 3 months.
•
Replace device soon.
W
WARNING
Patient at risk of death
If EOS replacement indication occurs before replacement of the device, then the
patient is without therapy.
•
Replace device immediately.
•
Monitor patient constantly until immediate replacement of the device!
Note:
Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
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19
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
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20
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
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 N.n. bpm UTR +
N.n.
x
– 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
VR
DX
DR
HF
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
VR
DX
DR
HF
PMT detection/termination OFF; ON ON x x x
VA criterion N.n. ms N.n. ms x x x
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21
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
atrial capture control OFF; ATM ATM x x
Parameter Range of values Standard
VR
DX
DR
HF
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
x
Sensing polarity LV (IS-1) UNIP; BIPL UNIP x
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22
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
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23
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
VR
DX
DR
HF
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
VR
DX
DR
HF
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
VR
DX
DR
HF
Parameter Range of values Standard
VR
DX
DR
HF
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
VR
DX
DR
HF
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
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24
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
VR
DX
DR
HF
Parameter Range of values Standard
VR
DX
DR
HF
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
VR
DX
DR
HF
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
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25
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
AH
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
3
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
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26
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,
HF
V right: VR, DR,
HF
V left: HF
N.n. Hz N.n. dB N.n. dB N.n. dB N.n. dB
N.n. Hz N.n. dB N.n. dB N.n. dB N.n. dB
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
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27
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.
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28
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
2
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