BIOTRONIK SE and KG TACHNXT Users Manual
Iforia
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ICD Family • Tachyarrhythmia Therapy • Cardiac Resynchronization Therapy
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ICD Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie
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Technical Manual
Technická příručka
Brugermanual
Gebrauchsanweisung
Manual técnico
Käyttöohje
Manuel technique
Manuale tecnico di istruzione
Gebruikshandleiding
Instrukcja obsługi
Manual técnico
Bruksanvisning
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• cs
• da
• de
• es
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• fr
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0123
© BIOTRONIK SE & Co. KG
All rights reserved. Specications subject
to modication, revision and improvement.
® BIOTRONIK Home Monitoring, (ProMRI),
IEGM-Online HD and SMART Detecton are
registered trademarks of BIOTRONIK SE & Co. KG
0681 2012
12-D-xx
Revision: B (2012-xx-xx)
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
en • English ................................................................................................................................................................. 2
de • Deutsch ................................................................................................................................................................ 24
393467--B
en • English
Product Description
Intended Medical Use
Intended use
Iforia 3/5/7 is part of a family of implantable cardioverter-defibrillators (ICDs). Primary
objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is
capable of treating bradycardia arrhythmias and cardiac resynchronization therapy
with multisite ventricular pacing.
The implantation of an ICD is a symptomatic therapy with the following objectives:
•
Termination of spontaneous ventricular fibrillation (VF) through shock delivery
•
Termination of spontaneous ventricular tachycardia (VT) through antitachycardia
pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with
shock delivery
•
Cardiac resynchronization through multisite ventricular pacing (triple-chamber
devices)
•
Compensation of bradycardia through ventricular (single-chamber devices) or
AV sequential pacing (DX, dual- and triple-chamber devices)
Diagnosis and therapy forms
The device monitors the heart rhythm and automatically detects and terminates
cardiac arrest resulting from ventricular tachyarrhythmia. All major therapeutic
approaches from the field of cardiology and electrophysiology are included. BIOTRONIK
Home Monitoring® enables physicians to perform therapy management at any time.
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation and the operation conditions of a device system.
•
Only qualified medical specialists having this special knowledge required are
permitted to use implantable devices.
•
If users do not possess this knowledge, they must be trained accordingly.
Indications
Iforia can treat life-threatening ventricular arrhythmias with antitachycardia pacing
and defibrillation.
Generally approved differential diagnostics methods, indications, and recommendations for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardiology
associations for guidance.
We recommend observing the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC
(European Society of Cardiology). This also applies to the guidelines published by the
Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American
Heart Association (AHA), and other national cardiology associations.
Single-chamber and dual-chamber
Single-chamber and dual-chamber ICDs are indicated for patients with the following
risk:
•
Sudden cardiac death caused by ventricular arrhythmias
Triple-chamber
Triple-chamber ICDs are indicated for patients with the following risks:
•
Sudden cardiac death caused by ventricular arrhythmias
•
Congestive heart failure with ventricular asynchrony
Iforia is also indicated for primary prophylaxis in congestive heart failure patients.
Contraindications
Known contraindications:
•
Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning,
electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
•
Such frequent VT or VF that the therapies would cause an unacceptably rapid
depletion of the device batteries
•
VT with few or without clinically relevant symptoms
•
VT or VF treatable by surgery
•
Concomitant diseases that would substantially limit a positive prognosis
•
Accelerated idioventricular rhythm
System Overview
Device family
The complete Iforia 3/5/7 device familyconsists of several device types with a
DF-1/IS-1connection.
Single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection);
dual-chamber: DR-T; triple-chamber: HF-T. Not all device types are available in
every country.
2
Device
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
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 lead connection
The device labeling provides information pertaining to possible lead connections
depending on the device type and pertaining to connection assignment:
VR DX DR HF
Connector
Lead
port
Configuration Implantation site Device type
connector
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
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.
en • English
Telemetry
Telemetric communication between the device and the programmer can be carried out
following initialization either by applying the programming head (PGH) to the device or
by using radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this function SafeSync®.
Programmer
Implantation and follow-up are performed with BIOTRONIK's portable 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:
Device type Modes
VR VVI; VVIR; V00; OFF
DX VDD; VDDR; VDI; VDIR; VVI; VVIR; V00; OFF
DR, HF DDD; DDDR; DDI; DDIR; VDD; VDDR; VDI; VDIR
VVI; VVIR; AAI; AAIR; V00; D00; OFF
NBD and NBG codes
VVE is the NBD code for the antitachycardia mode of the single-chamber, dualchamber, and triple-chamber devices:
V Shock in the ventricle
V Antitachycardia pacing (ATP) in the ventricle
E Detection via IEGM analysis
DDDR is the NBG code for the antibradycardia mode of the dual-chamber device:
D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
3
DDDRV is the NBG code for the antibradycardia mode of the triple-chamber device:
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
VDDR is the NBG code for the antibradycardia mode of the single-chamber DX device:
VVentricular pacing
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber
device:
VVentricular pacing
V Sensing in the ventricle
I Pulse inhibition in the ventricle
R Rate adaptation
BIOTRONIK Home Monitoring
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
•
With Home Monitoring, diagnostic and therapeutic information as well as technical
data are automatically sent to a stationary or mobile transmitter via an antenna in
the device header. The data are encrypted and sent from the transmitter to the
BIOTRONIK Service Center via the cellular phone network.
•
The received data are deciphered and evaluated. Each physician can set the criteria
for evaluation to be used for each patient and can configure the time of notification
via E-mail, SMS or fax.
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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).
®
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Data transmission from the device is performed with a daily device message.
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Device messages, which indicate special events in the heart or in the device, are
forwarded immediately.
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A test message can be initiated at any time using the programmer to immediately
check the Home Monitoring function.
Technical manuals
The following technical manuals provide information about usage of the device
systems:
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Technical manual for the device
•
Technical manual for the HMSC
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Technical manuals for the programmer and the SafeSync Module
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Technical manual for device programs as online help on the user interface and as
a PDF file in the Manual Library at www.BIOTRONIK.com
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Technical manuals for the leads
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Technical manuals for cables, adapters and accessories
Order numbers for Iforia with DF-1/IS-1 connection
Not all device types are available in all countries:
VR-T 383586 383583 390081
VR-T DX — 383597 390093
DR-T 383570 383567 390067
HF-T 383554 383551 390054
Order numbers for Iforia ProMRI with DF-1/IS-1 connection
Not all device types are available in all countries:
VR-T 390119 390083
VR-T DX 390123 390095
DR-T 390115 390069
HF-T 390111 390056
Iforia 3 Iforia 5 Iforia 7
Iforia 5 ProMRI Iforia 7 ProMRI
4
Scope of delivery
The storage package includes the following:
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Sterile container with device
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Serial number label
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Patient ID card
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Warranty booklet
•
Technical manual for the device
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.
•
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.
en • English
Cardioversion, defibrillation
•
The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrillation. Shock polarity and energy can be programmed individually. Shock energies
between 2.0 and 40 J are possible. Before delivery of the shock, the ICD can be set
to only deliver a shock when ongoing tachyarrhythmia is confirmed; during this
time period the device can identify spontaneous conversion of the tachyarrhythmia
and cancel the charging process if necessary.
•
The shock paths can be set between the different shock coils (SVC/RV) and/or the
housing.
Antibradycardia pacing and CRT
•
Innovative rate hystereses, automatic sensor functions, and a night program
promote the patient's intrinsic rhythm, avoid overdrive pacing, and facilitate adaptation of the device to the individual needs of the patient.
•
Setting an upper tracking rate for the atrium prevents unspecific atrial pacing,
thus reducing the risk of pacemaker-mediated tachycardia.
•
Positive AV hysteresis functions support the intrinsic conduction and thus the
natural contraction sequence. Negative AV hysteresis functions support the cardiac
resynchronization therapy by maintaining pacing in stressful situations.
•
For resynchronization of the ventricles, triple-chamber devices have functions for
multisite ventricular pacing with possible VV delays in either direction.
•
To ensure that no additional surgery is necessary in case of a left-sided increase of
pacing threshold or undesired phrenic nerve stimulation, different paci ng polarities
can be set for the left ventricular lead with a triple-chamber device.
•
Automatic active capture control is available for the right and left ventricle with
automated tracking of the pacing threshold or automatic threshold monitoring
(ATM) for trend analysis.
With the Iforia 3, the pacing threshold is only measured.
Storing programs
The parameter settings can be saved in 3 individual therapy programs.
Home Monitoring functions
•
The device automatically sends information to the transmitter once a day. It also
sends messages related to events, which are immediately forwarded to the Service
Center. In addition to this, test messages can be initiated using the programmer.
•
Appointments for Home Monitoring-supported follow-ups can be scheduled via the
HMSC. This applies to Iforia 5/7.
5
•
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
General Safety Instructions
Operating Conditions
Care during shipping and storage
•
Devices are not to be stored or transported close to magnets or sources of electromagnetic interference.
•
Note the effects of the storage duration; see Battery Data.
Delivery in shipment mode
The device is delivered in shipment mode to protect the battery; capacitor reforming
required during storage could result in controlled extended charge times of the shock
capacitors.
•
The shipment mode is displayed on the programmer after loading the device
program (it is deactivated during implantation on initial measurement of the pacing
impedance).
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
•
Temperatures of 5°C to 45°C are permitted for transport, storage, and use.
Sterile delivery
The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if
the blister and quality control seal have not been damaged.
Sterile container
The device and screwdriver are packaged in two separately sealed blisters. The inner
blister is also sterile on the outside so that it can be transferred in a sterile state during
implantation.
Single use only
The device and screwdriver are intended for single use only.
•
Do not use the device if the package is damaged.
•
The device must not be resterilized and reused.
Possible Complications
General information on medical complications
Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices.
•
Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information include
current scientific and technological knowledge.
•
It is impossible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological
examinations. In rare cases the set parameters may become ineffective. It is
possible for therapies to induce or accelerate tachycardia and cause sustained
ventricular flutter or fibrillation.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate spectrum
of intrinsic events so that skeletal myopotentials are usually not recorded. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially at very high
sensing sensitivity and, depending on the interference, may cause inhibition or antiarrhythmia therapy.
In the case of undesired myopotentials, the device switches to asynchronous pacing if
the interference rate is exceeded.
Possible technical failures
Technical failure of a device system cannot be entirely ruled out. Possible causes can
include the following:
•
Lead dislodgement, lead fracture
•
Insulation defects
•
Device component failures
•
Battery depletion
•
Interrupted telemetry
6
Electromagnetic interference (EMI)
Any device can be sensitive to interference if external signals are sensed as intrinsic
rhythm or if measurements prevent rate adaptation.
•
BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal.
•
Due to the intensity and variety of EMI, there is no guarantee for safety. It is generally assumed that EMI produces only minor symptoms, if any, in patients.
•
Depending on the pacing mode and the type of interference, sources of interference
may lead to pulse inhibition or triggering, an increase in the sensor-dependent
pacing rate or asynchronous pacing.
•
Under unfavorable conditions, for example during therapeutic or diagnostic procedures, interference sources may induce such a high level of energy into the pacing
system that the cardiac tissue surrounding the lead tip is damaged.
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
Contraindicated procedures
The following procedures are contraindicated as they may cause harm to the patient or
damage the device and, as a result, put the system functionality at risk:
•
Therapeutic ultrasound: Harm to the patient via excess warming of body tissue
near the device system
•
Transcutaneous electrical nerve stimulation
•
Hyperbaric oxygen therapy
•
Applied pressures higher than normal pressure
Risky therapeutic and diagnostic procedures
If electrical current from an external source is conducted through the body for diagnostic or therapeutic purposes, then the device can be subjected to interference, which
can place the patient at risk.
Arrhythmia or ventricular fibrillation can be induced during diathermic procedures
such as electrocautery, HF ablation or HF surgery. For example, damaging 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 defibrillation. Nevertheless, any implanted device may be damaged by external defibrillation.
Specifically, the current induced in the implanted leads may result in necrotic tissue
formation close to the electrode/tissue interface. As a result, sensing properties and
pacing thresholds may change.
•
Place adhesive electrodes anterior-posterior or perpendicular to the axis formed
by the device to the heart at least 10 cm away from the device and from implanted
leads.
Radiation therapy
The use of radiation therapy is contraindicated due to possible damage to the device
and the resulting impaired functional safety. If this type of therapy is to be used anyway,
prior risk/benefit analysis is absolutely necessary. The complexity of influencing
factors such as different sources of radiation, a variety of devices and therapy conditions makes it impossible to issue directives that guarantee radiation therapy without
an impact on the device. The EN 45502 standard pertaining to active implantable
medical devices requires the following measures during the administration of therapeutic ionizing radiation:
•
Adhere to instructions for risky therapy and diagnosis procedures.
•
Shield device against radiation.
•
After applying radiation, double-check the device system to make sure it is functioning properly.
Note:
Please contact BIOTRONIK with questions during the risk/benefit analysis.
en • English
7
Magnetic resonance imaging
Magnetic resonance imaging (MRI) is contraindicated due to the high frequency fields
and the associated magnetic flux density: damage or destruction of the device system
by strong magnetic interaction and damage to the patient by excessive warming of the
body tissue in the area surrounding the device system.
Under certain conditions and when maintaining mandatory measures, magnetic resonance imaging can be performed to protect the patient and device system. BIOTRONIK
devices with the "MR conditional" function bear the identification ProMRI®.
•
The ProMRI® manual – MR conditional device systems – contains detailed information 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.
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 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
failures of the device:
•
Keep an external defibrillator and paddles or patch electrodes ready.
Unpacking the device
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.
•
Peel the sealing paper off of the outer blister at the marked position in the direction
indicated by the arrow. The inner blister may not come into contact with persons
who have not sterilized their hands or gloves, nor with non-sterile instruments.
•
Take hold of the inner blister by the gripping tab and take it out of the outer blister.
•
Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
Checking parts
Damage to any of the parts can result in complications or technical failures.
•
Check for damage before and after unpacking all parts.
•
Replace damaged parts.
•
The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be
connected and implanted in this state.
•
Leads may not be shortened.
Implantation site
•
Depending on lead configuration and the patient's anatomy, the ICD is generally
implanted subpectorally on the left side.
Preventing leakage currents
Leakage currents between the tools and the device must be prevented during implantation.
•
Electrically insulate the patient.
8
Preventing unintentional shock delivery
WARNING
Shock delivery with activated ICD
There is a risk of unintended shock delivery when handling an activated ICD.
•
Deactivate ICD therapy before touching the device during implantation, device
replacement and explantation.
Avoiding damage to the header
There is a blind plug for DF-1 and IS-1 connections in the header. The provided set
screws must be carefully loosened or tightened.
•
Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control!
•
Do not forcibly pull out the blind plug!
•
If lead repositioning is necessary, re-order sterile screwdrivers from BIOTRONIK.
Preventing short circuits in the header
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
•
Either leave unused ports closed with the premounted blind plugs, or close them
using the supplied blind plugs.
Connecting the lead connector to the device
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.
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.
4 Push the lead connector into the header without twisting or bending the con-
nector or conductor until the connector tip (on the DF-1 connector) (on the
DF4 connector) becomes visible behind the set screw block.
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 pro-
truding 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 u ntil torque control starts (you will he ar a clicking
sound).
8 Carefully withdraw the screwdriver without retracting the set screw.
•
In case of IS-1 connections with two set screws, tighten both screws!
•
When the screwdriver is withdrawn, the silicone plug automatically safely
seals the lead connector port.
Keeping distance between leads
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.
en • English
9
Implanting
1Prepare the vein.
2 Implant the leads, perform the measurements, and fixate the leads.
3 Form the device pocket.
4 Connect the lead connector to the device.
5 Insert the device.
6 Guide the fixation suture through the opening in the header and fixate the
device in the prepared device pocket.
7 Close the device pocket.
8 Check the device with standard tests.
Applying the programming head
The programming head (PGH) features a diagram of the device. This is used to assist in
positioning the head to ensure proper telemetry.
•
Make sure the PGH is positioned correctly.
Establishing telemetry contact
The programmer (or the SafeSync Module) can be no more than 3 m from the device;
ideally there should be no hindrances between the patient and the programmer.
•
Switch on RF telemetry on the programmer.
•
Apply the programming head for about 2 s until successful initialization is displayed
on the programmer:
The SafeSync symbol is displayed in the navigator and the signal
strength is displayed in the status line.
•
Remove the programming head.
Activating ICD therapy
•
Load the device program that is suitable for the device type in the programmer.
•
Activate ICD therapy.
•
Shipment mode is permanently deactivated once the leads have been connected
and initial measurement of the pacing impedance has been performed. The device
data are saved.
•
Take precautionary measures while programming.
•
If the device induces tachycardia while programming ATPs or does not deliver adequate therapy in the DFT test: use emergency shock or an external defibrillator.
Precautionary Measures while Programming
Performing standard tests and monitoring the patient
Critical conditions can occur for the patient even during standard tests due to 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 strain.
•
Check compatibility and effectiveness of parameter combinations after making
settings.
Check for leads suitable for shock path
Three shock paths can be set, two of which form an electrical path to the device
housing.
•
A second shock coil (dual shock coil) must be available for the shock path
RV -> SVC.
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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 tachycardia to the ventricle(s):
•
Set mode switching for indicated patients.
•
Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
•
Give preference to Wenckebach response and avoid 2:1 behavior.
•
Set all parameters so as to prevent constant changing between atrial and
ventricular-controlled modes.
Observing the shock impedance limit
The implanted device could be damaged if the shock impedance is too low.
•
The shock impedance must be > 25 Ω.
Preventing recurrence after therapy shock
After a therapy shock, pacing can be performed with a post-shock program if there is
no intrinsic rhythm.
Permanent program Post-shock program
DDD, DDI, AAI DDI
VDD, VDI VDI
VVI and OFF VVI
•
The following post-shock program parameters can be adjusted: post-shock
duration, basic rate, rate hysteresis, ventricular pacing, LV-T-wave protection,
triggering, AV delay (fixed, not dynamic).
•
The default settings for the post-shock program are as follows:
A and RV: 7.5 V, 1.5 ms
LV: settings from the permanent program
Phrenic nerve stimulation that cannot be terminated
In rare cases, chronic phrenic nerve stimulation cannot be terminated by reprogramming of the available left ventricular pacing configurations or by other measures.
•
As the case may be, set a right ventricular mode both in the permanent program as
well as the ATP, in the post-shock program and for mode switching.
Avoiding risks in the case of exclusive LV pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing and ATP therapy, induction of atrial arrhythmias.
•
Consider sensing and pacing parameters with reference to loss of therapy.
•
Exclusive LV pacing is not recommended for patients who depend on the device.
•
Take non-availability of automatic active capture control into consideration.
•
In the case of follow-ups and threshold tests, take loss of synchronized ventricular
pacing into consideration.
•
Mode switching and post-shock do not allow for exclusive LV pacing. Also take the
effects into account when setting the mode switching and post-shock parameters.
Recognizing lead failure
Automatic impedance measurement is always switched on.
•
Impedance values that indicate technical failure of a lead are documented in the
event list.
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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 reactivates the
therapy functions to prevent accidental permanent deactivation.
•
If detection interruptions of longer than 8 hours are required, the magnet has to be
briefly removed from the device. The 8 hour countdown restarts when the magnet
is applied again.
•
Use BIOTRONIK magnets: type M-50 permanent magnets.
Follow-up
Follow-up intervals
Follow-ups must be performed at regular, agreed intervals.
•
The first follow-up should be carried out by the physician using the programmer
(in-office follow-up) approximately 3 months after implantation following the lead
ingrowth phase.
•
The next in-office follow-up should be carried out once a year and no later than
12 months after the last in-office follow-up.
Follow-up with BIOTRONIK Home Monitoring®
Monitoring using the Home Monitoring function does not serve to replace regular inoffice appointments with the physician required for other medical reasons. Follow-up
supported by Home Monitoring can be used to functionally replace in-office follow-up
under the following conditions:
•
The patient was informed that the physician must be contacted despite use of the
Home Monitoring function if symptoms worsen or if new symptoms arise.
•
Device messages are transmitted regularly.
•
The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the device
system are sufficient. If not, an in-office follow-up has to be carried out.
Possible early detection due to information gained via Home Monitoring may necessitate an additional in-office follow-up. For example, the data may indicate at an early
stage lead problems or a foreseeable end of service time (ERI). Furthermore, the data
could provide indications of previously unrecognized arrhythmias or modification of the
therapy by reprogramming the device.
Follow-up with the programmer
Use the following procedure for in-office follow-up:
1 Record and evaluate the ECG.
2 Interrogate the device.
3 Evaluate the status and automatically measured follow-up data.
4 Check the sensing and pacing functions.
5 Possibly evaluate statistics and IEGM recording.
6 Manually perform standard tests if necessary.
7 Possibly customize program functions and parameters.
8 Transmit the program permanently to the device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
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.
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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 interference should not be brought into close proximity with the device.
•
Draw the patient's attention to special household appliances, security checkpoints,
anti-theft alarm systems, strong electromagnetic fields, cell phones, and transmitters among other things.
•
Request patients to do the following:
—
Use cell phones on the side of their body that is opposite of the device.
—
Keep the cell phone at least 15 cm away from the device both during use and
when stowing.
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.
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.
•
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.
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EOS replacement indication
End of Service can be detected by Home Monitoring.
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!
•
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.
Note:
Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
•
Explants are biologically contaminated and must be disposed of safely due to risk of
infection.
Device replacement
If, upon replacing the device, already implanted leads are no longer used but left in the
patient, then an additional uncontrolled current path to the heart can result.
•
Deactivate VT and VF therapies prior to device replacement.
•
Insulate connections that are not used.
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