BIOTRONIK SE and KG TACHBORAX implantable cardioverter defibrillator User Manual

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Inlexa 1
VR-T, DR-T, HF-T
ICD-Familie | Tachyarrhythmietherapie |
Kardiale Resynchronisationstherapie
Gebrauchsanweisung
420651
Revision: A (2015-12-09)
© BIOTRONIK SE & Co. KG
Alle Rechte vorbehalten.
Technische Änderungen vorbehalten.
® Alle verwendeten Produktnamen können Marken oder eingetragene Marken von
BIOTRONIK oder dem jeweiligen Eigentümer sein.
Index 420651GebrauchsanweisungInlexa 1 VR-T, DR-T, HF-T,
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
1
Product Description
Product Description1403736Technical Manual
Intended Medical Use
Intended use
Inlexa 1 is part of a family of implantable cardioverter-defibrillators (ICDs). The
primary objective of the therapy is to prevent sudden cardiac death. Furthermore,
the device is capable of treating bradycardia arrhythmias and cardiac 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 (dual- and triple-chamber devices)
Diagnosis and
therapy forms
Required expertise
Indications
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.
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation and the operation conditions of a device system.
• Only qualified medical specialists having this required special knowledge are
permitted to use implantable devices.
• If users do not possess this knowledge, they must be trained accordingly.
Inlexa 1 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 current guidelines of
cardiology associations for guidance.
We recommend observing the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC
(European Society of Cardiology). This also applies to the guidelines published by
the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the
American Heart Association (AHA), and other national cardiology associations.
Single-chamber and
dual-chamber
Triple-chamber
Single-chamber and dual-chamber ICDs are indicated for patients with the
following risk:
• Sudden cardiac death caused by ventricular arrhythmias
Triple-chamber ICDs are indicated for patients with the following risks:
• Sudden cardiac death caused by ventricular arrhythmias
• Congestive heart failure with ventricular asynchrony
2
Contraindications
Known contraindications:
• Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning,
electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
• Such frequent VT or VF that the therapies would cause an unacceptably rapid
depletion of the device batteries
• VT with few or without clinically relevant symptoms
• VT or VF treatable by surgery
• Concomitant diseases that would substantially limit a positive prognosis
• Accelerated intrinsic rhythm
System Overview
Device family
The complete Inlexa 1device family consists of several device types with a DF-1/IS-1
connection.
• Single-chamber: VR-T
• Dual-chamber: DR-T
• Triple-chamber: HF-T
Note: 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
The labeling on each device provides information pertaining to the connector port
assignment in the header.
VR
DR
DF-1
SVC
DF-1
RV
DF-1
SVC
IS-1
RA
DF-1
RV
IS-1
RV
IS-1
RV
HF
Connector Lead
Configuration
port
connector
Leads
IS-1
LV
IS-1
RA
IS-1
RV
DF-1
SVC
DF-1
RV
Implantation site Device type
RA
IS-1
Bipolar
Atrium
DR, HF
(R)V
IS-1
Bipolar
(Right) ventricle
VR, DR, HF
RV
DF-1
Shock coil
Right ventricle
VR, DR, HF
SVC
DF-1
Shock coil
Superior vena
cava
VR, DR, HF
LV
IS-1
Unipolar, bipolar
Left ventricle
HF
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.
3
Telemetry
Programmer
Telemetric communication between the device and the programmer can be carried
out following initialization either by applying the programming head (PGH) to the
device or by using wireless radio frequency (RF) telemetry in the programmer.
BIOTRONIK calls this function SafeSync®.
Implantation and follow-up are performed with BIOTRONIK's portable
programmer: Programmer software PSW version N.N. and higher
There is a programmer with integrated RF telemetry and one with a separate
SafeSync Module.
Leadless ECG, IEGM, markers and functions are displayed simultaneously on the
color display.
Using the programmer, the pacing thresholds can be determined and all tests can
be performed during in-office follow-up. If necessary, the current software is transferred to the device during implantation.
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.
Modes
The mode setting depends on the individual diagnosis:
Device type
NBD and NBG codes
Modes
VR
VVI; VVIR; VOO; OFF
DR, HF
DDD; DDDR; DDDR-ADIR; DDD-ADI; DDI; DDIR;
VDD; VDDR; VDI; VDIR
VVI; VVIR; AAI; AAIR; VOO; DOO; OFF
VVE is the NBD code for the antitachycardia mode of the single-chamber, dualchamber, and triple-chamber devices:
Shock in the ventricle
Antitachycardia pacing (ATP) in the ventricle
Detection via IEGM analysis
DDDR is the NBG code for the antibradycardia mode of the dual-chamber devices:
Pacing in the atrium and ventricle
Sensing in the atrium and ventricle
Pulse inhibition and pulse triggering
Rate adaptation
DDDRV is the NBG code for the antibradycardia mode of the triple-chamber devices:
Pacing in the atrium and ventricle
Sensing in the atrium and ventricle
Pulse inhibition and pulse triggering
Rate adaptation
Multisite pacing in both ventricles
VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber
device:
Ventricular pacing
Sensing in the ventricle
Pulse inhibition in the ventricle
Rate adaptation
4
BIOTRONIK
Home Monitoring®
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
• With Home Monitoring, diagnostic and therapeutic information as well as
technical data are automatically sent to a stationary or mobile transmitter via an
antenna in the device header. The data are encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network.
• The received data are deciphered and evaluated. Each physician can set the
criteria for evaluation to be used for each patient and can configure the time of
notification via e-mail, SMS or fax.
• A clear overview of the results of this analysis is displayed for the attending
physicians on the protected Internet platform Home Monitoring Service Center
(HMSC).
• Data transmission from the device is performed with a daily device message.
• Device messages which indicate special events in the heart or in the device are
forwarded immediately.
• A test message can be initiated at any time using the programmer to immediately check the Home Monitoring function.
Inlexa 1order numbers
Not all device types are available in every country:
Package contents
VR-T
DR-T
HF-T
405797
405796
40579
The storage package includes the following:
• Sterile packaging with device
• Serial number label
• Patient ID card
• Warranty booklet
Note: The technical manual pertaining to the device is either included in hard copy
form in the storage package or in digital form on the internet.
The sterile container includes the following:
• Device, blind plugs (if applicable)
• Screwdriver
5
Therapeutic and Diagnostic Functions
Diagnostic functions
•
•
•
•
Antitachycardia pacing
•
•
Cardioversion, defibrillation
•
•
Antibradycardia pacing
and CRT
•
•
•
•
•
•
Storing programs
Data from implantation and the most recent interrogations and follow-ups are
recorded as well as arrhythmia episodes; they are stored together with other
data to assess both the patients' and the device's state at any time.
To check the lead for proper functioning, an automatic impedance 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.
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.
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 depending on the device family.
Before delivery of the shock, the ICD can be set to only deliver a shock when
ongoing tachyarrhythmia is confirmed; during this time period the device can
identify spontaneous conversion of the tachyarrhythmia and cancel the charging
process if necessary.
The shock paths can be set between the different shock coils (SVC/RV) and/or
the housing.
Innovative rate hystereses, automatic sensor functions, and a night program
promote the patient's intrinsic rhythm, avoid overdrive pacing, and facilitate
adaptation of the device to the individual needs of the patient.
Thresholds: atrial as well as ventricular pacing thresholds are automatically
determined in the device, automatic threshold monitoring (ATM) for trend
analysis.
Setting an upper tracking rate for the atrium prevents unspecific atrial pacing,
thus reducing the risk of pacemaker-mediated tachycardia.
Positive AV hysteresis functions support intrinsic conduction and thus the
natural contraction sequence. Negative AV hysteresis functions support the
cardiac resynchronization therapy by maintaining pacing in stress situations.
For resynchronization of the ventricles, triple-chamber implants have functions
for multisite pacing with possible VV delays in either direction.
To ensure that no additional surgery is necessary in case of a left-sided increase
of pacing threshold or undesired phrenic nerve stimulation, different pacing
polarities can be set for the left ventricular lead with a triple-chamber device.
There are different therapy programs:
• Parameter settings effective for the most common indications in pre-configured
programs (Program Consult).
• For special indications, individual parameter settings can be stored in up to
three therapy programs.
6
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
7
General Safety Instructions
General Safety Instructions2403736Technical Manual
Operating Conditions
Technical manuals
The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manual for the electrodes
— Technical manuals for the programmer and its accessories
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
• Technical manuals are either included in hard copy form in the storage package
or in digital form on the internet: manuals.biotronik.com
• Follow all relevant technical manuals.
• Reserve technical manuals for later use.
Care during shipping
and storage
•
•
Delivery in shipment mode
Temperature
Sterile delivery
Sterile packaging
Single use only
Devices must not be stored or transported close to magnets or sources of electromagnetic interference.
Note the effects of the storage duration; see Battery Data.
The device is delivered in shipment mode to protect the battery; capacitor reforming
required during storage could result in controlled extended charge times of the
shock capacitors.
• The shipment mode is displayed on the programmer after the initial interrogation (it is deactivated during implantation by the first valid (in-range) measurement of the pacing impedance).
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.
The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only
if the blister and quality control seal have not been damaged.
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.
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.
8
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 range
of intrinsic events so that skeletal myopotentials are usually not recorded. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially at very
high sensing sensitivity and, depending on the interference, may cause inhibition or
antiarrhythmia therapy.
In the case of undesired myopotentials, the device switches to asynchronous pacing
if the interference rate is exceeded.
Possible technical failures
Technical failure of a device system cannot be entirely ruled out. Possible causes
can include the following:
• Lead dislodgement, lead fracture
• Insulation defects
• Device component failures
• Battery depletion
• Interrupted telemetry
Electromagnetic
interference (EMI)
Any device can be sensitive to interference if external signals are sensed as intrinsic
rhythm or if measurements prevent rate adaptation.
• BIOTRONIK devices have been designed so that their susceptibility to EMI is
minimal.
• Due to the intensity and variety of EMI, there is no guarantee for safety. It is
generally assumed that EMI produces only minor symptoms, if any, in patients.
• Depending on the pacing mode and the type of interference, sources of interference may lead to pulse inhibition or triggering, an increase in the sensordependent pacing rate or asynchronous pacing.
• Under unfavorable conditions, for example during therapeutic or diagnostic
procedures, interference sources may induce such a high level of energy into
the pacing system that the cardiac tissue surrounding the lead tip is damaged.
Device behavior in
case of EMI
In case of electromagnetic interference, the device switches to asynchronous
pacing for as long as the interference rate is exceeded.
Static magnetic fields
The magnetic sensor in the device detects magnetic fields starting at a magnetic
flux density of approximately 1.5 mT. Magnetic fields below 1 mT do not affect the
sensor.
9
Possible Risks
Procedures to avoid
Risky therapeutic and
diagnostic procedures
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
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
pressure levels may arise during lithotripsy. For example, excessive warming of
body tissue near the device system may occur during therapeutic ultrasound. 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 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 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.
Magnetic resonance
imaging
Magnetic resonance imaging must be avoided due to the associated high frequency
fields and magnetic flux density: Damage or destruction of the device system by
strong magnetic interaction and damage to the patient by excessive warming of the
body tissue in the area surrounding the device system.
10
Implantation
Implantation3403736Technical Manual
Implantation Procedure
Having parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/
EEC are required:
• BIOTRONIK device with blind plug and screwdriver
• BIOTRONIK leads and lead introducer set
— Single-chamber device: one bipolar ICD lead with 1 or 2 shock coils for the
ventricle
— Dual-chamber device: one bipolar lead for the atrium and one bipolar ICD
lead for the ventricle with 1 or 2 shock coils
— Triple-chamber device: an additional unipolar or bipolar LV lead
• The lead connections DF-1 and IS-1 are permitted. Use only adapters approved
by BIOTRONIK for leads with different lead connections or leads from other
manufacturers.
• BIOTRONIK programmer (with integrated SafeSync RF telemetry or with
separate SafeSync Module) and approved cables
• External multi-channel ECG device
• Keep spare parts for all sterile components.
Keeping an external
defibrillator ready
To be able to respond to unforeseeable emergencies or possible technical failures
of the device:
• Keep an external defibrillator and paddles or patch electrodes ready.
Unpacking the device
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.
•
•
•
Checking parts
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.
Damage to any of the parts can result in complications or technical failures.
• Check for damage before and after unpacking all parts.
• Replace damaged parts.
• Upon delivery, the tachyarrhythmia therapy function in the ICD is deactivated.
The ICD must only be implanted in this state.
• Leads must not be shortened.
11
Implantation site
Preventing leakage
currents
•
Depending on lead configuration and the patient's anatomy, the ICD is generally
implanted subpectorally on the left side.
Leakage currents between the tools and the device must be prevented during
implantation.
• Electrically insulate the patient.
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
Set screws and blind plugs (if applicable) must be tightened or loosened with care.
• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers 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
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
• Close unused connector ports with blind plugs.
Ensure that connector ports
are clean
In case of contamination during implantation:
• Clean lead connectors with a sterile cloth.
• Rinse connector port only with sterile water.
Overview: Implanting
Connecting the device
Prepare the vein.
Implant the leads, perform the measurements, and fixate the leads.
Form the device pocket.
Connect the lead connector to the device.
Insert the device.
Guide the fixation suture through the opening in the header and fixate the
device in the prepared device pocket.
Close the device pocket.
Check the device with standard tests.
The lead connectors are connected to the ports in the header of the device:
Disconnect stylets and stylet guides.
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.
12
DF-1/IS-1 connection:
• Connect the bipolar IS-1 connector for the atrium to RA.
• Connect the bipolar IS-1 connector for the right ventricle to RV.
• Connect the unipolar or the bipolar IS-1 connector for the left ventricle to
LV.
Push the lead connector into the header without twisting or bending the
connector or conductor until the connector tip (on the DF-1 connector)
becomes visible behind the set screw block. This indicator can vary
depending on the manufacturer of the lead used.
If you cannot easily plug the lead connector into the connection:
• Use only sterile water as lubricant.
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.
Turn the set screw clockwise until torque control starts (you will hear a
clicking sound).
Carefully withdraw the screwdriver without retracting the set screw.
• In case of IS-1 connections with 2 set screws, tighten both screws!
• When you withdraw the screwdriver, the silicone plug automatically seals
the access to the screw head safely.
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.
Applying the
programming head
Establishing
telemetry contact
Activating ICD therapy
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.
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.
•
•
•
•
•
Load the software that is suitable for the device type in the programmer.
Activate ICD therapy.
Shipment mode is permanently deactivated once the leads have been connected
and initial measurement of the pacing impedance has been performed successfully. 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.
13
Precautionary Measures while Programming
Performing standard tests
and monitoring the patient
Critical conditions can occur for the patient even during standard tests due to
inadequate parameter settings or interrupted telemetry.
• Ensure sufficient patient care even during tests.
• After the threshold test, check to determine whether the threshold is clinically
and technically justifiable.
• Continuously monitor the ECG and the patient's condition.
• Cancel testing if necessary.
Cancelling telemetry
Programmer interference or interrupted telemetry during performance of
temporary programs (follow-up tests) can result in inadequate pacing of the
patient. This is the case if the programmer can no longer be operated due to a
program error or a defective touch screen and therefore the temporary program
cannot be terminated. Under these circumstances, it is helpful to cancel telemetry,
in which case the device automatically switches to the permanent program.
• In the case of telemetry with programming head: lift the PGH by at least 30 cm.
• In the case of RF telemetry: switch off and reposition the programmer.
• Turn off possible sources of interference.
Avoiding critical
parameter settings
No modes and parameter combinations that pose a risk to the patient should be set.
• Prior to setting rate adaptation, determine the patient's capacity for exertion.
• Check compatibility and effectiveness of parameter combinations after making
settings.
• When setting atrial therapies after an AT or AF has been detected, note that no
ventricular tachyarrhythmia can be detected for the duration of atrial therapy
delivery.
Checking for electrodes
suitable for the shock path
Three different shock paths can be set. Two of these form an electrical path to the
housing of the implanted device.
• For the RV -> SVC shock path, a second shock coil must be available (dual shock
coil).
Monitoring the patient
when setting
asynchronous modes
The asynchronous modes V00 and D00 can only be set if tachyarrhythmia sensing is
deactivated. This would leave the patient without sensing and therefore without ICD
therapy.
• Continually monitor the patient.
• Keep an external defibrillator ready.
Setting sensing
Manually set parameters can be unsafe. For example, unsuitable far-field 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.
• Prefer Wenckebach response and avoid 2:1 behavior.
• Set all parameters so as to prevent constant changing between atrial and
ventricular-controlled modes.
14
Note the reduced
pulse amplitude due to a
battery voltage drop
If the rate and amplitude are set very high and the pulse width is set too long at the
same time, the battery voltage may temporarily drop so low that the actual pulse
amplitude drops well below the selected level.
• Continuously check the pacing efficiency using ECG monitoring.
Observe when inducing
short-term cardiac arrest
To permit TAVI (transcatheter aortic valve implantation), the pressure in the heart
must be reduced so that the heart valve can be correctly positioned. Intentional
cardiac arrest by high-rate pacing (rapid pacing) should be brief, must be tolerated
by the patient and can trigger a life-threatening arrhythmia.
• Take all necessary precautionary measures and keep required emergency
equipment ready.
• Continually monitor the patient by ECG.
• Complete the TAVI procedure before high-rate pacing ends. Extend the pacing
duration if necessary.
• Abort the procedure if it is not successfully completed within the maximum
pacing duration so that cardiac arrest can be stopped.
• Reactivate ICD therapy at a clinically indicated point in time when the TAVI
process is completed.
Avoiding AV crosstalk
When pacing using atrial ATP parameters, atrial pacing pulses can either be
conducted into the ventricle or be sensed such that ventricular pacing is prevented.
• Check the settings for the presence of crosstalk.
• If necessary, temporarily set VVI and a rate for backup stimulation so that no
ventricular pulses are prevented.
Observing the shock
impedance limit
Preventing recurrence
after therapy shock
The implanted device could be damaged if the shock impedance is too low.
• The shock impedance must be > 25 Ω.
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 the available left ventricular pacing configuration or using other
measures.
• Set a right ventricular mode both in the permanent program as well as the ATP,
in the post-shock program and for mode switching if need be.
Avoiding risks in the case of
exclusive LV pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing and ATP therapy, induction of atrial
arrhythmias.
• Consider sensing and pacing parameters with reference to loss of therapy.
• Exclusive LV pacing is not recommended for patients who depend on the device.
• Please note that capture control is not available.
• In the case of follow-ups and threshold tests, take loss of synchronized ventricular pacing into consideration.
• Mode switching and post shock do not permit exclusive LV pacing. Please note
the effects when programming mode switching and the post shock parameters.
15
Recognizing lead failure
Considering power
consumption and
service time
Automatic impedance measurement is always switched on.
• Impedance values that indicate technical failure of a lead are documented in the
event list.
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.
16
Follow-up
Follow-up intervals
Follow-up with BIOTRONIK
Home Monitoring®
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.
Monitoring using the Home Monitoring function does not serve to replace regular
in-office appointments with the physician required for other medical reasons.
Follow-up supported by Home Monitoring can be used to functionally replace inoffice follow-up under the following conditions:
• The patient was informed that the physician must be contacted despite use of
the Home Monitoring function if symptoms worsen or if new symptoms arise.
• Device messages are transmitted regularly.
• The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the
device system are sufficient. If not, an in-office follow-up needs 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:
Record and evaluate the ECG.
Interrogate the device.
Evaluate the status and automatically measured follow-up data.
Check the sensing and pacing functions.
Possibly evaluate statistics and IEGM recordings.
Manually perform standard tests if necessary.
Possibly customize program functions and parameters.
Transmit the program permanently to the device.
Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
17
Patient Information
Patient ID card
Prohibitory signs
Possible sources of
interference
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.
Premises with prohibitive signs must be avoided.
• Draw the patient's attention to prohibitory signs.
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.
18
Replacement Indications
Possible battery levels
•
•
•
•
•
Elective Replacement
Indication (ERI)
BOS: Beginning of Service: > 90% charge
MOS 1: Middle of Service: 90% to 40% residual charge
MOS 2: Middle of Service: < 40% residual charge
ERI: Elective Replacement Indication (i.e. RRT: Recommended Replacement
Time)
EOS: End of Service
Elective Replacement Indication 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.
•
•
•
EOS replacement indication
The device can monitor the heart rhythm for at least 3 more months.
At least 6 maximum energy shocks can be delivered until EOS occurs.
The selected parameters in the software do not change.
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
— Cycle duration for BIOTRONIK Home Monitoring®: 90 days
19
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.
•
Device replacement
Explants are biologically contaminated and must be disposed of safely due to
risk of infection.
If, upon replacing the device, already implanted leads are no longer used but left in
the patient, then an additional uncontrolled current path to the heart can result.
• Deactivate VT and VF therapies prior to device replacement.
• Insulate connector ports that are not used.
Basic principles:
• The device must not be resterilized and reused.
Cremation
Disposal
Devices must not be cremated.
• Explant the device before the cremation of a deceased patient.
BIOTRONIK takes back used products for the purpose of environmentally safe
disposal.
• Clean the explant with a solution of at least 1% sodium hypochlorite.
• Rinse off with water.
• Fill out explantation form and send to BIOTRONIK together with the cleaned
device.
20
Parameters
Parameters4403736Technical Manual
Bradycardia / CRT
General ICD therapy
Timing: Basic rate day/night
and rate hystereses
Parameter
Range of values
Standard VR DR HF
ICD therapy
OFF; ON
ON
Programs
Display standard
program; Display safe
program; Display first
interrogated program;
Individual 1, 2, 3;
Program Consult
—
Parameter
Range of values
Standard VR DR HF
Basic rate
30 ... (5) ... 100 ... (10)
... 160 bpm
40 bpm
Night rate
OFF; 30 ... (5) ... 100 bpm OFF
Night begins
00:00 ... (00:01)
... 23:59 hh:mm
Night ends
60 bpm
22:00 hh: x
mm
06:00 hh:
mm
Rate hysteresis
OFF; -5 ... (-5) ... -25 ...
(-20) ... -65 bpm
OFF
Scan/repetitive
OFF; ON
ON
Parameter
Range of values
Standard VR DR HF
AV dynamics
Low; Medium; High;
Fixed; (Individual)
Low
Timing: AV delay
AV delay (1 or 2) after:
– Pacing
15; 40 ... (5) ... 350 ms
–
– Sensing
Either automatic:
AV delay after pacing +
sense compensation
Or: 40 ... (5) ... 350 ms
–
– At rate 1
50 ... (10) ... 130 bpm
60 bpm
– At rate 2
60 ... (10) ... 140 bpm
130 bpm
Sense compensation
OFF; -5 ... (-5) ... -120 ms -40 ms
AV hysteresis mode
OFF; Positive; Negative;
IRSplus
OFF
OFF; Positive; Negative
OFF
AV hysteresis (positive)
70; 110; 150; 200 ms
70 ms
AV hysteresis (positive)
70; 110; 150 ms
110 ms
AV hysteresis (negative)
10 ... (10) ... 150 ms
50 ms
AV scan and repetitive
(positive)
OFF; ON
ON
21
Timing: Post-shock pacing
Parameter
Range of values
Standard VR DR HF
Post-shock duration
OFF; 10 s; 30 s; 1 min;
2 min; 5 min; 10 min
10 s
Post-shock basic rate
30 ... (5) ... 100 ... (10)
... 160 bpm
60 bpm
AV delay post shock
50 ... (10) ... 350 ms
140 ms
Ventricular post-shock
pacing
RV; BiV
RV
Parameter
Range of values
Standard VR DR HF
Timing: Upper rate
Upper rate
90 ... (10) ... 160 bpm
130 bpm
Atrial upper rate
OFF; 175; 200; 240 bpm
200 bpm
Timing: Mode switching
Parameter
Range of values
Standard VR DR HF
Intervention rate
OFF; 120 ... (10) ...
200 bpm
160 bpm
Onset criterion
3 ... (1) ... 8 (out of 8)
10 bpm
Resolution criterion
Modification of basic rate OFF; 5 ... (5) ... 30 bpm
After mode VDD(R): VDI(R) VDIR
After mode DDD(R):
DDI(R)
DDIR
– Rate
OFF; 5 ... (5) ... 50 bpm
10 bpm
– Duration
1 ... (1) ... 30 min
1 min
Parameter
Range of values
Standard VR DR HF
Mode
After mode switching:
Timing: Ventricular pacing
Permanent
RV; BiV; LV
BiV
Triggering
OFF; RVs; RVs+PVC
RVs
LV T-wave protection
OFF; ON
ON
UTR + 20; 90 ... (10)
... 160 bpm
UTR + 20
Maximum trigger rate:
– DDD(R) and VDD(R)
– DDI(R), VDI(R) and VVI(R) 90 ... (10) ... 160 bpm
130 bpm
Initially paced chamber
RV; LV
LV
VV delay after Vp
0 ... (5) ... 100 ms
0 ms
22
Timing: Refractory periods
and blanking periods
Parameter
Range of values
Standard VR DR HF
PVARP
AUTO; 175 ... (25) ...
600 ms
225 ms
PVARP extension
OFF; ON
ON
Blanking after atrial
pacing
50 ... (10) ... 100 ms
50 ms
LV blanking after
RV pacing
80 ms
RV blanking after
LV pacing
Far-field protection
after Vs
OFF; 25 ... (25) ... 225 ms
75 ms
Far-field protection
after Vp
50 ... (25) ... 225 ms
75 ms
Parameter
Range of values
Standard VR DR HF
PMT detection/termination
OFF; ON
ON
VA criterion
250 ... (10) ... 500 ms
350 ms
Parameter
Range of values
Standard VR DR HF
Maximum sensor rate
80 ... (10) ... 160 bpm
120 bpm x
Sensor gain
AUTO; Very low; Low;
Medium; High; Very high
Medium
Sensor threshold
Very low; Low; Medium;
High; Very high
Medium
Rate increase
1; 2; 4; 8 bpm/cycle
2 bpm/
cycle
Rate decrease
0.1; 0.2; 0.5; 1.0 bpm/
cycle
0.5 bpm/ x
cycle
Parameter
Range of values
Standard VR DR HF
Pulse amplitude A
0.5 ... (0.25) ... 4.0 ... (0.5)
... 6.0; 7.5 V
AUTO
Timing: PMT protection
Timing: Rate adaptation via
accelerometer
Pacing: Pulse amplitude
and pulse width
Pulse amplitude V/RV
Pulse amplitude LV
Pulse width A
0.4; 0.5 ... (0.25) ... 1.5 ms 0.4 ms
Pulse width V/RV
Pulse width LV
Pacing:
Atrial capture control
0.4 ms
Parameter
Range of values
Standard
Atrial capture control
OFF; ATM
ON
VR DR HF
Threshold test start
2.5 ... (0.5) ... 5.0 V
3.5 V
23
Pacing:
Ventricular capture control
Lead configuration LV
on IS-1 connection
Parameter
Range of values
Standard
VR DR HF
Ventricular capture
control
OFF; ATM
ON
Threshold test start
2.5 ... (0.5) ... 5.0 V
3.5 V
VR DR HF
Parameter
Range of values
Standard
Pacing polarity LV
(IS-1)
LV tip -> LV ring
LV tip -> RV shock coil
LV ring -> LV tip
LV ring -> RV shock coil
UNIP
LV tip -> RV
shock coil
Sensing polarity LV
(IS-1)
UNIP; BIPL
UNIP
24
Tachycardia
Detection
Parameter
Range of values
Standard VR DR HF
Interval AT/AF
240 ... 600 ms
300 ms
Interval VT1
OFF; 270 ... (10) ... 600 ms OFF
ON
Interval VT2
OFF; 270 ... (10) ... 500 ms
Interval VF
OFF; 240 ... (10) ... 400 ms 300 ms
Detection counter VT1
10 ... (2) ... 100
28
Detection counter VT2
10 ... (2) ... 80
20
Detection counter VF
6 out-of 8; 8 out-of 12;
18 out of
10 out-of 14; 12 out-of 16; 24
16 out-of 20; 18 out-of 24;
20 out-of 26; 22 out-of 30;
24 out-of 30; 30 out-of 40
Redetection counter VT1
10 ... (2) ... 50
20
Redetection counter VT2
10 ... (2) ... 40
14
Redetection counter VF
6 out-of 8; 8 out-of 12;
8 out
10 out-of 14; 12 out-of 16; of 12
16 out-of 20;
18 out-of 24; 20 out-of 26;
22 out-of 30; 24 out-of 30
SMART detection VT1/VT2 OFF; ON
SMART detection ON:
– Onset VT1/VT2
4 ... (4) ... 32%
20%
– Stability VT1/VT2
8 ... (4) ... 48%
12%
4 ... (4) ... 32%
20%
SMART detection OFF:
– Onset VT1/VT2
– Stability VT1/VT2
OFF; 8 ... (4) ... 48 ms
24 ms
MorphMatch
OFF; Monitoring; ON
OFF
Sustained VT
OFF; 1; 2; 3; 5; 10; 20;
30 min
OFF
Forced termination
OFF; 1 ... (1) ... 10 min
1 min
25
Therapy: ATP
Parameter
Range of values
Standard VR DR HF
Attempts
OFF; 1 ... (1) ... 10
OFF
ATP type for VT1/VT2
Burst; Ramp
Burst
ATP type for VF
OFF; Burst; Ramp
Burst
ATP optimization
OFF; ON
OFF
Number S1 for VT1/VT2
1 ... (1) ... 10
Number S1 for VF
S1 decrement for VT1/VT2 5 ... (5) ... 40 ms
and for VF
10 ms
Scan decrement
OFF; 5 ... (5) ... 40 ms
OFF
Add S1 for VT1/VT2
OFF; ON
ON
Ventricular pacing
for VT1/VT2
RV; LV; BiV
RV
Ventricular pacing for VF
RV
R-S1 interval for VT1/VT2 70 ... (5) ... 95%
80%
R-S1 interval for VF
85 %
Therapy: Shock
Parameter
Range of values
Standard VR DR HF
Number of shocks
VT1/VT2
0; 1; 2; 6; 8
Number of shocks VF
6; 8
1st Shock for VT1/VT2
OFF; 2 ... (2) ... 20 ... (5) ... 40 J
40 J
2nd Shock for VT1/VT2
OFF; 4 ... (2) ... 20 ... (5) ... 40 J
40 J
3rd - nth shock for VT1/
VT2
OFF; 4*40 J; 6*40 J
6*40 J
1st Shock for VF
2 ... (2) ... 20 ... (5) ... 40 J
40 J
2nd Shock for VF
4 ... (2) ... 20 ... (5) ... 40 J
40 J
3rd - nth shock for VF
4*40 J; 6*
6*40 J
For shock in VT1/VT2 and VF:
– Confirmation
OFF; ON
ON
– Polarity
Normal; Reverse; Alternating
Normal
– Shock form
Biphasic; Biphasic 2
Biphasic
– Shock path
RV -> ICD+SVC
RV -> ICD
RV -> SVC
RV->
ICD+SVC
RV -> ICD
26
Sensing
Sensitivity and thresholds
Parameter
Range of values
Standard VR DR HF
Sensing A
STD; OFF
STD
Sensing RV
STD; TWS; VFS; IND
STD
Sensing LV
STD; OFF; IND
STD
Upper threshold RV
50; 75%
50%
Upper threshold LV
50; 75%
50%
Upper threshold duration 110; 150 ... (50) ... 500 ms 350 ms
after detection
VFS: 110 ms
Upper threshold duration
after pacing
400 ms
Lower threshold RV
25; 50%
25%
T-wave suppression
after pacing
OFF; ON
OFF
Minimum threshold A
0.2 ... (0.1) ... 2.0 mV
0.4 mV
Minimum threshold RV
0.5 ... (0.1) ... 2.5 mV
0.8 mV
Minimum threshold LV
0.5 ... (0.1) ... 2.5 ... (0.5)
... 5.0 mV
1.6 mV
Diagnostics
The following can be set:
Parameter
Range of values
Standard
For AT/AF
OFF; ON
ON
ON
VR DR HF
For SVT
OFF; ON
Periodic recording
When Home Monitoring 90 days
OFF:
OFF; 30 ... (30) ...
180 days
IEGM configuration
RA, RV, LV
RA, RV, FF
FF; RV; LV
RA, RV, LV
Start resting period
00:00 ... (1:00 AM) ...
23:00 hh:mm
2:00
AM hh:mm
Duration of resting
period
0.5 ... (0.5) ... 12 h
4h
AV delay adjusted in
sensing test
OFF; 300 ms
300 ms
Thoracic impedance (TI) OFF, ON
OFF
27
Home Monitoring
Parameter
Range of values
Standard
VR DR HF
Home Monitoring
OFF; ON
OFF
Time of transmission
STD; 00:00 ... (1:00 AM) STD
... 23:00 hh:mm
IEGM for therapy
episodes
OFF; ON
ON
Ongoing atrial episode
OFF; 6; 12; 18 h
12 h
Transmission date
XX.XX.XXXX
Follow-up
+ 91 days
Cycle duration
20 ... (1) ... 366 days
91 days
IEGM for monitoring
episodes
28
Technical Data
Technical Data5403736Technical Manual
Mechanical Characteristics
Housing
Materials in contact with
body tissue
X-ray identification
Devices with header for DF-1 connector:
Type
Lead
connector
W x H x D in mm
Volume cm3
Mass g
VR
DF-1
69 x 55 x 12,5
38
71
DR
DF-1
69 x 55 x 12,5
39
71
HF
DF-1
69 x 58.5 x 12,5
40
73
•
•
•
HK
Housing: Titanium
Header: Epoxy resin
Silicone plugs and blind plugs (if applicable): Silopren or silastic
29
Electrical Characteristics
Standards
Measuring conditions
The specifications are made according to EN 45502-2-2:2008.
If not indicated otherwise, all specifications refer to the following conditions:
• Ambient temperature: 37ºC ± 2ºC
• Pacing/sensing: 500 Ω ±1%
• Shock: 50 Ω ±1%
Factory settings
•
•
•
Arrhythmia zones VT1, VT2, VF: OFF
Antibradycardia pacing: OFF
Home Monitoring: OFF
Telemetry data
•
•
MICS frequencies: 402-405 MHz
Maximum power of transmission: < 25 µW (–16 dBm)
International
radio certification
Devices with BIOTRONIK Home Monitoring® are equipped with an antenna for
wireless communication.
Telemetry information for Canada:
This device must neither interfere with meteorological and earth resources 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-TACHBORAX
The code IC in front of the certification/ registration number only indicates that
the technical requirements for Industry Canada are met.
Telemetry information for the USA:
This transmitter is authorized by rule under the Medical Device 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 operation. This transmitter shall be used only in accordance with the FCC
Rules governing the Medical Device Radiocommunication Service. Analog and
digital voice communications are prohibited. Although this transmitter has been
approved by the Federal Communications Commission, there is no guarantee that
it will not receive interference or that any particular transmission from this transmitter will be free from interference.
This device will be registered with Federal Communications Commission under the
following number:
FCC ID: QRITACHBORAX
Telemetry data for Japan:
In accordance with Japanese law, this device has been assigned an identification
number under the "Ordinance concerning certification of conformity with technical
regulations etc. of specified radio equipment", Article 2-1-8.
• R: 202-SMD021
30
Pulse form
The pacing pulse has the following form:
The pulse amplitude reaches its maximum value at
the beginning of the pulse (Ua). With increasing
pacing duration (tb), the pulse amplitude is reduced
dependent on the pacing impedance.
Common mode
rejection ratio
ATP amplitude
Rate
Common mode rejection ratio
Atrium: DR, HF
V right: VR, DR, HF V left: HF
16.6 Hz
72 dB
59 dB
57 dB
50 Hz
73 dB
66 dB
57 dB
60 Hz
71 dB
66 dB
62 dB
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:
ATP amplitude
Automatic
sensitivity control
Measured minimum
Measured maximum
Mean value
RA
7.57 V
7.49 V
5.1 V
RV
7.54 V
7.49 V
5.1 V
LV
7.55 V
7.51 V
5.1 V
Measurement of actual values and test signal wave shape: standard triangle.
Sensitivity
Value
Tolerance
Measured value
A: positive
0.2 mV
0.2 ... 0.5
0.23 mV
A: negative
RV: positive
0.24 mV
0.5 mV
0.3 ... 0.7
RV: negative
LV: positive
0.55 mV
0.58 mV
0.5 mV
0.3 ... 0.7
0.52 mV
LV: negative
Shock energy / peak voltage
With shock path: RV to housing + SVC
Shock energy
(Tolerance)
Tolerance
Peak voltage
Measured value Measured value
Shock energy
Peak voltage
1 J (0.7 ... 1.18)
100 ... 140 V
0.89 J
125,0 V
20 J (15.9 ... 21.6)
500 ... 550 V
16,62 J
530,4 V
40 J (32.0 ... 43.2)
710 ... 790 V
33,84 J
750,9 V
31
Battery Data
Battery characteristics
Storage period
Calculation
of service times
The following data is provided by the manufacturers:
Manufacturer
LITRONIK Batterietechnologie GmbH & Co
01796 Pirna, Germany
Battery type
LiS 3410 RR
System
LiMnO2
Battery ID number
shown on the programmer
Device type
VR-T, DR-T, HF-T
Battery voltage at ERI
2.85 V
Charge time at BOS
8s
Charge time at ERI
10 s
Usable capacity until ERI:
VR, DR, HF
1390 mAh
Usable capacity until EOS
1520 mAh
The storage period affects the battery service time.
• Devices should be implanted within 19 months between the manufacturing date
and the use by date (indicated on the package).
• If the ICD is implanted shortly before the use by date, the expected service time
may be reduced by up to 17 months.
•
•
Calculation
of the number of shocks
Inlexa 1 VR-T
The services times have been calculated as follows – in all chambers depending
on the device type:
— Pulse amplitude: 2.5 V
— Pulse width: 0.4 ms
— Pacing impedance: 500 Ω
— Basic rate: 60 bpm
— Home Monitoring: ON,
1 device message each day and 12 IEGM online HD transmissions per year
— Diagnostic functions and recordings: permanently set
Capacitor reforming is performed 4 times per year and therefore at least
4 maximum charges for shocks have to be assumed per year even if less than 4
are delivered.
Calculation of the number of shocks: Service time [in years] x number of shocks per
year
Service times with LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
10.3
8.3
7.0
6.0
5.3
15%
10.1
8.1
6.8
5.9
5.2
50%
9.5
7.8
6.6
5.7
5.0
100%
8.8
7.3
6.2
5.4
4.8
32
Inlexa 1 DR-T
Service times with LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
Inlexa 1 HF-T
12
16
20
0%
9.4
7.7
6.5
5.7
5.0
15%
9.0
7.4
6.3
5.5
4.9
50%
8.1
6.8
5.9
5.2
4.6
100%
7.1
6.1
5.3
4.7
4.3
Service times with LiS 3410 RR battery:
Service time [in years] at number of shocks per year
Pacing
12
16
20
0%
8.9
7.4
6.3
5.5
4.9
15%
8.3
7.0
6.0
5.2
4.7
50%
7.2
6.1
5.4
4.8
4.3
100%
6.0
5.3
4.7
4.2
3.9
33
Legend for the Label
Label on the package
The label icons symbolize the following:
Manufacturing date
Use by
Storage temperature
Order number
Serial number
Product identification
number
Dangerous voltages!
CE mark
Contents
Follow the instructions for
use
Sterilized with ethylene oxide
Do not resterilize
Single use only.
Do not reuse!
STERILIZE
Do not use if packaging is
damaged
Non-sterile
NON
STERILE
Transmitter with non-ionizing radiation at designated
frequency
TP2
Compatibility with telemetry protocol version 2
of BIOTRONIK Home Monitoring
Device:
NBG code and compatible leads
Example
Factory settings for therapy: OFF
Example
Screwdriver
Example of lead connection: DF-1/IS-1

---

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