BIOTRONIK ProMRI Etrinsa 6/8 Technical Manual
Etrinsa 6/8
( )
Pacemaker • Bradyarrhythmia Therapy • Cardiac Resynchronization Therapy
Herzschrittmacher • Bradyarrhythmietherapie • Kardiale Resynchronisationstherapie
Marcapasos • Terapia bradiarritmia • Terapia de resincronización cardiaca
Stimulateur cardiaque • Traitement de la bradyarythmie • Traitement par resynchronisation cardiaque
Kalp pili • Bradiaritmi terapisi • Kardiyak resenkronizasyon terapisi
Technical manual
Gebrauchsanweisung
Manual técnico
Manuel technique
Teknik manuel
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en • English ................................................................................................................................................................. 2
de • Deutsch ................................................................................................................................................................ 28
es • Español ................................................................................................................................................................. 54
fr • Français ............................................................................................................................................................... 81
tr • Türkçe .................................................................................................................................................................. 109
401314--G
en • English
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Precautionary Measures while Programming . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pacing and Sensing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
MRI Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Preset Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Electrical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Battery Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Legend for the Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Table of Contents
1 Product Description
Intended Medical Use
Intended use
Etrinsa is a family of implantable pacemakers that may be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of
improving patients' symptoms that can be clinically manifested. The implantation of
the pacemaker is a symptomatic therapy with the following objective:
•
Compensation of bradycardia by atrial, ventricular, or AV sequential pacing
•
Additional triple-chamber features: Resynchronization of ventricular chamber
contraction via biventricular pacing
Diagnosis and therapy forms
The cardiac rhythm is automatically monitored and bradycardia arrhythmias are
treated. All major therapeutic approaches from the field of cardiology and electrophysiology are unified in this pacemaker family. 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 of a device system.
•
Only qualified medical specialists having the special knowledge required for the
proper use of implanted devices are permitted to use them.
•
If users do not possess this knowledge, they must be trained accordingly.
Indications
Guidelines of cardiological societies
Generally approved differential diagnostic methods, indications, and recommendations
for pacemaker therapy apply to BIOTRONIK devices.
The guidelines provided by cardiology associations offer decisive information:
•
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.
2
Device types
For the following symptoms/expectations, the following device types are indicated:
Symptom/expectation SR DR HF
Disorientation due to bradycardia x x x
Presyncope x x x
Benefit from resynchronization of the right and
left ventricles
Syncope x x x
Pacing modes
For the following symptomatic, the following pacing modes are indicated:
Symptom/expectation Pacing mode
Sick sinus syndrome Dual-chamber pacing
Chronic, symptomatic second and third-degree AV block Dual-chamber pacing
Adams-Stokes syndrome Dual-chamber pacing
Symptomatic bilateral bundle branch block when tachy-
arrhythmia and other causes have been ruled out
•
Chronotropic incompetence
•
Benefit from increased pacing rate with physical
activity
Sinus node dysfunction in the presence of normal AV and
intraventricular conduction
Bradycardia in conjunction with the following:
•
Normal sinus rhythms with only rare episodes of
AV block or sinus arrest
•
Chronic atrial fibrillation
•
Severe physical disability
MR conditional
ProMRI® labeled MRI conditional pacemakers are safe for use in the MRI environment
when used in conjunction with a complete MRI conditional pacing system and according
to the instructions given in the ProMRI® manual.
en • English
Dual-chamber pacing
R mode or CLS
Atrial pacing
Ventricular pacing
x
Contraindications
Guidelines
No contraindications are known for the implantation of multifunctional singlechamber, dual-chamber or triple-chamber devices, provided differential diagnostics
precedes implantation according to the appropriate guidelines and no modes or
parameter combinations are configured that pose a risk to the patient.
Pacing modes and parameters
The compatibility and effectiveness of parameter combinations must be checked and,
as the case may be, adapted after programming.
Set of facts Contraindicated pacing mode
Additionally implanted ICD Unipolar pacing
Set of facts Inappropriate pacing mode
Chronic atrial tachycardia, chronic atrial
fibrillation or flutter
Poor tolerance of pacing rates above the
basic rate, e.g., angina pectoris
AV conduction disorder Atrial single-chamber pacing
Failing AV conduction
Set of facts Adapt parameters
Slow retrograde conduction after ventricular pacing: Risk of pacemaker-mediated
tachycardia
Poor tolerance of pacing rates above the
basic rate, e.g., angina pectoris
Atrial-controlled modes (DDD, VDD, AAI)
•
Extend atrial refractory period (ARP)
and/or:
•
Shorten AV delay
•
Rarely:
Program to DDI, DVI or VVI
•
Lower atrial upper rate
•
Lower maximum sensor rate
•
Deploy atrial overdrive pacing
3
System Overview
VVIR /AAIR
IS-1
DDDR
A
IS-1
DDDR
A
IS-1
V
LV
RV
Device family
This device family consists of single-chamber, dual-chamber and triple-chamber
devices with or without Home Monitoring. Not all device types are available in every
country.
The following device variants are available:
Device type Variant with
Single-chamber Etrinsa 8 SR-T, Etrinsa 6 SR-T Etrinsa 6 SR
Dual-chamber Etrinsa 8 DR-T, Etrinsa 6 DR-T Etrinsa 6 DR
Triple-chamber Etrinsa 8 HF-T —
Device
The device's housing is made of biocompatible titanium, welded from the outside and
therefore hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral
muscle area. The housing serves as an antipole in the case of unipolar lead configuration.
IS-1 lead connection
The device labeling provides information pertaining to the connection assignment:
SR DR HF
Connector
port
RA IS-1 Unipolar, bipolar Atrium DR, HF
RV IS-1 Unipolar, bipolar Right ventricle SR, DR, HF
LV IS-1 Unipolar, bipolar Left ventricle HF
Lead
connector
Home Monitoring
Variant without
Home Monitoring
Configuration Implantation site Device type
Note:
Use only adapters approved by BIOTRONIK for leads with different connections.
•
If you have any questions concerning the compatibility of other manufacturers'
leads, please contact BIOTRONIK.
Leads
BIOTRONIK leads are sheathed in 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 to
increase the gliding properties of the lead. Leads with steroids reduce inflammatory
processes. The fractal design of the leads allows for low pacing thresholds, high pacing
impedance, and a low risk of oversensing.
BIOTRONIK provides adapters to connect already implanted leads to new devices.
Telemetry
Telemetric communication between the device and the programmer can be carried out
following initialization either by applying the programming head (PGH) to the device or
by using radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this
function SafeSync®.
Programmer
Implantation and follow-up are performed with BIOTRONIK's portable programmer:
There are programmers with integrated or external SafeSync Module for RF telemetry.
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 Standard
SR(-T)
•
VVI-CLS (8 series only)
•
VVIR; V00R; AAIR; A00R
•
VVI; VVT; V00; AAI; AAT; A00
•
OFF
VVIR
4
Device type Modes Standard
DR(-T)
HF-T
Note:
•
VVI-CLS; DDD-CLS (8 series only)
•
DDDR; DDIR; DVIR; D00R
VDDR; VDIR; VVIR; V00R
AAIR; A00R
•
DDD; DDT; DDI; DVI; D00
VDD; VDI; VVI; VVT; V00
AAI; AAT; A00
•
DDD-ADI; DDDR-ADIR
•
OFF
•
DDD-CLS; VVI-CLS
•
DDDR; DDIR; DVIR; D00R
VDDR; VDIR; VVIR; V00R
AAIR; A00R
•
DDD; DDT; DDI; DVI; D00
VDD; VDI; VVI; VVT; V00
AAI; AAT; A00
•
DDD-ADI; DDDR-ADIR
•
OFF
Home Monitoring is possible in all modes.
DDDR
DDDR
NBG codes
AAIR or VVIR is the NBG code for the antibradycardia mode of the single-chamber
device:
A/V Pacing in the atrium or ventricle
A/V Sensing in the atrium or ventricle
I Pulse inhibition in the atrium and ventricle
R Rate adaptation
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
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
BIOTRONIK Home Monitoring
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
•
With Home Monitoring, diagnostic and therapeutic information and 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 patient's 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.
®
en • English
5
Order numbers Etrinsa
The devices can be obtained as follows:
Device type Etrinsa 6 Etrinsa 6
SR 394940 394984 — —
SR-T 394938 394983 394936 394978
DR 394928 394982 — —
DR-T 394933 394981 394931 394977
HF-T — — 394919 394976
Package contents
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
•
Screwdriver
ProMRI
Etrinsa 8 Etrinsa 8
ProMRI
Diagnostic and Therapy Functions
General overview
All the systems have extensive features that allow quick diagnosis and delivery of safe
therapy for bradycardia conditions.
•
Automatic functions make it easy and fast to implant, configure, and check the
pacemaker.
•
Auto-initialization after implantation: The device recognizes the implanted leads
autonomously and sets the polarity. The automatic functions of the software are
activated after 10 min.
Diagnostic functions
•
Data from the last 10 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.
•
Continuous automatic below-threshold impedance measurements are performed
in the device independent of the pacing pulse in order to check the lead for proper
functioning.
•
Once a telemetry connection has been established during a test procedure in
an in-office follow-up, the IEGM is displayed with markers.
Antibradycardia pacing
•
Sensing: The amplitudes of the P and R waves are measured in the implanted
device fully automatically to record varying amplitudes. The sensitivity for the
atrium and ventricle is adapted automatically on an ongoing basis. The measurement data are averaged and the trend can be displayed.
•
Thresholds: atrial as well as ventricular pacing thresholds are automatically determined in the device. Capture control is used to set the pulse amplitudes so that
pacing is performed with the optimum atrial and ventricular amplitude for the
patients with each change of the pacing threshold.
•
Timing: Pacing in the atrium is checked particularly carefully by an automatic
adaptation of the atrial refractory period in order to avoid pacemaker-mediated
tachycardia (Auto PVARP function: the postventricular atrial refractory period is
adapted automatically).
•
Additional, special form of rate adaptation with devices from the 8 series: an
increased cardiac output requirement is detected using physiological impedance
measurement. The measuring principle is based on contractile changes (ionotropy)
of the myocardium (CLS function: Closed Loop Stimulation). Rate adaptation is
automatically initialized and optimized in CLS mode.
•
Ventricular pacing suppression: unnecessary ventricular pacing is avoided by
promoting intrinsic conduction (Vp suppression function). The device can adapt
itsel f to condu ction cha nges. In t he case of intrinsic conduction, the device switches
to a DDD(R)-ADI(R) mode.
6
Resynchronisation therapy
Triple chamber devices have functions to configure different VV delays in order to
resynchronize the ventricles.
•
Capture Control is available for the left ventricle with automated tracking of the
pacing threshold or automatic threshold monitoring (ATM) for trend analysis.
•
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.
•
An additional diagnostic function with biventricular pacing: variability of the heart
rate, the patient activity and the thoracic impedance are monitored on a continual
basis.
Programs
There are two types of therapy programs:
•
Default parameters are offered for the most common indications (Program Consult
function).
•
Individual settings can be saved in 3 individual therapy programs.
Home Monitoring functions
The device automatically sends information to the transmitter once a day. Additionally,
the test messages can be initiated using the programmer. Important medical information includes, among others, the following:
•
Ongoing atrial and ventricular arrhythmia
•
Parameters relevant to leads in the atrium and ventricle: thresholds, sensing
amplitudes, impedances
•
Current statistics on bradycardia therapy
•
Individually adjustable timing interval for device messages which provide additional
information pertaining to the device messages
•
IEGM online HD® with up to 3 high definition channels
•
Transmission of these IEGM recordings along with device messages
2 General Safety Instructions
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 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.
•
Preserve technical manuals for later use.
Care during shipping and storage
•
Devices are not to be stored close to magnets or sources of electromagnetic interference.
•
Note the effects of the storage duration; see Battery Data.
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
•
Permitted for shipping and storage:
–10°C to 45°C
Sterile delivery
The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if
the blister and quality control seal have not been damaged.
Sterile packaging
The device and screwdriver are each packaged in 2 separately sealed blisters. The
inner blister is also sterile on the outside so that it can be transferred in a sterile state
during implantation.
en • English
7
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 not possible 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. In particular it is inevitable that tachyarrhythmias may be induced.
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 sensed. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially with
a unipolar configuration and/or very high sensitivity and, depending on the interference,
may cause inhibition or antiarrhythmia therapy.
Nerve and muscle stimulation
A device system consisting of a unipolar lead and an uncoated device may result in
undesirable pacing of the diaphragm in the case of an initial or permanent high setting
of the pulse amplitude.
Possible technical failures
Technical failure of a device system cannot be entirely ruled out. Possible causes may
include the following:
•
Lead dislodgement
•
Lead fracture
•
Insulation defects
•
Device component failures
•
Battery depletion
Electromagnetic interference (EMI)
Any device can be sensitive to interference, for example, when 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 in patients - if any.
•
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 diagnostic or therapeutic 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 the case of electromagnetic interference or undesired myopotentials, the device
switches to asynchronous pacing for the duration of the time that the interference rate
is exceeded.
Static magnetic fields
The reed switch in the pacemaker starts to close at a field strength of 1.5 mT.
Possible Risks
Procedures to avoid
The following procedures must be avoided as they may cause harm to the patient or
damage the device and, as a result, put the system functionality at risk:
•
Therapeutic ultrasound
•
Transcutaneous electrical nerve stimulation
•
Hyperbaric oxygen therapy
•
Applied pressures higher than normal pressure
Potentially 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 and
the patient placed at risk.
8
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. Influences on the device are not always immediately
clear.
If potentially risky procedures cannot be avoided, the following should be observed at
all times:
•
Electrically insulate patients.
•
Switch the pacemaker function to asynchronous modes if needed.
•
Do not introduce energy near the device system.
•
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 potentially risky therapeutic and diagnostic 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 on the risk/benefit analysis.
en • English
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.
Under certain conditions and when maintaining mandatory measures, magnetic
resonance imaging can be performed to protect 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:
manuals.biotronik.com
—
Order the printed manual at BIOTRONIK.
•
Does approval as "MR-Conditional" apply in your country or region? Ask for current
information at BIOTRONIK.
3 Implantation
Implantation Procedure
Having parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/EEC
are required:
•
Device with screwdriver from BIOTRONIK
•
BIOTRONIK leads and lead introducer set
—
Single-chamber device: unipolar or bipolar lead for the right ventricle
—
Double-chamber device: one unipolar or bipolar lead each for the atrium and
for the right ventricle
—
Triple-chamber device: an additional unipolar or bipolar LV lead
•
Approved connections are IS-1: Use only adapters approved by BIOTRONIK for
leads with different 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.
9
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
W
WARNING
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic parts
could be damaged.
•
Use a replacement device.
•
Return the damaged device to BIOTRONIK.
•
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!
•
Use the gripping tab on the inner plastic container to remove it from the outer
plastic container.
•
Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
Note:
The device is disabled on delivery and can be implanted immediately after
unpacking without manual activation.
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.
Implantation site
In general, the pacemaker is implanted on the right side subcutaneously or subpectorally, depending on the lead configuration as well as the anatomy of the patient.
Overview: Implanting
1 Shape the device pocket and prepare the vein.
2 Implant the leads and perform measurements.
3 Connect device and leads.
The device starts auto-initialization on its own.
4 Insert the device.
5 Guide the fixation suture through the opening in the header and fixate the device
in the prepared device pocket.
6 Close the device pocket.
7 Prior to testing and configuration, wait for the successful completion of
automatic device initialization.
Note:
If necessary, the device can also be programmed before or during auto-initial-
ization.
Avoid damage to the header
Set screws must be tightened or loosened with care.
•
Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control!
•
If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
Preventing short circuits in the header
W
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
•
Close unused connections with IS-1 blind plugs.
10
Keeping distance between leads
W
WARNING
Inadequate therapy
Insufficient lead spacing or inappropriate lead positioning may lead to far field
sensing.
•
Tip and ring electrodes must not have contact with each other.
Connecting the lead connector to the device
1 Disconnect stylets and stylet guides.
2•Connect the unipolar or bipolar IS-1 lead connector ventricle to RV.
•
Connect the unipolar or bipolar IS-1 lead connector atrium to A.
•
Connect the unipolar or bipolar IS-1 lead connector ventricle to LV.
3 Push the lead connector into the header without bending the conductor until the
connector tip becomes visible behind the set screw block.
4 If the lead connector cannot be inserted completely, the set screw may be
protruding into the drill hole of the set screw block. Carefully loosen the set
screw without completely unscrewing it, so that it does not become tilted upon
retightening.
5 Use the screwdriver to perpendicularly pierce through the slitting in the center
of the silicone plug until it reaches the set screw.
6 Turn the set screw clockwise until the torque control starts (you will hear
a clicking sound).
7 Carefully withdraw the screwdriver without retracting the set screw.
•
When the screwdriver is withdrawn, the silicone plug automatically seals the
lead connection safely.
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 le ss than 20 cm and 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 initial ization 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.
Auto-initialization
Auto-initialization begins automatically once the first connected lead is sensed.
Auto-initialization is terminated 10 minutes after connection of the first lead. If no other
program has been transferred in the meantime, the device subsequently works with
active automatic functions in the factory settings or with the preset program of the
user.
Manual setting of the lead polarity or measurement of lead impedances is not necessary.
Note:
After auto-initialization, all parameters are activated as in the factory settings.
Behavior during auto-initialization
•
During transmission of a permanent program:
Auto-initialization is terminated and the transferred program is active.
•
During testing:
Tests cannot be performed during auto-initialization; stop it beforehand.
Auto-initialization will not be continued upon completion of the test.
en • English
11
Precautionary Measures while Programming
Checking the device system
•
After auto-initialization, perform a follow-up to see if the device system is functioning properly.
•
Perform a pacing threshold test to determine the pacing threshold.
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.
Do not interrupt telemetry during a treatment.
Disconnecting the SafeSync Module from the programmer can result in interference
with or termination of the SafeSync wandless telemetry.
•
Do not disconnect the SafeSync Module from the programmer.
•
Do not take the Operation Module off the ICS 3000.
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 PGH: lift the programming head 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.
Manually setting lead polarity
Due to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing) should
only be set if bipolar leads are implanted.
Setting triggered mode
Triggered modes perform pacing regardless of intrinsic cardiac events. To prevent
undersensing due to electromagnetic interference in special cases, a triggered mode
can be displayed.
Setting sensing
Manually set parameters can be unsafe. For example, unsuitable far-field protection
may impede sensing of intrinsic pulses.
•
Use automatic sensitivity control.
Setting the sensitivity
A value set to < 2.5 mV/unipolar for device sensitivity may result in noise caused by
electromagnetic fields.
•
Therefore, it is recommended that a value of ≥ 2.5 mV/unipolar be set according
to paragraph 28.22.1 of the EN 45502-2-1 standard. Setting sensitivity values
< 2.5 mV/unipolar requires explicit clinical need. Values like this can onl y be set and
retained with physician supervision.
Preventing device-induced complications
BIOTRONIK devices are equipped with several functions to prevent device-induced
complications to the greatest extent possible:
•
Measure the retrograde conduction time.
•
If the function is not yet automatically set: activate PMT protection.
•
Set the VA criterion.
Preventing conduction of atrial tachycardia
BIOTRONIK devices are equipped with 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.
12
Phrenic nerve stimulation that cannot be terminated
With LV pacing, chronic phrenic nerve stimulation can in rare cases not be terminated
by reprogramming the available left ventricular pacing configurations or by other
measures.
•
Possibly set a right ventricular mode both in the permanent 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 as well as induction of atrial arrhythmia.
•
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 possible interruption 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 does not allow exclusive LV pacing; consider the consequences
when setting Mode Switching parameters.
If an ICD is implanted at the same time, do not permit unipolar pacing
If an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is possible
to switch to unipolar pacing after resetting the pacemaker or using the automatic lead
check. As a result, the ICD could falsely inhibit or trigger tachyarrhythmia therapy
activity.
•
Unipolar leads are not permitted in this configuration.
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.
Consider power consumption and service time
The pacemaker permits programming of high pulse amplitudes with long pulse widths
at high rates to be able to adequately treat even rare diagnoses. In combination with
low lead impedance, this results in a very high level of power consumption.
•
When programming large parameter values, take into account that the battery
depletion indicator ERI will be reached very early because the service time of the
battery may be reduced to less than 1 year.
•
Home Monitoring ON reduces the service time by 3 months approximately.
en • English
RF telemetry requires somewhat more power: More frequent use of RF telemetry than
assumed during service time calculation (20 min per year) reduces the service time by
about 7 days for the SR(-T), 6 days for the DR(-T), and 5 days for the HF-T device.
•
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
Programming head application
When the programming head is applied, time remains for device interrogation before
the device switches back to the previously set permanent therapy mode. The same
applies to programming head application to establish RF telemetry contact.
Magnet response in standard program
Applying a magnet or the programming head can result in an unphysiological rhythm
change and asynchronous pacing. The magnet response is set as follows in the
standard program of BIOTRONIK pacemakers:
•
Asynchronous:
For the duration of the magnet application – mode D00 (possibly V00 / A00) without
rate adaptation;
Magnet rate: 90 bpm
•
Automatic:
For 10 cycles – mode D00, subsequently mode DDD without rate adaptation;
Magnet rate: 10 cycles with 90 bpm, subsequently set basic rate
•
Synchronous:
Mode DDD (where applicable: VVI) without rate adaptation;
Magnet rate: set basic rate
Note:
See also the replacement indication information.
13
Magnet response with ERI
After reaching ERI, pacing is performed as follows after applying the magnet or
programming head:
Magnet
response
Automatic Asynchronous with 80 bpm Synchronous with basic rate
Asynchronous Asynchronous with 80 bpm Asynchronous with 80 bpm
Synchronous Synchronous with basic rate
Magnet application by patients
If patients are performing their own magnet application, the synchronous magnet
response has to have been programmed. Patients should also know the following:
•
When may the magnet be used?
In cases of severe dizziness and indisposition.
•
How long is the magnet placed on the pacemaker?
1 to 2 s.
•
What happens when the magnet is applied?
The IEGM of the last 10 seconds is stored.
•
What has to happen after magnet application?
The patient has to contact the physician for a follow-up.
Cycles 1 to 10 After 10th cyle
reduced by 4.5 to 11%
reduced by 4.5 to 11%
Synchronous with basic rate
reduced by 4.5 to 11%
Follow-up
Follow-up intervals
Follow-ups must be performed at regular, agreed intervals.
•
Following the lead ingrowth phase, approximately 3 months after implantation,
the first follow-up should be carried out by the physician using the programmer
(in-office follow-up).
•
The next in-office follow-up should be carried out once a year and no later than
12 months after the last in-office follow-up.
Follow-up with BIOTRONIK Home Monitoring®
Monitoring using the Home Monitoring function does not serve to replace regular
in-office appointments with the physician required for other medical reasons.
Follow-up supported by Home Monitoring can be used to functionally replace in-office
follow-up under the following conditions:
•
The patient was informed that the physician must be contacted if symptoms worsen
or if new symptoms arise despite the use of the Home Monitoring function.
•
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
therapy by reprogramming the device.
Follow-up with the programmer
Use the following procedure for in-house follow-up:
1 Record and evaluate the ECG.
2 Interrogate the device.
3 Evaluate the status and automatically measured follow-up data.
4 Check the sensing and pacing functions.
5 Possibly evaluate statistics and IEGM recordings.
6 Manually perform standard tests if necessary.
7 Possibly customize program functions and parameters.
8 Transmit the program permanently to the device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
14
Patient Information
Patient ID card
A patient ID card is included in delivery.
•
Provide the patient with the patient ID card.
•
Request that patients contact the physician in case of uncertainties.
Prohibitive signs
Premises with prohibitive signs must be avoided.
•
Draw the patient's attention to prohibitory signs.
Possible sources of interference
Electromagnetic interference should be avoided in daily activities. Sources of 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 opposite side of their body from 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
The time span from the beginning of service (BOS) to elective replacement indication
(ERI) is determined by, among others, the following:
•
Battery capacity
•
Lead impedance
•
Pacing program
•
Pacing to inhibition ratio
•
Pacemaker circuit properties
en • English
The following are the defined pacemaker operational statuses:
BOS
Beginning of service Battery is in good condition; normal follow-up.
ERI
Elective replacement
indication
EOS
End of service End of service time with regular pacemaker activity
ERI activation
ERI detection is automatically activated after the following events:
•
Successful auto-initialization
•
Storage for longer than 24 months
ERI display
ERI is displayed as follows:
•
On the programmer after interrogation of the pacemaker
•
By a defined decrease in the basic rate as well as the magnet rate
Change of the mode with ERI
This change depends on the mode which is set. It is displayed on the programmer.
•
Single-chamber modes: VVI
•
Double-chamber modes: VDD
•
Triple-chamber modes: Double-chamber pacing, one biventricular setting is kept
Deactivated functions with ERI
The following functions are deactivated:
•
Atrial pacing
•
Night program
•
Rate adaptation
•
Atrial and ventricular capture control
•
Rate fading
•
Atrial overdrive pacing
•
IEGM recordings
•
Statistics
•
Home Monitoring
•
Rate hysteresis
•
Ventricular pacing suppression
The replacement time has been reached. The
pacemaker must be replaced.
15
Rate decrease
The decrease of basic rate and magnet rate is defined as follows:
•
In the following modes, the pacing rate decreases by 11%:
DDD(R); DDT(R); D00(R); VDD(R); VDI(R); VVI(R); VVT(R); AAI(R); AAT(R); A00(R)
•
In the modes DDI(R) and DVI(R), only the VA interval is extended by 11%. This
reduces the pacing rate by 4.5 to 11%, depending on the configured AV delay.
Expected service time after ERI
•
The information is based on a lead impedance of 500 Ω at 100% pacing and the data
of the battery manufacturer.
•
Parameter with high pacing energy:
110 bpm; 4.6 V; 1.5 ms; 500 Ω
•
Parameters with low pacing energy:
30 bpm; 0.2 V; 0.1 ms; 500 Ω
•
Interval between ERI and EOS for the single-chamber device in AAI(R)/VVI(R) mode,
for the double and triple chamber device in DDD(R) mode, in standard program and
with both high and low pacing energy:
—
Mean value: 8 months
—
Minimum value: 6 months
Explantation and Device Replacement
Explantation
•
Disconnect the leads from the header.
•
Remove the device and, if necessary, leads using state-of-the-art technology.
•
Explants are biologically contaminated and must be disposed of safely due to risk of
infection.
Device replacement
The following applies to leads from a previous device that are intended for further use:
•
Check the leads prior to connecting to the new device.
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.
•
Insulate connections that are not used.
Basic principles:
•
The device must not be resterilized and reused.
Cremation
Devices should not be cremated.
•
Explant the device before the cremation of a deceased patient.
Disposal
BIOTRONIK takes back used products for the purpose of environmentally safe disposal.
•
Clean the explant with a solution of at least 1% sodium hypochlorite.
•
Rinse with water.
•
Fill out explantation form and send to BIOTRONIK together with the cleaned device.
4 Parameters
Timing
Basic rate day/night
Parameter Range of values Standard SR DR HF
Basic rate 30 ... (5) ... 100 ... (10)
Night rate OFF; 30 ... (5) ... 100 ... (10)
Night begins 00:00 ... (10 min) ... 11:50
Night ends 00:00 ... (10 min) ... 11:50
Rate hysteresises
Parameter Range of values Standard SR DR HF
Hysteresis OFF;
Repetitive / search
cycles
... 200 bpm
... 190 bpm
PM hh:mm
PM hh:mm
-5 ... (-5) ... -25 ... (-20)
... -65 bpm
OFF; ON OFF x x x
60 bpm x x
50 bpm x
OFF xxx
22:00 hh:mmxxx
06:00 hh:mmxxx
OFF xxx
16
AV delay
Parameter Range of values Standard SR DR HF
AV delay Low; Medium; High; Fixed;
Sense compensation OFF; -10 ... (-5) ... -120 ms -45 ms x x
AV safety interval 100 ms 100 ms x x
AV hystereses
Parameter Range of values Standard SR DR HF
AV hysteresis mode OFF; Positive; Negative
Positive modes:
AV hysteresis
Negative modes:
AV hysteresis
AV repetetive / scan
cyles
Ventricular pacing
Parameter Range of values Standard SR DR HF
Ventricular pacing BiV; RV; LV BiV x
Triggering OFF; RVs; RVs + PVC RVs x
LV T-wave protection ON; OFF ON x
Maximum trigger rate AUTO; 90 ... (10) ... 160 bpm AUTO x
Initially paced
chamber
Individual
20 ... (5) ... 350 ms
(in 6 rate ranges)
HF in RV modes: IRSplus
70; 110; 150; 200 ms 70 ms
10 ... (10) ... 150 ms 50 ms x x
ON; OFF ON x x
RV; LV LV x
Low x x
180-170-160150-140 ms
150-140-130120 ms
OFF x x
CLS modes:
110 ms
x
xx
Parameter Range of values Standard SR DR HF
VV delay after Vp 0 ... (5) ... 80 ... (10) ... 100 ms 0 ms x
VV delay after sense 0 ms 0 ms x
Upper rate
Parameter Range of values Standard SR DR HF
x
Upper rate
SR: in VVT mode
Wenckebach response Automatically set — x x
Atrial upper rate OFF;
Mode switching
Parameter Range of values Standard SR DR HF
Mode switching OFF; ON ON x x
Intervention rate 100 ... (10) ... 250 bpm 160 bpm x x
Switch to (mode) DDI; DDI(R) when
Ventricular pacing RV; BiV BiV x
Onset criterion 3 ... (1) ... 8 5 x x
Resolution criterion 3 ... (1) ... 8 5 x x
Change of the basic rate
with mode switching
Rate stabilization with
mode switching
2:1 lock-in protection OFF; ON DR: ON
90 ... (10) ... 200 bpm 130 bpm x x x
175; 200; 240 bpm
permanent DDD(R)
VDI; VDI(R) when
permanent VDD(R)
OFF; +5 ... (5) ... +30 bpm +10 bpm x x
OFF; ON OFF x x
240 bpm x x
DDI(R)
VDI(R)
HF: only
when RV
modes ON
xx
xx
en • English
17
Ventricular pacing suppression
Parameters valid for devices in DDD-ADI or DDDR-ADIR modes:
Parameter Range of values Standard SR DR HF
Vp suppression ON; OFF OFF x x
Pacing suppression after
consecutive Vs
Pacing supported after X-out-
of-8 cycles
Refractory periods
Parameter Range of values Standard SR DR HF
Refractory period 200 ... (25) ... 500 ms 250 ms x
Atrial refractory
period
Atrial refractory
period in the modes
AAI(R); AAT(R); DDT
AUTO PVARP ON; OFF ON x x
PVARP Auto PVARP OFF:
PVARP after PVC PVARP + 150 ms
Right ventricular
refractory period
Left ventricular
refractory period
1 ... (1) ... 8 6 x x
1; 2; 3; 4 3 x x
AUTO AUTO x x
300 ... (25) ... 775 ms 350 ms x x
175 ... (25) ... 600 ms
(max: 600 ms) is automatically programmed
200 ... (25) ... 500 ms 250 ms x x
200 ms 200 ms x
Auto PVARP ON:
Automatically set
400 ms x x
xx
Blanking periods
Parameter Range of values Standard SR DR HF
Far-field protection
after Vs
Far-field protection
after Vp
Ventricular blanking
period after Ap
PMT protection
Parameter Range of values Standard SR DR HF
PMT protection OFF; ON ON x x
VA criterion 250 ... (25) ... 500 ms 350 ms x x
100 ... (10) ... 220 ms 100 ms x x
100 ... (10) ... 220 ms 150 ms x x
30 ... (5) ... 70 ms 30 ms x x
Pacing and Sensing
Pulse amplitude and pulse width
Parameter Range of values Standard SR DR HF
Pulse amplitude
A/RV/LV
Pulse width A/RV/LV 0,1 ...(0,1) ... 0.5 ... (0.25)
Sensitivity
Parameter Range of values Standard SR DR HF
Sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x
Sensitivity A AUTO; 0.1 ... (0.1) ... 1.5 ... (0.5)
RV sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x x
LV sensitivity OFF; AUTO; 0.5 ... (0.5) ...
0.2 ... (0.2) ... 6.0 ... (0.5)
... 7.5 V
... 1.5 ms
... 7.5 mV
7.5 mV
3.0 V xxx
0.4 ms xxx
AUTO x x
AUTO x
18
Atrial capture control
Parameter Range of values Standard SR DR HF
Atrial capture control ATM (monitoring only); ON;
Minimum amplitude 0.5 ... (0.1) ... 4.8 V 1.0 V x x
Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x x
Safety margin 0.5 ... (0.1) ... 1.2 V 1.0 V x x
Search type Interval; time of day Time of day x x
Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x x
Time of day 00:00 ... (10 min) ... 23:50
Ventricular capture control
Parameter Range of values Standard SR DR HF
Ventricular capture
control RV, LV
Minimum amplitude 0.7 V 0.7 V x x
Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x x
RV safety margin 0.3 ... (0.1) ... 1.2 V 0.5 V x x
LV safety margin 1.0; 1.2 V 1.0 V x
Search type Interval; time of day Time of day x x
Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x x
Time of day 00:00 ... (00:10)
OFF
hh:mm
ATM (monitoring only); ON;
OFF
... 23:50 hh:mm
ON x x
02:00 AM
hh:mm
ON x x
00:30 hh:mm x x
xx
Atrial overdrive pacing
Parameter Range of values Standard SR DR HF
Atrial overdrive pacing ON; OFF
Lead configuration
Parameter Range of values Standard SR DR HF
Sensing polarity A Unipolar, Bipolar Unipolar x x
Sensing polarity RV Unipolar, Bipolar Unipolar x x x
Sensing polarity LV Unipolar, Bipolar Unipolar x
Pacing polarity A Unipolar, Bipolar Unipolar x x
Pacing polarity RV Unipolar, Bipolar Unipolar x x x
Pacing polarity LV LV tip -> LV ring
With ON: maximum overpacing rate 120 bpm, mean
rate increase approximately
8 bpm, rate decrease after
20 cycles
LV tip -> RV ring
LV ring -> LV tip
LV ring -> RV ring
LV tip -> housing
LV ring -> housing
OFF x x
LV tip –>
housing
x
en • English
19
IEGM recordings
Parameter Range of values Standard SR DR HF
IEGM recordings 6 series:
Types of
IEGM recordings
Pre-trigger recording 0; 25; 50; 75; 100% 75% x x x
IEGM signal Filtered; Unfiltered Filtered x x x
Rates for statistics
Parameter Range of values Standard SR DR HF
High atrial rate:
HAR limit
High ventricular rate:
HVR limit
HVR counter 4; 8; 12; 16 cycles 8 cycles x x x
Start resting period 00:00 ... (00:10) ...
Duration of resting
period
Enable lead check ON; OFF ON x x x
12 (quantity); each max. 10 s
8 series:
20 (quantity); each max. 10 s
High atrial rate (HAR) HAR x x x
Mode switching x x x
High ventricular rate (HVR) ON x x x
8 series:
Patient triggering (triggered
by patient)
100 ... (5) ... 250 bpm 200 bpm x x
150 ... (5) ... 200 bpm 180 bpm x x x
23:50 hh:mm
00:30 ... (00:30) ... 12:00
hh:mm
—xxx
OFF x x x
02:00 hh:mm x x x
04:00 hh:mm x x x
Rate Adaptation
CLS modes: closed loop stimulation
Parameters valid for 8 series devices:
Parameter Range of values Standard SR DR HF
Maximum CLS rate 80 ... (5) ... 160 bpm 120 bpm x x x
CLS response Very low; Low; Medium; High;
CLS resting rate
control
Vp required Yes; No No
R modes: Accelerometer
Parameter Range of values Standard SR DR HF
Sensor gain AUTO; Very low; Low;
Max. sensor rate 80 ... (5) ... 180 bpm 120 bpm x x x
Sensor threshold Very low; Low; Medium; High;
Rate fading OFF; ON OFF x x x
Rate increase 1; 2; 4; 8 bpm/cycle 2 bpm/cycle x x x
Rate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle 0.5 bpm/
Very high
OFF; +10 ... (10) ... +50 bpm +20 bpm x x x
Medium; High; Very high
Very high
Medium xxx
BiV modes:
Yes
AUTO xxx
Medium xxx
cycle
xxx
xxx
20
MRI Program
MRI modes
Modes valid for devices marked ProMRI
Mode Range of values Standard SR DR HF
MRI Program ON; OFF OFF x x x
MRI mode OFF; A00; V00 — x
MRI parameters
Preset parameters in the MRI program:
Parameter Range of values Standard SR DR HF
Basic rate 70 ... (10) ... 160 bpm — x x x
AV delay 110 ms — x x
Pulse amplitude A/RV 4.8 V — x x x
Pulse width A/RV 1.0 ms
Pulse amplitude LV As in permanent program — x
Pulse width LV
VV delay 0 ms — x
OFF; D00; A00; V00 — x
OFF; D00; A00; V00;
D00-BiV; V00-BiV
—x
Preset Programs
Standard and safe program
Mode after auto-initialization:
Parameter Factory
Mode VVI VVIR VVI
Mode DDD DDDR VVI x x
settings
Standard
program
Safe program SR DR HF
In the AAI mode, the safe
program is also AAI.
x
Lead configuration, determined and set immediately after connection (auto lead check)
Parameter Factory
Pacing polarity A/RV Unipolar Unipolar Unipolar x x x
Pacing polarity LV TCUP TCUP TCUP x
Sensing polarity A/RV Unipolar Unipolar Unipolar x x x
Sensing polarity LV Unipolar Unipolar Unipolar x
Automatic lead check ON ON — x x x
Parameters after auto-initialization:
Parameter Factory
Basic rate 60 bpm 60 bpm 70 bpm x x
Night program OFF OFF OFF x x x
Rate hysteresis OFF OFF OFF x x x
Upper rate 130 bpm 130 bpm — x x
Dynamic AV delay Low Low — x x
AV hysteresis OFF OFF — x x
Sense compensation -45 ms -45 ms — x x
AV safety delay 100 ms 100 ms — x x
VV delay 000 x
LV T-wave protection ON ON ON x
Far-field protection after Vs 100 ms 100 ms — x x
Far-field protection after Vp 150 ms 150 ms — x x
Ventricular blanking period
after Ap
PMT protection ON ON — x x
VA criterion 350 ms 350 ms — x x
Magnet response AUTO AUTO AUTO x x x
Standard
Safe
settings
program
Standard
settings
program
50 bpm x
30 ms 30 ms — x x
program
Safe
program
SR DR HF
SR DR HF
en • English
21
Parameter Factory
Pulse amplitude A 3.0 V 3.0 V — x x
Pulse amplitude RV 3.0 V3.0 V4.8 Vxxx
Pulse amplitude LV 3.0 V 3.0 V 4.8 V x
Pulse width A 0.4 ms 0.4 ms — x x
Pulse width RV 0.4 ms 0.4 ms 1.0 ms x x x
Pulse width LV 0.4 ms 0.4 ms 1.0 ms x
Sensitivity A AUTO AUTO — x x
Sensitivity RV AUTO AUTO 2.5 mV x x x
Sensitivity LV AUTO AUTO 2.5 mV x
Refractory period A AUTO AUTO — x x
Refractory period RV 250 ms 250 ms 300 ms x x x
Refractory period LV 200 ms 200 ms 200 ms x
Mode switching ON ON — x x
Onset criterion 5-out-of 8 5-out-of 8 — x x
Resolution criterion 5-out-of 8 5-out-of 8 — x x
Intervention rate 160 bpm 160 bpm — x x
Switches to DDIR DDIR — x x
The basic rate with
mode switching
Rate stabilization with
mode switching
PVARP AUTO (Start
PVARP after PVC 400 ms 400 ms — x x
Capture control A ON ON OFF x x x
Capture control RV ON ON OFF x x
Capture control LV ON ON OFF x
Atrial overdrive pacing OFF OFF — x x
Standard
Safe
settings
program
+10 bpm +10 bpm — x x
OFF OFF — x x
AUTO (Start
250 ms)
250 ms)
SR DR HF
program
—xx
Tolerances of Parameter Values
22
Parameter Factory
Vp suppression OFF OFF — x
IEGM recording (HAR, HVR) ON ON OFF x x x
Home Monitoring OFF OFF OFF x x x
Parameter Range of values Tolerance
Basic rate 30 ... (5) ... 100 ... (10)
Basic interval 1000 ms ± 20 ms
Magnet rate (magnet interval) 90 bpm (664 ms) ± 20 ms
Pulse amplitude 0.2 ... 7.5 V The greater value of ±50 mV
Pulse width 0.1 ... 0.4 ms ± 0.04 ms
Sensitivity A
EN 45502-2-1 triangle pulse
RV/LV sensitivity
EN 45502-2-1 triangle pulse
Refractory period 200 ... 500 ms + 10/-30 ms
Maximum activity rate 80 ... 180 bpm ± 20 ms
Lead impedance 100 ... 200 Ω ±50 Ω
Standard
settings
program
... 200 bpm
0.5 ... 1.0 ms ± 0.10 ms
1.25 ... 1.5 ms ± 0.15 ms
0.1 ... 0.2 mV ±0,05 mV
0.3 ... 7.5 mV ±20%
0.5 ... 7.5 mV ±50%
201 ... 2500 Ω ±25%
Safe
program
± 20 ms
or +20/-25%
SR DR HF
5 Technical Data
Mechanical Characteristics
Measurements for the housing
Device W x H x D [mm]
Single-chamber SR(-T) 53 x 39 x 6.5 11 24
Dual-chamber DR(-T) 53 x 44.5 x 6.5 12 25
Triple-chamber HF-T 53 x 49 x 6.5 14 27
Note:
D = housing without header
X-ray identification
BIO SF
Materials in contact with body tissue
•
Housing: titanium
•
Header: epoxy resin
•
Plugs in the header: silicone
Volume [cm3]
Electrical Characteristics
Electrically conductive surface
The device housing has the form of a flattened ellipsoid. The electrically conductive
area is 33 cm2.
Components and input values
Electrical characteristics determined at 37°C, 500 Ω:
Circuit Hybrid electronics with VLSI-CMOS chip
Input impedance > 10 kΩ
Pulse form Biphasic, asymmetric
Polarity Cathodic
en • English
Mass [g]
Telemetry data
•
MISC frequencies: 402 to 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-PRIMUSNXT
The code IC in front of the certification/registration number only indicates that the
technical requirements for Industry Canada are met.
•
Telemetry information 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-LSB053
•
Telemetry information for the USA:
Telemetry data for the USA: This transmitter is authorized by rule under the
Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must
not cause harmful interference to stations operating in the 400.150-406.000 MHz
band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite
Services and must accept interference that may be caused by such stations,
including interference that may cause undesired 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: QRIPRIMUSNXT
23
Pulse form
The pacing pulse has the following form:
The pulse amplitude reaches its maximum value
at the beginning of the pulse (Ua). With
increasing pacing duration (tb), the pulse
amplitude is reduced dependent on the pacing
impedance.
Resistance to interference
All variants of BIOTRONIK devices comply with the requirements of prEN 45502-2-1:
2006, § 27.5.1 at the highest sensitivity.
Battery Data
Battery characteristics
The following data is provided by the manufacturers:
Manufacturer LITRONIK GmbH, 01796 Pirna, Germany
Battery type LiS 3150M
System LiMn0
Device type SR(-T); DR(-T); HF-T
Battery voltage at BOS 3.1 V
Open-circuit voltage 3.1 V
Nominal capacity 1.2 Ah
Remaining capacity at ERI 0.2 Ah
Usable capacity until EOS 1.0 Ah
Shortening of the service time after long storage period
Depending on the storage period, the service time from the beginning of service BOS to
the replacement time ERI decreases as follows:
•
After 1 year by three months
•
After 1.5 years by four months
2
Power consumption
•
BOS, inhibited: SR(-T), DR(-T) 6 µA; HF-T: 7 µA
•
BOS, 100% pacing: SR(-T) 9 µA; DR(-T) 14 µA; HF-T: 18 µA
Calculation of service times
Mean service times are valid for devices with and without Home Monitoring; they are
pre-estimated from the following and other data:
•
Technical data of the battery manufacturer:
•
Basic rate of 60 bpm in AAIR/VVIR modes (single-chamber devices) or DDDR modes
(dual-chamber and triple-chamber devices)
•
Home Monitoring configuration: OFF
•
With 10-minute RF telemetry twice a year as well as without RF telemetry
•
Configuration of different pulse amplitudes and lead impedances
Mean service times SR(-T)
For single-chamber devices, the following times (in years) result:
Using RF telemetry:
Amplitude Impedance [Ω] Pacing
1.5 V 500 14.7 14.4 13.8
1000 14.9 14.8 14.4
2.5 V 500 14.1 13.5 11.8
1000 14.5 14.2 13.1
3.0 V 500 13.5 13.1 10.8
1000 14.2 13.6 12.4
3.5 V 500 13.1 12.8 10.1
1000 13.9 13.3 11.8
5.0 V 500 10.4 8.7 6.2
1000 12.1 10.8 8.3
10 % 50 % 100 %
24
Without using RF telemetry:
Amplitude Impedance [Ω] Pacing
10 % 50 % 100 %
1.5 V 500 >15 >15 >15
1000 >15 >15 >15
2.5 V 500 >15 >15 13.3
1000 >15 >15 >15
3.0 V 500 >15 14.2 11.2
1000 >15 >15 14.1
3.5 V 500 14.9 12.9 10.1
1000 >15 >15 12.9
5.0 V 500 11.3 9.1 6.2
1000 14.5 12.5 9.4
Mean service times DR(-T)
For dual-chamber devices, the following times (in years) result:
Using RF telemetry:
Amplitude Impedance [Ω] Pacing
10 % 50 % 100 %
1.5 V 500 12.7 12.3 11.4
1000 12.9 12.8 12.2
2.5 V 500 11.8 11.0 8.9
1000 12.4 11.9 10.4
3.0 V 500 11.0 9.9 7.9
1000 11.9 11.2 9.7
3.5 V 500 10.5 9.3 7.1
1000 11.6 10.7 8.9
5.0 V 500 7.5 5.8 3.8
1000 9.3 7.8 5.5
Without using RF telemetry:
Amplitude Impedance [Ω] Pacing
1.5 V 500 >15 14.8 13.0
2.5 V 500 13.6 12.1 9.4
3.0 V 500 12.1 10.2 7.9
3.5 V 500 11.1 9.3 7.1
5.0 V 500 7.8 5.8 3.8
Mean service times HF-T
For triple-chamber devices, the following times (in years) result:
Using RF telemetry:
Pulse width: 0.4 ms
Amplitude:
A: 2.5 V
RV: 2.5 V
LV: 3.5 V
A: 2.5 V
RV: 2.5 V
LV: 2.5 V
1000 >15 >15 14.7
1000 >15 14.1 12.0
1000 14.2 12.7 10.1
1000 13.4 11.7 8.9
1000 10.7 8.7 5.9
Pacing Impedance:
atrial + biventric-
ular 100%
0% 7.8 8.4 9.3
30 % 7.5 8.1 9.1
50 % 7.3 7.9 8.9
100 % 6.9 7.5 8.6
0% 8.9 9.4 10.3
30 % 8.6 9.0 9.9
50 % 8.3 8.8 9.8
100 % 7.8 8.2 9.3
10 % 50 % 100 %
A+RV+LV:
500 Ω
A+RV: 500 Ω
LV: 800 Ω
A+RV+LV:
1000 Ω
en • English
25
Pulse width: 0.4 ms
Amplitude:
A: 3.5 V
RV: 3.5 V
LV: 5 V
A: 2.0 V
RV: 2.2 V
LV: 2.4 V
A: 3.0 V
RV: 3.0 V
LV: 3.0 V
Without using RF telemetry:
Pulse width: 0.4 ms
Amplitude:
A: 2.0 V
RV: 2.2 V
LV: 2.4 V
A: 2.5 V
RV: 2.5 V
LV: 2.5 V
Pacing Impedance:
atrial + biventric-
ular 100%
0% 4.8 5.7 6.6
30 % 4.6 5.3 6.3
50 % 4.5 5.2 6.2
100 % 4.2 4.8 5.8
0% 9.1 9.5 10.3
30 % 8.8 9.2 10.0
50 % 8.6 8.9 9.9
100 % 8.1 8.4 9.6
0% 7.6 8.1 9.2
30 % 7.2 7.6 8.8
50 % 6.9 7.3 8.6
100 % 6.3 6.7 8.1
Pacing Impedance:
atrial + biventric-
ular 100%
0% 10.6 11.1 12.2
30 % 10.2 10.8 11.9
50 % 9.9 10.4 11.8
100 % 9.4 9.8 11.3
0% 10.3 10.8 12.0
30 % 9.8 10.4 11.7
50 % 9.6 10.1 11.4
100 % 9.0 9.4 10.9
A+RV+LV:
500 Ω
A+RV+LV:
500 Ω
A+RV: 500 Ω
LV: 800 Ω
A+RV: 500 Ω
LV: 800 Ω
A+RV+LV:
1000 Ω
A+RV+LV:
1000 Ω
Pulse width: 0.4 ms
Amplitude:
A: 2.5 V
RV: 2.5 V
LV: 3.5 V
A: 3.0 V
RV: 3.0 V
LV: 3.0 V
A: 3.5 V
RV: 3.5 V
LV: 5 V
26
Pacing Impedance:
atrial + biventric-
ular 100%
0% 8.8 9.8 10.8
30 % 8.5 9.3 10.6
50 % 8.3 9.1 10.4
100 % 7.8 8.6 10.0
0% 8.8 9.4 10.8
30 % 8.3 8.8 10.3
50 % 7.9 8.5 10.1
100 % 7.3 7.8 9.5
0% 5.3 6.4 7.7
30 % 5.1 6.1 7.3
50 % 4.9 5.8 7.2
100 % 4.6 5.3 6.8
A+RV+LV:
500 Ω
A+RV: 500 Ω
LV: 800 Ω
A+RV+LV:
1000 Ω
Legend for the Label
NON
STERILE
Meaning of the symbols
Manufacturing date Use by
Storage temperature Order number
Serial number Product identification
European approval mark
Contents Consult the instructions for
Sterilized with ethylene oxide
Do not resterilize Single use only.
Do not use if packaging is
damaged
number
use
Do not reuse!
Non-sterile
Transmitter with non-ionizing radiation at
designated frequency
Label icon on devices with ProMRI®:
TP2
Compatibility with telemetry protocol version 2
of BIOTRONIK Home Monitoring
MR conditional: Patients having a device
system implanted whose components are
labeled with this symbol on the packaging
can be examined using an MR scan under
precisely defined conditions.
Uncoated device: NBG code and
compatible leads
Example
Coated device: NBG code and compatible
leads
Example
Screwdriver
Header
Example
Bipolar IS-1 connector
Unipolar IS-1 connector
en • English
27
de • Deutsch
Produktbeschreibung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Medizinische Zweckbestimmung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Indikationen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Kontraindikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Systemübersicht . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Diagnostik- und Therapiefunktionen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Allgemeine Sicherheitshinweise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Betriebsbedingungen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Mögliche Komplikationen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Mögliche Risiken. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Implantationsablauf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Vorsichtsmaßnahmen beim Programmieren . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Magnetverhalten . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Nachsorgen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Patientenaufklärung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Austauschindikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Explantation und Implantatwechsel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Zeitsteuerung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Stimulation und Wahrnehmung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Frequenzadaption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
MRT-Programm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Voreingestellte Programme. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Toleranzen der Parameterwerte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Technische Daten . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Mechanische Kenndaten . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Elektrische Kenndaten . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Batteriedaten. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Legende zum Etikett. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Inhaltsverzeichnis
1 Produktbeschreibung
Medizinische Zweckbestimmung
Bestimmungsgemäße Anwendung
Etrinsa ist der Name einer Familie von implantierbaren Herzschrittmachern, die bei
allen Indikationen von bradykarden Herzrhythmusstörungen implantiert werden
können. Primäres Ziel der Therapie ist die Verbesserung klinisch manifestierbarer
Symptome der Patienten. Die Implantation des Schrittmachers ist eine symptomatische Therapie mit folgendem Ziel:
•
Kompensation von Bradykardien durch atriale, ventrikuläre oder AV-sequenzielle
Stimulation
•
Bei 3-Kammer-Implantaten zusätzlich: Resynchronisation der ventrikulären
Kammerkontraktion durch biventrikuläre Stimulation
Diagnose- und Therapieformen
Der Herzrhythmus wird automatisch überwacht und bradykarde Rhythmusstörungen
werden behandelt. Alle wesentlichen Therapieansätze aus Kardiologie und Elektrophysiologie sind in dieser Implantatfamilie vereint. BIOTRONIK Home Monitoring®
ermöglicht Ärzten ein Therapiemanagement rund um die Uhr.
Vorausgesetzte Fachkenntnisse
Außer den medizinischen Grundlagen sind detaillierte Kenntnisse über die Funktionsweise und die Einsatzbedingungen eines Implantatsystems erforderlich.
•
Nur medizinische Fachkräfte mit diesen besonderen Kenntnissen können Implantate bestimmungsgemäß anwenden.
•
Wenn diese Kenntnisse nicht vorhanden sind, müssen die Anwender geschult
werden.
Indikationen
Leitlinien kardiologischer Gesellschaften
Für aktive Implantate von BIOTRONIK gelten die allgemein anerkannten Methoden der
Differentialdiagnostik, die Indikationen sowie die Empfehlungen für die Herzschrittmachertherapie.
Maßgebliche Orientierung bieten die Leitlinien der Kardiologieverbände:
28
•
Wir empfehlen, die von der Deutschen Gesellschaft für Kardiologie, Herz- und
Kreislaufforschung (DGK) und der European Society of Cardiology (ESC) veröffentlichten Indikationen zu beachten.
•
Desgleichen die der Heart Rhythm Society (HRS), des American College of Cardiology (ACC), der American Heart Association (AHA) sowie die anderer nationaler
Kardiologieverbände.
Implantattypen
Für folgende Symptomatik/Erwartung sind folgende Implantattypen indiziert:
Symptomatik/Erwartung SR DR HF
Desorientiertheit wegen Bradykardie x x x
Präsynkope x x x
Vorteil aus der Resynchronisation des rechten und
linken Ventrikels
Synkope x x x
Stimulationsarten
Für folgende Symptomatik sind folgende Stimulationsarten indiziert:
Symptomatik/Erwartung Stimulationsarten
Sick-Sinus-Syndrom 2-Kammer-Stimulation
AV-Block II. oder III. Grades; chronischer, symptoma-
tischer
Adams-Stokes-Syndrom 2-Kammer-Stimulation
Schenkelblock; symptomatischer bifaszikulärer, wenn
Tachyarrhythmie und andere Ursachen ausgeschlossen
wurden
•
Chronotrope Inkompetenz
•
Vorteil aus erhöhter Stimulationsfrequenz bei körperlicher Aktivität
Sinusknotenfunktionsstörung bei intakter AV- und intraventrikulärer Überleitung
de • Deutsch
2-Kammer-Stimulation
2-Kammer-Stimulation
Modus R oder CLS
Atriale Stimulation
x
Symptomatik/Erwartung Stimulationsarten
Bradykardie in Kombination mit Folgendem:
•
Normaler Sinusrhythmus mit nur seltenen Episoden
eines AV-Blocks oder Sinusknotenausfalls
•
Chronisches atriales Flimmern
•
Schwere körperliche Behinderung
MR conditional
Ein mit ProMRI® gekennzeichneter MR-conditional-Herzschrittmacher kann in der
MRT-Umgebung bedingt risikofrei verwendet werden, wenn er zusammen mit einem
vollständigen MR-conditional-Implantatsystem und in Übereinstimmung mit den
Anweisungen in dem MRT-Handbuch eingesetzt wird.
Ventrikuläre Stimulation
Kontraindikationen
Leitlinien
Es sind keine Kontraindikationen für die Implantation von multifunktionalen 1-, 2-oder
3-Kammer-Schrittmachern bekannt, vorausgesetzt, der Implantation geht eine Differentialdiagnostik gemäß der einschlägigen Leitlinien voran, und es werden keine den
Patienten gefährdende Modi oder Parameterkombinationen eingestellt.
Stimulationsarten und Parameter
Die Verträglichkeit und Wirksamkeit von Parameterkombinationen muss geprüft und
nach der Programmierung kontrolliert und gegebenenfalls angepasst werden:
Sachverhalt Kontraindizierte Stimulationsart
Zusätzlich implantierter ICD Unipolare Stimulation
Sachverhalt Unzweckmäßige Stimulationsart
Chronische atriale Tachykardien, chronisches atriales Flimmern oder Flattern
Schlechte Toleranz von Stimulationsfrequenzen oberhalb der Grundfrequenz,
beispielsweise bei Angina pectoris
AV-Leitungsstörung Atriale 1-Kammer-Stimulation
Nachlassende AV-Überleitung
Vorhofgesteuerte Modi (DDD, VDD, AAI)
29
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