BIOTRONIK ProMRI Evity 6/8 Technical Manual
Evity 6/8
Pacemaker | Bradyarrhythmia Therapy | Cardiac Resynchronization Therapy
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
Manual técnico
Manuel technique
Teknik Manuel
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en • English
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Medical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Precautionary Measures while Programming . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
en • English
Table of Contents
1 Product Description
Intended Medical Use
Intended use
Evity is a family of implantable pacemakers that can 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.
1
417783--F
Device types
For the following symptoms/expectations, the following device types are indicated:
Symptom/exp ectation SR DR HF
Disorientation due to bradycardia x x x
Presyncope xxx
Benefit from resynchronization of the right and
left ventricles
Syncope xxx
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 c omplete MRI conditional pacing system and according
to the instructions given in the ProMRI® manual.
Dual-chamber pacing
R mode or CLS
Atrial pacing
Ventricular pacing
Contraindications
Guidelines
No contraindications are known for the implantation of multifunctional singlechamber, dual-chamber, or triple-chamber pacemakers, 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.
x
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
2
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
System Overview
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 Evity 6 SR-T, Evity 8 SR-T —
Dual-chamber Evity 6 DR-T, Evity 8 DR-T —
Triple-chamber Evity 8 HF-T, Evity 8 HF-T QP —
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.
Lead connections
BIOTRONIK provides pacemakers with headers for different standardized lead connections:
•
IS-1
•
IS-1/IS4
Note:
•
A device's IS-1 connector port must only be used for connecting leads with
an IS-1 connector that conform to ISO 5841-3.
•
A device's IS4 connector port must only be used for connecting leads with
an IS4 connector that conform to ISO 27186.
Note:
•
Only quadripolar leads must be connected to the IS4 connector on device
type HF QP with IS4.
en • English
Home Monitoring
Suitable leads must comply with the norms:
The device and leads have to match.
Variant without
Home Monitoring
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.
IS-1
The device labeling provides information pertaining to the connection assignment:
SR DR HF
Connector
Lead
port
connector
A/RA IS-1 Unipolar, bipolar Atrium DR, HF
V/RV IS-1 Unipolar, bipolar Right ventricle SR, DR, HF
LV IS-1 Unipolar, bipolar Left ventricle HF
IS-1/IS4
The device labeling provides information pertaining to the connection assignment:
HF QP
Connector
Lead
port
connector
RA IS-1 Unipolar, bipolar Atrium HF QP
RV IS-1 Unipolar, bipolar Right ventricle HF QP
LV IS4 Unipolar, bipolar Left ventricle HF QP
Configuration Implantation site Device type
Configuration Implantation site Device type
3
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 which
is known to increase the gliding properties for 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 wireless wandless telemetry in the programmer.
Programmer
Using the programmer, the pacing thresholds can be determined and all tests can
be performed during implantation and 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
DR
•
VVI-CLS(8 series only)
•
VVIR, V00R, AAIR, A00R
•
VVI, VVT, V00, AAI, AAT, A00
•
OFF
•
VVI-CLS; DDD-CLS(8 series only)
•
DDD-ADI, DDDR-ADIR (6 and 8 series)
•
DDDR, DDIR, DVIR, D00R, VDDR, VDIR
•
VVIR, V00R, AAIR, A00R
•
DDD, DDT, DDI, DVI, D00, VDD, VDI
•
VVI, VVT, V00, AAI, AAT, A00
•
OFF
VVIR
DDDR
Device type Modes Standard
HF (QP)
•
(8 series)
Note:
Home Monitoring is possible in all modes.
The OFF mode only functions temporary, i.e. during a test.
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
VVI-CLS, DDD-CLS
•
DDD-ADI, DDDR-ADIR
•
DDDR, DDIR, DVIR, D00R, VDDR, VDIR
•
VVIR, V00R, AAIR, A00R
•
DDD, DDT, DDI, DVI, D00, VDD, VDI
•
VVI, VVT, V00, AAI, AAT, A00
•
OFF
DDDR
4
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 criteri a
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 with the following message.
•
A test message can be initiated at any time using the programmer to immediately
check the Home Monitoring function.
Order numbers for Evity
The devices can be obtained as follows:
Evity 6 SR-T 407161 Evity 8 DR-T 407146
Evity 6 DR-T 407149 Evity 8 HF-T 407140
Evity 8 SR-T 407158 Evity 8 HF-T QP 407139
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 packaging includes the following:
•
Device
•
Screwdriver
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 interrogations and follow-ups are recorded as well as
arrhythmia episodes; they are stored together with other data to assess the state of
both the patient and 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 and permanently 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.
•
Pacing thresholds: Pacing thresholds are automatically identified in the device:
In single-chamber devices the right ventricular, in dual-chamber devices the atrial
and right ventricular, in triple-chamber devices the atrial, right and left ventricular
pacing thresholds. Capture control adjusts the pulse amplitudes in such a way that
every change of the pacing threshold results in the patient being paced at an
optimal amplitude.
en • English
5
•
Timing: Pacing in the atrium is checked particularly carefully in dual and triplechamber devices 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 (inotropy)
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
itself to conduction changes. In the case of intrinsic conduction, the device switches
from a DDD(R) to an ADI(R) mode.
•
8 series: In the course of the follow-up, an automatic test of the AV delay is
performed to improve the heart performance. AV delays are calculated; the
optimum values can be applied.
Resynchronization therapy
Triple-chamber devices have functions to configure different VV delays in order to
resynchronize the ventricles.
•
Capture Control is also 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, di fferent pacing polarities
can be set for the left ventricular lead with a triple-chamber device. Up to
13 vectors can be used with the HF QP device type.
•
8 series: With the QP device type, the LV vector test provides a fast measurement of
the pacing threshold, the phrenic nerve pacing threshold and the pacing impedance. The relative influence on the service time is also displayed. The measurement
results are evaluated automatically so that the optimal pacing polarity can be set.
The short RV-LV conduction test also supports the selection.
•
An additional diagnostic function with biventricular pacing: Variability of the heart
rate, patient activity, and 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 (ProgramConsult
function).
•
Individual settings can be saved in 3 individual therapy programs.
ProMRI devices recognize magnetic resonance imaging devices
The static magnetic field of magnetic resonance imaging devices is reliably recognized
with the aid of a sensor. This sensor can be activated for a maximum of 14 days using
the MRI AutoDetect function during an interrogation.
If the patient comes near a magnetic resonance imaging device within the time set, the
implanted device recognizes the static magnetic field and automatically activates the
preset MRI program. Reprogramming to the permanent program occurs also automatically after leaving the imaging device.
Home Monitoring functi ons
The device automatically sends information to the transmitter once a day. In addition to
this, 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 with device messages
6
2 General Safety Instructions
W
CAUTION
Safety information
Cardiac electrotherapy is subject to special operating conditions and possible complications and risks.
•
Please take all precautionary measures carefully into account.
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 leads
— 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.
•
Keep 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 period; 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 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.
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 antiarrythmia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological
examinations. In rare cases the set parameters can 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.
en • English
7
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.
•
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
paces asynchronously for the duration of the time that the interference rate is
exceeded.
Static magnetic fields
The pacemaker switches to magnet response from a field strength > 1.0 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.
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.
8
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.
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 to protect the
patient and the device system, magnetic resonance imaging can be performed.
BIOTRONIK devices with the "MR conditional" function bear the identification ProMRI.
•
The ProMRI manual – MR conditional device systems – contains detailed 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
—
Dual-chamber device: one unipolar or bipolar lead each for the atrium and for
the right ventricle
—
Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV lead
•
Approved connections are IS-1 and IS4: Use only adapters approved by BIOTRONIK
for leads with different connections or leads from other manufacturers.
•
BIOTRONIK programmer (with integrated wandless 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
In order to be able to respond to unforeseeable emergencies or possible technical
failures of the device:
•
Keep an external defibrillator and paddles or adhesive 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.
en • English
9
•
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 blister to remove it from the outer blister.
•
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 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.
4 Insert the device.
The device starts auto-initialization on its own.
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 connector ports with blind plugs.
Keeping distance between leads
W
WARNING
Inadequate therapy
Insufficient lead spacing or inappropriate lead positioning may lead to far-field
sensing.
•
Leads must not contact each other. Position the tip and ring of newly implanted
leads with a sufficient distance from old implanted leads.
Connecting the lead connector to the device
1 Remove stylets and stylet guides.
2•Connect the unipolar or bipolar IS-1 lead connector for the right ventricle to
RV.
•
Connect the unipolar or bipolar IS-1 lead connector atrium to A.
•
Connect the unipolar or bipolar IS-1 or the quadripolar IS4 lead connector
for the left 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.
10
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 wandless telemetry
The programmer must be no less 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 wandless telemetry on the programmer.
•
Apply the programming head for about 2 s until successful initialization is displayed
on the programmer:
The wandless telemetry 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 usually 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 standard
program.
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.
Precautionary Measures while Programming
W
CAUTION
Safety information
The programming of device systems requires special precautions.
•
Please carefully take all precautionary measures into account.
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.
en • English
11
Do not interrupt wandless 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 wandless 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 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 must only be set
and retained with physician supervision.
Note:
Sensitivity in the atrium meets the requirements for electromagnetic compatibility as long as it is ≥ 0.3 mV/bipolar. Measures must be taken to assure interferencefree therapy if more sensitive values < 0.3 mV/bipolar are set.
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: The aim is to set a VA criterion that is longer than the longest
measured retrograde conduction time.
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.
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 left ventricular 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 left ventricular pacing is not recommended for patients who depend on
the device.
12
•
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 left ventricular 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 fail ure 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 tachyarrhythmiatherapy
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 replacement indication ERI will be reached very early because the service time of the
battery may be reduced to less than 1 year.
Home Monitoring: The CardioMessenger should be relatively close to the patient; if it is
too far away, the device constantly seeks and consumes more power than necessary.
•
Home Monitoring ON reduces the service time by approximately 15% in single- and
dual-chamber devices and by approximately 10% in triple-chamber devices.
Wandless telemetry: 15 minutes of usage reduces the service time by approximately
7 days.
•
Do not establish unnecessary wandless telemetry.
•
After 5 min without input, the device 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 wandless 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 (where applicable V00 / A00)
without rate adaptation;
Magnet rate: 90 bpm
•
Automatic:
For 10 cycles – mode D00, subsequently mode DDDR;
Magnet rate: 10 cycles with 90 bpm, subsequently set basic rate
•
Synchronous:
Mode DDDR (VVIR as the case may be);
Magnet rate: set basic rate
Note:
See also the replacement indication information for magnet response at ERI.
Magnet application by patients
If patients are performing their own magnet application, the synchronous magnet
response must 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.
en • English
13
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 regarding 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 Manually perform standard tests if necessary.
6 Possibly evaluate statistics and IEGM recordings.
7 Possibly adjust program functions and parameters.
8 Transmit the permanent program to the implanted device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
Patient Information
Patient ID card
A patient ID card is included in delivery.
•
Provide the patient with the patient ID 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 of the device.
•
Draw the patient's attention to special household appliances, security checkpoints,
anti-theft alarm systems, strong electromagnetic fields, cellular phones, and
transmitters among other things.
•
Request patients to do the following:
—
Use cellular phones on the opposite side of their body from the device.
—
Keep the cellular phone at least 15 cm away from the device both during use
and when stowing.
Replacement Indications
Possible charging status
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
14
The following are the defined pacemaker operational statuses:
•
BOS: Beginning of Service: > 90%
•
ERI: Elective Replacement Indication (i.e., RRT: Recommended Replacement Time)
•
EOS: End of Service
ERI activation
ERI detection is automatically activated after the following events:
•
Successful auto-initialization
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
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; D00(R); VDD(R); VDI(R); VVI(R); VVT; AAI(R); AAT; A00(R)
•
In the modes DDI(R) and DVI(R), only the VA interval is extended by 11%. This
reduces the pacing rate by up to 11%, depending on the configured AV delay.
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
•
Dual-chamber modes: VDD
•
Triple-chamber modes: Dual-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
Magnet response at 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
Expected service times after ERI
The information is based on the following:
•
Lead impedance of 500 Ω or 600 Ω
•
100% pacing
•
Interval from ERI to EOS for the single-chamber device in AAI(R)/VVI(R) mode, for
the dual and triple-chamber device in DDD(R) mode
•
Standard program with both high and low pacing energy
•
Data of the battery manufacturer (see the battery data)
110 bpm
4.6 V
1.5 ms
500 Ω
Mean value: 8 months
Minimum value: 6 months—Minimum value: 6 months—Minimum value: 6 months
Cycles 1 to 10 After 10th cycle
reduced by 11%
reduced by 11%
30 bpm
0.2 V
0.1 ms
500 Ω
70 bpm
2.5 V
0.4 ms
500 Ω
Synchronous with basic rate
reduced by 11%
70 bpm
5.0 V
0.4 ms
500 Ω
60 bpm
2.5 V
0.4 ms
600 Ω
60 bpm
5 V
0.4 ms
600 Ω
en • English
15
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.
•
Isolate unused lead connectors and close unused connector ports.
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
Note:
Unless described separately, information for device type HF also applies to
device type HF QP.
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) ...
Night ends
Rate hystereses
Parameter Range of values Standard SR DR HF
Hysteresis OFF; -5 ... (-5) ... -25 ... (-20)
Repetitive/ search cycles OFF; ON OFF x x x
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
... 200 bpm
... 200 bpm
23:50 hh:mm
... -65 bpm
Individual
20 ... (5) ... 350 ms
(in 6 rate ranges)
CLS and all HF modes:
20 ... (5) ... 350 ms
(in 6 rate ranges)
60 bpm x x
50 bpm x
OFF xxx
— xxx
OFF xxx
Low x x
180-170-160150-140 ms
150-140-130120-120 ms
16
x
xx
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
VV delay after Vp 0 ... (5) ... 80 ... (10) ... 100 ms 0 ms x
VV delay after Vs 0 ms 0 ms x
Upper rate
Parameter Range of values Standard SR DR HF
Upper rate
SR: in VVT mode
Wenckebach response/
2:1 rate
Atrial upper rate OFF; 175; 200; 240 bpm 240 bpm x x
HF when setting RV: IRSplus
70; 110; 150; 200 ms 70 ms
10 ... (10) ... 150 ms 50 ms x x
OFF; ON ON x x
RV; LV LV x
90 ... (10) ... 200 bpm 130 bpm x x x
Automatically set — x x
OFF x x
CLS modes:
110 ms
xx
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 (out of 8) 5 x x
Resolution criterion x x
Change of the basic rate
with mode switching
Rate stabilization with
mode switching
2:1 lock-in protection OFF; ON ON x
Ventricular pacing suppression
Parameters valid for devices in DDD-ADI or DDDR-ADIR modes:
Parameter Range of values Standard SR DR HF
Vp suppression OFF; ON OFF x x
Pacing suppression after
consecutive Vs
Pacing support after x cycles 1 ... (1) ... 4 (out of 8) 3 x x
permanent DDD(R)
VDI; VDI(R) when
permanent VDD(R)
OFF; +5 ... (5) ... +30 bpm +10 bpm
OFF; ON OFF x x
When setting RV: OFF;
ON
1 ... (1) ... 8 6 x x
DDI(R) x x
ON x
en • English
17
Refractory periods
Parameter Range of values Standard SR DR HF
RV refractory period 200 ... (25) ... 500 ms 250 ms x x x
Atrial refractory
period
Atrial refractory
period in the modes
AAI(R); AAT(R); DDT
LV refractory period 200 ms 200 ms x
AUTO PVARP OFF; ON ON x x
PVARP 175 ... (25) ... 600 ms 225 ms x x
PVARP after PVC PVARP + 150 ms
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
AUTO AUTO x x
300 ... (25) ... 775 ms 350 ms x x
(max: 600 ms)
100 ... (10) ... 220 ms 100 ms x x
100 ... (10) ... 220 ms 150 ms x x
30 ... (5) ... 70 ms 30 ms x x
Automatically set 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 OFF; AUTO; 0.1 ... (0.1) ... 1.5
RV sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x x x
LV sensitivity OFF; AUTO; 0.5 ... (0.5) ...
Atrial capture control
Parameter Range of values Standard SR DR HF
Atrial capture
control
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 ... (00:10) ...
0.2 ... (0.2) ... 6.0 ... (0.5)
... 7.5 V
... 1.5 ms
... (0.5) ... 7.5 mV
7.5 mV
ATM (monitoring only); ON;
OFF
23:50 hh:mm
3.0 V xxx
0.4 ms xxx
AUTO x x
AUTO x
ON x x
00:30 hh:mm x x
18
Ventricular capture control
Parameter Range of values Standard SR DR HF
Capture control RV ATM (monitoring only); ON;
Capture control LV x
Minimum
amplitude RV
Minimum
amplitude LV
Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x 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 x
Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x x x
Time of day 00:00 ... (00:10)
Atrial overdrive pacing
Parameter Range of values Standard SR DR HF
Atrial overdrive pacing OFF; ON
OFF
0.7 V 0.7 V x x x
... 23:50 hh:mm
With ON: maximum overpacing rate 120 bpm, mean
rate increase approximately
8 bpm, rate decrease after
20 cycles
ON xxx
00:30 hh:mm x x x
OFF x x
Lead configuration
Parameter Range of values Standard SR DR HF
Sensing polarity A Unipolar; bipolar Unipolar x 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 x
x
Pacing polarity RV Unipolar; bipolar Unipolar x x x
Pacing polarity LV Device type HF:
LV1 tip -> LV2 ring
LV1 tip -> RV ring
LV2 ring -> LV1 tip
LV2 ring -> RV ring
LV1 tip -> housing
LV2 ring -> housing
Device type HF QP
LV1 tip -> LV2 ring
LV1 tip -> LV4 ring
LV1 tip -> RV ring
LV1 tip -> housing
LV2 ring -> LV1 tip
LV2 ring -> LV4 ring
LV2 ring -> RV ring
LV2 ring -> housing
LV3 ring -> LV2 ring
LV3 ring -> LV4 ring
LV3 ring -> RV ring
LV4 ring -> LV2 ring
LV4 ring -> RV ring
LV1 tip –>
housing
LV1 tip –>
LV2 ring
x
x
en • English
19
IEGM recordings
Parameter Range of values Standard SR DR HF
Number of recordings
(each max. 10 s)
High atrial rate (HAR) OFF; AT; mode switching AT x x x
High ventricular rate
(HVR)
8 series:
Patient triggering
(triggered by patient)
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
HAR limit 100 ... (10) ... 250 bpm 200 bpm x x
HVR limit 150 ... (5) ... 200 bpm 180 bpm x x x
HVR counter 4; 8; 12; 16 events 8 events x x x
Start resting period 00:00 ... (1:00) ... 23:00 hh:mm 2:00 hh:mm x x x
Duration of resting
period
Lead check OFF; ON ON x x x
6 series: 12
8 series: 20
OFF; ON ON x x x
OFF; ON OFF x x x
0.5 ... (0.5) ... 12 h 4 h x x x
— xxx
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 ... (10) ... 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
Parameters valid for devices with R modes:
Parameter Range of values Standard SR DR HF
Sensor gain AUTO; Very low; Low;
Max. activity rate 80 ... (10) ... 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
When BiV is
set: Yes
AUTO x x x
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; AUTO OFF x x x
Expiration date Today's date ... (1 day) ...
MRI mode OFF; A00; V00 Dependent
MRI parameters
Preset parameters in the MRI program:
Parameter Range of values Standard SR DR HF
Basic rate 70 ... (10) ... 160 bpm 90 bpm x x x
AV delay 110 ms 110 ms x x
VV delay 0 ms 0 ms x
Pulse amplitude A/RV 4.8 V — x x x
Pulse width A/RV 1.0 ms
Pulse amplitude LV 0.2 … (0.2) … 6.0 … (0.5) … 7.5 V As in
Pulse width LV 0.1 … (0.1) … 0.5 … (0.25) … 1.5 ms
today's date + 14 days
OFF; D00; A00; V00 x
OFF; D00; A00; V00;
D00-BiV; V00-BiV
Today's date
+ 14 days
on
permanent
program
permanent
program
xxx
x
Preset Programs
Standard and safe program
Mode after auto-initialization:
Parameter Factory setting Standard Safe program SR DR HF
Mode VVI VVIR VVI
Mode DDD DDDR VVI x x
en • English
In the AAI mode, the safe
program is also AAI.
x
Lead configuration, determined and set immediately after connection (auto lead check):
Parameter Factory setting Standard Safe program SR DR HF
Pacing polarity A/RV Unipolar Unipolar Unipolar x x x
Pacing polarity LV TCUP TCUP — x
Sensing polarity A/RV Unipolar Unipolar Unipolar x x x
Sensing polarity LV Unipolar Unipolar — x
Automatic lead check ON ON — x x x
Parameters after auto-initialization:
x
Parameter Factory
Basic rate 60 bpm 60 bpm 70 bpm x x
Night rate OFF OFF OFF x x x
Rate hysteresis OFF OFF OFF x x x
Upper rate 130 bpm 130 bpm — x x
AV dynamics Low Low — x x
AV hysteresis mode OFF OFF — x x
Sense compensation -45 ms -45 ms — x x
AV safety delay 100 ms 100 ms — x x
x
VV delay 0 0 — x
LV T-wave protection 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 30 ms 30 ms — x x
PMT protection ON ON — x x
VA criterion 350 ms 350 ms — x x
Magnet response AUTO AUTO AUTO x x x
Pulse amplitude A 3.0 V 3.0 V — x x
Pulse amplitude RV 3.0 V 3.0 V 4.8 V x x x
Standard Safe
setting
50 bpm 50 bpm x
program
21
SR DR HF
Parameter Factory
Pulse amplitude LV 3.0 V 3.0 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 — x
Sensitivity A AUTO AUTO — x x
Sensitivity RV AUTO AUTO 2.5 mV x x x
Sensitivity LV AUTO AUTO — 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 — x
Mode switching ON ON — x x
Onset criterion 5-out-
Resolution criterion 5-out-
Intervention rate 160 bpm 160 bpm — x x
Switches to DDIR DDIR — x x
The basic rate with mode switching +10 bpm +10 bpm — x x
Rate stabilization with
mode switching
PVARP AUTO
PVARP after PVC 400 ms Automati-
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
setting
5-out-of 8 — x x
of 8
5-out-of 8 — x x
of 8
OFF OFF — x x
225 ms — x x
(Start
250 ms)
cally set
SR DR HF
program
—xx
Parameter Factory
Vp suppression OFF OFF — x
IEGM recording (HAR) ON AT OFF x x x
IEGM recording (HVR) ON ON OFF x x x
Home Monitoring OFF OFF OFF xxx
setting
Standard Safe
program
SR DR HF
Tolerances of Parameter Values
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 ... 1.5 ms The greater value of ±20 µs
Sensitivity A
EN 45502-2-1 triangle pulse
Sensitivity RV/LV
EN 45502-2-1 triangle pulse
Refractory period 200 ... 500 ms ± 20 ms
Maximum activity rate 80 ... 180 bpm ± 20 ms
Lead impedance 100 ... 200 Ω ±50 Ω
... 200 bpm
0.1 ... 0.2 mV The greater value of ±0.1 mV
0.3 ... 7.5 mV
0.5 ... 7.5 mV ±20%
201 ... 2500 Ω ±10%
± 20 ms
or +20/-25%
or ±10%
or ±20%
22
5 Technical Data
Mechanical Characteristics
Measurements for the housing
Device W x H x D [mm]
Single-chamber SR(-T) 48 x 40 x 6.5 10 20.8
Dual-chamber DR(-T) 48 x 44 x 6.5 11 23.2
Triple-chamber HF-T 53 x 52 x 6.5 14 26.9
Triple-chamber HF-T QP 53 x 53 x 6.5 15 31.2
Note:
D = housing without header
X-ray identification
All device types receive the BIOTRONIK logo for X-ray identification. It can be found
centrally between the circuitry and the battery inside the housing and is visible on the
X-ray image.
Materials in contact with body tissue
•
Housing: Titanium
•
Header: Epoxy, polysulfone; IS4 seal: Silastic
•
Silicone plug: Silopren or silastic
Volume [cm3]
Mass [g]
Electrical Characteristics
Components and input values
Electrical characteristics determined at 37°C, 500 Ω:
Circuit technology Dycostrate
Input impedance > 10 kΩ
Pulse form Biphasic, asymmetric
Polarity Cathodic
Electrically conductive surface
The device housing has the form of a flattened ellipsoid. The electrically conductive
area is for:
•
Single and dual-chamber devices: 30 cm
•
Triple-chamber devices: 33 cm
Telemetry data
•
MICS frequency: 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 Australia:
This product is in compliance with the Australian "Radiocommuniations
Act 1992" and therefore it is labelled according to the "Radiocommunications
(Compliance Labelling - Devices) Notice."
•
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-LSE015
2
2
en • English
23
•
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: QRIPNP
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 EN 45502-2-1:
2003, § 27.5.1 at the highest sensitivity.
Battery Data
Battery characteristics
The following data is provided by the manufacturers:
Manufacturer Wilson
Battery type GB 3193 LiS 2650MK LiS 3150MK
System
GREATBATCH, INC.
Clarence, NY 14031
®
QMR
Li-CFX/SVO
LITRONIK GmbH
01796 Pirna
Germany
LiMn0
2
LiMn0
Device type SR; DR SR; DR HF; HF QP
Battery voltage at BOS 3.3 V 3.1 V 3.1 V
Open-circuit voltage 3.3 V 3.1 V 3.1 V
Nominal capacity 1010 mAh 950 mAh 1200 mAh
Usable capacity until EOS 971 mAh 880 mAh 1066 mAh
Remaining capacity at ERI 39 mAh 70 mAh 134 mAh
Shortening of the service time after long storage period
In case of implantation after an average storage period – about 1 year before the end of
the use by date – the average service time decreases by about 1%.
Devices should be implanted within 19 months between the manufacturing date and the
use by date (indicated on the package).
Power consumption
•
BOS, inhibited: SR(-T), DR(-T) 6 µA; HF-T (QP) 7 µA
•
BOS, 100% pacing: SR(-T) 8 µA; DR(-T) 11 µA; HF-T (QP) 14 µA
Calculation of service times
Mean service times pre-estimated from the following and other data:
•
Storage for 6 months
•
Technical data of the battery manufacturer
•
Basic rate of 60 bpm in AAIR/VVI R modes (single-chamber devices) or DDDR mode s
(dual-chamber and triple-chamber devices)
•
Home Monitoring configuration: OFF
•
No wandless telemetry
•
Configuration of different pulse amplitudes and lead impedances
24
2
Mean service times SR
For single-chamber devices the following times result when set to AAIR or VVIR, with
a basic rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω:
Amplitude Pacing Average service time
2.5 V 100% 13 years
3.0 V 100% 11 years, 3 months
5.0 V 100% 5 years, 6 months
Mean service times DR
For dual-chamber devices, the following times result when set to DDDR with a basic
rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω:
Amplitude Pacing Average service time
A: 2.5 V
RV: 2.5 V
A: 3.0 V
RV: 3.0 V
A: 5.0 V
RV: 5.0 V
50% 14 years, 9 months
50% 13 years, 7 months
100% 9 years, 4 months
50% 11 years, 4 months
100% 7 years, 8 months
50% 10 years
100% 3 years, 2 months
Mean service times HF
For triple-chamber devices of the 8 series, the following times result when set to DDDR
with a basic rate of 60 bpm, 100% biventricular pacing and a pulse width of 0.4 ms at an
impedance of 500 Ω:
Amplitude Pacing Average service time
A: 2.5 V 10% 9 years, 8 months
RV: 2.5 V
LV: 2.5 V
A: 3.0 V 10 % 8 years
RV: 3.0 V
LV: 3.0 V
A: 5.0 V
RV: 5.0 V
LV: 5.0 V
100%
100%
100% 2 years, 6 months
en • English
25
Legend for the Label
NON
STERILE
The label icons symbolize the following:
Manufacturing date Use by
Storage temperature Order number
Serial number Product identification
CE mark
Contents Follow the instructions for
number
use!
Label icon on devices with ProMRI®:
TP2
Compabiltiy with telemetry protocol version 2
of BIOTRONIK Home Monitoring
Example
Transmitter with non-ionizing radiation at
designated frequency
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
Screwdriver
Sterilized with ethylene oxide
Do not resterilize Single use only,
Do not use if packaging is
damaged
do not reuse
Non-sterile
Examples of the connector allocation: IS-1, IS-1/IS4
26
es • Español
Descripción del producto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Uso médico indicado. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Indicaciones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Contraindicaciones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Presentación del sistema. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Funciones diagnósticas y terapéuticas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Indicaciones generales de seguridad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Condiciones de funcionamiento. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Posibles complicaciones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Posibles riesgos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Implantación . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Procedimiento de implantación. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Medidas de precaución durante la programación . . . . . . . . . . . . . . . . . . . . . . . 38
Respuesta imán . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Seguimiento . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Información para el paciente. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Indicaciones de recambio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Explantación y sustitución del generador. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Parámetros . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Temporizado . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Estimulación y detección . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Adaptación de frecuencia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Programa RMN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Programas preconfigurados . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Tolerancias de los valores de los parámetros . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Datos técnicos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Datos de referencia mecánicos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Características eléctricas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Información de la batería. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Leyenda de la etiqueta . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Índice
1 Descripción del producto
Uso médico indicado
Uso conforme a lo previsto
Evity es el nombre de una gama de marcapasos implantables que se pueden implantar
en caso de cualquiera de las indicaciones de arritmias bradicárdicas. El objetivo
primordial de la terapia es mejorar los síntomas del paciente de manifestación clínica.
La implantación del marcapasos supone una terapia sintomática con el objetivo
siguiente:
•
Compensación de bradicardias mediante la estimulación auricular, ventricular
o secuencial AV
•
Con generadores tricamerales también: Resincronización de la contracción
ventricular por estimulación biventricular
Formas de diagnóstico y de tratamiento
El ritmo cardiaco se supervisa automáticamente; las arritmias bradicárdicas son
tratadas. Esta familia de generadores reúne todos los modelos esenciales de terapia
cardiológica y electrofisiológica. BIOTRONIK Home Monitoring® permite a los médicos
gestionar la terapia las 24 horas del día.
Conocimientos técnicos requeridos
Aparte de los conocimientos médicos básicos, es necesario tener conocimientos
específicos acerca del funcionamiento y las condiciones de empleo de un sistema
generador.
•
Únicamente personal médico especializado con estos conocimientos específicos
está capacitado para emplear de forma adecuada el generador.
•
En caso de no poseer estos conocimientos los usuarios deben recibir formación
específica.
Indicaciones
Directrices de las sociedades cardiológicas
Las recomendaciones, indicaciones y métodos de diagnósticos diferenciales aprobados
generalmente para la terapia de marcapasos se aplican a los generadores de
BIOTRONIK.
es • Español
27
Todo ello se basa en las directrices de las asociaciones cardiológicas:
•
Recomendamos que se tengan en cuenta las indicaciones publicadas por la DGK
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) y la ESC
(European Society of Cardiology).
•
Recomendamos así que se tengan en cuenta la Heart Rhythm Society (HRS),
la American College of Cardiology (ACC), la American Heart Association (AHA) y
otras asociaciones de cardiología nacionales.
Tipos de generadores
Ante los siguientes síntomas o expectativas están indicados los tipos de generadores
que se indican a continuación:
Síntomas/expectativas SR DR HF
Desorientación causada por bradicardia x x x
Presíncope xxx
Beneficio de la resincronización del ventrículo derecho e
izquierdo
Síncope xxx
Modos de estimulación
Ante los siguientes síntomas están indicados los modos que se indican a continuación:
Síntomas/expectativas Modos de estimulación
Síndrome del nodo sinusal Estimulación bicameral
Bloqueo AV de segundo o tercer grado; crónico,
sintomático
Síndrome de Adams Stokes Estimulación bicameral
Bloqueo de rama bifascicular sintomático, siempre que la
taquiarritmia u otras causas estén descartadas
•
Incompetencia cronotrópica
•
Beneficio por un aumento de la frecuencia de
estimulación al realizar una actividad física
Disfunción del nodo sinusal con conducción intraventricular y AV intacta
Estimulación bicameral
Estimulación bicameral
Modo R o CLS
Estimulación auricular
Síntomas/expectativas Modos de estimulación
Bradicardia en combinación con:
•
Ritmo sinusal normal con solo episodios raros de
bloqueo AV o anomalías del nodo sinusal
•
Fibrilación auricular crónica
•
Discapacidad física grave
Compatibilidad condicionada con RMN (MR conditional)
Los marcapasos MR conditional marcados con ProMRI® pueden emplearse sin riesgo
en entornos condicionados de RMN, siempre que se utilicen junto con un sistema
implantable MR conditional completo y de acuerdo a las instrucciones proporcionadas
en el manual ProMRI.
Contraindicaciones
Pautas fundamentales
x
No se conocen contraindicaciones para la implantación de marcapasos multifuncionales monocamerales, bicamerales o tricamerales. Debe existir siempre un diagnóstico diferencial previo para la implantación de acuerdo con las directrices aplicables.
No se configurarán los modos ni las combinaciones de parámetros que puedan poner
en peligro al paciente.
Modos y parámetros
Se debe comprobar que las combinaciones de parámetros sean efectivas y compatibles. Después de la programación también deben controlarse y, en caso necesario,
adaptarse.
Condiciones Modo contraindicado
DAI adicional implantado Estimulación unipolar
Condiciones Modo inadecuado
Taquicardias auriculares crónicas, fibrilación auricular
crónica o flúter
Mala tolerancia a frecuencias de estimulación por encima
de la frecuencia básica, por ejemplo, angina de pecho
Trastorno de conducción AV Estimulación monocaDisminución de conducción AV
28
Estimulación ventricular
Modos con control
auricular (DDD, VDD, AAI)
meral en aurícula
Condiciones Adaptación de parámetros
Conducción retrógrada lenta tras estimulación ventricular: Riesgo de taquicardias
mediadas por el marcapasos
Mala tolerancia a frecuencias de estimulación por encima de la frecuencia básica,
por ejemplo, angina de pecho
•
Prolongar el periodo refractario
auricular
o bien:
•
Reducir el retardo AV
•
Más raramente:
Programar DDI, DVI o VVI
•
Reducir la frecuencia superior
•
Reducir la frecuencia máxima del
sensor
•
Aplicar sobreestimulación auricular
Presentación del sistema
Familia de generadores
Esta familia de generadores está compuesta por generadores mono, bi y tricamerales
con o sin Home Monitoring. No todos los tipos de generadores se encuentran disponibles en todos los países.
Existen las variantes de generador siguientes:
Tipo de
generador
Monocameral Evity 6 SR-T, Evity 8 SR-T —
Bicameral Evity 6 DR-T, Evity 8 DR-T —
Tricameral Evity 8 HF-T, Evity 8 HF-T QP —
Generador
La carcasa del generador es de titanio biocompatible, está soldada por fuera, de modo
que queda sellada herméticamente. La forma elipsoidal facilita el encapsulamiento en
la zona de los músculos pectorales. La carcasa actúa como polo opuesto en caso de
configuración unipolar de los electrodos.
Conexiónes de los electrodos
BIOTRONIK ofrece marcapasos con bloques conectores para distintos puertos
estandarizados.
•
IS-1
•
IS-1/IS4
es • Español
Variantes con
Home Monitoring
Variantes sin
Home Monitoring
Nota:
Los electrodos adecuados deben ser acordes con las normas:
•
Al puerto IS-1 de un generador solo se le pueden conectar electrodos que
cumplan la norma ISO 5841-3 y que incorporen un conector de electrodo IS-1.
•
Al puerto IS4 de un generador solo se le pueden conectar electrodos que cumplan
la norma ISO 27186 y que incorporen un conector de electrodo IS4.
Nota:
El generador y los electrodos deben ser compatibles.
•
Al tipo de generador HF QP con IS4 solo se le pueden conectar electrodos tetrapolares a los puertos de los conectores IS4.
Nota:
Para conectar electrodos con otro tipo de conexiones utilice solo los adapta-
dores autorizados por BIOTRONIK.
•
Diríjase a BIOTRONIK para aclarar cualquier duda acerca de la compatibilidad con
electrodos de otros fabricantes.
IS-1
La inscripción del generador aporta información sobre la disposición de las
conexiones:
SR DR HF
Puerto Conector de
electrodo
A/AD IS-1 Unipolar, bipolar Aurícula DR, HF
V/VD IS-1 Unipolar, bipolar Ventrículo derecho SR, DR, HF
LV IS-1 Unipolar, bipolar Ventrículo izquierdo HF
Configuración Lugar de
implantación
29
Tipo de
generador
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