BIOTRONIK SE and KG PRIMUS PRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers User Manual QRIPRIMUS UserMan

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© BIOTRONIK GmbH & Co. KG
All rights reserved. Specifications
subject to modification, revision
and improvement.
2009-D-xx
Cardiac Rhythm Management
Bradycardia therapy
Technical Manual
® BIOTRONIK Home Monitoring and
Entovis are registered trademarks of
BIOTRONIK GmbH & Co. KG
Evia
Pacemaker with automatic Functions
and BIOTRONIK Home Monitoring®
This product conforms with the
directives 90/385/EEC relating to
active implantable medical devices
and 99/5/EC on radio equipment and
telecommunication terminal equipment. It was approved by independent
Notified Bodies and is therfore
designated with the CE mark. The
product can be used in all European
Union countries as well as in countries
that recognize the above-mentioned
directives.
365353--A_GA_Evia_A6_Cover_PB.in1-2 1-2
BIOTRONIK GmbH & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel+49 (0) 30 68905–0
Fax+49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com
23.04.2009 15:45:24
Evia DR-T, DR, SR-T, SR
Pacemaker
Bradycardia therapy
Technical manual for the implant
Doc. Id.: 365353-A
Index 365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
sbiotronik
2
3
Table of Contents
Table of Contents
Table of Contents
Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Implant Variants and NBG Codes . . . . . . . . . . . . . . . . . . . . . . 8
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . 9
Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Possible Medical Complications. . . . . . . . . . . . . . . . . . . . . . 13
Possible Technical Complications . . . . . . . . . . . . . . . . . . . . 14
Possible Electromagnetic Complications . . . . . . . . . . . . . . 15
Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Prior to Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Indications and Contraindications . . . . . . . . . . . . . . . . . . . . 17
Ambient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Preparing the Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . 20
Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Implanting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Connecting PM Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Precautionary Measures while Programming . . . . . . . . . . 24
After Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Notes for the Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Explantation and Implant Replacement. . . . . . . . . . . . . . . . 31
4
Table of Contents
Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Timing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Timing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Pacing and Sensing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . 38
Pacing and Sensing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Preset Programs DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Preset Programs SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . . 45
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . 47
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . 51
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5
Product Description
Intended Medical Use
Product Description1365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Intended use
Evia 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:
•
Diagnosis and
therapy forms
Compensation of bradycardia by atrial, ventricular, or AV sequential pacing
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 the Evia family.
BIOTRONIK Home Monitoring® enables physicians to perform therapy management any time.
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of an implant system. Only qualified medical specialists having the special knowledge required for the proper use of implants are permitted to
use them. If users do not possess this knowledge, they must be trained accordingly.
6
Product Description
System Overview
Parts
Implant
The implant system consists of the following parts:
•
Implant with connections for unipolar or bipolar sensing and pacing
•
Suitable leads and approved accessories
•
Programmer
•
Current implant programs
The implant's housing is made of biocompatible titanium, welded from outside and
thus 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.
BIOTRONIK provides silicone-coated implants to avoid muscle twitching near the
implanted pacemaker in the case of unipolar pacing.
The labeling provides information about the implant type and arrangement of the
connections.
Leads
The leads are sheathed with biocompatible silicone. They can be flexibly maneuvered, are long-term stable, 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 sliding properties of the lead.
The coating of steroid-eluting leads reduces inflammatory processes. The fractal
design of the leads provides for low pacing thresholds, high pacing impedance, and
a low risk of oversensing.
Programmer
The transportable programmer is used to transfer the appropriate implant program to the implant. In addition to this, the programmer is used for interrogation
and storage of data from the implant. And it acts as an ECG and IEGM monitor with
Miniclinic.
The programmer communicates with the implant via the programming head. The
operation module of the programmer has a TFT touch screen with color display, on
which the ECG, IEGM, marker and functions are shown simultaneously.
The programmer has, among others, the following functions:
•
Perform all tests during follow-up
•
Display and print real-time and saved IEGMs with annotated markers
•
Determine the pacing threshold
7
BIOTRONIK
Home Monitoring®
Technical manuals
Product Description
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
•
With Home Monitoring, diagnostic and therapeutic information and technical
data are sent via an antenna in the implant header to a mobile or stationary
transmitter. The encrypted data are 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 fax, SMS or E-mail.
•
A clear overview of the analysis results is displayed for the attending physicians
on the protected Internet platform HMSC (Home Monitoring Service Center).
•
Data transmission from the implant is performed on a daily basis with the trend
message. Depending on the transmitter used, these data are passed on immediately or, if the data is normal, it is collected for up to 2 weeks. If certain events
occur in the patient's heart or in the implant itself, an event message is sent.
Additionally, patients can send a patient message by applying the magnet.
The following technical manuals provide information about usage of the implant
system:
•
Technical manual for the implant
•
Technical manual for the programmer
•
User manual for the implant program:
— As a help function in the user interface
— As a file on CD
•
Technical manual for the leads
8
Product Description
Implant Variants and NBG Codes
Evia family
The following implant variants are available:
Implant type
Variant with
Home Monitoring
Variant without
Home Monitoring
Dual-chamber
Evia DR-T
Evia DR
Single-chamber
Evia SR-T
Evia SR
Note: The setting of the pacing mode depends on the individual diagnosis; the
modes are listed in the section pertaining to adjustable parameters.
NBG-Code for Evia DR(-T)
NBG-Code for Evia SR(-T)
The NBG code for dual-chamber implants is DDDR:
Pacing in both chambers
Sensing in both chambers
Pulse inhibition and pulse triggering
Rate adaptation
The NBG code for single-chamber implants is AAIR or VVIR:
A/V
Pacing in one chamber
A/V
Sensing in one chamber
Pulse inhibition in A/V
Rate adaptation
9
Product Description
Diagnostic and Therapy Functions
General overview
Diagnostic functions
Antibradycardia pacing
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 implant automatically detects the
implanted leads, sets the polarity and activates the automatic functions after
10 min.
•
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 implant at any time.
•
Automatic below-threshold impedance measurement is performed in the
implant independent of the pacing pulse in order to check the lead for proper
functioning.
•
When performing follow-ups using the programmer, the IEGM is indicated with
markers after applying the programming head during the test procedure.
•
Sensing: the amplitudes of the P and R waves are measured in the implant 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 implant. Active capture control is used to set the pacing
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 is particularly checked in the atrium by automatic adaptation
of the atrial refractory period to avoid pacemaker-induced tachycardia.
(Auto PVARP function: automatic postal-atrial refractory period)
•
Additional, special form of rate adaptation: an increased cardiac output requirement is detected using physiological impedance measurement. The measuring
principle is based on contractile changes (ionotropy) of the myocardium
(CLS function: Closed Loop Stimulation). The suitable 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 implant can
adapt itself to conduction changes. In the case of intrinsic conduction, the
implant switches to a mode similar to AAI.
10
Home Monitoring
Product Description
The implant automatically sends information to the transmitter once a day. Additionally, the test messages can be initiated using the programmer. Important medical information include, 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 remote interrogation messages which enhance the
standard message with additional information relevant for follow-up
•
IEGM online HD® with up to 3 channels in high definition with markers for RA
and RV, which each include the intrinsic rhythm and sequences with encouraged sensing and encouraged pacing
•
Sending of these IEGM recordings with remote interrogation messages
•
Test message triggered by the programmer to immediately check the Home
Monitoring function including notification of the physician
11
Product Description
Scope of Delivery
Standard
The storage package includes the following:
•
Implant in sterile packaging
•
Patient's manual
•
Serial number label
•
Patient ID card
•
Warranty card
•
Technical manual
The sterile container contains the following:
Order numbers Evia
Accessories
•
Implant
•
Screwdriver
The implants can be obtained as follows:
Implant
Order number: uncoated
Order number: coated
DR-T
359529
359530
DR
359524
359528
SR-T
359533
359534
SR
359531
359532
All BIOTRONIK products correspond to the requirements of the
EC Directive 90/385/EEC:
•
BIOTRONIK leads
•
BIOTRONIK programming and monitoring devices
•
Permanent magnet
•
For Home Monitoring: BIOTRONIK transmitters
12
Product Description
13
General Safety Instructions
General Safety Instructions2365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Possible Medical Complications
General information
on medical complications
Complications for patients and implant systems generally recognized among practitioners also apply to BIOTRONIK implants.
•
Normal complications may include fluid accumulation within the implant
pocket, infections, or tissue reactions. Primary sources of complication information include current scientific and technological knowledge.
•
It is impossible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological examinations. In rare cases the set parameters may become ineffective. In
particular it cannot be excluded that tachyarrhythmias be induced.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the implant to the rate
spectrum of intrinsic events so that skeletal myopotentials are usually not sensed.
Skeletal myopotentials can nonetheless be sensed as intrinsic events especially
with a unipolar configuration and, depending on the interference pattern, may
cause inhibition or antiarrhythmia therapy.
Nerve and
muscle stimulation
An implant system consisting of a unipolar lead and an uncoated implant may
result in undesirable pacing of the diaphragm in the case of an initial or permanent
high setting of the pacing amplitude.
•
BIOTRONIK also provides coated implants.
14
General Safety Instructions
Possible Technical Complications
Technical malfunctions
Technical implant malfunctions cannot entirely be excluded. Possible causes can
include the following:
•
Lead dislocation
•
Lead fracture
•
Insulation defects
•
Implant component failures
•
Battery depletion
15
General Safety Instructions
Possible Electromagnetic Complications
Electromagnetic
interference (EMI)
Any implant can be sensitive to interference, for example, when external signals
are sensed as intrinsic rhythm or if measurements prevent rate adaptation.
•
BIOTRONIK implants 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 sensordependent pacing rate or fixed-rate pacing.
•
Under unfavorable conditions, for example during diagnostic or therapeutic
procedures, the interference sources may induce such a high level of energy
into the pacing system that the implant or cardiac tissue around the lead tip is
damaged.
Implant behavior
in case of EMI
Upon exceeding the interference rate, the implant switches to another pacing
mode. Depending on whether the interference occurs in one chamber or both
chambers, the implant switches to the A00(R), V00(R) or D00(R) mode for the duration of the interference.
Static magnetic fields
The Reed contact in the pacemaker closes beginning at a field strength of 1.5 tesla.
16
General Safety Instructions
Possible Risks
Risky diagnostic and
therapeutic procedures
If electrical current from an external source is conducted through the body for diagnostic or therapeutic purposes, then the implant can be subjected to interference
and the patient placed at risk. Therefore the following always applies:
•
External defibrillation
The implant 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.
•
Contraindicated procedures
Magnetic resonance
imaging
Place adhesive electrodes anterior-posterior or perpendicular to the axis
formed by the implant to the heart at least 10 cm away from the device and from
implanted leads.
The following procedures are contraindicated:
•
Therapeutic ultrasound and diathermy: damage to the patient via excess warming of body tissue near the implant system
•
Transcutaneous electrical nerve stimulation (TENS)
•
Lithotripsy
•
Electrocautery and high-frequency surgery: damage to the patient via the
induction of arrhythmia or ventricular fibrillation
•
Hyperbaric oxygen therapy
•
Applied pressures higher than normal pressure
Magnetic resonance imaging is contraindicated due to the associated magnetic flux
density: damage or destruction of the implant system by strong magnetic interaction and damage to the patient by excessive warming of the body tissue in the area
surrounding the implant system.
•
Therapeutic
ionizing radiation
Monitor the patient.
Under certain conditions one can perform special measures with magnetic resonance imaging to protect the patient and implant.
Radiation can cause latent damage. This damage cannot be recognized immediately. Therefore, the following applies to X-ray diagnosis and radiation therapy:
•
Sufficiently shield implant against radiation.
•
After applying radiation, double-check the implant system to make sure it is
functioning properly.
17
Prior to Implantation
Prior to Implantation3365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Indications and Contraindications
Guidelines of
cardiologic societies
Generally approved differential diagnostics methods, indications, and recommendations for pacemaker therapy apply to BIOTRONIK implants.
The guidelines provided by cardiology associations offer decisive information.
Indications
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). Likewise those published by the Heart Rhythm
Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA) as well as other national cardiology associations.
Contraindications
No contraindications are known for the implantation of multiprogrammable and
multifunctional single-chamber or dual-chamber implants, provided differential
diagnostics precedes implantation according to the appropriate guidelines and no
modes or parameter combinations are configured which pose a risk to the patient.
Note: The compatibility and effectiveness of parameter combinations must be
checked after programming.
18
Prior to Implantation
Ambient Conditions
Temperature
Storage location
Storage period
Extremely low and high temperatures affect the service time of the battery in the
implant.
•
The following temperatures are permitted for transport, storage, and use:
– 10°C to 45°C (50°F to 113°F)
•
Implants are not to be stored close to magnets or sources of electromagnetic
interference.
The duration of storage affects the service time of the battery of the implant
(see battery data).
19
Prior to Implantation
Sterility
Delivery
Sterile container
Single use only
The implant and the accessories have been gas sterilized. Sterility is guaranteed
only if the plastic container and quality control seal have not been damaged.
The implant and accessories are packaged respectively in two separately sealed
plastic containers. The inner plastic container is also sterile on the outside so that
it can be transferred in a sterile state during implantation.
The implant and the screwdriver are only intended for one-time use.
•
Do not use if package is damaged.
•
Do not resterilize.
•
Do not reuse.
20
Prior to Implantation
Preparing the Implantation
Have parts ready
•
Ensure that sterile spare parts are available for all parts that are to be
implanted.
•
Only use products that correspond to the requirements of the
EC Directive 90/385/EEC:
—
—
—
—
—
BIOTRONIK implant and blind plugs
BIOTRONIK leads and lead introducer
BIOTRONIK programmer with approved cable and adapter accessories
External multi channel ECG recorder
External defibrillator and paddles or adhesive electrodes
WARNING
Inadequate therapy due to defective implant
If an unpacked implant is dropped on a hard surface during handling, electronic
parts could be damaged.
Unpacking the implant
•
Use a replacement implant.
•
Send the damaged implant to BIOTRONIK.
Proceed as follows:
Peel off the sealing paper of the outer plastic container at the marked
position in the direction indicated by the arrow.
The inner plastic container may 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 off the sealing paper of the sterile inner plastic container at the
marked position in the direction indicated by the arrow.
Note: The implant is disabled on delivery and can be implanted immediately after
unpacking without manual activation.
21
Implantation
Implanting
Implantation4365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Implantation site
Sequence
In general the pacemaker is implanted subcutaneously or subpectorally on the
right depending on the lead configuration as well as the anatomy of the patient.
Proceed as follows:
Shape the implant pocket and prepare the vein.
Implant the leads and perform measurements.
Connect implant and leads.
The implant starts auto-initialization on its own.
Insert the implant.
Guide the fixation suture through the opening in the header and fixate
the implant in the prepared pocket.
Close the implant pocket.
Prior to testing and configuration, wait for the successful completion
of automatic implant initialization.
Note: If necessary, the implant can also be programmed before or during autoinitialization.
22
Implantation
Connecting PM Leads
Connection options
BIOTRONIK pacemakers are designed for leads with unipolar or bipolar IS-1 connection. A unipolar or bipolar lead can be connected to Evia for sensing and pacing:
DR-T and DR
Atrium
SR-T and SR
IS-1 unipolar or bipolar
Ventricle
Note: Use only adapters approved by BIOTRONIK for leads with different connections.
•
Connection schemes
If you have any questions concerning the compatibility of other manufacturers' leads, please contact BIOTRONIK.
Connection scheme for dual-chamber and single-chamber implants:
DR-T and DR
SR-T and SR
DDDR
VVIR/AAIR
IS-1
Connecting the lead
connector to the implant
IS-1
Proceed as follows:
Disconnect stylets and insertion aids from the lead connector.
•
Connect the unipolar or bipolar IS-1 lead connector atrium to A.
•
Connect the unipolar or bipolar IS-1-lead connector ventricle to V.
Push the lead connector into the header without bending the conductor until the connector tip becomes visible behind the set screw block.
If the lead connector cannot be inserted completely, the set screw
may be protruding into the cavity of the set screw block. Carefully
loosen the set screw without completely unscrewing it, so that it does
not become tilted upon retightening.
Use the screwdriver to perpendicularly pierce through the slitting in
the center of the silicone plug until it reaches the set screw.
Turn the set screw clockwise until the torque control starts (you will
hear a clicking sound).
Carefully withdraw the screwdriver without retracting the set screw.
•
When you withdraw the screwdriver, the silicone plug automatically seals the lead connection safely.
WARNING
Short circuit due to open lead connections
Open, and thus not electrolyte-tight, IS-1 connections may cause undesired
current flow to the body and penetration of bodily fluid into the implant.
•
Close IS-1 connections that are not in use with IS-1 blind plugs.
23
Auto-initialization
Implantation
Auto-initialization begins automatically once the first connected lead is detected.
Auto-initialization is terminated 10 minutes after connection of the first lead. If no
other program has been transferred in the meantime, the implant subsequently
works with active automatic functions in the standard program.
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 with the following exceptions:
Behavior during
auto-initialization
•
DDD-CLS
•
VVI
•
The automatically determined lead configuration (unipolar or bipolar) is set.
•
During reprogramming: auto-initialization is canceled and the transferred
program is immediately active.
•
During testing: auto-initialization is subsequently continued.
•
During transmission of a permanent program: auto-initialization is terminated
and the transferred program is active.
24
Implantation
Precautionary Measures while Programming
Checking the
implant system
Monitoring the patient
Manually setting
lead polarity
•
After auto-initialization perform follow-up to see if the implant system is functioning properly.
•
Perform a pacing threshold test to determine the pacing threshold.
The patient could be subjected to critical states if, for example, inadequate parameters are set or due to telemetry interference during a temporary program.
•
Continuously monitor the ECG and the patient's condition.
•
Remove the programming head to a distance of at least 30 cm and the permanent program will be reactivated immediately.
Due to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing)
should only be set if bipolar leads are implanted.
Setting the
triggered pacing mode
Triggered pacing modes perform pacing regardless of intrinsic cardiac events. To
prevent undersensing due to electromagnetic interference in special cases, a triggered pacing mode can be displayed.
Avoiding
asynchronous pacing
High pacing rates with long refractory periods (a/v) can lead to intermittent, asynchronous pacing. Such programming can be contraindicated in some cases.
Setting sensing
Setting the sensitivity
Preventing implant-induced
complications
•
In order to avoid errors in manually set parameters, set automatic sensitivity
control.
•
Unsuitable far-field protection can hinder pacemaker sensing (undersensing).
A value set to < 2.5 mV/unipolar for implant 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 only be set
and retained with physician supervision.
•
Measure the retrograde conduction time.
•
If the function is not yet automatically set: activate PMT protection.
•
Set the VA criterion.
25
Information on
magnet response
Implantation
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 ppm
•
Automatic: for 10 cycles – mode D00, subsequently mode DDD without rate
adaptation; magnet rate: 10 cycles with 90 ppm, subsequently set basic rate
•
Synchronous: mode DDD without rate adaptation; magnet rate: set basic rate
Note: See information pertaining to replacement indications for magnet behavior
at ERI.
Preventing conduction
of atrial tachycardia
to the ventricle
If an ICD is implanted
at the same time,
do not permit unipolar pacing
•
If the function is not yet automatically set: activate 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.
If an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is possible to switch to unipolar pacing after a pacemaker reset or using the automatic
lead check. The ICD could therefore falsely inhibit or trigger tachyarrhythmia therapy activity.
•
Consider power consumption
and service time
Unipolar leads are not permitted in this configuration.
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 activated very early because the service time of
the battery may be reduced to less than 1 year.
26
Implantation
27
After Implantation
Follow-up
After Implantation 5365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Follow-up intervals
Follow-ups must be performed at regular agreed intervals.
•
Follow-up with
the programmer
Follow-ups with the programmer should take place in intervals between
6 to 12 months considering the expected service life of the implant.
Proceed as follows:
Record and evaluate the external ECG.
Check the pacing function.
Interrogate the implant.
Evaluate the status and automatically measured follow-up data.
Possibly evaluate statistics and Holter/IEGM recording.
Manually perform standard tests if necessary.
Possibly customize program functions and parameters.
Transmit the program permanently to the implant.
Print and document follow-up data (print report).
10
Finish the follow-up for this patient.
28
After Implantation
Notes for the Physician
Notes for patients
Possible sources
of interference
Using cellular phones
Magnet application
by patients
A patient brochure and a patient ID card are supplied with the device.
•
Provide the patient with the patient brochure and patient ID card.
•
Draw the patient's attention to prohibitory signs: places with prohibitory signs
must be avoided.
Interference can be caused by, among others, the following:
•
Household appliances
•
Safety locks or anti-theft installations
•
Strong electromagnetic fields
•
Cellular phones and transmitters
Electromagnetic interference has a temporary effect only. Generally, BIOTRONIK
implant functions return to normal when the respective cellular phone is removed
from the proximity of the implant.
•
Patients are advised to hold cellular phones to the ear opposite the side on
which the device is implanted. Cellular phones should also be kept at least
15 cm away from the implant. If the power of transmission is greater than
3 watts, they must be kept at least 30 cm away.
•
Some cellular phones emit signals when in stand-by mode, i.e., even when not
in use. Therefore, patients should not carry a cellular phone in a chest pocket
or attached to a belt or within a radius of 15 cm from the implant.
If patients are to be entrusted with magnet application, the synchronous magnet
mode 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?
•
What happens when the magnet is applied?
1 to 2 seconds
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 check-up
29
After Implantation
Replacement Indications
Pacemaker operational
status indications
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
The following are the defined pacemaker operational statuses:
ERI activation
ERI display
Change of the pacing mode
with ERI
Deactivated functions
with ERI
BOS
Beginning of Service
Battery is in good condition; normal
follow-up.
ERI
Elective Replacement
Indication
The replacement time has been reached.
The pacemaker must be replaced.
EOS
End of Service
End of service time with regular pacemaker activity.
ERI detection is automatically activated after the following events:
•
Successful auto-initialization
•
Storage for longer than 24 months
ERI is displayed as follows:
•
By a defined decrease in the basic rate as well as the magnet rate
•
After interrogation of the pacemaker
From dual-chamber modes, the pacemaker switches to single-chamber pacing.
This replacement mode depends on the programmed mode and is displayed on the
programmer.
The following functions are deactivated:
•
Atrial pacing
•
Night program
•
Rate adaptation
•
Atrial and ventricular active capture control
•
Rate fading
•
Atrial overdrive pacing
•
IEGM recordings
•
Statistics
•
Home Monitoring
•
Rate hysteresis
•
Ventricular pacing suppression
30
Rate decrease
Magnet response at ERI
After Implantation
The decrease of basic rate and magnet rate is defined as follows:
•
In the following pacing modes the pacing rate decreases by 11%: DDD(R);
DDT(R); DOO(R) VDD(R); VDI(R); VVI(R), VVT(R) AAI(R); AAT(R); AOO(R).
•
In the pacing 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.
After reaching ERI pacing is performed as follows after applying the magnet or programming head:
Magnet mode
Expected service time
after ERI
Cycles 1 to 10:
After 10th cycle:
Automatically
Asynchronous with rate at
80 ppm
Synchronous with basic rate
reduced by 4.5 to 11%
Asynchronous
Asynchronous with rate at
80 ppm
Asynchronous with rate at
80 ppm
Synchronous
Synchronous with basic rate
reduced by 4.5 to 11%
Synchronous with basic rate
reduced by 4.5 to 11%
•
The information is based on a lead impedance of 500 Ohm at 100% pacing and
the data of the battery manufacturer.
•
For a lead impedance of 300 Ohm instead of 500 Ohm, these times decrease by
max. 30%.
•
Parameter with high pulse energy: 110 ppm; 4.6 V; 1.5 ms; 500 Ohm
•
Parameter with low pulse energy: 30 ppm; 0.2 V; 0.1 ms; 500 Ohm
•
Dual-chamber implant in DDDR mode; single-chamber implant in
AAIR/VVR mode:
[in months]
ERI to EOS interval Standard program
With high pulse
energy
With low pulse
energy
Mean value
Minimum value
31
After Implantation
Explantation and Implant Replacement
Explantation
Implant replacement
•
Disconnect the leads from the header.
•
Remove the implant and, if necessary, leads using state-of-the-art technology.
•
Explants are biologically contaminated and must be disposed safely due to risk
of infection.
•
Implanted leads of a predecessor implant must be checked before they are connected to a new implant.
WARNING
Interference with functioning of the implant system
If, upon replacing the implant, predecessor leads are no longer used but left in
the patient, then an additional uncontrolled current path to the heart can result.
•
Cremation
Implants should not be cremated.
•
Disposal
Insulate connections that are not used.
Explant the implant before the cremation of a deceased patient.
BIOTRONIK takes back used products for the purpose of environmentally safe disposal.
•
Clean the explant with an at least 1% sodium-hyperchlorine solution.
•
Rinse off with water.
•
Fill out explantation form and send to BIOTRONIK together with the cleaned
implant.
32
After Implantation
33
Parameters
Pacing Modes
Parameters6365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Evia family
The following pacing modes are available:
Implant type
Pacing mode
Standard
DR(-T)
•
DDD-CLS, VVI-CLS
DDDR
•
DDDR, DDIR, DVIR, DOOR
VDDR, VDIR, VVIR, VVTR, VOOR
AAIR, AATR, AOOR
•
DDD, DDT, DDI, DVI, DOO
VDD, VDI, VVI, VVT, VOO
AAI, AAT, AOO
OFF
SR(-T)
•
VVI-CLS
•
VVIR, VOOR
AAIR*, AATR*, AOOR*
•
VVI, VVT, VOO
AAI*, AAT*, AOO*
OFF
*depends on the programmer software
Note: Home Monitoring is possible in all pacing modes.
VVIR
34
Parameters
Timing DR(-T)
Basic rate day/night
Parameter
Range of values
Standard
Basic rate
30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140
... (5) ... 200 ppm
60 ppm
Night rate
OFF;
30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140
... (5) ... 200 ppm
OFF
Night begins
00:00 ... (10 min) ... 23:59 hh:mm
22:00 hh:mm
Night ends
00:00 ... (10 min) ... 23:59 hh:mm
06:00 hh:mm
Rate hysteresis
Parameter
Range of values
Standard
Rate hysteresis
OFF;
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis
OFF; 1 ... (1) ... 15
OFF
Scan hysteresis
OFF; 1 ... (1) ... 15
OFF
Parameter
Range of values
Standard
AV delay
Low; medium; high; fixed;
individual
Low
AV delay
15 ... (5) ... 350 ms
(in 6 rate ranges)
180 ms
Sense compensation
OFF;
-10 ... (5) ... -120 ms
-45 ms
AV safety delay
100 ms
100 ms
Parameter
Range of values
Standard
AV hysteresis mode
OFF;
Negative, low; medium; high;
IRSplus
OFF
Positive repetitive
AV hysteresis
OFF;
1 ... (1) ... 10
OFF
Negative repetitive
AV hysteresis
OFF;
1 ... (1) ... 15 ... (5) ... 100 ... (10)
... 180
OFF
AV scan hysteresis
OFF;
1 ... (1) ... 10
OFF
AV delay
AV hystereses
35
Parameters
Ventricular
pacing suppression
Parameter
Range of values
Standard
Vp suppression
OFF; ON
OFF
Pacing suppression after
consecutive Vs
1 ... (1) ... 8
Pacing supports after
X-out-of-8 cycles
1; 2; 3; 4
Upper rate
Parameter
Range of values
Standard
Upper rate
90 ... (10) ... 200 ppm
130 ppm
Atrial upper rate
OFF;
240 ppm
240 ppm
Mode switching
Parameter
Range of values
Standard
Mode switching
OFF; ON
ON
Intervention rate
100 ... (10) ... 250 ppm
160 ppm
Switch to (mode)
DDI;
DDI(R) when permanent DDD(R)
VDI;
VDI(R) when permanent VDD(R)
DDIR
VDIR
Onset criterion
3 ... (1) ... 8
Resolution criterion
3 ... (1) ... 8
Change of the basic rate
with mode switching
OFF;
+5 ... (5) ... +30 ppm
+10 ppm
Rate stabilization with
mode switching
OFF; ON
OFF
Parameter
Range of values
Standard
Atrial refractory period
AUTO
AUTO
Atrial refractory period in
the modes AAI(R); AAT(R);
DDT
300 ... (25) ... 775 ms
350 ms
PVARP
AUTO;
175 ... (5) ... 600 ms
AUTO
PVARP after PVC
PVARP + 150 ms (max: 600 ms)
is automatically programmed
400 ms
Ventricular
refractory period
200 ... (25) ... 500 ms
250 ms
Refractory periods
36
Parameters
Blanking periods
Parameter
Range of values
Standard
Far-field protection after Vs
100 ... (10) ... 220 ms
100 ms
Far-field protection after Vp
100 ... (10) ... 220 ms
150 ms
Ventricular blanking after Ap 30 ... (5) ... 100 ms
30 ms
Parameter
Range of values
Standard
PMT detection/termination
OFF; ON
ON
VA criterion
250 ... (10) ... 500 ms
350 ms
PMT protection
37
Parameters
Timing SR(-T)
Basic rate day/night
Parameter
Range of values
Standard
Basic rate
30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140
... (5) ... 200 ppm
60 ppm
Night rate
OFF
30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140
... (5) ... 200 ppm
OFF
Night begins
00:00 ... (10 min) ... 23:59 hh:mm
22:00 hh:mm
Night ends
00:00 ... (10 min) ... 23:59 hh:mm
06:00 hh:mm
Parameter
Range of values
Standard
Rate hysteresis
OFF
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis
OFF; 1 ... (1) ... 15
OFF
Scan hysteresis
OFF; 1 ... (1) ... 15
OFF
Parameter
Range of values
Standard
Upper rate
90 ... (10) ... 200 ppm
130 ppm
Parameter
Range of values
Standard
Refractory period
200 ... (25) ... 500 ms
250 ms
Rate hysteresis
Upper rate
Refractory period
38
Parameters
Pacing and Sensing DR(-T)
Pulse amplitude
and pulse width
Parameter
Range of values
Standard
Pulse amplitude A
0.2 ... (0.1) ... 6.2; 7.5 V
3.0
Pulse width A
0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms
0.4 ms
Pulse amplitude V
0.2 ... (0.1) ... 6.2; 7.5 V
3.0 V
Pulse width V
0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms
0.4 ms
Parameter
Range of values
Standard
Sensitivity A
AUTO
0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mV
AUTO
Sensitivity V
AUTO
0.5 ... (0.5) ... 7.5 mV
AUTO
Parameter
Range of values
Standard
Atrial capture control
ATM (monitoring only); OFF
OFF
Min. amplitude
0.5 ... (1) ... 4.8 V
1.0 V
Threshold test start
2.4; 3.0; 3.6; 4.2; 4.8 V
3.0 V
Safety margin
0.5 ... (1) ... 1.2 V
1.0 V
Search time
Interval; time of day
Interval
Interval
0.1; 0.3; 1; 3; 6; 12; 24 h
24 h
Time of day
00:00 ... (15 min) ... 23:45
02:00
Parameter
Range of values
Standard
Ventricular capture control
ON; ATM (monitoring only); OFF
ON
Min. amplitude
0.7 V
0.7 V
Threshold test start
2.4; 3.0; 3.6; 4.2; 4.8 V
3.0 V
Safety margin
0.3 ... (1) ... 1.2 V
0.5 V
Search time
Interval; time of day
Interval
Interval
0.1; 0.3; 1; 3; 6; 12; 24 h
24 h
Time of day
00:00 ... (15 min) ... 23:45 hh:mm
02:00 hh:mm
Sensitivity
Atrial capture control
Ventricular capture control
39
Parameters
Lead configuration
Parameter
Range of values
Standard
Pacing polarity A
Unipolar; bipolar
Unipolar
Pacing polarity V
Unipolar; bipolar
Unipolar
Sensing polarity A
Unipolar; bipolar
Unipolar
Sensing polarity V
Unipolar; bipolar
Unipolar
Parameter
Range of values
IEGM recordings
20 (quantity); each max. 10 s
Types of IEGM recordings
High atrial rate (HAR)
IEGM recordings
Mode switching (MSW)
High ventricular rate (HVR)
Patient triggered (Pt.)
IEGM recording prior to event 0; 25; 50; 75; 100%
IEGM signal
Filtered; unfiltered
Parameter
Range of values
Standard
High atrial rate (HAR)
100 ... (5) ... 250 bpm
600; 572 ... 245; 240 ms
200 bpm
300 ms
High ventricular rate (HVR)
150 ... (5) ... 200 bpm
400; 378 ... 308; 300 ms
180 bpm
333 ms
HVR counter
4; 8; 12; 16
Rates for statistics
40
Parameters
Pacing and Sensing SR(-T)
Pulse amplitude
and pulse width
Parameter
Range of values
Standard
Pulse amplitude
0.2 ... (0.1) ... 6.2; 7.5 V
3.0 V
Pulse width
0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.25;
1.5 ms
0.4 ms
Parameter
Range of values
Standard
Sensitivity
AUTO
0.5 ... (0.5) ... 7.5 mV
AUTO
Parameter
Range of values
Standard
Ventricular capture control
ON; ATM (monitoring only)
OFF
ON
Min. amplitude
0.7 V
0.7 V
Threshold test start
2.4; 3.0; 3.6; 4.2; 4.8 V
3.0 V
Safety margin
0.3 ... (1) ... 1.2 V
0.5 V
Search time
Interval; time of day
Interval
Interval
0.1; 0.3; 1; 3; 6; 12; 24 h
24 h
Time of day
00:00 ... (15 min) ... 23:45 hh:mm
02:00 hh:mm
Parameter
Range of values
Standard
Pacing polarity
Unipolar; bipolar
Unipolar
Sensing polarity
Unipolar; bipolar
Unipolar
Sensitivity
Ventricular capture control
Lead configuration
IEGM recordings
Parameter
Range of values
IEGM recordings
20 (quantity); each max. 10 s
Types of IEGM recordings
High rate (HR)
Patient triggered (Pt.)
IEGM recording prior to event
0; 25; 50; 75; 100%
IEGM signal
Filtered; unfiltered
Rates for statistics
Parameter
Range of values
Standard
High rate (HR)
150 ... (5) ... 200 bpm
400; 387 ... 308; 300 ms
180 bpm
333 ms
HF counter
4; 8; 12; 16
41
Parameters
Rate Adaptation
Closed Loop Stimulation
rate adaptation
Rate adaptation
via accelerometer
CLS modes:
Parameter
Value range
Standard
Max. CLS rate
80 ... (5) ... 160 ppm
120 ppm
CLS response
Very low; low; medium; high;
very high
Medium
Resting rate control
OFF;
+10 ... (10) ... +50 ppm
+20 ppm
CLS required
Yes; no
No
R modes:
Parameter
Range of values
Standard
Sensor gain
1 ... 23
Max. activity rate
80 ... (5) ... 160 ppm
120 ppm
Automatic gain
OFF; ON
ON
Sensor threshold
Very low; low; medium; high; very
high
Medium
Rate increase
1; 2; 4; 8 ppm/cycle
4 ppm/cycle
Rate decrease
0.1; 0.2; 0.5; 1.0 ppm/cycle
0.5 ppm/
cycle
Rate fading
OFF; ON
OFF
42
Parameters
Preset Programs DR(-T)
Standard and safe program
Only the auto-initialization function is activated as a factory setting. All the other
functions of the standard program are deactivated.
Parameter
Standard program
Safe program
Mode (after auto initialization:
DDD-CLS)
DDDR
VVI
Basic rate
60 ppm
70 ppm
Night program
OFF
OFF
Rate hysteresis
OFF
OFF
Upper rate
130 ppm
—
Dynamic AV delay
Low
—
AV hysteresis
OFF
—
Sense compensation
–45 ms
—
AV safety delay
100 ms
—
Far-field protection after Vs
100 ms
—
Far-field protection after Vp
150 ms
—
Ventricular blanking period after Ap
32 ms
—
PMT protection
ON
—
VA criterion
380 ms
—
Magnet response
AUTO
AUTO
Pulse amplitude A
3.0 V
—
Pulse amplitude V
3.0 V
4.8 V
Pulse width A
0.4 ms
—
Pulse width V
0.4 ms
1.0 ms
Sensitivity A
AUTO
—
Sensitivity V
AUTO
2.5 mV
Refractory period A
AUTO
—
Refractory period V
250 ms
300 ms
Mode switching
ON
—
Onset criterion
5-out-of 8
—
Resolution criterion
5-out-of 8
—
Intervention rate
160 ppm
—
Switches to
DDIR
—
Basic rate with mode switching
+10 ppm
—
Rate stabilization with
mode switching
OFF
—
PVARP
AUTO
AUTO
PVARP after PVC
400 ms
—
43
Parameters
Parameter
Standard program
Safe program
Lead configuration, automatically determined and set:
Pacing polarity
Unipolar
Unipolar
Sensing polarity
Unipolar
Unipolar
Automatic lead check A/V
ON
ON
Active capture control
ATM
OFF
IEGM recording (HAR)
ON
OFF
Home Monitoring
OFF
OFF
44
Parameters
Preset Programs SR(-T)
Standard and safe program
Only the auto-initialization function is activated as a factory setting. All the other
functions of the standard program are deactivated.
Parameter
Standard program
Safe program
Mode (after auto initialization: VVI)
VVI
VVI
In the AAI mode, the safe program is also
AAI.
Basic rate
60 ppm
70 ppm
Night program
OFF
OFF
Rate hysteresis
OFF
OFF
Magnet response
AUTO
AUTO
Pulse amplitude
3.0 V
4.8 V
Pulse width
0.4 ms
1.0 ms
Sensitivity
AUTO
2.5 ms
Refractory period
250 ms
300 ms
Lead configuration, automatically determined and set
Pacing polarity
Unipolar
Unipolar
Sensing polarity
Unipolar
Unipolar
Automatic lead check
ON
ON
Active capture control
ATM
OFF
IEGM recording
ON
OFF
Home Monitoring
OFF
OFF
45
Parameters
Tolerances of Parameter Values
DR(-T)
Parameter
Range of values
Tolerance
Basic rate
30 ... 100 ppm
+/-1.5 ppm
102 ... 195 ppm
+/-2.0 ppm
200 ppm
+0.0/-3.0 ppm
Basic interval
1000 ms
+/-20 ms
Magnet rate
90 ppm
+/-1.5 ppm
Magnet interval
664 ms
+/-20 ms
AV delay
15 ... 350 ms
+20/-5 ms
A/V pulse amplitude
0.2 V
+/-0.10 V
0.3 ... 7.5 V
+20/-25%
0.1 ... 0.4 ms
+/-0.04 ms
0.5 ... 1.0 ms
+/-0.10 ms
1.25 ... 1.5 ms
+/-0.15 ms
Sensitivity A
45502-2-1 Delta pulse
0.1 ... 0.5 mV
+/-0.10 mV
0,6 ... 7.5 mV
+/-20%
Sensitivity V
45502-2-1 Delta pulse
0.5 ... 7,5 mV
+/-20%
Refractory period A
300 ... 775 ms
+10/-30 ms
Refractory period V
200 ... 500 ms
+10/-30 ms
A/V pulse duration
PVARP
175 ... 600 ms
+10/-30 ms
PVARP after PVC
325 ... 600 ms
+10/-30 ms
Max. activity rate
80 ... 100 ppm
+/-1.5 ppm
105 ... 160 ppm
+/-2.0 ppm
90 ... 190 ppm
+/-2.0 ppm
200 ppm
+0/-2.0 ppm
High rate protection
200 ppm
+20/-0 ppm
Lead impedance
100 ... 200 Ohm
+/-50 Ohm
201 ... 2500 Ohm
+/-25%
Upper rate
46
Parameters
SR(-T)
Parameter
Range of values
Tolerance
Basic rate
30 ... 100 ppm
+/-1.5 ppm
102 ... 195 ppm
+/-2.0 ppm
200 ppm
+0.0/-3.0 ppm
Basic interval
1000 ms
+/-20 ms
Magnet rate
90 ppm
+/-1.5 ppm
Magnet interval
664 ms
+/-20 ms
Pulse amplitude
0.2 V
+/-0.10 V
0.3 ... 7.5 V
+20/-25%
0.1 ... 0.4 ms
+/-0.04 ms
0.5 ... 1.0 ms
+/-0.10 ms
1.25 ... 1.5 ms
+/-0.15 ms
Sensitivity
45502-2-1 Delta pulse
0.5 ... 7.5 mV
+/-20%
Refractory period
200 ... 500 ms
+10/-30 ms
Max. activity rate
80 ... 100 ppm
+/-1.5 ppm
105 ... 160 ppm
+/-2.0 ppm
High rate protection
200 ppm
+20/-0 ppm
Lead impedance
100 ... 200 Ohm
+/-50 Ohm
201 ... 2500 Ohm
+/-25%
Pulse width
47
Technical Data
Technical Data7365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
Mechanical Characteristics
Measurements for
the housing
The measurements refer to the housing without header.
Implant
W x H x D [mm]
Volume [cm3]
Mass [g]
DR-T
53 x 44.5 x 6.5
12
25
DR
53 x 43 x 6.5
11
26
SR-T
53 x 39 x 6.5
11
24
SR
53 x 39 x 6.5
10
25
Radiopaque marker
BIO SF
Materials in contact
with body tissue
•
Housing: titanium
•
Header: epoxy resin
•
Sealing plug: silicone
•
Coating, if applicable: silicone
FCC Statement
(FCC ID: QRIPRIMUS) 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.
48
Technical Data
Electrical Characteristics
Components
and input values
Housing shape
Electrically
conductive surface
Pulse form
Electrical characteristics determined at 37°C, 500 Ohm
Circuit
Hybrid electronics with VLSI-CMOS
chip
Input impedance
> 10 kOhm
Pulse form
Biphasic, asymmetric
Polarity
Cathodic
The implant housing has the following shape:
Implant type
DR(-T), SR(-T)
Uncoated
Flattened ellipsoid
Coated
Ellipse
The implant housing has the following surface:
Implant type
DR(-T), SR(-T)
Uncoated [cm2]
33
Coated [cm2]
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
Telemetry
All variants of BIOTRONIK implants comply with the requirements of
prEN 45502-2-2: 2006, Section 27.5.1 at the highest sensitivity.
Telemetry data for Home Monitoring:
Nominal carrier frequency
Maximum power of transmission
403.62 MHz
< 25 μW
-16 dBm
49
Technical Data
Battery Data
Battery type characteristics
Power consumption
The following data is entered by the manufacturer:
Manufacturer
GREATBATCH, INC.
Clarence, NY 14031, USA
LITRONIK GmbH
01796 Pirna, Germany
Battery type
GB 8431
GB 2596
LiS 3150
LiS 3150M
System
LiJ
Ag/SVO/CFx
QMR®
LiJ
LiMn02
Implant
DR
SR
DR-T
SR-T
DR
SR
DR-T
SR-T
Battery voltage
at BOS
2.8 V
3.0 V
2.8 V
3.1 V
Open-circuit voltage
2.8 V
3.0 V
2.8 V
3.1 V
Nominal capacity
1.3 Ah
1.3 Ah
1.3 Ah
1.2 Ah
Usable capacity
until EOS
1.2 Ah
1.1 Ah
1.2 Ah
1.0 Ah
The implant has the following power consumption:
Power consumption
DR(-T)
SR(-T)
BOS, inhibited
6 μA
6 μA
BOS, 100% pacing
13 μA
9 μA
Average service time
Average service times are precalculated using the battery manufacturer's technical
specifications, a basic rate of 60 ppm and the setting of different pulse amplitudes
and lead impedances.
Service times DR(-T)
For dual-chamber implants, the following times (in years) result:
Amplitude Impedance Pacing
[Ohms]
10%
1.5 V
2.5 V
3.0 V
3.5 V
5.0 V
50%
100%
DR-T
DR
DR-T
DR
DR-T
DR
500
19.3
17.8
17.2
15.8
15.0
13.9
1000
19.7
18.0
18.3
16.9
17.0
15.7
500
17.8
16.6
13.6
12.8
9.4
10.0
1000
18.8
17.4
15.3
14.9
12.5
12.7
500
17.3
15.8
11.8
10.9
8.5
7.8
1000
18.5
16.9
14.6
13.4
11.6
10.7
500
16.5
15.1
10.4
9.7
7.2
6.6
1000
18.0
16.5
13.4
12.4
10.2
9.4
500
12.4
12.1
5.4
6.2
3.2
3.8
1000
15.2
14.6
8.3
9.2
5.3
6.3
50
Service times SR(-T)
Technical Data
For single-chamber implants, the following times (in years) result:
Amplitude
1.5 V
2.5 V
3.0 V
3.5 V
5.0 V
Shortening
of the service time
after long storage period
Impedance
[Ohms]
Pacing
10%
50%
100%
SR-T
SR
SR-T
SR
SR-T
SR
500
23.3
21.3
21.7
19.8
19.9
18.3
1000
23.6
21.5
22.7
20.7
21.6
19.8
500
22.1
20.3
17.8
17.3
14.3
14.6
1000
22.8
21.0
20.2
19.2
17.5
17.2
500
21.7
19.8
16.8
15.5
13.2
12.2
1000
22.7
20.7
19.5
17.8
16.6
15.3
500
20.9
19.1
15.3
14.2
11.5
10.7
1000
22.3
20.3
18.4
16.9
15.1
13.9
500
17.2
16.3
9.1
10.1
5.7
6.8
1000
19.8
18.7
12.8
13.7
8.9
10.2
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:
— DR(-T) by 6 months
— SR(-T) by 8 months
•
After 1.5 years:
— DR(-T) by 9 months
— SR(-T) by 12 months
51
Technical Data
Country-Related Information
International certification
Industry Canada
Other notes specific to each country will follow in the course of international product certification.
Telemetry data
•
This device may not interfere with stations operating in the rate range of
400.150 - 406.000 MHz in the meteorological aids, meteorological-satellite, and
earth exploration-satellite services and must accept any interference received,
including interference that may cause undesired operation.
•
This implant will be registered with Industry Canada under the following
number:
IC: 4708A-PRIMUS
•
China
25
The code IC in front of the certification/ registration number only indicates that
the technical requirements for Industry Canada are met.
The following provides information according to the ordinance no. 39 issued by the
'Ministry for Industry and Information Technology' of the People's Republic of
China pertaining to the materials which are contained in BIOTRONIK's pacemakers, ICDs and external devices:
Dangerous material
In PCBs
In cables
Lead
Pb
Yes (soldering agent)
Yes
Mercury
Hg
No
No
Cadmium
Cd
No
No
Chrome compounds
Cr6+
No
No
Polybrominated biphenyls
PBB
No
No
Polybrominated diphenyl ether
PBDE
No
No
52
Technical Data
Legend for the Label
The label icons symbolize the following:
Manufacturing date
Expiration date:
Use by
Storage temperature
BIOTRONIK order number
Serial number
Product identification number
Sterilization with ethylene oxide
Resterilization prohibited
STERILIZE
Not for reuse
Non-sterile
NON
STERILE
Usage information
Contents
Do not use if packaging is damaged.
European approval mark
Non-ionizing radiation
53
Technical Data
Transfer sheath for leads with PIN-lock PE lead connector (5 mm) to connect to pacemakers with PEC
sockets (6 mm)
Implant with NBG encoding and name of compatible
leads (example)
Silicone-coated implant with NBG encoding and designation of the compatible leads (example)
Screwdriver
DDDR
Position of connector ports in the header (example)
IS-1
Unipolar IS-1 connector
Bipolar IS-1 connector
Atrium
Ventricle
UNI/BI
Unipolar/bipolar configuration
Vp
Vs
Ventricular pace
Ventricular sense
Ap
As
Atrial pace
Atrial sense
54
Technical Data

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