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

BIOTRONIK SE & Co. KG PRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers QRIPRIMUS UserMan

Contents

QRIPRIMUS UserMan

BIOTRONIK GmbH & Co. KGWoermannkehre 112359 Berlin · GermanyTel+49 (0) 30 68905–0Fax+49 (0) 30 6852804sales@biotronik.comwww.biotronik.comCardiac Rhythm ManagementBradycardia therapyTechnical ManualEviaPacemaker with automatic Functionsand BIOTRONIK Home Monitoring®© BIOTRONIK GmbH & Co. KG All rights reserved. Specifi cations subject to modifi cation, revision and improvement. 2009-D-xx® BIOTRONIK Home Monitoring and Entovis are registered trademarks of BIOTRONIK GmbH & Co. KG 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 equip- ment. It was approved by independent Notifi ed 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.9365353--A_GA_Evia_A6_Cover_PB.in1-2 1-2 23.04.2009 15:45:24
sbiotronikEvia DR-T, DR, SR-T, SRPacemaker Bradycardia therapy Technical manual for the implantDoc. Id.: 365353-AIndex 365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SR
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3Table of Contents Table of ContentsTable of Contents Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Implant Variants and NBG Codes . . . . . . . . . . . . . . . . . . . . . . 8Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . 9Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Possible Medical Complications. . . . . . . . . . . . . . . . . . . . . . 13Possible Technical Complications . . . . . . . . . . . . . . . . . . . . 14Possible Electromagnetic Complications . . . . . . . . . . . . . . 15Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Prior to Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Indications and Contraindications . . . . . . . . . . . . . . . . . . . . 17Ambient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Preparing the Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . 20Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Implanting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Connecting PM Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Precautionary Measures while Programming . . . . . . . . . . 24After Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Notes for the Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Explantation and Implant Replacement. . . . . . . . . . . . . . . . 31
4Table of ContentsParameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Timing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Timing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Pacing and Sensing DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . 38Pacing and Sensing SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . 40Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Preset Programs DR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Preset Programs SR(-T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . . 45Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . 47Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . 51Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
51 Product Description Product Description1365353-ATechnical manual for the implan tEvia DR-T, DR, SR-T, SRIntended Medical UseIntended use Evia is a family of implantable pacemakers that may be implanted for all bradycar-dia arrhythmia indications. The primary objective of the therapy consists of improv-ing 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 pacingDiagnosis and therapy formsThe cardiac rhythm is automatically monitored and bradycardia arrhythmias are treated. All major therapeutic approaches from the field of cardiology and electro-physiology are unified in the Evia family.BIOTRONIK Home Monitoring® enables physicians to perform therapy manage-ment any time.Required expertise In addition to having basic medical knowledge, the user must be thoroughly famil-iar with the operation of an implant system. Only qualified medical specialists hav-ing 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.
6Product DescriptionSystem OverviewParts 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 programsImplant 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 maneu-vered, 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 pro-gram 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
7Product DescriptionBIOTRONIK 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 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 imme-diately 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.Technical manuals 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
8Product DescriptionImplant Variants and NBG CodesEvia family The following implant variants are available: NBG-Code for Evia DR(-T) The NBG code for dual-chamber implants is DDDR: NBG-Code for Evia SR(-T) The NBG code for single-chamber implants is AAIR or VVIR: Implant type Variant with Home Monitoring Variant without Home MonitoringDual-chamber Evia DR-T Evia DRSingle-chamber Evia SR-T Evia SRNote: The setting of the pacing mode depends on the individual diagnosis; the modes are listed in the section pertaining to adjustable parameters.D Pacing in both chambersD Sensing in both chambersD Pulse inhibition and pulse triggeringR Rate adaptationA/V Pacing in one chamberA/V Sensing in one chamberI Pulse inhibition in A/VR Rate adaptation
9Product DescriptionDiagnostic and Therapy FunctionsGeneral 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 implant automatically detects the implanted leads, sets the polarity and activates the automatic functions after 10 min.Diagnostic functions • Data from the last 10 interrogations and follow-ups are recorded as well as arrhythmia episodes; they are stored together with other data to assess patients and the state of the 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.Antibradycardia pacing • 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 require-ment 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 auto-matically 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 Product DescriptionHome Monitoring The implant automatically sends information to the transmitter once a day. Addi-tionally, the test messages can be initiated using the programmer. Important med-ical 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 encour-aged 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 DescriptionScope of DeliveryStandard The storage package includes the following:• Implant in sterile packaging• Patient's manual• Serial number label• Patient ID card• Warranty card• Technical manualThe sterile container contains the following:• Implant• ScrewdriverOrder numbers Evia The implants can be obtained as follows: Accessories 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 transmittersImplant Order number: uncoated Order number: coatedDR-T 359529 359530DR 359524 359528SR-T 359533 359534SR 359531 359532
12 Product Description
132 General Safety Instructions General Safety Instructions2365353-ATechnical manual for the im plantEvia DR-T, DR, SR-T , SRPossible Medical ComplicationsGeneral information on medical complicationsComplications for patients and implant systems generally recognized among prac-titioners also apply to BIOTRONIK implants.• Normal complications may include fluid accumulation within the implant pocket, infections, or tissue reactions. Primary sources of complication infor-mation 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 electrophysiolog-ical 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 stimulationAn 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 InstructionsPossible Technical ComplicationsTechnical 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 InstructionsPossible Electromagnetic ComplicationsElectromagnetic 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 gen-erally assumed that EMI produces only minor symptoms in patients - if any.• Depending on the pacing mode and the type of interference, sources of interfer-ence may lead to pulse inhibition or triggering, an increase in the sensor-dependent 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 dura-tion 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 InstructionsPossible RisksRisky diagnostic and therapeutic proceduresIf electrical current from an external source is conducted through the body for diag-nostic or therapeutic purposes, then the implant can be subjected to interference and the patient placed at risk. Therefore the following always applies:• Monitor the patient.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, sens-ing properties and pacing thresholds may change. • 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.Contraindicated procedures The following procedures are contraindicated:• Therapeutic ultrasound and diathermy: damage to the patient via excess warm-ing 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 pressureMagnetic resonance imagingMagnetic resonance imaging is contraindicated due to the associated magnetic flux density: damage or destruction of the implant system by strong magnetic interac-tion and damage to the patient by excessive warming of the body tissue in the area surrounding the implant system. • Under certain conditions one can perform special measures with magnetic res-onance imaging to protect the patient and implant.Therapeutic ionizing radiationRadiation can cause latent damage. This damage cannot be recognized immedi-ately. 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.
173 Prior to Implantation Prior to Implantation3365353-ATechnical manual for the impla ntEvia DR-T, DR, SR-T , SRIndications and ContraindicationsGuidelines of cardiologic societiesGenerally approved differential diagnostics methods, indications, and recommen-dations 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 Asso-ciation (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 ImplantationAmbient ConditionsTemperature 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)Storage location • Implants are not to be stored close to magnets or sources of electromagnetic interference.Storage period The duration of storage affects the service time of the battery of the implant (see battery data).
19 Prior to ImplantationSterilityDelivery 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. Sterile container 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.Single use only 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 ImplantationPreparing the ImplantationHave 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 electrodesUnpacking the implant Proceed as follows: WARNINGInadequate therapy due to defective implant If an unpacked implant is dropped on a hard surface during handling, electronic parts could be damaged. • Use a replacement implant.• Send the damaged implant to BIOTRONIK.1 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.2 Use the gripping tab on the inner plastic container to remove it from the outer plastic container.3 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.
214 Implantation Implantation4365353-ATechnical manual for the implantEvi a DR-T, DR, SR-T, SRImplantingImplantation site 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.Sequence Proceed as follows: 1 Shape the implant pocket and prepare the vein.2 Implant the leads and perform measurements.3 Connect implant and leads.The implant starts auto-initialization on its own.4 Insert the implant.5 Guide the fixation suture through the opening in the header and fixate the implant in the prepared pocket.6 Close the implant pocket.7 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 auto-initialization.
22 ImplantationConnecting PM LeadsConnection options BIOTRONIK pacemakers are designed for leads with unipolar or bipolar IS-1 con-nection. A unipolar or bipolar lead can be connected to Evia for sensing and pacing: Connection schemes Connection scheme for dual-chamber and single-chamber implants: Connecting the lead connector to the implantProceed as follows: DR-T and DR SR-T and SRAtrium IS-1 unipolar or bipolarVentricleNote: Use only adapters approved by BIOTRONIK for leads with different connec-tions.• If you have any questions concerning the compatibility of other manufactur-ers' leads, please contact BIOTRONIK.DR-T and DR SR-T and SRDDDRAIS-1VVIR/AAIRIS-11 Disconnect stylets and insertion aids from the lead connector.2 • Connect the unipolar or bipolar IS-1 lead connector atrium to A.• Connect the unipolar or bipolar IS-1-lead connector ventricle to V.3 Push the lead connector into the header without bending the conduc-tor until the connector tip becomes visible behind the set screw block.4 If the lead connector cannot be inserted completely, the set screw may be protruding into the cavity 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 you withdraw the screwdriver, the silicone plug automati-cally seals the lead connection safely.WARNINGShort circuit due to open lead connectionsOpen, 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 ImplantationAuto-initialization 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.Behavior during auto-initialization• 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.Note: After auto-initialization, all parameters are activated as in the standard program with the following exceptions:• DDD-CLS• VVI• The automatically determined lead configuration (unipolar or bipolar) is set.
24 ImplantationPrecautionary Measures while ProgrammingChecking the implant system• After auto-initialization perform follow-up to see if the implant system is func-tioning properly.• Perform a pacing threshold test to determine the pacing threshold.Monitoring the patient The patient could be subjected to critical states if, for example, inadequate param-eters 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 perma-nent program will be reactivated immediately.Manually setting lead polarityDue 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 modeTriggered pacing modes perform pacing regardless of intrinsic cardiac events. To prevent undersensing due to electromagnetic interference in special cases, a trig-gered pacing mode can be displayed. Avoiding asynchronous pacingHigh pacing rates with long refractory periods (a/v) can lead to intermittent, asyn-chronous pacing. Such programming can be contraindicated in some cases.Setting sensing • In order to avoid errors in manually set parameters, set automatic sensitivity control.• Unsuitable far-field protection can hinder pacemaker sensing (undersensing).Setting the sensitivity 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.Preventing implant-induced complications• Measure the retrograde conduction time.• If the function is not yet automatically set: activate PMT protection.• Set the VA criterion.
25 ImplantationInformation on magnet responseApplying 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 ratePreventing conduction of atrial tachycardia to the ventricle• 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 ven-tricular-controlled modes.If an ICD is implanted at the same time, do not permit unipolar pacingIf an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is pos-sible to switch to unipolar pacing after a pacemaker reset or using the automatic lead check. The ICD could therefore falsely inhibit or trigger tachyarrhythmia ther-apy activity.• Unipolar leads are not permitted in this configuration.Consider power consumption and service timeThe pacemaker permits programming of high pulse amplitudes with long pulse widths at high rates to be able to adequately treat even rare diagnoses. In combina-tion 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.Note: See information pertaining to replacement indications for magnet behavior at ERI.
26 Implantation
275 After Implantation After Implantation 5365353-ATechnical manual for the implan tEvia DR-T, DR, SR-T, SRFollow-upFollow-up intervals Follow-ups must be performed at regular agreed intervals.• Follow-ups with the programmer should take place in intervals between 6 to 12 months considering the expected service life of the implant.Follow-up withthe programmerProceed as follows: 1 Record and evaluate the external ECG.2 Check the pacing function.3 Interrogate the implant.4 Evaluate the status and automatically measured follow-up data.5 Possibly evaluate statistics and Holter/IEGM recording.6 Manually perform standard tests if necessary.7 Possibly customize program functions and parameters.8 Transmit the program permanently to the implant.9 Print and document follow-up data (print report).10 Finish the follow-up for this patient.
28 After ImplantationNotes for the PhysicianNotes for 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. Possible sources of interferenceInterference can be caused by, among others, the following:• Household appliances• Safety locks or anti-theft installations• Strong electromagnetic fields• Cellular phones and transmitters Using cellular phones 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.Magnet application by patientsIf 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?1 to 2 seconds• 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 check-up
29 After ImplantationReplacement IndicationsPacemaker operational status indicationsThe time span from the beginning of service (BOS) to elective replacement indica-tion (ERI) is determined by, among others, the following:• Battery capacity• Lead impedance• Pacing program• Pacing to inhibition ratio• Pacemaker circuit propertiesThe following are the defined pacemaker operational statuses: ERI activation ERI detection is automatically activated after the following events:• Successful auto-initialization• Storage for longer than 24 monthsERI display ERI is displayed as follows:• By a defined decrease in the basic rate as well as the magnet rate• After interrogation of the pacemakerChange of the pacing mode with ERIFrom dual-chamber modes, the pacemaker switches to single-chamber pacing. This replacement mode depends on the programmed mode and is displayed on the programmer.Deactivated functions with ERIThe 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 suppressionBOS Beginning of Service Battery is in good condition; normal follow-up.ERI Elective Replacement IndicationThe replacement time has been reached. The pacemaker must be replaced.EOS End of Service End of service time with regular pace-maker activity.
30 After ImplantationRate decrease 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.Magnet response at ERI After reaching ERI pacing is performed as follows after applying the magnet or pro-gramming head: Expected service time after ERI• 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] Magnet modeCycles 1 to 10: After 10th cycle:Automatically Asynchronous with rate at 80 ppmSynchronous with basic rate reduced by 4.5 to 11%Asynchronous Asynchronous with rate at 80 ppmAsynchronous with rate at 80 ppmSynchronous Synchronous with basic rate reduced by 4.5 to 11%Synchronous with basic rate reduced by 4.5 to 11%ERI to EOS interval Standard program With high pulse energy With low pulse energyMean value 8 8 8Minimum value 6 6 6
31 After ImplantationExplantation and Implant ReplacementExplantation • 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. Implant replacement • Implanted leads of a predecessor implant must be checked before they are con-nected to a new implant.Cremation Implants should not be cremated.• Explant the implant before the cremation of a deceased patient.Disposal BIOTRONIK takes back used products for the purpose of environmentally safe dis-posal.• 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.WARNING Interference with functioning of the implant systemIf, 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.• Insulate connections that are not used.
32 After Implantation
336 Parameters Parameters6365353-ATechnical manual for the implantEvia DR-T, DR, SR-T, SRPacing ModesEvia family The following pacing modes are available: Implant type Pacing mode StandardDR(-T) • DDD-CLS, VVI-CLS• DDDR, DDIR, DVIR, DOORVDDR, VDIR, VVIR, VVTR, VOORAAIR, AATR, AOOR• DDD, DDT, DDI, DVI, DOOVDD, VDI, VVI, VVT, VOOAAI, AAT, AOOOFFDDDRSR(-T) • VVI-CLS• VVIR, VOORAAIR*, AATR*, AOOR* • VVI, VVT, VOOAAI*, AAT*, AOO*OFF*depends on the programmer softwareVVIRNote: Home Monitoring is possible in all pacing modes.
34 ParametersTiming DR(-T)Basic rate day/nightRate hysteresisAV delayAV hysteresesParameter Range of values StandardBasic rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppm60 ppmNight rate OFF; 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppmOFFNight begins 00:00 ... (10 min) ... 23:59 hh:mm 22:00 hh:mmNight ends 00:00 ... (10 min) ... 23:59 hh:mm 06:00 hh:mmParameter Range of values StandardRate hysteresis OFF; -5 ... (-5) ... -90 ppmOFFRepetitive hysteresis OFF; 1 ... (1) ... 15 OFFScan hysteresis OFF; 1 ... (1) ... 15 OFFParameter Range of values StandardAV delay Low; medium; high; fixed; individualLowAV delay 15 ... (5) ... 350 ms (in 6 rate ranges)180 msSense compensation OFF;-10 ... (5) ... -120 ms-45 msAV safety delay 100 ms 100 msParameter Range of values StandardAV hysteresis mode OFF;Negative, low; medium; high; IRSplus OFFPositive repetitive AV hysteresisOFF;1 ... (1) ... 10OFFNegative repetitive AV hysteresisOFF;1 ... (1) ... 15 ... (5) ... 100 ... (10) ... 180OFFAV scan hysteresis OFF; 1 ... (1) ... 10 OFF
35 ParametersVentricular pacing suppressionUpper rateMode switchingRefractory periodsParameter Range of values StandardVp suppression OFF; ON OFFPacing suppression after consecutive Vs1 ... (1) ... 8 6Pacing supports after X-out-of-8 cycles1; 2; 3; 4 3Parameter Range of values StandardUpper rate 90 ... (10) ... 200 ppm 130 ppmAtrial upper rate OFF; 240 ppm240 ppmParameter Range of values StandardMode switching OFF; ON ONIntervention rate 100 ... (10) ... 250 ppm 160 ppmSwitch to (mode) DDI; DDI(R) when permanent DDD(R)VDI; VDI(R) when permanent VDD(R)DDIRVDIROnset criterion 3 ... (1) ... 8 5Resolution criterion 3 ... (1) ... 8 5Change of the basic rate with mode switchingOFF; +5 ... (5) ... +30 ppm+10 ppmRate stabilization with mode switchingOFF; ON OFFParameter Range of values StandardAtrial refractory period AUTO AUTOAtrial refractory period in the modes AAI(R); AAT(R); DDT300 ... (25) ... 775 ms 350 msPVARP AUTO; 175 ... (5) ... 600 msAUTOPVARP after PVC PVARP + 150 ms (max: 600 ms) is automatically programmed400 msVentricular refractory period200 ... (25) ... 500 ms 250 ms
36 ParametersBlanking periodsPMT protectionParameter Range of values StandardFar-field protection after Vs100 ... (10) ... 220 ms 100 msFar-field protection after Vp100 ... (10) ... 220 ms 150 msVentricular blanking after Ap30 ... (5) ... 100 ms 30 msParameter Range of values StandardPMT detection/termination OFF; ON ONVA criterion 250 ... (10) ... 500 ms 350 ms
37 ParametersTiming SR(-T)Basic rate day/nightRate hysteresisUpper rate Refractory periodParameter Range of values StandardBasic rate 30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppm60 ppmNight rate OFF30 ... (1) ... 90 ... (2) ... 122 ... (3) ... 140 ... (5) ... 200 ppmOFFNight begins 00:00 ... (10 min) ... 23:59 hh:mm 22:00 hh:mmNight ends 00:00 ... (10 min) ... 23:59 hh:mm 06:00 hh:mmParameter Range of values StandardRate hysteresis OFF-5 ... (-5) ... -90 ppmOFFRepetitive hysteresis OFF; 1 ... (1) ... 15 OFFScan hysteresis OFF; 1 ... (1) ... 15 OFFParameter Range of values StandardUpper rate 90 ... (10) ... 200 ppm 130 ppmParameter Range of values StandardRefractory period 200 ... (25) ... 500 ms 250 ms
38 ParametersPacing and Sensing DR(-T) Pulse amplitude and pulse widthSensitivityAtrial capture controlVentricular capture controlParameter Range of values StandardPulse 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 msPulse amplitude V 0.2 ... (0.1) ... 6.2; 7.5 V 3.0 VPulse width V 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 msParameter Range of values StandardSensitivity A AUTO0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mVAUTOSensitivity V AUTO0.5 ... (0.5) ... 7.5 mVAUTOParameter Range of values StandardAtrial capture control ATM (monitoring only); OFF OFFMin. amplitude 0.5 ... (1) ... 4.8 V 1.0 VThreshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.0 VSafety margin 0.5 ... (1) ... 1.2 V 1.0 VSearch time Interval; time of day IntervalInterval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 hTime of day 00:00 ... (15 min) ... 23:45 02:00Parameter Range of values StandardVentricular capture control ON; ATM (monitoring only); OFF ONMin. amplitude 0.7 V 0.7 VThreshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.0 VSafety margin 0.3 ... (1) ... 1.2 V 0.5 VSearch time Interval; time of day IntervalInterval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 hTime of day 00:00 ... (15 min) ... 23:45 hh:mm 02:00 hh:mm
39 ParametersLead configurationIEGM recordingsRates for statisticsParameter Range of values StandardPacing polarity A Unipolar; bipolar UnipolarPacing polarity V Unipolar; bipolar UnipolarSensing polarity A Unipolar; bipolar UnipolarSensing polarity V Unipolar; bipolar UnipolarParameter Range of valuesIEGM recordings 20 (quantity); each max. 10 sTypes of IEGM recordings High atrial rate (HAR)Mode switching (MSW)High ventricular rate (HVR)Patient triggered (Pt.)IEGM recording prior to event 0; 25; 50; 75; 100%IEGM signal Filtered; unfilteredParameter Range of values StandardHigh atrial rate (HAR) 100 ... (5) ... 250 bpm600; 572 ... 245; 240 ms200 bpm300 msHigh ventricular rate (HVR) 150 ... (5) ... 200 bpm400; 378 ... 308; 300 ms180 bpm333 msHVR counter 4; 8; 12; 16 8
40 ParametersPacing and Sensing SR(-T) Pulse amplitude and pulse widthSensitivityVentricular capture controlLead configurationIEGM recordingsRates for statisticsParameter Range of values StandardPulse amplitude 0.2 ... (0.1) ... 6.2; 7.5 V 3.0 VPulse width 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.25; 1.5 ms0.4 msParameter Range of values StandardSensitivity AUTO 0.5 ... (0.5) ... 7.5 mVAUTOParameter Range of values StandardVentricular capture control ON; ATM (monitoring only)OFFONMin. amplitude 0.7 V 0.7 VThreshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.0 VSafety margin 0.3 ... (1) ... 1.2 V 0.5 VSearch time Interval; time of day IntervalInterval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 hTime of day 00:00 ... (15 min) ... 23:45 hh:mm 02:00 hh:mmParameter Range of values StandardPacing polarity Unipolar; bipolar UnipolarSensing polarity Unipolar; bipolar UnipolarParameter Range of valuesIEGM recordings 20 (quantity); each max. 10 sTypes of IEGM recordings High rate (HR)Patient triggered (Pt.)IEGM recording prior to event 0; 25; 50; 75; 100%IEGM signal Filtered; unfilteredParameter Range of values StandardHigh rate (HR) 150 ... (5) ... 200 bpm400; 387 ... 308; 300 ms180 bpm333 msHF counter 4; 8; 12; 16 8
41 ParametersRate Adaptation Closed Loop Stimulation rate adaptationCLS modes: Rate adaptation via accelerometerR modes: Parameter Value range StandardMax. CLS rate 80 ... (5) ... 160 ppm 120 ppmCLS response Very low; low; medium; high; very highMediumResting rate control OFF;+10 ... (10) ... +50 ppm+20 ppmCLS required Yes; no NoParameter Range of values StandardSensor gain 1 ... 23 4Max. activity rate 80 ... (5) ... 160 ppm 120 ppmAutomatic gain OFF; ON ONSensor threshold Very low; low; medium; high; very highMediumRate increase 1; 2; 4; 8 ppm/cycle 4 ppm/cycleRate decrease 0.1; 0.2; 0.5; 1.0 ppm/cycle 0.5 ppm/cycleRate fading OFF; ON OFF
42 ParametersPreset 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 programMode (after auto initialization: DDD-CLS)DDDR VVIBasic rate 60 ppm 70 ppmNight program OFF OFFRate hysteresis OFF OFFUpper rate 130 ppm —Dynamic AV delay Low —AV hysteresis OFF —Sense compensation –45 ms —AV safety delay 100 ms —Far-field protection after Vs100 ms —Far-field protection after Vp150 ms —Ventricular blanking period after Ap32 ms —PMT protection ON —VA criterion 380 ms —Magnet response AUTO AUTOPulse amplitude A 3.0 V —Pulse amplitude V 3.0 V 4.8 VPulse width A 0.4 ms —Pulse width V 0.4 ms 1.0 msSensitivity A AUTO —Sensitivity V AUTO 2.5 mVRefractory period A AUTO —Refractory period V 250 ms 300 msMode 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 switchingOFF —PVARP AUTO AUTOPVARP after PVC 400 ms —
43 ParametersLead configuration, automatically determined and set:Pacing polarity Unipolar UnipolarSensing polarity Unipolar UnipolarAutomatic lead check A/V ON ONActive capture control ATM OFFIEGM recording (HAR) ON OFFHome Monitoring OFF OFFParameter Standard program Safe program
44 ParametersPreset 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 programMode (after auto initialization: VVI) VVI VVIIn the AAI mode, the safe program is also AAI.Basic rate 60 ppm 70 ppmNight program OFF OFFRate hysteresis OFF OFFMagnet response AUTO AUTOPulse amplitude 3.0 V 4.8 VPulse width 0.4 ms 1.0 msSensitivity AUTO 2.5 msRefractory period 250 ms 300 msLead configuration, automatically determined and setPacing polarity Unipolar UnipolarSensing polarity Unipolar UnipolarAutomatic lead check ON ONActive capture control ATM OFFIEGM recording ON OFFHome Monitoring OFF OFF
45 ParametersTolerances of Parameter ValuesDR(-T)Parameter Range of values ToleranceBasic rate 30 ... 100 ppm +/-1.5 ppm102 ... 195 ppm +/-2.0 ppm200 ppm +0.0/-3.0 ppmBasic interval 1000 ms +/-20 msMagnet rate 90 ppm +/-1.5 ppmMagnet interval 664 ms +/-20 msAV delay 15 ... 350 ms +20/-5 msA/V pulse amplitude 0.2 V +/-0.10 V0.3 ... 7.5 V +20/-25%A/V pulse duration 0.1 ... 0.4 ms +/-0.04 ms0.5 ... 1.0 ms +/-0.10 ms1.25 ... 1.5 ms +/-0.15 msSensitivity A45502-2-1 Delta pulse0.1 ... 0.5 mV +/-0.10 mV0,6 ... 7.5 mV +/-20%Sensitivity V45502-2-1 Delta pulse0.5 ... 7,5 mV +/-20%Refractory period A 300 ... 775 ms +10/-30 msRefractory period V 200 ... 500 ms +10/-30 msPVARP 175 ... 600 ms +10/-30 msPVARP after PVC 325 ... 600 ms +10/-30 msMax. activity rate 80 ... 100 ppm +/-1.5 ppm105 ... 160 ppm +/-2.0 ppmUpper rate 90 ... 190 ppm +/-2.0 ppm200 ppm +0/-2.0 ppmHigh rate protection 200 ppm +20/-0 ppmLead impedance 100 ... 200 Ohm +/-50 Ohm201 ... 2500 Ohm +/-25%
46 ParametersSR(-T)Parameter Range of values ToleranceBasic rate 30 ... 100 ppm +/-1.5 ppm102 ... 195 ppm +/-2.0 ppm200 ppm +0.0/-3.0 ppmBasic interval 1000 ms +/-20 msMagnet rate 90 ppm +/-1.5 ppmMagnet interval 664 ms +/-20 msPulse amplitude 0.2 V +/-0.10 V0.3 ... 7.5 V +20/-25%Pulse width 0.1 ... 0.4 ms +/-0.04 ms0.5 ... 1.0 ms +/-0.10 ms1.25 ... 1.5 ms +/-0.15 msSensitivity45502-2-1 Delta pulse0.5 ... 7.5 mV +/-20%Refractory period 200 ... 500 ms +10/-30 msMax. activity rate 80 ... 100 ppm +/-1.5 ppm105 ... 160 ppm +/-2.0 ppmHigh rate protection 200 ppm +20/-0 ppmLead impedance 100 ... 200 Ohm +/-50 Ohm201 ... 2500 Ohm +/-25%
477 Technical Data Technical Data7365353-ATechnical manual for the implantEvia DR-T, DR, SR- T, SRMechanical CharacteristicsMeasurements for the housingThe measurements refer to the housing without header. Radiopaque marker BIO SFMaterials in contact with body tissue• Housing: titanium• Header: epoxy resin• Sealing plug: silicone• Coating, if applicable: siliconeImplant W x H x D [mm] Volume [cm3] Mass [g]DR-T 53 x 44.5 x 6.5 12 25DR 53 x 43 x 6.5 11 26SR-T 53 x 39 x 6.5 11 24SR 53 x 39 x 6.5 10 25(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 Ser-vices 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 Radiocom-munication 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.FCC Statement
48 Technical DataElectrical CharacteristicsComponents and input valuesElectrical characteristics determined at 37°C, 500 Ohm Housing shape The implant housing has the following shape: Electrically conductive surfaceThe implant housing has the following surface: 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 implants comply with the requirements of prEN 45502-2-2: 2006, Section 27.5.1 at the highest sensitivity.Telemetry Telemetry data for Home Monitoring: Circuit Hybrid electronics with VLSI-CMOS chipInput impedance > 10 kOhmPulse form Biphasic, asymmetricPolarity CathodicImplant type DR(-T), SR(-T)Uncoated Flattened ellipsoidCoated EllipseImplant type DR(-T), SR(-T)Uncoated [cm2]33Coated [cm2]7Nominal carrier frequency Maximum power of transmission403.62 MHz < 25 μW-16 dBm
49 Technical DataBattery DataBattery type characteristics The following data is entered by the manufacturer: Power consumption The implant has the following power consumption: 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: Manufacturer GREATBATCH, INC. Clarence, NY 14031, USA LITRONIK GmbH 01796 Pirna, GermanyBattery type GB 8431 GB 2596 LiS 3150 LiS 3150MSystem LiJ Ag/SVO/CFxQMR® LiJ LiMn02Implant DRSRDR-TSR-TDRSRDR-TSR-TBattery voltage at BOS 2.8 V 3.0 V 2.8 V 3.1 VOpen-circuit volt-age2.8 V 3.0 V 2.8 V 3.1 VNominal capacity 1.3 Ah 1.3 Ah 1.3 Ah 1.2 AhUsable capacity until EOS1.2 Ah 1.1 Ah 1.2 Ah 1.0 AhPower consumption DR(-T) SR(-T)BOS, inhibited 6 μA 6 μABOS, 100% pacing 13 μA 9 μAAmplitude Impedance [Ohms] Pacing10% 50% 100%DR-T DR DR-T DR DR-T DR1.5 V 500 19.3 17.8 17.2 15.8 15.0 13.91000 19.7 18.0 18.3 16.9 17.0 15.72.5 V 500 17.8 16.6 13.6 12.8 9.4 10.01000 18.8 17.4 15.3 14.9 12.5 12.73.0 V 500 17.3 15.8 11.8 10.9 8.5 7.81000 18.5 16.9 14.6 13.4 11.6 10.73.5 V 500 16.5 15.1 10.4 9.7 7.2 6.61000 18.0 16.5 13.4 12.4 10.2 9.45.0 V 500 12.4 12.1 5.4 6.2 3.2 3.81000 15.2 14.6 8.3 9.2 5.3 6.3
50 Technical DataService times SR(-T) For single-chamber implants, the following times (in years) result: Shortening of the service time after long storage periodDepending 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 monthsAmplitude Impedance [Ohms] Pacing10% 50% 100%SR-T SR SR-T SR SR-T SR1.5 V 500 23.3 21.3 21.7 19.8 19.9 18.31000 23.6 21.5 22.7 20.7 21.6 19.82.5 V 500 22.1 20.3 17.8 17.3 14.3 14.61000 22.8 21.0 20.2 19.2 17.5 17.23.0 V 500 21.7 19.8 16.8 15.5 13.2 12.21000 22.7 20.7 19.5 17.8 16.6 15.33.5 V 500 20.9 19.1 15.3 14.2 11.5 10.71000 22.3 20.3 18.4 16.9 15.1 13.95.0 V 500 17.2 16.3 9.1 10.1 5.7 6.81000 19.8 18.7 12.8 13.7 8.9 10.2
51 Technical DataCountry-Related InformationInternational certification Other notes specific to each country will follow in the course of international prod-uct certification.Industry Canada 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• The code IC in front of the certification/ registration number only indicates that the technical requirements for Industry Canada are met.China 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 pacemak-ers, ICDs and external devices: Dangerous material In PCBs In cablesLead Pb Yes (soldering agent) YesMercury Hg No NoCadmium Cd No NoChrome compounds Cr6+ No NoPolybrominated biphenyls PBB No NoPolybrominated diphenyl ether PBDE No No25
52 Technical DataLegend for the LabelThe label icons symbolize the following: Manufacturing dateExpiration date:Use byStorage temperatureBIOTRONIK order numberSerial numberProduct identification numberSterilization with ethylene oxideResterilization prohibitedNot for reuseNon-sterileUsage informationContentsDo not use if packaging is damaged.European approval markNon-ionizing radiationSTERILIZE2NONSTERILE
53 Technical DataTransfer sheath for leads with PIN-lock PE lead con-nector (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 des-ignation of the compatible leads (example)ScrewdriverPosition of connector ports in the header (example)Unipolar IS-1 connectorBipolar IS-1 connectorA AtriumV VentricleUNI/BI Unipolar/bipolar configurationVpVsVentricular pace Ventricular senseApAsAtrial pace Atrial senseDDDRAIS-1
54 Technical Data

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