BIOTRONIK SE and KG PNP Medical Implant Pacemaker User Manual eIFU en 417804 B Enticos ProMRI 2016 03 23

BIOTRONIK SE & Co. KG Medical Implant Pacemaker eIFU en 417804 B Enticos ProMRI 2016 03 23

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Enticos 4/8Pacemaker | Bradyarrhythmia Therapy | Cardiac Resynchronization TherapyTechnical Manual417804Revision: B (2016-03-23)© BIOTRONIK SE & Co. KGAll rights reserved.Specification subject to modification, revision and improvement.® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner.Index 417804Technical ManualEnticos 4/80123 2016BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin · GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804sales@biotronik.comwww.biotronik.com
2Table of Contents Table of ContentsTable of Contents Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Intended Medical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . 10General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Precautionary Measures while Programming . . . . . . . . . . . . 18Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Explantation and Device Replacement . . . . . . . . . . . . . . . . . . 26Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Pacing and Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Preset Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Tolerances of Parameter Values. . . . . . . . . . . . . . . . . . . . . . . 35Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3Product DescriptionIntended Medical Use1 Product DescriptionProduct Description1417804Technical ManualEnticos 4/ 8Intended Medical UseIntended useEnticos is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective:• Compensation of bradycardia by atrial, ventricular, or AV sequential pacing• Additional triple-chamber features: Resynchronization of ventricular chamber contraction via biventricular pacingDiagnosis and therapy formsThe cardiac rhythm is automatically monitored and bradycardia arrhythmias are treated. All major therapeutic approaches from the field of cardiology and electrophysiology are unified in this pacemaker family. BIOTRONIK Home Monitoring® enables physicians to perform therapy management at any time.Required expertiseIn addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of a device system.• Only qualified medical specialists having the special knowledge required for the proper use of implanted devices are permitted to use them.• If users do not possess this knowledge, they must be trained accordingly.
4Product DescriptionIndicationsIndicationsGuidelines of cardiological societiesGenerally approved differential diagnostic methods, indications, and recommendations for pacemaker therapy apply to BIOTRONIK devices.The guidelines provided by cardiology associations offer decisive information: • We recommend observing the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC (European Society of Cardiology).• This also applies to the guidelines published by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and other national cardiology associations.Device types For the following symptoms/expectations, the following device types are indicated: Pacing modes For the following symptomatic, the following pacing modes are indicated: Symptom/expectation SR DR HFDisorientation due to bradycardia x x xPresyncope x x xBenefit from resynchronization of the right and left ventriclesxSyncope xxxSymptom/expectation Pacing modeSick sinus syndrome Dual-chamber pacingChronic, symptomatic second and third-degree AV block Dual-chamber pacing Adams-Stokes syndrome Dual-chamber pacingSymptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled outDual-chamber pacing• Chronotropic incompetence• Benefit from increased pacing rate with physical activityR mode or CLSSinus node dysfunction in the presence of normal AV and intraventricular conductionAtrial pacingBradycardia in conjunction with the following: • Normal sinus rhythms with only rare episodes of AV block or sinus arrest• Chronic atrial fibrillation• Severe physical disabilityVentricular pacing
5Product DescriptionContraindicationsContraindicationsGuidelinesNo contraindications are known for the implantation of multifunctional single-chamber, dual-chamber, or triple-chamber pacemakers, provided differential diagnostics precedes implantation according to the appropriate guidelines and no modes or parameter combinations are configured that pose a risk to the patient. Pacing modes and parametersThe compatibility and effectiveness of parameter combinations must be checked and, as the case may be, adapted after programming. Set of facts Contraindicated pacing modeAdditionally implanted ICD Unipolar pacingSet of facts Inappropriate pacing modeChronic atrial tachycardia, chronic atrial fibrillation or flutterAtrial-controlled modes (DDD, VDD, AAI)Poor tolerance of pacing rates above the basic rate, e.g., angina pectorisAV conduction disorder Atrial single-chamber pacingFailing AV conductionSet of facts Adapt parametersSlow retrograde conduction after ventricular pacing: Risk of pacemaker-mediated tachycardia• Extend atrial refractory period (ARP) and/or:• Shorten AV delay• Rarely: Program to DDI, DVI or VVIPoor tolerance of pacing rates above the basic rate, e.g., angina pectoris• Lower atrial upper rate• Lower maximum sensor rate• Deploy atrial overdrive pacing
6Product DescriptionSystem OverviewSystem OverviewDevice familyThis device family consists of single-chamber, dual-chamber and triple-chamber devices with or without Home Monitoring. Not all device types are available in every country.The following device variants are available: DeviceThe device's housing is made of biocompatible titanium, welded from the outside and therefore hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an antipole in the case of unipolar lead configuration.Lead connectionsBIOTRONIK provides pacemakers with headers for different standardized lead connections:•IS-1•IS-1/IS4Note: Suitable leads must comply with the norms:Note: The device and leads have to match.Note: Use only adapters approved by BIOTRONIK for leads with different connec-tions.IS-1The device labeling provides information pertaining to the connection assignment: Device type Variant withHome Monitoring Variant withoutHome MonitoringSingle-chamber Enticos 8 SR-T Enticos 4 S, Enticos 4 SRDual-chamber Enticos 8 DR-T Enticos 4 D, Enticos 4 DRTriple-chamber Enticos 8 HF-T, Enticos 8 HF-T QP —• A device's IS-1 connector port must only be used for connecting leads with an IS-1 connector that conform to ISO 5841-3.• A device's IS4 connector port must only be used for connecting leads with an IS4 connector that conform to ISO 27186.• Only quadripolar leads must be connected to the IS4 connector on device type HF QP with IS4.• If you have any questions concerning the compatibility of other manufacturers' leads, please contact BIOTRONIK.SSRDDRHFConnector port Lead connector Configuration Implantation site Device typeA/RA IS-1 Unipolar, bipolar Atrium D, DR, HFV/RV IS-1 Unipolar, bipolar Right ventricle S, SR, D, DR, HFLV IS-1 Unipolar, bipolar Left ventricle HF
Note: Home Monitoring is possible in all modes.The OFF mode only functions temporary, i.e. during a test.7Product DescriptionSystem OverviewIS-1/IS4The device labeling provides information pertaining to the connection assignment: LeadsBIOTRONIK leads are sheathed in biocompatible silicone. They can be flexibly maneuvered, are stable long-term, and are equipped for active or passive fixation. They are implanted using a lead introducer set. Some leads are coated with polyurethane which is known to increase the gliding properties for the lead. Leads with steroids reduce inflammatory processes. The fractal design of the leads allows for low pacing thresholds, high pacing impedance, and a low risk of oversensing. BIOTRONIK provides adapters to connect already implanted leads to new devices.TelemetryTelemetric communication between the device and the programmer can be carried out following initialization either by applying the programming head (PGH) to the device or by using wireless wandless telemetry in the programmer.ProgrammerUsing the programmer, the pacing thresholds can be determined and all tests can be performed during implantation and in-office follow-up. In addition to this, the programmer is used to set mode and parameter combinations, as well as for interrogation and saving of data from the device. Leadless ECG, IEGM, markers and functions are displayed simultaneously on the color display.ModesThe mode setting depends on the individual diagnosis: HF QPConnector port Lead connector Configuration Implantation site Device typeRA IS-1 Unipolar, bipolar Atrium HF QPRV IS-1 Unipolar, bipolar Right ventricle HF QPLV IS4 Unipolar, bipolar Left ventricle HF QPDevice type Modes StandardS • VVI, VVT, V00, AAI, AAT, A00•OFFVVISR • VVI-CLS(8 series only)• VVIR, V00R, AAIR, A00R• VVI, VVT, V00, AAI, AAT, A00•OFFVVIRD • DDD, DDT, DDI, DVI, D00, VDD, VDI• VVI, VVT, V00, AAI, AAT, A00, VVIR, V00R•OFFDDDDR • VVI-CLS; DDD-CLS(8 series only)• DDD-ADI, DDDR-ADIR (8 series) • DDDR, DDIR, DVIR, D00R, VDDR, VDIR• VVIR, V00R, AAIR, A00R• DDD, DDT, DDI, DVI, D00, VDD, VDI• VVI, VVT, V00, AAI, AAT, A00•OFFDDDRHF (QP) (8 series)• VVI-CLS, DDD-CLS• DDD-ADI, DDDR-ADIR• DDDR, DDIR, DVIR, D00R, VDDR, VDIR• VVIR, V00R, AAIR, A00R• DDD, DDT, DDI, DVI, D00, VDD, VDI• VVI, VVT, V00, AAI, AAT, A00•OFFDDDR
8Product DescriptionSystem OverviewNBG codesAAI or VVI is the NBG code for the antibradycardia mode of the single-chamber device without rate adaptation (device type S and D); AAIR or VVIR is the NBG code for the antibradycardia mode of the single-chamber device with rate adaptation (device type SR and DR): DDDR is the NBG code for the antibradycardia mode of the dual-chamber device: DDDRV is the NBG code for the antibradycardia mode of the triple-chamber device: BIOTRONIK Home Monitoring®In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system:• With Home Monitoring, diagnostic and therapeutic information and technical data are automatically sent to a stationary or mobile transmitter via an antenna in the device header. The data are encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network.• The received data are deciphered and evaluated. Each physician can set the criteria for evaluation to be used for each patient and can configure the time of notification via e-mail, SMS or fax.• A clear overview of the results of this analysis is displayed for the attending physicians on the protected internet platform Home Monitoring Service Center (HMSC).• Data transmission from the device is performed with a daily device message.• Device messages, which indicate special events in the patient's heart or in the device, are forwarded with the following message.• A test message can be initiated at any time using the programmer to immediately check the Home Monitoring function.Order numbers for EnticosThe devices can be obtained as follows: A/V Pacing in the atrium or ventricleA/V Sensing in the atrium or ventricleI Pulse inhibition in the atrium and ventricleR Rate adaptationD Pacing in the atrium and ventricleD Sensing in the atrium and ventricleD Pulse inhibition and pulse triggeringR Rate adaptationD Pacing in the atrium and ventricleD Sensing in the atrium and ventricleD Pulse inhibition and pulse triggeringR Rate adaptationV Multisite pacing in both ventriclesEnticos 4 S 407168 Enticos 8 SR-T 407160Enticos 4 SR 407167 Enticos 8 DR-T 407148Enticos 4 D 407156 Enticos 8 HF-T 407144Enticos 4 DR 407155 Enticos 8 HF-T QP 407143
9Product DescriptionSystem OverviewPackage contentsThe storage package includes the following:• Sterile packaging with device• Serial number label• Patient ID card• Warranty bookletNote: The technical manual pertaining to the device is either included in hard copy form in the storage package or in digital form on the internet.The sterile packaging includes the following:•Device• Screwdriver
10Product DescriptionDiagnostic and Therapy FunctionsDiagnostic and Therapy FunctionsGeneral overviewAll the systems have extensive features that allow quick diagnosis and delivery of safe therapy for bradycardia conditions. • Automatic functions make it easy and fast to implant, configure, and check the pacemaker.• Auto-initialization after implantation: The device recognizes the implanted leads autonomously and sets the polarity. The automatic functions of the software are activated after 10 min.Diagnostics functions• For devices from the 8 series: Data from the last interrogations and follow-ups are recorded as well as arrhythmia episodes; they are stored together with other data to assess the state of both the patient and the device at any time.• Continuous automatic below-threshold impedance measurements are performed in the device independent of the pacing pulse in order to check the lead for proper functioning.• Once a telemetry connection has been established during a test procedure in an in-office follow-up, the IEGM is displayed with markers.Antibradycardia pacing• Sensing: The amplitudes of the P and R waves are measured in the implanted device fully automatically and permanently to record varying amplitudes. The sensitivity for the atrium and ventricle is adapted automatically on an ongoing basis. The measurement data are averaged and the trend can be displayed.• Pacing thresholds: Pacing thresholds are automatically identified in the device, in single and dual-chamber devices the right ventricular, in triple-chamber devices the right and left ventricular pacing thresholds. Capture control adjusts the pulse amplitudes in such a way that every change of the pacing threshold results in the patient being paced at an optimal amplitude.• Timing: Pacing in the atrium is checked particularly carefully in dual and triple-chamber devices by an automatic adaptation of the atrial refractory period in order to avoid pacemaker-mediated tachycardia (Auto PVARP function: the postventricular atrial refractory period is adapted automatically).• Additional, special form of rate adaptation with devices from the 8 series: An increased cardiac output requirement is detected using physiological impedance measurement. The measuring principle is based on contractile changes (ionotropy) of the myocardium (CLS function: Closed Loop Stimulation). Rate adaptation is automatically initialized and optimized in CLS mode.• Ventricular pacing suppression with devices from the 8 series: Unnecessary ventricular pacing is avoided by promoting intrinsic conduction (Vp suppression function). The device can adapt itself to conduction changes. In the case of intrinsic conduction, the device switches from a DDD(R) to an ADI(R) mode.• 8 series: In the course of the follow-up, an automatic test of the AV delay is performed to improve the heart performance. AV delays are calculated; the optimum values can be applied.
11Product DescriptionDiagnostic and Therapy FunctionsResynchronisation therapyTriple-chamber devices have functions to configure different VV delays in order to resynchronize the ventricles.• Capture Control is also available for the left ventricle with automated tracking of the pacing threshold or automatic threshold monitoring (ATM) for trend analysis.• To ensure that no additional surgery is necessary in case of a left-sided increase of pacing threshold or undesired phrenic nerve stimulation, different pacing polarities can be set for the left ventricular lead with a triple-chamber device. Up to 13 vectors can be used with the HF QP device type.• 8 series: With the QP device type, the LV vector test provides a fast measurement of the pacing threshold, the phrenic nerve pacing threshold and the pacing impedance. The relative influence on the service time is also displayed. The measurement results are evaluated automatically so that the optimal pacing polarity can be set.The short RV-LV conduction test supports also the selection.• An additional diagnostic function with biventricular pacing: Variability of the heart rate, patient activity, and thoracic impedance are monitored on a continual basis.ProgramsThere are two types of therapy programs:• Default parameters are offered for the most common indications (ProgramConsult function).• Individual settings can be saved in 3 individual therapy programs.Home Monitoring functionsThe device automatically sends information to the transmitter once a day. In addition to this, test messages can be initiated using the programmer. Important medical information includes, among others, the following:• Ongoing atrial and ventricular arrhythmia• Parameters relevant to leads in the atrium and ventricle: thresholds, sensing amplitudes, impedances• Current statistics on bradycardia therapy• Individually adjustable timing interval for device messages which provide additional information pertaining to the device messages• IEGM online HD® with up to 3 high definition channels• Transmission of these IEGM recordings with device messages
12General Safety InstructionsOperating Conditions2 General Safety InstructionsGeneral Safety Instructions2417804Technical ManualEnticos 4/8!!CAUTIONSafety informationCardiac electrotherapy is subject to special operating conditions and possible complications and risks.Operating ConditionsTechnical manualsThe following technical manuals provide information about usage of the device systems:— Technical manual for the device— Technical manual for the HMSC— Technical manuals for leads— Technical manuals for the programmer and its accessories— Technical manuals for the user interface— Technical manuals for cables, adapters and accessories• Technical manuals are either included in hard copy form in the storage package or in digital form on the internet:manuals.biotronik.com• Follow all relevant technical manuals.• Keep technical manuals for later use.Care during shipping and storage• Devices are not to be stored close to magnets or sources of electromagnetic interference.• Note the effects of the storage period; see Battery Data.TemperatureExtremely low and high temperatures affect the service time of the battery in the device. • Permitted for shipping and storage:–10°C to +45°CSterile deliveryThe device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if the blister and quality control seal have not been damaged. Sterile packagingThe device and screwdriver are each packaged in 2 separately sealed blisters. The inner blister is also sterile on the outside so that it can be transferred in a sterile state during implantation.Single use onlyThe device and screwdriver are intended for single use only.• Do not use the device if the package is damaged.• The device must not be resterilized and reused.• Please take all precautionary measures carefully into account.
13General Safety InstructionsPossible ComplicationsPossible ComplicationsGeneral information on medical complicationsComplications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices.• Normal complications may include fluid accumulation within the device pocket, infections, or tissue reactions. Primary sources of complication information include current scientific and technological knowledge.• It is not possible to guarantee the efficacy of antiarrythmia therapy, even if the programs have proven successful during tests or subsequent electrophysiological examinations. In rare cases the set parameters can become ineffective. In particular it is inevitable that tachyarrhythmias may be induced.Skeletal myopotentialsBipolar sensing and control of sensitivity are adapted by the device to the rate range of intrinsic events so that skeletal myopotentials are usually not sensed. Skeletal myopotentials can nonetheless be classified as intrinsic events especially with a unipolar configuration and/or very high sensitivity and, depending on the interference, may cause inhibition or antiarrhythmia therapy.Nerve and muscle stimulationA device system consisting of a unipolar lead and an uncoated device may result in undesirable pacing of the diaphragm in the case of an initial or permanent high setting of the pulse amplitude.Possible technical failuresTechnical failure of a device system cannot be entirely ruled out. Possible causes may include the following:• Lead dislodgement• Lead fracture• Insulation defects• Device component failures• Battery depletionElectromagnetic interference (EMI)Any device can be sensitive to interference, for example, when external signals are sensed as intrinsic rhythm.• BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal. • Due to the intensity and variety of EMI, there is no guarantee for safety. It is generally assumed that EMI produces only minor symptoms in patients - if any.• Depending on the pacing mode and the type of interference, sources of interference may lead to pulse inhibition or triggering, an increase in the sensor-dependent pacing rate or asynchronous pacing.• Under unfavorable conditions, for example during diagnostic or therapeutic procedures, interference sources may induce such a high level of energy into the pacing system that the cardiac tissue surrounding the lead tip is damaged.Device behavior in case of EMI In the case of electromagnetic interference or undesired myopotentials, the device paces asynchronously for the duration of the time that the interference rate is exceeded.Static magnetic fieldsThe pacemaker switches to magnet response from a field strength > 1.0 mT.
14General Safety InstructionsPossible RisksPossible RisksProcedures to avoidThe following procedures must be avoided as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk: • Therapeutic ultrasound• Transcutaneous electrical nerve stimulation• Hyperbaric oxygen therapy• Applied pressures higher than normal pressurePotentially risky therapeutic and diagnostic proceduresIf electrical current from an external source is conducted through the body for diagnostic or therapeutic purposes, then the device can be subjected to interference and the patient placed at risk.Arrhythmia or ventricular fibrillation can be induced during diathermic procedures such as electrocautery, HF ablation or HF surgery. For example, damaging pressure levels may arise during lithotripsy. Influences on the device are not always immediately clear.If potentially risky procedures cannot be avoided, the following should be observed at all times:• Electrically insulate patients.• Switch the pacemaker function to asynchronous modes if needed.• Do not introduce energy near the device system.• Check the peripheral pulse of the patient.• Monitor the patient during and after every intervention.External defibrillationThe device is protected against the energy that is normally induced by external defibrillation. Nevertheless, any implanted device may be damaged by external defibrillation. Specifically, the current induced in the implanted leads may result in necrotic tissue formation close to the electrode/tissue interface. As a result, sensing properties and pacing thresholds may change. • Place adhesive electrodes anterior-posterior or perpendicular to the axis formed by the device to the heart at least 10 cm away from the device and from implanted leads.Radiation therapyThe use of radiation therapy must be avoided due to possible damage to the device and the resulting impaired functional safety. If this type of therapy is to be used anyway, prior risk/benefit analysis is absolutely necessary. The complexity of influencing factors such as different sources of radiation, a variety of devices and therapy conditions makes it impossible to issue directives that guarantee radiation therapy without an impact on the device. The EN 45502 standard pertaining to active implantable medical devices requires the following measures during the administration of therapeutic ionizing radiation:• Adhere to instructions for potentially risky therapeutic and diagnostic procedures.• Shield device against radiation.• After applying radiation, double-check the device system to make sure it is functioning properly.Note: Please contact BIOTRONIK with questions on the risk/benefit analysis.Magnetic resonance imagingMagnetic resonance imaging must be avoided due to the associated high frequency fields and magnetic flux density: Damage or destruction of the device system by strong magnetic interaction and damage to the patient by excessive warming of the body tissue in the area surrounding the device system.
15ImplantationImplantation Procedure3 ImplantationImplantation3417804Technical ManualEnt icos 4/8Implantation ProcedureHaving parts readyThe following parts that correspond to the requirements of the EC Directive 90/385/EEC are required:• Device with screwdriver from BIOTRONIK• BIOTRONIK leads and lead introducer set— Single-chamber device: unipolar or bipolar lead for the right ventricle— Dual-chamber device: one unipolar or bipolar lead each for the atrium and for the right ventricle— Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV lead• Approved connections are IS-1 and IS4: Use only adapters approved by BIOTRONIK for leads with different connections or leads from other manufacturers.• BIOTRONIK programmer (with integrated wandless telemetry or with separate SafeSync Module) and approved cables• External multi-channel ECG device• Keep spare parts for all sterile components.Keeping an external defibrillator readyIn order to be able to respond to unforeseeable emergencies or possible technical failures of the device:• Keep an external defibrillator and paddles or adhesive electrodes ready.!!WARNINGInadequate therapy due to defective device If an unpacked device is dropped on a hard surface during handling, electronic parts could be damaged. Unpacking the device• Peel the sealing paper off of the outer blister at the marked position in the direction indicated by the arrow. The inner blister must not come into contact with persons who have not sterilized their hands or gloves, nor with non-sterile instruments.• Use the gripping tab on the inner blister to remove it from the outer blister.• Peel the sealing paper off of the sterile inner blister at the marked position in the direction indicated by the arrow.Note: The device is disabled on delivery and can be implanted immediately after unpacking without manual activation.Checking partsDamage to any of the parts can result in complications or technical failures. • Check for damage before and after unpacking all parts.• Replace damaged parts.• Use a replacement device.• Return the damaged device to BIOTRONIK.
Note: If necessary, the device can also be programmed before or during auto-initialization.16ImplantationImplantation ProcedureImplantation siteIn general, the pacemaker is implanted subcutaneously or subpectorally, depending on the lead configuration as well as the anatomy of the patient.Overview: ImplantingAvoid damage to the headerSet screws must be tightened or loosened with care. • Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control!• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.!!WARNINGShort circuit due to open lead connector portsConnector ports in the header which are open and thus not electrolyte-proof may cause undesired current flows to the body and penetration of body fluid into the device.!!WARNINGInadequate therapyInsufficient lead spacing or inappropriate lead positioning may lead to far-field sensing.Preventing short circuits in the headerKeeping distance between leads1 Shape the device pocket and prepare the vein.2 Implant the leads and perform measurements.3 Connect device and leads.4 Insert the device. The device starts auto-initialization on its own.5 Guide the fixation suture through the opening in the header and fixate the device in the prepared device pocket.6 Close the device pocket.7 Prior to testing and configuration, wait for the successful completion of automatic device initialization.• Close unused connector ports with blind plugs. • Leads must not contact each other. Position the tip and ring of newly implanted leads with a sufficient distance from old implanted leads.
17ImplantationImplantation ProcedureConnecting the lead connector to the deviceApplying the programming headThe programming head (PGH) features a diagram of the device. This is used to assist in positioning the head to ensure proper telemetry.• Make sure the PGH is positioned correctly.Establishing wandless telemetryFor devices from the 8 series: The programmer must be no less than 20 cm and no more than 3 m from the device; ideally there should be no hindrances between the patient and the programmer.• Switch on wandless telemetry on the programmer.• Apply the programming head for about 2 s until successful initialization is displayed on the programmer:The wandless telemetry symbol is displayed in the navigator and the signal strength is displayed in the status line.• Remove the programming head.Note: After auto-initialization, all parameters are activated as in the standard program.Auto-initializationAuto-initialization begins automatically once the first connected lead is sensed.Auto-initialization is usually terminated 10 minutes after connection of the first lead. If no other program has been transferred in the meantime, the device subsequently works with active automatic functions in the factory settings or with the preset program of the user.Manual setting of the lead polarity or measurement of lead impedances is not necessary.Behavior during auto-initialization• During transmission of a permanent program: Auto-initialization is terminated and the transferred program is active.• During testing:Tests cannot be performed during auto-initialization; stop it beforehand. Auto-initialization will not be continued upon completion of the test.1 Remove stylets and stylet guides.2 • Connect the unipolar or bipolar IS-1 lead connector for the right ventricle to RV.• Connect the unipolar or bipolar IS-1 lead connector atrium to A.• Connect the unipolar or bipolar IS-1 or the quadripolar IS4 lead connector for the left ventricle to LV.3 Push the lead connector into the header without bending the conductor until the connector tip becomes visible behind the set screw block.4 If the lead connector cannot be inserted completely, the set screw may be protruding into the drill hole of the set screw block. Carefully loosen the set screw without completely unscrewing it, so that it does not become tilted upon retightening.5 Use the screwdriver to perpendicularly pierce through the slitting in the center of the silicone plug until it reaches the set screw.6 Turn the set screw clockwise until the torque control starts (you will hear a clicking sound). 7 Carefully withdraw the screwdriver without retracting the set screw. • When the screwdriver is withdrawn, the silicone plug automatically seals the lead connection safely.
18ImplantationPrecautionary Measures while ProgrammingPrecautionary Measures while Programming!!CAUTIONSafety informationThe programming of device systems requires special precautions.Checking the device system• After auto-initialization, perform a follow-up to see if the device system is functioning properly.• Perform a pacing threshold test to determine the pacing threshold.Performing standard tests and monitoring the patientCritical conditions can occur for the patient even during standard tests due to inadequate parameter settings or interrupted telemetry. • Ensure sufficient patient care even during tests.• After the threshold test, check to determine whether the threshold is clinically and technically justifiable.• Continuously monitor the ECG and the patient's condition.• Cancel testing if necessary.Do not interrupt wandless telemetry during a treatmentDisconnecting the SafeSync Module from the programmer can result in interference with or termination of the SafeSync wandless telemetry.• Do not disconnect the SafeSync Module from the programmer.• Do not take the Operation Module off the ICS 3000.Cancelling telemetryProgrammer interference or interrupted telemetry during performance of temporary programs (follow-up tests) can result in inadequate pacing of the patient. This is the case if the programmer can no longer be operated due to a program error or a defective touch screen and therefore the temporary program cannot be terminated. Under these circumstances, it is helpful to cancel telemetry, in which case the device automatically switches to the permanent program. • In the case of telemetry with PGH: lift the programming head by at least 30 cm.• In the case of wandless telemetry: switch off and reposition the programmer.• Turn off possible sources of interference.Avoiding critical parameter settingsNo modes and parameter combinations that pose a risk to the patient should be set.• Prior to setting rate adaptation, determine the patient's capacity for strain.• Check compatibility and effectiveness of parameter combinations after making settings.Manually setting lead polarityDue to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing) should only be set if bipolar leads are implanted.Setting sensingManually set parameters can be unsafe. For example, unsuitable far-field protection may impede sensing of intrinsic pulses.• Use automatic sensitivity control.Setting the sensitivityA value set to < 2.5 mV/unipolar for device sensitivity may result in noise caused by electromagnetic fields. • Therefore, it is recommended that a value of ≥ 2.5 mV/unipolar be set according to paragraph 28.22.1 of the EN 45502-2-1 standard. Setting sensitivity values < 2.5 mV/unipolar requires explicit clinical need. Values like this must only be set and retained with physician supervision.• Please carefully take all precautionary measures into account.
19ImplantationPrecautionary Measures while ProgrammingPreventing device-induced complicationsBIOTRONIK devices are equipped with several functions to prevent device-induced complications to the greatest extent possible:• Measure the retrograde conduction time.• If the function is not yet automatically set: activate PMT protection.• Set the VA criterion: The aim is to set a VA criterion that is longer than the longest measured retrograde conduction time. Preventing conduction of atrial tachycardiaBIOTRONIK devices are equipped with several functions to prevent conduction of atrial tachycardia to the ventricle(s):•Set Mode Switching for indicated patients.• Set the upper rate and the refractory periods to prevent abrupt ventricular rate switching.• Prefer Wenckebach response and avoid 2:1 behavior.• Set all parameters so as to prevent constant changing between atrial and ventricular-controlled modes.Phrenic nerve stimulation that cannot be terminatedWith LV pacing, chronic phrenic nerve stimulation can in rare cases not be terminated by reprogramming the available left ventricular pacing configurations or by other measures.• Possibly set a right ventricular mode both in the permanent program and for Mode Switching.Avoiding risks in the case of exclusive left ventricular pacingLead dislodgement in the case of exclusive left ventricular pacing could pose the following risks: loss of ventricular pacing as well as induction of atrial arrhythmia.• Consider sensing and pacing parameters with reference to loss of therapy. • Exclusive left ventricular pacing is not recommended for patients who depend on the device.• Take possible interruption of automatic Active Capture Control into consideration. • In the case of follow-ups and threshold tests, take loss of synchronized ventricular pacing into consideration. • Mode Switching does not allow exclusive left ventricular pacing; consider the consequences when setting Mode Switching parameters.If an ICD is implanted at the same time, do not permit unipolar pacingIf an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is possible to switch to unipolar pacing after resetting the pacemaker or using the automatic lead check. As a result, the ICD could falsely inhibit or trigger tachyarrhythmiatherapy activity.• Unipolar leads are not permitted in this configuration.Recognizing lead failureAutomatic impedance measurement is always switched on.• Impedance values that indicate technical failure of a lead are documented in the event list.
20ImplantationPrecautionary Measures while ProgrammingConsider 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 combination with low lead impedance, this results in a very high level of power consumption.• When programming large parameter values, take into account that the replacement indication ERI will be reached very early because the service time of the battery may be reduced to less than 1 year.Home Monitoring: The CardioMessenger should be relatively close to the patient; if it is too far away, the device constantly seeks and consumes more power than necessary. • Home Monitoring ON reduces the service time by approximately 15% in single- and dual-chamber devices and by approximately 10% in triple-chamber devices.Wandless telemetry: 15 minutes of usage reduces the service time by approximately 7 days.• Do not establish unnecessary wandless telemetry.•After 5 min without input, the device switches to the economy mode.• Check the battery capacity of the device at regular intervals.
21ImplantationMagnet ResponseMagnet ResponseProgramming head applicationWhen the programming head is applied, time remains for device interrogation before the device switches back to the previously set permanent therapy mode. The same applies to programming head application to establish wandless telemetry contact.Magnet response in standard programApplying a magnet or the programming head can result in an unphysiological rhythm change and asynchronous pacing. The magnet response is set as follows in the standard program of BIOTRONIK pacemakers:• Asynchronous:For the duration of the magnet application – mode D00 (where applicable V00 / A00) without rate adaptation;Magnet rate: 90 bpm•Automatic:For 10 cycles – mode D00, subsequently mode DDI without rate adaptation;Magnet rate: 10 cycles with 90 bpm, subsequently set basic rate• Synchronous:Note: See also the replacement indication information for magnet response at ERI.Mode DDD (where applicable: VVI) without rate adaptation;Magnet rate: set basic rateMagnet application by patientsIf patients are performing their own magnet application, the synchronous magnet response must have been programmed. Patients should also know the following:• When may the magnet be used? In cases of severe dizziness and indisposition.• How long is the magnet placed on the pacemaker?1 to 2 s.• What happens when the magnet is applied?The IEGM of the last 10 seconds is stored.• What has to happen after magnet application? The patient has to contact the physician for a follow-up.
22ImplantationFollow-upFollow-upFollow-up intervalsFollow-ups must be performed at regular, agreed intervals.• Following the lead ingrowth phase, approximately 3 months after implantation, the first follow-up should be carried out by the physician using the programmer (in-office follow-up).• The next in-office follow-up should be carried out once a year and no later than 12 months after the last in-office follow-up.Follow-up with BIOTRONIK Home Monitoring®Monitoring using the Home Monitoring function does not serve to replace regular in-office appointments with the physician required for other medical reasons.Follow-up supported by Home Monitoring can be used to functionally replace in-office follow-up under the following conditions:• The patient was informed that the physician must be contacted if symptoms worsen or if new symptoms arise despite the use of the Home Monitoring function.• Device messages are transmitted regularly.• The physician decides whether the data transmitted via Home Monitoring with regard to the patient's clinical condition as well as the technical state of the device system are sufficient. If not, an in-office follow-up has to be carried out.Possible early detection due to information gained via Home Monitoring may necessitate an additional in-office follow-up. For example, the data may indicate at an early stage lead problems or a foreseeable end of service time (ERI). Furthermore, the data could provide indications of previously unrecognized arrhythmias or regarding modification of therapy by reprogramming the device.Follow-up with the programmerUse the following procedure for in-house follow-up: 1 Record and evaluate the ECG.2 Interrogate the device.3 Evaluate the status and automatically measured follow-up data.4 Check the sensing and pacing functions.5 Manually perform standard tests if necessary.6 Possibly evaluate statistics and IEGM recordings.7 Possibly adjust program functions and parameters.8 Transmit the program permanently to the device.9 Print and document follow-up data (print report).10 Finish the follow-up for this patient.
23ImplantationPatient InformationPatient InformationPatient ID card A patient ID card is included in delivery.• Provide the patient with the patient ID card.• Request that patients contact the physician in case of uncertainties.Prohibitive signs Premises with prohibitive signs must be avoided.• Draw the patient's attention to prohibitory signs.Possible sources of interferenceElectromagnetic interference should be avoided in daily activities. Sources of interference should not be brought into close proximity of the device.• Draw the patient's attention to special household appliances, security checkpoints, anti-theft alarm systems, strong electromagnetic fields, cellular phones, and transmitters among other things.• Request patients to do the following: — Use cellular phones on the opposite side of their body from the device.— Keep the cellular phone at least 15 cm away from the device both during use and when stowing.
24ImplantationReplacement IndicationsReplacement IndicationsPossible charging statusThe 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 propertiesThe following are the defined pacemaker operational statuses:• BOS: Beginning of Service: > 90%• ERI: Elective Replacement Indication (i.e., RRT: Recommended Replacement Time)• EOS: End of ServiceERI activationERI detection is automatically activated after the following events:• Successful auto-initializationERI displayERI is displayed as follows:• On the programmer after interrogation of the pacemaker• By a defined decrease in the basic rate as well as the magnet rateRate decrease The decrease of basic rate and magnet rate is defined as follows:• In the following modes, the pacing rate decreases by 11%:DDD(R); DDT; D00(R); VDD(R); VDI(R); VVI(R); VVT; AAI(R); AAT; A00(R)• In the modes DDI(R) and DVI(R), only the VA interval is extended by 11%. This reduces the pacing rate by up to 11%, depending on the configured AV delay.Change of the mode with ERIThis change depends on the mode which is set. It is displayed on the programmer. • Single-chamber modes: VVI• Dual-chamber modes: VDD• Triple-chamber modes: Dual-chamber pacing, one biventricular setting is keptDeactivated functions with ERIThe following functions are deactivated: • Atrial pacing• Night program• Rate adaptation• Atrial and ventricular capture control• Rate fading• Atrial overdrive pacing• IEGM recordings• Statistics• Home Monitoring• Rate hysteresis• Ventricular pacing suppression
25ImplantationReplacement IndicationsMagnet response at ERIAfter reaching ERI, pacing is performed as follows after applying the magnet or programming head: Expected service times after ERIThe information is based on the following:• Lead impedance of 500 Ω or 600 Ω• 100% pacing• Interval from ERI to EOS for the single-chamber device in AAI(R)/VVI(R) mode, for the dual and triple-chamber device in DDD(R) mode• Standard program with both high and low pacing energy• Data of the battery manufacturer (see the battery data)Magnet response Cycles 1 to 10 After 10th cycleAutomatic Asynchronous with 80 bpm Synchronous with basic rate reduced by 11%Asynchronous Asynchronous with 80 bpm Asynchronous with 80 bpmSynchronous Synchronous with basic rate reduced by 11%Synchronous with basic rate reduced by 11%110 bpm4.6 V1.5 ms500 Ω30 bpm0.2 V0.1 ms500 Ω70 bpm2.5 V0.4 ms500 Ω70 bpm5.0 V0.4 ms500 Ω60 bpm2.5 V0.4 ms600 Ω60 bpm5 V0.4 ms600 ΩMean value: 8 monthsMinimum value: 6 months—Minimum value: 6 months—Minimum value: 6 months
26ImplantationExplantation and Device ReplacementExplantation and Device ReplacementExplantation• Disconnect the leads from the header.• Remove the device and, if necessary, leads using state-of-the-art technology.• Explants are biologically contaminated and must be disposed of safely due to risk of infection. Device replacementThe following applies to leads from a previous device that are intended for further use:• Check the leads prior to connecting to the new device.If, upon replacing the device, already implanted leads are no longer used but left in the patient, then an additional uncontrolled current path to the heart can result.• Isolate unused lead connectors and close unused connector ports.Basic principles:• The device must not be resterilized and reused.CremationDevices should not be cremated.• Explant the device before the cremation of a deceased patient.DisposalBIOTRONIK takes back used products for the purpose of environmentally safe disposal.• Clean the explant with a solution of at least 1% sodium hypochlorite.• Rinse with water.• Fill out explantation form and send to BIOTRONIK together with the cleaned device.
27ParametersTiming4 ParametersParameters4417804Technical ManualEnticos 4/8Note: Unless described separately, information for device type HF also applies to device type HF QP.TimingBasic rate day/nightRate hysteresesAV delayAV hysteresesParameter Range of values Standard SR DR HFBasic rate 30 ... (5) ... 100 ... (10) ... 200 bpm60 bpm x x50 bpm xNight rate OFF; 30 ... (5) ... 100 ... (10) ... 200 bpmOFF x x xNight begins 00:00 ... (10 min) ... 23:50 hh:mm—xxxNight ends Parameter Range of values Standard SR DR HFHysteresis OFF; -5 ... (-5) ... -25 ... (-20) ... -65 bpmOFF x x xRepetitive/ search cycles OFF; ON OFF x x xParameter Range of values Standard SR DR HFAV delay Low; Medium; High; Fixed; IndividualLow x x20 ... (5) ... 350 ms (in 6 rate ranges)180-170-160-150-140 msxCLS and all HF modes:20 ... (5) ... 350 ms (in 6 rate ranges)150-140-130-120-120 msxxSense compensation OFF; -10 ... (-5) ... -120 ms -45 ms x xParameter Range of values Standard SR DR HFAV hysteresis mode OFF; Positive; Negative HF when setting RV: IRSplusOFF x xPositive modes: AV hysteresis70; 110; 150; 200 ms 70 msCLS modes: 110 msxxNegative modes: AV hysteresis10 ... (10) ... 150 ms 50 ms x xAV repetetive / scan cylesOFF; ON ON x x
28ParametersTimingVentricular pacingUpper rateMode switchingVentricular pacing suppression Parameters valid for devices in DDD-ADI or DDDR-ADIR modes: Parameter Range of values Standard SR DR HFVentricular pacing BiV, RV; LV BiV xTriggering OFF; RVs; RVs + PVC RVs xLV T-wave protection ON; OFF ON xMaximum trigger rate AUTO; 90 ... (10) ... 160 bpm AUTO xInitially paced chamberRV; LV LV xVV delay after Vp 0 ... (5) ... 80 ... (10) ... 100 ms 0 ms xVV delay after Vs 0 ms 0 ms xParameter Range of values Standard SR DR HFUpper rateSR: in VVT mode90 ... (10) ... 200 bpm 130 bpm x x xWenckebach response/ 2:1 rateAutomatically set — x xAtrial upper rate OFF; 175; 200; 240 bpm 240 bpm x xParameter Range of values Standard SR DR HFMode switching OFF; ON ON x xIntervention rate 100 ... (10) ... 250 bpm 160 bpm x xSwitch to mode DDI; DDI(R) when permanent DDD(R)VDI; VDI(R) when permanent VDD(R)DDI(R) x xVentricular pacing RV; BiV BiV xOnset criterion 3 ... (1) ... 8 (out of 8) 5 x xResolution criterion x xChange of the basic rate with mode switchingOFF; +5 ... (5) ... +30 bpm +10 bpmRate stabilization with mode switchingOFF; ON OFF x x2:1 lock-in protection OFF; ON ON xWhen setting RV: OFF; ON ON xParameter Range of values Standard SR DR HFVp suppression OFF; ON OFF x xPacing suppression after consecutive Vs1 ... (1) ... 8 6 x xPacing support after x cycles 1 ... (1) ... 4 (out of 8) 3 x x
29ParametersTimingRefractory periodsBlanking periodsPMT protectionParameter Range of values Standard SR DR HFRV refractory period 200 ... (25) ... 500 ms 250 ms x x xAtrial refractory periodAUTO AUTO x xAtrial refractory period in the modes AAI(R); AAT(R); DDT300 ... (25) ... 775 ms 350 ms x xLV refractory period 200 ms 200 ms xAUTO PVARP OFF; ON ON x xPVARP 175 ... (25) ... 600 ms 225 ms x xPVARP after PVC PVARP + 150 ms (max: 600 ms) Automatically set x xParameter Range of values Standard SR DR HFFar-field protection after Vs100 ... (10) ... 220 ms 100 ms x xFar-field protection after Vp100 ... (10) ... 220 ms 150 ms x xVentricular blanking period after Ap30 ... (5) ... 70 ms 30 ms x xParameter Range of values Standard SR DR HFPMT protection OFF; ON ON x xVA criterion 250 ... (25) ... 500 ms 350 ms x x
30ParametersPacing and SensingPacing and SensingPulse amplitude and pulse widthSensitivityAtrial capture controlVentricular capture controlAtrial overdrive pacingParameter Range of values Standard SR DR HFPulse amplitude A/RV/LV0.2 ... (0.2) ... 6.0 ... (0.5) ... 7.5 V3.0 V x x xPulse width A/RV/LV 0.1 ...(0.1) ... 0.5 ... (0.25) ... 1.5 ms0.4 ms x x xParameter Range of values Standard SR DR HFSensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO xSensitivity A AUTO; 0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mVAUTO x xRV sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x x xLV sensitivity OFF; AUTO; 0.5 ... (0.5) ... 7.5 mVAUTO xParameter Range of values Standard SR DR HFAtrial capture control ATM (monitoring only); ON; OFFON x xMinimum amplitude 0.5 ... (0.1) ... 4.8 V 1.0 V x xThreshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x xSafety margin 0.5 ... (0.1) ... 1.2 V 1.0 V x xSearch type Interval; time of day Time of day x xInterval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x xTime of day 00:00 ... (00:10) ... 23:50 hh:mm00:30 hh:mm x xParameter Range of values Standard SR DR HFCapture control RV ATM (monitoring only); ON; OFFON x x xCapture control LV xMinimum amplitude RV0.7 V 0.7 V x x xMinimum amplitude LVxThreshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x x xRV safety margin 0.3 ... (0.1) ... 1.2 V 0.5 V x xLV safety margin 1.0; 1.2 V 1.0 V xSearch type Interval; time of day Time of day x x xInterval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x x xTime of day 00:00 ... (00:10) ... 23:50 hh:mm00:30 hh:mm x x xParameter Range of values Standard SR DR HFAtrial overdrive pacing OFF; ONWith ON: maximum over-pacing rate 120 bpm, mean rate increase approximately 8 bpm, rate decrease after 20 cyclesOFF x x
31ParametersPacing and SensingLead configurationIEGM recordingsRates for statisticsParameter Range of values Standard SR DR HFSensing polarity A Unipolar; bipolar Unipolar x x xSensing polarity RV Unipolar; bipolar Unipolar x x xSensing polarity LV Unipolar; bipolar Unipolar xPacing polarity A Unipolar; bipolar Unipolar x x xPacing polarity RV Unipolar; bipolar Unipolar x x xPacing polarity LV Device type HF:LV1 tip -> LV2 ringLV1 tip -> RV ringLV2 ring -> LV1 tipLV2 ring -> RV ringLV1 tip -> housingLV2 ring -> housingLV1 tip –> housingxDevice type HF QPLV1 tip -> LV2 ringLV1 tip -> LV4 ringLV1 tip -> RV ringLV1 tip -> housingLV2 ring -> LV1 tipLV2 ring -> LV4 ringLV2 ring -> RV ringLV2 ring -> housingLV3 ring -> LV2 ringLV3 ring -> LV4 ringLV3 ring -> RV ringLV4 ring -> LV2 ringLV4 ring -> RV ringLV1 tip –> LV2 ringxParameter Range of values Standard SR DR HFNumber of recordings (each max. 10 s)4 series: 4128 series: 20 —xxxHigh atrial rate (HAR) OFF; AT; mode switching AT x x xHigh ventricular rate (HVR)OFF; ON ON x x x8 series:Patient triggering (triggered by patient)OFF; ON OFF x x xPre-trigger recording 0; 25; 50; 75; 100% 75% x x xIEGM signal Filtered; Unfiltered Filtered x x xParameter Range of values Standard SR DR HFHAR limit 100 ... (10) ... 250 bpm 200 bpm x xHVR limit 150 ... (5) ... 200 bpm 180 bpm x x xHVR counter 4; 8; 12; 16 events 8 events x x xStart resting period 00:00 ... (1:00 AM) ... 23:00 hh:mm2:00 hh:mm x x xDuration of resting period0.5 ... (0.5) ... 12 h 4 h x x xEnable lead check OFF; ON ON x x x
32ParametersRate AdaptationRate Adaptation CLS modes: closed loop stimulation Parameters valid for 8 series devices: R modes: AccelerometerParameters valid for devices with R modes: Parameter Range of values Standard SR DR HFMaximum CLS rate 80 ... (10) ... 160 bpm 120 bpm x x xCLS response Very low; Low; Medium; High; Very highMedium x x xCLS resting rate controlOFF; +10 ... (10) ... +50 bpm +20 bpm x x xVp required Yes; No NoWhen BiV is set: YesxxxParameter Range of values Standard SR DR HFSensor gain AUTO; Very low; Low; Medium; High; Very highAUTO x x xMax. activity rate 80 ... (10) ... 180 bpm 120 bpm x x xSensor threshold Very low; Low; Medium; High; Very highMedium x x xRate fading OFF; ON OFF x x xRate increase 1; 2; 4; 8 bpm/cycle 2 bpm/cycle x x xRate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle 0.5 bpm/cyclexxx
33ParametersPreset ProgramsPreset ProgramsStandard and safe programMode after auto-initialization: Lead configuration, determined and set immediately after connection (auto lead check) Parameters after auto-initialization: Parameter Factory setting Standard Safe program SR DR HFMode VVI VVIR VVIIn the AAI mode, the safe program is also AAI.xMode DDD DDDR VVI x xParameter Factory setting Standard Safe program SR DR HFPacing polarity A/RV Unipolar Unipolar Unipolar x x xPacing polarity LV TCUP TCUP TCUP xSensing polarity A/RV Unipolar Unipolar Unipolar x x xSensing polarity LV Unipolar Unipolar Unipolar xAutomatic lead check ON ON — x x xParameter Factory setting Standard Safe program SR DR HFBasic rate 60 bpm 60 bpm 70 bpm x x50 bpm 50 bpm xNight rate OFF OFF OFF x x xRate hysteresis OFF OFF OFF x x xUpper rate 130 bpm 130 bpm — x xAV dynamics Low Low — x xAV hysteresis mode OFF OFF — x xSense compensation -45 ms -45 ms — x xAV safety delay 100 ms 100 ms — x xVV delay 0 0 0 xLV T-wave protection ON ON ON xFar-field protection after Vs 100 ms 100 ms — x xFar-field protection after Vp 150 ms 150 ms — x xVentricular blanking period after Ap30 ms 30 ms — x xPMT protection ONON— xxVA criterion 350 ms 350 ms — x xMagnet response AUTO AUTO AUTO x x xPulse amplitude A 3.0 V 3.0 V — x xPulse amplitude RV 3.0 V 3.0 V 4.8 V x x xPulse amplitude LV 3.0 V 3.0 V 4.8 V xPulse width A 0.4 ms 0.4 ms — x xPulse width RV 0.4 ms 0.4 ms 1.0 ms x x xPulse width LV 0.4 ms 0.4 ms 1.0 ms xSensitivity A AUTO AUTO — x xSensitivity RV AUTO AUTO 2.5 mV x x xSensitivity LV AUTO AUTO 2.5 mV x
34ParametersPreset ProgramsRefractory period A AUTO AUTO — x xRefractory period RV 250 ms 250 ms 300 ms x x xRefractory period LV 200 ms 200 ms 200 ms xMode switching ON ON — x xOnset criterion 5-out-of 8 5-out-of 8 — x xResolution criterion 5-out-of 8 5-out-of 8 — x xIntervention rate 160 bpm 160 bpm — x xSwitches to DDIR DDIR — x xThe basic rate with mode switching+10 bpm +10 bpm — x xRate stabilization with mode switchingOFF OFF — x xPVARP AUTO (Start 250 ms)225 ms) — x xPVARP after PVC 400 ms Automati-cally set—xxCapture control A ON ON OFF x x xCapture control RV ON ON OFF x xCapture control LV ON ON OFF xAtrial overdrive pacing OFF OFF — x xVp suppression OFF OFF — xIEGM recording (HAR) ON AT OFF x x xIEGM recording (HVR) ON ON OFF x x xHome Monitoring OFF OFF OFF x x xParameter Factory setting Standard Safe program SR DR HF
35ParametersTolerances of Parameter ValuesTolerances of Parameter ValuesParameter Range of values ToleranceBasic rate 30 ... (5) ... 100 ... (10) ... 200 bpm± 20 msBasic interval 1000 ms ± 20 msMagnet rate (magnet interval) 90 bpm (664 ms) ± 20 msPulse amplitude 0.2 ... 7.5 V The greater value of ±50 mV or +20/-25%Pulse width 0.1 ... 1.5 ms ±10%Sensitivity AEN 45502-2-1 triangle pulse0.1 ... 0.2 mV ±0,05 mV0.3 ... 7.5 mV ±20%Sensitivity RV/LVEN 45502-2-1 triangle pulse0.5 ... 7.5 mV ±20%Refractory period 200 ... 500 ms ± 20 msMaximum activity rate 80 ... 180 bpm ± 20 msLead impedance 100 ... 200 Ω ±50 Ω201 ... 2500 Ω ±10%
36Technical DataMechanical Characteristics5 Technical DataTechnical Data5417804Technical ManualEnticos 4/8Note: D = housing without headerMechanical CharacteristicsMeasurements for the housingX-ray identificationAll device types receive the BIOTRONIK logo for X-ray identification. It can be found centrally between the circuitry and the battery.Materials in contact with body tissue• Housing: Titanium• Header: Epoxy, polysulfone; IS4 seal: Silastic• Silicone plug: Silopren or silasticDevice W x H x D [mm] Volume [cm3] Mass [g]Single-chamber S, SR(-T)48 x 40 x 6.5 10 20.8Dual-chamber D, DR(-T)48 x 44 x 6.5 11 23.2Triple-chamber HF-T 53 x 52 x 6.5 14 26.9Triple-chamber HF-T QP53 x 53 x 6.5 15 31.2
37Technical DataElectrical CharacteristicsElectrical CharacteristicsComponents and input valuesElectrical characteristics determined at 37°C, 500 Ω: Electrically conductive surfaceThe device housing has the form of a flattened ellipsoid. The electrically conductive area is for:• Single and dual-chamber devices: 30 cm2• Triple-chamber devices: 33 cm2Telemetry data• MICS frequency: 402 - 405 MHz• Maximum power of transmission: < 25 µW (-16 dBm)International radio certificationDevices with BIOTRONIK Home Monitoring® are equipped with an antenna for wireless communication.• Telemetry information for Australia: This product is in compliance with the Australian "Radiocommuniations Act 1992" and therefore it is labelled according to the "Radiocommunications (Compliance Labelling - Devices) Notice." • Telemetry information for Canada:This device must neither interfere with meteorological and earth resources technology satellites nor with meteorological stations working in the 400,150 to 406,000 MHZ band, and it must accept any interference received, including interference that may cause undesired operation.This device will be registered with Industry Canada under the following number:IC: 4708A-PNPThe code IC in front of the certification/registration number only indicates that the technical requirements for Industry Canada are met.• Telemetry information for Japan:In accordance with Japanese law, this device has been assigned an identification number under the "Ordinance concerning certification of conformity with technical regulations etc. of specified radio equipment", Article 2-1-8.R 202-LSE015• Telemetry information for the USA:Telemetry data for the USA: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.This device will be registered with Federal Communications Commission under the following number:FCC ID: QRIPNPCircuit technology DycostrateInput impedance > 10 kΩPulse form Biphasic, asymmetricPolarity Cathodic
38Technical DataElectrical CharacteristicsPulse formThe 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 interferenceAll variants of BIOTRONIK devices comply with the requirements of EN 45502-2-1: 2003, § 27.5.1 at the highest sensitivity.
39Technical DataBattery DataBattery DataBattery characteristicsThe following data is provided by the manufacturers: Shortening of the service time after long storage periodIn case of implantation after an average storage period – about 1 year before the end of the use by date – the average service time decreases by about 1%.Power consumption• BOS, inhibited: SR(-T), DR(-T) 6 µA; HF-T (QP) 7 µA• BOS, 100% pacing: SR(-T) 8 µA; DR(-T) 11 µA; HF-T (QP) 14 µACalculation of service timesMean service times pre-estimated from the following and other data:• Storage for 6 months• Technical data of the battery manufacturer• Basic rate of 60 bpm in AAIR/VVIR modes (single-chamber devices) or DDDR modes (dual-chamber and triple-chamber devices)•Home Monitoring configuration: OFF • No wandless telemetry• Configuration of different pulse amplitudes and lead impedancesMean service times S, SRFor single-chamber devices of the 4 series the following times result when set to AAI(R) or VVI(R), with a basic rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω: For single-chamber devices of the 8 series the following times result when set to AAI(R) or VVI(R), with a basic rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω: Manufacturer Wilson GREATBATCH, INC. Clarence, NY 14031 LITRONIK GmbH, 01796 Pirna, GermanyBattery type GB 3395 LiS 2650 LiS 3150MKSystem Li-Iodine Li-Iodine LiMn02Device type S; SR; D; DR S; SR; D; DR HF; HF QPBattery voltage at BOS 2.8 V 2.8 V 3.1 VOpen-circuit voltage 2.8 V 2.8 V 3.1 VNominal capacity 960 mAh 960 mAh 1200 mAhUsable capacity until EOS 905 mAh 905 mAh 1066 AhRemaining capacity at ERI 55 mAh 55 mAh 134 mAhAmplitude Pacing Average service time2.5 V 100% 14 years50% 16 years, 10 months3.0 V 100% 12 years50% 14 years, 10 months5.0 V 100% 4 years, 7 monthsAmplitude Pacing Average service time2.5 V 100% 13 years50% 14 years, 9 months3.0 V 100% 11 years, 3 months50% 13 years, 7 months5.0 V 100 % 5 years, 6 months
40Technical DataBattery DataMean service times D, DRFor dual-chamber devices of the 4 series the following times result when set to DDD(R), with a basic rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω: For dual-chamber devices of the 8 series the following times result when set to DDD(R), with a basic rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω: Mean service times HFFor triple-chamber devices of the 8 series the following times result when set to DDDR with a basic rate of 60 bpm, 100% biventricular pacing and a pulse width of 0.4 ms at an impedance of 500 Ω: Amplitude Pacing Average service timeA: 2.5 VRV: 2.5 V100% 9 years, 10 months50% 12 years, 4 monthsA: 3.0 VRV: 3.0 V100% 7 years, 11 months50% 10 years, 8 monthsA: 5.0 VRV: 5.0 V100% 8 years, 1 monthsAmplitude Pacing Average service timeA: 2.5 VRV: 2.5 V100% 9 years, 4 months50% 11 years, 4 monthsA: 3.0 VRV: 3.0 V100% 7 years, 8 months50% 10 yearsA: 5.0 VRV: 5.0 V100% 3 years, 2 monthsAmplitude Pacing Average service timeA: 2.5 V 10% 9 years, 8 monthsRV: 2.5 VLV: 2.5 V100%A: 3.0 V 10 % 8 yearsRV: 3.0 VLV: 3.0 V100%A: 5.0 VRV: 5.0 VLV: 5.0 V100% 2 years, 6 months
41Technical Data Legend for the Label Legend for the LabelThe label icons symbolize the following: Manufacturing date Use byStorage temperature Order numberSerial number Product identification numberCE markContents Follow the instructions for useSterilized with ethylene oxideDo not resterilize Single use only. Do not re-use!Do not use if packaging is damagedNon-sterileTransmitter with non-ionizing radiation at designated frequencyTP2 Compabiltiy with telemetry protocol version 2 of BIOTRONIK Home Monitoring ExampleUncoated device: NBG code and compatible leadsScrewdriver Examples of the connector allocation: IS-1, IS-1/IS4NONSTERILE

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