BIOTRONIK SE and KG TACHBORAX implantable cardioverter defibrillator User Manual

BIOTRONIK SE & Co. KG implantable cardioverter defibrillator

15_TACHBorax UserMan

BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin · GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804sales@biotronik.comwww.biotronik.comInlexa 1 VR-T, DR-T, HF-TICD-Familie | Tachyarrhythmietherapie | Kardiale ResynchronisationstherapieGebrauchsanweisung420651Revision: A (2015-12-09)© BIOTRONIK SE & Co. KGAlle Rechte vorbehalten.Technische Änderungen vorbehalten.® Alle verwendeten Produktnamen können Marken oder eingetragene Marken von BIOTRONIK oder dem jeweiligen Eigentümer sein.Index 420651GebrauchsanweisungInlexa 1 VR-T , DR-T, HF-T,
11 Product Description Product Description1403736Technical ManualIntended Medical UseIntended use Inlexa 1 is part of a family of implantable cardioverter-defibrillators (ICDs). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchroni-zation therapy with multisite ventricular pacing.The implantation of an ICD is a symptomatic therapy with the following objectives: • Termination of spontaneous ventricular fibrillation (VF) through shock delivery• Termination of spontaneous ventricular tachycardia (VT) through antitachy-cardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with shock delivery • Cardiac resynchronization through multisite ventricular pacing (triple-chamber devices)• Compensation of bradycardia through ventricular (single-chamber devices) or AV sequential pacing (dual- and triple-chamber devices)Diagnosis and therapy formsThe device monitors the heart rhythm and automatically detects and terminates cardiac arrest resulting from ventricular tachyarrhythmia. All major therapeutic approaches from the field of cardiology and electrophysiology are included. BIOTRONIK Home Monitoring® enables physicians to perform therapy manage-ment at any time.Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation and the operation conditions of a device system.• Only qualified medical specialists having this required special knowledge are permitted to use implantable devices.• If users do not possess this knowledge, they must be trained accordingly.Indications Inlexa 1 can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation.Generally approved differential diagnostics methods, indications, and recommen-dations for ICD therapy apply to BIOTRONIK devices. See the current guidelines of cardiology associations for guidance. 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.Single-chamber and dual-chamberSingle-chamber and dual-chamber ICDs are indicated for patients with the following risk:• Sudden cardiac death caused by ventricular arrhythmiasTriple-chamber Triple-chamber ICDs are indicated for patients with the following risks:• Sudden cardiac death caused by ventricular arrhythmias• Congestive heart failure with ventricular asynchrony
2Contraindications Known contraindications:• Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction• Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries• VT with few or without clinically relevant symptoms• VT or VF treatable by surgery• Concomitant diseases that would substantially limit a positive prognosis• Accelerated intrinsic rhythmSystem OverviewDevice family The complete Inlexa 1device family consists of several device types with a DF-1/IS-1 connection.•Single-chamber: VR-T•Dual-chamber: DR-T• Triple-chamber: HF-TDevice The device's housing is made of biocompatible titanium, welded from outside and thus hermetically sealed. The ellipsoid shape facilitates implantation in the pectoral muscle area.The connections for bipolar pacing and sensing (and unipolar connections for the triple-chamber device) as well as for shock delivery are found in the device header.The housing serves as a potential antipole during shock delivery or in the case of unipolar lead configuration.DF-1/IS-1 The labeling on each device provides information pertaining to the connector port assignment in the header. Leads BIOTRONIK leads are sheathed with 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 poly-urethane which is known to increase the sliding properties for the lead. Leads with steroids reduce inflammatory processes. The fractal design of the electrodes provides for low pacing thresholds. BIOTRONIK provides adapters to connect already implanted leads to new devices.Note: Not all device types are available in every country.VR DR HFConnector port Lead connector Configuration Implantation site Device typeRA IS-1 Bipolar Atrium DR, HF(R)V IS-1 Bipolar (Right) ventricle VR, DR, HFRV DF-1 Shock coil Right ventricle VR, DR, HFSVC DF-1 Shock coil Superior vena cavaVR, DR, HFLV IS-1 Unipolar, bipolar Left ventricle HF DF-1RVSVCDF-1IS-1RV DF-1 RV SVCDF-1 IS-1RAIS-1RV DF-1RVSVCDF-1 IS-1RAIS-1RVLVIS-1
3Telemetry Telemetric communication between the device and the programmer can be carried out following initialization either by applying the programming head (PGH) to the device or by using wireless radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this function SafeSync®.Programmer Implantation and follow-up are performed with BIOTRONIK's portable programmer: Programmer software PSW version N.N. and higherThere is a programmer with integrated RF telemetry and one with a separate SafeSync Module.Leadless ECG, IEGM, markers and functions are displayed simultaneously on the color display.Using the programmer, the pacing thresholds can be determined and all tests can be performed during in-office follow-up. If necessary, the current software is trans-ferred to the device during implantation.In addition to this, the programmer is used to set mode and parameter combina-tions, as well as for interrogation and saving of data from the device.Modes The mode setting depends on the individual diagnosis: NBD and NBG codes VVE is the NBD code for the antitachycardia mode of the single-chamber, dual-chamber, and triple-chamber devices: DDDR is the NBG code for the antibradycardia mode of the dual-chamber devices: DDDRV is the NBG code for the antibradycardia mode of the triple-chamber devices: VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber device: Device type ModesVR VVI; VVIR; VOO; OFFDR, HF DDD; DDDR; DDDR-ADIR; DDD-ADI; DDI; DDIR;VDD; VDDR; VDI; VDIRVVI; VVIR; AAI; AAIR; VOO; DOO; OFFV Shock in the ventricleV Antitachycardia pacing (ATP) in the ventricleE Detection via IEGM analysisD 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 ventriclesV Ventricular pacingV Sensing in the ventricleI Pulse inhibition in the ventricleR Rate adaptation
4BIOTRONIK Home Monitoring®In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system: • With Home Monitoring, diagnostic and therapeutic information as well as 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 trans-mitter 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 heart or in the device are forwarded immediately.• A test message can be initiated at any time using the programmer to immedi-ately check the Home Monitoring function.Inlexa 1order numbers Not all device types are available in every country: Package contents The storage package includes the following: • Sterile packaging with device• Serial number label• Patient ID card• Warranty bookletThe sterile container includes the following: • Device, blind plugs (if applicable)• Screwdriver VR-T DR-T HF-T405797 405796 40579Note: 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.
5Therapeutic and Diagnostic FunctionsDiagnostic functions • Data from implantation and the most recent interrogations and follow-ups are recorded as well as arrhythmia episodes; they are stored together with other data to assess both the patients' and the device's state at any time.• To check the lead for proper functioning, an automatic impedance measure-ment using subthreshold pacing pulses is performed in the device.• Leadless ECG function: For all device types, far-field derivation can be measured without external leads between the right ventricular shock coil and housing, which, depending on the implantation site, corresponds to ECG derivation II or III (Einthoven).• Once a telemetry connection has been established during a test procedure in an in-office follow-up, the leadless ECG and the IEGM are displayed with markers.Antitachycardia pacing • The ICD can treat ventricular tachycardia with antitachycardia pacing (ATP); ATP can also be delivered in the VF zone (ATP One Shot) when the stability criterion indicating that this will be effective before shock delivery (monomorphic rapid VTs) is met.• Depending on the device type, the device program contains not only the ICD functions but also all pacemaker functions for 1, 2 or 3 chambers. The heart rhythm is continuously monitored; each arrhythmia is classified according to the heart rate and the adjustable detection criteria. Depending on the preset values, antibradycardia as well as antitachycardia therapy is inhibited or delivered.Cardioversion, defibrillation • The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defi-brillation. Shock polarity and energy can be programmed individually. Shock energies between 2.0 and 40 J are possible depending on the device family. Before delivery of the shock, the ICD can be set to only deliver a shock when ongoing tachyarrhythmia is confirmed; during this time period the device can identify spontaneous conversion of the tachyarrhythmia and cancel the charging process if necessary.• The shock paths can be set between the different shock coils (SVC/RV) and/or the housing.Antibradycardia pacing and CRT• Innovative rate hystereses, automatic sensor functions, and a night program promote the patient's intrinsic rhythm, avoid overdrive pacing, and facilitate adaptation of the device to the individual needs of the patient.• Thresholds: atrial as well as ventricular pacing thresholds are automatically determined in the device, automatic threshold monitoring (ATM) for trend analysis.• Setting an upper tracking rate for the atrium prevents unspecific atrial pacing, thus reducing the risk of pacemaker-mediated tachycardia.• Positive AV hysteresis functions support intrinsic conduction and thus the natural contraction sequence. Negative AV hysteresis functions support the cardiac resynchronization therapy by maintaining pacing in stress situations.• For resynchronization of the ventricles, triple-chamber implants have functions for multisite pacing with possible VV delays in either direction.• 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.Storing programs There are different therapy programs: • Parameter settings effective for the most common indications in pre-configured programs (Program Consult).• For special indications, individual parameter settings can be stored in up to three therapy programs.
6Home Monitoring functions • The device automatically sends information to the transmitter once a day. It also sends messages related to events, which are immediately forwarded to the Service Center. In addition to this, test messages can be initiated using the programmer.• Appointments for Home Monitoring-supported follow-ups can be scheduled via the HMSC.• Important medical information in the device messages include the following:— Atrial and ventricular arrhythmias— Parameters relevant to leads in the atrium and ventricle: pacing thresholds, sensing amplitudes, impedances— Current statistics—IEGM online HD® with up to 3 high definition channels
72 General Safety Instructions General Safety Instructio ns2403736Technical ManualOperating ConditionsTechnical manuals The following technical manuals provide information about usage of the device systems:— Technical manual for the device— Technical manual for the HMSC— Technical manual for the electrodes— 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.• Reserve technical manuals for later use.Care during shipping and storage• Devices must not be stored or transported close to magnets or sources of elec-tromagnetic interference.• Note the effects of the storage duration; see Battery Data.Delivery in shipment mode The device is delivered in shipment mode to protect the battery; capacitor reforming required during storage could result in controlled extended charge times of the shock capacitors.• The shipment mode is displayed on the programmer after the initial interroga-tion (it is deactivated during implantation by the first valid (in-range) measure-ment of the pacing impedance).Temperature Extremely low and high temperatures affect the service time of the battery in the device. • Temperatures of +5°C to +45°C are permitted for transport, storage, and use.Sterile delivery The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if the blister and quality control seal have not been damaged. Sterile packaging The device and screwdriver are packaged in two separately sealed blisters. The inner blister is also sterile on the outside so that it can be transferred in a sterile state during implantation.Single use only The device and screwdriver are intended for single use only. • Do not use the device if the package is damaged.• The device must not be resterilized and reused.
8Possible ComplicationsGeneral information on medical complicationsComplications for patients and device systems generally recognized among practi-tioners 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 impossible to guarantee the efficacy of antitachycardia therapy, even if the programs have proven successful during tests or subsequent electrophysio-logical examinations. In rare cases the set parameters may become ineffective. It is possible for therapies to induce or accelerate tachycardia and cause sustained ventricular flutter or fibrillation.Skeletal myopotentials Bipolar sensing and control of sensitivity are adapted by the device to the rate range of intrinsic events so that skeletal myopotentials are usually not recorded. Skeletal myopotentials can nonetheless be classified as intrinsic events especially at very high sensing sensitivity and, depending on the interference, may cause inhibition or antiarrhythmia therapy.In the case of undesired myopotentials, the device switches to asynchronous pacing if the interference rate is exceeded.Possible technical failures Technical failure of a device system cannot be entirely ruled out. Possible causes can include the following: • Lead dislodgement, lead fracture • Insulation defects• Device component failures• Battery depletion• Interrupted telemetryElectromagnetic interference (EMI)Any device can be sensitive to interference if external signals are sensed as intrinsic rhythm or if measurements prevent rate adaptation. • BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal. • Due to the intensity and variety of EMI, there is no guarantee for safety. It is generally assumed that EMI produces only minor symptoms, if any, in patients.• Depending on the pacing mode and the type of interference, sources of inter-ference may lead to pulse inhibition or triggering, an increase in the sensor-dependent pacing rate or asynchronous pacing.• Under unfavorable conditions, for example during therapeutic or diagnostic 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 EMIIn case of electromagnetic interference, the device switches to asynchronous pacing for as long as the interference rate is exceeded. Static magnetic fields The magnetic sensor in the device detects magnetic fields starting at a magnetic flux density of approximately 1.5 mT. Magnetic fields below 1 mT do not affect the sensor.
9Possible RisksProcedures to avoid The following procedures must be avoided, as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk: • Transcutaneous electrical nerve stimulation• Hyperbaric oxygen therapy• Applied pressures higher than normal pressureRisky therapeutic and diagnostic proceduresIf electrical current from an external source is conducted through the body for diag-nostic or therapeutic purposes, then the device can be subjected to interference, which can place the patient 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. For example, excessive warming of body tissue near the device system may occur during therapeutic ultrasound. Influ-ences on the device are not always immediately clear.If risky procedures cannot be avoided, the following should be observed at all times:• Electrically insulate the patient.• Switch off the ICD's detection function. The pacemaker function can remain active. The device may need to be switched to asynchronous modes for this.• Do not introduce energy near the device system.• Additionally check the peripheral pulse of the patient.• Monitor the patient during and after every intervention.External defibrillation The device is protected against the energy that is normally induced by external defi-brillation. Nevertheless, any implanted device may be damaged by external defibril-lation. Specifically, the current induced in the implanted leads may result in necrotic tissue formation close to the electrode/tissue interface. As a result, sensing prop-erties and pacing thresholds may change. • Place adhesive electrodes anterior-posterior or perpendicular to the axis formed by the device to the heart at least 10 cm away from the device and from implanted leads.Radiation therapy The use of radiation therapy must be avoided due to possible damage to the device and the resulting impaired functional safety. If this type of therapy is to be used anyway, prior risk/benefit analysis is absolutely necessary. The complexity of influ-encing 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 adminis-tration of therapeutic ionizing radiation:• Adhere to instructions for risky therapy and diagnosis procedures.• Shield device against radiation.• After applying radiation, double-check the device system to make sure it is func-tioning properly.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.Note: Please contact BIOTRONIK with questions during the risk/benefit analysis.
103 Implantation Implantation3403736Technical M anualImplantation ProcedureHaving parts ready The following parts that correspond to the requirements of the EC Directive 90/385/EEC are required:• BIOTRONIK device with blind plug and screwdriver• BIOTRONIK leads and lead introducer set— Single-chamber device: one bipolar ICD lead with 1 or 2 shock coils for the ventricle — Dual-chamber device: one bipolar lead for the atrium and one bipolar ICD lead for the ventricle with 1 or 2 shock coils— Triple-chamber device: an additional unipolar or bipolar LV lead• The lead connections DF-1 and IS-1 are permitted. Use only adapters approved by BIOTRONIK for leads with different lead connections or leads from other manufacturers.• BIOTRONIK programmer (with integrated SafeSync RF telemetry or with separate SafeSync Module) and approved cables• External multi-channel ECG device• Keep spare parts for all sterile components.Keeping an external defibrillator readyTo be able to respond to unforeseeable emergencies or possible technical failures of the device:• Keep an external defibrillator and paddles or patch electrodes ready.Unpacking the device• 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!• Take hold of the inner blister by the gripping tab and take it out of the outer blister.• Peel the sealing paper off of the sterile inner blister at the marked position in the direction indicated by the arrow.Checking parts Damage to any of the parts can result in complications or technical failures. • Check for damage before and after unpacking all parts.• Replace damaged parts.• Upon delivery, the tachyarrhythmia therapy function in the ICD is deactivated. The ICD must only be implanted in this state.• Leads must not be shortened.!!WARNINGInadequate therapy due to defective deviceIf an unpacked device is dropped on a hard surface during handling, electronic parts could be damaged. • Use a replacement device.• Return the damaged device to BIOTRONIK.
11Implantation site • Depending on lead configuration and the patient's anatomy, the ICD is generally implanted subpectorally on the left side.Preventing leakage currentsLeakage currents between the tools and the device must be prevented during implantation.• Electrically insulate the patient.Preventing unintentional shock deliveryAvoiding damage to the headerSet screws and blind plugs (if applicable) must be tightened or loosened with care. • Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screw-drivers with torque control!• Do not forcibly pull out the blind plug!• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.Preventing short circuits in the headerEnsure that connector ports are cleanIn case of contamination during implantation:• Clean lead connectors with a sterile cloth.• Rinse connector port only with sterile water.Overview: ImplantingConnecting the device The lead connectors are connected to the ports in the header of the device: !!WARNINGShock delivery with activated ICDThere is a risk of unintended shock delivery when handling an activated ICD.• Deactivate ICD therapy before touching the device during implantation, device replacement and explantation.!!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.• Close unused connector ports with blind plugs.1 Prepare the vein.2 Implant the leads, perform the measurements, and fixate the leads.3 Form the device pocket.4 Connect the lead connector to the device.5 Insert the device.6 Guide the fixation suture through the opening in the header and fixate the device in the prepared device pocket.7 Close the device pocket.8 Check the device with standard tests.1 Disconnect stylets and stylet guides.2 DF-1/IS-1 connection:• Connect the DF-1 connector for the right-ventricular shock coil to RV.• Connect the DF-1 connector for the supraventricular shock coil to SVC.Or connect a subcutaneous array to SVC.
12Keeping distance between leadsApplying 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 telemetry contactThe programmer (or the SafeSync Module) can be no more than 3 m from the device; ideally there should be no hindrances between the patient and the programmer.• Switch on RF telemetry on the programmer.• Apply the programming head for about 2 s until successful initialization is displayed on the programmer:The SafeSync symbol is displayed in the navigator and the signal strength is displayed in the status line.• Remove the programming head.Activating ICD therapy • Load the software that is suitable for the device type in the programmer.• Activate ICD therapy.• Shipment mode is permanently deactivated once the leads have been connected and initial measurement of the pacing impedance has been performed success-fully. The device data are saved.• Take precautionary measures while programming.• If the device induces tachycardia while programming ATPs or does not deliver adequate therapy in the DFT test: use emergency shock or an external defibril-lator.3 DF-1/IS-1 connection:• Connect the bipolar IS-1 connector for the atrium to RA.• Connect the bipolar IS-1 connector for the right ventricle to RV.• Connect the unipolar or the bipolar IS-1 connector for the left ventricle to LV.4 Push the lead connector into the header without twisting or bending the connector or conductor until the connector tip (on the DF-1 connector) becomes visible behind the set screw block. This indicator can vary depending on the manufacturer of the lead used.5 If you cannot easily plug the lead connector into the connection:• Use only sterile water as lubricant.6 If the lead connector cannot be inserted completely, the set screw may be protruding into the drill hole of the set screw block. • Use the screwdriver to perpendicularly pierce through the slitted point in the center of the silicone plug until it reaches the set screw.• Carefully loosen the set screw without completely unscrewing it, so that it does not become tilted upon retightening.7 Turn the set screw clockwise until torque control starts (you will hear a clicking sound). 8 Carefully withdraw the screwdriver without retracting the set screw. • In case of IS-1 connections with 2 set screws, tighten both screws!• When you withdraw the screwdriver, the silicone plug automatically seals the access to the screw head safely.!!WARNINGInadequate therapyWhen leads are not spaced sufficiently apart or are positioned inappropriately, this can lead to far-field sensing or insufficient defibrillation.• The distance between 2 shock coils must be greater than 6 cm.• Tip and ring electrodes must not have contact with each other.
13Precautionary Measures while ProgrammingPerforming 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.Cancelling telemetry Programmer interference or interrupted telemetry during performance of temporary programs (follow-up tests) can result in inadequate pacing of the patient. This is the case if the programmer can no longer be operated due to a program error or a defective touch screen and therefore the temporary program cannot be terminated. Under these circumstances, it is helpful to cancel telemetry, in which case the device automatically switches to the permanent program. • In the case of telemetry with programming head: lift the PGH by at least 30 cm.• In the case of RF telemetry: switch off and reposition the programmer.• Turn off possible sources of interference.Avoiding critical parameter 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 exertion.• Check compatibility and effectiveness of parameter combinations after making settings.• When setting atrial therapies after an AT or AF has been detected, note that no ventricular tachyarrhythmia can be detected for the duration of atrial therapy delivery.Checking for electrodes suitable for the shock pathThree different shock paths can be set. Two of these form an electrical path to the housing of the implanted device. • For the RV -> SVC shock path, a second shock coil must be available (dual shock coil).Monitoring the patient when setting asynchronous modesThe asynchronous modes V00 and D00 can only be set if tachyarrhythmia sensing is deactivated. This would leave the patient without sensing and therefore without ICD therapy.• Continually monitor the patient.• Keep an external defibrillator ready.Setting sensing Manually set parameters can be unsafe. For example, unsuitable far-field protec-tion may impede sensing of intrinsic pulses.• Note automatic sensitivity control.Preventing device-induced complicationsBIOTRONIK devices feature several functions to prevent device-induced complica-tions to the greatest extent possible:• Measure the retrograde conduction time.• Set PMT protection.• Set the VA criterion.Preventing conduction of atrial tachycardiaBIOTRONIK devices feature several functions to prevent conduction of atrial tachy-cardia 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.
14Note the reduced pulse amplitude due to a battery voltage dropIf the rate and amplitude are set very high and the pulse width is set too long at the same time, the battery voltage may temporarily drop so low that the actual pulse amplitude drops well below the selected level.• Continuously check the pacing efficiency using ECG monitoring.Observe when inducing short-term cardiac arrestTo permit TAVI (transcatheter aortic valve implantation), the pressure in the heart must be reduced so that the heart valve can be correctly positioned. Intentional cardiac arrest by high-rate pacing (rapid pacing) should be brief, must be tolerated by the patient and can trigger a life-threatening arrhythmia.• Take all necessary precautionary measures and keep required emergency equipment ready.• Continually monitor the patient by ECG.• Complete the TAVI procedure before high-rate pacing ends. Extend the pacing duration if necessary.• Abort the procedure if it is not successfully completed within the maximum pacing duration so that cardiac arrest can be stopped.• Reactivate ICD therapy at a clinically indicated point in time when the TAVI process is completed.Avoiding AV crosstalk When pacing using atrial ATP parameters, atrial pacing pulses can either be conducted into the ventricle or be sensed such that ventricular pacing is prevented.• Check the settings for the presence of crosstalk.• If necessary, temporarily set VVI and a rate for backup stimulation so that no ventricular pulses are prevented.Observing the shock impedance limitThe implanted device could be damaged if the shock impedance is too low.• The shock impedance must be > 25 Ω.Preventing recurrence after therapy shockAfter a therapy shock, pacing can be performed with a post-shock program if there is no intrinsic rhythm. • The following post-shock program parameters can be adjusted: Post-shock duration, basic rate, rate hysteresis, ventricular pacing, LV T-wave protection, triggering, AV delay (fixed, not dynamic)• The default settings for the post-shock program are as follows:A and RV: 7.5 V, 1.5 msLV: settings from the permanent programPhrenic nerve stimulation that cannot be terminatedIn rare cases, chronic phrenic nerve stimulation cannot be terminated by repro-gramming the available left ventricular pacing configuration or using other measures.• Set a right ventricular mode both in the permanent program as well as the ATP, in the post-shock program and for mode switching if need be.Avoiding risks in the case of exclusive LV pacingLead dislodgement in the case of exclusive left ventricular pacing could pose the following risks: loss of ventricular pacing and ATP therapy, induction of atrial arrhythmias.• Consider sensing and pacing parameters with reference to loss of therapy. • Exclusive LV pacing is not recommended for patients who depend on the device.• Please note that capture control is not available. • In the case of follow-ups and threshold tests, take loss of synchronized ventric-ular pacing into consideration. • Mode switching and post shock do not permit exclusive LV pacing. Please note the effects when programming mode switching and the post shock parameters.Permanent program Post-shock programDDDDDI, AAIDDIVDD, VDI VDIVVI and OFF VVI
15Recognizing lead failure Automatic impedance measurement is always switched on.• Impedance values that indicate technical failure of a lead are documented in the event list.Considering power consumption and service timeRF telemetry requires somewhat more power: Consumption during implantation corresponds to approximately 10 days of service time and consumption during a 20-minute follow-up corresponds to approximately 3 days.• Do not establish unnecessary RF telemetry.• After 5 minutes without input, SafeSync switches to the economy mode.• Check the battery capacity of the device at regular intervals. Magnet ResponseApplication of the programming head when ICD therapy is set If a connected programming head is applied and is communicating with the programmer and ICD therapy is permanently set, detection and therapy remain intact except during the diagnostic tests. If ICD therapy is not set as permanent, no therapy is delivered when the programming head is applied.Programming head applicationWhen the programming head is applied, time remains for device interrogation and for manual activation or deactivation of the therapy before the device switches back to the previously set permanent therapy mode. The same applies to programming head application to establish RF telemetry contact.Application of a permanent magnetApplying a permanent magnet interrupts detection and therapy of tachycardia events. After 8 hours of this type of deactivation, the device automatically reacti-vates the therapy functions to prevent accidental permanent deactivation. • If detection interruptions of longer than 8 hours are required, the magnet has to be briefly removed from the device. The 8 hour countdown restarts when the magnet is applied again.• Use BIOTRONIK magnets: type M-50 permanent magnets.
16Follow-upFollow-up intervals Follow-ups must be performed at regular, agreed intervals.• The first follow-up should be carried out by the physician using the programmer (in-office follow-up) approximately 3 months after implantation following the lead ingrowth phase.• 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 despite use of the Home Monitoring function if symptoms worsen or if new symptoms arise.• 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 needs to be carried out.Possible early detection due to information gained via Home Monitoring may neces-sitate 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 modi-fication of the therapy by reprogramming the device.Follow-up with the programmerUse the following procedure for in-office follow-up: 1 Record and evaluate the ECG.2 Interrogate the device.3 Evaluate the status and automatically measured follow-up data.4 Check the sensing and pacing functions.5 Possibly evaluate statistics and IEGM recordings.6 Manually perform standard tests if necessary.7 Possibly customize program functions and parameters.8 Transmit the program permanently to the device.9 Print and document follow-up data (print report).10 Finish the follow-up for this patient.
17Patient InformationPatient ID card A patient ID card is included in delivery.• Provide the patient with the patient ID.• Request that patients contact the physician in case of uncertainties.Prohibitory 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 inter-ference should not be brought into close proximity with the device.• Draw the patient's attention to special household appliances, security check-points, anti-theft alarm systems, strong electromagnetic fields, cell phones, and transmitters among other things.• Request patients to do the following: — Use cell phones on the side of their body that is opposite of the device.— Keep the cell phone at least 15 cm away from the device both during use and when stowing.
18Replacement IndicationsPossible battery levels • BOS: Beginning of Service: > 90% charge• MOS 1: Middle of Service: 90% to 40% residual charge• MOS 2: Middle of Service: < 40% residual charge• ERI: Elective Replacement Indication (i.e. RRT: Recommended Replacement Time)• EOS: End of ServiceElective Replacement Indication (ERI)Elective Replacement Indication can be detected by Home Monitoring.• The device can monitor the heart rhythm for at least 3 more months. • At least 6 maximum energy shocks can be delivered until EOS occurs.• The selected parameters in the software do not change.EOS replacement indication End of Service can be detected by Home Monitoring.• VT and VF detection and all therapies are deactivated!• The antibradycardia function remains active in the VVI mode:— Ventricular pacing: RV; basic rate 50 bpm; without special pacemaker functions such as hysteresis, etc.— Pulse amplitude of 6 V; pulse width of 1.5 ms— Cycle duration for BIOTRONIK Home Monitoring®: 90 days!!CAUTIONTemporally limited therapyIf ERI occurs shortly after follow-up and is only detected during the subsequent follow-up, then the remaining service time can be much less than 3 months.• Replace device soon.!!WARNINGPatient at risk of deathIf EOS replacement indication occurs before replacement of the device, then the patient is without therapy.• Replace device immediately.• Monitor patient constantly until immediate replacement of the device!
19Explantation and Device ReplacementExplantation •Interrogate the device status.• Deactivate VT and VF therapies prior to explantation.• Remove the leads from the header. Do not simply cut them loose.• Use state-of-the-art techniques to remove the device and, if necessary, the leads.• Explants are biologically contaminated and must be disposed of safely due to risk of infection.Device replacement 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.• Deactivate VT and VF therapies prior to device replacement.• Insulate connector ports that are not used.Basic principles:• The device must not be resterilized and reused.Cremation Devices must not be cremated. • Explant the device before the cremation of a deceased patient.Disposal BIOTRONIK takes back used products for the purpose of environmentally safe disposal. • Clean the explant with a solution of at least 1% sodium hypochlorite.• Rinse off with water.• Fill out explantation form and send to BIOTRONIK together with the cleaned device.Note: Normal oxidation processes may cause ICD housing discolorations. This is neither a device defect nor does it influence device functionality.
204 Parameters Parameters4403736Technical ManualBradycardia / CRTGeneral ICD therapyTiming: Basic rate day/night and rate hysteresesTiming: AV delayParameter Range of values Standard VR DR HFICD therapy OFF; ON ON x x xPrograms Display standard program; Display safe program; Display first interrogated program; Individual 1, 2, 3; Program Consult— xxxParameter Range of values Standard VR DR HFBasic rate 30 ... (5) ... 100 ... (10) ... 160 bpm40 bpm x60 bpm x xNight rate OFF; 30 ... (5) ... 100 bpm OFF x x xNight begins 00:00 ... (00:01) ... 23:59 hh:mm22:00 hh:mmxxxNight ends 06:00 hh:mmRate hysteresis OFF; -5 ... (-5) ... -25 ... (-20) ... -65 bpmOFF xxxScan/repetitive OFF; ON ON x x xParameter Range of values Standard VR DR HFAV dynamics Low; Medium; High; Fixed; (Individual) Low x xAV delay (1 or 2) after:– Pacing 15; 40 ... (5) ... 350 ms – x x– Sensing Either automatic: AV delay after pacing + sense compensationOr: 40 ... (5) ... 350 ms–xx– At rate 1 50 ... (10) ... 130 bpm 60 bpm– At rate 2 60 ... (10) ... 140 bpm 130 bpmSense compensation OFF; -5 ... (-5) ... -120 ms -40 ms x xAV hysteresis mode OFF; Positive; Negative; IRSplusOFF xOFF; Positive; Negative OFF xAV hysteresis (positive) 70; 110; 150; 200 ms 70 ms x xAV hysteresis (positive) 70; 110; 150 ms 110 ms x xAV hysteresis (negative) 10 ... (10) ... 150 ms 50 ms x xAV scan and repetitive (positive)OFF; ON ON x x
21Timing: Post-shock pacingTiming: Upper rateTiming: Mode switchingTiming: Ventricular pacingParameter Range of values Standard VR DR HFPost-shock duration OFF; 10 s; 30 s; 1 min; 2 min; 5 min; 10 min10 s x x xPost-shock basic rate 30 ... (5) ... 100 ... (10) ... 160 bpm60 bpm x x xAV delay post shock 50 ... (10) ... 350 ms 140 ms x xVentricular post-shock pacingRV; BiV RV xParameter Range of values Standard VR DR HFUpper rate 90 ... (10) ... 160 bpm 130 bpm x xAtrial upper rate OFF; 175; 200; 240 bpm 200 bpm x xParameter Range of values Standard VR DR HFIntervention rate OFF; 120 ... (10) ... 200 bpm160 bpm x xOnset criterion 3 ... (1) ... 8 (out of 8) 5 x xResolution criterionModification of basic rate OFF; 5 ... (5) ... 30 bpm 10 bpm x xMode After mode VDD(R): VDI(R) VDIR x xAfter mode DDD(R): DDI(R)DDIR x xAfter mode switching:– Rate OFF; 5 ... (5) ... 50 bpm 10 bpm x x– Duration 1 ... (1) ... 30 min 1 minParameter Range of values Standard VR DR HFPermanent RV; BiV; LV BiV xTriggering OFF; RVs; RVs+PVC RVs xLV T-wave protection OFF; ON ON xMaximum trigger rate:– DDD(R) and VDD(R) UTR + 20; 90 ... (10) ... 160 bpmUTR + 20 x– DDI(R), VDI(R) and VVI(R) 90 ... (10) ... 160 bpm 130 bpmInitially paced chamber RV; LV LV xVV delay after Vp 0 ... (5) ... 100 ms 0 ms x
22Timing: Refractory periods and blanking periodsTiming: PMT protectionTiming: Rate adaptation via accelerometerPacing: Pulse amplitude and pulse widthPacing: Atrial capture controlParameter Range of values Standard VR DR HFPVARP AUTO; 175 ... (25) ... 600 ms225 ms x xPVARP extension OFF; ON ON x xBlanking after atrial pacing50 ... (10) ... 100 ms 50 ms x xLV blanking after RV pacing80 ms xRV blanking after LV pacingFar-field protection after VsOFF; 25 ... (25) ... 225 ms 75 ms x xFar-field protection after Vp50 ... (25) ... 225 ms 75 ms x xParameter Range of values Standard VR DR HFPMT detection/termina-tionOFF; ON ON x xVA criterion 250 ... (10) ... 500 ms 350 ms x xParameter Range of values Standard VR DR HFMaximum sensor rate 80 ... (10) ... 160 bpm 120 bpm x x xSensor gain AUTO; Very low; Low; Medium; High; Very highMediumxxxSensor threshold Very low; Low; Medium; High; Very highMediumxxxRate increase 1; 2; 4; 8 bpm/cycle 2 bpm/cyclexxxRate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle0.5 bpm/cyclexxxParameter Range of values Standard VR DR HFPulse amplitude A 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.0; 7.5 VAUTO x xPulse amplitude V/RV x x xPulse amplitude LV xPulse width A 0.4; 0.5 ... (0.25) ... 1.5 ms 0.4 ms x xPulse width V/RV xxxPulse width LV 0.4 ms xParameter Range of values Standard VR DR HFAtrial capture control OFF; ATM ON x xThreshold test start 2.5 ... (0.5) ... 5.0 V 3.5 V x x
23Pacing: Ventricular capture control Lead configuration LV on IS-1 connectionParameter Range of values Standard VR DR HFVentricular capture controlOFF; ATM ON xxxThreshold test start 2.5 ... (0.5) ... 5.0 V 3.5 V x x xParameter Range of values Standard VR DR HFPacing polarity LV (IS-1)LV tip -> LV ringLV tip -> RV shock coilLV ring -> LV tipLV ring -> RV shock coilUNIPLV tip -> RV shock coilxSensing polarity LV (IS-1)UNIP; BIPL UNIP x
24TachycardiaDetection Parameter Range of values Standard VR DR HFInterval AT/AF 240 ... 600 ms 300 ms x xInterval VT1 OFF; 270 ... (10) ... 600 ms OFF x x xInterval VT2 OFF; 270 ... (10) ... 500 msInterval VF OFF; 240 ... (10) ... 400 ms 300 msDetection counter VT1 10 ... (2) ... 100 28 x x xDetection counter VT2 10 ... (2) ... 80 20Detection counter VF 6 out-of 8; 8 out-of 12; 10 out-of 14; 12 out-of 16;16 out-of 20; 18 out-of 24; 20 out-of 26; 22 out-of 30; 24 out-of 30; 30 out-of 4018 out of 24Redetection counter VT1 10 ... (2) ... 50 20 x x xRedetection counter VT2 10 ... (2) ... 40 14Redetection counter VF 6 out-of 8; 8 out-of 12; 10 out-of 14; 12 out-of 16; 16 out-of 20;18 out-of 24; 20 out-of 26; 22 out-of 30; 24 out-of 308 out of 12xxxSMART detection VT1/VT2 OFF; ON ON x xSMART detection ON:– Onset VT1/VT2 4 ... (4) ... 32% 20% x x– Stability VT1/VT2 8 ... (4) ... 48% 12%SMART detection OFF:– Onset VT1/VT2 4 ... (4) ... 32% 20% x x x– Stability VT1/VT2 OFF; 8 ... (4) ... 48 ms 24 msMorphMatch OFF; Monitoring; ON OFF x x xSustained VT OFF; 1; 2; 3; 5; 10; 20; 30 minOFF xxxForced termination OFF; 1 ... (1) ... 10 min 1 min x x
25Therapy: ATPTherapy: ShockParameter Range of values Standard VR DR HFAttempts OFF; 1 ... (1) ... 10 OFF x x xATP type for VT1/VT2 Burst; Ramp Burst x x xATP type for VF OFF; Burst; Ramp Burst x x xATP optimization OFF; ON OFF x x xNumber S1 for VT1/VT2 1 ... (1) ... 10 5 x x xNumber S1 for VF 8S1 decrement for VT1/VT2 and for VF5 ... (5) ... 40 ms 10 ms x x xScan decrement OFF; 5 ... (5) ... 40 ms OFF x x xAdd S1 for VT1/VT2 OFF; ON ON x x xVentricular pacing for VT1/VT2RV; LV; BiV RV xVentricular pacing for VF RVR-S1 interval for VT1/VT2 70 ... (5) ... 95% 80% x x xR-S1 interval for VF 85 %Parameter Range of values Standard VR DR HFNumber of shocks VT1/VT20; 1; 2; 6; 8 8 x x xNumber of shocks VF 6; 8 8 x x x1st Shock for VT1/VT2 OFF; 2 ... (2) ... 20 ... (5) ... 40 J40 J x x x2nd Shock for VT1/VT2 OFF; 4 ... (2) ... 20 ... (5) ... 40 J40 J x x x3rd - nth shock for VT1/VT2OFF; 4*40 J; 6*40 J 6*40 J x x x1st Shock for VF 2 ... (2) ... 20 ... (5) ... 40 J 40 J x x x2nd Shock for VF 4 ... (2) ... 20 ... (5) ... 40 J 40 J x x x3rd - nth shock for VF 4*40 J; 6* 6*40 J x x xFor shock in VT1/VT2 and VF:– Confirmation OFF; ON ON x x x– Polarity Normal; Reverse; Alter-natingNormal– Shock form Biphasic; Biphasic 2 Biphasic– Shock path RV -> ICD+SVCRV -> ICDRV -> SVCRV-> ICD+SVCxxxRV -> ICD
26Sensing Sensitivity and thresholdsDiagnosticsThe following can be set: Parameter Range of values Standard VR DR HFSensing A STD; OFF STD x xSensing RV STD; TWS; VFS; IND STD x x xSensing LV STD; OFF; IND STD xUpper threshold RV 50; 75% 50% x x xUpper threshold LV 50; 75% 50% xUpper threshold duration after detection110; 150 ... (50) ... 500 msVFS: 110 ms350 ms x x xUpper threshold duration after pacing400 msLower threshold RV 25; 50% 25% x x xT-wave suppression after pacingOFF; ON OFF x x xMinimum threshold A 0.2 ... (0.1) ... 2.0 mV 0.4 mV x xMinimum threshold RV 0.5 ... (0.1) ... 2.5 mV 0.8 mV x x xMinimum threshold LV 0.5 ... (0.1) ... 2.5 ... (0.5) ... 5.0 mV1.6 mV xParameter Range of values Standard VR DR HFFor AT/AF OFF; ON ON x xFor SVT OFF; ON ON x xPeriodic recording When Home Monitoring OFF: OFF; 30 ... (30) ... 180 days90 days x x xIEGM configuration RA, RV, LVRA, RV, FFFF; RV; LVRA, RV, LV xStart resting period 00:00 ... (1:00 AM) ... 23:00 hh:mm2:00 AM hh:mmxxxDuration of resting period0.5 ... (0.5) ... 12 h 4 h x x xAV delay adjusted in sensing testOFF; 300 ms 300 ms x xThoracic impedance (TI) OFF, ON OFF x x x
27Home MonitoringParameter Range of values Standard VR DR HFHome Monitoring OFF; ON OFF x x xTime of transmission STD; 00:00 ... (1:00 AM) ... 23:00 hh:mmSTD xxxIEGM for therapy episodesOFF; ON ON x x xIEGM for monitoring episodesOngoing atrial episode OFF; 6; 12; 18 h 12 h x xTransmission date XX.XX.XXXX Follow-up + 91 daysxxxCycle duration 20 ... (1) ... 366 days 91 days x x x
285Technical Data Technical Data5403736Technical M anualMechanical CharacteristicsHousing Devices with header for DF-1 connector: Materials in contact with body tissue• Housing: Titanium• Header: Epoxy resin• Silicone plugs and blind plugs (if applicable): Silopren or silasticX-ray identification HKType Lead connector W x H x D in mm Volume cm3Mass gVR DF-1 69 x 55 x 12,5 38 71DR DF-1 69 x 55 x 12,5 39 71HF DF-1 69 x 58.5 x 12,5 40 73
29Electrical CharacteristicsStandards The specifications are made according to EN 45502-2-2:2008.Measuring conditions If not indicated otherwise, all specifications refer to the following conditions:• Ambient temperature: 37ºC ± 2ºC• Pacing/sensing: 500 Ω ±1%• Shock: 50 Ω ±1% Factory settings • Arrhythmia zones VT1, VT2, VF: OFF• Antibradycardia pacing: OFF• Home Monitoring: OFFTelemetry data • MICS frequencies: 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 Canada:This device must neither interfere with meteorological and earth resources tech-nology 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-TACHBORAXThe code IC in front of the certification/ registration number only indicates that the technical requirements for Industry Canada are met. Telemetry information for the USA:This transmitter is authorized by rule under the Medical Device Radiocommunica-tion 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 Meteoro-logical Satellite, or the Earth Exploration Satellite Services and must accept inter-ference 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 trans-mitter will be free from interference.This device will be registered with Federal Communications Commission under the following number:FCC ID: QRITACHBORAXTelemetry data 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-SMD021
30Pulse 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.Common mode rejection ratioATP amplitude A burst was measured at 500 Ω, an amplitude of 7.5 V (tolerance ±1.5 V), pulse width of 1.5 ms, R-S1 interval of 300 ms and an S1 count of 5: Automatic sensitivity controlMeasurement of actual values and test signal wave shape: standard triangle. Shock energy / peak voltage With shock path: RV to housing + SVC Rate Common mode rejection ratioAtrium: DR, HF V right: VR, DR, HF V left: HF16.6 Hz 72 dB 59 dB 57 dB50 Hz 73 dB 66 dB 57 dB60 Hz 71 dB 66 dB 62 dBATP amplitude Measured minimum Measured maximum Mean valueRA 7.57 V 7.49 V 5.1 VRV 7.54 V 7.49 V 5.1 VLV 7.55 V 7.51 V 5.1 VSensitivity Value Tolerance Measured valueA: positive 0.2 mV 0.2 ... 0.5 0.23 mVA: negative 0.24 mVRV: positive 0.5 mV 0.3 ... 0.7 0.55 mVRV: negative 0.58 mVLV: positive 0.5 mV 0.3 ... 0.7 0.52 mVLV: negativeShock energy(Tolerance) Tolerance Peak voltage Measured valueShock energy Measured valuePeak voltage1 J (0.7 ... 1.18) 100 ... 140 V 0.89 J 125,0 V20 J (15.9 ... 21.6) 500 ... 550 V 16,62 J 530,4 V40 J (32.0 ... 43.2) 710 ... 790 V 33,84 J 750,9 V
31Battery DataBattery characteristics The following data is provided by the manufacturers: Storage period The storage period affects the battery service time.• Devices should be implanted within 19 months between the manufacturing date and the use by date (indicated on the package).• If the ICD is implanted shortly before the use by date, the expected service time may be reduced by up to 17 months.Calculation of service times• The services times have been calculated as follows – in all chambers depending on the device type:— Pulse amplitude: 2.5 V— Pulse width: 0.4 ms— Pacing impedance: 500 Ω— Basic rate: 60 bpm— Home Monitoring: ON, 1 device message each day and 12 IEGM online HD transmissions per year— Diagnostic functions and recordings: permanently set• Capacitor reforming is performed 4 times per year and therefore at least 4 maximum charges for shocks have to be assumed per year even if less than 4 are delivered.Calculation of the number of shocksCalculation of the number of shocks: Service time [in years] x number of shocks per yearInlexa 1 VR-T Service times with LiS 3410 RR battery: Manufacturer LITRONIK Batterietechnologie GmbH & Co01796 Pirna, GermanyBattery type LiS 3410 RRSystem LiMnO2Battery ID number shown on the programmer6Device type VR-T, DR-T, HF-TBattery voltage at ERI 2.85 VCharge time at BOS 8 sCharge time at ERI 10 sUsable capacity until ERI: VR, DR, HF1390 mAhUsable capacity until EOS 1520 mAhPacing Service time [in years] at number of shocks per year481216200% 10.3 8.3 7.0 6.0 5.315% 10.1 8.1 6.8 5.9 5.250% 9.5 7.8 6.6 5.7 5.0100% 8.8 7.3 6.2 5.4 4.8
32Inlexa 1 DR-T Service times with LiS 3410 RR battery: Inlexa 1 HF-T Service times with LiS 3410 RR battery: Pacing Service time [in years] at number of shocks per year481216200% 9.4 7.7 6.5 5.7 5.015% 9.0 7.4 6.3 5.5 4.950% 8.1 6.8 5.9 5.2 4.6100% 7.1 6.1 5.3 4.7 4.3Pacing Service time [in years] at number of shocks per year481216200% 8.9 7.4 6.3 5.5 4.915% 8.3 7.0 6.0 5.2 4.750% 7.2 6.1 5.4 4.8 4.3100% 6.0 5.3 4.7 4.2 3.9
33Legend for the LabelLabel on the package The label icons symbolize the following: Manufacturing date Use byStorage temperature Order numberSerial number Product identification numberDangerous voltages! CE markContents Follow the instructions for use Sterilized with ethylene oxideDo not resterilize Single use only. Do not reuse!Do not use if packaging is damagedNon-sterileTransmitter with non-ionizing radiation at designated frequencyTP2 Compatibility with telemetry protocol version 2 of BIOTRONIK Home Monitoring ExampleDevice: NBG code and compatible leads ExampleFactory settings for therapy: OFFScrewdriver Example of lead connection: DF-1/IS-1STERILIZE2NONSTERILE

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