BIOTRONIK SE and KG TACHNT2 Implantable Cardioverter Defibrillator User Manual 417635 B GA Inlexa mul

BIOTRONIK SE & Co. KG Implantable Cardioverter Defibrillator 417635 B GA Inlexa mul

Contents

15a_[TACHNT2] UserMan_Inlexa

Inlexa 3/7ICD Family • Tachyarrhythmia Therapy • Cardiac Resynchronization TherapyICD-Familie • Tachyarrhythmietherapie • Kardiale ResynchronisationstherapieFamilia de DAI • Terapia antitaquiarritmia • Terapia de resincronización cardiacaFamille des DAI • Traitement de la tachyarythmie • Traitement par resynchronisation cardiaqueTechnical manual GebrauchsanweisungManual técnicoManuel technique• en• de • es• fr
BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin · GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804sales@biotronik.comwww.biotronik.com16-D-xxRevision: B (2015-11-06)© BIOTRONIK SE & Co. KG All rights reserved. Specications subject to modication, revision and improvement.® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner.01230681 2016
en • English1en • English Table of ContentsProduct Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Therapeutic and Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Precautionary Measures while Programming . . . . . . . . . . . . . . . . . . . . . . . . . . 13Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Bradycardia / CRT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Electrical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291 Product DescriptionIntended Medical UseIntended useInlexa belongs to a family of implantable cardioverter-defibrillators (ICD). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization 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 antitachycardia 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 (DX, dual- and triple-chamber devices). VR-T DX and HF-T/HF-T QP devices types with DX functionality are only indicated for patients not requiring atrial pacing.Diagnosis and therapy formsThe device monitors the heart rhythm and automatically detects and treats 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 management at any time.Required expertiseIn 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.417635--B_GA_Inlexa_mul.fm Page 1 Friday, November 6, 2015 8:30 PM
2Indications Inlexa can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation.Generally approved differential diagnostics methods, indications, and recommenda-tions 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, (DGK)) and the European Society of Cardiology (ESC). 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-chamberTriple-chamber ICDs are indicated for patients with the following risks:•Sudden cardiac death caused by ventricular arrhythmias•Congestive heart failure with ventricular asynchronyContraindicationsKnown contraindications:•Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, elec-trolyte 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 familyThe complete Inlexa 3/7 device family consists of several device types with a DF-1/IS-1 or DF4/IS-1 connection or with DF4/IS-1 or DF4/IS4/IS-1 connection.•Single-chamber: VR-T and VR-T DX (device type with only a DF-1/IS-1 connection)•Dual-chamber: DR-T•Triple-chamber: HF-T and HF-T QP Note: Not all device types are included in every device family. Note: Not all device types are available in every country. Note: Not all device types are approved in every country.Note: Not all functions and parameters mentioned in this technical manual are featured by each device type of each device family.DeviceThe 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.417635--B_GA_Inlexa_mul.fm Page 2 Friday, November 6, 2015 8:30 PM
en • English3Lead connectorsBIOTRONIK offers ICDs with headers for different standardized lead connections:•DF-1/IS-1 and DF-1/IS-1/IS4•DF4, DF4/IS-1 and DF4/IS-1/IS4Note: Suitable leads must comply with the norms:•A device's DF-1 connector port may only be used for connecting leads with a DF-1 connector that conform to ISO 11318.•A device's IS-1 connector port may only be used for connecting leads with a IS-1 connector that conform to ISO 5841-3.•A device's DF4 connector port may only be used for connecting leads with a DF4 connector that conform to ISO 27186.•A device's IS4 connector port may only be used for connecting leads with a IS4 connector that conform to ISO 27186.Note: The device and leads have to match.•Only DX type leads by BIOTRONIK may be connected to the device type VR DX with DF-1/IS-1.•Only quadripolar leads may be connected to the device type HF QP with IS4.•When working with DX functionality, the device type HF (QP) with DF-1 (7 series) may be connected to DX type leads by BIOTRONIK.DF-1/IS-1The labeling on each device provides information pertaining to the connector port assignment in the header. DF-1/IS-1/IS4The labeling on each device provides information pertaining to the connector port assignment in the header. VR VR DX DR HF DF-1RVSVCDF-1IS-1RV DF-1RVSVCDF-1 IS-1RAIS-1RV DF-1 RV SVCDF-1 IS-1RAIS-1RV DF-1RVSVCDF-1 IS-1RAIS-1RVLVIS-1Connector port Lead connector Configuration Implantation site Device typeRA IS-1 Bipolar Atrium VR DX, DR, HFRV IS-1 bipolar Right ventricle VR, VR DX, DR, HFRV DF-1 Shock coil Right ventricle VR, VR DX, DR, HFSVC DF-1 Shock coil Superior vena cava VR, VR DX, DR, HFLV IS-1 Unipolar, bipolar Left ventricle HFHF QPConnector port Lead connector Configuration Implantation site Device typeRA IS-1 Bipolar Atrium HF QPRV IS-1 Bipolar Right ventricle HF QPRV DF-1 Shock coil Right ventricle HF QPSVC DF-1 Shock coil Superior vena cava HF QPLV IS4 Unipolar, bipolar Left ventricle HF QPIS4-LLLLLVIS-1RAIS-1RVDF-1SVCDF-1RV417635--B_GA_Inlexa_mul.fm Page 3 Friday, November 6, 2015 8:30 PM
4DF4/IS-1The labeling on each device provides information pertaining to the connector port assignment in the header. DF4/IS-1/IS4The labeling on each device provides information pertaining to the connector port assignment in the header. LeadsBIOTRONIK 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 polyurethane 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.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 radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this function SafeSync.ProgrammerImplantation and follow-up are performed with BIOTRONIK's portable programmer: Software PSW as of version 1505.There are programmers with integrated or external SafeSync Module for RF telemetry.Leadless ECG, IEGM, markers and functions are displayed simultaneously on the color display.The programmer allows you to determine the thresholds and to perform all tests during an in-office follow-up; in addition, you can change the permanent program and send it to the implanted device.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.VR DR HFConnector port Lead connector Configuration Implantation site Device typeRA IS-1 Bipolar Atrium DR, HFRV DF4 Bipolar and shock coil Right ventricle VR, DR, HFLV IS-1 Unipolar, bipolar Left ventricle HFHF QPConnector port Lead connector Configuration Implantation site Device typeRA IS-1 Bipolar Atrium HF QPRV DF4 Bipolar and shock coil Right ventricle HF QPLV IS4 Unipolar, bipolar Left ventricle HF QPDF4-LLHHRV DF4-LLHHRVRAIS-1DF4-LLHHRVRAIS-1LVIS-1DF4-LLHHRVLVIS4-LLLL IS-1RA417635--B_GA_Inlexa_mul.fm Page 4 Friday, November 6, 2015 8:30 PM
Note: Not all functions and parameters mentioned in this technical manual are featured by each device type of each device family.en • English5ModesThe mode setting depends on the individual diagnosis: NBD and NBG codesVVE is the NBD code for the antitachycardia mode of the single-chamber, dual-chamber, and triple-chamber devices without atrial therapy: VDE is the NBD code for the antitachycardia mode of the dual-chamber and triple-chamber devices with atrial therapy: 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: VDDR is the NBG code for the antibradycardia mode of the single-chamber type DX device: VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber device: Device type ModesVR VVI; VVIR; VOO; OFF7 series: VVI-CLS7 series: VR DX VDD; VDDR; VDI; VDIR; VVI; VVIR; V00; OFFVVI-CLSDR, HF (QP) DDD; DDDR; DDI; DDIR7 series: DDDR-ADIR; DDD-ADIVDD; VDDR; VDI; VDIRVVI; VVIR; AAI; AAIR; VOO; DOO; OFF7 series: VVI-CLS; DDD-CLSV Shock in the ventricleV Antitachycardia pacing (ATP) in the ventricleE Detection via IEGM analysisV Shock in the ventricleD Antitachycardia pacing (ATP) in the atrium and 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 pacingD Sensing in the atrium and ventricleD Pulse inhibition and pulse triggeringR Rate adaptationV Ventricular pacingV Sensing in the ventricleI Pulse inhibition in the ventricleR Rate adaptation417635--B_GA_Inlexa_mul.fm Page 5 Friday, November 6, 2015 8:30 PM
6BIOTRONIK 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 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 physi-cians 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 immediately check the Home Monitoring function.Inlexa order numbersNot all device types are available in every country: Package 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 container includes the following: •Device, blind plugs (if applicable)•Screwdriver Inlexa 3DF-1/IS-1 DF4/IS-1 DF-1/IS4/IS-1 DF4/IS4/IS-1VR-T 404703 404704 — —VR-T DX————DR-T 404701 404702 — —HF-T 404699 404700 — —HF-T QP — — 416037 416038Inlexa 7DF-1/IS-1 DF4/IS-1 DF-1/IS4/IS-1 DF4/IS4/IS-1VR-T 404643 404644 — —VR-T DX 404642 — — —DR-T 404640 404641 — —HF-T 404636 404637 — —HF-T QP — — 404638 404639417635--B_GA_Inlexa_mul.fm Page 6 Friday, November 6, 2015 8:30 PM
en • English7Therapeutic 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 measurement 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 (monomorphic rapid VTs) is met before shock delivery.•The ICD can also respond to atrial tachycardia with antitachycardia pacing (ATP) in case of stable heart rates or with high-rate pacing (HF bursts) in case of unstable heart rates.•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, antibrady-cardia as well as antitachycardia therapy is inhibited or delivered.Cardioversion, defibrillation•The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrilla-tion. Shock polarity and energy can be programmed individually. Shock energies between 2.0 J and 40 J are possible. 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•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.•Both atrial and ventricular thresholds are determined automatically in the device. For the 7 series, capture control is used to set the pulse amplitudes so that pacing is performed with the optimum atrial and ventricular amplitude for the patients with each change of the pacing threshold.•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 resyn-chronization 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. Up to 12 vectors can be used with the HF QP device type.•With the HF QP device of the 7 series: Two stimuli can be configured for the left ventricle with a view to improve the resonchronization of the ventricles. The stimuli can be delivered sequentially or simultaneously.•Additional, special form of rate adaptation with devices from the 7 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 7 series: unnecessary ventricular pacing is avoided by promoting intrinsic conduction (Vp suppression function). The device can thereby adapt to conduction changes and switch between an ADI(R) and a DDD(R) mode.417635--B_GA_Inlexa_mul.fm Page 7 Friday, November 6, 2015 8:30 PM
8Storing programsThere 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.Home 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 channels2 General Safety InstructionsOperating 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.•Reserve technical manuals for later use.Care during shipping and storage•Devices must not be stored or transported close to magnets or sources of electro-magnetic interference.•Note the effects of the storage duration; see Battery Data.Delivery in shipment modeThe 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 interrogation (it is deactivated during implantation by the first valid (in-range) measurement of the pacing impedance).TemperatureExtremely low and high temperatures affect the service time of the battery in the device. •Permitted for shipping and storage are +5°C to +45°C.417635--B_GA_Inlexa_mul.fm Page 8 Friday, November 6, 2015 8:30 PM
en • English9Sterile 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 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 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.Possible ComplicationsGeneral information on medical complicationsComplications for patients and device systems generally recognized among practitio-ners 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 electrophysiological 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 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 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 anti-arrhythmia therapy.In the case of undesired myopotentials, the device switches to asynchronous pacing if the interference rate is exceeded.Possible technical failuresTechnical 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 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 therapeutic or diagnostic proce-dures, 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 fieldsThe 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.417635--B_GA_Inlexa_mul.fm Page 9 Friday, November 6, 2015 8:30 PM
10Possible 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: •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 diagnostic 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. Influences 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 may remain active, switch to asynchronous modes if necessary.•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 defibrillationThe device is protected against the energy that is normally induced by external defibril-lation. 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 condi-tions 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 thera-peutic 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.Note: Please contact BIOTRONIK with questions during 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.417635--B_GA_Inlexa_mul.fm Page 10 Friday, November 6, 2015 8:30 PM
en • English113 ImplantationImplantation ProcedureHaving parts readyThe 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 or quadripolar LV lead•The lead connections DF-1, DF4 as well as IS-1 and IS4 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.Inadequate 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.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 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.•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.Implantation 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 implanta-tion.•Electrically insulate the patient.WWARNING417635--B_GA_Inlexa_mul.fm Page 11 Friday, November 6, 2015 8:30 PM
Shock 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.12Preventing 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.Short 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.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 deviceThe lead connectors are connected to the ports in the header of the device: WWARNINGWWARNING1Prepare 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 Remove stylets and stylet guides.2 Connect lead for defibrillation: DF-1/IS-1 or DF-1/IS4/IS-1•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).Connect lead for defibrillation (and sensing/pacing): DF4/IS-1 or DF4/IS4/IS-1•Connect the DF4 connector to RV.3 Connect lead for sensing/pacing: DF-1/IS-1 or DF-1/IS4/IS-1•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 bipolar IS-1 connector for the left ventricle or the quadripolar IS4 connector for the left ventricle to LV.Connect lead for sensing/pacing: DF4/IS-1 or DF4/IS4/IS-1•Connect the bipolar IS-1 connector for the atrium to RA.•Connect the unipolar or bipolar IS-1 connector for the left ventricle or the quadripolar IS4 connector for the left ventricle to LV.417635--B_GA_Inlexa_mul.fm Page 12 Friday, November 6, 2015 8:30 PM
Inadequate 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.en • English13Keeping 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 RF telemetryThe 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 defibrillator.Precautionary 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.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) or the insertion indicator (on the DF4 and the IS4 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.WWARNING417635--B_GA_Inlexa_mul.fm Page 13 Friday, November 6, 2015 8:30 PM
14Cancelling 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 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.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 arrhyth-mias.•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 ventricular 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.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.Complying with the morphology criteriaTo distinguish between ventricular and supraventricular tachyarrhythmia, QRS complexes, among other aspects, are compared to each other. You can set a MorphMatch threshold for the purpose of tachyarrhythmia discrimination, usually a standard value. Settings that differ, that is to say, a higher or lower threshold to discriminate the individual QRS complexes, may lead to a delayed/inhibited or unneces-sary therapy.•Set deviations from the standard with particular caution.Setting sensingManually set parameters can be unsafe. For example, unsuitable far-field protection may impede sensing of intrinsic pulses.•Note automatic sensitivity control.Preventing device-induced complicationsBIOTRONIK devices feature several functions to prevent device-induced complications 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 ventric-ular-controlled modes.417635--B_GA_Inlexa_mul.fm Page 14 Friday, November 6, 2015 8:30 PM
en • English15Avoiding AV crosstalkWhen 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 and 1.5 msLV: settings from the permanent programPhrenic nerve stimulation that cannot be terminatedIn rare cases, chronic phrenic nerve stimulation cannot be terminated by reprogram-ming 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.Note 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.Checking the settings of the DX leadThe triple-chamber device allows for a DX lead to be implanted for the right atrium and connected to the IS-1 connector of the device.•DX sensing in the atrium requires a special setting in the programmer which then has to be transmitted.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).Recognizing lead failureAutomatic impedance measurement is always switched on.•Impedance values that indicate technical failure of a lead are documented in the event list.Permanent program Post-shock programDDD(R), DDI(R), AAI(R)7 series: DDD-ADI(R), DDD-CLSDDIVDD(R), VDI(R) VDIVVI(R) and OFF7 series: VVI-CLSVVI417635--B_GA_Inlexa_mul.fm Page 15 Friday, November 6, 2015 8:30 PM
16Considering power consumption and service timeRF telemetry requires somewhat more power: Consumption during implantation corre-sponds to approximately 7 days of service time and consumption during a 20-minute follow-up corresponds to approximately 2 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. Note: Multi pole pacing also needs more power, which leads to various lengths of service time.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 appli-cation 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 reactivates 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.Follow-upFollow-up intervalsFollow-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 necessi-tate 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 modification 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 permanent program to the implanted device.9 Print and document follow-up data (print report).10 Finish the follow-up for this patient.417635--B_GA_Inlexa_mul.fm Page 16 Friday, November 6, 2015 8:30 PM
en • English17Patient InformationPatient ID cardA 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 signsPremises 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 checkpoints, anti-theft alarm systems, strong electromagnetic fields, cell phones, and transmit-ters 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.Replacement 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 ServiceTemporally 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.Elective 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 set parameters in the device do not change.Patient 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!EOS replacement indicationEnd 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 daysWCAUTIONWWARNING417635--B_GA_Inlexa_mul.fm Page 17 Friday, November 6, 2015 8:30 PM
18Explantation 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.Note: Normal oxidation processes may cause ICD housing discolorations. This is neither a device defect nor does it influence device functionality.•Explants are biologically contaminated and must be disposed of safely due to risk of infection.Device replacementIf, 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.•Cap unused lead connectors and plug unused connector ports.Basic principles:•The device must not be resterilized and reused.CremationDevices must 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 off with water.•Fill out explantation form and send to BIOTRONIK together with the cleaned device.4 ParametersBradycardia / CRTGeneral ICD therapyTiming: Basic rate day/night and rate hysteresesParameter Range of values Standard VR DX DR HFICD therapy OFF; ON ON xxxxPrograms Display standard program; Display safe program; Display first interrogated program; Individual 1, 2, 3; ProgramConsult— xxxxParameter Range of values Standard VR DX DR HFBasic rate 30 ... (5) ... 100 ... (10) ... 160 bpm40 bpm x x60 bpm x xNight rate OFF; 30 ... (5) ... 100 bpm OFF xxxxNight begins 00:00 ... (00:01) ... 23:59 hh:mm22:00 hh:mmxxxxNight ends 06:00 hh:mmRate hysteresis OFF; -5 ... (-5) ... -25 ... (-20) ... -65 bpmOFF xxxxScan/repetitive OFF; ON ON xxxx417635--B_GA_Inlexa_mul.fm Page 18 Friday, November 6, 2015 8:30 PM
en • English19Timing: AV delayTiming: Post-shock pacingTiming: Upper rateTiming: Mode switchingTiming: Ventricular pacing suppressionThe following parameters apply to the 7 series:Parameter Range of values Standard VR DX DR HFAV dynamics Low; Medium; High; Fixed; (Individual) Low xxxAV delay (1 or 2) after:– Pacing 40 ... (5) ... 350 msOnly for Fixed, also: 15–xx– Sensing Either automatic: AV delay after pacing + sense compensationOr: 15; 40 ... (5) ... 350 ms– xxx– 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 x xOFF; Positive; Negative OFF xAV hysteresis (positive) 70; 110; 150; 200 ms 70 ms x x x7 series, CLS modes: AV hysteresis (positive)70; 110; 150 ms 110 ms x x xAV hysteresis (negative) 10 ... (10) ... 150 ms 50 ms x x xAV scan and repetitive (positive)OFF; ON ON x x xParameter Range of values Standard VR DX DR HFPost-shock duration OFF; 10 s; 30 s; 1 min; 2 min; 5 min; 10 min10 s xxxxPost-shock basic rate 30 ... (5) ... 100 ... (10) ... 160 bpm60 bpm xxxxAV delay post shock 50 ... (10) ... 350 ms 140 ms x xVentricular post-shock pacingRV; BiV RV xParameter Range of values Standard VR DX DR HFUpper rate 90 ... (10) ... 160 bpm 130 bpm x x xAtrial upper rate OFF; 175; 200; 240 bpm 200 bpm x xParameter Range of values Standard VR DX DR HFIntervention rate OFF; 120 ... (10) ... 200 bpm 160 bpm x x xOnset criterion 3 ... (1) ... 8 (out of 8) 5 x x xResolution criterionModification of basic rate OFF; 5 ... (5) ... 30 bpm 10 bpm x x xMode After mode VDD(R): VDI(R) VDIR x x xAfter mode DDD(R): DDI(R)7 series, after mode DDD-CLS, DDD-ADI(R): DDI(R)DDIR x xAfter mode switching:– Rate OFF; 5 ... (5) ... 50 bpm 10 bpm x x x– Duration 1 ... (1) ... 30 min 1 min7 series – Rate stabiliza-tion with mode switchingON; OFF OFF xxxParameter Range of values Standard VR DX DR HFVp suppression OFF; ON OFF x xPacing suppression after consecutive Vs1 ... (1) ... 8 6 x xPacing support after X-out-of-8 cycles1; 2; 3; 4 3 x x417635--B_GA_Inlexa_mul.fm Page 19 Friday, November 6, 2015 8:30 PM
20Timing: Ventricular pacingTiming: Ventricular multi pole pacingThe following parameters apply for devices of the 7 series, HF QP type: Timing: Refractory periods and blanking periodsTiming: PMT protectionTiming: Rate adaptation via accelerometerParameter Range of values Standard VR DX 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 xParameter Range of values Standard HF QPPacing polarity 2nd LV OFF;LV1 tip -> LV2 ringLV1 tip -> LV4 ringLV1 tip -> RV coilLV1 tip -> housingLV2 ring -> LV1 tipLV2 ring -> LV4 ringLV2 ring -> RV coilLV3 ring -> LV2 ringLV3 ring -> LV4 ringLV3 ring -> RV coilLV4 ring -> LV2 ringLV4 ring -> RV coilOFF xLV-LV delay 0 ... (5) ... 50 ms 0 ms xPulse amplitude LV 2nd LV 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.0; 7.5 V2.5 V xPulse width LV 2nd LV 0.4; 0.5 ... (0.25) ... 1.5 ms 0.4 ms xParameter Range of values Standard VR DX DR HFPVARP AUTO; 175 ... (25) ... 600 ms 225 ms x x xPVARP extension OFF; ON ON x x xBlanking RV after atrial pacing40 ... (10) ... 100 ms 50 ms x xLV blanking after RV pacing50 ... (10) ... 100 ms 80 ms xRV blanking after LV pacingFar-field protection after VsOFF; 25 ... (25) ... 225 ms 75 ms x x xFar-field protection after Vp50 ... (25) ... 225 ms 75 ms x x xParameter Range of values Standard VR DX DR HFPMT detection/termination OFF; ON ON x x xVA criterion 250 ... (10) ... 500 ms 350 ms x x xParameter Range of values Standard VR DX DR HFMaximum sensor rate 80 ... (10) ... 160 bpm 120 bpm xxxxSensor gain AUTO; Very low; Low; Medium; High; Very highMediumxxxxSensor threshold Very low; Low; Medium; High; Very highMediumxxxxRate increase 1; 2; 4; 8 bpm/cycle 2 bpm/cyclexxxxRate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle 0.5 bpm/cyclexxxx7 series: Rate fading OFF; ON OFF xxxx417635--B_GA_Inlexa_mul.fm Page 20 Friday, November 6, 2015 8:30 PM
en • English21Timing: Rate adaptation via CLSThe following parameters apply to devices of series 7: Pacing: Pulse amplitude and pulse widthPacing: Atrial capture controlPacing: Ventricular capture control Lead configuration LV on IS-1 connectionParameter Range of values Standard VR DX DR HFMaximum sensor rate 80 ... (10) ... 160 bpm 120 bpm xxxxCLS response Very low; Low; Medium; High; Very highMediumxxxxCLS resting rate control OFF; +10 ... (+10) ... +50 bpm+20 bpmxxxxVp required Yes; No No x x xYes Yes xParameter Range of values Standard VR DX DR HFPulse amplitude A 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.0; 7.5 VAUTO x xPulse amplitude V/RV xxxxPulse amplitude LV xPulse width A 0.4; 0.5 ... (0.25) ... 1.5 ms 0.4 ms x xPulse width V/RV xxxxPulse width LV xParameter Range of values Standard VR DX DR HFAtrial capture control 3 series: OFF; ATM ATM x x7 series: OFF; ATM; ON ON x xThreshold test start with ATT: 2.5 ... (0.5) ... 5.0 Vwith ATM: 3.5 V3.5 V x xMinimum amplitude 0.5 ... (0.25) ... 4.0 V 1.0 V x xSafety margin 0.5; 1.0; 1.2 V 1.0 V x xParameter Range of values Standard VR DX DR HFVentricular capture control RV + LV3 series: OFF; ATM ATM xxxx7 series: OFF; ATM; ONON xxxxThreshold test start with ATT: 2.5 ... (0.5) ... 5.0 Vwith ATM: 3.5 V3.5 V xxxxMinimum amplitude 1.0 ... (0.25) ... 4.0 V 1.0 V xxxxSafety margin 1.0; 1.2 V 1.0 V xxxxParameter Range of values Standard VR DX DR HFPacing polarity LV (IS-1)LV tip -> LV ringLV tip -> RV coilLV ring -> LV tipLV ring -> RV coilUNIPLV tip -> RV coilxSensing polarity LV (IS-1)UNIP; BIPL UNIP x417635--B_GA_Inlexa_mul.fm Page 21 Friday, November 6, 2015 8:30 PM
22Lead configuration LV on IS4 connectionTachycardiaDetectionParameter Range of values Standard HF QPPacing polarity LV (IS4)LV1 tip -> LV2 ringLV1 tip -> LV4 ringLV1 tip -> RV coilLV1 tip -> housingLV2 ring -> LV1 tipLV2 ring -> LV4 ringLV2 ring -> RV coilLV3 ring -> LV2 ringLV3 ring -> LV4 ringLV3 ring -> RV coilLV4 ring -> LV2 ringLV4 ring -> RV coilLV1 tip -> LV2 ringxSensing polarity LV (IS4)LV1 tip -> LV2 ringLV1 tip -> housingLV2 ring -> LV3 ringLV2 ring -> housingLV3 ring -> LV4 ringLV3 ring -> housingLV4 ring -> housingLV1 tip -> LV2 ringxParameter Range of values Standard VR DX DR HFInterval AT/AF 240 ... 600 ms 300 ms x x xInterval VT1 OFF; 270 ... (10) ... 600 msOFF xxxxInterval VT2 OFF; 270 ... (10) ... 500 msInterval VF OFF; 240 ... (10) ... 400 ms 300 msDetection counter VT1 10 ... (2) ... 100 28 xxxxDetection 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 xxxxRedetection 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 12xxxxSMART detection VT1/VT2 OFF; ON ON x x xSMART detection ON:– Onset VT1/VT2 4 ... (4) ... 32% 20% x x x– Stability VT1/VT2 8 ... (4) ... 48% 12%SMART detection OFF:– Onset VT1/VT2 OFF; 4 ... (4) ... 32% 20% xxxx– Stability VT1/VT2 OFF; 8 ... (4) ... 48 ms8 ... (4) ... 48%12%MorphMatch OFF; Monitoring; ON OFF xxxxMorphMatch threshold Low; Std; High Std. xxxxSustained VT OFF; 1; 2; 3; 5; 10; 20; 30 minOFF xxxx417635--B_GA_Inlexa_mul.fm Page 22 Friday, November 6, 2015 8:30 PM
en • English23Therapy: Atrial therapyThe following parameters apply to devices of series 7: Therapy: Ventricular ATPTherapy: ShockParameter Range of values Standard VR DX DR HFAtrial therapy in the presence of stable atrial flutter:ATP type OFF; Burst; Ramp OFF x xNumber S1 2 ... (1) ... 10 5 x xP-S1 interval 70 ... (5) ... 95% 80% x xS1 decrement 5 ... (5) ... 40 ms 10 ms x xBackup stimulation OFF; 70; 90; OFF x xAtrial therapy in the presence of unstable atrial fibrillation:Therapy OFF; HF (high frequency) burst OFF x xRate 10 ... (5) ... 40 Hz 40 Hz x xDuration 2 ... (1) ... 10 3 s x xBackup stimulation OFF; 70; 90; OFF x xParameter Range of values Standard VR DX DR HFFor VT1/VT2: Attempts OFF; 1 ... (1) ... 10 OFF xxxxATP type for VT1/VT2 Burst; Ramp Burst xxxxATP type for VF OFF; Burst; Ramp Burst xxxxATP optimization OFF; ON OFF xxxxNumber S1 for VT1/VT2 1 ... (1) ... 15 5 xxxxNumber S1 for VF 8S1 decrement for VT1/VT2 and for VF5 ... (5) ... 40 ms 10 ms xxxxScan decrement for VT1/VT2OFF; 5 ... (5) ... 40 ms OFF xxxxAdd S1 for VT1/VT2 OFF; ON ON xxxxVentricular pacing RV; LV; BiV RV xR-S1 interval for VT1/VT2 70 ... (5) ... 85; 88; 90; 95% 80% xxxxR-S1 interval for VF 88%7 series: Early ATP delivery for VFOFF; ON OFF xxxxParameter Range of values Standard VR DX DR HFNumber of shocks VT1/VT20; 1; 2; 6; 8 8 xxxxNumber of shocks VF 6; 8 8 xxxx1st Shock for VT1/VT2 OFF; 2 ... (2) ... 20 ... (5) ... 40 J 40 J xxxx2nd Shock for VT1/VT2 OFF; 4 ... (2) ... 20 ... (5) ... 40 J40 J xxxx3rd - nth shock for VT1/VT2OFF; 4*40 J; 6*40 J 6*40 J xxxx1st Shock for VF 2 ... (2) ... 20 ... (5) ... 40 J 40 J xxxx2nd Shock for VF 4 ... (2) ... 20 ... (5) ... 40 J 40 J xxxx3rd - nth shock for VF 4*40 J; 6*40 J 6*40 J xxxxFor shock in VT1/VT2 and VF:– Confirmation OFF; ON ON xxxx– Polarity Normal; inverse; Normal -> alternating;7 series: Inverse -> alternatingNormal– Shock form Biphasic; Biphasic 2;7 series: Biphasic -> alternating; biphasic 2 -> alternatingBiphasic– Shock path RV -> housing + SVCRV -> housingRV -> SVCRV-> ICD+SVCxxxRV -> ICD xParameter Range of values Standard VR DX DR HF417635--B_GA_Inlexa_mul.fm Page 23 Friday, November 6, 2015 8:30 PM
24Sensing Sensitivity and thresholdsDiagnosticsThe following can be set: Home MonitoringParameter Range of values Standard VR DX DR HFSensing A STD; OFF STD x x xSensing RV STD; TWS; VFS; IND STD xxxxSensing LV STD; OFF; IND STD x7 series: DX sensing ON; OFF OFF xUpper threshold RV 50; 75% 50% xxxxUpper threshold LV 50; 75% 50% xUpper threshold duration RV after detection110; 150 ... (50) ... 500 msVFS: 110 ms350 ms xxxxUpper threshold duration RV after pace400 msLower threshold RV 25; 50% 25% xxxxT-wave suppression after pacingOFF; ON OFF xxxxMinimum threshold A 0.2 ... (0.1) ... 2.0 mV 0.4 mV x x xMinimum threshold RV 0.5 ... (0.1) ... 2.5 mV 0.8 mV xxxxMinimum threshold LV 0.5 ... (0.1) ... 2.5 ... (0.5) ... 5.0 mV1.6 mV xParameter Range of values Standard VR DX DR HFFor AT/AF OFF; ON7 series: Extended ON ON xxxFor SVT OFF; ON ON x x xFor nsVT OFF; ON ON xxxxPeriodic recording When Home Monitoring is deactivated: OFF; 30 ... (30) ... 180 days90 days xxxxIEGM 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:mmxxxxDuration of resting period0.5 ... (0.5) ... 12 h 4 h xxxxAV delay adjusted in sensing testOFF; 300 ms 300 ms x x x7 series: Thoracic impedance (TI)OFF, ON OFF xxxxParameter Range of values Standard VR DX DR HFHome Monitoring OFF; ON OFF xxxxTime of transmission STD; 00:00 ... (1:00 AM) ... 23:00 hh:mmSTD xxxxIEGM for therapy episodesOFF; ON ON xxxxIEGM for monitoring episodesOngoing atrial episode OFF; 6; 12; 18 h 12 h x x xConfigurable in the HMSC:Transmission date XX.XX.XXXX Follow-up + 91 daysxxxxCycle duration 20 ... (1) ... 366 days 91 days xxxxParameter Range of values Standard VR DX DR HF417635--B_GA_Inlexa_mul.fm Page 24 Friday, November 6, 2015 8:30 PM
en • English255 Technical DataMechanical CharacteristicsHousingDevices with header for DF-1 and DF4 connector: Materials in contact with body tissue•Housing: Titanium•Header: epoxy, polysulfone; DF4 seal: silastic•Silicone plugs and blind plugs (if applicable): Silopren or silasticX-ray identificationNKElectrical CharacteristicsStandardsThe specifications are made according to EN 45502-2-2:2008.Measuring conditionsIf 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 for Home Monitoring:•MISC 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 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-TACHNT2The 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: QRITACHNT2Type Lead connector W x H x D in mm Volume [cm3]Mass gVR DF-1 65 x 55 x 11 33 82DF4 65 x 54 x 11 31 81VR DX DF-1 65 x 55 x 11 33 82DR DF-1 65 x 55 x 11 33 82DF4 65 x 56 x 11 32 82HF DF-1 65 x 58.5 x 11 34 83DF4 65 x 56 x 11 33 82HF QP DF-1 65 x 60.5 x 11 36 86DF4 65 x 58.5 x 11 36 87417635--B_GA_Inlexa_mul.fm Page 25 Friday, November 6, 2015 8:30 PM
26Telemetry 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-LSD078Pulse 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 interference•Note on device type VR DX (only devices with a DF-1/IS-1 connection): The EMC requirements are met as long as atrial sensitivity is set to 1.0 mV (factory settings) or values ≥ 1.0 mV. Measures must be taken to assure interference-free therapy if more sensitive values are set.•Note on device type HF and HF QP: In the case of unipolar sensing, the requirement for interference voltages of ≤ 0.3 mV (peak to peak) is met.Common mode rejection ratio*Devices with a DF-1/IS-1 connection only; ** Information for device type HF also applies to device type HF QP. ATP amplitudeA 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. For the device type VR DX, the programmed atrial sensitivity is intensified by a factor of 4. Shock energy / peak voltageWith shock path: RV to housing + SVC Rate Common mode rejection ratioAtrium: DX* Atrium: DR, HF** V right: VR, DR, HF** V left: HF**16.6 Hz 76 dB 72 dB 58 dB 55 dB50 Hz 73 dB 72 dB 65 dB 55 dB60 Hz 75 dB 71 dB 66 dB 62 dBATP amplitude Measured minimum Measured maximum Mean valueRA 7.23 V 7.27 V 4.93 VRV 7.26 V 7.52 V 5.04 VLV 7.51 V 7.54 V 5.07 VSensitivity Value Tolerance Measured valueA: positive 0.2 mV 0.2 ... 0.5 0.27 mVA: negative 0.26 mVDX: A: positive 0.2 mV 0.2 ... 0.52(0.05 to 0.13)0.11 mVDX: A: negativeRV: positive 0.5 mV 0.3 ... 0.7 0.53 mVRV: negative 0.57 mVLV: positive 0.5 mV 0.3 ... 0.7 0.53 mVLV: negativeShock energy(Tolerance) Tolerance Peak voltage Measured valueShock energy Measured valuePeak voltage1 J (0.7 ... 1.18) 90 ... 120 V 0.83 J 98.1 V20 J (15.9 ... 21.6) 440 ... 480 V 17.4 J 462 V40 J (33.8 ... 41.4) 620 ... 690 V 36.7 J 659 V417635--B_GA_Inlexa_mul.fm Page 26 Friday, November 6, 2015 8:30 PM
en • English27Battery DataBattery characteristicsThe following data is provided by the manufacturers: Storage periodThe 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 24 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 yearManufacturer GREATBATCH, INC. Clarence, NY 14031 LITRONIK Batterietechnologie GmbH01796 Pirna, GermanyBattery type GB 2992 LiS 3410 RRSystem Li/SVO/CFx LiMnO2Battery ID number shown on the programmer36Device type VR, VR DX, DR, HF, HF QPBattery voltage at ERI 2.5 V 2.85 VCharge time at BOS 8 s 8 sCharge time at ERI 10 s 10 sUsable capacity until ERI3 series: VR, DR, HF, HF QP7 series: VR, VR DX, DR1390 mAh 1390 mAhUsable capacity until ERI: 7 series: HF, HF QP1600 mAh —Usable capacity until EOS 1730 mAh 1520 mAh417635--B_GA_Inlexa_mul.fm Page 27 Friday, November 6, 2015 8:30 PM
28Inlexa 3/7 VR-TService times with GB 2992 or LiS 3410 RR battery: Inlexa 7 VR-T DXService times with GB 2992 or LiS 3410 RR battery: Inlexa 3/7 DR-TService times with GB 2992 or LiS 3410 RR battery: Inlexa 3 HF-T (QP)Service times with GB 2992 or LiS 3410 RR battery: Inlexa 7 HF-T (QP)Service times with battery GB 2992 without multipolar pacing: Service times with battery GB 2992 with multipolar pacing: Pacing Service time [in years] at number of shocks per year4 8 12 16 200%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 4.8Pacing Service time [in years] at number of shocks per year4 8 12 16 200%9.4 7.7 6.5 5.7 5.015%9.2 7.6 6.4 5.6 4.950%8.7 7.2 6.2 5.4 4.8100%8.1 6.8 5.9 5.2 4.6Pacing Service time [in years] at number of shocks per year4 8 12 16 200%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 year4 8 12 16 200%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 3.9Pacing Service time [in years] at number of shocks per year4 8 12 16 200%10.1 8.4 7.2 6.3 5.515%9.4 7.9 6.8 6.0 5.350%8.2 7.0 6.1 5.5 4.9100%6.9 6.0 5.4 4.8 4.4Pacing Service time [in years] at number of shocks per year4 8 12 16 200%10.1 8.4 7.2 6.3 5.515%9.2 7.8 6.7 5.9 5.350%7.7 6.6 5.9 5.2 4.7100%6.2 5.5 5.0 4.5 4.1417635--B_GA_Inlexa_mul.fm Page 28 Friday, November 6, 2015 8:30 PM
en • English29Legend for the LabelLabel on the packageThe label icons symbolize the following: Manufacturing date Use byStorage temperature Order numberSerial number Product identification numberDangerous voltages! European approval markContents Consult 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 frequencyNONSTERILETP2Compatibility with telemetry protocol version 2 of BIOTRONIK Home Monitoring ExampleDevice: NBG code and compatible leadsExampleFactory settings for therapy: OFFScrewdriver Examples of the connector allocation:DF-1/IS-1, DF4/IS-1, DF4/IS4/IS-1Bipolar IS-1 connectorUnipolar IS-1 connector Unipolar DF-1 connector IS4 connector, DF4 connector 417635--B_GA_Inlexa_mul.fm Page 29 Friday, November 6, 2015 8:30 PM

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