BIOTRONIK SE and KG TACH70 implantable cardioverter defibrillator User Manual
BIOTRONIK SE & Co. KG implantable cardioverter defibrillator
15_[TACH70] UserMan
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| Document ID | 2250181 |
| Application ID | KOpdIPWOj5+petoCs3PWmg== |
| Document Description | 15_[TACH70] UserMan |
| Short Term Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 33.58kB (419785 bits) |
| Date Submitted | 2014-04-24 00:00:00 |
| Date Available | 2014-10-21 00:00:00 |
| Creation Date | 2013-07-26 14:26:13 |
| Producing Software | Acrobat Distiller 9.0.0 (Windows) |
| Document Lastmod | 2014-04-08 13:49:26 |
| Document Title | untitled |
| Document Creator | FrameMaker 8.0 |
Inventra 7 Iperia 5/7 Itrevia 5/7 Product Description Intended Medical Use Intended use Inventra/Iperia/Itrevia are parts of a familiy of implantable cardioverter-defibrillators (ICDs). 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, VR-T DX DR-T HF-T, HF-T QP ICD-Families Tachyarrhythmia Therapy Cardiac Resynchronization Therapy Diagnosis and therapy forms The 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 management 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 special knowledge required are permitted to use implantable devices. • If users do not possess this knowledge, they must be trained accordingly. Technical Manual Draft Subject to completion and modification System Overview Indications Inventra/Iperia/Itrevia can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation. Generally approved differential diagnostics methods, indications, and recommendations for ICD therapy apply to BIOTRONIK devices. See the 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-chamber Single-chamber and dual-chamber ICDs are indicated for patients with the following risk: • Sudden cardiac death caused by ventricular arrhythmias Device family This device families consist of several device types with different lead connections: DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1: single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection) dual-chamber: DR-T triple-chamber: HF-T and HF-T QP (only devices with a DF4 connection) All devices include BIOTRONIK Home Monitoring. Not all device types are available in every country. Device 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. Triple-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 DF-1/IS-1 or DF4/IS-1 or DF4/IS4 BIOTRONIK provides ICDs with headers for different standardized lead connections: DF-1/IS-1, DF4/IS-1 and DF4/IS4. Contraindications 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 idioventricular rhythm Note: The device type DX can only be connected using a DF-1/IS-1 connector. The device type HF QP can only be connected using a DF4/IS-1 or DF4/IS4 connector. DF-1/IS-1 lead connection The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: VR DX DR HF DF-1 SVC DF-1 RV IS-1 RV DF-1 SVC IS-1 RA DF-1 SVC IS-1 RA DF-1 RV IS-1 RV DF-1 RV IS-1 RV IS-1 LV DF-1 SVC IS-1 RA DF-1 RV IS-1 RV Connector port RV SVC Lead Configuration connector DF-1 Shock coil DF-1 Shock coil RA (R)V LV IS-1 IS-1 IS-1 Bipolar Bipolar Unipolar, bipolar Implantation site Device type Right ventricle Superior vena cava Atrium (Right) ventricle Left ventricle VR, DX, DR, HF VR, DX, DR, HF DF4/IS4/IS-1 lead connection The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: HF QP DX, DR, HF VR, DX, DR, HF HF DF4-LLHH RV DF4/IS-1 lead connection The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: VR DR HF DF4-LLHH RV Connector port RA LV RV, SVC Lead connector IS-1 IS-1 DF4 DF4-LLHH RV Configuration Connector port RA LV RV, SVC IS-1 LV IS-1 RA IS-1 RA DF4-LLHH RV Implantation site Bipolar Atrium Unipolar, bipolar Left ventricle Bipolar and shock Right ventricle IS-1 RA IS4-LLLL LV Lead connector IS-1 IS4 DF4 Configuration Implantation site Bipolar Atrium Unipolar, bipolar Left ventricle Bipolar and shock Right ventricle Device type HF QP HF QP HF QP Note: The device's DF4/IS4 connector port may only be used for connecting leads with a DF4/IS4 connector that conform to ISO 27186. Device type 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 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. Telemetry 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 radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this function SafeSync®. DR, HF HF VR, DR, HF Note: The device's DF4 connector port may only be used for connecting leads with a DF4 connector that conform to ISO 27186. Programmer Implantation and follow-up are performed with BIOTRONIK's portable programmer: There is one with integrated RF telemetry and one with a separate SafeSync Module. The programmer is used during implantation to transfer the current device program to the device. The pacing thresholds can be determined and all tests can be performed during in-office follow-up. In addition to this, the programmer is used to set mode and parameter combinations, as well as for interrogation and saving of data from the device. Leadless ECG, IEGM, markers and functions are displayed simultaneously on the color display. Modes The mode setting depends on the individual diagnosis: Device type Modes VR VVI; VVIR; V00; OFF Series 7: VVI-CLS DX VDD; VDDR; VDI; VDIR; VVI; VVIR; V00; OFF Series 7: VVI-CLS DR, HF, QP DDD; DDDR; DDD-ADI; DDDR-ADIR; DDI; DDIR; VDD; VDDR; VDI; VDIR VVI; VVIR; AAI; AAIR; V00; D00; OFF Series 7: VVI-CLS; DDD-CLS DDDR is the NBG code for the antibradycardia mode of the dual-chamber device: Pacing in the atrium and ventricle Sensing in the atrium and ventricle Pulse inhibition and pulse triggering Rate adaptation NBD and NBG codes VVE is the NBD code for the antitachycardia mode of the single-chamber, dualchamber, and triple-chamber devices: Shock in the ventricle VVIR is the NBG code for the antibradycardia pacing modes of the single-chamber device: Ventricular pacing Sensing in the ventricle Pulse inhibition in the ventricle DDDRV is the NBG code for the antibradycardia mode of the triple-chamber device: Pacing in the atrium and ventricle Sensing in the atrium and ventricle Pulse inhibition and pulse triggering Rate adaptation Multisite pacing in both ventricles VDDR is the NBG code for the antibradycardia mode of the single-chamber DX device: Ventricular pacing Sensing in the atrium and ventricle Pulse inhibition and pulse triggering Rate adaptation Antitachycardia pacing (ATP) in the ventricle Detection via IEGM analysis VDE is the NBD code for the antitachycardia mode of the dual-chamber, and triplechamber devices: Shock in the ventricle Antitachycardia pacing (ATP) in the atrium and ventricle Detection via IEGM analysis Rate adaptation BIOTRONIK 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 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 immediately check the Home Monitoring function. Order numbers for Iperia with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Order numbers for Inventra with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Iperia 5 Iperia 7 DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4 VR-T 393052 393053 — 393035 3393031 — VR-T DX 393049 — — 393033 — — DR-T 392415 392420 — 392410 392424 — HF-T 393028 393026 — 393008 393010 — HF-T QP — — 402658 — — 401658 Order numbers for Iperia ProMRI with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Iperia 5 ProMRI Iperia 7 ProMRI DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4 VR-T 393034 3393051 — 393050 3393030 — VR-T DX 393048 — — 393032 — — DR-T 392418 392419 — 392409 392423 — HF-T 393027 393025 — 393007 393009 — HF-T QP — — 402656 — — 401657 Order numbers for Inventra with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Order numbers for Itrevia with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Itrevia 5 Itrevia 7 Inventra 7 DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4 393058 393059 — 393040 393041 — VR-T VR-T DX 393055 — — 393037 — — DR-T 392417 392422 — 392412 392426 — HF-T 393066 393064 — 393014 393016 HF-T QP — — 402659 — — VR-T DF-1/IS-1 DF4/IS-1 DF4/IS4 399443 399441 — VR-T DX 399437 — — DR-T 399431 399429 — — HF-T 399423 399422 — 401662 HF-T QP — — 393012 Order numbers for Inventra ProMRI with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Order numbers for Itrevia ProMRI with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Itrevia 5 ProMRI Itrevia 7 ProMRI Inventra 7 ProMRI DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4 393056 393057 — 393038 393039 — VR-T VR-T DX 393054 — — 393036 — — DR-T 392416 392421 — 392411 392425 — HF-T 393065 393063 — 393013 393015 HF-T QP — — 402657 — — VR-T DF-1/IS-1 DF4/IS-1 DF4/IS4 399442 399440 — VR-T DX 399436 — — DR-T 399430 399428 — — HF-T 399419 393020 — 401661 HF-T QP — — 393011 Therapeutic and Diagnostic Functions Package contents The storage package includes the following: • Sterile packaging with device • Serial number label • Patient ID card • Warranty booklet Note: Technical manuals are available either printed in the storage package or digitally in the internet. Diagnostic 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 patients and the state of the device 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 inoffice 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. • Arial tachycardia can be treated with antitachycardia pacing (atrial ATP) at stable heart rhythms and with high frequency bursts (HF burst) at instabil heart rhythms. • 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 defibrillation. Shock polarity and energy can be programmed individually. Shock energies between 2.0 and 45 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. The sterile container includes the following: • Device, blind plug DF-1 (if applicable) and blind plug IS-1 for device type HF • Screwdriver 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. 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 the intrinsic conduction and thus the natural contraction sequence. Negative AV hysteresis functions support the cardiac resynchronization therapy by maintaining pacing in stressful situations. • For resynchronization of the ventricles, triple-chamber devices have functions for multisite ventricular pacing with possible VV delays in either direction. • To ensure that no additional surgery is necessary in case of a left-sided increase of the pacing threshold or undesired phrenic nerve stimulation, different pacing polarities can be set for the left ventricular lead with a triple-chamber device. With the HF-T QP device up to 12 vectors are possible. • Automatic active capture control is available for the right and left ventricle with automated tracking of the pacing threshold or automatic threshold monitoring (ATM) for trend analysis. • Series 7: additional, special form of rate adaptation: an increased cardiac output requirement is detected using physiological impedance measurement. The measuring principle is based on contractile changes (inotropy) of the myocardium (CLS function: Closed Loop Stimulation). The suitable rate adaptation is automatically initialized and optimized in CLS mode. • Ventricular pacing suppression: unnecessary ventricular pacing is avoided by promoting intrinsic conduction (Vp suppression function). The device can adapt itself to conduction changes. In the case of intrinsic conduction, the device switches to a DDD(R)-ADI(R) mode. Storing programs There are two types of therapy programs: — Default parameters are offered for the most common indications (BradyProgramConsult function). — Individual settings can be saved in 3 individual 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 channels 2 General Safety Instructions 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. Operating Conditions Technical manuals Folgende Gebrauchsanweisungen informieren über die Anwendung von Implantatsystemen: — Technical manual for the device — Technical manual for the HMSC — Technical manuals for the programmer and the SafeSync Module — Technical manuals for the user interface — Technical manuals for cables, adapters and accessories • Technical manuals are available either printed in the storage package or digitally in the internet: https://manuals.biotronik.com/manuals/home • Consider all relevant technical manuals. • Keep technical manuals for further use. Possible Complications General information on medical complications Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices. • Normal complications may include fluid accumulation within the device pocket, infections, or tissue reactions. Primary sources of complication information include current scientific and technological knowledge. • It is 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. Care during shipping and storage • Devices must not be stored or transported close to magnets or sources of electromagnetic 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 loading the device program (it is deactivated during implantation on initial measurement of the pacing impedance). Skeletal myopotentials Bipolar sensing and control of sensitivity are adapted by the device to the rate spectrum 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. 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. Possible Risks 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 telemetry Procedures, which must be avoided 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 pressure Risky therapeutic and diagnostic procedures If 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 or during the application of therapeutic ultrasound. For example, damaging heat can result during lithotripsy. 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 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. Electromagnetic 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 procedures, interference sources may induce such a high level of energy into the pacing system that the cardiac tissue surrounding the lead tip is damaged. Device behavior in case of EMI In case of electromagnetic interference, the device switches to asynchronous pacing for as long as the interference rate is exceeded. Static magnetic fields The reed switch in the device closes starting at a field strength of 1.8 mT. The reed switch opens if the magnetic field falls below 1 mT. External defibrillation The device is protected against the energy that is normally induced by external defibrillation. Nevertheless, any implanted device may be damaged by external defibrillation. Specifically, the current induced in the implanted leads may result in necrotic tissue formation close to the electrode/tissue interface. As a result, sensing properties and pacing thresholds may change. • Place adhesive electrodes anterior-posterior or perpendicular to the axis formed by the device to the heart at least 10 cm away from the device and from implanted leads. 10 3 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 influencing factors such as different sources of radiation, a variety of devices and therapy conditions makes it impossible to issue directives that guarantee radiation therapy without an impact on the device. The EN 45502 standard pertaining to active implantable medical devices requires the following measures during the administration of therapeutic ionizing radiation: • Adhere to instructions for risky therapy and diagnosis procedures. • Shield device against radiation. • After applying radiation, double-check the device system to make sure it is functioning properly. Implantation Implantation Procedure Having 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 • DF-1, DF4 and IS-1 connections are approved. For leads with a different connection or leads from other manufacturers, use adapters approved by BIOTRONIK only. • BIOTRONIK programmer (with integrated SafeSync RF telemetry or with separate SafeSync Module) and approved cable • External multi-channel ECG device • Keep spare parts for all sterile components. Note: Please contact BIOTRONIK with questions during the risk/benefit analysis. Magnetic resonance imaging Magnetic resonance imaging (MRI) must be avoided due to the high frequency fields and the associated 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. Under certain conditions and when maintaining mandatory measures to protect the patient and device system, magnetic resonance imaging can be performed. BIOTRONIK devices with the "MR conditional" function bear the identification ProMRI®. • The ProMRI® manual – MR conditional device systems – contains detailed information on safely conducting an MRI. — Download the digital manual from the web site: www.biotronik.com/manuals/manualselection — Order the printed manual from BIOTRONIK. • Does approval as "MR-Conditional" apply in your country or region? Request current information from BIOTRONIK. Keeping an external defibrillator ready In order to be able to respond to unforeseeable emergencies or possible technical failures of the device: • Keep an external defibrillator and paddles or patch electrodes ready. 11 Unpacking the device Preventing unintentional shock delivery W WARNING W WARNING Inadequate therapy due to defective device If 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. Shock delivery with activated ICD There 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. Avoiding damage to the header There is a blind plug for DF-1 and IS-1 connections in the header. The provided set screws must be carefully loosened or tightened. • Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control! • Do not forcibly pull out the blind plug! • If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK. • 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. • The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be connected and implanted in this state. • Leads must not be shortened. Preventing short circuits in the header W WARNING Short circuit due to open lead connector ports Connector 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. • Either leave unused ports closed with the premounted blind plugs, or close them using the supplied blind plugs. Implantation site • Depending on lead configuration and the patient's anatomy, the ICD is generally implanted subpectorally on the left side. Ensure that connections are clean In case of contamination during implantation: • Clean lead connectors with a sterile cloth. • Rinse connection only with sterile water. Preventing leakage currents Leakage currents between the tools and the device must be prevented during implantation. • Electrically insulate the patient. 12 Connecting the lead connector to the device Disconnect stylets and stylet guides. 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. DF4/IS-1 or DF4/IS4 connection: • Connect the DF4 connector to RV DF-1/IS-1 connection: • Connect the bipolar IS-1 lead connector for the atrium to RA. • Connect the IS-1 lead connector for the right ventricle to RV. • Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle to LV. DF4/IS-1 or DF4/IS4 connection: • Connect the bipolar IS-1 lead connector for the atrium to RA. • Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle to LV. • Or: Connect the quadripolar IS4 lead connector for the left ventricle to LV. 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 /IS4 connector) becomes visible behind the set screw block. This indicator can vary depending on the manufacturer of the lead used. If you cannot easily plug the lead connector into the connection: • Use only sterile water as lubricant. 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. Turn the set screw clockwise until torque control starts (you will hear a clicking sound). Carefully withdraw the screwdriver without retracting the set screw. • In case of IS-1 connections with two set screws, tighten both screws! • When the screwdriver is withdrawn, the silicone plug automatically seals the lead connector port safely. Keeping distance between leads W WARNING Inadequate therapy When 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. Implanting 13 Prepare the vein. Implant the leads, perform the measurements, and fixate the leads. Form the device pocket. Connect the lead connector to the device. Insert the device. Guide the fixation suture through the opening in the header and fixate the device in the prepared device pocket. Close the device pocket. Check the device with standard tests. Precautionary Measures while Programming Applying the programming head The 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. Performing standard tests and monitoring the patient Critical 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. Establishing telemetry contact The 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 device program 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. 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. 14 Avoiding critical parameter settings No modes and parameter combinations that pose a risk to the patient should be set. • Prior to setting rate adaptation, determine the patient's capacity for strain. • Check compatibility and effectiveness of parameter combinations after making settings. Preventing conduction of atrial tachycardia BIOTRONIK devices feature several functions to prevent conduction of atrial tachycardia to the ventricle(s): • Set mode switching for indicated patients. • Set the upper rate and the refractory periods to prevent abrupt ventricular rate switching. • Give preference to Wenckebach response and avoid 2:1 behavior. • Set all parameters so as to prevent constant changing between atrial and ventricular-controlled modes. Checking for electrodes suitable for the shock path Three 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). Observing the shock impedance limit The implanted device could be damaged if the shock impedance is too low. • The shock impedance must be > 25 Ω. Monitoring the patient when setting asynchronous modes The 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. Preventing recurrence after therapy shock After a therapy shock, pacing can be performed with a post-shock program if there is no intrinsic rhythm. Permanent program Post-shock program DDD, DDD-CLS DDI DDI, AAI, DDD-ADI VDD, VDI VDI VVI, VVI-CLS and OFF VVI Setting sensing Manually set parameters can be unsafe. For example, unsuitable far-field protection may impede sensing of intrinsic pulses. • Note automatic sensitivity control. Preventing device-induced complications BIOTRONIK 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. • 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 ms LV: settings from the permanent program Phrenic nerve stimulation that cannot be terminated In rare cases, chronic phrenic nerve stimulation cannot be terminated by reprogramming 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. 15 Magnet Response Avoiding risks in the case of exclusive LV pacing Lead 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 active 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 allow for exclusive LV pacing. Please note the effects when programming mode switching and the post shock parameters. Recognizing lead failure Automatic impedance measurement is always switched on. • Impedance values that indicate technical failure of a lead are documented in the event list. Application 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 application When 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 magnet Applying 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. Considering power consumption and service time RF 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. Follow-up Follow-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. 16 Follow-up with BIOTRONIK Home Monitoring® Monitoring using the Home Monitoring function does not serve to replace regular inoffice 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 necessitate an additional in-office follow-up. For example, the data may indicate at an early stage lead problems or a foreseeable end of service time (ERI). Furthermore, the data could provide indications of previously unrecognized arrhythmias or modification of the therapy by reprogramming the device. Follow-up with the programmer Use 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. Patient Information Patient 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 Places with prohibitory signs must be avoided. •Draw the patient's attention to prohibitory signs. Possible sources of interference Electromagnetic interference should be avoided in daily activities. Sources of interference 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 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. Replacement Indications Possible battery levels • BOS: Beginning of Service: > 70% charge • MOS 1: Middle of Service: 70% 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 Service Elective Replacement Indication (ERI) Elective Replacement Indication can be detected by Home Monitoring. 17 Explantation and Device Replacement W CAUTION Explantation • 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. Temporally limited therapy If 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. • 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 device program do not change. 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. EOS replacement indication End of Service can be detected by Home Monitoring. 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 connections that are not used. Basic principles: • The device must not be resterilized and reused. W WARNING Patient at risk of death If 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! Cremation Devices must not be cremated. • Explant the device before the cremation of a deceased patient. • 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 — Time of transmission for Home Monitoring: 90 days Disposal BIOTRONIK takes back used products for the purpose of environmentally safe disposal. • Clean the explant with an at least 1% sodium hypochlorite solution. • Rinse off with water. 18 4 Parameters Timing: AV delay Range of values Standard AV dynamics Low; Medium; High; Fixed; (Individual) Low x x x N.n. ms Either automatic: AV delay after pacing + sense compensation Or: N.n. ms N.n. bpm N.n. bpm OFF; N.n. ms OFF; Positive; Negative; IRSplus OFF; Positive; Negative N.n. ms – – x x x x x Range of values Standard OFF; ON Display standard program; Display safe program; Display first interrogated program; Individual 1,2,3 ON – x x x x x x x x AV delay (1 or 2) after: – Pacing – Sensing – At rate 1 – At rate 2 Sense compensation AV hysteresis mode Parameter Range of values Standard VR DX DR HF Timing: Basic rate day/night and rate hystereses Basic rate N.n. bpm x x Night rate Night begins Night ends Rate hysteresis Scan/repetitive OFF; N.n. bpm N.n. hh:mm N.n. bpm N.n. bpm OFF N.n. hh:mm N.n. hh:mm OFF ON OFF; N.n. bpm OFF; ON x x x x x x x x x x AV hysteresis (positive) x x x x x x x x AV hysteresis (negative) N.n. ms AV scan and repetitive OFF; ON (positive) N.n. bpm N.n. bpm N.n. ms OFF OFF N.n. ms CLS modes: N.n. ms N.n. ms ON x x x x x x x x x x x x x Timing: Post-shock pacing 19 Parameter Range of values Standard Post-shock duration Post-shock basic rate AV delay post-shock Ventricular post-shock pacing OFF; N.n. s N.n. bpm N.n. ms RV; BiV N.n. s x x x x N.n. bpm x x x x N.n. ms x x RV VR DX DR HF Parameter ICD therapy Programs VR DX DR HF Parameter General ICD therapy VR DX DR HF Bradycardia / CRT Timing: Ventricular pacing Upper rate Atrial upper rate N.n. bpm OFF; N.n. bpm N.n. bpm N.n. bpm Parameter Range of values Standard Intervention rate Onset criterion Resolution criterion Modification of basic rate Mode OFF; N.n. bpm N.n. N.n. bpm N.n. x x x x x x OFF; N.n. bpm After mode VDD(R): VDI(R) After mode DDD(R): DDI(R) N.n. bpm VDI DDI x x x x x x x x OFF; N.n. bpm N.n. min N.n. bpm N.n. min x x x x x x x x After mode switching: – Rate – Duration VR DX DR HF Timing: Mode switching Standard VR DX DR HF Range of values Vp suppression OFF; ON Pacing suppression [consec- N.n. utive Vs] Pacing support N.n. [out of 8 cycles] OFF N.n. x x x x N.n. x x Range of values Standard Permanent Triggering LV T-wave protection Maximum trigger rate: – DDD(R) and VDD(R) RV; BiV; LV OFF; RVs; RVs+PVC OFF; ON BiV RVs ON UTR N.n. bpm – DDI(R), VDI(R) and VVI(R) Initially paced chamber VV delay after Vp N.n. bpm RV; LV N.n. ms UTR + N.n. N.n. bpm LV N.n. ms Timing: Refractory periods and blanking periods Timing: Ventricular pacing supression Parameter Parameter Parameter Range of values Standard PVARP Blanking after atrial pacing LV blanking after RV pacing RV blanking after LV pacing Far-field protection after Vs Far-field protection after Vp AUTO; N.n. ms N.n. ms N.n. ms N.n. ms N.n. ms x x x x x OFF; N.n. ms N.n. ms N.n. ms N.n. ms x x x x x x Parameter Range of values Standard PMT detection/termination VA criterion OFF; ON N.n. ms ON N.n. ms VR DX DR HF Standard Timing: PMT protection 20 VR DX DR HF Range of values VR DX DR HF Parameter VR DX DR HF Timing: Upper rate x x x x x x Pacing: Ventricular capture control Timing: Rate adaptation via accelerometer Maximum sensor rate Sensor gain N.n. bpm AUTO; Very low; Low; Medium; High; Very high Very low; Low; Medium; High; Very high N.n. bpm/cycle N.n. bpm/cycle 160 bpm Medium Medium x x x x Rate increase Rate decrease Range of values Standard x x x x x x x x Ventricular capture control Threshold test start OFF; ATM; ON N.n. V x x x x x x x x Minimum amplitude Safety margin N.n. V N.n. V ATM ATM: N.n.V ON: N.n. V N.n. V N.n. V x x x x x x x x N.n. bpm x x x x N.n. bpm x x x x Pacing: atrial capture control Parameter Range of values Standard VR DX DR HF Timing CLS-Modes: Closed Loop Stimulation Parameters valid for devices of the series 7: Max. CLS rate CLS response N.n. bpm Very low; Low; Medium; High; Very high OFF; N.n. bpm Yes; No N.n. bpm Medium x x x x x x x STD No Biv modes: Yes x x x x CLS resting rate control Vp required Parameter Range of values Standard atrial capture control OFF; ATM ATM LV lead configuration with IS-1 Pacing: Pulse amplitude and pulse width Parameter Range of values Standard Pacing polarity LV (IS-1) LV tip -> LV ring; LV tip -> RV coil; LV ring -> LV tip; LV ring -> RV coil; UNIP UNIP; BIPL LV tip -> RV coil UNIP Range of values Standard VR DX DR HF Sensing polarity LV (IS-1) Parameter Pulse amplitude A Pulse amplitude V/RV Pulse amplitude LV Pulse width A Pulse width V/RV Pulse width LV N.n. V N.n. V N.n. ms N.n. ms x x x x x x x x x x x x N.n. ms x x 21 VR DX DR HF Sensor threshold Parameter VR DX DR HF Standard VR DX DR HF Range of values VR DX DR HF Parameter Tachycardia LV lead configuration with IS4 Pacing polarity LV (IS4) LV1 tip ->LV2 ring LV1 tip -> LV4 ring LV1 tip -> RV coil LV1 tip -> ICD LV2 ring -> LV1 tip LV2 ring -> LV4 ring LV2 ring -> RV coil LV3 ring -> LV2 ring LV3 ring -> LV4 ring LV3 ring -> RV coil LV4 ring -> LV2 ring LV4 ring -> RV coil LV1 tip -> LV2 ring LV2 ring -> LV3 ring LV3 ring -> LV4 ring LV1 tip -> ICD LV2 tip -> ICD LV3 tip -> ICD LV4 tip -> ICD LV1 tip >LV2 ring MRI program Valid for devices with ProMRI®: Parameter Range of values Mode Basic rate Ventricular pacing V00; OFF V00; D00; OFF N.n. bpm RV; BiV LV1 tip -> LV2 ring Standard VR DX DR HF Sensing polarity LV (IS4) Detection OFF x x N.n. bpm RV x x x x Parameter Range of values Standard VR DX DR HF Standard Interval AT/AF Interval VT1 Interval VT2 Interval VF Detection counter VT1 Detection counter VT2 Detection counter VF Redetection counter VT1 Redetection counter VT2 Redetection counter VF SMART detection VT1/VT2 SMART detection ON: – Onset VT1/VT2 – Stability VT1/VT2 MorphMatch SMART detection OFF: – Onset VT1/VT2 – Stability VT1/VT2 Sustained VT Forced termination N.n. ms OFF; N.n.ms OFF; N.n. ms OFF; N.n. ms N.n. N.n. N.n. N.n. N.n. N.n. OFF; ON 300 ms OFF x x x x x x x 300 ms N.n. N.n. N.n. N.n. N.n. N.n. ON N.n.% N.n.% OFF; Monitor; ON N.n.% N.n.% OFF OFF; N.n.% OFF; N.n. ms OFF; N.n. min OFF; N.n. min N.n.% N.n. ms OFF N.n. min x x x x VR DX DR HF Range of values HF QP Parameter x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Therapy: atrial ATP 22 Parameter Range of values Standard ATP Type Number S1 P-S1 interval OFF; Burst; Ramp N.n. N.n.% OFF N.n. N.n.% x x x x x x N.n. ms Therapy: Shock x x x x x x OFF Parameter Range of values Standard Therapy Rate Duration Backup Stimulation Mode OFF; HF burst N.n. Hz N.n. s OFF; N.n. bpm OFF; V00 OFF N.n. Hz N.n. s OFF OFF VR DX DR HF Therapy: atrial HF-Burst Parameter Range of values Standard VR DX DR HF Therapy: ATP Parameter Attempts ATP type for VT1/VT2 ATP type for VF ATP optimization Number S1 for VT1/VT2 Number S1 for VF S1 decrement for VT1/VT2 and for VF Scan decrement Additional S1 for VT1/VT2 Ventricular pacing for VT1/VT2 Ventricular pacing for VF R-S1 interval for VT1/VT2 R-S1 interval for VF OFF; N.n. Burst; Ramp OFF; Burst; Ramp OFF; ON N.n. OFF Burst Burst OFF N.n. N.n. N.n. ms OFF ON RV RV N.n.% N.n.% x x x x x x x x N.n. ms OFF; N.n. ms OFF; ON RV; LV; BiV N.n.% Range of values Number of shocks VT1/VT2 N.n. Number of shocks VF N.n. 1st Shock for VT1/VT2 OFF; N.n. J 2nd Shock for VT1/VT2 OFF; N.n. J 3rd - nth shock for VT1/VT2 OFF; N.n. J 1st Shock for VF N.n. J 2nd Shock for VF N.n. J 3rd - nth Shock for VF N.n. J For shock in VT1/VT2 and VF: – Confirmation OFF; ON – Polarity Normal; Reverse; Alternating – Shock form Biphasic; Biphasic 2 – Shock path RV -> ICD+SVC RV -> ICD RV -> SVC Standard VR DX DR HF Standard N.n. ms OFF; N.n. bpm OFF; VVI N.n. N.n. N.n. J N.n. J N.n. J N.n.J N.n. J N.n. J ON Normal x x x x Biphasic RV-> x x ICD+SVC RV -> ICD Sensing Sensitivity and thresholds x x x x x x x x 23 Parameter Range of values Standard VR DX DR HF Range of values S1 decrement Backup Stimulation Mode VR DX DR HF Parameter Sensing A Sensing RV Sensing LV Upper threshold RV Upper threshold LV STD; OFF; IND STD; TWS; VFS; IND STD; OFF; IND N.n.% N.n.% STD STD STD N.n.% N.n.% x x x x x x x x x x x Range of values Standard VR DX DR HF Diagnostics Upper threshold duration after detection Upper threshold duration after pacing Lower threshold RV T-wave suppression after pacing Minimum threshold A Minimum threshold RV Minimum threshold LV N.n. ms VFS: N.n. ms N.n. ms x x x x The following can be set: Parameter N.n. ms N.n.% OFF x x x x x x x x N.n. mV N.n. mV N.n. mV N.n. mV N.n. mV N.n. mV x x x x x x x OFF; ON; Advanced ON OFF; ON When Home Monitoring OFF: OFF; N.n. days IEGM configuration RA, RV, LV RA, RV, FF FF; RV; LV Start resting period N.n. hh:mm Duration of resting period N.n. h AV delay modification in OFF; N.n. ms sensing test Thoracic impedance (TI) OFF, ON Standard ON ON N.n. days x x x x x x x x x x x RA, RV, LV N.n. hh:mm N.n. h N.n. ms x x x x x x x x x x x OFF x x x x Home Monitoring 24 Parameter Range of values Standard VR DX DR HF N.n.% OFF; ON Range of values For AT/AF For SVT Periodic recording VR DX DR HF Parameter Home Monitoring Time of transmission IEGM for: – Therapy episodes – Monitoring episodes Ongoing atrial episode OFF; ON STD; N.n. hh:mm OFF STD x x x x x x x x OFF; ON ON x x x x OFF; N.n. h N.n. h x x x 5 Technical Data Factory settings • Arrhythmia zones VT1, VT2, VF: OFF • Antibradycardia pacing: OFF • Home Monitoring: OFF Mechanical Characteristics Housing Devices with a DF-1/IS-1, DF4/IS-1 or DF4/IS4 header: Type Connector port W x H x D in mm Volume cm3 VR DX DR HF HF QP DF-1 DF4 DF-1 — DF-1 DF4 DF-1 DF4 DF4/IS4 Telemetry data • Nominal carrier frequency: 403.6 MHz • Maximum power of transmission: < 25 µW (-16 dBm) Mass g 65 x 55 x 12.5 65 x 52 x 12.5 65 x 55 x 12.5 36 34 36 86 86 86 65 x 55 x 12.5 65 x 56 x 12.5 65 x 58.5 x 12.5 65 x 56 x 12.5 65 x 59x 12.5 36 35 37 36 37 86 87 88 87 89 International radio certification Devices with BIOTRONIK Home Monitoring® are equipped with an antenna for wireless communication. Telemetry data 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–TACH70 The code IC in front of the certification/ registration number only indicates that the technical requirements for Industry Canada are met. Materials in contact with body tissue • Housing: Titanium • Header: Epoxy resin • Blind plug and silicone plug: Silopren or silastic DF4 /IS4 seal: Silastic X-ray identification AH Telemetry 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-SMC010 Electrical Characteristics Telemetry data for the USA: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids ( i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communica- Standards 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 ± 2°C • Pacing/sensing: 500 Ω ± 1% • Shock: 50 Ω ±1% 25 tions are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. • This device will be registered with Federal Communications Commission under the following number: FCC ID: QRITACH70 ATP 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: ATP amplitude RV LV Pulse form The pacing pulse has the following form: The pulse amplitude reaches its maximum value at the beginning of the pulse (Ua). With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the pacing impedance. Common mode rejection ratio Common mode rejection ratio Atrium: DX* Atrium: DR, V right: VR, DR, HF HF N.n. Hz N.n. dB N.n. dB N.n. Hz N.n. dB N.n. dB N.n. Hz N.n. dB N.n. dB * only devices with a DF-1/IS-1 connection. N.n. dB N.n. dB N.n. dB Measured maximum N.n. V N.n. V Mean value N.n. V N.n. V Automatic sensitivity setting Measurement of actual values and test signal wave shape: standard triangle. For the device type DX, the programmed atrial sensitivity is intensified by a factor of 4. Sensitivity Value Tolerance Measured value A: positive N.n. mV N.n. N.n. mV A: negative N.n. mV DX: A: positive N.n. mV N.n. N.n. mV (N.n.) DX: A: negative N.n. mV RV: positive N.n. mV N.n. N.n. mV RV: negative N.n. mV LV: positive N.n. mV N.n. N.n. mV LV: negative N.n. mV Resistance to interference • Note on device type 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: In the case of unipolar sensing, the requirement for interference voltages of ≤ 0.3 mV (tip to tip) is met. Rate Measured minimum N.n. V N.n. V Shock energy / peak voltage With shock path: RV to housing + SVC Shock energy Tolerance peak (Tolerance) voltage 1 J (N.n.) N.n. V 20 J (N.n.) N.n. V 45 J (N.n.) N.n. V V left: HF N.n. dB N.n. dB N.n. dB 26 Measured value Shock energy N.n. J N.n. J N.n. J Measured value Peak voltage N.n. V N.n. V N.n. V Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer GREATBATCH, INC. Clarence, NY 14031 Battery type GB 2992 Battery ID number shown on the 3 programmer Device type Battery voltage at ERI Charge time at BOS Charge time at ERI Usable capacity until ERI Usable capacity until EOS VR, (DX), DR, HF 2.5 V 10 s 12 s 1590 mAh 1730 mAh • Capacitor reforming is performed N.n. times per year and therefore at least N.n. maximum charges for shocks have to be assumed per year even if less than N.n. are delivered. Calculation of the number of shocks Calculation of the maximum number of shocks: Service time [in years] x number of shocks per year Service times single-chamber Service times with GB 2992 or LiS 3410 RR battery, subject to change: Service time [in years] at number of shocks per year Pacing 12 16 20 0, 15, 50, 100% N.n. N.n. N.n. N.n. N.n. LITRONIK GmbH & Co 01796 Pirna, Germany LiS 3410 RR N.n. N.n. V N.n. s N.n. s N.n. mAh N.n. mAh Service times dual-chamber Service times with GB 2992 or LiS 3410 RR battery (only devices with DF-1/IS-1 connection), subject to change: Service time [in years] at number of shocks per year Pacing 12 16 20 0, 15, 50, 100% N.n. N.n. N.n. N.n. N.n. Storage period The storage period affects the battery service time. • Devices should be implanted within N.n. 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 N.n. months. Service times triple-chamber Service times with GB 2992 or LiS 3410 RR battery, subject to change: Service time [in years] at number of shocks per year Pacing 12 16 20 0, 15, 50, 100% N.n. N.n. N.n. N.n. N.n. 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 27 Legend for the Label TP2 Compatibility with telemetry protocol, version 2 of BIOTRONIK Home Monitoring Label on the package The label icons symbolize the following: Manufacturing date Use by Temperature limit Order number Serial number Product identification number Dangerous voltages! CE mark Contents Follow the instructions for use Device: NBG code and compatible leads Example Factory settings for therapy: OFF Example Screwdriver Examples of DF-1/IS-1 or DF4/IS-1 header Sterilized with ethylene oxide Do not resterilize STERILIZE Do not use if packaging is damaged Single use only. Do not reuse! Examples of DF4/IS4/IS-1 header Bipolar IS-1 connector Non-sterile NON STERILE Unipolar IS-1 connector Unipolar DF-1 connector Transmitter with non-ionizing radiation at designated frequency Label icon on devices with ProMRI® DF4/IS4 connector MR conditional: Patients who have a system with devices labeled with this symbol on the packaging can be examined using an MRI scan under precisely defined conditions. 28
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