BIOTRONIK Lexos DR-T Technical Manual
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BIOTRONIK Lexos DR-T Technical Manual

Family of implantable cardioverter defibrillators
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Family of Implantable Cardioverter
Defibrillators
Technical Manual

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  • Page 1 Lexos Family of Implantable Cardioverter Defibrillators Technical Manual...
  • Page 2 Lexos DR, DR-T, VR and VR-T Implantable Cardioverter Defibrillator Inside the housing, right-hand side: X-Ray identification Year of manufacture AUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. 2003 BIOTRONIK, Inc., all rights reserved.

  • Page 3: Table Of Contents

    Lexos Technical Manual i Contents 1. General................1 1.1 System Description............1 1.2 Indications and Usage ..........2 1.3 Contraindications ............3 1.4 Warnings and Precautions.........3 1.4.1 Sterilization, Storage, and Handling ....4 1.4.2 Device Implantation and Programming....4 1.4.3 Lead Evaluation and Connection.......6 1.4.4 Follow-up Testing..........8 1.4.5 Pulse Generator Explant and Disposal....8 1.4.6...
  • Page 4 ii Lexos Technical Manual 2.2 Ventricular Tachyarrhythmia Detection ......30 2.2.1 VF Classifications ..........31 2.2.2 VT Interval Counters ..........31 2.2.3 VT Classification ..........31 2.2.4 SMART Detection™...........32 2.2.5 Onset..............33 2.2.6 Stability...............33 2.2.7 Sustained VT Timer ...........34 2.3 Tachyarrhythmia Redetection ........34 2.3.1 VT Redetection ..........35 2.3.2 SMART Redetection ..........35 2.3.3...
  • Page 5 Manual ATP ............57 2.7.7 Test Shock ............57 2.8 Special Features............58 2.8.1 Detection and Therapy Status ......58 2.8.2 Home Monitoring (Lexos DR-T and VR-T Only) 59 2.8.3 Real-time IEGM Transmission......64 2.8.4 Capacitor Reformation ........64 2.8.5 Patient and Implant Data ........65 2.8.6 System Status ............66...
  • Page 6 iv Lexos Technical Manual *Lexos VR and VR-T ICDs do not have an atrial pace/sense port Lexos Specifications and Description Battery Voltage: 6.3 Volts Maximum Shock Energy: 30 joules Defibrillation Lead Ports Two DF-1 (3.2 mm) Pacing Lead Ports Two IS-1 (3.2 mm) (one for Lexos VR and VR-T) Dimension: 67 x 55 x 12 mm...

  • Page 7: General

    Lexos Technical Manual 1 1. General 1.1 System Description The Lexos family of Implantable Cardioverter Defibrillators (ICDs) detect and treat ventricular tachyarrhythmias and provide rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician’s assessment of a patient’s condition and the performance of the implanted device.

  • Page 8: Indications And Usage

    BIOTRONIK’s SMART Detection algorithm. • Lexos DR-T is identical to the Lexos DR with the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

  • Page 9: Contraindications

    Lexos Technical Manual 3 1.3 Contraindications Do not use the Lexos Implantable Cardioverter Defibrillators (ICDs) in patients: • Whose ventricular tachyarrhythmias may have transient or reversible causes including: − acute myocardial infarction − digitalis intoxication − drowning − electrocution − electrolyte imbalance −...

  • Page 10: Sterilization, Storage, And Handling

    Device Packaging - Do not use the device if the device’s packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK. Re-sterilization - Do not re-sterilize and re-implant explanted devices.
  • Page 11 (or explanted if previously implanted). Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition. Programmers - Use only BIOTRONIK programmers to PLUS PLUS communicate with the device (TMS 1000 or EPR 1000...

  • Page 12: Lead Evaluation And Connection

    6 Lexos Technical Manual Sealing System - Failure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle may result in damage to the sealing system and its self-sealing properties. Programming Wand Separation Distance – The wand must not be placed closer than 2 cm to the device (implanted or out of the box).
  • Page 13 Leave the torque wrench in the slot of the setscrew(s) while the lead is inserted. Tightening Setscrew(s) – Do not overtighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench.

  • Page 14: Follow-Up Testing

    The ICD must be explanted prior to cremation. Explanted Devices – Return all explanted devices to BIOTRONIK. Unwanted Shocks – Always program the therapy status to DISABLED prior to handling the device to prevent the delivery of serious shocks to the patient or the person handling the device...

  • Page 15: Hospital And Medical Hazards

    Lexos Technical Manual 9 1.4.6 Hospital and Medical Hazards Electromagnetic interference (EMI) signals present in hospital and medical environments may affect the function of any ICD or pacemaker. The ICD is designed to selectively filter out EMI noise. However, due to the variety of EMI signals, absolute protection from EMI is not possible with this or any other ICD.

  • Page 16: Home And Occupational Hazards

    10 Lexos Technical Manual • Position the adhesive electrodes or defibrillation paddles of the external defibrillator anterior-posterior or along a line perpendicular to the axis formed by the implanted device and the heart. • Set the energy to a level not higher than is required to achieve defibrillation.

  • Page 17: Cellular Phones

    6 inches (15 cm) of the ICD, when the ICD is programmed to standard sensitivity. Patients having an implanted BIOTRONIK ICD who operate a cellular telephone should: •...

  • Page 18: Electronic Article Surveillance (Eas)

    12 Lexos Technical Manual 1.4.9 Electronic Article Surveillance (EAS) Equipment such as retail theft prevention systems may interact with pulse generators. Patients should be advised to walk directly through and not to remain near an EAS system longer than necessary. 1.4.10 Home Appliances Home appliances normally do not affect ICD operation if the appliances are in proper working condition and correctly...

  • Page 19: Adverse Events

    Lexos Technical Manual 13 1.5 Adverse Events 1.5.1 Potential Adverse Events The following is a list of the potential risks that may occur with this device: • Acceleration of arrhythmias • Air embolism • Bleeding • Chronic nerve damage • Erosion •...

  • Page 20: Observed Adverse Events

    126 patients with a cumulative implant duration of 795.5 months (mean implant duration 6.3 months). The Phylax AV ICD is an earlier generation of BIOTRONIK devices. The Lexos family is based upon the Phylax AV and other BIOTRONIK ICDs (i.e., Phylax, Tachos, and Belos families of ICDs).
  • Page 21 Lexos Technical Manual 15 Table 1: Reported Adverse Events # of % of # of AE / Patients Patients pt-yrs with AEs with AEs Complications Total 11.1% 0.27 Lead Repositioning 7.9% 0.18 Discomfort at Implant 0.8% 0.02 Site Infection 0.8% 0.02 Thrombus 0.8%...
  • Page 22 16 Lexos Technical Manual # of % of # of AE / Patients Patients pt-yrs with AEs with AEs SVT Therapy-Related to 1.6% 0.06 SMART Initial therapy did not 1.6% 0.03 convert VT/VF Low P/R-Wave 1.6% 0.03 Amplitude Intermittent Under / 1.6% 0.03 Oversensing...

  • Page 23: Clinical Studies

    Lexos Technical Manual 17 1. This category includes various anomalies that were related to the programmer software used in the clinical study, I-GAV.1.U. Each of these events has been resolved through revisions to the programmer software resulting in version I-GAV.2.U. 2.
  • Page 24 18 Lexos Technical Manual 1.6.1.1 Study Objectives The objective of the clinical evaluation was to gather basic information about the function and performance of the Tachos DR ICD in patients with standard ICD indications. 1.6.1.2 Results The mean implant duration was 5.7 months with cumulative implant duration of 323 patient months.

  • Page 25: Phylax Av

    / ischemic cardiomyopathy; 65.1% presented with monomorphic ventricular tachycardia (MVT) as their primary tachyarrhythmia. The Phylax AV ICD is an earlier generation of BIOTRONIK devices. The Lexos family is based upon the Phylax AV and other BIOTRONIK ICDs (i.e., Phylax, Tachos, and Belos families of ICDs).
  • Page 26 1.6.2.3 SMART Detection Algorithm The SMART Detection algorithm is an integral function of BIOTRONIK’s dual chamber ICD product line (i.e., Phylax AV, Tachos DR, and Belos DR) and is designed to discriminate life- threatening ventricular tachycardias from relatively harmless atrial tachyarrhythmias. This algorithm uses information about...

  • Page 27: Patient Selection And Treatment

    SVTs can initiate unwanted device therapy. • Direct any questions regarding individualization of patient therapy to your BIOTRONIK representative or BIOTRONIK technical services at 1-800-547-0394. The prospective patient’s size and activity level should be evaluated to determine whether a pectoral or abdominal implant is suitable.

  • Page 28: Specific Patient Populations

    22 Lexos Technical Manual If the patient’s condition permits, use exercise stress testing to do the following: • Determine the maximum rate of the patient’s normal rhythm. • Identify any supraventricular tachyarrhythmias. • Identify exercise-induced tachyarrhythmias. The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters.

  • Page 29: Patient Counseling Information

    (For additional copies of the patient manual, contact the BIOTRONIK at the address listed in this manual.) 1.9 Evaluating Prospective ICD Patients The prospective ICD implant candidate should undergo a cardiac evaluation to classify any and all tachyarrhythmias.
  • Page 30 Some changes may necessitate a re-assessment of sensing, pacing, or arrhythmia conversion treatment. Thorough technical knowledge of BIOTRONIK ICDs, additional ICD experience, and individual medical judgment will aid in determining the need for additional testing and follow-up.

  • Page 31: Device Features

    Lexos Technical Manual 25 2. Device Features The Lexos family feature set is presented under the following sub-headings: Tachyarrhythmia Detection, Tachyarrhythmia Redetection / Acceleration, Tachyarrhythmia Therapy, Tachyarrhythmia Termination, Bradycardia Therapy, EP Test Functions and Special Features. The features apply to all members of the Lexos family except where specifically referenced differently.
  • Page 32 26 Lexos Technical Manual Table 4: Sensitivity Settings Setting Definition for Use Standard This setting is recommended for most patients, especially for those with measured R-wave amplitude of ≥3 mV. Enhanced This setting offers suppression of T-wave T Wave oversensing. This mode should not to be Suppression used on patients with the following conditions:...
  • Page 33 Lexos Technical Manual 27 Figure 1 Automatic Sensitivity Control with Standard Setting Figure 1 provides an illustration of Automatic Sensitivity Control with the sensitivity programmed to Standard. The tracked R – wave is measured to be 6.0 mV, following the sensed refractory period, the upper threshold is set to 3.0 mV.

  • Page 34: Minimum Ventricular Threshold

    28 Lexos Technical Manual The Enhanced T-Wave Suppression setting is specifically designed to avoid double counting of each QRS-T complexes during normal sinus rhythms. With sensitivity programmed to Enhanced T-Wave Suppression; • High pass filtering is increased to reduce low frequency signal components such as T-waves and respiratory artifacts.

  • Page 35: Minimum Atrial Threshold

    Lexos Technical Manual 29 Typically, the upper threshold is reset with each sensed P-wave, but in order to ensure that pacing does not occur during an episode of AF/VF, the ASC behaves differently with paced events. Each paced event is followed by a paced refractory period after which the atrial threshold is set to the minimum programmed value.

  • Page 36: Ventricular Tachyarrhythmia Detection

    30 Lexos Technical Manual 2.2 Ventricular Tachyarrhythmia Detection The Lexos ICDs detect and measure the rate of sensed cardiac signals to discriminate ventricular tachyarrhythmias from supraventricular tachycardias, sinus rhythm sinus bradycardia. This is accomplished through programmable rate detection parameters in the device. When a tachyarrhythmia is present, the ICD classifies the arrhythmia and delivers the appropriate therapy.

  • Page 37: Vf Classifications

    Lexos Technical Manual 31 2.2.1 VF Classifications Detection of ventricular fibrillation (VF) utilizes programmable X out of Y criterion. Both X and Y are programmable. If X number of intervals within the sliding window (defined by Y) are shorter than the programmed VF rate interval (>bpm), VF is detected. After fibrillation is detected, the programmed therapy sequence for VF is initiated.

  • Page 38: Smart Detection

    32 Lexos Technical Manual The ICDs may be programmed to use ventricular-only information, or both atrial and ventricular information for the discrimination of ventricular tachycardias. With SMART Detection™ turned ON, the Lexos ICDs use atrial and ventricular signals for discrimination of fast heart rhythms. With SMART Detection™...

  • Page 39: Onset

    Lexos Technical Manual 33 If the ventricular rhythm is stable and the atrial rate is not a multiple of the ventricular rate, then the rhythm is declared a VT and ventricular tachycardia therapy is delivered. In the event that both the atrial and ventricular signals are detected at the same rate, a series of additional discrimination tests are applied.

  • Page 40: Sustained Vt Timer

    34 Lexos Technical Manual 2.2.7 Sustained VT Timer The Sustained VT Timer can be programmed between 30 seconds and 30 minutes (or to OFF). When the timer expires, therapy is initiated regardless of the detection enhancements. The Sustained VT parameter is intended to force tachycardia therapy in cases where a cardiac rhythm meets the VT rate criteria but does not satisfy one or more detection enhancement criterion (Onset, SMART Detection, or Stability) for an extended...

  • Page 41: Vt Redetection

    Lexos Technical Manual 35 2.3.1 VT Redetection The Redetection Counter parameter may be programmed separately for each arrhythmia class, independent of the initial detection parameters: Redetection of an ongoing tachyarrhythmia is declared when the Redetection Counter is satisfied (based on individual cycles). If a sensed cardiac signal meets any VT rate criteria, following therapy, that signal is counted and compared to the programmed Redetection Counter setting.

  • Page 42: Tachyarrhythmia Therapy

    36 Lexos Technical Manual 2.5 Tachyarrhythmia Therapy The Lexos ICDs offer a variety of therapy options that can be tailored to meet a patient’s specific anti-tachycardia or defibrillation therapy requirements. Anti-tachycardia pacing (ATP) therapies can be combined with defibrillation therapies to provide a broad spectrum of tachyarrhythmia treatment options.
  • Page 43 Lexos Technical Manual 37 Add S1 - This feature can be programmed with any Burst, Ramp, or Burst + PES scheme. When “Add S1” is “ON,” the number of S1 intervals is incremented by one on each successive ATP therapy. The new S1-S1 interval is dependent on the initial start interval (S1 decrement) and the programmed scan decrement (if activated).
  • Page 44 38 Lexos Technical Manual 2.5.2.2 ATP Therapy Optimization In order to optimize future therapies, the ICD will store the parameter configuration of the last successful ATP attempt in each the VT1 and VT2 classes. The last successful stored ATP attempt is then used as the starting point for the next detected episode of the same arrhythmia class.

  • Page 45: Shock Therapy

    Lexos Technical Manual 39 2.5.3 Shock Therapy Shock Therapy can be delivered as defibrillation shocks with or without confirmation (while the capacitors are being charged). The first shock energy in each shock module has independently programmable Shock Energy, and confirmation programmable ON/OFF.
  • Page 46 40 Lexos Technical Manual AUTION Shock Therapy Confirmation – Programming CONFIRMATION to OFF may increase the incidence of the ICD delivering inappropriate shocks. Y N C H R O N I Z AT I O N A synchronization window is started at the end of the charging period.
  • Page 47 Lexos Technical Manual 41 BIOTRONIK recommends use of the standard Biphasic shock waveform for initial defibrillation threshold testing. If testing demonstrates high defibrillation thresholds, testing with the Biphasic 2ms waveform is offered as a therapeutic alternative to the standard Biphasic shock.

  • Page 48: Progressive Course Of Therapy

    42 Lexos Technical Manual 2.5.3.5 Shock Polarity The polarity of the shock therapy may be programmed and changed non-invasively. The Normal polarity configures the HV 1 connector port as the negative electrode and the HV 2 connector port and the outer housing of the ICD as the positive electrode for the first phase of the shock.

  • Page 49: Bradycardia Therapy

    Lexos Technical Manual 43 2.6 Bradycardia Therapy The Lexos ICDs have independently programmable dual chamber bradycardia and post-shock bradycardia pacing functions. The post-shock bradycardia parameters may be programmed to higher rates or output values for the period following a delivered shock, without compromising the longevity of the ICD for patients who require chronic bradycardia pacing.

  • Page 50: Basic Rate

    44 Lexos Technical Manual The pacing modes with an “R” indicate rate adaptive pacing controlled by a motion based capacitive sensor. These modes are functionally the same as the corresponding non-rate- adaptive modes, except that the pacing rate is increased based on physical activity.
  • Page 51 Lexos Technical Manual 45 Hysteresis can be programmed OFF or to values as low as -65 bpm of the basic rate. Hysteresis is initiated by a sensed event. The resulting Hysteresis rate is always less than the lower rate. The Hysteresis rate is limited to only providing a basic rate that is 30 bpm or greater.
  • Page 52 46 Lexos Technical Manual Figure 3. Repetitive Hysteresis Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce pulse generator energy consumption. Repetitive and Scan Hysteresis are not active during the programmed Night Rate and are only available when Hysteresis is selected on.
  • Page 53 Lexos Technical Manual 47 2.6.4.2 Scan Hysteresis Scan hysteresis is expanded programmability of the Hysteresis feature. Scan hysteresis searches for an underlying intrinsic cardiac rhythm, which may exist slightly below the programmed lower rate (or sensor-indicated rate) of the pulse generator. Following 180 consecutive paced events, the stimulation rate is temporarily decreased to the hysteresis rate for a programmed number of beats.

  • Page 54: Dynamic Av Delay

    48 Lexos Technical Manual Magnet application (closing of reed switch) suspends 180 consecutive event counter independent of the magnet effect. 2.6.5 Dynamic AV Delay The AV Delay defines the interval between an atrial paced or sensed event and the ventricular pacing pulse. If the pulse generator is programmed to a dual chamber sensing mode, an intrinsic ventricular event falling within the AV Delay will inhibit...

  • Page 55: Upper Tracking Rate

    Lexos Technical Manual 49 2.6.6 Upper Tracking Rate In the atrial tracking modes (DDDR, DDIR, VDDR, VDIR, DDD, DDI, VDD and VDI), ventricular pacing tracks atrial pace/sense events. The maximum tracking rate (ventricular pacing rate) is limited by the Upper Rate parameter. The UTR response will automatically toggle between 2:1 and WKB (Wenkebach) depending on the relative programmed values for upper rate and atrial refractory period.

  • Page 56: Mode Switching

    50 Lexos Technical Manual The Lexos DR and Lexos DR-T ICDs the UTR is programmable within the VT-1 zone. This feature is for patients that are active and have exercise and VT rates that overlap. This may be desirable in young active patients.

  • Page 57: Pmt Management

    Lexos Technical Manual 51 2.6.8 PMT Management The following features provide prevention, detection, and termination of pacemaker-mediated tachycardias (PMT): • PMT prevention by extending PVARP • PMT protection (PMT detection and termination) PMT Prevention - To prevent PMT, the pacemaker restarts the basic rate and PVARP when there is ventricular sensing but no atrial event preceding it.
  • Page 58 52 Lexos Technical Manual Lexos ICDs allow the selection of rate-responsive pacing modes. These modes allow the ICD’s bradycardia therapy function to adapt the pacing rate to increasing or decreasing patient physical activity, based on data collected from a motion based sensor within the ICD.

  • Page 59: Pulse Amplitude

    Lexos Technical Manual 53 When the Automatic Sensor Gain is activated, the pulse generator samples the sensor-indicated rate. If, during the 24 hour period beginning at midnight, the total time recorded at maximum sensor rate exceeds 90 seconds, the sensor gain setting is reduced by one step.

  • Page 60: Noise Response

    54 Lexos Technical Manual 2.6.14 Noise Response The Lexos ICD’s response to detected noise is to deliver asynchronous pacing in the affected channel. 2.6.15 Post Shock Pacing Separately programmable bradycardia pacing support is available with the ICD following shock therapy delivery. Because a delay in bradycardia pacing may avoid re-initiation of a tachyarrhythmia after a short blanking period (1 second) the ICD will begin bradycardia therapy at the post shock pacing rate,...

  • Page 61: Testing For Retrograde Conduction

    Lexos Technical Manual 55 To permit evaluation of the sensing function, the pacing rate must be lower than the patient's intrinsic rate. In demand pacing, the proper sensing function can be recognized if the interval between intrinsic events and the following pacing pulse equals the basic interval (if no Hysteresis is programmed).

  • Page 62: Pacing Threshold

    56 Lexos Technical Manual 2.7.3 Pacing Threshold The test is activated as a temporary program, and removal of the programmer head immediately stops the test and reactivates the permanent program. The following parameters are programmable during the pacing threshold test: Appropriate chamber and pacing mode, pacing rate, AV Delay (if appropriate), pulse amplitude and pulse width, number of pulses for each test voltage and automatic printing capabilities.

  • Page 63: Manual Shock

    Lexos Technical Manual 57 Burst + PES Induction delivers a programmed number of burst of pacing stimuli followed by a programmable number of timed extra stimuli. The burst rate is independently programmable, as is the Number S1. The interval between S1s and the remaining programmed extra stimuli (PES: S1 through S4 possible) is also programmable.

  • Page 64: Special Features

    58 Lexos Technical Manual ARNING Resuscitation Availability - Do not perform induction testing unless an alternate source of patient defibrillation such as an external defibrillator is readily available. In order to implant the ICD system, it is necessary to induce and convert the patient’s ventricular tachyarrhythmias.

  • Page 65: Home Monitoring (Lexos Dr-T And Vr-T Only)

    Lexos Technical Manual 59 2.8.2 Home Monitoring (Lexos DR-T and VR-T Only) Home Monitoring enables the exchange of information about a patient’s cardiac status from the implant to the physician. Home Monitoring can be used to provide the physician with advance reports from the implant and process them into graphical and tabular format called a Cardio Report.
  • Page 66 24 hours. It receives information from the implant and forwards it via the mobile network to a BIOTRONIK Service Center. For additional information about the patient device, please refer to its manual. Figure 5: Example of Patient Device with Charging Stand...
  • Page 67 To assure successful transmission of the patient data, the Lexos VR-T and Lexos DR-T send 4 repetitive transmissions of identical data at a 60 minute time interval. Battery voltage and pace/sense lead impedance are measured before the first transmission of the day.
  • Page 68 62 Lexos Technical Manual The following cardiac and technical events initiate an immediate message transmission: • Special Device Status • Detected and terminated VT-1 • Detected and terminated VT-2 • Detected and terminated VF • First ineffective 30 J shock detected •...
  • Page 69 Lexos Technical Manual 63 The monitoring interval is considered the time period since the last trend information was sampled. In the absence of an event report, the monitoring interval would be 24 hours. For an event report, the monitoring interval would be less than 24 hours, since these reports are sent after the programmed time of trend transmission.

  • Page 70: Real-Time Iegm Transmission

    64 Lexos Technical Manual • Status • Remarks *Available only with dual chamber ICDs. 2.8.3 Real-time IEGM Transmission The pulse generators provide real time transmission of the unfiltered intracardiac electrogram (IEGM) to the programmer. During dual chamber operation, IEGMs from the atrium and ventricle can be simultaneously recorded with a bandwidth of 0.5 to 200 Hz.

  • Page 71: Patient And Implant Data

    The capacitors may be reformed manually, or the ICD may be programmed to reform the capacitors automatically. Biotronik recommends automatic reforming capacitors, because disabling this function may reduce the benefits associated with frequent capacitor charging (e.g., short charge times in patients who have infrequent shock therapy).

  • Page 72: System Status

    66 Lexos Technical Manual 2.8.6 System Status Various device parameters can be monitored through the Status section of the programmer screen. Displayed data includes ICD information, charge circuit parameters, capacitor reform information, battery status and voltage, and lead information. The system status screen presents a large variety of information about the Lexos ICDs including: •...
  • Page 73 Lexos Technical Manual 67 P I S O D E E T AI L S Detailed information about each individual episode presented as a table of events ordered from most recently delivered to the first delivered. Each IEGM segment can be viewed from the episode detail sub-menu by selecting the EGM button.
  • Page 74 68 Lexos Technical Manual I E G M T O R E D The ICD can store up to 30 minutes of dual chamber intracardiac electrograms (IEGMs) including the history and prehistory of the following events: • Detection • Redetection •...

  • Page 75: Real-Time Iegm

    Lexos Technical Manual 69 The device history regarding several therapy and detection parameters is presented in the “Counters” screen. This screen contains both the number of events since the last ICD follow-up and totals since the device was implanted. The available parameters include: E T E C T I O N P I S O D E S...

  • Page 76: Brady Diagnostics

    70 Lexos Technical Manual 2.8.9 Brady Diagnostics The ICD stores a variety of useful diagnostic data of the bradycardia history as described in the following sections. 2.8.9.1 Event Counters The total number of atrial sensed, atrial paced, ventricular sense and ventricular paced events since the statistics package was initiated are available.
  • Page 77 Lexos Technical Manual 71...

  • Page 78: Sterilization And Storage

    Device Packaging - Do not use the device if the device’s packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK. Re-sterilization - Do not re-sterilize and re-implant explanted devices.
  • Page 79 Lexos Technical Manual 73...

  • Page 80: Implant Procedure

    Program detection and therapy to “Disabled” prior to handling the Lexos ICD. Sufficient training on the device and its associated components is required prior to implanting the ICD. For additional information, training and training materials contact your BIOTRONIK representative.
  • Page 81 Connector Compatibility lead system compatibility should be confirmed prior to the implant procedure. Consult your BIOTRONIK representative regarding lead/pulse generator compatibility prior to the implantation of an ICD system. For further information, please refer to Appendix Pacemaker/ICD Interaction - In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed.

  • Page 82: Lead System Evaluation

    76 Lexos Technical Manual AUTION Shock Impedance - If the shock impedance is less than twenty-five ohms, reposition the lead system to allow a greater distance between the electrodes. Never implant the device with a lead system that has a measured shock impedance of less than twenty-five ohms.

  • Page 83: Pocket Preparation

    Device Packaging - Do not use the device if the device’s packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK. 4.4 Pocket Preparation Using standard surgical technique, create a pocket for the device either in the patient’s pectoral or abdominal region...

  • Page 84: Lead To Device Connection

    78 Lexos Technical Manual AUTION The ICD system should have detection and therapy disabled prior to performing medical procedures. In addition, the ICD should be checked after the procedures to assure proper programming: Electrocautery - Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause device malfunction or damage.
  • Page 85 Lexos Technical Manual 79 Figure 6. Header Ports...
  • Page 86 Setscrew(s) – overtighten setscrew(s). Use only the BIOTRONIK supplied torque wrench. Sealing System – Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle. Failure to do so may result in damage to the plug and its self-sealing properties.

  • Page 87: Blind Plug Connection

    Lexos Technical Manual 81 Refer to the following steps when connecting the leads to the device. 1. Confirm that the setscrews are not protruding into the connector receptacles. To retract a setscrew, insert the enclosed torque wrench through the perforation in the self-sealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew.
  • Page 88 82 Lexos Technical Manual 1. Confirm that the setscrews are not protruding into the connector receptacles. To retract a setscrew, insert the enclosed torque wrench through the perforation in the self-sealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew. Rotate the wrench counterclockwise until the receptacle is clear of obstruction.

  • Page 89: Pacemaker Interaction Testing

    Lexos Technical Manual 83 4.7 Pacemaker Interaction Testing There are three situations in which pacemaker/ICD interaction testing is appropriate when: • a pacemaker and an ICD are implanted at the same procedure • an ICD is implanted in a patient with a chronic pacemaker •...
  • Page 90 84 Lexos Technical Manual Part 1 Verify that inappropriate therapy will not be initiated by oversensing of pacemaker pulses. 1. Program the detection status and magnet mode of the ICD to “DISABLED”. 2. Keep the programming wand in place over the ICD to observe the intracardiac electrograms and markers when the pacemaker is inhibited.
  • Page 91 Lexos Technical Manual 85 5. If the ICD did not detect the tachyarrhythmia, reduce the pacemaker’s output settings and repeat step 4 until maximum allowable pacemaker output settings are defined. The maximum allowable programming set should be recorded in the patient’s records for future reference, should reprogramming be required.

  • Page 92: Program The Icd

    AUTION Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition. Programmers - Use only BIOTRONIK programmers to communicate with device (TMS 1000 PLUS...

  • Page 93: Implant The Icd

    Connector Compatibility lead system compatibility should be confirmed prior to the implant procedure. Consult your BIOTRONIK representative regarding lead/pulse generator compatibility prior to the implantation of an ICD system. For further information, please refer to Appendix Pacemaker/ICD Interaction - In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed.
  • Page 94 88 Lexos Technical Manual ARNING Resuscitation Availability - Do not perform induction testing unless an alternate source of patient defibrillation such as an external defibrillator is readily available. In order to implant the ICD system, it is necessary to induce and convert the patient’s ventricular tachyarrhythmias.
  • Page 95 Close the device pocket using standard surgical technique. As the final step at device implant and each patient follow-up, permanent program should retransmitted to the ICD. Complete the Medical Device Registration Form provided with the ICD and return it to BIOTRONIK.
  • Page 96 90 Lexos Technical Manual...

  • Page 97: Follow-Up Procedures

    Lexos Technical Manual 91 5. Follow-up Procedures 5.1 General Considerations An ICD follow-up serves to verify appropriate function of the ICD system, and to optimize the programmable parameter settings. In addition to evaluating the patient’s stored therapy history and electrograms, acute testing sensing...

  • Page 98: Longevity

    92 Lexos Technical Manual 5.2 Longevity The service time of an ICD can vary based on several factors, including the number of charge sequences, programmed parameters, number of tachyarrhythmias detected, relative amount of bradycardia pacing required, pacing lead impedance, storage time, battery properties,...
  • Page 99 Lexos Technical Manual 93 Table 8: Longevity Estimates DDD Pacing Shocks Years Support Per Year 100 % 50 % 15 % Each maximum energy (30 joule), high voltage charging sequence reduces the longevity of the device by approximately 21 days. Upon reaching ERI, the battery has enough energy left to continue monitoring for three months and to deliver six high energy shocks.

  • Page 100: Explantation

    Explanted ICDs, lead systems, and accessories may not be reused. Please complete the appropriate out of service (OOS) form and return it to BIOTRONIK with the explanted devices. All explanted devices should be sent either to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal.

  • Page 101: Technical Specifications

    Lexos Technical Manual 95 6. Technical Specifications The following are the technical specifications for the Lexos ICDs. The ranges are presented in the format: x…(y)…z where x = the lowest value, y = the increment, and z = the largest value. Mechanical Properties Parameter Value Range...
  • Page 102 96 Lexos Technical Manual Parameters – Tachyarrhythmias continued… Parameter Value Range Std Program/ Safe Program Detection Parameters for VT Arrhythmia Classes (Cont….) Number of 10…(2)… 30 Intervals – 14 (VT-2) Detection Number of 10…(2)… 30 Intervals – 10 (VT-2) Redetection SMART ON, OFF Detection...
  • Page 103 Lexos Technical Manual 97 Bradycardia Therapy Lexos Pacing Modes Mode Lexos DR and DR-T Lexos VR and VR-T DDDR DDIR VDDR VDIR AAIR VVIR Parameter Value Range Safe Program Program Mode Lexos VR and VR-T Lexos DR and DR-T Basic Rate 30…(5)…160 ppm Night Rate OFF,...
  • Page 104 98 Lexos Technical Manual Parameter Value Range Safe Program Program Hysteresis OFF, -5…(-5)…- 65 ppm Repetitive OFF, 1…(1)…10 Hysteresis Scan OFF, 1…(1)…10 Hysteresis Sense OFF, Compensation -20…(-20)…-120 ppm Safety Window 70, 85, 100 ms Mode Switch DDI, DDIR, VDI, mode VDIR Intervention OFF,...
  • Page 105 Lexos Technical Manual 99 Additional Sensing Parameters Parameter Value Range Std Program/ Safe Program Sensitivity – Standard Atrium Free (Locked-out in US) Sensitivity – Standard Ventricle Enhanced T wave suppression Enhanced VF sensitivity Free (Locked-out in US) Atrial Minimum 0.1…(0.1)…2.0 mV Threshold Ventricular 0.5…(0.1)…2.5 mV...
  • Page 106 100 Lexos Technical Manual Parameters – Bradyarrhythmias continued… Atrial Paced 180 … (10) … 400 ms Refractory Period Ventricular Paced 250 … (10) … 400 ms Refractory Period Cross Blanking 4 … (4) …96 ms Post-Shock Bradycardia Therapy Parameter Value Range Safe Program Program...
  • Page 107 Lexos Technical Manual 101 Basic ATP Therapy Parameter Value Range Std Program/ Safe Program Pacing Mode ATP Type OFF, BURST, BURST RAMP, BURST + PES Amplitude 7.5 V Pulse Width 1.50 ms 1.50 Attempts OFF, 1 ... (1) ... 10 S1 Count 1 ...
  • Page 108 102 Lexos Technical Manual Shock Therapy Parameter Value Range Safe Program Program Number of VT Off, 1...(1)...8 Shocks Number of VF 6...(1)...8 Shocks Shock Biphasic, Biphasic Biphasic Waveform Biphasic 2ms Confirmation ON, OFF Shock 5 …(1) … 11, 13, 14, Energy (Joules) 15, 17, 18, 20, 21, 23, 25, 26, 28, 30...

  • Page 109: Appendix A

    Appendix A Connector Compatibility Lexos ICDs are indicated for use only with commercially available BIOTRONIK bipolar ICD lead systems or other lead systems with which it has been tested. The separate atrial pacing/sensing lead may be any commercially available pacing lead.
  • Page 110 Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: BIOTRONIK GmbH & Co. Woermannkehre 1 D-12359 Berlin Germany M4092-A 07/03...

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