BIOTRONIK Lumax VR ICD Series Technical Manual
  1. Manuals
  2. Brands
  3. BIOTRONIK Manuals
  4. Medical Equipment
  5. Lumax VR ICD Series
  6. Technical manual

BIOTRONIK Lumax VR ICD Series Technical Manual

Implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators
Hide thumbs
Table of Contents

Advertisement

Quick Links

Lumax
Family of Implantable Cardioverter
Defibrillators and Cardiac
Resynchronization Therapy
•
•
•
•
•
•
Technical Manual
Defibrillators
VR ICD
VR-T ICD
DR ICD
DR-T ICD
HF CRT-D
HF-T CRT-D

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Lumax VR ICD Series and is the answer not in the manual?

Questions and answers

Related Manuals for BIOTRONIK Lumax VR ICD Series

Summary of Contents for BIOTRONIK Lumax VR ICD Series

  • Page 1 Lumax Family of Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators VR ICD • VR-T ICD • DR ICD • DR-T ICD • HF CRT-D • HF-T CRT-D • Technical Manual...
  • Page 2 Lumax Family Implantable Cardioverter Defibrillator Cardiac Resynchronization Therapy Defibrillators Inside the housing: 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. 2008 BIOTRONIK, Inc., all rights reserved.

  • Page 3: Table Of Contents

    Lumax Technical Manual i Contents 1.1 System Description ............1 1.2 Indications and Usage...........3 1.3 Contraindications............4 1.4 Warnings and Precautions ..........4 1.4.1 Sterilization, Storage, and Handling ......7 1.4.2 Device Implantation and Programming ....7 1.4.3 Lead Evaluation and Connection ......9 1.4.4 Follow-up Testing ..........11 1.4.5 Pulse Generator Explant and Disposal ....11 1.4.6...
  • Page 4 ii Lumax Technical Manual 2.2.6 Minimum Left Ventricular Threshold....61 2.2.7 Far Field Protection ..........61 2.2.8 Additional Sensing Parameters ......62 2.3 Automatic Threshold Measurement (ATM) ....63 2.3.1 Functional Description.........63 2.4 Intra-Thoracic Impedance Measurement ....65 2.4.1 Functional Description.........65 2.5 Ventricular Tachyarrhythmia Detection .......66 2.5.1 VF Classifications ..........67 2.5.2...
  • Page 5 Lumax Technical Manual iii 2.9.7 Upper Tracking Rate ...........91 2.9.8 Mode Switching ...........93 2.9.9 PMT Management ..........94 2.9.10 VES Discrimination after Atrial Sensed Events...97 2.9.11 Rate Adaptive Pacing ..........98 2.9.12 Pulse Amplitude...........99 2.9.13 Pulse Width ............99 2.9.14 Post Ventricular Atrial Refractory Period...100 2.9.15 PVARP after VES ..........100 2.9.16 Auto PVARP ............100 2.9.17 Noise Response ..........100...
  • Page 6 iv Lumax Technical Manual 2.11.12 Sensor ..............3 2.11.13 Sensing..............3 2.11.14 Impedances ............4 2.11.15 Automatic Threshold..........4 4.1 Implant Preparation ............7 4.2 Lead System Evaluation..........12 4.3 Opening the Sterile Container ........12 4.4 Pocket Preparation............13 4.5 Lead to Device Connection .........13 4.6 Blind Plug Connection ..........16 4.7 Program the ICD/CRT-D ..........17 4.8 Implant the ICD/CRT-D ..........18 5.1 General Considerations ..........23...
  • Page 7 Lumax Technical Manual v Lumax Specifications and Description Battery Voltage: 3.2 Volts 300/500 models: 30 Joules programmed Maximum Shock Energy: 340/540 models: 40 Joules programmed Maximum Shock Energy: Defibrillation Lead Ports Two DF-1 (3.2 mm) Pacing Lead Ports Three IS-1 (3.2 mm) (one for Lumax VR (-T) and two for Lumax DR (-T)s)
  • Page 8 vi Lumax Technical Manual...

  • Page 9: System Description

    Lumax HF-T - In addition to the functionality found with HF model Lumax HF-T also has 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...
  • Page 10 Lumax DR-T - In addition to the functionality found with the DR model it also has 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 11: Indications And Usage

    Lumax Technical Manual 3 The Lumax HF (-T) models have three IS-1 pacing/sensing header ports and two DF-1 defibrillation/cardioversion ports. The Lumax DR (-T) models have two IS-1 pacing/sensing header ports. The Lumax VR (-T) models have one IS-1 pacing/sensing header ports.

  • Page 12: Contraindications

    Electrical Isolation - To prevent inadvertent arrhythmia induction, electrically isolate the patient during the implant procedure from potentially hazardous leakage currents. Left Ventricular Lead Systems – BIOTRONIK CRT-Ds may be implanted with any legally marketed, compatible LV lead. Compatibility is defined as: •...
  • Page 13 St. Jude Medical QuickSite 1056K (unipolar) • ELA Situs OTW (unipolar) • Biotronik Corox OTW 75-UP Steroid #346542 (unipolar) • Biotronik Corox+ LV-H 75-BP #341885 (bipolar) ICD Lead Systems – BIOTRONIK ICDs/CRT-Ds maybe implanted with any legally marketed, compatible ICD lead.
  • Page 14 6 Lumax Technical Manual The following leads were evaluated in a retrospective study with BIOTRONIK’s ICDs/CRT-Ds: • Medtronic Sprint 6932 • Medtronic Sprint 6943 • Medtronic Sprint Quattro 6944 • Medtronic Transvene RV 6936 • St. Jude (Ventritex) TVL- ADX 1559 •...

  • Page 15: Sterilization, Storage, And Handling

    Reforming. Connector Compatibility – ICD/CRT-D and 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/CRT-D system. For further information, please refer to Appendix...
  • Page 16 Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition. Programmers - Use only BIOTRONIK ICS 3000 programmers to communicate with the device. Sealing System - Failure to properly insert the torque wrench...

  • Page 17: Lead Evaluation And Connection

    Lumax Technical Manual 9 Shipment Mode – The shipment mode is a factory set mode that controls the charge current of automatic capacitor reformations. This mode controls the charge current to avoid temporary low battery readings. The shipment mode is automatically deactivated soon electrophysiological...
  • Page 18 Tightening Setscrew(s) – Do not overtighten the 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.

  • Page 19: Follow-Up Testing

    Devices – Return explanted devices BIOTRONIK. Unwanted Shocks – Always program ICD Therapy to OFF prior to handling the device to prevent the delivery of serious shocks to the patient or the person handling the device during the implant procedure.

  • Page 20: Lead System Evaluation

    12 Lumax Technical Manual The ICD/CRT-D system should have detection and therapy disabled (OFF) prior to performing any of the following medical procedures. In addition, the ICD/CRT-D should be checked after the procedures to assure proper programming: Diathermy - Diathermy therapy is not recommended for ICD/CRT-D patients due to possible heating effects of the pulse generator and at the implant site.

  • Page 21: Home And Occupational Hazards

    1.4.8 Cellular Phones Testing has indicated there may be a potential interaction between cellular phones and BIOTRONIK ICD/CRT-D systems. Potential effects may be due to either the cellular phone signal or the magnet within the telephone and may include inhibition of...

  • Page 22: Electronic Article Surveillance (Eas)

    14 Lumax Technical Manual • Set the telephone to the lowest available power setting, if possible. • Patients should hold the phone to the ear opposite the side of the implanted device. Patients should not carry the telephone in a breast pocket or on a belt over or within 6 inches (15 centimeters) of the implanted device as some telephones emit signals when they are turned ON, but not in use (i.e., in the listen or stand-by mode).

  • Page 23: Home Monitoring

    Lumax Technical Manual 15 1.4.11 Home Monitoring Patient’s Ability - Use of the Home Monitoring system requires the patient and/or caregiver to follow the system instructions and cooperate fully when transmitting data. If the patient cannot understand or follow the instructions because of physical or mental challenges, another adult who can follow the instructions will be necessary for proper transmission.

  • Page 24: Potential/Observed Effects Of The Device On Health

    16 Lumax Technical Manual 1.5 Potential/Observed Effects of the Device on Health 1.5.1 Potential Adverse Events The following are possible adverse events that may occur relative to the implant procedure and chronic implant of the CRT-D: • • Lead fracture/ insulation Air embolism •...

  • Page 25: Observed Adverse Events

    1.5.2.1 Kronos LV-T Study The Kronos LV-T CRT-D is an earlier generation of BIOTRONIK devices. The Lumax CRT-Ds are based upon the Kronos LV-T and other BIOTRONIK CRT-Ds and ICDs (i.e., Tupos LV/ATx CRT-D, Lexos and Lumos families of ICDs).
  • Page 26 18 Lumax Technical Manual The HOME-CARE Observational study, conducted outside the US on the Kronos LV-T cardiac resynchronization defibrillator (CRT-D) in patients with congestive heart failure (CHF) involved 45 devices implanted with a cumulative implant duration of 202 months (mean implant duration of 4.5 months). adverse events reported,...
  • Page 27 Lumax Technical Manual 19 Table 2: Summary of Observations – Kronos LV-T Number Category Number patient- Patients Patients year Unsuccessful LV 17.8% 0.48 lead implant Elevated LV pacing 11.1% 0.30 threshold Phrenic nerve 6.7% 0.18 stimulation Elevated DFT 4.4% 0.12 measurement 4.4% 0.12...
  • Page 28 20 Lumax Technical Manual 1.5.2.2 Tupos LV/ATx Study The clinical study information included in this section and in Section 1.6.2 was performed with the Tupos LV/ATx CRT-D, which is an earlier version of the Lumax CRT-D/ICD families. The clinical study data presented here is applicable because Lumax family downsized...
  • Page 29 Lumax Technical Manual 21 Complications and observations for the Tupos LV/ATx study group are summarized in Table 3 Table 4. The total number of patients may not equal the sum of the number of patients listed in each category, as an individual patient may have experienced more than one complication or observation.
  • Page 30 22 Lumax Technical Manual Table 3: Summary of Complications – Tupos LV/ATx Number Complications % of Number of Category per patient- Patients Complications Patients year Device Related Infection 2.26% 0.07 Device migration 3.01% 0.04 Elective replacement 3.01% 0.04 indicator reached Inductions and 0.75% 0.01...
  • Page 31 Lumax Technical Manual 23 For the Tupos LV/ATx study group, there were 210 observations in 104 patients with cumulative implant duration of 1240.4 months (101.9 patient years). 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year was 2.06.
  • Page 32 24 Lumax Technical Manual Table 4: Summary of Observations – Tupos LV/ATx Number % of per patient- Category Number Patients year Patients Device Related Infection 0.75% 0.01 Inductions and 4.51% 0.06 conversions Inappropriate sensing 15.04% 0.20 Symptomatic with 1.50% 0.02 biventricular pacing Total 18.80%...
  • Page 33 Lumax Technical Manual 25 There have been 4 patient deaths reported for the control group (out of 67 total control patients) and 10 patient deaths have been reported for the study group (out of 133 total study patients). None of the deaths were related to the implanted CRT-D system. One patient in the control group died prior to receiving a biventricular device implant.
  • Page 34 26 Lumax Technical Manual Control Study Log Rank = 0.795 Survival Time (months) Figure 1: Kaplan-Meier Survival Curves Table 6 Survival Table Study Group Control Group (n = 133) (n = 66) Number Number Enrollment 100.00% 100.00% 3-month 98.50% 94.03% 6-month 95.49% 94.03%...

  • Page 35: Clinical Studies

    Lumax Technical Manual 27 1.6 Clinical Studies The Kronos LV-T Clinical study (HOME-CARE, Section 1.6.1) supports the safety of the Lumax CRT-D/ICD device family. Additionally, because the Tupos LV/ATx and the Lumax CRT-D devices have identical CRT and ventricular ICD therapy, the effectiveness results from the OPTION CRT/ATx IDE Clinical study (Tupos LV/ATx, Section...
  • Page 36 28 Lumax Technical Manual Exclusion Criteria To support the objectives of this investigation, the exclusion criteria at the time of patient enrollment included the following: • Permanent atrial fibrillation • Myocardial infarction or unstable angina pectoris within the last 3 prior to enrollment •...

  • Page 37: Tupos Lv/Atx Study

    Lumax Technical Manual 29 Primary Endpoint The safety of the Kronos LV-T was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Kronos LV-T, the right atrial lead, the right ventricular ICD lead, and the left ventricular lead.
  • Page 38 Tupos LV/ATx Cardiac Resynchronization Therapy Defibrillator (CRT-D) in patients with congestive heart failure (CHF) and atrial tachyarrhythmias. Patients in the study group were implanted with a BIOTRONIK Tupos LV/ATx. Patients in the control group were implanted with any legally marketed CRT-D.
  • Page 39 Lumax Technical Manual 31 • For patients with an existing ICD/CRT-D, optimal and stable CHF drug regimen including ACE-inhibitors and beta-blockers unless contraindicated (stable is defined as changes in dosages less than 50% during the last 30 days) • Indicated for ICD therapy •...
  • Page 40 32 Lumax Technical Manual • Acute myocardial infarction, unstable angina or cardiac revascularization within the last 30 days prior to enrollment • Conditions that prohibit placement of any of the lead systems 1.6.2.3 Summary of Clinical Results A total of 200 patients were enrolled in the OPTION CRT/ATx clinical study at 25 sites: There were 133 study patients and 67 active control patients in this prospective, multi-center, randomized clinical study.
  • Page 41 Lumax Technical Manual 33 Enrolled and Randomized Patients Study Control No implant Attempted Withdrawal of Consent Study Control Not Meeting Inclusion Criteria Study Control Implant Attempted Study Control Unsuccessful implant Withdrawal of IC before 2nd Attempt Study Control Expired before Second Attempt Study Control Successful implant...
  • Page 42 34 Lumax Technical Manual • For the study group, there have been 278 adverse events (210 observations in 104 patients and 68 complications in 50 patients). There has been one unanticipated adverse device effect reported. • For the control group, there have been 105 adverse events (81 observations in 44 patients complications in 19 patients).
  • Page 43 Lumax Technical Manual 35 Table 7: Composite of Six Minute Walk Test and QOL (Effectiveness) Study Control Group Group Category P-value* (N = 74) (N = 38) Mean ± SE Mean ± SE Distance Walked at 310.51 ± 288.76 ± 0.249 Baseline 10.89...
  • Page 44 36 Lumax Technical Manual 1.6.2.5 Effectiveness Endpoint Analysis and Conclusions A composite rate of six minute walk test and QOL improvement from Baseline to the Six-Month follow-up is evaluated as a measure of CRT effectiveness. For this analysis both six minute walk test and QOL are equally weighted at 50%.
  • Page 45 Lumax Technical Manual 37 Table 8: Complications at 6-Month – Study and Control Study versus Control Study Control Comparison Category N = 133 N = 67 Delta 95% CI P-value Procedure 6 (4.51%) 3.02 [-3.64%, 0.428 Related (1.49%) 8.45%] Atrial Lead 3 (2.26%) 0.76 [-5.74%,...
  • Page 46 38 Lumax Technical Manual 1.6.2.8 Post-hoc Safety Analysis BIOTRONIK did not meet the pre-specified objective performance criteria of 85% within 10% for the safety endpoint. Therefore, a post-hoc safety analysis was conducted. It was noted that 79.80% (39 out of 49 events) of the complications were right atrial lead, right ventricular ICD lead, left ventricular lead and procedure related.
  • Page 47 CRT-D clinical studies: Table 10 Safety Endpoint Comparisons Estimated freedom from Lower 95% lower CRT-D Study Complications bound @ 6mos. criteria BIOTRONIK OPTION 70.68% 63.5% (Original Analysis) BIOTRONIK OPTION 78.95% 72.29% (Post-hoc Analysis) Medtronic Insync ICD 81.1% 77.6% Guidant Contak CD St.
  • Page 48 AT (atrial tachycardia) and AF (atrial fibrillation). The results from the OPTION study were compared to the results from BIOTRONIK’s TACT study (P000009/S4, dated 09-09-2002) that demonstrated the effectiveness of these atrial therapy features in the Tachos DR - Atrial Tx ICD.
  • Page 49 Lumax Technical Manual 41 2. The purpose of Secondary Endpoint 2 is to evaluate VT (ventricular tachycardia) and VF (ventricular fibrillation) detection times of the Tupos LV/ATx. This is a measure of the ability of the ventricular detection algorithm to detect VT and VF in an appropriate timeframe.
  • Page 50 42 Lumax Technical Manual Table 13: Percentage of Ventricular Pacing – 3-Month and 6-Month Follow-ups Percentage of 3-Months 6-Months Patients Ventricular Patients (percentage) Pacing (percentage) <80% 9 (7.4%) 4 (4.0%) 81 – 85 % 4 (3.3%) 2 (2.0%) 86 – 90 % 13 (10.7%) 9 (9.1%) 91 –...
  • Page 51 Lumax Technical Manual 43 Table 14: Six Minute Walk Distance Distance Study Control (meters) Baseline Mean ± SE 283.14 ± 9.27 269.43 ± 13.77 Range 23 to 511 29 to 507 Median 302.00 244.00 Six-Month Mean ± SE 329.73 ± 10.82 310.70 ±...
  • Page 52 44 Lumax Technical Manual The study and the control group have similar NYHA classes and similar rates of improvement in NYHA class from Baseline to the Six-Month follow-up. 6. The purpose of Secondary Endpoint 6 is to evaluate the rate of hospitalization, for CHF and for all other causes.
  • Page 53 Lumax Technical Manual 45 Table 16: Hospitalization, ER Visits and Outpatient Visits Study Control Medical Visits (N=128) (N=65) Hospital CHF Related: CHF Related: Admissions Patients 20 (15.6%) 5 (7.7%) Hospitalizations All causes: All causes: Patients 68 (53.1%) 29 (44.6%) Hospitalizations Emergency Room Visits CHF Related:...
  • Page 54 46 Lumax Technical Manual 7. The purpose of Secondary Endpoint 7 is to evaluate the observation rate. Observations are defined as clinical events that do not require additional invasive intervention to resolve. For the study group, there were 210 observations in 104 patients with cumulative implant duration of 1240.4 months (101.9 patient years).
  • Page 55 The OPTION CRT/ATx clinical report includes data from multiple centers with centralized coordination, data processing, and reporting at BIOTRONIK. All of the clinical centers followed the requirements of an identical clinical protocol, and all of the clinical centers used the same methods to collect and report the clinical data.

  • Page 56: Patient Selection And Treatment

    BIOTRONIK representative 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. It is strongly recommended that candidates for an ICD/CRT-D have a complete cardiac evaluation including EP...

  • Page 57: Specific Patient Populations

    Lumax Technical Manual 49 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 58: Patient Counseling Information

    (For additional copies of the patient manual, contact the BIOTRONIK at the address listed in this manual.) 1.9 Evaluating Prospective CRT-D/ICD Patients The prospective ICD/CRT-D implant candidate should undergo a cardiac evaluation to classify any and all tachyarrhythmias.
  • Page 59 Some changes may necessitate a re-assessment of sensing, pacing, or arrhythmia conversion treatment. Thorough technical knowledge of BIOTRONIK CRT-D/ICDs, additional CRT-D/ICD experience, and individual medical judgment will aid in determining the need for additional testing and follow-up.
  • Page 60 52 Lumax Technical Manual...

  • Page 61: Cardiac Resynchronization Therapy (Crt)

    Lumax Technical Manual 53 2. Device Features The Lumax 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 Lumax family except where specifically referenced differently.
  • Page 62 54 Lumax Technical Manual As a result of the device design and header configuration, ventricular pacing pulses can be delivered between the right / left ventricular lead tip electrodes simultaneously (cathode) and the ring of the right ventricular lead (anode). Ventricular sensing primarily uses the poles of the right ventricular lead tip and ring.
  • Page 63 Lumax Technical Manual 55 Table 18. Lead Configurations Configuration Explanation Sensing Sensing takes place between RV Only the tip and ring electrodes of the right ventricular lead. LV Only Sensing takes place between the tip and ring electrodes (bipolar) or the tip electrode of the left ventricular lead and the CRT-D housing (unipolar).

  • Page 64: Sensing (Automatic Sensitivity Control)

    56 Lumax Technical Manual For CRT to be effective, ventricular pacing must occur. Therefore, AV delays must be programmed short enough to override intrinsic ventricular contractions. Additional information further optimize delays obtained with echocardiography. CRT can be programmed ON or OFF via the programmer using the [Ventricular Pacing] parameter.

  • Page 65: Right Ventricular Sensitivity Settings

    Lumax Technical Manual 57 2.2.1 Right Ventricular Sensitivity Settings There are three programmable preset options for setting the sensitivity of the right ventricular input stage. The sensitivity selections are designed to adapt the parameters of the input stage to various signal conditions. The predefined parameter sets are described in Table...
  • Page 66 58 Lumax Technical Manual For example, the upper threshold is set at 50% of the measured R-wave for the Standard sensitivity setting following the 100 ms sensed refractory period. The upper threshold decays 0.125 mV every 250 ms through the T-wave discrimination period (hold of upper threshold: 360 ms).

  • Page 67: Minimum Right Ventricular Threshold

    Lumax Technical Manual 59 • The T-wave discrimination period (hold of upper threshold) is decreased to 100 ms, thus eliminating the Upper Threshold. • The decay rate of the Lower Threshold is increased to 0.125 mV every 250 ms. These adjustments ensure that the threshold reaches the lower values more quickly in order to assure that all VF signals are sensed appropriately.

  • Page 68: Minimum Atrial Threshold

    60 Lumax Technical Manual Table 20: Atrial Sensitivity Settings Setting Definition for Use Standard This setting is recommended for all patients with a functioning atrial lead. Inactive This setting deactivates the atrial channel for sensing, EGM telemetry and Holter recording and is typically used when no atrial lead is implanted.

  • Page 69: Minimum Left Ventricular Threshold

    Lumax Technical Manual 61 Table 21: Atrial Sensitivity Settings Setting Definition for Use Standard This setting is recommended for all patients with a functioning left ventricular lead. Inactive This setting deactivates the left ventricular channel for sensing, EGM telemetry and Holter recording and is typically used when no LV lead is implanted.

  • Page 70: Additional Sensing Parameters

    62 Lumax Technical Manual 2.2.8 Additional Sensing Parameters The parameters of the Additional Sensing Parameters menu are to provide additional flexibility for physicians to non-invasively correct over/undersensing situations. The ranges and nominal values are located in table titled Additional Sensing Parameters in Section Upper Threshold (A, RV &...

  • Page 71: Automatic Threshold Measurement (Atm)

    This information is available on the programmer during in-office follow-ups and via BIOTRONIK’s Home Monitoring system. The permanent pacing amplitude is not adjusted by the ATM feature. 2.3.1 Functional Description The ATM features of Lumax 500/540 are based on the evaluation of the morphology of the ventricular evoked response (VER) to determine if the pacing pulse has captured the myocardium.
  • Page 72 64 Lumax Technical Manual The signal quality check determines if the morphology of the evoked response of a captured beat is sufficiently different from the morphology of the evoked response of a non-captured pace. If the SQC is sufficient (i.e., if the algorithm can clearly distinguish between capture and non-capture), then the automatic threshold measurement is activated by initiating a series of pacing pulses.

  • Page 73: Intra-Thoracic Impedance Measurement

    Lumax Technical Manual 65 2.3.1.2.1 Loss of Capture Detection In order to ensure against ATM loss of capture detection due to an isolated non-capture event (i.e. as a result of VES), loss of capture is only declared if two out of three consecutive cycles show loss of capture.

  • Page 74: Ventricular Tachyarrhythmia Detection

    66 Lumax Technical Manual 2.5 Ventricular Tachyarrhythmia Detection The Lumax ICDs/CRT-Ds detect and measure the rate of sensed cardiac signals to discriminate ventricular tachyarrhythmias from supraventricular tachycardias, sinus rhythm or sinus bradycardia. This is accomplished through programmable rate detection parameters in the device. When a tachyarrhythmia is present, the ICD/CRT-D classifies the arrhythmia and delivers the appropriate therapy.

  • Page 75: Vf Classifications

    Lumax Technical Manual 67 2.5.1 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 76: Smart Detection

    68 Lumax Technical Manual The ICDs/CRT-Ds 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 Lumax ICDs/CRT-Ds use atrial and ventricular signals for discrimination of fast heart rhythms. With SMART Detection™...

  • Page 77: Onset

    Lumax Technical Manual 69 If the ventricular signal is stable, and the atrial rate is a multiple of the ventricle rate, then the rhythm is declared a supraventricular tachyarrhythmia (SVT) and ventricular therapy is typically withheld. 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.

  • Page 78: Sustained Vt Timer

    70 Lumax Technical Manual The SMART Detection™ algorithm utilizes both atrial and ventricular STABILITY as integral parts of the discrimination algorithm. Therefore, when SMART Detection™ is enabled, the STABILITY parameter must also remain enabled and set to 12%. 2.5.7 Sustained VT Timer The Sustained VT Timer can be programmed between 30 seconds and 30 minutes (or to OFF).

  • Page 79: Atrial Monitoring Zone

    Lumax Technical Manual 71 2.5.9 Atrial Monitoring Zone This feature allows the device to store an IEGM for atrial tachyarrhythmias such as Atrial Fibrillation or Atrial Flutter. The zone is programmed by rate with a range of 100 bpm to 250 bpm. Any atrial tachyarrhythmia meeting the Atrial Arrhythmia Monitor Zone criteria will store an IEGM.

  • Page 80: Smart Redetection

    72 Lumax Technical Manual 2.6.2 SMART Redetection DR and HF versions only With SMART Redetection programmed ON, both atrial and ventricular signals are used for redetection after initial detection and therapy for a VT. SMART Detection™ will function identically as in initial VT detection. 2.6.3 Forced Termination DR and HF versions only With SMART Redetection programmed ON, this programmed...

  • Page 81: Therapy Options

    Lumax Technical Manual 73 2.8.1 Therapy Options The Lumax ICDs/CRT-Ds offer multiple therapy options for each tachyarrhythmia class (VT1, VT2, VF). Therapy options (up to 10 ATP sequences and 8 shocks) are available for the VT1 and VT2 zones, whereas ATP One Shot and up to 8 shock therapies are available for the VF class.
  • Page 82 74 Lumax Technical Manual Number S1 - This parameter defines the number of stimuli for an ATP. For Burst + PES, a single extra stimulus with a separate parameter setting is coupled. Add S1 - This feature can be programmed with any Burst, Ramp, or Burst + PES scheme.
  • Page 83 Lumax Technical Manual 75 2.8.2.2 ATP 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 84: Shock Therapy

    76 Lumax Technical Manual 2.8.2.4 ATP One Shot ATP One Shot offers the opportunity to treat fast VTs that are detected in the VF zone with a single ATP sequence delivered immediately before charging of the high energy capacitors. The device performs a stability check (same as VT zones, criterion 12% fixed) to determine if the arrhythmia might be a fast VT and if the rhythm is stable, the programmed ATP sequence is delivered...
  • Page 85 Lumax Technical Manual 77 2.8.3.1 Confirmation The Confirmation parameter is used to verify the presence of a tachyarrhythmia during charging of the shock capacitors. This function is designed to avoid delivery of shock therapy if a tachyarrhythmia spontaneously terminated. programmed shock will be delivered unless bradycardia or a normal sinus rhythm is detected during the Confirmation period.
  • Page 86 Figure 5 provides a pictorial representation of both biphasic waveforms. 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 87 Lumax Technical Manual 79 Actual energy delivered for each programmable shock energy is approximately equal to the “Energy Delivered” for the high energy Lumax 340/540 variants in Table 22, and for the Lumax 300/500 in Table 23. Table 22 Delivered Shock Energy (340/540 Variants) Programmed Energy Approximate Delivered (joules)
  • Page 88 80 Lumax Technical Manual Table 23 Delivered Shock Energy (300/500 Variants) Programmed Energy Approximate Delivered (joules) Energy (joules) 10.6 11.4 12.3 13.1 14.2 16.0 17.7 19.5 21.4 23.2 24.9 27.0...
  • Page 89 Lumax Technical Manual 81 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 measured shock impedance as less than twenty-five ohms.

  • Page 90: Progressive Course Of Therapy

    82 Lumax Technical Manual 2.8.3.6 Third Programmable Shock Pathway Lumax 500/540 Models only The Lumax 500/540 models offer three programmable shock delivery configurations. The defibrillation shock pathways include a “non-active housing” shock path and a shock paths between the ICD/CRT-D housing and either or both shock coils when connected to a dual coil shock lead.

  • Page 91: Bradycardia Therapy

    Lumax Technical Manual 83 Furthermore, the ICD/CRT-D prevents therapies of different arrhythmia classes from permanently retarding or accelerating a VT in such a way that the cardiac rhythm fluctuates between the different arrhythmia classes without achieving termination of the arrhythmia regardless of the Progressive Course of Therapy setting.

  • Page 92: Basic Rate

    84 Lumax Technical Manual Table 25 Lumax Pacing Modes Mode Lumax HF Lumax DR Lumax VR DDDR DDIR VDDR VDIR AAIR VVIR The basic rate timer is started by a sensed or paced event. A sensed event outside of the refractory period inhibits pacing and resets the lower rate time;...

  • Page 93: Night Rate

    Lumax Technical Manual 85 2.9.3 Night Rate The night rate is the effective basic rate during the programmed “sleep” period for the patient. This parameter provides a different pacing rate during the patient’s normal sleep time in an attempt to match for example the decreased metabolic needs during sleep.
  • Page 94 86 Lumax Technical Manual If Hysteresis is used in the DDI mode, the AV delay must be programmed shorter than the spontaneous AV conduction time. Otherwise, stimulation in the absence of spontaneous activity occurs at the hysteresis rate instead of the lower rate. Night Rate is the limit for the Hysteresis when Night Mode is active.
  • Page 95 Lumax Technical Manual 87 Figure 6. Repetitive Hysteresis Repetitive hysteresis been incorporated promote spontaneous cardiac rhythm and may reduce pulse generator energy consumption. Repetitive and Scan Hysteresis are only available when Hysteresis is selected on. There is one Standard Hysteresis interval which occurs before the programmable number of Repetitive Hysteresis.

  • Page 96: Dynamic Av Delay

    88 Lumax Technical Manual If an intrinsic cardiac rhythm is detected within the programmed number of beats between the hysteresis rate and the lower rate, the intrinsic rhythm is allowed and the pulse generator inhibits. Figure 7. Scan Hysteresis Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce pulse generator energy consumption.
  • Page 97 Lumax Technical Manual 89 In addition to selecting the preset values (Low, Medium, and High) with the Dynamic AV Delay window, the Dynamic AV Delays may be programmed individually (Individual) for each rate zone or to a fixed AV Delay (Fixed). The AV Delay feature includes an AV Delay shortening option (Sense Compensation) for dual chamber pacing modes.
  • Page 98 90 Lumax Technical Manual 2.9.5.3 AV Scan Hysteresis With AV Scan Hysteresis enabled, after 180 consecutive pacing cycles, the AV delay is extended for the programmed number of pacing cycles. (OFF, 1 … 10). If an intrinsic rhythm is detected within the extended AV delay and the longer AV delay remains in effect.

  • Page 99: Iopt

    Lumax Technical Manual 91 2.9.6 IOPT DR versions only The IOPT function serves to support the patient’s intrinsic rhythm and avoid excessive ventricular pacing. This feature simply activates all of the AV hysteresis parameters with a single selection. Table 26 details the settings that are preset when IOPT is turned ON: Table 26 IOPT Parameters Parameter...
  • Page 100 92 Lumax Technical Manual If the UTR is less than the maximum sensed atrial rate, defined by the atrial refractory period (60,000/ARP), the WKB response is utilized. Atrial rates exceeding the selected upper rate will result in a Wenckebach-type pacing pattern. This is accomplished by progressively lengthening the AV delay to keep the ventricular pacing rate at the upper rate.

  • Page 101: Mode Switching

    Lumax Technical Manual 93 2.9.8 Mode Switching DR and HF versions only Mode switching is designed to avoid tracking of atrial arrhythmias. In the presence of a high atrial rate, the bradycardia pacing mode is automatically reprogrammed to a non-atrial tracking mode. The modes available during mode switching are as shown in Table 27.

  • Page 102: Pmt Management

    94 Lumax Technical Manual In addition, the ventricular pacing configuration (RV or BiV) and biventricular pacing parameters (LV T-wave protection and Triggering) are programmable separately for mode switching events. 2.9.8.1 Mode Switch Basic Rate Whenever Mode Switching occurs, the device switches to a non- tracking mode and will provide bradycardia pacing support at the Mode Switch Basic Rate, which is displayed as the Change of Basic Rate parameter.
  • Page 103 Lumax Technical Manual 95 • Upon detection of a ventricular extrasystole (VES), the lower rate interval and the atrial refractory period (ARP) are reset. Additionally, in VDD mode, the atrial refractory period is initiated with a ventricular pacing pulse that has not been triggered by atrial detection.
  • Page 104 96 Lumax Technical Manual 2.9.9.2 Termination PMT termination can be accomplished by the following mechanism: The programmable dynamic AV delay in combination with a fixed TARP (i.e. modulated PVARP) can act as a ‘passive’ termination of a PMT. Because a PMT is generally at higher rates, the AV delay will be relatively short.

  • Page 105: Ves Discrimination After Atrial Sensed Events

    Lumax Technical Manual 97 • 8 successive V pace-A sense (Vp-As) sequences have occurred with a length shorter than the VA criterion. This VA criterion is programmable between 250 and 500 ms. • The mean deviation of these 8 Vp-As intervals is less than the Stability criterion parameter, defined as less than 25 ms.

  • Page 106: Rate Adaptive Pacing

    98 Lumax Technical Manual 2.9.11 Rate Adaptive Pacing ARNING Rate-Adaptive Pacing – Use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates. Lumax ICD/CRT-D allows the selection of rate-responsive pacing modes. These modes allow the ICD/CRT-D’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/CRT-D.

  • Page 107: Pulse Amplitude

    Lumax Technical Manual 99 2.9.11.3 Maximum Sensor Rate Regardless of the sensor output, the sensor-driven pacing rate never exceeds the programmable Max. Sensor Rate. maximum sensor rate only limits the pacing rate during sensor- driven pacing. 2.9.11.4 Auto Sensor Gain The Lumax ICDs/CRT-Ds offer Automatic Sensor Gain Auto Gain settings, which allows the Auto Gain parameter to be adjusted automatically.

  • Page 108: Post Ventricular Atrial Refractory Period

    100 Lumax Technical Manual 2.9.14 Post Ventricular Atrial Refractory Period DR and HF versions only Immediately following each paced ventricular event, an atrial refractory period is started; this period is called Post Ventricular Atrial Refractory Period or PVARP. Atrial signals are ignored during this time for bradycardia timing purposes to prevent the ICD/CRT-D from sensing inappropriate signals.

  • Page 109: Post Shock Pacing

    Lumax Technical Manual 101 2.9.18 Post Shock Pacing Separately programmable bradycardia pacing support is available with the ICD/CRT-D 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/CRT-D will begin in standard program DDI bradycardia therapy at the post shock pacing rate, amplitude (fixed to 7.5 V for RV and as permanent programmed for LV) , and pulse width...

  • Page 110: Pacing Impedance Measurements

    102 Lumax Technical Manual 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 111: Shock Impedance Measurements

    Lumax Technical Manual 103 2.10.3 Shock Impedance Measurements The Lumax ICDs/CRT-Ds have the ability to perform automatic and manual painless shock impedance measurements. devices can measure the shock impedance by delivering an undetectable 3 nJ shock by applying 1 ma of current. The device then measures the resulting voltage drop and calculates the resulting shock impedance.

  • Page 112: Pacing Threshold

    104 Lumax Technical Manual 2.10.5 Pacing Threshold The test is activated as a temporary program with specific operation. 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), upper rate, pulse amplitude and pulse width, and number of pulses for each test voltage.

  • Page 113: Manual Shock

    Lumax Technical Manual 105 Burst + PES Induction delivers a programmed number of pacing stimuli followed by a programmable number (Number S1) of timed extra stimuli. The burst rate (intervals) is independently programmable, as is the chamber being stimulated (RV, LV or BiV).

  • Page 114: Manual Atp

    106 Lumax 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/CRT-D system, it is necessary to induce and convert the patient’s ventricular tachyarrhythmias.

  • Page 115: Special Features

    Lumax Technical Manual 107 2.11 Special Features The Lumax includes several special features to improve ease of use and provide additional information to the user. 2.11.1 ICD Therapy Status Interrogate the device to observe the ICD Therapy window (upper right hand corner) of the main programming screen which indicates the ICD Therapy status (either ON or OFF).
  • Page 116 The patient device is rechargeable, allowing for an approximate operational time of approximately 24 hours. receives information from the implant and forwards it via telephone networks (cellular or traditional) to the BIOTRONIK Service Center.
  • Page 117 Figure 10: Example of CardioMessenger II with Charging Stand 2.11.2.3 Cardio Report The implant’s information is digitally formatted by the BIOTRONIK Service Center and processed into a concise report called a Cardio Report. The Cardio Report is available in two formats; via fax or via BIOTRONIK’s secure Internet connection.
  • Page 118 110 Lumax Technical Manual 2.11.2.4 Types of Report Transmissions When the Home Monitoring function is activated, the transmission of information from the implant can be triggered as follows: • Daily report – the time period (daily) initiates the transmission (IEGM included if not yet sent) •...
  • Page 119 Lumax Technical Manual 111 • Impedance out-of-range for A, RV, LV, shock lead (painless) • Special Device Status • First ineffective 30 J shock detected • Initial detection SVT • Percent of ventricular sensing below set limit • Device status – ERI/EOS/ROM-Mode Programmer Triggered Report With the device status screen, it is possible to test the ICD/CRT-D’s...
  • Page 120 112 Lumax Technical Manual • Device Status − Master-switch (e.g., ICD Therapy ON or OFF) − Standard error flags • Current Consumption for ERI calculation (done by the Service Center) • Date and time of Last Follow-up and Program Counter •...
  • Page 121 Lumax Technical Manual 113 − Atrial Paced Rhythm (ApVs) − Complete Paced Rhythm (ApVp) The above parameters are transmitted as 3 byte counter. Pacing Counters (CRT) • LV-RV-Sequences − BiVp (RVp-LVp or LVp-RVp − RVs-LVp − RVp-noLVp, RVs-noLVp (LV T-wave protection ON) −...
  • Page 122 114 Lumax Technical Manual − Started + successful ATP-one-Shot in VF − Started + cancelled + successful Shocks − Shock Path − Ineffective maximum energy shocks • Date, Time and Number of last Episode (number as in episode listing in Holter) •...
  • Page 123 Lumax Technical Manual 115 • HM Settings - (e.g., ON/OFF, transmission time (daily), IEGM transmissions ON/OFF, periodic IEGM, ongoing atrial episode, statistics, holter) System Information Information is also added by the CardioMessenger II to the message from the implant. This information contains the following data: •...
  • Page 124 116 Lumax Technical Manual • For the periodic IEGM only a pre-detection-part is available, recording of this episode is performed right before a periodic message, as often as configured. The Lumax ICD/CRT-D transmits the following data from the Episode List with the IEGM message: •...

  • Page 125: Real-Time Iegm Transmission

    Lumax Technical Manual 117 2.11.3 Real-time IEGM Transmission The pulse generators provide real time transmission of the unfiltered intracardiac electrogram (IEGM) to the programmer. IEGMs from the atrium and ventricles can be simultaneously recorded with a bandwidth of 0.5 to 200 Hz. Depending on the device, the following channels are simultaneously recorded: •...

  • Page 126: Capacitor Reforming

    118 Lumax Technical Manual 2.11.4 Capacitor Reforming Shock charge times may be prolonged if the high voltage capacitors remain uncharged for an extended period of time. Conditioning (or reforming) the capacitors by periodically charging them will help assure shorter charge times for those patients that do not regularly receive shock therapy.

  • Page 127: System Status

    Lumax Technical Manual 119 2.11.6 System Status Various device parameters can be monitored through the Status section of the programmer screen. Displayed data includes ICD/CRT-D 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 Lumax ICDs/CRT-Ds including: •...
  • Page 128 120 Lumax Technical Manual The sensor indicated pacing rate is the sensor rate above sensor’s threshold. The cumulative daily time when the sensor is active is stored in the device for a period of 240 days. After 240 days, new daily values replace the oldest daily values. 2.11.7.2 Mean Heart Rate The mean heart rate is calculated based on both ventricular sensed and paced events.

  • Page 129: Holter Memory

    Lumax Technical Manual 121 2.11.8 Holter Memory Various device information is available within the Holter memory. The Holter memory can be configured a number of different ways depending on the physician’s preference. 2.11.8.1 Episode List The ICD/CRT-D stores a variety of useful diagnostic data about tachyarrhythmia episodes, which may be used to optimize tachyarrhythmia detection and therapy parameters.

  • Page 130: Timing Statistics

    2 Lumax Technical Manual • Time • Impedance • Energy • Type of shock/Remark • • Charge time Shock Pathway 2.11.8.3 Counters The device history regarding several therapy and detection parameters is presented in the “Counters” screen. For detection and SVT details, this screen contains both the number of events since the last ICD/CRT-D follow-up and totals since the device was implanted.
  • Page 131 2 Lumax Technical Manual 2.11.9.1 Event Counters The total percentages of atrial sensed (PVARP and atrial refractory period), atrial paced, right ventricular sense (VES and refractory period) and ventricular paced events since the statistics package was initiated are available. The total percentage of time for each of the above listed events is also available.

  • Page 132: Atrial Arrhythmias

    Lumax Technical Manual 3 2.11.9.4 Rate Histogram The rate histogram shows the percentage of time the rate lies within given heart rate bins regardless if the sensor is used or not. The heart rate range is divided into sixteen segments ranging from less than 40 to greater than 380 ppm.

  • Page 133: Impedances

    4 Lumax Technical Manual 2.11.14 Impedances The activity report provides trend information on atrial and right ventricular pacing impedance as well as shock impedance measurements. 2.11.15 Automatic Threshold The activity report provides trend information on right and left ventricular pacing thresholds, if active.
  • Page 134 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 135 6 Lumax Technical Manual...

  • Page 136: Implant Preparation

    Lumax Technical Manual 7 4. Implant Procedure 4.1 Implant Preparation Prior to beginning the ICD/CRT-D implant procedure; ensure that all necessary equipment is available. The implant procedure requires the selected lead system (including sterile back-ups), the programmer with appropriate software, and the necessary cabling and accessories.
  • Page 137 8 Lumax Technical Manual Sufficient training on the device and its associated components is required prior to implanting the ICD/CRT-D. For additional information, training training materials contact your BIOTRONIK representative.
  • Page 138 Lumax Technical Manual 9 ARNING ICD Lead Systems - BIOTRONIK ICDs/CRT-Ds maybe implanted with any legally marketed, compatible ICD lead. Compatibility is defined as: • IS-1 pacing and sensing connector(s) • DF-1 shock coil connector(s) • Integrated or dedicated bipolar pacing and sensing configuration •...
  • Page 139 10 Lumax Technical Manual ARNING Left Ventricular Lead Systems – BIOTRONIK CRT-Ds maybe implanted with any legally marketed, compatible LV lead. Compatibility is defined as: • IS-1 pacing connector • Active or passive fixation technology • Insertion and withdrawal forces as specified by...
  • Page 140 Connector Compatibility - ICD/CRT-D and 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/CRT-D system. For further...

  • Page 141: Opening The Sterile Container

    12 Lumax Technical Manual 4.2 Lead System Evaluation ICD/CRT-D mechanically compatible with DF-1 defibrillation lead connectors and IS-1 sensing and pacing lead connectors. IS-1, wherever stated in this manual, refers to the international standard, whereby leads and pulse generators from different manufacturers are assured a basic fit [Reference ISO 5841-3:1992].

  • Page 142: 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 dependent on...
  • Page 143 14 Lumax Technical Manual Figure 11. Header Ports...
  • Page 144 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 145: Blind Plug Connection

    16 Lumax 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 146: Program The Icd/Crt-D

    Lumax Technical Manual 17 4. Securely tighten the setscrew of the connector clockwise with the torque wrench until torque transmission is limited by the wrench. 5. After carefully retracting torque wrench, perforation will self-seal. AUTION Blind Plug - A blind plug must be inserted and firmly connected into any unused header port to prevent chronic fluid influx and possible shunting of high energy therapy.

  • Page 147: Implant The Icd/Crt-D

    Programmers only BIOTRONIK’s ICS 3000 programmer to communicate with the device. Defibrillation Threshold - Be aware that the changes in the patient’s condition, drug regimen, and other factors may...
  • Page 148 Lumax Technical Manual 19 AUTION Connector Compatibility - ICD/CRT-D and 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/CRT-D system. For further information, please refer to Appendix Shock Impedance –...
  • Page 149 20 Lumax Technical Manual AUTION Pacing Threshold - Testing of the pacing threshold by the ICD/CRT-D system should be performed with the pacing rate programmed to a value higher than the patient's intrinsic rate. Defibrillation Threshold - Be aware that the changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT) which may result in non-conversion...
  • Page 150 "Shipment Mode Active" in the event list • The Shipment Mode is OFF if the device does not display "Shipment Mode Active" in the event list Complete the Medical Device Registration Form provided with the ICD/CRT-D and return it to BIOTRONIK.
  • Page 151 22 Lumax Technical Manual...

  • Page 152: General Considerations

    Lumax Technical Manual 23 5. Follow-up Procedures 5.1 General Considerations An ICD/CRT-D follow-up serves to verify appropriate function of the ICD/CRT-D system, and to optimize the programmable parameter settings. In addition to evaluating the patient’s stored therapy history and electrograms, acute testing sensing...

  • Page 153: Longevity

    24 Lumax Technical Manual 5.2 Longevity The service time of an ICD/CRT-D 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 154: Lumax 300/340 Devices

    Lumax Technical Manual 25 5.2.1 Lumax 300/340 Devices dual-chamber Lumax variants (Lumax 300 DR, Lumax 340 DR, Lumax 300 DR-T, and Lumax 340 DR-T) of ICDs are intended to operate for more than 5 years under normal use. Table 28 provides longevity estimates for the Lumax 340 DR-T ICD (order number 355267), which is has the worst case longevity estimates of the devices listed above..

  • Page 155: Lumax 500/540 Devices

    26 Lumax Technical Manual Table 29 Lumax 300 HF-T Longevity Estimates Shocks per year 100% Pacing Support (in years) Table 30 Lumax 340 HF-T Longevity Estimates Shocks per year 100% Pacing Support (in years) The Lumax 300/340 HF CRT-Ds (Lumax 300 HF-T, Lumax 340 HF-T) are intended to operate for more than 5 years under normal use.
  • Page 156 Lumax Technical Manual 27 Table 31 Lumax VR-T Longevity Estimates Pacing Support Device Shocks per 100% year 500 VR-T 540 VR-T The dual-chamber Lumax 500/540 variants (Lumax 500 DR-T, and Lumax 540 DR-T) of ICDs are intended to operate for more than 6 years under normal use.
  • Page 157 28 Lumax Technical Manual Table 33 Lumax 500/540 HF-T Longevity Estimates Pacing Support Device Shocks per 100% year 500 HF-T 540 HF-T Upon reaching ERI, the battery has enough energy left to continue monitoring for three months and to deliver six high energy shocks.

  • Page 158: Explantation

    Explanted ICDs/CRT-Ds, 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 159 30 Lumax Technical Manual 6. Technical Specifications following technical specifications Lumax ICDs/CRT-Ds. 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 Lumax Lumax Lumax Lumax 500 HF-T...
  • Page 160 Lumax Technical Manual 31 Parameter Range Standard Right-ventricular Sensing Parameters Sensing RV STD - standard, TWS - extended T-wave suppression, VFS - extended VF sensitivity Minimum threshold 0.5...(0.1)...2.5 mV 0.8 mV Blanking after atrial 50...(10)...100 ms 50 ms pacing Upper threshold 50;...
  • Page 161 32 Lumax Technical Manual Parameter Range Standard Shock Path (Valid for RV -> SVC + ICD (Housing) RV -> SVC + all shocks including the RV -> ICD (500/540 only) pain-free shock RV -> SVC (500/540 only) impedance) Pulse Amplitudes and Pulse Widths Pulse amplitude 0.2...(0.1)...6.2, 7.5 V 2.8 V...
  • Page 162 Lumax Technical Manual 33 Parameter Range Standard AV-hysteresis mode OFF, positive, negative AV hysteresis 10..(10)..150 ms [50 ms] AV repetitive OFF; 1..(1)..10 (positive) AV repetitive OFF; [180] (negative) 1..(1)..15..(5)..100..(10)..1 AV scan OFF, 1..(1)..10 I-Opt I-Opt OFF, ON AV hysteresis at I- 400 ms 400 ms AV repetitive at I-Opt OFF;...
  • Page 163 34 Lumax Technical Manual Parameter Range Standard Rate drop 0.25..(0.25)..1.25 ppm/cycle ppm/cycle Upper Tracking Rate (UTR) Upper tracking rate 90..(10)..160 ppm 130 ppm Upper tracking rate OFF, 240 ppm 240 ppm atrium Mode Switching Intervention rate OFF, 100..(10)..250 ppm 160 ppm Activation criterion X 3..(1)..8 Deactivation criterion...
  • Page 164 Lumax Technical Manual 35 Parameter Range Standard Onset Onset in VT1/2 with [20%] SMART Onset VT1 without OFF; 4…(4)…32% SMART Onset VT2 without OFF; 4…(4)…32% SMART Stability Stability in VT1/2 [12%] with SMART Stability VT1 without OFF; 8…(4)…48 ms 24 ms SMART Stability VT2 without OFF;...
  • Page 165 36 Lumax Technical Manual Parameter Range Standard Ventricular Therapy Parameters Energy 1st shock OFF; 1..(1)..16..(2)..30 J 30 J and 2nd shock VT1, VT2 (model 300/500) Energy 1st shock 1..(1)..16..(2)..30 J 30 J and 2nd shock VF (model 300/500) Energy 1st shock OFF;...
  • Page 166 Lumax Technical Manual 37 Parameter Range Standard S1-S2 interval 200...(10)...500 ms [70 %] (absolute); 70...(5)...95 % (adaptive) Minimal ATP interval 200...(5)...300 ms [200 ms] ATP timeout OFF, 00:15...(00:15)...05:00 mm:ss ATP optimization OFF, ON ATP pulse amplitude 7.5 V 7.5 V ATP pulse width 1.5 ms 1.5 ms...
  • Page 167 38 Lumax Technical Manual Parameter Range Standard Home Monitoring Home Monitoring OFF, ON Transmission time Time (hh:mm) [01:00 hh:mm] IEGM for therapy OFF, ON [OFF] episode IEGM for monitoring OFF, ON [OFF] episode Periodic IEGM OFF, 2, 3, 4, 6 months [OFF] Sustained atrial OFF, 0,5, 6, 12, 18 h...
  • Page 168 Lumax Technical Manual 39...
  • Page 169 Appendix A Connector Compatibility Lumax ICDs/CRT-Ds 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 170 Lumax Technical Manual 41...
  • Page 171 42 Lumax Technical Manual Appendix B – Known Anomalies Anomaly Possible Effect on Patient or Implant Procedure Lumax Application (Programmer Software) Farfield Blanking may be Limited potential effect on reduced after a Right patient, possibility to activate Ventricular refractory sense an inappropriate mode switch (RVrs) as compared to the is low.
  • Page 172 Lumax Technical Manual 43 Anomaly Possible Effect on Patient or Implant Procedure Lumax Application (Programmer Software) Graphic Holter data may be No effect on patient, missing omitted during data export if diagnostic information may graph files exceed 10,000 pixel cause user confusion rows.
  • Page 173 44 Lumax Technical Manual Anomaly Possible Effect on Patient or Implant Procedure Lumax Application (Programmer Software) SVT Detection Counters are Limited effect on patient, not incremented when SMART display of incorrect/missing is OFF and SVTs are detected, diagnostic data may cause still they are correctly recorded temporary user confusion in the Holter episodes.
  • Page 174 Lumax Technical Manual 45 Anomaly Possible Effect on Patient or Implant Procedure Lumax Application (Programmer Software) Dual Chamber devices only: Limited effect on patient, When programmed to DDDR temporary rate drop to mode and with sensor activity it programmed post-shock is possible for a sudden rate pacing rate ensures sufficient drop at start of a capacitor...
  • Page 176 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. KG Woermannkehre 1 12359 Berlin M4117-B 05/08 Germany...

This manual is also suitable for:

Lumax dr-t icd seriesLumax vr-t icd seriesLumax dr icd seriesLumax hf-t crt-d seriesLumax hf crt-d series

Table of Contents

Save PDF