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 1-1637
X-ray Identification Lumax Family Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillators Inside the housing: X-Ray identification Year of manufacture HR nn C AUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. ©2006 BIOTRONIK, Inc., all rights reserved.
Lumax Technical Manual i Contents 1. General ................................................................................. 6 1.1 System Description .......................................................... 6 1.2 Indications and Usage...................................................... 8 1.3 Contraindications.............................................................. 9 1.4 Warnings and Precautions ............................................... 9 1.4.1 Sterilization, Storage, and Handling ........
ii Lumax Technical Manual 2.2.7 Far Field Protection ................................................65 2.2.8 Additional Sensing Parameters ..............................66 2.3 Ventricular Tachyarrhythmia Detection...........................67 2.3.1 VF Classifications ...................................................68 2.3.2 VT Interval Counters...............................................69 2.3.3 VT Classification.....................................................69 2.3.4 SMART Detection™ ...........
Lumax Technical Manual iii 2.8 EP Test Functions...........................................................97 2.8.1 P and R-wave Amplitude Measurements ...............97 2.8.2 Pacing Impedance Measurements.........................98 2.8.3 Shock Impedance Measurements..........................98 2.8.4 Testing for Retrograde Conduction ........................98 2.8.5 Pacing Threshold....................................................99 2.8.6 Arrhythmia Induction Features .............................100 2.
iv Lumax Technical Manual 5.3 Explantation..................................................................136 6. Technical Specifications .................................................139 Appendix A .............................................................................
Lumax Technical Manual v Lumax Specifications and Description Battery Voltage: 3.2 Volts 300 models: 30 joules programmed Maximum Shock Energy: 26.6 joules delivered 340 models: 40 joules programmed Maximum Shock Energy: 35.7 joules Delivered Defibrillation Lead Ports Two DF-1 (3.2 mm) Pacing Lead Ports Three IS-1 (3.
6 Lumax Technical Manual 1. General 1.1 System Description The Lumax family of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) detect and treat ventricular tachyarrhythmias and provide rate adaptive bradycardia pacing support. The HF and HF-T versions of Lumax provide Cardiac Resynchronization Therapy (CRT) through biventricular pacing.
Lumax Technical Manual 7 • Lumax DR provides dual chamber rate adaptive bradycardia pacing support. The ICD uses atrial and ventricular sensing/pacing leads to provide enhanced atrial and ventricular tachyarrhythmia discrimination through BIOTRONIK’s SMART DetectionTM algorithm. • 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.
8 Lumax Technical Manual External devices that interact with and test the implantable devices are also part of the ICD/CRT-D System. These external devices include the ICS 3000 Programming and Tachyarrhythmia Monitoring System and the Implant Module System Analyzer for acute lead testing. This programmer is used to interrogate and program the ICD/CRT-D. 1.
Lumax Technical Manual 9 1.
10 Lumax Technical Manual • Guidant-Easytrak IS-1 • Guidant-Easytrak LV-1 • Guidant-Easytrak 2 • Guidant-Easytrak 3 • Medtronic-Attain • St. Jude-Aescula • St.
Lumax Technical Manual 11 • Single or dual defibrillation shock coil (s) • High energy shock accommodation of at least 30 joules • Insertion and withdrawal forces as specified by ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1 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 • St.
12 Lumax Technical Manual Unwanted Shocks – Always program Therapy status 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. Rate-Adaptive Pacing – Use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates. High Output Settings – High ventricular or biventricular pacing voltage settings may significantly reduce the life expectancy of the CRT-Ds.
Lumax Technical Manual 13 Capacitor Reformation - Infrequent charging of the high voltage capacitors may extend the charge times of the ICD/CRT-D. The capacitors are reformed automatically at least every 85 days and may be reformed manually. For further information, please refer to Section 2.9.4, Capacitor Reforming. Connector Compatibility – ICD/CRT-D and lead system compatibility should be confirmed prior to the implant procedure.
14 Lumax Technical Manual Manual Shocks – User-commanded shocks may be withheld if the ICD/CRT-D is already busy processing a manual command or the Battery Status is low. Charge Time - When preparing a high energy shock the charge circuit stops charging the capacitors after 20 seconds, and delivers the stored energy as shock therapy. After the device reaches ERI the stored energy may be less than the maximum programmable energy for each shock.
Lumax Technical Manual 15 Short Circuit - Ensure that none of the lead electrodes are in contact (a short circuit) during delivery of shock therapy as this may cause current to bypass the heart or cause damage to the ICD/CRT-D system. Far-field sensing of signals from the atrium in the ventricular channel or ventricular signals in the atrial channel should be avoided by appropriate lead placement, programming of pacing/sensing parameters, and maximum sensitivity settings.
16 Lumax Technical Manual 1.4.4 Follow-up Testing Defibrillation Threshold - Be aware that changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT), which may result in non-conversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively.
Lumax Technical Manual 17 The ICD/CRT-D system should have detection and therapy disabled 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.
18 Lumax Technical Manual MRI (Magnetic Resonance Imaging) - Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Radiation - High radiation sources such as cobalt 60 or gamma radiation should not be directed at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage and confirm its function after treatment.
Lumax Technical Manual 19 Patients having an implanted BIOTRONIK ICD/CRT-D who operate a cellular telephone should: • Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular telephone and the implanted device. • 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.
20 Lumax Technical Manual 1.4.10 Home Appliances Home appliances normally do not affect ICD/CRT-D operation if the appliances are in proper working condition and correctly grounded and shielded. There have been reports of the interaction of electric tools or other external devices (e.g. electric drills, older models of microwave ovens, electric razors, etc.) with ICDs/CRT-Ds when they are placed in close proximity to the device. 1.4.
Lumax Technical Manual 21 1.5 Potential and Observed Effects of the Device on Health 1.5.
22 Lumax Technical Manual In addition, patients implanted with the ICD/CRT-D system may have the following risks.
Lumax Technical Manual 23 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). Of the 31 adverse events reported, there have been 26 observations in 23 patients and 5 complications in 3 patients with a cumulative implant duration of 202 months (16.8 patientyears). 6.
24 Lumax Technical Manual Table 2: Summary of Observations – Kronos LV-T Category Unsuccessful LV lead implant Elevated LV pacing threshold Phrenic nerve stimulation Elevated DFT measurement T-wave oversensing Worsening CHF Elevated RV pacing threshold Hepatitis Arrhythmias Cardiac Decompensation Number of Patients %of Patients Number per patientyear 8 17.8% 8 0.48 5 11.1% 5 0.30 3 6.7% 3 0.18 2 4.4% 2 0.12 2 2 4.4% 4.4% 2 2 0.12 0.12 1 2.2% 1 0.06 1 1 2.2% 2.2% 1 1 0.06 0.
Lumax Technical Manual 25 1.5.2.2 Tupos LV/ATx Study N OTE : 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 the Lumax family are downsized versions of the Tupos LV/ATx CRT-D and Tachos ICD families.
26 Lumax Technical Manual Complications and observations for the Tupos LV/ATx study group are summarized in Table 3 and 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.
Lumax Technical Manual 27 Table 3: Summary of Complications – Tupos LV/ATx Category Infection Device migration Elective replacement indicator reached Inductions and conversions Unable to interrogate device Total Total Procedure and Device Related Number Complications % of Number of of per patientPatients Complications Patients year 3 4 Device Related 2.26% 3.01% 7 4 0.07 0.04 4 3.01% 4 0.04 1 0.75% 1 0.01 1 0.75% 1 0.01 12 9.02% 17 0.17 43 32.33% 58 0.
28 Lumax Technical Manual 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. Table 4 summarizes by category each type of observation for the study group.
Lumax Technical Manual 29 Table 4: Summary of Observations – Tupos LV/ATx Category Number of Patients % of Patients Number per patientyear Device Related Infection Inductions and conversions Inappropriate sensing Symptomatic with biventricular pacing Total Total Procedure, Lead and Device Related 1 0.75% 1 0.01 6 4.51% 6 0.06 20 15.04% 20 0.20 2 1.50% 2 0.02 25 18.80% 29 0.28 61 45.86% 77 0.
30 Lumax Technical Manual 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. There is no significant difference between the number of deaths in the study group versus the control group (p = 0.
Lumax Technical Manual 31 1.0 Control Cumulative Survival 0.9 Study 0.8 0.7 Log Rank = 0.795 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0 3 6 9 12 15 18 21 Survival Time (months) Figure 1: Kaplan-Meier Survival Curves Table 6 Survival Table Study Group (n = 133) Enrollment 3-month 6-month 12-month Number 133 131 127 123 % 100.00% 98.50% 95.49% 92.48% Control Group (n = 66) Number 67 63 63 63 % 100.00% 94.03% 94.03% 94.
32 Lumax Technical Manual 1.6 Clinical Studies The Kronos LV 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 1.6.2) support the effectiveness of the Lumax family. 1.6.
Lumax Technical Manual 33 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 • Planned cardio-surgical intervention within 3 months after enrollment (e.g.
34 Lumax Technical Manual 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. 5 complications were seen in 3 patients with cumulative implant duration of 202 months (16.8 patient-years). 6.7% of the patients had a reported complication.
Lumax Technical Manual 35 any legally marketed CRT-D. Patients in both the study and control groups were implanted with a legally marketed left ventricular lead. Methods Primarily, the study evaluates and compares the functional benefits of CRT between the two randomized groups using a composite endpoint consisting of a six-minute walk test (meters walked) and quality of life measurement (assessed using the Minnesota Living with Heart Failure Questionnaire).
36 Lumax Technical Manual Inclusion Criteria To support the objectives of this investigation, patients were required to meet the following inclusion criteria prior to enrollment: • Stable, symptomatic CHF status • NYHA Class III or IV congestive heart failure • Left ventricular ejection fraction ≤ 35% (measured within Six-Months prior to enrollment) • Intraventricular conduction delay (QRS duration greater than or equal to 130 ms) • For patients with an existing ICD/CRT-D, optimal and stable CHF dr
Lumax Technical Manual 37 Exclusion Criteria To support the objectives of this investigation, the exclusion criteria at the time of patient enrollment included the following: • Previously implanted CRT device • ACC/AHA/NASPE indication for bradycardia pacing (sinus node dysfunction) • Six-minute walk test distance greater than 450 meters • Chronic atrial tachyarrhythmias refractory to cardioversion shock therapy • Receiving intermittent, unstable intravenous inotropic drug therapy (patients on stable doses
38 Lumax Technical Manual Patient Accountability After randomization and enrollment, 7 patients (4 in the study group and 3 in the control group) did not receive an implant. The reasons for patients not receiving an implant are outlined in Figure 2.
Lumax Technical Manual 39 Overall Results • There were 192 endocardial and 19 epicardial leads implanted in 193 patients. Investigators were allowed to choose among any legally marketed LV lead according to familiarity with the lead and patient anatomy. The Tupos LV/ATx CRT-D was implanted with 7 endocardial and 4 epicardial lead models from 6 different manufacturers. There were no adverse events reported attributable to lead-generator incompatibility. • The cumulative implant duration was 1240.
40 Lumax Technical Manual Table 7 presents the average composite rate of improvement in six minute walk test distance and QOL score, the average 6minute walk test distance and the average QOL score at Baseline and at the Six-Month follow-up, as well as the average difference in 6-minute walk test distance and QOL score between Baseline and the Six-Month follow-up for the Study and Control Groups for those patients with six minute walk test data and complete QOL data at both Baseline and the Six-Month follow
Lumax Technical Manual 41 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 15.37 Distance Walked at Six-Months ∆ Distance Walked 340.77 ± 12.32 30.26 ± 10.40 17.27% ± 5.59% 301.84 ± 17.02 13.08 ± 13.05 8.71% ± 5.26% 0.067 0.322 0.326 QOL Score at Baseline 44.39 ± 2.78 45.53 ± 4.13 0.817 QOL Score at SixMonths 28.68 ± 2.66 33.95 ± 4.35 0.
42 Lumax Technical Manual 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%. The mean difference in the composite rate between study and control group was 20.53% with an associated one-sided, 95% confidence bound is (-6.10%). The p-value for non-inferiority within 10% is 0.030.
Lumax Technical Manual 43 Table 8: Complications at 6-Month – Study and Control Category Procedure Related Atrial Lead Related ICD Lead Related LV Lead Related Device Related Other Medical Related Total Procedure, Lead and Device Related Total Study N = 133 Control N = 67 6 (4.51%) 1 (1.49%) 1 (1.49%) 0 (0%) Study versus Control Comparison Delta 95% CI [-3.64%, 8.45%] [-5.74%, 5.37%] [-3.03%, 6.53%] [-5.50%, 16.45%] 2 (2.99%) 3.02 % 0.76 % 2.26 % 6.12 % 2.20 % 3.78 % 39 (29.32%) 15 (22.
44 Lumax Technical Manual 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. The atrial, ICD and LV leads used during this study are legally marketed devices.
Lumax Technical Manual 45 The pulse generator related complication rate is higher in the control group as compared to the study group. The complication rates for procedure related, atrial lead related, ICD lead related, LV lead related and other medical related are higher in the study group as compared to the control group.
46 Lumax Technical Manual Secondary Endpoint Results 1. The purpose of Secondary Endpoint 1 is to evaluate the overall ability of the Tupos LV/ATx to appropriately convert spontaneous 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.
Lumax Technical Manual 47 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. This endpoint was evaluated based on the review of electrograms following induced VT/VF episodes.
48 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 – 95 % 96 – 100 % Totals 19 (15.7%) 76 (62.8%) 121 (100%) 20 (20.2%) 64 (64.7%) 99 (100%) The majority of the follow-ups (84.9%) show a percentage of ventricular pacing of 91% or more at Six-Months. 4.
Lumax Technical Manual 49 There are no clinically relevant differences in the six minute walk test results between the study and the control group. 5. The purpose of Secondary Endpoint 5 is to evaluate the improvement in the patient’s NYHA classification. Table 15 summarizes the average improvement in NYHA from Baseline to Six-Months for 140 patients that were able to complete both NYHA classification evaluations.
50 Lumax Technical Manual 6. The purpose of Secondary Endpoint 6 is to evaluate the rate of hospitalization, for CHF and for all other causes. The occurrence rate and reasons for hospitalization of the study group were compared to the control group.
Lumax Technical Manual 51 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 28 9 All causes: All causes: Patients 68 (53.1%) 29 (44.6%) Hospitalizations 76 46 Emergency Room Visits CHF Related: CHF Related: Patients 1 (0.8%) 0 (0.0%) Visits 1 0 All causes: All causes: Patients 13 (10.1%) 2 (3.
52 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). 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year is 2.06.
Lumax Technical Manual 53 Table 17: Peak VO2 Testing Results – Patients with RER ≥ 1 Results Peak VO2 (ml/kg/min) Study N=32 Baseline: Mean: 13.46 ± 0.57 Range: 6.9 to 21.1 Six-Month: Mean: 13.39 ± 0.53 Range: 7.6 to 20.70 Difference: Mean: -0.06 ± 0.42 Range: -7.9 to 4.9 Control N=10 Baseline: Mean: 12.58 ± 0.75 Range: 8.0 to 14.8 Six-Month: Mean: 12.89 ± 0.94 Range: 7.0 to 17.2 Difference: Mean: 0.31 ± 0.67 Range: -2.7 to 4.6 1.6.2.
54 Lumax Technical Manual The results of these analyses demonstrate poolability of the data between sites. There were no significant differences in the second primary endpoint or any of the secondary endpoints between high and low volume implant centers. The gender distribution in this clinical investigation is consistent within the study groups and includes a representative proportion of female participants.
Lumax Technical Manual 55 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 testing prior to device implant to gather electrophysiologic information, including the rates and classifications of all the patient’s cardiac rhythms.
56 Lumax Technical Manual 1.7.2 Specific Patient Populations Pregnancy - If there is a need to image the device, care should be taken to minimize radiation exposure to the fetus and the mother. Nursing Mothers - Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachables in breast milk.
Lumax Technical Manual 57 1.9 Evaluating Patients Prospective CRT-D/ICD The prospective ICD/CRT-D implant candidate should undergo a cardiac evaluation to classify any and all tachyarrhythmias. In addition, other patient specific cardiac information will help in selecting the optimal device settings.
58 Lumax Technical Manual 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.
Lumax Technical Manual 59 Atrial Channel The Lumax ICDs/CRT-Ds pace and sense in bipolar configuration, between the atrial lead’s tip and ring electrodes. A bipolar atrial lead must be used to ensure reliable sensing of atrial activity. Ventricular Channel The Lumax HF devices can be programmed to pace in both the right and left ventricle (as well as RV only). The Lumax HF primarily senses in a bipolar configuration in the right ventricle.
60 Lumax Technical Manual Figure 3 Programmable BiV Pacing Configurations For CRT to be effective, ventricular pacing must occur. Therefore, AV delays must be programmed short enough to override intrinsic ventricular contractions. Additional information to further optimize AV delays can be obtained with Echocardiographs. CRT can be programmed ON or OFF via the programmer using the [Ventricular Pacing Config.] parameter.
Lumax Technical Manual 61 2.2 Sensing (Automatic Sensitivity Control) The Lumax ICDs/CRT-Ds use Automatic Sensitivity Control (ASC) to adjust the input stage sensitivity threshold for each channel to appropriately detect the various cardiac signals. The characteristics of the sensing circuitry have been optimized to ensure appropriate sensing during all potential cardiac rhythms. Cardiac signals vary in amplitude; therefore detection thresholds cannot be static.
62 Lumax Technical Manual Setting Standard Enhanced T Wave Suppression Enhanced VF Sensitivity Individual Table 19: Sensitivity Settings Definition for Use This setting is recommended for most patients, especially for those with measured R-wave amplitude of ≥3 mV. This setting offers suppression of T-wave oversensing. This mode should not to be used on patients with the following conditions: • Sinus rhythms with small signal amplitudes, R-waves <4 mV • VF with highly fluctuating signal amplitudes.
Lumax Technical Manual 63 Figure 4 Automatic Sensitivity Control with Standard Stetting Figure 4 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. After the T-wave discrimination period, the threshold is further reduced to 1.5 mV. Both the Upper and Lower Thresholds decay over time, but the Minimum Threshold is never violated.
64 Lumax 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. • The Upper Threshold is increased to 75% of the measured R-wave.
Lumax Technical Manual 65 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. 2.2.4 Minimum Atrial Threshold This parameter limits the minimum sensitivity of the ICD/CRT-D to a programmable value. Nominally, the minimum threshold is set to 0.
66 Lumax Technical Manual This parameter blanks the atrial channel of the ICD/CRT-D to the period before and after each ventricular event. This blanking period is programmable separately based on whether the ventricular event is a paced or sensed event and is designed to prevent sensing of ventricular signals with the atrial leads.
Lumax Technical Manual 67 Lower Threshold (A, RV & LV)- This feature allows the user to change the lower sensing threshold (labeled LT in Figure 4) from the default value of 25% of the sensed R-wave / P-wave amplitude to either 12.5 or 50% of the measured R-wave/ P-wave value. This feature is also used to alleviate T-wave oversensing and/or undersensing of small amplitude events (e.g., fine VF). Blank after atrial pacing (RV) .
68 Lumax Technical Manual W ARNING Unwanted Shocks – Always program Therapy status 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. Classification of cardiac signals is accomplished primarily by measuring the cardiac cycle length (R-R, P-R and P-P).
Lumax Technical Manual 69 2.3.2 VT Interval Counters The VT Interval Counters are separately programmable for VT-1 and VT-2 rate classifications. The Counter: Detection is the number of intervals required to declare a tachyarrhythmia as VT. A tachyarrhythmia must meet both the rate/interval criteria and the programmed Counter / Detection criteria, in addition to any other detection enhancements to be declared a tachycardia. 2.3.
70 Lumax Technical Manual This discrimination algorithm enhances VT-1 and VT-2 detection by applying a series of tests to the sensed cardiac signal. SMART Detection™ is intended to discriminate VT from a variety of supraventricular arrhythmias that are conducted to the ventricle and that would otherwise satisfy VT-1 or VT-2 rate detection criteria. First, the average ventricular rate is compared to the average atrial rate.
Lumax Technical Manual 71 2.3.6 Stability In VT-1 and VT-2 zones, the purpose of STABILITY is to assist in discriminating between stable ventricular tachyarrhythmias and supraventricular tachyarrhythmias that conduct irregularly to the ventricles. STABILITY evaluates sudden changes in the regularity of cardiac events (R-R and P-P intervals) on a beat by beat basis. The STABILITY criterion compares the current measured interval with the three preceding cardiac intervals.
72 Lumax Technical Manual The safety timer is not used in redetection. If initial detection was due to the safety timeout and SMART Redetection is programmed “ON”, then SMART Detection™ will not be used for redetection. 2.4 Tachyarrhythmia Redetection The Lumax ICDs/CRT-Ds offer independently programmable settings for determining if tachyarrhythmias remain after therapy has been delivered.
Lumax Technical Manual 73 2.4.3 Forced Termination DR and HF versions only. With SMART Redetection programmed ON, this programmed parameter sets a time after which the SMART Redetection will be terminated even if the SVT is still ongoing. This forces the device to terminate the episode and allow detection of a new VT or VF episode. 2.4.4 VF Redetection VF redetection uses the same X in Y algorithm as initial detection.
74 Lumax Technical Manual 2.6.2 Anti-Tachycardia Pacing (ATP) Anti-tachycardia pacing therapy (ATP) is available in both VT detection zones. Available modes of ATP include Burst, Ramp, and Burst + PES (Programmed Extra Stimuli). In addition, the Burst and Ramp modes allow interval scanning of the R-S1 Interval, the S1 Decrement, or both. The Attempts parameter determines the number of burst schemes to be delivered before the scan parameter is incremented.
Lumax Technical Manual 75 S1 Decrement - The S1 decrement continuously reduces the pulse intervals of the ATP from the second pulse onward. S1-S2 Interval - The S1-S2 programmable coupling interval occurs between the Burst sequence and the extra stimuli (PES). It defines the interval between the first stimulus (S1) and the extra stimuli (S2). Scan Decrement - The Scan decrement continuously reduces the starting pulse intervals of each Burst or Scan.
76 Lumax Technical Manual N OTE : In VT zones, the ICD/CRT-D stores successful ATP therapies only. The stored information includes not only the number of the ATP therapy (e.g., ATP2), but also the successful configuration in detail (for example: Burst; R-S1 Interval: 320 ms, S1-S1 Interval: 320 ms; etc.). 2.6.2.3 ATP Timeout ATP Timeout is a timer that decrements after the initial ventricular ATP is delivered (VT-1 zone) and limits the additional ATP therapies that may be delivered.
Lumax Technical Manual 77 A synchronization window is started at the end of the charging period. During this window, the device will attempt to synchronize the shock therapy to an R-wave. If no R-wave is detected, the shock will be delivered asynchronously at the end of the synchronization period. 2.6.3.1 Confirmation The Confirmation parameter is used to verify the presence of a tachyarrhythmia during charging of the shock capacitors.
78 Lumax Technical Manual 2.6.3.3 Shock Waveform Two waveforms of shock therapy are available with the Lumax ICDs/CRT-Ds, Biphasic and Biphasic 2ms. The following diagram describes each of the shock waveforms. Figure 5. Biphasic Waveforms Both waveforms start at the calculated voltage, based on the programmed energy level. After an exponential discharge through the lead system to 40% of the initial charge voltage, both shock waveforms switch polarity.
Lumax Technical Manual 79 2.6.3.4 Shock Energy The Lumax ICDs/CRT-Ds are designed to charge to the energy selected on the programmer screen, but similar to all other commercially available ICDs/CRT-Ds, the actual therapy delivered is somewhat less depending on several factors including the shock lead impedance. The first two shock energies in each therapy class are programmable between 1 joules and maximum energy for the device type. The energy of the second shock is always greater than the first shock.
80 Lumax Technical Manual Programmed Energy (joules) Approximate Delivered Energy (joules) 18 15.56 20 17.21 22 18.98 24 21.27 26 23.07 28 24.65 30 26.57 32 28.3 34 30.25 36 32.13 38 33.93 40 35.7 C 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.
Lumax Technical Manual 81 2.6.3.5 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/CRT-D as the positive electrode for the first phase of the shock. Reversed polarity will switch the electrical polarity of the connector ports and housing. The shock polarity is separately programmable for each arrhythmia zone.
82 Lumax Technical Manual If a defibrillation shock is delivered but does not terminate the arrhythmia, the next shock will always have the same or higher energy than the last delivered shock. Beginning with the third shock, all shocks are delivered at maximum energy (30 joules). 2.7 Bradycardia Therapy The Lumax ICDs/CRT-Ds have independently programmable single, dual and triple chamber and post-shock pacing functions.
Lumax Technical Manual 83 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; in the absence of a sensed event, a pacing pulse will be delivered at the end of the lower rate interval. The pacing modes with an “R” indicate rate adaptive pacing controlled by a motion based capacitive sensor.
84 Lumax Technical Manual 2.7.4 Rate Hysteresis The ability to decrease the effective lower rate through Hysteresis is intended to preserve a spontaneous rhythm. The pulse generator operates by waiting for a sensed event throughout the effective lower rate interval (Hysteresis interval). If no sensed event occurs, a pacing pulse is emitted following the Hysteresis interval. Hysteresis can be programmed OFF or to values as low as -65 bpm of the basic rate. Hysteresis is initiated by a sensed event.
Lumax Technical Manual 85 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 inhibits the pulse generator. Figure 6. Repetitive Hysteresis Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce pulse generator energy consumption.
86 Lumax Technical Manual 2.7.4.2 Scan Hysteresis Scan hysteresis is expanded programmability of the Hysteresis feature. Scan hysteresis searches for an intrinsic cardiac rhythm, which may exist just below the programmed lower rate (or sensorindicated rate). Following 180 consecutive paced events, the stimulation rate is temporarily decreased to the hysteresis rate for a programmed number of beats.
Lumax Technical Manual 87 2.7.5 Dynamic AV Delay DR and HF versions only. 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 the ventricular pacing pulse. If not contraindicated, a longer AV Delay can be selected to preserve intrinsic AV conduction.
88 Lumax Technical Manual 2.7.5.1 AV Hysteresis AV Hysteresis allows a user-programmable change in AV delay that is designed to encourage normal conduction of intrinsic signals from the atrium into the ventricles. With AV hysteresis enabled, the AV delay is extended by a defined time value after sensing a ventricular event (10 … (10) …150 ms). The long AV interval is used as long as intrinsic ventricular activity is detected. The programmed short AV delay interval resumes after a ventricular paced event. 2.
Lumax Technical Manual 89 Table 24: Negative AV Delay Hysteresis Values AV Delay AV Delay (Standard) (Negative Hysteresis ON) 100 ms 100 ms 120 ms 100 ms 130 ms 100 ms 140 ms 100 ms 150 ms 100 ms 160 ms 120 ms 170 ms 120 ms 180 ms 130 ms 190 ms 140 ms 200 ms 150 ms 225 ms 170 ms 250 ms 180 ms 300 ms 200 ms The normal AV delay resumes after the programmed number of consecutive ventricular paced events (Repetitive Negative AV Delay Hysteresis) elapses.
90 Lumax Technical Manual 2.7.6 IOPT Plus DR versions only. The IOPT Plus 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 25 details the settings that are preset when IOPT Plus is turned ON: Table 25 IOPT Plus Parameters Parameter IOpt Plus AV Hysteresis 400 ms AV Scan Hysteresis 5 Repetitive AV Hysteresis 5 2.7.7 Upper Tracking Rate DR and HF versions only.
Lumax Technical Manual 91 violates the programmed atrial refractory period causing a 2:1 or greater block. The 2:1 response is utilized when the rate defined by the atrial refractory period is less than the upper rate and Automatic Mode Conversion is OFF. In such a case, the maximum pacing rate is regulated by the inability to respond to P-waves falling within the atrial refractory period.
92 Lumax Technical Manual Table 26: Mode Switching Modes Programmed Mode Converted Mode DDIR DDDR DDI DDD DDIR DDI VDDR VDIR VDI VDD VDIR VDI Mode switching is initiated in atrial tracking modes when the atrial rate, defined by the programmable mode switch Intervention Rate is achieved. However, mode switching will not occur until the Mode Switch Activation Criteria is also met. The activation criterion is a programmable X out of 8 high rate intervals as programmed.
Lumax Technical Manual 93 2.7.8.2 Post Mode Switch Response Whenever Mode Switching event terminates, deactivating the mode switch pacing, the device can be programmed to react with different basic rate for a specified amount of time. Two parameters are used to set the Post Mode Switch Response. Post ModeSw Rate sets the rate difference (from permanent program) in pacing rate during the programmed Post ModeSw Duration time period.
94 Lumax Technical Manual If a ventricular event does not fall within the AV delay or the VES discrimination interval, it is classified as a VES. A ventricular event that is sensed within the VES discrimination interval, but outside the AV delay, starts a VA delay after which an atrial paced is delivered. 2.7.11 Rate Adaptive Pacing W ARNING Rate-Adaptive Pacing – Use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates.
Lumax Technical Manual 95 2.7.11.2 Rate Increase / Decrease The Rate Increase and Decrease parameters work with the Sensor Gain to determine how quickly the pacing rate will increase or decrease during changes in the sensor output. 2.7.11.3 Maximum Sensor Rate Regardless of the sensor output, the sensor-driven pacing rate never exceeds the programmable Max. Sensor Rate. The maximum sensor rate only limits the pacing rate during sensordriven pacing. 2.7.11.
96 Lumax Technical Manual 2.7.14 Post Ventricular Atrial Refractory Period DR and HF versions only. Immediately following a each sensed or 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. 2.7.15 PVARP after VES DR and HF versions only.
Lumax Technical Manual 97 Separate post shock programming of the following parameters is available: • Ventricular Pacing Configuration (RV) • Basic Rate • Rate Hysteresis • AV Delay If bradycardia pacing is still required after the post shock duration expires, standard bradycardia pacing parameters are active. 2.
98 Lumax Technical Manual For evaluation of the sensing function, the pulse generator features an intracardiac electrogram (IEGM) with marker signals to indicate sensed and paced events. 2.8.2 Pacing Impedance Measurements The Lumos ICDs/CRT-Ds have the ability to perform automatic and manual pacing impedance measurements. The devices can measure the pace impedance in any of the pacing configurations; RA, RV, LV or BiV.
Lumax Technical Manual 99 This measurement can be made for both the right and left ventricles, but only one at a time. The ventricle being tested, pacing rate, voltage and pulse width are all programmable. In addition, the pacing polarity of the left ventricle is also programmable as described in Section 2.1. Both the programmer display and printout provide measured retrograde conduction times. The duration of time that the test is conducted is based on how long the Measure button is depressed.
100 Lumax Technical Manual 2.8.6 Arrhythmia Induction Features The ICD/CRT-D offers three arrhythmia induction methods for non-invasive EP testing. These include the following: W 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.
Lumax Technical Manual 101 2.8.7 Manual Shock The ICD/CRT-D can deliver a manual shock on demand through a programmer command in the EP test menu. For manual shocks, the energy, polarity and waveform are programmable by the user. To deliver a shock, place the wand over the device and select the Start Shock button. A confirmation menu will appear and the shock command will be delivered upon selecting the OK button in this screen.
102 Lumax Technical Manual 2.8.9 Manual ATP The ICD/CRT-D can deliver a manual ATP on demand through a programmer command in the EP test menu. To deliver an ATP sequence, place the wand over the device and select the Start ATP button. A confirmation menu will appear and the programmed pacing sequence command will be delivered upon selecting the OK button in this screen. Programming of the manual ATP is similar to the programming available for automatic ATP therapy as described in Section 2.6.2. 2.8.
Lumax Technical Manual 103 2.9.2 Home Monitoring 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.
104 Lumax Technical Manual 2.9.2.2 CardioMessenger The CardioMessenger patient device (Figure 8) is designed for use in the home and is comprised of the mobile device and the associated charging station. The patient can carry the mobile device with them during his or her occupational and leisure activities. The patient device is rechargeable, allowing for an approximate operational time of approximately 24 hours.
Lumax Technical Manual 105 2.9.2.3 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. Reports are available depending on the type of report transmission – periodic or event triggered. This Cardio Report, which is adjusted to the individual needs of the patient, contains current and previous implant data.
106 Lumax Technical Manual N OTE : Battery voltage and pace/sense lead impedance are measured before the first transmission of the day. Therefore, the first transmission may occur 2 minutes after the programmed transmission time. Event Report When certain cardiac and technical events occur, a report is automatically generated. This information is described as an “event report.
Lumax Technical Manual 107 2.9.2.6 Description of Transmitted Data The following data are transmitted for the Cardio Report by the Home Monitoring system, when activated. In addition to the medical data, the serial number of the implant is also transmitted.
108 Lumax Technical Manual Table 28: Transmitted Home Monitoring parameters Home Monitoring Parameters Event Counter - Initial Detection in VT1 Event Counter- Initial Detection in VT2 Event Counter - Initial Detection in VF Event Counter - SVT ATP Counter – Delivered ATP ATP Counter – Successful ATP Shock Counter – Started Shocks Shock Counter – Successful Shocks Shock Counter – Canceled Shocks Shock Counter – Ineffective 30-Joule Shocks Date of the Last Follow-up Interrogation Indicator 2.9.2.
Lumax Technical Manual 109 • Zone of Initial Detection, • Number of delivered ATP and shocks during this episode, • Number of redetections per zone • SMART Detection setting (VT zones activated) • SMART path (for SVT) • Duration of episode The following markers are also transmitted: AS (including Ars), AP, VS (including Vrs), VP, VT1, VT2, VF, SVT(atrial and refractory sensed events included with sensed events).
110 Lumax Technical Manual 2.9.3 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. During single chamber operation, a far field ventricular electrogram can be simultaneously recorded.
Lumax Technical Manual 111 C AUTION Capacitor Reformation - Infrequent charging of the high voltage capacitors may extend the charge times of the ICD/CRT-D. The capacitors may be reformed manually. 2.9.5 Patient and Implant Data The Patient and Implant data screens allow input of data regarding the patient name, demographics, implanting physician, date, devices implanted, location of the implant, and various conditions related to the patient.
112 Lumax Technical Manual • Last Home Monitoring message o Type of message o Time and date 2.9.7 HF Monitor Statistics The ICD/CRT-D stores a variety of useful diagnostic data related to heart failure status as described in the following sections. 2.9.7.1 Patient Activity The patient’s activity is monitored based on the sensor indicated pacing rate in both, rate adaptive and non-rate adaptive pacing modes.
Lumax Technical Manual 113 2.9.7.3 Mean Heart Rate at Rest On a daily basis, the Kronos LV-T CRT-D measures and stores the patient’s resting heart rate (MHRR). Average values are calculated over a defined period. The daily value is based on the smallest mean value in any evaluation window over the resting period. The mean heart rate is calculated based on both ventricular sensed and paced events. All types of events, including VES (PVC) shall be included in the calculation of the mean value.
114 Lumax Technical Manual 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. From this screen, an IEGM can be expanded and scrolled to assist in a more accurate IEGM interpretation by enabling a closer examination of specific segments.
Lumax Technical Manual 115 2.9.8.3 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. The available parameters include: Detection Episodes implantation) • Atr.
116 Lumax Technical Manual 2.9.9 Real-time IEGM The surface ECG is continuously displayed in the Overview screen, the Sensing screen and the EP test functions module. Real-time IEGMs are available in the EP tests and sensing / impedance screens. The sensing / impedance screen allows automatic measurement of P-waves and R-waves. The sensing / impedance screen also allows a temporary bradycardia program to be sent to the Lumax for evaluation of pacing parameters.
Lumax Technical Manual 117 2.9.10.4 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. 2.9.10.5 Counters The following counters are available within the Timing Statistics: • PMTs • Safety Window Pacings • Mode Switching Episodes 2.9.
118 Lumax Technical Manual 3. Sterilization and Storage The ICD/CRT-D is shipped in a storage box, equipped with a quality control seal and product information label. The label contains the model specifications, technical data, serial number, use before date, as well as sterilization and storage information. The ICD/CRT-D and its accessories have been sealed in a container and gas sterilized with ethylene oxide. To assure sterility, the container should be checked for integrity prior to opening.
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120 Lumax Technical Manual 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.
Lumax Technical Manual 121 W ARNING ICD Lead Systems - BIOTRONIK ICDs/CRT-Ds maybe implanted with any legally marketed, compatible ICD lead.
122 Lumax Technical Manual W ARNING Left Ventricular Lead Systems – BIOTRONIK CRT-Ds maybe implanted with any legally marketed, compatible LV lead.
Lumax Technical Manual 123 C 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. 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 A.
124 Lumax Technical Manual 4.2 Lead System Evaluation The ICD/CRT-D is 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]. DF-1, wherever stated in this manual, refers to the international standard [Reference ISO 11318:1993].
Lumax Technical Manual 125 C AUTION 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 patient anatomy. The device may be implanted either below the subcutaneous tissue or in the muscle tissue.
126 Lumax Technical Manual 4.5 Lead to Device Connection The Lumax ICD/CRT-Ds have been designed and are recommended for use with a defibrillation lead systems having one IS-1 connector for ventricular sensing and pacing and up to two DF-1 connectors for delivery of shock therapy. A separate bipolar atrial lead with IS-1 connector is required for atrial sensing and pacing functions (Lumax DR and HF only) and the CS lead for biventricular pacing (LV) is utilized by the Lumax HF.
Lumax Technical Manual 127 C 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 A.
128 Lumax Technical Manual 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. Rotate the wrench counterclockwise until the receptacle is clear of obstruction. 2.
Lumax Technical Manual 129 1. Insert the blind plug into the connector port of the ICD/CRT-D until the connector pin becomes visible behind the setscrew. 2. Insert the enclosed torque wrench through the perforation in the self-sealing plug at an angle perpendicular to the connector until it is firmly placed in the setscrew. 3. Securely tighten the setscrew of the connector clockwise with the torque wrench until torque transmission is limited by the wrench. 4.
130 Lumax Technical Manual C AUTION Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition. Programmers - Use 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 change the defibrillation threshold (DFT) which may result in non-conversion of the arrhythmia post-operatively.
Lumax Technical Manual 131 C 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 A. Shock Impedance – If the shock impedance is less than twenty-five ohms, reposition the lead system to allow a greater distance between the electrodes.
132 Lumax Technical Manual C 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 at least 20 ppm 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 of the arrhythmia post-operatively.
Lumax Technical Manual 133 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 of sensing and pacing is recommended.
134 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, and circuit operating characteristics. Service time is the time from beginning of service (BOS) to the elective replacement indication (ERI).
Lumax Technical Manual 135 The 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 6 years under normal use. Table 29 provides longevity estimates for the Lumax DR-T ICD with Wilson Greatbatch batteries. The table provides several different support scenarios. It is assumed that the shocks are equally spaced throughout the life of the ICD.
136 Lumax Technical Manual Table 30 Lumax 340 HF-T Longevity Estimates Pacing Support Shocks per year 0% 15% 50% 100% 4 8.2 7.6 6.3 5.2 5 7.8 7.2 6.1 5.0 6 7.5 6.9 5.9 4.8 7 7.1 6.6 5.7 4.7 8 6.8 6.3 5.5 4.6 9 6.5 6.1 5.3 4.4 10 6.3 5.8 5.1 4.3 11 6.0 5.7 5.0 4.2 12 5.8 5.5 4.8 4.1 Upon reaching ERI, the battery has enough energy left to continue monitoring for three months and to deliver six high energy shocks.
Lumax Technical Manual 137 W ARNING Unwanted Shocks – Always program Therapy status 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. C AUTION Device Incineration – Never incinerate the ICDs/CRT-Ds due to the potential for explosion. The ICD/CRT-D must be explanted prior to cremation. Explanted Devices – Return all explanted devices to BIOTRONIK.
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Lumax Technical Manual 139 6. Technical Specifications The following are the technical specifications for the 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 340 LUMAX 300 (THICKER CAPACITORS) LUMAX 340 HF Dimensions (ICD/CRT-D) 66 mm x 55 mm x 12 mm 66 mm x 55 mm x 13 mm 66 mm x 59 mm x 13 mm Volume (ICD/CRT-D) 34.6 cm3 37.2 cm3 39.
140 Lumax Technical Manual Parameter Range Standard Far-field protection Off, 25...(25)...225 ms 75 ms after Vs Upper threshold 50; 75; 87.5 % 50 % Lower threshold 12.5; 25; 50 % 25 % Right-ventricular Sensing Parameters Sensing RV STD - standard, STD TWS - extended T-wave suppression, VFS - extended VF sensitivity, IND – Locked-out in US 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; 75; 87.5% 50 % Lower threshold 12.
Lumax Technical Manual 141 Parameter Range Standard Mode Mode (DR/HF) DDD, DDDR, DDI, DDIR, DDD VDD, VDDR, VDI, VDIR, VVI, VVIR, AAI, AAIR, OFF Mode (VR) VVI, VVIR, OFF VVI Basic Rate Day/Night Basic rate 30..(5)..100..(10)..160 60 ppm ppm Night rate OFF, 30..(5)..100 ppm OFF Night beginning 00:00..(1 min)..23:59 h:m [22:00 h:m] Night ending 00:00..(1 min)..23:59 h:m [06:00 h:m] Rate Hysteresis Rate hysteresis OFF, -5..(-5)..-90 ppm OFF Repetitive OFF; 1..(1)..15 [OFF] Scan OFF; 1..(1)..
142 Lumax Technical Manual Parameter Range Standard AV repetitive at I-Opt OFF; 1..(1)..10 [5] AV scan at I-Opt OFF, 1..(1)..10 [5] AV max at I-Opt 400 ms 400ms Post-ventricular Atrial Refractory Period (PVARP) PVARP 175..(25)..600 ms 250 ms Auto PVARP OFF, ON OFF VES Classification (VES Lock-in Protection) VES differentiation 250..(50)..450 ms 350 ms after As Rate Adaptation (Acceleration Sensor) Maximum sensor AUTO, 90..(5)..160ppm 120ppm rate Sensor gain 1.0; 1.1; 1.3; 1.4; 1.6; 1.8; 6.0 2.0; 2.2; 2.
Lumax Technical Manual 143 Parameter Mode Range Standard DDI, DDIR at permanent DDI DDD(R) [VDI] VDI, VDIR at permanent VDD(R) Change in basic rate OFF, +5 ... (5) ...+30 ppm +10 ppm Post-Mode Switch Response (PMSR) Post-ModeSw rate OFF, +5 ... (5) ...+50 ppm +10 ppm Post-ModeSw 1..(1)..30 min 1 min duration PMT Protection PMT detection / OFF, ON ON termination VA criterion 250..(10)..500 ms 350 ms Detection Detection / Therapy ENABLED ENABLED DISABLED Interval Interval VT1 OFF, 270...(10)...
144 Lumax Technical Manual Parameter Stability VT1 without SMART Stability VT2 without SMART Range OFF; 8…(4)…48 ms OFF; 8…(4)…48 ms Standard OFF OFF SMART Detection SMART detection OFF, ON [ON] VT1 SMART detection OFF, ON [ON] VT2 Sustained VT (without SMART and without SMART Redetection) Sustained VT OFF, 00:30, 01:00, 02:00, [OFF] 03:00, 05:00, 10:00, 15:00, 20:00, 25:00, 30:00 [mm:ss] Forced Termination (with SMART Incl.
Lumax Technical Manual 145 Parameter Number of shocks (VT1/VT2) Number of shocks (VF) Confirmation (per zone) Shock form (per zone) Polarity (per zone) ATP type ATP attempts S1 number Add. S1 R1-S1 interval S1 (RAMP) decrement Scan decrement S1-S2 interval Range 0..(1)..8 6..(1)..8 OFF, ON Standard [8] 8 ON Biphasic, biphasic2 Biphasic Normal, inverse, alternating ATP Parameters Burst, ramp, Burst + PES OFF, 1…(1)...10 1...(1)...10 OFF, ON 200...(10)...500 ms (absolute); 70...(5)...95 % (adaptive) 5.
146 Lumax Technical Manual Parameter S1 decrement S1-S2 interval Range Standard 5...(5)...40 ms [10ms] 200...(10)...350 ms [70%] (absolute); 70...(5)...95 % (adaptive) Stability 12% 12% ATP attempts 1 [1] ATP pulse amplitude 7.5 V 7.5 V ATP pulse width 1.5 ms 1.5 ms Post-Shock Pacing Mode DDI at permanent DDD(R), DDI (R), AAI(R) VDI at permanent VDD(R), VDI(R), VVI at permanent VVI(R), OFF Basic rate 30 .. (5)..100..(10) .. 160 60 ppm ppm Rate hysteresis OFF, -5 .. (-5) .. –65 bpm OFF AV delay 50..(10)..
Lumax Technical Manual 147 FCC Statement: (FCC ID: QRILUMAXT): This implant is equipped with an RF transmitter for wireless communications. This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.
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Lumax Technical Manual 149 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. The Lumax family of ICDs/CRT-Ds are mechanically compatible with: • IS-1 sensing/pacing lead connectors • DF-1 defibrillation lead connectors.
Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: M4117-A 9/06 BIOTRONIK GmbH & Co.
