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Table Of Contents

Lumax

Family of Implantable Cardioverter

Defibrillators and Cardiac

Resynchronization Therapy

Defibrillators

 VR ICD

 VR-T ICD

 VR-T DX ICD

 DR ICD

 DR-T ICD

 HF CRT-D

 HF-T CRT-D

Technical Manual

Summary of content (216 pages)

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Lumax Family of Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators        VR ICD VR-T ICD VR-T DX ICD DR ICD DR-T ICD HF CRT-D HF-T CRT-D Technical Manual
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X-ray Identification Lumax Family Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillators Inside the housing:
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Belos Technical Manual iii Model X-Ray Identification Year of Manufacture Lumax 300 HR nn Lumax 340 HR nn Lumax 500 SH nn Lumax 540 SH nn Lumax 600 RH nn Lumax 640 RH nn Lumax 700 RH nn Lumax 740 RH nn
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Lumax Technical Manual i Contents 1. General ..............................................................................1 1.1 System Description .......................................................1 1.2 Indications and Usage...................................................4 1.3 Contraindications...........................................................5 1.4 Warnings and Precautions ............................................5 1.4.1 Sterilization, Storage, and Handling ......................8 1.4.
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ii Lumax Technical Manual 2.3.3 Atrial Sensitivity Settings .....................................79 2.3.4 Minimum Atrial Threshold....................................80 2.3.5 Left Ventricular Sensitivity Settings .....................80 2.3.6 Minimum Left Ventricular Threshold....................81 2.3.7 Far Field Protection .............................................81 2.3.8 Additional Sensing Parameters ...........................81 2.4 Automatic Threshold Measurement (ATM) .................83 2.4.
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Lumax Technical Manual iii 2.9.7 Upper Tracking Rate .........................................110 2.9.8 Mode Switching .................................................111 2.9.9 PMT Management .............................................113 2.9.10 VES Discrimination after Atrial Sensed Events.115 2.9.11 Rate-Adaptive Pacing........................................116 2.9.12 Pulse Amplitude.................................................118 2.9.13 Pulse Width ................................................
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iv Lumax Technical Manual 2.11.18 Far-Field IEGM for Threshold Testing (Leadless ECG)..................................................................147 2.11.19 Advanced AT/AF Diagnostics (Lumax 700/740 only) ...........................................................................147 2.11.20 Atrial NIPS (Lumax 700/740 & 600/640 only) ...148 3. Sterilization and Storage .............................................149 4. Implant Procedure ........................................................151 4.
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Lumax Technical Manual v Figure 1. Lumax 300/340 ICDs and CRT-D VR(-T) DR(-T)/VR-T DX HF(-T) Figure 2. Lumax 500/540, 600/640 & 700/740 ICDs and CRT-D Table 1. Lumax Specifications Battery Voltage 3.2 Volts Maximum Shock Energy 300/500/600/700 Models 30 Joules programmed 340/540/640/740 Models 40 Joules programmed Defibrillation Lead Ports Two DF1 (3.
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vi Lumax Technical Manual VR(-T) Models DR(-T)/VR-T DX Models HF(-T) Models Materials Housing Header Sealing Plug One IS-1 (3.2 mm) Two IS-1 (3.2 mm) Three IS-1 (3.2 mm) Titanium Epoxy Resin Silicone Detailed technical specifications are provided in Section 6.
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Lumax Technical Manual 1 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.
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2 Lumax Technical Manual     Lumax DR-T - In addition, to the functionality found with the DR model, it also has 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. Lumax VR - provides single chamber rate adaptive bradycardia pacing support as well as tachyarrhythmia detection and therapy.
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Lumax Technical Manual 3 The Lumax 700/740 and 600/640 models feature ATM with automatic adjustment of pacing amplitudes (RV & LV Capture Control). This feature functions the same as ATM for threshold search and is also separately programmable for the right (RV) and left (LV) ventricle. In addition, it automatically adjusts the permanent pacing amplitude with a programmed safety margin. Section 2.4.5 provides a detailed description of this feature.
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4 Lumax Technical Manual BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home Monitoring, which is available in most models of this device. Refer to Section 1.6.4 for details regarding With the TRUST study, the study design and results. BIOTRONIK was able to show the following with regards to Home Monitoring:        BIOTRONIK Home Monitoring information may be used as a replacement for device interrogation during in-office follow-up visits.
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Lumax Technical Manual 5  Intraventricular conduction delay (QRS duration 130 ms) The Lumax Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation, for automated treatment of lifethreatening ventricular arrhythmias. 1.
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6 Lumax Technical Manual The following LV leads were evaluated in the OPTION CRT/ATx study with BIOTRONIK’s CRT-Ds:            Guidant-EASYTRAK® IS-1 Lead Guidant-EASYTRAK LV-1 Lead Guidant-EASYTRAK 2 Lead Guidant-EASYTRAK 3 Lead Medtronic-Attain® OTW Lead St. Jude-AesculaTM Lead St.
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Lumax Technical Manual 7  Insertion and withdrawal forces as specified ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1 by The following leads were evaluated in a retrospective study with BIOTRONIK’s ICDs/CRT-Ds:          Medtronic SprintTM Lead 6932 Medtronic Sprint Lead 6943 Medtronic Sprint QuattroTM Lead 6944 Medtronic TransveneTM RV Lead 6936 St. Jude (Ventritex) TVLTM- ADX Lead 1559 St.
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8 Lumax Technical Manual 1.4.1 Sterilization, Storage, and Handling Device Packaging - Do not use the device if the device’s packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK. Re-sterilization - Do not re-sterilize and re-implant explanted devices. Storage (temperature) - Store the device between 5° to 45°C (41° - 113° F) because temperatures outside this range could damage the device.
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Lumax Technical Manual 9 ERI (Elective Replacement Indicator) - Upon reaching ERI, the battery has sufficient energy remaining to continue monitoring for at least three months and to deliver a minimum of six maximum energy shocks. After this period (EOS), all tachyarrhythmia detection and therapy is disabled. Bradycardia functions are still active at programmed values until the battery voltage drops below 1.75 volts.
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10 Lumax Technical Manual Programming Wand Separation Distance – The wand (with magnet) must not be placed closer than 2 cm to the device (implanted or out of the box). Programming wand (with magnet) distance closer than 2 cm may damage the device. 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.
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Lumax Technical Manual 11 Kinking Leads - Do not kink leads. This may cause additional stress on the leads that can result in damage to the lead. Liquid Immersion - Do not immerse leads in mineral oil, silicone oil, or any other liquid. 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.
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12 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.
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Lumax Technical Manual 13 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. If diathermy therapy must be used, it should not be applied in the immediate vicinity of the pulse generator or lead system. Electrocautery - Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause device malfunction or damage.
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14 Lumax Technical Manual Radio Frequency Ablation - Prior to performing an ablation procedure, deactivate the ICD/CRT-D during the procedure. Avoid applying ablation energy near the implanted lead system whenever possible. 1.4.7 Home and Occupational Hazards Patients should be directed to avoid devices that generate strong electromagnetic interference (EMI) or magnetic fields. EMI could cause device malfunction or damage resulting in non-detection or delivery of unneeded therapy.
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Lumax Technical Manual 15  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). Store the telephone in a location opposite the side of implant.
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16 Lumax Technical Manual  The patient’s CardioMessenger is off or damaged and is not able to connect to the Home Monitoring system through an active telephone link  The CardioMessenger cannot establish a connection to the implanted device  The telephone and/or Internet connection do not operate properly  The Home Monitoring Service Center is off-line (upgrades are typically completed in less than 24 hours) Patient’s Ability - Use of the Home Monitoring system requires the patient and/or caregiv
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Lumax Technical Manual 17 1.5 Potential/Observed Effects of the Device on Health 1.5.
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18 Lumax Technical Manual In addition, patients implanted with the ICD/CRT-D system may have the following risks.
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Lumax Technical Manual 19 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.
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20 Lumax Technical Manual Table 3: 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 All Observations 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.
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Lumax Technical Manual 21 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.
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22 Lumax Technical Manual Complications and observations for the Tupos LV/ATx study group are summarized in Table 4 and Table 5. 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.
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Lumax Technical Manual 23 Table 4: 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 % of Number of of Patients Complications Patients 3 4 Device Related 2.26% 3.01% Complications per patient-year 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.
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24 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 5 summarizes by category each type of observation for the study group.
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Lumax Technical Manual 25 Table 5: Summary of Observations – Tupos LV/ATx Category Number % of of Number Patients Patients 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.
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26 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.
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Lumax Technical Manual 27 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 3: Kaplan-Meier Survival Curves Table 7 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% 94.03% 1.6 Clinical Studies The Kronos LV-T Clinical study (HOME-CARE, Section 1.6.
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28 Lumax Technical Manual 1.6.1 Kronos LV-T Study The purpose of the HOME-CARE Observational Study is to demonstrate the safety of the CE-marked Kronos LV-T cardiac resynchronization defibrillator (CRT-D) in patients with congestive heart failure (CHF). 1.6.1.1 Methods The multi-center, non-randomized observational study was designed to evaluate the safety of the Kronos LV-T through an analysis of the complication-free rate through three months.
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Lumax Technical Manual 29 At the enrollment screening, the physician evaluated the patient to verify that all inclusion/exclusion criteria were met in accordance to the protocol and the patient signed the informed consent. After successful enrollment, all patients were implanted with the Kronos LV-T CRT-D. Evaluations at the One- and Threemonth follow-ups included resting ECG, NYHA classification, medications, and activation of Home Monitoring. 1.6.1.
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30 Lumax Technical Manual 1.6.2 Tupos LV/ATx Study N OTE : The clinical study information included in this section 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.
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Lumax Technical Manual 31 1.6.2.2 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). Relevant measurements were completed twice for each patient: once at the Baseline evaluation (two-week post implant follow-up) and again at a six-month follow-up evaluation.
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32 Lumax Technical Manual    Ability to complete all required testing including the sixminute walk test and cardiopulmonary exercise testing Available for follow-up visits on a regular basis at the investigational site Age greater than or equal to 18 years 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 paci
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Lumax Technical Manual 33 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 4.
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34 Lumax Technical Manual     The cumulative implant duration was 1240.4 months with a mean duration of 9.6 months for the study group. The cumulative implant duration is 596.5 months with a mean duration of 9.3 months for the control group. 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.
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Lumax Technical Manual 35 Table 8: Composite of Six Minute Walk Test and QOL (Effectiveness) Category Study Group (N = 74) Mean  SE Control Group (N = 38) Mean  SE P-value* Distance Walked at Baseline 310.51 ± 10.89 288.76 ± 15.37 0.249 Distance Walked at Six-Months 340.77 ± 12.32 30.26 ± 10.40 17.27% ± 5.59% 301.84 ± 17.02 13.08 ± 13.05 8.71% ± 5.26% ∆ Distance Walked 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.
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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%. 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.
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Lumax Technical Manual 37 Table 9: 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.
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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. The atrial, ICD and LV leads used during this study are legally marketed devices.
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Lumax Technical Manual 39 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. 1.6.2.
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40 Lumax Technical Manual 1.6.2.10 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.
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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. This endpoint was evaluated based on the review of electrograms following induced VT/VF episodes.
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42 Lumax Technical Manual Table 14: 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.
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Lumax Technical Manual 43 Table 15: Six Minute Walk Distance Distance (meters) Baseline N Mean  SE Range Median Six-Month N Mean  SE Range Median Study Control 127 283.14  9.27 23 to 511 302.00 61 269.43  13.77 29 to 507 244.00 93 329.73  10.82 78 to 596 335.00 44 310.70  15.49 91 to 489 313.00 * Student's t-test, 2-sided There are no clinically relevant differences in the six minute walk test results between the study and the control group. 5.
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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. The occurrence rate and reasons for hospitalization of the study group were compared to the control group.
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Lumax Technical Manual 45 Table 17: 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.
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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). 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year is 2.06.
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Lumax Technical Manual 47 Table 18: Peak VO2 Testing Results – Patients with RER 1 Results Peak VO2 (ml/kg/min) Study Control 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 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.
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48 Lumax Technical Manual The gender distribution in this clinical investigation is consistent within the study groups and includes a representative proportion of female participants. There were no significant differences in any of the primary or secondary endpoints between the male and female population. 1.6.2.12 Conclusions The IDE Clinical study (OPTION LV/ATx) demonstrated that the safety and effectiveness of the Tupos LV/ATx CRT-D device is equivalent to that of similar legally marketed CRT-D devices.
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Lumax Technical Manual 49 1.6.3.2 Methods The study primarily evaluates and compares the functional benefits of the Lumax HF-T with OPT versus the Lumax HF-T with SIM using an endpoint that includes both a 6-minute walk (6MW) test and quality of life (QOL) measurement assessed using the Minnesota Living with Heart Failure questionnaire (MLWHFQ).
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50 Lumax Technical Manual The primary endpoint hypothesis required that a high proportion of subjects remain “not worsened” when CRT with V-V programmability and optimization was delivered compared to when CRT without V-V programmability and optimization.
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Lumax Technical Manual 51 Select permanent “Initially Paced Chamber” and “V-V delay after Vp” to reflect the maximum VTI measurement for final programming. Inclusion Criteria To support the objectives of this investigation, the inclusion criteria at the time of patient enrollment for this investigational study included the following requirements:        Meet the indications for therapy.
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52 Lumax Technical Manual  Presence of another life-threatening, underlying illness separate from their cardiac disorder. 1.6.3.3 Summary of Clinical Results The study involved 122 patients (96 males, 78.7%, and 26 females, 21.3%), with a mean age of 67.1 years (range: 35-87). The cumulative enrollment duration is 621.3 months with mean enrollment duration of 5.1 months. The patient follow-up compliance rate for all enrolled patients is 98.5% (394 of 400 required follow-ups). 1.6.3.3.
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Lumax Technical Manual 53 The analysis of the primary effectiveness endpoint is an intentionto-treat analysis based on the responder classification of changes in the MLWHFQ and 6-minute walk distance between periods of SIM and OPT, obtained at the 1-month and 2-month follow-ups. Table 20 presents the percentage of all patients worsened and not worsened to evaluate the effectiveness of OPT vs. SIM utilizing the QOL and 6-minute walk responder classification.
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54 Lumax Technical Manual Table 20. QOL and 6-Minute Walk Responder Classification (Effectiveness) QOL Group 1 (N = 56) Group 2 (N = 52) Total (N = 108) Worsened 9 (16.1%) 6 (11.5%) 15 (13.9%) Not worsened 47 (83.9%) 46 (88.5%) 93 (86.1%) (N = 56) (N = 51) (N = 107) Worsened 14 (25.0%) 15 (29.4%) 29 (27.1%) Not worsened 42 (75.0%) 36 (70.6%) 78 (72.9%) (N = 55) (N = 51) (N = 106) Worsened 21 (38.2%) 18 (35.3%) 39 (36.8%) Not worsened 34 (61.8%) 33 (64.7%) 67 (63.
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Lumax Technical Manual 55 The observed complication-free rate was 100.0%. The lower, exact, one-sided 95% confidence bound for this observed rate is 97.6%. This exceeds the pre-specified rate (90% - δ) required for demonstrating non-inferiority. 1.6.3.4 Conclusions The cumulative enrollment duration is 621.3 months with a mean duration of 5.1 months. Sixty-one (50.0%) of the patients have been enrolled for 91-180 days.
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56 Lumax Technical Manual 1.6.4.2 Methods All enrolled patients received a BIOTRONIK ICD with Home Monitoring/IEGM-Online technology and were randomized to either Group 1 (Home Monitoring (HM)) or Group 2 (No Home Monitoring (Control)) using a randomization ratio of 2:1. Group 1 (HM) Device evaluations for scheduled follow-ups, patient-initiated inquiries and event triggered notifications were performed with HM/IEGM Online.
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Lumax Technical Manual 57 Primary Endpoints The purpose of primary endpoint 1 (HM efficacy) was to compare the number of in-office ICD follow-ups for patients in Group 1 (HM) to the conventional, calendar-based method of ICD followup as in Group 2 (Control). The purpose of the primary endpoint 2 (safety) was to compare the Safety Event Rate (SER), which includes death, incidence of strokes and events requiring surgical interventions (e.g. device explants or lead revision) between the two groups.
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58 Lumax Technical Manual Clinical Events Committee The Clinical Events Committee (CEC) is an advisory review board comprised of three physicians that are not participating in the TRUST Study who reviewed and adjudicated all deaths, strokes, surgical interventions, and cardiac adverse events that occur during the study. The CEC also reviewed all divergent classifications of actionable vs.
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Lumax Technical Manual 59 Analysis The comparison of the number of 3, 6, 9, and 12 month and unscheduled office follow-up visits in Group 1 versus Group 2 showed that there was an average number of 1.9 office follow-up visits on a per year basis in Group 1 (HM) and an average number of 3.4 office follow-up visits on a per year basis in Group 2 (Control).
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60 Lumax Technical Manual Figure 5: Safety Event Rate Kaplan Meier Analysis The safety event rate for a 12-month duration was 14.8% for Group 1 (HM) and 16.4% for Group 2 (Control), with a noninferiority p-value of 0.005. Therefore, the safety event rate for HM Group was non-inferior to the safety event rate for the Control Group within 5%. The upper, one-sided 95% confidence bound for the difference was 2.7%.
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Lumax Technical Manual 61 Table 23 compares the time from onset to evaluation of the first AF, VT and VF events for each patient that have occurred in each group, as well as the first of any type of event for each patient in each group. Figure 6 illustrates the time from onset to evaluation of arrhythmic events in a box plot graph.
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62 Lumax Technical Manual Figure 6: Median Time from Onset to Evaluation of Arrhythmic Events Analysis The mean time from onset to evaluation of first AF, VT, and VF events in Group 2 is greater than the mean time from onset to evaluation of first AF, VT, or VF events in Group 1.
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Lumax Technical Manual 63  The safety event rate for a 12 month duration for Group 1 (HM) was non-inferior to the safety event rate for Group 2 (Control) within 5% (p = 0.005). The upper, one-sided 95% confidence bound for the difference was 2.7%.  The mean time from onset to evaluation of AF, VT and VF events indicates that those events for Group 1 patients are evaluated in significantly less time when compared to Group 2 patients (AF p = 0.005, VT p < 0.001, VF p < 0.001). 1.6.
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64 Lumax Technical Manual 1.6.5.1 U.S. Clinical Study 1.6.5.1.1 Patients Studied The Single-Lead ICD system clinical study involved 9 patients (7 males and 2 female) with a mean age of 58.8 years (range: 25 to 83 years). 66.7% presented with ventricular fibrillation/polymorphic ventricular tachycardia as their primary tachycardia. The Single-Lead ICD system was selected for the diagnostic value of the atrial EGMs in 88.9% of the patients. 1.6.5.1.
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Lumax Technical Manual 65 Description Results Complication Rate 11.1% (1/9) Appropriate Atrial Sensing Rate 1 97.6% (41/42) Appropriate Atrial Sensing during 24-hour Holter Test 100% (9/9) Appropriate Atrial Sensing during Exercise Treadmill Test 100% (6/6) Detection and Conversion of Ventricular Tachyarrhythmias 2 100% (68/68) 1.6.5.2 European Clinical Study 1.6.5.2.
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66 Lumax Technical Manual 1.6.5.2.2 Study Objectives This clinical investigation was designed to collect information on the performance and function of the Deikos A+/Kainox VDD ICD system. The specific predefined objectives of the investigation included the rate of inappropriate, i.e.
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Lumax Technical Manual 67 1.7 Patient Selection and Treatment 1.7.1 Individualization of Treatment  Determine whether the expected device benefits outweigh the possibility of early device replacement for patients whose ventricular tachyarrhythmias require frequent shocks.  Determine if the device and programmable options are appropriate for patients with drug-resistant supraventricular tachyarrhythmias (SVTs), because drugresistant SVTs can initiate unwanted device therapy.
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68 Lumax Technical Manual If the patient is being treated with antiarrhythmic or cardiac drugs, the patient should be on a maintenance drug dose rather than a loading dose at the time of pulse generator implantation. If changes to drug therapy are made, repeated arrhythmia inductions are recommended to verify pulse generator detection and conversion. The pulse generator also may need to be reprogrammed.
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Lumax Technical Manual 69 A patient manual is available for the patient, patient’s relatives, and other interested people. Discuss the information in the manual with concerned individuals both before and after pulse generator implantation so they are fully familiar with operation of the device. (For additional copies of the patient manual, contact BIOTRONIK at the address listed in this manual.) 1.
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70 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.
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Lumax Technical Manual 71 The SafeSync symbol is displayed in the navigator and the signal strength is displayed in green bars on the information line. The SafeSync telemetry status is shown in five increments: 1 bar = 20% up to 5 bars = 100%. A weak contact shows only one bar in green, whereas all five bars are shown in green when there is optimal contact. The bars are shown in gray if RF telemetry is lost. The display should have at least three green bars.
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72 Lumax Technical Manual  Apply the programming head on the patient over the device.  Select: More→Lumax→ Telemetry→PGH. Power Consumption Consideration: SafeSync telemetry requires somewhat more power than telemetry via the programming head. Power consumption during implantation corresponds to approximately 10 days of service time and consumption during 20-minute follow-up corresponds to approximately 3 days. As a result:  Do not establish unnecessarily.
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Lumax Technical Manual 73 2.2 Cardiac Resynchronization Therapy (CRT) HF versions only For Cardiac Resynchronization Therapy (CRT), a sensing/pacing lead is placed in the right atrium, while an ICD lead is placed in the right ventricle. The third lead is positioned to pace the left ventricle. When connected together, this system provides coordinated, simultaneous stimulation of the right and left ventricles.
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74 Lumax Technical Manual Sensing Table 26. Lead Configurations Configuration Explanation Sensing takes place between RV Only the tip and ring electrodes of the right ventricular lead. LV Only Pacing RV & LV Together (BiV) Pacing RV 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). Pacing configuration is programmable between the tip and ring electrodes of the right and left ventricular leads.
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Lumax Technical Manual 75 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 echocardiography. CRT can be programmed ON or OFF via the programmer using the [Ventricular Pacing] parameter.
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76 Lumax Technical Manual Prior to the V-V delay optimization procedure, each patient underwent an optimization of AV timing. Following the AV timing adjustment, this standardized procedure was followed for the optimization of V-V delay: 1. Program the Lumax HF-T “Initially Paced Chamber” parameter to either RV or LV based on preference 2.
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Lumax Technical Manual 77 Cardiac signals vary in amplitude; therefore detection thresholds cannot be static. With the Automatic Sensitivity Control (ASC) every paced/sensed event is measured, and the upper and lower thresholds are re-set accordingly (also known as beat-by-beat adaptation). The ASC begins by tracking the cardiac signals (R and P-waves) during the sensed refractory periods. The peak values measured during this time are used to set the sensing thresholds during the active detection periods.
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78 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). After the T-wave discrimination period, the threshold is decreased to the lower threshold. The lower threshold is set to 25% of the measured peak R-wave. The lower threshold then decreases 0.
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Lumax Technical Manual 79 The Enhanced VF Sensitivity setting is specifically designed to improve VF detection when the VF signal is very small. Two adjustments are made to ASC with this setting:   The T-wave discrimination period (hold of upper threshold) is decreased to 100 ms [110 ms for Lumax 600/640 and 700/740 models], thus eliminating the Upper Threshold. The decay rate of the Lower Threshold is increased to 0.125 mV every 250 ms. This is not applicable for the Lumax 600/640 and 700/740 models.
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80 Lumax Technical Manual Table 28: 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.
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Lumax Technical Manual 81 Table 29: Left Ventricular 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. 2.3.6 Minimum Left Ventricular Threshold This parameter limits the minimum sensitivity of the CRT-D to a programmable value.
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82 Lumax Technical Manual Upper Threshold (A, RV & LV) - This feature allows the user to change the upper sensing threshold level (UT in Figure 8) from the nominal value of 50% of the sensed R-wave/P-wave amplitude to either 75% or 87.5% of the R-wave/P-wave value. This feature is used in the ventricle for example to eliminate oversensing of large T-waves. This is not applicable to the Lumax 600/640 and 700/740 models.
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Lumax Technical Manual 83 2.4 Automatic Threshold Measurement (ATM) Lumax 500/540 Models only The Lumax 500/540 models have an automatic threshold measurement (ATM) feature for determining ventricular pacing thresholds. This feature is separately programmable for the right (RV) and left (LV) ventricles. ATM is initiated once each day, typically during the nighttime while the patient is normally sleeping.
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84 Lumax Technical Manual 2.4.1 Signal Quality Check During the Signal Quality Check, five single effective pacing pulses are delivered. These pulses are followed by five double pulses. The second pulse of each double pulse is delivered into the refractory phase of the ventricle (as a non-capturing pulse). The VER morphology of the single pulses and the second pulse of the double pulses are assessed.
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Lumax Technical Manual 85 Lumax 600/640 & 700/740 Models only 2.4.5 RV & LV Capture Control RV & LV Capture Control uses the determined pacing threshold to adjust the permanent pulse amplitude. The new permanent pulse amplitude is composed of the determined pacing threshold plus a safety margin (1.0 or 1.2 V) and is automatically programmed in the ICD. 2.
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86 Lumax Technical Manual 2.5.1 VF Classifications Detection of ventricular fibrillation (VF) utilizes programmable X out of Y criterion. For the Lumax 300/340 & 500/540 models, both X and Y are programmable. For the Lumax 600/640 and 700/740 models there are fixed combinations of X out of Y criterion. If X number of intervals within the sliding window (defined by Y) are shorter than the programmed VF rate interval (>bpm), VF is detected.
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Lumax Technical Manual 87 The ICDs/CRT-Ds may be programmed to use ventricular-only information, or both atrial and ventricular information for the discrimination of ventricular tachyarrhythmias. With SMART Detection™ turned ON, the Lumax ICDs/CRT-Ds use atrial and ventricular signals for discrimination of fast heart rhythms. With SMART Detection™ turned OFF, only the ventricular rate is used to discriminate between ventricular rhythm classes.
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88 Lumax Technical Manual If the ventricular rhythm is stable and the atrial rate is not a multiple of the ventricular rate, then the rhythm is declared a VT and ventricular tachycardia therapy is delivered. In the event that both the atrial and ventricular signals are detected at the same rate, a series of additional discrimination tests are applied. 2.5.
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Lumax Technical Manual 89 The Sustained VT parameter is intended to force tachycardia therapy in cases where a cardiac rhythm meets the VT rate criteria but does not satisfy one or more detection enhancement criterion (Onset, SMART Detection, or Stability) for an extended duration. This “safety” timer is initiated within one of the VT zones. If the programmed Sustained VT time period expires without tachycardia detection, redetection is initiated without utilizing the detection enhancements.
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90 Lumax Technical Manual 2.6 Tachyarrhythmia Redetection The Lumax ICDs/CRT-Ds offer independently programmable settings for determining if tachyarrhythmias remain after therapy has been delivered. The redetection routine allows the ICDs/CRT-Ds to determine whether further therapy is required when the initial therapy was unsuccessful in terminating the arrhythmia. Tachyarrhythmia redetection criteria are based on cardiac cycle length and number of intervals.
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Lumax Technical Manual 91 2.6.4 VF Redetection VF redetection uses the same X in Y algorithm as initial detection. The X and Y values for initial detection are also used for redetection to ensure consistent classification of VF. 2.7 Tachyarrhythmia Termination Termination of a ventricular tachyarrhythmia episode is declared when 12 out of 16 consecutive sensed intervals are longer than the VT-interval parameter of the lowest VT class (sinus or bradycardia rhythm). 2.
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92 Lumax Technical Manual Burst – This mode will deliver a series of pacing stimuli with user defined duration of the burst (Number S1), coupling cycle length (R-S1) and burst rate (S1-S1). The coupling interval and the start interval are calculated from the intrinsic R-R average. Ramp - This mode will deliver a series of pacing stimuli with the above options including a parameter which decrements each successive stimuli interval in the burst.
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Lumax Technical Manual 93 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.
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94 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.). 2.8.2.3 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.
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Lumax Technical Manual 95 2.8.3 Shock Therapy Shock Therapy is developed by internal circuitry that stores energy across high energy capacitors. The voltage level for the charging cycle is based on the programmed energy level. The energy is then delivered over the connected ICD lead and through the ICD/CRT-D housing utilizing a biphasic waveform. The first and second shock energies in each shock module have independently programmable Shock Energy.
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96 Lumax Technical Manual 2.8.3.2 Number of Shocks The number of shocks defines the total number of shock attempts per therapy zone (VT-1, VT-2 or VF). Up to 8 shocks are available in each therapy zone. The first and second shock energies are independently programmable, while the remaining shocks are fixed at maximum energy (30 joules for 300/500/600/700 series devices and 40 joules for 340/540/640/740 series devices). 2.8.3.
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Lumax Technical Manual 97 2.8.3.4 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.
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98 Lumax Technical Manual Table 30 Delivered Shock Energy (340/540/640/740 Variants) Programmed Energy Approximate Delivered (joules) Energy (joules) 1 0.8 2 1.7 3 2.6 4 3.5 5 4.3 6 5.2 7 6.1 8 6.9 9 7.8 10 8.7 11 9.6 12 10.5 13 11.3 14 12.2 15 13.1 16 13.9 18 15.7 20 17.3 22 19.1 24 21.1 26 22.8 28 24.4 30 26.3 32 27.9 34 29.7 36 31.5 38 33.3 40 35.
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Lumax Technical Manual 99 Table 31 Delivered Shock Energy (300/500/600/700 Variants) Programmed Energy Approximate Delivered (joules) Energy (joules) 1 0.8 2 1.7 3 2.5 4 3.3 5 4.3 6 5.1 7 6.0 8 7.0 9 7.8 10 8.6 11 9.6 12 10.6 13 11.4 14 12.3 15 13.1 16 14.2 18 16.0 20 17.7 22 19.5 24 21.4 26 23.2 28 24.9 30 27.
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100 Lumax Technical Manual C AUTION Shock Impedance - If the shock impedance is less than twenty-five ohms (25 Ω), 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 (25 Ω). Damage to the device may result.
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Lumax Technical Manual 101 2.8.3.6 Third Programmable Shock Pathway Lumax 500/540, 600/640 & 700/740 Models only The Lumax 500/540, 600/640 and 700/740 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. The Shock Configuration parameter operates independently of Shock Polarity.
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102 Lumax Technical Manual 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.
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Lumax Technical Manual 103 Mode VVIR DDD DDI VDD VDI AAI VVI V00 D00 OFF Table 33 Lumax Pacing Modes Lumax Lumax Lumax HF(-T) DR(-T) VR(-T) X X X X X N/A X X N/A X X N/A X X N/A X X N/A X X X X X X X X N/A X X X Lumax VR-T DX X N/A N/A X X N/A X X N/A X The basic rate timer is started by a sensed or paced event.
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104 Lumax Technical Manual At the programmed start time (Begin of Night), the rate gradually adapts to the night rate. When the internal clock reaches the programmed end time (End of Night), the pacing rate gradually changes to the programmed basic rate. The rate changes at the same rate as the Sensor Gain decrease and increase parameters. N OTE : The Night Mode time is based on the programmer clock. Therefore, the programmer time should be checked prior to device programming.
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Lumax Technical Manual 105 Night Rate is the limit for the Hysteresis when Night Mode is active. Programming conflicts arise when the total decrease in rate is below 30 ppm. Care should be exercised to avoid programming a Night Mode rate and hysteresis that are below what is appropriate and may be tolerated by the individual patient. 2.9.4.1 Repetitive Hysteresis Repetitive hysteresis is expanded programmability of the Hysteresis feature.
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106 Lumax Technical Manual Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce pulse generator energy consumption. N OTE : 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. 2.9.4.2 Scan Hysteresis Scan hysteresis is expanded programmability of the Hysteresis feature.
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Lumax Technical Manual 107 Figure 11. Scan Hysteresis Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce pulse generator energy consumption. 2.9.5 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.
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108 Lumax Technical Manual The AV Delay feature includes an AV Delay shortening option (Sense Compensation) for dual chamber pacing modes. When enabled, the AV Delay is shortened by the programmed value (-5 to -60 ms in Lumax 300/340 & 500/540 models and up to -120 ms in Lumax 600/640 & 700/740 models) from the programmed AV Delay after an intrinsic atrial sensed event. The Dynamic AV Delay is intended to mimic physiologicshortening of the AV Delay with increasing heart rate.
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Lumax Technical Manual 109 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) in Lumax 300/340 & 500/540 models and 5 fixed cycles with scan AV hysteresis in the Lumax 600/640 & 700/740 models. If an intrinsic rhythm is detected within the extended AV delay, the longer AV delay remains in effect.
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110 Lumax Technical Manual 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 34 details the settings that are preset when IOPT is turned ON: Table 34 IOPT Parameters Parameter IOPT AV Hysteresis (max AV Delay) 400 ms AV Scan Hysteresis 5 Repetitive AV Hysteresis 5 2.9.
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Lumax Technical Manual 111 The 2:1 response is utilized when the rate defined by the atrial refractory period is less than the upper rate. In such a case, the maximum pacing rate is regulated by the inability to respond to P-waves falling within the atrial refractory period. If the resulting length of the spontaneous atrial cycle is shorter than the atrial refractory period in a rate-adaptive mode, the resulting pacing rate will depend on whether the 2:1 rate has been exceeded.
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112 Lumax Technical Manual Table 35: 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 Onset Criterion is also met. The activation criterion is a programmable X out of 8 high rate intervals as programmed.
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Lumax Technical Manual 113 2.9.8.2 Post Mode Switch Response Whenever Mode Switching event terminates, deactivating the mode switch pacing, the device can be programmed to react with a 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.
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114 Lumax Technical Manual In these instances, the ARP will usually be long enough to prevent sensing of retrograde P-waves. Programming to an ARPE other than 0 ms may rarely be required but could provide additional protection if the ARP is limited or the retrograde conduction time extended. Figure 12. Prevention of PMT by VES starting ARP (DDD). 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.
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Lumax Technical Manual 115 2.9.9.3 PMT Detection and Termination In addition to PMT prevention, Lumax contains a programmable PMT detection and termination algorithm. The termination feature will take action in case the prevention was not effective and a PMT is detected. The PMT detection constantly monitors for the presence of a PMT. The Lumax PMT detection/termination algorithm consists of suspicion, confirmation and termination components and is described as follows.
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116 Lumax Technical Manual With each As and As (PVARP), a VES discrimination interval is started in the ventricle. If a ventricular sensed event occurs within the discrimination interval, this event is interpreted as a Vs (ventricular sensed event), and no PVARP after VES protection interval is started. In the factory setting, the VES discrimination after As is set to 350 ms (programmable: 250…(50)…450 ms in Lumax 300/340 & 500/540 models and up to 500 ms in the Lumax 600/640 & 700/740 models).
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Lumax Technical Manual 117 2.9.11.1 Sensor Gain and Threshold The Sensor Gain defines how much the sensor signal is amplified before it is transformed to a rate change. When the Sensor Gain is low (e.g., 2), a great deal of exertion is needed to cause a significant change in sensor output (and an equal change in the pacing rate). When the Sensor Gain is high (e.g., 18), little exertion is needed to increase the sensor output.
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118 Lumax Technical Manual  If 90% of the maximum sensor rate is reached for 1 hour within 24 hours, gain is reduced by one step. 2.9.12 Pulse Amplitude The Pulse Amplitude parameters, are separately programmable for atrial and both ventricular channels and they, define the amplitude in volts of the pacing pulses. The pulse amplitude is also independently programmable for normal bradycardia pacing and fixed to 7.5V for post-shock pacing in RA and RV and as permanent programmed in LV. 2.9.
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Lumax Technical Manual 119 2.9.16 Auto PVARP DR and HF versions only This parameter automatically adjusts the Post Ventricular Atrial Refractory Period (PVARP) and PVARP after VES, if a pacemaker mediated tachycardia (PMT) has been detected and terminated to avoid additional PMT events. After seven days, PVARP and PVARP after VES are reduced as short as possible until a new PMT occurs or the shortest value of these parameters is reached.
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120 Lumax Technical Manual 2.10 EP Test Functions Several EP test functions are available with the Lumax family of ICD/CRT-Ds including; P and R-wave amplitude, pacing and shock impedances, retrograde conduction and pacing threshold measurements. Extensive testing of defibrillation thresholds as well as the ability to verify the effectiveness of anti-tachycardia pacing and defibrillation shocks are also available. 2.10.
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Lumax Technical Manual 121 2.10.2 Pacing Impedance Measurements The Lumax ICDs/CRT-Ds have the ability to perform automatic and manual pacing impedance measurements. The devices can measure the pace impedance in all leads; RA, RV and LV. In Lumax 300/340 and 500/540 models, the measurement can be performed in any the of the pacing configurations; RA, RV, LV or BiV. In Lumax 600/640 and 700/740 models, it uses a subthreshold measurement in all channels connected to leads automatically.
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122 Lumax Technical Manual 2.10.4 Testing for Retrograde Conduction Retrograde conduction from the ventricles to the atrium can be assumed when a 1:1 relationship between the ventricular stimulation and atrial depolarization has been obtained with a constant coupling interval during ventricular stimulation. The ICD/CRT-D features a test for measuring retrograde conduction time.
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Lumax Technical Manual 123 2.10.6 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.
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124 Lumax Technical Manual 2.10.7 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.
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Lumax Technical Manual 125 2.10.9 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 2.8.2. 2.10.
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126 Lumax Technical Manual W ARNING 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. 2.11.2 Thoracic Impedance The thoracic impedance is measured between the distal shockcoil of the RV lead and the ICD housing. Up to 1,024 measurements are done every hour and these measurements are then averaged.
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Lumax Technical Manual 127       A strategy of care using BIOTRONIK Home Monitoring with office visits when needed has been shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK implantable devices in many patients. Home Monitoring data is helpful in determining the need for additional in-office follow-up.
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128 Lumax Technical Manual 2.11.3.1 Transmission of Information The implant transmits information with a small transmitter, which has a range of about 2 meters. The patient’s implant data are sent to the corresponding patient device in configurable periodic intervals. The transmissions may also be activated by the detection of a cardiac event, as programmed. The types of transmissions are discussed in Section 2.11.3.3.
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Lumax Technical Manual 129 Figure 14: Example of CardioMessenger II with Charging Stand 2.10.2.3 Transmitting Data 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.
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130 Lumax Technical Manual The password protected BIOTRONIK Home Monitoring website can be accessed at the following URL: www.biotronik-homemonitoring.com An online help menu is available in order to assist with the use of the Home Monitoring website. Use of the Internet for reviewing Home Monitoring data must be in conjunction with the system requirements listed in Table 36 Additionally, Table 36 provides system specifications that are recommended for optimizing usage of the Internet.
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Lumax Technical Manual 131 Table 36: System Requirements/Recommendations Communication Channel System Requirements System Recommendation s (for Optimal Usage) Fax (G3) or e-mail Fax (G3), e-mail or mobile phone 2.11.3.
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132 Lumax Technical Manual Periodic Report with IEGM The Lumax ICDs and CRT-Ds can be programmed to transmit IEGMs with the daily Home Monitoring report on a periodic basis with the interval selected; OFF, 2, 3, 4, or 6 months. Event Report When certain cardiac and technical events occur, a report is automatically generated. This information is described as an “event report.
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Lumax Technical Manual 133 Device Status & Home Monitoring Settings Containing device and message identifying values that pertain to the implant and Home Monitoring:         Implantation Date Battery voltage & Date of Measurement Device Status  Master-switch (e.g.
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134 Lumax Technical Manual Pacing Counters (Brady)  AV-Sequences  Intrinsic Rhythm (AsVs)  Conducted Rhythm (AsVp)  Atrial Paced Rhythm (ApVs)  Complete Paced Rhythm (ApVp) The above parameters are transmitted as 3 byte counter.
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Lumax Technical Manual 135    Initial Detections during Detection while Magnet applied (DTM) (induction)  Started + successful ATP in VT  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) Other Ventricular Arrhythmia  Number of Mean PVC/h per day ("per Day" is referenced to the Monitor Interval Duration) Heart Failure Monitoring (all data ba
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136 Lumax Technical Manual   Ventricular Tachycardia Therapy - (e.g., ATP Schemes, Shock energies) 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.
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Lumax Technical Manual 137  If an ongoing atrial episode fulfills a programmed time duration criteria, a message is triggered to provide the physician with the information early on.  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.
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138 Lumax Technical Manual 2.11.3.6 Scheduling Remote Follow-up The Lumax 700/740 and 600/640 ICDs/CRT-Ds provide the ability to automatically schedule remote follow-ups using the programmer. This feature has the following two options: 1. Fixed Follow-up Intervals (using 30-180 day cycles) from the date of the first scheduled transmission: 2. Selection of 5 sequential dates* with a minimum time lag of 20 days between any two selected dates.
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Lumax Technical Manual 139 The IEGMs may be transmitted to the programmer via the programming wand positioned over the implanted pulse generator. 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. They are then displayed together with surface ECG and markers on the programmer screen and printed on the ECG recorder.
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140 Lumax Technical Manual C AUTION Capacitor Reformation - Infrequent charging of the high voltage capacitors may extend the charge times of the ICD/CRT-D. The capacitors are automatically reformed. 2.11.6 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.
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Lumax Technical Manual 141 2.11.8 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. 2.11.8.1 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. The Lumax devices store information about the patient’s activity level based on the sensor indicated pacing rate on a daily basis.
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142 Lumax Technical Manual The MHRR value is measured during a programmed period, defined by a Rest Period Start Time and a Rest Period Duration. The resting period shall be adjustable via the programmer. The MHRR has a value range of 0 to 180 bpm. The daily value (MHRR) is stored for a period of 240 days. After 240 days, new daily values replace the oldest daily values. The programmer presents the daily bpm-value in a trend graph for the last 240 days. 2.11.8.
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Lumax Technical Manual 143 Stored IEGM The ICD/CRT-D can store up to 32 minutes of triple chamber intracardiac electrograms (IEGMs) including the history and prehistory of the following events regarding AT/AF, VT/VF and SVTs:  Time  Zone  Descriptions  PP and RR intervals (before detection and termination, displayed only in the episode list)  IEGMs 2.11.9.
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144 Lumax Technical Manual SVT Details  AFlut  AFib  Sinus T  1:1 Therapy Episodes (since last follow-up and since implantation)       Successful ATP Therapies in VT and ATP-One Shot Unsuccessful ATP Therapies in VT and ATP-One Shot Successful Shock Therapies Unsuccessful Shock Therapies Delivered ATP Therapies in VT and ATP-One Shot Delivered Shock Therapies 2.11.
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Lumax Technical Manual 145   BiVp (RVp-LVp or LVp-RVp  RVs-LVp  RVp-noLVp, RVs-noLVp (LV T-wave protection ON)  LVp, noLVp (LV pacing only) VES-Triggered Resynchronization  VES-LVp (Triggering: RVs+RVES)  VES-noLVp (LV T-wave protection ON)  VES per hour 2.11.10.3 Rate Trends The device counts the number of paced and sensed events and displays them in two different graphs (rate and paced). These trends are available for 24 hour periods and as long-term durations. 2.11.10.
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146 Lumax Technical Manual 2.11.13 Sensor This report contains individual rate bins for the sensor indicated rate percentages. The activity report provides information that can assist the physician in optimizing pacing and/or sensor parameters. 2.11.14 Sensing The activity report provides trend information on atrial and right ventricular sensing measurements. 2.11.
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Lumax Technical Manual 147 The patient must be monitored when asynchronous pacing modes are used. The asynchronous modes V00 and D00 can only be set if tachyarrhythmia sensing is deactivated. However, this would leave the patient without sensing and therefore without ICD therapy. Thus, during the use of asynchronous modes: - Continually monitor the patient. - Keep an external defibrillator ready. 2.11.
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148 Lumax Technical Manual 2.11.20 Atrial NIPS (Lumax 700/740 & 600/640 only) The Lumax 700/740 models offer Atrial Non-Invasive Programmable Stimulation (NIPS), which allows manual stimulation in the atrium via the programmer.
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Lumax Technical Manual 149 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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Lumax Technical Manual 151 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.
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152 Lumax Technical Manual W ARNING ICD Lead Systems - BIOTRONIK ICDs/CRT-Ds may be implanted with any legally marketed, compatible ICD lead.
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Lumax Technical Manual 153  St.
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154 Lumax Technical Manual W ARNING Left Ventricular Lead Systems – BIOTRONIK CRT-Ds maybe implanted with any legally marketed, compatible LV lead.
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Lumax Technical Manual 155 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.
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156 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].
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Lumax Technical Manual 157 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.
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158 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 and the CS lead for biventricular pacing (LV).
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Lumax Technical Manual 159 Figure 16.
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160 Lumax Technical Manual 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.
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Lumax Technical Manual 161 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.
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162 Lumax Technical Manual 5. Carefully retract the torque wrench. The perforation will self-seal. 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. 4.7 Program the ICD/CRT-D Program the ICD/CRT-D to appropriately treat the patient’s arrhythmias and other therapy needs.
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Lumax Technical Manual 163 W ARNING Unwanted Shocks – Always program ICD therapy to OFF prior to handling the device to prevent the delivery of shocks to the patient or the person handling the device during the implant procedure. 4.8 Implant the ICD/CRT-D The ICD/CRT-D may be placed in the pocket at this time. Place the device into the pocket with either side facing up (it can be interrogated and programmed from either side). Carefully coil any excess lead length behind the ICD/CRT-D.
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164 Lumax Technical Manual 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.
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Lumax Technical Manual 165 Prior to surgically closing the pocket, the telemetry contact should be evaluated to help ensure chronic programmer communication. Close the device pocket using standard surgical technique. As the final step at device implant and each patient follow-up, the permanent program should be retransmitted to the ICD/CRT-D. Typically, each device that you receive is in the “Shipment Mode”.
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Lumax Technical Manual 167 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.
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168 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).
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Lumax Technical Manual 169 5.2.1 Lumax 300/340 Devices The single chamber Lumax (Lumax 300 VR, Lumax 340 VR, Lumax 300 VR-T, and Lumax 340 VR-T) ICDs are intended to operate for more than 4 years under normal use. Table 37 provides longevity estimates for the Lumax 340 VR-T ICD, which has the worst case longevity estimates of the devices listed above. The table provides several different support scenarios. It is assumed that the shocks are equally spaced throughout the life of the ICD.
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170 Lumax Technical Manual Table 38 Lumax 340 DR-T Longevity Estimates Pacing Support Shocks per year 0% 15% 50% 100% (max energy) 4 5 6 7 8 9 10 11 12 5.7 5.4 5.2 5.0 4.8 4.6 4.4 4.2 4.1 5.4 5.1 4.9 4.7 4.5 4.4 4.2 4.0 3.9 4.8 4.6 4.4 4.2 4.1 3.9 3.8 3.7 3.6 4.1 3.9 3.8 3.7 3.6 3.4 3.3 3.2 3.2 Table 39 and Table 40 provide longevity estimates for the Lumax 300 & 340 HF-T CRT-D with Greatbatch batteries. The tables are limited to 100% ventricular pacing because that is the goal for each CRT-D device.
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Lumax Technical Manual 171 Table 40 Lumax 340 HF-T Longevity Estimates Shocks per year 100% Pacing Support (in years) 4 5.2 5 5.0 6 4.8 7 4.7 8 4.6 9 4.4 10 4.3 11 4.2 12 4.1 The Lumax 300/340 HF CRT-Ds (Lumax 300 HF-T, and Lumax 340 HF-T) are intended to operate for more than 5 years under normal use. 5.2.2 Lumax 500/540 Devices The single chamber Lumax 500/540 ICD variants (Lumax 500 VR-T and Lumax 540 VR-T) of are intended to operate for more than 6 years under normal use.
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172 Lumax Technical Manual 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. Table 42 provides longevity estimates for these devices. The table provides several different support scenarios. It is assumed that the shocks are equally spaced throughout the life of the ICD. Table 42 Lumax DR-T Longevity Estimates Pacing Support Device Shocks per 0% 15% 50% 100% year 4 7.9 7.5 6.7 5.8 500 DR-T 8 6.7 6.4 5.8 5.
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Lumax Technical Manual 173 Table 44 Lumax 500/540 HF-T Longevity Estimates Pacing Support Device Shocks per year 100% 4 5.6 5 5.5 6 5.4 7 5.2 500 HF-T 8 5.1 9 5.0 10 4.9 11 4.7 12 4.6 4 5.3 5 5.1 6 5.0 7 4.8 540 HF-T 8 4.6 9 4.5 10 4.4 11 4.3 12 4.1 Upon reaching ERI, the battery has enough energy left to continue monitoring for three months and to deliver six high energy shocks. The estimates associated with duration of ERI assume the ICD/CRT-D is sensing an intrinsic sinus rhythm at a rate of 70 bpm.
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174 Lumax Technical Manual 5.2.3 Lumax 600/640 & 700/740 Devices Table 41 provides longevity estimates for the single chamber Lumax 600/640 & 700/740 ICD variants (Lumax 600/700 VR-T and Lumax 640/740 VR-T). The table provides several different support scenarios. It is assumed that the shocks are equally spaced throughout the life of the ICD. Table 46 Lumax VR-T Longevity Estimates Pacing Support Device Shocks per 0% 15% 50% 100% year 4 9.91 9.60 8.95 8.17 600 VR-T 8 8.32 8.10 7.64 7.06 700 VR-T 12 7.17 7.
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Lumax Technical Manual 175 Table 48 Lumax VR-T DX Longevity Estimates Pacing Support Device Shocks per 0% 15% 50% 100% year 640 VR-T 4 9.31 9.07 8.54 7.89 DX 8 7.59 7.43 7.07 6.62 740 VR-T 12 DX 6.40 6.29 6.03 5.70 Table 44 provides longevity estimates for the Lumax 600/640 and 700/740 HF-T variants of CRT-Ds. The table provides several different support scenarios. It is assumed that the shocks are equally spaced throughout the life of the CRT-D.
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176 Lumax Technical Manual Upon reaching ERI, the battery has enough energy left to continue monitoring for three months and to deliver six high energy shocks. The estimates associated with duration of ERI assume the ICD/CRT-D is sensing an intrinsic sinus rhythm at a rate of 70 bpm. After this period the device is at EOS (End of Service) and requires explantation. Once at EOS, all tachyarrhythmia detection and therapy is disabled. The ERI voltages are listed in the Table 45.
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Lumax Technical Manual 177 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 179 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. Dimensions Volume Mechanical Properties Lumax Lumax Lumax 500 300/500 340/540 600/700 600/700 640/740 HF-T 66 mm x 66 mm x 66 mm x 55 mm x 55 mm x 59 mm x 12 mm 13 mm 12 mm Lumax 340/540 640/740 HF-T 66 mm x 59 mm x 13 mm 34.6 cm3 37.2 cm3 37.1 cm3 39.
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180 Lumax Technical Manual Parameter Range Standard Upper threshold 25, 50; 75 % 50 % (Lumax 700/740 & 600/640 only) Lower threshold 12.
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Lumax Technical Manual 181 Parameter Range 100...(20)...600 ms Hold of upper threshold Hold of upper 110, 150...(50)...500 ms threshold after Vs 110 ms (VFS) (Lumax 700/740 & 600/640 only) Hold of upper 110, 150...(50)...
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182 Lumax Technical Manual Parameter Range Standard Hold of upper 110, 150...(50)...500 ms 400 ms threshold after Vp (Lumax 700/740 & 600/640 only) Lower threshold 12.5; 25; 50 % 50 % Lower threshold 50 % 50 % (Lumax 700/740 & 600/640 only) In channel/Cross channel Blanking In-channel blank Auto, 100...(10)...350 ms Auto after RV pace RV Blanking after 100...(10)...350 ms 120 ms RV pacing (Lumax 700/740 & 600/640 only) In-channel blank Auto, 100...(10)...350ms Auto after LV pace LV Blanking after LV 100...
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Lumax Technical Manual 183 Parameter Range Standard Shock Path (Valid RV -> SVC + ICD RV -> SVC + for all shocks (Housing) ICD including the painRV -> ICD (500/540 only) free shock RV -> SVC (500/540 impedance) only) Pulse Amplitudes and Pulse Widths Pulse amplitude 0.2...(0.1)...6.2, 7.5 V 2.8 V Pulse amplitude 0.5…(0.25)…4.0…(0.5)… 2.5 V (Lumax 700/740 & ..6.0, 7.5 V 600/640 models only) Pulse width 0.4, 0.5, 0.7, 1.0, 1.2, 1.5 0.4 ms ms Pulse width 0.4, 0.5…(0.25)…1.5 ms 0.
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184 Lumax Technical Manual Parameter Modes (Lumax 700/740 & 600/640 models only) Modes (VR-T DX Only) Modes (Lumax 740/640 VR-T DX Only) Basic rate Night rate Night beginning Night ending Rate hysteresis Rate hysteresis (Lumax 740/640 VR-T DX Only) Repetitive Scan Scan / Repetitive (Lumax 740/640 VR-T DX Only) AV delay AV delay 1 AV delay 1 after pace (Lumax 740/640 VR-T DX Only) AV delay 1 after sense (Lumax 740/640 VR-T DX Only) AV rate 1 Range DDD, DDDR, DDI, DDIR, D00, VDD, VDDR, VDI, VDIR, VVI, VVIR,
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Lumax Technical Manual 185 Parameter AV rate 1 (Lumax 740/640 VR-T DX Only) AV delay 2 AV delay 2 (Lumax 740/640 VR-T DX Only) AV rate 2 AV rate 2 (Lumax 740/640 VR-T DX Only) Sense compensation Range 50..(10)..130 bpm Standard 60 bpm 40..(5)..350 ms 15, 40..(5)..350 ms 120 ms - 70..(10)..160 bpm 60..(10)..140 bpm 130 bpm 130 bpm OFF; -5..(-5)..-60 ms Sense compensation (Lumax 740/640 VR-T DX Only) AV-hysteresis mode OFF; -5..(-5)..
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186 Lumax Technical Manual Parameter AV repetitive (negative) (Lumax 740/640 VR-T DX Only) AV scan Range ON (180) OFF, 1..(1)..10 I-Opt OFF, ON 400 ms Standard ON (180) [5] I-Opt OFF AV hysteresis at I400 ms Opt AV repetitive at IOFF; 1..(1)..10 [5] Opt AV scan at I-Opt OFF, 1..(1)..10 [5] AV scan / repetitive ON (5) [ON(5)] at I-Opt (Lumax 740/640 VR-T DX Only) AV max at I-Opt 400 ms 400ms Post-ventricular Atrial Refractory Period (PVARP) PVARP 175..(25)..600 ms, Auto 250 ms PVARP 175..(25)..
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Lumax Technical Manual 187 Parameter Sensor gain Range 1.0; 1.1; 1.3; 1.4; 1.6; 1.8; 2.0; 2.2; 2.6; 3.0; 3.3; 3.7; 4.0; 4.5; 5.0; 6.0; 7.0; 8.0; 9.0; 10; 11; 12; 14; 16; 18; 20; 22; 24; 28; 32; 35; 40 Sensor gain AUTO, Very low (1.3), (Lumax 700/740 & Low (3), Medium (6), 600/640 only) High (12), Very high (26) Auto Sensor gain OFF, ON Sensor threshold Very low = 0 (numbers are not Low = 3 displayed on screen) Medium = 7 High = 11 Very high = 15 Rate increase 0.5; 1..(1)..
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188 Lumax Technical Manual Parameter Deactivation criterion Z Mode Range 3..(1)..8 DDI, DDIR at permanent DDD(R) VDI, VDIR at permanent VDD(R) Modes (VR-T DX VDI, VDIR at permanent Only) VDD(R) Change in basic rate OFF, +5 ... (5) ...+30 bpm Post-Mode Switch Response (PMSR) Post-ModeSw rate OFF, +5 ... (5) ...+50 bpm Post-ModeSw 1..(1)..30 min duration PMT Protection PMT OFF, ON detection/terminatio n VA criterion 250..(10)..500 ms Detection Detection/Therapy ON, OFF Interval Interval AT/AF 100….
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Lumax Technical Manual 189 Parameter Detection counter VF – X out of Y (Lumax 700/740 & 600/640 only) Onset in VT1/2 with SMART Onset VT1 without SMART Onset VT2 without SMART Range 6 out of 8 8 out of 12 10 out of 14 12 out of 16 16 out of 20 18 out of 24 20 out of 26 22 out of 30 24 out of 30 Onset 20% Standard 8 out of 12 [20%] OFF; 4…(4)…32% 20% OFF; 4…(4)…32% 20% Stability Stability in VT1/2 12% [12%] with SMART Stability VT1 without OFF; 8…(4)…48 ms 24 ms SMART Stability VT2 without OFF; 8…(4
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190 Lumax Technical Manual Parameter Forced termination (Lumax 700/740 & 600/640 only) Range OFF; 1…(1)…10 min Redetection Counter Redetection counter 10...(2)...30 VT1 Redetection counter 10...(2)...30 VT2 SMART Redetection SMART redetection OFF, ON (VT1 & VT2) Ventricular Therapy Parameters Energy 1st shock OFF; 1..(1)..16..(2)..30 J and 2nd shock VT1, VT2 (model 300/500) 1 Energy 1st shock of OFF; 2..(2)..20..(5)..30 J VT1, VT2 (Lumax 700/600 only) Energy 2nd shock of OFF; 4..(2)..20..(5)..
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Lumax Technical Manual 191 Parameter Energy 1st shock and 2nd shock VT1, VT2 (model 340/540) 1 Energy 1st shock of VT1, VT2 (Lumax 740/640 only) Energy 2nd shock of VT1, VT2 (Lumax 740/640 only) Energy 1st shock and 2nd shock VF (model 340/540) Range OFF; 1..(1)..16..(2)..40 J Standard 40 J OFF; 2..(2)..20..(5)..40 J 40 J OFF; 4..(2)..20..(5)..40 J 40 J 1..(1)..16..(2)..40 J 40 J 2..(2)..20..(5)..40 J 40 J 4..(2)..20..(5)..
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192 Lumax Technical Manual Parameter Polarity (per zone) ATP type ATP type (Lumax 700/740 & 600/640 only) ATP attempts ATP attempts (Lumax 700/740 & 600/640 only) S1 number Add. S1 R1-S1 interval R1-S1 interval (Lumax 700/740 & 600/640 only) S1 (RAMP) decrement Scan decrement S1-S2 interval Range Normal, Reverse, Alternating ATP Parameters Burst, Ramp, Burst + PES Burst, Ramp Standard Normal [Burst] [Burst] OFF, 1…(1)...10 OFF, 1…(1)...10 3 [OFF] 1...(1)...10 OFF, ON 200...(10)...
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Lumax Technical Manual 193 Parameter ATP type (Lumax 700/740 & 600/640 only) S1 number S1 number (Lumax 700/740 & 600/640 only) R-S1 interval R-S1 interval (Lumax 700/740 & 600/640 only) S1 decrement S1-S2 interval Range OFF, Burst, Ramp 1...(1)...10 1...(1)...10 200...(10)...350 ms (absolute); 70...(5)...95 % (adaptive) 70...(5)...95 % (adaptive) 5...(5)...40 ms 200...(10)...350 ms (absolute); 70...(5)...95 % (adaptive) Stability 12% ATP attempts 1 ATP pulse amplitude 7.5 V ATP pulse width 1.
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194 Lumax Technical Manual Parameter S3-S4 interval Minimum ATP interval Range OFF, 200...(10)...600 ms simply alterable via [+ / -] buttons 200 ms Atrial NIPS Lumax 700/740 & 600/640 Only Backup Stimulation OFF, 30 .. (10) .. 120 (VVI-Rate) bpm Report OFF, 5, 10, 25, 50 mm/s S1-S1 interval 80…(10)…2000 ms S1 cycles 0...(1)...10 S1-S2 interval None, 80...(10)...1000 ms simply alterable via [+ / -] buttons S2-S3 interval None, 80...(10)...
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Lumax Technical Manual 195 Parameter Rate hysteresis (Lumax 700/740 & 600/640 only) AV delay Range OFF Standard - 50..(10)..350 ms (fixed 140 ms AV delay) Post-shock duration OFF, 00:10 .. (00:10) .. 00:10 mm:ss 00:50, 01:00 .. (01:00) ..
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196 Lumax Technical Manual Parameter Sustained atrial episode (Lumax 700/740 & 600/640 only) Range OFF, 6, 12, 18 h (5 min, 30 min) Diagnostics Periodic Recordings if Home Monitoring ON: = (Lumax 700/740 & Cycle duration 600/640 only) If Home Monitoring OFF: OFF, 30 .. (30) .. 180 Standard [12 h] [90] [90] FCC Statement: (FCC ID: QRILUMAXT, QIRLUMAXT50): This implant is equipped with an RF transmitter for wireless communications. This device may not interfere with stations operating in the 400.150–406.
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Lumax Technical Manual 197
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198 Lumax Technical Manual 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.
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Lumax Technical Manual 199
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200 Lumax Technical Manual Appendix B – Known Anomalies Anomaly Possible Effect on Patient or Implant Procedure Impact on Lumax 700/740 & 600/640 Lumax Application (Programmer Software) RF communication session may be unexpectedly interrupted when a long episode is printed with high paper feed. ID# 424185 Limited effect on patient. Functional/Usability Issue (missing, insufficient user guidance, unexpected behavior): may cause follow-up prolongation.
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Lumax Technical Manual 201 Anomaly Possible Effect on Patient or Implant Procedure Impact on Lumax 700/740 & 600/640 Lumax Application (Programmer Software) The Far Field channel display may disappear when the ECG window is minimized after having been maximized immediately before. ID# 421905 Limited effect on patient. Diagnostic Data Issue (Interrogation, Display, Printout): Display/printout of missing diagnostic information may cause user confusion.
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202 Lumax Technical Manual Anomaly Possible Effect on Patient or Implant Procedure Impact on Lumax 700/740 & 600/640 Lumax Application (Programmer Software) The transmission date for Periodic IEGM messages for Remote Follow-Up (Home Monitoring) may be off by one day. ID# 412325 Event Counter Statistics may be slightly off by single counts of Vx events dependent on internal statistics state transitions. This is a rare event. ID# 410925 No effect on patient.
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Lumax Technical Manual 203 Anomaly Possible Effect on Patient or Implant Procedure Lumax Application (Programmer Software) Inconsistent No effect on patient. behavior for Functional/Usability "Alert" Issue (missing, navigation. insufficient user Clicking the guidance, unexpected alert icon on behavior): without the TrendView clinical relevance or time axis and negative on the therapeutical/diagnostic Information implication.
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204 Lumax Technical Manual Anomaly Possible Effect on Patient or Implant Procedure Impact on Lumax 700/740 & 600/640 Lumax Application (Programmer Software) For long patient names involving umlauts the transmission of patient data may suppress the patient name (empty field). ID# 393925 No effect on patient. Functional/Usability Issue (missing, insufficient user guidance, unexpected behavior): Unexpected/Unspecified behavior without clinical relevance or negative therapeutical/diagnostic implication.
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Lumax Technical Manual 205 Anomaly Possible Effect on Patient or Implant Procedure Impact on Lumax 700/740 & 600/640 Lumax Application (Programmer Software) An ineffective pacing program may continue during the threshold test at programming distances close to the loss of communication . Lifting the wand corrects the problem. ID# 17903 Limited potential effect on patient, non-capture is quickly recognized and removal of programming wand is typical response.
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Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: M4117-H 10/11 BIOTRONIK SE & Co.