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16 Lumax Technical Manual

1.5 Potential/Observed Effects of the

Device on Health

1.5.1 Potential Adverse Events

The following are possible adverse events that may occur relative
to the implant procedure and chronic implant of the CRT-D:

•

Air

embolism

•

Allergic reactions to

contrast media

•

Arrhythmias

•

Bleeding

•

Body

rejection

phenomena

•

Cardiac

tamponade

•

Chronic nerve damage

•

Damage to heart valves

•

Device

migration

•

Elevated

pacing

thresholds

•

Extrusion

•

Fluid

accumulation

•

Hematoma

•

Infection

•

Keloid

formation

•

Lead

dislodgment

•

Lead fracture/ insulation

damage

•

Lead-related thrombosis

•

Local tissue reaction /

fibrotic tissue formation

•

Muscle or nerve

stimulation

•

Myocardial damage

•

Myopotential sensing

•

Pacemaker mediated

tachycardia

•

Pneumothorax

•

Pocket erosion

•

Thromboembolism

•

Undersensing of intrinsic

signals

•

Venous occlusion

•

Venous or cardiac

perforation

Содержание Lumax DR ICD Series

Страница 1: ...Lumax Family of Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators VR ICD VR T ICD DR ICD DR T ICD HF CRT D HF T CRT D Technical Manual...

Страница 2: ...efibrillator and Cardiac Resynchronization Therapy Defibrillators Inside the housing X Ray identification Year of manufacture HR nn CAUTION Federal U S A law restricts this device to sale by or on the...

Страница 3: ...e Monitoring 15 1 5 Potential Observed Effects of the Device on Health 16 1 5 1 Potential Adverse Events 16 1 5 2 Observed Adverse Events 17 1 6 Clinical Studies 27 1 6 1 Kronos LV T Study 27 1 6 2 Tu...

Страница 4: ...T Detection 68 2 5 5 Onset 69 2 5 6 Stability 69 2 5 7 Sustained VT Timer 70 2 5 8 VT Monitoring Zone 70 2 5 9 Atrial Monitoring Zone 71 2 6 Tachyarrhythmia Redetection 71 2 6 1 VT Redetection 71 2 6...

Страница 5: ...ents 101 2 10 2 Pacing Impedance Measurements 102 2 10 3 Shock Impedance Measurements 103 2 10 4 Testing for Retrograde Conduction 103 2 10 5 Pacing Threshold 104 2 10 6 Arrhythmia Induction Features...

Страница 6: ...r 12 4 4 Pocket Preparation 13 4 5 Lead to Device Connection 13 4 6 Blind Plug Connection 16 4 7 Program the ICD CRT D 17 4 8 Implant the ICD CRT D 18 5 1 General Considerations 23 5 2 Longevity 24 5...

Страница 7: ...programmed 340 540 models Maximum Shock Energy 40 Joules programmed Defibrillation Lead Ports Two DF 1 3 2 mm Pacing Lead Ports Three IS 1 3 2 mm one for Lumax VR T and two for Lumax DR T s Dimension...

Страница 8: ...vi Lumax Technical Manual...

Страница 9: ...ogrammable anti tachycardia pacing ATP and or defibrillation therapy features The shock polarity and energy may be programmed to tailor the therapy to appropriately treat each patient s tachyarrhythmi...

Страница 10: ...d with standard VR model it also has the added functionality of BIOTRONIK s Home Monitoring system The Home Monitoring System enables automatic exchange of information about a patient s cardiac status...

Страница 11: ...rnal devices include the ICS 3000 Programming and Tachyarrhythmia Monitoring System and the Implant Module System Analyzer or Pacing System Analyzer for acute lead testing The ICS 3000 programmer is u...

Страница 12: ...MRI Magnetic Resonance Imaging Do not expose a patient to MRI device scanning Strong magnetic fields may damage the device and cause injury to the patient Electrical Isolation To prevent inadvertent...

Страница 13: ...Attain LV 2187 unipolar St Jude Medical QuickSite 1056K unipolar ELA Situs OTW unipolar Biotronik Corox OTW 75 UP Steroid 346542 unipolar Biotronik Corox LV H 75 BP 341885 bipolar ICD Lead Systems BIO...

Страница 14: ...dtronic Sprint 6942 Medtronic Sprint 6943 Medtronic Sprint 6945 Medtronic Sprint Quattro 6944 St Jude Riata 1571 65 St Jude SPL SPO1 Resuscitation Availability Do not perform induction testing unless...

Страница 15: ...because temperature extremes may affect initial device function Use Before Date Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity 1 4 2 Device Implantat...

Страница 16: ...0 programmers to communicate with the device Sealing System Failure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle may result in damage...

Страница 17: ...e to the device may result Negative AV Hysteresis This feature insures ventricular pacing a technique which has been used in patients with hypertrophic obstructive cardiomyopathy HOCM with normal AV c...

Страница 18: ...uturing Leads Do not suture directly over the lead body as this may cause structural damage Use the appropriate suture sleeve to immobilize the lead and protect it against damage from ligatures Tricus...

Страница 19: ...n pressing the Safe Program key on the programmer head immediately sends the safe program to the ICD CRT D 1 4 5 Pulse Generator Explant and Disposal Device Incineration Never incinerate the ICD CRT D...

Страница 20: ...untered from external defibrillation However any implanted device may be damaged by external defibrillation procedures In addition external defibrillation may also result in permanent myocardial damag...

Страница 21: ...lly allow the ICD CRT D to return to its normal mode of operation The following equipment and similar devices may affect normal ICD CRT D operation electric arc or resistance welders electric melting...

Страница 22: ...I emitting from a telephone does adversely affect an implanted ICD CRT D moving the telephone away from the immediate vicinity of the ICD CRT D should restore normal operation A recommendation to addr...

Страница 23: ...ot be utilized in areas where cellular phones are restricted or prohibited i e commercial aircraft Event Triggered Report A timely receipt of the event report cannot be guaranteed The receipt is also...

Страница 24: ...henomena Cardiac tamponade Chronic nerve damage Damage to heart valves Device migration Elevated pacing thresholds Extrusion Fluid accumulation Hematoma Infection Keloid formation Lead dislodgment Lea...

Страница 25: ...tential death due to inability to defibrillate or pace Shunting current or insulating myocardium during defibrillation with external or internal paddles There may be other risks associated with this d...

Страница 26: ...omplications The rate of complications per patient year was 0 30 51 of the enrolled study patients had a reported observation with 3 patients having more than 1 observation The rate of observations pe...

Страница 27: ...0 12 Elevated RV pacing threshold 1 2 2 1 0 06 Hepatitis 1 2 2 1 0 06 Arrhythmias 1 2 2 1 0 06 Cardiac Decompensation 1 2 2 1 0 06 All Observations 23 51 1 26 1 54 Number of Patients 45 Number of Pati...

Страница 28: ...er study to demonstrate the safety and effectiveness of the investigational Tupos LV ATx Cardiac Resynchronization Therapy Defibrillator CRT D in patients with congestive heart failure CHF and atrial...

Страница 29: ...ents Number of Complications Complications per patient year Procedure Related Hematoma 4 3 01 4 0 04 Pneumothorax 2 1 50 2 0 02 Total 6 4 51 6 0 06 Atrial Lead Related Dislodgement 3 2 26 3 0 03 Total...

Страница 30: ...9 6 77 10 0 10 Total All Patients and Categories 50 37 59 68 0 67 Number of Patients 133 Number of Patient Years 101 9 1 Unanticipated Adverse Device Effect UADE occurred with a Tupos LV ATx CRT D dur...

Страница 31: ...mmary of Observations Tupos LV ATx Category Number of Patients of Patients Number per patient year Procedure Related Hematoma 10 7 52 10 0 10 Cardiac arrest 2 1 50 2 0 02 Unable to implant system 1 0...

Страница 32: ...r pacing 2 1 50 2 0 02 Total 25 18 80 29 0 28 Total Procedure Lead and Device Related 61 45 86 77 0 76 Other Medical Related Non CHF Cardiac Symptoms 21 15 79 21 0 21 Ventricular arrhythmias 11 8 27 1...

Страница 33: ...the study group versus the control group p 0 777 Fisher s Exact Test 2 sided Table 5 provides a summary of reported patient deaths and Table 6 provides survival percentages by follow up interval durin...

Страница 34: ...4 0 3 0 2 0 1 0 0 Cumulative Survival Log Rank 0 795 Control Study Figure 1 Kaplan Meier Survival Curves Table 6 Survival Table Study Group n 133 Control Group n 66 Number Number Enrollment 133 100 00...

Страница 35: ...stive 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 thr...

Страница 36: ...sician 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...

Страница 37: ...two sided lower 95 confidence bound of 83 8 The null hypothesis is rejected and it is concluded that the complication free rate is equivalent to 85 within 10 1 6 2 Tupos LV ATx Study NOTE The clinica...

Страница 38: ...ith 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 evaluatio...

Страница 39: ...w 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 o...

Страница 40: ...were 133 study patients and 67 active control patients in this prospective multi center randomized clinical study For the study group there were 129 successful implants 91 4 of the Tupos LV ATx CRT D...

Страница 41: ...Study 21 Control 10 Patients completed 6 Month Follow up Study 100 Control 49 Figure 2 Patient Accountability Overall Results There were 192 endocardial and 19 epicardial leads implanted in 193 patien...

Страница 42: ...lated to the study device 1 6 2 4 Primary Endpoint 1 Six Minute Walk Test QOL Effectiveness The purpose of Primary Endpoint 1 is to evaluate the effectiveness of the Tupos LV ATx system in providing C...

Страница 43: ...ulated p values are associated with a Student s t test 2 sided of the equality of means in the two groups except for the p value of the composite rate which is associated with a test of equivalence no...

Страница 44: ...e walk test distance and QOL score demonstrates that the study group is non inferior to the control group and that the primary effectiveness endpoint was met p 0 030 1 6 2 6 Primary Endpoint 2 Complic...

Страница 45: ...edical Related 9 6 77 2 2 99 3 78 3 82 10 13 0 341 Total Procedure Lead and Device Related 39 29 32 15 22 39 6 94 6 46 19 17 0 317 Total 46 34 59 17 25 37 9 21 4 96 21 99 0 201 1 6 2 7 Primary Safety...

Страница 46: ...ated to the Tupos LV ATx device see Table 9 There were 11 patients who had an attempt to implant the LV lead but the physician was unsuccessful in either obtaining coronary sinus CS access or unable t...

Страница 47: ...or the different complication rate categories between the study and the control group Table 10 compares this post hoc Safety Endpoint analysis to previous CRT D clinical studies Table 10 Safety Endpoi...

Страница 48: ...he OPTION study compared to the TACT study The number of episodes and patients receiving any therapy is less than the total episodes of each therapy type as episodes may have included more than one ty...

Страница 49: ...Time Tachos DR Atrial Tx ICD Mean SE N Tupos LV ATx Mean SE N Difference Individual Readings 2 27 0 06 52 2 26 0 06 71 0 01 By Patient 2 27 0 07 26 2 24 0 06 35 0 03 The analysis demonstrates that the...

Страница 50: ...9 show a percentage of ventricular pacing of 91 or more at Six Months 4 The purpose of secondary endpoint 4 is to evaluate improvement in functional capacity as measured by the six minute walk test Th...

Страница 51: ...ontrol group 5 The purpose of Secondary Endpoint 5 is to evaluate the improvement in the patient s NYHA classification Table 15 summarizes the average improvement in NYHA from Baseline to Six Months f...

Страница 52: ...to the control group To be consistent with other large scale clinical trials clinical sites were instructed to report hospitalizations for CHF using the following definitions 1 hospitalization for he...

Страница 53: ...1 All causes 13 10 1 16 CHF Related 0 0 0 0 All causes 2 3 1 2 Outpatient Visits Patients Visits Patients Visits CHF Related 1 0 8 1 All causes 5 3 9 5 CHF Related 0 0 0 0 All causes 2 3 1 2 A large...

Страница 54: ...on of 596 5 months 49 0 patient years 65 7 of the enrolled control patients had a reported observation The rate of observations per patient year was 1 65 8 The purpose of Secondary Endpoint 8 is to ev...

Страница 55: ...ters used the same methods to collect and report the clinical data In order to justify pooling of the data from multiple centers several analyses were completed All of the centers were divided into tw...

Страница 56: ...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 patien...

Страница 57: ...mia inductions are recommended to verify pulse generator detection and conversion The pulse generator also may need to be reprogrammed Changes in a patient s antiarrhythmic drug or any other medicatio...

Страница 58: ...elivers a shock 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 pul...

Страница 59: ...apy parameter settings are relevant and appropriate Empirical changes to the detection or therapy parameters should be assessed based on patient safety Some changes may necessitate a re assessment of...

Страница 60: ...52 Lumax Technical Manual...

Страница 61: ...ic arrhythmias and condition 2 1 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...

Страница 62: ...rposes and LV pacing protection the Lumax HF devices can be programmed to sense in the left ventricle Atrial Channel The Lumax ICDs CRT Ds pace and sense in bipolar configuration between the atrial le...

Страница 63: ...the tip and ring electrodes bipolar or the tip electrode of the left ventricular lead and the CRT D housing unipolar Pacing RV LV Together BiV Pacing configuration is programmable between the tip and...

Страница 64: ...ventricle Triggered pacing can be programmed to react to only normal RV sensed events or to right ventricular extrasystoles as well as normal RV sensed events The maximum Trigger rate is normally limi...

Страница 65: ...This setting offers suppression of T wave oversensing This mode should not to be used on patients with the following conditions Sinus rhythms with small signal amplitudes R waves 4 mV VF with highly f...

Страница 66: ...he next sensed or paced event Figure 4 Automatic Sensitivity Control with Standard Setting Figure 4 provides an illustration of Automatic Sensitivity Control with the sensitivity programmed to Standar...

Страница 67: ...as T waves and respiratory artifacts The Upper Threshold is increased to 75 of the measured R wave The Upper Threshold may not retrigger with each sensed event it is only triggered when the new sensed...

Страница 68: ...s Each paced event is followed by a paced refractory period after which the atrial threshold is set to the minimum programmed value 2 2 4 Minimum Atrial Threshold This parameter limits the minimum sen...

Страница 69: ...arameter blanks the atrial channel of the ICD CRT D to the period before and after each ventricular event This blanking period is programmable separately based on whether the ventricular event is a pa...

Страница 70: ...ogrammed time Maximum Hold Time is programmable from 10 to 600 ms T Wave discrimination period Lower Threshold A RV LV This feature allows the user to change the lower sensing threshold labeled LT in...

Страница 71: ...the nighttime while the patient is normally sleeping It can measure the right and the left ventricular pacing thresholds and stores this information for use in trends of daily threshold values This i...

Страница 72: ...lse of the double pulses are assessed The signal quality check is successful if the single pulses are recognized as capturing pulses and the second pulses of the double pulses are classified as non ca...

Страница 73: ...oracic impedance measurement of Lumax 500 540 is based on the painless shock impedance feature of the Lumax ICD CRT D Family It utilizes 24 measurement windows evenly distributed over the course of 24...

Страница 74: ...to OFF prior to handling the device to prevent the delivery of serious shocks to the patient or the person handling the device during the implant procedure Classification of cardiac signals is accompl...

Страница 75: ...and VT 2 rate classifications The Counter Detection is the number of intervals required to declare a tachyarrhythmia as VT A tachyarrhythmia must meet both the rate interval criteria and the programme...

Страница 76: ...mia detection criteria including the VT sample counters are reset 2 5 4 SMART Detection DR and HF versions only This discrimination algorithm enhances VT 1 and VT 2 detection by applying a series of t...

Страница 77: ...arameter This parameter measures abrupt changes in ventricular cycle length to discriminate between sinus tachycardias and ventricular and atrial tachyarrhythmias which characteristically begin with a...

Страница 78: ...utilizing the detection enhancements A simple up down counter is used to initiate the safety timer The counter is incremented by one when an interval falls into a VT zone and decrements by one when a...

Страница 79: ...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 The...

Страница 80: ...isode 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...

Страница 81: ...ttempts parameter determines the number of burst schemes to be delivered before the scan parameter is incremented Burst This mode will deliver a series of pacing stimuli with user defined duration of...

Страница 82: ...1 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 D...

Страница 83: ...arameter NOTE 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 de...

Страница 84: ...n only be used with shock therapy is programmed ON 2 8 3 Shock Therapy Shock Therapy is developed by internal circuitry that stores energy across high energy capacitors The voltage level for the charg...

Страница 85: ...red to the patient during the synchronization period regardless of the detected cardiac signal Confirmation ON If the tachyarrhythmia spontaneously converts to bradycardia or a normal sinus rhythm dur...

Страница 86: ...standard Biphasic shock waveform for initial defibrillation threshold testing If testing demonstrates high defibrillation thresholds testing with the Biphasic 2ms waveform is offered as a therapeutic...

Страница 87: ...iants in Table 22 and for the Lumax 300 500 in Table 23 Table 22 Delivered Shock Energy 340 540 Variants Programmed Energy joules Approximate Delivered Energy joules 1 0 8 2 1 7 3 2 6 4 3 5 5 4 3 6 5...

Страница 88: ...Energy 300 500 Variants Programmed Energy joules Approximate Delivered 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...

Страница 89: ...ance that conversion will occur post operatively Shock Therapy Confirmation Programming CONFIRMATION to OFF may increase the incidence of the ICD CRT D delivering inappropriate shocks 2 8 3 5 Shock Po...

Страница 90: ...e 24 Lumax 500 540 Programmable Shock Pathways Electrical Pathway RV SVC and Housing can RV SVC RV Housing can 300 340 Models are limited to this configuration 2 8 4 Progressive Course of Therapy By d...

Страница 91: ...If a defibrillation shock is delivered but does not terminate the arrhythmia the next shock will always have the same or higher energy than the last delivered shock Beginning with the third shock all...

Страница 92: ...esets the lower rate time in the absence of a sensed event a pacing pulse will be delivered at the end of the lower rate interval The pacing modes with an R indicate rate adaptive pacing controlled by...

Страница 93: ...n the programmer clock Therefore the programmer time should be checked prior to device programming If a patient travels across different time zones the Night Mode time may require adjustment 2 9 4 Rat...

Страница 94: ...hysteresis is expanded programmability of the Hysteresis feature Repetitive hysteresis searches for an intrinsic cardiac rhythm which may exist below the programmed lower rate or sensor indicated rate...

Страница 95: ...s expanded programmability of the Hysteresis feature Scan hysteresis searches for an intrinsic cardiac rhythm which may exist just below the programmed lower rate or sensor indicated rate Following 18...

Страница 96: ...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 intri...

Страница 97: ...d HF T ICDs CRT Ds 2 9 5 1 Positive AV Hysteresis Positive AV Hysteresis allows a user programmable change in AV delay that is designed to encourage normal conduction of intrinsic signals from the atr...

Страница 98: ...lay is shortened by a defined hysteresis value after sensing an intrinsic ventricular event as described above The short AV Delay will retain until the programmed number of cycles has elapsed OFF 1 18...

Страница 99: ...OPT Parameters Parameter IOPT AV Hysteresis max AV Delay 400 ms AV Scan Hysteresis 5 Repetitive AV Hysteresis 5 2 9 7 Upper Tracking Rate DR and HF versions only In the atrial tracking modes DDDR VDDR...

Страница 100: ...ory 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...

Страница 101: ...DD 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 swit...

Страница 102: ...Response Whenever Mode Switching event terminates deactivating the mode switch pacing the device can be programmed to react with different basic rate for a specified amount of time Two parameters are...

Страница 103: ...ARPE is available in the DDD VDD DDT and VDT modes To prevent the initiation of a pacemaker mediated tachycardia PMT by a ventricular depolarization not preceded by an atrial depolarization the ARP w...

Страница 104: ...depolarization falls in the PVARP and thus will be inhibited terminating the PMT Figure 9 Dynamic AV delay for PMT termination 2 9 9 3 PMT Detection and Termination In addition to PMT prevention Lumax...

Страница 105: ...or one cycle to equal the V V interval 50 ms 2 9 10 VES Discrimination after Atrial Sensed Events Lumax ICD CRT D has a special timing interval VES As VES discrimination after atrial sense events to i...

Страница 106: ...ange 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 litt...

Страница 107: ...emented by one step 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...

Страница 108: ...ammed interval if the ventricular event is not followed by an atrial sensed event VES 2 9 16 Auto PVARP DR and HF versions only This parameter automatically adjusts the Post Ventricular Atrial Refract...

Страница 109: ...ration RV BiV Basic Rate Rate Hysteresis AV Delay Post Shock Duration If bradycardia pacing is still required after the post shock duration expires standard bradycardia pacing parameters are active 2...

Страница 110: ...gram IEGM with marker signals to indicate sensed and paced events 2 10 2 Pacing Impedance Measurements The Lumax ICDs CRT Ds have the ability to perform automatic and manual pacing impedance measureme...

Страница 111: ...ular stimulation The ICD CRT D features a test for measuring retrograde conduction time During operation of this test the patient is paced in VDI mode at an increased ventricular rate over several cyc...

Страница 112: ...ng the threshold testing by selecting the desired value from the table 2 10 6 Arrhythmia Induction Features The ICD CRT D offers three arrhythmia induction methods for non invasive EP testing These in...

Страница 113: ...grammable 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...

Страница 114: ...n will occur post operatively 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 dev...

Страница 115: ...in the ICD therapy window WARNING 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 dev...

Страница 116: ...th 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 acti...

Страница 117: ...n two formats via fax or via BIOTRONIK s secure Internet connection Reports are available depending on the type of report transmission periodic or event triggered This Cardio Report which is adjusted...

Страница 118: ...itted upon request of the physician in the clinic Daily Report The time of daily Home Monitoring Report transmission is programmable For periodic messages the time can be set anywhere between 0 00 and...

Страница 119: ...t transmission may occur 2 minutes after the programmed transmission time WARNING A timely receipt of the event report cannot be guaranteed The receipt is also dependent on whether the patient was phy...

Страница 120: ...hreshold Measured LV pacing threshold RV enabled disabled LV enabled disabled Date time of ATM measurement Pacing Impedance RA RV LV BiV Mean of 4 daily measurements Sensing Amplitude RA RV LV BiV Mea...

Страница 121: ...are transmitted as 3 byte counter Atrial Arrhythmia Atrial Tachy Episodes 36 out of 48 criteria Life Time Counter on AT AF detections Atrial Burden per Day Ongoing Atrial Episode Time programmable for...

Страница 122: ...Minimal ventricular heart rate at rest Max mean ventricular heart rate during atrial episodes Heart Rate Variability Atrial SDANN per day 5 min periods of As As Patient Activity Duration per day from...

Страница 123: ...the number of IEGM channels programmed in the Holter configuration If an episode is terminated each IEGM Frame contains up to 8s of pre detection IEGM and up to 2s of pre termination IEGM If the epis...

Страница 124: ...so transmitted AS including Ars AP VS including Vrs VP VT1 VT2 VF SVT atrial and refractory sensed events included with sensed events and AF The IEGM Online HD from the most recent episode is stored i...

Страница 125: ...to the programmer via the programming head positioned over the implanted pulse generator The surface ECG is continuously displayed in the Overview screen the Sensing screen and the EP test functions m...

Страница 126: ...capacitors and then allows the capacitors to discharge into an internal resistor No shock will be delivered to the patient Throughout the re formation process the ICD CRT D will provide bradycardia pa...

Страница 127: ...h a maximum energy charge Energy Charge time Date Time Total number of charges Last Home Monitoring message Type of message Time and date 2 11 7 HF Monitor Statistics The ICD CRT D stores a variety of...

Страница 128: ...Lumax CRT D measures and stores the patient s resting heart rate MHRR Average values are calculated over a defined period The daily value is based on the smallest mean value in any evaluation window o...

Страница 129: ...ch individual episode presented as a table of events ordered from most recently delivered to the first delivered Each IEGM segment can be viewed from the episode detail sub menu by selecting the IEGM...

Страница 130: ...ilable parameters include Detection Episodes since last follow up and since implantation Atr SVT VT1 VT2 VF SVT Details AFlut AFib Sinus T 1 1 Therapy Episodes since last follow up and since implantat...

Страница 131: ...of several timing events are displayed under the Event Episode heading These include Pacing Counters Brady AV Sequences Intrinsic Rhythm AsVs Conducted Rhythm AsVp Atrial Paced Rhythm ApVs Complete P...

Страница 132: ...atients susceptibility to atrial arrhythmias including Atrial Burden length of episodes Number of Episodes and Stress Duration minutes day This screen also includes graphing of the ventricular reactio...

Страница 133: ...report provides trend information on atrial and right ventricular pacing impedance as well as shock impedance measurements 2 11 15 Automatic Threshold The activity report provides trend information o...

Страница 134: ...ed 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 temp...

Страница 135: ...6 Lumax Technical Manual...

Страница 136: ...The PA 2 adapter is used to connect IS 1 compatible leads to the PK 44 cable The PA 3 adapter is used to connect DF 1 compatible leads to the PK 44 cable Adapter PA 4 used to connect the PK 44 cable...

Страница 137: ...l Manual Sufficient training on the device and its associated components is required prior to implanting the ICD CRT D For additional information training and training materials contact your BIOTRONIK...

Страница 138: ...5841 3 IS 1 and ISO 11318 1993 E DF 1 The following leads were evaluated in a retrospective study with BIOTRONIK s ICDs CRT Ds Medtronic Sprint 6932 Medtronic Sprint 6943 Medtronic Sprint Quattro 694...

Страница 139: ...LV 1 Guidant Easytrak 2 Guidant Easytrak 3 Medtronic Attain St Jude Aescula St Jude Quicksite Biomec Myopore Epicardial Medtronic Epicardial 5071 Medtronic CapSure EPI Biotronik ELC 54 UP The followin...

Страница 140: ...to the device implanted or out of the box Programming wand distance closer than 2 cm may damage the device CAUTION Shock Impedance If the shock impedance is less than twenty five ohms reposition the l...

Страница 141: ...SO 11318 1993 Refer to the appropriate lead system technical manual 4 3 Opening the Sterile Container The Lumax ICD CRT Ds are packaged in two plastic containers one within the other Each is individua...

Страница 142: ...prior to performing medical procedures In addition the ICD CRT D should be checked after the procedures to assure proper programming Electrocautery Electrosurgical cautery could induce ventricular arr...

Страница 143: ...14 Lumax Technical Manual Figure 11 Header Ports...

Страница 144: ...s inserted Tightening Setscrew s Do not overtighten the setscrew s Use only the BIOTRONIK supplied torque wrench Sealing System Be sure to properly insert the torque wrench into the perforation at an...

Страница 145: ...y tighten the setscrew of the connector clockwise with the torque wrench until torque transmission is limited by the wrench 5 After carefully retracting the torque wrench the perforation will self sea...

Страница 146: ...m the ICD CRT D to appropriately treat the patient s arrhythmias and other therapy needs The information obtained during the lead system evaluation should be helpful in tailoring the various parameter...

Страница 147: ...rance that conversion will occur post operatively WARNING 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...

Страница 148: ...k impedance is less than twenty five ohms reposition the lead system to allow a greater distance between the electrodes Never implant the device with a lead system that has a measured shock impedance...

Страница 149: ...prior to performing any of the following medical procedures In addition the ICD CRT D should be checked after the procedures to assure proper programming Electrocautery Electrosurgical cautery could i...

Страница 150: ...he device displays Shipment Mode Active in the event list The Shipment Mode is OFF if the device does not display Shipment Mode Active in the event list Complete the Medical Device Registration Form p...

Страница 151: ...22 Lumax Technical Manual...

Страница 152: ...follow up by viewing the parameters displayed on the programmer screen after the device has been programmed and interrogated As the final step at device implant and each patient follow up the permane...

Страница 153: ...l tachyarrhythmia detection and tachyarrhythmia therapy is disabled CAUTION Charge Time When preparing a high energy shock the charge circuit stops charging the capacitors after 20 seconds and deliver...

Страница 154: ...It is assumed that the shocks are equally spaced throughout the life of the ICD Table 28 Lumax 340 DR T Longevity Estimates Pacing Support Shocks per year max energy 0 15 50 100 4 5 7 5 4 4 8 4 1 5 5...

Страница 155: ...1 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 v...

Страница 156: ...ides several different support scenarios It is assumed that the shocks are equally spaced throughout the life of the ICD Table 32 Lumax DR T Longevity Estimates Pacing Support Device Shocks per year 0...

Страница 157: ...nitoring 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 p...

Страница 158: ...he explanted devices should be cleaned with a sodium hyperchlorine solution of at least 1 chlorine and then washed with water prior to shipping The pulse generator should be explanted before the crema...

Страница 159: ...66 mm x 59 mm x 13 mm Volume 34 6 cm3 37 2 cm3 37 1 cm3 39 8 cm3 Mass 81 g 92 g 83 g 94 g Housing Titanium Header Epoxy resin Seal Plug Silicone VR T Lead Ports 1 x 3 2 mm IS 1 Bipolar 2 x 3 2 mm DF 1...

Страница 160: ...0 5 0 1 2 5 mV 0 8 mV Blanking after atrial pacing Safety window 100 ms Upper threshold 50 75 87 5 50 Hold of upper threshold 100 20 600 ms 360 ms Lower threshold 12 5 25 50 50 In channel Cross channe...

Страница 161: ...DR DDI DDIR VDD VDDR VDI VDIR VVI VVIR AAI AAIR OFF DDD Basic Rate Day Night Basic rate 30 5 100 10 160 ppm 60 ppm Night rate OFF 30 5 100 ppm OFF Night beginning 00 00 1 min 23 59 h m 22 00 h m Night...

Страница 162: ...ms 400ms Post ventricular Atrial Refractory Period PVARP PVARP 175 25 600 ms Auto 250 ms Auto PVARP OFF ON OFF VES Classification VES Lock in Protection VES discrimination after As 250 50 450 ms 350 m...

Страница 163: ...I VDIR at permanent VDD R DDI VDI Change in basic rate OFF 5 5 30 ppm 10 ppm Post Mode Switch Response PMSR Post ModeSw rate OFF 5 5 50 ppm 10 ppm Post ModeSw duration 1 1 30 min 1 min PMT Protection...

Страница 164: ...48 ms 24 ms SMART Detection SMART detection VT1 OFF ON ON SMART detection VT2 OFF ON ON Sustained VT without SMART Detection and without SMART Redetection Sustained VT OFF 00 30 01 00 02 00 03 00 05...

Страница 165: ...and 2nd shock VF model 340 540 1 1 1 16 2 40 J 40 J Number of shocks VT1 VT2 0 1 8 8 Number of shocks VF 2 6 1 8 8 Confirmation per zone OFF ON ON Shock form per zone Biphasic biphasic2 Biphasic Polar...

Страница 166: ...mber 1 1 10 5 R S1 interval 200 10 350 ms absolute 70 5 95 adaptive 80 S1 decrement 5 5 40 ms 10ms S1 S2 interval 200 10 350 ms absolute 70 5 95 adaptive 70 Stability 12 12 ATP attempts 1 1 ATP pulse...

Страница 167: ...hs OFF Sustained atrial episode OFF 0 5 6 12 18 h 12 h FCC Statement FCC ID QRILUMAXT This implant is equipped with an RF transmitter for wireless communications This device may not interfere with sta...

Страница 168: ...Lumax Technical Manual 39...

Страница 169: ...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...

Страница 170: ...Lumax Technical Manual 41...

Страница 171: ...return to programmed behavior Unexpected RVs LVp sequences may appear in statistics despite R L tracking not being active when events occur ID 38908 No effect on patient additional diagnostic data is...

Страница 172: ...urate message that therapy is available is possible after a program transmission to a Lumax ICD in the reset state Actual therapy availability is based on the current setting of the master switch ID 2...

Страница 173: ...ect on patient sensor data collected from non rated adaptive pacing will not be optimized for later change to rate adaptive pacing settings In Sensing Test Freeze Window Display of P R wave amplitude...

Страница 174: ...ain sensor indicated rate ID 19607 Limited effect on patient temporary rate drop to programmed post shock pacing rate ensures sufficient support An ineffective pacing program may continue during the t...

Страница 175: ......

Страница 176: ...Distributed by BIOTRONIK Inc 6024 Jean Road Lake Oswego OR 97035 5369 800 547 0394 24 hour 503 635 9936 FAX Manufactured by BIOTRONIK GmbH Co KG Woermannkehre 1 12359 Berlin M4117 B 05 08 Germany...

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