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BIOTRONIK Evia DR, Техническое руководство

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Evia Technical Manual 45 

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. Patients were scheduled for office device 
interrogations only at the 3 month and 15 month follow-up points 
(following the HM online check).  At 6, 9 and 12 months, a HM 
check was performed first. Investigators may then elect to 
perform an office device interrogation if they determine that it is 
necessary after reviewing the HM data. 

Group 2 (Control) 

Patients were evaluated using conventional, calendar-based 
office visits at 3, 6, 9, 12 and 15 months post-implant.  Interim 
visits were made according to physician discretion (e.g. following 
any ICD discharges or symptoms).  Home Monitoring was to be 
programmed OFF for the duration of the study. 

HM Event Triggered Device Evaluations 

Investigators with patients in Group 1 (HM) may receive HM 
notifications in response to pre-programmed events such as VT1 
detected and SVT detected. Upon the receipt of a HM Event 
Notification, investigators reviewed the notification and the 
associated information on the HM/IEGM-Online website and 
recorded the type of event and what type of action, if any, was 
taken as a result of this notification. 

Patient-Initiated Device Evaluations 

Investigators may be contacted by the patient for 
device/arrhythmia-related care (e.g. perceived device discharge, 
symptoms).  For patients in Group 1 (HM), investigators triaged 
the complaint using the Home Monitoring website. Investigators 
recorded if the information from Home Monitoring was sufficient. 
For patients in Group 2 (Control), the complaint was assessed 
per standard of care or normal clinic procedures. 

Содержание Evia DR

Страница 1: ...Evia Family of Implantable Pulse Generators Technical Manual...

Страница 2: ...S 1 and VS 1 standards lead pulse generator compatibility should be confirmed with the pulse generator and or lead manufacturer prior to the implantation of a pacing system IS 1 wherever stated in thi...

Страница 3: ...lse Generator Explant and Disposal 19 5 Adverse Events 21 5 1 Observed Adverse Events 21 5 1 1 Dromos DR Clinical Study 21 5 1 2 PACC Clinical Study 23 5 1 3 Inos2 CLS Clinical Study 24 5 2 Potential...

Страница 4: ...ulse Width 64 7 4 Automatic Sensitivity Control ASC 64 7 5 Timing Features 65 7 5 1 Refractory Periods 65 7 5 2 PVARP 65 7 5 3 AV Delay 67 7 5 4 Ventricular Blanking Period 71 7 5 5 Atrial Blanking Pe...

Страница 5: ...Statistics Overview 109 8 1 1 Timing 109 8 1 2 Atrial Arrhythmia 109 8 1 3 Sensor 109 8 1 4 Sensing 110 8 1 5 Ventricular Arrhythmia 110 8 1 6 Pacing 110 8 1 7 General Statistical Information 110 8 2...

Страница 6: ...Auto Initialization 133 12 Follow up Procedures 136 12 1 General Considerations 136 12 2 Real time IEGM Transmission 137 12 3 Threshold Test 137 12 4 P R Measurement 138 12 5 Testing for Retrograde Co...

Страница 7: ...15 2 4Additional Functions 160 15 2 5NIPS Specifications 161 15 3 Programmer 161 15 4 Materials in Contact with Human Tissue 161 15 5 Electrical Data Battery 161 15 6 Mechanical Data 163 16 Order Inf...

Страница 8: ...vi Evia Technical Manual...

Страница 9: ...s the pulse generator can provide a pacing rate that is appropriate and specific to the patient s individual physiologic demands due to exercise and acute mental stress For standard motion based rate...

Страница 10: ...of arrhythmias BIOTRONIK Home Monitoring provides early detection of silent asymptomatic arrhythmias Automatic early detection of arrhythmias and device system anomalies by BIOTRONIK Home Monitoring...

Страница 11: ...ate adaptive unipolar bipolar with Home Monitoring Evia SR Single chamber rate adaptive unipolar bipolar Evia SR T Single chamber rate adaptive unipolar bipolar with Home Monitoring Throughout this ma...

Страница 12: ...sinus arrest sinus bradycardia sino atrial SA block second and third degree AV block and carotid sinus syndrome Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should...

Страница 13: ...Evia Technical Manual 5...

Страница 14: ...illator ICD because it may cause unwanted delivery or inhibition of ICD therapy Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction Dual chamber and single c...

Страница 15: ...Evia Technical Manual 7...

Страница 16: ...ate adaptive pacing with care in patients unable to tolerate increased pacing rates 4 1 Medical Therapy Before applying one of the following procedures a detailed analysis of the advantages and risks...

Страница 17: ...lectrode s should not be less than 10 cm 4 inches Radiation Pulse generator electronics may be damaged by exposure to radiation during radiotherapy To minimize this risk when using such therapy the pu...

Страница 18: ...e Device Packaging Do not use the device if the packaging is wet punctured opened or damaged because the integrity of the sterile packaging may be compromised Return the device to BIOTRONIK Storage ma...

Страница 19: ...of a pacing system IS 1 wherever stated in this manual refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit Reference ISO 5841 3 1992...

Страница 20: ...can be induced by stimulation in the atrium Ensure that an external cardiac defibrillator is easily accessible Only physicians trained and experienced in tachycardia induction and reversion protocols...

Страница 21: ...erefore may be contraindicated in some patients OFF Mode Use of the OFF mode should be avoided in pacemaker dependent patients The OFF mode can be transmitted as a temporary program only to permit eva...

Страница 22: ...hese modes is intended as a temporary setting in situations where maintaining the programming head in place would be impossible or impractical i e during exercise testing or extended Holter monitoring...

Страница 23: ...ricted or prohibited i e commercial aircraft 4 6 Electromagnetic Interference EMI The operation of any implanted pulse generator may be affected by certain environmental sources generating signals tha...

Страница 24: ...g it off will allow the pulse generator to return to its normal mode of operation Some potential EMI sources include High Voltage Power Transmission Lines High voltage power transmission lines may gen...

Страница 25: ...Cellular Phones Recent studies have indicated there may be a potential interaction between cellular phones and pulse generator operation Potential effects may be due to either the radio frequency sign...

Страница 26: ...re the phone in a location opposite the side of implant 4 6 3 Hospital and Medical Environments Electrosurgical Cautery Electrosurgical cautery could induce ventricular arrhythmias and or fibrillation...

Страница 27: ...rator Explant and Disposal Device Incineration Never incinerate a pulse generator Be sure the pulse generator is explanted before a patient who has died is cremated see Section 14 Explanted Devices Re...

Страница 28: ...20 Evia Technical Manual...

Страница 29: ...Events 5 1 1 Dromos DR Clinical Study The Dromos DR Clinical Study involved 273 patients with cumulative implant duration of 1418 months mean implant duration 5 2 months Eleven patients died during t...

Страница 30: ...Diaphragm atic Stimulation 3 1 1 3 0 0021 473 Unexplained Syncope 3 1 1 3 0 0021 473 Complications total 14 5 1 14 0 0099 101 Atrial Lead Dislodgment 6 2 2 6 0 0042 236 Ventricular Lead Dislodgment 4...

Страница 31: ...h a cumulative implant duration of 764 1 months average implant duration of 5 1 0 3 months A total of 109 patients had an implant duration of greater than 90 days There were two patient deaths reporte...

Страница 32: ...rse events reported below are from the Inos2 CLS clinical study which investigated the principle of Closed Loop Stimulation CLS and its regulation of heart rate Additionally the Protos AxVx Clinical E...

Страница 33: ...ents that were reported during the clinical study regardless of whether or not the event was related to the pacemaker system A complication was defined as a clinical event that resulted in additional...

Страница 34: ...ation Air embolism Pocket erosion Infection Lead fracture insulation damage Lead dislodgment Lead related thrombosis Body rejection phenomena Muscle or nerve stimulation Elevated pacing thresholds Poc...

Страница 35: ...rs with a range of 31 to 95 and 145 of 273 53 were male Pre implantation clinical symptomology was bradycardia in 44 of the patients dizziness in 31 syncope in 25 ECG indications were Sick Sinus Syndr...

Страница 36: ...ervations or complications see Section 5 Adverse Events Conclusions No unusual safety concerns were raised by the results of the clinical study The accelerometer based motion sensor provided the patie...

Страница 37: ...investigation was conducted at 14 centers The patients selected for participation were from the investigator s general patient population meeting the indications for use of the Philos DR ACC pulse gen...

Страница 38: ...ups for patients with a 90 day implant duration There were 104 patients with an implant duration of greater than 90 days who had an evaluable ECG tracing demonstrating 100 ventricular pacing with app...

Страница 39: ...A total of 3189 non captured events were documented on the Holter recordings and analyzed on a beat to beat basis The Holter recordings documented that 3189 back up pulses were delivered appropriately...

Страница 40: ...t and three others occurred at pre discharge follow up within 2 days of implant All subsequent follow ups after lead maturation for these four patients showed a difference of less than 0 5 volts betwe...

Страница 41: ...rence than mean difference It is concluded that the automatic ventricular pacing threshold is equivalent within 0 2 volts to the manual determination The threshold measurement analysis clearly demonst...

Страница 42: ...ove 4 8V where ACC remains activated Table 6 Highest Maximum ACC Amplitude Setting Testing of Maximum ACC Amplitude Result Number of tests completed Highest Functional Maximum ACC Amplitude 2 4 Volts...

Страница 43: ...portion of the Cylos family of pulse generators 1 The Protos DR CLS ER study provides information on the response of CLS to acute mental stress Section 6 3 1 2 The Protos DR CLS AxVx study provides i...

Страница 44: ...in a resting baseline for the patient s heart rate The second half of the presentation was to challenge the patient by asking questions regarding colors word association and mathematical equations For...

Страница 45: ...s testing significantly exceeds the average observed resting heart rate for the tested patient population As shown in Figure 3 for these 40 subjects the average heart rate increased from 64 27 4 8 bpm...

Страница 46: ...4 1 15 bpm and the age group 60 years was 18 79 5 89 bpm The rate response provided by CLS is consistent with those age matched healthy subjects in the literature CLS demonstrated an appropriate respo...

Страница 47: ...estigation was conducted at 5 centers The average patient was a 70 year old male with sinus bradycardia During a follow up visit the pacemakers were downloaded with the AxVx investigational software A...

Страница 48: ...d Loop Rate Figure 4 shows the obtained heart rate versus the expected heart rate during the CAEP treadmill test for all patients completing at least 3 stages of exercise n 13 0 00 0 20 0 40 0 60 0 80...

Страница 49: ...daptive algorithm provides appropriate rate response as tested during a symptom limited CAEP treadmill test for patients exhibiting a high percentage of ventricular sensing 99 1 for 13 patients meetin...

Страница 50: ...5 confidence interval of 0 75 0 89 These values meet the acceptance criterion for this objective Table 8 compares several predicted heart rates to the obtained rates as estimated by linear regression...

Страница 51: ...ed MCLR 46 2 24 52 Figure 5 shows the obtained heart rate versus the expected heart rate during the CAEP treadmill test for all patients completing at least 4 stages of exercise n 52 CAEP Workload nor...

Страница 52: ...re indicated for rate adaptive pacing The Inos Clinical Study fulfilled the predefined primary safety and efficacy endpoints These endpoints included appropriate obtained heart rates during exercise a...

Страница 53: ...implant Interim visits were made according to physician discretion e g following any ICD discharges or symptoms Home Monitoring was to be programmed OFF for the duration of the study HM Event Triggere...

Страница 54: ...time relative to onset Inclusion Criteria To support the objectives of this investigation the inclusion criteria at the time of patient enrollment for this investigational study included the followin...

Страница 55: ...ent duration is 18 367 months with mean enrollment duration of 12 7 months The patient follow up compliance rate for all enrolled patients is 87 5 in Group 1 and 78 8 in Group 2 6 4 3 1 Primary Endpoi...

Страница 56: ...1 The primary effectiveness endpoint was met 6 4 3 2 Primary Endpoint 2 Safety Event Rate The purpose of the primary endpoint 2 was to compare the Safety Event Rate SER which includes death incidence...

Страница 57: ...vent rate for the Control Group within 5 The upper one sided 95 confidence bound for the difference was 2 7 A rejection of the null hypothesis indicates that the safety event rate for Group 1 HM is eq...

Страница 58: ...Onset to Evaluation of First Event Patient Group 1 N 972 Group 2 N 471 p value AF Median Mean SD days Min Max of patients with events 5 0 25 2 34 2 0 171 73 7 5 39 5 46 8 33 7 1 114 28 5 9 p 0 001 p 0...

Страница 59: ...e from onset to evaluation of the first AF VT and VF events in Group 1 is significantly less than the mean time from onset to evaluation of the first AF VT and VF events in Group 2 P values are 0 005...

Страница 60: ...te 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...

Страница 61: ...rate adaptive modes function identically to the corresponding non rate adaptive modes except that the basic rate increases when physical activity is detected by the motion sensor In demand modes DDDR...

Страница 62: ...tion may be programmed to switch to motion based adaptation The DDD CLS and VVI CLS mode is functionally equivalent to the DDDR and VVIR pacing modes respectively However these modes use the CLS conce...

Страница 63: ...sic rate during an active Mode Switch in order to diminish undesirable hemodynamic behaviors The mode switch occurs from atrial tracking to non atrial tracking pacing modes e g DDDR to DDIR as describ...

Страница 64: ...ing has occurred The demand and corresponding triggered pacing modes are Demand DDD VVI AAI Triggered DDT VVT AAT The triggered pacing mode fixes the AV delay to 180 ms and does not provide a safety A...

Страница 65: ...tor inhibition by extracardiac interference To avoid the potential for early battery depletion it is important that the triggered modes are not used for long term therapy and that the pulse generator...

Страница 66: ...If no sensed event occurs a pacing pulse is emitted following the Hysteresis interval NOTE If rate adaptation is active the Hysteresis rate is based on the current sensor indicated rate and the value...

Страница 67: ...cardiac rhythm is not detected within the programmed number of beats at the hysteresis rate the stimulation rate returns back to the original lower rate or sensor indicated rate Several programmable...

Страница 68: ...the programmed lower rate or sensor indicated rate of the patient Following 180 consecutive sensed events this feature allows the intrinsic rhythm to drop to or below the hysteresis rate During the ti...

Страница 69: ...base rate is gradually and temporarily reduced to the programmed night pacing rate At the end of night mode the base rate gradually returns to the original values The Night Mode feature has been incor...

Страница 70: ...gy and fainting With Rate Fading enabled the pulse generator calculates the Fading Rate which is a four beat average of the intrinsic rate reduced by 10 ppm When the intrinsic rate drops considerably...

Страница 71: ...to a value higher than the programmed Maximum VCC Amplitude Max Ampl When VCC is programmed to ON the pulse amplitude will be set by the device to the threshold plus the programmed Safety Margin but...

Страница 72: ...rtifacts or interference a change to a lower sensitivity higher value may resolve the difficulty The sensitivity values for the atrial and ventricular channels are independently programmable or automa...

Страница 73: ...adjusted by the Auto Aref functionality PVARP is started with each ventricular pace outside of the AV delay In DDI mode PVARP is also started with a regular ventricular sense PVARP after PVC is start...

Страница 74: ...KB Vp SW Vp BU In R synchronous modes e g DDI the PVARP timer is started after Vp Vp SW Vp BU VES Vs and Vs AVC After a VES the parameter PVARP after PVC is automatically extended to PVARP 150ms up to...

Страница 75: ...aximum value of 600ms If there is no PMT detected by the algorithm both the PVARP and PVARP after PVC is reduced by 50ms every 7 days but no less than the minimum value of 175ms 7 5 3 AV Delay 7 5 3 1...

Страница 76: ...ove 130 bpm 180 ms 170 ms 160 ms 150 ms 140 ms CLS Modes below 70 bpm 70 90 bpm 91 110 bpm 111 130 bpm above 130 bpm 150 ms 140 ms 130 ms 120 ms 120 ms In addition the Dynamic AV Delays may be program...

Страница 77: ...tricular event The long AV interval is used as long as intrinsic ventricular activity is detected The programmed short AV delay interval resumes after a ventricular paced event Table 16 AV Hysteresis...

Страница 78: ...180 consecutive pacing cycles the AV delay is extended for the programmed number of pacing cycles 1 10 If an intrinsic rhythm is detected within the extended AV delay the longer AV delay remains in e...

Страница 79: ...n and or survival 7 5 3 6 I Opt The I Opt function serves to support the intrinsic rhythm of the heart It activates all of the AV hysteresis function parameters in a single step Subsequent to switchin...

Страница 80: ...l for both sensed and paced events to prevent inappropriate mode switching The blanking interval begins with a ventricular paced sensed event The device recognizes the paced sensed far field event on...

Страница 81: ...trial rate 7 6 Lead Polarity The programmed lead polarity determines whether the pulse generator senses or paces in a unipolar or bipolar configuration Lead polarity can be programmed separately for s...

Страница 82: ...e hybrid circuit of the pulse generator This sensor produces an electric signal during physical activity of the patient If a rate adaptive mode is programmed then the sensor signal controls the stimul...

Страница 83: ...permits adaptation of the individually programmed sensor gain to the desired rate response The optimum setting is achieved when the desired maximum pacing rate during exertion is reached during maximu...

Страница 84: ...over 7 consecutive days An increase in gain cannot occur more often than every 7 days If during the 24 hour period beginning at midnight the activity rate reaches or exceeds the programmed activity r...

Страница 85: ...rate response Figure 15 The programmable sensor threshold ensures that a stable rate at rest can be achieved by ignoring sensor signals of low amplitude that are not related to exertion If the pacing...

Страница 86: ...second increase in pacing rate would take 45 seconds to change from a pacing rate of 60 ppm to 150 ppm Table 18 Rate Increase Increase in Rate ppm s Time to Increase Rate seconds 1 90 2 45 4 23 10 9...

Страница 87: ...ly be made after careful clinical assessment Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm NOTE In the DDIR and DVIR modes the sensor rates con...

Страница 88: ...um rate of change in the pacing rate if the sensor signal indicates decreasing exertion In DDDR VDDR DOOR VVIR VOOR AAIR and AOOR the rate decrease setting of 0 5 ppm per second decrease in pacing rat...

Страница 89: ...n The pulse generator suspects 2 1 Lock In when the following criteria are met 8 successive V pace A sense VpAs sequences have occurred with an average length shorter than the 2 1 Lock In VA Length Cr...

Страница 90: ...ecommendations for programming the far field protection period in conjunction with the 2 1 Lock In Management feature 7 9 Atrial Upper Rate The atrial upper rate AUR prevents atrial pacing from occurr...

Страница 91: ...xed rate increase 8 ppm above the last P P interval If the intrinsic rate does not continue to rise after the programmable number of cycles overdrive pacing plateau the overdrive pacing rate is reduce...

Страница 92: ...activated for a third time because the average safety rate has been exceeded overdrive pacing remains OFF permanently The overdrive mode can not be reactivated until after the pacemaker has been progr...

Страница 93: ...rotection interval after each ventricular paced event If an atrial event is sensed within this PMT protection interval this will neither start an AV delay nor a basic interval The length of the PMT pr...

Страница 94: ...val remains stable a PMT is confirmed Otherwise a PMT is not confirmed and the algorithm restarts Once the PMT algorithm has confirmed a PMT the cycle is broken as follows Termination Evia extends PVA...

Страница 95: ...logy between the polarization artifact and the evoked response signal are used to distinguish capture events from non capture events The polarization artifact is the signal caused by the pacing pulse...

Страница 96: ...acing pulses at varying AV delays did not capture with a maximum of 3 consecutive NC s MaxVCCAmp Threshold test start This programmable parameter is the maximum voltage setting that VCC will set after...

Страница 97: ...pulse is emited if NC occurs pulse width set to 1ms y Set Amp MaxACCAmp or higher y Repeat SQC CTS at next scheduled time y Three consecutive double failures of SQC CTS will disable ACC Set Amp Thresh...

Страница 98: ...rovides a flow chart of the VCC operation Signal Analysis SA A polarization artifact that is too large may disturb the cardiac signal following the pacing pulse and result in misclassification of the...

Страница 99: ...distinguish capture from non capture If the artifact following the second pacing pulse is higher than a certain limit then SA is classified as unsuccessful If necessary this test can be repeated at a...

Страница 100: ...programmed safety margin If two non captures are detected when the voltage decrements are greater than 0 1 V the pacing amplitude is set to the previous amplitude and then the amplitude decrements by...

Страница 101: ...apture in the dual chamber pacing modes First fusion is diminished by extending the AV delay If a second non capture is detected the AV delay is returned to the programmed AV delay If a third consecut...

Страница 102: ...the threshold search decreases the output to 0 1 V without detecting non capture An ongoing SA CV sequence will abort when the following events occur Mode Switch Mode switch has a higher priority tha...

Страница 103: ...ular pacing amplitude is set to high output when the following events occur The ventricular rate is higher than 110 bpm CV is suspended while the ventricular rate is higher than 110 bpm When the ventr...

Страница 104: ...y that a depolarization occurred as a result of the pulse Upon detection of non capture the device will issue a back up pulse at a higher output pulse width increased to 1ms within 130 ms If loss of c...

Страница 105: ...the parameter page displays the suggested parameter values in blue color This indicates the recommended setting changes to the user from the current settings so that they can confirm them prior to ac...

Страница 106: ...ttings High atrial rate AT ModeSw ModeSw HVR limit bpm 180 160 160 Table 23 Permanent High Degree AV Block and Paroxysmal High Degree AV Block Standard Program Permanent High Degree AV Block Paroxysma...

Страница 107: ...ode Disease Permanent AV Block Valid for DR T DR T SR T DR T Parameters Mode DDD R VVI CLS DDD CLS Rate Hysteresis ppm OFF CLS Vp required No Yes CLS Resting Rate Control 20 20 AV Hysteresis OFF OFF 2...

Страница 108: ...cope Valid for DR T DR T DR T Parameters Mode DDD R DDD CLS DDD CLS Rate Hysteresis ppm OFF CLS Vp required No No CLS Resting Rate Control 20 OFF AV Hysteresis OFF IOPT IOPT Holter settings High atria...

Страница 109: ...HAR limit bpm 200 HVR limit bpm 180 HVR counter 8 7 15 Home Monitoring Evia DR T Home Monitoring enables the exchange of information about a patient s cardiac status from the implant to the physician...

Страница 110: ...of Home Monitoring data are no longer possible 7 15 1 Transmission of Information The implant transmits information with a small transmitter which has a range of about 6 feet 2 meters The patient s i...

Страница 111: ...TRONIK 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...

Страница 112: ...ccurrence of an Event Triggered Message through email or SMS i e mobile phone with a brief text message If registered for Internet availability the patient s detailed implant data can then be viewed b...

Страница 113: ...lect a time between 0 00 and 4 00 The length of the time interval monitoring interval is preset to daily For each monitoring interval a data set is generated in the implant and the transmission is ini...

Страница 114: ...dic message was transmitted In a periodic report the monitoring interval since the previous periodic report would be 24 hours The following data are transmitted for the Cardio Report by the Home Monit...

Страница 115: ...Rhythm ApVp Atrial Arrhythmia Atrial Tachy Episodes 36 out of 48 criteria Counter on AT AF detections per day Atrial Burden per day Ongoing Atrial Episode Time programmable for 6 12 or 18 hrs Mode Swi...

Страница 116: ...D IEGM and marker data from the periodic follow ups as an addition to the current messages An IEGM with up to 2 channels RV and or RA are sent in one message depending on the number of IEGM channels p...

Страница 117: ...of such features as rate histograms event counters sensor trends VES statistics and activity reports which are described in the following sections 8 1 1 Timing Event Counters Event Episodes Rate Trend...

Страница 118: ...ia pulse generators statistics modes are always in operation and cannot be selected OFF The counters within the statistic features do not operate when a magnet is applied to the pulse generator The co...

Страница 119: ...the PVARP window o Ars atrial events sensed in the ARP o As FFP atrial events sensed in the far field protection period o Ap atrial paced events Ventricular o Vs ventricular sensed events o PVC ventr...

Страница 120: ...The atrial and ventricular events recorded at a set time In the rate trend the heart rate in pulses per minute ppm is recorded in the upper rate chart and the percentage of pacing is shown in the lowe...

Страница 121: ...o a rate class width of 10 ppm to avoid distortion of the rate distribution 8 3 Arrhythmia Statistics 8 3 1 Atrial Burden Atrial Burden is the time that the patient is in an atrial tachycardia during...

Страница 122: ...on we recommend using the PVC analysis in DDD R mode only in conjunction with bipolar sensing and an appropriately high atrial sensitivity The interval between two consecutive PVC events must be short...

Страница 123: ...ctivity Report This feature operates by recording characteristic pulse generator data related to patient activity No Activity Activity Maximum Sensor Rate This data can assist in the analysis of heart...

Страница 124: ...cular pulse amplitude is within specific ranges The rate range is subdivided into categories ranging from 0 1 V to 6 0 V The ventricular pacing amplitude is sampled at 2 second intervals and entered i...

Страница 125: ...ble for review Far field Histogram The Far field Histogram provides information related to cross talk following Vp and Vs events The range is 30 ms to 220 ms for each type of event The display provide...

Страница 126: ...sed on programmable triggers for later display and review via the programmer screen The intracardiac events are represented on the programmer screen by event markers Recordings may be triggered by the...

Страница 127: ...ial IEGM Ventricular IEGM Evia pulse generators allow a maximum of twenty separate IEGM recordings that each include approximately 10 seconds per event Upon interrogation of the Evia pulse generator c...

Страница 128: ...120 Evia Technical Manual...

Страница 129: ...ia pulse generators Table 28 Safe Program Settings Parameter Dual chamber Single chamber Mode VVI VVI Pacing Rate 70 ppm 70 ppm Amplitude 4 8 V ventricle 4 8 V Pulse Width 1 0 ms 1 0 ms Sensitivity 2...

Страница 130: ...vided to avoid ventricular fusion beats in the presence of intact AV conduction This allows efficient diagnosis of ventricular capture or failure to capture Synchronous Magnet Effect If the magnet eff...

Страница 131: ...ams affecting patient safety like pacing threshold measurements in a pacemaker dependent patient should be activated as a temporary program only When interrogating the pulse generator the permanent pr...

Страница 132: ...PASSPORT code system The PASSPORT code is an identification system of two character codes that represent specific conditions A listing of the codes available with definitions is displayed on the scre...

Страница 133: ...etected by the atrial and or ventricular channel atrial and or ventricular asynchronous pacing at the programmed timing intervals will result for the duration of the interference The interference inte...

Страница 134: ...the pulse generator and product documentation The pulse generator and its accessories have been sealed in a container and gas sterilized with ethylene oxide To assure sterility the container should b...

Страница 135: ...containing magnets and sources of electromagnetic interference EMI to avoid damage to the device Use Before Date Do not implant the device after the USE BEFORE DATE because the device may have reduce...

Страница 136: ...tab and open it by peeling the sealing paper as indicated by the arrow A torque wrench is included within the blister package of each Evia pulse generator 10 3 Pulse Generator Orientation The pulse ge...

Страница 137: ...Evia Technical Manual 129...

Страница 138: ...planted in that chamber If either of the leads is unipolar unipolar sensing and pacing functions must be programmed in that chamber Failure to program the appropriate lead configuration could result i...

Страница 139: ...ing header Refer to the following steps when connecting a lead s to the pulse generator First confirm that the setscrew s is not protruding into the connector receptacle To retract a setscrew insert t...

Страница 140: ...d torque wrench Sealing System Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle Failure to do so may result in damage to the plug...

Страница 141: ...fter a bipolar lead is detected When the lead impedance is between 100 and 2500 Ohms the lead connected is classified as bipolar and the sense and pace polarities are set appropriately The device swit...

Страница 142: ...nfirmation phase has been successfully completed Auto Lead Check Capture Control Statistics Rate response Collection of patient specific impedance waveform characteristics for adapting the CLS algorit...

Страница 143: ...Evia Technical Manual 135...

Страница 144: ...ency into consideration The following notes are meant to stress certain product features which are of importance for follow up visit For detailed information on follow up procedures and medical aspect...

Страница 145: ...igh precision threshold test with a resolution of 0 1 V ranging from 0 1 V to 7 5 V The threshold test is activated as a temporary program whose specific operation is defined by the applicable softwar...

Страница 146: ...g rate must be lower than the patient s intrinsic rate In demand pacing the proper sensing function can be recognized if the interval between intrinsic events and the following pacing pulse equals the...

Страница 147: ...d may be selected To prevent retrograde P waves from triggering ventricular pulses thereby mediating a re entry tachycardia pacemaker mediated tachycardia PMT the programmed post ventricular atrial re...

Страница 148: ...en steps up or down respectively in 25 ppm steps As soon as the step up or step down key is released NIPS terminates Subsequent inductions resume at the initially programmed burst rate 12 6 3 Programm...

Страница 149: ...ilable to pacemaker dependent patients during burst or programmed burst stimulation through the back up pacing program as long as the wand is within 15 cm of the pulse generator Removing the programme...

Страница 150: ...ctivities facilitates evaluation of the parameter settings for rate adaptation The rolling mode of the A V rate trend is particularly useful during follow up since the time period immediately precedin...

Страница 151: ...the rate adaptive parameters 12 7 3 Adjusting the Sensor Threshold The sensor threshold controls the motion signal level that has to be exceeded to cause a rate increase This parameter is meant to ass...

Страница 152: ...144 Evia Technical Manual...

Страница 153: ...ice cycles at standard settings 37 C and with a lead impedance of 500 ohms The beginning of the replacement cycle is displayed on the programmer after pulse generator interrogation and appears on the...

Страница 154: ...er Cycle 10 Automatic Asynchronous basic rate at 80 ppm Synchronized with basic rate reduced by 4 5 11 Asynchronous Asynchronous basic rate at 80 ppm Asynchronous with basic rate at 80 Synchronous Syn...

Страница 155: ...Pacing 10 50 100 2 5 V 500 DR T SR T DR T SR T DR T SR T 12 1 15 0 10 7 14 1 8 2 11 9 The mean2 expected time intervals from ERI to EOS at standard program for Evia pulse generators is 6 months All s...

Страница 156: ...148 Evia Technical Manual...

Страница 157: ...ho has died is cremated Explanted Devices Return all explanted devices to BIOTRONIK 14 1 Common Reasons to Explant a Pulse Generator A pulse generator may be explanted emergently or at a physician s d...

Страница 158: ...ndustrial equipment electrocautery defibrillation radiation therapy RF ablation therapy etc No output rate increase rate decrease reversion to asynchronous mode loss of capture and or sensing Permanen...

Страница 159: ...on Myocardial irritability at time of insertion e g from an acute myocardial infarction Fibrillation Patient Threshold Elevation Loss of capture and or sensing Normal medical complication Infection Bo...

Страница 160: ...152 Evia Technical Manual...

Страница 161: ...VDIR X X DDT X X VVT X X X X VVTR X X X X AAT X X X X OFF X X X X AATR X X X X DOOR X X VOOR X X X X AOOR X X X X NOTE Programmability dependent on programmer software utilized Bold parameters indica...

Страница 162: ...e WRL automatic selection Rate Limitation4 5 6 190 220 ppm Dynamic AV Delay Dual chamber only Off low medium high individual or fixed IOpt 4 The corresponding intervals t correlate with the rates f by...

Страница 163: ...Repetitive Hysteresis Dual chamber only Off 1 1 10 AV Scan Hysteresis Dual chamber only Off 1 1 10 Repetitive AV Delay Hysteresis Negative AV Hysteresis Off 1 1 10 5 100 10 180 AV safety delay Dual ch...

Страница 164: ...net Effect synchronous with programmed basic rate Pulse amplitude A 0 2 0 1 3 0 0 1 6 0 0 5 7 5 V V 0 2 0 1 3 0 0 1 6 0 0 5 7 5 V Pulse width A 0 1 0 2 0 3 0 4 0 5 0 75 1 0 1 25 1 5 ms V 0 1 0 2 0 3 0...

Страница 165: ...ipolar Sense A unipolar bipolar V unipolar bipolar 15 2 1 Rate Adaptation Sensor gain 1 0 1 1 1 3 1 4 1 6 1 8 2 0 2 2 2 3 3 0 3 3 3 7 4 0 4 5 5 0 6 0 7 0 8 0 8 5 10 11 12 14 16 18 20 23 Sensor thresho...

Страница 166: ...8 V Safety Margin OFF 0 3 0 1 0 5 0 1 1 2V Search Scheduling Interval Time of Day Interval 0 1 0 3 1 3 6 12 24 hours Time of Day 00 00 23 50 in 10 minute increments nominal 02 00 15 2 3 Home Monitorin...

Страница 167: ...Evia Technical Manual 159 Ongoing Atrial Episode 6 12 18 hours Event Report Off On Patient Report Off On...

Страница 168: ...Two channel Real Time IEGM Transmission with markers Patient Data Memory Sensor Simulation Position Indicator for the programmer head 24 hour Trend Heart Rate Histogram Sensor Rate Histogram Sensor Te...

Страница 169: ...S4 S4 S5 Cycles 0 10 Pause ms Stop 50 No of intervals 4 Decrement ms 0 100 Back up Pacing Modes VOO VVI Rate ppm 30 200 Amplitude V 0 2 7 5 Pulse width ms 0 1 0 2 0 3 0 4 0 5 0 75 1 0 1 5 Pace Polarit...

Страница 170: ...same same Input impedance 10 k A 10 k V 10 k A 10 k V 10 k 10 k Power source LiJ Ag SVO C Fx QMR MDX Same as Evia DR Same as Evia DR T Battery voltage at BOS 2 8 V 3 0 V 2 8 V 3 0 V Conducting surfac...

Страница 171: ...63 15 6 Mechanical Data Model Leads Size Ma ss Volume Evia DR IS 1 6 5 x 43 x 53 mm 26 g 11 cc Evia DR T IS 1 6 5 x 44 5 x 53 mm 25 g 12 cc Evia SR IS 1 6 5 x 39 x 53 mm 25 g 10 cc Evia SR T IS 1 6 5...

Страница 172: ...164 Evia Technical Manual 16 Order Information Pulse Generator Type Order Number Evia DR 359 524 Evia DR T 359 529 Evia SR 359 531 Evia SR T 359 533...

Страница 173: ...ce that may cause undesired operation This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service Analog and digital voice communicatio...

Страница 174: ...nce who have an anticipated moderate or high level of activity and in whom there is a stable atrial rhythm and for whom DDD DDI DVI VDD or VVI pacing is also indicated Patients who have persistent VA...

Страница 175: ...usly setting the atrial and ventricular rates can inhibit tachyarrhythmia or if the pulse generator can be set to a pacing mode suited for interrupting arrhythmia The DDD mode is contraindicated in th...

Страница 176: ...ome presuming that setting the atrial rate and the AV interval with or without accompanying medication stops or prevents supraventricular arrhythmia The DVI mode is contraindicated for frequent or per...

Страница 177: ...indicated for all symptomatic bradyarrhythmias but particularly if 1 the atrium does not significantly contribute to the hemo dynamics persistent or paroxysmal atrial flutter or fibrillation dilated a...

Страница 178: ...dysfunction sick sinus syndrome given that adequate AV conduction has been established by an appropriate examination The AAI mode is conditionally indicated if the hemodynamics of patients with bradyc...

Страница 179: ...ction of myopotentials muscle stimulation etc The same applies to the asynchronous DOO R AOO R and VOO R pacing modes derived from the above by restricting the sensing functions SOO R mode available w...

Страница 180: ...ICS 3000 programmer may not recharge battery when device is in hibernation shut down mode OFF button quickly pressed No effect on patient If battery has depleted to a low level system boot may not be...

Страница 181: ...nfusion Evia Software Application If the sensing test fails during automatic follow up test sequence the error messages are displayed too quickly to read less than 1 second No effect on patient the te...

Страница 182: ......

Страница 183: ...Distributed by BIOTRONIK Inc 6024 Jean Road Lake Oswego OR 97035 5369 800 547 0394 24 hour 503 635 9936 FAX Manufactured by BIOTRONIK SE Co KG Woermannkehre 1 12359 Berlin Germany M4131 A 1 10...

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