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Evia Technical Manual 129

Summary of Contents for Evia DR

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 8: ...vi Evia Technical Manual...

Page 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...

Page 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...

Page 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...

Page 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...

Page 13: ...Evia Technical Manual 5...

Page 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...

Page 15: ...Evia Technical Manual 7...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 28: ...20 Evia Technical Manual...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 128: ...120 Evia Technical Manual...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 137: ...Evia Technical Manual 129...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 143: ...Evia Technical Manual 135...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 152: ...144 Evia Technical Manual...

Page 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...

Page 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...

Page 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...

Page 156: ...148 Evia Technical Manual...

Page 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...

Page 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...

Page 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...

Page 160: ...152 Evia Technical Manual...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 182: ......

Page 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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BIOTRONIK Evia DR, Technical Manual

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