Mintek Pacemaker LV-T Uživatelský manuál

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Strany 1 - Stratos

Stratos Family of Cardiac Resynchronization Therapy Pacemakers Technical Manual

Strany 2

2 Stratos LV/LV-T Technical Manual Stratos CRT-Ps are designed to meet all indications for Cardiac Resynchronization Therapy in CHF patients as wel

Strany 3 - Contents

92 Stratos LV/LV-T Technical Manual When the PMT is detected and terminated, the PMT protection interval is extended by 50 ms. If no additional PM

Strany 4

Stratos LV/LV-T Technical Manual 93 The features of Atrial Overdrive pacing include: After every atrial sensed event (non-AES), the pacing rate is in

Strany 5

94 Stratos LV/LV-T Technical Manual CAUTION Overdrive Pacing Mode - When programming the overdrive pacing mode, check whether the selected program

Strany 6

Stratos LV/LV-T Technical Manual 95 2.13.2 Post AES Stimulation The post AES stimulation (pacing) can be programmed for all atrial-controlled modes (

Strany 7

96 Stratos LV/LV-T Technical Manual The following diagnostic functions are available to tailor rate adaptive pacing for the individual patient. 2.1

Strany 8

Stratos LV/LV-T Technical Manual 97 When the Automatic Sensor Gain is activated, the CRT-P samples the sensor-indicated rate. If, during the 24 hour

Strany 9 - 1. General

98 Stratos LV/LV-T Technical Manual 2.14.6 Maximum Activity Rate Regardless of the sensor signal amplitude, the pacing rate during sensor-driven op

Strany 10 - 1.2 Indications

Stratos LV/LV-T Technical Manual 99 2.16 Rate Fading Rate Fading is intended to prevent a sudden drop in heart rate when the Stratos CRT-Ps transiti

Strany 11 - 1.4 Note to Physician

100 Stratos LV/LV-T Technical Manual Table 23. Backup and Target Rates Feature Description Backup Rate Rate that the CRT-P uses to pace when ther

Strany 12

Stratos LV/LV-T Technical Manual 101 CAUTION Patient’s Ability - Use of the Home Monitoring system requires the patient and/or caregiver to follow th

Strany 13

Stratos LV/LV-T Technical Manual 3 1.3 Contraindications Use of Stratos LV and Stratos LV-T CRT-Ps are contraindicated for the following patients: •

Strany 14

102 Stratos LV/LV-T Technical Manual CAUTION Patient-Activated Report - The magnet effect must be programmed “synchronous” if the [Patient Report]

Strany 15

Stratos LV/LV-T Technical Manual 103 2.17.2 Patient Device The patient device (Figure 9) is designed for use in or away from the home and is comprise

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104 Stratos LV/LV-T Technical Manual Table 24: System Requirements / Recommendations System Requirements System Recommendations (for Optimal Usag

Strany 17

Stratos LV/LV-T Technical Manual 105 Figure 9: Example of Patient Device with Charging Stand 2.17.4 Types of Report Transmissions When the Home Moni

Strany 18

106 Stratos LV/LV-T Technical Manual The length of the time interval (monitoring interval) is preset to “daily”. For each monitoring interval, a d

Strany 19 - 1.5.5 Home Monitoring

Stratos LV/LV-T Technical Manual 107 NOTE: The attending physician must notify the BIOTRONIK Service Center about which of these events he/she wishes

Strany 20

108 Stratos LV/LV-T Technical Manual Heart Failure Diagnostics • Mean Ventricular Heart Rate [ppm] • Mean Ventricular Heart Rate at Rest [ppm] •

Strany 21

Stratos LV/LV-T Technical Manual 109 2.18 Statistics Stratos CRT-Ps can store a variety of statistical information. The various statistics consist o

Strany 22 - 1.5.8 Cellular Phones

110 Stratos LV/LV-T Technical Manual 2.18.6 General Statistical Information • The Stratos CRT-P’s statistics modes are always in operation and can

Strany 23

Stratos LV/LV-T Technical Manual 111 2.20 Timing Statistics 2.20.1 Event Counter The event counter totals all of the sensed and paced events from all

Strany 24

4 Stratos LV/LV-T Technical Manual Magnetic Resonance Imaging (MRI) – Avoid use of magnetic resonance imaging as it has been shown to cause movemen

Strany 25 - 1.7 Clinical Studies

112 Stratos LV/LV-T Technical Manual NOTE: The VV value can deviate from the number of VES’ since the Stratos CRT-Ps can also classify ventricular

Strany 26

Stratos LV/LV-T Technical Manual 113 NOTE: The bars of the histogram are standardized to a rate class width of 10 ppm to avoid distortion of the rate

Strany 27

114 Stratos LV/LV-T Technical Manual In addition to the detection rate, an AF is classified using X-out-of-8 algorithm of mode switching. If mode

Strany 28

Stratos LV/LV-T Technical Manual 115 AES vs. Atrial Rate Information about the number of AES events as a function of the atrial rate can be found in

Strany 29

116 Stratos LV/LV-T Technical Manual VES Classification VES vs. Ventricular rate The VES versus the ventricular rate is likewise displayed in a his

Strany 30

Stratos LV/LV-T Technical Manual 117 2.22.2 Activity Report This feature operates by recording characteristic pulse generator data related to patient

Strany 31 - P-value

118 Stratos LV/LV-T Technical Manual R-Wave Trend This is the sensitivity of the ventricles displayed over time. The R-wave trend is displayed in

Strany 32

Stratos LV/LV-T Technical Manual 119 3. Follow-up Procedures 3.1 General Considerations The CRT-P follow-up serves to verify appropriate function of

Strany 33

120 Stratos LV/LV-T Technical Manual

Strany 34 - *Chi-Square test (2-sided)

Stratos LV/LV-T Technical Manual 121 4. Real-Time IEGM Stratos CRT-Ps offer the option of real-time transmission of the unfiltered intracardiac elect

Strany 35

Stratos LV/LV-T Technical Manual 5 Transcutaneous Electrical Nerve Stimulation (TENS) – Transcutaneous electrical nerve stimulation may interfere wit

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122 Stratos LV/LV-T Technical Manual A total of 64 recordings can be stored. Each of the four triggering types of recording can be assigned a spec

Strany 37

Stratos LV/LV-T Technical Manual 123 5. Battery, Pulse and Lead Data The following pulse, battery and lead data can be measured noninvasively by mean

Strany 38

124 Stratos LV/LV-T Technical Manual To determine the threshold, the ECG must be observed continuously. Based on the measured threshold, the pulse

Strany 39

Stratos LV/LV-T Technical Manual 125 5.3 Testing for Retrograde Conduction Retrograde conduction from the ventricle to the atrium can be assumed whe

Strany 40

126 Stratos LV/LV-T Technical Manual 5.4.2 Burst Stimulation Burst Stimulation offers a burst of pacing pulses to either atrium or ventricle when t

Strany 41

Stratos LV/LV-T Technical Manual 127 5.4.5 NIPS Safety Features The BIOTRONIK offers the following safety features during NIPS sessions. • Before t

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128 Stratos LV/LV-T Technical Manual

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Stratos LV/LV-T Technical Manual 129 6. Other Functions/Features Stratos CRT-Ps offer many additional functions and features to assist with the physi

Strany 44

130 Stratos LV/LV-T Technical Manual 6.2 Patient Data Memory Individual patient data can be stored in the Stratos CRT-Ps. For example, the follow

Strany 45

Stratos LV/LV-T Technical Manual 131 6.4 Magnet Effect Automatic Magnet Effect: After magnet application the pulse generator paces at 90 ppm for 10 c

Strany 46

6 Stratos LV/LV-T Technical Manual For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed under the

Strany 47

132 Stratos LV/LV-T Technical Manual 6.6 Pacing When Exposed to Interference CAUTION EMI – Computerized systems are subject to (Electromagnetic In

Strany 48

Stratos LV/LV-T Technical Manual 133 Table 27: Response to EMI MODE EMI* (A) EMI* (V) EMI* (A+V) DDD(R) DDI(R) DVI(R) VDD(R) VVI(R) AAI(R) DDT DDI

Strany 49

134 Stratos LV/LV-T Technical Manual

Strany 50 - VES (n=2)

Stratos LV/LV-T Technical Manual 135 7. Product Storage and Handling 7.1 Sterilization and Storage Stratos CRT-Ps are shipped in a cardboard box, eq

Strany 51

136 Stratos LV/LV-T Technical Manual CAUTION FOR SINGLE USE ONLY - Do not re-sterilize the CRT-P or accessories packaged with the CRT-P, they are

Strany 52

Stratos LV/LV-T Technical Manual 137 Peel off the sealing paper of the outer container as indicated by the arrow. Take out the inner sterile con

Strany 53

138 Stratos LV/LV-T Technical Manual CAUTION Muscle or Nerve Stimulation – Inappropriate muscle or nerve stimulation may occur with unipolar pacin

Strany 54

Stratos LV/LV-T Technical Manual 139 8. Lead Connection 8.1 Lead Configuration The Stratos CRT-Ps allows programming of separate lead polarities for

Strany 55

140 Stratos LV/LV-T Technical Manual Table 28: Lead Configuration Configuration Description bipolar RV tip Æ RV ring Sensing* RV unipolar RV tip Æ

Strany 56

Stratos LV/LV-T Technical Manual 141 Lead Compatibility The Stratos CRT-Ps have been designed for connection with a bipolar lead in the atrium and tw

Strany 57 - OPTION CRT/ATx

Stratos LV/LV-T Technical Manual 7 1.5.3 Lead Connection and Evaluation Lead Check – Feature Description: Lead Check is a feature that, when activa

Strany 58

142 Stratos LV/LV-T Technical Manual Connecting the Stratos LV with the IS-1 Connector In order to avoid programming errors with the Stratos LV, al

Strany 59

Stratos LV/LV-T Technical Manual 143 1. Insert the enclosed torque wrench through the perforation in the self-sealing plug at an angle perpendicular

Strany 60

144 Stratos LV/LV-T Technical Manual 6. Pass non-absorbable ligature through the hole in the connector receptacle to secure the CRT-P in the pock

Strany 61

Stratos LV/LV-T Technical Manual 145 9. Elective Replacement Indication (ERI) Service times for the Stratos CRT-Ps vary based on several factors, inc

Strany 62

146 Stratos LV/LV-T Technical Manual The pacing rate decreases by 11% when programmed to DDD(R), DDT(R), D00(R), VDD(R), VDI(R), VDT(R), VVI(R), VV

Strany 63 - 14 (20.9%)

Stratos LV/LV-T Technical Manual 147 The following functions remain active when the replacement indication is reached: • Mode switching • PMT detect

Strany 64

148 Stratos LV/LV-T Technical Manual Table 32 shows the mean* expected time intervals (in months) from ERI to EOS at standard program for Stratos C

Strany 65

Stratos LV/LV-T Technical Manual 149 10. Explantation Explanted devices and accessories may not be reused. Explanted CRT-Ps can be delivered to the

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150 Stratos LV/LV-T Technical Manual

Strany 67

Stratos LV/LV-T Technical Manual 151 11. Technical Data 11.1 Available Pacing Modes DDDR, DDTRA, DDTR, DDIR, DDITR, DVIR, DVTR, DOOR, VDDR, VDTR, VD

Strany 68

8 Stratos LV/LV-T Technical Manual IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators from di

Strany 69

152 Stratos LV/LV-T Technical Manual Dynamic AV Delay (Dual chamber only) low; medium; high; individual; fixed AV Delay Values (Dual chamber modes

Strany 70

Stratos LV/LV-T Technical Manual 153 Pulse Width 0.1; 0.2; 0.3; 0.4; 0.5…(0.25)…1.5 ms (3 channels separately programmable) Sensitivity A 0.1... (0.

Strany 71 - 2. Programmable Parameters

154 Stratos LV/LV-T Technical Manual Intervention Rate 100… (10)…250 ppm X-out-of-8 Activation Criterion 3… (1)…8 Z-out-of-8 Termination Criterion

Strany 72

Stratos LV/LV-T Technical Manual 155 Rate Fading Rate Increase 0.5; 1; 2… (1)…6 ppm/cycle Rate Fading Rate Decrease 0.25; 0.5… (0.25)…1.25 ppm/cycle

Strany 73

156 Stratos LV/LV-T Technical Manual 11.3 Diagnostic Memory Functions IEGM Recoding AF OFF; 3… (1)…31 count AF Detection Rate 100… (10)…300… (20)

Strany 74

Stratos LV/LV-T Technical Manual 157 Patient-Triggered Messages ON, OFF Time of Trend Message 00:00... (00:10)...23:50 11.5 Additional Functions NOTE

Strany 75 - 2.1.5 VDD

158 Stratos LV/LV-T Technical Manual NIPS Specifications Burst Mode Burst Chamber Atrium, Ventricle Coupling Interval /ms None… 2000 Burst Type

Strany 76 - 2.1.10 VDI

Stratos LV/LV-T Technical Manual 159 11.7 Default Programs Stratos LV / LV-T Parameter/ Function Factory settings/ Standard Program Safe Program Mod

Strany 77 - Stratos CRT-Ps

160 Stratos LV/LV-T Technical Manual Parameter Stratos LV Pace Unipolar/bipolar Pulse form Biphasic, asymmetric Polarity Cathodic Input impedance

Strany 78 - 2.3 Timing Functions

Stratos LV/LV-T Technical Manual 161 12. Order Information Pulse Generator Type Order Number Stratos LV 338 200 Stratos LV-T 338 202

Strany 79

Stratos LV/LV-T Technical Manual 9 AV Hysteresis – If the AV hysteresis is enabled along with the algorithm for recognizing and terminating PMTs (PMT

Strany 80 - 2.3.3 Scan Hysteresis

162 Stratos LV/LV-T Technical Manual

Strany 81

Stratos LV/LV-T Technical Manual 163 Appendix A Known Software Anomalies Anomaly Possible Effect on Patient or Implant Procedure General Programmer

Strany 82 - 2.3.4 Repetitive Hysteresis

Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: BIOTRO

Strany 83 - 2.3.5 Night Mode

10 Stratos LV/LV-T Technical Manual Pacing thresholds – When decreasing programmed output (pulse amplitude and/or pulse width), the pacing threshol

Strany 84 - 2.3.6 Refractory Periods

Stratos LV/LV-T Technical Manual 11 Atrial Sensitivity – In dual chamber systems, the atrial sensitivity of 0.1 mV should only be programmed in conju

Strany 85 - 2.3.7 Atrial PMT Protection

Stratos CRT-Ps Implantable Cardiac Resynchronization Therapy Pacemakers Stratos X-Ray identification Radiopaque Identification A radiopaque identifi

Strany 86 - 2.3.9 AV Delay

12 Stratos LV/LV-T Technical Manual If the patient cannot understand or follow the instructions because of physical or mental challenges, another a

Strany 87

Stratos LV/LV-T Technical Manual 13 1.5.6 Electromagnetic Interference (EMI) The operation of any implanted device may be affected by certain enviro

Strany 88 - 2.3.11 Sense Compensation

14 Stratos LV/LV-T Technical Manual Home Appliances – Home appliances normally do not affect CRT-P operation if the appliances are in proper condit

Strany 89 - 2.3.13 Safety AV Delay

Stratos LV/LV-T Technical Manual 15 Based on testing to date, effects resulting from an interaction between cellular phones and the implanted pacemak

Strany 90

16 Stratos LV/LV-T Technical Manual 1.6 Potential Effects of the Device on Health The following possible adverse events may occur with this type o

Strany 91

Stratos LV/LV-T Technical Manual 17 1.7 Clinical Studies The subsequent sections summarize the following three clinical studies that were used to sup

Strany 92 - 2.5 Automatic Lead Check

18 Stratos LV/LV-T Technical Manual • Patients assigned to Group 1 received biventricular pacing with CLS-based rate adaptive pacing using BIOTRON

Strany 93

Stratos LV/LV-T Technical Manual 19 Clinical Inclusion Criteria To support the objectives of this investigation, patients were required to meet the f

Strany 94 - 2.7 Wenckebach 2:1

20 Stratos LV/LV-T Technical Manual Clinical Exclusion Criteria To support the objectives of this investigation, the exclusion criteria at the time

Strany 95

Stratos LV/LV-T Technical Manual 21 Clinical Endpoints Primary Endpoint: Complication-free Rate (Safety) The safety of the Stratos LV was evaluated b

Strany 96 - 2.8 Mode Switching

Stratos LV/LV-T Technical Manual i Contents 1. General ...1 1.1 Device D

Strany 97 - 2.9 PMT Management

22 Stratos LV/LV-T Technical Manual No implant AttemptedWithdrawal of ConsentGroup 1 2Group 2 4Group 3 3Not Meeting Inclusion Criter

Strany 98 - 2.9.2 PMT Detection

Stratos LV/LV-T Technical Manual 23 Table 1: Patient Demographics at Enrollment Characteristic Group1 Group 2 Group 3 P-value Age @ Enrollment (Yr

Strany 99

24 Stratos LV/LV-T Technical Manual Table 1: Patient Demographics at Enrollment Characteristic Group1 Group 2 Group 3 P-value Other Medical Hist

Strany 100 - (Overdrive Mode)

Stratos LV/LV-T Technical Manual 25 Table 2: Atrial Fibrillation Demographics at Enrollment Characteristic Group 1 Group 2 Group 3 P-value* Clas

Strany 101

26 Stratos LV/LV-T Technical Manual Table 2: Atrial Fibrillation Demographics at Enrollment Characteristic Group 1 Group 2 Group 3 P-value* Ra

Strany 102 - CAUTION

Stratos LV/LV-T Technical Manual 27 Table 3: Current Cardiac Medications at Enrollment Drug Category Group 1 N=42 Group 2 N=50 Group 3 N=25 P-value*

Strany 103

28 Stratos LV/LV-T Technical Manual • The study was designed to enroll 265 patients. However, the study was terminated early due to slow patient

Strany 104 - 2.14.3 Automatic Sensor Gain

Stratos LV/LV-T Technical Manual 29 Primary Endpoint—Complication-free Rate (Safety) The safety of the Stratos LV was evaluated based on complication

Strany 105 - 2.14.5 Rate Increase

30 Stratos LV/LV-T Technical Manual Table 4: AVAIL CLS/CRT Complication-Free Rate at 6 months – Stratos LV Category Number of Patients% of Patient

Strany 106 - 2.15 Sensor Stimulation

Stratos LV/LV-T Technical Manual 31 Table 4: AVAIL CLS/CRT Complication-Free Rate at 6 months – Stratos LV Category Number of Patients% of PatientsN

Strany 107 - 2.16 Rate Fading

ii Stratos LV/LV-T Technical Manual 2.1.11 OFF (ODO)...69 2.2 Biventricular Synchronizatio

Strany 108

32 Stratos LV/LV-T Technical Manual Complications and observations for the Stratos LV study groups are summarized in Table 5 and Table 6. The tota

Strany 109

Stratos LV/LV-T Technical Manual 33 Table 5: Summary of Complications – Stratos LV Category Number of Patients% of PatientsNumber of ComplicationsCom

Strany 110

34 Stratos LV/LV-T Technical Manual Table 5: Summary of Complications – Stratos LV Category Number of Patients% of PatientsNumber of ComplicationsC

Strany 111 - 2.17.3 Transmitting Data

Stratos LV/LV-T Technical Manual 35 Table 6: Summary of Observations – Stratos LV Category Number of Patients% of PatientsNumber of ComplicationsObse

Strany 112

36 Stratos LV/LV-T Technical Manual Primary Endpoint: Six Minute Walk Test & QOL (Effectiveness) The purpose of Primary Endpoint 1 was to evalu

Strany 113

Stratos LV/LV-T Technical Manual 37 Table 8: Composite of Six Minute Walk Test and QOL (Effectiveness) Category CRT (Group 1 & 2)(N = 53) Mean ±

Strany 114

38 Stratos LV/LV-T Technical Manual Primary Effectiveness Endpoint Analysis and Conclusions The primary effectiveness endpoint evaluated CRT effect

Strany 115

Stratos LV/LV-T Technical Manual 39 The gender distribution in this clinical investigation was consistent within the study groups and included a repr

Strany 116

40 Stratos LV/LV-T Technical Manual Clinical Inclusion Criteria To support the objectives of this investigation, patients were required to meet the

Strany 117 - 2.18 Statistics

Stratos LV/LV-T Technical Manual 41 Clinical Endpoints The safety of the Stratos LV was evaluated based on complications (adverse events that require

Strany 118 - Statistics

Stratos LV/LV-T Technical Manual iii 2.14.6 Maximum Activity Rate...98 2.14.7 Rate Decay...

Strany 119 - 2.20 Timing Statistics

42 Stratos LV/LV-T Technical Manual Table 9: Patient Demographics Characteristic Results Age at Implant (Years) n=88 Mean ± SD 68 ± 10 Range 34

Strany 120 - 2.20.3 Rate Trend

Stratos LV/LV-T Technical Manual 43 Safety and Effectiveness Results • The cumulative implant duration was 760 months with a mean duration of 9.2 mo

Strany 121 - 2.21 Arrhythmia Statistics

44 Stratos LV/LV-T Technical Manual The freedom from Stratos LV system-related and procedure- related complications was 88.76% with a one sided low

Strany 122 - 2.21.3 AES Statistics

Stratos LV/LV-T Technical Manual 45 Table 10: Summary of Complications at 6 months Category Number of Patients% of PatientsNumber of ComplicationsCom

Strany 123 - 2.21.4 VES Statistics

46 Stratos LV/LV-T Technical Manual Table 11: Summary of Observations at 6 months Category Number of Patients % of Patients Number of ObservationsO

Strany 124 - 2.22 Sensor Statistics

Stratos LV/LV-T Technical Manual 47 1.7.3 AVAIL and OVID Combined Primary Endpoint-Complication-free Rate (Safety) The results from for the AVAIL CL

Strany 125 - 2.23 Sensing Statistics

48 Stratos LV/LV-T Technical Manual Table 12: OVID and AVAIL Complication-Free Rate - Stratos LV Category Number of Patients% of PatientsNumber of

Strany 126 - 2.24 Pacing Statistics

Stratos LV/LV-T Technical Manual 49 The freedom from Stratos LV system-related and procedure-related complications was 87.2% with a one sided lower 9

Strany 127 - 3. Follow-up Procedures

50 Stratos LV/LV-T Technical Manual Primarily, the study evaluates and compares the functional benefits of CRT between the two randomized groups us

Strany 128

Stratos LV/LV-T Technical Manual 51 • Ability to tolerate the surgical procedure required for implantation • Ability to complete all required testi

Strany 129 - 4. Real-Time IEGM

iv Stratos LV/LV-T Technical Manual 5. Battery, Pulse and Lead Data ...123 5.1 Threshold Test - Testing the Pa

Strany 130

52 Stratos LV/LV-T Technical Manual Follow-Up Schedule After successful enrollment, all patients were randomly assigned to either the study group o

Strany 131 - 5. Battery, Pulse and Lead

Stratos LV/LV-T Technical Manual 53 Enrolled and RandomizedPatientsStudy 133Control 67No implant Attempted Withdrawal of ConsentStudy 2Control 1Not

Strany 132 - Sensing Function

54 Stratos LV/LV-T Technical Manual Table 13: Patient Demographics at Pre-Enrollment Characteristic Study N=133 Control N=67 P-value Age at Enrollm

Strany 133 - Stimulation (NIPS)

Stratos LV/LV-T Technical Manual 55 Table 14 provides a summary of cardiac medications patients were taking at the time of enrollment. Some categori

Strany 134

56 Stratos LV/LV-T Technical Manual • There were 192 endocardial and 19 epicardial leads implanted in 193 patients. Investigators were allowed to

Strany 135 - 5.4.5 NIPS Safety Features

Stratos LV/LV-T Technical Manual 57 Table 15: Composite of Six Minute Walk Test and QOL (Effectiveness) Category Study Group (N = 74) Mean ± SE Contr

Strany 136

58 Stratos LV/LV-T Technical Manual Primary Effectiveness Endpoint Analysis and Conclusions A composite rate of six minute walk test and QOL improv

Strany 137 - 6. Other Functions/Features

Stratos LV/LV-T Technical Manual 59 There are no clinically relevant differences in the six minute walk test results between the study and the contro

Strany 138 - 6.3 Safe Program Settings

60 Stratos LV/LV-T Technical Manual Multi-site Poolability and Gender Analysis The OPTION CRT/ATx clinical report includes data from multiple cente

Strany 139 - 6.5 Position Indicator

Stratos LV/LV-T Technical Manual 61 1.7.5 Conclusions Drawn from Studies The clinical study results support the safety and effectiveness of the Stra

Strany 140 - Interference

Stratos LV/LV-T Technical Manual v 12. Order Information...161 Appendix A ...

Strany 141

62 Stratos LV/LV-T Technical Manual

Strany 142

Stratos LV/LV-T Technical Manual 63 2. Programmable Parameters For a complete list of programmable parameters and the available settings for the Stra

Strany 143 - Handling

64 Stratos LV/LV-T Technical Manual In the case of ventricular sensed events outside of the AV delay and the VES discrimination interval after a ve

Strany 144

Stratos LV/LV-T Technical Manual 65 Table 18: Timing Intervals Event Timing Interval Ap As As (PMT) Vp Vsp VS VES AV delay X X Safety AV d

Strany 145

66 Stratos LV/LV-T Technical Manual In the DDI/T and DVT pacing modes, the basic interval is not restarted if ventricular sensing occurs within the

Strany 146

Stratos LV/LV-T Technical Manual 67 2.1.3 DDI In contrast to DDD mode, the basic interval in the DDI mode is not restarted by sensed P-waves, but by

Strany 147 - 8. Lead Connection

68 Stratos LV/LV-T Technical Manual 2.1.6 AAI and VVI The pacing modes AAI and VVI provide atrial and ventricular demand pacing. The lower rate t

Strany 148 - 8.2 Lead Connection

Stratos LV/LV-T Technical Manual 69 2.1.11 OFF (ODO) In this mode, pacing and sensing functions are off. The OFF mode is used to determine and evalu

Strany 149

70 Stratos LV/LV-T Technical Manual During biventricular pacing in the Stratos CRT-Ps, the right ventricle is paced first. Starting from the initi

Strany 150 - Bipolar lead in right atrium

Stratos LV/LV-T Technical Manual 71 In the ventricular-controlled modes, the basic interval is started by a ventricular event. CAUTION Programming Mo

Strany 151

vi Stratos LV/LV-T Technical Manual

Strany 152

72 Stratos LV/LV-T Technical Manual The rate hysteresis is deactivated in the standard setting, but can be programmed from -5… (-5) … -90. If Hyste

Strany 153 - Indication (ERI)

Stratos LV/LV-T Technical Manual 73 Figure 3. Scan Hysteresis Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may red

Strany 154

74 Stratos LV/LV-T Technical Manual 2.3.4 Repetitive Hysteresis Repetitive hysteresis is expanded programmability of the Hysteresis feature. Repet

Strany 155 - WARNING

Stratos LV/LV-T Technical Manual 75 Repetitive Hysteresis is only available when Hysteresis is selected on. Magnet application (closing of reed switc

Strany 156

76 Stratos LV/LV-T Technical Manual 2.3.6 Refractory Periods Sensed events that occur during the refractory period have no effect on pacemaker timi

Strany 157 - 10. Explantation

Stratos LV/LV-T Technical Manual 77 In the case an atrial sense event falls within the PMT protection window, the Stratos CRT-Ps start a minimal ARP.

Strany 158

78 Stratos LV/LV-T Technical Manual 2.3.8 Ventricular Refractory Period In all modes in which a ventricular depolarization can be sensed, the Stra

Strany 159 - 11. Technical Data

Stratos LV/LV-T Technical Manual 79 The Dynamic AV Delay is intended to mimic the physiologic, catecholamine-induced shortening of the AV Delay with

Strany 160

80 Stratos LV/LV-T Technical Manual 2.3.9.4 AV Scan Hysteresis With AV Scan Hysteresis enabled, after 180 consecutive pacing cycles, the AV delay

Strany 161

Stratos LV/LV-T Technical Manual 81 2.3.12 Ventricular Blanking Period The ventricular blanking time is the period after an atrial pacing pulse durin

Strany 162

Stratos LV/LV-T Technical Manual 1 1. General 1.1 Device Description The Stratos LV and Stratos LV-T CRT-Ps are rate adaptive pacemakers designed to

Strany 163

82 Stratos LV/LV-T Technical Manual Figure 5. Ventricular blanking time and safety AV 2.4 Pacing and Sensing Functions 2.4.1 Pulse Amplitude a

Strany 164

Stratos LV/LV-T Technical Manual 83 CAUTION Pulse Amplitude – Programming of pulse amplitudes, higher than 4.8 V, in combination with long pulse widt

Strany 165 - 11.5 Additional Functions

84 Stratos LV/LV-T Technical Manual The Stratos CRT-Ps have a specially designed header that allows the CRT-Ps to simultaneously sense and pace in

Strany 166 - 11.6 Programmers

Stratos LV/LV-T Technical Manual 85 CAUTION Lead Check – Lead check will not lead to disabling of cardiac resynchronization therapy. It limits the u

Strany 167 - Synchronization

86 Stratos LV/LV-T Technical Manual 2.6 Antitachycardia Functions: The antitachycardia functions include: • Upper basic rate • Tachycardia mode •

Strany 168 - 11.10 Mechanical Data

Stratos LV/LV-T Technical Manual 87 Wenckebach Behavior If the end of the AV delay falls within the upper threshold rate interval, ventricular pacing

Strany 169 - 12. Order Information

88 Stratos LV/LV-T Technical Manual 2.8 Mode Switching Mode switching prevents the conduction of paroxysmal atrial tachycardias to the ventricle.

Strany 170

Stratos LV/LV-T Technical Manual 89 Reversion back to the programmed pacing mode occurs in a similarly programmable manner. If a programmable number

Strany 171 - Appendix A

90 Stratos LV/LV-T Technical Manual To prevent occurrence of a PMT, Stratos CRT-Ps start an atrial PMT protection interval after each ventricular p

Strany 172 - Manufactured by:

Stratos LV/LV-T Technical Manual 91 Confirmation When the suspicion criterion has been met, the Stratos CRT-Ps slightly modify the AV delay interval

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