BIOTRONIK Enitra HF-T Technical Manual
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BIOTRONIK Enitra HF-T Technical Manual

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Cardiac Rhythm Management //
Edora, Evity, Enitra HF-T / HF-T QP CRT-P Pacemakers
Edora, Evity, Enitra HF-T / HF-T QP CRT-P Pacemakers
Technical Manual

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  • Page 1 Cardiac Rhythm Management // Edora, Evity, Enitra HF-T / HF-T QP CRT-P Pacemakers Edora, Evity, Enitra HF-T / HF-T QP CRT-P Pacemakers Technical Manual...
  • Page 2 Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Edora, Evity, Enitra HF-T / HF-T QP Implantable CRT-P Pacemakers X-ray identification Radiopaque Identification A radiopaque identification code is visible on standard X-ray, and identifies the pacemaker: Edora, Evity, Enitra HF-T / HF-T QP...

  • Page 3: Table Of Contents

    Table of Contents Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Contents 1. Device Description ......................1 2. Indications ........................... 3 3. Contraindications ....................... 5 4. Warnings and Precautions ....................7 4.1 Medical Therapy ......................7 4.2 Storage and Sterilization ....................8 4.3 Lead Connection and Evaluation ...................
  • Page 4 Table of Contents Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.5.4 AV Delay ........................32 5.5.4.1 Dynamic AV Delay ....................33 5.5.4.2 AV Hysteresis ......................33 5.5.4.3 AV Repetitive Hysteresis ..................34 5.5.4.4 AV Scan Hysteresis ....................34 5.5.4.5 Negative AV Delay Hysteresis ................35 5.5.4.6 I-Opt ........................36...
  • Page 5 Table of Contents Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.18 Home Monitoring ......................62 5.18.1 Transmission of Information ..................62 5.18.2 Patient Device ......................63 5.18.3 Transmitting Data .....................63 5.18.4 Types of Report Transmissions ................64 5.18.4.1 Trend Report ......................64 5.18.4.2 Event Report ......................64 5.18.5 Description of Transmitted Data ................64...
  • Page 6 Table of Contents Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 6.6.9 Far-field Histogram .....................84 6.6.10 Vp suppression......................85 6.7 IEGMs ...........................86 7. Other Functions/Features ....................89 7.1 Wandless (RF) Telemetry ....................89 7.1.1 Establishing Wandless Telemetry ................89 7.1.2 Economy Mode ......................90 7.2 Safe Program Settings ....................92...
  • Page 7 Table of Contents Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 10.8.1 Measuring Retrograde Conduction ................110 10.8.2 Requirements for Measurement ................110 10.8.3 Follow-up History....................110 10.9 Atrial Non-Invasive Programmed Stimulation (NIPS) ..........111 10.9.1 Description ......................111 10.9.2 Burst Stimulation ....................111 10.9.3 Programmed Stimulation ..................112...
  • Page 8 Table of Contents Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE vi...

  • Page 9: Device Description

    BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home Monitoring. With the TRUST study, BIOTRONIK was able to show the following with regards to Home Monitoring: • BIOTRONIK Home Monitoring information may be used as a replacement for device interrogation during in-office follow-up visits.
  • Page 10 Edora, Evity, Enitra HF-T QP unipolar/bipolar pacing with Home Monitoring Refer to Chapter 14 of this manual for order information for the Edora, Evity, Enitra HF-T / HF-T QP devices. The above mentioned pacemakers are MR Conditional devices. Therefore, MR scans are permissible under certain conditions.

  • Page 11: Indications

    Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 2. Indications Rate-adaptive pacing with Edora, Evity, Enitra HF-T / HF-T QP pacemakers is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.
  • Page 12 Chapter 2 Indications Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 4...

  • Page 13: Contraindications

    Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 3. Contraindications Use of Edora, Evity, Enitra HF-T / HF-T QP pacemakers are contraindicated for the following patients: • Unipolar pacing is contraindicated for patients with an implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy.
  • Page 14 Chapter 3 Contraindications Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 6...

  • Page 15: Warnings And Precautions

    Chapter 4 Warnings and Precautions Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 4. Warnings and Precautions Certain therapeutic and diagnostic procedures may cause undetected damage to a pacemaker, resulting in malfunction or failure at a later time. Please note the following warnings and precautions: Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates.

  • Page 16: Storage And Sterilization

    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 (magnets) Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference (EMI) to avoid damage to the device.

  • Page 17: Programming And Operation

    (NIPS). Unipolar/Bipolar All Edora, Evity, Enitra HF-T / HF-T QP pacemakers can be used with either unipolar or bipolar IS-1 leads. The HF-T QP members of the family also use one IS4 lead.

  • Page 18: Home Monitoring

    CLS Rate-Adaptation Under certain circumstances (e.g., EMI, lead dislodgment), the Edora, Evity, Enitra HF-T / HF-T QP pacemaker may not be able to obtain a usable impedance measurement as required for CLS rate-adaptive pacing. At this point, CLS rate-adaptation will be inactive until the situation is corrected.

  • Page 19: Electromagnetic Interference (Emi)

    4.6.1 Wireless Technology The wireless technology incorporated into the Edora, Evity, Enitra HF-T / HF-T QP devices is defined in 47 CFR 95.601-95.673 (Medical Implant Communication Service). One applicable EMC standard is ISO 14117, and the device has passed all compliance testing. Additionally, the device fulfills Part 15 of the FCC rules and regulations.

  • Page 20: Home And Occupational Environments

    Chapter 4 Warnings and Precautions Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Technology Inductive Coil Telemetry Radio Frequency (RF) Field Strength Less than -50 dBuV/m Less than 18.2 mV/m With a bit error rate less Requires near field (within...

  • Page 21: Cellular Phones

    Chapter 4 Warnings and Precautions Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Patients should exercise reasonable caution in avoidance of devices which generate a strong electric or magnetic field. If EMI inhibits operation of a pacemaker or causes it to revert to asynchronous operation at the programmed pacing rate or at the magnet rate, moving away from the source or turning it off will allow the pacemaker to return to its normal mode of operation.

  • Page 22: Hospital And Medical Environments

    Chapter 4 Warnings and Precautions Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 4.6.4 Hospital and Medical Environments Electrosurgical Cautery Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause asynchronous or inhibited pacemaker operation. If use of electrocautery is necessary, the current path (ground plate) should be kept as far away from the pacemaker and leads as possible.

  • Page 23: Programmable Parameters

    For a complete list of programmable parameters and the available settings, see Section 13. 5.1 Pacing Modes A complete list of pacing modes available for Edora, Evity, Enitra HF-T / HF-T QP devices are shown below. Figure 1: Pacing Modes...

  • Page 24: Non-Rate-Adaptive Modes

    QP pacemakers perform similarly to earlier generations of BIOTRONIK pacemakers. 5.1.4 Mode Switching Edora, Evity, Enitra HF-T / HF-T QP pacemakers provide Mode switching to change pacing modes as a result of atrial tachycardias. Mode switching is designed to avoid tracking of non-physiologic atrial rates due to paroxysmal atrial tachycardias (PATs).
  • Page 25 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Table 2 is a summary of the parameters associated with Mode switching. Parameter Range Default Setting Mode Switching ON, OFF Intervention Rate 100...(10)...250 bpm 160 bpm Switch to...
  • Page 26 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The higher the X value, the harder it is to declare Mode Switching. Conversely, the lower the value, the easier it is for Mode Switching to occur.

  • Page 27: Pacing Modes With Triggered Response

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Mode Switch Events are recorded in memory and are available to the user through the following diagnostics: • IEGM Recordings Found in the Recordings Tab • Mode switch counter in Diagnostics •...

  • Page 28: Basic Rate

    3) sets the lower pacing rate for the pacemaker and may be programmed from 30 bpm to 200 bpm. Edora, Evity, Enitra HF-T / HF-T QP pacemakers will allow pacing lower than the programmed rate when the parameter Hysteresis is enabled. The lowest pacing rate possible with Hysteresis programmed ON is 30 ppm.

  • Page 29: Scan Hysteresis

    Figure 4: Example of Rate Hysteresis Repetitive Rate Hysteresis and Scan Rate Hysteresis are Rate Hysteresis enhancements available in the Edora, Evity, Enitra HF-T / HF-T QP pacemaker family. These features encourage a patient’s own rhythm, periodically allowing for, or looking for, intrinsic activity.

  • Page 30: Repetitive Hysteresis

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual In the left portion of Figure 5, pacing occurs at the hysteresis rate for the programmed number of five cycles. With no return of intrinsic rhythm, the device resumes pacing at the basic rate. Once pacing begins at the basic rate, the Scan Hysteresis count starts over.

  • Page 31: Night Mode

    OFF. When Night rate ends, Edora, Evity, Enitra HF-T / HF-T QP pacemakers use the Sensor rate Increase value to return to the basic rate. If the sensor is programmed OFF, the device will use the default sensor rate increase/decrease values.

  • Page 32: Rate Fading

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.2.6 Rate Fading Rate Fading is intended to prevent a sudden drop in heart rate when the pacemaker transitions from tracking an intrinsic rhythm to pacing due to an abrupt decrease in the intrinsic rate, in order to prevent potential reactions such as dizziness, light headedness, lack of energy and fainting.

  • Page 33: Pulse Width

    Pulse width remains constant throughout the service life of the pacemaker. Edora, Evity, Enitra HF-T / HF-T QP pacemakers come with nine available Pulse Width choices in each chamber, providing a wide variety of choices for pacing management. The Pulse width options are...

  • Page 34: Automatic Sensitivity Control (Asc)

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual NOTE: When VCC is programmed to ON or ATM, the pulse width cannot be programmed to a value higher than 0.4 ms. 5.4 Automatic Sensitivity Control (ASC)
  • Page 35 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Atrial and ventricular ASC function for sensed events are the same, except that the Detection Hold-off and Step Duration periods use different values. This is shown in...
  • Page 36 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Detection Hold-off Period (DHP) Detection Hold-off Period (DHP) Ventricle Ventricle 200 ms 200 ms Step Duration Step Duration 125 ms 125 ms 2x Step 2x Step +/- Sensitivity Threshold...

  • Page 37: Ventricular Pacing Parameter Options

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Ventricular Pacing Overview Table 10 shows a ventricular pacing overview and applies to bradycardia programming and Mode Switch programming. Parameter Range Default Ventricular pacing BiV, RV, LV...

  • Page 38: Timing Features

    V-V delay after Vs (ms) 0 ms (fixed) When Trigger pacing is programmed to one of the active modes, the Edora, Evity, Enitra HF-T / HF-T QP HF-T device will deliver a LV pace when an RVs and/or PVC occurs below the maximum trigger rate.

  • Page 39: Atrial Refractory Period

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual CAUTION Short Pacing Intervals Use of short pacing intervals (high pacing rates) with long atrial and/or ventricular refractory periods may result in intermittent asynchronous pacing and, therefore, may be contraindicated in some patients.

  • Page 40: Auto Pvarp

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Table 11 shows the PVARP parameter values and ranges. Parameter Name Range Standard Value Units PVARP AUTO, 175..(25)..600 225 ms PVARP + 150 ms to a PVARP after PVC...

  • Page 41: Dynamic Av Delay

    (Individual). Similar to previous generations of devices, Edora, Evity, Enitra HF-T / HF-T QP pacemakers allow the user to program individual AV Delay programs. Edora, Evity, Enitra HF-T / HF-T QP pacemakers provide the option of changing the values on the AV Delay visual display in addition to changing the numeric parameter buttons.

  • Page 42: Av Repetitive Hysteresis

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual AV repetitive/scan cycles: OFF, ON The AV Hysteresis mode choice of Positive is designed to promote intrinsic activity by periodically extending the AV interval to look for intrinsic activity. If intrinsic activity is present, the AV Delay maintains the hysteresis value to allow intrinsic R-waves to conduct.

  • Page 43: Negative Av Delay Hysteresis

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Scan AV Hysteresis programmed to 5 events Programmed AV Interval After 180 consecutive ventricular paced events, the AV Delay extends to the AV Hysteresis value. In this example, no intrinsic R waves were detected. Therefore after...

  • Page 44: I-Opt

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.5.4.6 I-Opt Only available if BiV pacing is OFF I-Opt is a one-button feature designed to promote intrinsic activity in the ventricle. When programmed ON, AV Hysteresis is extended to 400 ms, regardless of the programmed AV Delay. As the heart rate...

  • Page 45: Ventricular Blanking After Ap

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The AV Opt. Test can be initiated by the user as part of a device follow-up. This will trigger the implant to send IEGMs from the implant to the programmer, first during intrinsic rhythm, followed by atrial paced rhythm.

  • Page 46: Far-Field Protection

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Crosstalk may be encountered if a shorter blanking time, unipolar ventricular sensing, a higher ventricular sensitivity (lower value) and/or a high atrial pulse amplitude and pulse width are programmed.

  • Page 47: Lead Polarity

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual When the atrial rate surpasses the UTR, one of two different responses may occur, depending on the programmed value and the . Both responses — 2:1 block and Wenckebach —...

  • Page 48: Parameters For Rate-Adaptive Pacing

    IS-1 leads. 5.7 Parameters for Rate-Adaptive Pacing The Edora, Evity, Enitra HF-T / HF-T QP pacemaker family achieves rate adaptation through programming of either standard motion-based pacing via a capacitive accelerometer or by the means of the principle of closed loop stimulation (CLS) which involves the translation of myocardial contractility into patient-specific pacing rates.

  • Page 49: Sensor Gain

    By monitoring these changes, the pacemaker can provide a pacing rate that is appropriate and specific to the patient’s physiologic demands. For a complete list of rate-adaptive pacing modes available in the Edora, Evity, Enitra HF-T / HF-T QP pacemaker family, see Section 13.1.
  • Page 50 Figure 25: Influence of Sensor Gain on the Rate Response Edora, Evity, Enitra HF-T / HF-T QP pacemakers offer an Automatic Sensor Gain setting, which allows the physician to have the Sensor Gain parameter adjusted automatically. This is shown in Figure When the Automatic Sensor Gain is activated, the pacemaker samples the sensor-indicated rate.

  • Page 51: Sensor Threshold

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.7.2 Sensor Threshold The effects of rate adaptation are limited to sensor signals exceeding the programmable sensor threshold. Sensor signals below this threshold do not affect rate response (Figure 27).

  • Page 52: Maximum Closed Loop Rate

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Regardless of the sensor signal strength, the pacing rate during sensor-driven operation will never exceed the programmed maximum sensor rate. The maximum sensor rate only limits the pacing rate during sensor-driven operation and is independent of the rate limit.

  • Page 53: Atrial Upper Rate

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The 2:1 Lock-In Management feature consists of suspicion, confirmation and termination phases, which are described below: Suspicion The pacemaker suspects 2:1 Lock-In when the following criteria are met: •...
  • Page 54 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The features of Atrial Overdrive pacing include: Heart Rate Maximum Overdrive Rate Overdrive Stepsize Figure 29: Overdrive Pacing After every atrial sensed event (non-AES), the pacing rate is increased by a non-programmable 8 bpm rate increase above the intrinsic event.

  • Page 55: Management Of Specific Scenarios

    To prevent occurrence of a PMT, Edora, Evity, Enitra HF-T / HF-T QP pacemakers start an atrial PMT protection 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.

  • Page 56: Adjustment Of The Pmt Protection Window

    Rate Interval + 50 ms Table 19: PMT Confirmation Intervals Termination Edora, Evity, Enitra HF-T / HF-T QP extends PVARP (Post Ventricular Atrial Refractory Period) to the VA interval + 50 ms. 5.12 Adjustment of the PMT Protection Window The PMT protection window can be automatically adjusted. This automatic adjustment functions in the following manner: When the PMT is detected and terminated, the PMT protection interval is extended by 50 ms.

  • Page 57: Ventricular Capture Control (Vcc)

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.13 Ventricular Capture Control (VCC) 5.13.1 Feature Description The VCC feature periodically measures the capture threshold, and automatically adjusts the pacing output (with a programmable safety margin) when programmed ON. Additionally, the feature continuously assesses ventricular pacing capture on a beat-to-beat basis and responds to any loss of capture with a safety back-up pulse.

  • Page 58: Search Type

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Parameters associated with Ventricular Capture Control are shown in Table Parameter Range Default Capture Control ON, ATM, OFF Threshold Test Start 2.4, 3.0, 3.6, 4.2, 4.8 V 3.0 V...
  • Page 59 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual This feature determines when the device performs a Ventricular Capture Control test to check the current threshold. • Interval — Interval starts the next Active Threshold Monitoring test at a programmed time from when the previous threshold test was performed.
  • Page 60 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 32: VCC Flow Chart The feature includes three primary components: Signal Analysis, Capture Threshold Search, and Capture Verification. The following paragraphs describe the operation of these three components (SA, ATM, and CV) of VCC while active in DDD(R) pacing mode.
  • Page 61 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Automatic Threshold Measurement • The Automatic Threshold Measurement is the component of the VCC feature that measures the ventricular pacing threshold by stepping down the output until non-capture occurs.

  • Page 62: Algorithm Suspension, Abort And Disabling

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.13.3.1 Algorithm Suspension, Abort and Disabling The VCC feature is inactive until the first SA and CV after programming is completed successfully. The SA/CV sequence is unsuccessful when the SA or CV fail or are aborted. In addition, an SA/CV sequence can be postponed and CV can be temporarily suspended.

  • Page 63: Ventricular Capture Control Programming

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.13.4 Ventricular Capture Control Programming VCC is programmable to ON, Active Threshold Monitoring (ATM) modes, and OFF. Table 22 provides details about the VCC programmability. Programmable Modes for VCC...
  • Page 64 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 3. Confirmation phase: The pacing threshold is considered to be confirmed if capture is determined with the first step and loss of capture is confirmed with the second step.

  • Page 65: Search Type

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Capture Control OFF, ON, ATM When Atrial Capture Control is OFF, the user can manually program the output based on current threshold and physician preference. When Atrial Capture Control is ON, the feature will determine the capture threshold and program the output based on the capture threshold and programmable safety margin.

  • Page 66: Ventricular Pace Suppression (Vp-Suppression)

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual • Interval — Interval starts the next Active Threshold Monitoring test at a programmed time from when the previous threshold test was performed. The interval begins with a permanent program being sent to the device.

  • Page 67: Thoracic Impedance

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual activated. If six events do not occur, the device will return to the programmed AV Delay and a new search will be performed at a specific time interval. More detail on search intervals will be found in the following section, Intelligent Search.

  • Page 68: Programconsult

    This feature is part of the programmer parameter section and is located on the main Edora, Evity, Enitra HF-T / HF-T QP pacemaker programmer screen under the selection Program Sets. Upon selection of ProgramConsult, a sub-window opens with multiple selections depending on the underlying disease.
  • Page 69 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual HF with HF with normal HF with HF with low HF with high moderate sinus function permanent AF patient activity patient activity patient activity Change of basic...

  • Page 70: Home Monitoring

    Home Monitoring can be utilized as a functional replacement for in-office follow-up visits and allows the time between routine, scheduled, in-office follow-ups of BIOTRONIK implantable devices to be extended to twelve months or more. Home Monitoring evaluation of implanted devices and patient status is as safe as conventional in-office follow-ups.

  • Page 71: Patient Device

    For additional information about the patient device (CardioMessenger), please refer to its manual. 5.18.3 Transmitting Data The implant’s information is digitally formatted by the BIOTRONIK Service Center and processed into a concise report called a Cardio Report. The Cardio Report, which is adjusted to the individual needs of the patient, contains current and previous implant data.

  • Page 72: Types Of Report Transmissions

    • Atrial tachyarrhythmia persisting beyond a programmable time limit or • Mode Switch episode persisting beyond a programmable time limit NOTE: The attending physician must notify the BIOTRONIK Service Center about which of these events he/ she wishes to be informed. 5.18.5 Description of Transmitted Data The following data are transmitted by the Home Monitoring system, when activated.
  • Page 73 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Device Status & Home Monitoring Settings Containing device and message identifying values that pertain to the implant and Home Monitoring: • Implantation Date • Device Status • Remaining capacity for ERI calculation (done by the Service Center) •...

  • Page 74: Iegm Online Hds

    The pacemakers include a programmable parameter to disable or enable the IEGM transmission. 5.18.5.2 Periodic IEGM for Home Monitoring Follow-up The Edora, Evity, Enitra HF-T / HF-T QP pacemaker family provides the ability to automatically schedule remote follow-ups through the Home Monitoring Service Center. There are two options available.

  • Page 75: Mri Programming

    Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 5.19 MRI Programming The Edora/Evity/Enitra ProMRI pacemaker families allow the device to be programmed to an ® asynchronous pacing mode or to the OFF mode when pacing is not required during the procedure. The device provides an AUTO program for MRI procedures.
  • Page 76 Chapter 5 Programmable Parameters Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 35: MRI screen with MRI test in progress PAGE 68...

  • Page 77: Diagnostics

    6. Diagnostics 6.1 Diagnostics Overview Edora, Evity, Enitra HF-T / HF-T QP pacemakers can store a variety of diagnostic information. The various diagnostics consist of such features as rate histograms, event counters, sensor trends, PVC statistics, and activity reports, which are described in the following sections.

  • Page 78: Timing Statistics

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The histogram bars are standardized to a rate class width of 10 bpm to avoid distortion of the rate distribution that would be caused by varying rate class widths. The formula is:...

  • Page 79: Rate Histograms

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Pacing Counters (Brady) • Atrial pace percentage • BiV pace percentage (Rvp/LVp) • CRT pace percentage (Rvp/LVp plus trigger pace) Each event is recorded into one of these categories and displayed on this screen. The event episodes are not updated when the patient is in Mode Switch due to the change in device timing.

  • Page 80: Arrhythmia Statistics

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 6.3 Arrhythmia Statistics 6.3.1 Atrial Burden Figure 37: Atrial Arrhythmia Atrial burden is the percentage of time the patient is in an atrial tachycardia during a given day. The...

  • Page 81: Duration Of Tachycardia Episode

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 6.3.2 Duration of Tachycardia Episode The Duration of tachycardia episode shows the time duration of each AT episode met. The percentage is the number of events in each time bin divided by the total number of events. Knowing the duration of the events can help determine clinical intervention.

  • Page 82: Mean Heart Rate

    Heart Rate Variability, which is the standard deviation of the 5-minute mean normal to normal interval over the recorded time is available in the statistics of the Edora, Evity, Enitra HF-T / HF-T QP. This is based on the atrial rate (P-P).
  • Page 83 Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Key points: The heart-rate graph reports mean heart rate (indicated by “V” in the key) and resting heart rate (indicated by “V at rest” in the key). • Mean heart rate reports the average of the ventricular rate over a 24-hour period (based on Vs, Vp, Vrs, and PVCs).

  • Page 84: Hours

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 6.5 24 Hours Figure 39: 24 Hours 6.5.1 Rate The atrial and right ventricular rates are displayed over the last 24 hours prior to interrogation. The data is presented in 11 minute averages 6.5.2 Percent Paced...
  • Page 85 - RV sensed events. - RV extrasystoles (VES). Edora, Evity, Enitra HF-T / HF-T QP pacemakers define a PVC as two ventricular events without an atrial event in between. A VT with a slower atrial rhythm will have those events following the...

  • Page 86: Event Episodes And Events

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 6.6.2 Event Episodes and Events Figure 41: Event episodes and events The Event episodes and events, shown in Figure 41, presents data collected on the different pacing states of the device; As-Vp, As-Vs, Ap-Vp, Ap-Vs and Vx-Vx. Vx-Vx are ventricular events without an atrial event between.

  • Page 87: Ax-Vs Interval Distribution

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 42: Pulse Amplitude/Threshold Trend Key Points: • Pulse amplitude displays the measured threshold for each day throughout the duration of the statistics. • Pacing threshold measurements can be programmed to ATM or VCC in the device from the parameters screen under the Bradycardia tab.

  • Page 88: Sensor Rate

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 43: Ax-Vs interval distribution 6.6.5 Sensor Rate This function records how often the sensor rate is within certain ranges. The rate range is subdivided into 16 rate classes going from 40 to 180, including bins for rates < 40 bpm and rates > 180 bpm. The percentage and total number of sensed and paced events occurring within a rate class is displayed.

  • Page 89: Arrhythmia

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual graph to closely match the rate histogram graph. The graph is divided into sixteen 10-beat bins. The duration of recording is displayed on the lower right corner. The user may use the arrow keys, or simply touch on any particular rate within the graph, to review the data.

  • Page 90: P/R Wave Trend

    6.6.7 P/R wave trend Edora, Evity, Enitra HF-T / HF-T QP pacemakers periodically perform P- and RV-wave amplitude measurements to be displayed later as trend data. A P- and R-wave long-term trend of up to 240 days is available. After the initial timeframe has elapsed, the first data stored is overwritten with new data;...

  • Page 91: Lead Impedance Trends With Lead Check

    The range for normal lead impedance is from 100 to 2500 ohms. If the Edora, Evity, Enitra HF-T / HF-T QP pacemaker detects a bipolar lead failure, polarity for the respective lead will automatically be changed to unipolar configuration. A bipolar lead failure is verified if the lead impedance measurement falls outside of the acceptable range for three consecutive readings.

  • Page 92: Far-Field Histogram

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 47: Lead Impedance Trend The lead impedance trend, shown in Figure 47, displays the impedance data collected since the last time the statistics were restarted. Impedance data is collected throughout the day, and the average value is displayed for the 24-hour period.

  • Page 93: Vp Suppression

    Chapter 6 Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The Far-field histogram in Figure 48 provides information related to sensed events in the atrium occurring after ventricular paced or sensed events. Data is measured in 10 ms intervals. The maximum value measured is 225 ms after a ventricular paced or sensed event.

  • Page 94: Iegms

    • Lead failure (not programmable) Edora, Evity, Enitra HF-T / HF-T QP pacemakers can be programmed to store an IEGM on any or all of the events listed above. However, the programmability of the High Atrial Rate and Mode Switch triggers are linked such that only one trigger can be activated at a time.
  • Page 95 An example of a stored IEGM is provided in Figure 51. The IEGM demonstrates AF from an Edora, Evity, Enitra HF-T / HF-T QP pacemaker. The IEGMs from each channel are provided along with the marker channels for each. Figure 51: AT episode recording...
  • Page 96 Chapter 6 Other Functions/Features Diagnostics Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 88...

  • Page 97: Other Functions/Features

    Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 7. Other Functions/Features Edora, Evity, Enitra HF-T / HF-T QP pacemakers offer many additional functions and features to assist the physician in the care of the pacemaker patient. 7.1 Wandless (RF) Telemetry The pacemakers offer ”wandless”...

  • Page 98: Economy Mode

    Chapter 7 Other Functions/Features Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 53: Message for programming wand removal 7.1.2 Economy Mode To conserve device battery, the system provides an Economy mode. After three minutes of programmer inactivity, the RF telemetry is suspended. When the telemetry is suspended, the IEGMs will not be present on the programmer screen.
  • Page 99 Figure 55: End session message To switch between RF and wand (PGH) telemetry, go to the Edora, Evity, Enitra HF-T / HF-T QP tab under the More section. To disable RF telemetry, press the PGH button. If a session is active, a message stating “RF telemetry is deactivated”...

  • Page 100: Safe Program Settings

    Chapter 7 Other Functions/Features Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 7.2 Safe Program Settings Activating the preset values for the Safe Program is a quick and convenient way to provide VVI pacing at a high output setting in urgent situations.

  • Page 101: Temporary Programming

    • Lead Serial Number • City WARNING Unipolar/Bipolar – Edora, Evity, Enitra HF-T / HF-T QP pacemakers can be used with either unipolar or bipolar IS-1 leads. If the pacing or sensing function is to be programmed to bipolar, it must be verified that bipolar leads have been implanted in that chamber.

  • Page 102: Position Indicator

    Chapter 7 Other Functions/Features Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Symptom, etiology and ECG indication are specified using the European 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 screen of the programmer when patient data is selected.

  • Page 103: Product Storage And Handling

    (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 reduced longevity. If a replacement pacemaker is needed, contact your local BIOTRONIK representative. PAGE 95...

  • Page 104: Opening The Sterile Container

    Take out the inner sterile container by the gripping 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 Edora, Evity, Enitra HF-T / HF-T QP pacemaker. 8.3 Pacemaker Orientation The pacemaker may be used in either the left or right side pectoral implants.

  • Page 105: Lead Connection

    Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 9. Lead Connection Edora, Evity, Enitra HF-T / HF-T QP pacemakers have been designed and are recommended for use with bipolar or unipolar leads having an IS-1 connector. The IS-1 configured leads may be placed in one or both chambers of the heart, depending upon model selected.

  • Page 106: Auto Initialization

    Auto Initialization consists of four phases, which are described below. 1. Lead detection In order to detect a lead, the Edora, Evity, Enitra HF-T / HF-T QP pacemaker continuously delivers sub-threshold paces in both the ventricular and the atrial channel to measure the lead impedance.
  • Page 107 Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 2. Detection and Configuration of the Lead Polarity By default, the Edora, Evity, Enitra HF-T / HF-T QP pacemaker starts with the unipolar lead measurement and then follows with the bipolar measurement. Pre-programming the device to bipolar prior to lead connection allows for an immediate pacing response.
  • Page 108 Chapter 9 Lead Connection Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 100...

  • Page 109: Follow-Up Procedures

    40 bpm or above 100 bpm. 10.2 Real-time IEGM Transmission The Edora, Evity, Enitra HF-T / HF-T QP pacemaker provides real time transmission of the intracardiac electrogram (IEGM) to the programmer. During dual chamber operation, IEGMs from the atrium and ventricle can be simultaneously recorded.

  • Page 110: Impedance Test

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 10.3 Impedance test Figure 57: Impedance test The atrial and right ventricular impedance values are measured in both unipolar and bipolar pacing configurations, as shown in Figure 57.
  • Page 111 The intrinsic rate helps the user select the best pacing rate for the test. The Edora, Evity, Enitra HF-T / HF-T QP pacemaker allows real-time changes during the threshold tests. The user can now change any of the values while the test is ongoing. If a value is changed, the device will automatically stop the ongoing test and then restart the test with the new value(s).

  • Page 112: P/R Measurement

    10.5 P/R Measurement The Edora, Evity, Enitra HF-T / HF-T QP pacemakers sensing test is the first test that appears when selecting the Tests button on the right hand side of the programmer screen, shown in Figure 61.

  • Page 113: Start (Test)

    Intrinsic Rhythm support for the duration the button is depressed. Edora, Evity, Enitra HF-T / HF-T QP pacemakers will display the measured values on the IEGM screen while the test is in progress.

  • Page 114: Mode

    10.5.4 Sensing test parameters 10.5.4.1 Basic Rate 30…(5)…100…(10)…200 bpm. Default value of 30 bpm. The Edora, Evity, Enitra HF-T / HF-T QP pacemaker will provide support pacing at the programmed Basic rate during the Sensing test. 10.5.4.2 AV Delay 20...(5)...300 ms Default of 180 ms with the DDI mode and 50 ms when the VDD mode is selected.

  • Page 115: Pacing Polarity

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Left Ventricle: OFF, Auto, 0.5 - 7.5 mV Default of Auto Independently programmable for each chamber. 10.5.4.7 Pacing Polarity Unipolar, Bipolar. Independently programmable for each chamber if AUTO test is OFF.

  • Page 116: Av Opt. Test

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 10.7 AV Opt. Test Figure 65: AV Opt. Test The AV Opt. Test measures p-wave durations for sensed and paced atrial events and provides programming suggestions for the sensed and paced AV-delay. The test is executed in RV DDD mode using a fixed AV-delay of 250ms and PVARP of 350ms.
  • Page 117 Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 66: Retrograde Conduction Test with a Negative Result Figure 67: Retrograde Conduction Test with a Positive Result Retrograde conduction from the ventricle to the atrium can be confirmed when a 1:1 relationship with a constant V-A interval is present.

  • Page 118: Measuring Retrograde Conduction

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 10.8.1 Measuring Retrograde Conduction The Retrograde Conduction measurement is initiated from the Retrograde conduction tab. During the test, the pacemaker operates in VDI mode at a programmable rate that must exceed the heart’s intrinsic rate.

  • Page 119: Atrial Non-Invasive Programmed Stimulation (Nips)

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 68: Follow-up History Page 10.9 Atrial Non-Invasive Programmed Stimulation (NIPS) WARNING NIPS – Life threatening ventricular arrhythmias can be induced by stimulation in the atrium. Ensure that an external cardiac defibrillator is easily accessible.

  • Page 120: Programmed Stimulation

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Burst Stimulation offers a burst of pacing pulses to the atrium when the programming wand is placed directly over the pacemaker. The duration of the burst is as long as the burst key on the programmer is touched.

  • Page 121: Back Up Pacing

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Figure 70: Atrial Burst Stimulation Screen 10.9.4 Back up Pacing The back up pacing program remains active once NIPS has been selected and remains active during burst or programmed burst stimulation and within this menu. This program remains active until the Stop touch key is pressed.

  • Page 122: Optimizing Rate Adaptation

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual To perform NIPS function, the programmer wand must be placed directly over the pacemaker to enable continuous telemetry. 10.10 Optimizing Rate Adaptation It is recommended to check the parameters controlling rate adaptation during each follow-up for their individual therapeutic suitability.

  • Page 123: Adjusting The Sensor Gain

    Chapter 10 Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 10.10.2 Adjusting the Sensor Gain The sensor gain controls the change in stimulation rate for a certain change in workload detected by the sensor. An exercise test is recommended in order to achieve a rate response proportional to work load by optimizing the sensor gain.
  • Page 124 Chapter 10 Elective Replacement Indication (ERI) Follow-up Procedures Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 116...

  • Page 125: Elective Replacement Indication (Eri)

    Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 11. Elective Replacement Indication (ERI) The service time of Edora, Evity, Enitra HF-T / HF-T QP pacemakers vary based on several factors, including battery properties, storage time, lead system impedance, programmed parameters, amount of pacing and sensing required, and circuit operating characteristics.
  • Page 126 Table 32 shows the expected longevity from BOS to ERI for the Edora, Evity, Enitra HF-T / HF-T QP pacemakers. The programmer software for the Edora, Evity, Enitra HF-T / HF-T QP pacemakers provides an estimated time to ERI in months and years that is updated each time the device is reprogrammed.

  • Page 127: Explantation

    Explanted pacemakers or explanted accessories may not be reused. Explanted pacemakers can be sent either to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal. If possible, the explanted pacemaker should be cleaned with a sodium-hyperchlorine solution of at least 1% chlorine and, thereafter, washed with water prior to shipping.
  • Page 128 Chapter 12 Explantation Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Source Cause Possible Effect Intermittent or continuous loss of capture and/ Displacement, fracture, loss of or sensing; excessive current drain; early battery insulation integrity. depletion. The above plus cardiac tamponade; muscle or...

  • Page 129: Technical Data

    Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 13. Technical Data 13.1 Modes HF-T DDD-CLS, VVI-CLS DDDR-ADIR, DDD-ADI, DDD(R), DDI(R), DVI(R), DOO(R), DDT VDD(R), VDI(R), VVI(R), VOO(R), VVT AAI(R), AOO(R), AAT, OFF (Temporary only) NOTE: Programmability dependent on programmer software utilized.
  • Page 130 Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual LV Pacing Polarity LV Tip > LV Ring LV Tip > RV Ring LV Ring > LV Tip LV Ring > RV Ring LV Tip > can LV Ring >...
  • Page 131 Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Positive AV Hysteresis 70, 110, 150, 200 ms Negative AV Hysteresis 10…(10)…150 ms AV safety delay 100 ms Sense Compensation Off; -10...(-5)…-45…(-5)...-120 ms Far Field after Vs 100…(10)…220 ms...

  • Page 132: Rate Adaptation

    Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual X = 3, 4, 5, 6, 7, 8 out of 8 Z= 3, 4, 5, 6, 7, 8 out of 8 Intervention Rate 100...(10)...160…(10)…250 bpm Mode Switch Basic Rate OFF, +5…(5)…+10…(5)…+30...

  • Page 133: Right/Left Ventricular Capture Control (Rvcc/Lvcc)

    Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Interval 0.1, 0.3, 1, 3, 6, 12, 24 hours Time of Day 00:00 … 23:50 in 10 minute increments, nominal 00:30 13.2.3 Right/Left Ventricular Capture Control (RVCC/LVCC)

  • Page 134: Additional Functions

    Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 13.2.5 Additional Functions NOTE: Availability of the following functions is dependent upon pacemaker configuration. • Thoracic Impedance • AV Optimization • LV Vector Optimization • RF Telemetry •...

  • Page 135: Nips Specifications

    Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 13.2.6 NIPS Specifications Burst Mode Burst Chamber Atrium Coupling Interval / ms None, 80...(10)… 2000 Burst stimulation Burst Type Pushbutton, Ramp A. Only Burst Range / bpm 125…800...

  • Page 136: Electrical Data/Battery

    Chapter 13 Technical Data Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 13.5 Electrical Data/Battery NOTE: At 37º C, with pacing impedance of 500 Ohms. Edora, Evity, Enitra HF-T / Parameter HF-T QP Pace Unipolar/bipolar Pulse form Biphasic, asymmetric...

  • Page 137: Order Information

    Chapter 14 Order Information Edora, Evity, Enitra HF-T / HF-T QP Technical Manual 14. Order Information Pacemaker Type Order Number Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP...
  • Page 138 Chapter 14 Order Information Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 130...
  • Page 139 These indications include but are not limited to sick sinus syndrome and AV block. The rate-adaptive modes of the Edora, Evity, Enitra HF-T / HF-T QP pacemaker family are contraindicated for patients who are known to develop angina or ischemia at accelerated pacing rates.
  • Page 140 Appendix A Edora, Evity, Enitra HF-T / HF-T QP Technical Manual • AV sequential contraction is necessary due to symptomatic bradycardia and slow atrial rate, and/or • a pacemaker syndrome has already been documented. The DVI mode is conditionally indicated for •...
  • Page 141 Appendix A Edora, Evity, Enitra HF-T / HF-T QP Technical Manual The VVI mode is contraindicated if • a pacemaker syndrome is known to exist or if the patient develops particular symptoms during temporary pacing or pacemaker implantation, and/or • there is a need to maximize the atrial contribution due to •...
  • Page 142 Appendix A Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 134...
  • Page 143 Appendix B Edora, Evity, Enitra HF-T / HF-T QP Technical Manual Appendix B Known Software Anomalies Possible Effect on User Anomaly (Patient or Implant Procedure) LVVO Test: LV amplitude values and the Flash-Window- Missing diagnostic information in display/ IEGM may not be visible after connection interrupt...
  • Page 144 Edora, Evity, Enitra HF-T / HF-T QP Pacemakers Technical Manual BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 M4210-B 07/17 (800) 547-0394 (24-hour) © 2017 BIOTRONIK, Inc. All rights reserved. (800) 291-0470 (fax) MN076r1 7/21/17 www.biotronik.com...

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