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.
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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.
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.
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.
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.
(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.
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.
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.
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...
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.
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.
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...
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).
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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...
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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.
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 •...
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.
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.
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.
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.
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.
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...
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)
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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...
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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...
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.
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.
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...
(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.
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.
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...
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...
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.
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.
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 —...
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.
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.
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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.
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.
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: •...
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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.
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.
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.
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.
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...
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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.
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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.
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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.
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.
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...
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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.
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.
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.
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.
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.
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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...
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.
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.
• 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.
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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) •...
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.
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.
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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...
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.
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:...
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.
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...
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.
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).
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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).
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...
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- 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...
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.
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.
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.
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.
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;...
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.
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.
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.
• 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.
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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...
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”...
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.
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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”...
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.
• 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.
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.
(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...
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.
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.
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.
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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.
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.
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.
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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).
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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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...
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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 >...
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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...
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...
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Chapter 14 Order Information Edora, Evity, Enitra HF-T / HF-T QP Technical Manual PAGE 130...
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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.
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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 •...
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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 •...
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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...
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