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BIOTRONIK ProMRI Enitra 6 Function Manual
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BIOTRONIK ProMRI Enitra 6 Function Manual

BIOTRONIK ProMRI Enitra 6 Function Manual

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Enitra 6/8
Function Manual

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Summary of Contents for BIOTRONIK ProMRI Enitra 6

  • Page 1 Enitra 6/8 Function Manual...
  • Page 2 Enitra 6/8  Function Manual Enitra Pacemaker Family Doc. Id.: 429316--C Index XXXXXX--AEnitra 6/8 Function Manual...
  • Page 3 Table of Contents Table of Contents Table of Contents Characteristics of the Device Family ........7 System Description .
  • Page 4 Table of Contents Timing Functions ........... . 53 Programs and Parameters .
  • Page 5 Table of Contents Rate Adaptation ........... . 106 Pacing Modes .
  • Page 6 Table of Contents Statistics (Diagnostics) ........148 Statistics Classes .
  • Page 7 Table of Contents NIPS - Non-Invasive Programmed Stimulation ......196 NIPS - Non-Invasive Programmed Stimulation..197 NIPS - Executing Burst Pacing .
  • Page 8 Characteristics of the Device Family Characteristics of the Device Family Characteristics of the Device FamilyIXXXXXX--AEnitra 6/8 Function Manual What's in this part? Chapter Chapter name Page System Description Overview You will find a description of the characteristics of the device family in part I of the function manual.
  • Page 9 System Description System Description System Description1XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Intended Medical Use System Overview Diagnostic and Therapy Functions Replacement Indications...
  • Page 10 All major therapeutic approaches from the field of cardiology and electro- ® physiology are unified in this pacemaker family. BIOTRONIK Home Monitoring enables physicians to perform therapy management at any time. Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of a device system.
  • Page 11 • Only quadripolar leads must be connected to the IS4 connector on device type HF QP with IS4. Note: Use only adapters approved by BIOTRONIK for leads with different connec- tions. • If you have any questions concerning the compatibility of other manufacturers' leads, please contact BIOTRONIK.
  • Page 12 System Description Modes The mode setting depends on the individual diagnosis: Device type Modes Standard • VVI-CLS (8 series only) VVIR • VVIR, V00R, AAIR, A00R • VVI, VVT, V00, AAI, AAT, A00 • OFF • VVI-CLS; DDD-CLS (8 series only) DDDR •...
  • Page 13 System Description BIOTRONIK In addition to effective pacing therapy, BIOTRONIK provides a complete therapy ® Home Monitoring management system: • With Home Monitoring, diagnostic and therapeutic information and technical data are automatically sent to a stationary or mobile transmitter via an antenna in the device header.
  • Page 14 System Description Diagnostic and Therapy Functions General overview All the systems have extensive features that allow quick diagnosis and delivery of safe therapy for bradycardia conditions. • Automatic functions make it easy and fast to implant, configure, and check the pacemaker.
  • Page 15 System Description Resynchronization therapy Triple-chamber devices have functions to configure different VV delays in order to resynchronize the ventricles. • Capture Control is also available for the left ventricle with automated tracking of the pacing threshold or automatic threshold monitoring (ATM) for trend analysis.
  • Page 16 System Description Replacement Indications Possible charging status The time span from the beginning of service (BOS) to elective replacement indica- tion (ERI) is determined by, among others, the following: • Battery capacity • Lead impedance • Pacing program • Pacing to inhibition ratio •...
  • Page 17 System Description Magnet response at ERI After reaching ERI, pacing is performed as follows after applying the magnet or programming head: After 10th cycle Magnet Cycles 1 to 10 response Automatic Asynchronous with 80 bpm Synchronous with basic rate reduced by 11% Asynchronous Asynchronous with 80 bpm Asynchronous with 80 bpm Synchronous...
  • Page 18 Functional Description and Handling Functional Description and Handling Functional Description and HandlingIIXXXXXX--AEnitra 6/8 Function Manual What's in this part? Chapter Chapter name Page Auto-initialization Lead Configuration and Monitoring Sensing Functions Bradycardia Therapy Home Monitoring Evaluate Recordings Statistics (Diagnostics) System Functions of the Device Overview Please see part II of the function manual for a description of the device functions and how to use them.
  • Page 19 Auto-initialization Auto-initialization Auto-initialization2XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Auto-Initialization of the Device...
  • Page 20 Auto-initialization Auto-Initialization of the Device Purpose The auto-initialization function automatically puts the device into operation. Functional principle Auto-initialization starts once a lead is connected to the device for the first time and lead impedance < 2500 Ω is measured. The device begins normal operation if stable impedances are measured in a confir- mation phase lasting up to 10 minutes (up to 20 minutes with two unipolar leads) and the lead polarities are confirmed.
  • Page 21 Lead Configuration and Monitoring Lead Configuration and Monitoring Lead Configuration and Monitoring3XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Automatic Lead Impedance Measurement Lead Configuration Setting Lead Polarity...
  • Page 22 Lead Configuration and Monitoring Automatic Lead Impedance Measurement Navigation: Parameters → Diagnostics → Enable lead check Objective The automatic lead check function can be used to quickly detect technical failures in the system (device and lead) resulting from a defective lead or faulty connection of the leads.
  • Page 23 Lead Configuration and Monitoring Automatic lead check The automatic lead check verifies whether the measured values are within a range from 100 to 2500 ohms, which is defined as acceptable. If a measurement result is outside this impedance range, the measurement is repeated in the next two cardiac cycles.
  • Page 24 Lead Configuration and Monitoring Lead Configuration • In a unipolar configuration, the negative pole (the cathode) is situated in the heart, while the positive pole (the anode) is formed by the housing of the device. • In a bipolar configuration, both poles of the leads are situated in the heart. The devices allow for programming separate lead polarities for pacing and sensing.
  • Page 25 Sensing Functions Sensing Functions  Sensing Functions 4XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Sensing Concept Automatic Sensitivity Control Interference Interval as Interference Protection Manual or Automatic Sensitivity Control...
  • Page 26 Sensing Functions Sensing Concept Background Sensing thresholds of leads usually remain steady for an extended period of time. Typical values are 3 - 4 mV for the atrium and about 12 mV for the ventricle. Development of the Early generations of pacemakers used the sensing of atrial events even during automatic sensitivity atrial flutter or fibrillation for pacemaker timing and thus often induced ventricular control function...
  • Page 27 Sensing Functions Automatic Sensitivity Control The input filters of the device are aligned with signal sensing in the range between the sinus rhythm, atrial fibrillation and ventricular fibrillation. Noise is suppressed during signal sensing. The sensitivity values in the atrium and right ventricle are dynamically adapted independently of each other with each cardiac activity (beat-to-beat).
  • Page 28 Sensing Functions Automatic sensitivity control in the ventricle in the case of sensing, functions the same way in the atrium Phases of automatic sensitivity control The timing intervals for periodic adaptations of the sensitivity in the case of a sensed event are specified in different ways for the atrium and the ventricle: •...
  • Page 29 Sensing Functions Automatic sensitivity control in the ventricle in Detection hold-off period the case of pacing, functions the same way in the atrium Predefined +/- Maximum value sensitivity Paced 2 x Step duration Step duration ¼ of predefined value ½ of predefined value Fix predefined value: Atrium: 2 mV...
  • Page 30 Sensing Functions Interference Interval as Interference Protection Function The interference interval prevents intrinsic events or paced events in the ventricle from being incorrectly sensed in the atrium and vice versa. Therefore, the blanking periods following atrial and ventricular events guarantee adequate sensing.
  • Page 31 Sensing Functions Manual or Automatic Sensitivity Control Navigation: Parameters → Bradycardia/CRT → Sensing Objective The sensitivity of the device's sensing function is either dynamically updated by the automatic sensitivity control or it is manually programmed to a set value. An optimally configured sensing threshold guarantees reliable sensing of intrinsic events, but at the same time ignores electromagnetic interference and other inter- ference signals.
  • Page 32 Bradycardia Therapy Bradycardia Therapy Bradycardia Therapy5XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Section Topic Page Pacing Modes Resynchronization Therapy Pacing Parameters Timing Functions Atrial and Ventricular Capture Control Rate Adaptation Antitachycardia Functions Patient Data, Home Monitoring, Diagnostics...
  • Page 33 Bradycardia Therapy Pacing Modes What's in this section? Topic Page Mode (Pacing Mode) Standard Pacing Modes Triple-chamber modes Summary of the Functions and Time Intervals of the Pacing Modes Rate-Adaptive Modes Pacing when Exposed to Interference Setting the Magnet Response...
  • Page 34 Bradycardia Therapy Mode (Pacing Mode) Navigation: Parameters → Bradycardia/CRT WARNING Unphysiological rhythm changes during magnet application! During asynchronous magnet response, unphysiological rhythm changes can occur. • Implement countermeasures if necessary! Standard Pacing Modes Overview The following pacing modes will be described: •...
  • Page 35 Bradycardia Therapy Atrial/ventricular events Atrial/ventricular sensed events have the following impact in DDD mode: If ... Then ... If an atrial sensed or paced event Then the AV delay starts with the basic takes place, interval. If no ventricular sensed event occurs Then the pacemaker delivers a pacing pulse in the ventricle at the end of the ...
  • Page 36 Bradycardia Therapy Sensed events Absence of sensed events has the following impact in VDD mode: • If the sensed event does not take place, then the basic interval starts with an atrial sensed event, a premature ventricular contraction or with the end of the preceding basic interval.
  • Page 37 Bradycardia Therapy Atrial/ventricular events Atrial/ventricular sensed events have the following impact in DDI mode: If ... Then ... If no atrial or ventricular  Then atrial pacing takes place at the end of the sensed events occur during the VA interval. The AV delay is restarted together VA interval, with the pacing.
  • Page 38 Bradycardia Therapy Triggered pacing The triggered pacing modes correspond to the respective demand pacing modes with the following distinction: No pulse inhibition takes place upon sensing of an atrial/ventricular event outside of the refractory period. Instead, pacing is carried out immediately in the respective chamber. The corresponding pacing modes are: Pacing mode Demand pacing mode...
  • Page 39 Bradycardia Therapy Triple-chamber modes The device with HF-T added to its name is the triple-chamber model in the pacemaker family. The NBG code is DDDRV. Triple-chamber pacing can be carried out using two leads in a single ventricle or in each of the two ventricles. Multisite ventricular pacing is the primary function of cardiac resynchronization therapy.
  • Page 40 Bradycardia Therapy Summary of the Functions and Time Intervals of the Pacing Modes About this table The table summarizes the functions and time intervals that apply to the various pacing modes. Not included are rate-adaptive parameters and parameters that can be programmed in all pacing modes.
  • Page 41 Bradycardia Therapy Rate-Adaptive Modes Rate adaptation via CLS The device achieves physiological rate adaptation with closed loop stimulation. The closed loop modes are functionally identical to the non rate-adaptive modes, but differ in that the basic rate increases if the device senses patient stress or exertion. The closed loop modes are indicated by CLS.
  • Page 42 Bradycardia Therapy Setting the Magnet Response Navigation: Parameters → Bradycardia/CRT → Basic rate/Night rate →  Show magnet response parameters Objective Magnet responses are used to check the device's pacing functions. Description When the magnet is applied, the reed switch in the device closes. The device's response to magnet application is programmable with the following settings: •...
  • Page 43 Bradycardia Therapy Automatic magnet response • During the first 10 cycle after magnet application: Asynchronous pacing (see above). The AV delay is reduced to 100 ms if a longer interval has been set. This avoids ventricular fusion beats when AV conduction is intact and makes it easier to sense the effectiveness of ventricular pacing.
  • Page 44 Bradycardia Therapy Resynchronization Therapy What's in this section? Topic Page Special Settings HF(-T) / QP devices: Setting the Lead Polarity for the Left Ventricle Setting Ventricular Pacing...
  • Page 45 Bradycardia Therapy Special Settings Multiple left ventricular The special complex location of the left ventricular lead results in extracardiac polarity pace pacing (e.g. phrenic nerve stimulation) more often than right ventricular leads do in practice. Ideally, the LV lead is placed in a lateral or posterolateral coronary sinus vein and thus very close to the left-side phrenic nerve and to its area of stimulation as well.
  • Page 46 Bradycardia Therapy WARNING Right ventricle triggering In patients with intact AV conduction, intrinsic atrial tachycardia can be conducted into the right ventricle at a rate of up to 160 bpm. In such cases, deactivate triggering or reduce the maximum trigger rate. LV T-wave protection For protection against pacing in the vulnerable phase of the left ventricle, triple- chamber devices have a function that is controlled by sensed left ventricular events.
  • Page 47 Bradycardia Therapy HF(-T) / QP devices: Setting the Lead Polarity for the Left Ventricle Navigation: Parameters → Bradycardia/CRT → LV Objective The goal of left ventricular pacing is to do the following: • Optimize hemodynamics • Suppress phrenic nerve stimulation •...
  • Page 48 Bradycardia Therapy Phrenic nerve stimulation Note: • Resynchronization therapy can be effective only with continuous biventricular pacing. Patients cannot tolerate phrenic nerve stimulation. • Phrenic nerve stimulation can be prevented by programming the lead configu- ration. Concept: from minus to plus Proceed as follows: If ...
  • Page 49 Bradycardia Therapy Setting Ventricular Pacing Navigation: Parameters → Bradycardia/CRT Objective Configure ventricular pacing for cardiac resynchronization therapy (CRT), etc.: • Right ventricular • Biventricular • Exclusively left ventricular Biventricular pacing In the case of biventricular pacing, you can pace either the right or the left ventricle first.
  • Page 50 Bradycardia Therapy WARNING Triggering the ventricle: Conduction of atrial tachycardias For patients with intact AV conduction, intrinsic atrial tachycardias can be conducted to the ventricle to a maximum of 160 bpm. • In such cases, deactivate triggering or reduce the maximum trigger rate. User interface...
  • Page 51 Bradycardia Therapy Pacing Parameters What's in this section? Topic Page Setting Pulse Amplitude and Pulse Width Basic Rate during the Day and at Night Setting the Basic Rate for Day and Night...
  • Page 52 Bradycardia Therapy Setting Pulse Amplitude and Pulse Width Navigation: Parameters → Bradycardia/CRT Objective Optimized pulse amplitude and pulse width values ensure effective and reliable pacing. The lower the parameter values (fine tuning without safety margin for the pulse amplitudes), the longer the service time of the device. Safe and regular pulse The pulse amplitude and pulse width values are continuously maintained during the amplitudes and widths...
  • Page 53 Bradycardia Therapy Setting the Basic Rate for Day and Night Navigation: Parameters → Bradycardia/CRT → Basic rate/Night rate Objective The basic rate serves as the device's pacing rate, which can be adapted to meet the patient's individual needs. Description The basic rate is the lower rate limit, at which the device paces the heart if the intrinsic rhythm is irregular or no longer present.
  • Page 54 Bradycardia Therapy Timing Functions What's in this section? Section Topic Page 5.4.1 Programs and Parameters 5.4.2 Functions of Rate Hysteresis 5.4.3 Functions of the Dynamic AV Delay 5.4.4 Refractory and Blanking Times...
  • Page 55 Bradycardia Therapy 5.4.1 Programs and Parameters What's in this section? Topic Page Setting and Transmitting Parameters ProgramConsult - Selecting Programs by Indication Creating and Using Individual Therapy Programs Setting and Transmitting Parameters Objective Use the parameters to adjust the device to individual patient requirements. Sequence •...
  • Page 56 Bradycardia Therapy ProgramConsult - Selecting Programs by Indication Navigation: Parameters → Bradycardia/CRT → Program sets Objective The ProgramConsult function provides a number of programs with default parameters for the most common pacemaker indications. By selecting a program suggestion for a specific indication, a number of default parameters are loaded which have shown to be effective for these indications.
  • Page 57 Bradycardia Therapy Creating and Using Individual Therapy Programs Overview It is possible to create up to three individually configured therapy programs. To do this, the therapy parameters can be set as needed and stored under a name of your choice. Purpose This function serves to provide frequently required parameter configurations at the push of a button.
  • Page 58 Bradycardia Therapy 5.4.2 Functions of Rate Hysteresis What's in this section? Topic Page Rate Hysteresis Repetitive Rate Hysteresis Rate Scan Hysteresis Setting Rate Hystereses Rate Hysteresis Definition The rate hysteresis is specified as the difference from the basic rate. In rate- adaptive pacing, the hysteresis remains constant while the hysteresis rate follows the variable (sensor-controlled) basic rate.
  • Page 59 Bradycardia Therapy Repetitive Rate Hysteresis Objective The repetitive rate hysteresis helps to maintain the intrinsic rhythm and avoid unnecessary pacing in situations that exceed the basic hysteresis, such as post- extrasystolic pauses. The repetitive rate hysteresis can only be used in conjunction with the rate scan hysteresis.
  • Page 60 Bradycardia Therapy Rate Scan Hysteresis Definition The rate scan hysteresis scans an intrinsic rhythm during longer phases of pacing. Description If the scan hysteresis is activated, the pacemaker will temporarily reduce the pacing rate to the hysteresis rate after every 180 consecutive paced events. If no intrinsic event is sensed during these five scan intervals, pacing at the basic rate is then resumed (at the sensor rate in rate-adaptive mode).
  • Page 61 Bradycardia Therapy Setting Rate Hystereses Objective The device has a hysteresis function intended to maintain and support the patient's intrinsic heart rhythm for as long as possible. In addition to the conventional hysteresis function, additional hysteresis functions (repetitive/scan cycles) can be activated.
  • Page 62 Bradycardia Therapy 5.4.3 Functions of the Dynamic AV Delay What's in this section? Topic Page Dynamic AV Delay Setting AV Delay AV Safety Delay Sense Compensation AV Hysteresis AV Repetitive Hysteresis AV Scan Hysteresis Negative AV Hysteresis Setting AV Hystereses The Concept of Ventricular Pacing Suppression Functioning of Ventricular Pacing Suppression Setting Ventricular Pacing Suppression...
  • Page 63 Bradycardia Therapy Preset dynamic AV delays Preset dynamic AV delays in the DDDR mode (standard program) Frequency range AV delay (in ms) for programming the dynamic AV delay to Medium High At 60 bpm At 80 bpm At 100 bpm At 120 bpm At 140 bpm Fixed for all rate ranges...
  • Page 64 Bradycardia Therapy Optimize AV delay The AV delay can be optimized with the following functions: • IRSplus: — Intrinsic Rhythm Support can support the heart's intrinsic rhythm. The objective is to maintain spontaneous AV conduction of the heart as long as possible.
  • Page 65 Bradycardia Therapy AV Safety Delay Protection against If an atrial pace triggers ventricular oversensing through crosstalk, undesired pulse pulse inhibition inhibition in the ventricle can result. Sensing of the atrial pulse delivery in the ventricular channel during the AV delay can be incorrectly interpreted as intrinsic ventricle excitation.
  • Page 66 Bradycardia Therapy Sense Compensation Objective For hemodynamic reasons, it is desirable to maintain a constant period between an atrial and a ventricular contraction and to adjust it to physiologic conditions. For this purpose, sense compensation can be used to shorten the AV delay after an atrial sensed event.
  • Page 67 Bradycardia Therapy AV Repetitive Hysteresis Objective The AV repetitive hysteresis reduces pacing when existing intrinsic activity within the extended AV delay is suppressed by occasional paced events. Description Even when AV repetitive hysteresis is activated, the AV delay is extended by the defined hysteresis value after sensing an intrinsic ventricular event.
  • Page 68 Bradycardia Therapy Negative AV Hysteresis Objective In individual cases, it may be necessary to support ventricular pacing and allow the least possible conduction of the atrial intrinsic rhythm. This may be necessary particularly for patients with hypertrophic obstructive cardiomyopathy (HOCM). Description With a ventricular sensed event (Vs), the function decreases the AV delay and thereby promotes ventricular pacing.
  • Page 69 Bradycardia Therapy • If an intrinsic activity occurs during one of these repetitive cycles, the long  Positive AV delay remains intact. Only when the repetitive cycles have elapsed without spontaneous AV conduction does the pacemaker switch back to the short  AV delay.
  • Page 70 Bradycardia Therapy The Concept of Ventricular Pacing Suppression Why should right Right ventricular pacing evokes an asymmetrical contraction of the ventricle due to ventricular pacing be the unphysiological activation of the cardiac conduction system. avoided? Various randomized studies performed with pacemaker and ICD patients have shown that frequent ventricular pacing is connected with an increased risk of congestive heart failure and atrial fibrillation as long-term effects.
  • Page 71 Bradycardia Therapy Functioning of Ventricular Pacing Suppression Overview The following topics are described within this segment: • Activation of Vp suppression • Mode of functioning • Switching from DDD(R) to ADI(R) • Switching criterion and Vs continuity search • Vs continuity search triggered by a single Vs •...
  • Page 72 Bradycardia Therapy Switching from DDD(R) If Vp suppression is activated by switching on the DDD(R)-ADI(R) mode, the function to ADI(R) initially works in DDD(R) mode, so that a ventricular pace is triggered at the end of the AV delay. In DDD(R) mode, the device systematically scans to determine whether there is an intrinsic ventricular rhythm.
  • Page 73 Bradycardia Therapy Vs continuity search If the DDD(R)-ADI(R) mode has been set and the device paces with the programmed triggered by a timing AV delay in the ventricle, then the initial Vs continuity search begins 30 s after interval removing the programming head. DDD(R) Vs Continuity ADI(R)
  • Page 74 Bradycardia Therapy Switching from ADI(R) If an intrinsic ventricular rhythm is no longer sensed, it switches to DDD(R) mode. to DDD(R) In order to safely account for all situations, there are 4 different criteria which result in switching and they all work independently: •...
  • Page 75 Bradycardia Therapy Switching criterion: In order to avoid irregular ventricular rhythms while in ADI(R) mode, only a programmable number programmable number of cycles is permissible without an intrinsic event. The X-out-of-8 cycles without Vs default setting is 3 out of 8 cycles. If this criterion is met, it switches to DDD(R) mode.
  • Page 76 Bradycardia Therapy You will find the diagnostics for Vp suppression under Diagnostics →  Diagnostics recordings of Vp suppression More diagnostics → Vp suppression The Vp suppression diagnostic function records the actions of these functions numerically and chronologically: • 240-day trend for the duration of ADI(R). Like all long-term trends, this is a rolling recording in which one data point is recorded per day.
  • Page 77 Bradycardia Therapy Setting Ventricular Pacing Suppression Navigation: Parameters → Bradycardia/CRT → Vp suppression Objective The ventricular pacing suppression function serves to promote the intrinsic ventric- ular rhythm with AV conduction. Description The Vp suppression function supports intrinsic AV conduction. The function can only be set in DDD(R)-ADI(R) mode.
  • Page 78 Bradycardia Therapy IRSplus - Promoting Intrinsic AV Conduction Navigation: Parameters → Bradycardia/CRT The IRSplus (Intrinsic Rhythm Support) function is intended to support the  Objective heart's intrinsic rhythm. All parameters of the AV hysteresis functions are set simultaneously in a single step. The objective is to maintain spontaneous  AV conduction of the patient's heart as long as possible.
  • Page 79 Bradycardia Therapy 5.4.4 Refractory and Blanking Times What's in this section? Topic Page Timing of the Atrial Refractory Periods (ARP, PVARP) Setting Refractory Periods, Blanking Periods and PMT Protection Timing of the Atrial Refractory Periods (ARP, PVARP) Abbreviations Abbreviations and their meanings in graphics and text: Abbreviation Meaning Basic interval...
  • Page 80 Bradycardia Therapy Definition: Atrial refractory • The atrial refractory period (ARP) starts with a sensed or paced event. period in the device's timing Each of the following atrial events (As, As(AV), Ap, Ap(AUR) and As(PVARP)) starts an atrial refractory period (ARP). Atr.
  • Page 81 Bradycardia Therapy Post-ventricular atrial The post-ventricular atrial refractory period function prevents atrial pacing from refractory period (PVARP) being triggered directly after a ventricular event. This prevents a pacemaker- mediated tachycardia (PMT). • In all P-synchronous modes (e.g., DDD), a PVARP starts in the case of the following events: Vp, Vp(WKB), Vp(SW), Vp(BU) •...
  • Page 82 Bradycardia Therapy PVARP - Description of the The PVARP lengthens the atrial refractory period (ARP) after a ventricular event parameters (PV = post-ventricular). The total atrial refractory period is divided into the atrial refractory period (ARP) and two other safety intervals - the far-field blanking (FFB) and PVARP.
  • Page 83 Bradycardia Therapy Purpose of PMT protection With its basic algorithm, PMT protection can interrupt the persistance of a pacemaker-mediated tachycardia (PMT). When the AUTO (PVARP) parameter value is set, where a PMT has been confirmed, the PVARP is extended automatically, see also: PVARP - Description of the param- eters, p.
  • Page 84 Bradycardia Therapy Atrial and Ventricular Capture Control What's in this section? Section Topic Page 5.5.1 Atrial Capture Control 5.5.2 Ventricular Capture Control 5.5.3 Configuring Capture Control, Parameters, and FAQ Overview The functions of atrial capture control are designed as follows: •...
  • Page 85 Bradycardia Therapy 5.5.1 Atrial Capture Control What's in this section? Topic Page Atrial Capture Control - Overview Automatic Threshold Measurement Atrial Capture Control - Overview Overview • Objective of atrial capture control • Function • Advantages Objective of atrial capture Lead aging, changes to the medication, lead dislodgement and pathological control changes can result in changes to the pacing threshold.
  • Page 86 Bradycardia Therapy Automatic Threshold Measurement Overview • Testing principle • Determining the intrinsic rate and performing overdrive pacing • Searching for the pacing threshold • Confirming the pacing threshold • Automatic active capture control • Programming suggestions Testing principle When measuring the atrial threshold, the pulse amplitude is reduced until pacing in the heart no longer triggers a response.
  • Page 87 Bradycardia Therapy Searching for the Mode and AV delay during the test pacing threshold • DDI mode: Pacing in DDI mode prevents tracking of retrograde conducted P waves, which can occur if the atrial paced response is lost during the pacing threshold test. In DDD mode, retrograde conducted P waves can trigger pacemaker-mediated tachycardias.
  • Page 88 Bradycardia Therapy • After each test pulse sequence with the same pacing energy, a synchronization pulse is delivered to ensure that the AV synchrony is restored after possible loss of pacing. For technical reasons, the synchronization pulse is even delivered without a loss of capture response.
  • Page 89 Bradycardia Therapy Example: Loss of capture at 0.6 V; only atrial markers outside the far-field protec- tion interval (150 ms after Vp) are evaluated. 0.6 V 0.6 V 0.6 V 0.6 V Far-field protection (FFP) Second intrinsic event First intrinsic event detected detected outside FFP >threshold above 0.6 V...
  • Page 90 Note: If atrial capture control is deactivated, an error message is displayed in the Follow- up window and an event message is generated for BIOTRONIK Home Monitoring. Unsuccessful measurements of atrial capture control are shown in the Home Monitoring statistics as gaps.
  • Page 91 Bradycardia Therapy Programming suggestions • The value of the "Threshold test start" parameter does not influence the success of the test (as opposed to ventricular capture control), but decre- menting makes it several seconds faster. • The test is repeated daily at the programmed time. Note: Make sure there is a sufficient difference between the threshold and the value of the threshold test start parameter, so that pacing threshold changes can be monitored following implantation.
  • Page 92 Bradycardia Therapy 5.5.2 Ventricular Capture Control What's in this section? Topic Page Ventricular Capture Control – Overview Signal Analysis Automatic Threshold Measurement Verification of Capture Response Ventricular Capture Control – Overview • Components of the algorithm • Characteristics • Manual/automatic determination of the pacing threshold •...
  • Page 93 Bradycardia Therapy The algorithm is based on the comparison of the signals from the evoked response and the polarization artifact. Successful pacing Unsuccessful pacing Characteristics The function comprises of the following characteristics: • The function periodically measures the pacing threshold, automatically adjusts the pulse amplitude and offers a programmable safety margin.
  • Page 94 Bradycardia Therapy Terms The following table lists and describes all terms that are used in connection with ventricular capture control. Term Description Evoked response Intracardiac signal which arises through the excitation of the myocardium tissue. The evoked response is inde- pendent from the pulse amplitude and the pacing threshold.
  • Page 95 Bradycardia Therapy Signal Analysis Purpose This sub-function analyzes the signal quality of the ventricular evoked stimulus response when the stimulus is effective, and the polarization artifacts when the stimulus is ineffective. The function ensures that only undisturbed and suitable signals are evaluated.  The signal analysis function works up to a ventricular rate of 100 bpm.
  • Page 96 Bradycardia Therapy Example: Checking signal quality, analysis of evoked responses 3.0 V 3.0 V 3.0 V 3.0 V 3.0 V 3.0 V 3.0 V 3.0 V 3.0 V 3.0 V Evaluation signal quality check: 5 single stimuli; 5 doubled simuli Start threshold test: first stimulus Test start...
  • Page 97 Bradycardia Therapy Automatic Threshold Measurement Objective The sub-function Pacing threshold measurement enables the pacing threshold with the resulting stimulus to be automatically determined. The ventricular threshold is periodically measured and the pulse amplitude is adjusted if neces- sary. Prerequisite Only after the signal quality has successfully been checked can the pacing threshold measurement and capture control functions be executed.
  • Page 98 Bradycardia Therapy Automatic determination of If ... Then ... the pacing threshold If a single ineffective pace is sensed Then the pacing value is set at the previous during the first pulse amplitude value minus 0.1 V and the amplitude is then decrement (0.6 V), reduced by 0.1 V in order to determine the pacing threshold.
  • Page 99 Bradycardia Therapy Verification of Capture Response Overview • Functionality (verification of the capture response) • Backup pace • Algorithm for fusion discrimination • Fusion discrimination in 3 stages Objective This sub-function allows the pulse amplitude to be continuously verified. Verifica- tion of the capture response is possible up to a ventricular rate of 110 bpm.
  • Page 100 Bradycardia Therapy Algorithm for fusion Fusion beats can significantly compromise signal morphology, which, in some discrimination cases, may cause such fusion beats to be classified as ineffective pacing. A fusion beat occurs when the spontaneous depolarization could still not be sensed before the stimulus delivery from the pacemaker.
  • Page 101 Bradycardia Therapy 5.5.3 Configuring Capture Control, Parameters, and FAQ What's in this section? Topic Page Setting Capture Control Ventricular and Atrial Capture Control - Programmable Parameters FAQ - Frequently Asked Questions Comparison of Atrial and Ventricular Capture Control Setting Capture Control Navigation: Parameters →...
  • Page 102 Bradycardia Therapy Setting parameters Proceed as follows: Step Action Select [Threshold test start], to set the initial value of the pacing threshold measurement. Select [Min. amplitude] to prevent the minimum amplitude from falling below a particular value. Select [Safety margin], to adjust the safety margin. After successfully making automatic threshold measurements, if capture control = ON, the pulse amplitude is made up of the pacing threshold plus a safety margin.
  • Page 103 Bradycardia Therapy Ventricular and Atrial Capture Control - Programmable Parameters Parameter overview Parameter Range of values and explanations Capture control ON; OFF; ATM (monitoring only) Minimum amplitude (atrial) 0.5 ... (0.1) ... 4.8 V The minimum amplitude and threshold test start (maximum atrial amplitude) parameters prevent a certain value of the ventricular amplitude from being exceeded or undershot during the threshold search.
  • Page 104 Bradycardia Therapy FAQ - Frequently Asked Questions The following questions regarding the behavior of capture control in particular  Overview situations will be answered: • When are the atrial and ventricular thresholds measured? • Which atrial and ventricular events cause temporary deactivation of capture control? •...
  • Page 105 Bradycardia Therapy How do fusion beats affect If pacing is classified as ineffective because of a fusion beat, a backup pace is deliv- ventricular capture control? ered. Fusion beats do not compromise safety, however, they lead to unnecessary backup pacing. In the following cycles the AV delay can be extended or shortened to 15/50 ms (after As/Ap) in order to avoid fusion beats and to prevent the sensing of loss of capture response (3 consecutive ineffective Vp) because of fusion beats.
  • Page 106 Bradycardia Therapy Comparison of Atrial and Ventricular Capture Control A comparison of differences between atrial and ventricular capture control Atrial capture control Ventricular capture control The pacing threshold is determined The pacing threshold is determined by using sensing markers the beat-to-beat measurement of evoked responses.
  • Page 107 Bradycardia Therapy Rate Adaptation What's in this section? Section Topic Page 5.6.1 Pacing Modes 5.6.2 Physiological Rate Adaptation (CLS Function) 5.6.2 Rate Adaptation using the Accelerometer...
  • Page 108 Bradycardia Therapy 5.6.1 Pacing Modes What's in this section? Topic Page Rate-Adaptive Modes Rate-Adaptive Modes Rate adaptation principles The device uses 2 independent principles for rate adaptation: • Physiological rate adaptation via Closed Loop Stimulation • Rate adaptation using the accelerometer An overview of The programmable rate-adaptive modes can be categorized as follows: rate adaptation...
  • Page 109 Bradycardia Therapy 5.6.2 Physiological Rate Adaptation (CLS Function) What's in this section? Topic Page The Closed Loop Stimulation Principle Individual Adjustment of CLS Parameters CLS Safety Feature Setting Closed Loop Stimulation The Closed Loop Stimulation Principle The contraction dynamics of the myocardium vary depending on the patient's exertion.
  • Page 110 Bradycardia Therapy Among other things, pacing cycles with extended or shortened AV delays update the reference impedance curves at regular intervals. However, some individual cases (e.g. if the patient is extremely active or extremely inactive) may require adjustment of the CLS. Individual Adjustment of CLS Parameters Overview The following parameters can be individually adjusted in the CLS →...
  • Page 111 Bradycardia Therapy Resting rate control This parameter limits the pacing rate attainable at rest to the programmable value of, e.g., 20 bpm above the set basic rate. This serves to suppress unspecific rate excursions at rest without limiting rate adaptation in cases of mental stress. This can be switched off if a high rate limit is not desired from the clinical perspective.
  • Page 112 Bradycardia Therapy 5.6.3 Rate Adaptation using the Accelerometer What's in this section? Topic Page The Principle of Rate Adaptation via Accelerometer Maximum Activity Rate Sensor Gain Automatic Sensor Gain Sensor Threshold Rate Increase Rate Decrease Sensor Simulation Rate Fading Sensor Functions – Details The Principle of Rate Adaptation via Accelerometer Objective Sensor-controlled rate adaptation allows an adjustment of the pacing rate to...
  • Page 113 Bradycardia Therapy Maximum Activity Rate Description Regardless of the sensor's sensed signal amplitude, the pacing rate will not exceed the programmed maximum activity rate. The programmed value applies only to the maximum pacing rate during sensor- controlled operation and is independent of the upper tracking rate. Note: In the DDIR and DVIR modes, lower maximum sensor rates result than those indicated here, depending on the selected AV delay.
  • Page 114 Bradycardia Therapy Sensor Gain Definition The sensor gain designates the factor by which the electric signal of the sensor is amplified before subsequent signal processing occurs. Objective The programmable sensor gain permits adaptation of the desired rate adaptation to the individually variable signal strengths. Description The optimal parameter setting is achieved when the desired maximum pacing rate is reached during maximum exertion.
  • Page 115 Bradycardia Therapy Automatic Sensor Gain Description The manually programmable sensor gain is supplemented by an automatic sensor gain function. When the function is enabled, the pacemaker continuously checks whether sensor gain optimally corresponds to the patient's needs and makes adjustments if necessary. The automatic sensor gain function checks daily whether 90% of the set maximum activity rate has been reached for a total of 90 seconds.
  • Page 116 Bradycardia Therapy Rate Increase Description The rate increase parameter determines the maximum speed at which the pacing rate rises if the sensor signal indicates increasing exertion. For example, setting the rate increase to 2 bpm per cycle means that the rate increases from 60 bpm to 150 bpm in 45 cycles.
  • Page 117 Bradycardia Therapy Sensor Simulation Definition Even when a non-rate-adaptive mode is programmed, the sensor response is recorded without being effective. In other words, the sensor simulation indicates how the sensor would have responded if a rate-adaptive mode had been programmed. Purpose This function is helpful to find the optimum sensor settings and to compare the sensor rate with the intrinsic rhythm.
  • Page 118 Bradycardia Therapy In cases of sudden atrial tachycardia, which result in mode switching, the target rate is set to the sensor or basic rate. The current pacing rate in the ventricle results from the current value of the backup rate prior to the mode switching event. If the pacing rate reaches the heart rate upon rate decrease, then at least 4 consec- utive intrinsic cycles above the pacing rate are required to adjust the pacing rate to the last intrinsic event.
  • Page 119 Bradycardia Therapy Automatic gain The programmable sensor gain is supplemented by the automatic sensor gain function. Every day, the device checks whether 90% of the set maximum sensor rate has been reached for a certain total duration (for at least 90 s (cumulative) within one day).
  • Page 120 Bradycardia Therapy Antitachycardia Functions What's in this section? Topic Page Upper Rate Atrial Upper Rate Mode Switching 2:1 or Wenckebach Response 2:1 Lock-In Management PMT Prevention PMT protection PVC Discrimination after As Atrial Overdrive Pacing - Concept Atrial Overdrive Pacing...
  • Page 121 Bradycardia Therapy Upper Rate Navigation: Parameters → Bradycardia/CRT → Upper rate Description In all of the triggered pacing modes, the upper rate limits the pacing rate triggered by atrial sensing. The settings help prevent the conduction of atrial tachycardias to the ventricle. WARNING Triggering the ventricle: Conduction of atrial tachycardias Intrinsic atrial tachycardias can be transmitted to the ventricle from the device at...
  • Page 122 Bradycardia Therapy Atrial Upper Rate Abbreviations Abbreviations and their meanings in graphics and text: Abbreviation Meaning Intrin. atr. refr. Intrinsic atrial refractory period Basic interval AV delay Atrial sensed event Atrial paced event Atrial refractory period Atrial upper rate Ventricular sensed event Ventricular paced event Ventricular refractory period PVARP...
  • Page 123 Bradycardia Therapy Atrial upper rate as This function protects against atrial tachycardias. The safety interval functions as safety interval follows: • Each sensed atrial event during the PVARP (As(PVARP)) starts the atrial upper rate (AUR). • During a sustained episode of AUR, an intended atrial pace (Ap) is shifted to the end of the AUR.
  • Page 124 Bradycardia Therapy Mode Switching Navigation: Parameters → Bradycardia/CRT → Mode switching Objective The conduction of high atrial rates and atrial tachycardias to the ventricle is prevented through the use of mode switching, for example, from DDD to DDI on the basis of X/Z-out-of-8 algorithm.
  • Page 125 Bradycardia Therapy 2:1 or Wenckebach Response Description The resulting mode, either 2:1 or Wenckebach (WKB), is automatically displayed, depending on the combination of selected parameters. The parameters that affect this are: • Upper tracking rate (UTR) • Atrial refractory period Wenckebach response A response similar to Wenckebach block (Wenckebach response) results if the selected upper tracking rate is lower than the rate corresponding to the atrial...
  • Page 126 Bradycardia Therapy 2:1 Lock-In Management In cases of high atrial rates (atrial flutter) in combination with a relatively long  Description AV delay, it is possible that every second P wave regularly occurs in the atrial far-field blanking. In this case, the device detects only half of the present atrial rate. Therefore the behavior of the device is similar to a 2:1 block.
  • Page 127 Bradycardia Therapy PMT Prevention Purpose PMT prevention PMT occurrence • Pacemaker-mediated tachycardia is generally triggered by ventricle depolariza- tion that is asynchronous with atrial depolarization, e.g., as would be the case in premature ventricular contractions (PVC). • The tachycardia is maintained retrogradely by VA conduction of paced ventricle depolarization and antegradely by P-wave-triggered ventricular pacing.
  • Page 128 Bradycardia Therapy PMT protection Overview • PMT detection • PMT termination Objective Pacemaker-mediated tachycardias can also be caused by artifacts and atrial extrasystoles. In such cases, the PMT protection algorithm offers functions to provide both reliable detection as well as termination of PMTs. In this way, the hemodynamically more favorable AV synchronization can rapidly be re-established.
  • Page 129 Bradycardia Therapy Termination algorithm The algorithm for terminating PMTs becomes effective as follows: Sequence Description The PMT is terminated by extending PVARP by one pacing cycle. This interrupts the retrograde conduction and hence the PMT. Consequently the PVARP must be longer than the retrograde conduction period after ventricular pacing or sensing.
  • Page 130 Bradycardia Therapy Atrial Overdrive Pacing - Concept Description Atrial overdrive pacing is used as a preventive measure to reduce the number of atrial tachycardia incidences. Numerous clinical examinations and publications provide information as to reducing the risk of forming atrial tachycardia. The overdrive algorithm causes atrial overdrive pacing and ensures pacing at a rate slightly above the intrinsic rhythm.
  • Page 131 Bradycardia Therapy Atrial Overdrive Pacing Navigation: Parameters → Bradycardia/CRT → Basic rate/Night rate Available for the • 6 and 8 series following devices • DR, DR-T and HF, HF-T Objective Atrial overdrive pacing is intended to reduce the occurrence of atrial tachycardias by means of atrial overdrive pacing above the sinus rhythm.
  • Page 132 Bradycardia Therapy Patient Data, Home Monitoring, Diagnostics What's in this section? Topic Page Setting Home Monitoring Setting Diagnostic Functions Patient and Device Data Thoracic Impedance Thoracic Impedance Measurement – Details...
  • Page 133 Time of day at which the message from the device to transmission the CardioMessenger and from there to the BIOTRONIK Home Monitoring Service Center (HMSC) is sent. AUTO = at a default time in the early hours of the morning – which will depend on the serial number of...
  • Page 134 Description [Send test message] Checks the data transmission function PID is the ID number for the device and is required to initialize Home Monitoring at the BIOTRONIK HMSC. Setting Diagnostic Functions Navigation: Parameters → Diagnostics Objective Make your settings for the various parameters for statistics and IEGM recordings in the Diagnostics tab.
  • Page 135 The devices in this product family can measure thoracic impedance and transmit this information to the BIOTRONIK Service Center via Home Monitoring. In addition, the impedance trend can also be displayed on the programmer: Display HF Monitor Statistics, ...
  • Page 136 • The average daily impedance measurement values are stored in the device. • Via the daily transmission made using Home Monitoring, the data are sent to the BIOTRONIK Home Monitoring Service Center, where they are evaluated. • The impedance measurements are displayed as thoracic impedance trend.
  • Page 137 Home Monitoring Home Monitoring  Home Monitoring 6XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Introduction Home Monitoring Parameters Types of Device Messages Criteria for the Use of Home Monitoring Periodic and Event-based IEGM...
  • Page 138 Internet and thus always be informed of your patient's cardiac status. A patient device receives messages from the device and transmits them to the BIOTRONIK Service Center. At the Center, the data are processed and are made available via a secure Internet connection.
  • Page 139 Home Monitoring Home Monitoring concept CardioMessenger Data transmission Patient Home Monitoring Physician Service Center Home Monitoring Parameters Home Monitoring OFF, ON You can activate or deactivate the Home Monitoring function using the program- ming device. The additional sub-functions can only be used if Home Monitoring has been activated.
  • Page 140 Home Monitoring Event-based IEGM Event-based IEGMs are transmitted to the BIOTRONIK Service Center if you have activated this parameter. These events include high atrial and ventricular rates as well as lead failures. Periodic IEGM Configure the interval or date for generating and transmitting the periodic IEGM in the Home Monitoring Service Center.
  • Page 141 Home Monitoring and its individualized therapy options. The Home Monitoring Service Center can be used as a diagnostic tool for all patients who have a BIOTRONIK implanted device with Home Monitoring function and who have been equipped with a corresponding transmitter by their physician. The indication for...
  • Page 142 Recognized warnings and precautions for pacemakers and ICDs are applicable and are independent of Home Monitoring. However, there are specific precautions for Home Monitoring. Please follow the specific warnings and precautions for Home Monitoring in the BIOTRONIK Home Monitoring Service Center manual and the patient device manual.
  • Page 143 Home Monitoring Periodic and Event-based IEGM The device can record the following IEGM types: • Periodic: Recording is time-controlled at regular intervals and is transmitted together with the daily device message. — The periodic IEGM is deleted following transmission. Therefore, it can only be viewed in the Home Monitoring Service Center and not with the programmer.
  • Page 144 Home Monitoring IEGM type: normal IEGM type: encouraged sensing IEGM type: encouraged pacing Event-based IEGM The IEGM is recorded and transmitted to the Home Monitoring Service Center are performed if the following events occur: • High atrial rates • High ventricular rates •...
  • Page 145 Home Monitoring IEGM type: high atrial rates IEGM type: high ventricular rates IEGM type: lead failure...
  • Page 146 Evaluate Recordings Evaluate Recordings Evaluate Recordings7XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page IEGM Recordings...
  • Page 147 Evaluate Recordings IEGM Recordings Recording capacity Each IEGM recording has a duration of approximately 10 s. Device family Maximum amount of recordings Edora 8, Evity 8, Enitra 8, Enticos 8 Evity 6, Enitra 6 Enticos 4 Showing the graphic display Proceed as follows: of an IEGM recording Step...
  • Page 148 Evaluate Recordings Displaying, evaluating, Proceed as follows to display an IEGM with the programmer from the list of record- saving, and printing ings: the IEGM Step Action Click on the IEGM symbol of the desired recording in the  View column. The programmer opens an IEGM display window with an expressive signal display, comprehensive remarks, options for adapting the display, and buttons for printing and saving.
  • Page 149 Statistics (Diagnostics) Statistics (Diagnostics) Statistics (Diagnostics)8XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Section Topic Page Statistics Classes Evaluating Statistics...
  • Page 150 Statistics (Diagnostics) Statistics Classes What's in this section? Topic Page Selecting Statistics for Diagnostics Using the Statistics The numerous statistics functions that save the data and the special events occurring between follow-ups in the device are assigned to various statistics classes according to content.
  • Page 151 Statistics (Diagnostics) Selecting Statistics for Diagnostics Navigation: Diagnostics Overview The following actions can be performed with the Diagnostics function: • Interrogate statistics: Statistics are always interrogated during initial interrogation of the device. • Displaying statistics • Selecting statistics • Evaluating statistics •...
  • Page 152 Statistics (Diagnostics) Update statistics by device The statistical data is updated when it is reinterrogated. This reinterrogation will reinterrogation replace the device values previously displayed on the programmer with the current device values. Step Action Select [End], to return to the start screen and confirm your action with [OK].
  • Page 153 Statistics (Diagnostics) Using the Statistics Navigation: Diagnostics Displaying the statistics The statistics feature shows recorded data such as events, event sequences, and classifications as follows: • Graphical display as histogram • Numerical (absolute) quantity • Occurrence expressed as a percentage •...
  • Page 154 Statistics (Diagnostics) Evaluating Statistics What's in this section? Topic Page Displaying Timing Statistics Displaying Atrial Arrhythmia Statistics Display HF Monitor Statistics Statistics for the Last 24 Hours Displaying Other Statistics...
  • Page 155 Statistics (Diagnostics) Displaying Timing Statistics Navigation: Diagnostics → Timing Overview The following trends and histograms are available for use in statistics: • Rate histograms • Event episodes and events; see also Follow-up → Details: Event episodes • Pacing trends as long-term trends over 240 days; see also Follow-up →...
  • Page 156 Statistics (Diagnostics) Displaying Atrial Arrhythmia Statistics Navigation: Diagnostics → Arrhythmia A Overview The following statistics are available for atrial arrhythmias: • Arrhythmia burden — Total number of episodes since starting the statistics — Accumulated arrhythmia burden expressed as a percentage since starting the statistics —...
  • Page 157 Statistics (Diagnostics) Display HF Monitor Statistics Navigation: Diagnostics → HF monitor Overview The following HF monitor statistics are displayed as a long-term trend: • Mean heart rate • Mean heart rate at rest • Variability of the mean heart rate •...
  • Page 158 Statistics (Diagnostics) • For each separate trend the display shows the mean values on all days for which valid values are present. • Variability of the mean heart rate The variability of the heart rate is recorded in bpm according to the SDANN algorithm, as a long-term trend for up to 240 days with a resolution of one day.
  • Page 159 Statistics (Diagnostics) Statistics for the Last 24 Hours Purpose These statistics provide important data recorded in the last 24 hours. You can evaluate a summary of important data from the individual statistics (timing, atrial arrhythmia) at a glance. The following statistics are displayed as short-term trends: •...
  • Page 160 Statistics (Diagnostics) Displaying Other Statistics Navigation: Diagnostics → More diagnostics The following statistics are shown with histograms and trends in the Statistics Overview group box: • Event counters: As, As (PVARP), Ars, Ars (FFP), Ap, RVs, PVC, RVrs, RVp, LVs, LVrs, LVp •...
  • Page 161 System Functions of the Device System Functions of the Device System Functions of the Device9XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Transmitting Device Data Activating RF Telemetry...
  • Page 162 System Functions of the Device Transmitting Device Data Navigation: More -> [Name of device] Objective To be able to export device data to an external data medium, the data must first be transmitted to the programmer. Transmitting data To apply this function, proceed as follows: Step Action Select [More] and click on the tab with the name of the device, e.g.,...
  • Page 163 System Functions of the Device Activating RF Telemetry Navigation: More -> [Name of device] Definition and description of The RF telemetry function is also referred to as SafeSync RF telemetry. In this RF telemetry manual, the function is referred to in the short form, RF telemetry. RF telemetry enables permanent wireless communication between the programmer and the device over a distance of up to three meters.
  • Page 164 System Functions of the Device Telemetry control The control indicators for PGH and RF telemetry are shown in the following table: indicators Telemetry Illustration Remark Active RF telemetry The RF telemetry status is shown in five increments: from 1 bar = 20% to 5 bars = 100%.
  • Page 165 System Functions of the Device RF telemetry and Telemetry switches to economy mode if the programmer is not used for 3 minutes during a follow-up. Additionally, the patient name is displayed in the Economy economy mode mode window. RF telemetry is fully reactivated when the window is closed. RF telemetry and safety The RF telemetry function can only establish a connection to the device of one patient at a time so that there is no possibility of confusion.
  • Page 166 System Functions of the Device Restore RF telemetry by Restore RF telemetry after a connection loss by restarting the programmer. restarting If the programmer is restarted and an RF telemetry connection was present within the preceding five minutes, the programmer displays a dialog box to restore the session.
  • Page 167 Follow-up Follow-up Follow-upIIIXXXXXX--AEnitra 6/8 Function Manual What's in this part? Chapter Chapter name Page Performing Automatic Follow-Up Archive - Events - Measured Value Trends Performing Manual Follow-up See part III of the function manual for further information on all topics related to follow-up.
  • Page 168 Performing Automatic Follow-Up Performing Automatic Follow-Up Performing Automatic Follow-Up10XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Interrogating the Device Automatically Follow-up Follow-up Window Legend for the Follow-up Window Real-Time IEGM on the User Interface Configuring and Performing Automatic Follow-up The follow-up concept The follow-up is virtually fully automated since all relevant data is measured at a glance...
  • Page 169 (in-office follow-up). • The next in-office follow-up should be carried out once a year and no later than 12 months after the last in-office follow-up. Follow-up with BIOTRONIK Monitoring using the Home Monitoring function does not serve to replace regular ®...
  • Page 170 Performing Automatic Follow-Up Follow-up with the Use the following procedure for in-house follow-up: programmer Record and evaluate the ECG. Interrogate the device. Evaluate the status and automatically measured follow-up data. Check the sensing and pacing functions. Manually perform standard tests if necessary. Possibly evaluate statistics and IEGM recordings.
  • Page 171 Performing Automatic Follow-Up Legend for the Follow-up Window Navigation: Follow-up Battery charging status The various abbreviations mean the following: Abbreviation Meaning Beginning of Service: • > 90% charge Elective Replacement Indication (i.e., RRT: Recommended Replace- ment Time): • indicates that the device must be replaced End of service: •...
  • Page 172 Performing Automatic Follow-Up Recording the IEGM The Freeze button can be used to have the software display a recording of the IEGM in another window. Detailed markers and entries of measured values are displayed in this window. Marker overview The following marker symbols and labels are displayed in the IEGM window and in the Freeze window.
  • Page 173 Performing Automatic Follow-Up WARNING Patient endangered by interrupted telemetry! Interruptions in telemetry between the programmer and the device during  follow-up tests may result in inadequate pacing. • Telemetry using PGH Lift the programming head 30 cm; the device switches automatically to the permanent program.
  • Page 174 Archive - Events - Measured Value Trends Archive - Events - Measured Value Trends Archive - Events - Measured Value Trends11XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Display Events Meaning of Event Messages Pacing Thresholds, P and R Wave Amplitudes – Details Archiving Follow-up Results Evaluate Trends in Measured Values TrendView –...
  • Page 175 Note: The following table shows all possible event messages and explains their meaning. The precise messages shown will depend on the device type. Event text Meaning Device error Device error has occurred; contact BIOTRONIK. ERI occurred Elective replacement indication: indicates device must be replaced Lead status / lead The device has been switched to unipolar pacing.
  • Page 176 Archive - Events - Measured Value Trends Pacing Thresholds, P and R Wave Amplitudes – Details Navigation: Follow-up → TrendView Pacing threshold trends Enable the function for recording threshold trends here: • Parameters → Bradycardia/CRT → Capture control → ON or  ->...
  • Page 177 Archive - Events - Measured Value Trends Evaluate Trends in Measured Values Navigation: Follow-up → TrendView Display trends The Trends function provides you with a structured overview of important measured values, which are displayed as graphic trends since the last follow-up. •...
  • Page 178 Archive - Events - Measured Value Trends Arrow keys for navigation The arrow keys have the following functions: Icon Functions Arrow keys with event icon: navigate to the left or right to the next event. Simple arrow keys: move the cursor to the right or left from one day to the next one.
  • Page 179 Archive - Events - Measured Value Trends Details of Diagnostics Navigation: Follow-up In the Diagnostics group box in the Follow-up window you can display selected Objective statistical data for diagnostic purposes all together in a single window. Here, you can evaluate the most important data from the individual statistics at a glance. User interface Details of diagnostics;...
  • Page 180 Performing Manual Follow-up Performing Manual Follow-up Performing Manual Follow-up12XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Section Topic Page 12.1 Impedance Test 12.2 Sensing Test 12.3 Threshold Test 12.4 AV Optimization Test 12.5 LV VectorOpt 12.6 NIPS - Non-Invasive Programmed Stimulation 12.7 Retrograde Conduction Test 12.8...
  • Page 181 Performing Manual Follow-up 12.1 Impedance Test What's in this section? Topic Page Measuring Impedance Objective • The impedance test measures the following conductor resistances of the implanted leads: — Pacing impedance • The measured values serve to check the leads (for example, in case of lead fracture) and to evaluate the lead position.
  • Page 182 Performing Manual Follow-up Measuring Impedance Navigation: Tests → Impedance WARNING Interrupted telemetry can cause incorrect data display Interrupted telemetry between the device and the programmer can cause false data to be displayed on the programmer. • In order to continuously monitor the effectiveness of pacing and the plausibility of the test results at any time, use an external ECG device during tests.
  • Page 183 Performing Manual Follow-up 12.2 Sensing Test What's in this section? Topic Page Performing the Sensing Test Sensing Test – Details...
  • Page 184 Performing Manual Follow-up Performing the Sensing Test Navigation: Tests → Sensing Objective The sensing test has the following clinical benefits: • Evaluation of the position of the leads • Check of prerequisites for additional electrophysiological tests • Determination of optimal sensitivity for the device WARNING Interrupted telemetry can cause incorrect data display Interrupted telemetry between the device and the programmer can cause false...
  • Page 185 Performing Manual Follow-up Performing the sensing test To perform the sensing test, proceed as follows: Step Action Remark Evaluate the default parameter values for the test program and adjust them if necessary. Select Basic rate and Display of measured values: reduce the basic rate to a •...
  • Page 186 Performing Manual Follow-up 12.3 Threshold Test What's in this section? Topic Page Conducting the Threshold Test Threshold Test – Parameters...
  • Page 187 Performing Manual Follow-up Conducting the Threshold Test Navigation: Tests → Threshold Objective The threshold test determines the lowest value of pacing energy needed to pace the heart. Low values for pulse width and pulse amplitudes increase the service time of the implanted device.
  • Page 188 Performing Manual Follow-up User interface Conducting the If you want to run the threshold test using the default settings or adjusted para- meters in the Test program group box, then proceed as follows: threshold test Step Action Evaluate the default parameter values for the test program and adjust them if necessary.
  • Page 189 Performing Manual Follow-up Accept the threshold value in the Threshold window. You can print out the results Evaluating and adopting the results if required. WARNING Ineffective pacing due to modified pacing threshold The values determined by the threshold test can vary from follow-up to follow-up. •...
  • Page 190 Performing Manual Follow-up 12.4 AV Optimization Test What's in this section? Topic Page AV Optimization by Testing...
  • Page 191 Performing Manual Follow-up AV Optimization by Testing Navigation: Parameters → Dynamic AV delay → AV optimization test Note: Stop the temporary program • In the case of telemetry with PGH: — Raise the programming head by at least 30 cm; the device will switch  automatically to the permanent program.
  • Page 192 Performing Manual Follow-up Parameters for The following parameters control the test: AV optimization test Parameter Meaning Mode RV DDD The test is performed in DDD mode and determines the perceived and paced duration of P-waves. RV indicates that pacing is only performed in the right ventricle.
  • Page 193 Performing Manual Follow-up 12.5 LV VectorOpt What's in this section? Topic Page Test LV Pacing Measuring the RV-LV Conduction Time...
  • Page 194 Performing Manual Follow-up Test LV Pacing Navigation: Tests → LV VectorOpt Note: Stop the temporary program • In the case of telemetry with PGH: — Raise the programming head by at least 30 cm; the device will switch  automatically to the permanent program. •...
  • Page 195 Performing Manual Follow-up Setting additional The parameters for the LV threshold test and the phrenic nerve stimulation can be parameters set directly: • Pulse amplitude: — Change the amplitude using [-] and [+] in a number of preset step sizes —...
  • Page 196 Performing Manual Follow-up Measuring the RV-LV Conduction Time Navigation: Tests → LV VectorOpt Note: Stop the temporary program • In the case of telemetry with PGH: — Raise the programming head by at least 30 cm; the device will switch  automatically to the permanent program.
  • Page 197 Performing Manual Follow-up 12.6 NIPS - Non-Invasive Programmed Stimulation What's in this section? Topic Page NIPS - Non-Invasive Programmed Stimulation NIPS - Executing Burst Pacing NIPS - Executing Programmed Stimulation NIPS - Description of Selected Parameters...
  • Page 198 Performing Manual Follow-up NIPS - Non-Invasive Programmed Stimulation Navigation: Tests → Atr. NIPS WARNING Triggering arrhythmias Depending on the type of high-rate stimulation and the predispositions of the patient, dangerous arrhythmias, including ventricular fibrillation, may be  triggered. • External pacing may only be performed by physicians familiar with high-rate stimulation procedures.
  • Page 199 Performing Manual Follow-up NIPS - Executing Burst Pacing Navigation: Tests → Atr. NIPS WARNING Triggering arrhythmias Depending on the type of high-rate stimulation and the predispositions of the patient, dangerous arrhythmias, including ventricular fibrillation, may be  triggered. • External pacing may only be performed by physicians familiar with high-rate stimulation procedures.
  • Page 200 Performing Manual Follow-up Backup pacing Preparation: • For Backup stimulation select the pacing rate (or OFF if NIPS is to be performed without safety pacing). Start: • Select [Start backup program]: — Safety pacing is performed in VVI mode as a temporary program with the selected rate.
  • Page 201 Performing Manual Follow-up NIPS - Executing Programmed Stimulation Navigation: Tests → Atr. NIPS WARNING Triggering arrhythmias Depending on the type of high-rate stimulation and the predispositions of the patient, dangerous arrhythmias, including ventricular fibrillation, may be triggered. • External pacing may only be performed by physicians familiar with high-rate stimulation procedures.
  • Page 202 Performing Manual Follow-up Backup pacing Preparation: • For Backup stimulation select the pacing rate (or OFF if NIPS is to be performed without safety pacing). Start: • Select [Start backup program]: — Safety pacing is performed in VVI mode as a temporary program with the selected rate.
  • Page 203 Performing Manual Follow-up NIPS - Description of Selected Parameters Burst pacing Form of therapy = burst pacing: Parameter Description Coupling interval • Burst pacing is started after the coupling interval has passed. • The coupling interval synchronizes burst pacing with the first paced or sensed event.
  • Page 204 Performing Manual Follow-up 12.7 Retrograde Conduction Test What's in this section? Topic Page Conducting the Retrograde Conduction Test Test for Retrograde Conduction – Details...
  • Page 205 Performing Manual Follow-up Conducting the Retrograde Conduction Test Navigation: Tests → Retrogr. conduct. Objective Starting from the measured conduction times, you can set the temporal control parameters in order to optimize hemodynamics and prevent pacemaker-mediated tachycardia. WARNING Interrupted telemetry can cause incorrect data display Interrupted telemetry between the device and the programmer can cause false data to be displayed on the programmer.
  • Page 206 Performing Manual Follow-up Conducting the test Step Action Evaluate the default parameter values for the test program and adjust them if necessary. In the Basic rate field, select the rate with which stimulation is required during testing. The rate must be above the intrinsic rhythm. Start the test by pressing [Start].
  • Page 207 Performing Manual Follow-up 12.8 Sensor Optimization What's in this section? Topic Page Sensor Optimization...
  • Page 208 Performing Manual Follow-up Sensor Optimization Navigation: Tests → Sensor opt. Objective Sensor optimization adjusts the sensor function in the device to the patient's needs during the exercise test. Description For the duration of sensor optimization, create a rate profile of the patient by performing exercise tests.
  • Page 209 Performing Manual Follow-up Details on the simulation The sensor optimization window also includes the parameters for rate adaptation. preview These correspond to the settings that are valid while the trend is being recorded. Note: If sensor optimization has been performed with a pacing mode without rate adaptation, then the corresponding rate-adaptive program is shown as a parameter suggestion.
  • Page 210 ProMRI ProMRI  ProMRI IVXXXXXX--AEnitra 6/8 Function Manual What's in this part? Chapter Chapter name Page Preparing the MRI Scan Overview See part IV for further information on conditions and instructions for the MR scan.
  • Page 211 Preparing the MRI Scan Preparing the MRI Scan Preparing the MRI Scan13XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page MRI Program - Device Preparation MRI Programs - Details Radiological Information for the Patient...
  • Page 212 Preparing the MRI Scan MRI Program - Device Preparation MRI Manual Note: Always observe the information given in the MRI manual by BIOTRONIK: • It can be found at: manuals.biotronik.com/ Product Group: ProMRI -> Product: ProMRI Selecting a program Select your program setting with the MRI → MRI program function:...
  • Page 213 Preparing the MRI Scan MRI Programs - Details MRI program: AUTO Note: Using the MRI AutoDetect function requires a bipolar sensing polarity in the permanent program. • With the MRI AutoDetect function, the device has a sensor which recognizes  the fields of an MRI scanner and switches automatically into the predefined ...
  • Page 214 Technical Data Technical Data Technical DataVXXXXXX--AEnitra 6/8 Function Manual What's in this part? Chapter Chapter name Page Parameters Technical Data Overview The technical data is documented in part V.
  • Page 215 Parameters Parameters Parameters14XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Timing Pacing and Sensing Rate Adaptation MRI Program Preset Programs Tolerances of Parameter Values...
  • Page 216 Parameters Note: Unless described separately, information for device type HF also applies to device type HF QP. Timing Basic rate day/night Parameter Range of values Standard SR DR HF Basic rate 30 ... (5) ... 100 ... (10) 60 bpm ...
  • Page 217 Parameters Upper rate Parameter Range of values Standard SR DR HF Upper rate 90 ... (10) ... 200 bpm 130 bpm SR: in VVT mode Wenckebach response/ Automatically set — 2:1 rate Atrial upper rate OFF; 175; 200; 240 bpm 240 bpm Mode switching Parameter...
  • Page 218 Parameters Blanking periods Parameter Range of values Standard SR DR HF Far-field protection 100 ... (10) ... 220 ms 100 ms after Vs Far-field protection 100 ... (10) ... 220 ms 150 ms after Vp Ventricular blanking 30 ... (5) ... 70 ms 30 ms period after Ap PMT protection...
  • Page 219 Parameters Ventricular capture control Parameter Range of values Standard SR DR HF Capture control RV ATM (monitoring only); ON; Capture control LV Minimum 0.7 V 0.7 V amplitude RV Minimum amplitude LV Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V RV safety margin 0.3 ...
  • Page 220 Parameters IEGM recordings Parameter Range of values Standard SR DR HF Number of recordings 6 series: 12 — (each max. 10 s) 8 series: 20 High atrial rate (HAR) OFF; AT; mode switching High ventricular rate OFF; ON (HVR) 8 series: OFF;...
  • Page 221 Parameters MRI Program MRI modes Modes valid for devices marked ProMRI: Mode Range of values Standard SR DR HF MRI program ON; OFF; AUTO Expiration date Today's date ... (1 day) ... Today's date today's date + 14 days + 14 days MRI mode OFF;...
  • Page 222 Parameters Parameter Factory Standard Safe SR DR HF setting program Upper rate 130 bpm 130 bpm — AV dynamics — AV hysteresis mode — Sense compensation -45 ms -45 ms — AV safety delay 100 ms 100 ms — VV delay —...
  • Page 223 Parameters Tolerances of Parameter Values Parameter Range of values Tolerance Basic rate 30 ... (5) ... 100 ... (10) ± 20 ms ... 200 bpm Basic interval 1000 ms ± 20 ms Magnet rate (magnet interval) 90 bpm (664 ms) ±...
  • Page 224 Technical Data Technical Data Technical Data15XXXXXX--AEnitra 6/8 Function Manual What's in this chapter? Topic Page Mechanical Characteristics Electrical Characteristics Battery Data Legend for the Label...
  • Page 225 31.2 Note: D = housing without header X-ray identification All device types receive the BIOTRONIK logo for X-ray identification. It can be found centrally between the circuitry and the battery inside the housing and is visible on the X-ray image.
  • Page 226 Technical Data Battery Data Battery characteristics The following data is provided by the manufacturers: Wilson  Manufacturer LITRONIK GmbH GREATBATCH, INC. 01796 Pirna Clarence, NY 14031 Germany Battery type GB 3193 LiS 2650MK LiS 3150MK System ® LiMn0 LiMn0 Li-CFX/SVO Device type SR;...
  • Page 227 Technical Data Mean service times HF For triple-chamber devices of the 8 series, the following times result when set to DDDR with a basic rate of 60 bpm, 100% biventricular pacing and a pulse width of 0.4 ms at an impedance of 500 Ω: Amplitude Pacing Average service time...
  • Page 228  MR scan under precisely defined  conditions. Compabiltiy with telemetry protocol version 2 of BIOTRONIK Home Monitoring Uncoated device: NBG code and compatible leads Example Screwdriver...
  • Page 229 Enitra 6/8 Function Manual BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany © BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-0 All rights reserved. Specifications Fax +49 (0) 30 6852804 are subject to modification, revision, sales@biotronik.com...

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