BIOTRONIK Evia HF, Evia HF-T Technical Manual
Evia HF / HF-T
Techncal Manual
Cardiac Rhythm Management
Heart Failure Therapy
Evia HF / HF-T
Evia HF / HF-T
Implantable Pulse Generators
Evia HF / HF-T
X-Ray identication
Radiopaque Identication
A radiopaque identication code is visible on standard x-ray, and identies the pulse generator:
Evia HF / HF-T SF
CAUTION
Because of the numerous available 3.2-mm congurations (e.g., the
IS-1 and VS-1 standards), lead/pulse generator compatibility should
be conrmed with the pulse generator and/or lead manufacturer prior
to the implantation of a pacing system.
CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the order of, a
physician (or properly licensed practitioner).
© 2016 BIOTRONIK, Inc., all rights reserved.
Table of Contents
Evia HF / HF-T Technical Manual
Contents
1. Device Description ...............................................................................................................1
2. Indications .............................................................................................................................3
3. Contraindications .................................................................................................................5
4. Warnings and Precautions ..................................................................................................7
4.1 Medical Therapy ...............................................................................................................7
4.2 Storage and Sterilization ..................................................................................................8
4.3 Lead Connection and Evaluation .....................................................................................8
4.4 Programming and Operation ............................................................................................9
4.5 Home Monitoring ............................................................................................................10
4.6 Electromagnetic Interference (EMI) ................................................................................11
4.6.1 Home and Occupational Environments ......................................................................11
4.6.2 Cellular Phones ..........................................................................................................12
4.6.3 Hospital and Medical Environments ...........................................................................12
4.7 Pulse Generator Explant and Disposal ..........................................................................12
5. Programmable Parameters ................................................................................................13
5.1 Pacing Modes .................................................................................................................13
5.1.1 Motion Based Rate-Adaptive Modes ..........................................................................13
5.1.2 CLS Modes.................................................................................................................13
5.1.3 Non-Rate-Adaptive Modes .........................................................................................14
5.1.4 Mode Switching ..........................................................................................................14
5.1.5 Pacing Modes with Triggered Response ....................................................................16
5.2 Rate Related Functions ..................................................................................................17
5.2.1 Basic Rate ..................................................................................................................17
5.2.2 Rate Hysteresis ..........................................................................................................18
5.2.3 Scan Hysteresis .........................................................................................................19
5.2.4 Repetitive Hysteresis..................................................................................................19
5.2.5 Night Mode .................................................................................................................20
5.2.6 Rate Fading ................................................................................................................22
5.3 Pulse Specic Features ..................................................................................................22
5.3.1 Pulse Amplitude..........................................................................................................22
5.3.2 Pulse Width ................................................................................................................23
5.4 Automatic Sensitivity Control (ASC) ...............................................................................24
5.4.1 Ventricular Pacing Parameter Options .......................................................................28
5.5 Timing Features ..............................................................................................................29
5.5.1 Refractory Periods......................................................................................................29
5.5.2 Atrial Refractory Period ..............................................................................................29
5.5.3 PVARP .......................................................................................................................29
5.5.3.1 AUTO PVARP .........................................................................................................30
5.5.3.2 Right Ventricular Refractory Period ........................................................................30
5.5.3.3 Left Ventricular Refractory Period ..........................................................................30
5.5.4 AV Delay .....................................................................................................................31
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Chapter Table of Contents
Evia HF / HF-T Technical Manual
5.5.4.1 Dynamic AV Delay ..................................................................................................31
5.5.4.2 AV Hysteresis .........................................................................................................32
5.5.4.3 AV Repetitive Hysteresis ........................................................................................33
5.5.4.4 AV Scan Hysteresis ...............................................................................................34
5.5.4.5 Negative AV Delay Hysteresis ................................................................................34
5.5.4.6 I-Opt ......................................................................................................................35
5.5.4.7 EasyAV ...................................................................................................................35
5.5.5 Ventricular Blanking After Ap ......................................................................................36
5.5.6 Far-Field Protection ....................................................................................................37
5.5.7 Safety AV Delay ..........................................................................................................37
5.5.8 Upper Rate and UTR Response ................................................................................38
5.6 Lead Polarity ..................................................................................................................38
5.7 Parameters for Rate-Adaptive Pacing ............................................................................39
5.7.1 Sensor Gain ...............................................................................................................40
5.7.2 Automatic Sensor Gain...............................................................................................41
5.7.3 Sensor Threshold .......................................................................................................42
5.7.4 Rate Increase .............................................................................................................42
5.7.5 Maximum Sensor Rate ...............................................................................................43
5.7.6 Maximum Closed Loop Rate ......................................................................................43
5.7.7 Rate Decrease ...........................................................................................................44
5.8 Management of Specic Scenarios ................................................................................44
5.8.1 2:1 Lock-In Management............................................................................................44
5.9 Atrial Upper Rate ............................................................................................................45
5.10 Atrial Overdrive Pacing (Overdrive Mode) ....................................................................45
5.11 Management of Specic Scenarios ..............................................................................46
5.11.1 PMT Management ....................................................................................................46
5.11.2 PMT Protection .........................................................................................................46
5.11.2.1 PMT Detection and Termination ...........................................................................47
5.12 Adjustment of the PMT Protection Window ..................................................................48
5.13 Right/left Ventricular Capture Control (VCC) ................................................................48
5.13.1 Feature Description ..................................................................................................48
5.13.2 Right/Left Ventricular Capture Control Parameters ..................................................49
5.13.3 Search Type .............................................................................................................50
5.13.3.1 Algorithm Suspension, Abort and Disabling .........................................................53
5.13.4 Ventricular Capture Control Programming ...............................................................54
5.14 Atrial Capture Control (ACC) ........................................................................................54
5.14.1 Feature Description ..................................................................................................54
5.14.2 Search Type .............................................................................................................56
5.15 Ventricular Pace Suppression (Vp-Suppression) .........................................................57
5.15.1 Feature Description ..................................................................................................57
5.15.2 Programmability .......................................................................................................57
5.15.3 How the Vp Suppression Algorithm Works ...............................................................57
5.16 Thoracic Impedance .....................................................................................................58
5.17 ProgramConsult® .........................................................................................................58
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Chapter Table of Contents
Evia HF / HF-T Technical Manual
5.18 Home Monitoring (Evia HF-T) ......................................................................................60
5.18.1 Transmission of Information .....................................................................................61
5.18.2 Patient Device ..........................................................................................................61
5.18.3 Transmitting Data .....................................................................................................61
5.18.4 Types of Report Transmissions ................................................................................62
5.18.4.1 Trend Report ........................................................................................................62
5.18.4.2 Event Report ........................................................................................................62
5.18.5 Description of Transmitted Data ...............................................................................63
5.18.5.1 IEGM Online HDs .................................................................................................64
6. Statistics ..............................................................................................................................65
6.1 Statistics Overview .........................................................................................................65
6.1.1 General Statistical Information ...................................................................................66
6.2 Timing Statistics .............................................................................................................66
6.2.1 Event Counter ............................................................................................................66
6.2.2 Event Sequences .......................................................................................................67
6.2.3 Rate Trend 24 Hours ..................................................................................................68
6.2.4 Rate Trend 240 Days .................................................................................................70
6.2.5 Atrial and Ventricular Rate Histogram ........................................................................71
6.3 Arrhythmia Statistics .......................................................................................................72
6.3.1 Atrial Burden ...............................................................................................................72
6.3.2 Time of occurrence .....................................................................................................73
6.3.3 Mode Switching ..........................................................................................................73
6.3.4 Ventricular Arrhythmia ................................................................................................74
6.4 Sensor Statistics .............................................................................................................75
6.4.1 Sensor Histogram.......................................................................................................75
6.4.2 Activity Report ............................................................................................................76
6.4.2.1 No Activity...............................................................................................................76
6.4.2.2 Activity ....................................................................................................................77
6.4.2.3 Max Sensor Rate....................................................................................................77
6.5 Pacing Statistics .............................................................................................................77
6.5.1 Lead Impedance Trends with Lead Check .................................................................77
6.5.2 Pacing Amplitude Histogram ......................................................................................78
6.5.3 Pacing Threshold Trend .............................................................................................78
6.5.4 Capture Control Status ...............................................................................................79
6.6 Sensing Statistics ...........................................................................................................80
6.6.1 P- and R-wave Trends................................................................................................80
1.1.1 Far-eld Histogram ....................................................................................................80
6.6.2 Ap-Vs interval distribution curve .................................................................................81
6.6.3 Av-Vs interval distribution curve .................................................................................82
6.6.4 Vp Suppression ..........................................................................................................83
6.7 Heart Failure Monitoring Statistics .................................................................................83
6.7.1 Mean Heart Rate ........................................................................................................83
6.7.2 Mean Heart Rate at Rest............................................................................................83
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Evia HF / HF-T Technical Manual
6.7.3 Heart Rate Variability ..................................................................................................84
6.7.4 Patient Activity ............................................................................................................84
6.7.5 Thoracic Impedance ...................................................................................................84
6.8 IEGM Recordings ...........................................................................................................85
7. Other Functions/Features ..................................................................................................87
7.1 Safe Program Settings ...................................................................................................87
7.2 Magnet Effect .................................................................................................................87
7.2.1 Automatic Magnet Effect ............................................................................................87
7.2.2 Asynchronous Magnet Effect ......................................................................................87
7.2.3 Synchronous Magnet Effect .......................................................................................87
7.3 Temporary Programming ................................................................................................88
7.4 Patient Data Memory ......................................................................................................88
7.5 Position Indicator ............................................................................................................89
7.6 Pacing When Exposed to Interference ...........................................................................89
8. Product Storage and Handling ..........................................................................................91
8.1 Sterilization and Storage ................................................................................................91
8.2 Opening the Sterile Container ........................................................................................92
8.3 Pulse Generator Orientation ...........................................................................................92
9. Lead Connection .................................................................................................................93
9.1 Auto Initialization ............................................................................................................94
10. Follow-up Procedures ......................................................................................................97
10.1 General Considerations ................................................................................................97
10.2 Real-time IEGM Transmission .....................................................................................97
10.3 Threshold Test ..............................................................................................................98
10.4 P/R Measurement ......................................................................................................100
10.4.1 START (test) ...........................................................................................................101
10.4.2 Intrinsic Rhythm (test) ............................................................................................101
10.4.3 Mode .....................................................................................................................102
10.4.4 Sensing test parameters ........................................................................................102
10.4.4.1 Basic Rate ..........................................................................................................102
10.4.4.2 AV Delay .............................................................................................................102
10.4.4.3 Upper Rate .........................................................................................................102
10.4.4.4 Report.................................................................................................................102
10.4.4.5 Pulse Amplitude..................................................................................................102
10.4.4.6 Pulse Width ........................................................................................................102
10.4.4.7 Sensitivity ...........................................................................................................103
10.4.4.8 Pacing Polarity ...................................................................................................103
10.4.4.9 Sensing Polarity .................................................................................................103
10.5 Testing for Retrograde Conduction .............................................................................103
10.5.1 Measuring Retrograde Conduction ........................................................................104
10.5.2 Requirements for Measurement .............................................................................104
10.5.3 Follow-up History....................................................................................................105
10.6 Atrial Non-Invasive Programmed Stimulation (NIPS) .................................................105
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Chapter Table of Contents
Evia HF / HF-T Technical Manual
10.6.1 Description .............................................................................................................105
10.6.2 Burst Stimulation ....................................................................................................106
10.6.3 Programmed Stimulation ........................................................................................106
10.6.4 Back up Pacing ......................................................................................................107
10.6.5 NIPS Safety Features.............................................................................................107
10.7 Optimizing Rate Adaptation ........................................................................................108
10.7.1 Rate/Sensor Trend .................................................................................................108
10.7.2 Adjusting the Sensor Gain ......................................................................................108
10.7.3 Adjusting the Sensor Threshold .............................................................................109
11. Elective Replacement Indication (ERI).......................................................................... 111
12. Explantation ....................................................................................................................113
12.1 Common Reasons to Explant a Pulse Generator ......................................................113
13. Technical Data .................................................................................................................115
13.1 Modes ......................................................................................................................... 11 5
13.2 Pulse- and Control Parameters ..................................................................................115
13.2.1 Rate Adaptation ......................................................................................................118
13.2.2 Atrial Capture Control (ACC) ..................................................................................118
13.2.3 Right/Left Ventricular Capture Control (RVCC/LVCC) 119
13.2.4 Home Monitoring Parameters ................................................................................119
13.2.5 Additional Functions ...............................................................................................120
13.2.6 NIPS Specications ................................................................................................120
13.3 Programmer ...............................................................................................................121
13.4 Materials in Contact with Human Tissue ....................................................................121
13.5 Electrical Data/Battery ................................................................................................121
13.6 Mechanical Data .........................................................................................................121
14. Order Information ...........................................................................................................123
Appendix A .............................................................................................................................125
Appendix B .............................................................................................................................129
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the order of,
a physician (or properly licensed practitioner).
PAGE v
Chapter Table of Contents
Evia HF / HF-T Technical Manual
PAGE vi
Chapter 1 Device Description
Evia HF / HF-T Technical Manual
1. Device Description
Evia HF / HF-T is a multi-programmable, three chamber pulse generator with rate-adaptive pacing.
The Evia HF / HF-T pulse generator is BIOTRONIK’s state of the art pacing system with two methods
of rate-adaptation. Rate-adaptation is achieved through programming of either the unique principle of
closed-loop stimulation (CLS) or by motion-based pacing via a capacitive accelerometer.
The basic function of CLS involves the translation of myocardial contractility into patient-specic
pacing rates. Specically, the pulse generator monitors and processes the intracardiac impedance
signals associated with myocardial contraction dynamics. Changes in the waveform of this impedance
signal are associated with changes in the contraction dynamics of the patient’s heart due to the
heart’s inotropic response to exercise and acute mental stress. By monitoring these changes, the
pulse generator can provide a pacing rate that is appropriate and specic to the patient’s individual
physiologic demands due to exercise and acute mental stress.
For standard motion-based rate-adaptation, the Evia HF / HF-T is equipped with an accelerometer
located within the pulse generator. This sensor produces an electric signal during physical activity of the
patient. If a rate-adaptive (R) mode is programmed, then the accelerometer sensor signal controls the
stimulation rate.
Evia HF-T also employs Home Monitoring™ technology, which is an automatic, wireless, remote
monitoring system for management of patients with pulse generators. With Home Monitoring,
physicians can review data about the patient’s cardiac status and pulse generator’s functionality
between regular follow-up visits, allowing the physician to optimize the therapy process.
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.
• A strategy of care using BIOTRONIK Home Monitoring with office visits when needed has been
shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK
implantable devices in many patients. Home Monitoring data is helpful in determining the need for
additional in-office follow-up.
• BIOTRONIK Home Monitoring-patients—who are followed remotely with office visits when
needed—have been shown to have similar numbers of strokes, invasive procedures and deaths as
patients followed with conventional in-office follow-ups.
• BIOTRONIK Home Monitoring provides early detection of arrhythmias.
• BIOTRONIK Home Monitoring provides early detection of silent, asymptomatic arrhythmias.
• Automatic early detection of arrhythmias and device system anomalies by BIOTRONIK Home
Monitoring allows for earlier intervention than conventional in-office follow-ups.
• BIOTRONIK Home Monitoring allows for improved access to patient device data compared to
conventional in-office follow-ups since device interrogation is automatically scheduled at
regular intervals.
Evia HF / HF-T provides three chamber pacing in a variety of rate-adaptive and non-rate adaptive
pacing modes. Pacing capability is supported by a sophisticated diagnostic set.
The device is designed and recommended for use with atrial and ventricular unipolar or bipolar leads
having IS-1 compatible connectors. (Note that IS-1 refers to the International Standard whereby leads
and generators from different manufacturers are assured a basic t [Reference ISO 5841-3:1992]).
PAGE 1
Chapter 1 Device Description
Evia HF / HF-T Technical Manual
Evia HF / HF-T is designed to meet all indications for bradycardia and resynchronization therapy as
exhibited in a wide variety of patients. The Evia HF / HF-T family is comprised of two CRT-Ps that are
designed to handle a multitude of situations.
Evia HF
Triple chamber, rate-adaptive, unipolar/
bipolar pacing CRT-P
Triple chamber, rate-adaptive, unipolar/
Evia HF-T
bipolar pacing CRT-P with Home
Monitoring
Throughout this manual, specic feature and function descriptions may only be applicable to the Evia
HF-T and those features will be referenced as such. Otherwise, reference to Evia CRT-Ps refers to
both devices.
PAGE 2
Chapter 2 Indications
Evia HF / HF-T Technical Manual
2. Indications
The Evia HF and Evia HF-T Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) are indicated
for patients who have moderate to severe heart failure (NYHA Class III/IV), including left ventricular
dysfunction (EF ≤ 35%) and QRS ≥ 120 ms and remain symptomatic despite stable, optimal heart
failure drug therapy.
PAGE 3
Chapter 2 Indications
Evia HF / HF-T Technical Manual
PAGE 4
Chapter 3 Contraindications
Evia HF / HF-T Technical Manual
3. Contraindications
Use of Evia HF / HF-T pulse generator is 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.
• Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction.
• Dual chamber and single chamber atrial pacing is contraindicated for patients with chronic
refractory atrial tachyarrhythmias.
For a complete discussion of mode-specic contraindications, please refer to Appendix A of this
manual.
PAGE 5
Chapter 3 Contraindications
Evia HF / HF-T Technical Manual
PAGE 6
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
4. Warnings and Precautions
Certain therapeutic and diagnostic procedures may cause undetected damage to a pulse generator,
resulting in malfunction or failure at a later time. Please note the following warnings and precautions:
Magnetic Resonance Imaging (MRI) Avoid use of magnetic resonance imaging as it has been
shown to cause movement of the pulse generator within the subcutaneous pocket and may cause pain
and injury to the patient and damage to the pulse generator. If the procedure must be used, constant
monitoring is recommended, including monitoring the peripheral pulse.
Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients unable to tolerate increased
pacing rates.
High Output Settings High output settings combined with extremely low lead impedance may reduce
the life expectancy of the pulse generator to less than 1 year. Programming of pulse amplitudes, higher
than 4.8 V, in combination with long pulse widths and/or high pacing rates may lead to premature
activation of the replacement indicator.
4.1 Medical Therapy
Before applying one of the following procedures, a detailed analysis of the advantages and risks
should be made. Cardiac activity during one of these procedures should be conrmed by continuous
monitoring of peripheral pulse or blood pressure. Following the procedures, pulse generator function
and stimulation threshold must be checked.
Therapeutic Diathermy Equipment Use of therapeutic diathermy equipment is to be avoided for
pacemaker patients due to possible heating effects of the pulse generator and at the implant site.
If diathermy therapy must be used, it should not be applied in the immediate vicinity of the pulse
generator/lead. The patient’s peripheral pulse should be monitored continuously during the treatment.
Transcutaneous Electrical Nerve Stimulation (TENS) Transcutaneous electrical nerve stimulation
may interfere with pulse generator function. If necessary, the following measures may reduce the
possibility of interference:
• Place the TENS electrodes as close to each other as possible.
• Place the TENS electrodes as far from the pulse generator/lead system as possible.
• Monitor cardiac activity during TENS use.
Debrillation The following precautions are recommended to minimize the inherent risk of pulse
generator operation being adversely affected by debrillation:
• The paddles should be placed anterior-posterior or along a line perpendicular to the axis formed by
the pulse generator and the implanted lead.
• The energy setting should not be higher than required to achieve defibrillation.
• The distance between the paddles and the pacer/electrode(s) should not be less than 10 cm
(4 inches).
Radiation Pulse generator electronics may be damaged by exposure to radiation during radiotherapy.
To minimize this risk when using such therapy, the pulse generator should be protected with local
radiation shielding.
Lithotripsy Lithotripsy treatment should be avoided for pacemaker patients since electrical and/
or mechanical interference with the pulse generator is possible. If this procedure must be used, the
greatest possible distance from the point of electrical and mechanical strain should be chosen in order
to minimize a potential interference with the pulse generator.
PAGE 7
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Electrocautery Electrocautery should never be performed within 15 cm (6 inches) of an implanted
pulse generator or lead because of the danger of introducing brillatory currents into the heart and/
or damaging the pulse generator. Pacing should be asynchronous and above the patient’s intrinsic
rate to prevent inhibition by interference signals generated by the cautery. When possible, a bipolar
electrocautery system should be used.
For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed
under the buttocks or around the thigh, but not in the thoracic area where the current pathway could
pass through or near the pacing system.
4.2 Storage and Sterilization
Storage (temperature) Recommended storage temperature range is -10° to 45°C (14°-113°F).
Exposure to temperatures outside this range may result in pulse generator malfunction (see
Section 8.1).
Handling Do not drop. If an unpackaged pulse generator is dropped onto a hard surface, return it to
BIOTRONIK (see Section 8.1).
FOR SINGLE USE ONLY Do not resterilize the pulse generator or accessories packaged with the
pulse generator, they are intended for one-time use.
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.
Temperature Stabilization Allow the device to reach room temperature before programming or
implanting the device. Temperature extremes may affect the initial device function.
Use Before Date Do not implant the device after the USE BEFORE DATE because the device sterility
and longevity may be compromised.
4.3 Lead Connection and Evaluation
The pulse generator requires atrial and ventricular leads with IS-1 compatible connectors. There are
no requirements specic to the atrial lead. It is required to use a low polarization ventricular lead for
activation of Ventricular Capture Control.
Lead Check The Evia HF / HF-T pulse generators have an automatic lead check feature which may
switch from bipolar to unipolar pacing and sensing without warning. This situation may be inappropriate
for patients with an Implantable Cardioverter Debrillator (ICD).
Lead/pulse Generator Compatibility Because of the numerous available 3.2-mm congurations (e.g.,
the IS-1 and VS-1 standards), lead/pulse generator compatibility should be conrmed with the pulse
generator and/or lead manufacturer prior to the implantation of a pacing system.
IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators
from different manufacturers are assured a basic t. [Reference ISO 5841-3:1992(E)].
Lead Conguration Lead conguration determines proper programming of the pulse generator. Pacing
will not occur with a unipolar lead if the lead conguration is programmed to bipolar (see Section 9).
Setscrew Adjustment Back-off the setscrew(s) prior to insertion of lead connector(s) as failure to do
so may result in damage to the lead(s), and/or difculty connecting lead(s).
PAGE 8
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Cross Threading Setscrew(s) To prevent cross threading the setscrew(s), do not back the
setscrew(s) completely out of the threaded hole. Leave the torque wrench in the slot of the setscrew(s)
while the lead is inserted.
Tightening Setscrew(s) Do not overtighten the setscrew(s). Use only the BIOTRONIK supplied
torque wrench.
Sealing System Be sure to properly insert the torque wrench into the perforation at an angle
perpendicular to the connector receptacle. Failure to do so may result in damage to the plug and its
self-sealing properties.
4.4 Programming and Operation
Negative AV Delay Hysteresis This feature insures ventricular pacing, a technique which has been
used in patients with hypertrophic obstructive cardiomyopathy (HOCM) with normal AV conduction
in order to replace intrinsic ventricular activation. No clinical study was conducted to evaluate this
feature, and there is conicting evidence regarding the potential benet of ventricular pacing therapy
for HOCM patients. In addition, there is evidence with other patient groups to suggest that inhibiting
the intrinsic ventricular activation sequence by right ventricular pacing may impair hemodynamic
function and/or survival.
Programming VCC If lead polarization check is not successful, program another pulse width on test
start amplitude. If still unsuccessful, program the pacing pulse amplitude manually.
NIPS Life threatening ventricular arrhythmias can be induced by stimulation in the atrium. Ensure
that an external cardiac debrillator is easily accessible. Only physicians trained and experienced in
tachycardia induction and reversion protocols should use non-invasive programmed stimulation (NIPS).
Unipolar/Bipolar All Evia CRT-P models 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 veried that bipolar leads
have been implanted in that chamber. If either of the leads is unipolar, unipolar sensing and pacing
functions must be programmed in that chamber. Failure to program the appropriate lead conguration
could result in entrance and/or exit block.
Programmers Use only appropriate BIOTRONIK programmers equipped with appropriate software to
program Evia CRT-Ps. Do not use programmers from other manufacturers.
Pulse Amplitude Programming of pulse amplitudes, higher than 4.8 V, in combination with long pulse
widths and/or high pacing rates can lead to premature activation of the replacement indicator.
Pacing thresholds When decreasing programmed output (pulse amplitude and/or pulse width),
the pacing threshold must rst be accurately assessed to provide a 2:1 safety margin. When using
the Ventricular Capture Control feature, the device will automatically set the output to the measured
threshold plus the programmed Safety Margin. A new threshold search will occur at scheduled intervals
or upon loss of capture.
EMI Computerized systems are subject to EMI or “noise”. In the presence of such interference,
telemetry communication may be interrupted and prevent programming.
Programming Modications Extreme programming changes should only be made after careful
clinical assessment. Clinical judgment should be used when programming permanent pacing rates
below 40 ppm or above 100 ppm.
Short Pacing Intervals Use of short pacing intervals (high pacing rates) with long atrial and/or
ventricular refractory periods may result in intermittent asynchronous pacing and, therefore, may be
contraindicated in some patients.
PAGE 9
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
OFF Mode Use of the OFF mode should be avoided in pacemaker dependent patients. The OFF mode
can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm.
Myopotential Sensing The lter characteristics of BIOTRONIK pulse generators have been optimized
to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing
skeletal myopotentials. However, the risk of pulse generator operation being affected by myopotentials
cannot be eliminated, particularly in unipolar systems. Myopotentials may resemble cardiac activity,
resulting in pulse generator pulse inhibition, triggering and/or emission of asynchronous pacing pulses,
depending on the pacing mode and the interference pattern. Certain follow-up procedures, such as
monitoring pulse generator performance while the patient is doing exercises involving the use of
pectoral muscles, as well as Holter monitoring, have been recommended to check for interference
caused by myopotentials. If sensing of myopotentials is encountered, corrective actions may include
selection of a different pacing mode or sensitivity.
Muscle or Nerve Stimulation Inappropriate muscle or nerve stimulation may occur with unipolar
pacing when using a non-coated pulse generator.
CLS Rate-Adaptation Under certain circumstances (e.g., EMI, lead dislodgment), the Evia CRT-P
device may not be able to obtain a useable impedance measurement as required for CLS rate-adaptive
pacing. At this point, CLS rate-adaptation will be inactive until the situation is corrected. Rate-adaptation
may be programmed to switch to motion based adaptation.
Programmed to Triggered Modes When programmed to triggered modes, pacing rates up to the
programmed upper limit may occur in the presence of either muscle or external interference.
Triggered Modes While the triggered modes (DDT, VVT, and AAT) can be programmed permanently,
the use of these modes is intended as a temporary setting in situations where maintaining the
programming head in place would be impossible or impractical (i.e., during exercise testing or extended
Holter monitoring) or as a short term solution to pulse generator inhibition by extracardiac interference.
To avoid the potential for early battery depletion, it is important that the triggered modes are not used
for long term therapy, and that the pulse generator is returned to a non-triggered permanent program.
4.5 Home Monitoring
BIOTRONIK’s Home Monitoring system is designed to notify clinicians in less than 24 hours of changes
to the patient’s condition or status of the implanted device. Updated data may not be available if:
• The patient’s CardioMessenger is off or damaged and is not able to connect to the Home
Monitoring system through an active telephone link.
• The CardioMessenger cannot establish a connection to the implanted device.
• The telephone and/or Internet connection do not operate properly
• The Home Monitoring Service Center is off-line (upgrades are typically completed in less than
24 hours)
Patient’s Ability Use of the Home Monitoring system requires the patient and/or caregiver to follow
the system instructions and cooperate fully when transmitting data.
If the patient cannot understand or follow the instructions because of physical or mental challenges,
another adult who can follow the instructions will be necessary for proper transmission.
Electromagnetic Interference (EMI) Precautions for EMI interference with the Evia CRT-Ps are
provided in Section 4.6. Sources of EMI including cellular telephones, electronic article surveillance
systems, and others are discussed therein.
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Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Use in Cellular Phone Restricted Areas The mobile patient device (transmitter/receiver) should not
be utilized in areas where cellular phones are restricted or prohibited (i.e., commercial aircraft).
4.6 Electromagnetic Interference (EMI)
The operation of any implanted pulse generator may be affected by certain environmental sources
generating signals that resemble cardiac activity. This may result in pulse generator pulse inhibition
and/or triggering or in asynchronous pacing depending on the pacing mode and the interference
pattern. In some cases (i.e., diagnostic or therapeutic medical procedures), the interference sources
may couple sufcient energy into a pacing system to damage the pulse generator and/or cardiac tissue
adjacent to the electrodes.
BIOTRONIK pulse generators have been designed to signicantly reduce susceptibility to
electromagnetic interference (EMI). However, due to the variety and complexity of sources creating
interference, there is no absolute protection against EMI. Generally, it is assumed that EMI produces
only minor effects, if any, in pacemaker patients. If the patient presumably will be exposed to one of the
following environmental conditions, then the patient should be given the appropriate warnings.
4.6.1 Home and Occupational Environments
The following equipment (and similar devices) may affect normal pulse generator operation: electric arc
welders, electric melting furnaces, radio/television and radar transmitters, power-generating facilities,
high-voltage transmission lines, electrical ignition systems (also of gasoline-powered devices) if
protective hoods, shrouds, etc., are removed, electrical tools, anti-theft devices of shopping centers and
electrical appliances, if not in proper condition or not correctly grounded and encased.
Patients should exercise reasonable caution in avoidance of devices which generate a strong electric
or magnetic eld. If EMI inhibits operation of a pulse generator 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 pulse generator to return to its normal mode of operation. Some potential EMI
sources include:
High Voltage Power Transmission Lines High voltage power transmission lines may generate
enough EMI to interfere with pulse generator operation if approached too closely.
Home Appliances Home appliances normally do not affect pulse generator operation if the appliances
are in proper condition and correctly grounded and encased. There are reports of pulse generator
disturbances caused by electrical tools and by electric razors that have touched the skin directly over
the pulse generator.
Communication Equipment Communication equipment such as microwave transmitters, linear
power ampliers, or high-power amateur transmitters may generate enough EMI to interfere with pulse
generator operation if approached too closely.
Commercial Electrical Equipment Commercial electrical equipment such as arc welders, induction
furnaces, or resistance welders may generate enough EMI to interfere with pulse generator operation if
approached too closely.
Electrical Appliances Electric hand-tools and electric razors (used directly over the skin of the pulse
generator) have been reported to cause pulse generator disturbances. Home appliances that are in
good working order and properly grounded do not usually produce enough EMI to interfere with pulse
generator operation.
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Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Electronic Article Surveillance (EAS) Equipment such as retail theft prevention systems may interact
with the pulse generators. Patients should be advised to walk directly through and not to remain near
an EAS system longer than necessary.
4.6.2 Cellular Phones
Recent studies have indicated there may be a potential interaction between cellular phones and pulse
generator operation. Potential effects may be due to either the radio frequency signal or the magnet
within the phone and could include inhibition or asynchronous pacing when the phone is within close
proximity (within 6 inches [15 centimeters]) to the pulse generator.
Based on testing to date, effects resulting from an interaction between cellular phones and the
implanted pulse generators have been temporary. Simply moving the phone away from the implanted
device will return it to its previous state of operation. Because of the great variety of cellular phones
and the wide variance in patient physiology, an absolute recommendation to cover all patients cannot
be made.
Patients having an implanted pulse generator who operate a cellular phone should:
• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular
phone and the implanted device. Portable and mobile cellular phones generally transmit at higher
power levels compared to hand held models. For phones transmitting above 3 watts, maintain a
minimum separation of 12 inches (30 centimeters) between the antenna and the implanted device.
• Patients should hold the phone to the ear opposite the side of the implanted device. Patients
should not carry the phone in a breast pocket or on a belt over or within 6 inches (15 centimeters)
of the implanted device as some phones emit signals when they are turned ON but not in use (i.e.,
in the listen or standby mode). Store the phone in a location opposite the side of implant.
4.6.3 Hospital and Medical Environments
Electrosurgical Cautery Electrosurgical cautery could induce ventricular arrhythmias and/or
brillation, or may cause asynchronous or inhibited pulse generator operation. If use of electrocautery
is necessary, the current path (ground plate) should be kept as far away from the pulse generator and
leads as possible.
Lithotripsy Lithotripsy may damage the pulse generator. If lithotripsy must be used, do not focus the
beam near the pulse generator.
External Debrillation External debrillation may damage the pulse generator. Attempt to minimize
current owing through the pulse generator and lead system by following the precautions.
High Radiation Sources High radiation sources such as cobalt 60 or gamma radiation should not
be directed at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse
generator, place lead shielding over the device to prevent radiation damage.
4.7 Pulse Generator Explant and Disposal
Device Incineration Never incinerate a pulse generator. Be sure the pulse generator is explanted
before a patient who has died is cremated (see Section 12).
Explanted Devices Return all explanted devices to BIOTRONIK.
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
5. Programmable Parameters
For a complete list of programmable parameters and the available settings, see Section 13.
5.1 Pacing Modes
A complete list of pacing modes available in Evia HF / HF-T is shown below.
Figure 1: Pacing Modes in Evia HF / HF-T
NOTE:
Ventricular Capture Control is only available with the following pacing modes: DDD-CLS, VVI-CLS,
DDDR, VDDR, VVIR, DDD, VDD, VVI, DDD-ADI, and DDDR-ADIR.
5.1.1 Motion Based Rate-Adaptive Modes
The motion based rate-adaptive modes are designated with an “R” in the fourth position of the NBG
pacemaker code on the programmer screen. The rate-adaptive modes function identically to the
corresponding non-rate-adaptive modes, except that the basic rate increases when physical activity is
detected by the motion sensor.
In demand modes (DDDR, DDIR, DVIR, VDDR, VVIR, AATR, VVTR, VDIR, AAIR), it is possible that
the atrial and/or ventricular refractory period can comprise a major portion of the basic interval at high
sensor-modulated rates. This may limit the detection of spontaneous events or even exclude their
recognition altogether. Further details of this potential occurrence are provided in Section 5.5.1.
5.1.2 CLS Modes
As explained in the device description, Evia CRT-P also can be programmed to use a unique rateadaptive principle called Closed Loop Stimulation (CLS) to adapt the patient’s pacing rate.
The Evia CRT-P measures electrical impedance by injecting a small AC current between the pulse
generator case and the ventricular electrode tip. The induced voltage (which is proportional to the
intracardiac impedance) is also measured between pulse generator case and ventricular electrode tip.
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Chapter 5 Programmable Parameters
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CAUTION
Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients
unable to tolerate increased pacing rates.
CLS Rate Adaptation Under certain circumstances (e.g., EMI, lead
dislodgment), the Evia CRT-P device may not be able to obtain a
useable impedance measurement as required for CLS rate-adaptive
pacing. At this point, CLS rate-adaptation will be inactive until the
situation is corrected. Rate-adaptation may be programmed to switch
to motion based adaptation.
The DDD-CLS and VVI-CLS mode is functionally equivalent to the DDDR and VVIR pacing modes,
respectively. However these modes use the CLS concept to determine the pacing rate variations that
are mediated by the body’s own cardiovascular control. In these modes, the atrial and/or ventricular
refractory periods may comprise a major portion of the basic interval at high rates. This could limit
the detection of spontaneous events or even exclude their recognition altogether. However, this
phenomenon will not limit the functionality of the mode switch.
Motion based rate adaptive pacing will take over if the CLS pacing algorithm switches into a
passive mode.
5.1.3 Non-Rate-Adaptive Modes
Non-rate-adaptive modes that are programmable with the Evia CRT-P perform similarly to earlier
generations of BIOTRONIK pulse generators (i.e., Philos II DR and Dromos DR).
5.1.4 Mode Switching
Evia CRT-P provides 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). Mode Switching is only available in atrial tracking modes DDD(R), VDD(R), DDDCLS, and DDDR-ADIR.
Table 1 is a summary of the parameters associated with Mode Switching.
Parameter Range Default Setting
Mode Switching ON, OFF ON
Intervention Rate 100...(10)...250 bpm 160 bpm
Switch to
Ventricular Pacing Biv/RV Biv
Onset Criterion 3...(1)...8 5
Resolution Criterion 3...(1)...8 5
Dependent on Basic
Mode Setting
DDIR
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Basic Rate during
mode Switching
Rate stabilization
during mode switching
2:1 Lock-in Protection ON, OFF ON
OFF, +5...(+5)...+30 +10
ON, OFF OFF
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Table 1: Mode Switching Parameter Summary
Intervention rate
The Intervention rate is the minimum atrial rate at which Mode Switching will occur and is
programmable by the user.
Switch to Pacing
Switch to pacing is the mode the device reverts to during Mode Switch.
Table 2 shows the choices for Mode Switch modes based on the programmed device mode.
Programmed
Device Mode
Mode Switch
Mode Options
Default Mode for
Mode Switch
DDDR-ADIR DDIR DDIR
DDD-ADI DDI,DDIR DDIR
DDD-CLS DDIR DDIR
DDDR DDIR DDIR
DDD DDI, DDIR DDIR
VDDR VDIR VDIR
VDD VDI, VDIR VDIR
Table 2: Mode Switch Mode Operations
Ventricular Pacing (Evia HF / HF-T only)
RV only or BiV pacing uses the same pacing programming values as seen under the Ventricular pacing
parameter button. With Biventricular pacing programmed ON, pacing during Mode Switch will be
Biventricular as well.
Onset Criterion
The mode switch onset criterion uses an X of 8 rolling counter with a default X value of 5. This means
that 5 out of the last 8 atrial events must be faster than the programmed intervention rate for Mode
Switch to occur.
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.
Atrial oversensing due to far-eld events sensed in the atrial channel may lead to inappropriate Mode
Switch declaration.
Evia CRT-P does not use intervals with paced events towards the mode switch count, thereby reducing
the risk of inappropriate mode switch due to sensor competition.
Resolution Criterion
The resolution criterion uses an X of 8 rolling counter with a default X value of 5. This means that 5
out of the last 8 atrial events must be slower than the programmed intervention rate for a return to the
programmed pacing mode.
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
The higher the resolution criterion, the harder it is to end a Mode Switching event. Conversely, the
lower the value, the easier it is for Mode Switching to end.
Basic Rate during Mode Switching
This refers to the basic pacing rate while mode switching is active. The value selected is added to the
programmed basic rate value to become the basic rate during mode switch. By default this value is
+10 ppm. If the basic rate is programmed to 60 ppm, then the Basic Rate during mode switching would
be 70 ppm (60 ppm +10 ppm).
Rate Stabilization during Mode Switching
This feature is designed to minimize sudden rate changes in the ventricle that can occur with Ab and
intact conduction. To minimize the sudden rate changes, Evia CRT-P uses the Rate Fading concept.
The device determines a four-beat ventricular rate average and provides ventricular support pacing any
time the rate goes below the averaged rate minus 10 bpm.
2:1 Lock-In Protection (available in the Evia HF/HF-T only if RV only pacing is programmed)
For patients who experience atrial utter, there is a small chance that Mode Switch will not occur due
to atrial events falling within far-eld protection. As a result, inappropriate fast tracking up to the upper
tracking rate may occur. The 2:1 Lock-in protection feature is designed to promote Mode Switching and
prevent the patient discomfort that may be associated with an inappropriately tracked atrial tachycardia.
2:1 Lock-in Protection behavior is more likely to occur if the far-eld protection parameter is
programmed too long (greater than 150 ms). This potentially allows every other atrial event to occur in
the far-eld protection interval.
When Evia CRT-P senses eight consecutive atrial events in the far-eld protection window and the
ventricular paced response rate is greater than 100 bpm, the AV Delay is extended to a maximum value
of 300 ms (AV Delay + FFP interval to a max of 300 ms) for one event. If the event sensed in the FFP
window moves with the ventricular paced event during the extension of the AV Delay, it is a cross-talk
event due to ventricular pacing. However, if it does not move with the ventricular paced event when the
AV Delay is extended, it is a intrinsic atrial event (atrial utter event)
Additionally, during DDI(R), the AV-delay is set to 100 ms.
Mode Switch Events are recorded in memory and are available to the user through the following
diagnostics:
• IEGM Recordings Found in the Holter Tab
• Mode Switch Counter
• Total Mode Switch Duration
Mode Switching is available during magnet application after 10 cycles of ASYNC pacing and
during ERI.
5.1.5 Pacing Modes with Triggered Response
Pacing modes with triggered response correspond to their respective demand pacing modes, except
that a sensed event will not inhibit but will rather trigger a pacing pulse, simultaneously with the sensed
event, into the same chamber where sensing has occurred. The demand and corresponding triggered
pacing modes are:
Demand: DDD VVI AAI
Triggered: DDT VVT AAT
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
The triggered pacing mode xes the AV delay to 180 ms and does not provide a safety AV delay.
Pacing modes with triggered response may be indicated in the presence of interference signals to
prevent inappropriate pulse inhibition. They may also have diagnostic application for ECG identication
of sense events as an alternative to marker signals. Triggered pacing may also be used for
hemodynamic as well as electrophysiologic studies and for termination of tachycardias by non-invasive
triggering of pulse generator pulses with chest wall stimuli generated by an external pulse generator.
CAUTION
Programmed to Triggered Modes When programmed to triggered
modes, pacing rates up to the programmed upper limit may occur in
the presence of either muscle or external interference.
Triggered Modes While the triggered modes (DDT, VVT, and AAT) can
be programmed permanently, the use of these modes is intended as
a temporary setting in situations where maintaining the programming
head in place would be impossible or impractical (i.e., during exercise
testing or extended Holter monitoring) or as a short term solution to
pulse generator inhibition by extracardiac interference. To avoid the
potential for early battery depletion, it is important that the triggered
modes are not used for long term therapy, and that the pulse generator
is returned to a non-triggered permanent program.
5.2 Rate Related Functions
The availability of parameters and parameter values is determined by the software used for
programming/ interrogating the pulse generator.
5.2.1 Basic Rate
The Basic rate parameter (Figure 2) sets the lower pacing rate for the pacemaker and may be
programmed from 30 bpm to 200 bpm. Evia HF / HF-T will allow pacing lower than the programmed
rate when the parameter Hysteresis is enabled. The Hysteresis parameter is found under Basic rate /
Night rate.
Programming conicts for Basic rate occur when Atrial and/or Ventricular Capture Control is
programmed ON. When capture control is programmed ON, the basic rate is limited to 100 bpm.
Figure 2: Basic Rate/Night Rate Screen with Default Settings
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
CAUTION
Programming Modication Extreme programming changes should
only be made after careful clinical assessment. Clinical judgment
should be used when programming permanent pacing rates below
40 ppm or above 100 ppm.
5.2.2 Rate Hysteresis
Parameter Name Range Standard Value Unit
Rate Hysteresis OFF, -5...(-5)...-90 OFF bpm
Scan Hysteresis OFF, 1...(1)...15 OFF cycles
Repetitive Hysteresis OFF, 1...(1)...15 OFF cycles
Rate Hysteresis may be programmed to promote intrinsic conduction for patients who can tolerate
intrinsic activity below a programmed pacing or sensor-indicated rate. This hysteresis rate becomes
the lowest rate permitted before the device begins pacing. Rate hysteresis requires a sensed event
in order to activate. Rate hysteresis will remain active as long as the intrinsic activity remains above
the programmed hysteresis rate. When the intrinsic rate falls to the hysteresis rate, the device will
deliver one paced event at the hysteresis rate and then begin pacing at the programmed basic rate.
Pacing will remain at the basic/sensor rate until a new intrinsic event occurs. This new intrinsic event
reactivates rate hysteresis. An example is shown in Figure 3. Features such as scan and repetitive
hysteresis are available to promote intrinsic activity and are discussed in this chapter.
Figure 3: Example of Rate Hysteresis
Repetitive Rate Hysteresis and Scan Rate Hysteresis are Rate Hysteresis enhancements available in
the Evia CRT-P family. These features encourage a patient’s own rhythm, periodically allowing for, or
looking for, intrinsic activity.
NOTE:
If rate adaptation is active, the Hysteresis rate is based on the current sensor-indicated rate and the
value of the programmable parameter.
Hysteresis is not available in CLS or DVI, and DVIR modes.
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
If Hysteresis is used in the DDI mode, the AV delay must be programmed shorter than the spontaneous
AV conduction time. Otherwise, stimulation in the absence of spontaneous activity occurs at the
hysteresis rate instead of the lower rate.
During night mode the rate will not fall below the programmed night rate even if Hysteresis can take
it to a lower rate. Programming conicts arise when the total decrease in rate is below 30 ppm. Care
should be exercised to avoid programming a Night Mode rate and hysteresis that is below what is
appropriate and may be tolerated by the individual patient.
5.2.3 Scan Hysteresis
Scan Rate Hysteresis seeks to encourage an intrinsic rhythm during long periods of pacing. The
algorithm is enabled after 180 consecutive paced events. Once the 180 paced events are met, the
device will pace at the hysteresis rate for the programmed number of events (1-15). If intrinsic activity
does not return during that period, pacing will continue at the programmed bradycardia rate or sensor
indicated rate, whichever is higher.
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
178
178
Bas ic rate
Bas ic rate
179
179
180
180
2
3
2
1
1
4
3
4
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
178
178
Bas ic rate
Bas ic rate
179
179
180
180
Hysteresis rate
Hysteresis rate
Paced event
Paced event
Hysteresis rate
Hysteresis rate
Paced event
Paced event
Sens ed event
Sens ed event
Figure 4: Scan Hysteresis
In the left portion of Figure 4, pacing occurs at the hysteresis rate for the programmed number of ve
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. The right side of Figure 4 shows a
return of intrinsic activity after two paced events at the hysteresis rate. Once the intrinsic rate returns,
hysteresis is maintained.
Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce pulse
generator energy consumption.
NOTE:
Scan Hysteresis can be used during night mode, but it will not take the rate below the programmed
night rate.
Scan Hysteresis is only available when Hysteresis is selected on.
After the ASYNC effect following magnet application, hysteresis is available.
5.2.4 Repetitive Hysteresis
When Repetitive Rate Hysteresis is activated (after 180 consecutive sensed events), the feature allows
a programmed number of paced events (1-15) at the hysteresis rate to occur before returning to the
programmed basic/sensor rate. This is done to allow return of intrinsic activity in the hysteresis zone. If
intrinsic activity is sensed, pacing will be inhibited. If no intrinsic activity returns within the programmed
number of events, pacing will resume at the programmed basic rate or sensor rate.
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
1
178
178
Bas ic rate
Bas ic rate
179
179
180
180
1
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
2
2
3
3
4
4
178
178
Bas ic rate
Bas ic rate
179
179
180
180
Hysteresis ra te
Hysteresis ra te
Paced event
Paced event
Hysteresis ra te
Hysteresis ra te
Paced event
Paced event
Sens ed event
Sens ed event
Figure 5: Repetitive Hysteresis
In the left portion of Figure 5, pacing occurs at the hysteresis rate for the programmed number of
ve cycles. Because there is no return of the intrinsic rhythm, the device restores pacing at the
programmed/sensor rate. The right side of Figure 5 shows a return of intrinsic activity after two paced
events at the hysteresis rate.
Once the intrinsic rhythm returns, the repetitive hysteresis count begins again. If the intrinsic rhythm
falls to the hysteresis rate before the 180 count has been met, the device uses the standard rate
hysteresis.
Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce
pulse generator energy consumption.
NOTE:
Repetitive Hysteresis can be used during night mode but it will not take the rate below the programmed
night rate.
Repetitive Hysteresis is only available when Hysteresis is selected on.
There is one Standard Hysteresis interval which occurs before the programmable number of Repetitive
Hysteresis occur.
5.2.5 Night Mode
Night rate is designed to reduce the pacing rate to emulate the decreased metabolic needs during
sleep. When Night Rate is active, the pacing rate automatically decreases during the programmed
hours. The Night Rate is programmable from 30 to 200 bpm or OFF.
Night rate can be programmed as low as 30 bpm EXCEPT when Ventricular Capture Control is
programmed ON in the Evia HF / HF-T if Bi-V pacing is turned OFF. When Ventricular Capture Control
is enabled, the lowest rate Night rate can be programmed is 45 bpm. This is because Ventricular
Capture Control requires a “working margin” of 15 bpm for AV modulation during capture testing. These
conicts will appear in blue, as seen in Figure 6.
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Figure 6: Night Rate Screen
When Night rate is active, the Basic rate is reduced to the Night rate using the Sensor rate Decrease
value programmed in the device, even when the sensor is OFF. When Night rate ends, Evia CRT-P
uses 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.
The use of sensor increase/decrease values prevents sudden rate changes that may be felt by the
patient.
During Night rate, the accelerometer remains active, and the patient will continue to receive the benet
of sensor-driven pacing.
Night rate is NOT available when CLS is active as CLS determines rate requirements for the patient.
One may consider reducing the basic rate of the device to optimize the intrinsic rhythm.
Caution should be used in patients who travel across time zones as Night rate is clock-based. Night
rate start and stops times are programmable in 10 minute increments.
The blue conicts show permanent programming conicts when ventricular capture control (VCC) is
programmed ON. These conicts appear when VCC is programmed ON in single/dual chamber Evia
and when RV only pacing is programmed ON in the Evia HF / HF-T.
The red conicts seen in Figure 6 show that Night Rate cannot be programmed greater than the basic
rate value. The value OFF will always correspond to the programmed basic rate of the device.
NOTE:
When Night rate and Rate Hysteresis are programmed, the lowest pacing rate possible is the
programmed Night rate. Evia CRT-P does not allow programming less than 30 bpm.
NOTE:
When Night Mode and Ventricular Capture Control are programmed ON simultaneously in VVI(R),
VCC will not take the rate below the programmed night rate
Over time, the pulse generator’s internal time-of-day clock will exhibit a discrepancy with the actual
time (less than 1 hour per year). This will cause a corresponding discrepancy between the programmed
bed and wake times and the actual times that the system changes the rate.
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Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
The programmer automatically updates the pulse generator time-of-day clock each time the pulse
generator is programmed.
The actual time when the respective increase or decrease in rate occurs may begin up to 4 minutes
after the programmed time because of internal pulse generator timing.
5.2.6 Rate Fading
Rate Fading is intended to prevent a sudden drop in heart rate when the pulse generator 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.
With Rate Fading enabled, the pulse generator calculates the Fading Rate, which is a four beat
average of the intrinsic rate reduced by 10 ppm. When the intrinsic rate drops considerably (below the
Fading Rate), the pacing rate begins at the RF rate and then decreases gradually by the programmable
Decay Rate to the Sensor Indicated Rate or Basic Rate.
NOTE:
The Fading Rate cannot exceed the programmed Maximum Activity Rate and cannot increase faster
than the RF Rate decrease (programmable in ppm/cycle).
Figure 7: Rate Fading
The Rate Fading feature is available after 10 ASYNC while in magnet mode and disabled at ERI and in
backup mode.
5.3 Pulse Specic Features
Features related to the pacing pulse.
5.3.1 Pulse Amplitude
The pulse amplitude can be programmed as shown in Table 3.
Chamber Range Default
Atrium
Right/Left
Ventricle
Table 3: Pulse Amplitude Parameters
0.2...(0.1)...3.0...
(.1)...6.0...(0.5)...7.5 V
0.2...(0.1)...3.0...
(.1)...6.0...(0.5)...7.5 V
3.0 V
3.0 V
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