BIOTRONIK Enitra HF-T User manual

ardac Rhythm Management // Edora, Evty, Entra HF-T / HF-T QP RT-P Pacemakers
Edora, Evty, Entra HF-T / HF-T QP RT-P Pacemakers
Techncal Manual

Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
Edora, Evity, Enitra HF-T / HF-T QP
Implantable CRT-P Pacemakers
X-ray identication
Radiopaque Identication
A radiopaque identication code is visible on standard X-ray, and identies the pacemaker:
Edora, Evity, Enitra HF-T / HF-T QP BIOTRONIK Logo
CAUTION
Because of the numerous available 3.2-mm congurations (e.g., the
IS-1 and VS-1 standards), lead/pacemaker compatibility should be
conrmed with the pacemaker 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).
© 2017 BIOTRONIK, Inc., all rights reserved.

PAGE i
Table of Contents
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
Contents
1. Device Description ............................................................................................................. 1
2. Indications........................................................................................................................... 3
3. Contraindications ............................................................................................................... 5
4. Warnings and Precautions ................................................................................................ 7
4.1 Medical Therapy............................................................................................................. 7
4.2 Storage and Sterilization ................................................................................................ 8
4.3 Lead Connection and Evaluation ................................................................................... 8
4.4 Programming and Operation .......................................................................................... 9
4.5 Home Monitoring .......................................................................................................... 10
4.6 Electromagnetic Interference (EMI).............................................................................. 11
4.6.1 Wireless Technology ................................................................................................ 11
4.6.2 Home and Occupational Environments.................................................................... 12
4.6.3 Cellular Phones........................................................................................................ 13
4.6.4 Hospital and Medical Environments......................................................................... 14
4.7 Pacemaker Explant and Disposal ................................................................................ 14
5. Programmable Parameters.............................................................................................. 15
5.1 Pacing Modes............................................................................................................... 15
5.1.1 Motion Based Rate-Adaptive Modes........................................................................ 15
5.1.2 CLS Modes............................................................................................................... 15
5.1.3 Non-Rate-Adaptive Modes....................................................................................... 16
5.1.4 Mode Switching........................................................................................................ 16
5.1.5 Pacing Modes with Triggered Response.................................................................. 19
5.2 Rate Related Functions................................................................................................ 19
5.2.1 Basic Rate................................................................................................................ 20
5.2.2 Rate Hysteresis........................................................................................................ 20
5.2.3 Scan Hysteresis ....................................................................................................... 21
5.2.4 Repetitive Hysteresis................................................................................................ 22
5.2.5 Night Mode............................................................................................................... 23
5.2.6 Rate Fading.............................................................................................................. 24
5.3 Pulse Specic Features................................................................................................ 24
5.3.1 Pulse Amplitude........................................................................................................ 24
5.3.2 Pulse Width .............................................................................................................. 25
5.4 Automatic Sensitivity Control (ASC) ............................................................................. 26
5.4.1 Ventricular Pacing Parameter Options .................................................................... 29
5.5 Timing Features............................................................................................................ 30
5.5.1 Atrial Refractory Periods........................................................................................... 30
5.5.2 Atrial Refractory Period ............................................................................................ 31
5.5.3 PVARP ..................................................................................................................... 31
5.5.3.1 AUTO PVARP....................................................................................................... 32
5.5.3.2 Right Ventricular Refractory Period...................................................................... 32
5.5.3.3 Left Ventricular Refractory Period ........................................................................ 32

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5.5.4 AV Delay.....................................................................................................................32
5.5.4.1 Dynamic AV Delay..................................................................................................33
5.5.4.2 AV Hysteresis .........................................................................................................33
5.5.4.3 AV Repetitive Hysteresis ........................................................................................34
5.5.4.4 AV Scan Hysteresis...............................................................................................34
5.5.4.5 Negative AV Delay Hysteresis................................................................................35
5.5.4.6 I-Opt ......................................................................................................................36
5.5.4.7 AV Opt. Test ...........................................................................................................36
5.5.5 Ventricular Blanking After Ap......................................................................................37
5.5.6 Far-Field Protection....................................................................................................38
5.5.7 Safety AV Delay..........................................................................................................38
5.5.8 Upper Rate and UTR Response ................................................................................38
5.6 Lead Polarity ..................................................................................................................39
5.7 Parameters for Rate-Adaptive Pacing............................................................................40
5.7.1 Sensor Gain ...............................................................................................................41
5.7.2 Sensor Threshold .......................................................................................................43
5.7.3 Rate Increase.............................................................................................................43
5.7.4 Maximum Activity (Sensor) Rate ................................................................................43
5.7.5 Maximum Closed Loop Rate......................................................................................44
5.7.6 Rate Decrease ...........................................................................................................44
5.8 Management of Specic 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 Specic Scenarios ..............................................................................47
5.11.1 PMT Management ....................................................................................................47
5.11.2 PMT Protection.........................................................................................................47
5.11.2.1 PMT Detection and Termination ...........................................................................47
5.12 Adjustment of the PMT Protection Window ..................................................................48
5.13 Ventricular Capture Control (VCC) ...............................................................................49
5.13.1 Feature Description..................................................................................................49
5.13.2 Capture Control Parameters ....................................................................................49
5.13.3 Search Type .............................................................................................................50
5.13.3.1 Algorithm Suspension, Abort and Disabling .........................................................54
5.13.4 Ventricular Capture Control Programming ...............................................................55
5.14 Atrial Capture Control (ACC) ........................................................................................55
5.14.1 Feature Description..................................................................................................55
5.14.2 Search Type .............................................................................................................58
5.15 Ventricular Pace Suppression (Vp-Suppression) .........................................................58
5.15.1 Feature Description..................................................................................................58
5.15.2 Programmability .......................................................................................................58
5.15.3 How the Vp Suppression Algorithm Works...............................................................58
5.16 Thoracic Impedance.....................................................................................................59
5.17 ProgramConsult®.........................................................................................................60

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5.18 Home Monitoring ..........................................................................................................62
5.18.1 Transmission of Information .....................................................................................62
5.18.2 Patient Device ..........................................................................................................63
5.18.3 Transmitting Data .....................................................................................................63
5.18.4 Types of Report Transmissions ................................................................................64
5.18.4.1 Trend Report ........................................................................................................64
5.18.4.2 Event Report ........................................................................................................64
5.18.5 Description of Transmitted Data...............................................................................64
5.18.5.1 IEGM Online HDs.................................................................................................66
5.18.5.2 Periodic IEGM for Home Monitoring Follow-up....................................................66
5.19 MRI Programming ........................................................................................................67
6. Diagnostics .........................................................................................................................69
6.1 Diagnostics Overview.....................................................................................................69
6.1.1 General Diagnostic Information..................................................................................69
6.2 Timing Statistics ............................................................................................................70
6.2.1 Event episodes and events ........................................................................................70
6.2.2 Rate histograms .........................................................................................................71
6.2.3 AV histogram ..............................................................................................................71
6.2.4 Pacing trends .............................................................................................................71
6.3 Arrhythmia Statistics.......................................................................................................72
6.3.1 Atrial Burden...............................................................................................................72
6.3.2 Duration of Tachycardia Episode................................................................................73
6.3.3 Tachy Episodes/24 h ..................................................................................................73
6.3.4 AT/AF Burden .............................................................................................................73
6.3.5 Ventricular Response .................................................................................................73
6.4 Heart Failure (HF) Monitor .............................................................................................73
6.4.1 Mean Heart Rate........................................................................................................74
6.4.2 Mean Heart Rate at Rest............................................................................................74
6.4.3 Heart Rate Variability..................................................................................................74
6.4.4 Patient Activity............................................................................................................74
6.4.5 Thoracic Impedance...................................................................................................74
6.5 24 Hours.........................................................................................................................76
6.5.1 Rate............................................................................................................................76
6.5.2 Percent Paced............................................................................................................76
6.6 More Statistics................................................................................................................76
6.6.1 Event Counters...........................................................................................................76
6.6.2 Event Episodes and Events .......................................................................................78
6.6.3 Pulse Amplitude and Threshold..................................................................................78
6.6.4 Ax-Vs Interval Distribution ..........................................................................................79
6.6.5 Sensor Rate ...............................................................................................................80
6.6.6 Arrhythmia ..................................................................................................................81
6.6.7 P/R wave trend...........................................................................................................82
6.6.8 Lead Impedance Trends with Lead Check.................................................................83

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Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
6.6.9 Far-eld Histogram.....................................................................................................84
6.6.10 Vp suppression.........................................................................................................85
6.7 IEGMs ...........................................................................................................................86
7. Other Functions/Features..................................................................................................89
7.1 Wandless (RF) Telemetry ...............................................................................................89
7.1.1 Establishing Wandless Telemetry...............................................................................89
7.1.2 Economy Mode ..........................................................................................................90
7.2 Safe Program Settings ...................................................................................................92
7.3 Magnet Effect .................................................................................................................92
7.3.1 Automatic Magnet Effect ............................................................................................92
7.3.2 Asynchronous Magnet Effect......................................................................................92
7.3.3 Synchronous Magnet Effect .......................................................................................92
7.4 Temporary Programming................................................................................................93
7.5 Patient Data Memory......................................................................................................93
7.6 Position Indicator............................................................................................................94
7.7 Pacing When Exposed to Interference...........................................................................94
8. Product Storage and Handling..........................................................................................95
8.1 Sterilization and Storage ................................................................................................95
8.2 Opening the Sterile Container ........................................................................................96
8.3 Pacemaker Orientation...................................................................................................96
9. Lead Connection.................................................................................................................97
9.1 Auto Initialization ............................................................................................................98
10. Follow-up Procedures....................................................................................................101
10.1 General Considerations..............................................................................................101
10.2 Real-time IEGM Transmission ...................................................................................101
10.3 Impedance test...........................................................................................................102
10.4 Threshold test.............................................................................................................102
10.5 P/R Measurement ......................................................................................................104
10.5.1 START (test)...........................................................................................................105
10.5.2 Intrinsic Rhythm (test) ............................................................................................105
10.5.3 Mode .....................................................................................................................106
10.5.4 Sensing test parameters ........................................................................................106
10.5.4.1 Basic Rate..........................................................................................................106
10.5.4.2 AV Delay.............................................................................................................106
10.5.4.3 Upper Rate.........................................................................................................106
10.5.4.4 Pulse Amplitude..................................................................................................106
10.5.4.5 Pulse Width ........................................................................................................106
10.5.4.6 Sensitivity ...........................................................................................................106
10.5.4.7 Pacing Polarity ...................................................................................................107
10.5.4.8 Sensing Polarity .................................................................................................107
10.6 LV VectorOpt ..............................................................................................................107
10.7 AV Opt. Test................................................................................................................108
10.8 Testing for Retrograde Conduction.............................................................................108

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10.8.1 Measuring Retrograde Conduction ........................................................................110
10.8.2 Requirements for Measurement.............................................................................110
10.8.3 Follow-up History....................................................................................................110
10.9 Atrial Non-Invasive Programmed Stimulation (NIPS) ................................................. 111
10.9.1 Description ............................................................................................................. 111
10.9.2 Burst Stimulation .................................................................................................... 111
10.9.3 Programmed Stimulation........................................................................................112
10.9.4 Back up Pacing ......................................................................................................113
10.9.5 NIPS Safety Features.............................................................................................113
10.10 Optimizing Rate Adaptation......................................................................................114
10.10.1 Sensor optimization..............................................................................................114
10.10.2 Adjusting the Sensor Gain....................................................................................115
10.10.3 Adjusting the Sensor Threshold ...........................................................................115
11. Elective Replacement Indication (ERI)..........................................................................117
12. Explantation ....................................................................................................................119
12.1 Common Reasons to Explant a Pacemaker ..............................................................119
13. Technical Data.................................................................................................................121
13.1 Modes.........................................................................................................................121
13.2 Pulse- and Control Parameters ..................................................................................121
13.2.1 Rate Adaptation......................................................................................................124
13.2.2 Atrial Capture Control (ACC) ..................................................................................124
13.2.3 Right/Left Ventricular Capture Control (RVCC/LVCC)............................................125
13.2.4 Home Monitoring Parameters ................................................................................125
13.2.5 Additional Functions ...............................................................................................126
13.2.6 NIPS Specications................................................................................................127
13.3 Programmer ...............................................................................................................127
13.4 Materials in Contact with Human Tissue ....................................................................127
13.5 Electrical Data/Battery................................................................................................128
13.6 Mechanical Data.........................................................................................................128
14. Order Information ...........................................................................................................129
Appendix A.............................................................................................................................131
Appendix B.............................................................................................................................135

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Table of Contents
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual

Chapter 1 Device Description
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 1
1. Device Description
Edora, Evity, Enitra HF-T / HF-T QP pacemakers are BIOTRONIK's state-of-the-art pacing system,
providing wandless telemetry communication, intended to simplify implantation and follow-up
procedures.
The pacemakers provide 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-specic
pacing rates. Specically, the pacemaker 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 pacemaker
can provide a pacing rate that is appropriate and specic to the patient’s individual physiologic
demands due to exercise and acute mental stress.
For standard motion-based rate-adaptation, the pacemakers are equipped with an accelerometer
located within the pacemaker. 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.
Edora, Evity, Enitra HF-T / HF-T QP pacemakers also employs Home Monitoring™ technology, which
is an automatic, wireless, remote monitoring system for management of patients with pacemakers.
With Home Monitoring, physicians can review data about the patient’s cardiac status and pacemaker’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.
Edora, Evity, Enitra HF-T / HF-T QP pacemakers include two types of wireless technology:
• Inductive coil telemetry link (short range, near-field at 32.768 kHz; for interrogation and
programming of the device during follow-ups using the programmer wand)

Chapter 1 Device Description
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 2
• RF link (long range, far-field at 403 MHz; for Home Monitoring and wandless telemetry
communication used for interrogating and programming the device during follow-ups)
For more information regarding the wireless technology in this device and recommendations for safe
and effective operation, refer to Section 4.6.1 of this manual.
Edora, Evity, Enitra HF-T / HF-T QP pacemakers provide pacing support with a variety of rate-adaptive
and non-rate adaptive pacing modes. Pacing capability is supported by a sophisticated diagnostic set.
The Edora, Evity, Enitra HF-T / HF-T QP pacemakers are 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]). The QP model use an IS4 lead for the left ventricle. IS4 refers
to the international standard ISO 27186:2010.
The Edora, Evity, Enitra HF-T / HF-T QP pacemakers are comprised of triple-chamber devices that are
designed to handle a multitude of situations.
Edora, Evity, Enitra HF-T Triple chamber, rate-adaptive, unipolar/bipolar pacing with Home
Monitoring
Edora, Evity, Enitra HF-T QP Triple chamber with quadpolar LV pacing, rate-adaptive,
unipolar/bipolar pacing with Home Monitoring
Refer to Chapter 14 of this manual for order information for the Edora, Evity, Enitra HF-T / HF-T QP
devices.
The above mentioned pacemakers are MR Conditional devices. Therefore, MR scans are permissible
under certain conditions. Refer to the ProMRI® Technical Manual for specic MR conditions of use.

Chapter 2 Indications
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
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2. Indications
Rate-adaptive pacing with Edora, Evity, Enitra HF-T / HF-T QP pacemakers is indicated for patients
exhibiting chronotropic incompetence and who would benet from increased pacing rates concurrent
with physical activity.
Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus
syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA)
block, second- and third- degree AV block, and carotid sinus syndrome.
Patients who demonstrate hemodynamic benet through maintenance of AV synchrony should be
considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specically
indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony
such as AV nodal disease, diminished cardiac output or congestive heart failure associated with
conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
The Edora HF-T QP/HF-T, Evity HF-T QP/HF-T, and Enitra HF-T QP/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.

Chapter 2 Indications
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 4

Chapter 3 Contraindications
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 5
3. Contraindications
Use of Edora, Evity, Enitra HF-T / HF-T QP pacemakers are contraindicated for the following patients:
• Unipolar pacing is contraindicated for patients with an implanted cardioverter-defibrillator (ICD)
because it may cause unwanted delivery or inhibition of ICD therapy.
• 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-specic contraindications, please refer to Appendix A of
this manual.

Chapter 3 Contraindications
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 6

Chapter 4 Warnings and Precautions
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 7
4. Warnings and Precautions
Certain therapeutic and diagnostic procedures may cause undetected damage to a pacemaker,
resulting in malfunction or failure at a later time. Please note the following warnings and precautions:
Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients unable to tolerate increased
pacing rates.
High Output Settings High output settings combined with extremely low lead impedance may reduce
the life expectancy of the pacemaker 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 conrmed by continuous
monitoring of peripheral pulse or blood pressure. Following the procedures, pacemaker 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 pacemaker and at the implant site. If
diathermy therapy must be used, it should not be applied in the immediate vicinity of the pacemaker/
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 pacemaker 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 pacemaker/lead system as possible.
• Monitor cardiac activity during TENS use.
Debrillation The following precautions are recommended to minimize the inherent risk of pacemaker
operation being adversely affected by debrillation:
• The paddles should be placed anterior-posterior or along a line perpendicular to the axis formed by
the pacemaker 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 Pacemaker electronics may be damaged by exposure to radiation during radiotherapy. To
minimize this risk when using such therapy, the pacemaker should be protected with local radiation
shielding.
Lithotripsy Lithotripsy treatment should be avoided for pacemaker patients since electrical and/or
mechanical interference with the pacemaker 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 pacemaker.
Electrocautery Electrocautery should never be performed within 15 cm (6 inches) of an implanted
pacemaker or lead because of the danger of introducing brillatory currents into the heart and/
or damaging the pacemaker. 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.

Chapter 4 Warnings and Precautions
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 8
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 pacemaker malfunction (see Section 8.1).
Handling Do not drop. If an unpackaged pacemaker is dropped onto a hard surface, return it to
BIOTRONIK (see Section 8.1).
FOR SINGLE USE ONLY Do not resterilize the pacemaker or accessories packaged with the
pacemaker, 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 pacemaker requires atrial and ventricular leads with IS-1 compatible connectors. There are no
requirements specic to the atrial lead. It is required to use a low polarization ventricular lead for
activation of Ventricular Capture Control.
Lead Check The Edora/Evity/Enitra HF-T / HF-T QP pacemakers have an programmable ON/OFF
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 Debrillator
(ICD).
Lead/pacemaker Compatibility Lead/pacemaker compatibility should be conrmed with the
pacemaker and/or lead manufacturer prior to the implantation of a pacing system.
IS-1 and IS4, wherever stated in this manual, refer to international standards whereby leads and
generators from different manufacturers are assured a basic t. [Reference ISO 5841-3:1992(E) and
Reference ISO 27186:2010, respectively].
Lead Conguration Lead conguration determines proper programming of the pacemaker. Pacing will
not occur with a unipolar lead if the lead conguration 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 difculty connecting lead(s).
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.

Chapter 4 Warnings and Precautions
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 9
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 conicting evidence regarding the potential benet 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 the lead polarization check is not successful, program a shorter pulse width
or reduce the starting test amplitude to make the lead polarization check pass. 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 debrillator is easily accessible. Only physicians trained and experienced in
tachycardia induction and reversion protocols should use non-invasive programmed stimulation (NIPS).
Unipolar/Bipolar All Edora, Evity, Enitra HF-T / HF-T QP pacemakers can be used with either unipolar
or bipolar IS-1 leads. The HF-T QP members of the family also use one IS4 lead.
If the pacing or sensing function is to be programmed to bipolar, it must be veried 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 conguration
could result in entrance and/or exit block.
Programmers Use only appropriate BIOTRONIK programmers equipped with appropriate software
to program Edora, Evity, Enitra HF-T / HF-T QP pacemakers. 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.
Electromagnetic Interference (EMI) Active medical devices are subject to electromagnetic
interference. In the presence of such interference, telemetry communication may be interrupted and
prevent programming.
Intrinsic Rhythm (test) When selecting the Intrinsic Rhythm button, there is no support pacing for
the duration the button is depressed. This test should not be performed with pacemaker-dependent
patients.
Programming Modications Extreme programming changes should only be made after careful
clinical assessment. Clinical judgment should be used when programming permanent pacing rates
below 40 bpm or above 100 bpm.

Chapter 4 Warnings and Precautions
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 10
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.
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 pacemakers have been optimized to
sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing skeletal
myopotentials. However, the risk of pacemaker operation being affected by myopotentials cannot be
eliminated, particularly in unipolar systems. Myopotentials may resemble cardiac activity, resulting
in pacemaker 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
pacemaker 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 pacemaker.
CLS Rate-Adaptation Under certain circumstances (e.g., EMI, lead dislodgment), the Edora, Evity,
Enitra HF-T / HF-T QP pacemaker may not be able to obtain a usable impedance measurement as
required for CLS rate-adaptive pacing. At this point, CLS rate-adaptation will be inactive until the
situation is corrected. 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 pacemaker 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 pacemaker 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.

Chapter 4 Warnings and Precautions
Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 11
Electromagnetic Interference (EMI) Precautions for EMI interference with the Edora, Evity, Enitra
HF-T / HF-T QP pacemakers are provided in Section 4.6. Sources of EMI including cellular telephones,
electronic article surveillance systems, and others are discussed therein.
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 pacemaker may be affected by certain environmental sources
generating signals that resemble cardiac activity. This may result in pacemaker 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
sufcient energy into a pacing system to damage the pacemaker and/or cardiac tissue adjacent to the
electrodes.
BIOTRONIK pacemakers have been designed to signicantly 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.
Patients should adhere to the following general guidelines regarding EMI:
• Consult with a doctor before entering an area where signs are posted prohibiting persons with an
implanted cardiac device, such as a pacemaker.
• If the patient becomes dizzy or feels rapid or irregular heartbeats while using an electrical item,
release whatever is being touched or move away from the item. The pacemaker should
immediately return to normal operation. Consult with a doctor if symptoms do not improve after
moving away from the item.
4.6.1 Wireless Technology
The wireless technology incorporated into the Edora, Evity, Enitra HF-T / HF-T QP devices is dened
in 47 CFR 95.601-95.673 (Medical Implant Communication Service). One applicable EMC standard is
ISO 14117, and the device has passed all compliance testing. Additionally, the device fullls Part 15 of
the FCC rules and regulations.
An overview of the operating characteristics of the wireless technology is provided in the table below.
Technology Inductive Coil Telemetry Radio Frequency (RF)
Uses Follow-up, programming
Wandless device interrogation
and programming during
follow-up and Home Monitoring*
Operating Range 0 – 5 cm 0 – 3 meters
Carrier Frequency 32.768 kHz 403 MHz
MedRadio (MICS)
Modulation Pulse distance coding, OOK Binary FSK
Uplink Data Rate 2978 bps 16 kbps
Downlink Data Rate 2978 bps 4 kbps
Effective RF Radiated Output
Power -64.09 dBm EIRP Less than 25μW EIRP

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Edora, Evity, Enitra HF-T / HF-T QP Technical Manual
PAGE 12
Technology Inductive Coil Telemetry Radio Frequency (RF)
Field Strength Less than -50 dBuV/m Less than 18.2 mV/m
Quality of Service
Requires near eld (within
5 cm) communication with
programmer wand
With a bit error rate less
than or equal to 10-3 for the
system, there is no degradation
in the wandless telemetry
performance.
Security
Coil communication requires
close proximity (less than 10
cm) and patient acceptance.
The wireless wand session
can only be started via coil,
which requires close proximity
(less than 10 cm) and patient
acceptance. During wireless
wand initiation, the implant
and programmer are “paired”
via a secondary channel (coil
exchange).
Bandwidth 4.71 kHz Less than 300 kHz
FCC Regulation 47 CFR 15.209(a) 47 CFR Part 95
Table 1: Wireless Communication
* No BIOTRONIK devices can be programmed via Home Monitoring.
To ensure proper Wandless Telemetry operation, please refer to the Electromagnetic Interference
section of the Renamic Programmer Technical Manual.
The communication provided by the implant system is robust against EMI. To avoid interference, it is
recommended that the distance between the device and programmer is maintained within 3 meters.
If the connection deteriorates due to the programmer being too close to an electromagnetic device
or radio emitter, unplug the programmer and move the programmer to another location that is free of
noise. Reconnect the power cord and reboot the programmer.
In rare cases that the Wandless Telemetry feature ceases operation due to strong electromagnetic
interference, communication can be re-established with coil communication (programmer wand) so that
the patient follow up can continue nearly seamlessly. Also, the system is designed so that if telemetry
is ever lost or interrupted for any reason during programming, the patient is not left in a potentially
unsafe partially programmed state.
Wireless security is ensured by a proprietary communication protocol to implantable devices that is
security protected by state-of-the-art measures.
4.6.2 Home and Occupational Environments
The following equipment (and similar devices) may affect normal pacemaker 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.