BIOTRONIK Eluna 8, Eluna 8 SR, Eluna 8 DR-T, Eluna 8 HF-T, Eluna 8 SR-T Technical Manual

BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel [phone]
Fax [phone]
[e-mail]
www.biotronik.com

Eluna 8

SR(-T), DR(-T), HF-T (Pr oMRI

®

)

Pacemaker | Bradyarrhythmia Therapy | 
Cardiac Resynchronization Therapy

Technical Manual

403587

Revision: F (2014-08-04)

© BIOTRONIK SE & Co. KG

All rights reserved.
Specification subject to modification, revision and improvement.

® Registered trademarks of BIOTRONIK SE & Co. KG:

BIOTRONIK Home Monitoring, Eluna, ProMRI

Index 403587Technical ManualEluna SR(-T), DR(-T), HF(-T)

0123
0681 2014

2 Table of Contents

Table of Contents

Table of Contents

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . 8

General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Implantation Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Precautionary Measures while Programming. . . . . . . . . . . 17

Magnet Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Explantation and Device Replacement . . . . . . . . . . . . . . . . . 22

Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Pacing and Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

MRI Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Preset Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . . 30

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Mechanical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . 31

Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3 Product Description

1 Product Description

Product Description1403587Technical ManualEluna SR(-T), DR(-T), HF(-T)

Intended Medical Use

Intended use Eluna is a family of implantable pacemakers that may be implanted for all brady-

cardia arrhythmia indications. The primary objective of the therapy consists of
improving patients' symptoms that can be clinically manifested. The implantation of
the pacemaker is a symptomatic therapy with the following objective:

• Compensation of bradycardia by atrial, ventricular, or AV sequential pacing

• Additional triple-chamber features: Resynchronization of ventricular chamber
contraction via biventricular pacing

Diagnosis and

therapy forms

The cardiac rhythm is automatically monitored and bradycardia arrhythmias are
treated. All major therapeutic approaches from the field of cardiology and electro-

physiology are unified in this pacemaker family. BIOTRONIK Home Monitoring

®

enables physicians to perform therapy management at any time.

Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar

with the operation of a device system.

• Only qualified medical specialists having the special knowledge required for the
proper use of implanted devices are permitted to use them.

• If users do not possess this knowledge, they must be trained accordingly.

Indications

Guidelines of

cardiological societies

Generally approved differential diagnostic methods, indications, and recommenda­tions for pacemaker therapy apply to BIOTRONIK devices.

The guidelines provided by cardiology associations offer decisive information:

• We recommend observing the indications published by the German Cardiac
Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung)
and the ESC (European Society of Cardiology).

• This also applies to the guidelines published by the Heart Rhythm Society (HRS),
the American College of Cardiology (ACC), the American Heart Association
(AHA), and other national cardiology associations.

Device types For the following symptoms/expectations, the following device types are indicated:

Symptom/expectation SR DR HF

Disorientation due to bradycardia x x x
Presyncope x x x
Benefit from resynchronization of the right and left

ventricles

x

Syncope x x x

4 Product Description

Pacing modes For the following symptomatic, the following pacing modes are indicated:

MR conditional

ProMRI® labeled MRI conditional pacemakers are safe for use in the MRI environ­ment when used in conjunction with a complete MRI conditional pacing system and
according to the instructions given in the ProMRI® manual.

Contraindications

Guidelines No contraindications are known for the implantation of multifunctional single-

chamber, dual-chamber or triple-chamber devices, provided differential diagnos­tics precedes implantation according to the appropriate guidelines and no modes or
parameter combinations are configured that pose a risk to the patient.

Pacing modes

and parameters

The compatibility and effectiveness of parameter combinations must be checked
and, as the case may be, adapted after programming.

Symptom/expectation Pacing mode

Sick sinus syndrome Dual-chamber pacing
Chronic, symptomatic second and third-degree AV block Dual-chamber pacing
Adams-Stokes syndrome Dual-chamber pacing
Symptomatic bilateral bundle branch block when tach-

yarrhythmia and other causes have been ruled out

Dual-chamber pacing

• Chronotropic incompetence

• Benefit from increased pacing rate with physical
activity

R mode or CLS

Sinus node dysfunction in the presence of normal AV and
intraventricular conduction

Atrial pacing

Bradycardia in conjunction with the following:

• Normal sinus rhythms with only rare episodes of 
AV block or sinus arrest

• Chronic atrial fibrillation

• Severe physical disability

Ventricular pacing

Set of facts Contraindicated pacing mode

Additionally implanted ICD Unipolar pacing

Set of facts Inappropriate pacing mode

Chronic atrial tachycardia, chronic
atrial fibrillation or flutter

Atrial-controlled modes (DDD, VDD,
AAI)

Poor tolerance of pacing rates above the
basic rate, e.g., angina pectoris

AV conduction disorder Atrial single-chamber pacing
Failing AV conduction

Set of facts Adapt parameters

Slow retrograde conduction after
ventricular pacing: Risk of pacemaker­mediated tachycardia

• Extend atrial refractory period (ARP)
and/or:

• Shorten AV delay

•Rarely:
Program to DDI, DVI or VVI

Poor tolerance of pacing rates above the
basic rate, e.g., angina pectoris

• Lower atrial upper rate

• Lower maximum sensor rate

• Deploy atrial overdrive pacing

5 Product Description

System Overview

Note: Use only adapters approved by BIOTRONIK for leads with different connec-

tions.

• If you have any questions concerning the compatibility of other manufacturers'
leads, please contact BIOTRONIK.

Device family This device family consists of single-chamber, dual-chamber and triple-chamber

devices with or without Home Monitoring. Not all device types are available in every
country.

The following device variants are available:

Device The device's housing is made of biocompatible titanium, welded from the outside

and therefore hermetically sealed. The ellipsoid shape facilitates ingrowth into the
pectoral muscle area. The housing serves as an antipole in the case of unipolar lead
configuration.

IS-1 lead connection The device labeling provides information pertaining to the connection assignment:

Leads BIOTRONIK leads are sheathed in biocompatible silicone. They can be flexibly

maneuvered, are stable long-term, and are equipped for active or passive fixation.
They are implanted using a lead introducer set. Some leads are coated with poly­urethane to increase the gliding properties of the lead. Leads with steroids reduce
inflammatory processes. The fractal design of the leads allows for low pacing
thresholds, high pacing impedance, and a low risk of oversensing.

BIOTRONIK provides adapters to connect already implanted leads to new devices.

Telemetry Telemetric communication between the device and the programmer can be carried

out following initialization either by applying the programming head (PGH) to the
device or by using radio frequency (RF) telemetry in the programmer. BIOTRONIK

calls this function SafeSync

®

.

Device type Variant with

Home Monitoring

Variant without
Home Monitoring

Single-chamber Eluna 8 SR-T Eluna 8 SR
Dual-chamber Eluna 8 DR-T Eluna 8 DR
Triple-chamber Eluna 8 HF-T —

SR DR HF

Connector
port

Lead
connector

Configuration Implantation site Device type

RA IS-1 Unipolar, bipolar Atrium DR, HF
RV IS-1 Unipolar, bipolar Right ventricle SR, DR, HF
LV IS-1 Unipolar, bipolar Left ventricle HF

VVIR /AAIR

IS-1

DDDR

A

IS-1

DDDR

A

IS-1

V

LV

RV

Note: Home Monitoring is possible in all modes.

6 Product Description

Programmer Implantation and follow-up are performed with BIOTRONIK's portable

programmer: There are programmers with integrated or external SafeSync Module
for RF telemetry.

The programmer is used during implantation to transfer the current device
program to the device. The pacing thresholds can be determined and all tests can
be performed during in-office follow-up. In addition to this, the programmer is used
to set mode and parameter combinations, as well as for interrogation and saving of
data from the device. Leadless ECG, IEGM, markers and functions are displayed
simultaneously on the color display.

Modes The mode setting depends on the individual diagnosis:

NBG codes AAIR or VVIR is the NBG code for the antibradycardia mode of the single-chamber

device:

DDDR is the NBG code for the antibradycardia mode of the dual-chamber device:

Device type Modes Standard

SR(-T) • VVI-CLS (8 series only)

• VVIR; V00R; AAIR; A00R

• VVI; VVT; V00; AAI; AAT; A00

•OFF

VVIR

DR(-T) • VVI-CLS; DDD-CLS (8 series only)

• DDDR; DDIR; DVIR; D00R
VDDR; VDIR; VVIR; V00R

AAIR; A00R

• DDD; DDT; DDI; DVI; D00
VDD; VDI; VVI; VVT; V00

AAI; AAT; A00

• DDD-ADI; DDDR-ADIR

•OFF

DDDR

HF-T • DDD-CLS; VVI-CLS

• DDDR; DDIR; DVIR; D00R
VDDR; VDIR; VVIR; V00R

AAIR; A00R

• DDD; DDT; DDI; DVI; D00
VDD; VDI; VVI; VVT; V00

AAI; AAT; A00

• DDD-ADI; DDDR-ADIR

•OFF

DDDR

A/V Pacing in the atrium or ventricle
A/V Sensing in the atrium or ventricle
I Pulse inhibition in the atrium and ventricle
R Rate adaptation

D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation

7 Product Description

DDDRV is the NBG code for the antibradycardia mode of the triple-chamber device:

BIOTRONIK

Home Monitoring

®

In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:

• With Home Monitoring, diagnostic and therapeutic information and technical
data are automatically sent to a stationary or mobile transmitter via an antenna
in the device header. The data are encrypted and sent from the transmitter to
the BIOTRONIK Service Center via the cellular phone network.

• The received data are deciphered and evaluated. Each physician can set the
criteria for evaluation to be used for each patient and can configure the time of
notification via e-mail, SMS or fax.

• A clear overview of the results of this analysis is displayed for the attending
physicians on the protected internet pl

atform Home Monitoring Service Center

(HMSC).

• Data transmission from the device is performed with a daily device message.

• Device messages which indicate special events in the patient's heart or in the
device are forwarded immediately.

• A test message can be initiated at any time using the programmer to immedi­ately check the Home Monitoring function.

Order numbers Eluna The devices can be obtained as follows:

Package contents The storage package includes the following:

• Sterile packaging with device

• Serial number label

• Patient ID card

• Warranty booklet

Note: The technical manual pertaining to the device is either included in hard copy
form in the storage package or in digital form on the internet.

The sterile container includes the following:

•Device

• Screwdriver

D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
V Multisite pacing in both ventricles

Device type Eluna 8 Eluna 8 ProMRI

SR 394939 394972
SR-T 394934 394971
DR 394927 394970
DR-T 394929 394969
HF-T 394917 394968

8 Product Description

Diagnostic and Therapy Functions

General overview All the systems have extensive features that allow quick diagnosis and delivery of

safe therapy for bradycardia conditions.

• Automatic functions make it easy and fast to implant, configure, and check the
pacemaker.

• Auto-initialization after implantation: The device recognizes the implanted leads
autonomously and sets the polarity. The automatic functions of the software are
activated after 10

min.

Diagnostic functions • Data from the last 10 interrogations and follow-ups are recorded as well as

arrhythmia episodes; they are stored together with other data to assess patients
and the state of the device at any time.

• Continuous automatic below-threshold impedance measurements are
performed in the device independent of the pacing pulse in order to check the
lead for proper functioning.

• Once a telemetry connection has been established during a test procedure in an
in-office follow-up, the IEGM is displayed with markers.

Antibradycardia pacing • Sensing: The amplitudes of the P and R waves are measured in the implanted

device fully automatically to record varying amplitudes. The sensitivity for the
atrium and ventricle is adapted automatically on an ongoing basis. The
measurement data are averaged and the trend can be displayed.

• Thresholds: atrial as well as ventricular pacing thresholds are automatically
determined in the device. Capture control is used to set the pulse amplitudes so
that pacing is performed with the optimum atrial and ventricular amplitude for
the patients with each change of the pacing threshold.

• Timing: Pacing in the atrium is checked particularly carefully by an automatic
adaptation of the atrial refractory period in order to avoid pacemaker-mediated
tachycardia.(Auto PVARP function: the postventricular atrial refractory period is
adapted automatically).

• Additional, special form of rate adaptation with devices from the 8 series: an
increased cardiac output requirement is detected using physiological imped

­ance measurement. The measuring principle is based on contractile changes
(ionotropy) of the myocardium (CLS function: Closed Loop Stimulation). Rate
adaptation is automatically initialized and optimized in CLS mode.

• Ventricular pacing suppression with devices from the 8 series: unnecessary
ventricular pacing is avoided by promoting intrinsic conduction (Vp suppression
function). The device can adapt itself to conduction changes. In the case of
intrinsic conduction, the device switches to a DDD(R)-ADI(R) mode.

Resynchronisation therapy Triple chamber devices have functions to configure different VV delays in order to

resynchronize the ventricles.

• Capture Control is available for the left ventricle with automated tracking of the
pacing threshold or automatic threshold monitoring (ATM) for trend analysis.

• To ensure that no additional surgery is necessary in case of a left-sided increase
of pacing threshold or undesired phrenic nerve stimulation, different pacing
polarities can be set for the left ventricular lead with a triple-chamber device.

• An additional diagnostic function with biventricular pacing: variability of the
heart rate, the patient activity and the thoracic impedance are monitored on a
continual basis.

9 Product Description

Programs There are two types of therapy programs:

• Default parameters are offered for the most common indications (Program
Consult function).

• Individual settings can be saved in 3 individual therapy programs.

Home Monitoring functions The device automatically sends information to the transmitter once a day. Addition-

ally, the test messages can be initiated using the programmer. Important medical
information includes, among others, the following:

• Ongoing atrial and ventricular arrhythmia

• Parameters relevant to leads in the atrium and ventricle: thresholds, sensing
amplitudes, impedances

• Current statistics on bradycardia therapy

• Individually adjustable timing interval for device messages which provide addi­tional information pertaining to the device messages

• IEGM online HD® with up to 3 high definition channels

• Transmission of these IEGM recordings along with device messages

10 General Safety Instructions

2 General Safety Instructions

General Safety Instructions2403587Technical ManualEluna SR(-T), DR(-T), HF(-T)

Operating Conditions

Technical manuals The following technical manuals provide information about usage of the device

systems:

— Technical manual for the device

— Technical manual for the HMSC

— Technical manuals for the programmer and its accessories

— Technical manuals for the user interface

— Technical manuals for cables, adapters and accessories

• Technical manuals are either included in hard copy form in the storage package
or in digital form on the internet:

manuals.biotronik.com

• Follow all relevant technical manuals.

• Preserve technical manuals for later use.

Care during shipping and

storage

• Devices are not to be stored close to magnets or sources of electromagnetic
interference.

• Note the effects of the storage duration; see Battery Data.

Temperature Extremely low and high temperatures affect the service time of the battery in the

device.

• The following temperatures are permitted for transport, storage, and use:
–10°C to 45°C

Sterile delivery The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only

if the blister and quality control seal have not been damaged.

Sterile packaging The device and screwdriver are each packaged in 2 separately sealed blisters. The

inner blister is also sterile on the outside so that it can be transferred in a sterile
state during implantation.

Single use only The device and screwdriver are intended for single use only.

• Do not use the device if the package is damaged.

• The device must not be resterilized and reused.

11 General Safety Instructions

Possible Complications

General information on

medical complications

Complications for patients and device systems generally recognized among practi­tioners also apply to BIOTRONIK devices.

• Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information
include current scientific and technological knowledge.

• It is not possible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiolog

­ical examinations. In rare cases the set parameters may become ineffective. In
particular it is inevitable that tachyarrhythmias may be induced.

Skeletal myopotentials Bipolar sensing and control of sensitivity are adapted by the device to the rate range

of intrinsic events so that skeletal myopotentials are usually not sensed. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially with a
unipolar configuration and/or very high sensitivity and, depending on the interfer­ence, may cause inhibition or antiarrhythmia therapy.

Nerve and muscle

stimulation

A device system consisting of a unipolar lead and an uncoated device may result in
undesirable pacing of the diaphragm in the case of an initial or permanent high
setting of the pulse amplitude.

Possible technical failures Technical failure of a device system cannot be entirely ruled out. Possible causes

may include the following:

• Lead dislodgement

• Lead fracture

• Insulation defects

• Device component failures

• Battery depletion

Electromagnetic

interference (EMI)

Any device can be sensitive to interference, for example, when external signals are
sensed as intrinsic rhythm or if measurements prevent rate adaptation.

• BIOTRONIK devices have been designed so that their susceptibility to EMI is
minimal.

• Due to the intensity and variety of EMI, there is no guarantee for safety. It is
generally assumed that EMI produces only minor symptoms in patients - if any.

• Depending on the pacing mode and the type of interference, sources of interfer­ence may lead to pulse inhibition or triggering, an increase in the sensor-depen­dent pacing rate or asynchronous pacing.

• Under unfavorable conditions, for example during diagnostic or therapeutic
procedures, interference sources may induce such a high level of energy into
the pacing system that the cardiac tissue surrounding the lead tip is damaged.

Device behavior

in case of EMI

In the case of electromagnetic interference or undesired myopotentials, the device
switches to asynchronous pacing for the duration of the time that the interference
rate is exceeded.

Static magnetic fields The reed switch in the pacemaker starts to close at a field strength of 1.5 mT.