BIOTRONIK SE and KG PNP Medical Implant Pacemaker User Manual eIFU en 417803 B Edora ProMRI 2016 03 23

BIOTRONIK SE & Co. KG Medical Implant Pacemaker eIFU en 417803 B Edora ProMRI 2016 03 23

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Edora 8 ProMRI®

Pacemaker | Bradyarrhythmia Therapy | 

Cardiac Resynchronization Therapy

Technical Manual

417803

Revision: B (2016-03-23)

Specification subject to modification, revision and improvement.

® All product names in use may be trademarks or registered trademarks held 

by BIOTRONIK or the respective owner.

Index 417803Technical ManualEdora 8

0123 2016

BIOTRONIK SE & Co. KG

Woermannkehre 1

12359 Berlin · Germany

Tel +49 (0) 30 68905-0

Fax +49 (0) 30 6852804

sales@biotronik.com

www.biotronik.com

Table of Contents



Table of Contents

Table of Contents

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

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

Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . . 9

General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Precautionary Measures while Programming . . . . . . . . . . . . 18

Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Explantation and Device Replacement . . . . . . . . . . . . . . . . . . 26

Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Pacing and Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

MRI Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Preset Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Tolerances of Parameter Values. . . . . . . . . . . . . . . . . . . . . . . 36

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Product Description



Intended Medical Use

1 Product Description

Product Description1417803Technical ManualEdora 8

Intended Medical Use

Intended use

Edora is a family of implantable pacemakers that can be implanted for all

bradycardia 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

electrophysiology 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.

Product Description



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:

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.

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

Syncope xxx

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 

tachyarrhythmia 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

Product Description



Contraindications

Guidelines

No contraindications are known for the implantation of multifunctional single-

chamber, dual-chamber, or triple-chamber pacemakers, 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.

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 pacemaker-

mediated 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

Product Description



System Overview

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.

Lead connections

BIOTRONIK provides pacemakers with headers for different standardized lead

connections:

•IS-1

•IS-1/IS4

Note: Suitable leads must comply with the norms:

Note: The device and leads have to match.

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

tions.

IS-1

The device labeling provides information pertaining to the connection assignment:

Device type Variant with

Home Monitoring Variant without

Home Monitoring

Single-chamber Edora 8 SR-T Edora 8 SR

Dual-chamber Edora 8 DR-T Edora 8 DR

Triple-chamber Edora 8 HF-T, Edora 8 HF-T QP —

• A device's IS-1 connector port must only be used for connecting leads with an

IS-1 connector that conform to ISO 5841-3.

• A device's IS4 connector port must only be used for connecting leads with an

IS4 connector that conform to ISO 27186.

• Only quadripolar leads must be connected to the IS4 connector on device

type HF QP with IS4.

• If you have any questions concerning the compatibility of other manufacturers'

leads, please contact BIOTRONIK.

SR DR HF

Connector

port Lead

connector Configuration Implantation site Device type

A/RA IS-1 Unipolar, bipolar Atrium DR, HF

V/RV IS-1 Unipolar, bipolar Right ventricle SR, DR, HF

LV IS-1 Unipolar, bipolar Left ventricle HF

Note: Home Monitoring is possible in all modes.

The OFF mode only functions temporary, i.e. during a test.

Product Description



System Overview

IS-1/IS4

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 which is known to increase the gliding properties for 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 wireless wandless telemetry in the programmer.

Programmer

Using the programmer, the pacing thresholds can be determined and all tests can

be performed during implantation and 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:

HF QP

Connector

port Lead

connector Configuration Implantation site Device type

RA IS-1 Unipolar, bipolar Atrium HF QP

RV IS-1 Unipolar, bipolar Right ventricle HF QP

LV IS4 Unipolar, bipolar Left ventricle HF QP

Device type Modes Standard

SR • VVI-CLS

• VVIR, V00R, AAIR, A00R

• VVI, VVT, V00, AAI, AAT, A00

•OFF

VVIR

DR • VVI-CLS; DDD-CLS

• DDD-ADI, DDDR-ADIR

• DDDR, DDIR, DVIR, D00R, VDDR, VDIR

• VVIR, V00R, AAIR, A00R

• DDD, DDT, DDI, DVI, D00, VDD, VDI

• VVI, VVT, V00, AAI, AAT, A00

•OFF

DDDR

HF (QP) • VVI-CLS, DDD-CLS

• DDD-ADI, DDDR-ADIR

• DDDR, DDIR, DVIR, D00R, VDDR, VDIR

• VVIR, V00R, AAIR, A00R

• DDD, DDT, DDI, DVI, D00, VDD, VDI

• VVI, VVT, V00, AAI, AAT, A00

•OFF

DDDR

Product Description



System Overview

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:

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 platform 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 with the following message.

• A test message can be initiated at any time using the programmer to

immediately check the Home Monitoring function.

Order numbers for Edora

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 packaging includes the following:

•Device

• Screwdriver

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

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

Edora 8 SR 407164 Edora 8 DR-T 407145

Edora 8 SR-T 407157 Edora 8 HF-T 407138

Edora 8 DR 407152 Edora 8 HF-T QP 407137

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.

Diagnostics functions

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

arrhythmia episodes; they are stored together with other data to assess the

state of both the patient and 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 and permanently 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.

• Pacing thresholds: Pacing thresholds are automatically identified in the device,

in single and dual-chamber devices the right ventricular, in triple-chamber

devices the right and left ventricular pacing thresholds. Capture control adjusts

the pulse amplitudes in such a way that every change of the pacing threshold

results in the patient being paced at an optimal amplitude.

• Timing: Pacing in the atrium is checked particularly carefully in dual and triple-

chamber devices 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: An increased cardiac output

requirement is detected using physiological impedance 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 from a DDD(R) to an ADI(R) mode.

• In the course of the follow-up, an automatic test of the AV delay is performed to

improve the heart performance. AV delays are calculated; the optimum values

can be applied.

Product Description



Diagnostic and Therapy Functions

Resynchronisation therapy

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

resynchronize the ventricles.

• Capture Control is also available for the left ventricle with automated tracking of

the pacing threshold or automatic threshold monitoring (ATM) for trend

analysis.

• 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.

Up to 13 vectors can be used with the HF QP device type.

• With the QP device type, the LV vector test provides a fast measurement of the

pacing threshold, the phrenic nerve pacing threshold and the pacing

impedance. The relative influence on the service time is also displayed. The

measurement results are evaluated automatically so that the optimal pacing

polarity can be set.

The short RV-LV conduction test supports also the selection.

• An additional diagnostic function with biventricular pacing: Variability of the

heart rate, patient activity, and thoracic impedance are monitored on a continual

basis.

Programs

There are two types of therapy programs:

• Default parameters are offered for the most common indications

(ProgramConsult function).

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

ProMRI devices recognize

magnetic resonance imaging

devices

The static magnetic field of magnetic resonance imaging devices is reliably

recognized with the aid of a sensor. This sensor can be activated for a maximum of

14 days using the MRI AutoDetect function during an interrogation.

If the patient comes near a magnetic resonance imaging device within the time set,

the implanted device recognizes the static magnetic field and automatically

activates the preset MRI program. Reprogramming to the permanent program

occurs also automatically after leaving the imaging device.

Home Monitoring functions

The device automatically sends information to the transmitter once a day. In

addition to this, 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 with device messages

General Safety Instructions



Operating Conditions

2 General Safety Instructions

General Safety Instructions2417803Technical ManualEdora 8

CAUTION

Safety information

Cardiac electrotherapy is subject to special operating conditions and possible

complications and risks.

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 leads

— 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.

• Keep 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 period; see Battery Data.

Temperature

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

device.

• Permitted for shipping and storage:

–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.

• Please take all precautionary measures carefully into account.

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 antiarrythmia therapy, even if the

programs have proven successful during tests or subsequent

electrophysiological examinations. In rare cases the set parameters can

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.

• 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

paces asynchronously for the duration of the time that the interference rate is

exceeded.

Static magnetic fields

The pacemaker switches to magnet response from a field strength > 1.0 mT.

General Safety Instructions



Possible Risks

Procedures to avoid

The following procedures must be avoided as they may cause harm to the patient or

damage the device and, as a result, put the system functionality at risk:

• Therapeutic ultrasound

• Transcutaneous electrical nerve stimulation

• Hyperbaric oxygen therapy

• Applied pressures higher than normal pressure

Potentially risky therapeutic

and diagnostic procedures

If electrical current from an external source is conducted through the body for

diagnostic or therapeutic purposes, then the device can be subjected to

interference and the patient placed at risk.

Arrhythmia or ventricular fibrillation can be induced during diathermic procedures

such as electrocautery, HF ablation or HF surgery. For example, damaging

pressure levels may arise during lithotripsy. Influences on the device are not always

immediately clear.

If potentially risky procedures cannot be avoided, the following should be observed

at all times:

• Electrically insulate patients.

• Switch the pacemaker function to asynchronous modes if needed.

• Do not introduce energy near the device system.

• Check the peripheral pulse of the patient.

• Monitor the patient during and after every intervention.

External defibrillation

The device is protected against the energy that is normally induced by external

defibrillation. Nevertheless, any implanted device may be damaged by external

defibrillation. Specifically, the current induced in the implanted leads may result in

necrotic tissue formation close to the electrode/tissue interface. As a result,

sensing properties and pacing thresholds may change.

• Place adhesive electrodes anterior-posterior or perpendicular to the axis

formed by the device to the heart at least 10 cm away from the device and from

implanted leads.

Radiation therapy

The use of radiation therapy must be avoided due to possible damage to the device

and the resulting impaired functional safety. If this type of therapy is to be used

anyway, prior risk/benefit analysis is absolutely necessary. The complexity of

influencing factors such as different sources of radiation, a variety of devices and

therapy conditions makes it impossible to issue directives that guarantee radiation

therapy without an impact on the device. The EN 45502 standard pertaining to active

implantable medical devices requires the following measures during the

administration of therapeutic ionizing radiation:

• Adhere to instructions for potentially risky therapeutic and diagnostic

procedures.

• Shield device against radiation.

• After applying radiation, double-check the device system to make sure it is

functioning properly.

Note: Please contact BIOTRONIK with questions on the risk/benefit analysis.

General Safety Instructions



Possible Risks

Magnetic resonance imaging

Magnetic resonance imaging must be avoided due to the associated high frequency

fields and magnetic flux density: Damage or destruction of the device system by

strong magnetic interaction and damage to the patient by excessive warming of the

body tissue in the area surrounding the device system.

Under certain conditions and when maintaining mandatory measures to protect the

patient and the device system, magnetic resonance imaging can be performed.

BIOTRONIK devices with the "MR conditional" function bear the identification

ProMRI.

• The ProMRI manual – MR conditional device systems – contains detailed

information on safely conducting an MRI.

— Download the digital manual from the web site:

manuals.biotronik.com

— Order the printed manual at BIOTRONIK.

• Does approval as "MR conditional" apply in your country or region? 

Ask for current information at BIOTRONIK.

Implantation



Implantation Procedure

3 Implantation

Implantation3417803Technical ManualEdora 8

Implantation Procedure

Having parts ready

The following parts that correspond to the requirements of the EC Directive

90/385/EEC are required:

• Device with screwdriver from BIOTRONIK

• BIOTRONIK leads and lead introducer set

— Single-chamber device: unipolar or bipolar lead for the right ventricle

— Dual-chamber device: one unipolar or bipolar lead each for the atrium and

for the right ventricle

— Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV

lead

• Approved connections are IS-1 and IS4: Use only adapters approved by

BIOTRONIK for leads with different connections or leads from other

manufacturers.

• BIOTRONIK programmer (with integrated wandless telemetry or with separate

SafeSync Module) and approved cables

• External multi-channel ECG device

• Keep spare parts for all sterile components.

Keeping an external

defibrillator ready

In order to be able to respond to unforeseeable emergencies or possible technical

failures of the device:

• Keep an external defibrillator and paddles or adhesive electrodes ready.

WARNING

Inadequate therapy due to defective device

If an unpacked device is dropped on a hard surface during handling, electronic

parts could be damaged.

Unpacking the device

• Peel the sealing paper off of the outer blister at the marked position in the

direction indicated by the arrow. The inner blister must not come into contact

with persons who have not sterilized their hands or gloves, nor with non-sterile

instruments.

• Use the gripping tab on the inner blister to remove it from the outer blister.

• Peel the sealing paper off of the sterile inner blister at the marked position in

the direction indicated by the arrow.

Note: The device is disabled on delivery and can be implanted immediately after

unpacking without manual activation.

Checking parts

Damage to any of the parts can result in complications or technical failures.

• Check for damage before and after unpacking all parts.

• Replace damaged parts.

• Use a replacement device.

• Return the damaged device to BIOTRONIK.

Note: If necessary, the device can also be programmed before or during auto-

initialization.

Implantation



Implantation Procedure

Implantation site

In general, the pacemaker is implanted subcutaneously or subpectorally,

depending on the lead configuration as well as the anatomy of the patient.

Overview: Implanting

Avoid damage to the header

Set screws must be tightened or loosened with care.

• Loosen set screws with the supplied screwdriver. Use only BIOTRONIK

screwdrivers with torque control!

• If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.

WARNING

Short circuit due to open lead connector ports

Connector ports in the header which are open and thus not electrolyte-proof may

cause undesired current flows to the body and penetration of body fluid into the

device.

WARNING

Inadequate therapy

Insufficient lead spacing or inappropriate lead positioning may lead to far-field

sensing.

Preventing short circuits

in the header

Keeping distance

between leads

1 Shape the device pocket and prepare the vein.

2 Implant the leads and perform measurements.

3 Connect device and leads.

4 Insert the device.

The device starts auto-initialization on its own.

5 Guide the fixation suture through the opening in the header and fixate the

device in the prepared device pocket.

6 Close the device pocket.

7 Prior to testing and configuration, wait for the successful completion of

automatic device initialization.

• Close unused connector ports with blind plugs.

• Leads must not contact each other. Position the tip and ring of newly implanted

leads with a sufficient distance from old implanted leads.

Implantation



Implantation Procedure

Connecting the lead connector

to the device

Applying the programming

head

The programming head (PGH) features a diagram of the device. This is used to

assist in positioning the head to ensure proper telemetry.

• Make sure the PGH is positioned correctly.

Establishing wandless

telemetry

The programmer must be no less than 20 cm and no more than 3 m from the

device; ideally there should be no hindrances between the patient and the

programmer.

• Switch on wandless telemetry on the programmer.

• Apply the programming head for about 2 s until successful initialization is

displayed on the programmer:

The wandless telemetry symbol is displayed in the navigator and the

signal strength is displayed in the status line.

• Remove the programming head.

Note: After auto-initialization, all parameters are activated as in the standard

program.

Auto-initialization

Auto-initialization begins automatically once the first connected lead is sensed.

Auto-initialization is usually terminated 10 minutes after connection of the first

lead. If no other program has been transferred in the meantime, the device

subsequently works with active automatic functions in the factory settings or with

the preset program of the user.

Manual setting of the lead polarity or measurement of lead impedances is not

necessary.

Behavior during auto-

initialization

• During transmission of a permanent program:

Auto-initialization is terminated and the transferred program is active.

• During testing:

Tests cannot be performed during auto-initialization; stop it beforehand. 

Auto-initialization will not be continued upon completion of the test.

1 Remove stylets and stylet guides.

2 • Connect the unipolar or bipolar IS-1 lead connector for the right ventricle

to RV.

• Connect the unipolar or bipolar IS-1 lead connector atrium to A.

• Connect the unipolar or bipolar IS-1 or the quadripolar IS4 lead connector

for the left ventricle to LV.

3 Push the lead connector into the header without bending the conductor until

the connector tip becomes visible behind the set screw block.

4 If the lead connector cannot be inserted completely, the set screw may be

protruding into the drill hole of the set screw block. Carefully loosen the set

screw without completely unscrewing it, so that it does not become tilted

upon retightening.

5 Use the screwdriver to perpendicularly pierce through the slitting in the

center of the silicone plug until it reaches the set screw.

6 Turn the set screw clockwise until the torque control starts (you will hear a

clicking sound).

7 Carefully withdraw the screwdriver without retracting the set screw.

• When the screwdriver is withdrawn, the silicone plug automatically seals

the lead connection safely.

Implantation



Precautionary Measures while Programming

CAUTION

Safety information

The programming of device systems requires special precautions.

Checking the device system

• After auto-initialization, perform a follow-up to see if the device system is

functioning properly.

• Perform a pacing threshold test to determine the pacing threshold.

Performing standard tests and

monitoring the patient

Critical conditions can occur for the patient even during standard tests due to

inadequate parameter settings or interrupted telemetry.

• Ensure sufficient patient care even during tests.

• After the threshold test, check to determine whether the threshold is clinically

and technically justifiable.

• Continuously monitor the ECG and the patient's condition.

• Cancel testing if necessary.

Do not interrupt wandless

telemetry during a treatment

Disconnecting the SafeSync Module from the programmer can result in

interference with or termination of the SafeSync wandless telemetry.

• Do not disconnect the SafeSync Module from the programmer.

• Do not take the Operation Module off the ICS 3000.

Cancelling telemetry

Programmer interference or interrupted telemetry during performance of

temporary programs (follow-up tests) can result in inadequate pacing of the

patient. This is the case if the programmer can no longer be operated due to a

program error or a defective touch screen and therefore the temporary program

cannot be terminated. Under these circumstances, it is helpful to cancel telemetry,

in which case the device automatically switches to the permanent program.

• In the case of telemetry with PGH: lift the programming head by at least 30 cm.

• In the case of wandless telemetry: switch off and reposition the programmer.

• Turn off possible sources of interference.

Avoiding critical parameter

settings

No modes and parameter combinations that pose a risk to the patient should be set.

• Prior to setting rate adaptation, determine the patient's capacity for strain.

• Check compatibility and effectiveness of parameter combinations after making

settings.

Manually setting lead polarity

Due to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing)

should only be set if bipolar leads are implanted.

Setting sensing

Manually set parameters can be unsafe. For example, unsuitable far-field

protection may impede sensing of intrinsic pulses.

• Use automatic sensitivity control.

Setting the sensitivity

A value set to < 2.5 mV/unipolar for device sensitivity may result in noise caused by

electromagnetic fields.

• Therefore, it is recommended that a value of ≥ 2.5 mV/unipolar be set according

to paragraph 28.22.1 of the EN 45502-2-1 standard. Setting sensitivity values

< 2.5 mV/unipolar requires explicit clinical need. Values like this must only be

set and retained with physician supervision.

• Please carefully take all precautionary measures into account.

Implantation



Precautionary Measures while Programming

Preventing device-induced

complications

BIOTRONIK devices are equipped with several functions to prevent device-induced

complications to the greatest extent possible:

• Measure the retrograde conduction time.

• If the function is not yet automatically set: activate PMT protection.

• Set the VA criterion: The aim is to set a VA criterion that is longer than the

longest measured retrograde conduction time.

Preventing conduction of atrial

tachycardia

BIOTRONIK devices are equipped with several functions to prevent conduction of

atrial tachycardia to the ventricle(s):

•Set Mode Switching for indicated patients.

• Set the upper rate and the refractory periods to prevent abrupt ventricular rate

switching.

• Prefer Wenckebach response and avoid 2:1 behavior.

• Set all parameters so as to prevent constant changing between atrial and

ventricular-controlled modes.

Phrenic nerve stimulation that

cannot be terminated

With LV pacing, chronic phrenic nerve stimulation can in rare cases not be

terminated by reprogramming the available left ventricular pacing configurations

or by other measures.

• Possibly set a right ventricular mode both in the permanent program and for

Mode Switching.

Avoiding risks in the case of

exclusive left ventricular

pacing

Lead dislodgement in the case of exclusive left ventricular pacing could pose the

following risks: loss of ventricular pacing as well as induction of atrial arrhythmia.

• Consider sensing and pacing parameters with reference to loss of therapy.

• Exclusive left ventricular pacing is not recommended for patients who depend

on the device.

• Take possible interruption of automatic Active Capture Control into

consideration.

• In the case of follow-ups and threshold tests, take loss of synchronized

ventricular pacing into consideration.

• Mode Switching does not allow exclusive left ventricular pacing; consider the

consequences when setting Mode Switching parameters.

If an ICD is implanted at the

same time, do not permit

unipolar pacing

If an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is

possible to switch to unipolar pacing after resetting the pacemaker or using the

automatic lead check. As a result, the ICD could falsely inhibit or trigger

tachyarrhythmiatherapy activity.

• Unipolar leads are not permitted in this configuration.

Recognizing lead failure

Automatic impedance measurement is always switched on.

• Impedance values that indicate technical failure of a lead are documented in the

event list.

Implantation



Precautionary Measures while Programming

Consider power consumption

and service time

The pacemaker permits programming of high pulse amplitudes with long pulse

widths at high rates to be able to adequately treat even rare diagnoses. In

combination with low lead impedance, this results in a very high level of power

consumption.

• When programming large parameter values, take into account that the

replacement indication ERI will be reached very early because the service time

of the battery may be reduced to less than 1 year.

Home Monitoring: The CardioMessenger should be relatively close to the patient; if

it is too far away, the device constantly seeks and consumes more power than

necessary.

• Home Monitoring ON reduces the service time by approximately 15% in single-

and dual-chamber devices and by approximately 10% in triple-chamber devices.

Wandless telemetry: 15 minutes of usage reduces the service time by

approximately 7 days.

• Do not establish unnecessary wandless telemetry.

•After 5 min without input, the device switches to the economy mode.

• Check the battery capacity of the device at regular intervals.

Implantation



Magnet Response

Programming head application

When the programming head is applied, time remains for device interrogation

before the device switches back to the previously set permanent therapy mode. The

same applies to programming head application to establish wandless telemetry

contact.

Magnet response in

standard program

Applying a magnet or the programming head can result in an unphysiological

rhythm change and asynchronous pacing. The magnet response is set as follows in

the standard program of BIOTRONIK pacemakers:

• Asynchronous:

For the duration of the magnet application – mode D00 (where applicable 

V00 / A00) without rate adaptation;

Magnet rate: 90 bpm

•Automatic:

For 10 cycles – mode D00, subsequently mode DDI without rate adaptation;

Magnet rate: 10 cycles with 90 bpm, subsequently set basic rate

• Synchronous:

Note: See also the replacement indication information for magnet response at ERI.

Mode DDD (where applicable: VVI) without rate adaptation;

Magnet rate: set basic rate

Magnet application by patients

If patients are performing their own magnet application, the synchronous magnet

response must have been programmed. Patients should also know the following:

• When may the magnet be used?

In cases of severe dizziness and indisposition.

• How long is the magnet placed on the pacemaker?

1 to 2 s.

• What happens when the magnet is applied?

The IEGM of the last 10 seconds is stored.

• What has to happen after magnet application?

The patient has to contact the physician for a follow-up.

Implantation



Follow-up

Follow-up intervals

Follow-ups must be performed at regular, agreed intervals.

• Following the lead ingrowth phase, approximately 3 months after implantation,

the first follow-up should be carried out by the physician using the programmer

(in-office follow-up).

• The next in-office follow-up should be carried out once a year and no later than

12 months after the last in-office follow-up.

Follow-up with BIOTRONIK

Home Monitoring

Monitoring using the Home Monitoring function does not serve to replace regular

in-office appointments with the physician required for other medical reasons.

Follow-up supported by Home Monitoring can be used to functionally replace 

in-office follow-up under the following conditions:

• The patient was informed that the physician must be contacted if symptoms

worsen or if new symptoms arise despite the use of the Home Monitoring

function.

• Device messages are transmitted regularly.

• The physician decides whether the data transmitted via Home Monitoring with

regard to the patient's clinical condition as well as the technical state of the

device system are sufficient. If not, an in-office follow-up has to be carried out.

Possible early detection due to information gained via Home Monitoring may

necessitate an additional in-office follow-up. For example, the data may indicate at

an early stage lead problems or a foreseeable end of service time (ERI).

Furthermore, the data could provide indications of previously unrecognized

arrhythmias or regarding modification of therapy by reprogramming the device.

Follow-up with the

programmer

Use the following procedure for in-house follow-up:

1 Record and evaluate the ECG.

2 Interrogate the device.

3 Evaluate the status and automatically measured follow-up data.

4 Check the sensing and pacing functions.

5 Manually perform standard tests if necessary.

6 Possibly evaluate statistics and IEGM recordings.

7 Possibly adjust program functions and parameters.

8 Transmit the program permanently to the device.

9 Print and document follow-up data (print report).

10 Finish the follow-up for this patient.

Implantation



Patient Information

Patient ID card

A patient ID card is included in delivery.

• Provide the patient with the patient ID card.

• Request that patients contact the physician in case of uncertainties.

Prohibitive signs

Premises with prohibitive signs must be avoided.



• Draw the patient's attention to prohibitory signs.

Possible sources of

interference

Electromagnetic interference should be avoided in daily activities. Sources of

interference should not be brought into close proximity of the device.

• Draw the patient's attention to special household appliances, security

checkpoints, anti-theft alarm systems, strong electromagnetic fields, cellular

phones, and transmitters among other things.

• Request patients to do the following:

— Use cellular phones on the opposite side of their body from the device.

— Keep the cellular phone at least 15 cm away from the device both during use

and when stowing.

Implantation



Replacement Indications

Possible charging status

The time span from the beginning of service (BOS) to elective replacement

indication (ERI) is determined by, among others, the following:

• Battery capacity

• Lead impedance

• Pacing program

• Pacing to inhibition ratio

• Pacemaker circuit properties

The following are the defined pacemaker operational statuses:

• BOS: Beginning of Service: > 90%

• ERI: Elective Replacement Indication (i.e., RRT: Recommended Replacement

Time)

• EOS: End of Service

ERI activation

ERI detection is automatically activated after the following events:

• Successful auto-initialization

ERI display

ERI is displayed as follows:

• On the programmer after interrogation of the pacemaker

• By a defined decrease in the basic rate as well as the magnet rate

Rate decrease

The decrease of basic rate and magnet rate is defined as follows:

• In the following modes, the pacing rate decreases by 11%:

DDD(R); DDT; D00(R); VDD(R); VDI(R); VVI(R); VVT; AAI(R); AAT; A00(R)

• In the modes DDI(R) and DVI(R), only the VA interval is extended by 11%. This

reduces the pacing rate by up to 11%, depending on the configured AV delay.

Change of the mode with ERI

This change depends on the mode which is set. It is displayed on the programmer.

• Single-chamber modes: VVI

• Dual-chamber modes: VDD

• Triple-chamber modes: Dual-chamber pacing, one biventricular setting is kept

Deactivated functions with ERI

The following functions are deactivated:

• Atrial pacing

• Night program

• Rate adaptation

• Atrial and ventricular capture control

• Rate fading

• Atrial overdrive pacing

• IEGM recordings

• Statistics

• Home Monitoring

• Rate hysteresis

• Ventricular pacing suppression

Implantation



Replacement Indications

Magnet response at ERI

After reaching ERI, pacing is performed as follows after applying the magnet or

programming head:

Expected service times

after ERI

The information is based on the following:

• Lead impedance of 500 Ω or 600 Ω

• 100% pacing

• Interval from ERI to EOS for the single-chamber device in AAI(R)/VVI(R) mode,

for the dual and triple-chamber device in DDD(R) mode

• Standard program with both high and low pacing energy

• Data of the battery manufacturer (see the battery data)

Magnet

response Cycles 1 to 10 After 10th cycle

Automatic Asynchronous with 80 bpm Synchronous with basic rate

reduced by 11%

Asynchronous Asynchronous with 80 bpm Asynchronous with 80 bpm

Synchronous Synchronous with basic rate

reduced by 11%

Synchronous with basic rate

reduced by 11%

110 bpm

4.6 V

1.5 ms

500 Ω

30 bpm

0.2 V

0.1 ms

500 Ω

70 bpm

2.5 V

0.4 ms

500 Ω

70 bpm

5.0 V

0.4 ms

500 Ω

60 bpm

2.5 V

0.4 ms

600 Ω

60 bpm

5 V

0.4 ms

600 Ω

Mean value: 8 months

Minimum value: 6 months

—

Minimum value: 6 months

—

Minimum value: 6 months

Implantation



Explantation and Device Replacement

Explantation

• Disconnect the leads from the header.

• Remove the device and, if necessary, leads using state-of-the-art technology.

• Explants are biologically contaminated and must be disposed of safely due to

risk of infection.

Device replacement

The following applies to leads from a previous device that are intended for further

use:

• Check the leads prior to connecting to the new device.

If, upon replacing the device, already implanted leads are no longer used but left in

the patient, then an additional uncontrolled current path to the heart can result.

• Isolate unused lead connectors and close unused connector ports.

Basic principles:

• The device must not be resterilized and reused.

Cremation

Devices should not be cremated.

• Explant the device before the cremation of a deceased patient.

Disposal

BIOTRONIK takes back used products for the purpose of environmentally safe

disposal.

• Clean the explant with a solution of at least 1% sodium hypochlorite.

• Rinse with water.

• Fill out explantation form and send to BIOTRONIK together with the cleaned

device.

Parameters



Timing

4 Parameters

Parameters4417803Technical ManualEdora 8

Note: Unless described separately, information for device type HF also applies to

device type HF QP.

Timing

Basic rate day/night

Rate hystereses

AV delay

AV hystereses

Parameter Range of values Standard SR DR HF

Basic rate 30 ... (5) ... 100 ... (10)

... 200 bpm

60 bpm x x

50 bpm x

Night rate OFF; 30 ... (5) ... 100 ... (10)

... 200 bpm

OFF x x x

Night begins 00:00 ... (10 min) ...

23:50 hh:mm

—xxx

Night ends

Parameter Range of values Standard SR DR HF

Hysteresis OFF; -5 ... (-5) ... -25 ... (-20)

... -65 bpm

OFF x x x

Repetitive/ search

cycles

OFF; ON OFF x x x

Parameter Range of values Standard SR DR HF

AV delay Low; Medium; High; Fixed;

Individual

Low x x

20 ... (5) ... 350 ms

(in 6 rate ranges)

180-170-

160-150-

140 ms

CLS and all HF modes:

20 ... (5) ... 350 ms

(in 6 rate ranges)

150-140-

130-120-

120 ms

Sense compensation OFF; -10 ... (-5) ... -120 ms -45 ms x x

Parameter Range of values Standard SR DR HF

AV hysteresis mode OFF; Positive; Negative

HF when setting RV: IRSplus

OFF x x

Positive modes: 

AV hysteresis

70; 110; 150; 200 ms 70 ms

CLS modes:

110 ms

Negative modes: 

AV hysteresis

10 ... (10) ... 150 ms 50 ms x x

AV repetetive / 

scan cyles

OFF; ON ON x x

Parameters



Timing

Ventricular pacing

Upper rate

Mode switching

Ventricular pacing

suppression

Parameters valid for devices in DDD-ADI or DDDR-ADIR modes:

Parameter Range of values Standard SR DR HF

Ventricular pacing BiV, RV; LV BiV x

Triggering OFF; RVs; RVs + PVC RVs x

LV T-wave protection ON; OFF ON x

Maximum trigger rate AUTO; 90 ... (10) ... 160 bpm AUTO x

Initially paced

chamber

RV; LV LV x

VV delay after Vp 0 ... (5) ... 80 ... (10) ... 100 ms 0 ms x

VV delay after Vs 0 ms 0 ms x

Parameter Range of values Standard SR DR HF

Upper rate

SR: in VVT mode

90 ... (10) ... 200 bpm 130 bpm x x x

Wenckebach response/

2:1 rate

Automatically set — x x

Atrial upper rate OFF; 175; 200; 240 bpm 240 bpm x x

Parameter Range of values Standard SR DR HF

Mode switching OFF; ON ON x x

Intervention rate 100 ... (10) ... 250 bpm 160 bpm x x

Switch to mode DDI; DDI(R) when

permanent DDD(R)

VDI; VDI(R) when

permanent VDD(R)

DDI(R) x x

Ventricular pacing RV; BiV BiV x

Onset criterion 3 ... (1) ... 8 (out of 8) 5 x x

Resolution criterion x x

Change of the basic rate

with mode switching

OFF; +5 ... (5) ... +30 bpm +10 bpm

Rate stabilization with

mode switching

OFF; ON OFF x x

2:1 lock-in protection OFF; ON ON x

When setting RV: OFF;

ON x

Parameter Range of values Standard SR DR HF

Vp suppression OFF; ON OFF x x

Pacing suppression after

consecutive Vs

1 ... (1) ... 8 6 x x

Pacing support after x cycles 1 ... (1) ... 4 (out of 8) 3 x x

Parameters



Timing

Refractory periods

Blanking periods

PMT protection

Parameter Range of values Standard SR DR HF

RV refractory period 200 ... (25) ... 500 ms 250 ms x x x

Atrial refractory

period

AUTO AUTO x x

Atrial refractory

period in the modes

AAI(R); AAT(R); DDT

300 ... (25) ... 775 ms 350 ms x x

LV refractory period 200 ms 200 ms x

AUTO PVARP OFF; ON ON x x

PVARP 175 ... (25) ... 600 ms 225 ms x x

PVARP after PVC PVARP + 150 ms

(max: 600 ms)

Automatically set x x

Parameter Range of values Standard SR DR HF

Far-field protection

after Vs

100 ... (10) ... 220 ms 100 ms x x

Far-field protection

after Vp

100 ... (10) ... 220 ms 150 ms x x

Ventricular blanking

period after Ap

30 ... (5) ... 70 ms 30 ms x x

Parameter Range of values Standard SR DR HF

PMT protection OFF; ON ON x x

VA criterion 250 ... (25) ... 500 ms 350 ms x x

Parameters



Pacing and Sensing

Pulse amplitude and

pulse width

Sensitivity

Atrial capture control

Ventricular capture control

Atrial overdrive pacing

Parameter Range of values Standard SR DR HF

Pulse

amplitude A/RV/LV

0.2 ... (0.2) ... 6.0 ... (0.5)

... 7.5 V

3.0 V x x x

Pulse width A/RV/LV 0.1 ...(0.1) ... 0.5 ... (0.25)

... 1.5 ms

0.4 ms x x x

Parameter Range of values Standard SR DR HF

Sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x

Sensitivity A AUTO; 0.1 ... (0.1) ... 1.5 ...

(0.5) ... 7.5 mV

AUTO x x

RV sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x x x

LV sensitivity OFF; AUTO; 0.5 ... (0.5) ...

7.5 mV

AUTO x

Parameter Range of values Standard SR DR HF

Atrial capture control ATM (monitoring only); ON;

OFF

ON x x

Minimum amplitude 0.5 ... (0.1) ... 4.8 V 1.0 V x x

Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x x

Safety margin 0.5 ... (0.1) ... 1.2 V 1.0 V x x

Search type Interval; time of day Time of day x x

Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x x

Time of day 00:00 ... (00:10) ...

23:50 hh:mm

00:30 hh:mm x x

Parameter Range of values Standard SR DR HF

Capture control RV ATM (monitoring only); ON;

OFF

ON x x x

Capture control LV x

Minimum

amplitude RV

0.7 V 0.7 V x x x

Minimum

amplitude LV

Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V x x x

RV safety margin 0.3 ... (0.1) ... 1.2 V 0.5 V x x

LV safety margin 1.0; 1.2 V 1.0 V x

Search type Interval; time of day Time of day x x x

Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h x x x

Time of day 00:00 ... (00:10)

... 23:50 hh:mm

00:30 hh:mm x x x

Parameter Range of values Standard SR DR HF

Atrial overdrive

pacing

OFF; ON

With ON: maximum over-

pacing rate 120 bpm, mean

rate increase approximately

8 bpm, rate decrease after

20 cycles

OFF x x

Parameters



Pacing and Sensing

Lead configuration

IEGM recordings

Rates for statistics

Parameter Range of values Standard SR DR HF

Sensing polarity A Unipolar; bipolar Unipolar x x x

Sensing polarity RV Unipolar; bipolar Unipolar x x x

Sensing polarity LV Unipolar; bipolar Unipolar x

Pacing polarity A Unipolar; bipolar Unipolar x x x

Pacing polarity RV Unipolar; bipolar Unipolar x x x

Pacing polarity LV Device type HF:

LV1 tip -> LV2 ring

LV1 tip -> RV ring

LV2 ring -> LV1 tip

LV2 ring -> RV ring

LV1 tip -> housing

LV2 ring -> housing

LV1 tip –>

housing

Device type HF QP

LV1 tip -> LV2 ring

LV1 tip -> LV4 ring

LV1 tip -> RV ring

LV1 tip -> housing

LV2 ring -> LV1 tip

LV2 ring -> LV4 ring

LV2 ring -> RV ring

LV2 ring -> housing

LV3 ring -> LV2 ring

LV3 ring -> LV4 ring

LV3 ring -> RV ring

LV4 ring -> LV2 ring

LV4 ring -> RV ring

LV1 tip –>

LV2 ring

Parameter Range of values Standard SR DR HF

Number of recordings

(each max. 10 s)

—xxx

High atrial rate (HAR) OFF; AT; mode switching AT x x x

High ventricular rate

(HVR)

OFF; ON ON x x x

Patient triggering

(triggered by patient)

OFF; ON OFF x x x

Pre-trigger recording 0; 25; 50; 75; 100% 75% x x x

IEGM signal Filtered; Unfiltered Filtered x x x

Parameter Range of values Standard SR DR HF

HAR limit 100 ... (10) ... 250 bpm 200 bpm x x

HVR limit 150 ... (5) ... 200 bpm 180 bpm x x x

HVR counter 4; 8; 12; 16 events 8 events x x x

Start resting period 00:00 ... (1:00 AM) ...

23:00 hh:mm

2:00 hh:mm x x x

Duration of resting

period

0.5 ... (0.5) ... 12 h 4 h x x x

Enable lead check OFF; ON ON x x x

Parameters



Rate Adaptation

CLS modes: closed loop

stimulation

R modes: Accelerometer

Parameters valid for devices with R modes:

Parameter Range of values Standard SR DR HF

Maximum CLS rate 80 ... (10) ... 160 bpm 120 bpm x x x

CLS response Very low; Low; Medium;

High; Very high

Medium x x x

CLS resting rate

control

OFF; +10 ... (10) ... +50 bpm +20 bpm x x x

Vp required Yes; No No

When BiV is

set: Yes

xxx

Parameter Range of values Standard SR DR HF

Sensor gain AUTO; Very low; Low;

Medium; High; Very high

AUTO x x x

Max. activity rate 80 ... (10) ... 180 bpm 120 bpm x x x

Sensor threshold Very low; Low; Medium;

High; Very high

Medium x x x

Rate fading OFF; ON OFF x x x

Rate increase 1; 2; 4; 8 bpm/cycle 2 bpm/cycle x x x

Rate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle 0.5

bpm/cycle

xxx

Parameters



MRI Program

MRI modes

Modes valid for devices marked ProMRI:

MRI parameters

Preset parameters in the MRI program:

Mode Range of values Standard SR DR HF

MRI program ON; OFF; AUTO OFF x x x

Expiration date Today's date ... (1 day) ...

today's date + 14 days

Today's date

+ 14 days

xxx

MRI mode OFF; A00; V00 Dependent

permanent

program

OFF; D00; A00; V00 x

OFF; D00; A00; V00;

D00-BiV; V00-BiV

Parameter Range of values Standard SR DR HF

Basic rate 70 ... (10) ... 160 bpm 90 bpm x x x

AV delay 110 ms 110 ms x x

VV delay 0 ms 0 ms x

Pulse amplitude A/RV 4.8 V — x x x

Pulse width A/RV 1.0 ms

Pulse amplitude LV 0.2 … (0.2) … 6.0 … (0.5) …

7.5 V

As in

permanent

program

Pulse width LV 0.1 … (0.1) … 0.5 … (0.25) …

1.5 ms

Parameters



Preset Programs

Standard and safe program

Mode after auto-initialization:

Lead configuration, determined and set immediately after connection (auto lead

check)

Parameters after auto-initialization:

Parameter Factory

setting Standard Safe program SR DR HF

Mode VVI VVIR VVI

In the AAI mode, the

safe program is also

AAI.

Mode DDD DDDR VVI x x

Parameter Factory

setting Standard Safe

program SR DR HF

Pacing polarity A/RV Unipolar Unipolar Unipolar x x x

Pacing polarity LV TCUP TCUP TCUP x

Sensing polarity A/RV Unipolar Unipolar Unipolar x x x

Sensing polarity LV Unipolar Unipolar Unipolar x

Automatic lead check ON ON — x x x

Parameter Factory

setting Standard Safe

program SR DR HF

Basic rate 60 bpm 60 bpm 70 bpm x x

50 bpm 50 bpm x

Night rate OFF OFF OFF x x x

Rate hysteresis OFF OFF OFF x x x

Upper rate 130 bpm 130 bpm — x x

AV dynamics Low Low — x x

AV hysteresis mode OFF OFF — x x

Sense compensation -45 ms -45 ms — x x

AV safety delay 100 ms 100 ms — x x

VV delay 0 0 0 x

LV T-wave protection ON ON ON x

Far-field protection after Vs 100 ms 100 ms — x x

Far-field protection after Vp 150 ms 150 ms — x x

Ventricular blanking period

after Ap

30 ms 30 ms — x x

PMT protection ONON— xx

VA criterion 350 ms 350 ms — x x

Magnet response AUTO AUTO AUTO x x x

Pulse amplitude A 3.0 V 3.0 V — x x

Pulse amplitude RV 3.0 V 3.0 V 4.8 V x x x

Pulse amplitude LV 3.0 V 3.0 V 4.8 V x

Pulse width A 0.4 ms 0.4 ms — x x

Pulse width RV 0.4 ms 0.4 ms 1.0 ms x x x

Pulse width LV 0.4 ms 0.4 ms 1.0 ms x

Sensitivity A AUTO AUTO — x x

Sensitivity RV AUTO AUTO 2.5 mV x x x

Sensitivity LV AUTO AUTO 2.5 mV x

Parameters



Preset Programs

Refractory period A AUTO AUTO — x x

Refractory period RV 250 ms 250 ms 300 ms x x x

Refractory period LV 200 ms 200 ms 200 ms x

Mode switching ON ON — x x

Onset criterion 5-out-of 8 5-out-of 8 — x x

Resolution criterion 5-out-of 8 5-out-of 8 — x x

Intervention rate 160 bpm 160 bpm — x x

Switches to DDIR DDIR — x x

The basic rate with mode

switching

+10 bpm +10 bpm — x x

Rate stabilization with

mode switching

OFF OFF — x x

PVARP AUTO (Start

250 ms)

225 ms) — x x

PVARP after PVC 400 ms Automati-

cally set

—xx

Capture control A ON ON OFF x x x

Capture control RV ON ON OFF x x

Capture control LV ON ON OFF x

Atrial overdrive pacing OFF OFF — x x

Vp suppression OFF OFF — x

IEGM recording (HAR) ON AT OFF x x x

IEGM recording (HVR) ON ON OFF x x x

Home Monitoring OFF OFF OFF x x x

Parameter Factory

setting Standard Safe

program SR DR HF

Parameters



Tolerances of Parameter Values

Parameter Range of values Tolerance

Basic rate 30 ... (5) ... 100 ... (10)

... 200 bpm

± 20 ms

Basic interval 1000 ms ± 20 ms

Magnet rate (magnet interval) 90 bpm (664 ms) ± 20 ms

Pulse amplitude 0.2 ... 7.5 V The greater value of ±50 mV

or +20/-25%

Pulse width 0.1 ... 1.5 ms ±10%

Sensitivity A

EN 45502-2-1 triangle pulse

0.1 ... 0.2 mV ±0,05 mV

0.3 ... 7.5 mV ±20%

Sensitivity RV/LV

EN 45502-2-1 triangle pulse

0.5 ... 7.5 mV ±20%

Refractory period 200 ... 500 ms ± 20 ms

Maximum activity rate 80 ... 180 bpm ± 20 ms

Lead impedance 100 ... 200 Ω ±50 Ω

201 ... 2500 Ω ±10%

Technical Data



Mechanical Characteristics

5 Technical Data

Technical Data5417803Technical ManualEdora 8

Note: D = housing without header

Mechanical Characteristics

Measurements for the housing

X-ray identification

All device types receive the BIOTRONIK logo for X-ray identification. It can be found

centrally between the circuitry and the battery.

Materials in contact with

body tissue

• Housing: Titanium

• Header: Epoxy, polysulfone; IS4 seal: Silastic

• Silicone plug: Silopren or silastic

Device W x H x D [mm] Volume [cm3] Mass [g]

Single-chamber SR(-T) 48 x 40 x 6.5 10 20.8

Dual-chamber DR(-T) 48 x 44 x 6.5 11 23.2

Triple-chamber HF-T 53 x 52 x 6.5 14 26.9

Triple-chamber 

HF-T QP

53 x 53 x 6.5 15 31.2

Technical Data



Electrical Characteristics

Components and input values

Electrical characteristics determined at 37°C, 500 Ω:

Electrically conductive surface

The device housing has the form of a flattened ellipsoid. The electrically conductive

area is for:

• Single and dual-chamber devices: 30 cm2

• Triple-chamber devices: 33 cm2

Telemetry data

• MICS frequency: 402 - 405 MHz

• Maximum power of transmission: < 25 µW (-16 dBm)

International radio

certification

Devices with BIOTRONIK Home Monitoring® are equipped with an antenna for

wireless communication.

• Telemetry information for Australia:



This product is in compliance with the Australian

"Radiocommuniations Act 1992" and therefore it is labelled according to 

the "Radiocommunications (Compliance Labelling - Devices) Notice."

• Telemetry information for Canada:

This device must neither interfere with meteorological and earth resources

technology satellites nor with meteorological stations working in the 400,150 to

406,000 MHZ band, and it must accept any interference received, including

interference that may cause undesired operation.

This device will be registered with Industry Canada under the following number:

IC: 4708A-PNP

The code IC in front of the certification/registration number only indicates that

the technical requirements for Industry Canada are met.

• Telemetry information for Japan:

In accordance with Japanese law, this device has been assigned an

identification number under the "Ordinance concerning certification of

conformity with technical regulations etc. of specified radio equipment",

Article 2-1-8.

R 202-LSE015

• Telemetry information for the USA:

Telemetry data for the USA: This transmitter is authorized by rule under the

Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and

must not cause harmful interference to stations operating in the 400.150-

406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers

used to communicate weather data), the Meteorological Satellite, or the Earth

Exploration Satellite Services and must accept interference that may be caused

by such stations, including interference that may cause undesired operation.

This transmitter shall be used only in accordance with the FCC Rules governing

the Medical Device Radiocommunication Service. Analog and digital voice

communications are prohibited. Although this transmitter has been approved by

the Federal Communications Commission, there is no guarantee that it will not

receive interference or that any particular transmission from this transmitter

will be free from interference.

This device will be registered with Federal Communications Commission under

the following number:

FCC ID: QRIPNP

Circuit technology Dycostrate

Input impedance > 10 kΩ

Pulse form Biphasic, asymmetric

Polarity Cathodic

Technical Data



Electrical Characteristics

Pulse form

The pacing pulse has the following form:

The pulse amplitude reaches its maximum

value at the beginning of the pulse (Ua). With

increasing pacing duration (tb), the pulse

amplitude is reduced dependent on the pacing

impedance.

Resistance to interference

All variants of BIOTRONIK devices comply with the requirements of 

EN 45502-2-1: 2003, § 27.5.1 at the highest sensitivity.

Technical Data



Battery Data

Battery characteristics

The following data is provided by the manufacturers:

Shortening of the service time

after long storage period

In case of implantation after an average storage period – about 1 year before the

end of the use by date – the average service time decreases by about 1%.

Power consumption

• BOS, inhibited: SR(-T), DR(-T) 6 µA; HF-T (QP) 7 µA

• BOS, 100% pacing: SR(-T) 8 µA; DR(-T) 11 µA; HF-T (QP) 14 µA

Calculation of service times

Mean service times pre-estimated from the following and other data:

• Storage for 6 months

• Technical data of the battery manufacturer

• Basic rate of 60 bpm in AAIR/VVIR modes (single-chamber devices) or 

DDDR modes (dual-chamber and triple-chamber devices)

•Home Monitoring configuration: OFF

• No wandless telemetry

• Configuration of different pulse amplitudes and lead impedances

Mean service times SR

For single-chamber devices the following times result when set to AAIR or VVIR,

with a basic rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω:

Mean service times DR

For dual-chamber devices the following times result when set to DDDR with a basic

rate of 60 bpm and a pulse width of 0.4 ms at an impedance of 500 Ω:

Manufacturer Wilson GREATBATCH,

INC. Clarence, NY 14031 LITRONIK GmbH,

01796 Pirna, Germany

Battery type GB 3193 LiS 2650MK LiS 3150MK

System QMR LiMn02LiMn02

Device type SR; DR HF; HF QP

Battery voltage at BOS 3.3 V 3.1 V 3.1 V

Open-circuit voltage 3.3 V 3.1 V 3.1 V

Nominal capacity 1010 mAh 950 mAh 1200 mAh

Usable capacity until EOS 971 mAh 880 mAh 1066 Ah

Remaining capacity at ERI 39 mAh 70 mAh 134 mAh

Amplitude Pacing Average service time

2.5 V 100% 13 years

50% 14 years, 9 months

3.0 V 100% 11 years, 3 months

50% 13 years, 7 months

5.0 V 100% 5 years, 6 months

Amplitude Pacing Average service time

A: 2.5 V

RV: 2.5 V

100% 9 years, 4 months

50% 11 years, 4 months

A: 3.0 V

RV: 3.0 V

100% 7 years, 8 months

50% 10 years

A: 5.0 V

RV: 5.0 V

100% 3 years, 2 months

Technical Data



Battery Data

Mean service times HF

For triple-chamber devices the following times result when set to DDDR with a

basic rate of 60 bpm, 100% biventricular pacing and a pulse width of 0.4 ms at an

impedance of 500 Ω:

Amplitude Pacing Average service time

A: 2.5 V 10% 9 years, 8 months

RV: 2.5 V

LV: 2.5 V

100%

A: 3.0 V 10 % 8 years

RV: 3.0 V

LV: 3.0 V

100%

A: 5.0 V

RV: 5.0 V

LV: 5.0 V

100% 2 years, 6 months

Technical Data



Legend for the Label

The label icons symbolize the following:

Manufacturing date Use by

Storage temperature Order number

Serial number Product identification

number

CE mark

Contents Follow the instructions for

use

Sterilized with ethylene oxide

Do not resterilize Single use only. 

Do not re-use!

Do not use if packaging is

damaged

Non-sterile

Transmitter with non-ionizing radiation

at designated frequency

Label icon on devices with ProMRI®:MR conditional: Patients having a device

system implanted whose components

are labeled with this symbol on the

packaging can be examined using an MR

scan under precisely defined conditions.

TP2 Compabiltiy with telemetry protocol version 2

of BIOTRONIK Home Monitoring

Example

Uncoated device: NBG code and

compatible leads

Screwdriver

Examples of the connector allocation: IS-1, IS-1/IS4

NON

STERILE

BIOTRONIK SE and KG PNP Medical Implant Pacemaker User Manual eIFU en 417803 B Edora ProMRI 2016 03 23

BIOTRONIK SE & Co. KG Medical Implant Pacemaker eIFU en 417803 B Edora ProMRI 2016 03 23

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