BIOTRONIK SE and KG BM2 Users Manual

BioMonitor 2

Implantable cardiac monitor with Home Monitoring
Implantierbarer Herzmonitor mit Home Monitoring
Monitor cardiaco implantable con Home Monitoring
Moniteur cardiaque implantable avec Téléc@rdiologie

Technical manual

Gebrauchsanweisung

Manual técnico

Manuel t

echnique

• en

•

de

• es

• fr

( )

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

14-D-xx

Revision:  (2014-09-05)

© BIOTRONIK SE & Co. KG
All rights reserved. Specifications subject
to modification, revision and improvement.

® BIOTRONIK Home Monitoring and
ProMRI are registered trademarks
of BIOTRONIK SE & Co. KG

0123
0681 2015

1

BioMonitor 2

Implantable cardiac monitor with
Home Monitoring

Technical manual for the device

GA-HW_en_-[[_BioMonitor 2_(ProMRI)

I ndex G A-HW_en--mul_378622-E_BioMonitor- ProMRITechnical manual for thedev iceB ioMonitor

Table of Contents

Table of Contents

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Arrhythmia Detection Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Home Monitoring Parameter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Battery Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Legend for the Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2

1 Product Description

Product Description1GA-HW_en--mul_378622-E_BioMonitor-ProMRITechn ical manual for the deviceBioMonitor

Intended Medical Use

Intended use

BioMonitor 2 is the name of an implantable cardiac monitor for the monitoring of heart
rhythm.
Its primary purpose is to provide early detection and diagnostics of symptoms of
arrhythmias, such as atrial fibrillation and the causes of syncope, which can be mani­fested clinically.

Form of diagnosis

The heart rhythm is continuously monitored; the possible detection types are atrial
fibrillation, high ventricular rate, asystole, or bradycardia. Depending on the preset
parameters, subcutaneous ECGs and other data are recorded.
The patient can also initiate a recording of a subcutaneous ECG.

BIOTRONIK Home Monitoring® enables physicians to perform a multi-year diagnosis
management at any time.

Required expertise

In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation of the implantable cardiac monitor and the specified conditions for
its use. Only qualified medical specialists having the special knowledge are permitted
to implant the BioMonitor 2 and make diagnoses.

Guidelines of cardiological societies

It is recommended that the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC
(European Society of Cardiology) are observed. 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.

Indications

•

Clinical symptoms or increased risk of cardiac arrhythmias

•

Temporary symptoms that may indicate cardiac arrhythmia

Contraindications

There are no known contraindications.
However, the particular patient's state of health determines whether a subcutaneous
device will be tolerated long-term.

System Overview

Device family

BioMonitor 2 is a cardiac monitor.The device family consists of BioMonitor 2-AF and
BioMonitor 2-S. Not all device types are available in ecvery country.

Parts

The system consists of the following parts:

•

Device with electrode integrated in the header and insertion tool

•

Programmer

•

Current software version for the implanted device

•

Remote Assistant for the patient

Cardiac monitor

These devices have a retrospective loop memory, which continuously records the last

minutes of a patient's electrocardiograms. They include a patient-activation function,
which allows the patient to activate ECG storage (with the help of a patient device) as a
result of a symptomatic episode, and an auto-detection function that allows capture of
events without relying on patient compliance or perception of symptoms
The device's housing is made of biocompatible titanium, welded from the outside and
therefore hermetically sealed. It is coated in silicone or parylene. The shape facilitates
ingrowth into the pectoral muscle area.
The cardiac monitor's sensing principle is based on one vector.
The device labeling provides information about the BioMonitor 2.

Note:

BioMonitor 2 does not have a pacing function.

3

Programmer

Implantation and follow-up are performed with a portable BIOTRONIK programmer.
During the implantation, the current device program is transferred to the device on
initial interrogation via the programmer. In addition, the programmer is used to set
parameter combinations, as well as for interrogation and device data storage. Subcuta­neous ECG, markers, and functions are displayed simultaneously on the color display.

Telemetry

Telemetric communication between the device and the programmer can be carried out
by applying a programming head (PGH).

BIOTRONIK Home Monitoring

®

The BIOTRONIK cardiac monitor provides a complete diagnosis management system:

•

With Home Monitoring, diagnostic information as well as technical data of the
device are automatically and wirelessly 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 heart or in the device are
forwarded at the set time.

•

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

BioMonitor 2 order numbers

Not all device types are available in all countries:

Package contents

The storage package includes the following:

•

Sterile packaging with device

•

Serial number label

•

Patient ID card

•

Technical manual for the device

The sterile packaging includes the following:

•

Device

Note:

It is not permitted to use the device's ECG display for diagnostic purposes
because it does not meet all requirements of the standard (IEC 60601-2-25)
concerning diagnostic ECG devices.

Device Coating Order number

BioMonitor 2-S Silicone 398494
BioMonitor 2-S Parylene 403227
BioMonitor 2-AF Silicone 398493
BioMonitor 2-AF Parylene 403226