BIOTRONIK SE and KG BM2610 Implantable Cardiac Monitor User Manual P BL 0001136

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Date Submitted	2018-12-21 00:00:00
Date Available	2018-12-21 00:00:00
Creation Date	2018-11-08 12:41:35
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Document Author:	BIOTRONIK SE & Co. KG // Woermannkehre 1 // D-12359 Berlin // Germany

BIOMONITOR III
ProMRI
Cardiac Monitor | premounted in the Fast Insert Tool OneStep |
BIOTRONIK Home Monitoring
Technical Manual
Revision: Axx (2018-11-08)
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification, revision and improvement.
® All product names in use may be trademarks or registered trademarks held by
BIOTRONIK or the respective owner.
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
Index 439151Technical ManualBIOMONITOR III
2
Table of Contents
Table of Contents
Table of Contents
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Medical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
General Information on Safe Handling of the Device. . . . . . . . 8
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Insertion Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Precautionary measures while programming . . . . . . . . . . . . 20
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Patient information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Replacement indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . 24
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Saving and Transmitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
3
Product Description
Intended Medical Use
Product Description
Product Description1439151Technical ManualBIOMONITOR III
Intended Medical Use
Intended use
BIOMONITOR III is the product name of an implantable cardiac monitor for monitoring and automatically recording heart rhythms. The primary purpose is to
provide early detection and diagnostics in the following clinical scenarios:
• Patients with clinical syndromes, which lead to an increased risk of cardiac
rhythm disturbances
• Patients with temporary clinical symptoms, including dizziness, palpitations,
syncope, or chest pain, which may be the result of a cardiac rhythm disturbance
Note: The cardiac monitor does not have any therapeutic function.
BIOMONITOR III is housed in the front part of the FIT OneStep insertion tool
(Fast Insert Tool). The insertion tool is used for forming the device pocket and for
subsequent positioning of the cardiac monitor in the subcutaneous left pectoral
area. The use of this tool ensures an optimal anatomical implantation site, which is
a requirement for recording meaningful subcutaneous ECGs.
Form of diagnosis
The heart rhythm is continuously and automatically recorded and monitored. The
following are possible detection types:
• Atrial tachycardia
• High ventricular rate
• Asystole
• Bradycardia
• Sudden rate drop
Depending on the preset parameters, subcutaneous ECGs, and other data may be
recorded.
The patient can also trigger the recording of subcutaneous ECGs using the
Remote Assistant III accessory if subjectively symptomatic episodes occur.
The recordings can be transmitted to the BIOTRONIK Home Monitoring
Service Center. This enables physicians to perform complete diagnosis management.
Guidelines of
cardiological societies
It is recommended that the indications published by the DGK (German Cardiac
Society) and the ESC (European Society of Cardiology) are observed. This also
applies to the guidelines published by the HRS (Heart Rhythm Society), the ACC
(American College of Cardiology), the AHA (American Heart Association), and other
national cardiology associations.
4
Indications
Product Description
Intended Medical Use
Generally approved differential diagnostic methods, as well as the indications and
recommendations for the medical use of implantable cardiac monitors apply to
BIOMONITOR III.
The cardiac monitor BIOMONITOR III is an implantable monitoring system that
records subcutaneous ECGs. Recording is activated both automatically and by the
patient. Their use is indicated for the following cases:
• Clinical syndromes or increased risk of cardiac arrhythmias
• Temporary, unexplained symptoms that may indicate cardiac arrhythmia
• Evaluation of palpitations of unclear etiology
• Recurrent syncope of unclear etiology
• Confirmation or monitoring of atrial fibrillation
• Clarification of a cryptogenic cerebrovascular stroke
Contraindications
There are no known contraindications.
However, the particular patient's state of health determines whether a subcutaneous device will be tolerated long-term.
5
Product Description
System Overview
System Overview
Device
BIOMONITOR III
This device is not available in all countries.
Parts
The system consists of the following parts:
• Device with flexible lead body; the device is inside the FIT OneStep insertion tool
• Incision tool
• Programmer and current software version for the device
• The Remote Assistant III accessory for triggering recordings by the patient
(optional)
Incision tool
•
The incision tool is used for making a surgical cut for the device pocket. The
blade is 13 mm wide and due to its design it can cut a maximum of 10 mm deep.
Insertion tool (with
premounted device)
•
The FIT OneStep insertion tool is used for controlled insertion and positioning of
the device. The device itself is sterile and located securely inside the tool, in the
blue tunneling tip in front of the white gripping sleeve; the whole device is not
visible from the outside, only the QR code of the device is visible through a small
window.
Cardiac monitor
The device itself is called BIOMONITOR III. It consists of a solid housing and a flexible lead body.
The device's housing is made of hermetically sealed biocompatible titanium coated
in silicone. At the rounded end of the housing there is an opening in the coating, so
that the metal housing forms the antipole to the lead tip.
The flexible lead body is made of silicone and it has a fractally coated electrode on
its tip. The lead’s conductor also serves as an antenna for Home Monitoring.
The device has an overall length of 7.75 cm, which is approximately identical to the
sensing vector and correlates linearly with the sensing amplitude.
6
Programmer
Product Description
System Overview
Implantation and follow-up are performed with a portable BIOTRONIK programmer
using the current PSW software version 1901.A or higher.
The standard program is activated in the device on initial programming via the
programmer. The programmer is used to set parameter combinations, as well as
for interrogation and saving of data from the device. Electrocardiogram, subcutaneous ECG, markers, and functions are displayed simultaneously on the color
display.
Note: The programmer's ECG display must not be used for diagnostics, because it
does not meet all the standard requirements for diagnostic ECG devices
(IEC 60601-2-25).
Telemetry
Telemetric communication between the device and the programmer can be carried
out by applying the programming head (PGH).
BIOTRONIK Home Monitoring®
The BIOTRONIK cardiac monitors provide a complete diagnosis management
system:
• With Home Monitoring, diagnostic information as well as device technical data
are automatically and wirelessly sent to a stationary or mobile transmitter via
an antenna in the lead body. The data is encrypted and sent from the transmitter
to the protected internet platform BIOTRONIK Home Monitoring Service Center
(HMSC) through a cellular phone network.
• The received data is deciphered and evaluated; the criteria for evaluation to be
used for each patient can be set individually and the time of notification via email or fax can be configured.
• A clear overview of the results of this evaluation is displayed on the HMSC.
• Data transmission from the device is performed at a preset time with a daily
device message.
• Device messages that indicate special events in the heart or in the device are
also forwarded at the preset time.
• A test message can be initiated at any time using the programmer to immediately check the Home Monitoring function.
• The recording of a subcutaneous ECG in the BIOMONITOR III device can be triggered by the patient using the external Remote Assistant III device.
BIOMONITOR III
order number
Package contents
This device is not available in all countries.
Device
Order number
BIOMONITOR III
436066
The storage package includes the following:
• Sterile packaging with device premounted in the insertion tool and with incision
tool
• Serial number label
• Patient ID card
• Quick reference guide for insertion of BIOMONITOR III
Note: The technical manual pertaining to the cardiac monitor is included in hard
copy form in the storage package and/or is available in digital form on the internet.
7
Product Description
Diagnostic Functions
Diagnostic Functions
General overview
•
Automatic functions facilitate quick and simple setting and control of the
BIOMONITOR III cardiac monitor.
Detection and data storage
•
The sensing parameters are combined into one program (SensingConsult) and
can be set individually for each patient:
— Standard
— Sense after large PVCs
— Sense small PVCs
— Sense short intervals
— T-wave suppression
The signals are automatically recorded and stored if a detection type is activated
and detection occurs.
Multiple detection types can be activated simultaneously.
The device can store episodes with subcutaneous ECGs with a minimum overall
length of 60 min.
A total of 55 individual episodes with a length of at least 40 s each can be stored
automatically. The maximum storage period for an individual episode is 60 s.
A total of 4 recordings triggered by the patient with a duration of at least 7.5 min
can be stored. The recording includes 7 min of pre-episode history and 0.5 min
of post-episode history relative to the time of triggering.
When performing in-office follow-ups using the programmer, the unfiltered
subcutaneous ECG is indicated with markers. The filtered subcutaneous ECG
can also be displayed if the corresponding settings have been made.
•
•
•
•
•
Diagnostics
Home Monitoring functions
The following functions are available:
• Longest AF episode
• AF burden
• AF details:
— AF trend
— AF time distribution
— AF duration
— Ventricular rate during AF
• Cardiac rhythm disturbances detections:
— Atrial fibrillation
— High ventricular rate
— Bradycardia
— Sudden rate drop
— Asystole
— Patient trigger
• Activity:
— Heart rate variability
— Patient activity
— Heart rate
• Sensing
— R-wave trend
— Noise duration trend
Important medical information includes the following:
• Sustained atrial arrhythmias
• Sustained ventricular arrhythmias
• Current statistics
• Periodically recorded subcutaneous ECGs that are transmitted according to an
individually adjustable timing interval in addition to the regular device message
This is a necessary condition for performing Home Monitoring-supported
follow-ups.
8
General Safety Instructions
General Information on Safe Handling of the Device
General Safety Instructions
General Safety Instructions2439151Technical ManualBIOMONITOR III
General Information on Safe Handling of the Device
Follow notes and instructions
CAUTION
Risk to patient, risk to doctor, and interferences of device
The operation of electronic devices close to the heart is subject to special conditions. From transport to storage, concerns about sterility and technical complications, requirements for special care or risky therapies, as well as instructions
regarding implantation and care for persons who have an implanted device must
all be adhered to: The device is sensitive and must not be damaged, in order not to
harm patients.
• It is always necessary that all information in this, as well as related technical
manuals, must be observed and followed.
Safety instructions and
warnings in this technical
manual
This technical manual provides safety-relevant information on several topics:
• On the one hand, there are general safety warnings, which are fundamentally
valid. In this technical manual, the main topics are as below:
— General information on the safe handling of the product
— Operating conditions
— Possible technical complications
— Possible medical complications
• On the other hand, there are special and general warnings regarding the insertion of the device that provide education and instructions for safely working with
and performing actions related to the device. In this technical manual, the main
topics are as below:
— Insertion Procedure
— Precautionary measures while programming
— Patient information
— Disposal
• Warnings have been particularly indicated in this technical manual
with
a symbol and a signal word: Non-compliance with the instructions
can cause injury to the patient.
9
Technical manuals
General Safety Instructions
General Information on Safe Handling of the Device
The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the Home Monitoring Service Center (HMSC)
— Technical manuals for the programmer and the Remote Assistant III
— Technical manuals for the user interface
• Technical manuals are either included in hard copy form in the product package
or are available in digital form on the internet:
https:\\manuals.biotronik.com
• Follow all relevant technical manuals.
• Keep technical manuals for later use.
Note: Observe the quick reference guide included in the package contents.
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operating conditions and functionality of an implantable cardiac monitor.
Only qualified medical specialists with specialized knowledge are permitted to
implant the BIOMONITOR III and make diagnoses.
10
General Safety Instructions
Operating conditions
Operating conditions
CAUTION
Risk to patient and interferences of device
The operation of electronic devices in the proximity of the heart is subject to
special operating conditions. If these are not fulfilled, the functionality of the device
may be impaired; if the functionality of the device is impaired, the patient may be at
risk.
• Please observe the following operating conditions.
Care during
shipping and storage
•
•
Devices must not be stored or transported close to magnets or sources of electromagnetic interference.
Note the effects of storage period and service time for the device. See Battery
Data.
Temperature
Extremely low and high temperatures affect the service time of the device's battery.
• Permitted for shipping and storage:
-10°C to +45°C (-40°F to 158°F)
Sterile delivery
The incision tool and the insertion tool as well as the device itself are delivered gassterilized (ethylene oxide). Sterility is guaranteed if the blister itself and the blister's
sealing paper have not been damaged.
Device sterile packaging
Incision tool and insertion tool with premounted device are packaged inside a single
sealed sterile blister pack.
Single use only
The incision tool and the insertion tool, as well as the device itself, are intended for
single use only.
• Do not use the incision tool or the insertion tool with premounted device if the
sterile packaging is damaged.
• Do not resterilize or reuse the incision tool or the insertion tool, or the device
itself.
11
General Safety Instructions
Possible Complications
Possible Complications
CAUTION
Risk to patient and interferences of device
Electronic devices close to the heart may be subject to special complications. They
must be considered, so that the functionality of the device is not impaired and as a
result may put the patient at risk.
• Please take all the following safety information carefully into account.
General information on
medical complications
Possible technical failures
Electromagnetic
interference (EMI)
Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices.
• Known complications are foreign body rejection phenomena, local tissue reactions, migration of the device, accumulation of fluid in the device pocket, transdermal erosions, as well as hemorrhage, and/or infections. Primary sources of
complication information include current scientific and technological knowledge.
Technical failure of a device system cannot be entirely ruled out. Possible causes
can include the following:
• Component failure of the device or an accessory
• Battery depletion
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.
• Under unfavorable conditions, especially during diagnostic and therapeutic
procedures, sources of interference may induce such a high level of energy into
the device that the data recording can be influenced or the device may be
damaged.
12
General Safety Instructions
Possible Risks
Possible Risks
CAUTION
Risk to patient and interferences of device
Electronic devices close to the heart may be subject to special risks. They must be
considered so that the functionality of the device is not impaired and, as a result,
put the patient at risk.
• Please take all the following safety information carefully into account.
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:
• Hyperbaric oxygen therapy
• Applied pressure significantly higher than normal atmospheric pressure,
maximum 1.5 bar
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,
which can place the patient at risk.
Harmful effects may occur, for example, during electrocautery, HF ablation,
HF surgery, shortwave therapy, or microwave therapy. For example, damaging
pressure levels may arise during lithotripsy. Excessive warming of body tissue near
the device may occur during therapeutic ultrasound. The effect on the device is not
always immediately apparent.
If risky procedures cannot be avoided, the following should be observed at all times:
• Electrically insulate the patient.
• Do not localize energy near the device.
• Monitor the patient during and after every intervention.
• After every procedure, verify normal device function.
During lithotripsy, the following also applies:
• Keep the focus of the lithotripter beam at least 2.5 cm away from the device.
For HF ablation or HF surgery, the following also applies:
• Avoid direct contact between the ablation catheter and the device.
• Position the grounding pad so that the current path does not pass through or
near the device; the current path must be at least 15 cm away from the device.
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. The sensing properties may change as a result.
• Position the adhesive electrode anterior-posterior or vertical to the direction of
the device, with its sensing vector and at least 10 cm away from the device.
13
Radiation therapy
General Safety Instructions
Possible Risks
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 nevertheless
to be used, 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 information in combination with
therapeutic ionizing radiation:
• Adhere to instructions for risky therapeutic and diagnostic procedures.
• Shield device against radiation.
• After applying radiation, repeatedly check the device for proper functioning.
Note: Please contact BIOTRONIK with questions during the risk/benefit analysis.
Magnetic resonance imaging
Magnetic resonance imaging (MRI) should only be performed under certain conditions. Damage or destruction of the device system by strong magnetic interaction or
damage to the patient by excessive warming of the body tissue in the area
surrounding the device system must be avoided.
BIOTRONIK devices with the "MR conditional" function display the identification
ProMRI. Magnetic resonance imaging (MRI) should only be performed while
following mandatory precautions to protect the device system and the patient.
• The ProMRI manual – MR conditional device systems – contains detailed information on safely conducting an MRI scan.
— Download the digital manual from the website:
https:\\manuals.biotronik.com
— Order the printed manual from BIOTRONIK.
• Does approval as "MR conditional" apply in your country or region? Request
current information from BIOTRONIK.
14
Handling
Insertion Procedure
Handling
Handling3439151Technical ManualBIOMONITOR III
Insertion Procedure
CAUTION
Risk to patient, risk to physician, and interference with the device
Manufacturing, planning, and insertion procedures require special measures.
• Please follow all procedures carefully.
Having parts ready
The following parts that correspond to the requirements of EC Directive 90/385/EEC
are required:
• Insertion tool with premounted device from BIOTRONIK
• Incision tool
• BIOTRONIK programmer and BIOTRONIK approved cables, if necessary
• Have spares of all sterile components available
Unpack the parts
CAUTION
Inadequate function due to defective device
If a device still in packaging is dropped on a hard surface during handling, electronic parts could be damaged.
• Use a replacement device.
• Return the damaged device to BIOTRONIK.
The incision tool and the insertion tool – including the premounted device – have
been individually packaged in sterile blister packs.
• Check the use by date.
• Open blister at the marked position. The tools must not come into contact with
persons who have not sterilized their hands or gloves or with non-sterile instruments!
• Remove the incision tool and the insertion tool from the package.
Note: The incision tool has a sharp blade; to avoid cuts, handle the tool with care.
15
Implantation site
Handling
Insertion Procedure
The cardiac monitor is inserted subcutaneously on the left side of the patient.
Note: There are 2 primary positions for device placement, between the 3rd and
6th costal arch, with consideration to the patient's anatomy and the body tissue's
texture.
For a high signal amplitude, it is important for the direction of the sensing vector to
be parallel to the heart's electrical axis as much as possible.
Position A: device pocket in the left parasternal region
Position B: device pocket at an angle of about 45° to the sternum, parallel to the
cardiac vector
Note: In exceptional cases, a position beneath the left breast can be selected.
•
While selecting a position, also take into consideration future diagnostics, e.g.,
mammography.
Note: The lead tip can be positioned upward or downward, considering patientspecific as well as cosmetic aspects: The subcutaneous electrocardiogram can
also be displayed reversed by appropriate programming.
Sequence of the procedure
Follow these steps to insert the cardiac monitor:
16
Make a skin fold and an
incision for the device pocket
Handling
Insertion Procedure
•
Make a skin fold across the direction of the incision and position the incision tool
diagonally.
•
Make an incision of the width and depth specified by the insertion tool tip; this
incision will determine the placement of the device pocket.
17
Position the insertion tool
and tunnel
Handling
Insertion Procedure
•
•
•
Hold the insertion tool firmly by the white gripping sleeve, with the thumb on the
front gripping tab and the other fingers in the gripping tab on the opposite side.
Place the blue tunneling tip on the incision and push forward into the subcutaneous tissue layer to form the device pocket.
Push the blue tunneling part subcutaneously, parallel to the surface of the
chest, in to the incision up to the small, semi-cylindrical curvature just before
the handle. The device pocket is now created, and the device is already in the
correct position.
18
Release the insertion tool
Handling
Insertion Procedure
•
Hold the white gripping sleeve of the insertion tool firmly with one hand, and
with the other hand turn the blue knob to release.
•
The symbols on the gripping sleeve indicate in which direction to turn so that the
premounted device inside can be released.
19
Pull back the insertion tool
and lift to remove it
Handling
Insertion Procedure
•
While holding the white gripping sleeve in position, pull the blue rotary knob (in
the released condition) outwards. The device is in the intended position when the
blue inner part of the insertion tool is completely pulled back.
•
Pull the tip of the tool remaining in the body out of the incision.
End the procedure
•
•
If necessary, check the signals using the programmer.
Close the device pocket.
Applying the
programming head
Apply the programming head (PGH) and turn to align if necessary to ensure correct
telemetry.
• Make sure the PGH is positioned correctly.
Establishing telemetry contact
•
The device requires some time for interrogation once the programming head is
applied.
Activate diagnostics
•
Confirm the standard program is loaded on the programmer.
20
Handling
Precautionary measures while programming
Precautionary measures while programming
CAUTION
Risk to patient
The programming of devices requires special precautionary measures.
• Please perform the following precautionary measures carefully.
Note when adjusting
bigeminy rejection
For sensitive AF detection, Bigeminy rejection is preset to Standard.
If bigeminy rejection is set to Aggressive, the sensitivity of the AF detection may be
slightly reduced, depending on the patient.
• Adjust the setting for this parameter based on the current patient data.
21
Handling
Follow-up
Follow-up
Follow-up intervals
Follow-ups can be performed at regular, agreed-upon intervals.
• Following the ingrowth phase, approximately 3 months after insertion, the first
follow-up should be carried out by the physician using the programmer (inoffice 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 is not intended to replace regular
in-office appointments with the physician required for other medical reasons.
Home Monitoring-supported follow-up 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, is sufficient. If not, an in-office follow-up must be performed.
Possible early detection due to information gained via Home Monitoring may necessitate an additional in-office follow-up. For example, the data may provide early
indication of a foreseeable end of service (EOS). Furthermore, the data could
provide indications of previously unrecognized arrhythmias.
Follow-up with the
programmer
Use the following procedure for in-office follow-up:
Record and evaluate the ECG if necessary.
Interrogate the device.
Check the sensing function.
Evaluate status and, if necessary, statistics and subcutaneous ECGs.
If necessary, customize the program functions and parameters and transmit
the edited program to the device.
Print and document follow-up data (print report).
Finish the follow-up for this patient.
22
Handling
Patient information
Patient information
Note: The education of patients requires special information. Please share all of
the following information carefully.
Patient ID card
Prohibitive signs
A patient ID card is included in package contents.
• Provide the patient with the patient ID card.
• Request that patients contact the physician in case of uncertainties.
Premises with prohibitive signs must be avoided.
•Educate the patient regarding prohibitive signs.
Possible sources of
interference
Electromagnetic interference should be avoided in daily activities. Sources of interference should not be brought into close proximity with the device.
• Educate the patient on sources of electromagnetic interference which include
special household appliances, safety locks/anti-theft alarm systems, cell
phones, and transmitters.
• Request patients to heed the following:
— Use cell phones on the side of the body that is opposite of the device.
— Keep the cell phone at least 15 cm away from the device both during use and
during storage.
Recording via
Remote Assistant
If needed, patients can also manually trigger the recording of a subcutaneous ECG
in the BIOMONITOR III device using the Remote Assistant III accessory. Patient
information includes:
• Making sure the patient understands how to handle the Remote Assistant III by
means of the technical manual.
• When should the Remote Assistant III be used?
In case of symptoms such as severe dizziness, indisposition, or palpitations, as
well as after fainting.
• How is a recording triggered?
The technical manual for the Remote Assistant III describes the handling of the
small device and explains the meaning of the LED signals.
• What happens when a recording is triggered?
The subcutaneous ECG of the last 7.5 min is stored. This includes 7 min of preepisode history and 0.5 min of post-episode history relative to the time of
triggering. Between 40 s and 60 s are transmitted at the daily transmission time
via Home Monitoring.
• What has to happen after triggering a recording?
The patient should contact the physician.
23
Handling
Replacement indications
Replacement indications
Possible battery levels
Elective replacement
indication (ERI)
•
•
•
BOS: Beginning of Service
ERI: Elective Replacement Indication
EOS: End of Service
ERI is displayed on the programmer during the follow-up and transmitted via
Home Monitoring.
Upon reaching ERI, recording of statistics and episodes is stopped.
Once ERI has been reached, the remaining life of the device is at least 2 months
until EOS is reached.
Home Monitoring is still available for at least 2 weeks after reaching ERI. After this
period, the device stops transmitting messages to the Home Monitoring
Service Center.
EOS replacement indication
The end of service has been reached.
24
Handling
Explantation and Device Replacement
Explantation and Device Replacement
CAUTION
Risk to patient, environmental hazard
Explanations and device replacements require special measures.
• Please follow all procedures carefully.
Explantation
Device replacement
Cremation
Disposal of the device
Disposal of the tools
•
•
•
Interrogate the device status.
Remove the device using state-of-the-art methodology.
Explanted devices are biologically contaminated and must be disposed of safely
due to risk of infection.
Basic principles:
• The device must not be resterilized or reused.
Devices should not be cremated.
• Explant the device before the cremation of a deceased patient.
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 off with water.
• Send the cleaned explant to BIOTRONIK.
Incision tool and insertion tool:
• Used accessories must be disposed of as medical waste in an environmentally
friendly and proper manner.
25
Parameters
Detection
Parameters
Parameters4439151Technical ManualBIOMONITOR III
Detection
Atrial fibrillation
The following can be set:
Parameter
Range of values
Standard
Atrial fibrillation (AF)
ON; OFF
ON
AF sensitivity
Low; Medium; High
In case of change of the AF
expert parameters: individual
Medium
RR variability limit
6; 9; 12; 15; 18 %
12 %
Confirmation time
1 ... (1) ... 6; 10; 20; 30 min
6 min
Bigeminy rejection
OFF; Standard; Aggressive
Standard
Additional AF expert parameters can be set individually:
Parameter
Range of values
Standard
Size of detection/termination
window
8/16; 16/24; 24/32 cycles
8/16 cycles
(medium)
Detection intervals
5 ... (2) ... 23 cycles
5 cycles
(medium)
Number of detection windows
1 ... (1) ... 4
2 (medium)
Termination intervals
1 ... (2) ... 7 cycles
1 cycle (medium)
Number of termination
windows
1 ... (1) ... 4
2 (medium)
The AF parameters are preset as follows:
High ventricular rate (HVR)
Bradycardia
Parameter
Low
Medium
High
RR variability limit
12 %
12 %
12 %
Size of detection/termination
window
16/24 cycles
8/16 cycles
8/16 cycles
Detection intervals
11 cycles
5 cycles
5 cycles
Termination intervals
5 cycles
1 cycle
1 cycle
Number of detection windows
Number of termination
windows
The following can be set:
Parameter
Range of values
Standard
High ventricular rate
ON; OFF
ON
HVR limit
100 ... (10) ... 200 bpm
180 bpm
HVR counter
8 ... (4) ... 24; 32; 48 cycles
16 cycles
Range of values
Standard
The following can be set:
Parameter
Bradycardia
ON; OFF
ON
Brady zone limit
30 ... (5) ... 80 bpm
40 bpm
Brady duration
5 ... (5) ... 30 s
10 s
26
Sudden rate drop
Parameters
Detection
The following can be set:
Parameter
Range of values
Standard
Sudden rate drop (SRD)
ON; OFF
OFF
SRD rate decrease
20 ... (10) ... 70 %
50
SRD sensitivity
Low; Medium; High
In case of change of the SRD
expert parameters: individual
Medium
Additional SRD expert parameters can be set:
Parameter
Range of values
Standard
Baseline intervals
48; 64; 128; 256 cycles
64 cycles
(medium)
Rate-drop intervals
8; 16; 32 cycles
16 cycles
(medium)
The SRD expert parameters are preset as follows:
Parameter
Asystole duration
Patient trigger
Indication-dependent
detection settings
ProgramConsult
Low
Medium
High
Baseline intervals
256 cycles
64 cycles
48 cycles
Rate-drop intervals
32 cycles
16 cycles
8 cycles
The following can be set:
Parameter
Range of values
Standard
Asystole
ON; OFF
ON
Asystole duration
2 ... (1) ... 10 s
3s
Parameter
Range of values
Standard
Patient trigger
ON; OFF
ON
The following can be set:
For each indication, there is a compilation of preset detection parameters
(ProgramConsult):
Parameter
Range of values Syncope
(standard)
Palpitations
AF monitoring
Cryptogenic
cerebrovascular
stroke
Atrial fibrillation ON; OFF
ON
ON
ON
ON
Sensitivity
Low
Medium
Medium
High
Low; Medium;
High
RR variability
6; 8; 12; 15; 18% 12 %
12 %
12 %
12 %
Confirmation
time
1; 2; 3; 4; 5; 6; 10; 10 min
20; 30 min
6 min
6 min
1 min
Bigeminy
rejection
OFF; Standard;
Aggressive
Aggressive
Aggressive
Standard
Standard
ON
ON
ON
ON
High ventricular ON; OFF
rate
Limit
100 ... (10) ... 180; 160 bpm
190; 200 bpm
180 bpm
180 bpm
180 bpm
Counters
8; 12; 16; 20; 24; 16
32; 48
32
48
48
Bradycardia
ON; OFF
ON
ON
ON
Zone
30; 35; 40 ... (5) ... 35
80 bpm
30
30
30
Duration
5; 10 ... (5) ... 30 s 20
30
30
30
ON
27
Parameters
Detection
Parameter
Resting rate period
Range of values Syncope
(standard)
ON
Palpitations
AF monitoring
Cryptogenic
cerebrovascular
stroke
Asystole
ON; OFF
ON
ON
ON
Duration
2; 3 ... (1) ... 10 s 3
Sudden rate
drop
ON; OFF
ON
OFF
OFF
OFF
Rate decrease
20 ... (10) ... 50;
60; 70%
50
—
—
—
Sensitivity
Low; Medium;
High
Low
—
—
—
All statistics-based settings are as follows:
Parameter
Range of values
Standard
Start resting period
00:00 ... (1:00 AM) ... 11:00
PM hh:mm
2:00 AM hh:mm
Duration of resting period
1 ... (1) ... 12 h
4h
28
Parameters
Sensing
Sensing
The following can be set:
Parameter
Range of values
Standard
SensingConsult
Standard
Sense after large PVCs
Sense small PVCs
Sense short intervals
T-wave suppression
Standard
Sensing filter
4.5; 10; 18; 24
10 Hz
(SECG) Display
Normal; Inverted
Normal
(SECG) Signal filter
0.05; 0.5 Hz
0.5 Hz
29
Parameters
Home Monitoring
Home Monitoring
General settings
The following settings apply to all detection types:
Parameter
Range of values
Standard
Home Monitoring
ON; OFF
ON
Time of transmission
STD;
00:00 ... (12:30 AM) ... 11:30
PM hh:mm
STD
Note: Selection and cycle length of periodic subcutaneous ECGs are set in the
Home Monitoring Service Center (HMSC).
HM episode trigger
Episode triggers for Home Monitoring can be set for all automatic detection types:
Detection type
Range of values
Standard
Atrial fibrillation (AF)
ON; OFF; Detection ON
only
High ventricular rate (HVR)
ON; OFF
ON
Bradycardia
ON; OFF
ON
Sudden rate drop (SRD)
ON; OFF
OFF
Asystole
ON; OFF
ON
Patient trigger
ON; OFF
ON
30
Parameters
Saving and Transmitting
Saving and Transmitting
When detection is set, it can also be decided, for all automatic detection types, as
well as for the patient trigger, whether the subcutaneous ECG should be saved, and
whether it should be transmitted to the Home Monitoring Service Center (HMSC).
Detection type
Detection
Saving
Sending to
HMSC
Atrial fibrillation (AF)
ON; OFF
ON; OFF
ON; OFF;
Detection only
High ventricular rate (HVR) ON; OFF
ON; OFF
ON; OFF
Bradycardia
ON; OFF
ON; OFF
ON; OFF
Sudden rate drop (SRD)
ON; OFF
ON; OFF
ON; OFF
Asystole
ON; OFF
ON; OFF
ON; OFF
Patient trigger
ON; OFF
ON; OFF
ON; OFF
Note: When detection type AF, HVR, or Bradycardia is set, the oldest, the most
recent, and the longest episodes are saved.
When detection type Asystole or SRD is set, the oldest and the two most recent
episodes are saved.
When Patient trigger is set, the 4 most recent episodes are saved.
31
Technical Data
Mechanical Characteristics
Technical Data
Technical Data5439151Technical ManualBIOMONITOR III
Mechanical Characteristics
Dimensions
L x Diameter [mm]
Incision tool
130 x 13
Insertion tool
200 x 24
L x H x D [mm]
Volume [cm3]
Mass [g]
BIOMONITOR III device
including antenna
77.5 x 8.6 x 4.6
1.9
Housing without antenna
47.5 x 8.3 x 4.3
1.7
—
X-ray identification
Materials in contact with body
tissue
•
•
•
•
•
•
•
Housing: titanium, electrode surface fractally coated with iridium
Lead body: silicone
Lead tip: titanium, fractally coated with iridium
Insulation of the housing: silicone
Additional components (adhesive): silicone
Incision tool: plastic (POM) and stainless steel
Insertion tool: plastic (POM)
32
Technical Data
Electrical Characteristics
Electrical Characteristics
Components and input values
Housing shape
Electrically conductive
surfaces
Telemetry
International
radio certification
Electrical characteristics determined at 37°C, 500 Ω
Circuit
Hybrid electronics with VLSI-CMOS chip
Input impedance
> 100 kΩ
The device housing has an elongated, flattened shape, connected to a narrow, flexible lead body.
There is an electrically conductive surface on the housing as well as on the lead
body:
Area of the electrically conductive
housing surface
Area of the electrically conductive lead
tip
25 ± 5 mm2
25 ± 5 mm2
Telemetry data for Home Monitoring:
MICS frequencies
Maximum power of transmission
402 – 405 MHz
< 25 µW
-16 dBm
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 "Radiocommunications Act 1992" and therefore it is labeled according to the "Radiocommunications (Compliance Labeling - 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-BM2610
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.
• Telemetry information for the USA:
This transmitter is authorized 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 to 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: QRI-BM2610
33
Technical Data
Battery Data
Battery Data
Battery characteristics
Average service time
The following data is provided by the manufacturers:
Manufacturer
LITRONIK GmbH 01796 Pirna, Germany
Battery type
LiS 2044 / LiS 2044k
System
Li-MDX / Li-CFx
Device type
BIOMONITOR III
Battery voltage at BOS
3.1 V / 3.0 V
Open-circuit voltage
3.2 V/ 3.1 V
Based on the technical specifications of the battery manufacturer and the devicespecific detection parameters, the average service time (until reaching ERI) of
BIOMONITOR III is 48 months.
This calculation is based on:
• Sensing at 60 bpm
• 6-month storage period
• Daily device message via Home Monitoring, including recorded subcutaneous
ECGs:
1 automatic subcutaneous ECG per day
plus up to 2 subcutaneous ECGs per month, triggered by the patient
Storage period
Shortening of the service time
after long storage period
The storage period affects the battery service time.
• Devices should be implanted within 19 months between the manufacturing date
and the use by date (indicated on the package).
Depending on the storage period, the service time from the beginning of service
(BOS) to the replacement time ERI decreases as follows:
• After 1 year by 3 months
• After 1.5 years by 6 months
34
Technical Data
Legend for the Label
Legend for the Label
Meaning of the symbols
The label icons symbolize the following:
Manufacturing date
Use by
Storage temperature
Order number
Serial number
Product identification
number
CE mark
Lot number
Contents
Follow the instructions for
use!
manuals.biotronik.com
Follow the electronically available
instructions for use!
Manufacturer
Distributor in the USA
Caution: Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
Sterilized with
ethylene oxide
Single sterile blister
Do not resterilize
Do not use if packaging is
damaged
Single use only. Do not reuse!
Non-sterile
NON
STERILE
Transmitter with non-ionizing radiation at designated frequency
TP2
Compatibility with telemetry protocol version 2 of
BIOTRONIK Home Monitoring
Cardiac monitor, device
Incision tool
Risk of injury
35
Technical Data
Legend for the Label
Insertion tool
Device, premounted in the insertion tool,
plus incision tool

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