BIOTRONIK BIOMONITOR IV User manual

BIOMONITOR IV
Technical Manual

© 2023 BIOTRONIK, Inc., All rights reserved.
CAUTION
Federal (U.S.A.) law restricts this device to sale
by, or on the order of, a physician (or properly
licensed practitioner).
BIOMONITOR IV
Injectable Cardiac Monitor
Radiopaque Identification
A radiopaque identification code is visible on standard X-ray, and identifies the injectable cardiac
monitor:
BIOMONITOR IV
Technical Manual
BIOMONITOR IV

BIOMONITOR IV Technical Manual
Contents
Chapter 1: Device Description 1
Chapter 2: Indications 3
Chapter 3: Contraindications 5
Chapter 4: Warnings and Precautions 7
4.1 MR SAFETY INFORMATION 7
4.1.1 Patient Pre-MR Conditions 8
4.1.2 MR Scanner Limitations 8
4.1.3 Restrictions during the MR Scan 8
4.2 Implanted Pacemakers and Defibrillators 9
4.3 Medical Therapy 9
4.4 Storage and Handling 10
4.5 Electromagnetic Interference (EMI) 10
4.5.1 Home and Occupational Environments 11
4.5.2 Cellular Phones 11
4.5.3 Hospital and Medical Environments 12
4.6 Home Monitoring 12
4.7 Insertable Cardiac Monitor Explant and Disposal 13
Chapter 5: Programmable Parameters 15
5.1 Parameters 15
5.1.1 ProgramConsult 16
5.1.2 Atrial Fibrillation (AF) 18
5.1.3 Tachycardia 23
5.1.4 Bradycardia 24
5.1.5 Sudden Rate Drop (SRD) 25
5.1.6 Pause Duration 26
5.1.7 Symptom 27
5.1.8 Resting Rate Period 27

BIOMONITOR IV Technical Manual
5.2 Home Monitoring (HM) 28
5.2.1 HM PID 28
5.2.2 Home Monitoring 28
5.2.3 Time of Transmission 28
5.2.4 Periodic Subcutaneous Electrocardiogram (sECG) 28
5.2.5 Daily Presenting Electrocardiogram (sECG) 29
5.2.6 Last Message 29
5.2.7 Episode Recording/Transmission 29
5.3 Sensing Settings 31
5.3.1 SensingConsult 32
5.3.2 Sensing High-Pass Filter 33
5.3.3 Input Signal Polarity 33
5.3.4 Input High-Pass Filter 34
5.4 Patient Data 34
5.4.1 ID 34
5.4.2 First / Last Name 34
5.4.3 Date of Birth 34
5.4.4 Gender 35
5.4.5 Date of Implant 35
5.4.6 Hospital, City 35
5.4.7 Physician 35
5.4.8 NYHA 35
5.4.9 Symptom 36
5.4.10 Etiology 36
5.4.11 Remark 36
Chapter 6: Diagnostics 37
6.1 Diagnostics Overview 37
6.2 General Statistical Information 37
6.3 Activity 37
6.3.1 Rate Trends 38
6.3.2 Rate Histogram 38
6.3.3 Activity Trend 39
6.4 AF Details 39
6.4.1 AF Trends 39
6.4.2 AF Time of Occurrence 40
6.4.3 AF Duration 40
6.4.4 Ventricular Rate During AF 41
6.4.5 Ectopy count 41

BIOMONITOR IV Technical Manual
6.5 Sensing 42
6.5.1 R-wave Trend 42
6.5.2 Noise Duration Trend 42
Chapter 7: Other Functions/Features 43
7.1 Home Monitoring 43
7.2 Transmission of Information to Home Monitoring 43
7.3 Types of Report Transmissions 44
7.4 Description of Transmitted Data 44
7.5 Evaluation of Episodes with SmartECG 45
7.6 Patient Data Memory 47
7.7 Position Indicator 48
Chapter 8: Product Storage and Handling 49
8.1 Sterilization and Storage 49
Chapter 9: Follow-up Procedures 51
9.1 General Considerations 51
9.2 Real-time sECG Display 51
9.3 Follow-up Page 51
9.4 Recordings 52
9.5 sECG 53
9.5.1 Atrial Fibrillation 53
9.5.2 Tachycardia 54
9.5.3 Bradycardia 54
9.5.4 Pause 55
9.5.5 Symptom 55
Chapter 10: Elective Replacement Indication (ERI) 57
Chapter 11: Insertion/Removal 59
11.1 Opening the Sterile Container 59
11.2 Insertion 59
11.3 Removal 62

BIOMONITOR IV Technical Manual
Chapter 12: Remote Assistant III 63
12.1 General Information on the Remote Assistant III 63
12.2 Remote Assistant III Functional Testing 63
12.3 Getting to Know the Remote Assistant III 63
12.4 Triggering a Manual Recording 64
12.5 Battery LED Indicator Explained 65
12.6 Signal Transmission LED Explained 65
Chapter 13: Technical Data 67
13.1 Parameters 67
13.1.1 Atrial Fibrillation 67
13.1.2 Tachycardia 67
13.1.3 Bradycardia 67
13.1.4 Sudden Rate Drop (SRD) 68
13.1.5 Pause Duration 68
13.1.6 Symptom 68
13.1.7 Resting Rate Period 68
13.1.8 Home Monitoring 69
13.2 Materials in Contact with Human Tissue 69
13.3 Electrical Data/Battery 69
13.4 Mechanical Data 69
Chapter 14: Order Information 71

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Chapter 1
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Chapter 1: Device Description
BIOMONITOR IV is a programmable, subcutaneous injectable cardiac monitor able to record
subcutaneous ECGs (sECGs) and other physiological parameters.
The BIOMONITOR IV is designed to automatically record the occurrence of arrhythmias in a
patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, pause, sudden
rate drop, or tachycardia. In addition, the BIOMONITOR IV can be activated by the patient to record
cardiac rhythm during symptomatic episodes.
Note - The BIOMONITOR IV subcutaneous ECG may differ from a surface ECG due to differences
in electrode separation and device placement in the body.
BIOMONITOR IV detects a subcutaneous ECG from a pair of electrodes. These signals are filtered
in two different ways. For detection of QRS complexes, the signals are filtered with a passband
of 10-40 Hz in order to suppress T-waves, artifacts, and baseline drift at low frequencies, and
myopotentials and EMI at high frequencies. The resulting signal is appropriate for QRS detection
as other components of the signal have been suppressed. This signal naturally does not have a
typical ECG morphology due to the bandpass. For waveform display (real-time streaming sECG
with the physician’s programmer and snapshots for review by the physician), a different passband
is utilized to retain signal features that may have diagnostic value. This passband is 0.5 – 40 Hz,
which is designed to retain morphological features of a typical ECG while still rejecting large low
frequency artifacts and baseline drift.
The BIOMONITOR IV system consists of three main components:
1. BIOMONITOR IV insertable cardiac monitor - The BIOMONITOR IV is a small, leadless
device that is typically inserted under the skin, in the chest. The device uses two
electrodes on the body of the device to continuously monitor the patient’s subcutaneous
ECG. BIOMONITOR IV can store up to 96 minutes (67 min minimum) of subcutaneous
ECG (sECG) recordings from both automatically detected arrhythmias and from
manually triggered symptom episodes. When a patient experiences symptoms, the
sECG recordings can be manually triggered by placing the Remote Assistant III over the
BIOMONITOR IV. The injectable cardiac monitor is provided preloaded in an insertion
tool. An incision tool is also provided.
2. BIOTRONIK Renamic / Renamic Neo Programmer – The programmer is used to set up
the BIOMONITOR IV to detect arrhythmias. It also allows one to view, save, or print the
stored information.
3. BIOTRONIK CardioMessenger®Smart is a telemetry patient device that forwards the
data from the BIOMONITOR IV to BIOTRONIK’s Home Monitoring Service Center.
BIOMONITOR IV may be used with BIOTRONIK Home Monitoring®technology, which is an
automatic, wireless, remote monitoring system for management of patients with insertable
cardiac monitors. When active, Home Monitoring enables the exchange of information about a
patient’s cardiac status from the implant to the Home Monitoring Service Center (HMSC) where
the physician may log in to view the data. The HMSC can be used to provide the physician with
advanced reports from the implanted device and process them into a graphical and tabular

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format that is accessible via the internet platform HMSC. This information may help the physician
optimize the therapy process, possibly providing earlier notification of clinically relevant events to
help guide future therapy.
BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home
Monitoring. With the TRUST study, BIOTRONIK was able to show the following with regards to
Home Monitoring:
• BIOTRONIK Home Monitoring information may be used as a replacement for device
interrogation during in-office follow-up visits.
• A strategy of care using BIOTRONIK Home Monitoring with office visits when needed
has been shown to extend the time between routine, scheduled in-office follow-ups of
BIOTRONIK implantable devices in many patients. Home Monitoring data is helpful in
determining the need for additional in-office follow-up.
• BIOTRONIK Home Monitoring provides early detection of arrhythmias.
• BIOTRONIK Home Monitoring provides early detection of silent, asymptomatic
arrhythmias.
• Automatic early detection of arrhythmias and device system anomalies by BIOTRONIK
Home Monitoring allows for earlier intervention than conventional in-office follow-ups.
• BIOTRONIK Home Monitoring allows for improved access to patient device data
compared to conventional in-office follow-ups since device data is automatically
collected and reported on a daily basis.
The implanted device’s Home Monitoring function can be used for the entire operational life of the
implanted device (prior to ERI).
NOTE: When ERI mode is reached, this status is transmitted and Home Monitoring®will be
discontinued after two weeks.

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Chapter 2: Indications
The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:
• Atrial fibrillation
• Bradycardia
• Sudden rate drop
• Tachycardia
• Pause
The BIOMONITOR IV is indicated for use in:
• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• Patients who experience transient symptoms that may suggest a cardiac arrhythmia
The device has not been tested for and it is not intended for pediatric use.

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Chapter 3
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Chapter 3: Contraindications
There are no known contraindications for the insertion of the BIOMONITOR IV. However, the
patient’s particular physical or medical condition may dictate whether or not a subcutaneous,
chronically inserted device can be tolerated.

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Chapter 4
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Chapter 4: Warnings and Precautions
Consult the technical manuals for information about other devices used with the BIOMONITOR
IV, including the CardioMessenger Smart or Renamic/Renamic Neo Programmer, and related
accessories.
Please keep technical manuals for later use.
Certain therapeutic and diagnostic procedures may cause undetected damage to an insertable
cardiac monitor (ICM), resulting in malfunction or failure at a later time. Please note the following
warnings and precautions:
4.1 MR SAFETY INFORMATION
MR Conditional - The cardiac monitor is labeled and certified MR conditional.
Conditions for an MR scan are provided below. Failure to adhere to provided patient position or
scan time limitations may result in excessive tissue warming during an MR scan.
Cardiac data recorded by the implanted device during an MR scan may include artifacts
that are due to the MR scan and not the patient’s cardiac function. Exercise care when
interpreting any such data.
MR Safety Information
Aperson implanted with BIOMONITOR IV may be safely scanned under the following conditions.
Failure to follow these conditions may result in injury.
Device Name BIOMONITOR IV
Static Magnetic Field Strength (B0) 1.5T or 3.0T
Maximum Spatial Field Gradient 30 T/m
RF Excitation 1.5T: Circularly Polarized (CP)
3.0T: Circularly Polarized (CP) or MC-2
RF Transmit Coil Type Whole Body Volume Transmit Coil; Local Volume Transmit Coil limited
to head or extremities
RF Receive Coil Type There are no Receive Coil restrictions
Operating Mode Normal Operating Mode/First Level Controlled mode
Maximum Whole-Body SAR 4 W/kg
Maximum Head SAR 3.2 W/kg
Scan Duration Scan duration is limited to an active scan time of up to 60 minutes
within any 90-minute period
MR Image Artifact The presence of this implant may produce an image artifact
Table 1 Magnetc Resonance Imagng (MRI) Scannng ondtons

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4.1.1 Patient Pre-MR Conditions
The followng requrements must always be fullled n order to perform an MR scan usng
BIOTRONIK’s BIOMONITOR IV
• There are no other active or abandoned cardiac implants (e.g., lead extensions, lead
adapters or abandoned leads) in the patient’s body.
• Other active or passive implants are permitted if they are identified as MR conditional
by the manufacturer.
NOTE An MR scan s permtted only f the product-specc condtons are met for all mplants
and f no metal mplantable devce longer than 5 cm s n the vcnty of the BIOTRONIK cardac
montor wthn a dstance of less than 4 cm
• The device is located in the patient’s chest area.
4.1.2 MR Scanner Limitations
The MR scanner has to meet the followng condtons
• Use of a clinical MR system with a cylindrical bore and a static magnetic field strength of
1.5 Tesla or 3.0 Tesla
• The slew rate of the MR scanner’s gradient fields should not exceed 200 T/m/s per axis.
• Local receive-only coils may be used without restriction.
• Local circularly polarized or quadrature volume transmit-only or transmit-and-receive
coils are only permitted for the head (including cervical spine) and extremities.
• Local circularly polarized or quadrature transmit-only or transmit-and-receive coils
are NOT permitted for the thorax (the area from the shoulders to lower ribs), pelvis, or
abdominal regions.
• Maximum spatial gradient of the static magnetic field specification must be
≤ 30 T/m (3,000 Gauss/cm).
• Under worst case conditions, the BIOMONITOR IV is expected to produce a maximum
temperature rise of <4.5° C after 30 minutes of continuous scanning.
• Image artifact and distortion can result from the presence of the BIOMONITOR IV device
within the field of view. Image artifact and distortion resulting from the presence of the device
within the field of view must be considered when selecting the field of view and imaging
parameters. These factors must also be considered when interpreting the MR images.
4.1.3 Restrictions during the MR Scan
The followng condtons must be met durng the MR scan
• The mean specific absorption rate (SAR) for the whole body as displayed by the MR
scanner must not exceed 4.0 W/kg.
• The head absorption rate displayed by the MR scanner must not exceed 3.2 W/kg.

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4.2 Implanted Pacemakers and Defibrillators
The BIOMONITOR IV is not intended for use in patients with an implanted pacemaker or
defibrillator. If the patient has a co-implanted pacemaker or defibrillator, the automatic detection
of arrhythmic episodes in the BIOMONITOR IV may be affected by the paced heart rhythm.
4.3 Medical Therapy
Before applying one of the following procedures, a detailed analysis of the advantages and risks
should be made. Following the procedures, insertable cardiac monitor function must be checked.
Therapeutic Diathermy Equipment - Use of therapeutic diathermy equipment is to be avoided
for insertable cardiac monitor patients due to possible heating effects of the insertable cardiac
monitor and at the implant site. If diathermy therapy must be used, it should not be applied in
the immediate vicinity of the insertable cardiac monitor.
Transcutaneous Electrical Nerve Stimulation (TENS) - Transcutaneous electrical nerve
stimulation may interfere with insertable cardiac monitor function and is therefore not
recommended. If necessary, the following measures may reduce the possibility of interference:
• Place the TENS electrodes as close to each other as possible.
• Place the TENS electrodes as far from the insertable cardiac monitor as possible.
Defibrillation - The following precautions are recommended to minimize the inherent risk of
insertable cardiac monitor operation being adversely affected by defibrillation:
• The paddles should not be placed directly over the implant.
• The paddles should be placed anterior-posterior or along a line perpendicular to the
axis formed by the insertable cardiac monitor.
• The energy setting should not be higher than required to achieve defibrillation.
• After defibrillation, evaluate the BIOMONITOR IV for proper function.
Radiation - Insertable cardiac monitor electronics may be damaged by exposure to radiation
during radiotherapy. To minimize this risk when using such therapy, the insertable cardiac monitor
should be protected with local radiation shielding.
Lithotripsy - Lithotripsy treatment should be avoided for insertable cardiac monitor patients
since electrical and/or mechanical interference with the insertable cardiac monitor is possible.
If this procedure must be used, the greatest possible distance from the point of electrical
and mechanical strain should be chosen (25 cm minimum) in order to minimize a potential
interference with the insertable cardiac monitor.
Ablation/Electrocautery - Ablation/Electrocautery - Position the grounding pad so that the
current path does not pass through or near the device. When possible, a bipolar electrocautery
system should be used. After ablation or electrocautery, evaluate the BIOMONITOR IV for proper
function.
Transurethral resection of the prostate - It is recommended that the cautery ground plate be
placed under the buttocks or around the thigh, but not in the thoracic area where the current
pathway could pass through or near the cardiac monitor.

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Hyperbaric Oxygen Therapy (HBOT) - Hyperbaric oxygen therapy (HBOT) for patients with
BIOTRONIK CRM devices is not recommended due to the potential for damage or impaired
function of the implant after exposure. The physician should conduct a risk-benefit analysis
if HBOT treatment is necessary. The device specified in this manual has been tested to be in
compliance with ISO 14708-2:2012, where the device is exposed to 40 cycles of ambient pressure
up to 450 kPa (4.5 bar).
Therapeutic Ultrasound - The BIOMONITOR IV should not be exposed to therapeutic levels of
ultrasound energy, as the active implantable medical device can inadvertently concentrate the
ultrasound field and cause harm.
4.4 Storage and Handling
Failure to adhere to storage and handling recommendations may result in device damage or
malfunction.
Storage (temperature) - Recommended storage temperature range is -10° to 45°C (14°-113°F).
Exposure to temperatures outside this range may result in insertable cardiac monitor malfunction
(see Section 8.1).
Handling - Do not drop. The monitor is preloaded into the insertion tool. If the tool is dropped onto
a hard surface, return it to BIOTRONIK (see Section 8.1).
FOR SINGLE USE ONLY - Do not resterilize the insertable cardiac monitor, incision tool or
insertion tool; they are intended for one-time use.
Device Packaging - Do not use the device if the packaging is wet, punctured, opened or damaged
because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK.
Storage - Store the device in a clean area, away from sources of disturbance to avoid damage to
the device.
Temperature Stabilization - Allow the device to reach room temperature before programming or
implanting the device. Temperature extremes may affect the initial device function.
Use Before Date - Do not implant the device after the USE BEFORE DATE because the device
sterility and longevity may be compromised.
Sharp - Packaging includes an incision tool that is sharp and should be handled with care.
4.5 Electromagnetic Interference (EMI)
The operation of any insertable cardiac monitor can be affected by certain environmental sources
generating signals that resemble cardiac activity. In some cases the disturbance sources can
couple sufficient energy to damage the insertable cardiac monitor.
BIOTRONIK insertable cardiac monitors have been designed to significantly reduce susceptibility
to disturbance sources. However, due to the variety and complexity of sources creating
interference, there is no absolute protection against disturbance sources. Generally, it is assumed
that disturbance sources produce only minor effects, if any, in insertable cardiac monitor patients.
If the patient presumably will be exposed to one of the following environmental conditions, then
the patient should be given the appropriate warnings.

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4.5.1 Home and Occupational Environments
The followng equpment (and smlar devces) may affect normal nsertable cardac montor
operaton electrc arc welders, electrc meltng furnaces, rado/televson and radar
transmtters, power generatng facltes, hgh voltage transmsson lnes, electrcal gnton
systems (also of gasolne powered devces) f protectve hoods, shrouds, etc, are removed,
electrcal tools, ant-theft devces of shoppng centers and electrcal applances, f not n
proper condton or not correctly grounded and encased
Patents should exercse reasonable cauton n avodance of devces whch generate a strong
electrc or magnetc eld Some potental EMI sources nclude
• High Voltage Power Transmission Lines - High voltage power transmission lines
may generate enough EMI to interfere with insertable cardiac monitor operation if
approached too closely.
• Home Appliances - Home appliances normally do not affect insertable cardiac monitor
operation if the appliances are in proper condition and correctly grounded and encased.
• Communication Equipment - Communication equipment such as microwave
transmitters, linear power amplifiers, or high-power amateur transmitters may
generate enough EMI to interfere with insertable cardiac monitor operation if
approached too closely.
• Commercial Electrical Equipment - Commercial electrical equipment such as arc
welders, induction furnaces, or resistance welders may generate enough EMI to
interfere with insertable cardiac monitor operation if approached too closely.
• Electrical Appliances - Electric hand-tools and electric razors (used directly over
or on the skin covering the insertable cardiac monitor) have been reported to cause
insertable cardiac monitor disturbances.
• Electronic Article Surveillance (EAS) - Equipment such as retail theft prevention systems
may interact with the insertable cardiac monitor devices. Patients should be advised to
walk directly through and not to remain near an EAS system longer than necessary.
4.5.2 Cellular Phones
Recent studes have ndcated there may be a potental nteracton between cellular phones
and nsertable cardac montor operaton Potental effects may be due to the rado frequency
sgnal when the phone s wthn close proxmty (wthn 6 nches [15 centmeters]) to the
nsertable cardac montor
Based on testng to date, effects resultng from an nteracton between cellular phones and
the nsertable cardac montors have been temporary Smply movng the phone away from the
nserted devce wll return t to ts prevous state of operaton
To mnmze such nteractons, patents havng an nserted cardac montor who operate a
cellular phone should
• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held
personal cellular phone and the inserted device. Portable and mobile cellular phones
generally transmit at higher power levels compared to hand held models. For
phones transmitting above 3 watts, maintain a minimum separation of 12 inches (30
centimeters) between the antenna and the inserted device.

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• Patients should hold the phone to the ear opposite the side of the inserted device.
Patients should not carry the phone in a breast pocket or on a belt over or within 6
inches (15 centimeters) of the inserted device as some phones emit signals when they
are turned ON but not in use (i.e., in the listen or standby mode). Store the phone in a
location opposite the side of the cardiac monitor.
4.5.3 Hospital and Medical Environments
Electrosurgcal autery - Electrosurgcal autery may nhbt nsertable cardac montor
sensng operaton If use of electrocautery s necessary, the current path (ground plate) should
be kept as far away from the nsertable cardac montor as possble
Lthotrpsy - Lthotrpsy may damage the nsertable cardac montor If lthotrpsy must be
used, do not focus the beam near the nsertable cardac montor
External Debrllaton - External debrllaton may damage the nsertable cardac montor
Attempt to mnmze current flowng through the nsertable cardac montor by followng
the precautons
Hgh Radaton Sources - Hgh radaton sources such as cobalt 60 or gamma radaton should
not be drected at the nsertable cardac montor If a patent requres radaton therapy n
the vcnty of the nsertable cardac montor, place lead sheldng over the devce to prevent
radaton damage
4.6 Home Monitoring
All BIOMONITOR IV devices can be used with BIOTRONIK’s Home Monitoring®system. The Home
Monitoring system enables wireless automatic transmission of information about a patient’s
cardiac status from the implanted device to the physician remotely.
Programming Overview
BIOTRONIK’s Home Monitoring system is designed to notify clinicians in less than 24 hours
about changes to the patient’s condition or status of the implanted device. Updated data may not
be available if:
• The patient’s CardioMessenger®is unplugged or damaged and is not able to connect to
the Home Monitoring system through an active cellular network.
• The CardioMessenger cannot establish a connection to the implanted device.
• The cellular network is not operational or the patient lives in a geographical area not
covered by cellular networks.
• The Home Monitoring Service Center is off-line (upgrades are typically completed in
less than 24 hours).
Patient’s Ability - Use of the Home Monitoring system requires the patient and/or caregiver to
follow the system instructions and cooperate fully when transmitting data.