BIOTRONIK BIOMONITOR IV Technical Manual
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BIOTRONIK BIOMONITOR IV Technical Manual

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March 9, 2025

How to remove a Biotronik Remote assistance

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Summary of Contents for BIOTRONIK BIOMONITOR IV

  • Page 1 BIOMONITOR IV Technical Manual...
  • Page 2 A radiopaque identification code is visible on standard X-ray, and identifies the injectable cardiac monitor: BIOMONITOR IV CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner). © 2023 BIOTRONIK, Inc., All rights reserved.

  • Page 3: Table Of Contents

    BIOMONITOR IV Technical Manual Contents Chapter 1: Device Description Chapter 2: Indications Chapter 3: Contraindications Chapter 4: Warnings and Precautions 4.1 MR SAFETY INFORMATION 4.1.1 Patient Pre-MR Conditions 4.1.2 MR Scanner Limitations 4.1.3 Restrictions during the MR Scan 4.2 Implanted Pacemakers and Defibrillators 4.3 Medical Therapy...
  • Page 4 BIOMONITOR IV Technical Manual 5.2 Home Monitoring (HM) 5.2.1 HM PID 5.2.2 Home Monitoring 5.2.3 Time of Transmission 5.2.4 Periodic Subcutaneous Electrocardiogram (sECG) 5.2.5 Daily Presenting Electrocardiogram (sECG) 5.2.6 Last Message 5.2.7 Episode Recording/Transmission 5.3 Sensing Settings 5.3.1 SensingConsult 5.3.2 Sensing High-Pass Filter 5.3.3 Input Signal Polarity...
  • Page 5 BIOMONITOR IV Technical Manual 6.5 Sensing 6.5.1 R-wave Trend 6.5.2 Noise Duration Trend Chapter 7: Other Functions/Features 7.1 Home Monitoring 7.2 Transmission of Information to Home Monitoring 7.3 Types of Report Transmissions 7.4 Description of Transmitted Data 7.5 Evaluation of Episodes with SmartECG 7.6 Patient Data Memory...
  • Page 6 BIOMONITOR IV Technical Manual Chapter 12: Remote Assistant III 12.1 General Information on the Remote Assistant III 12.2 Remote Assistant III Functional Testing 12.3 Getting to Know the Remote Assistant III 12.4 Triggering a Manual Recording 12.5 Battery LED Indicator Explained 12.6 Signal Transmission LED Explained...
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  • Page 9: Chapter 1: Device Description

    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.
  • Page 10 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.

  • Page 11: Chapter 2: Indications

    Chapter 2 BIOMONITOR IV Technical Manual 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: •...
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  • Page 13: Chapter 3: Contraindications

    BIOMONITOR IV Technical Manual 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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  • Page 15: Chapter 4: Warnings And Precautions

    MR scan and not the patient’s cardiac function. Exercise care when interpreting any such data. MR Safety Information A person implanted with BIOMONITOR IV may be safely scanned under the following conditions. Failure to follow these conditions may result in injury. Device Name...

  • Page 16: Patient Pre-Mr Conditions

    NOTE: An MR scan is permitted only if the product-specific conditions are met for all implants and if no metal implantable device longer than 5 cm is in the vicinity of the BIOTRONIK cardiac monitor within a distance of less than 4 cm.

  • Page 17: Implanted Pacemakers And Defibrillators

    BIOMONITOR IV Technical Manual 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.

  • Page 18: Storage And Handling

    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.

  • Page 19: Home And Occupational Environments

    Chapter 4 BIOMONITOR IV Technical Manual 4.5.1 Home and Occupational Environments The following equipment (and similar devices) may affect normal insertable cardiac monitor operation: electric arc welders, electric melting furnaces, radio/television and radar transmitters, power generating facilities, high voltage transmission lines, electrical ignition systems (also of gasoline powered devices) if protective hoods, shrouds, etc., are removed,...

  • Page 20: Hospital And Medical Environments

    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: •...

  • Page 21: Insertable Cardiac Monitor Explant And Disposal

    4.7 Insertable Cardiac Monitor Explant and Disposal Device Incineration - Never incinerate an insertable cardiac monitor. Be sure the insertable cardiac monitor is explanted before a patient who has died is cremated (see Section 11.3). Explanted Devices - Return all explanted devices to BIOTRONIK.
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  • Page 23: Chapter 5: Programmable Parameters

    (AF), tachycardia, bradycardia, sudden rate drop, pause, and symptom events. With the BIOMONITOR IV, there are preconfigured programming sets that can be selected under program sets to automatically manage these recording parameters based on patient indication through the ProgramConsult.

  • Page 24: Programconsult

    Chapter 5 BIOMONITOR IV Technical Manual 5.1.1 ProgramConsult The ProgramConsult menu is located under Program sets and allows for the selection of a preconfigured programming set based on common patient indications. Selecting one of these options provides programming assistance by bundling the suggested recording criteria parameters to a single choice.
  • Page 25 Chapter 5 BIOMONITOR IV Technical Manual Parameter Syncope Palpitations AF Monitoring Cryptogenic Stroke Atrial fibrillation (AF) AF sensitivity Medium Medium Medium RR variability limit Confirmation time Bigeminy rejection Aggressive Aggressive Standard Aggressive Ectopy rejection AF recording AF transmission Detect only...

  • Page 26: Atrial Fibrillation (Af)

    Chapter 5 BIOMONITOR IV Technical Manual 5.1.2 Atrial Fibrillation (AF) The Atrial Fibrillation Menu (Figure 3) allows the user to program AF detection ON or OFF as well as set the detection criteria. Figure 3: AF menu This section includes: •...
  • Page 27 Chapter 5 BIOMONITOR IV Technical Manual Parameter Range Medium (Default) High Atrial fibrillation detection OFF, ON Detection/termination window size 8/16, 16/24, 24/32 16/24 8/16 8/16 Detection intervals 5...(2)...23 Number of detection windows 1...(1)...4 Termination intervals 1...(2)...7 Number of termination windows 1...(1)...4...
  • Page 28 Chapter 5 BIOMONITOR IV Technical Manual Detection/Termination Window Size The number of cycle lengths used to determine detection and termination of AF. Figure 6 shows the selectable values for Detection and Termination. For example, a Detection value of 8 means the device monitors groups of 8 cycle lengths to determine the RR variability by comparing each of those 8 events to the variability limit value.
  • Page 29 Chapter 5 BIOMONITOR IV Technical Manual Number of Termination Windows Number of consecutive windows that are required to be determined stable for the device to terminate the episode. Figure 8: Number of termination windows Detection Intervals The Detection Intervals represents the number of intervals that must be unstable within the programmed detection window for the rhythm to be considered unstable.
  • Page 30 Chapter 5 BIOMONITOR IV Technical Manual Termination Intervals The Termination Intervals represents the maximum number of unstable events within the programmed termination window allowed to terminate an AF episode. If more than the programmed number of unstable intervals are present, the device will continue to declare an AF event active.

  • Page 31: Tachycardia

    Figure 13: Ectopy Rejection 5.1.3 Tachycardia BIOMONITOR IV may be programmed to record tachycardia events using a rate limit and counter for criteria. Both the tachy limit and tachy counter criteria must be met for an event to be classified as a tachy episode. An event meeting the criteria would record an sECG and...

  • Page 32: Bradycardia

    Chapter 5 BIOMONITOR IV Technical Manual Tachy Limit This parameter value represents the lower rate limit required to be considered a tachy episode. Figure 14: Tachy limit Tachy Counter This parameter value represents the count limit for tachycardia classification. This is an up/ down counter.

  • Page 33: Sudden Rate Drop (Srd)

    Chapter 5 BIOMONITOR IV Technical Manual Brady Duration The Brady Duration is the time in seconds over which the average heart rate is assessed. When the average heart rate is below the programmed bradycardia zone limit for the device, bradycardia is confirmed.

  • Page 34: Pause Duration

    Chapter 5 BIOMONITOR IV Technical Manual Baseline Intervals This parameter value represents the number of averaged intervals to determine a baseline rate for sudden rate drop determination. Figure 20: Baseline intervals Rate-drop Intervals This parameter value represents the number of averaged intervals to determine a change in the heart rate.

  • Page 35: Symptom

    The Resting Period Duration parameter is the time duration the data is collected for the Resting Rate trend diagnostic. BIOMONITOR IV collects resting heart rate values in 10-min blocks of time over a programmable number of hours (nominally 4 hours). The lowest average collected over the recording period is used as the statistical point for that given day.

  • Page 36: Home Monitoring (Hm)

    Figure 26: Time of transmission 5.2.4 Periodic Subcutaneous Electrocardiogram (sECG) The BIOMONITOR IV can send sECGs up to 60 s each (40 s minimum) in length periodically based on user preference. This allows the user to assess sECGs routinely, even when no events have occurred.

  • Page 37: Daily Presenting Electrocardiogram (Secg)

    BIOMONITOR IV Technical Manual 5.2.5 Daily Presenting Electrocardiogram (sECG) The BIOMONITOR IV sends one sECG of up to 6 seconds in length daily, which will be presented on the Status Summary page on the Home Monitoring Service Center website. This allows the user to assess a short sECG for the last received monitoring period.
  • Page 38 Chapter 5 BIOMONITOR IV Technical Manual The user can modify the Recording and Transmission options. The only programmable options are ON and OFF with the exception of Atrial Fibrillation transmissions and Symptom transmissions. Atrial Fibrillation transmissions also include a Detect Only option. This option will transmit just the sECG for detection and not the one for termination.

  • Page 39: Sensing Settings

    Chapter 5 BIOMONITOR IV Technical Manual 5.3 Sensing Settings This section allows the user to change the SensingConsult, sensing filter settings, and stored/ real-time signal choices. Figure 31: Sensing setting...

  • Page 40: Sensingconsult

    Chapter 5 BIOMONITOR IV Technical Manual 5.3.1 SensingConsult SensingConsult is a feature that allows the user to select a sensing profile to match the patient condition. Selecting one of these options results in the device automatically adjusting the threshold decay, reduction time, and threshold percentages to optimize sensing for that particular patient presentation.

  • Page 41: Sensing High-Pass Filter

    Chapter 5 BIOMONITOR IV Technical Manual 5.3.2 Sensing High-Pass Filter This section allows the user to change the filter setting of the signal. The higher the value, the more of the baseline and T-wave signals are removed from the sensing signal. This may be used if the baseline signal wanders or if oversensing from T-waves or P-waves occurs.

  • Page 42: Input High-Pass Filter

    Chapter 5 BIOMONITOR IV Technical Manual 5.3.4 Input High-Pass Filter The sECG channel input contains a selectable analog high-pass filter with a cutoff value of 0.05 Hz or 0.5 Hz. This will take effect for stored sECGs and streamed real-time sECGs.

  • Page 43: Gender

    Chapter 5 BIOMONITOR IV Technical Manual 5.4.4 Gender This section allows the user to select the patient’s gender. 5.4.5 Date of Implant The implantation date is entered by the user. 5.4.6 Hospital, City The hospital name and city name can be added. As with entering the patient’s name, up to 20 characters are available to add hospital and city information.

  • Page 44: Symptom

    Chapter 5 BIOMONITOR IV Technical Manual 5.4.9 Symptom This section allows the user to select one or multiple symptoms related to the patient. Selecting a symptom will result in a check mark appearing in the box to the left. Once completed, press the OK button.

  • Page 45: Chapter 6: Diagnostics

    BIOMONITOR IV Technical Manual Chapter 6: Diagnostics 6.1 Diagnostics Overview BIOMONITOR IV can store a variety of statistical information. The various statistics consist of such features as rate histograms, rate trends, and activity trends, which are described in the following sections.

  • Page 46: Rate Trends

    Heart rate information is based on the daily average heart rate and is displayed as a single data point for the day. BIOMONITOR IV collects resting heart rate values in 10-minute blocks of time during the mean heart rate at rest recording time. The lowest average collected over the recording period is used as the statistical point for that given day.

  • Page 47: Activity Trend

    Chapter 6 BIOMONITOR IV Technical Manual 6.3.3 Activity Trend The Activity trend, shown in Figure 39, displays the daily percentage of activity as detected by the motion sensor of the device. Figure 41: Activity trend 6.4 AF Details 6.4.1 AF Trends The AF trends diagnostic provides information related to the number and duration in hours of AF events on a daily basis.

  • Page 48: Af Time Of Occurrence

    Chapter 6 BIOMONITOR IV Technical Manual 6.4.2 AF Time of Occurrence The time of occurrence, shown in Figure 41, summarizes the times of day that atrial tachyarrhythmia episodes began and is broken into three-hour time blocks. Knowing the time of day when atrial tachyarrhythmias begin may help determine whether a particular event will precipitate the tachyarrhythmia.

  • Page 49: Ventricular Rate During Af

    Chapter 6 BIOMONITOR IV Technical Manual 6.4.4 Ventricular Rate During AF The ventricular rate during AF graph provides the mean and the maximum heart rate during AF. Large differences in the mean and maximum rates may indicate an irregular ventricular response during the AF while small differences may imply that ventricular rate is more stable during AF.

  • Page 50: Sensing

    The noise duration trend provides the amount of noise sensed daily by the device, expressed as a percentage of time per day by the BIOMONITOR IV. A high percentage of noise events could interfere with the BIOMONITOR IV’s ability to detect arrhythmias.

  • Page 51: Chapter 7: Other Functions/Features

    Home Monitoring can be used to provide the physician with reports from the BIOMONITOR IV and can process them into graphical and tabular format called a Home Monitoring Report. This information helps the physician optimize the diagnostic process, as it allows the patient to be scheduled for additional clinical appointments between regular follow-up visits if necessary.

  • Page 52: Types Of Report Transmissions

    24 hours. The following data are transmitted for the Home Monitoring Report by the Home Monitoring system, when activated. In addition to the medical data, the serial number of the BIOMONITOR IV is also transmitted.

  • Page 53: Evaluation Of Episodes With Smartecg

    7.5 Evaluation of Episodes with SmartECG The SmartECG function is available for the BIOMONITOR IV. With the SmartECG function, AF, Brady, Tachy, and Pause episodes that the device sends to the Home Monitoring Service Center can be automatically evaluated.
  • Page 54 Chapter 7 BIOMONITOR IV Technical Manual 3. Activate or deactivate SmartECG for the patient by selecting Enable (Yes/No). ► The [Recordings] tab and the Quick View banner will show whether SmartECG is activated. Setting SmartECG criteria for a patient SmartECG criteria can be set for each patient, and transmitted episodes will be evaluated against these criteria.

  • Page 55: Patient Data Memory

    Chapter 7 BIOMONITOR IV Technical Manual The filter settings that you set in the [Finding options] tab continue to apply for all episode types that cannot be evaluated by SmartECG. NOTE: Sudden Rate Drop and Symptom recordings are not evaluated by SmartECG. These...

  • Page 56: Position Indicator

    Chapter 7 BIOMONITOR IV Technical Manual • Phone • Remark Symptom and etiology are specified using the European PASSPORT code system. The PASSPORT code is an identification system of two character codes that represent specific conditions. A listing of the codes available with definitions is displayed on the screen of the programmer when patient data is selected.

  • Page 57: Chapter 8: Product Storage And Handling

    (EMI) to avoid damage to the device. Use Before Date – Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity. If a replacement injectable cardiac monitor is needed, contact your local BIOTRONIK representative.
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  • Page 59: Chapter 9: Follow-Up Procedures

    Chapter 9 BIOMONITOR IV Technical Manual Chapter 9: Follow-up Procedures 9.1 General Considerations The injectable cardiac monitor follow-up serves to monitor and provide information related to the patient’s rhythm. The follow-up intervals are, therefore, primarily determined by medical judgment. The following notes are meant to stress certain product features, which are of importance for follow-up visits.

  • Page 60: Recordings

    Chapter 9 BIOMONITOR IV Technical Manual 9.4 Recordings The Recordings page provides a list of stored episodes since the last time it was cleared. Information includes the time and date of the event, the duration, the type of event, mean heart rate and a sECG link to the recording.

  • Page 61: Secg

    BIOMONITOR IV Technical Manual 9.5 sECG BIOMONITOR IV can store up to 96 minutes (67 minutes minimum) of sECGs. The types of sECG recording include Tachycardia, Bradycardia, SRD, AF, Pause and Symptom events. If sECG snapshots of all arrhythmia types are available, the minimum number of each type of...

  • Page 62: Tachycardia

    Chapter 9 BIOMONITOR IV Technical Manual 9.5.2 Tachycardia Figure 50 shows an example of a tachycardia recording. The black vertical bar indicates when the Tachy criteria were met. Figure 52: Tachycardia sECG 9.5.3 Bradycardia Figure 51 shows an example of a bradycardia recording.

  • Page 63: Pause

    Chapter 9 BIOMONITOR IV Technical Manual 9.5.4 Pause Figure 52 shows a Pause recording. Figure 54: Pause sECG 9.5.5 Symptom Figure 53 shows a recording from a Symptom event. Figure 55: Symptom sECG...
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  • Page 65: Chapter 10: Elective Replacement Indication (Eri)

    Table 5: Service cycle definitions Table 6 shows the expected longevity (in years) from BOS to ERI for the BIOMONITOR IV injectable cardiac monitors. The programmer software for the BIOMONITOR IV injectable cardiac monitors provides a fuel gauge to provide information related to the battery status.
  • Page 66 Chapter 10 BIOMONITOR IV Technical Manual The remaining minimum service time is provided in Table 7 below. Monitor Status ERI to EOS in Months Table 7: Remaining minimum service time All service intervals, including the above-cited nominal injectable cardiac monitor longevity, are based on considerations that include the battery discharge behavior and the hybrid circuit properties including current consumption and replacement indicator.

  • Page 67: Chapter 11: Insertion/Removal

    Chapter 11: Insertion/Removal 11.1 Opening the Sterile Container The BIOMONITOR IV is preloaded in the insertion tool and is packaged with an incision tool in a single container sterilized with ethylene oxide. Peel off the sealing paper of the outer container as indicated by the arrow.
  • Page 68 Chapter 11 BIOMONITOR IV Technical Manual BIOMONITOR IV has been developed to be inserted in a close-fitting subcutaneous tunnel, preferably in or around the left side of the chest. Recommended locations are those areas close to the heart where the implant will be exposed to minimal movement from body positional changes or from arm movement.
  • Page 69 The FIT OneStep Tool with the preloaded BIOMONITOR IV implant is then advanced within a sub-dermal plane until the skin reaches the insertion stopping point, to create a tunnel for the BIOMONITOR IV implant. Step 3 Once the tunneling part of the tool is fully inserted, the knob at the proximal end of the handle is turned counter-clockwise to the unlocked icon.

  • Page 70: Removal

    Removed cardiac monitors or accessories may not be reused. Removed cardiac monitors can be sent either to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal. If possible, the removed cardiac monitor should be cleaned with a sodium-hyperchlorite solution of at least 1% chlorine and, thereafter, washed with water prior to shipping.

  • Page 71: Chapter 12: Remote Assistant Iii

    Chapter 12: Remote Assistant III 12.1 General Information on the Remote Assistant III The Remote Assistant III is an accessory for the BIOMONITOR IV that allows patients to manually trigger the recording of an sECG. Place the Remote Assistant over the inserted BIOMONITOR IV and press the trigger key on the Remote Assistant III to send a signal.

  • Page 72: Triggering A Manual Recording

    The device emits an acoustic signal, and the signal transmission LED lights up continuously yellow for approximately three seconds. 3. If the recording has been successfully triggered in the BIOMONITOR IV, the signal transmission LED lights up continuously green for a maximum of 30 seconds before the device automatically turns off.

  • Page 73: Battery Led Indicator Explained

    12.6 Signal Transmission LED Explained LED behavior Explanation LED is continuously lit yellow The trigger key has been pressed. LED flashes yellow Recording in the BIOMONITOR IV was not successfully triggered. LED is continuously lit green Recording in the BIOMONITOR IV was triggered successfully.
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  • Page 75: Chapter 13: Technical Data

    Chapter 13 BIOMONITOR IV Technical Manual Chapter 13: Technical Data 13.1 Parameters 13.1.1 Atrial Fibrillation OFF, ON AF Sensitivity Low, Medium, High Bigeminy Rejection OFF, Standard, Agressive RR variability 6%, 9%, 12%, 15%, 18% Confirmation Time 0.5, 1, 2, 3, 4, 5, 6, 10, 20, 30...

  • Page 76: Sudden Rate Drop (Srd)

    Chapter 13 BIOMONITOR IV Technical Manual Recording OFF, ON Transmission OFF, ON 13.1.4 Sudden Rate Drop (SRD) OFF, ON SRD rate decrease (%) 20, 30 40, 50, 60, 70 SRD Sensitivity Low, Medium, High Recording OFF, ON Transmission OFF, ON 13.1.5 Pause Duration...

  • Page 77: Home Monitoring

    Chapter 13 BIOMONITOR IV Technical Manual 13.1.8 Home Monitoring OFF, ON Time of transmission (hh:mm) Std.; 00:00..(00:30)..23:30 13.2 Materials in Contact with Human Tissue Device Coating: Silicone Electrodes Coating: Iridium 13.3 Electrical Data/Battery NOTE: At 37º C Parameter BIOMONITOR IV...
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  • Page 79: Chapter 14: Order Information

    Chapter 14 BIOMONITOR IV Technical Manual Chapter 14: Order Information Injectable Cardiac Monitor Type Order Number BIOMONITOR IV 471155 FCC Statement - BIOMONITOR: This device complies with part 15 of the FCC Rules. Operation is subject to the following two...
  • Page 80 Chapter 14 BIOMONITOR IV Technical Manual This device complies with part 15 of the FCC rules and regulations. The operation is subject to the following two conditions: 1. The device must not cause any harmful interference and 2. the device must be able to cope with any interference, including interference that may cause an adverse mode of operation.
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  • Page 84 BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) M4235-B 07/23 (800) 291-0470 (fax) © 2023 BIOTRONIK, Inc. All rights reserved. www.biotronik.com MN101r1 7/17/23...

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