FCC ID: QRI-BM2610 Implantable Cardiac Monitor

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 1 Product Description Intended Medical Use Product Description1439151Technical ManualBIOMONITOR III Intended use Form of diagnosis BIOMONITOR III is the product name of an implantable cardiac monitor for moni-

toring 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. 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 manage-

ment. 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 Product Description Intended Medical Use Indications 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 subcuta-

neous device will be tolerated long-term. 5 Product Description System Overview System Overview Device Parts BIOMONITOR III This device is not available in all countries. 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 flex-

ible 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 leads 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 Product Description System Overview Programmer 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, subcuta-

neous 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 e-

mail 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 immedi-

ately check the Home Monitoring function. The recording of a subcutaneous ECG in the BIOMONITOR III device can be trig-

gered by the patient using the external Remote Assistant III device. BIOMONITOR III order number This device is not available in all countries. Device BIOMONITOR III Order number 436066 Package contents 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 Detection and data storage Automatic functions facilitate quick and simple setting and control of the BIOMONITOR III cardiac monitor. 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 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 Home Monitoring functions 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 2 General Safety Instructions General Information on Safe Handling of the Device General Safety Instructions2439151Technical ManualBIOMONITOR III Follow notes and instructions

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Safety instructions and warnings in this technical manual CAUTION Risk to patient, risk to doctor, and interferences of device The operation of electronic devices close to the heart is subject to special condi-

tions. From transport to storage, concerns about sterility and technical complica-

tions, 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. 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 inser-

tion 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

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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 General Safety Instructions General Information on Safe Handling of the Device Technical manuals 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

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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 elec-

tromagnetic 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:

-10C to +45C (-40F to 158F) Sterile delivery The incision tool and the insertion tool as well as the device itself are delivered gas-

sterilized (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

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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 Complications for patients and device systems generally recognized among practi-

tioners also apply to BIOTRONIK devices. Known complications are foreign body rejection phenomena, local tissue reac-

tions, migration of the device, accumulation of fluid in the device pocket, trans-

dermal erosions, as well as hemorrhage, and/or infections. Primary sources of complication information include current scientific and technological knowl-

edge. Possible technical failures 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 Electromagnetic interference (EMI) Any device can be sensitive to interference, for example, when external signals are sensed as intrinsic rhythm. BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal. 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

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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 diag-

nostic 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 General Safety Instructions Possible Risks Radiation therapy The use of radiation therapy must be avoided due to possible damage to the device and the resulting impaired functional safety. If this type of therapy is 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 condi-

tions. 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 infor-

mation 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 3 Handling Insertion Procedure Handling3439151Technical ManualBIOMONITOR III

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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

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CAUTION Inadequate function due to defective device If a device still in packaging is dropped on a hard surface during handling, elec-

tronic 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 instru-

ments!

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 Handling Insertion Procedure Implantation site 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. 3 4 B 5 6 A 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 patient-

specific 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 Handling Insertion Procedure Make a skin fold and an incision for the device pocket 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 Handling Insertion Procedure Position the insertion tool and tunnel 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 subcuta-

neous 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 Handling Insertion Procedure Release the insertion tool 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 Handling Insertion Procedure Pull back the insertion tool and lift to remove it 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

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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-up with BIOTRONIK Home Monitoring Follow-up with the programmer 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 (in-

office follow-up). The next in-office follow-up should be carried out once a year and no later than 12 months after the last in-office follow-up. 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 func-

tion. 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 neces-

sitate 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. Use the following procedure for in-office follow-up:

Interrogate the device. 1 Record and evaluate the ECG if necessary. 2 3 Check the sensing function. 4 Evaluate status and, if necessary, statistics and subcutaneous ECGs. 5 If necessary, customize the program functions and parameters and transmit the edited program to the device. 6 Print and document follow-up data (print report). 7 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 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. Prohibitive signs Premises with prohibitive signs must be avoided. Educate the patient regarding prohibitive signs. Possible sources of interference Recording via Remote Assistant Electromagnetic interference should be avoided in daily activities. Sources of inter-

ference 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. 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 pre-

episode 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

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CAUTION Risk to patient, environmental hazard Explanations and device replacements require special measures. Please follow all procedures carefully. Explantation 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. Device replacement Basic principles:

The device must not be resterilized or reused. Cremation Devices should not be cremated. Explant the device before the cremation of a deceased patient. Disposal of the device 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. Disposal of the tools Incision tool and insertion tool:

Used accessories must be disposed of as medical waste in an environmentally friendly and proper manner. 25 Parameters Detection 4 Parameters Detection Parameters4439151Technical ManualBIOMONITOR III Atrial fibrillation The following can be set:

Parameter Atrial fibrillation (AF) AF sensitivity RR variability limit Confirmation time Bigeminy rejection Range of values ON; OFF Low; Medium; High In case of change of the AF expert parameters: individual 6; 9; 12; 15; 18 %

1 ... (1) ... 6; 10; 20; 30 min OFF; Standard; Aggressive Standard ON Medium 12 %

6 min Standard Additional AF expert parameters can be set individually:

Parameter Size of detection/termination window Detection intervals Range of values 8/16; 16/24; 24/32 cycles 5 ... (2) ... 23 cycles Number of detection windows Termination intervals Number of termination windows 1 ... (1) ... 4 1 ... (2) ... 7 cycles 1 ... (1) ... 4 Standard 8/16 cycles

(medium) 5 cycles

(medium) 2 (medium) 1 cycle (medium) 2 (medium) Low 12 %

16/24 cycles The AF parameters are preset as follows:

Parameter RR variability limit Size of detection/termination window Detection intervals Termination intervals Number of detection windows Number of termination windows 11 cycles 5 cycles 3 2 5 cycles 1 cycle 2 2 Medium 12 %

8/16 cycles High 12 %

8/16 cycles High ventricular rate (HVR) Bradycardia The following can be set:

Parameter High ventricular rate HVR limit HVR counter The following can be set:

Parameter Bradycardia Brady zone limit Brady duration Range of values ON; OFF 100 ... (10) ... 200 bpm 8 ... (4) ... 24; 32; 48 cycles Range of values ON; OFF 30 ... (5) ... 80 bpm 5 ... (5) ... 30 s 5 cycles 1 cycle 1 3 Standard ON 180 bpm 16 cycles Standard ON 40 bpm 10 s 26 Parameters Detection Sudden rate drop The following can be set:

Parameter Sudden rate drop (SRD) SRD rate decrease SRD sensitivity Range of values ON; OFF 20 ... (10) ... 70 %

Low; Medium; High In case of change of the SRD expert parameters: individual Standard OFF 50 Medium Asystole duration Patient trigger Indication-dependent detection settings ProgramConsult Additional SRD expert parameters can be set:

Range of values Parameter Baseline intervals 48; 64; 128; 256 cycles Rate-drop intervals 8; 16; 32 cycles The SRD expert parameters are preset as follows:

Parameter Baseline intervals Rate-drop intervals Low 256 cycles 32 cycles Medium 64 cycles 16 cycles The following can be set:

Parameter Asystole Asystole duration The following can be set:

Parameter Patient trigger Range of values ON; OFF 2 ... (1) ... 10 s Range of values ON; OFF Standard 64 cycles

(medium) 16 cycles

(medium) High 48 cycles 8 cycles Standard ON 3 s Standard ON For each indication, there is a compilation of preset detection parameters

(ProgramConsult):

Parameter Range of values

(standard) Syncope Palpita-

tions AF moni-

toring Crypto-

genic cerebro-

vascular stroke ON Atrial fibrillation ON; OFF Sensitivity ON Low ON Medium Medium High ON Low; Medium;

High 6; 8; 12; 15; 18% 12 %

1; 2; 3; 4; 5; 6; 10;

20; 30 min OFF; Standard;

Aggressive ON; OFF Aggres-

sive ON 10 min 16 100 ... (10) ... 180;

190; 200 bpm 8; 12; 16; 20; 24;

32; 48 ON; OFF 30; 35; 40 ... (5) ... 80 bpm 5; 10 ... (5) ... 30 s 20 ON 35 RR variability Confirmation time Bigeminy rejection High ventricular rate Limit Counters Bradycardia Zone Duration 12 %

6 min 12 %

6 min 12 %

1 min Aggres-

sive ON Standard Standard ON ON 160 bpm 180 bpm 180 bpm 180 bpm 32 ON 30 30 48 ON 30 30 48 ON 30 30 27 Parameters Detection Parameter Range of values

(standard) Syncope Palpita-

tions AF moni-

toring Asystole Duration Sudden rate drop Rate decrease Sensitivity ON ON; OFF 2; 3 ... (1) ... 10 s 3 ON; OFF ON 20 ... (10) ... 50;

60; 70%

Low; Medium;

High 50 Low ON 5 OFF ON 5 OFF Crypto-

genic cerebro-

vascular stroke ON 5 OFF Resting rate period All statistics-based settings are as follows:

Parameter Start resting period Duration of resting period Range of values 00:00 ... (1:00 AM) ... 11:00 PM hh:mm 1 ... (1) ... 12 h Standard 2:00 AM hh:mm 4 h 28 Parameters Sensing Sensing The following can be set:

Parameter SensingConsult Sensing filter

(SECG) Display

(SECG) Signal filter Range of values Standard Sense after large PVCs Sense small PVCs Sense short intervals T-wave suppression 4.5; 10; 18; 24 Normal; Inverted 0.05; 0.5 Hz Standard Standard 10 Hz Normal 0.5 Hz 29 Parameters Home Monitoring Home Monitoring General settings HM episode trigger The following settings apply to all detection types:

Range of values Parameter Home Monitoring ON; OFF STD;

Time of transmission 00:00 ... (12:30 AM) ... 11:30 PM hh:mm Standard ON STD Note: Selection and cycle length of periodic subcutaneous ECGs are set in the Home Monitoring Service Center (HMSC). Episode triggers for Home Monitoring can be set for all automatic detection types:

Detection type Atrial fibrillation (AF) Standard ON High ventricular rate (HVR) Bradycardia Sudden rate drop (SRD) Asystole Patient trigger Range of values ON; OFF; Detection only ON; OFF ON; OFF ON; OFF ON; OFF ON; OFF ON ON OFF ON 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 Atrial fibrillation (AF) ON; OFF ON; OFF High ventricular rate (HVR) ON; OFF ON; OFF Bradycardia ON; OFF Sudden rate drop (SRD) Asystole ON; OFF ON; OFF Patient trigger ON; OFF ON; OFF ON; OFF ON; OFF ON; OFF Sending to HMSC ON; OFF;

Detection only ON; OFF ON; OFF 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 5 Technical Data Mechanical Characteristics Technical Data5439151Technical ManualBIOMONITOR III Dimensions Incision tool Insertion tool L x Diameter [mm]

130 x 13 200 x 24 BIOMONITOR III device including antenna Housing without antenna L x H x D [mm]

77.5 x 8.6 x 4.6 Volume [cm3]

1.9 Mass [g]

4 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 Electrical characteristics determined at 37C, 500 Circuit Input impedance Hybrid electronics with VLSI-CMOS chip

> 100 k Housing shape The device housing has an elongated, flattened shape, connected to a narrow, flex-

ible lead body. Electrically conductive surfaces There is an electrically conductive surface on the housing as well as on the lead body:

Area of the electrically conductive housing surface 25 5 mm2 Area of the electrically conductive lead tip 25 5 mm2 Telemetry Telemetry data for Home Monitoring:

MICS frequencies 402 405 MHz Maximum power of transmission

< 25 W

-16 dBm International radio certification Devices with BIOTRONIK Home Monitoring are equipped with an antenna for wire-

less communication. Telemetry information for Australia:

This product is in compliance with the Australian "Radiocommuni-

cations Act 1992" and therefore it is labeled according to the "Radio-

communications (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 Battery type System Device type Battery voltage at BOS Open-circuit voltage LITRONIK GmbH 01796 Pirna, Germany LiS 2044 / LiS 2044k Li-MDX / Li-CFx BIOMONITOR III 3.1 V / 3.0 V 3.2 V/ 3.1 V Based on the technical specifications of the battery manufacturer and the device-

specific 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 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). Shortening of the service time after long storage period 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 CE mark Contents Product identification number Lot number 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 Do not resterilize Single sterile blister Single use only. Do not re-

use!

Do not use if packaging is damaged 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

BIOTRONIK SE & Co. KG Postfach 470255 12311 Berlin Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-1921 dirk.koenig@biotronik.com www.biotronik.com Berlin, 27-Nov-19 relating to applications in all matters To whom it may concern:

We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf for equipment authorization FCC ID: QRI-BM2610 including the signing of all documents related to these matters. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same effect as acts of our own. We also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Sincerely, Dirk Knig Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 info@biotronik.com www.biotronik.com Geschftsfhrende Direktoren:

Dr. Daniel Bhler Dr. Ralf Lieb Thomas Simmerer Kommanditgesellschaft:

HRA 6501 B, AG Berlin-Charlottenburg Komplementrin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin, Germany Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-1921 dirk.koenig@biotronik.com www.biotronik.com Berlin, November 12, 2019 BIOTRONIK SE & Co. KG Postfach 47025 Eurofins Product Service GmbH Storkower Strae 38c 15526 Reichenwalde Germany Subject: changes to BIOMONITOR III family of devices Herewith we like to inform about proposed hardware changes of BIOTRONIKs BIOMONITOR III family of implantable cardiac monitors. Changes are driven by product design improvement. This results in addition of D301 and therefore slight PCB layout adjustments which also improve manufacturability. Due to the layout adjustments some BOM positions need to be adjusted in their values. This also included an adjustment of an antenna matching component in C807. The hardware changes that have been made are listed in the following table:

Component Old Value New Value Not Present CDBQR0230R C804 10uF 22uF C813 10uF Not C815 22uF 10uF C807 39pF 27pF C814 22uF 10uF D301 Populated BIOMONITOR IIIm 7183RamRev_02.02 Model BIOMONITOR III RAM 7848RAMRev_04.06 Hardware BOM-0428_02 SCH-0295_03 ASM-0929_06 ROM 7848ROMRev_01.03 In addition to the above mentioned PCB hardware changes it was decided to add a new model number to the device family. Existing model Additional model Both models share the identical RF antenna and electronics included the PCB changes mentioned above. The only differences are BIOMONITOR IIIm owns an extended battery capacity which results in an extended service lifetime and extended therapeutic features which result in a different RAM firmware version as mentioned above. The RAM firmware differences do not alter the radio transceiver parameters. Sincerely, Dirk Knig Regulatory Affairs Senior Manager BIOTRONIK SE & CO. KG BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Kommanditgesellschaft:

HRA 6501 B, AG Berlin-Charlottenburg Komplementrin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Geschftsfhrende Direktoren:

Dr. Daniel Bhler Dr. Ralf Lieb Thomas Simmerer Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 info@biotronik.com www.biotronik.com

BIOTRONIK SE & Co. KG Postfach 470255 12311 Berlin Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-1921 dirk.koenig@biotronik.com www.biotronik.com Berlin, 27 November 2019 Request for Permanent Confidentiality Company name: BIOTRONIK SE & Co. KG FCC ID: QRI-BM2610 FCC Part 15 Certification Gentlemen, In accordance with CFR 47 0.457 and CFR 47 0.459 BIOTRONIK SE & Co. KG hereby requests confidentiality of following attachments:

(1) schematic diagrams,

(2) detailed block diagrams,

(3) detailed operational descriptions,

(4) parts lists. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK SE & Co. KG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK SE & Co. KG considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Dirk Knig Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 info@biotronik.com www.biotronik.com Geschftsfhrende Direktoren:

Dr. Daniel Bhler Dr. Ralf Lieb Thomas Simmerer Kommanditgesellschaft:

HRA 6501 B, AG Berlin-Charlottenburg Komplementrin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg

BIOTRONIK SE & Co. KG Postfach 470255 12311 Berlin Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-1921 dirk.koenig@biotronik.com www.biotronik.com Berlin, 27 November 2019 Request for Short Term Confidentiality, intended to allow importation / distribution of authorized equipment while maintaining confidentiality before product launch Company name: BIOTRONIK SE & Co. KG FCC ID: QRI-BM2610 FCC Part 15 Certification Gentlemen, In accordance with 0.457 and 0.459 of CFR 47, BIOTRONIK SE & Co. KG hereby requests for Short Term Confidentiality of all External Photos, Test Setup Photos, Internal Photos, attachments for the subject application. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK SE & Co. KG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK SE & Co. KG considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Dirk Knig Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 info@biotronik.com www.biotronik.com Geschftsfhrende Direktoren:

Dr. Daniel Bhler Dr. Ralf Lieb Thomas Simmerer Kommanditgesellschaft:

HRA 6501 B, AG Berlin-Charlottenburg Komplementrin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg