FARASTAR Users Manual

TABLE OF CONTENTS 1. DEVICE DESCRIPTION... 3 Contents... 3 FARASTAR MSM Specifications... 3 System Components... 3 Mapping System Module Connection Diagram... 3 Panel Interfaces... 4 Mapping System Module Front Panel... 4 Mapping System Module Rear Panel... 5 Cable Connections... 5 Additional Items for Safe Use... 5 Intended User... 5 2. INTENDED USE... 5 3. INDICATIONS FOR USE... 5 4. INTENDED PATIENT POPULATION... 5 5. CLINICAL BENEFIT STATEMENT... 5 6. SUMMARY OF SAFETY AND CLINICAL PERFORMANCE... 5 7. CONTRAINDICATIONS... 5 8. WARNINGS... 5 9. PRECAUTIONS... 6 10. ADVERSE EVENTS... 7 11. HOW SUPPLIED... 7 Device Details... 7 Handling and Storage... 7 Service Life... 7 12. OPERATIONAL INSTRUCTIONS... 7 Power Supply Cord... 7 Prior to Procedure... 7 Usage during an Electrophysiology Procedure... 8 13. ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION... 8 EMC Specifications & Labeling... 8 Separation distances... 9 Pass/Fail Criteria Definition... 10 14. DISPOSAL... 10 15. MAINTENANCE... 10 16. INSPECTION... 10

BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

17. CLEANING... 10 18. END-USER TRAINING MATERIALS... 10 19. CYBERSECURITY... 10 20. COMPLAINT REPORTING AND REQUESTS FOR INFORMATION... 10 Contacts... 10 21. PATIENT COUNSELING INFORMATION... 11 22. WARRANTY... 11 23. SYMBOL DEFINITIONS... 11

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FARASTAR™

Mapping System Module

Note: The equipment documented in the Contents section (Mapping System Module) is supplied non-sterile and cannot be sterilized. The equipment is intended for multi-patient reuse. Carefully read all ancillary device instructions prior to use. Observe all contraindications, warnings, and precautions noted in these directions. Failure to do so may result in patient complications. 1. DEVICE DESCRIPTION The FARASTAR Mapping System Module (henceforth referred to as FARASTAR MSM) is an optional accessory component to the FARASTAR Pulse Field Ablation (PFA) Generator, and its primary function is intended to filter/protect the inputs of the Boston Scientific RHYTHMIA HDx Mapping System from their connections to the patient during PFA delivery. These inputs include ablation catheter EGMs, back patch signals, and magnetic tracking sensor signals. The secondary function of the MSM is to provide a notification signal to the RHYTHMIA HDx Mapping System during the intervals of active PFA delivery. 1.1 Contents One (1) FARASTAR Mapping System Module 1.2 FARASTAR MSM Specifications Voltage

100VAC-240VAC, 50Hz/60Hz, 1.5A

External Fuses

2x 250VAC, 1.6A, 215 Series Ceramic Fuse, Timelag, Cartridge, 5 mm diameter x 20 mm length

Power Supply Cord

See Section 12.1

IEC Compliance

IEC 60601-1 3.2 2020, Class I type CF defibrillation proof

Mode of Operation

Continuous

Weight

61.74lbs/28kg.

FARASTAR MSM has no essential performance specifications. 1.3 System Components The basic connection scheme is shown below:

1

2 IN

7

6

OUT CONSOLE

STIM

ECG

+ IN

OUT

FARAPULSE

EGM

STIM

AUX

CH1

BLANK

CH2

8

EGM

9

4

3 CATH (PATIENT)

CATH (GENERATOR)

PATCH (PATIENT)

PATCH (RHYTHMIA)

FARAPULSE POWER BLANK

10

11 AUX IN

RHYTHMIA ABL

ANALOG OUT (RHY THMIA)

RHYTHMIA M/A/B

ERROR

12

5

13 14 15 16

FARAWAVE

17

Figure 1. Mapping System Module Connection Diagram Figure 1 Legend: 1 - FARASTAR PFA Generator 2 - FARASTAR Recording System Module 3 - FARASTAR Mapping System Module 4 - FARASTAR Stim Module Cable 5 - FARASTAR Catheter Connection Cable

6 - FARASTAR “Y” Stim Cable 7 - FARASTAR ECG Output Module 8 - FARASTAR RSM Catheter Pin Cable 9 - FARASTAR ECG Trunk Cable Limb & Chest Leads 10 - FARASTAR EGM Input Module

11 - AUX Cable 12 - Rhythmia ABL Cable 13 - RHYTHMIA Breakout Box Cable 14 - RHYTHMIA Analog Interface 15 - RHYTHMIA BP Interface

16 - RHYTHMIA Back Patch 17 - FARAWAVE NAV Catheter

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MB Drawing 50573138

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BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

CATHETER

POWER

The MSM resides between the patient and the RHYTHMIA HDx Mapping System. Its functionality is implemented by a set of relay switches that can be open or closed by a synchronization signal (‘Blank’) coming from the Recording System Module, through the AUX connector. In the default Pass-Through Mode, the MSM closes internal switches which pass the patient catheter EGMs, sensor signals, and Back Patch signals through to the RHYTHMIA HDx Mapping System and disconnects the ablation catheter signals from the FARASTAR Generator. Prior to an application of Pulsed Field Ablation energy, the FARASTAR Generator signals the RSM and MSM to enter Blank Mode which is maintained during any periods of PFA delivery. During Blank Mode, the EGMs, sensor signals, and Back Patch signals are disconnected from the patient, and the inputs to the RHYTHMIA HDx Mapping System are electronically tied together by the MSM to reduce any noise pickup from being injected into the Mapping System. The MSM also connects the ablation catheter signals to the FARASTAR Generator to enable PFA delivery. When ablation is complete, the MSM returns to Pass-Through Mode. A manual test switch on the back of the MSM enclosure forces temporary entry into Blank Mode and must only be used for testing purposes. If the generator synchronization signal or the manual test switch instructs the MSM to enter Blank Mode, the mode will be entered. There is a BLANK LED indicator on the MSM enclosure showing when Blank Mode is active. The mode of the MSM is also communicated to the RHYTHMIA HDx Mapping System via the Analog Out connector and BNC/Phono cable. When the MSM is powered off, there is a direct connection between the input and output signals. This mimics direct connections between the patient and the attached down-stream equipment to ensure a safe mode if the MSM is off or unintentionally unpowered. There is a POWER LED indicator on the MSM enclosure showing the power state of the device. The MSM also internally checks the state of the switches which route the high-voltage PFA delivery. If there is any detected issue, the ERROR LED indicator will light up on the front panel during Blank Mode. The MSM is meant to be used in conjunction with: • FARASTAR PFA Generator • FARASTAR Recording System Module • Compatible Boston Scientific navigation-enabled PFA catheter • FARASTAR Catheter Connection Cable (GEN 1.0 or GEN 2.0) • FARASTAR Mapping System Module Back Patch Cable • FARASTAR Mapping System Module Back Patch Cable, Male • FARASTAR Mapping System Module BNC/Phono Cable • FARASTAR Mapping System Module RHYTHMIA ABL Cable • FARASTAR Mapping System Module RHYTHMIA Breakout Box Cable • FARASTAR Auxiliary Cable • Boston Scientific RHYTHMIA HDx Mapping System 1.4 Panel Interfaces The front and rear panel interfaces of the Mapping System Module shown below.

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BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

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2

6

7

3

8

9

4

10

11

Figure 2. Mapping System Module Front Panel Figure 2 Legend: 1 - CATH (PATIENT) 2 - CATH (GENERATOR) 3 - AUX

4 - RHYTHMIA ABL 5 - PATCH (PATIENT) 6 - PATCH (RHYTHMIA)

7 - POWER LED 8 - BLANK LED 9 - ERROR LED

10 - ANALOG OUT 11 - RHYTHMIA M/A/B

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1

2

3

4

Figure 3. Mapping System Module Rear Panel Figure 3 Legend: 1 - Power Switch

2 - Blanking Switch

3 - Power Cord Port

4 - Equipotential

1.5 Cable Connections • CATH (PATIENT): Connnect the FARASTAR Catheter Connection Cable (GEN 2.0). Connect the other end to a compatible Boston Scientific navigation-enabled PFA catheter. • CATH (GENERATOR): Connnect the FARASTAR Catheter Connection Cable (GEN 1.0 or GEN 2.0). Connect the other end to the FARASTAR Generator CATH connector. • PATCH (PATIENT): Connnect the Mapping System Module Back Patch Cable. Connect the other end to the RHYTHMIA HDx Mapping System Back Patch. • PATCH (RHYTHMIA): Connnect the Mapping System Module Back Patch Cable, Male. Connect the other end to the RHYTHMIA HDx Mapping System Patch connector. • AUX: Connnect the FARASTAR Auxiliary Cable. Connect the other end to the FARASTAR Recording System Module AUX connector. • ANALOG OUT (RHYTHMIA): Connnect the Mapping System Module BNC/Phono Cable. Connect the other end to the RHYTHMIA HDx Mapping System Analog Input port. • RHYTHMIA ABL: Connnect the Mapping System Module RHYTHMIA ABL Cable. Connect the other end to the RHYTHMIA HDx Mapping System ABL IN port. • RHYTHMIA M/A/B: Connect the Mapping System Module RHYTHMIA Breakout Box Cable. Connect the other end to the RHYTHMIA HDx Mapping System A or B port. 1.6 Additional Items for Safe Use • Boston Scientific-approved back patch 1.7 Intended User Use of the FARASTAR MSM is intended for those physicians who are specialists trained in cardiac ablation procedures to treat cardiac arrhythmias in a fully-equipped electrophysiology laboratory. Device specific physician in-service training is made available by Boston Scientific. 2. INTENDED USE The FARASTAR Mapping System Module by Boston Scientific is a component to the FARASTAR PFA Generator, and its primary function is intended to filter/protect the inputs of the Boston Scientific RHYTHMIA HDx Mapping System, when used with a compatible Boston Scientific navigation-enabled PFA catheter. The FARASTAR MSM is part of the FARAPULSE PFA System.

4. INTENDED PATIENT POPULATION The FARAPULSE PFA System is intended for use in adult (18 ≤ age ≤ 75 years) cardiac arrhythmia patients, excluding pregnant or nursing patients, as there are no studies to support the use of the FARAPULSE PFA System in patients who are pregnant, nursing, < 18 years of age, or > 75 years of age. 5. CLINICAL BENEFIT STATEMENT The FARASTAR MSM is part of the FARAPULSE PFA System. Refer to the compatible Boston Scientific navigation-enabled PFA catheter Instructions for Use for the Clinical Benefits of the FARAPULSE PFA System. 6. SUMMARY OF SAFETY AND CLINICAL PERFORMANCE For customers in the European Union, use the device name found in the labeling to search for the device’s Summary of Safety and Clinical Performance, which is available on the European database on medical devices (EUDAMED) website: https://ec.europa.eu/tools/eudamed 7. CONTRAINDICATIONS The FARASTAR MSM is contraindicated where such use may present an unacceptable risk to the patient. Refer to the contraindications section in the respective catheter Instructions for Use and FARASTAR PFA Generator User Manual. 8. WARNINGS • The FARASTAR MSM must be installed by a qualified/trained Boston Scientific representative. For assistance with installation, please contact your local Boston Scientific representative or Technical Support. • Cardiac mapping and ablation procedures should be performed only by physicians thoroughly trained in invasive cardiology, in the techniques of mapping and ablation, and in the specific approach to be used, in a fully-equipped electrophysiology lab. 5

MB Drawing 50573138

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BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

3. INDICATIONS FOR USE The FARASTAR Mapping System Module (MSM) is indicated for use in an electrophysiology lab environment, as a filtering/protection unit for inputs of the Boston Scientific RHYTHMIA HDx Mapping System, when used with a compatible Boston Scientific navigation-enabled PFA catheter.

• • • • • • • • • • •

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BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

• •

Ensure that all devices are connected to their properly labeled connections. Failure to do so can result in inaccurate catheter or ECG recordings, inaccurate pacing locations, inaccurate rendering on the Navigation System, which may result in patient injury not limited to cardiac trauma or arrhythmia. To avoid the risk of electric shock, the FARASTAR MSM must always be connected to a supply mains with protective earth. There are no user serviceable parts in the FARASTAR MSM and it should not be opened. Maintenance should only be carried out by trained authorized personnel. Do not attempt to service the FARASTAR MSM while in use with a patient as patient or user injury may occur. The Equipotential ground provides a direct connection between the chassis of the FARASTAR MSM and the equalization bus of the electrical installation. It is not a protective earth connection point. Before using, inspect the FARASTAR MSM for any defects or physical damage. Do not use defective or damaged devices. Replace damaged equipment if necessary. No modification of this equipment is allowed. The FARASTAR MSM must only be used with equipment and accessories listed in this manual or patient injury or death may occur. Use only with equipment and cabling that are listed in this manual or tested during installation of the equipment. Use with untested equipment or cables could result in increased EM emissions or decreased EM immunity. Portable Radiofrequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of this equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result in patient or user harm. Direct patient contact should be avoided during ablation delivery as this may result in a mild electrical sensation and/or electric shock to the user. Do not touch the FARASTAR PFA Generator/accessories and the patient simultaneously as this may cause excessive leakage currents on the patient which could lead to arrhythmias. Ensure that any additional equipment used with the FARAPULSE PFA System has been certified to IEC 60601-1. Use of non-certified equipment can increase the risk of patient harm due to failure of protective isolation barriers that could place hazardous voltages on the patient or operator or cause excessive leakage currents that may increase the risk of cardiac arrhythmias. Do not use a power bar or extension cord when connecting the FARASTAR PFA Generator and accessories to the hospital AC source as this could cause an increase in leakage currents. Ensure that each powered component used within the FARAPULSE PFA System is plugged into separate AC mains connections. Do not use a power bar to connect any combination of powered components together to an AC mains supply as doing this could cause an increase in leakage currents. Ensure that equipment is used at 100VAC-240VAC, 50Hz/60Hz. Carefully read the RHYTHMIA Mapping System instructions prior to use as patient or user injury may occur.

9. PRECAUTIONS • During the procedure, if unexpected behavior of down-stream equipment is experienced, check the cable connections to the FARASTAR Generator, Recording System Module, and RHYTHMIA HDx Mapping System, confirm all units are powered on, and ensure the MSM Test switch is set to Normal mode. See the respective user manuals of each component for details on system connections and setup. • During the procedure, the Blank LED should light each time an ablation is performed by the Generator. This is required for the ablation energy to reach the patient and perform the intended therapy. If the Blank LED does not light during ablation, the unit should be checked by a trained field service representative or returned to Boston Scientific for repair. • If the Error LED is observed during use of the MSM, the unit should be checked by a trained field service representative or returned to Boston Scientific for repair. • If the RHYTHMIA HDx Mapping System is re-started or if the MSM is power cycled during the procedure, the recognition of the catheter and Mapping System Module may need to be refreshed. If this occurs, disconnect and reconnect the cable connection between the MSM and RHYTHMIA HDx Signal Station’s ABL IN port to allow the RHYTHMIA HDx Mapping System to recognize the catheter and MSM. • Ensure the Phono jack connection from the MSM is fully inserted into the RHYTHMIA Analog Input connector on the rear panel of the RHYTHMIA HDx Signal Station to provide solid connections. • If after an ablation the RHYTHMIA HDx Mapping System is showing that ablation ON is still detected (e.g. glow at the ablation catheter tip, colored overlays on RHYTHMIA graph displays), power-cycle the MSM and double-check the Phono jack connection is fully inserted into the Signal Station’s Analog Input port. • For purpose of disconnection, the mains connection is on the back side of the device. • The MSM component should be tested prior to use by installation staff personnel to ensure proper function. • Before cleaning the MSM, ensure that it is powered OFF and disconnect the mains cord from the device. Clean the module by wiping down surfaces using a non-abrasive cloth with a mild detergent solution (not containing enzymes, abrasives, bleach, or alkali) or isopropyl alcohol. • Electromagnetic interference (EMI) produced by the FARASTAR MSM may adversely affect the performance of other equipment. When EMI is observed on other equipment, contact Boston Scientific personnel for assistance. Avoid placing this equipment adjacent to or stacking on top of other electrical equipment. • This equipment is intended for use in hospitals except near active High Frequency (HF) surgical equipment (including diathermy and electrocautery equipment) or Radiofrequency (RF) shielded room of a Medical Electrical (ME) system for magnetic resonance imaging where the intensity of Electromagnetic Interference (EMI) is high. • Do not use the FARASTAR MSM closer than 30 cm (12 inches) to any Wireless Power Transfer (WPT) and 5G cellular devices, otherwise electromagnetic interference from those devices could result in degradation of the performance of this equipment. • The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). • Perform pulsed field ablation procedures only within environmental parameters as outlined in section 11.2. • It is the user’s responsibility to ensure that the equipment used with the system meets all local applicable electrical safety standards. • Use of this equipment adjacent to or stacked with other equipment should be avoided as it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. • Inspect all components before use. Do not use if the package or items therein appear to be damaged or defective. • Test Mode is only meant for temporary use during installation and system checks-do not leave the unit in test mode. Defibrillation of the patient should not be performed when the unit is in Test Mode or during PFA deliveries. • Avoid intentional or accidental liquid spills on the FARASTAR MSM. Do not place cups or containers of liquid on the module. Do not handle the module with wet hands or gloves. Do not use the module near irrigation equipment.

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10. ADVERSE EVENTS Any potential clinical complications are in large part expected to be related to the FARASTAR PFA Generator/accessories, RHYTHMIA Mapping System, and/or catheters that are used with the system, rather than the system itself. In order to identify potential adverse events, the user is instructed to read the pertinent instructions for use associated with the generator, catheters, and accessories that will be employed during the ablation procedure. 11. HOW SUPPLIED The MSM is packaged and supplied in a corrugated box. 11.1 Device Details Do not use if package is damaged or unintentionally opened before use. Do not use if labeling is incomplete or illegible. 11.2 Handling and Storage Do not use if the FARASTAR MSM is exposed to environmental conditions outside of the following ranges: Operating Conditions Temperature: 15 °C to 30 °C Relative Humidity: 30% to 75% Atmospheric Pressure: 80 kPa to 106 kPa Transport and Storage Conditions Temperature: -30 °C to 60 °C Relative Humidity: 15% to 90% Atmospheric Pressure: Uncontrolled 11.3 Service Life The expected service life of this equipment is 3 years. 12. OPERATIONAL INSTRUCTIONS

Model Number

Geography

Overall Length

M004FP6210

European Union (EU)

2.5 m

M004FP6220

Italy

2.5 m

M004FP6230

Australia / New Zealand

2.5 m

M004FP6240

North America

3.05 m

M004FP6250

Japan

2.5 m

M004FP6260

Switzerland

2.5 m

M004FP6270

United Kingdom (UK) / Ireland

2.5 m

M004FP6280

China

2.5 m

M004FP6290

Argentina

2.5 m

M004FP62100

Brazil

2.5 m

M004FP62110

Denmark

2.5 m

M004FP62120

Israel

2.5 m

M004FP62130

South Africa

2.5 m

M004FP62140

India

2.5 m

M004FP62150

Korea

2.5 m

12.1.1 Instructions for Use - Power Supply Cord If not already connected, connect the Power Supply Cord to the FARASTAR MSM and to the hospital wall outlet prior to powering up the FARASTAR MSM. After shutting down the FARASTAR MSM, disconnect the Power Supply Cord from the hospital wall outlet. 12.2 Prior to Procedure Prior to the procedure, perform the following steps: 1. Ensure the FARASTAR MSM has been tested on site and verified as functional by trained personnel. 2. Prior to the procedure, plug in the MSM’s power supply cord to the hospital wall out and turn on the power switch. Confirm the POWER LED is illuminated. The MSM must be powered before connecting it to the RHYTHMIA HDx Mapping System inputs. 3. Confirm that when the switch on the back is set to TEST, the BLANK LED is illuminated and the ERROR LED is not illuminated. 4. Before the procedure, ensure the TEST switch is in the NORMAL position, the BLANK LED is not illuminated, and the ERROR LED is not illuminated. 5. Connect the Mapping System Module front panel as described in the Cable Connections section. 6. Connect the Recording System Module and FARASTAR Generator as instructed in their respective User’s Manuals.

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MB Drawing 50573138

Black (K) ∆E ≤5.0 / CMYK

BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

12.1 Power Supply Cord The FARASTAR MSM Power Supply Cord supplies AC electricity to the FARASTAR MSM. It is required for MSM operation. The Power Supply Cord connects to the FARASTAR MSM at the designated inlet on the rear of the MSM. The other end connects to a standard source of line power (wall outlet). The following Power Supply Cord models are designed for use with the FARASTAR MSM.

12.3 Usage during an Electrophysiology Procedure During the procedure, perform the following steps: 1. Ensure the MSM is powered on throughout the procedure and is set to NORMAL mode. The POWER LED is illuminated and the BLANK LED is not illuminated in this mode. 2. If using a compatible mapping catheter, ensure the compatible mapping catheter is disconnected from the RHYTHMIA HDx Mapping System Signal Station M IN port prior to starting PFA deliveries. 3. Physical interaction with the MSM is not required during the procedure. The following methods are provided for debugging purposes. • If the RHYTHMIA HDx Mapping System is unable to recognize a compatible Boston Scientific navigation-enabled PFA catheter, with both systems still powered on, disconnect and reconnect the ABL or Breakout Box Cable connected to the respective port(s) on the RHYTHMIA HDx Signal Station. • When PFA exposure is imminent, the FARASTAR Generator, via a synchronization signal from the Recording System Module, will automatically switch the MSM into Blank Mode temporarily, in which case the BLANK LED will light. This may be visually monitored during ablations to confirm operation. If the BLANK LED does not light during ablations, check cable connections. • If during PFA delivery the MSM’s ERROR LED is illuminated, the unit must be removed from the setup for the remainder of the procedure, as this error may indicate reduced therapy is getting to the patient. If a replacement MSM is not available, the RHYTHMIA HDx Mapping System should not be used and must be removed from the setup. The EGM signals from the compatible navigation-enabled PFA catheter may be accessed using the EGM connector port on the FARASTAR Generator panel and provided to the Recording System Breakout Box inputs using the appropriate FARASTAR EGM Cable for the remainder of the procedure. In this setup, display and tracking of compatible navigation-enabled PFA catheter will not be available. • If the RHYTHMIA HDx Mapping System is re-started during the procedure or if the MSM is power-cycled, the recognition of the catheter and MSM may need to be refreshed. If this occurs, disconnect and reconnect the cable connection between the MSM and RHYTHMIA HDx Signal Station’s ABL IN, A, or B port to allow the RHYTHMIA HDx Mapping System to recognize the catheter and MSM. • If after an ablation the RHYTHMIA HDx Mapping System is showing that ablation ON is still detected (e.g. glow at the ablation catheter tip, colored overlays on RHYTHMIA graph displays), power-cycle the MSM and ensure the Phono jack connection is fully inserted into the Signal Station’s Analog Input port. • If any down-stream equipment experiences inappropriate reset or sensed activity, ensure there are no parallel connections around the MSM which would connect the patient directly to the equipment. Also, confirm power and connections, verify input vs. output cabling is well separated, and check that output cable lengths are minimized/coiled on their way to the down-stream equipment. • If signals are unable to reach the down-stream equipment, double check connections. If that does not resolve the issue, power-off the MSM which directly connects input to output, to debug the root of the problem. 4. At the completion of the procedure, power OFF the MSM. Disconnect inputs/outputs and store the unit flat with feet side down. 13. ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION The tables below contain FARASTAR MSM compliance information on the electromagnetic emissions and immunity. As the equipment user, you have shared responsibility in meeting compliance levels by ensuring that the electromagnetic environment requirements are met. 13.1 EMC Specifications & Labeling FARASTAR MSM Electromagnetic Emissions

BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

The FARASTAR MSM is intended for use in the electromagnetic environment specified below. The customer or the user of the FARASTAR MSM should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment

RF Emissions EN 55011 /CISPR 11

Group 1 Note: Group 1 Industrial, Scientific and Medical (ISM) Equipment is equipment containing intentionally generated and/or used conductivity coupled radio-frequency that is necessary for the internal functioning of the equipment itself.

The system uses RF energy only for its internal function. Nearby electric equipment may be affected.

RF Emissions EN 55011 /CISPR 11

Class A Note: Class A equipment is equipment suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.

Harmonic Emissions EN 61000-3-2

Class A

The system is suitable for use in all establishments other than domestic, and may be used connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: WARNING: The system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orientating or relocating the system or shielding the location.

Flicker Emissions IEC 61000-3-3

Complies

13.2 Electromagnetic Immunity FARASTAR MSM-Electromagnetic Immunity The FARASTAR MSM is intended for use in the electromagnetic environment specified below. The customer or the user of the FARASTAR MSM should assure that it is used in such an environment. System Error would indicate any essential performance loss or degradation due to EM disturbances. Immunity Test

EN 60601 Test Level

Compliance Level

Electromagnetic Environment

Electrostatic Discharge EN 61000-4-2

± 8 kV contact discharge ± 15 kV air discharge

± 8 kV contact discharge ± 2, 4, 8, 15 kV air discharge

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient/Burst EN 61000-4-4

± 2 kV AC mains ± 1 kV I/O lines 5 kHz burst

± 2 kV AC Mains ± 1 kV I/O lines 5 kHz burst

Mains power quality should be that of a typical commercial or hospital environment. Sharing mains power lines with large motors and/or noisy equipment must be avoided.

Surge Line to Line (AC Power) EN 61000-4-5

± 1 kV line to line ± 2 kV line to ground

± 0.5, 1 kV line to line ± 0.5, 1, 2 kV line to ground

Mains power quality should be that of a typical commercial or hospital environment.

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Immunity Test

EN 60601 Test Level

Compliance Level

Electromagnetic Environment

Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11

0% dip in Ut .5 cycle 0% dip in Ut 1 cycles 70% dip in Ut 25/30 cycles at 50/60Hz 0% dip in Ut 250/300 cycles at 50/60Hz

0% dip in Ut .5 cycle 0% dip in Ut 1 cycles 70% dip in Ut 25/30 cycles at 50/60Hz 0% dip in Ut 250/300 cycles at 50/60Hz Note: The system passed this specific test requirement, however if the loss of power turns off the system, the power switch must be turned OFF and then back ON.

Mains power quality should be that of a typical commercial or hospital environment. If you require continued operation of the system during power mains interruptions, use an uninterruptible power supply.

Power Frequency (50/60 Hz) Magnetic Field EN 61000-4-8

30 A/M

30 A/M

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Conducted RF EN 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

6 Vrms in ISM Bands between 0.15 MHz and 80 MHz

6 Vrms

3 V/m 80 MHz to 2.7 GHz And Proximity fields from RF wireless communication equipment per 8.10 of EN 60601-1-2

3 V/m And Per 8.10 of EN 60601-1-2

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = (3,5 / ) 150 KHz to 80 MHz d = (3,5 / E1) √P 80 MHz to 800 MHz d = (7 / ) √P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

65 A/m RMS before modulation is applied, at 134.2 kHz test frequency with a 2.1 kHz pulse modulated square wave at 50% duty cycle. 7.5 A/m RMS before modulation is applied, at 13.56 MHz test frequency with a 50 kHz pulse modulated square wave at 50% duty cycle.

65 A/m RMS before modulation is applied, at 134.2 kHz test frequency with a 2.1 kHz pulse modulated square wave at 50% duty cycle. 7.5 A/m RMS before modulation is applied, at 13.56 MHz test frequency with a 50 kHz pulse modulated square wave at 50% duty cycle.

Radiated RF EN 61000-4-3

Proximity Fields Immunity EN 61000-4-39

This symbol is labeled on medical equipment that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment. Close proximity magnetic fields should be that of a typical commercial or hospital environment.

13.3 Separation distances The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment. Radiated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

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Recommended separation distances between portable and mobile RF communications equipment and the system.

13.4 Pass/Fail Criteria Definition Test Category

Pass/Fail Criteria

Conducted Emissions

Class A – Group 1

Radiated Emissions

Class A – Group 1

Electrostatic Discharge

The system does not change state (charge or start an ablation) or freeze.1

Radiated RF EM Field

The system does not change state (charge or start an ablation) or freeze.1

Electrical Fast Transients/Bursts

The system does not change state (charge or start an ablation) or freeze.1

Surges Immunity

The system does not change state (charge or start an ablation) or freeze.1

Conducted Disturbances induced by RF fields

The system does not change state (charge or start an ablation) or freeze.1

Rated Power Frequency Magnetic Fields

The system does not change state (charge or start an ablation) or freeze.1

Voltage Dips

The system does not change state (charge or start an ablation) or freeze.1

Voltage Interruptions

The system does not change state (charge or start an ablation) or freeze.1

Proximity Fields Immunity

The system does not change state (charge or start an ablation) or freeze.1

Flicker Emissions

The system does not change state (charge or start an ablation) or freeze.1

Harmonic Emissions

The system does not change state (charge or start an ablation) or freeze.1

1

Error messages may be displayed and the system may reboot as this does not present an unacceptable risk to the user or patient.

14. DISPOSAL It is important to understand and follow all local laws regarding the safe and proper disposal of electrical instrumentation. The durable portions of the FARAPULSE PFA System shall be disposed of in accordance with local regulations. If you wish to discard this product(s), please contact your local authority or dealer for the correct method of electrical equipment disposal. 15. MAINTENANCE • The FARASTAR MSM must undergo annual preventative maintenance. Contact your local Boston Scientific representative to schedule this service, or for technical support. • Only trained and certified personnel may perform service or maintenance on the FARAPULSE PFA System. • Do not service the FARASTAR Generator, the FARASTAR Recording System Module, or FARASTAR MSM while the System is in use with a patient. • Any FARAPULSE PFA System component exposed to excessive shock, vibration, or any mishandling should be returned to Boston Scientific for evaluation. 16. INSPECTION FARASTAR MSM and components should be inspected for damage prior to use. Regularly inspect reusable cables for visual evidence of damage. Replace damaged components. 17. CLEANING • As needed, use a non-abrasive cloth with a mild detergent solution (not containing enzymes, abrasives, bleach, or alkali) or isopropyl alcohol to clean the outer surfaces of the FARASTAR MSM, power supply cord, and cables. • Cleaning should be performed at the end of each case at a minimum. • Do not attempt to clean any of the electrical connectors. Do not allow moisture or fluids to enter any of the electrical connectors or vents. • Never clean and reuse components that are sterile or that are intended for single use. 18. END-USER TRAINING MATERIALS End-user training materials have been developed for the FARAPULSE PFA System in accordance with Boston Scientific Standard Operating Procedures, to enable users to safely and properly use the device.

BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

19. CYBERSECURITY The FARASTAR MSM is not intended to be incorporated into an IT Network. 20. COMPLAINT REPORTING AND REQUESTS FOR INFORMATION In the event that a serious incident occurred in relation to the device, including all patient deaths for procedures where the Boston Scientific product was used, the event should be reported to Boston Scientific and the competent authority of the Member State in which the user and/or patient is established. Returning products for analysis and providing product performance observations helps drive higher reliability on an ongoing basis. 20.1 Contacts For service and support in using this system please contact Boston Scientific Support using the resources given below. Do not send any parts or equipment for service to Boston Scientific without prior authorization. Technical Support (North America) Tel 800 949 6708 Fax 510 624 2493 [email protected]

Technical Support (Europe, Middle East, Africa) Tel 0031 (0)45 5467707 Fax 0031 (0)45 5467805 [email protected]

Technical Support (Japan) Tel +81 03 6853 1000 Fax +81 45 444 2799 [email protected]

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21. PATIENT COUNSELING INFORMATION The physician should consider the following points while counseling patients on the use of the FARAPULSE PFA System and compatible Boston Scientific PFA Catheters in association with the electrophysiological cardiac interventional procedure: • Discuss the risks and benefits including review of potential adverse events associated with the system and catheter. • Discuss post procedure instructions, including any lifestyle changes, medications, when to call the Healthcare Provider (HCP) and any post procedure follow-up that might be needed. 22. WARRANTY For device warranty information, visit (www.bostonscientific.com/warranty). FARAPULSE, FARASTAR, FARAWAVE, RHYTHMIA, and RHYTHMIA HDx are trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.

23. SYMBOL DEFINITIONS Medical device symbols that appear on the device and/or labeling are defined at the end of this document. Additionally, commonly used medical device symbols are also defined at www. bostonscientific.com/SymbolsGlossary. The following symbols appear on the FARASTAR MSM: Meaning

Location

OFF (power) When a mains switch is moved to the position marked by this symbol, the FARASTAR MSM is OFF.

On the Power Switch.

ON (power) When a mains switch is moved to the position marked by this symbol, the FARASTAR MSM is ON.

On the Power Switch.

Defibrillation-proof type CF applied part

On patient side ECG and EGM connections and printed on label.

Equipotentiality

On the Equipotential Ground Post on the unit.

Fuse

On the rear, adjacent to the power supply cord inlet.

Non-ionizing electromagnetic radiation

This symbol does not appear on the device. The symbol is referenced by Section 13.2.

BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

Symbol

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MB Drawing 50573138

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Contents

Separate Collection

[blue safety sign] Follow Instructions For Use

AC Input

Temperature limitation.

Humidity limitation.

Atmospheric Pressure Limitation

Do not use if package is damaged.

Date of Manufacture

Manufacturer

Lot Number

Medical Device under EU Legislation

Authorized Representative in the European Community

Unique Device Identifier

Catalog Number

Serial Number

Importer

Authorized representative

BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

Authorized representative

Authorized representative

Authorized representative

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BSC (MB IFU Template 8.5 x 11 Global, 92310050M), IFU, MB, FARASTAR MSM, OUS, EN, 51663561-01A

Boston Scientific AG Ritterquai 8 4500 Solothurn Switzerland Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link bostonscientific.com/arg Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 Boston Scientific Limited Ballybrit Business Park Galway IRELAND Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA USA Customer Service +1-888-272-1001 www.bostonscientific.com

© 2024 Boston Scientific Corporation or its affiliates. All rights reserved.

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MB Drawing 50573138