AVVIGO Guidance System Users Manual April 2020

TABLE OF CONTENTS

SETTING UP THE NETWORK... 44

WARNING... 3

DICOM SETUP... 45

DEVICE DESCRIPTION... 3

CASE MANAGEMENT... 50

Contents... 3

SYSTEM UTILITIES... 51

INTENDED USE / INDICATIONS FOR USE... 3

Settings... 51

CONTRAINDICATIONS... 3

FFR / DFR™ Case Settings... 51

WARNINGS AND PRECAUTIONS... 3

FFR Link Management... 52

WARNINGS... 3

Set Date and Time... 52

Precautions ... 4

USER MANAGEMENT... 53

ADVERSE EVENTS... 4

Configure AVVIGO™ User(s)... 53

CLINICAL STUDIES... 4

Change Password... 53

CONFORMANCE TO STANDARDS... 5

Doctor Management... 54

Electromagnetic Emissions and Immunity Specifications... 6

Vessel Management... 54

HOW SUPPLIED... 8

Software Management... 54

Device Details... 8

Event Viewer... 55

Tablet... 8

AVVIGO SYSTEM SOFTWARE... 56

Battery... 9

PRIVACY AND SECURITY FEATURES... 56

Power Supply and Power Cord... 10

Technical Assistance... 58

Digital Pen... 10

WARRANTY... 59

Tablet Mobile Pole... 10

APPENDIX A: SYSTEM SPECIFICATIONS... 60

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Pole Docking Station... 10 Desktop Docking Station... 11

APPENDIX B: REQUIRED HARDWARE, SOFTWARE, AND DRIVERS FOR THE SYSTEM ... 60

Handling and Storage ... 11

APPENDIX C: COMPATIBLE ACCESSORIES ... 61

OPERATIONAL INSTRUCTIONS... 12

APPENDIX D: DFR™ VALIDATION STUDY SUMMARY... 61

Installation and Servicing... 12

SYMBOLS ON DEVICES AND PACKAGING... 62

Cleaning... 12 INSTALLATION GUIDE... 14 PROCEDURE... 36 Measuring Blood Pressure... 36 Connect to a FFR Link... 36 Zero AO... 37 Connect Pressure Guidewire... 37 Equalizing Pa and Pd... 37 Recording... 40 Reviewing a Run Recorded in FFR or DFR™... 41 Adding Case Information... 43 Closing a Case... 44

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CONTRAINDICATIONS The FFR / DFR modalities of the System has no patient alarm functions and should not be used for cardiac monitoring.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNINGS AND PRECAUTIONS It is not possible for Boston Scientific Corporation (hereafter referred to as “Boston Scientific” or “BSC”), to anticipate every condition and situation in which the AVVIGO System is used. The following warnings and precautions represent typical situations that require special attention. Your knowledge and experience with your specific application and environment must also be taken into consideration in order to help assure safety for personnel.

WARNING Carefully read all instructions prior to use. Observe all indications, contraindications, warnings, cautions, and precautions noted in these directions. Introduction This manual describes how to appropriately and safely use, maintain and troubleshoot the AVVIGO™ Guidance System.

Warning: A warning indicates that personal illness, injury, or death may occur to a patient and / or user if you do not observe the provided information.

DEVICE DESCRIPTION The AVVIGO Guidance System (hereafter, referred to the System) is a medical device system that consists of a touchscreen tablet with battery, a digital pen, a power supply and cable which can be mounted to a mobile pole via the pole docking station, or set on table top via the desktop docking station. The tablet is a non-sterile, non-implantable tablet computer controlled by a graphic user interface (GUI) displayed on a touchscreen. The tablet is powered by either AC Line power or a lithium polymer battery. The system software displays patient’s blood pressure measurements that are received from the coronary pressure guidewire and transducer that is connected to a FFR Link. The FFR Link digitizes and wirelessly streams the data which is displayed on the tablet.

WARNINGS Carefully read all instructions prior to use. Observe all indications, contraindications, warnings and precautions noted in these directions before attempting to use the AVVIGO System. • The System can only be used with Boston Scientific specified accessories and cables. The use of accessories and cables other than the items provided by Boston Scientific may result in increased emission or decreased immunity of the System. For questions regarding this matter, please contact Boston Scientific for technical assistance. • Use a shielded HDMI cable that is no longer than 2 meters when duplicating display. Use of a shielded HDMI cable that is longer than 2 m could result in increased electromagnetic emissions or reduced immunity. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. • The System is intended for use by healthcare professionals only. This equipment / system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the AVVIGO System or shielding the location. • Equipment is suitable for hospital environment except for near active high frequency surgical equipment and the RF shielded room of medical equipment for magnetic resonance imaging, where the intensity of electromagnetic disturbances is high. • Use of this equipment adjacent to or stacked with other equipment should be avoided because 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. • The System and / or the external equipment can be damaged if signal levels are not appropriate. If equipment not specifically authorized by Boston Scientific is to be connected, it must meet all applicable electrical safety standards that apply to the System in order to maintain the System’s safety integrity. • To achieve proper grounding reliability, the power plug must be

Note: The screen images used in this manual are representative and may not exactly match your screens. Contents The following are the contents of the standard packaging: Tablet (with AVVIGO Software and Battery) Power Supply Digital Pen Power Cable Tablet Mobile Pole Docking Station Desktop Docking Station Tablet Mobile Pole (packaged separately) FFR Link with accessories (packaged separately) User Information Intended clinical users for the FFR and DFR™ functionalities of the System are intended for use only by medical professionals fully qualified to perform interventional human blood pressure measurement procedures. It is assumed that all users are fully qualified in proper laboratory procedures and protocols. The System should only be assembled and installed by a trained biomedical technician. INTENDED USE / INDICATIONS FOR USE FFR and DFR are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

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Precaution: A precaution indicates that you could be inconvenienced by things such as loss of text entries or saved settings if you do not observe the provided information.

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fully inserted into a receptacle marked “Hospital Grade.” If there is any question of power outlet or power cord integrity, do not proceed. Obtain qualified technical assistance. To avoid the risk of electrical shock, this equipment must only be connected to a receptacle marked Hospital Grade supply mains with protective earth. The battery used in this device may present a risk of fire or chemical burn if mistreated. Do no disassemble, heat above 50 °C, or incinerate. Dispose of used battery promptly. To prevent fire or shock hazard, do not expose the AVVIGO™ System to moisture or rain. If it is necessary to transport the System through rain, place a protective cover over it. If moisture gets into the instrument, allow it to dry thoroughly before plugging the AC power cord into an electrical outlet. Spilling liquids on the System can damage it or cause it to shut down. Never pour any liquid into an opening. This may cause fire or electrical shock. In the unlikely event that smoke, abnormal noise, or strange odor is present, immediately power off the tablet and disconnect all power sources. Report the problem to Boston Scientific Technical Assistance immediately. During the operation, do not touch the metal part of battery connector / SIP / SOP output on touchscreen and the PATIENT simultaneously. Appropriately position the mobile pole / power cord to minimize tripping hazard. Avoid rolling the mobile pole over objects to prevent tipping and possible damage to the system. Inappropriate use of the System may lead to patient illness or injury. Please read this User Guide and the DFUs for the FFR link and pressure guidewires carefully and completely before attempting to use the System. Inappropriate use of the System may lead to misinterpretation of patient data and subsequent misdiagnosis / mistreatment, potentially leading to injury. No modification of this system is allowed. Do not attempt to disassemble any component of the Mobile Pole. The System is not intended for use in the sterile field. If the System stops functioning during a procedure, follow the procedure described in “Troubleshooting”. Exercise care when depressing the tablet touchscreen. Depressing the touchscreen too rapidly or too firmly can lead to it operating in an unintended manner. It is required to configure and run the System diagnostics tests as the first step to establish connectivity to various peripherals and verify successful installation. JPEG compression reduces both the spatial and grayscale quality of the stored image, even at the highest (100%) setting. This could impact the diagnostic quality of the images. Do not utilize this System setting without approval from your institution. Fluctuations in AC power (voltage dips or surges), may result in unpredictable behavior of the System and may affect the reliability of diagnostic waveforms.

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ADVERSE EVENTS None known DISCLAIMERS Document Boston Scientific makes no representations or warranties of any kind concerning the contents of this publication. Under no circumstances will Boston Scientific be held liable for any loss or other damages pertaining to the use of this publication. This publication is general in nature. The information contained in this publication is subject to change without notice. Boston Scientific reserves the right to make changes and product improvements at any time and without prior notice. Consult your local Boston Scientific representative for information regarding the current version of this publication that is applicable to your System. Proper Usage: Indemnification Since its products are used in circumstances beyond Boston Scientific’s control, the buyer and user agree to assume all liability and to be solely responsible for, and to defend, indemnify, and hold Boston Scientific harmless from any claims or damages whether arising from warranty, contract, or otherwise (including negligence, strict liability, and failure to warn) based on improper inspection, selection of patients, application, operation, or use of Boston Scientific products, including multiple use of single-use items.

Precautions • Always exercise care and caution when operating and handling the System. • Avoid rolling equipment casters of any size or weight over the cables. • The AVVIGO System must be shutdown using the application software

CLINICAL STUDIES Refer to Appendix C for the DFR™ Validation Study Summary. This summary also includes the contrast studies.

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controls. Avoid using the Power Button (“hold 4 + seconds” feature) to turn off the tablet-this form of hardware shutdown is intended to be a means of recovery from lockups, and not as normal operation. If the tablet power button is pressed while recording a run, the recorded data may become corrupted. In case of abnormal System operation, the System may require shut down and restart to bring it to normal operation. Follow the normal shutdown and startup procedures listed in the Operating Instructions. If you archive- the case will be deleted after 6 months, if you don’t archive the system will prompt the user to archive when the disk space is less then 20 percent of the maximum capacity. Make certain that you have selected only the cases you want to delete, and that you have read and understand the warning in the Delete Selected Cases Confirmation window. After you select Yes in this window, your selected cases are deleted and cannot be recovered. Before attempting to write DICOM files to removable media, make sure that a removable USB is inserted in the tablet. Double-check to be sure you select the bookmark you want to delete. There will be no warning from the System. This action cannot be undone. Medical electrical equipment requires special precautions regarding electromagnetic compatibility. Use only with BSC supplied external power supply. Using other power supplies may cause damage to the tablet. The power supply and the tablet may become hot during normal use. Allow for proper ventilation around the power supply and charging tablet. Only use your finger or the BSC supplied digital pen to tap to operate the touchscreen. Do not use sharp pointed objects to operate the Touchscreen, as doing this could cause permanent damage to the touchscreen and void the warranty.

CONFORMANCE TO STANDARDS The AVVIGO™ Guidance System has been designed, manufactured, and tested to comply with the following internationally recognized standards:

Standard Number

Details of Standard to which the System complies

EN 60601-1

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

EN 60601-1-1

MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

EN 60601-1-2

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS

EN 60601-2-34

International Electrotechnical Commission (IEC) standard describing the safety and performance of invasive blood pressure monitoring equipment. Note: The FFR Link complies with EN 60601-2-34.

EN 62304

Medical Device Software - Software Life-Cycle Processes.

EN 62133

International Standard that specifies requirements and tests for the safe operation of portable sealed secondary cells and batteries (other than button) containing alkaline or other non-acid electrolyte, under intended use and reasonably foreseeable misuse.

IC-RSS-210

License-exempt Radio Apparatus (All Frequency Bands): Category I Equipment. This document sets out the minimum certification requirements for equipment certification of low power radio apparatus used for radio communication other than broadcasting.

EN 62353

Recurrent test and test after repair of medical electrical equipment - Section 5 Interval for Recurrent Electrical Safety Testing – Annex F Example of Test Documentation- Annex G

IEC 62366-1

Medical devices – Part 1: Application of usability engineering to medical devices

2014/30/EU

Harmonization of the laws of the Member States relating to electromagnetic compatibility (EMC Directive)

2011/65/EU

Restriction of the use of certain hazardous substances in electrical and electronic equipment

2006/66/EC

Battery Directive

RoHS Directive

Directive of the European Parliament and of the Council on the restriction on the use of certain hazardous substances in electrical and electronic equipment

Brazil RDC 185

TECHNICAL REGULATION REGISTRATION OF MEDICAL PRODUCTS, ITS ALTERATION, REVALIDATION, OR CANCELLATION

Waste Electrical and Electronic Equipment (WEEE)

Directive of the European Parliament and of the Council on waste electrical and electronic equipment

Radio Equipment Directive

European Union Compliance Radio Equipment Directive. Establishes a regulatory framework for placing radio equipment on the market. The full text of the compliance documentation is available at the internet address: www.bostonscientific.com/EUcompliance/RED

Note: The battery, power supply, power cable, pole docking station and desktop docking station are non-medical accessories and are individually CE marked by the respective manufacturers.

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Table 1. AVVIGO Guidance System Conformance to Standards

Electromagnetic Emissions and Immunity Specifications Refer to the following tables, which present electromagnetic emissions and immunity specifications for the AVVIGO™ Guidance System and the applicable international standards to which these specifications comply. As the equipment user, you have shared responsibility in meeting compliance levels by ensuring that the electromagnetic environment requirements are met. Precaution: The System can only be used with Boston Scientific specified accessories, catheters, and cables. The use of accessories and cables other than the items provided by Boston Scientific may result in increased emission or decreased immunity of the System. For questions regarding this matter, please contact Boston Scientific for technical assistance. Table 2. AVVIGO Guidance System Electromagnetic Emissions The AVVIGO Guidance System is designed for use in the electromagnetic environment specified below. Ensure that this system is used in such an environment. Emission Test

Compliance

Electromagnetic Environment

RF Emissions EN 55011 / CISPR 11

Group 1

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

RF Emissions EN 55011 / CISPR 11

Class A2

The AVVIGO Guidance System is suitable for use in all establishments other than domestic, and may be used connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: The AVVIGO Guidance 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 BSC Guidance System or shielding the location.

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Harmonic Emissions EN 61000-3-2 Voltage Fluctuations / flicker emissions EN 61000-3-3

Compliant

Group 1 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. 2 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.

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Table 3. AVVIGO™ Guidance System Electromagnetic Immunity The AVVIGO Guidance System is designed for use in the electromagnetic environment specified below. Ensure that the System is used in such an environment. Immunity Test

EN 60601 Test Level

Electrostatic Discharge (ESD) EN 61000-4-2

± 8 kV contact discharge ± 8 kV contact discharge ± 2 kV, ± 4 kV, ± 8 kV, ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air discharge ± 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 100 kHz repetition frequency

± 2 kV AC Mains ± 1 kV I/O Lines 100 kHz repetition frequency

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

± 1 kV Line to Line ± 2 kV Line to Ground1

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

Voltage dips IEC 61000-4-11

0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT 1 cycle and 70% UT 25/30 cycles Single phase: at 0°

0 % UT; 0.5 cycle Mains power quality should be that of a typical At 0°, 45°, 90°, 135°, commercial or hospital environment. If you require 180°, 225°, 270° and 315°1 continued operation of the AVVIGO Guidance System during power mains interruptions, use an uninterruptible 0% UT 1 cycle and power supply. 70% UT 25/30 cycles Single phase: at 0°

Voltage interruptions IEC 61000-4-11

0% UT 250/300 cycle

0% UT 250/300 cycle1

Power Frequency (50 / 60 Hz) magnetic field EN 61000-4-8

30 A/m

30 A/m

50 Hz or 60 Hz

50 Hz and 60 Hz

Conducted RF

6 V in ISM bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz

6 V in ISM bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz

3 V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz

3 V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz

380 - 390 MHz: 27 V/m 430 - 470 MHz: 28 V/m 704 - 787 MHz: 9 V/m 800 - 960 MHz: 28 V/m 1700 - 1990 MHz: 28 V/m 2400 - 2570 MHz: 28 V/m 5100 - 5800 MHz: 9 V/m

380 - 390 MHz: 27 V/m 430 - 470 MHz: 28 V/m 704 - 787 MHz: 9 V/m 800 - 960 MHz: 28 V/m 1700 - 1990 MHz: 28 V/m 2400 - 2570 MHz: 28 V/m 5100 - 5800 MHz: 9 V/m

Radiated RF EN 61000-4-3 Proximity Fields from RF wireless communications equipment EN 61000-4-3

Electromagnetic Environment

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital (Professional healthcare) environment. 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:

This symbol is labeled on medical equipment that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment

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. FFR modality function provides real-time intravascular pressure readings, and a ratio of these two pressure readings. It is possible that the system can be subjected to line surges and voltage dips / interruptions at or less than the levels defined in the Electromagnetic Immunity Table above and result in a loss of Bluetooth™ wireless connection. Loss of Bluetooth wireless connection would consequently result in the loss of FFR modality function. If this occurs, follow the System’s on-screen instructions to re-establish this function. 1

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EN 61000-4-6

Compliance Level

Federal Communication Commission Interference This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and Canadian ICES-003. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. This device and its antenna(s) must not be co-located or operating in conjunction with any other antenna or transmitter. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio / TV technician for help. There is no guarantee that interference will not occur in a particular installation. FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. HOW SUPPLIED Device Details The System equipment and accessories are supplied non-sterile in individual shipping containers. The System consists of a touchscreen tablet with battery and power supply, power cord, mobile pole, pole docking station, desktop docking station and digital pen. Before use, inspect for any damage or defects. Do not use if package is damaged or unintentionally opened before use. Do not use if labeling is incomplete or illegible. Do not use potentially defective equipment. If the System appears to be damaged, contact your Boston Scientific representative. Tablet The touchscreen tablet is supplied with built in software and battery. The tablet is primarily intended to be operated while connected to the ACpowered external power supply, and may also be operated on battery power provided that the battery is adequately charged. Make sure the battery is adequately charged prior to use.    

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Figure 1. AVVIGO™ Systems Connections [1] Headphones, [2] USB 3.0 Port, [3] DC Power Connection, [4] Ethernet Port, [5] HDMI Port, [6] USB 2.0 Port, [7] USB 2.0 Port, [8] Programmable Button (disabled), [9] Programmable Button (disabled), [10] Programmable Button (disabled), [11] Power, [12] Tablet Docking Station Connector Power Button- To activate the tablet, push the Power Button and hold until the power indicator illuminates, then release it.

Power Indicator

AVVIGO Guidance System TM

+ #

Power

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Figure 2–. AVVIGO Power Button and Indicator •

Avoid using the Power Button (“hold 4 + seconds” feature) to turn off the tablet-this form of hardware shutdown is intended to be a means of recovery from lockups, and not as normal operation. 8

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Note: Blinking blue indicates the battery is charging.

Note: To conserve battery power, use push and quick release on the power button which will “Shutdown” the tablet.

2. •

On screen selections are activated by a finger press or the digital pen.

Embedded in Tablet Software Battery Status Icons Indicating Charge Percentage and is displayed in the lower right corner on the touchscreen.

Percent (%) Charge

1

ICON Color

35-100 Green 15 - 35 Yellow

2

Below 15

Figure 3. AVVIGO™ Back Panel

Red

Note: Depending on the age and usage history of the battery, a maximum charge should last significantly longer than two hours of normal operation.

[1] Replacement Battery, [2] Tablet Stand Battery The battery is provided with the tablet and as a replaceable accessory. The battery shipped with your tablet may be low in power. To adequately charge the battery, plug the power supply into the tablet and power cord into a grounded hospital supply mains. The battery will (re)charge whenever it is connected to the ACpowered external power supply. When the battery is charging, the blue-colored Battery indicator light should blink slowly. If plugging in the power adapter does not trigger this blinking activity and the LED stays dark, the battery may have been drained substantially. Try unplugging / replugging the power supply to the tablet a few times to activate the charging process. The tablet has a built in extended battery life mode which prevents it from being charged above 80%.

Battery Replacement Note: The battery is recommended to be replaced when it no longer maintains a charge for at least two hours. How to replace your tablet battery:

1. 2.

Turn off the tablet and disconnect the power cable. Turn the tablet over so the bottom is facing up and locate the battery latch. (Remove tablet handstrap if necessary) A. Slide the safety lock. B. Push the latch switch down to release the battery. C. Lift up on the battery to remove it from the compartment.

Battery Indicator

AVVIGO Guidance System TM

B 

+ #

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A  C 

Figure 4. AVVIGO Power Indicator Battery status is a percent of charge remaining. The battery charge status is displayed in two ways: 1. On Tablet- Power Indicator Percent (%) Charge

Indicator Color

25-100

Blue

11-25

Orange

Below 10

Blinking Orange

Figure 5. Battery Replacement Note: Avoid touching the contacts on the battery itself or inside the compartment as the fingertip oils could reduce the battery conductivity.

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Note: Do not remove the battery from its original packaging until required for use.

3.

Take the replacement battery and line up the conductors and slide it into the compartment. Make sure the battery is in the correct orientation. 4. Push down on the battery until the latch clicks, then slide the safety lock button into the lock position. 5. Plug in the power cable to charge the battery. Battery Specifications Battery Capacity

5400mAh or 61.56Wh

Output Voltage

11.4Vdc

Sustaining Time

2 hours

Expected Service Life

2 Years*

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*May vary with usage.

Power Supply and Power Cord The power supply and cord powers the tablet directly, or indirectly via the pole or desktop docking station(s) and charges the battery when plugged into a hospital mains power socket. The power supply plugs to the DC-In on the tablet and the power cord plugs from the power supply AC adapter to the hospital mains power socket. The cables are supplied in 15 ft lengths with country specific prong configurations. Digital Pen The digital pen is designed to work like a mouse tool to select GUI elements on the tablet touchscreen. The digital pen is supplied with a AAAA battery and can be attached to the tablet with the lanyard (refer to the Installation Guide Step 10). Turn on the digital pen by pressing the pen power button. The pen will power off after two minutes without use.

  Figure 8. The tablet mobile pole is supplied with the following features: 1. Tilt Adjustment – the tablet viewing angle can be adjusted using the mobile pole tilt adjustment handle. 2. Handle – facilitates repositioning of the System. Note: It is recommended to use the handle to move the System. 3.

Pen Power Button

4. 5.

Pen Tip

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Figure 6. Digital Pen To add and replace the digital pen battery: 1. Unscrew the top cap of the digital pen 2. Remove the battery, and then replace with a new AAAA battery.

Bracket with cord wrap hook secures the power supply and power cord during use and storage. Locking wheels provide stability during use and storage. Foot pedal adjusts the tablet mobile pole height. Caution: The tablet mobile pole height adjustment operates by pneumatic pressure and will travel upward when the foot pedal is engaged. Ensure that nothing obstructs the upward movement of the pole.

1.

Pole Docking Station Is designed to mount the tablet to the pole and consists of DC-in port for the power supply, one HDMI Port to support external monitor display, an ethernet port and USB ports. Always seat the tablet securely onto the cradle. The station must be powered by the power supply for the ethernet, HDMI and USB ports to function. The battery on the tablet may be recharged while the tablet is docked, and powered.

2.

Figure 7. Digital Pen Battery Replacement Tablet Mobile Pole The tablet mobile pole is designed to allow transport of the mounted tablet and power supply with power cord.

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 Figure 13. Desktop Mount FSide View

Figure 9. Pole Docking Station

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[1] DC Power Connection, [2] Ethernet (DICOM- Modality Worklist), [3] HDMI Port, [4] USB Port, [5] USB Port, [6] USB Port Handling and Storage Refer to Appendix A: System Specifications for System Operating, and Storage environmental limits. System Move or Storage To move the System to another catheterization laboratory, or to a storage facility, follow these instructions: 1. Unplug the power cable from the wall outlet and wrap cord on to the hook. 2. Unlock wheel locks. 3. Move the system to the appropriate location, and lock wheel locks. Long Term Storage of the AVVIGO™ System If the tablet is to be stored for long periods (e.g. months), remove the battery to prevent it from discharging to a point where recharging would be required in order to use it again. After extended periods of storage, it may be necessary to charge and discharge the battery several times to obtain maximum performance. Avoid sudden changes in temperature as condensation can form on the internal parts of the System. If the System has to be moved into a warm location after prolonged exposure to cold temperatures, allow it to acclimate for a minimum of two to three hours before plugging it into an electrical outlet. Do not expose the System to extremely high temperatures as damage may result. Avoid storing the System in a hot environment. Handle and transport the System gently. Do not expose it to rough movements or vibrations, as damage may result. Avoid prolonged exposure of the touchscreen to any strong heat source. Wherever possible, the Tablet should face away from direct light to reduce glare. Disposal This device and associated electrical and electronic equipment should not be incinerated or included with municipal waste. To dispose of the tablet and accessories, take them to a recovery and recycling designated collection facility for electrical and electronic equipment waste for proper treatment. The tablet and accessories should be safely disposed of in accordance with hospital, administrative, and / or local government policy.

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Figure 10. Pole Docking Station Connectors [1] DC Power Connection, [2] Ethernet (DICOM- Modality Worklist) [3] HDMI Port, [4] USB Ports, [5] COM Port (factory use only), [6] Unlock button Desktop Docking Station The desktop docking station allows the tablet to stand upright on the desktop and consists of DC-In port for the power supply, HDMI port outputs to support external monitor display, an Ethernet port and USB ports. Always seat the tablet securely into the cradle. The station must be powered for the Ethernet HDMI and USB ports to function. The battery on the tablet may be recharged while the tablet is docked and powered.

Figure 11. Desktop Mount Front View





 4



Figure 12. Desktop Mount Back View

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Boston Scientific (Perfect Bound Manual Template, 8.5in x 11in Global, 90123456A) eManual, MB, AVVIGO, en, 51033423-01A

Figure 14. Desktop Mount Side View

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Lithium Polymer Battery The Battery is a Lithium polymer battery and, as such, is deemed a Dangerous Good in regards to shipping. If the battery must be shipped, contact BSC for instructions and shipping requirements. Do not incinerate battery. Dispose of the battery as required by local Regulations.

Port Cover +

Port Cover

OPERATIONAL INSTRUCTIONS Installation and Servicing Installation Prior to installing the system, gently wipe down the tablet and accessories with a soft, clean, dry cloth. Follow the assembly instructions to ensure the system is assembled correctly. Servicing There are no user-accessible or user-serviceable parts or components in the AVVIGO™ Guidance System. If any service, repair, or replacement of accessories or internal components on the tablet are needed contact BSC Technical Assistance Center(s). Refer to BSC Technical Assistance Center section. When requesting service, please provide information concerning the nature of the failure and the manner in which the equipment was used when the failure occurred. The model number and serial number should also be provided. Maintenance The Avvigo Guidance System does not require BSC routine maintenance. It is recommended that the System and accessories are periodically inspected for damage. Contact BSC Technical Assistance Center if any of the following are discovered: a. The power cord or plug is damaged. b. Liquid has penetrated into the equipment. c. The equipment has been exposed to moisture. d. The equipment does not work as expected. e. The equipment has been dropped and damaged. f. The equipment has obvious signs of breakage. Cleaning It is recommended that the tablet and accessories be kept away from dust and dirt and cleaned periodically. Do not use harsh chemicals, cleaning solvents, or strong detergents. To clean the system and accessories: 1. Turn the System off. 2. Close tablet port covers. 3. Gently wipe the System and accessories clean with a soft / non-abrasive cloth moistened with (up to) 70% isopropyl alcohol. Do not spray into the ports. 4. Dry immediately to remove residue.

*

Figure 15. Battery Care Never attempt to disassemble the tablet battery, as this will void the warranty. Do not short circuit a battery. Take care to store batteries separate from each other and other metal objects. Charging the Tablet When not in use, it is recommended that the tablet remain connected to the external power supply, which in turn is connected to the AC mains. This will ensure that the battery is adequately charged. Digital Pen Care Do not attempt to open or disassemble the digital pen (except to change the battery). Note: Do not expose the digital pen to extreme temperature or direct sunlight. Mobile Pole Care It is recommended to inspect all fasteners associated with the pole mounting system and tightened as necessary. Preparation Refer to APPENDIX A System Specifications. Refer to APPENDIX B Required Hardware, Software, and Drivers for the System. Installation and System Setup The following instructions details the initial installation of the tablet to the mobile pole and the AVVIGO System Setup in order to begin a procedure.

NOTE: Do not allow moisture to seep into the ports.

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#

AVVIGO™ System Setup

       Figure 16. 1.

Secondary display (not provided by BSC) Note: To connect to a duplicate display, use a shielded HDMI cable only (not provided by BSC).

2. FFR Link 3. Technologist 4. AVVIGO System on mobile pole 5. Patient table (not provided by BSC) 6. Patient 7. Physician Setting up the System Warning: It is required to configure and run the system diagnostics tests as the first step to establish connectivity to various peripherals and verify successful installation.

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BOSTON SCIENTIFIC INFORMATIONAL RESOURCES The following informational resources are available from Boston Scientific: • DICOM Conformance Statement (in English only) • Individual Directions for Use for FFR Link and BSC Pressure Guidewires

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AVVIGO™ Guidance System INSTALLATION GUIDE Disclaimer: This is a supplemental document to the AVVIGO Guidance System User’s Manual.

CONTENTS COMPLETE SECTIONS A, B, AND C OUTSIDE THE CATHETERIZATION LAB: Section A: Preparation Section B: Mobile Pole Assembly... Steps 1-5 Section C: Pole Docking Station Assembly... Steps 6-10

COMPLETE SECTION D INSIDE THE CATHETERIZATION LAB: Section D: AVVIGO Guidance System Setup ... Steps 11-32 FFR Link and Cable Setup ...Step 11 Power On ...Step 12 Set Date and Time ... Steps 19-21 Diagnostic Tests ... Steps 22-29

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User Management ... Steps 30-32

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Section A: Preparation UNPACK MOBILE POLE / MOBILE POLE DOCKING STATION COMPONENTS Note: The parts for the AVVIGO™ Mobile Pole and the Pole Docking Station are packaged separately. Remove all parts, hardware, and tools from packaging, keeping components with associated hardware / parts. CHECK PARTS AND QUANTITIES Ensure that all parts and quantities are correct (see below) and that no items are missing or damaged. If any items are missing or damaged, contact Boston Scientific Technical Assistance immediately. Mobile Pole

Tools

A Pole B Base C Foot pedal + (2) hex-head screws

D Power supply bracket + (2) Phillips-head scews E Power bracket cord clip + (1) washer + (1) Phillips-head screw F Handle + (2) Phillips-head screws

A x1

C x1

B x1

D x1

G #2 Phillips-head screwdriver H 9/64 in hex wrench I 3/16 in hex wrench E

x2

x1 x1 x1

x2 G x1

H

I x2

x1

x1

Boston Scientific (Perfect Bound Manual Template, 8.5in x 11in Global, 90123456A) eManual, MB, AVVIGO, en, 51033423-01A

F x1

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Section A: Preparation Mobile Pole Docking Station

Tools

J AVVIGO™ Touchscreen Tablet K Power Supply for Tablet and Docking Station (2) L Power Supply Cords (2 M Desktop Docking Station)

J 1x

K x2

L x2

N Pole Docking Station + (4) bushings + (4) mounting screws + cord clip + (1) Phillips-head screw O Digital Pen + (1) AAAA battery P Lanyard for Digital Pen Q Mount clip for Digital Pen M x1

N x1

R #2 Phillips-head screwdriver

x4

x4

O + (1) AAAA battery x1

P x1

Q x1

x4

R x1

x4

Boston Scientific (Perfect Bound Manual Template, 8.5in x 11in Global, 90123456A) eManual, MB, AVVIGO, en, 51033423-01A

Note: The images shown in the legend above are for reference only and are not represented to scale.

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Section B: Mobile Pole Assembly Mobile Pole Assembly Overview

Tablet Mount

Handle Assembly

Step 3 Power Supply Bracket / Cord Wrap Assembly

Step 4

Step 1

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Pole

Base

Step 2 Foot Pedal IG_Figure 1.

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Section B: Mobile Pole Assembly STEP 1

STEP 3

Install the Pole in the Base

Install the Handle on the Pole

Insert the bottom of the pole in the base. Confirm the locator pin seats correctly in the slot (Fig. 2).

3.1 Position the clamp and handle around the pole (Fig. 4). 3.2 Insert both screws through the clamp and tighten using the #2 Phillips-head screwdriver until the handle is secured to the pole (Fig. 5) (do not over-tighten).

Clamp

Locator Pin Slot IG_Figure 4.

IG_Figure 2.

STEP 2

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Install the Foot Pedal to the Base 2.1 Lay the pole / base assembly on its side. 2.2 Position the foot pedal under the base and insert both hex screws through the foot pedal holes and thread both hex screws into the bottom of the pole (Fig. 3). 2.3 Use the 3/16 in hex wrench to tighten both screws (do not overtighten). 2.4 Return the pole to upright position. 2.5 Press down on all 5 of the wheel locks to secure the pole mount.

IG_Figure 5.

Pole Base Lock

Foot Pedal Hex Screws IG_Figure 3.

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Section B: Mobile Pole Assembly STEP 4 Install the Power Supply Bracket on the Pole IMPORTANT: The power supply bracket must be installed approximately 40 cm (16 in) above the base in order for the power cord to reach the tablet when the pole is fully extended.

Strain Relief

4.1 Position the power supply clamp #2 (with the strain relief bracket towards the bottom) and the cord wrap clamp #1 around the Pole (Fig. 6). 4.2 Insert both screws through clamp #1, and tighten to clamp #2 using the #2 Phillips-head screwdriver until the power supply bracket is secured on the pole (do not over-tighten).

Cord Clip

Washer Screw

Cord Wrap

Figure 7. Power Supply Strap Clamp #2 Clamp #1 Strain Relief Bracket

IG_Figure 6.

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STEP 5 Install the Cord Clip, Power Supply, and Power Cord on the Power Supply Bracket Install the Cord Clip (Fig. 7): 5.1 Insert the power cord into the cord clip. 5.2 Place the washer, then the cord clip on the screw shaft and insert into the strain relief hole on the power supply bracket. 5.3 Use the #2 Phillips-head screwdriver to tighten the screw until the cord clip is secured on the strain relief of the power supply bracket (do not over-tighten). Install the Power Supply and Power Cord (Figs. 7 and 8): 5.4 Insert the power cord plug into the receptacle on the power supply. 5.5 Position the power supply on the strain relief, securing it with the power dupply straps. 5.6 Wind the power cord around the cord wrap hook. 5.7 Run the DC power cord up through the handle of the mobile pole.

IG_Figure 8.

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Section C: Pole Docking Station Installation STEP 6 Tablet Mount Tilt Tension adjustment 6.1 Grasp the tablet mount and tilt to desired angle. 6.2 Adjust tilt tension by equally tightening or loosening the (2) tension screws with the 9/64 in hex wrench (Fig. 9).

Tilt Adjustment Handle

NOTE: Once overall tilt tension is set, it is possible but not required, to use the tilt adjustment handle to fine tune / lock tilt position.

9/64 in Hex Wrench

IG_Figure 10. Tablet Mount Tilt Adjustment Handle Tension Screws

IG_Figure 9.

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Tablet Mount Tilt adjustment 6.3 Adjust tilt by loosening the tilt adjustment handle. 6.4 Grasp the tablet mount and tilt to desired angle. 6.5 Tighten tilt adjustment handle clockwise to lock position (Fig. 10). Installation Note: The tilt adjustment handle is a multi-position clamping handle that operates by lifting, rotating, and releasing the handle.

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