Acclarent ENT Navigation System Instructions for Use May 2017

© Acclarent, Inc. 2016 - 2017 All rights reserved. CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician. Third-party trademarks used herein are trademarks of their respective owners. The ACCLARENT® ENT Navigation System is covered by one or more of the following US patents owned by Biosense Webster: 6,226,542; 6,484,118; 6,650,927; 6,690,963. Some pictures of the workstation are provided courtesy of Dell Computer Corporation, ©Dell Computer Corporation 2007.

P.N.: UG-2000-00 (02A) 28 May 2017

TABLE OF CONTENTS

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Table of Contents About the ACCLARENT® ENT Navigation System ... 1 Typical Setup ... 1 General Workflow ... 2 Working Volume... 3 Viewing System Information ... 3 Notes, Cautions, and Warnings ... 3 Safety Information ... 5 Indications for Use ... 5 Qualified Users and Training ... 6 Location Accuracy ... 6 Warnings and Precautions ... 6 Clinical Safety ... 6 Physical Setup ... 7 Preventing Fire and Electrical Shock ... 7 Interference with Other Equipment ... 7 Security ... 8 Electromagnetic Compatibility (EMC) ... 8 Symbols ... 13 External Product Labels ... 15 Standards Compliance and Classifications... 16 Hardware ... 17 System Specifications ... 17 Component Dimensions ... 17 Power Consumption ... 18 Environmental Conditions ... 18 System Components ... 19 Navigation Console Connections ... 21 Instrument Hub Connections ... 21 Workstation Connections ... 22 Periodic Maintenance ... 23 When the System is Idle ... 23 Cleaning the System Components ... 23 Overview of User Interface ... 24 Opening Screen ... 24 Main Toolbar... 25 Image Preview ... 26 Registration Screen ... 27 Navigation Views ... 29 Status Indication ... 30 Performing a Procedure ... 32 Setup ... 32 Applying the Patient Tracker ... 32 Loading the CT Image ... 34 Registration ... 35 UG-2000-00 (02A)

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TABLE OF CONTENTS Adjusting the View ... 40 Capturing Screen Shots and Video Clips ... 40 Troubleshooting ... 42 Power Supply Interruptions ... 42 System Messages ... 42

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ABOUT THE ACCLARENT® ENT NAVIGATION SYSTEM

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Chapter 1

About the ACCLARENT® ENT Navigation System In This Chapter: Typical Setup ... 1 General Workflow ... 2 Working Volume... 3 Viewing System Information ... 3 Notes, Cautions, and Warnings ... 3

The ACCLARENT® ENT Navigation System is an image-guided navigation system designed for use during intranasal and paranasal surgical procedures. When using the System, ENT physicians can track and display the real-time location of the tip of navigated instruments relative to pre-acquired CT images. The ACCLARENT® ENT Navigation System is composed of several components. 

The Field Ring emits a known electromagnetic field throughout the procedure. The Patient Tracker, a patch with an embedded magnetic sensor, provides a location reference.



The Navigation Console drives the Field Ring signals and communication between the system components.



The workstation, with the ACCLARENT® ENT Application installed, processes information from the Navigation Console and displays it on the monitor.



A pressure-sensitive Registration Probe with an embedded magnetic sensor is used to register the pre-acquired image to the patient's head at the beginning of the procedure.



The Patient Tracker, Registration Probe, and other surgical instruments connect to the Instrument Hub.

Field Service Engineers are responsible for the installation of the System. See also: 

System Components

Typical Setup The ACCLARENT® ENT Navigation System is designed for use in either a hospital operating room or a clinic procedure room with the patient in supine position. During a procedure, the Field Ring is positioned around the patient's head. Ensure that it is fixed securely in place before beginning the procedure. UG-2000-00 (02A)

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ABOUT THE ACCLARENT® ENT NAVIGATION SYSTEM When not in use, all system components can be stored on a shelf or cart. NOTE The system can be used with the components on a cart. Always ensure that all components are connected only to the Isolation Transformer that is provided with the system.

Figure 1: ACCLARENT® ENT Navigation System Components on Cart

General Workflow The general workflow involves the following stages: 1.

It is recommended to load and review the CT image before the procedure. (See Image Preview.)

2.

Connect the tools needed for the procedure. (See Performing a Procedure.)

3.

Perform Registration. (See Registration.)

4.

Start the procedure. During the procedure, the location of the ACCLARENT® NAVWIRE™ Sinus Navigation Guidewire tip is displayed on the CT image. (See Navigation Views.)

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Working Volume The ACCLARENT® ENT Navigation System has a working volume of 20 cm x 20 cm x 16 cm with an accuracy of better than 2 mm. The overall working volume includes a reduced accuracy zone with an extra 2 cm in each direction (24 cm x 24 cm x 20 cm). If the active tool is in the reduced accuracy zone, the status icon for the tool is indicated in orange.

Viewing System Information To view information about the installed application, click the onscreen logo.

Figure 2: About Dialog

Notes, Cautions, and Warnings This document uses various types of notes. An explanation of each type, in the appropriate format, is given below. NOTE A note provides important information, emphasizing or supplementing the main text. The information does not relate directly to issues that might cause injury to patients or users, or damage to the system.

CAUTION A caution provides information relating to issues that might cause injury to patients or users, or damage to the system UG-2000-00 (02A)

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ABOUT THE ACCLARENT® ENT NAVIGATION SYSTEM

WARNING A warning provides information relating to issues that might cause serious, life-threatening injury to patients or users, or serious, irreparable damage to the system.

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SAFETY INFORMATION

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Chapter 2

Safety Information In This Chapter: Indications for Use ... 5 Qualified Users and Training ... 6 Location Accuracy ... 6 Warnings and Precautions ... 6 Clinical Safety ... 6 Physical Setup ... 7 Preventing Fire and Electrical Shock ... 7 Interference with Other Equipment ... 7 Security ... 8 Electromagnetic Compatibility (EMC) ... 8 Symbols ... 13 External Product Labels ... 15 Standards Compliance and Classifications... 16

This chapter provides important information regarding the safe functioning of the ACCLARENT® ENT Navigation System. Follow the instructions in this manual carefully. In addition, consider current medical practices regarding patient care and safety. WARNINGS 

Failure to observe the guidelines and instructions provided in this document could result in patient injury.



Failure to observe the guidelines and instructions provided in this document could result in faulty functioning of the ACCLARENT® ENT Navigation System.

Indications for Use The ACCLARENT® ENT Navigation System is intended for use during intranasal and paranasal image-guided navigation procedures for patients who are eligible for sinus procedures. See also: 

Location Accuracy



Interference with Other Equipment

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SAFETY INFORMATION

Qualified Users and Training Training is available for physicians and medical staff designated to be ACCLARENT ® ENT Navigation System users. Please contact your Acclarent Representative to arrange training.

Location Accuracy The navigation capability in the ACCLARENT® ENT Navigation System is based on the interactions between a known electromagnetic field (emitted by the Field Ring) and magnetic sensors (embedded in the ACCLARENT® NAVWIRE™ Sinus Navigation Guidewire and other navigated tools). System accuracy is better than 2 mm. Ensure that the Field Ring is fixed securely in place before beginning registration. Do not allow the Field Ring to move during the procedure. Movement of the Field Ring after the beginning of the registration process might affect location accuracy. Ensure that the guidewire shaft does not come close to one of the transmitters located on the Field Ring. If the shaft is in close proximity to a transmitter, location accuracy might be affected. Metal interference caused by a ferromagnetic material placed within the working volume might affect location accuracy, which can cause difficulty in tracking navigated tools. Keep ferromagnetic material outside the working volume. If metal interference is detected: 

The status icon for the affected tool displays the error status. (See Status Indication.)



The affected tool is not displayed in the 3D rendered view or in the multiplanar (MPR) view.

If accuracy seems to be affected, check for ferromagnetic objects in the working volume. If removing objects from the working volume does not help, exit the procedure. Continue to use the endoscope without navigation support and gently remove the ACCLARENT ® NAVWIRE™ Sinus Navigation Guidewire and contact Customer Support. Before each procedure the system performs a self-test to verify internal component calibration and location accuracy resulting from it. If the self-test fails, an error message is displayed. Contact Customer Support for service.

Warnings and Precautions The order of the following warning statements does not indicate their relative importance.

Clinical Safety 

Distortion to the ACCLARENT® ENT Navigation System magnetic field may degrade the accuracy of the ACCLARENT® NAVWIRE™ Sinus Navigation Guidewire icon's position in relation to the registered CT image.



Never advance or retract the ACCLARENT® NAVWIRE™ Sinus Navigation Guidewire or balloon catheter against unknown resistance as this can cause tissue trauma or device damage.

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Physical Setup 

The ACCLARENT® ENT Navigation System is designed for use in either a hospital operating room or a clinic procedure room with the patient in supine position.



The system is ready for first clinical use only after it has been fully tested as part of the installation process.



Do not cover the vent openings of the Navigation Console or the workstation while the system is functioning. Doing so may stop the procedure and damage the equipment.



Do not modify the internal components of the system in any way.



Use only parts and accessories manufactured or recommended by Biosense Webster. Parts and accessories used must meet the requirements for the applicable IEC 60601 series safety standards. The ACCLARENT® ENT Navigation System does not interface with any external medical device.



Connect the system components only to the power supply that is provided with the ACCLARENT® ENT Navigation System. Do not use a different power supply.



It is recommended that the system components be powered from an uninterruptible power supply (UPS). This will enable continuous operation during power mains interruptions.



Take precautions against electrostatic discharge when working with the system.



Before turning on the equipment, ensure that all system cables are securely connected.

Preventing Fire and Electrical Shock 

Ensure that all ACCLARENT® ENT Navigation System components are connected to the common protective ground in the procedure room, or to a separation device. Do not connect electrical components of the ACCLARENT® ENT Navigation System to a multiple socket power outlet. Using a multiple socket outlet might compromise safety.



Do not connect or disconnect power cables and Field Ring cables while the ACCLARENT® ENT Navigation System is turned on. Doing so could result in minor shock to the user and/or damage to the system.



Do not connect or disconnect the system power supply while it is turned on. Doing so could result in damage to the system.



To reduce the risk of fire, do not use the ACCLARENT ® ENT Navigation System in the presence of flammable anesthetic mixtures or other flammable gases.



For continued protection against the risk of fire, only use replacement fuses that have the same type and rating as the original fuses (250 V~, 5 AL).

Interference with Other Equipment 

The functioning of the system might interfere with minute ventilation rateadaptive pacemakers. When performing a procedure on a patient who has such a device, consider changing the operating mode of the pacemaker to a minute ventilation insensitive mode before performing the procedure. If necessary, consult the pacemaker manufacturer's instructions.

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SAFETY INFORMATION 

Do not use a cellular phone in the procedure room during a clinical procedure with the ACCLARENT® ENT Navigation System. Doing so may cause interference with equipment resulting in inaccurate location or inability to use the system.

Security The workstation (computer) supplied with the ACCLARENT® ENT Navigation System is a dedicated computer for the system. Do not install unauthorized software on the system. To protect against computer viruses, do not use the workstation for any other purpose.

Electromagnetic Compatibility (EMC) The following tables present data regarding compliance of the ACCLARENT® ENT Navigation System with IEC 60601-1-2, 4th edition. Table 1: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions - For All Medical Electrical Equipment and Systems

The ACCLARENT® ENT Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCLARENT® ENT Navigation System should assure that it is used in such an environment. Emissions Test

Compliance

RF emissions

Group 1

The ACCLARENT® ENT Navigation System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The ACCLARENT® ENT Navigation System is suitable for use in all establishments other than domestic.

Voltage fluctuations or flicker emissions IEC 61000-3-3

Compliance

CISPR 11

Electromagnetic Environment – Guidance

WARNING This system (including its peripheral components) is intended for use by healthcare professionals only. This system (including its peripheral components) might cause radio interference or might disrupt the operation of nearby equipment.

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Table 2: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Specifications for all Medical Electrical Equipment and Systems)

The ACCLARENT® ENT Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCLARENT® ENT Navigation System should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact ±15 kV air

±8 kV contact ±15 kV air

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 or burst IEC 61000-4-4

±2 kV for power supply lines

±2 kV for power supply lines

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

±1 kV for input/output lines

N/A

±1 kV line(s) to line(s)

±1 kV line(s) to line(s)

±2 kV line(s) to earth

±2 kV line(s) to earth

0% UT; 0.5 cycle

0% UT; 0.5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% UT; 1 cycle

and

Surge IEC 61000-4-5

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

0% UT; 1 cycle

and

70% UT; 25 cycles

70% UT; 25/30 cycles

Single phase: at 0°

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the ACCLARENT® ENT Navigation System requires continued operation during power mains interruptions, it is recommended that the ACCLARENT® ENT Navigation System be powered from an uninterruptible power supply (UPS).

Single phase: at 0°

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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0% UT; 250 /300 cycle

0% UT; 250 cycle

30 A/m

30 A/m @ 50 Hz

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

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SAFETY INFORMATION

NOTE UT is the AC mains voltage prior to application of the test level.

Table 3: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Specifications for Medical Electrical Equipment and Systems That Are Not Life Supporting)

The ACCLARENT® ENT Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCLARENT® ENT Navigation System should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Conducted RF

3 Vrms

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

150 kHz to 80 MHz (V1)

ACCLARENT® ENT INSTRUCTIONS FOR USE

Electromagnetic Environment – Guidance Portable and mobile RF communication equipment should be used no closer to any part of the ACCLARENT® ENT Navigation System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

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The ACCLARENT® ENT Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCLARENT® ENT Navigation System should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Radiated RF

3 V/m

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

80 MHz to 2.5 GHz (E1)

Electromagnetic Environment – Guidance Recommended separation distance:

80 MHz to 800 MHz 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 strength from fixed RF transmitters as determined by an electromagnetic site survey,1 should be less than the compliance level in each frequency range.2 Interference may occur in the vicinity of equipment marked with the following symbol:

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system. 1

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m. 2

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SAFETY INFORMATION

The ACCLARENT® ENT Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCLARENT® ENT Navigation System should assure that it is used in such an environment. Immunity Test

Immunity from Proximity field from wireless communications equipment

IEC 60601 Test Level

Compliance Level

IEC 61000-4-3

Electromagnetic Environment – Guidance

List of frequencies, from 9 V/m up to 28 V/m, PM (18 Hz or 217 Hz), FM 1 kHz

NOTES 

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.



These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Table 4: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ACCLARENT® ENT Navigation System (Specifications for Medical Electrical Equipment and Systems that are Not LifeSupporting)

Recommended separation distances between portable and mobile RF communications equipment and the ACCLARENT® ENT Navigation System The ACCLARENT® ENT Navigation System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ACCLARENT® ENT Navigation System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ACCLARENT® ENT Navigation System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

[W]

[m] 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2

d = 1.2

d = 2.33

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

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Recommended separation distances between portable and mobile RF communications equipment and the ACCLARENT® ENT Navigation System The ACCLARENT® ENT Navigation System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ACCLARENT® ENT Navigation System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ACCLARENT® ENT Navigation System as recommended below, according to the maximum output power of the communications equipment. 1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTES 

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.



These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Symbols The following table displays the symbols used on the system hardware and in the accompanying documentation (including this manual). Table 5: Legend to Symbols Appearing on the System Hardware and Documentation

Symbol

Description Accompanying Documents The device is shipped with accompanying documents. Please read all documents before operating the system. Instructions for Use Refer to accompanying Instructions for Use.

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Symbol

Description Instructions for Use Consult accompanying Instructions for Use. (Packaging label.)

Equipotential Ground Pin The device comes equipped with an equipotential earth pin. This pin should be connected as per standard hospital procedure. Date of Manufacture Hardware supplied with the device is labeled with the date of manufacture, as indicated by this symbol. Manufactured By The manufacturer for the device is marked by this symbol. Distributed By The Distributer for the device is marked by this symbol. Canadian Standards Association Certification Mark The device has been CSA certified to comply with the Safety Standard for Medical Devices IEC 60601-1. Customer Support/Call Center The contact information for the authorized Service and Support Department representatives is marked with this symbol. Heavy Object To prevent injury, precautions should be taken when lifting or moving objects marked with this symbol. Non-ionizing Electromagnetic Radiation Fragile: Handle with Care This medical device can be broken or damaged if not handled carefully. Keep Dry This medical device must be protected from moisture. Humidity Limitation This label indicates the range of humidity to which the medical device can be safely exposed. Atmospheric Pressure Limitation This label indicates the range of atmospheric pressure to which the medical device can be safely exposed.

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External Product Labels

Figure 3: System Label

Figure 4: Navigation Console Label

Figure 5: Power Supply Label

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SAFETY INFORMATION

Standards Compliance and Classifications The ACCLARENT® ENT Navigation System complies with the current edition of the following standards and regulations. Table 6: ACCLARENT® ENT System Compliance

Source

Standard Number

Title

CAN/CSAC

22.2 No.60601-1

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

EN

1041

INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES

EN

ISO15223-1

MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS

IEC

60601-1

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

IEC

60601-1-2

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

The Biosense Webster Quality System complies with the current edition of the following standards and regulations. Table 7: Quality System Standards

Source

Standard Number

Title

ISO

13485

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS REQUIREMENTS FOR REGULATORY PURPOSES

FDA

21 CFR Part 820

QUALITY SYSTEM REGULATION

ISO

14971

MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

IEC

62304

MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES

ISO

14001

ENVIRONMENTAL MANAGEMENT SYSTEMS REQUIREMENTS WITH GUIDANCE FOR USE

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