Auris Monarch platform User manual

300-002547-00 rev7

MONARCH™ PLATFORM

User Manual

300-002547-00 rev7

Monarch™ Platform

User Manual

Date of Last Revision: 2018-05-08

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Auris Health, Inc. Headquarters and Manufacturing

150 Shoreline Drive

Redwood City, CA 94065

Tel: +1.650.264.6000

Manufacturer Responsible for Placing Products on the Market

Auris Health, Inc.

150 Shoreline Drive

Redwood City, CA 94065

Tel: +1.650.264.6000

Customer Support

Only qualified service personnel should service or maintain hardware components. If you

feel that the Monarch Platform hardware components or associated features or functions

do not perform as expected, or they provide results that are inconsistent with your

established clinical and research protocols, contact Auris Customer Care at

+1.800.434.0032 (toll-free within the United States) or +1.650.264.6000 (Worldwide).

You can also email [email protected].

This document, the software and products to which this document refers, and any other

related materials are the copyrighted and proprietary information of Auris Health, Inc.

and may not be used or distributed without written authorization of Auris Health, Inc. No

part of this document may be photocopied, reproduced, or translated into another

language without written permission from Auris Health, Inc.

AURIS, MONARCH, MONARCH READY, and MONARCH ELEVATE are trademarks

and/or registered trademarks of Auris Health, Inc. in the United States and in other

countries and may not be used or distributed without written authorization from Auris

Health, Inc. Use of Auris Health, Inc.’s trademarks require written authorization from

Auris Health, Inc. The following logos are trademarks of Auris Health, Inc.:

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All other trademarks and product names used herein are the property of their respective

owners. Monarch™ Pre-Op Planning Application and Monarch™ Navigation Application

are distributed on Auris Health, Inc. hardware.

Auris Health, Inc. provides this guide "as is" and "as available" without any warranties,

including, without limitation, warranties of merchantability, fitness for any particular

purpose, title and noninfringement. Auris Health, Inc. expressly excludes and disclaims

such warranties.

To the maximum extent permitted by law, Auris, its suppliers, affiliates, officers,

directors, employees, agents, and assigns will not be liable: (a) for costs of procurement

of substitute goods, technology, or services, lost profits or business opportunities or any

other special, indirect, incidental, consequential or reliance damages arising from any

claim related to this manual or use of Auris’s products discussed herein, however

caused and under any theory of liability, whether based in contract, tort (including

negligence and strict liability) or otherwise; (b) for content or data that is transmitted over

or through Auris’s networks, equipment or systems; (c) for any unavailability, defect,

error, interruption, delay, downtime, loss, or attenuation of services caused by or

resulting from any act or omission by the user of Auris’s products and services; or (d) for

injury, death, or harm of any nature (whether direct or indirect, and whether or not

foreseeable) resulting from (i) materials, equipment or accessories not furnished by

Auris, (ii) lost components, parts, and accessories, (iii) any product which has been

modified, altered, repaired, serviced, or reinstalled by anyone other than Auris or its

authorized representative, (iv) any product stored, used, or handled in any manner

inconsistent with Auris’s trainings and written instructions, or by individuals who have not

been adequately trained on the proper use of the product, (v) any product damaged due

to accident, negligence, misuse, or abnormal use, (vi) any product damaged through no

fault of Auris during shipment, or (vii) damage or failure of a product for which Auris

provided an update or replacement and the damage or failure would not have occurred

but for user’s failure to install such update or replacement (failure to install includes

failure to allow Auris to remotely install security patches and provide preventive and

remedial diagnostic services by connecting the Monarch System to Auris’s proprietary

cloud platform over the internet).

Unauthorized modifications of any Auris products may void any and all warranties. Auris

Health, Inc. does not assume any responsibility or liability with respect to unauthorized

modification or substitution of subsystems or components.

This manual applies to the Monarch™ Platform, Monarch™ Pre-Op Planning Application

2.1.1, and Monarch™ Navigation Application 2.1.1.

Expected Life Statement

With proper care and maintenance, the expected service life of the system is 7 years.

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Introduction

This manual provides information specific to the Monarch™ Platform, also known as the

Monarch™ Platform. The operating instructions and feature descriptions herein are

specific to the software versions listed on page iii.

NOTE: Anyone who operates, services, maintains, or is otherwise associated with the

Monarch Platform must read, understand, and be thoroughly familiar with the

information in this manual, and take precautions to protect themselves, their

associates, patients, and the equipment. At each step in the installation, specific

warnings and cautions are given for specific actions.

Auris Health, Inc. reserves the right to revise this publication and to make changes in

content from time to time without obligation on the part of Auris Health, Inc. to provide

notification of such revision or change.

Intended Use/Indications for Use

The Monarch™ Endoscopy Platform (Monarch Platform) and its accessories are

intended to provide bronchoscopic visualization of and access to patient airways for

diagnostic and therapeutic procedures.

Contraindications

Contraindications include but are not limited to:

 Patient whose general health or respiratory function or both are compromised to the

point that the patient would not tolerate flexible bronchoscopy.

 Absence of a trained bronchoscopist to perform or closely and directly supervise the

procedure, as well as manage complications common to flexible bronchoscopy.

 Use of the system in patients with electrically or magnetically activated implanted

medical devices.

Warnings

A thorough understanding of the technical principles, clinical applications, and risks

associated with pulmonary bronchoscopy is necessary before using this device.

Additional warnings are detailed throughout this document to describe actions or

conditions that could result in injury or death.

Adverse Effects

Complications from bronchoscopy are rare and most often minor, but if they occur, may

include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting,

dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or

an allergic reaction to medications. Only rarely do patients experience other more

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serious complications (for example, collapsed lung, respiratory failure, heart attack

and/or cardiac arrhythmia).

Prescription Device Statement

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Safety Precautions and Warnings

Safe operation of the Monarch Platform requires careful attention to the serious hazards

associated with use of the device and ways to avoid or minimize the hazards, and

familiarity with emergency procedures. Untrained or careless operation of the Monarch

Platform can damage the system, its components or other property; cause poor

performance; or lead to serious bodily injury and possibly death.

Auris Health, Inc. strongly recommends that personnel be trained by Auris on the

Monarch Platform prior to use for research or clinical purposes. Only physicians having

adequate training and experience with endoscopic techniques should perform

endoscopic procedures.

Users must follow all instructions for use supplied with the system, its components,

instruments and accessories, including any instructions for use (IFUs) provided with

instruments or accessories. The IFU provided are the primary sources for detailed safety

information.

Under the conditions described in the declaration of immunity section, the system may

fault in an immobilized state. Follow the directions indicated to return to normal

operation.

System Error Messages

Under the error conditions described in Appendix B, all robotic functions are disabled.

Follow the directions indicated to return to normal operation.

Notations

This manual uses the special notations below to bring your attention to important

information.

WARNING: Describes actions or conditions that could result in injury or death.

CAUTION: Describes actions or conditions that could result in damage to the

equipment or minor harm to the user or patient.

NOTE: Provides more information about a subject.

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Disposal

When an Auris product reaches the end of its useful life and your facility desires to

remove the device, contact Auris Customer Care at +1.800.434.0032 (toll-free within the

United States) or +1.650.264.6000 (Worldwide) to uninstall and appropriately dispose of

the components.

When disposing of instruments, accessories, or any of their components, follow all

applicable national and local laws and guidelines.

Regulatory Compliance with Directives and Standards

The Monarch Platform complies with the regulatory requirements of Directive 2017/745,

the Medical Device Directive of the European Economic Community (EEC).

The Monarch Platform and accessories have been tested for compliance to the following

standards:

Standard Number Standard Title

AAMI/ANSI ES60601-1:2005 (Third

Edition)

Medical electrical equipment - Part 1: General

requirements for basic safety and essential performance

EN 60601-1-2:2007 (Third Edition) Medical electrical equipment - Part 1-2: General

requirements for basic safety and essential performance –

Collateral standard: Electromagnetic compatibility –

Requirements and tests

IEC 60601-1-6:2010 (Third Edition) Medical electrical equipment – Part 1-6: General

requirements for basic safety and essential performance –

Collateral standard: Usability

IEC 60601-2-18:2009 (Third Edition) Medical electrical equipment - Part 2-18: Particular

requirements for the basic safety and essential

performance of endoscopic equipment

IEC 62366:2007 Medical devices -- Application of usability engineering to

medical devices

IEC 62366-1:2015 Medical devices -- Part 1: Application of usability

engineering to medical devices

ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device

labels, labelling and information to be supplied -- Part 1:

General requirements

ISO 14971:2007 Medical devices -- Application of risk management to

medical devices

ISO 11135:2014 Sterilization of health-care products – Ethylene Oxide –

Requirements for the development, validation, and routine

control of a sterilization process for medical devices

ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part

1: Requirements for materials, sterile barrier systems and

packaging systems

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Standard Number Standard Title

ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part

2: Validation requirements for forming, sealing and

assembly processes

ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for

in vitro cytotoxicity (Biocompatibility)

ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests

for irritation and skin sensitization (Biocompatibility)

ISO 10993-11:2006 Biological evaluation of medical devices – Part 11: Tests

for systemic toxicity (Biocompatibility)

ISO 8600-1:2015

Endoscopes -- Medical endoscopes and endotherapy

devices -- Part 1: General requirements

ISO 8600-3:1997 Optics and optical instruments -- Medical endoscopes and

endoscopic accessories -- Part 3: Determination of field of

view and direction of view of endoscopes with optics

ISO 8600-4:2014

Endoscopes -- Medical endoscopes and endotherapy

devices -- Part 4: Determination of maximum width of

insertion portion

BS EN 1041:2008 Information supplied by a manufacturer of medical devices

BS EN 556-1:2001 Sterilization of medical devices - Requirements for medical

devices to be designated ""STERILE"" – Part 1:

Requirements for terminally sterilized medical devices"

ANSI/AAMI/ISO 14937:2009 Sterilization of health care products -- General

requirements for characterization of a sterilizing agent and

the development, validation and routine control of a

sterilization process for medical devices

CSA 22.2 NO 60601-1:14 Medical Electrical Equipment, Part 1: General

requirements for basic safety and essential performance

FCC ID: 2AOXMMonarch

NOTE: This equipment has been tested and found to comply with the limits for a Class

A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to

provide reasonable protection against harmful interference when the equipment is

operated in a commercial environment. This equipment generates, uses, and can

radiate radio frequency energy and, if not installed and used in accordance with the

instruction manual, may cause harmful interference to radio communications.

Operation of this equipment in a residential area is likely to cause harmful interference

in which case the user will be required to correct the interference at his own expense.

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Contents



............................................................. 1

Monarch Platform Device Overview ............................................................................ 2

System Overview ........................................................................................................ 3

Pre-Procedural Planning ....................................................................................... 3

Monarch Cart ......................................................................................................... 3

Monarch Tower ..................................................................................................... 7

Monarch Bronchoscope System ........................................................................... 9

Working Channel Instruments ............................................................................. 10

Accessories ......................................................................................................... 10

Classifications ........................................................................................................... 11

Monarch Platform Labels .......................................................................................... 12

Label Locations ................................................................................................... 15

Technical Specifications ............................................................................................ 16

Physical Dimensions, Weight, and Power Requirements .................................... 16

Declaration of Emissions ........................................................................................... 17

Declaration of Immunity ............................................................................................. 19

Original Documentation ............................................................................................. 22

................................................................................................ 23

Recommended CT Scan and Reconstruction Parameters ....................................... 24

Monarch Pre-Op Planning Application User Interface ............................................... 26

Patient List ........................................................................................................... 26

Planning .............................................................................................................. 29

Manual Path ........................................................................................................ 32

Before You Can Plan ................................................................................................. 33

Create a Plan ............................................................................................................ 33

Identify a Target .................................................................................................. 35

Export a Patient Case ............................................................................................... 37

Import a Patient Case ................................................................................................ 38

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Perform an Unplanned Case ..................................................................................... 38

............................................................................................................ 39

Software Information ................................................................................................. 40

Suggested Bronchoscopy Suite Configuration .......................................................... 40

Prepare the Bronchoscopy Suite ............................................................................... 41

Prepare the Patient ................................................................................................... 41

Prepare the Monarch Bronchoscope System ............................................................ 43

Monarch Tower System Setup Guidance .................................................................. 44

Monarch Controller .............................................................................................. 44

Fluidics System ................................................................................................... 45

Camera ................................................................................................................ 46

Navigation ........................................................................................................... 46

Monarch Cart System Setup Guidance ..................................................................... 48

Unstow Cart ......................................................................................................... 48

Load the Monarch Bronchoscope System ........................................................... 51

............................................................................................ 53

Overview ................................................................................................................... 54

Functional Descriptions of Monarch Components ..................................................... 54

Monarch Bronchoscope and Monarch Bronchoscope Sheath ............................ 54

Monarch Controller .............................................................................................. 55

Working Channel Instruments ................................................................................... 57

Monarch Navigation Application User Interface ........................................................ 58

Top Navigation Bar .............................................................................................. 60

Primary Area ....................................................................................................... 60

Scrolling Area ...................................................................................................... 61

CT Area ............................................................................................................... 62

Full Screen Mode ................................................................................................ 63

Menu System ...................................................................................................... 63

Navigation Views ................................................................................................. 65

Configuring View Screens ................................................................................... 75

Quick Action Button ............................................................................................. 77

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Procedural Steps or Actions ...................................................................................... 78

Scope Insertion ................................................................................................... 78

Navigation Initialization ........................................................................................ 79

Monarch Bronchoscope Advancement ............................................................... 79

Perform Biopsy .......................................................................................................... 80

Monarch Controller .............................................................................................. 80

Post-procedure .......................................................................................................... 81

Retraction ............................................................................................................ 81

........................................................................ 83

Prepare the Patient for Discharge ............................................................................. 84

Remove the Monarch Bronchoscope System ..................................................... 84

Remove Monarch Navigation Patient Sensors .................................................... 84

Remove the Bronchoscope Patient Introducer .................................................... 84

Remove and Clean Equipment ................................................................................. 84

Disassemble and Clean the Monarch Bronchoscope System ............................. 84

Clean Monarch Navigation Patient Sensors ........................................................ 85

Disassemble and Clean the Monarch Navigation Field Generator ...................... 86

Disassemble and Clean Bronchoscope Patient Introducer Mount ...................... 86

Clean and Store the Monarch Cart ...................................................................... 86

Clean the Monarch Tower and Store the Monarch Platform ............................... 86

Servicing .................................................................................................................... 87

Preventative Maintenance ................................................................................... 87

Configuration ....................................................................................................... 87

Maintenance ........................................................................................................ 87

............................................................................... 91

User Administration ................................................................................................... 92

User Types .......................................................................................................... 92

Add New User ..................................................................................................... 92

Change User Password ...................................................................................... 93

Disable Existing User .......................................................................................... 94

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System Security ........................................................................................................ 95

Virus Protection ................................................................................................... 95

Patient Data Security ........................................................................................... 95

Networking ................................................................................................................ 95

Firewall ................................................................................................................ 95

Internet Connectivity ............................................................................................ 95

...................................................................................................... 97

Fault Messages and Troubleshooting ....................................................................... 98

Emergency Removal ........................................................................................... 98

E-Stop Recovery ................................................................................................. 98

Joystick Articulations Not Matching Directionally ................................................ 98

Controller Does Not Appear Functional ............................................................... 98

Field Generator or Patient Introducer Mount Clamps Do Not Tighten ................. 99

Monarch Platform Will Not Turn On..................................................................... 99

Tower and Cart Do Not Turn On Simultaneously ................................................ 99

Video (Start Screen) Does Not Appear on Tower and Cart Monitor After System

Turns On ........................................................................................................... 100

Loss of Video on Tower or Cart Touchscreen (During Procedure) ................... 100

Navigation Patient Sensors Not Detected During Setup ................................... 100

CT Scan or Pre-Planned Case Cannot be Uploaded to Tower ......................... 101

Keyboard on Planning Laptop Is Unresponsive ................................................ 101

Planning Laptop Will Not Turn on ...................................................................... 101

Unable to log on to Physician User Account on Tower or Planning Laptop ...... 101

Unable to log on to Admin User Account on Tower or Planning Laptop ........... 101

................................................................................................................................ 103

Errors and Messages ................................................................................................................ 103

System Messages ................................................................................................... 104

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Safety Information and Technical

Description

This chapter provides information that is essential for the safe operation, transport, and

storage of the Monarch Platform.