auris Monarch Platform User manual
300-002547-00 rev7
MONARCH™ PLATFORM
User Manual
300-002547-00 rev7
300-002547-00 rev7
Monarch™ Platform
User Manual
Date of Last Revision: 2018-05-08
ii 300-002547-00 rev7
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].
Copyright © 2016-2018 Auris Health, Inc. All rights reserved.
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.:
300-002547-00 rev7 iii
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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Table of contents
