ENT-4000 and 4500 User Manual Rev F June 2015

©2009, 2012, 2015 Cogentix Medical, Inc. All rights reserved. Printed in the United States of America. The information contained herein is the exclusive and confidential property of Cogentix Medical, Inc. No part of this manual may be disclosed or reproduced in whole or in part without permission from Cogentix Medical, Inc.

How to Use This Manual This User’s Manual contains the recommended procedures for preparing and using the Cogentix Medical ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope. It is intended for physicians and other medical personnel who will come in contact with the endoscope before, during, and after any patient procedures performed with it. The manual also contains pertinent information on the proper care and handling of the endoscope. Please read and become familiar with this entire manual before using the endoscope. This manual contains the following information:     

Description of the endoscope The endoscope’s intended use Components and features of the endoscope and peripheral equipment used in conjunction with the endoscope Complete instructions on endoscope preparation, inspection, operation, reprocessing, and storage Warning and Caution statements that must be observed by endoscope users to ensure patient and user safety

If you are a first time endoscope user, Cogentix Medical strongly recommends that you read this manual from beginning to end and become intimately familiar with the endoscope and its use. If you are an experienced endoscope user, select specific chapters and/or sections that pertain to features and procedures that you are using. _______________________________________________________________________

Organization of this Manual Following is a list of the chapters included in this manual. Each chapter’s title is listed at the top of all pages after the title page, so that you can quickly access the information you need.

Chapter 1, Symbols and Terms – This chapter defines the symbols on the endoscope and peripheral equipment. There is also a brief list of the terms that are commonly used in the manual.

Chapter 2, Important Information – The information in this chapter is a

summary of critical Warning and Caution statements in the manual. This information is essential to the safe operation and reprocessing of the endoscope. Cogentix Medical strongly recommends that this chapter be read thoroughly and completely understood by all users before working with the endoscope.

Chapter 3, Endoscope and Accessories – Introduces the ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope and compatible peripheral equipment. This chapter includes instrument diagrams, identifies components, and defines their functions.

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How to Use This Manual

Chapter 4, Preparation, Inspection and Operation – This chapter describes how to prepare the endoscope and peripheral equipment for use, and the assembly of the equipment into a system. The chapter also leads you through a detailed inspection procedure to confirm that the equipment is undamaged and working properly before it is used in a procedure.

Chapter 5, Reprocessing – This chapter contains important instructions on the proper cleaning, disinfection, and sterilization of the endoscope before its first use and after each subsequent use. Strict adherence to the instructions in this chapter will render the endoscope “patient-ready” for each procedure.

Chapter 6, Care and Storage – If the equipment will not be used for a prolonged period, refer to this chapter for instructions on safe, secure storage.

Chapter 7, Troubleshooting – Describes possible problems that may be

encountered with the endoscopic system, and suggests corrective actions to take towards resolving minor problems.

Chapter 8, Warranty and Service – This chapter contains the terms of the

Cogentix Medical warranty on the endoscope, any restrictions that apply and user actions that may void the warranty if taken. This chapter also includes shipping instructions in case the endoscope must be returned to Cogentix Medical for repair or service. The Appendix contains the technical specifications for the ENT-4000/4500 Nasopharyngo-Laryngoscope, and infection control information.

Additional Information The information in this User’s Manual is subject to change without notice. If you have any questions regarding any of the material contained in this manual, or wish to confirm that this is the most comprehensive information available for these products, please contact your local distributor or Cogentix Medical Customer Service Department at 866 258-2182 (toll free in U.S.) or (+1) 952-426-6189 (international).

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Table of Contents How to Use This Manual ...i Organization of this Manual ... i Additional Information... ii 1

Symbols and Terms ... 1

Symbols ... 1 Terms ... 2 2

Important Information ... 3

Intended Use ... 3 User Qualifications ... 3 Reprocessing ... 3 Maintenance and Repair ... 4 Signal Words ... 4 Important Safety Precautions... 4 Preparation, Inspection and Assembly ... 4 During Use ... 5 Reprocessing ... 6 3

Endoscope and Accessories ... 7

Inspect the Standard Set ... 8 Equipment Diagrams ... 9 ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope 9 Accessories ... 12 Light Sources ... 12 BLS-1000 Battery Powered Light Source ... 12 Light Guide Cables ... 12 Add-On Camera System ... 12 Leak Testing ... 12 Reprocessing ... 12 Light Source Adapters (Light Guide Sleeves) ... 13 4

Preparation, Inspection and Operation ... 15

Preparation and Inspection ... 16 Endoscope Operation with BLS-1000 Battery Powered Light Source ... 16 Endoscope Operation – Other Light Source ... 18 5

Reprocessing ... 19

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Table of Contents Reprocessing Steps ... 20 Leak Testing... 20 Attach the Leak Tester to the Endoscope ... 21 Leak Test Connection Components ... 21 Pressurize the Endoscope ... 21 Cleaning/Disinfection/Sterilization... 23 Cleaning and Intermediate Level Disinfection After Slide-On® Endo-Sheath® Technology Use ... 23 High-Level Disinfection and Sterilization ... 24 Recommended High Level Disinfection and Sterilization Procedures 24 Incompatible Methods ... 25 High-Level Disinfection Protocol ... 26 Cleaning... 26 High-Level Disinfection ... 26 Rinsing ... 26 Ethylene Oxide (EtO) Gas Sterilization ... 27 STERRAD® and STERIS® Sterilization ... 28 6

Care and Storage ... 29

Storage ... 29 Disposal ... 29 7

Troubleshooting ... 31

8

Warranty and Service ... 35

Warranty Information... 35 Cogentix Medical Service Information ... 35 Shipping to Cogentix Medical or Distributor ... 36 Appendix ... 37 Specifications ... 37 Infection Control Information ... 38

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Table of Contents

Index of Figures Figure 3-1: ENT-4000/4500 Nasopharyngo-Laryngoscope ... 9 Figure 3-2: ENT-4000/4500 Nasopharyngo-Laryngoscope (Control Body) ... 10 Figure 3-3: Light Source Adapters (Light Guide Sleeves) ... 13 Figure 5-1: Leak Tester Connection ... 21 Figure 5-2: Opening the Vent Valve ... 23

Index of Tables Table 3-1: ENT-4000/4500 Nasopharyngo-Laryngoscope Standard Sets ... 8 Table 5-1: STERRAD® and STERIS® Validated Systems/Cycles ... 28 Table 7-1: Troubleshooting ... 32 Table A-1: Specifications ... 37

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1 Symbols and Terms Symbols The symbols listed below can be found on the ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope and on other components of the endoscopic system. Type BF applied part 1(Safety degree specified by IEC 60601-1). Alerts the user to the presence of important operating, maintenance, and service instructions. Refer to and become familiar with the user’s manuals for all equipment used in the procedure. Serial number of the endoscope Equipment bearing this mark has been designed, tested, and certified as essentially compliant with all applicable European Union (EU) regulations and recommendations. Up position for the angulation lever Down position for the angulation lever Underwriters Laboratories Component Recognition Mark STERIS® and STERRAD® Reprocessing Compatibility Refer to Chapter 5, Reprocessing (Endoscope must feature the S symbol for compatibility to apply)

○

Products do not contain natural rubber latex

Consult Instructions for Use The presence of this symbol on the product or packaging indicates that the device is RoHS compliant.

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Symbols and Terms

Terms The following terms are used throughout this User’s Manual: 



2

“Laryngoscope”, “Endoscope”, or “ENT Scope” - Refers to the Cogentix Medical ENT-4000/4500 Nasopharyngo-Laryngoscope.

“Sheath” – Refers to the disposable ENT Slide-On® EndoSheath® Technology for the ENT-4000/4500 Nasopharyngo-Laryngoscope.

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2 Important Information The information in this chapter is essential for the correct and safe operation of the ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope. Please read and understand this information before preparing or using the endoscope or any peripheral equipment with which it will be used.

Intended Use The Cogentix Medical ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope is intended to be used for flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. NOTE: The ENT-4000/4500 is not intended for electrosurgical procedures. Do not use the endoscope for any purpose other than these intended uses.

User Qualifications This equipment should only be used in a medical facility by or under the supervision of a physician trained in laryngoscopy. Only use the endoscope and peripheral equipment according to the instructions and under the operating conditions described in this manual. Failure to do so could result in compromised safety, equipment malfunction and/or instrument damage. For preparation of the device before use, and disassembly and proper cleaning after use, users should be adequately trained in the proper procedures. Failure to thoroughly understand these details, such as – but not limited to – EndoSheath® Technology installation and authorized disinfection protocols, may pose an infection-control risk and/or cause equipment damage. If training assistance is desired from either the manufacturer or a local distributor, please contact Cogentix Medical Customer Service at 866 258-2182 (toll free in U.S.) or (+1) 952-426-6189 (international).

Reprocessing The endoscope must be thoroughly cleaned, disinfected, and/or sterilized before its first use and after each subsequent use. This is the only way to ensure that a “patient-ready” endoscope is used in every procedure. See Chapter 5, Reprocessing, for information on reprocessing equipment and procedures.

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Important Information

Maintenance and Repair The endoscope contains no user-serviceable parts; never attempt to modify or repair it. Doing so may cause further equipment damage and/or compromise patient safety if the endoscope is subsequently used in a procedure. The endoscope may only be serviced / repaired at an authorized Cogentix Medical facility. The endoscope should be thoroughly inspected before each procedure and should be periodically inspected to determine if there is damage or wear that requires attention.

Signal Words Information included in this manual to warn users of the possibility of patient injury and/or equipment damage is signified by the Warning and Caution symbols below. Warnings, Cautions and Notes will appear throughout this manual; carefully read and follow all statements. Alerts the user to situations which, if not avoided, could result in death or serious injury. Alerts the user to situations which, if not avoided, could result in moderate or minor injury to the user or patient. It is also used to alert the user to conditions and actions that could cause equipment damage.

 N : Indicates additional helpful information. OTE

Important Safety Precautions The following precautions should always be exercised when using the endoscope and all medical equipment to ensure safety to all involved parties – user(s), patient(s), etc. They are summarized here in the order of the stages of the endoscope’s use.

Preparation, Inspection and Assembly Carefully inspect all equipment before using it in a procedure, and do not use any equipment that is damaged or excessively worn. Doing so could lead to patient injury and/or further damage to the equipment. If inspection reveals difficulty in articulation of the endoscope’s Distal Bending Section, the endoscope may be damaged. Do not use the endoscope in this case. Contact your local distributor or call the Cogentix Medical Customer Service Department.

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Important Information All devices that are connected to the ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope must be Classified Medical Equipment. Before using any additional equipment confirm that it complies with the appropriate end-product safety standard (such as IEC 60950-1) and the Standards for Medical Electrical Equipment, UL 60601-1 or IEC 60601-1. Never drop the equipment or subject it to severe impact, as it could compromise the functionality and/or safety of the equipment or system. Should the equipment be mishandled or dropped, do not use it. Immediately return it to an authorized Cogentix Medical service facility for inspection and repair.



NOTE: The Cogentix Medical ENT-4000 and ENT-4500 Flexible Nasopharyngo-Laryngoscopes and Slide-On® EndoSheath® Technology are not made with natural rubber latex.

During Use Do not use this equipment in the presence of a flammable anesthetic mixture containing air, oxygen or nitrous oxide. There is a possibility of fire or explosion. The ENT-4000/4500 is not intended to be used with electrosurgical devices. If any of the components of the endoscopic system malfunctions during the procedure, or if the endoscopic image is lost or compromised, immediately move the endoscope’s Distal Bending Section into the neutral position and slowly withdraw the endoscope from the patient. Using an endoscope that is not functioning properly could cause patient injury and/or further damage to the equipment. Always wear appropriate personal protective equipment when using the endoscope and/or sheath, such as a gown, gloves, and face and eye shields. Avoid excessive bending or twisting of the endoscope’s Insertion Tube. Although they are designed to bend, excessive bending can damage the fiber bundles and internal components. Should the endoscope develop a severe kink or bend, do not attempt to straighten the Insertion Tube. Contact Cogentix Medical Customer Service for assistance. DO NOT apply excessive pressure to the Angulation Lever, as it could damage the endoscope and lead to patient injury. DO NOT look directly at the intense light emitted from the endoscope tip to avoid the possibility of eye injury.

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Important Information

Reprocessing The endoscope must be properly reprocessed, by cleaning, disinfection and/or sterilization, before its first use and after each subsequent use. Using an endoscope in a procedure that has not been properly reprocessed presents an acute infection-control risk to both the patient and medical personnel performing or assisting in the procedure. Always wear appropriate personal protective equipment when reprocessing the endoscope, such as a gown, gloves, and face and eye shields. Use extreme care when reprocessing the endoscope. Do not forcefully pull, push, or drag wipes, towels, or cloths along the Insertion Tube. The use of excessive force could damage the endoscope. DO NOT immerse the endoscope in disinfectant solution for long periods of time (in excess of 1 hour). Prolonged immersions may damage the outer coverings of the endoscope and allow fluid infiltration. DO NOT place the endoscope in or near contaminated areas after it has been reprocessed. Doing so can re-contaminate the endoscope and require reprocessing to be repeated. DO NOT place the endoscope in awkward or confining areas between procedures as this could result in equipment damage.

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3 Endoscope and Accessories The Cogentix Medical ENT-4000/4500 Flexible Nasopharyngo-Laryngoscopes are designed to perform safe, sterile, and efficient endoscopy. This equipment has been designed for the examination of the upper airway from the nasal passages to the vocal cords, including the larynx. With proper use, the endoscope provides a thorough examination for more accurate diagnoses with minimal patient discomfort. The ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope is shown in Figures 3-1 and 3-2 on pages 9 and 10. The endoscope does not have a working channel; it contains three fiberoptic light bundles and a fiberoptic image bundle. The ENT-4000/4500 Flexible Nasopharyngo-Laryngoscopes are validated for use with the Slide-On® EndoSheath® Technology. The ENT-4000/4500 endoscopes can be used with or without the Slide-On® EndoSheath® Technology. The sterile, disposable Sheaths are installed over the endoscope’s Insertion Tube, acting as a protective barrier to protect patients and users from the spread of potentially pathogenic materials. Be sure to handle the endoscope with care during use, reprocessing and storage. The fiberoptics are comprised of thin glass fibers which can be damaged by physical trauma, extreme temperatures, high humidity, or fluid invasion of the endoscope.

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Endoscope and Accessories

Inspect the Standard Set Do not use any equipment that is observed to be damaged or excessively worn. Doing so could lead to patient injury and/or further damage to the equipment. When the endoscope is received from Cogentix Medical, immediately confirm that the items listed in Table 3-1 below have been shipped, and inspect them for damage. If any item is missing or damaged, do not use the endoscope. Contact Cogentix Medical to obtain a replacement part. ENT-4000 NASOPHARYNGO-LARYNGOSCOPE STANDARD SET CATALOG NO.

DESCRIPTION

02-4202

ENT-4000 Endoscope

07-3060

Light Guide Cable, 1.8m

07-6015

Vent Cap

07-6180

Cogentix Medical ENT-4000/4500 Carrying Case

ENT-4000/4500 User’s Manual (this document) ENT-4500 NASOPHARYNGO-LARYNGOSCOPE STANDARD SET 02-4502 ENT-4500 Endoscope 07-3060

Light Guide Cable, 1.8m

07-6015

Vent Cap

07-6180

Cogentix Medical ENT-4000/4500 Carrying Case

ENT-4000/4500 User’s Manual (this document) OPTIONAL ITEMS AND ACCESSORIES (NOT SHIPPED WITH ENDOSCOPE) 07-6160 Installation Stand, Floor Model 07-6161

Installation Stand, Clamp Model

07-6162

Installation Stand, Wall Mount

07-6010

Endoscope Leak Tester

07-3050

Light Guide Sleeve Adapter BLS-1000 Battery Powered Light Source Set (with Batteries and Battery Charger) BLS-1000 Battery Powered Light Source (Replacement)

07-3058*

BLS-1000 Battery Charger (Replacement)

07-3059

BLS-1000 Batteries (2 Batteries) (Replacement)

See List on Page 13

07-3053*

Table 3-1: ENT-4000/4500 Nasopharyngo-Laryngoscope Standard Sets

*Contact distributor for region-specific configuration

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Endoscope and Accessories

Equipment Diagrams ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope

Figure 3-1: ENT-4000/4500 Nasopharyngo-Laryngoscope

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Endoscope and Accessories

ENT-4000/4500 Flexible Nasopharyngo-Laryngoscope

Figure 3-2: ENT-4000/4500 Nasopharyngo-Laryngoscope (Control Body) Endoscope and Control Body: 1. Angulation Lever: This integral component of the Control Body controls the endoscope’s Distal Tip deflection. 2. Light Guide Cable Connector (Light Post): One end of the Detachable Light Guide Cable is inserted into the external Light Source to allow light to be projected to the endoscope’s Distal Tip. The other end of the Cable is attached to this Connector on the Control Body. 3. Eyepiece/Ocular: Located at the top of the Control Body, this feature allows the user to view the image directly. Alternatively, a standard video camera, still photography system, or teaching attachment can be connected to the eyepiece, allowing the image to be displayed on a video monitor and/or photographed.

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Endoscope and Accessories 4. EndoSheath® Interface: Located at the base of the Control Body, this component secures the disposable Slide-On® EndoSheath® Technology to the endoscope. 5. Identification Ring: Includes the Serial Number, which is a unique number identifying the endoscope; and the ○ S symbol, which indicates the endoscope can be sterilized using a validated STERIS® or STERRAD® system. The endoscope must feature this symbol on the ID ring in order for STERIS® or STERRAD® compatibility to apply. Also includes a UL symbol (Underwriters Laboratories), which indicates the fiberscope is recognized as a component that can be used in tandem with add-on components such as light sources and camera attachments. 6. Vent Valve: When the Vent Cap is connected here, this Valve allows access to the interior of the endoscope for EtO or STERRAD® Gas Sterilization, and should be connected during transport. The Vent Cap must be attached to this Valve prior to EtO or STERRAD® Gas Sterilization and prior to shipping. The valve is also used as a Leak Tester Connector for Leak Testing. 7. Distal Bending Section: Deflects up and down when the Angulation Lever is actuated by the user. 8. Distal Tip: The terminating point of the image fiber bundle [Objective Lens] and the light guide fiber bundles [Light Guides]. 9. Control Body: This segment allows physician control over endoscopic functions. 10. Insertion Tube: This component, along with the Distal Tip, is the part of the endoscope that is inserted into the patient. 11. Diopter Adjustment Ring: Located on the Control Body, this ring turns clockwise or counterclockwise to adjust the image until the image is clear. When a video camera, still photography systems, or teaching attachment is used, the white dot on the control body should be aligned with the white dot on the Diopter Adjustment Ring. When using an add-on camera, use the Focus Ring on the camera to adjust focus, instead of the Diopter Adjustment Ring.

Not Shown in Diagram: Detachable Light Guide Cable: Standard 1.8m cable shipped with endoscope. Light Guide Sleeve: Adapts the Light Guide Cable to make it compatible with different light sources.

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Endoscope and Accessories

Accessories Do not use any accessories that are not in compliance with the equivalent safety requirements of this equipment. Doing so may reduce the operational safety of the system and could cause patient and/or user injury. For all accessories, confirm that the safety certifications have been performed in accordance with the appropriate standard (IEC 60601-1 and/or IEC 60601-1-1). Use of accessories not specified in this manual or sold by Cogentix Medical may result in increased electromagnetic emissions or decreased immunity of the equipment or system.

Light Sources BLS-1000 Battery Powered Light Source An LED light source that allows for endoscopic illumination without a light guide cable. Refer to Chapter 4, Preparation, Inspection and Operation for proper set-up and operation information. The ENT-4000/4500 Endoscope is designed to be used with the BLS-1000 Battery Powered Light Source.

Light Guide Cables Additionally, the ENT-4000/4500 Endoscope is designed to be compatible with various light sources when using the detachable Light Guide Cable. To ensure proper mating with the selected light source, be sure that the appropriate Light Guide Sleeve is securely threaded onto the Light Guide Cable. Refer to Figure 3-3 for a complete list and diagrams of the available Light Guide Sleeves.

Add-On Camera System The ENT-4000/4500 Endoscope features a “rigid” style eyepiece compatible with most manufacturers’ Add-On Camera Systems. Ensure that the Camera System’s coupler is designed for a “rigid” style eyepiece. If it is not, please contact Cogentix Medical for compatibility assistance.

Leak Testing The ENT-4000/4500 Endoscope may only be leak tested with a Cogentix Medical Endoscope Leak Tester.

Reprocessing The ENT-4000/4500 Endoscope may be reprocessed by a variety of methods. Refer to Chapter 5, Reprocessing for the accessories that will be used when reprocessing the endoscope. Contact Cogentix Medical Customer Service for advice on compatibility issues. 12

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Endoscope and Accessories

Light Source Adapters (Light Guide Sleeves) The following Light Guide Sleeves are available to adapt Cogentix Medical endoscopes for use with other manufacturers’ light sources when using a Detachable Light Guide Cable. Using an incorrect or incompatible adapter could result in impaired operation and viewing, and could cause damage to the endoscope, light guide cable and/or light source.

LIGHT GUIDE SLEEVE DIAGRAM

CATALOG NUMBER & COMPATIBLE LIGHT SOURCES 06-6019: Cogentix Medical HLS-1500 / XLS-3000, Circon and ACMI Light Sources 06-6009: Cogentix Medical LS-150 and Pentax Light Sources

06-6044: Olympus Light Sources

06-6020: Smith & Nephew, Gyrus, and Richard Wolf Light Sources

06-6029: Machida Light Sources

06-6023: Karl Storz Light Sources

Figure 3-3: Light Source Adapters (Light Guide Sleeves)

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