ENT-5000 and ENT-7000 User Manual Rev F Aug 2015

© 2008, 2009, 2010, 2012, 2013, 2014, 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-5000/ENT-7000 Flexible Video NasopharyngoLaryngoscope. 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 them. The manual also contains pertinent information on the proper care and handling of the equipment. 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 User’s 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, Inc. 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-5000/ENT7000 Flexible Video 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 how to assemble 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 endoscope 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 or a regional distributor for repair. The Appendix contains the technical specifications for the ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscopes 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 this product, please contact your local distributor or Cogentix Medical Customer Service Department at (866) 258-2182 or (+1) 952 426-6189 (International).

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ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope User’s Manual

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 ... 7 Equipment Diagrams ... 8 ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope ... 8 DPU-5000/7000 Series Digital Video Processor ... 10 The Slide-On® EndoSheath® Technology ... 11 Accessories ... 11 Video Processor ... 11 Light Sources ... 11 Leak Testing ... 12 Reprocessing ... 12 4 Preparation, Inspection and Operation ... 13 Preparation and Inspection ... 14 Select an Installation Site ... 14 Endoscope Operation ... 15 5 Reprocessing ... 17 Reprocessing Steps ... 18 ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope User’s Manual

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Table of Contents Leak Testing... 18 Attach the Leak Tester to the Endoscope ... 19 Pressurize the Endoscope ... 19 Cleaning, Disinfection, and Sterilization... 21 Use of the Vent Cap... 21 Cleaning After Slide-On® EndoSheath® Technology Use ... 21 High-Level Disinfection and Sterilization ... 22 Recommended Disinfection and Sterilization Procedures ... 22 Incompatible Methods ... 23 High-Level Disinfection Protocol ... 24 Pre-Cleaning ... 24 Disinfection ... 24 Rinsing ... 24 Ethylene Oxide (EtO) Gas Sterilization ... 25 EtO Gas Sterilization Parameters ... 25 After EtO Gas Sterilization ... 25 STERRAD® and STERIS® Sterilization ... 26 6 Care and Storage... 27 Storage ... 27 Disposal ... 28 7 Troubleshooting ... 29 8 Warranty and Service ... 33 Warranty Information... 33 Cogentix Medical Service Information ... 33 Shipping to Cogentix Medical or Distributor ... 34 Appendix ... 35 Specifications ... 35 Electromagnetic Compatibility Declarations ... 36

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Table of Contents

Index of Figures Figure 3-1: ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope ... 8 Figure 3-2: ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope–Control Body ... 9 Figure 3-3: DPU-5000/7000 Series Digital Video Processor ... 10 Figure 5-1: Leak Tester Connection ... 19 Figure 5-2: Opening the Vent Valve ... 21

Index of Tables Table 3-1: ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope Standard Set ... 7 Table 5-1: STERRAD® and STERIS® Validated Systems/Cycles ... 26 Table 7-1: Troubleshooting ... 30 Table A-1: Specifications ... 35 Table A-2: Electromagnetic Emissions Declaration... 36 Table A-3: Electromagnetic Immunity Declaration ... 37 Table A-4: Electromagnetic Immunity Declaration ... 38 Table A-5: Recommended Separation Distances ... 39

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1 Symbols and Terms Symbols The symbols listed below can be found on the ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope and on other components of the endoscopic system. Type BF applied part (Safety degree specified by IEC 60601-1) Alerts the user to the presence of important operating, maintenance, and service instructions. Refer to the user’s manuals for warnings and safety precautions associated with equipment used in the procedure. Endoscopes bearing this mark indicate compliance with all applicable European Union (EU) regulations and recommendations. Serial number of the endoscope

Up position for the Angulation Lever

Down position for the Angulation Lever STERIS® and STERRAD® Reprocessing Compatibility Refer to Chapter 5, Reprocessing (Endoscope must feature the S symbol for STERIS® / STERRAD® compatibility)

○

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: “Laryngoscope”, “Endoscope”, “Videoscope”, or “ENT Scope” refers to the Cogentix Medical ENT-5000/ENT-7000 Flexible Video NasopharyngoLaryngoscope. “Slide-On® EndoSheath® Technology” or “Sheath” refers to the disposable Slide-On® EndoSheath® Technology for the ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope. “Processor” refers to the DPU-5000/7000 Series Video Processors.

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2 Important Information The information in this chapter is essential for the correct and safe operation of the ENT-5000/ENT-7000 Flexible Video 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-5000/ENT-7000 Flexible Video NasopharyngoLaryngoscope is intended to be used for flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. Do not use the endoscope for any purpose other than these intended uses.

User Qualifications The equipment should only be used in a medical facility by or under the supervision of a physician trained in laryngoscopy. Use of the system does not require any deviation from standard laryngoscopy technique. However, the operator should have complete familiarity with the operation of the entire system prior to clinical use. 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 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 or (+1) (952) 426-6189.

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 all 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. In addition to thoroughly inspecting the endoscope before each procedure, it 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 shown 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.



NOTE: Indicates additional helpful information.

Important Safety Precautions The following precautions should always be exercised when using the endoscope and all medical equipment to ensure the safety of 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 if damage occurs; doing so could cause patient injury, and may result in further damage to the endoscope.

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Important Information All devices that are connected to the ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope and DPU-5000/ 7000 Series Video Processors 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-5000/ENT-7000 Flexible Video 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. If any of the components of the endoscopic system malfunction 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 and Videoscope Cable. 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 endoscope’s 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, disinfecting and/or sterilizing, 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 (>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 recontaminate 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-5000/ENT-7000 Flexible Video NasopharyngoLaryngoscope has been designed for examination of the upper airway from the nasal passages to the vocal cords. With proper use, the endoscope provides a thorough examination for more accurate diagnoses with minimal patient discomfort. The ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope is shown in Figures 3-1 and 3-2 on pages 8 and 9. The endoscope’s Insertion Tube has no Working Channel; it contains the video camera module and illumination bundles.

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 all applicable items listed in Table 3-1 have been shipped, and inspect them for damage. If any item is missing or damaged, do not use the endoscope. Contact Cogentix Medical Customer Service to obtain a replacement part. ENT-5000/ENT-7000 NASOPHARYNGO-LARYNGOSCOPE STANDARD SET COGENTIX MEDICAL CATALOG NO. DESCRIPTION 02-5201 ENT-5000 Flexible Video Nasopharyngo-Laryngoscope (NTSC) 02-5202

ENT-5000 Flexible Video Nasopharyngo-Laryngoscope (PAL)

02-7201

ENT-7000 Flexible Video Nasopharyngo-Laryngoscope (NTSC)

02-7202

ENT-7000 Flexible Video Nasopharyngo-Laryngoscope (PAL)

07-6180

Cogentix Medical ENT-5000/ENT-7000 Carrying Case

07-6015

Vent Cap

ENT-5000/ENT-7000 User’s Manual (this document) VIDEO PROCESSORS (NOT SHIPPED WITH ENDOSCOPE) 07-5050 DPU-5050 Video Processor with LCD Display* 07-5051

DPU-5050A Video Processor with Air Pump and LCD Display*

07-7001

DPU-7000A Video Processor with LCD Display OPTIONAL ITEMS/ACCESSORIES

07-6010

V1 Endoscope Leak Tester

Table 3-1: ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope Standard Set *Available in select markets only

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Endoscope and Accessories

Equipment Diagrams ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope

Figure 3-1: ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope

A. Control Body B. Insertion Tube

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Endoscope and Accessories

Figure 3-2: ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope – Control Body

Instrument Components

1. Angulation Lever: Controls Distal Bending Section deflection. 2. Videoscope Cable: The connector (plug) at the end of the cable connects to the DPU-5000/7000 Series Digital Video Processor. 3. Control Buttons: Four programmable buttons allow the user to activate different functions of the video system. Consult the DPU-5000/7000 Series Video Processor User’s Manual for instructions regarding the control functions and how to program the buttons. 4. EndoSheath Interface: Secures the disposable EndoSheath® cover to the endoscope body. 5. Identification Ring: Includes the Serial Number, which is a unique number identifying the endoscope; and the ○ S symbol, indicating the endoscope can be sterilized using a validated STERRAD®/STERIS® system. The endoscope must feature this symbol on the Identification Ring in order for STERRAD®/STERIS® compatibility to apply.

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Endoscope and Accessories 6. Vent Valve: When the Vent Cap is connected, this Valve allows access to the interior of the endoscope for EtO and STERRAD® gas sterilization and should be connected during transport. The Vent Cap must be attached to the Valve prior to EtO or STERRAD® gas sterilization and prior to shipping. The Valve is also used as Leak Tester Connector for Leak Testing. 7. Distal Bending Section: Deflects up and down when the Angulation Lever is actuated. 8. Distal Tip: The terminating point of the video camera module and the lightguide fiber bundles [Light Guides]. 9. Sealing Cap: This Videoscope Cable component seals the plug prior to soaking for leak testing or disinfection. This should also be kept closed when the cable is not in use and/or when the endoscope is being transported.

DPU-5000/7000 Series Digital Video Processor The ENT-5000/ENT-7000 Flexible Video NasopharyngoLaryngoscopes are not compatible with any other manufacturers’ video processors. Attempting to connect the endoscope to or use it in conjunction with another manufacturer’s video processor could cause damage to the endoscope and/or the video processor. The ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscopes must be used in conjunction with a DPU-5000 or DPU-7000 Series Video Processor (Figure 3-3). Refer to the DPU-5000/7000 Series Video Processor User’s Manual for complete instructions on the operation of the unit.

Figure 3-3: DPU-5000/7000 Series Digital Video Processor

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Endoscope and Accessories

The Slide-On® EndoSheath® Technology Do not use the Slide-On® EndoSheath® Technology without first reviewing its Instructions-For-Use, which are shipped with each box of Sheaths. Cogentix Medical recommends the use of the Slide-On® EndoSheath® Technology with the ENT-5000/ENT-7000 Flexible Video NasopharyngoLaryngoscope. The Slide-On® EndoSheath® Technology is a sterile, disposable, protective covering which limits the need for elaborate chemical disinfection or sterilization procedures after every endoscopic procedure. The complete system enables the user to implement a fast and effective method of reprocessing an endoscope, and benefits both user and patient by providing an insertion tube covered with a sterile Sheath for every procedure. Contact your local distributor or Cogentix Medical Customer Service Center for information on ordering the SlideOn® EndoSheath® Technology. Use of the Slide-On® EndoSheath® Technology does not require any deviation from standard nasopharyngoscopy technique; however, the physician should have complete familiarity with the operation of the system prior to clinical use.

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 the safety certifications have been performed in accordance with the appropriate standard (IEC 60601-1 and/or IEC 60601-1-1). The 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.

Video Processor The ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscopes are designed to work with the Cogentix Medical DPU-5000/7000 Series Digital Video Processors. The endoscopes are not compatible with any other manufacturers’ video processors.

Light Sources The ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope has an integrated, solid-state light source which is controlled by the DPU-5000/7000 Series Digital Video Processors. No external light source is required for the ENT5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope.

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Endoscope and Accessories Leak Testing The ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope may only be leak tested with a Cogentix Medical V1 Endoscope Leak Tester.

Reprocessing The ENT-5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope 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.

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4 Preparation, Inspection and Operation

If an abnormality is detected during endoscope preparation, do not use the endoscope; refer to the tables in Chapter 7, Troubleshooting. If the problem cannot be solved using the information in that chapter, contact your regional distributor or Cogentix Medical Customer Service. When using the Slide-On® EndoSheath® Technology with the endoscope, refer to the Instructions-for-Use that are shipped with the Sheaths. These instructions will provide complete details on preparing, installing and removing the disposable Sheath. During the procedure, the temperature at the distal end of endoscope may exceed 41oC (106 oF) due to the intense endoscope illumination. Surface temperatures over 41oC (106 oF) may cause mucosal burns. Always use the minimum level of illumination necessary for adequate viewing. Whenever possible, avoid close stationary viewing and do not leave the distal end of the endoscope in close proximity to mucous membranes for a long time. The Slide-On® EndoSheath® Technology is shipped sterile and intended for a single use only; do not reuse it. When the procedure is complete, remove the Sheath from the endoscope and dispose of it. Reusing the Sheath can damage it, and in turn cause endoscope damage. In addition, a reused Sheath presents a marked infection-control risk to the next patient. If you are not using the Slide-On® EndoSheath® Technology, ensure that the endoscope has undergone the appropriate disinfection process. Please refer to Chapter 5, Reprocessing, for compatible reprocessing methods and procedures. A complete review and understanding of the DPU-5000/7000 Series User’s Manual is recommended before using the ENT5000/ENT-7000 Flexible Video Nasopharyngo-Laryngoscope.

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