TNE-5000 User Manual Rev E Oct 2015

©2008, 2009, 2011, 2012, 2013, 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 TNE-5000 Flexible Video Esophagoscope and the Slide-On® EndoSheath® Technology. It is intended for physicians and other medical personnel who will come in contact with the equipment 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 equipment. This manual contains the following information:     

The endoscope’s intended use Description of the endoscope and Slide-On® EndoSheath® Technology 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 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 TNE-5000 Flexible Video Esophagoscope and compatible peripheral equipment. This chapter includes instrument diagrams, identifies components, and defines their functions.

Chapter 4, Installing and Removing Slide-On® EndoSheath® Technology – Slide-On® EndoSheath® Technology is a sterile, single-use barrier placed over

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How to Use This Manual the endoscope’s Insertion Tube before the procedure, and removed and discarded after the procedure is completed. This chapter includes the procedures for installing the sheath prior to the procedure and removing it when the procedure is over.

Chapter 5, 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 6, 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 7, 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 8, Troubleshooting – Describes possible problems that may be encountered with the endoscopic system, and suggests corrective actions to take towards resolving minor problems.

Chapter 9, 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.

The Appendix contains the technical specifications for the TNE-5000 Flexible Video Esophagoscope 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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TNE-5000 Flexible Video Esophagoscope 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...6 Reprocessing ...7 3 Endoscope and Accessories ... 9 Inspect the Standard Set ... 10 Equipment Diagrams ... 11 TNE-5000 Flexible Video Esophagoscope ... 11 TV-2.1 Slide-On® EndoSheath® Technology ... 14 TV-1.5 Slide-On® EndoSheath® Technology ... 16 DPU-5000/7000 Series Digital Video Processor ... 18 Installation Stand ... 19 Accessories ... 20 Video Processor... 20 Light Sources ... 20 Leak Testing ... 20 Reprocessing ... 20 Therapeutic Accessories ... 20 4 Installing and Removing the Slide-On® EndoSheath® Technology ... 21 Install the Slide-On® EndoSheath® Technology ... 21 Prepare the Endoscope and Sheath ... 22

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Table of Contents Insert the Endoscope Into the Sheath ... 22 Connect Tubing / Complete Sheath Attachment ... 24 Complete System Assembly ... 24 Observe the Endoscopic Image ... 24 Remove the Slide-On® EndoSheath® Technology ...25 5 Preparation, Inspection and Operation ... 27 Preparation and Inspection ...27 Select an Installation Site ... 27 Endoscope Operation ...29 Insufflation ...30 Suction ...30 Inserting Accessories...30 Electrosurgical Devices/Accessories ...31 Laser Devices/Accessories ...32 6 Reprocessing ... 33 Reprocessing Steps ...34 Leak Testing ...34 Attach the Leak Tester to the Endoscope ... 34 Pressurize the Endoscope ... 35 Cleaning, Disinfection, and Sterilization ...37 Use of the Vent Cap ... 37 Cleaning After Slide-On® EndoSheath® Technology Usage ... 37 High-Level Disinfection and Sterilization ...38 Recommended Disinfection and Sterilization Procedures ... 38 Acceptable Reprocessing Materials ...39 Incompatible Methods ...39 High-Level Disinfection Protocol ...40 Pre-Cleaning ... 40 Disinfection ... 40 Rinsing ... 40 Ethylene Oxide (EtO) Gas Sterilization ...41 EtO Gas Sterilization Parameters ... 41 After EtO Gas Sterilization ... 41 STERRAD® and STERIS® Sterilization...42 7 Care and Storage ... 43 Storage ...43 Disposal ...44

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Table of Contents 8 Troubleshooting ... 45 9 Warranty and Service ... 53 Warranty Information... 53 Cogentix Medical Service Information ... 53 Shipping to Cogentix Medical ... 54 Appendix... 55 Specifications TNE-5000 ... 55 Infection Control Information ... 56 Electromagnetic Compatibility Declarations ... 57

Index of Figures Figure 2-1: Incorrect and Correct Sheath Alignment ...5 Figure 3-1: TNE-5000 Flexible Video Esophagoscope ... 11 Figure 3-2: TNE-5000 Flexible Video Esophagoscope – Control Body ... 12 Figure 3-3: TV-2.1 Slide-On® EndoSheath® Technology ... 14 Figure 3-4: TV-1.5 Slide-On® EndoSheath® Technology ... 16 Figure 3-5: DPU-5000/7000 Series Digital Video Processor... 18 Figure 3-6: Installation Stand ... 19 Figure 4-1: Incorrect and Correct Sheath Alignment ... 23 Figure 6-1: Leak Tester Connection ... 35 Figure 6-2: Opening the Vent Valve ... 37

Index of Tables Table 3-1: TNE-5000 Flexible Video Esophagoscope – Components ... 10 Table 6-1: STERRAD® and STERIS® Validated Systems/Cycles ... 42 Table 8-1: Troubleshooting ... 46 Table A-1: Specifications... 55 Table A-2: Electromagnetic Emissions Declaration ... 57 Table A-3: Electromagnetic Immunity Declaration ... 58 Table A-4: Electromagnetic Immunity Declaration ... 59 Table A-5: Recommended Separation Distances... 60

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1 Symbols and Terms Symbols The symbols listed below can be found on the TNE-5000 Flexible Video Esophagoscope 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/or service instructions. Refer to the user’s manuals for warnings and safety precautions associated with equipment used in the procedure. The equipment has been designed, tested, and certified as essentially compliant 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 6, 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: “Esophagoscope”, “Endoscope”, or “Videoscope” - refers to the Cogentix Medical TNE-5000 Flexible Video Esophagoscope. “Slide-On® EndoSheath® Technology” or “Sheath” refers to the disposable TV-2.1 or TV-1.5 Slide-On® EndoSheath® Technology for the TNE-5000 Flexible Video Esophagoscope. “Processor” refers to the DPU-5000/7000 Series Video Processors.

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TNE-5000 Flexible Video Esophagoscope User’s Manual

2 Important Information The information in this chapter is essential for the correct and safe operation of the TNE-5000 Flexible Video Esophagoscope. 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 TNE-5000 Flexible Video Esophagoscope with Slide-On® EndoSheath® Technology is intended to be used for endoscopic access and examination of the larynx, esophagus, and gastro-esophageal junction. The equipment may also be used to assist in intubation. Do not use the equipment 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 endoscopy. Use of the system does not require any deviation from standard esophagoscopy 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 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 “patientready” endoscope is used in every procedure. See Chapter 6, 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. The endoscope should be thoroughly inspected before each procedure; it should also 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.



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 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 The TNE-5000 and Slide-On® EndoSheath® Technology are designed to operate as an integrated system. Neither component can be used independently of the other. The Slide-On® EndoSheath® Technology is designed for a single patient use only. Do not reuse or attempt to re-sterilize the Sheath. For installing the Sheath in a sterile environment, users should wear two (2) pairs of sterile gloves. Refer to Chapter 4, Installing and Removing the Slide-On® EndoSheath® Technology, for complete details.

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Important Information 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. While the Sheath is being installed, the endoscope should move freely without the application of force. Should ANY resistance be encountered, verify that the Sheath’s channel is properly aligned. 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 a damaged endoscope; doing so could cause patient injury, and may result in further damage to the endoscope. If the channel of the sheath is misaligned, straighten out the channel before continuing scope insertion, as shown in Figure 2-1 below. Also refer to Chapter 8, Troubleshooting, for further information. If the suggestions given in that chapter do not solve the alignment or insertion problems, contact your local distributor or Cogentix Medical Customer Service Department.



NOTE: The Cogentix Medical TNE-5000 Flexible Video Esophagoscope and Slide-On® EndoSheath® Technology are not made with natural rubber latex.

MISALIGNED

ALIGNED PROPERLY

Figure 2-1: Incorrect and Correct Sheath Alignment

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Important Information All devices that are connected to the TNE-5000 Flexible Video Esophagoscope and DPU-5000/7000 Series Video Processor 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, and Safety Requirements for Medical Electrical Equipment, IEC 60601-1-1. DO NOT expose the Sheath to alcohol or other cleaning agents prior to use. The Working Channel of the TV-2.1 Slide-On® EndoSheath® Technology accommodates instrumentation indicated by the accessory manufacturer to be compatible with a 2.1 mm or smaller working channel. All instrumentation must be tested for compatibility with the channel prior to clinical use. If assistance is needed to determine compatibility, contact your local distributor or Cogentix Medical Customer Service. DO NOT allow liquids to get inside the Sheath prior to use. Doing so could damage the Sheath and/or the endoscope.

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 to 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 If resistance is encountered when inserting an instrument into the Sheath, do not force it, as it could damage the instrument, the endoscope and/or the Slide-On® EndoSheath® Technology. A thorough understanding of the principles and techniques involved in laser, electrosurgical and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device and other medical instruments. Ensure that insulation or grounding is not compromised.

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 TNE-5000 Flexible Video Esophagoscope and Slide-On® EndoSheath® Technology are designed to perform safe, sterile, and efficient esophagoscopy procedures. The two major components of the endoscopic system are: 

The TNE-5000 Flexible Video Esophagoscope, which is shown in Figures 3-1 and 3-2 on pages 11 and 12. The endoscope’s Insertion Tube has no working channel; it contains the video camera module and illumination bundles.



The disposable 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. The sheaths also contain working channels through which insufflation, suction, and/or accessory equipment can be used. There are two types of sheaths available for use with the TNE-5000: 



The TV-2.1 Slide-On® EndoSheath® Technology (see Figure 3-3 on page 14). This Sheath contains a 2.1mm (6.3Fr) channel through which air insufflation and suction can be performed, or accessory instruments inserted. The TV-1.5 Slide-On® EndoSheath® Technology (see Figure 3-4 on page 16) has a 1.5mm (4.5Fr) channel that supports insufflation and suction, but cannot accommodate the insertion of accessory devices.

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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 all of the ordered 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 to obtain replacement parts.

TNE-5000 ESOPHAGOSCOPE STANDARD SET COGENTIX MEDICAL CATALOG NO. 03-5201 OR 03-5202

DESCRIPTION TNE-5000 Flexible Video Esophagoscope, NTSC TNE-5000 Flexible Video Esophagoscope, PAL

07-6182

Cogentix Medical TNE-5000 Carrying Case

07-6015

Vent Cap TNE-5000 User’s Manual (this document)

VIDEO PROCESSORS (NOT SHIPPED WITH ENDOSCOPE) 07-5050 DPU-5050 Video Processor with LCD Display* 07-5051 07-7001

DPU-5050A Video Processor with Air Pump and LCD Display* DPU-7000A Video Processor with LCD Display

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

Videoscope Leak Tester

ENDOSHEATH® TECHNOLOGY 03-5101

03-5102

TV-2.1 Slide-On® EndoSheath® Technology with 2.1mm (6.3Fr) Working Channel for the TNE-5000 Flexible Video Esophagoscope TV-1.5 Slide-On® EndoSheath® Technology with 1.5mm (4.5Fr) Air/Suction Channel for the TNE-5000 Flexible Video Esophagoscope

Table 3-1: TNE-5000 Flexible Video Esophagoscope – Components

*Available in select markets only

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Endoscope and Accessories

Equipment Diagrams TNE-5000 Flexible Video Esophagoscope

Figure 3-1: TNE-5000 Flexible Video Esophagoscope

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Endoscope and Accessories

Figure 3-2: TNE-5000 Flexible Video Esophagoscope – Control Body

Instrument Components 1. Angulation Lever: Controls deflection of the endoscope’s Distal Bending Section. 2. Dual Pinch Valves: Attach the Insufflation/Suction Tubing to the valves to regulate insufflation and suction during use. 3. Videoscope Cable: The connector (plug) at the end of the cable connects to the DPU-5000/7000 Series Digital Video Processor. 4. Control Buttons: Four programmable function buttons which 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. 5. Locking Knob: Mates with the EndoSheath® Rigid Connector to secure the SlideOn® EndoSheath® Technology to the endoscope.

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Endoscope and Accessories 6. EndoSheath Interface: Secures the disposable EndoSheath® cover to the endoscope body. 7. 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 Identification Ring in order for STERIS® / STERRAD® compatibility to apply. 8. 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 and STERRAD® gas sterilization and prior to shipping. The valve is also used as a Leak Tester Connector for Leak Testing. 9. Distal Bending Section: Deflects up and down when the Angulation Lever is actuated. 10. Distal Tip: The terminating point of the video camera module and the light guide fiber bundles [Light Guides]. 11. Sealing Cap: Seals the plug prior to soaking for leak testing or disinfection. 12. Control Body: This segment allows physician control over endoscopic functions. 13. Insertion Tube: This component, along with the Distal Tip, is the part of the endoscope that is inserted into the patient.

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Endoscope and Accessories

TV-2.1 Slide-On® EndoSheath® Technology The TV-2.1 Slide-On® EndoSheath® Technology shown in Figure 3-3 is a sterile, disposable barrier for the Cogentix Medical TNE-5000 Flexible Video Esophagoscope. The Sheath isolates the endoscope from contact with patient fluid and material during the procedure.

Figure 3-3: TV-2.1 Slide-On® EndoSheath® Technology 1. Control Body Cover: Covers and protects the endoscope’s Control Body from contaminants during the procedure. 2. Slot for Locking Knob: Slides past the Locking Knob to secure the Sheath to the endoscope. 3. Accessory Port with Removable Seal: Allows rapid fluid injection and passage of accessories during procedures. A removable Accessory Port Valve Seal allows for secure Luer-Lock syringe attachment for fluid withdrawal. 4. EndoSheath® Connector: Secures the Sheath to the endoscope. 5. Working Channel: A solid, impermeable tubing that runs the length of the Sheath, allowing for maximum air insufflation and suction while also allowing the passage of accessory devices. 6. Insertion Tube Barrier: A flexible elastomeric sleeve that creates a barrier covering for the endoscope’s Insertion Tube.

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TNE-5000 Flexible Video Esophagoscope User’s Manual