BRS-4000 Users Manual Rev F Dec 2015

©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 BRS-4000 Flexible Fiberoptic Bronchoscope and the SlideOn® 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 with it. 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 and accessories. The manual contains the following information:     

The endoscope’s intended use Description of the endoscope and the 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, 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.

Chapter 3, Endoscope and Accessories - Introduces the BRS-4000 Flexible Fiberoptic Bronchoscope, the Slide-On® EndoSheath® Technology, 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, Installing and Removing the Slide-On® EndoSheath® Technology - The Slide-On® EndoSheath® Technology is a sterile, single use barrier placed over 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. This 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 or service. The Appendix contains the technical specifications for the BRS-4000 Flexible Fiberoptic Bronchoscope, 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 User’s 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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BRS-4000 Flexible Bronchoscope 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 ... 4 Maintenance and Repair ... 4 Signal Words ... 4 Important Safety Precautions ... 4 Preparation, Inspection and Assembly ... 5 During Use ... 7 Reprocessing ... 8 3 Endoscope and Accessories ... 9 Inspect the Standard Set ... 10 Equipment Diagrams... 11 BRS-4000 Flexible Bronchoscope ... 11 BF-2.8*, BF-2.1 and BF-1.5 Slide-On® EndoSheath® Technology ... 14 BF-0 Slide-On® EndoSheath® Technology ... 16 Installation Stand ... 17 Accessories ... 18 BLS-1000 Battery Powered Light Source ... 18 Light Guide Cables ... 18 Other Light Sources ... 18 Add-On Camera Systems ... 18

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Table of Contents Leak Testing ... 19 Reprocessing ... 19 Therapeutic/Diagnostic Accessories ... 19 Light Source Adapters ... 20 4 Installing and Removing the Slide-On® EndoSheath® Technology ... 21 Install the Slide-On® EndoSheath® Technology ... 21 Prepare the Endoscope and Sheath ... 22 Insert the Endoscope Into the Sheath ... 22 Connect Suction Tubing ... 23 Complete System Assembly ... 24 Remove the Slide-On® EndoSheath® Technology... 25 5 Preparation, Inspection and Operation ... 27 Preparation and Inspection... 27 Endoscope Operation with BLS-1000 Battery Powered Light Source ... 29 Endoscope Operation – Other Light Sources ... 30 Suction ... 31 Instilling Fluids ... 31 Inserting Accessories... 31 Electrosurgical Devices / Accessories ... 32 Laser Devices / Accessories ... 34 6

Reprocessing ... 35 Reprocessing Steps ... 36 Leak Testing ... 36 Attach the Leak Tester to the Endoscope ... 37 Pressurize the Endoscope ... 37 Cleaning / Disinfection / Sterilization ... 39 Use of the Vent Cap ... 39 Cleaning after Slide-On® EndoSheath® Technology Use ... 39 High-Level Disinfection and Sterilization... 40 Recommended Disinfection and Sterilization Procedures ... 40 Acceptable Reprocessing Materials... 41

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Table of Contents Incompatible Methods ... 41 High-Level Disinfection Protocol ... 42 Cleaning... 42 Disinfection ... 42 Rinsing ... 42 Ethylene Oxide (EtO) Gas Sterilization ... 43 EtO Gas Sterilization Parameters ... 43 After EtO Gas Sterilization ... 43 STERRAD® and STERIS® Sterilization ... 44 7

Care and Storage ... 45 Storage... 45 Disposal... 45

8

Troubleshooting... 47

9

Warranty and Service ... 53 Warranty Information ... 53 Cogentix Medical Service Information ... 53 Shipping to Cogentix Medical or Distributor ... 54

Appendix ... 55 Specifications ... 55 Infection Control Information ... 56

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Table of Contents Index of Figures Figure 2-1: Sheath Alignment ... 6 Figure 3-1: BRS-4000 Flexible Bronchoscope... 11 Figure 3-2: BRS-4000 Flexible Bronchoscope – Control Body ... 12 Figure 3-3: BF-2.8*, BF-2.1 and BF-1.5 Slide-On® EndoSheath® Technology ... 14 Figure 3-4: BF-0 Slide-On® EndoSheath® Technology... 16 Figure 3-5: Installation Stand ... 17 Figure 3-6: Light Source Adapters (Light Guide Sleeves) ... 20 Figure 4-1: Sheath Alignment ... 23 Figure 6-1: Leak Tester Connection ... 37 Figure 6-2: Opening the Vent Valve... 39

Index of Tables Table 3-1: Standard Set Components ... 10 Table 6-1: STERRAD® and STERIS® Validated Systems/Cycles ... 44 Table 8-1: Troubleshooting ... 48

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1 Symbols and Terms Symbols The symbols listed below can be found on the BRS-4000 Flexible Bronchoscope and/or 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. 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 STERRAD® and STERIS® Reprocessing Compatibility Refer to Chapter 6, 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 Throughout this manual, the following terms are used: “Endoscope” or “Bronchoscope” refers to the Cogentix Medical BRS-4000 Flexible Bronchoscope. “Slide-On® EndoSheath® Technology” or “Sheath” refers to the disposable BF-2.8* and BF-2.1 Therapeutic Slide-On® EndoSheath® Technology, and/or the BF-1.5 and BF-0 Diagnostic Slide-On® EndoSheath® Technology.

*Available in Select Markets Only

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BRS-4000 Flexible Bronchoscope User’s Manual

2 Important Information The information in this chapter is essential for the correct and safe operation of the BRS-4000 endoscope and Slide-On® EndoSheath® Technology. Please read and understand this information before preparing or using the endoscope and any peripheral equipment with which it will be used.

Intended Use The BRS-4000 and Slide-On® EndoSheath® Technology are designed to be used for airway management of the trachea and other major passages of the lungs, and endoscopic treatment, diagnosis, and intubation of the airways. The instrument may be introduced via trans-oral or trans-nasal insertion, as per physician preference or anatomical requirements. Combined with accessory devices, the endoscope can be used to perform various diagnostic and therapeutic procedures. Do not use this 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 bronchoscopy 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 User’s 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).

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Important Information

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 6, Reprocessing, for information on all reprocessing equipment and procedures.

Maintenance and Repair The endoscope does not contain user-serviceable parts. Never attempt to modify or repair the endoscope. 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. Notes are also included, to advise of important information. 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 also alerts 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.

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BRS-4000 Flexible Bronchoscope User’s Manual

Important Information Preparation, Inspection and Assembly The BRS-4000 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. Never drop this equipment or subject it to severe impact as it could compromise the functionality and/or safety of the unit. Should any of the equipment be mishandled or dropped, do not use it. Return it to an authorized Cogentix Medical service facility for inspection and repair. While the Sheath is being installed, the Bronchoscope 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 the endoscope in this case. Doing so could cause patient injury, and may result in further damage to the endoscope. If the channel is misaligned as shown in Figure 2-1, straighten the channel before continuing endoscope insertion. If the problem continues, refer to Chapter 8, Troubleshooting for further instructions. If this does not help solve the problem, contact your local distributor or call Cogentix Medical Customer Service Department.



NOTE: The Cogentix Medical BRS-4000 Flexible Bronchoscope and Slide-On® EndoSheath® Technology are not made with natural rubber latex.

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Important Information

MISALIGNED

ALIGNED

Figure 2-1: Sheath Alignment All devices that are connected to the Bronchoscope must be Classified Medical Equipment. Before using any additional equipment, confirm that it complies with the appropriate endproduct 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 Systems, IEC 60601-1-1. DO NOT expose the Sheath to alcohol or other cleaning agents prior to use. The Working Channel of the BF-2.8* and BF-2.1 Slide-On® EndoSheath® Technology accommodates instrumentation indicated by the accessory manufacturer to be compatible with a 2.8 mm and 2.1 mm (respectively) 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.

(*Available in select markets only)

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BRS-4000 Flexible Bronchoscope User’s Manual

Important Information During Use Exercise caution when using 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 component 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 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. DO NOT use any accessory instrumentation that is damaged. Doing so may result in instrumentation malfunction during the procedure, which could cause serious patient injury and/or further damage to the endoscope. 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. If resistance is encountered when inserting an instrument into the Sheath, do not force it, as it could damage the instrument, the Bronchoscope and/or the Slide-On® EndoSheath® Technology. DO NOT attempt to advance an exposed needle or other sharp instruments through the working channel. Doing so could damage the Sheath’s channel. 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. 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 that has not been properly reprocessed in a procedure 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 one 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 BRS-4000 Bronchoscope and Slide-On® EndoSheath® Technology are designed to perform safe, sterile, and efficient endoscopic procedures. The two major components of the endoscopic system are: 

The BRS-4000 Bronchoscope, which is shown in Figure 3-1 on page 11. The endoscope’s Insertion Tube does not have a working channel. It contains the fiberoptic image and illumination bundles only.



The disposable 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 BF-2.8*, BF-2.1 and BF-1.5 Sheaths also contain working channels through which suction and/or accessory equipment can be used. The four types of Sheaths available for use with the BRS-4000 are: 







The BF-2.8 Slide-On® EndoSheath® Technology* (Figure 3-3 on page 14). This Sheath contains a 2.8mm (8.4Fr) channel through which suction can be performed, and/or accessory instruments can be inserted. The BF-2.1 Slide-On® EndoSheath® Technology (Figure 3-3 on page 14). This Sheath contains a 2.1mm (6.3Fr) channel through which suction can be performed, and/or accessory instruments can be inserted. The BF-1.5 Slide-On® EndoSheath® Technology (Figure 3-3 on page 14) has a 1.5mm (4.5Fr) channel that supports suction, but cannot accommodate the insertion of accessory instruments. The BF-0 EndoSheath® Technology (Figure 3-4 on page 16) has no working channel and does not support the use of accessory instruments.

(*Available in select markets only)

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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 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.

BRS-4000 BRONCHOSCOPE STANDARD SET COGENTIX MEDICAL CATALOG NO. 04-4201

DESCRIPTION BRS-4000 Flexible Bronchoscope (Figure 3-1 and 3-2)

07-3060

Detachable Light Guide Cable 1.8m

07-6182

Cogentix Medical BRS-4000 Carrying Case

07-6015

Vent Cap BRS-4000 User’s Manual (this manual)

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 BLS-1000 Battery Powered Light Source Kit 07-3053* Includes Batteries and Battery Charger 07-3050 BLS-1000 Battery-Powered Light Source (Replacement) Battery Charger (Replacement) 07-3048* 07-3049 Batteries (2 Batteries) (Replacement) 07-6010 Endoscope Leak Tester See List on Page 20 Light Guide Sleeve Adapter SLIDE-ON® ENDOSHEATH® TECHNOLOGY (NOT SHIPPED WITH ENDOSCOPE) 04-4103

BF-2.8 Therapeutic Slide-On® EndoSheath® Technology** (2.8mm Working Channel) for the BRS-4000 Bronchoscope (Figure 3-3) **Available in select markets only

04-4101

BF-2.1 Therapeutic Slide-On® EndoSheath® Technology (2.1mm Working Channel) for the BRS-4000 Bronchoscope (Figure 3-3) BF-1.5 Diagnostic Slide-On® EndoSheath® Technology (1.5 Channel) (Figure 3-3) BF-0 Diagnostic Slide-On® EndoSheath® Technology (No Channel) (Figure 3-4)

04-4102 04-4105

Table 3-1: Standard Set Components *Contact distributor for region-specific configuration

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BRS-4000 Flexible Bronchoscope User’s Manual

Endoscope and Accessories

Equipment Diagrams BRS-4000 Flexible Bronchoscope

Figure 3-1: BRS-4000 Flexible Bronchoscope

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Endoscope and Accessories

BRS-4000 Flexible Bronchoscope Control Body

Figure 3-2: BRS-4000 Flexible Bronchoscope – Control Body

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BRS-4000 Flexible Bronchoscope User’s Manual