Cogentix TNE-5000 User Manual
NOTE: Federal (USA) law restricts this device to sale by, or on the order
of, a physician or other appropriately licensed medical professional.
USER’S MANUAL
COGENTIX MEDICAL
Flexible Video Esophagoscope
TNE-5000
and Slide-On® EndoSheath® Technology
www.cogentixmedical.com
©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
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.
®
EndoSheath® Technology
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
endoscope and peripheral equipment. There is also a brief list of the terms that are
commonly used in the manual.
Chapter 2, Important Information
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
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
– This chapter defines the symbols on the
– The information in this chapter is a
– Introduces the TNE-5000 Flexible
–
TNE-5000 Flexible Video Esophagoscope User’s Manual i
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
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
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
prolonged period, refer to this chapter for instructions on safe, secure storage.
Chapter 8, Troubleshooting
encountered with the endoscopic system, and suggests corrective actions to take
towards resolving minor problems.
Chapter 9, Warranty and Service
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
Video Esophagoscope and infection control information.
contains the technical specifications for the TNE-5000 Flexible
– This chapter contains important instructions on the
– If the equipment will not be used for a
– Describes possible problems that may be
– This chapter contains the terms of the
– This chapter describes
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).
ii 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
TNE-5000 Flexible Video Esophagoscope User’s Manual iii
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
iv TNE-5000 Flexible Video Esophagoscope User’s Manual
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
TNE-5000 Flexible Video Esophagoscope User’s Manual v
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.
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.
TNE-5000 Flexible Video Esophagoscope User’s Manual 1
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.
2 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 “patient-
ready” endoscope is used in every procedure. See Chapter 6, Reprocessing, for
information on all reprocessing equipment and procedures.
TNE-5000 Flexible Video Esophagoscope User’s Manual 3
Important Information
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.
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.
NOTE: Indicates additional helpful 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.
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
4 TNE-5000 Flexible Video Esophagoscope User’s Manual
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
TNE-5000 Flexible Video Esophagoscope User’s Manual 5
Figure 2-1: Incorrect and Correct Sheath Alignment
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.
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.
During Use
6 TNE-5000 Flexible Video Esophagoscope User’s Manual
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.
Reprocessing
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.
TNE-5000 Flexible Video Esophagoscope User’s Manual 7
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
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
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
page 16) has a 1.5mm (4.5Fr) channel that supports insufflation and
suction, but cannot accommodate the insertion of accessory devices.
®
EndoSheath® Technology. The sterile,
®
EndoSheath® Technology (see Figure 3-3 on page
®
EndoSheath® Technology (see Figure 3-4 on
TNE-5000 Flexible Video Esophagoscope User’s Manual 9
Endoscope and Accessories
TNE-5000 ESOPHAGOSCOPE STANDARD SET
COGENTIX MEDICAL
CATALOG NO.
DESCRIPTION
03-5201
OR
TNE-5000 Flexible Video Esophagoscope, NTSC
03-5202
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
DPU-5050A Video Processor with Air Pump and LCD
Display*
07-7001
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
TV-2.1 Slide-On® EndoSheath® Technology with
2.1mm (6.3Fr) Working Channel for the TNE-5000
Flexible Video Esophagoscope
03-5102
TV-1.5 Slide-On® EndoSheath® Technology with
1.5mm (4.5Fr) Air/Suction Channel for the TNE-5000
Flexible Video Esophagoscope
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.
Inspect the Standard Set
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.
Table 3-1: TNE-5000 Flexible Video Esophagoscope – Components
*Available in select markets only
10 TNE-5000 Flexible Video Esophagoscope User’s Manual
Equipment Diagrams
TNE-5000 Flexible Video Esophagoscope
Endoscope and Accessories
Figure 3-1: TNE-5000 Flexible Video Esophagoscope
TNE-5000 Flexible Video Esophagoscope User’s Manual 11
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
On® EndoSheath® Technology to the endoscope.
®
Rigid Connector to secure the Slide-
12 TNE-5000 Flexible Video Esophagoscope User’s Manual
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.
TNE-5000 Flexible Video Esophagoscope User’s Manual 13
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
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.
®
Connector: Secures the Sheath to the endoscope.
14 TNE-5000 Flexible Video Esophagoscope User’s Manual
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