Cogentix Medical DCH-5000 User manual

USER’S MANUAL
COGENTIX MEDICAL
Add-On Digital Camera
DCH-5000
www.cogentixmedical.com
NOTE: Federal (USA) law restricts this device to sale by, or on the order
of, a physician or other appropriately licensed medical professional.

©2008, 2009, 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.

DCH-5000 Add-On Digital Camera User’s Manual i
How to Use This Manual
This User’s Manual contains the recommended procedures for preparing and using
the Cogentix Medical DCH-5000 Add-On Digital Camera. 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 camera.
Additionally, the DCH-5000 Digital Camera is utilized exclusively with the Cogentix
Medical DPU-5000 or DPU-7000 Series Video Processors. Users should also
review the DPU-5000/7000 Series User’s Manual before using the camera.
The manual contains the following information:
The camera’s intended use
Description of the DCH-5000 Digital Camera
Features of the camera
Instructions on camera preparation, inspection, operation, and reprocessing
Warning and Caution statements that must be observed by camera users to
ensure patient and user safety
If you are a first time user, Cogentix Medical strongly recommends that you read
this manual and become intimately familiar with the information provided, including
instructions on connecting to the video processor and setting image quality.
If you are an experienced user, select specific chapters and/or sections that
pertain to features and functions that you want to work with.
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 ([phone]
(international).

DCH-5000 Add-On Digital Camera User’s Manual iii
Table of Contents
How to Use This Manual........................................................................................................ i
Additional Information..................................................................................i
1Symbols and Terms....................................................................................................... 1
Symbols.....................................................................................................1
Terms........................................................................................................1
2Important Information.................................................................................................. 3
Intended Use..............................................................................................3
User Qualifications ......................................................................................3
Reprocessing..............................................................................................3
Maintenance and Repair ..............................................................................3
Signal Words ..............................................................................................4
Important Safety Precautions.......................................................................4
Prior to Use..................................................................................................................... 5
During Use ...................................................................................................................... 5
After Use ......................................................................................................................... 5
3Equipment and Features............................................................................................... 7
Inspect the Standard Set.............................................................................7
Camera Components...................................................................................8
4Installation and Use ...................................................................................................... 9
Camera Assembly .......................................................................................9
Connecting to Video Processor .....................................................................9
Connecting Camera Unit to the Endoscope....................................................9
Using the Camera .....................................................................................10
After Use..................................................................................................11
5Reprocessing ................................................................................................................ 13
Acceptable Reprocessing Materials .............................................................13
Reprocessing Steps...................................................................................13
EtO Gas Sterilization Parameters............................................................................... 14
After EtO Gas Sterilization .......................................................................................... 14
6Troubleshooting ........................................................................................................... 15
7Warranty and Service.................................................................................................. 17

Table of Contents
iv DCH-5000 Add-On Digital Camera User’s Manual
Cogentix Medical Service Information......................................................... 17
Shipping to Cogentix Medical or Distributor................................................. 18
Appendix ............................................................................................................................... 19
Specifications DCH-5000 Digital Camera ..................................................... 19
Index of Figures
Figure 3-1: DCH-5000 Digital Camera…………………………………………………...………8
Index of Tables
Table 3-1: Standard Set Components ........................................................................... 7
Table 6-1: Troubleshooting .......................................................................... 15
Table A-1: Specifications.............................................................................. 19

DCH-5000 Add-On Digital Camera User’s Manual 1
1Symbols and Terms
Symbols
The symbols listed below can be found on the DCH-5000 Digital Camera and on
other components of the 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 and become
familiar with the user’s manuals for all equipment used in the
procedure.
Equipment bearing this mark has been designed, tested, and
certified as essentially compliant with all applicable European
Union (EU) regulations and recommendations.
S/N
Serial number of the camera
Consult Instructions for Use
The presence of this symbol on the product or packaging
indicates that the device is RoHS compliant.
Terms
Throughout this manual, the following terms are used:
DCH-5000 refers to the Cogentix Medical DCH-5000 Add-On Digital Camera.
DPU-5000/7000 refers to the Cogentix Medical DPU-5000 Series or DPU-
7000 Series Video Processors.

DCH-5000 Add-On Digital Camera User’s Manual 3
2Important Information
This information is essential to the safe and effective operation of the camera. Please
read and understand this information before preparing or using the camera or any
equipment with which it will be used.
Intended Use
The Cogentix Medical DCH-5000 Digital Camera is intended to be used for
endoscopic procedures, and is designed to be used with flexible fiberscopes or rigid
endoscopes. The DCH-5000 Camera can be used only with a Cogentix Medical DPU-
5000 or DPU-7000 Series Video Processor.
Do not use this camera for any other purposes or with other video
equipment.
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 technique. However, the operator should have complete familiarity
with the operation of the camera and video processor prior to clinical use.
Only use the camera 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 damage to the camera.
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 ([phone] (international).
Reprocessing
The camera 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” camera is used in every procedure. See Chapter 5, Reprocessing, for
information on all reprocessing equipment and procedures.
Maintenance and Repair
The camera 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 camera is subsequently used in a procedure. The camera may
only be serviced / repaired at an authorized Cogentix Medical facility.

Important Information
4 DCH-5000 Add-On Digital Camera User’s Manual
In addition to thoroughly inspecting the camera 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 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
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.
Important Safety Precautions
The following precautions should always be exercised when using the camera and all
related medical equipment to ensure safety for all involved parties –user(s),
patient(s), etc.
WARNING: Never drop the equipment or subject it to severe
impact, as it could compromise the functionality and/or
safety of the unit. Should this equipment be mishandled or
dropped, do not use it. Return it to an authorized Cogentix
Medical service facility for inspection and repair.
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.
NOTE: The DCH-5000 Camera is shipped assembled as one
unit. In the event it becomes necessary to re-assemble the
components, this manual will instruct you on proper assembly
technique.

NOTE:Indicates additional helpful information.


Important Information
DCH-5000 Add-On Digital Camera User’s Manual 5
Prior to Use
To prevent electrical shock when used with endoscopes, this camera is
insulated (type BF electro-medical equipment). Do not allow it to be
grounded to other electrical devices being used on a patient. Rubber
gloves should always be worn to prevent grounding through users.
Confirm that other devices used in conjunction with the equipment are
functioning properly, and that these other devices will not adversely affect
the operation of the camera. If any component of the endoscopic system
is not functioning properly, the procedure should not be performed.
To prevent any potential electromagnetic interference, do not use a
cellular phone near the camera.
Check and confirm that all cords and/or cables are connected correctly and
securely.
During Use
Do not connect or disconnect the camera head from the DPU-5000/
7000 Series Video Processor during use while power is on. This may
cause unrecoverable damage to the camera head.
To prevent electric shock, do not open or expose the DPU-5000/7000
Series Video Processor to water or moisture, and do not immerse camera
in any liquid during use.
Avoid looking directly at the intense light emitted from the endoscope tip
to prevent possible eye injury.
After Use
Refer to Chapter 5, Reprocessing, for proper cleaning and disinfection
instruction after using the camera in a procedure.

DCH-5000 Add-On Digital Camera User’s Manual 7
3Equipment and Features
The Cogentix Medical DCH-5000 Digital Video Camera is an add-on camera used
for imaging during endoscopic procedures. This video component is intended for
use with flexible fiberscopes or rigid endoscopes, and is designed to plug directly
into a Cogentix Medical DPU-5000 or DPU-7000 Series Video Processor. The
DCH-5000 Camera is not compatible with any other Video Processor.
The three major components of the camera unit (shown in Figure 3-1 on page 8)
are:
1) DCH-5000 Camera Head
2) MicroFocus Lens (f=25mm)
3) SmartLock Coupler
The DCH-5000 Digital Video Camera is easy to use and reliable. This add-on
camera, when used with a Cogentix Medical DPU-5000/7000 Series Video
Processor, delivers optimal image quality by enabling the user to enhance
brightness, adjust contrast, and control white balance and colors for sharp image
representation and tissue differentiation.
Inspect the Standard Set
When the camera is received from Cogentix Medical, immediately confirm that the
items listed in Table 3-1 below have been received, and inspect them for damage. If
any item is missing or damaged, do not use the camera. Contact Cogentix Medical to
obtain a replacement part.
Do not use any equipment that is observed to be damaged or
excessively worn. Doing so can lead to patient injury and/or
further damage to the equipment.
DCH-5000 ADD-ON DIGITAL CAMERA STANDARD SET
COGENTIX MEDICAL
CATALOG NO.
DESCRIPTION
07-5010
DCH-5000 Digital Camera (NTSC)
07-5011
DCH-5000 Digital Camera (PAL)
(Both the NTSC and PAL format cameras include
Camera Head, Lens, and Coupler)
DCH-5000 Camera User’s Manual (this document)
Table 3-1: Standard Set Components

Equipment and Features
8 DCH-5000 Add-On Digital Camera User’s Manual
Equipment Diagram
Figure 3-1: DCH-5000 Digital Add-On Camera
Camera Components
1. SmartLock Coupler: This device attaches to the camera lens and also
attaches the camera unit to the endoscope eyepiece using the SmartLock
feature. The Coupler must be used with a standard eyepiece.
2. MicroFocus Lens: 25mm Focus Lens with Anti-Moiré filter. Features
Focus Ring, which allows user to adjust focus by turning the ring both
clockwise and counter-clockwise.
3. Free-Spin Lock: The Lens also has a free-spin locking lever which allows
the camera to either freely spin (unlocked) or to be in a fixed position
(locked) when the endoscope is rotated.
4. Camera Head: Features (2) two one-touch programmable Control
Buttons. The Camera Head includes the video cable.
5. Plug: This part of the camera cable plugs into a Cogentix Medical DPU-
5000/7000 Series Video Processor.
6. Sealing Cap: This Cap at the tip of the Plug should be sealed when the
video cable is not in use, and prior to reprocessing.

DCH-5000 Add-On Digital Camera User’s Manual 9
4Installation and Use
Camera Assembly
The DCH-5000 Camera is shipped assembled as a complete unit. When it becomes
necessary to re-assemble the camera components, follow these steps:
1. Thread the MicroFocus Lens onto the Camera Head. Gently twist the Lens
onto the Camera Head until it is securely fastened.
2. Thread the SmartLock Coupler onto the MicroFocus Lens with a gentle
twisting action.
NOTE: The free-spin lock on the MicroFocus Lens must be set to the
“LOCK” position in order for the Coupler to be secured to the Lens
during assembly.
Connecting to Video Processor
The first step is to plug the camera into the Cogentix Medical DPU-5000/7000
Series Video Processor. Once you have securely plugged in the camera, turn on
the system.
Connecting Camera Unit to the Endoscope
Before attaching the camera to the endoscope, align the two focusing dots on the
endoscope; one is at the top of the endoscope and the other is directly above it
on the Ocular/Eyepiece. Ensure these dots are in direct alignment.
1. Grasp the coupler on the camera and rotate the outer ridged locking ring a
quarter turn in the direction marked “UNLOCK” until it clicks and remains
in the open position. If the coupler is already unlocked, it will not click.
2. Seat the coupler over the eyepiece of the endoscope and gently press until
the coupler snaps onto the endoscope. If the camera to endoscope
connection feels loose, gently rotate the ridged locking ring away from the
direction marked “UNLOCK.”
3. Set the free-spin locking lever on the MicroFocus Lens to either the Locked
or Unlocked position as desired.
NOTE: Completing the connection of the camera assembly to the
endoscope is audibly confirmed by a snapping sound which signifies
that the camera is properly seated on the endoscope.



Installation and Use
10 DCH-5000 Add-On Digital Camera User’s Manual
Using the Camera
Before using the camera, perform the White Balance adjustment procedure as
follows:
1. Set the light source intensity to the desired level. Point the distal end of the
endoscope at a white object, such as a white cloth or white sheet of paper.
Hold the endoscope tip approximately one inch (2–3 cm) from the white
target and keep it steady during the White Balance procedure.

NOTE:Make sure the picture is not saturated by excessive illumination.
Keep the endoscope tip at least one inch (2–3 cm) away.
2. Press and hold the Processor’s WHITE BALANCE (Left Arrow) button, on
the front panel, until a beep sounds (approx. 2 seconds). Alternatively, on
the DPU-5000 unit, press and hold the Ctrl + F2 keys on the keyboard
simultaneously until a beep sounds. On the DPU-7000 unit, press and hold
the “W Bal” key on the keyboard until a beep sounds.
If White Balance is successfully completed, the following message is displayed
in the Message Field and a short beep sounds:
W/B OK
If the White Balance was not completed successfully, the following message is
displayed in the Message Field with a long beep:
W/B FAILED
Repeat the above procedures if the White Balance is not completed successfully
or as needed. The DPU-5000/7000 Series Video Processor stores the White
Balance setting until it is reset by a user for different lighting conditions or the
processor has been turned off. This adjustment should be performed before each
procedure, if the system had previously been turned off.
NOTE: To focus during the procedure, only use the Focus Ring on
the Lens of the camera. Do not use the Diopter Adjustment Ring
on the endoscope.
Free-Spin/Orientation Mechanism
1. When using a flexible endoscope, release the free-spin lock on the Lens
(refer to Figure 3-1) and rotate the endoscope until the arrow in the
view field points to twelve o’clock. Then return the free-spin lock to its
locked position.
2. When using a rigid endoscope, release the free-spin lock on the Lens,
rotate the endoscope to the required position, then return the free-spin
lock to its locked position.
Refer to the DPU-5000/7000 Series Video Processors User’s Manual for
instructions on proper set-up and operation of the video processor, as well as
programming the camera head control buttons.


Installation and Use
DCH-5000 Add-On Digital Camera User’s Manual 11
After Use
Removing the Camera
1. Place endoscope with attached camera on flat surface.
2. Hold the neck of the Coupler (near the Focus Ring) with one hand,
while using the other hand to turn the ridged locking ring on Coupler in
the direction marked “UNLOCK” until the Coupler snaps in the unlocked
position. The camera will easily disengage from the endoscope
eyepiece once unlocked.

DCH-5000 Add-On Digital Camera User’s Manual 13
5Reprocessing
The DCH-5000 Digital Camera must be properly reprocessed by cleaning,
disinfection and/or sterilization before first use and after each subsequent use.
Using an Add-On Digital Camera that has not been properly reprocessed presents
an acute infection-control risk to both the patient and medical personnel
performing the procedure.
Some methods of disinfection and sterilization may be harmful
to the camera components and exposure to them could result
in extensive equipment damage. Please contact Cogentix
Medical Customer Service to verify the compatibility of a
cleaning method not listed in this manual and/or a complete list
of functionally compatible agents.

NOTE: THE DCH-5000 CAMERA IS NOT AUTOCLAVABLE.
Do not use abrasive materials to clean the Lens. Doing so
could damage the Lens and impair the camera’s imaging
capability.
Acceptable Reprocessing Materials
Cleaning
Soft Material Lint-Free Gauze (4x4)
Enzymatic Cleaner
Instrument Grade Detergent
Disinfection
70% Isopropyl or Ethyl Alcohol
2.4% Glutaraldehyde-based solution
Surface Disinfectant
Sterilization
EtO Gas Sterilization
Reprocessing Steps
Always turn power off first, then disconnect the camera head cable from
the DPU-5000/7000 Series Video Processor before cleaning or
disinfecting the camera components.
Make sure the sealing cap on the camera head cable is
securely placed over the end of the plug before
immersing the camera in any liquid, or prior to any
cleaning procedures.
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.

Reprocessing
14 DCH-5000 Add-On Digital Camera User’s Manual
It is recommended that the Cleaning and Disinfecting procedures be
performed while the Coupler and Lens are still attached to prevent fogging
of the optics. Do not allow cleaning agents or liquids to enter the interior
of the camera components.
Carefully wipe the camera unit and cable with 70% isopropyl or ethyl
alcohol-soaked gauze, or gauze soaked in enzymatic solution. Then wipe
down the outside surface with lint-free dry gauze, until completely dry.
Do not use cleaning/disinfecting agents that are not permitted for use with
plastics (for example, ammonia, acetone, or salty acids such as HCl).
The camera should be Disinfected only with agents designed for external
disinfection of electromedical equipment and should be used according to
the manufacturer’s instructions.
Immerse the camera head in approved solution; allow the camera head to
remain immersed in disinfectant for only the period of time recommended
by the manufacturer (no longer).
The DCH-5000 Digital Camera may be Sterilized using a validated ethylene oxide
(EtO) gas sterilization protocol.
EtO Gas Sterilization Parameters
Temperature: 125o 5oF (52oC 3oC)
Relative Humidity:50% 10%
EtO Concentration: 600 mg/liter
Exposure Time: 3 hours + 1/-0 hour
Post-Sterilization Aeration: 12 hours at 130oF (55oC) or 72
hours at 75oF (24oC)

NOTE:It is recommended that the sealing cap be uncapped from the
plug prior to EtO gas sterilization.
After EtO Gas Sterilization
Effective aeration must be completed after EtO gas sterilization. Cogentix
Medical recommends following the instructions-for-use supplied by the
manufacturer of the gas sterilizer, and that a biological indicator is used to
confirm sterilization efficacy.