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.
