Table of Contents
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Summary of Contents for Cogentix Medical DCH-5000
- Page 1 ’ ANUAL COGENTIX MEDICAL Add-On Digital Camera DCH-5000 NOTE: Federal (USA) law restricts this device to sale by, or on the order of, a physician or other appropriately licensed medical professional. www.cogentixmedical.com...
- Page 2 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.
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Page 3: How To Use This Manual
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. -
Page 5: Table Of Contents
After Use ....................11 Reprocessing ........................ 13 Acceptable Reprocessing Materials ............. 13 Reprocessing Steps ................... 13 EtO Gas Sterilization Parameters ................14 After EtO Gas Sterilization ..................14 Troubleshooting ......................15 Warranty and Service ....................17 DCH-5000 Add-On Digital Camera User’s Manual... - Page 6 Table of Contents 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 ................
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Page 7: Symbols And Terms
Symbols 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. -
Page 9: Important Information
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. -
Page 10: Signal Words
Doing so could lead to patient injury and/or further damage to the equipment. : 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. -
Page 11: Prior To 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... -
Page 13: Equipment And Features
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. -
Page 14: Camera Components
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. -
Page 15: Installation And Use
Installation 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. -
Page 16: Using The Camera
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. DCH-5000 Add-On Digital Camera User’s Manual... -
Page 17: After Use
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... -
Page 19: Reprocessing
Reprocessing 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. -
Page 20: Eto Gas Sterilization Parameters
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: 125 ... -
Page 21: Troubleshooting
Troubleshooting The information in this chapter is designed to help users diagnose problems that may occur during operation of the DCH-5000 Digital Camera. The table includes some of the problems that could arise during operation, possible causes for those problems, and suggested corrective action. -
Page 23: Warranty And Service
Note: Alterations or repairs done by persons not authorized by Cogentix Medical will void this warranty. Cogentix Medical is not liable for any damages to the DCH-5000 Digital Camera resulting from misuse, negligence, or improper cleaning or storage. The warranty defined herein shall apply only to the original buyer. -
Page 24: Shipping To Cogentix Medical Or Distributor
2. Provide a detailed description of the problem. 3. If troubleshooting cannot solve the problem, a Returned Goods Authorization (RGA) number will be issued. 4. Complete an Incident Report Form and send it to Cogentix Medical along with the returned goods. Shipping to Cogentix Medical or Distributor... -
Page 25: Appendix
700 to 1060 hPa Mode of Operation Continuous Electrical Safety IEC 60601-1 & IEC 60601-2-18 Thermal Safety IEC 60601-1 & IEC 60601-2-18 Electromagnetic Compatibility IEC 60601-1-2 Degree of Protection Against Type BF Electrical Shock Table A-1: Specifications DCH-5000 Add-On Digital Camera User’s Manual... - Page 28 For additional product information or questions pertaining to Sales and Service, please contact the local distributor or the manufacturer. MedPass International Ltd. Windsor House, Bretforton, Evesham, Worcestershire WR11 7JJ, United Kingdom © 2008, 2009, 2015 Cogentix Medical (12/15) 11908-EN Rev. C (13715)
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