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40002160 Rev A

by copyright. Copying, disclosure to others, or the
use of this publication is prohibited without the
express written consent of Medivators Inc.

DSD EDGE™
is a trademark of Medivators Inc.

ACTRIL™
is a trademark of Medivators Inc.

INTERCEPT™
is a trademark of Medivators Inc.

RAPICIDE™
is a trademark of Medivators Inc.

All other company or product names referenced in this
document are trademarks of their respective owner.

Medivators reserves the right to make changes in
the specifications shown herein without notice or
obligation. Contact your Medivators representative or
Medivators customer service for more information.

NOTE TO ALL PARTIES: This manual is only suitable for use in the US.

Содержание MEDIVATOR DSD EDGE

Страница 1: ...1 USER MANUAL USER MANUAL REPROCESSING DSD EDGE Automated Endoscope Reprocessor...

Страница 2: ...of Medivators Inc INTERCEPT is a trademark of Medivators Inc RAPICIDE is a trademark of Medivators Inc All other company or product names referenced in this document are trademarks of their respectiv...

Страница 3: ...and Program 21 Program status 21 User Prompts 21 Date and Time 21 Numeric Keypad 22 Function Keys 22 CHAPTER 3 DISINFECTION CYCLE OVERVIEW 23 Automated Leak Tester 24 Reprocessing Cycle 25 CHAPTER 4 D...

Страница 4: ...Display Time Remaining and State Time 54 Open Internal Water Supply Valve 55 Create a Custom Cycle Program 55 Custom Program Reference Chart 58 Enter Diagnostics 58 CHAPTER 7 PERIODIC MAINTENANCE 59 I...

Страница 5: ...5 CHAPTER 1 INTRODUCTION...

Страница 6: ...ditional important information An example of each is illustrated below USE OF THE MANUAL Note A note refers to relevant information not covered in the main body of the text Service A service note refe...

Страница 7: ...quipment may be impaired FACILITY REQUIREMENTS Only properly trained individuals may operate or service the reprocessor Never use the reprocessor for any purpose other than the manufacturer s specific...

Страница 8: ...ower to avoid damage to the machine or personal injury If there is any possibility of the machine being jolted during a move remove the drain manifold to prevent damage to the manifold or basin Note T...

Страница 9: ...for optimal performance Excessive water hardness may void the warranty The high performance 0 2 micron bacteria retentive filter included with the reprocessor is a bacteria retentive filter The routi...

Страница 10: ...ent of a chemical spill or emergency resulting in contact with any chemical that is considered hazardous ALCOHOL SOLUTION The DSD EDGE Reprocessor accommodates user supplied 70 Ethyl Alcohol or 70 Iso...

Страница 11: ...igh Level Disinfectant DISINFECTING WATER LINES Chemical disinfection of the water treatment filtration and delivery system must be performed on a weekly basis and whenever the 0 2 micron absolute bac...

Страница 12: ...ENDOSCOPE PRE CLEANING AND TESTING All endoscopes must be manually pre cleaned prior to disinfection Follow the endoscope manufacturer instructions and established professional guidelines to properly...

Страница 13: ...0 So Parker Rd Suite 300 Denver CO 80231 5711 TEL 303 755 6304 FAX 303 750 3462 http www aorn org British Society of Gastroenterology 3 St Andrews Place Regents Park London NW1 4LB 01144 171 387 3534...

Страница 14: ...14...

Страница 15: ...R 2 COMPONENTS This chapter provides labeled diagrams for the DSD EDGE Reprocessor including External component diagrams Internal component diagram Control panel diagram and overview of control panel...

Страница 16: ...Station A Disinfectant sampling port Process Indicatiors Station B Lid Station B Basin Endoscope Hookup Connector Endoscope Leak Test Connector Basin Level Sensor Station B Disinfectant sampling port...

Страница 17: ...asin with Floating Lid Figure 2 3 External Side View Figure 2 4 External Rear View Floating Lids 3 8 NPT water connection water PSI 35 min 40 max 1 NPT facility drain coupling right angle hose connect...

Страница 18: ...ve Assembly Disinfectant Filter Air Valve Assembly Dosing Pump Assembly Regulator Air Compressor Disinfectant Drawer RS 232 Service only Blue Handled Air Bleed Valve Water Filter Detergent Reservoir A...

Страница 19: ...NEL OVERVIEW The control panel allows the operator to specify settings operate the reprocessor and monitor system messages errors and warnings Figure 2 6 Control Panel LED indicators Function Keys LCD...

Страница 20: ...s indicators blink if an error occurs or if a cycle has been stopped The upper indicator identifies station A The lower indicator identifies station B Phase Indicators Phase indicators identify which...

Страница 21: ...tom row User Prompts Messages and queries display in the top row A represents station A B represents station B Program status The status of the program displays to the right of the program number No i...

Страница 22: ...ENTER Figure 2 9 Numeric Keypad FUNCTION KEYS The function keys are used to control operation of the reprocessor Instructions for when to use these functions are provided throughout this User Guide Fi...

Страница 23: ...ISINFECTION CYCLE OVERVIEW The DSD EDGE Reprocessor reprocessing cycle is comprised of a number of phases designed to ensure proper endoscope disinfection This section provides a general overview of t...

Страница 24: ...ure occurred AUTOMATED LEAK TESTER An endoscope leak test can be enabled to run during the Startup phase If enabled a 40 second leak test is added to the startup process During the test the endoscope...

Страница 25: ...els with air and emptying the basin of water An additional one or two soak segments can be added to the Flush phase No detergent is injected during additional soak segments Endoscope channels are flus...

Страница 26: ...ter Basin is drained while the channels are purged with fresh water Concludes by purging scope channels with air Repeats the process performed in Rinse 2 Alcohol is injected through scope channels fol...

Страница 27: ...at the beginning of each day to properly inspect and prepare the reprocessor for operation Check System Time Check Pre Filters Check Alcohol and Detergent Levels Check Disinfectant Containers Check In...

Страница 28: ...if the dynamic pressure drop across any filter is greater than 5 psi for filter replacement instructions see Periodic Maintenance Figure 4 1 Inspect Pressure Gauges for Pressure Drop Note The personn...

Страница 29: ...date the reservoir sensors 1 Check the alcohol reservoir if utilized for proper alcohol level 2 If necessary remove reservoir bottle and add alcohol to fill line 3 Re attach bottle to cap Figure 4 2 A...

Страница 30: ...any spills immediately Note On the control panel LCD screen error message Low Part A Low Part B displays if a disinfectant container is low and needs to be replaced Do not manually determine whether d...

Страница 31: ...s are in the past replace both containers 3 To load new containers do the following a Place the Part B container in the drawer b Remove the bottle cap c Insert the Part B Uptake Tube white cap and ful...

Страница 32: ...4 6 Part A Uptake Tube blue cap CHECK INCOMING DYNAMIC WATER PRESSURE AND TEMPERATURE Run water through the machine after any long period of inactivity This allows cool water in the supply lines to b...

Страница 33: ...verify the incoming water temperature readings on the control panel LCD screen The incoming water temperature for each basin displays in the second column Incoming water temperature should be approxi...

Страница 34: ...ote This procedure is applicable if the automated Leak Test function is enabled 1 Inspect the leak test connector O rings to determine if lubrication is required There are O rings on each end of the L...

Страница 35: ...endoscope for disinfecting and loading the endoscope into the reprocessor basin Starting the disinfection cycle Manually interrupting a cycle if necessary Completing the disinfection process Shutting...

Страница 36: ...lympus EndoChoice Karl Storz Vision Sciences Welch Allyn and Xion Endoscopes LOAD ENDOSCOPE INTO BASIN Warning Periodically test hookups to ensure there are no blockages and that the connections are s...

Страница 37: ...l section of the endoscope in the right rear of the basin b Position the light guide in the left front of the basin c Ensure the distal end is not pointing upward toward the floating lid 3 Attach the...

Страница 38: ...asin 7 Verify the endoscope or hookup does not protrude from the basin or contact the floating basin lid the endoscope must be completely submerged when basin is filled 8 Close the reprocessor lid Fig...

Страница 39: ...Type the operator ID number then press ENTER c Patient displays on the screen Type the patient ID number then press ENTER d Physician displays on the screen Type the physician ID number then press EN...

Страница 40: ...et by following the RAPICIDE PA High Level Disinfectant Test Strips Instructions for Use 1 Dip a test strip into the disinfectant sample port located near the front left corner of the basin 2 Compare...

Страница 41: ...be performed using a manual leak test or validated Dry Leak Test System prior to reprocessing in the DSD EDGE Reprocessor The Leak Testing system in the DSD EDGE Reprocessor is for redundancy purpose...

Страница 42: ...e been initiated by the operator or result from a system interruption A system interruption may be caused by loss of water or air loss of power or by a lack of available Part A and Part B disinfectant...

Страница 43: ...terminated the reprocessor fails to a safe mode and the disinfection cycle must be re run for the endoscope An endoscope must not be used until the entire disinfection process has successfully complet...

Страница 44: ...44...

Страница 45: ...45 CHAPTER 6 ADDITIONAL OPERATION FUNCTIONS This chapter covers additional operator functions These functions are accessed using the SETUP function key on the control panel...

Страница 46: ...ram 6 Waterline Disinfect 8 Display Log Information 9 Disable Logging 10 Clear Log 13 Display Temperatures 17 Display Time Remaining 18 Display State Time number time 21 Print Entire Log 22 Cancel Pri...

Страница 47: ...side of Set Up mode day of the week displays as two alpha characters Su Mo etc and month displays as three alpha characters Jan Feb etc SET SYSTEM TIME This setting changes both the control panel disp...

Страница 48: ...the on board 2 micron water filter housing of air Note Both stations must be idle to perform this procedure 1 On the control panel press SETUP 2 Type 6 on the keypad then press ENTER 3 Press START Att...

Страница 49: ...r station Once the log is full additional records will overwrite the oldest entries Print a copy of the log and clear the log at regular intervals Note The selected station must be idle to perform thi...

Страница 50: ...in Celsius for both stations 3 View the temperatures 4 To exit press SETUP DISPLAY TIME REMAINING View the cycle time remaining for both stations 1 On the control panel press SETUP 2 Type 17 on the k...

Страница 51: ...press SETUP PRINT ENTIRE LOG Print a copy of the disinfection cycle log then clear the log at regular intervals Only the information saved since the last time the log was cleared is printed 1 Verify...

Страница 52: ...press START 6 To exit press SETUP CANCEL PRINT RUN Clear the print queue of all data Clearing the queue will stop the print function There is approximately a 15 second delay before printing will stop...

Страница 53: ...cessary press STATION SELECT to choose the station A or B 2 Press SETUP 3 Type 28 on the keypad then press ENTER Delayed Start displays on the top line of the screen 4 Day display on the bottom line T...

Страница 54: ...on the keypad then press ENTER 5 To exit press SETUP DISPLAY TIME REMAINING AND STATE TIME View the cycle time and state time remaining for both stations 1 On the control panel press SETUP 2 Type 42 o...

Страница 55: ...oming water supply solenoid valve automatically closes 3 To manually close the internal water supply valve press STOP 4 To exit press SETUP CREATE A CUSTOM CYCLE PROGRAM Custom programs allow the oper...

Страница 56: ...ENTER 7 Detergent Inject displays on the screen To set the desired detergent inject time type the two digit number of seconds then press ENTER The volume of detergent is controlled by the number of s...

Страница 57: ...wo digit number of seconds then press ENTER The volume of alcohol is controlled by the number of seconds entered on the screen up to a maximum of 59 seconds 1 second injection 3 ml alcohol 13 Air disp...

Страница 58: ...tergent Inject Rinse 1 Rinse 2 Rinse 3 Alcohol Alcohol Inject Air Phase Program 6 Program 7 Program 8 Program 9 Flush Soak 1 Soak Rinse 1 Soak 2 Soak Rinse 2 Detergent Inject Rinse 1 Rinse 2 Rinse 3 A...

Страница 59: ...rocessor including Inspect Clean Disinfectant Filter Replace Internal 0 2 Micron Bacteria retentive filter Replace Pre Filters Replace Air Filter Purge air from the On Board 2 Micron Water Filter Hous...

Страница 60: ...lter Note The reprocessor must be in idle state to perform this procedure The disinfectant filter should be checked and cleaned on a monthly basis 1 Place a container under the filter to catch any exc...

Страница 61: ...ousing A counter on the LCD display begin to count down from 250 to 0 in one second increments After 250 seconds the incoming water supply solenoid valve automatically closes 3 Do the following to rel...

Страница 62: ...the housing cap b Rotate the filter to the right to tighten 15 Clean the filter housing using soap and water and then rinse thoroughly 16 Apply an NSF approved silicone lubricant to the housing O rin...

Страница 63: ...n to count down from 250 to 0 in one second increments After 250 seconds the incoming water supply solenoid valve automatically closes 3 Do the following to release the pressure in the water lines and...

Страница 64: ...re 7 12 8 Apply an NSF approved silicone lubricant to the housing O ring to aid assembly and sealing 9 Insert the new filter into the housing 10 Re attach the filter housing FIgure 7 13 Hand tighten o...

Страница 65: ...y to the on board 2 micron filter housing A counter on the LCD display begin to count down from 250 to 0 in one second increments After 250 seconds the incoming water supply solenoid valve automatical...

Страница 66: ...ment cover on the reprocessor 2 Remove the used paper spool 3 Insert the new paper roll Figure 7 16 4 Unroll several inches of paper from the new roll allowing the paper to lay over the front of the p...

Страница 67: ...67 APPENDIX...

Страница 68: ...ay of Week Prompts the user to enter the current day of the week Sunday is 1 Day Prompts the user to enter the current day of the month 01 31 Detergent Inject Prompts the user to enter the detergent f...

Страница 69: ...ss the Enter button to cancel an alarm Scope Prompts the user to enter the scope ID Set Hours Prompts the user to enter the programmable hours Set Minutes Prompts the user to enter the programmable mi...

Страница 70: ...s the user to press the Enter button to clear a system alarm such as a NVRAM error Flash High Error Indicates that the high code flash CRC test did not pass Flash Low Error Indicates that the low code...

Страница 71: ...e leak tester measured pressure at the start of a cycle SNVRAM Err Short Non Volatile RAM error can only be cleared in Diagnostics 70 SSG A low Alarm indicating that the SSG has timed out before filli...

Страница 72: ...capacitive sensor missing SSG Missing Alarm indicating the DSD detected a failure in the SSG Communication DSD doesn t see the SSG SSG Rsvr Err Alarm indicating that an SSG dosing reservoir sensor has...

Страница 73: ...le occurred HLD Fail Disinfectant efficacy has failed MRC test HLD Pass Disinfectant efficacy has passed MRC test Leak Disabled Leak tester was disabled Leak Fail Leak test failed Leak Test Indicates...

Страница 74: ...e 3 portion of a cycle occurred S N Indicates the machine s serial number Start Indicates when a cycle was started Stop Indicates when a cycle was manually stopped Temp Indicates the basin temperature...

Страница 75: ...k post rinse and air purge high level disinfectant A germicide that inactivates all microbial pathogens except large numbers of bacterial endospores when used according to labeling Rutala 1990 Spauldi...

Страница 76: ...ning usage history error status and processed endoscope serial numbers stop state operating state during which a disinfection protocol is in progress but the current cycle is suspended SSG Single Shot...

Страница 77: ...C 2 Ensure water hardness is less than 12 gpg 200 ppm for optimal performance Ensure water pressure is 40 psi at 3 2 gpm Water Consumption Approx 7 5 gallons 28 liters per cycle Designed for Use Indo...

Страница 78: ...78...

Страница 79: ...79 WARRANT Y...

Страница 80: ...ith i external causes including without limitation accident vandalism acts of God power failure or electric power surges ii abuse misuse or neglect of the Product by the customer or use of unauthorize...

Страница 81: ...LE TO CUSTOMER FOR CONSEQUENTIAL INCIDENTAL INDIRECT PUNITIVE OR SPECIAL DAMAGES OR LOSSES INCLUDING WITHOUT LIMITATION DAMAGES ARISING OUT OF OR IN CONNECTION WITH ANY MALFUNCTIONS DELAYS LOSS OF PRO...

Страница 82: ......

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