SOW Attachment 7_5 Medivator DSD Edge critical water sample collection process.pdf

Product Bulletin For Distribution To:

• International Distributors

• International Management

• U.S. Clinical Specialists

• U.S. Customer Service

• U.S. Field Sales

• U.S. Technical & Field Service

Date: April 24, 2020

RE: DSD EDGE™ Automated Endoscope Reprocessor System Disinfection and Recovery Instructions

The following procedure outlines Cantel’s recommendation for recommissioning a DSD EDGE™ Automated Endoscope Reprocessor (AER) after prolonged downtime when weekly maintenance procedures could not be performed. For detailed instructions on any of the steps listed below, refer to the Medivators DSD EDGE Reprocessor User and/or Service manuals, or call the Cantel Technical Service for assistance.

Note: Please read through these instructions in their entirety prior to starting the procedure.

Please refer to your facility and/or governmental protocols where applicable. Estimated time to complete this procedure: 5 Hours.

Items Required

Part Number Description ML02-0145 INTERCEPT™ PLUS Detergent; two gallons required per reprocessor.

N/A PPE including gloves, eye/face protection and gown.

MF01-0013 Two 0.2 micron bacteria retentive filter.

MF01-0015 One 0.45 micron filter.

MF01-0014 One 1.0 micron filter.

N/A Measuring beaker for up to 1000 mL of fluid.

N/A Clean 1-2 gallon bucket.

N/A 2 teaspoons of table salt.

System Disinfection and Recovery Procedure

There are five parts to performing the System Disinfection and Recovery Procedure on the DSD EDGE™ Reprocessor.

1. Replace the water filters.

2. Perform three standard reprocessing cycles per basin utilizing INTERCEPT™ PLUS Detergent.

3. Perform a Water Line Disinfection cycle utilizing INTERCEPT PLUS Detergent.

4. Replace the water filters.

5. Perform a standard Water Line Disinfection.

Follow the steps below to perform the System Disinfection and Recovery Procedure.

1. Close water valve(s) supplying water to the machine.

2. Put a restrictor in each basin.

3. Bleed water pressure from the water supply by opening the bleeder valve at the 0.2 µ filter housing (see Replacing Internal

0.2 micron Bacteria Retentive Filter in User manual for details).

4. Remove all three water filters (1.0, 0.45 and 0.2) and clean the filter housings with soap and water.

5. Put new water filters in all three filter housings.

6. Open water valves(s) supplying water to the machine.

7. Purge the air out of the filter housings using the bleeder valve on the 0.2 filter.

8. Fill a 1-2 gallon bucket with a mild salt water solution – approximately 1 teaspoon of salt per gallon of water.

9. Remove the RAPIDICE™ PA High-Level Disinfectant (HLD) Part A and B chemical containers and cap them.

10. Put both Part A and B chemical uptake tubes into the bucket of salt water.

11. Measure out 750 mL of INTERCEPT PLUS Detergent into a container.

Note: Cantel recommends use of INTERCEPT™ PLUS Detergent for the Detergent Waterline Decontamination Process based on superior results and compatibility with AER waterline filters in eliminating potential contamination.

12. Start a normal cycle on Side A.

13. When the disinfect phase of the cycle begins, press the STOP button on the key pad (the control panel has LED indicators to identify what phase of the cycle the machine is in – see DSD EDGE Reprocessor Components in User manual for details).

14. Open the lid and add the pre-measured 750 mL of INTERCEPT PLUS Detergent into the basin.

15. Close the lid and press the START button.

16. Measure out another 750 mL of INTERCEPT PLUS Detergent into a container.

17. Start a normal cycle on Side B.

18. When the disinfect phase of the cycle begins, press the STOP button on the key pad.

19. Open the lid and add the pre-measured 750 mL of INTERCEPT PLUS Detergent into the basin.

20. Close the lid and press the START button.

21. Repeat Steps 11 – 20 until you have run three complete cycles in each basin.

22. When three cycles are complete for each basin proceed to the Water Line Disinfect process in the next section.

Water Line Disinfection utilizing INTERCEPT™ PLUS Detergent in place of RAPICIDE™ PA High-Level Disinfectant.

1. Measure out another 750 mL of INTERCEPT™ PLUS Detergent into a container.

Note: Cantel recommends use of INTERCEPT™ PLUS Detergent for the Detergent Waterline Decontamination Process based on superior results and compatibility with the AER waterline filters in eliminating potential contamination.

2. Run a Water Line Disinfection cycle on Side B (see Disinfect Water Lines in User Manual for details).

3. When the disinfect phase of the Water Line Disinfection begins, press the STOP button on the key pad (the control panel has LED indicators to identify what phase of the cycle the machine is in – see DSD EDGE™ Reprocessor Components in User manual for details).

4. Open the lid and add 750 mL of INTERCEPT PLUS Detergent into the basin.

5. Close the lid and press the START button.

6. When the Water Line Disinfection is complete, close the valve(s) supplying water to the machine and bleed the pressure at the 0.2 filter bleeder valve.

7. Replace the 0.2 filter with a new 0.2 filter.

8. Open water valves(s) supplying water to the machine.

9. Purge the air out of the filter housings using the bleeder valve on the 0.2 filter.

10. Put the RAPICIDE PA High-Level Disinfectant Part A and B chemical bottles back in place and secure the uptake tubes to the bottle.

11. Run a Water Line Disinfect cycle on Side B.

12. The System Disinfection and Recovery Process is complete.

Obtaining Water Quality Samples

Cantel recommends performing confirmatory microbiological testing of the AER water quality prior to resuming clinical use of equipment for all DSD EDGE Reprocessors that have been unused for over seven days and weekly maintenance procedures could not be performed.

Instructions on the appropriate method for obtaining a water sample can be found below.

When interpreting water quality results, Cantel recommends following facility protocols and guidelines regarding appropriate water quality. Where internal facility or local country guidelines have not been established, Cantel recommends leveraging published industry guidelines and best practices regarding acceptable water quality, such as AAMI TIR 34 section 4.2 Table 1 or ISO 15883-4 section 4.9.2.

Should the provided System Disinfection and Recovery Instructions fail to produce results in compliance with internal facility policies or published industry guidelines, contact Cantel Technical Service for further system disinfection instructions and options for recommissioning the DSD EDGE Reprocessor.

Note: Samples must be taken so that no microbial contamination is introduced during the sampling process.

Items Needed

Part Number Description N/A New disposable gloves.

N/A Sterile container that will hold at least 100 mL; quantity of two.

N/A Restrictors (disinfected); quantity of two.

Water Sample Collection Procedure

Water samples from both basins must be obtained. For each basin, follow the procedure below.

1. Disable the basin lid sensors.

2. Press SETUP, 88, ENTER, 135, ENTER, 41, ENTER, 0, ENTER.

3. Press CANCEL until you are back to the Home screen on the display.

4. Make sure there is a restrictor in each basin.

5. Start a disinfect cycle in each basin.

6. When the cycle reaches the final rinse, open the lid.

7. With gloved hands, collect a water sample by placing the sterile sample container in the water stream coming out of the basin restrictor. Be careful not to touch the restrictor with the sample container. Collect at least 100 mL.

8. Cap the sample container immediately.

9. Close the lid and allow the cycle to run to completion.

10. When the samples are collected, enable the lid sensors.

11. Press SETUP, 88, ENTER, 135, ENTER, 41, ENTER, 1, ENTER.

12. Press CANCEL until you are back at the Home screen.

DSD EDGE™, INTERCEPT™, and RAPICIDE™ are trademarks of Medivators Inc.

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

www.cantelmedical.com

Medivators Inc.

14605 28th Avenue North Minneapolis, MN

55447-4822 USA

Tel: +1.763.553.3300 Fax: +1.763.553.3387

PCN-00072 Rev A