SURESTORE Instructions for Use Rev D March 2021

2 I INSTRUCTIONS FOR USE

SURESTORE™ is a trademark of Cantel (UK) Ltd CLEANASCOPE™ is a trademark of Cantel (UK) Ltd N-SURE™ is a trademark of Cantel (UK) Ltd TRAVELSCOPE™ is a trademark of Cantel (UK) Ltd All other company and product names are trademarks of their respective owners.

Medical Device Regulation (EU) 2017/745 as amended

Cantel Medical (Italy) S.r.l. Via Laurentina, 169, 00071 Pomezia (RM), Italia Phone: +39 06 9145 399 Fax: +39 06 9146 099 Email: [email protected] Website: www.cantelmedical.eu

LIT-00219 REV.D – 03/2021 © 2021 All rights reserved. This publication is protected by copyright laws. Copying, distribution or use of this publication are prohibited without the express written consent of Cantel.

Cantel reserves the right to amend the specifications described herein without any obligation for advance warning. For further information, contact your Cantel representative.

INSTRUCTIONS FOR USE I 3

CONTENTS OVERVIEW Features & Components

05

OPERATION SURESTORE™ Storage & Endoscope Transport System

08

Endoscope Conditioning Stage

10

Vacuum Stage

15

Example Label

21

Processing a Non Lumen Endoscope

22

Accessory Items

28

Consumable Items

29

Technical Specifications

31

MAINTENANCE

32

Periodic maintenance that must be performed by the operator

32

Periodic maintenance that must be performed by Cantel Technical Service

33

Recycling

33

Associated Symbols

34

TROUBLESHOOTING

35

Hardware troubleshooting

35

Software troubleshooting

37

Printing troubleshooting

37

IMS error codes

38

APPENDICES

39

Trouble Shooting

51

Neqis Independent Monitoring System Network connection

59

Contact Information

60

Daily Unit Check Sheet

61

Daily Fluid Prime Check Sheet

62

Endoscope Inventory Input Check Sheet

63

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THIS PAGE IS INTENTIONALLY BLANK

INSTRUCTIONS FOR USE I 5

OVERVIEW FEATURES AND COMPONENTS

Barcode Reader Vacuum Connector Channel Connector

Endoscope Support Tray Pull out Top Panel

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Keyboard

Touchscreen/PC USB Printer

INSTRUCTIONS FOR USE I 7

STEP E

SURESTORE™ Storage System HEPA Air Filter 10

N-SURE™ Conditioning Solution 5L Bottle 11

STEP F

Storage drawer for consumables 12

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OPERATION AS ADVISED IN EN 16442, IT IS RECOMMENDED THAT USERS VERIFY THE MICROBIOLOGICAL QUALITY OF THE ENDOSCOPES INTENDED TO BE CONDITIONED IN SURESTORE™ STORAGE SYSTEM BEFORE USE. IMPORTANT: PRIOR TO USING THE SURESTORE™ STORAGE SYSTEM FOR THE FIRST TIME, PLEASE ENSURE THAT THE UNIT HAS BEEN INSTALLED BY APPROPRIATELY APPROVED PERSONNEL. ALL ENDOSCOPES TO BE PROCESSED SHOULD HAVE BEEN ADDED TO THE INVENTORY BEFORE USE. TO UPDATE THE INVENTORY, PLEASE REFER TO THE CHART IN THE APPENDICES. ALL DATA ENTERED SHOULD BE CHECKED BY A SUITABLY QUALIFIED PERSON. SURESTORE™ STORAGE SYSTEM SHOULD ONLY BE OPERATED BY TRAINED AND CERTIFIED PERSONNEL. IT IS THE RESPONSIBILITY OF THE USER TO UNDERTAKE A RISK ASSESSMENT ON THE USE OF THE SURESTORE™ STORAGE SYSTEM AS PART OF THE COMPLETE REPROCESSING CYCLE. IF ANY SERIOUS INCIDENT OCCURS WITH THE SURESTORE™ STORAGE AND ENDOSCOPE TRANSPORTATION SYSTEM PLEASE ENSURE TO REPORT THE INCIDENT TO BOTH CANTEL AND YOUR LOCAL COMPETENT AUTHORITY AFTER UNPACKING AN ENDOSCOPE WHICH HAS BEEN CONDITIONED USING THE SURESTORETM STORAGE SYSTEM, FLUSH ALL ENDOSCOPE CHANNELS FOR A MINIMUM OF 20 SECONDS PRIOR TO USE ON A PATIENT. USERS SHOULD REFER TO THE INSTRUMENT MANUFACTURER’S INSTRUCTIONS FOR USE FOR GUIDANCE IN THE PREPARATION OF THE ENDOSCOPE. NOTE: SURESTORE™ OUTER POUCH CAN BE DISPOSED OF IN GENERAL WASTE. WHEN USED FOR THE RETURN OF CONTAMINATED ENDOSCOPES THE OUTER POUCH MUST BE DISPOSED OF IN CONTAMINATED WASTE.

INSTRUCTIONS FOR USE I 9

CAUTION: READ BEFORE PROGRESSING TO THE NEXT STEP.

INTENDED USE The SURESTORE™ Storage System prolongs the High-Level Disinfection Status Period (HLDSP) of freshly reprocessed endoscopes for up to 100 days, or in the case of a non-lumen endoscope, for up to 35 days. The SURESTORE™ Storage System provides a transportable bio-static storage environment for endoscopes in which the HLDSP is maintained throughout the period of storage.

STEP 1

Ensure that the unit has power. If not, check that the power cord is plugged into the mains and that the socket is switched on. Switch the power switch on at the rear of the unit.

Power switch Appliance inlet

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ENDOSCOPE CONDITIONING STAGE ALWAYS WEAR THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN HANDLING N-SURE™ AND N-SURE™ ZERO AND WHEN OPERATING THE SURESTORE™ SYSTEM. NSURETM AND N-SURETM ZERO ARE NON-FLAMMABLE AND NON-COMBUSTIBLE SOLUTIONS. FOR ALL HEALTH AND SAFETY RELATED INFORMATION, INCLUDING SAFE DISPOSAL, PLEASE REFER TO THE N-SURE™ AND N-SURE™ ZERO SAFETY DATA SHEET (SDS). IMPORTANT: CHECK THE SURESTORE™ STORAGE SYSTEM IS PRESSURISED BEFORE USE. WHEN PRESSURISED, THE N-SURE™ CONDITIONING SOLUTION BOTTLE WILL APPEAR INFLATED. IF IN DOUBT, RE-PRESSURISE THE SYSTEM. TO PRESSURISE THE SYSTEM, HOLD THE ENDS OF THE CHANNEL TUBES INTO AN EMPTY CONTAINER AND PRESS THE “FLUID PRIME” BUTTON. AT THIS POINT THE SYSTEM IS PRESSURISED AND READY FOR USE. PRIOR TO EACH USE, ENSURE THE TOP OF THE SURESTORE™ STORAGE SYSTEM AND SCOPE SUPPORT TRAY OUTSIDE SURFACES ARE WIPED WITH HIGH-LEVEL DISINFECTANT WIPES, OR ANY SUITABLE DISINFECTANT AGENT, IN LINE WITH YOUR HOSPITAL POLICY.

STEP 2

Place the SURESTORE™ Storage System endoscope support tray on top of the SURESTORE™ Storage System. Ensure that the large rounded corners of the tray are at the back of the unit.

Large, rounded corners of TM SURESTORE Storage System endoscope support tray to be at the rear.

INSTRUCTIONS FOR USE I 11

CLEANASCOPE™ Base Liner

STEP 3

Open a packet of CLEANASCOPE™ Liners and line the SURESTORE™ Storage System endoscope support tray with a clear base liner.

SURESTORE tray

TM

Storage System endoscope support

Endoscope

STEP 4

Remove the endoscope to be conditioned from the AER/ EWD or drying cabinet, and place into the lined SURESTORE™ Storage System endoscope support tray.

TM

SURESTORE endoscope support tray

IF THE ENDOSCOPE IS TAKEN DIRECTLY FROM THE AER/EWD IT IS RECOMMENDED TO WIPE DOWN WITH A SURESTORE™ STORAGE SYSTEM COLLECTION PAD, OR SIMILAR STERILE PAD, TO REMOVE ALL VISIBLE RESIDUAL FLUID. IF THE ENDOSCOPE IS PLACED ON A SURFACE BEFORE PLACEMENT IN THE SURESTORE™ STORAGE SYSTEM TRAY, ENSURE THAT THIS SURFACE IS DECONTAMINATED.

12 I INSTRUCTIONS FOR USE

SURESTORE collection pad

STEP 5

TM

Storage System

Fold the SURESTORE™ Storage System collection pad around the distal tip of the scope. Ensure that the SURESTORE™ Storage System collection pad is securely positioned before proceeding. Please note that more than one absorbent pad maybe required dependant upon the volume of residual fluid on the endoscope when removed from the AER/EWD.

PRIOR TO EACH USE, ENSURE THE SURESTORE™ STORAGE SYSTEM TUBING SET AND BLOCKER OUTSIDE SURFACES ARE WIPED WITH DISINFECTANT WIPES, OR ANY SUITABLE HIGHLEVEL DISINFECTANT AGENT, IN LINE WITH YOUR HOSPITAL POLICY. ONLY USE SURESTORE™ STORAGE SYSTEM TUBE AND BLOCKER SETS. DO NOT MODIFY IN ANY WAY AS PERFORMANCE OF THE SYSTEM CAN BE AFFECTED.

STEP 6

Attach the supplied channel blockers and the biopsy valve cap to the endoscope where required. Connect the endoscope to the relevant channels, including the auxiliary channel where applicable. Please refer to the ‘SURESTORE™ Storage System Endoscope Connections Guide’ APPENDICES page: 40.

Channel connections to endoscope

INSTRUCTIONS FOR USE I 13

OPERATING THE USER INTERFACE

STEP 7

Press ‘SELECT SCOPE’ button.

STEP 8

Select the Endoscope, AER/ EWD and Institute from the relevant inventory. It is also possible to search for an endoscope or serial number by typing the number in the relevant search box or via the Barcode scanner. Please refer to the ‘Barcode Scanner Guide’ – APPENDICES pg: 41. Confirm that the details on the screen match those of the endoscope to be processed, the AER/ EWD, and the institute. Press ‘DONE’.

STEP 9

Press ‘START CONDITIONING’ The unit will enter ‘Pre-Flush phase’ to clear the channels of any residual moisture from the AER/ EWD, and then automatically starts the conditioning phase.

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STEP 10

Select operator name from the list provided.

STEP 11

A system notification message prompts you to verify that all the channels are connected, including the auxiliary/raiser bridge channel where applicable. Once all the connections have been made, press ‘CONTINUE’.

IF THERE IS INSUFFICIENT N-SURE™ CONDITIONING SOLUTION TO RUN A CYCLE, A WARNING WILL BE DISPLAYED (FIGURE A). ENSURE THAT THE SOLUTION IS REPLACED BEFORE RUNNING THE CYCLE. ONLY N-SURE™ CONDITIONING SOLUTION IS VALIDATED FOR USE IN SURESTORE™ STORAGE SYSTEM, USING ANYTHING ELSE WILL INVALIDATE THE PROCESS. THE SOLUTION BOTTLE CAN BE FOUND BEHIND THE DOOR AT THE REAR OF THE UNIT (SEE PAGE 7). AFTER REPLACING THE BOTTLE, THE ‘RESET RESERVOIR VOLUME’ BUTTON MUST BE PRESSED. PLEASE REFER TO THE ‘N-SURE™ SOLUTION BOTTLE CHANGE GUIDE’ – APPENDICES PAGE: 48.

Figure A

INSTRUCTIONS FOR USE I 15

STEP 12

Allow the unit to complete the conditioning process. A ‘Conditioning complete’ system message informs you when processing is complete and prompts you to commence the vacuum phase.

SURESTORE™ Storage System collection pad

STEP 13

If fluid is present in the base of the tray, check all connections for correct fitment as this could indicate a leak. Refit connections and recondition the endoscope. Remove the SURESTORE™ Storage System collection pad from the distal tip and discard.

NOTE: SURESTORE™ STORAGE SYSTEM COLLECTION PAD CAN BE DISPOSED OF IN GENERAL WASTE.

STEP 14

Disconnect all channel connections from the endoscope. Remove the air/water and aspiration channel blocker and the air/water bottle connection cover where applicable.

16 I INSTRUCTIONS FOR USE

STEP 15 TM

CLEANASCOPE Liner green cover

Place a folded red CLEANASCOPE™ Liner cover inside the SURESTORE™ Storage System endoscope support tray and cover the tray with a green CLEANASCOPE™ Liner cover.

STEP 16

TM

CLEANASCOPE Liner red cover

SURESTORE outer pouch

TM

Storage System TM

Slide the SURESTORE™ Storage System endoscope support tray with the pull out top panel on top of the unit towards you, away from the screen. Position an open SURESTORE™ Storage System outer pouch behind the SURESTORE™ Storage System endoscope support tray and insert the tray into the pouch.

SURESTORE Storage System endoscope support tray

Pull-out top panel

17 I INSTRUCTIONS FOR USE

STEP 17

Insert the printed label from the AER/ EWD inside the outer pouch, on top of the green CLEANASCOPE™ Liner cover.

TM

SURESTORE Storage System outer pouch

STEP 18

Seal the SURESTORE™ Storage System outer pouch by firmly placing the SURESTORE™ Storage System pouch sealing tool over the two zip seals. Slide along the full length of the seal in one continuous motion to the end of the pouch, ensuring that both zip lock seals are between the tool at all times during the action. Repeat if necessary. Ensure a continuous seal by feeling along both zips and pressing together any open sections.

Sealing tool

18 I INSTRUCTIONS FOR USE

STEP 19 SURESTORE™ Storage System outer pouch

Push the vacuum connector fully into the valve on the SURESTORE™ Storage System outer pouch. Check that the tubing is not kinked.

Vacuum connector

STEP 20

Press “OK” on the system message box. Start the vacuum by pressing ‘VACUUM START’.

IF THE SURESTORE™ STORAGE SYSTEM OUTER POUCH IS NOT HOLDING A VACUUM PLEASE REFER TO THE ‘OUTER POUCH TROUBLESHOOTING GUIDE’ - APPENDICES PAGE: 53/54. IF THE POUCH IS DAMAGED, DISCARD THE POUCH AND REPEAT THE PROCESS FROM THE BEGINNING.

19 I INSTRUCTIONS FOR USE

When the vacuum cycle is complete, a label will print.

DO NOT DISCONNECT THE VACUUM CONNECTOR FROM THE POUCH UNTIL A LABEL HAS PRINTED OUT OF THE MACHINE. FAILURE TO DO SO WILL RESULT IN A ‘VOID’ CYCLE.

STEP 21 Vacuum connector

Disconnect the vacuum connector from the pouch, ensuring that the valve cap is positioned correctly within the valve body and return to the vacuum connector holder at the rear of the unit. Prior to final closure of the SURESTORE™ Storage System outer pouch, first ensure a valid label has been printed from the SURESTORE™ storage system. Seal the adhesive tape at the top of the pouch by removing the backing paper and pressing down on the flap.

Vacuum receptacle

20 I INSTRUCTIONS FOR USE

STEP 22

A SURESTORE™ Storage System tracking label will emerge from the upper drawer unit.

IF A SURESTORE™ STORAGE SYSTEM LABEL DOES NOT PRINT, CHECK THAT THERE ARE LABELS IN THE PRINTER AND THAT THE LABELS HAVE NOT GOT JAMMED INSIDE THE DRAWER. CHECK THE ALIGNMENT OF THE PRINTER. IT MUST BE IN FULL CONTACT WITH THE FLANGE AT THE FRONT OF THE INSIDE OF THE DRAWER. FOR MORE INFORMATION PLEASE REFER TO APPENDICES PAGES 55/56/57. IF PROBLEMS PERSIST, PLEASE CONTACT THE CANTEL CUSTOMER SUPPORT LINE.

STEP 23

Tear off the SURESTORE™ Storage System label and attach to the SURESTORE™ Storage System outer pouch.