Steris RAS 12 Rack Manual

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A Word from STERIS

Introduction - A Word from STERIS

This manual contains important information on the proper use and routine maintenance of the RAS 12 Rack and the

RAS 12 Long Rack. All personnel involved in the use and routine maintenance of this equipment must carefully

review and comply with the Safety Precautions and instructions contained in this manual. These instructions are

important to protect the health and safety of personnel using the RAS 12 Rack to process items in the AMSCO®

7052HP Single-Chamber Washer/Disinfector; or the RAS 12 Long Rack to process items in the AMSCO® 7053HP

Single-Chamber Washer/Disinfector, and should be retained in a conveniently accessible area for quick reference.

NOTE: Please note the abbreviation "RAS" stands for Robotic Assisted Surgery.

NOTE: Please note that "RAS Rack" used throughout the manual stands for both Racks (the RAS 12 Rack as well as the

RAS 12 Long Rack).

Advisory

IMPORTANT: A listing of the Safety Precautions to be observed when using and servicing this equipment can be found in the

Safety Precautions section of this manual. Do not use the equipment until you have become familiar with this information.

STERIS does not intend, recommend or represent in any way that the RAS Rack be used in the washer/disinfector for

the terminal disinfection or sterilization of any da Vinci®

disinfect reusable da Vinci instruments in the washer/disinfector.

When da Vinci instruments will be contacting blood or compromised tissues, such instruments must be terminally

processed in accordance with Good Hospital Practices before each use in human patients, and also in accordance with

all directions specified in the latest Intuitive Surgical®

Rack and Cycle as described herein) as well as in any instrument specific instructions and supplements that may come

with individual instruments.

The RAS Rack is specifically designed to only hold da Vinci instruments as outlined in this manual. If there is any doubt

about a specific material or product, contact the instrument manufacturer for recommended washing techniques.

Any alteration of this equipment not authorized or performed by STERIS will void the warranty. Alteration of this

equipment which could adversely affect its operation and efficacy may violate national, state and local laws or

regulations.

Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and

competent authority in the country where the incident occurred.

Indications For Use

The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO

7053HP Single-Chamber Washer/Disinfector for the effective cleaning, rinsing, intermediate level disinfection and

drying of reusable da Vinci X/Xi and S/Si EndoWrist instruments.

da Vinci is a registered trademark of Intuitive Surgical, Inc.

Intuitive Surgical is a registered trademark of Intuitive Surgical, Inc.

Operator Manual

instruments. The RAS Rack is intended only to clean and

Reprocessing Instructions (except steps replaced by use of RAS

RAS 12 Racks

10295965_G

Table of Contents

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Summary of Contents for Steris RAS 12 Rack

Page 1 Single-Chamber Washer/Disinfector, and should be retained in a conveniently accessible area for quick reference. NOTE: Please note the abbreviation "RAS" stands for Robotic Assisted Surgery. NOTE: Please note that "RAS Rack" used throughout the manual stands for both Racks (the RAS 12 Rack as well as the RAS 12 Long Rack).
Page 2 STERIS maintains a global staff of well-equipped, qualified service technicians to provide this service, as well as professional repair services. Please contact STERIS for details.
Page 3 European Community Representative: STERIS Ireland Limited IDA Business and Technology Park Tullamore County Offaly R35 X865 Ireland Switzerland Authorized Representative: STERIS GmbH c/o BDO AG Längfeldweg 116A CH-2504 Biel-Bienne, Switzerland +41.32.37.60-200 UK Responsible Person: STERIS Solutions Limited Chancery House, Rayns Way...
Page 4: Table Of Contents
Illustrated Parts Breakdown - General ............... 38 5.10 RAS 12 Rack (FD256) and RAS 12 Long Rack (FD257) – Part 1 of 2....... 39 5.11 RAS 12 Rack (FD256) and RAS 12 Long Rack (FD257) – Part 2 of 2....... 41...
Page 5: Safety Precautions
Regularly scheduled preventive maintenance is required for safe and reliable operation of the washer/disinfector and this equipment. Contact STERIS to schedule preventive maintenance. Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service personnel. Repairs and adjustments performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, void the warranty or result in costly damage.
Page 6 Processing the instruments in the RAS Rack and RAS Cycle does not replace the OR steps in the applicable da Vinci Reprocessing Instructions. STERIS makes no claim of effective processing when these instructions are not followed, or are applied to devices that do not match the descriptions and depictions provided.
Page 7: Loading Instructions
Port Connectors (X 14) [12 Located on Rack and 2 Additional Ones] Holding Cords (X 12) Flexible Hoses For Port Connections (X 12) Cool-Touch Handle (X 4) Rotary Spray Arm Assembly Figure 2-1. RAS 12 Rack Shown — Components Operator Manual RAS 12 Racks 10295965_G...
Page 8: Da Vinci Instruments
2 — Loading Instructions 2.3 da Vinci Instruments The RAS Rack can process the following da Vinci instruments: Models da Vinci S/Si Example of a 5 mm Instrument Example of a 8 mm Instrument Secondary Flush Port Primary Flush Port Models da Vinci X/Xi Example of a 8 mm Instrument Secondary Flush port...
Page 9: Before Processing Instruments
Detergent must be used in the washer/disinfector to ensure proper cleaning and disinfection of da Vinci instruments. Before processing da Vinci instruments using the RAS 12 Rack within the AMSCO® 7052HP Single-Chamber Washer/Disinfector or the RAS 12 Long Rack within the AMSCO® 7053HP Single-Chamber Washer/Disinfector, complete the following checklist to help ensure correct equipment operation: ◻...
Page 10 2 — Loading Instructions Figure 2-3. Soaking Instrument e. Fill sink bay with fresh cold water. f. Using a water gun and Luer fitting, spray instrument’ s tip using pressurized cold water (30 psig [2 bar]) (see Figure 2-4). Ensure tip moves through its full range of motion while being sprayed. IMPORTANT: Ensure spraying is performed while instrument is still submerged to avoid splashing of contaminated water.
Page 11: Loading Ras Rack - General
2.6 Loading RAS Rack — General WARNING INEFFECTIVE PROCESS HAZARD STERIS makes no claim of effective processing when these instructions are not followed, or are applied to devices that do not match the descriptions and depictions provided. CAUTION POSSIBLE EQUIPMENT DAMAGE...
Page 12: Loading Da Vinci Instruments - General
2 — Loading Instructions 2.7 Loading da Vinci Instruments — General WARNING PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD Always wear appropriate Personal Protective Equipment (PPE) when loading and unloading RAS Rack. da Vinci instruments tips protruding upward from rack can be extremely sharp and can cause injuries such as cuts.
Page 13 2 — Loading Instructions Example of a 5 mm da Vinci S/Si Instrument Secondary Flush Port Primary Flush Port 1. Locate port connectors on instrument holder. Each connector is installed on rack as shown in Figure 2-6. Figure 2-6. Connector 2.
Page 14 2 — Loading Instructions Drawing Simplified For Clarity. Figure 2-7. Removing Connector 3. Reconnect hose on connector as shown in Figure 2-8. IMPORTANT: Reinstall hose only when connector ends are completely dry to avoid disconnection while processing instruments. Connector End Reconnect Hose Insert While Firmly Pushing...
Page 15 2 — Loading Instructions Figure 2-9. Reinstalling Connector 5. Repeat Step 1 Step 4 until having all required port connectors ready. 6. Retrieve instruments with two ports on instrument housing. 7. Insert shaft of instrument into hole identified with an arrow, in shaft holder, to ensure proper alignment and processing.
Page 16 2 — Loading Instructions Drawings Simplified For Clarity. Guiding Slider Port Connector Holder Channel Figure 2-11. Guiding Slider Into Holder Channel 11. Once instrument is on top of port connector, ensure both connector ends enter instrument housing flush ports. 12. Install all remaining instruments. 10295965_G RAS 12 Racks Operator Manual...
Page 17 2 — Loading Instructions Drawing Simplified For Clarity. Flush Ports Connector Ends Figure 2-12. Connecting Instrument WARNING INEFFECTIVE PROCESS HAZARD If the da Vinci instrument is not properly connected at the end of cycle, instrument has to be reprocessed to ensure proper cleaning and disinfection. 13.
Page 18 2 — Loading Instructions Drawing Simplified For Clarity. Figure 2-13. Securing Connection 14. Gently pull on device to ensure it remains connected. 15. Install holding cord on all instruments as shown in Figure 2-14. 10295965_G RAS 12 Racks Operator Manual...
Page 19: Loading Da Vinci Instruments - Model Da Vinci X/Xi
2 — Loading Instructions Drawing Simplified For Clarity. Instrument Shaft Holding Cord Instrument Figure 2-14. Installing Holding Cord 2.9 Loading da Vinci Instruments — Model da Vinci X/Xi WARNING PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD Do not reprocess the da Vinci Stapler using the RAS Rack and Cycle. Doing so could damage the Stapler, which may lead to patient harm.
Page 20 2 — Loading Instructions Example of a 8 mm da Vinci X/Xi Instrument Secondary Flush Port Primary Flush Port 1. Locate port connectors on instrument holder. Each connector is installed on rack as shown in Figure 2-15. Figure 2-15. Connector 2.
Page 21 2 — Loading Instructions Arrow Figure 2-16. Instrument Shaft Into Hole 4. Ensure to open each instrument tip before processing load in washer/disinfector. 5. Once instrument is in front of port connector, carefully push on instrument housing to ensure both connector ends enter instrument housing flush ports.
Page 22 2 — Loading Instructions NOTE: Drawings Simplified For Clarity. Flush ports Connector Ends Figure 2-17. Connecting Instrument 7. Gently pull on device to ensure it remains connected. 8. Install holding cord on all instruments as shown in Figure 2-18. 10295965_G RAS 12 Racks Operator Manual...
Page 23 2 — Loading Instructions NOTE: Drawing Simplified For Clarity. Holding Cord Instrument Figure 2-18. Installing Holding Cord Operator Manual RAS 12 Racks 10295965_G...
Page 24: Operating Instructions
3 — Operating Instructions Operating Instructions 3.1 Operating Instructions — Introduction IMPORTANT: A listing of the Safety Precautions to be observed when using and servicing this equipment can be found in the Safety Precautions section of this manual. Do not use the equipment until you have become familiar with this information. 3.2 RAS Cycle Operation WARNING SLIPPING HAZARD...
Page 25 Table 3-1. Cycle Description Chart — RAS Cycle Table 3-1, Cycle Description Chart, for more information about RAS Cycle and parameters within cycle such as temperature, chemicals used, injection rate, etc. Use this chart as a reference while processing RAS Cycle. Operator Manual RAS 12 Racks 10295965_G...
Page 26: Unloading Instructions
4 — Unloading Instructions Unloading Instructions 4.1 Unloading Instructions — Introduction IMPORTANT: A listing of the Safety Precautions to be observed when using and servicing this equipment can be found in the Safety Precautions section of this manual. Do not use the equipment until you have become familiar with this information. 4.2 Unloading Instructions WARNING PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD...
Page 27 4. When inspection is completed and all instruments are properly cleaned, remove holding cords, carefully disconnect instruments and empty rack. NOTE: Some instruments might need to be slightly inclined to evacuate any remaining water inside ports. IMPORTANT: STERIS recommends unloading RAS Rack on an appropriate surface or work table. Operator Manual RAS 12 Racks...
Page 28: Routine Maintenance And Replacement Parts
Regularly scheduled preventive maintenance is required for safe and reliable operation of the washer/disinfector and this equipment. Contact STERIS to schedule preventive maintenance. Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service personnel. Repairs and adjustments performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, void the warranty or result in costly damage.
Page 29: Routine Maintenance - General
(see Section 5.6, Replacing Flexible Hoses on Rack Instrument Holder). Verify holding cords on rack instrument holder. If damaged, replace; or contact STERIS* or Customer’ s maintenance service to replace (see Section 5.7, Replacing Holding Cords Once a Month on Rack Instrument Holder).
Page 30: Inspecting And Cleaning Rotary Spray Arm Assembly
5 — Routine Maintenance and Replacement Parts 5.4 Inspecting and Cleaning Rotary Spray Arm Assembly Once a week, the operator should inspect and clean chamber rotary rack spray arm assemblies as follows: 1. Remove pin securing rotary spray arm assembly to RAS Rack. Figure 5-1.
Page 31 5 — Routine Maintenance and Replacement Parts Figure 5-3. Removing End Spray Jets 5. Use a fine wire (approximately wire gauge of a paper clip) to clean sediment from spray jets and end spray jets. If desired, cleaning needle can also be used (P117072281). Figure 5-4.
Page 32: Cleaning Rack Filter
5 — Routine Maintenance and Replacement Parts Figure 5-5. Rinsing Assembly 7. Reinstall end spray jets on rotary spray arm assembly using previously removed safety latches. 8. Once cleaning procedure is completed, reinstall rotary spray arm assembly to rack using previously removed pin. 9.
Page 33 5 — Routine Maintenance and Replacement Parts Filter Housing Filter Figure 5-6. Removing Rack Filter 2. While rinsing filter under water, use a tube brush to clean inside and outside filter. 3. Always clean filter while it is still wet, before debris dries. Figure 5-7.
Page 34: Replacing Flexible Hoses On Rack Instrument Holder
5 — Routine Maintenance and Replacement Parts 5.6 Replacing Flexible Hoses on Rack Instrument Holder Every two years, or if flexible hose(s) are damaged, replace flexible hoses as follows [or contact STERIS or Customer ’s maintenance service to replace]: NOTE: Routine Maintenance is not covered under warranty.
Page 35 5 — Routine Maintenance and Replacement Parts Flexible Hoses ( X Twelve) Irrigation Ports Figure 5-9. Removing Hoses 4. Retrieve new hoses (see Table 5-2). 5. Pour some 70% isopropyl alcohol on end of hose to be reinstalled on irrigation port. Connect hose on rack. Repeat for remaining hoses.
Page 36 Figure 5-10. Installing Hoses and Port Connectors Flexible Hoses On Top of Rack NOTE: Hose and Clip Assembly Kits or Routine Maintenance Kit For Customer can be ordered from STERIS (see Table 5- 1. Remove each hose from top connection.
Page 37 5 — Routine Maintenance and Replacement Parts Clip Top Connection Figure 5-11. Removing Hose From Top Connection 3. Using pliers or equivalent, remove each hose from its irrigation port. If part of hose remains on irrigation port, remove using cutting pliers or equivalent. Discard. Flexible Hoses (X Twelve) Irrigation Port Figure 5-12.
Page 38: Replacing Holding Cords On Rack Instrument Holder
Figure 5-13. Installing Hoses 5.7 Replacing Holding Cords on Rack Instrument Holder Every two years, or if holding cord(s) are damaged, replace holding cords as follows [or contact STERIS* or Customer’ s maintenance service to replace]: NOTE: Routine Maintenance is not covered under warranty.
Page 39 5 — Routine Maintenance and Replacement Parts Holding Cords O-rings (X 24) Holding Cords O-rings (X 24) Holding Cords (X 12) Figure 5-14. Removing Holding Cords O-rings 3. Pull on holding cord to remove. Operator Manual RAS 12 Racks 10295965_G...
Page 40 5 — Routine Maintenance and Replacement Parts Figure 5-15. Removing Holding Cords Top Connection 4. Retrieve new holding cords and O-rings (see Table 5-2). 5. Pour a small quantity of 70% isopropyl alcohol on both ends of each holding cord to be reinstalled on rack. 6.
Page 41: Replacement Parts
3. Send your order directly to STERIS. NOTE: Use only STERIS authorized parts on this equipment. Use of unauthorized parts will void the warranty. NOTE: See Illustrated Parts Breakdown Section to visualize the location of the parts listed in the following list.
Page 42: Illustrated Parts Breakdown - General
5.9 Illustrated Parts Breakdown - General IMPORTANT: Rack regular service and maintenance MUST be performed only by STERIS or a STERIS-trained technician. Any work performed by inexperienced or unqualified persons or the installation of unauthorized parts on Rack could cause personal injury, invalidate the warranty or result in costly damage.
Page 43: Ras 12 Rack (Fd256) And Ras 12 Long Rack (Fd257) - Part 1 Of 2
5 — Routine Maintenance and Replacement Parts 5.10 RAS 12 Rack (FD256) and RAS 12 Long Rack (FD257) – Part 1 of 2 Operator Manual RAS 12 Racks 10295965_G...
Page 44 5 — Routine Maintenance and Replacement Parts Units per Description Item Part Number Ass'y RAS 12 RACK (FD256) AND RAS 12 LONG RACK (FD257) – PART 1 OF 2 1 P117043015 NUT, S/S, M5 X 0.8 MM 2 P117043315 SCREW, PAN HEAD, S/S, M4 X 0.7 MM X 6 MM 3 P117048907 O-RING, SILICONE, 3/8"...
Page 45: Ras 12 Rack (Fd256) And Ras 12 Long Rack (Fd257) - Part 2 Of 2
5 — Routine Maintenance and Replacement Parts 5.11 RAS 12 Rack (FD256) and RAS 12 Long Rack (FD257) – Part 2 of 2 Operator Manual RAS 12 Racks 10295965_G...
Page 46 5 — Routine Maintenance and Replacement Parts Units per Description Item Part Number Ass'y RAS 12 RACK (FD256) AND RAS 12 LONG RACK (FD257) – PART 2 OF 2 1 P117917234 O-RING, SILICONE, 3/8" OD, X 3/16" ID 10077806 KIT, RACK SERVICE MAINTENANCE (NOT SHOWN)

This manual is also suitable for:

Ras 12 long rack Fd256 Fd257