Steris Amsco 7052Hp Washer Disinfector Operating instructions

Brand: Steris

Model: Amsco 7052Hp Washer Disinfector

Type: Operating instructions

Operator Manual RAS 12 Racks 10295965_F

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®1instruments. The RAS Rack is intended only to clean and

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®2Reprocessing Instructions (except steps replaced by use of RAS

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.

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

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

10295965_F RAS 12 Racks Operator Manual

Trademarks

Please take note of the following registered trademarks of Intuitive Surgical, Inc. that apply to the wording used

throughout the manual:

•da Vinci®S/Si EndoWrist®

•da Vinci®X/Xi EndoWrist®

• Intuitive Surgical®

•da Vinci® Surgical Systems

• Single-Site® Instrument

Service Information

A thorough preventive maintenance program is essential to help ensure safe and proper washer/disinfector and rack

operation. This manual contains a routine maintenance procedure which should be followed for satisfactory equipment

performance.

Customers are encouraged to contact STERIS concerning extended service maintenance agreements to give your

washer/disinfector and rack planned maintenance, which will help ensure equipment performance according to factory

specifications. 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.

Certification

The AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber

Washer/Disinfector, both compatible with the RAS Rack, meet the applicable requirements of certain standards. Refer

to washer/disinfector Operator Manual (10432589) for the current list of standards.

Addresses

The base language of this document

is ENGLISH. Any translation must be

made from the base language

document.

Manufactured by:

STERIS Canada ULC

490 boulevard Armand-Paris

Québec (Québec)

CANADA G1C 8A3

Sales and Service – Americas:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060

440-354-2600 • 800-548-4873

European Community Representative:

STERIS Ireland Limited

IDA Business and Technology Park

Tullamore

County Offaly

R35 X865

Ireland

Website: www.steris.com

Operator Manual RAS 12 Racks 10295965_F

10295965_F RAS 12 Racks Operator Manual

TABLE OF CONTENTS

Section Number Description Page

1 Safety Precautions ............................................................................................................................ 1

1.1 Safety Precautions — Introduction .............................................................................. 1

1.2 Safety Precautions ......................................................................................................... 1

2 Loading Instructions.......................................................................................................................... 3

2.1 Loading Instructions — Introduction............................................................................ 3

2.2 RAS Rack Main Components ........................................................................................ 3

2.3 da Vinci Instruments ....................................................................................................... 4

2.4 Before Processing Instruments..................................................................................... 5

2.5 Preparing Instruments .................................................................................................. 5

2.6 Loading RAS Rack — General ...................................................................................... 7

2.7 Loading da Vinci Instruments — General ..................................................................... 8

2.8 Loading da Vinci Instruments — Model da Vinci S/Si................................................... 8

2.9 Loading da Vinci Instruments — Model da Vinci X/Xi................................................. 15

3 Operating Instructions ....................................................................................................................20

3.1 Operating Instructions — Introduction ...................................................................... 20

3.2 RAS Cycle Operation..................................................................................................... 20

4 Unloading Instructions.................................................................................................................... 22

4.1 Unloading Instructions — Introduction ...................................................................... 22

4.2 Unloading Instructions ................................................................................................. 22

5 Routine Maintenance and Replacement Parts.............................................................................24

5.1 Routine Maintenance and Replacement Parts — Introduction................................ 24

5.2 Preventive Maintenance .............................................................................................. 24

5.3 Routine Maintenance — General................................................................................ 25

5.4 Inspecting and Cleaning Rotary Spray Arm Assembly............................................... 26

5.5 Cleaning Rack Filter ...................................................................................................... 28

5.6 Replacing Flexible Hoses on Rack Instrument Holder ............................................... 30

5.7 Replacing Holding Cords on Rack Instrument Holder................................................ 34

5.8 Replacement Parts ....................................................................................................... 37

5.9 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

1 — Safety Precautions

Operator Manual RAS 12 Racks 10295965_F

Safety Precautions

1.1 Safety Precautions — Introduction

The following Safety Precautions must be observed when using or servicing this equipment. WARNING indicates the

potential for personal injury and CAUTION indicates the potential for damage to equipment. For emphasis, certain

Safety Precautions are repeated throughout the manual. It is important to review ALL Safety Precautions before using

or servicing the equipment.

Strictly following these Safety Precautions enhances the Customer ’s ability to safely and effectively utilize the RAS Rack

within the washer/disinfector and helps avoid improper maintenance methods which may damage the equipment or

render it unsafe. It is important to understand that these Safety Precautions are not exhaustive; Customers are

encouraged to develop their own safety policies and procedures to enhance and complement these Safety Precautions.

1.2 Safety Precautions

WARNING

CUTTING 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.

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.

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. Contact STERIS regarding service options.

WARNING

BURN HAZARD

RAS Rack and items are extremely hot when cycle is completed. Allow rack and items to cool to room

temperature and always wear appropriate Personal Protective Equipment (PPE) before reaching into

chamber.

1 — Safety Precautions

10295965_F RAS 12 Racks Operator Manual

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.

Only RAS Cycle must be used along with the RAS Rack to ensure proper cleaning and disinfection of da

Vinci instruments.

Only Prolystica® Ultra Concentrate HP Enzymatic Cleaner and Prolystica® Ultra Concentrate HP Neutral

Detergent must be used in the washer/disinfector to ensure proper cleaning and disinfection of da Vinci

instruments.

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.

WARNING

SLIPPING HAZARD

To prevent slips, keep floors dry. Promptly clean up any spills or drippage. For spills or drippage of

detergents or other chemicals, follow safety precautions and handling procedures set forth on detergent

or chemical label and/or Safety Data Sheet (SDS).

CAUTION

POSSIBLE EQUIPMENT DAMAGE

da Vinci Single-Site instruments are not compatible with automated reprocessing and should not be

processed in the RAS 12 Racks.

To avoid equipment damage and maximize processing efficiency, always load soiled items as instructed in

this RAS Rack Operator Manual.

To avoid instrument or equipment damage, STERIS does not recommend processing flexible endoscopes,

single-use instruments, rigid telescopes (optical lens), fiber-optic cables, multipart instruments that

cannot be disassembled, heat-sensitive devices and coagulating electrodes using the RAS Rack in the

washer/disinfector. All instruments processed using the RAS Rack in the washer/disinfector must

withstand temperatures of up to 240°F (116°C).

Use nonabrasive cleaners when cleaning RAS Rack. Follow directions on containers and rub in a back-and

forth motion (in same direction as surface grain). Abrasive cleaners will damage stainless steel.

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

Loading Instructions

2.1 Loading 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.

2.2 RAS Rack Main Components

IMPORTANT: Before using the RAS Rack, it is important to become familiar with the rack components.

1. Instrument Shaft Holder

2. Instrument Holder

3. Port Connectors (X 14) [12 Located on Rack and 2 Additional Ones]

4. Holding Cords (X 12)

5. Flexible Hoses For Port Connections (X 12)

6. Cool-Touch Handle (X 4)

7. Rotary Spray Arm Assembly

Figure 2-1. RAS 12 Rack Shown — Components

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

2.3 da Vinci Instruments

The RAS Rack can process the following da Vinci instruments:

Models da Vinci S/Si

1. Example of a 5 mm Instrument

2. Example of a 8 mm Instrument

3. Secondary Flush Port

4. Primary Flush Port

Models da Vinci X/Xi

1. Example of a 8 mm Instrument

2. Secondary Flush port

3. Primary Flush Port

Figure 2-2. Examples of da Vinci Instruments

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

2.4 Before Processing Instruments

WARNING

INEFFECTIVE PROCESS HAZARD

Only Prolystica® Ultra Concentrate HP Enzymatic Cleaner and Prolystica® Ultra Concentrate HP Neutral

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:

◻All packaging material has been properly removed from the RAS Rack;

◻Two additional port connectors were safely put aside;

◻RAS Rack filter assembly is in place (refer to Section 5.5, Cleaning Rack Filter);

◻Manually rotate RAS Rack spray arm assembly to ensure movement is not obstructed;

◻If required, ensure washer/disinfector software update has been performed so RAS cycle is available for use;

◻Processing da Vinci instruments with RAS Rack requires the use of Prolystica® Ultra Concentrate HP Chemicals;

verify that Prolystica Ultra Concentrate HP Enzymatic Cleaner and Prolystica Ultra Concentrate HP Neutral

Detergent are properly loaded and set in the Chemical Setting menu of Service mode.

2.5 Preparing Instruments

WARNING

INEFFECTIVE PROCESS HAZARD

Processing the instruments in the RAS Rack and RAS Cycle does not replace the OR steps in the

applicable da Vinci Reprocessing Instructions.

WARNING

SLIPPING HAZARD

To prevent slips, keep floors dry. Promptly clean up any spills or drippage. For spills or drippage of

detergents or other chemicals, follow safety precautions and handling procedures set forth on detergent

or chemical label and/ or Safety Data Sheet (SDS).

To prepare da Vinci instruments for processing, proceed as follows:

1. Perform the OR steps described in the applicable da Vinci Reprocessing Instructions.

• This should include removing the accessories and checking the maximum use indicator if applicable.

2. Perform the following pre-cleaning steps for each instrument to be processed:

a. Prepare fresh pH neutral to mildly alkaline enzymatic solution (pH 7-11).

b. Prime primary flush port by injecting at least 15 ml of cleaning solution (see Figure 2-2 for location of

primary flush port).

c. Place instrument in container, sink or bin filled with the enzymatic detergent solution.

d. Soak instrument for 10 minutes (see Figure 2-3).

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

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.

g. Perform spraying for at least 30 seconds.

Figure 2-4. Spraying Instrument’s Tip

h. Using a soft-bristled nylon brush, thoroughly brush entire instrument under cold running water for at least

60 seconds or until entire instrument is visibly clean (see Figure 2-5).

Pay attention to the tip. Ensure tip moves intermittently through its full range of motion while being

brushed (see Figure 2-5).

IMPORTANT: Carefully brush tip to avoid any damage to instrument.

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

Figure 2-5. Brushing Entire Instrument

3. Under 4X magnification, inspect all instruments for visible debris. If soil is present, repeat pre-cleaning process.

4. Sort instruments by type and proceed with loading of RAS Rack.

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

To avoid instrument or equipment damage, STERIS does not recommend processing flexible endoscopes,

single-use instruments, rigid telescopes (optical lens), fiber-optic cables, multipart instruments that

cannot be disassembled, heat-sensitive devices and coagulating electrodes using the RAS Rack in the

washer/disinfector. All instruments processed using the RAS Rack in the washer/disinfector must

withstand temperatures of up to 240°F (116°C).

The RAS Rack is designed to process up to twelve da Vinci instruments:

• Positions 1 to 6 on Instrument Holder.

• 12 instruments maximum per load.

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

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.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

To avoid equipment damage and maximize processing efficiency, always load soiled items as instructed in

this RAS Rack Operator Manual.

To load da Vinci instruments in RAS Rack, proceed as follows:

1. Ensure RAS Rack is located on appropriate loading cart or surface.

2. Bring da Vinci instruments to be processed next to rack.

3. Ensure all instruments are sorted by type.

4. Proceed to appropriate Section for da Vinci instruments connection:

•Section 2.8, Loading da Vinci Instruments — Model da Vinci S/Si

•Section 2.9, Loading da Vinci Instruments — Model da Vinci X/Xi

2.8 Loading da Vinci Instruments — Model da Vinci S/Si

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.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

da Vinci Single-Site instruments are not compatible with automated reprocessing and should not be

processed in the RAS 12 Racks.

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

1. Example of a 5 mm da Vinci S/Si Instrument

2. Secondary Flush Port

3. 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. Disconnect hose from connector and carefully pull on port connector to remove it from instrument holder.

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

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.

1. Connector End

2. Reconnect Hose

3. Insert While Firmly Pushing...

4. ... and Slightly Turn

Figure 2-8. Reconnecting Hose on Connector

4. Reinstall port connector in place, as show in Figure 2-9, by carefully sliding connector into place.

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

Figure 2-9. Reinstalling Connector

5. Repeat Step 1 to 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.

1. Arrow

Figure 2-10. Instrument Shaft Into Hole

8. Ensure to open each instrument tip before processing load in washer/disinfector.

9. Locate instrument guiding slider and instrument holder channel.

10. While lowering instrument toward port connector, ensure to slide instrument guiding slider in instrument holder

channel.

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

Drawings Simplified For Clarity.

1. Guiding Slider

2. Port Connector

3. 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.

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

Drawing Simplified For Clarity.

1. Flush Ports

2. 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. Once all instruments are connected, use one hand to secure each connection as follows:

• Place thumb below port connector;

• Place remaining fingers on top of instrument housing;

• Carefully push on instrument housing and on port connector to tighten connection.

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

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.

2 — Loading Instructions

Operator Manual RAS 12 Racks 10295965_F

Drawing Simplified For Clarity.

1. Instrument Shaft

2. Holding Cord

3. 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.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

da Vinci Single-Site instruments are not compatible with automated reprocessing and should not be

processed in the RAS 12 Racks.

2 — Loading Instructions

10295965_F RAS 12 Racks Operator Manual

1. Example of a 8 mm da Vinci X/Xi Instrument

2. Secondary Flush Port

3. 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. Retrieve instruments to be processed.

3. Insert shaft of instrument into hole identified with an arrow, in shaft holder, to ensure proper alignment and

processing.

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Steris Amsco 7052Hp Washer Disinfector Operating instructions

Brand: Steris

Model: Amsco 7052Hp Washer Disinfector

Type: Operating instructions

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Steris Amsco 7052Hp Washer Disinfector Operating instructions

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