Steris Amsco 7052Hp Washer Disinfector Operating instructions

Type
Operating instructions
11748808
Revision D
FOR EXPORT ONLY
NOT FOR SALE OR USE IN USA
RAS 12 Racks (EMEA)
RAS 12 Rack and RAS 12 Long Rack
Operator Manual
ii
11748808_D RAS 12 Racks (EMEA) Operator Manual
© 2023 STERIS. All rights reserved.
Published: 2023-10-11
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
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 robotic 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.
This Operator Manual is not for use in USA.
Indications For Use
The RAS Racks are used in the robotic cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the
AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, rinsing and intermediate level
disinfection 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.
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11748808_D RAS 12 Racks (EMEA) 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
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
© 2023, STERIS Corporation. All rights reserved. Printed in Canada.
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11748808_D RAS 12 Racks (EMEA) 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 Robotic Cycle Configuration........................................................................................... 5
2.6 Running Test Cycle ....................................................................................................... 14
2.7 Preparing Instruments ................................................................................................. 15
2.8 Loading RAS Rack General .................................................................................... 16
2.9 Loading da Vinci Instruments General ................................................................... 16
2.10 Loading da Vinci Instruments — Model da Vinci S/Si................................................. 17
2.11 Loading da Vinci Instruments — Model da Vinci X/Xi................................................. 24
3 Operating Instructions ....................................................................................................................29
3.1 Operating Instructions Introduction ...................................................................... 29
3.2 Robotic Cycle Operation ............................................................................................... 29
4 Unloading Instructions.................................................................................................................... 32
4.1 Unloading Instructions Introduction ...................................................................... 32
4.2 Unloading Instructions ................................................................................................. 32
5 Routine Maintenance and Replacement Parts.............................................................................34
5.1 Routine Maintenance and Replacement Parts Introduction................................ 34
5.2 Preventive Maintenance .............................................................................................. 34
5.3 Routine Maintenance General................................................................................ 35
5.4 Inspecting and Cleaning Rotary Spray Arm Assembly............................................... 36
5.5 Cleaning Rack Filter ...................................................................................................... 38
5.6 Replacing Flexible Hoses on Rack Instrument Holder ............................................... 40
5.7 Replacing Holding Cords on Rack Instrument Holder................................................ 44
5.8 Replacement Parts ....................................................................................................... 47
5.9 Illustrated Parts Breakdown - General ....................................................................... 48
5.10 RAS 12 Rack (FD256) and RAS 12 Long Rack (FD257) – Part 1 of 2....................... 49
5.11 RAS 12 Rack (FD256) and RAS 12 Long Rack (FD257) – Part 2 of 2....................... 51
1 — Safety Precautions
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
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
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11748808_D RAS 12 Racks (EMEA) 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 custom robotic 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 custom robotic cycle does not replace OR steps, Decon
steps or Prepare for Automated Cleaning steps.
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
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
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
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11748808_D RAS 12 Racks (EMEA) 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
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
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;
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.
Ensure your robotic cycle was configured on your Washer/Disinfector. If not, configure as detailed in Section 2.5,
Robotic Cycle Configuration.
2.5 Robotic Cycle Configuration
To modify an available cycle into customized robotic cycle, proceed as follows:
1. Access Supervisor mode. Display shows Supervisor mode screen:
2. Press Cycles on touch screen. Display shows Supervisor screen:
2 — Loading Instructions
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11748808_D RAS 12 Racks (EMEA) Operator Manual
3. Press Modify Cycles on touch screen. Display shows Cycle Selection screen:
4. Scroll to select any available cycle to modify. Display shows Cycle Modification screen:
Proceed with specified settings:
NOTE: Any cycle set to locked is not available in cycle start selection.
2 — Loading Instructions
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
IMPORTANT: The Customer should pay particular attention when setting pump speed as it has a direct effect on the
washer/disinfector performances when combined with particular accessories.
a. Press NAME on touch screen to modify name to “Robotic”:
b. Continue with remaining settings:
BARCODE: Corresponding barcode tag number.
PUMP SPEED: HIGH
STATE: Unlocked
5. Press PARAMETERS on touch screen to modify cycle phases. Set the following parameters as indicated. Begin
with PRE-WASH Phases settings.
PRE-WASH Phases
1. Display shows Robotic phase screen:
2. Press “1” on PRE-WASH menu. Set following parameters:
2 — Loading Instructions
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11748808_D RAS 12 Racks (EMEA) Operator Manual
3. Once parameters set, press “2” on PRE-WASH menu. Set following parameters:
4. When settings are completed, press Close (X) to return to Phase screen. Then, proceed with WASH Phase
settings.
WASH Phase
1. Display shows Robotic phase screen:
2 — Loading Instructions
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
2. Press “1” on WASH menu. Set following parameters:
NOTE: CW+RW is not allowed to be used for this cycle.
3. Once parameters set, press Right arrow to access following screen (STAGE 1). Set following parameters:
NOTE: Ensure to assign PUC HP Enzymatic Cleaner only for Wash 1 Stage 1.
4. Once parameters set, press Right arrow to access following screen (STAGE 2). Set following parameters:
2 — Loading Instructions
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11748808_D RAS 12 Racks (EMEA) Operator Manual
5. Once parameters set, press Right arrow to access following screen. Set following parameters:
NOTE: Ensure to assign PUC HP Neutral Detergent only for Wash 1 Stage 2.
6. When settings are completed, press Close (X) until returning to Phase screen. Then, proceed with RINSE Phase
settings.
RINSE Phase
1. Display shows Robotic phase screen:
2 — Loading Instructions
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
2. Press Right arrow to access following phases. Display shows:
3. Press “1” on RINSE menu. Set following parameters:
NOTE: PW can alternatively be used for Rinse 1, but it is not allowed if washer is equipped with optional Acu-
Rinse Reservoir since phase time cannot be set to desired time in this configuration.
2 — Loading Instructions
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11748808_D RAS 12 Racks (EMEA) Operator Manual
4. When settings are completed, press Close (X) until returning to Phase screen. Then, proceed with THERMAL RINSE
Phase settings.
THERMAL RINSE Phase
1. Display shows Robotic phase screen:
2. Press “1” on THERMAL RINSE menu. Set following parameters:
NOTE: PW can alternatively be used for Thermal Rinse.
NOTE: A0 Thermal Rinse Type can alternatively be used to set proper disinfection level.
3. Press Right arrow to access following menu. Set following parameter:
2 — Loading Instructions
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Operator Manual RAS 12 Racks (EMEA) 11748808_D
4. Press Right arrow to access following menu. Set following parameters:
NOTE: For Customer located at an altitude above 762 m (2500 ft). 02:49 must be used instead at a temperature
of 85.5°C (185°F).
NOTE: If A0 Thermal Rinse Type is used, a value of 600 or above must be selected.
5. When settings are completed, press Close (X) until returning to Phase screen. Then, proceed with DRYING
settings.
DRYING
1. Display shows Robotic phase screen:
2 — Loading Instructions
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11748808_D RAS 12 Racks (EMEA) Operator Manual
2. Press “1” on DRYING menu. Set following parameters:
IMPORTANT: Drying phase of this cycle is only intended for chamber venting to moisture removal on the exterior of the
instruments; interior must be dried following cycle completion.
3. When settings are completed, press Close (X) until returning to Supervisor mode screen.
4. When settings are completed, proceed to Section 2.6, Running Test Cycle.
2.6 Running Test Cycle
When all settings are completed, proceed with a Test cycle as follows:
1. Place empty RAS 12 Rack inside chamber.
2. Start robotic cycle.
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Steris Amsco 7052Hp Washer Disinfector Operating instructions

Type
Operating instructions

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