Steris Reliance Vision Single-Chamber Washer/Disinfector Operating instructions

Type
Operating instructions
OPERATOR MANUAL
da Vinci
®
Rack
(2019-09-23) 10160662
i
Introduction Operator Manual 10160662
This manual contains important information on the proper use and
routine maintenance of the da Vinci® 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 this da Vinci Rack to process
items in the Reliance® Vision® Single-Chamber Washer/Disinfector,
and should be retained in a conveniently accessible area for quick
reference.
Advisory IMPORTANT: A listing of the Safety Precautions to be observed
when using and servicing this equipment can be found in SECTION 1
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
da Vinci Rack be used in the Reliance Vision Single-Chamber
Washer/Disinfector for the terminal disinfection or sterilization of any
EndoWrist® instruments. The da Vinci Rack is intended only to clean
and disinfect reusable EndoWrist instruments in the washer/
disinfector.
When EndoWrist 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® Reprocessing Instructions
as well as in any instrument specific instructions and supplements
that may come with individual instruments.
STERIS does not recommend processing flexible endoscopes,
single-use instruments, rigid telescopes (optical lens), fiber-optic
cables, multi-part instruments that cannot be disassembled, heat-
sensitive devices and coagulating electrodes using the da Vinci
Rack in the washer/disinfector. Processing these types of
instruments may result in instrument or equipment damage as well
as improperly cleaned items. All EndoWrist instruments processed
using the da Vinci Rack in the washer/disinfector must withstand
temperatures of up to 240°F (116°C).
The da Vinci Rack is specifically designed to only hold EndoWrist
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.
©2019, STERIS Corporation. All rights reserved. Printed in Canada.
A WORD FROM STERIS
ii
10160662 Operator Manual Introduction
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.
Indications For Use The da Vinci Rack is designed to be used in the Reliance Vision
Single-Chamber Washer/Disinfector for the efficient cleaning,
rinsing, drying and intermediate level disinfection of EndoWrist
instruments.
IMPORTANT: EndoWrist instruments must be manually pre-cleaned
before processing in the da Vinci Rack. Refer to the latest Intuitive
Surgical Reprocessing Instructions as well as to any instrument
specific instructions and supplements that may come with individual
instruments for details on manual pre-cleaning.
IMPORTANT: The da Vinci Rack is designed to be used only with the
Robotic cycle.
Trademarks Please take note of the following registered trademarks of Intuitive
Surgical, Inc. that apply to the wording used throughout the manual:
•EndoWrist
®
da Vinci S®
da Vinci Si®
da Vinci Xi®
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 Reliance Vision Single-Chamber Washer/Disinfector,
compatible with the da Vinci Rack, meet the applicable requirements
of certain standards. Refer to washer/disinfector Operator Manual
(P920508-556) for the current list of standards.
iii
Introduction Operator Manual 10160662
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
European Community Representative:
STERIS Ireland Limited
IDA Business and Technology Park
Tullamore
County Offaly
R35 X865
Ireland
Sales and Service -- Europe, Middle-East and Africa:
STERIS
116 Avenue de Magudas, 33185
Le Haillan
FRANCE
Support Service, by email:
Support_EMEA_IPT_SE@steris.com
All other requests, by phone: +33 5 56 93 94 94
Sales and Service -- Americas, Oceania and Asia:
STERIS Corporation
5960 Heisley Road
Mentor, Ohio 44060
440-354-2600 • 800-548-4873
Website:
www.steris.com
iv
10160662 Operator Manual Introduction
Healthcare
Capital Equipment
v
Table of Contents Operator Manual 10160662
A WORD FROM STERIS............................................................................................i
Advisory............................................................................................................................................................ i
Indications For Use...........................................................................................................................................ii
Trademarks.......................................................................................................................................................ii
Service Information...........................................................................................................................................ii
Certification.......................................................................................................................................................ii
1 SAFETY PRECAUTIONS ......................................................................................1-1
2 LOADING INSTRUCTIONS ...................................................................................2-1
2.1 Da Vinci Rack – Main Components .................................................................................................... 2-1
2.2 EndoWrist Instruments........................................................................................................................ 2-2
2.3 Before Processing Instruments........................................................................................................... 2-3
2.4 Preparing Instruments ........................................................................................................................ 2-3
2.5 Loading da Vinci Rack........................................................................................................................ 2-4
2.5.1 Mesh trays .............................................................................................................................. 2-4
2.5.2 EndoWrist Instruments — General ........................................................................................ 2-5
2.5.3 EndoWrist Instruments — Model da Vinci S/Si ..................................................................... 2-6
2.5.4 EndoWrist Instruments — Model da Vinci Xi ...................................................................... 2-20
3 OPERATING INSTRUCTIONS ..............................................................................3-1
3.1 Robotic Cycle Operation .................................................................................................................... 3-1
3.2 Cycle Description Chart...................................................................................................................... 3-2
4 UNLOADING INSTRUCTIONS ..............................................................................4-1
5 ROUTINE MAINTENANCE AND REPLACEMENT PARTS .....................................5-1
5.1 Preventive Maintenance ..................................................................................................................... 5-1
5.2 Routine Maintenance .......................................................................................................................... 5-2
5.2.1 Inspecting and Cleaning Rotary Spray Arm Assembly.......................................................... 5-3
5.2.2 Cleaning Rack Filter ............................................................................................................... 5-6
5.2.3 Replacing Flexible Hoses on Rack Instrument Holder........................................................... 5-7
5.2.4 Replacing Holding Cords on Rack Instrument Holder......................................................... 5-11
5.3 Replacement Parts ........................................................................................................................... 5-14
TABLE OF CONTENTS
Section
Number Description Page
vi
10160662 Operator Manual Table of Contents
TABLE OF CONTENTS (Cont’d)
Section
Number Description Page
Healthcare
Capital Equipment
vii
List of Illustrations Operator Manual 10160662
Section 2: Loading Instructions
Figure 2-1. da Vinci Rack – Components ................................................................................................ 2-1
Figure 2-2. Examples of EndoWrist Instruments ...................................................................................... 2-2
Figure 2-3. Mesh Trays ............................................................................................................................ 2-4
Figure 2-4. Connector .............................................................................................................................. 2-6
Figure 2-5. Removing Connector............................................................................................................. 2-6
Figure 2-6. Reconnecting Hose on Connector ........................................................................................ 2-7
Figure 2-7. Reinstalling Connector .......................................................................................................... 2-7
Figure 2-8. Instrument Shaft Into Hole ..................................................................................................... 2-7
Figure 2-9. Guidance Slider Into Holder Channel.................................................................................... 2-8
Figure 2-10. Connecting Instrument .......................................................................................................... 2-8
Figure 2-11. Securing Connection ............................................................................................................. 2-9
Figure 2-12. Installing Holding Cord.......................................................................................................... 2-9
Figure 2-13. Numbered Positions on Instrument Holder ......................................................................... 2-10
Figure 2-14. Connector ............................................................................................................................ 2-10
Figure 2-15. Removing Connector........................................................................................................... 2-11
Figure 2-16. Reconnecting Hose on Connector ......................................................................................2-11
Figure 2-17. Reinstalling Connector ........................................................................................................ 2-12
Figure 2-18. Instrument Shaft Into Hole ................................................................................................... 2-12
Figure 2-19. Guidance Slider Into Holder Channel.................................................................................. 2-13
Figure 2-20. Connecting Instrument ........................................................................................................ 2-14
Figure 2-21. Securing Connection ........................................................................................................... 2-15
Figure 2-22. Installing Hose and Clip ...................................................................................................... 2-15
Figure 2-23. Installing Holding Cord........................................................................................................ 2-16
Figure 2-24. Numbered Positions of Instrument Holder .......................................................................... 2-16
Figure 2-25. Instrument Shaft Into Hole ................................................................................................... 2-17
Figure 2-26. Connecting Instrument ........................................................................................................ 2-18
Figure 2-27. Securing Connection ........................................................................................................... 2-19
Figure 2-28. Installing Hose and Clip ...................................................................................................... 2-19
Figure 2-29. Installing Holding Cord........................................................................................................ 2-20
Figure 2-30. Connector ............................................................................................................................ 2-20
Figure 2-31. Instrument Shaft Into Hole ................................................................................................... 2-21
Figure 2-32. Connecting Instrument ........................................................................................................ 2-22
Figure 2-33. Installing Holding Cord........................................................................................................ 2-23
LIST OF ILLUSTRATIONS
Figure Description Page
(Continued...)
viii
10160662 Operator Manual List of Illustrations
Section 2: Loading Instructions (Cont’d)
Figure 2-34. Numbered Positions of Instrument Holder .......................................................................... 2-23
Figure 2-35. Connector ............................................................................................................................ 2-24
Figure 2-36. Connector Port Position ....................................................................................................... 2-24
Figure 2-37. Instrument Shaft Into Hole ................................................................................................... 2-25
Figure 2-38. Connecting Instrument ........................................................................................................ 2-26
Figure 2-39. Installing Holding Cord........................................................................................................ 2-27
Section 3: Operating Instructions
Figure 3-1. Robotic Cycle Selection ........................................................................................................ 3-1
Section 5: Routine Maintenance and Replacement Parts
Figure 5-1. Removing Pin......................................................................................................................... 5-3
Figure 5-2. Removing Rotary Spray Arm Assembly ................................................................................ 5-3
Figure 5-3. Removing End Spray Jets ..................................................................................................... 5-4
Figure 5-4. Cleaning Spray Jets .............................................................................................................. 5-4
Figure 5-5. Rinsing Assembly .................................................................................................................. 5-4
Figure 5-6. Removing Rack Filter............................................................................................................. 5-6
Figure 5-7. Cleaning Rack Filter .............................................................................................................. 5-6
Figure 5-8. Removing Port Connectors.................................................................................................... 5-7
Figure 5-9. Removing Hoses ................................................................................................................... 5-7
Figure 5-10. Installing Hoses and Port Connectors ................................................................................... 5-8
Figure 5-11. Removing Hose From Top Connection ................................................................................. 5-9
Figure 5-12. Removing Hoses ................................................................................................................... 5-9
Figure 5-13. Installing Hoses ................................................................................................................... 5-10
Figure 5-14. Removing Holding Cords O-rings ....................................................................................... 5-11
Figure 5-15. Removing Holding Cords .................................................................................................... 5-12
Figure 5-16. Installing Holding Cords and O-Rings................................................................................. 5-13
Figure Description Page
LIST OF ILLUSTRATIONS (Cont’d)
1-1
Safety Precautions Operator Manual 10160662
1
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
da Vinci® Rack within the Reliance® Vision® Single-Chamber 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.
WARNING – CUTTING HAZARD:
WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:
WARNING – BURN HAZARD:
WARNING – INEFFECTIVE PROCESS HAZARD:
Always wear appropriate Personal Protective Equipment (PPE) when loading and unloading da Vinci
Rack. EndoWrist instruments tips protruding upward from rack can be extremely sharp and can cause
injuries such as cuts.
Always load or unload da Vinci Rack on appropriate loading cart or surface.
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.
da Vinci 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.
When cycle is completed, wait until water flow stops before opening door and unloading washer/
disinfector. Hot water or steam may be sprayed through door opening if door is opened too soon. Wear
appropriate Personal Protective Equipment (PPE) whenever reaching into chamber.
EndoWrist instruments must be manually pre-cleaned before processing in the da Vinci Rack to ensure
proper cleaning and disinfection.
SAFETY PRECAUTIONS
1-2
10160662 Operator Manual Safety Precautions
WARNING – INEFFECTIVE PROCESS HAZARD (Cont’d):
WARNING – SLIPPING HAZARD:
CAUTION – POSSIBLE EQUIPMENT DAMAGE:
If the EndoWrist instrument is not properly connected at the end of Robotic cycle, instrument has to be
reprocessed to ensure proper cleaning and disinfection.
Only Robotic cycle must be used along with the da Vinci Rack to ensure proper cleaning and
disinfection of EndoWrist instruments.
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 avoid equipment damage and maximize processing efficiency, always load soiled items as instructed
in this da Vinci Rack Operator Manual.
To prevent voiding the warranty or damaging the equipment, use only authorized STERIS replacement
parts.
Use nonabrasive cleaners when cleaning da Vinci 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
2-1
Loading Instructions Operator Manual 10160662
2.1 Da Vinci Rack –
Main Components
See Figure 2-1.
Before using the da Vinci® Rack, it is important to become familiar
with the rack components.
IMPORTANT: A listing of the Safety Precautions to be observed when using and servicing this equipment
can be found in SECTION 1 of this manual. Do not use the equipment until you have become familiar with
this information.
Rotary Spray
Arm Assembly
Flexible Hoses For Port
Connections (X 12)
Instrument Shaft Holder
Instrument Holder
Port Connectors (X 14)
[12 Located on Rack
and 2 Additional Ones]
Provided Mesh Trays (X 2)
Holding Cords (X 12) Figure 2-1. da Vinci Rack – Components
LOADING INSTRUCTIONS
2-2
10160662 Operator Manual Loading Instructions
2.2 EndoWrist
Instruments
See Figure 2-2.
The da Vinci Rack can process the following EndoWrist
instruments:
Figure 2-2. Examples of EndoWrist Instruments
Models da Vinci S/Si
Example of a 5 mm Instrument
Flushing
Ports
Example of a Single-Site Instrument
Flushing Port Flushing Port
on Shaft
Example of a 8 mm Instrument
Flushing
Ports
Model da Vinci Xi
Example of a 8 mm Instrument
Flushing
Ports
Example of a 12 mm Stapler
Flushing
Ports
Flushing
Port
Example of a 12 mm Stapler
Flushing Port
on Shaft
2-3
Loading Instructions Operator Manual 10160662
2.3 Before Processing
Instruments
Before processing EndoWrist instruments using the da Vinci Rack
within the Reliance® Vision® Single-Chamber Washer/Disinfector,
complete the following checklist to help ensure correct equipment
operation:
All packaging material has been properly removed from da Vinci
Rack;
Two additional port connectors were safely put aside;
da Vinci Rack filter assembly is in place;
Manually rotate da Vinci Rack spray arm assembly to ensure
movement is not obstructed;
If required, washer/disinfector software update has been
performed using USB key;
Verify type of chemicals used (Prolystica® Ultra Concentrate
Chemicals or other chemicals) with washer/disinfector in
Hardware menu of Service mode; processing EndoWrist
instruments with da Vinci Rack requires the use of Prolystica
Ultra Concentrate Chemicals;
If type of chemical is set to Other: additional chemical
pumps might be necessary to allow the use of Prolystica
Ultra Concentrate Chemicals to process loads (refer to
Table 3-1, Cycle description Chart, for more information
about chemicals and pumps usage). If additional pumps are
required, call STERIS;
If type of chemical is set to Other: Only Prolystica® Ultra
Concentrate Alkaline Detergent can be used with chemical
injection pump 3 (refer to Table 3-1, Cycle description
Chart).
2.4 Preparing
Instruments
To prepare EndoWrist instruments for processing, proceed as
follows:
1. Manually pre-clean outside of instruments as well as flushing
ports of instruments to be processed in da Vinci Rack. Refer to
the latest Intuitive Surgical Reprocessing Instructions as well as
to any instrument specific instructions and supplements that
may come with individual instruments for details on manual pre-
cleaning.
2. Sort instruments by types.
IMPORTANT: Refer to the latest Intuitive Surgical Reprocessing
Instructions for detailed descriptions of the procedures for
reprocessing instruments and accessories designed for use with
Intuitive Surgical’s da Vinci Surgical Systems.
When reprocessing Intuitive Surgical instruments, it is important that
the healthcare facility follow all directions in the latest Intuitive
Surgical Reprocessing Instructions as well as in any instrument
specific instructions and supplements that may come with individual
instruments.
2-4
10160662 Operator Manual Loading Instructions
2.5 Loading da Vinci
Rack
The da Vinci Rack is designed to process up to twelve EndoWrist
instruments:
Stapler Instruments (see Figure 2-2):
Positions 5 and 6 on Instrument Holder.
4 instruments maximum per load.
Single-Site Instruments (see Figure 2-2):
Positions 1 to 4 on Instrument Holder.
8 instruments maximum per load.
Other Instruments (see Figure 2-2):
Positions 1 to 6 on Instrument Holder.
12 instruments maximum per load.
Some da Vinci System accessories can also be processed within
two mesh trays provided with the rack. Refer to the latest Intuitive
Surgical Reprocessing Instructions for more information about the
accessories that can be processed within the washer/disinfector
using da Vinci Rack.
2.5.1 Mesh trays See Figure 2-3.
To load mesh trays, proceed as follows:
1. Pull out two small mesh trays from da Vinci Rack.
2. Place accessories to be processed in mesh trays.
3. Reinstall mesh trays back in position in rack.
Figure 2-3. Mesh Trays
2-5
Loading Instructions Operator Manual 10160662
2.5.2 EndoWrist
Instruments — General
To load EndoWrist instruments in da Vinci Rack, proceed as follows:
1. Ensure da Vinci Rack is located on appropriate loading cart or
surface.
2. Bring EndoWrist instruments to be processed next to rack.
3. Ensure all instruments are sorted by types.
4. Proceed to appropriate SECTION for EndoWrist instruments
connection:
SECTION 2.5.3, ENDOWRIST INSTRUMENTS — MODEL DA VINCI S/SI
SECTION 2.5.4, ENDOWRIST INSTRUMENTS — MODEL DA VINCI XI
2-6
10160662 Operator Manual Loading Instructions
2.5.3 EndoWrist
Instruments — Model
da Vinci S/Si
See Figures 2-4 to 2-29.
1. Verify how many flushing ports are located on each instrument
housing (1 or 2) (see Figure 2-2).
2. Verify if any instrument is equipped with a flushing port on
instrument shaft (see Figure 2-2).
•Ports on Instrument Housing 3. If instrument has one port on instrument housing and one port
on instrument shaft, proceed to Ports on Instrument Housing
and Instrument Shaft ON PAGE 2-10.
If instrument has two ports on instrument housing, proceed as
follows:
a. Locate port connectors on instrument holder. Each
connector is installed on rack as shown in Figure 2-4.
b. Disconnect hose from connector and carefully pull on port
connector to remove it from instrument holder.
Example of a 5 mm Instrument
Flushing
Ports
Figure 2-4. Connector
Figure 2-5. Removing Connector
NOTE: Drawing
Simplified For Clarity.
2-7
Loading Instructions Operator Manual 10160662
c. Reconnect hose on connector as shown in Figure 2-6.
IMPORTANT: Reinstall hose only when connector ends are
completely dry to avoid disconnection while processing
instruments.
d. Reinstall port connector in place, as show in Figure 2-7, by
carefully sliding connector into place.
e. Repeat Steps a to d until having all required port connectors
ready.
f. Retrieve instruments with two ports on instrument housing.
g. Insert shaft of instrument into hole identified with an arrow, in
shaft holder, to ensure proper alignment and processing.
Figure 2-6. Reconnecting Hose on Connector
Reconnect Hose Insert While
Firmly
Pushing...
... and
Slightly
Turn
Connector End
Figure 2-7. Reinstalling Connector
Figure 2-8. Instrument Shaft Into Hole
Arrow
2-8
10160662 Operator Manual Loading Instructions
IMPORTANT: Ensure to open each instrument tip before
processing load in washer/disinfector.
h. Locate instrument guidance slider and instrument holder
channel.
i. While lowering instrument toward port connector, ensure to
slide instrument guidance slider in instrument holder channel.
j. Once instrument is on top of port connector, ensure both
connector ends enter instrument housing flushing ports.
k. Install all remaining instruments.
Guidance
Slider
Figure 2-9. Guidance Slider Into Holder Channel
Port
Connector
Holder
Channel
NOTE: Drawings
Simplified For Clarity.
Connector Ends
Flushing Ports
Figure 2-10. Connecting Instrument
NOTE: Drawing
Simplified For Clarity.
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Steris Reliance Vision Single-Chamber Washer/Disinfector Operating instructions

Type
Operating instructions

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