Steris Reliance Vision Single-Chamber Washer/Disinfector 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.

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.

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).

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.

WARNING – PERSONAL INJURY

AND/OR EQUIPMENT DAMAGE

HAZARD: Always load or

unload da Vinci Rack on

appropriate loading cart or

surface.

CAUTION – POSSIBLE EQUIPMENT

DAMAGE: To avoid equipment

damage and maximize

processing efficiency, always

load soiled items as

instructed in this da Vinci

Rack Operator Manual.

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

WARNING – PERSONAL INJURY

AND/OR EQUIPMENT DAMAGE

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.

WARNING – INEFFECTIVE

PROCESS HAZARD: EndoWrist

instruments must be manually

pre-cleaned before processing

in the da Vinci Rack to ensure

proper cleaning and

disinfection.

CAUTION – POSSIBLE EQUIPMENT

DAMAGE: To avoid equipment

damage and maximize

processing efficiency, always

load soiled items as

instructed in this da Vinci

Rack Operator Manual.

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

Steris Reliance Vision Single-Chamber Washer/Disinfector Operating instructions

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