da Vinci SP

INSTRUMENTS
Reprocessing
Instructions
EndoWrist SP®

Cleaning, Disinfection, and Sterilization

Information for Reusable Instruments
that are used with da Vinci SP Systems

The reprocessing instructions and parameters given represent

the manufacturer’s recommendations according to
BS EN ISO 17664:2017 and ANSI/AAMI ST81:2004/(R) 2016.
These Reprocessing Instructions are intended to be used
together with the Reprocessing Instructions Appendices
(PN 553486), which is provided in a separate document.

PN 553905-01
553927-01 Rev. D
 Copyright
© 2018 Intuitive Surgical, Inc. All rights reserved.

Trademarks
Intuitive Surgical, da Vinci SP, EndoWrist SP, EnergyShield, and EntryGuide are trademarks or
registered trademarks of Intuitive Surgical, Inc. Product names are trademarks or registered
trademarks of their respective holders.

Rx Only

2 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

Table of
Contents
INTRODUCTION 5
Symbols: Warnings, Cautions, and Notes 5
General Warnings, Cautions, and Notes 6
Glossary 8

DA VINCI SP INSTRUMENTS 9
Instrument Overview 11
Instrument Flush Ports 11
Process Overview 12

Operating Room (OR)....................................................13

Check Expiration 15
Remove Accessories 16
Wipe 23
Prime and Wet 24
Transport 25

Decon.............................................................................27
Remove Accessories 29
Prepare Solution 36
Prime 37
Soak 37
Flush 38
Instrument Spray Areas 40
Spray 41
Brush 43
Rinse 44
Ultrasonic Cleaning 45
Flush 47
Final Rinse 49
Final Decon Inspect 49
Thermal Disinfection 50
Transfer 51

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 3

Table of Contents (continued)

Prep and Pack................................................................53

Dry 55
Final Inspection 56
Instrument Lubrication Areas 58
Lubricate 59
Sterilization Warnings, Cautions, and Notes 61
Pack 62
Sterilization Process Parameters 63
Wrap or Prep 64
Sterilize 65
Store 65

SYMBOL GLOSSARY 66

4 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 INTRODUCTION

Introduction
These Instructions for Use contain the cleaning, disinfection, and sterilization instructions
and parameters recommended by Intuitive Surgical. These instructions apply to the
da Vinci SP® Instruments only. These instructions contain essential information for
reprocessing instruments. Read these instructions in their entirety before reprocessing the
instruments. Instruments are not supplied sterile and must be reprocessed prior to first use.
If there are any questions or comments about any information in these instructions, or if a
problem occurs while reprocessing that cannot be resolved, contact Intuitive Surgical.

Symbols: Warnings, Cautions, and Notes

The most frequently used symbols in these instructions are provided below.
See Symbol Glossary for a complete list of symbols.

WARNING
Alerts the reader about a situation which, if not
avoided, could result in death or serious injury.

CAUTION
Alerts the reader about a potentially hazardous
situation which, if not avoided, may result in
minor or moderate injury to the user or patient
or damage to the equipment or other property.
It may also be used to alert against unsafe
practices. This includes the special care necessary
for the safe and effective use of the device and
the care necessary to avoid damage to a device
that may occur as a result of use or misuse.

NOTE
Highlights important information.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 5

INTRODUCTION

General Warnings, Cautions, and Notes

WARNING
• Devices are to be handled, reprocessed, and operated by trained personnel only.
Inadequate training may result in device damage or patient/operator harm.
• Remove all accessories before cleaning. Failure to remove accessories prior to
reprocessing may result in inadequate cleaning and sterilization, or parts in patient.
• Do not reuse or reprocess single-use devices after being removed from package, even if
unused, as this may result in incomplete sterilization and/or device damage.
• Use only the validated sterilization machines, parameters and cycles, and follow
instructions in entirety. Any other cycles and parameters have not been validated and
may damage the device, or may result in incomplete sterilization.
• Exercise care while handling devices with sharp points or cutting edges. Failure to follow
Universal Precautions could result in injury.
• Use care in handling chemicals and contaminated solutions, as skin contact, inhalation, or
ingestion may cause injury.
• Prior to use, after use or reprocessing, always inspect devices for any defects or damage.
Failure to inspect may result in patient harm and/or additional device damage.

CAUTION
• Do not use chemical disinfection for devices. Chemical disinfection may result in device
damage.
• Handle devices with care to avoid mechanical shock or stress, which may result in device
damage.
• Universal Precautions should be observed by all hospital personnel that work with
contaminated or potentially contaminated devices. Personal Protective Equipment
(PPE) should be worn when handling or working with contaminated or potentially
contaminated devices. PPE includes: gloves, gown, mask, goggles or face shield and
shoe covers.
• Immediate-use steam sterilization (IUSS) or flash sterilization is not validated. Hospitals
should follow their policies regarding the use of IUSS or flash sterilization.

6 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 INTRODUCTION

General Warnings, Cautions, and Notes (continued)

NOTE
• Reusable devices are not supplied sterile and must be cleaned and sterilized before use.
• Do not use equipment (for example, steam cleaning devices) or procedures that employ
pre-cleaning temperatures > 140 °F (60 °C). High temperatures may fix residual soil to
the surface, and make cleaning more difficult.
• Use only process chemicals that conform to legal and regulatory requirements for safety
as required by the jurisdiction in question.
• When disposing of Intuitive Surgical instruments, accessories, or components, follow
institution biohazard protocol and all applicable national and local laws and guidelines.
• Follow AAMI/ISO 17665-1:2006/(R)2013 or BS EN ISO 17665-1:2006 and the
specifications of the sterilization device manufacturer.
• Refer to the sterilization system manufacturer’s instructions for proper use of the system
and recommendations for sterilization.
• Use the Intuitive Surgical-provided Luer fitting or equivalent as defined by ISO 80369-
7:2016 attached to a pressurized cold water line.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 7

INTRODUCTION

Glossary
Accessories: Components that are used in conjunction with instruments or other
devices.
Cold Water: Unless otherwise specified, the term "cold water" refers to tap water that
is 50-77 °F (10-25 °C) and potable or better as defined by AAMI TIR34.
Critical Water: Examples of critical water include deionized (DI) water, reverse
osmosis (RO), and distilled water. Critical water is a type of water defined by AAMI
TIR34:2014. Critical water is extensively treated (usually by a multi-step treatment
process that could include a carbon bed, softening, DI, and RO or distillation) to
ensure that microorganisms and the inorganic and organic material are removed from
the water.
Decon: An area in hospitals and other healthcare facilities where medical devices are
cleaned and disinfected. Decon is sometimes referred to as the "dirty side."
Entry Guide: Alternate name for EntryGuideTM Cannula Insert.
Final Rinse Step: The final rinsing step of a cleaning process.
Immediate-Use Steam Sterilization (IUSS): Process designed for the cleaning, steam
sterilization, and delivery of patient care items for immediate use. Previously known as
flash sterilization.
Prep and Pack: An area in hospitals and other healthcare facilities where medical
devices that have already been cleaned in "Decon" are inspected, packaged, and
sterilized. Prep and pack is sometimes referred to as the "clean side."
Soil: Also called "residual soil." Body fluids or tissue that may remain on the device
after reprocessing.
Sterile Processing Department (SPD): Also called Central Sterile Supply Department
(CSSD) is a department in hospitals and other healthcare facilities that performs
cleaning, sterilization and other actions on medical devices and equipment.
Ultrasonic Bath with Flushing: A mechanical cleaning system that performs both
ultrasonication, flushing, and rinsing of lumened devices.

8 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 SP INSTRUMENTS
da Vinci SP
INSTRUMENTS
Cleaning, Disinfection, and Sterilization
Information for Reusable Instruments
that are used with da Vinci SP Systems

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 9

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10 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 INSTRUMENTS

Instrument Overview

Disc Face

Upper Arm Elbow Forearm Wrist Reusable or

Single-Use Tip

Release Button

Grip Release Dial

Housing Sheath Connector Snap Lock Shaft

Please note that the Instrument shaft is rarely perfectly straight, and is able to bend in many ways.

Instrument Flush Ports

EndoWrist SP® Instruments have a primary and secondary flush port.

1 2
1 2
Primary flush port
Secondary flush port

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 11

INSTRUMENTS

Process Overview
Reprocessing the instrument requires cleaning, thermal disinfection (optional), and
sterilization. The 'Prime and Wet' step for the instrument should begin immediately after
the procedure to prevent drying. If 'Prime and Wet' step in the operating room (OR) is
not possible within 60 minutes, start the 'Prime' step and 'Soak' step in decon within 60
minutes. See the diagram below for an overview of the reprocessing steps that take place
in the OR, decon, and prep and pack.

OR (pg. 13)

Decon (pg. 27)

OR Prep
Prep and Pack (pg. 53)
Step 1 Check Expiration Decon Prep
Step 2 Remove Accessories
Step 1 Remove Accessories Sterilization Prep
Step 3 Wipe
Step 2 Prepare Solution
Step 1 Dry
Step 4 Prime and Wet
Conduct Cleaning Step 2 Final Inspection
Step 5 Transport
Step 3 Prime Step 3 Lubricate

Step 4 Soak Pack and Sterilize

Step 5 Flush
Step 4 Pack
Step 6 Spray
Step 5 Wrap or Prep
Step 7 Brush
Step 6 Sterilize
Step 8 Rinse
Store
Step 9 Ultrasonic Cleaning
Step 7 Store
Step 10 Flush

Step 11 Final Rinse

Step 12 Final Decon Inspect

Step 13 Thermal Disinfection (optional)

Step 14 Transfer

12 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 INSTRUMENTS: OR

Operating Room
(OR)
The following pages contain step by step instructions for the
process outlined below.

INSTRUMENTS
OR-
OR

OR Prep

Step 1 Check Expiration

Step 2 Remove Accessories

Step 3 Wipe

Step 4 Prime and Wet

Step 5 Transport

Supplies needed in OR
See the following pages for step by step instructions using the following materials:

• Large container to fit instrument (27 inches or 70 cm minimum length)

• Instrument tray or container
• Fluid to keep tip moist (one of the following):
−−pH-neutral preparation cleaner (preferred)
−−pH-neutral spray
−−water
−−moistened cloth
• Syringe with Luer tip (20 mL minimum)
• Fluid for priming:
−−pH-neutral preparation cleaner (preferred)
−−water

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 13

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14 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: OR CHECK EXPIRATION

STEP 1

Check Expiration
A CHECK EXPIRATION
Install instrument on system.
Check number of uses remaining.
If any issues are found, contact Intuitive Surgical
Customer Service.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 15

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2

Remove Accessories
WARNING
• Remove all accessories (for example, Monopolar Curved Scissors Tips, also known as
MCS Tips) before cleaning. Failure to remove accessories prior to reprocessing may result
in inadequate cleaning and sterilization, or parts in patient.
• Do not reuse or reprocess single-use devices after being removed from package, even if
unused as this may result in incomplete sterilization and/or device damage.

CAUTION
Immediate-use steam sterilization (IUSS) or flash sterilization is not validated. Hospitals
should follow their policies regarding the use of IUSS or flash sterilization.

NOTE
• Sheaths are single-use and should not be left on the devices during reprocessing.
• If metal shaft of instrument is visible, sheath has already been removed. Proceed to the
'Wipe' step.
• Carefully remove all accessories, including reusable and single-use attachments, before
reprocessing. See accessories table for examples of common accessories.

16 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2 (continued)

Remove Accessories
BEFORE YOU START
Reprocessing steps may differ for devices. Identify the device before reprocessing by the housing
label, or by the device tips, below.

MONOPOLAR CURVED MONOPOLAR CAUTERY ALL OTHER INSTRUMENTS

SCISSORS (MCS) (HOOK OR SPATULA) (WITH REUSABLE TIPS)
Tip Tips Tips (example)

GO TO PAGE 18 GO TO PAGE 20 GO TO PAGE 22

SINGLE-USE ACCESSORIES REUSABLE ACCESSORIES

Sheaths (Instrument and Camera) Cannula

Instrument Tips (MCS Tip, hook and spatula tip) Obturator
Seal (Cannula) EnergyShield® Monopolar Cautery Cord
Entry Guide Bipolar Cautery Cord

NOTE
See instrument and accessory manuals for information on accessory removal.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 17

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2: MONOPOLAR CURVED SCISSORS

Remove Accessories
WARNING
When removing single-use tips (Hook, Spatula, or Monopolar Curved Scissors Tip, also
known as MCS Tip), do not place fingers on the metal tip (blades/tip). Always place fingers
on the base of the tip to remove. Using the metal tip to remove may result in user injury and/
or damage to the device. Device damage could result in electric burn, shock, or parts falling
in the patient during subsequent instrument use.

A CLOSE BLADES
If blades are open, turn the Grip Release Dial
counterclockwise to close.

B PLACE GUARD AND UNLOCK TIP

Firmly grasp the base of the tip with one hand and
with the other hand slide the silicone blade guard, if
available, over closed blades.
Grasp the base of the tip and gently rotate
counterclockwise a 1/4 turn using the black line as a
guide.
Do not remove tip yet.

C RELEASE AND REMOVE TIP

Rotate the Grip Release Dial clockwise until tension
is felt in the dial and the tip is visibly extended from
shaft.

Remove tip.

18 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2: MONOPOLAR CURVED SCISSORS

Remove Accessories
D UNLOCK SHEATH
Firmly squeeze sheath connector tabs at base of shaft
to unlock and slide about 1 inch until shaft is visible.

E REMOVE SHEATH
Grasp sheath near tip and use thumb to advance
sheath off shaft until removed.
A dry cloth may be used to assist with gripping the
sheath.
Note: By design, the sheath fits tightly on the shaft.

PROCEED TO 'WIPE' (STEP 3)

ON PAGE 23

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 19

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2: MONOPOLAR CAUTERY (HOOK OR SPATULA)

Remove Accessories
WARNING
When removing single-use tips (Hook, Spatula, or Monopolar Curved Scissors Tip, also
known as MCS Tip), do not place fingers on the metal tip (blades/tip). Always place fingers
on the base of the tip to remove. Using the metal tip to remove may result in user injury and/
or damage to the device. Device damage could result in electric burn, shock, or parts falling
in the patient during subsequent instrument use.

A PLACE GUARD ON TIP

Firmly grasp the base of the tip with one hand
and with the other hand slide the silicone guard, if
available, over tip.

B UNSCREW AND REMOVE TIP

Place fingers on base of tip and unscrew
counterclockwise to release. The metal hook and
spatula do not turn with the base.

Remove tip.

20 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2: MONOPOLAR CAUTERY (HOOK OR SPATULA)

Remove Accessories
C UNLOCK SHEATH
Firmly squeeze sheath connector tabs at base of shaft
to unlock and slide about 1 inch until shaft is visible.

D REMOVE SHEATH
Grasp sheath near tip and use thumb to advance
sheath off shaft until removed.
A dry cloth may be used to assist with gripping the
sheath.
Note: By design, the sheath fits tightly on the shaft.

PROCEED TO 'WIPE' (STEP 3)

ON PAGE 23

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 21

INSTRUMENTS: OR REMOVE ACCESSORIES

STEP 2: ALL OTHER INSTRUMENTS (WITH REUSABLE TIPS)

Remove Accessories
A UNLOCK SHEATH
Firmly squeeze sheath connector tabs at base of shaft
to unlock and slide about 1 inch until shaft is visible.

B REMOVE SHEATH
Grasp sheath near tip and use thumb to advance
sheath off shaft until removed.
A dry cloth may be used to assist with gripping the
sheath.
Note: By design, the sheath fits tightly on the shaft.

PROCEED TO 'WIPE' (STEP 3)

ON PAGE 23

22 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: OR WIPE

STEP 3

Wipe
A WIPE
Wipe off excess soil.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 23

INSTRUMENTS: OR PRIME AND WET

STEP 4

Prime and Wet

WARNING
Use only pH-neutral solutions when preparing devices in the operating room (OR) after a
procedure, as the splash of non-pH neutral solutions may cause skin irritation or burns.

NOTE
Follow the manufacturers' instructions for the preparation and use of cleaning solutions,
including temperature and concentration.

BEFORE YOU START

Begin to prime and wet the instrument immediately after the procedure to prevent soil from drying
on the instrument: either place the instrument in a bin of pH-neutral preparation cleaner (preferred)
or cold water, spray with pH-neutral cleaner, or use other method to keep the tip moist.
If 'Prime and Wet' step in the OR is not possible within 60 minutes, start the prime and soak in decon
within 60 minutes.

A PRIME PORT 1
Insert the Luer tip fully into the primary flush port and
15 mL twist to secure.
Inject at least 15 mL of pH-neutral enzymatic cleaner
or cold water into the port.

B WET TIP
Place the instrument in a bin with solution, or spray
to wet all surfaces, and/or wrap a moistened cloth to
keep the tip moist.
Do not soak in saline.

24 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: OR TRANSPORT

STEP 5

Transport safely
to decon

A TRANSPORT
Transport the instrument to decon.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 25

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26 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 INSTRUMENTS: DECON

Decon
The following pages contain step by step instructions for the
process outlined below.

Decon

Decon Prep

Step 1 Remove Accessories

Step 2 Prepare Solution

Conduct Cleaning

Step 3 Prime

Step 4 Soak

Step 5 Flush

Step 6 Spray

INSTRUMENTS
DECON -
Step 7 Brush

Step 8 Rinse

Step 9 Ultrasonic Cleaning

Step 10 Flush

Step 11 Final Rinse

Step 12 Final Decon Inspect

Step 13 Thermal Disinfection (optional)

Step 14 Transfer

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 27

INSTRUMENTS: DECON

Supplies needed in Decon

See the following pages for step by step instructions using the following materials:

• Large container or sink to fit instrument (27 inches or 70 cm minimum length)

• pH-neutral to mildly alkaline enzymatic solution (pH 7-11)
• Syringe with Luer tip (20 mL minimum)
• Running cold water
• Gauge monitored pressurized water (30 psi/2 bar)
• Critical water, per AAMI TIR34:2014
• Clean nylon brush
• Flush port adapter (Luer fitting, Intuitive Surgical cleaning kit)
• Magnifying glass (4X)
• Ultrasonic Bath with the following recommended parameters:
−−Ultrasonic Performance: 48 watts/gallon (13 watts/liter) or greater
−−Ultrasonic Frequency: 38 kHz or greater
−−Ultrasonic Bath Size: Large enough to fully submerge devices with at least 1
inch (25 mm) clearance around all ultrasonic bath edges

28 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1

Remove Accessories
WARNING
• Remove all accessories (for example, Monopolar Curved Scissors Tips, also known as
MCS Tips) before cleaning. Failure to remove accessories prior to reprocessing may result
in inadequate cleaning and sterilization, or parts in patient.

NOTE
• Sheaths are single-use and should not be left on the devices during reprocessing.
• Carefully remove all accessories, including reusable and single-use attachments, before
reprocessing. See accessories table for examples of common accessories.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 29

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1 (continued)

Remove Accessories
BEFORE YOU START
Reprocessing steps may differ for devices. Identify the device before reprocessing by the housing
label, or by the device tips, below.

MONOPOLAR CURVED MONOPOLAR CAUTERY ALL OTHER INSTRUMENTS

SCISSORS (HOOK OR SPATULA) (WITH REUSABLE TIPS)
Tip Tips Tips (example)

GO TO PAGE 31 GO TO PAGE 33 GO TO PAGE 35

SINGLE-USE ACCESSORIES REUSABLE ACCESSORIES

Sheaths (Instrument and Camera) Cannula

Instrument Tips (MCS Tip, hook and spatula tip) Obturator
Seal (Cannula) EnergyShield® Monopolar Cautery Cord
Entry Guide Bipolar Cautery Cord

30 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1: MONOPOLAR CURVED SCISSORS

Remove Accessories
WARNING
When removing single-use tips (Hook, Spatula, or Monopolar Curved Scissors Tip, also
known as MCS Tip), do not place fingers on the metal tip (blades/tip). Always place fingers
on the base of the tip to remove. Using the metal tip to remove may result in user injury and/
or damage to the device. Device damage could result in electric burn, shock, or parts falling
in the patient during subsequent instrument use.

A CLOSE BLADES
If blades are open, turn the Grip Release Dial
counterclockwise to close.

B PLACE GUARD AND UNLOCK TIP

Firmly grasp the base of the tip with one hand and
with the other hand slide the silicone blade guard, if
available, over closed blades.
Grasp the base of the tip and gently rotate
counterclockwise a 1/4 turn using the black line as a
guide.
Do not remove tip yet.

C RELEASE AND REMOVE TIP

Rotate the Grip Release Dial clockwise until tension is
felt in the dial and the tip is visibly extended from the
shaft.

Remove tip.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 31

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1: MONOPOLAR CURVED SCISSORS

Remove Accessories
D UNLOCK SHEATH
Firmly squeeze sheath connector tabs at base of shaft
to unlock and slide about 1 inch until shaft is visible.

E REMOVE SHEATH
Grasp sheath near tip and use thumb to advance
sheath off shaft until removed.
A dry cloth may be used to assist with gripping the
sheath.
Note: By design, the sheath fits tightly on the shaft.

PROCEED TO 'PREPARE SOLUTION' (STEP 2)

ON PAGE 36

32 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1: MONOPOLAR CAUTERY (HOOK OR SPATULA)

Remove Accessories
WARNING
When removing single-use tips (Hook, Spatula, or Monopolar Curved Scissors Tip, also
known as MCS Tip), do not place fingers on the metal tip (blades/tip). Always place fingers
on the base of the tip to remove. Using the metal tip to remove may result in user injury and/
or damage to the device. Device damage could result in electric burn, shock, or parts falling
in the patient during subsequent instrument use.

A PLACE GUARD ON TIP

Firmly grasp the base of the tip with one hand
and with the other hand slide the silicone guard, if
available, over tip.

B UNSCREW AND REMOVE TIP

Place fingers on base of tip and unscrew
counterclockwise to release. The metal hook and
spatula do not turn with the base.

Remove tip.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 33

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1: MONOPOLAR CAUTERY (HOOK OR SPATULA)

Remove Accessories
C UNLOCK SHEATH
Firmly squeeze sheath connector tabs at base of shaft
to unlock and slide about 1 inch until shaft is visible.

D REMOVE SHEATH
Grasp sheath near tip and use thumb to advance
sheath off shaft until removed.
A dry cloth may be used to assist with gripping the
sheath.
Note: By design, the sheath fits tightly on the shaft.

PROCEED TO 'PREPARE SOLUTION' (STEP 2)

ON PAGE 36

34 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON REMOVE ACCESSORIES

STEP 1: ALL OTHER INSTRUMENTS (WITH REUSABLE TIPS)

Remove Accessories
A UNLOCK SHEATH
Firmly squeeze sheath connector tabs at base of shaft
to unlock and slide about 1 inch until shaft is visible.

B REMOVE SHEATH
Grasp sheath near tip and use thumb to advance
sheath off shaft until removed.
A dry cloth may be used to assist with gripping the
sheath.
Note: By design, the sheath fits tightly on the shaft.

PROCEED TO 'PREPARE SOLUTION' (STEP 2)

ON PAGE 36

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 35

INSTRUMENTS: DECON PREPARE SOLUTION

STEP 2

Prepare Solution
WARNING
Use care in handling chemicals and contaminated solutions, as skin contact, inhalation, or
ingestion may cause injury.

CAUTION
• Use only the following reprocessing cleaners:
−−In OR, pH-neutral or water only
−−In decon, pH-neutral to mildly alkaline (pH 7-11)
−−For mildly alkaline, use ≤ 1% (v/v) or 1:100 maximum concentration
Do not use cleaners that are:

−−Acidic (pH < 7)

−−Strong alkaline (pH > 11)
−−Bleach-based
−−Hydrogen Peroxide (H2O2)-based cleaning agents
−−Rinse aids
Failure to follow these precautions may result in device damage (for example, laser
marking may fade or device may corrode).
• Do not pull out or damage the Grip Release Dial, or use non-recommended chemicals for
cleaning devices. Damaging the Grip Release Dial may result in device damage and/or
patient injury.

NOTE
Follow the manufacturers' instructions for the preparation and use of cleaning solutions,
including temperature and concentration.

A PREPARE SOLUTION
Prepare fresh pH-neutral to mildly alkaline enzymatic
solution (pH 7-11) in a suitable container, sink, or bin,
pH 7-11 enough to soak entire instrument.

36 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON PRIME AND SOAK

STEP 3

Prime
A PRIME PORT 1
Insert the Luer tip fully into the primary flush port and
15 mL twist to secure.
Inject at least 15 mL of cleaning solution into the port.

STEP 4

Soak
A SOAK
Soak the instrument for 30 minutes.
30 min

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 37

INSTRUMENTS: DECON FLUSH

STEP 5

Flush with pressurized

cold water

WARNING
If water does not run clear, or if water does not flow freely through all flush ports, do not
use the device because the device may be damaged. Contact Intuitive Surgical Customer
Service.

BEFORE YOU START

Confirm sink has a Flush Port Adapter (Luer fitting) with pressure gauge. Confirm that the water is
pressurized to 30 psi (2 bar). Before flushing, point the instrument tip away from you.

A INSERT TIP
Insert Luer tip fully into the primary flush port and
twist to secure.

B FLUSH PORT 1 AND MOVE ELBOW

Begin to flush.
10 sec
While flushing, rotate the elbow through its full range
of motion for at least 10 seconds.
Continue motion and flush until the water runs clear.

38 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON FLUSH

STEP 5 (continued)

Flush with pressurized

cold water

C FLUSH PORT 1 AND MOVE WRIST

Continue flushing.
10 sec
While flushing, rotate the wrist through its full range
of motion for at least 10 seconds.
Continue motion and flush until the water runs clear.

D FLUSH PORT 2
Insert Luer tip fully into the secondary flush port and
20 sec
twist to secure.
Flush for at least 20 seconds until the water runs clear
from housing.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 39

INSTRUMENTS: DECON

Instrument Spray Areas

2 Spray Area 2

Spray Area 1 1

40 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON SPRAY

STEP 6

Spray with pressurized

cold water

NOTE
For best spray results, submerge device and apply pressurized Luer tip directly on device
surfaces while gliding tip over spray areas.

BEFORE YOU START

Confirm that the water is pressurized to 30 psi (2 bar).

A SUBMERGE
Submerge the entire instrument in cold water.
Spraying the instrument should be performed
underwater to prevent splashing of contaminated
water.

B SPRAY AREA 1 (HOLES)

Place the Luer tip directly in contact with the
30 sec
instrument while spraying all surfaces of Spray Area 1.
While spraying, rotate shaft and move joint within
Spray Area 1 through full range of motion.
Spray Area 1 for at least 30 seconds.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 41

INSTRUMENTS: DECON SPRAY

STEP 6 (continued)

Spray with pressurized

cold water

C OPEN GRIPS/TIPS
If tip is present, turn the Grip Release Dial clockwise to
open the tip.

D SPRAY AREA 2 (WRIST AND TIP)

Place the Luer tip directly in contact with the
30 sec
instrument while spraying all surfaces of Spray Area 2.
While spraying, rotate shaft, move joints, and open
and close jaws (if present) within Spray Area 2 through
full range of motion.
Spray Area 2 for at least 30 seconds.

42 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON BRUSH

STEP 7

Brush under running

cold water

WARNING
Do not use brushes, pipe cleaners, or any other objects in the flush ports. Doing so may
result in device damage or incomplete reprocessing.

CAUTION
Use only nylon (soft-bristled) brushes for cleaning. The use of metal brushes or abrasive
materials for cleaning may result in device damage.

A BRUSH SUBMERGED OR UNDER RUNNING WATER

Brush entire device thoroughly with nylon brush for
60 sec at least 60 seconds under running cold water or until
visibly clean.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 43

INSTRUMENTS: DECON RINSE

STEP 8

Rinse under running

cold water

A RINSE
Rinse entire instrument with running cold water for
60 sec at least 60 seconds until all visible soil and cleaning
agents are removed.
Rinse where the shaft connects to the housing.
Rinse the elbow, wrist, and tip.

44 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON ULTRASONIC CLEANING

STEP 9

Ultrasonic Cleaning
CAUTION
Prolonged exposure to either ultrasonic cleaning or cleaning agents may result in device
damage.

NOTE
• Manual preparation of the solution and filling of the bath may not be required if
ultrasonic cleaner is equipped with these functions.

• Follow the manufacturer's instructions for use of the ultrasonic bath.

• Some ultrasonic baths do not fill until the lid is closed. In this case, prime the shaft and
place the instrument in the ultrasonic bath taking care to prevent cleaner from exiting the
shaft.

A PREPARE SOLUTION
Prepare fresh pH-neutral to mildly alkaline enzymatic
solution (pH 7-11).
pH 7-11
Follow cleaning solution manufacturer’s instructions
for use, temperature, and concentration.

B FILL ULTRASONIC BATH

Fill ultrasonic bath with the prepared solution.

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INSTRUMENTS: DECON ULTRASONIC CLEANING

STEP 9 (continued)

Ultrasonic Cleaning
C PRIME PORT 1
Insert the Luer tip fully into the primary flush port and
15 mL twist to secure.
Inject at least 15 mL of cleaning solution into the port.

D PLACE
Place the instrument into the ultrasonic bath.

E ULTRASONICALLY CLEAN
15 min Ultrasonically clean for 15 minutes using the
recommended parameters for the ultrasonic bath.

IF ULTRASONIC BATH HAS AN AUTOMATED

RINSE AND FLUSH CAPABILITY, PROCEED TO
‘FINAL DECON INSPECT’ (STEP 12) ON PAGE 49.
OTHERWISE PROCEED TO ‘FLUSH’ (STEP 10) ON
PAGE 47.

46 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON FLUSH

STEP 10

Flush with pressurized

cold water

WARNING
If water does not run clear, or if water does not flow freely through all flush ports, do not use
the instrument because the device may be damaged. Contact Intuitive Surgical Customer
Service.

BEFORE YOU START

Confirm sink has a Flush Port Adapter (Luer fitting) with pressure gauge and check that the water is
pressurized to 30 psi (2 bar). Before flushing, point the instrument tip away from you.

A INSERT TIP
Insert Luer tip fully into the primary flush port and
twist to secure.

B FLUSH PORT 1 AND MOVE ELBOW

Begin to flush.
10 sec
While flushing, rotate the elbow through its full range
of motion for at least 10 seconds.
Continue motion and flush until the water runs clear.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 47

INSTRUMENTS: DECON FLUSH

STEP 10 (continued)

Flush with pressurized

cold water

C FLUSH PORT 1 AND MOVE WRIST

Continue flushing.
10 sec
While flushing, rotate the wrist through its full range
of motion for at least 10 seconds.
Continue motion and flush until the water runs clear.

D FLUSH PORT 2
Insert Luer tip fully into the secondary flush port and
20 sec
twist to secure.
Flush for at least 20 seconds until the water runs clear
from housing.

48 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON FINAL RINSE AND FINAL DECON INSPECT

STEP 11

Final Rinse
NOTE
The use of critical water is recommended per AAMI TIR34:2014.

A RINSE
Rinse entire instrument for at least 60 seconds until all
60 sec
visible soil and cleaning agents are removed.
Rinse where the shaft connects to the housing.
Rinse the elbow, wrist, and tip.

STEP 12

Final Decon Inspect

A INSPECT FOR SOIL
Inspect entire instrument for soil under magnification.
If soil is present, repeat entire cleaning process.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 49

INSTRUMENTS: DECON THERMAL DISINFECTION

STEP 13 (optional)

Thermal Disinfection
A DISINFECT
Perform disinfection per hospital policy and regional
guidelines. Thermal disinfection is not a substitute for
reprocessing.

PARAMETER VALUE

Temperature 185 °F - 199 °F (85 °C - 93 °C)

Time 1 - 5 minutes

50 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: DECON TRANSFER

STEP 14

Transfer safely to
prep and pack

CAUTION
Use care and appropriate container that protects the tip during handling and transport.
Failure to do so may result in device damage.

A TRANSFER
Transfer the instrument to prep and pack.

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52 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

 INSTRUMENTS: PREP AND PACK

Prep and Pack

The following pages contain step by step instructions for the
process outlined below.

Prep and Pack

Sterilization Prep

Step 1 Dry

Step 2 Final Inspection

Step 3 Lubricate

Pack and Sterilize

Step 4 Pack

Step 5 Wrap or Prep

Step 6 Sterilize

Store

Step 7 Store

Supplies needed in Prep and Pack

See the following pages for step by step instructions using the following materials:

INSTRUMENTS
PREP AND PACK-
• Sterilization tray, container, or peel pack
• Sterilization machine (see Sterilization Process Parameters)
• Sterilization wrap or container filter
• Magnifying glass (4X preferred)
• Lubricant (legally marketed, steam permeable, pH-neutral)
• Lint-free cloth
• Compressed, clean dry air (optional)

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54 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: PREP AND PACK DRY

STEP 1

Dry the instrument

thoroughly

A DRAIN WATER
Empty all water from the instrument.

B DRY
Dry all surfaces with a cloth.

C BLOW AIR (OPTIONAL)

Blow clean dry air through the flush ports and housing
as needed.

NOTE
Ensure instrument is dry before moving to the next step.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 55

INSTRUMENTS: PREP AND PACK FINAL INSPECTION

STEP 2

Final Inspection
WARNING
Prior to use, after use or reprocessing, always inspect devices for any defects or damage.
Failure to inspect may result in patient harm and/or additional device damage.

NOTE
It is normal for SP Instrument shafts to be bent, and do not need to be straightened.

A INSPECT FOR SOIL

Inspect entire instrument to confirm that no soil is
present. If present, repeat the cleaning process.

B INSPECT FOR DAMAGE

Inspect entire instrument for damage. Examples of
damage include:

−−cracked or damaged instrument housing

−−bent or broken jaws or tips
−−broken or frayed cables
−−cracked tip, deformations, or burn marks
−−loose or cracked Grip Release Dial

IF DAMAGED
If any issues are found, contact Intuitive Surgical
Customer Service.

56 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: PREP AND PACK FINAL INSPECTION

STEP 2 (continued)

Final Inspection
C INSPECT BENDS
Inspect the shaft for any bends that are not at the
joints.

IF DAMAGED
If any issues are found, contact Intuitive Surgical
Customer Service.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 57

INSTRUMENTS: PREP AND PACK

Instrument Lubrication Areas

1
Grip Slot
(not present
for monopolar)
2 Wrist Joint

3 Wrist Joint

4 Wrist Joint

5
Elbow Joint

58 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: PREP AND PACK LUBRICATE

STEP 3

Lubricate
NOTE
• Use a legally marketed, steam permeable, pH-neutral lubricant.
• Refer to lubricant manufacturer’s labeling instructions for use.

BEFORE YOU START

Ensure instrument is dry.

A
A LUBRICATE AREA 1 (TIP)
Apply 1 – 2 drops of lubricant to the grip slot, if
present.

B LUBRICATE AREAS 2, 3 AND 4 (WRIST)

Apply 1 – 2 drops of lubricant to each wrist joint while
device is lying flat.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 59

INSTRUMENTS: PREP AND PACK LUBRICATE

STEP 3 (continued)

Lubricate
C MOVE WRIST JOINTS
Open and close the jaws using Grip Release Dial.
Move the wrist joints to spread lubricant.

D LUBRICATE AREA 5 (ELBOW)

Apply 1 – 2 drops of lubricant to the elbow joint.

E MOVE ELBOW JOINT

Move the elbow joint to spread lubricant.

60 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: PREP AND PACK

Sterilization Warnings, Cautions, and Notes

WARNING
Use only the validated sterilization machines, parameters and cycles, and follow instructions
in entirety. Any other cycles and parameters have not been validated and may damage the
device, or may result in incomplete sterilization.

CAUTION
Following steam sterilization, allow all components to cool to room temperature. Sudden
changes in temperature may damage the components.

NOTE
Refer to the sterilization system manufacturer’s instructions for proper use of the system and
recommendations for sterilization.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 61

INSTRUMENTS: PREP AND PACK PACK

STEP 4

Pack
NOTE
For compatible sterilization methods for devices, see the Sterilization Process Parameters.

BEFORE YOU START

Select a validated instrument sterilization tray or container (legally marketed, FDA-cleared).

A SELECT TRAY, CONTAINER, OR PEEL PACK

Use Sterilization Process Parameters to select the
appropriate, clean tray, container or peel pack for
sterilization machine and cycle. Trays and containers
validated by Intuitive Surgical may be found in
Reprocessing Instructions Appendices (PN 553486).

Aesculap Container Bottom (PN JN445), Aesculap

Basket w/Rack (PN MA003) are shown in illustration.

B POSITION INSTRUMENT
Place the instrument in position in the appropriate
tray or container according to manufacturer's
instructions.

C LOCK LID
Place the lid on the tray or container. Lock the lid
latches.
Aesculap Container Lid (PN JK490) is shown in
illustration.

62 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: PREP AND PACK STERILIZATION PROCESS PARAMETERS

Sterilization
Process Parameters
Pre-vacuum Steam Sterilization

PARAMETER

Temperature 270 ℉ (132 ℃)

Full Cycle Exposure Time 4 minutes

Dry Time 30-50 minutes

Drying time will vary depending on the packing system used,
steam quality and load size of the sterilizer, and environmental
conditions. Drying times after steam sterilization are between
30 and 50 minutes based on validation studies performed by
Intuitive Surgical.
Per ANSI/AAMI ST79: 2010, "drying should be evaluated by
controlled, random sampling and opening selected sets at
the completion of the drying/cooling time. Health care facility
policy will dictate the frequency of sampling."

da Vinci SP INSTRUMENT

Tray/Container Refer to Reprocessing Instructions

Appendices PN 553486.

NOTE
• Dry time may vary with use of other trays/containers, other configurations, autoclave type,
and autoclave load.
• The maximum sterilization time and temperature that have been validated for
compatibility are 18 minutes and 278 ℉ (137 ℃).

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 63

INSTRUMENTS: PREP AND PACK WRAP OR PREP

STEP 5

Wrap or Prep
NOTE
Double-wrap sterilization trays with a legally marketed, FDA-cleared sterilization wrap.

A WRAP TRAY
If using sterilization tray, double wrap according to
both sterilization system and tray manufacturers’
instructions.

B CONTAINER PREP
If using container system, replace filter and other
components using both sterilization system and
container manufacturers’ instructions.

C PEEL PACK PREP

If using peel packs, follow peel pack manufacturer's
instructions. Devices may be single or double peel
packed.

64 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments

INSTRUMENTS: PREP AND PACK STERILIZE AND STORE

STEP 5

Sterilize
A STERILIZE
Sterilize using the Sterilization Process Parameters.
Refer to table on page 63.

STEP 7

Store in clean
dry place

A STORE
Store the sterilized container or wrapped tray in a
clean, dry place.

Reprocessing Manual for da Vinci SP EndoWrist SP Instruments 65

SYMBOL GLOSSARY

Symbol Glossary

CLEAN, DRY AIR

CHEMICAL (BOTTLE)

SPRAY BOTTLE MAGNIFIER

FLUSH PORT ICON SOAK BIN

TIME: SECONDS CRITICAL WATER

seconds

TIME: MINUTES STERILIZATION WRAP

minutes

SYRINGE (LUER SLIP STERILIZATION

TIP) CONTAINER

LINT-FREE CLOTH PEEL PACKS

FLUSH PORT ADAPTER STERILIZATION MACHINE

or
THERMAL DISINFECTION
MACHINE

NYLON BRUSH

66 Reprocessing Manual for da Vinci SP EndoWrist SP Instruments