I N T U r T I V E
`S U R G I C A L
`
`SureForm™ 60
`
`S T A P L E R U S E R M A N U A L
`
`I N S T R U M E N T S A N D A C C E S S O R I E S
`U S E R M A N U A L A D D E N D U M
`
`Intuitive Surgical, inc.
`1266 Kifer R°ad
`Sunnyvale,CA 94086 USA
`www.intuitivesurgical.com
`
`| EC I REP I Intuitive Surgical, SSrl
`1, chemin des MCiriers,
`_i
`r •„
`i
`1170 Aubonne Switzerland
`
`0543 C€
`
`PN 553910-03 Rev. A 2018.03
`
`1
`
`IS 1027
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`

`

`2
`
`Copyright
`© 2018 Intuitive Surgical, Inc. All rights reserved.
`
`Trademarks
`Intuitive, Intuitive Surgical, Beyond the Limits of the Human Hand, da Vinci, da Vinci S, da Vinci Si,
`da Vinci Xi, da Vinci X, ProGrasp, HotShears, EndoWrist, EndoPass, ClearField, CardioVac, Vacuum
`Source, SureForm, TilePro, and InSite are trademarks or registered trademarks of Intuitive
`Surgical, Inc. Other parties'trademarks are the property of their respective owners and should
`be treated as such.
`
`Rx only
`
`da Vinci Xi and da Vinci X SureForm 60 User Manual Addendum
`
`2
`
`

`

`Contents
`
`1 Introduction
`• 1.1 Contact Information
`• 1.2 About This Manual
`• 1.3 Indications for Use
`J
`• 1.4 Contraindications
`• 1.5 Compatibility Information
`• 1.6 General Warnings and Cautions
`• 1.7 Device Description
`• Articulation Overview
`• 1.8 Stapler Components Defined
`
`2 Preparation and Use
`• 2.1 Open Packaging
`• 2.2 Device Inspection
`• 2.3 Spare Items and Emergency Equipment
`• 2.4 Prepare for Intraoperative Use
`• Install Reload
`• 2.5 Intraoperative Use
`• Precautions for Intraoperative Use
`• Install onto Instrument Arm
`• Calibration Sequence
`• Clamp and Fire Overview
`• Clamp and Fire Instructions
`• SmartFire™
`• Instrument Removal
`• Remove and Replace SureForm 60 Reload
`• Stapler Guided Tool Change
`• Disposal
`
`3 Troubleshooting
`• 3.1 Stapler Initialization Failed
`• 3.2 Missing or Used Reload
`• Missing or Used Reload
`• 3.3 SureForm 60 Reload Recognition
`• SureForm 60 Reload Type Not Detected
`• Dual Console
`• 3.4 Wrong Reload Selected or Reload Shown Mismatch
`• 3.5 Fire Unable to Complete
`• 3.6 Mid-Procedure Restart
`• 3.7 Blade Exposed
`• 3.8 Force Unclamp
`
`da VinciXi and da Vinci X SureForm 60 User Manual Addendum
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`Contents
`
`3
`
`5
`5
`5
`6
`6
`6
`6
`9
`9
`10
`
`14
`14
`14
`14
`14
`15
`16
`16
`17
`18
`19
`19
`22
`24
`24
`26
`26
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`27
`27
`27
`27
`28
`28
`30
`30
`30
`31
`31
`32
`
`3
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`

`

`• 3.9 Manual Stapler Release Instructions
`
`A Appendix A: MR) Safety Information
`• RF Heating
`• MR Artifact
`
`B Appendix B: Symbols and Icons Reference Table
`
`C Appendix C: Natural Rubber Latex
`
`D Appendix D: Sterilization Methods
`
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`4
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`

`

`Introduction
`
`Introduction
`
`This addendum to the da Vinci® System Instruments and Accessories User Manual provides
`details specific to the SureForm 60 and SureForm 60 reloads. This document is not a reference
`for surgical techniques. Refer to the appropriate da Vinci System User Manual, for full system
`information and warnings.
`Failure to properly follow all instructions, including instructions supplied with the
`da Vinci System, may lead to injury and ^result in improper functioning of the device.
`
`1.1 Contact Information
`For Customer Service and Reporting of Complaints or Adverse Events
`Use the following information for customer service, including ordering, reporting complaints
`or adverse events, and general information regarding Intuitive Surgical or our products and
`services.
`
`In the U.S.
`Intuitive Surgical, Inc.
`1266 KiferRoad
`Sunnyvale, CA 94086 USA
`Toll free: 1.800.876.1310
`Direct: 408.523.2100
`Fax: 408.523.2377
`
`In Europe
`Intuitive Surgical
`1, chemin des Muriers,
`1170 Aubonne, Switzerland
`Toll free: +800.0821.2020
`Direct: +41.21.821.2020
`Fax: +41.21.821.2021
`
`For Technical Support
`If the system requires maintenance or service, please call ourTechnical Support line. In the US,
`call 1.800.876.1310, where phones are staffed 24 hours a day, seven days a week. In Europe,
`call+41.21.821.2020.
`
`Manufacturer
`
`_
`
`Intuitive Surgical, Inc.
`
`•aaI 1266 Kifer Road
`mi
`
`Sunnyvale, CA 94086 USA
`www.intuitivesurgical.com
`
`1.2 About This Manual
`This manual presents representative images of the stapler instrument. The representative
`images provide instruction on the use of the product. In some cases, the aesthetics or length
`of the device shown in the representative images may be different from the product in use.
`
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`

`

`Introduction
`
`1.3 Indications for Use
`SureForm 60
`The Intuitive Surgical SureForm 60, SureForm 60 reloads, and other stapler accessories are
`intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation
`of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device
`can be used with staple line or tissue buttressing material (natural or synthetic).
`
`Additional Considerations - Precautions for Use of the Stapler in Smaller Patients
`Performance in pediatric surgical procedures is based on similarity of tasks and target tissues
`encountered in adult surgical procedures. As is appropriate with any surgical procedure,
`consideration must be given to patient size and workspace volume when using the stapler.
`
`1.4 Contraindications
`• Do not use the SureForm 60 or SureForm 60 reloads on the aorta.
`
`1.5 Compatibility Information
`The stapler referenced in this manual is compatible for use with the:
`
`• da Vinci Xi Surgical System, model IS4000 (referred to in this manual as the da Vinci Xi
`System, or the system)
`
`• da Vinci X Surgical System, model IS4200 (referred to in this manual as the da Vinci X
`System, or the system)
`
`It is not compatible for use with the da Vinci, da Vinci S, or da Vinci Si Systems.
`The stapler is compatible for use with the accessories listed in Table 1-1 on page 10.
`
`The SureForm 60 is only compatible with the SureForm 60 reloads referenced in this manual.
`The stapler is not compatible with third-party reloads. Do not use the stapler with
`incompatible reloads.
`
`1.6 General Warnings and Cautions
`/i\ WARNING: Proper surgical procedures and techniques are the responsibility of the
`medical professional. Procedures described herein are furnished for information
`purposes only. Each surgeon must evaluate the appropriateness of the procedure based
`on their own medical training and experience, the type of surgical procedure, and the
`type of systems utilized.
`
`^ WARNING: Only surgeons who have developed adequate robotic skills to perform the
`tasks associated with each procedure and who have received specific training provided
`by Intuitive Surgical, Inc., in the use of the da Vinci Xi System and, or the da Vinci X
`System should use the system. Training provided by Intuitive Surgical is limited to the
`use of the da Vinci Xi System and, or the da Vinci X System and does not replace the
`necessary medical training and experience required to perform surgery.
`
`da Vinci Xi and da Vinci X SureForm 60 User Manual Addendum
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`6
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`

`

`Introduction
`
`a WARNING: Only surgeons who have received specific training provided by
`Intuitive Surgical, Inc., in the use of the stapler should use the instrument. Training
`provided by Intuitive Surgical is limited to the use of the stapler and does not replace the
`necessary medical training and experience required to perform surgery.
`
`^ WARNING: Be sure to read and understand all information, particularly the caution and
`warning information, found in the applicable user manuals before using these products.
`Failure to properly follow all instructions, including those in the da VinciXi System User
`Manual or the da Vinci X System User Manual, and instructions supplied with accessory
`devices like generators, may lead to injury and result in improper functioning of the
`device.
`
`^ WARNING: Do not use the stapler where adequacy of hemostasis cannot be verified
`visually after staple line formation.
`
`^ WARNING: Do not use the white reloads on any tissue that can be easily compressed to
`less than 1.0 mm in thickness, or on any tissue that cannot comfortably compress to
`1.0 mm.
`
`^ WARNING: Do not use the blue reloads on any tissue that can be easily compressed to
`less than 1.5 mm in thickness, or on any tissue that cannot comfortably compress to
`1.5 mm.
`
`^ WARNING: Do not use the green reloads on any tissue that can be easily compressed to
`less than 2.0 mm in thickness, or on any tissue that cannot comfortably compress to
`2.0 mm.
`A WARNING: Do not use the black reloads on any tissue that can be easily compressed to
`less than 2.3 mm in thickness, or on any tissue that cannot comfortably compress to
`2.3 mm.
`
`^WARNING:
`• Always inspect the tissue thickness and select an appropriate stapler reload before
`application of a staple line using the stapler.
`
`•
`
`Improper reload color selection (staple size) can result in over-compression or
`under-compression of tissue and improper staple formation.
`
`^ WARNING: Preoperative radiotherapy may result in changes to tissue. These changes
`may, for example, cause the tissue thickness to exceed the indicated range for the
`selected staple size. Careful consideration should be given to any pre-surgical treatment
`the patient may have undergone.
`
`^ WARNING: Never activate an electrocautery instrument while in contact with the stapler.
`
`^ WARNING: Eliminate tension when stapling on vasculature, as the seal may be
`compromised.
`
`^ WARNING: After firing, always inspect the staple line for hemostasis. Minor bleeding
`may be controlled by electrocautery or manual sutures.
`
`^ WARNING: Use instruments with care. Avoid contact between instruments inside the
`patient and do not use any instrument to apply force to the stapler inside the patient.
`
`da Vinci Xi and da Vinci X Sure Form 60 User Manual Addendum
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`

`

`Introduction
`
`a WARNING: Remove any loose staples, needles or metal clips from between instrument
`jaws and from the surrounding target tissue before and after stapling.
`
`^WARNING: Do not use an instrument to clean debris from another instrument
`intraoperatively. This may result in damage to the instruments and other unintended
`consequences, such as disengagement of the stapler reload.
`
`A WARNING: The staples are made of titanium alloy. Ensure that patients do not have
`metal allergies.
`
`^CAUTION: The stapler is shipped sterile. Do not reuse or re-sterilize the stapler if it has
`been removed from its package, even if unused. Attempts to do so could cause device
`malfunction and serious injury to the patient.
`
`^CAUTION: Stapler reloads are shipped sterile. Do not reuse or re-sterilize stapler reloads
`that have been removed from their package, even if unused. Attempts to do so could
`cause device malfunction and serious injury to the patient.
`
`^CAUTION: Endoscopic instruments are designed and manufactured for a specific
`surgical function. Use of an instrument for a task other than that for which it is intended
`may result in a damaged or broken instrument.
`
`/j\ CAUTION: Handle the instruments with care. Avoid mechanical shock or stress that can
`cause damage to the instruments.
`
`/f\ CAUTION: As a general precaution, alternative methods to establish adequate
`hemostasis or tissue approximation should be held readily available in the operating
`room.
`
`^CAUTION: Always close the jaws and straighten the wrist of the stapler before
`introducing or removing the instrument through the cannula.
`
`Caution for single-use devices
`
`A breach in the sterile packaging of a single-use device indicates possible
`contamination. Do not use the device if the packaging is not intact.
`
`Caution for MR Environment Compatibility
`/^CAUTION: The RF heating behavior does not scale with static field strength. Devices that
`do not exhibit detectable heating at one field strength may exhibit high values of
`localized heating at another field strength. See Appendix A: MRI Safety Information on
`page 35 for more information.
`
`da VinciXi and da Vinci X SureForm 60 User Manual Addendum
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`

`

`Introduction
`
`1.7 Device Description
`The SureForm 60, when used with the compatible SureForm 60 reloads, delivers multiple rows
`of staples and transects the tissue along the middle of the staple line. The SureForm 60 and
`the SureForm 60 reloads (available in various sizes) are single-use/disposable devices.
`
`Setup and intraoperative use of the stapler may require sterile and non-sterile tasks
`performed by the following users: surgeon, circulating nurse (non-sterile user) or scrub nurse
`(sterile user).
`
`Articulation Overview
`The stapler allows the da Vinci surgeon to position, clamp, and fire (simultaneously staple and
`cut) target tissue using the da Vinci System.
`
`The stapler features fully-wristed articulation with grip, full roll and extensive up-and-down
`and left-to-right range of motion up to 60 degrees in each direction (Figure 1.1). First-time
`users should become familiar with the stapler's long jaws and their full range of motion
`characteristics before clinical use.
`
`Up
`
`A
`
`Right v m
`
`t r
`
`Down
`
`Figure 1.1 Stapler range of motion
`
`da VinciXi and da Vinci X SureForm 60 User Manual Addendum
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`

`

`Introduction
`
`1.8 Stapler Components Defined
`Table 1-1 shows reusable and disposable components, and compatible accessories for the
`stapler.
`
`Table 1-1 Stapler and Accessories
`Part Number (PN)
`Reusable Component Name
`PN 470375
`12 mm & Stapler Cannula, Standard
`PN 470389
`12 mm & Stapler Cannula, Long
`PN 470376
`12 mm & Stapler Blunt Obturator, Standard
`PN 470390
`12 mm & Stapler Blunt Obturator, Long
`PN 470395
`12 mm & Stapler Bladeless Obturator, Standard
`PN 470396
`12 mm & Stapler Bladeless Obturator, Long
`Disposable Component Name
`Part Number (PN)
`PN 480460
`SureForm 60
`See Table 1-2
`SureForm 60 reloads
`PN 470380
`12 mm & Stapler Cannula Seal
`PN 470403
`12 mm Bladeless Optical Obturator, Standard
`PN 470404
`12 mm Bladeless Optical Obturator, Long
`PN 470381
`1 2 - 8 m m R e d u c e r
`
`Caution for single-use devices
`
`A CAUTION:
`
`DO NOT RE-STERILIZE. (^) 00 N0T RE-USE.
`
`Reprocessing and, or reuse of products intended for single use may result in degraded
`instrument performance or loss of functionality, and in exposure to viral, bacterial,
`fungal, or prionic pathogens.
`
`Stapler: The stapler includes the jaws (anvil and reload channel), shaft, and instrument
`housing (Figure 1.2). The functions of the stapler are initiated by the hand controls (master
`grips) and the associated pair of foot pedals on the Surgeon Console. The stapler provides
`fully-wristed articulation with grip, full roll, and extensive up-and-down and left-to-right range
`of motion used to position the jaws across the target tissue (Figure 1.1). Additionally, the
`clamp feature, which is the same motion as grip, provides higher compression on the tissue
`than grip before staple firing. The fire feature simultaneously activates stapling and cutting of
`tissue with a knife blade. The Reload Channel holds the SureForm 60 reload, and the anvil
`contains features that form the staples to capture tissue.
`
`da VinciXi and da VinciXSureForm 60 User Manual Addendum
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`

`

`Introduction
`
`Stapler Name
`
`Release Button
`
`Manual Release
`Knob
`
`Figure 1.2 Stapler (reload installed)
`
`Etching on Jaws Explained
`Lines are etched on the reload channel to indicate the cut and staple boundaries. Thick lines
`indicate the cut boundaries and thin lines indicate staple boundaries and increments.
`Numbers (where included with staple boundaries or increments) indicate length in
`millimeters (mm). The 0 line closest to the tip shows the distal boundary of the staple line. The
`thick line closest to the hinge shows the proximal boundary of the cut line (Figure 1.3).The cut
`boundaries are also shown on the anvil.
`
`_ Distal staple
`boundary
`
`SIDE
`
`ANVIL
`
`CHANNEL
`
`l-Beam Home
`Position
`
`with SmartFIrem
`
`CUT: Distal
`Boundary
`
`CUT: Proximal
`boundary
`
`Figure 1.3 Etching on jaws explained
`
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`

`Introduction
`
`^ Note: The stapler is designed for tissue to be loaded only as far as the CUT boundaries
`on the reload channel. It will not cut tissue past the CUT boundaries shown on the reload
`channel and anvil. Load target tissue between the CUT boundaries shown on the
`instrument jaws. More than one SureForm 60 reload may be necessary if a longer staple
`line is desired.
`
`Fires Remaining
`The SureForm 60 is programmed to complete 12 fires. Once the stapler is installed, if five or
`fewer fires remain, a message displays the number of fires left (Figure 1.4). In addition,
`immediately following the last fire, a message appears indicating the stapler has expired.
`Discard expired staplers immediately.
`
`FIRES REMAINING: 3
`
`R 3
`
`SUREFORM 60 (BLUE)
`
`R
`
`A
`
`Figure 1.4 Fires remaining message example
`For further information on instrument expiration, such as how to view remaining uses or fires,
`see the da Vinci System User Manual.
`Disposable SureForm 60 Reloads: The SureForm 60 reloads are sterile, disposable, single-use
`cartridges that contain staggered rows of unformed titanium alloy staples and a cutting blade.
`SureForm 60 reloads come in various staple sizes, distinguished by color. Each is packaged
`with a staple retainer.
`The staple line produced by the SureForm 60 reload is approximately 60 mm long and the cut
`line is approximately 55 mm long.
`A staple retainer holds the staples in place during installation of the reload into the instrument
`jaws. Remove the staple retainer only after the reload has been installed, and before inserting
`the loaded stapler into the cannula.
`^ Note: Use only da VinciXi or da Vinci X SureForm 60 reloads in the da VinciXi or da VinciX
`SureForm 60. Table 1-2 describes the SureForm 60 reload specifications.
`
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`

`

`Introduction
`
`Table 1-2 SureForm 60 Reload Specifications
`
`Reload
`
`Component Name
`
`Part
`Number
`(PN)
`
`Reload
`Length
`(mm)
`
`Staple Leg
`Length
`(mm)
`
`Closed
`Staple
`Height (mm)
`
`Number of
`Staples
`
`Total
`Number of
`Staggered
`Staple Rows
`
`SureForm 60 White
`Reload
`
`SureForm 60 Blue
`Reload
`
`SureForm 60 Green
`Reload
`
`SureForm 60 Black
`Reload
`
`PN 48360W
`
`60
`
`2.5
`
`1.0
`
`90
`
`PN 48360B
`
`60
`
`3.5
`
`1.5
`
`90
`
`PN 48360G
`
`60
`
`4.3
`
`2.0
`
`90
`
`PN 48360T
`
`60
`
`4.6
`
`2.3
`
`90
`
`End of section
`
`6
`
`6
`
`6
`
`6
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`da VinciXi and da Vinci X SureForm 60 User Manual Addendum
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`

`

`14 Preparation and Use
`
`2 Preparation and Use
`
`2.1 Open Packaging
`1. Inspect the outer box, inner Tyvek lid, and clear plastic blister pack for any potential
`damage or break in the sterile barrier. Make sure to inspect the expiration date on the
`packaging and do not use the device or reload if expired.
`2. Using proper sterile technique, remove the stapler from its packaging and transfer to the
`sterile field. Always use 2 people for transfer (one sterile and one non-sterile). Do not let
`the stapler fall from its packaging on to a surface as damage may possibly occur.
`
`2.2 Device Inspection
`Proper care and handling is essential for satisfactory performance of surgical instruments and
`accessories. Examine the stapler thoroughly - including all of its components, reloads and
`accessories - before and after each use. Do not use the device if any abnormality is found.
`Examples of damage include misaligned or loose jaws and deformed or bent shaft
`components. Use the device for Its Intended purpose only.
`
`2.3 Spare Items and Emergency Equipment
`^ WARNING: The following spare item should be ready for use during the procedure:
`
`• Stapler
`
`2.4 Prepare for Intraoperative Use
`
`^CAUTION: Do not lift the stapler by the jaws when the stapler is not installed on an
`instrument arm. Support the housing or the shaft of the stapler instrument and do not
`manipulate it by the jaws, as this may damage the instrument.
`
`Follow these steps to prepare the stapler for use.
`
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`

`

`Preparation and Use
`
`Install Reload
`
`/j\ WARNING: Make sure the reload channel on the stapler is free of foreign material or
`debris before installing a reload.
`
`^CAUTION: Keep the stapler wrist straight when removing and loading reloads or
`otherwise handling the instrument when it is not installed on an instrument arm.
`
`1. Before installing a reload, ensure that the stapler jaws are fully open. If jaws are closed,
`gently turn the Manual Release Knob in a counterclockwise direction until jaws are fully
`open (Figure 2.1).
`
`Figure 2.1 Open the jaws with Manual Release Knob
`2. Select a reload with the appropriate staple size and closed staple height for the tissue
`thickness of the target tissue. See Table 1-2 on page 13 for reference.
`3. Using sterile technique, remove the reload from its packaging, but do not remove the
`staple retainer.
`4. With the retainer in place, hold the reload by the distal (tapered) end (Figure 2.2).
`
`rr
`
`A
`
`**
`
`3.
`
`Figure 2.2 Reload with staple retainer in place
`
`5. Insert the reload into the reload channel
`(bottom jaw) of the stapler: place the
`proximal end into the reload channel at
`a slight angle.
`
`6. Slide the reload firmly into the reload
`channel as far as it will go.
`
`Figure 2.3 Insert at an angle, then slide in
`
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`

`16 Preparation and Use
`
`7. Once firmly inserted, press down on the
`tapered end of the reload until it snaps
`into the reload channel with an audible
`click.
`
`Figure 2.4 Snap reload into reload channel
`
`8. After installation, remove the retainer
`and inspect the reload surface for
`damage before use. Dispose of the
`retainer.
`
`fa WARNING: After installing the reload, remove the staple retainer and inspect the stapler
`reload surface for damage before use. Examples of damage include an exposed blade,
`protruding staple tips, or missing staples. Replace the reload if damage is observed.
`
`Figure 2.5 Remove retainer
`
`2.5 Intraoperative Use
`
`Precautions for Intraoperative Use
`
`^WARNING: Be deliberate in selecting tissue to clamp, as clamp compression may
`damage tissue.
`
`fa WARNING: Make sure that no obstructions (such as clips, staples, bone or other hard
`objects) are between the jaws. Firing over an obstruction may result in incomplete
`cutting action and, or improperly formed staples.
`
`^WARNING: To avoid tissue damage, visually check for pinching of tissue at the
`instrument wrist.
`
`fa WARNING: Ensure the tissue lies flat and is positioned properly between the jaws. Any
`bunching of tissue within the jaws may result in an incomplete staple line.
`
`^ WARNING: While working inside the body cavity, do not collide the stapler with other
`instruments or hard surfaces. Doing so may cause the reload to dislodge or damage the
`instrument.
`
`fa WARNING: If the reload dislodges during use, remove the instrument from the body and
`reseat the reload by hand. Do not attempt to reseat the reload by closing the jaws on the
`dislodged reload.
`
`^WARNING: To prevent patient injury, if any stapler abnormality or malfunction is
`suspected during use, stop using the
`instrument and
`immediately contact
`Intuitive Surgical Customer Service.
`
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`

`

`Preparation and Use
`
`a CAUTION: Do not use excessive force while inserting or removing instruments through
`the cannula because it may damage the seal. If there is significant resistance, stop and
`check the seal for damage. Replace the seal if damaged.
`
`a Note: The stapler will not fire until the instrument is fully clamped.
`
`install onto Instrument Arm
`Q Note: For visibility of system hardware, this section presents images of the Patient Cart
`arm without sterile drapes.
`
`Always use two hands when installing the stapler; one hand holding the jaws closed and the
`other supporting the housing of the stapler. Insert the instrument tip into the cannula and
`slide the instrument housing into the sterile adapter.
`
`Figure 2.6 Inserting the instrument into the cannula and sterile adapter
`
`^Note: For further details and instructions on instrument installation, insertion, and
`removal, see the da Vinci System User Manual.
`
`da VinciXi and da Vinci X SureForm 60 User Manual Addendum
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`

`

`18 Preparation and Use
`
`Calibration Sequence
`To ensure full functionality of the stapler, a calibration/initialization sequence occurs each
`time the stapler is successfully engaged on the instrument arm. If the calibration/initialization
`sequence does not initiate, the instrument may not be properly installed into the sterile
`adapter. Remove and re-install the instrument. While calibrating, the affected instrument LED
`blinks and an on-screen message appears (Figure 2.7).
`
`CALIBRATING. DO NOT REMOVE
`INSTRUMENT: 30%
`R
`3
`
`SUREFORM 60
`
`A
`
`| PiRt
`
`Figure 2.7 Calibration in progress
`
`A WARNING: Always insert the instrument into the patient under visualization.
`
`/K CAUTION: Do not remove the stapler while calibrating.
`
`During calibration, the system can detect and report various issues. Refer to Troubleshooting
`on page 27 for more information.
`When calibration completes, an audio tone sounds and a message appears on the stereo
`viewer and touchscreen (Figure 2.8). The patient-side assistant must clutch the arm and
`advance the instrument tip through the cannula, after which the surgeon can control the
`instrument.
`
`INSTRUMENT TIP IN CANNULA.
`CLUTCH AND ADVANCE.
`
`3
`
`SUREFORM 60 [BLUE]
`
`CLAMP
`
`Figure 2.8 Advance tip through cannula
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`Preparation and Use
`
`Clamp and Fire Overview
`The stapler is activated from the associated pair of Surgeon Console foot pedals by applying
`two controls in succession: first, the associated blue pedal applies clamp, which compresses
`the tissue; then the associated yellow pedal fires the instrument to staple and cut target
`tissue, and provide additional compression. You must clamp before firing. Activate each
`control as described in this section. See Figure 2.9 for reference.
`
`Yellow: Fire
`
`Blue: Clamp
`
`Figure 2.9 Pedal activation
`
`Ciamp and Fire Instructions
`When ready to clamp, follow these instructions:
`1. Position the stapler Jaws across the target tissue. Load target tissue between the cut
`boundaries. Squeeze the hand control to grasp the target tissue. Make sure the jaws are
`not in contact with non-target tissue. If necessary, open the hand control to reposition
`the jaws before applying clamp.
`2. Clamp: To clamp tissue, press and hold the associated blue pedal while holding the hand
`control closed. Figure 2.10 shows on the 3D viewer and touchscreen that clamping is
`occurring. To complete clamping, hold down the associated blue pedal and hold the
`hand control closed until an audible tone sounds, and the "Ready to Fire" message is
`displayed (Figure 2.11). Before the audible tone sounds and the "Ready to Fire" message
`appears, lifting foot off the associated blue pedal or opening the hand control will cause
`the stapler to unclamp.
`
`CLAMPING...
`
`vR
`
`":-i
`
`SUREFORM 60 (BLUE)
`
`R CLAMP
`
`Figure 2.10 Clamping in progress
`
`READY TO FIRE.
`
`iUREFORM 60 (BLUE)
`
`EL FIRE
`
`R CLAMP
`
`Figure 2.11 Ready to Fire
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`Preparation and Use
`
`The stapler remains clamped on tissue when foot is lifted off the associated blue pedal. While
`clamped, the instrument has limited range of motion.
`To unclamp without firing, tap the associated blue pedal once. After unclamping is complete,
`match grips to control the instrument as needed.
`If during the clamp cycle the device detects that there is either too much tissue in the crotch
`of the jaws or the tissue is simply too thick to begin firing, the message in Figure 2.12 will
`display. Unclamp the device and either reposition the tissue or upsize the reload.
`
`Figure 2.12 Unable to Clamp
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`da Vinci Xi and da Vinci X SureForm 60 User Manual Addendum
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`Preparation and Use
`
`3. Fire (Staple and Cut): Press and hold the associated yellow pedal for three seconds to
`staple and cut the target tissue. The system emits an audible tone and counts down on
`screen "3-2-1" before firing starts (Figure 2.13). This provides the chance to release the
`associated yellow pedal during countdown and prevent firing. When the 3-2-1
`countdown completes, the instrument fires; at this point, firing - both staple and cut -
`continues to completion even if the associated yellow pedal is released. The progress bar
`shows firing progress and the system plays the firing sound through both the Surgeon
`Console and the Patient Cart.
`
`FIRING IN 3...
`
`fl 3
`°
`
`SUREFORM 60 (BLUE)
`
`1 R FIRE
`
`"3-2-1"
`countdown
`while holding
`the
`associated
`yellow pedal
`
`FIRING IN 2...
`
`B
`
`O
`
`SUREFORM 60 (BLUE)
`
`R FIRE
`
`F I R I N G I N 1
`
`o
`
`SUREFORM 60 (BLUE)
`
`R FIRE
`
`1
`
`Fire Progress bar
`corresponds to
`markings on the —
`reload channel
`
`Firing starts
`and cannot
`be stopped
`
`Figure 2.13 3-2-1 Fire sequence
`^)Note: During clamping and while the fire progress bars fill, the hand controls cannot be
`used to move, articulate, or roll the stapler.
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`Preparation and Use
`
`When firing completes, the instrument automatically unclamps, as shown on screen (Figure
`2.14) and a message displays to straighten the wrist prior to removal (Figure 2.15). An audible
`tone sounds when unclamping completes.
`
`Figure 2.14 Automatic unclamp
`
`Figure 2.15 Straighten wrist before removing stapler
`4. When unclamping completes, match grips to take control of the Instrument again.
`5. Under endoscopic vision, gently remove the jaws from tissue. Check the site for tissue
`approximation and hemostasis. Minor bleeding can be controlled using electrocautery,
`clips, or sutures.
`6. After the stapler is undamped, straighten the wrist and remove the device from the
`instrument arm.
`QNote: For problems with unclamping, see Manual Stapler Release Instructions on
`page 32.
`
`SmartFire™
`The stapler uses SmartFire to create the best opportunity for a properly formed staple line
`while avoiding potential tissue damage, such as serosal tearing, due to an excessive clamp
`force. SmartFire takes into account multiple variables in order to deliver the appropriate
`compression for the targeted tissue for the SureForm 60 reload selected. The SmartFire
`algorithm can cause the system to pause during firing to allow better tissue compression prior
`to continuing the fire, this happens automatically without the need for user interaction.
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`Preparation and Use
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`During the firing cycle if additional compression is required, the system pauses, displays the
`"Pausing For Compression" message (Figure 2.16) and plays audio feedback. Once the
`appropriate compression is gained on the target tissue, the system resumes firing. Additional
`pauses can happen during a single firing cycle as SmartFire continuously monitors the
`appropriate variables that influence staple line formation.
`
`PADS ;\G (-OR 110MPRESS'SN
`
`«1
`
`O
`O
`
`SUREFORM 60 [BLUE]
`
`R FIRE
`
`Figure 2.16 Pausing For Compression
`If during the firing cycle the system detects that the tissue simply cannot be compressed
`based on the reload selected without leading to malformed staples or causing damage to
`the tissue, the system displays the "Tissue Too Thick to Continue" message (Figure 2.17).
`
`'TISSUE ICQ THICK TO CONTINU E.
`
`AO i • Mm
`TAP 8LUE PEDAL TO UNCLAMP
`CONSIDER CHAN SING RELOAD
`1 COLOR.
`
`
`
`
`
`3 3 3
`
`
`
`
`
`SUREFORM 60 [BLUE] SUREFORM 60 [BLUE] SUREFORM 60 [BLUE]
`
`R CLAMP
`
`J
`1
`
`Figure 2.17 Tissue Too Thick To Continue
`The progress bar will display how far the firing cycle had progressed before being unable to
`proceed. The tissue is transected to the distance indicated on the firing progress bar. There will
`be at least one fully formed set of staples just beyond the cut progress to ensure proper tissue
`apposition up to this point. Unclamp the device and inspect the area that could not be
`transected to ensure there are no elements that would prevent continuation of the staple line
`with a reload designed for thicker tissue. Consider changing reload colors before continuing.
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`Preparation and Use
`
`Instrument Removal
`
`A WARNING: Do not remove the stapler, or any