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EEA™
Circular Stapler with Tri-Staple™ Technology
PT00168175
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1.2 - 1.75 mm
1.5 -2.0 mm
1.2 - 1.75 mm
1.5 -2.0 mm
1.2 - 1.75 mm
1.5 -2.0 mm
1.2 - 1.75 mm
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BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques.
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This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its
failure and subsequent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination and
patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTION
The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess
tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle rmly as far as it will go. The diameter of
the staple line is determined by the selection of the 33 mm, 31 mm, 28 mm, 25 mm, 21 mm* stapler. The EEA™ circular stapler with
Tri-Staple™ technology is available in 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are oered in 2 staple
sizes, medium/thick and extra thick. Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0 mm,
3.5 mm and 4.0 mm titanium staples. Staplers with extra thick staple size (black) deploy three height-progressive rows of 4.0 mm, 4.5
mm and 5.0 mm titanium staples. The low prole Tilt-Top™ anvil is available on all staplers.
*21 mm staplers not cleared for sale in the US market.
INDICATIONS
The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end,
end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
CONTRAINDICATIONS
1. This device is not designed, sold, or intended for use except as indicated.
2. Do not use the stapler on any tissue that, in the opinion of the surgeon, will not be able to tolerate conventional suture materials
3. The device should not be used to staple tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or edematous
4. Do not use the stapler with medium/thick staple size (purple) on any tissue that compresses to less than 1.5 mm in thickness. In
5. Do not use the stapler with medium/thick staple size (purple) on any tissue that will not comfortably compress to 2.25 mm in
6. Do not use the stapler with extra thick staple size (black) on any tissue that compresses to less than 2.25 mm in thickness. In such
7. Do not use the stapler with extra thick staple size (black) on any tissue that will not comfortably compress to 3.0 mm in thickness.
N
8. Do not use the stapler if unusual eort is required to turn the twist knob in order to visualize at least a portion of the green bar in
9. Do not use the stapler if the tissue is stretched or thinned out by introducing a cartridge that is too large for the diameter of the
10. Do not use the stapler unless there is sucient tissue to allow proper inversion of tissue edges so staples can be placed securely in
11. Do not use the stapler where adequacy of hemostasis cannot be veried visually after ring.
WARNINGS AND PRECAUTIONS
1. As with all surgical staplers, surgeons should consider specic patient factors before deciding if the device is suitable for use. For
T
Purple
21
Black
Purple
25
Black
Purple
28
Black
Purple
31
Black
Purple
33
Black
or conventional closure techniques.
tissues.
such cases, the staples will not be tight enough to ensure hemostasis.
thickness. The instrument should not be used if unusual eort is required to turn the twist knob in order to visualize at least a
portion of the green bar in the indicator window.
cases, the staples will not be tight enough to ensure hemostasis.
The instrument should not be used if unusual eort is required to turn the twist knob in order to visualize at least a portion of the
green bar in the indicator window.
the indicator window.
structure. Leakage and narrowing of the anastomosis could occur. Refer to the staple specication chart. Reusable sizers are
available to evaluate the size of the structures.
the inverted edges. The pursestring suture must be tied securely above the pursestring notch on the anvil/center rod assembly.
example, 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 and in corresponding selection of staple size.
4mm3.5mm3
5
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4mm3.5mm3
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4.5
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mm
4mm3.5mm3
5
4.5
mm
mm
4mm3.5mm3
5
4.5
mm
mm
4mm3.5mm3
5
4.5
mm
mm
W
0.24
mm
0.24
mm
0.24
0.24
mm
0.24
mm
0.24
mm
0.24
mm
0.24
mm
0.24
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mm
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12.5
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12.5
mm
16.6
mm
16.6
mm
22.5
mm
22.5
mm
24.6
mm
24.6
mm
19.5
mm
19.5
mm
1.5-2.25
27
mm
2.25-3.0
27
mm
1.5-2.25
33
mm
2.25-3.0
33
mm
1.5-2.25
39
mm
2.25-3.0
39
mm
1.5-2.25
45
mm
2.25-3.0
45
mm
1.5-2.25
48
mm
2.25-3.0
48
mm
21
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21
mm
25
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25
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28
mm
28
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31
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2. Pursestring sutures must be placed no more than 2.5 mm from the cut edge of the tissue to avoid excessive tissue
within the closed anvil and cartridge, which could cause staple malformation or leakage.
3. Cleaning the bowel too far from the cut edge could result in devascularizing the inverted tissue, causing poor healing.
The safety range for cleaning back tissue is as follows: EEA™ circular stapler with Tri-Staple™ technology 33 mm stapler
- 1.5 cm, 31 mm stapler - 1.5 cm, 28 mm stapler - 1.0 cm, 25 mm stapler - 0.5 cm, 21 mm stapler - 0.25 cm
4. When positioning the stapler on the application site, ensure that no unintentional obstructions, such as clips, are
incorporated between the anvil and the cartridge prior to clamping. Firing over an obstruction may result in incomplete
cutting action and/or improperly formed staples.
5. If the procedure requires the use of multiple staplers of varying sizes, ensure that the anvil and stapler sizes always match.
6. When piercing tissue with the instrument integrated trocar or anvil trocar tip accessory, keep the point and puncture
site visualized at all times to prevent inadvertent damage to surrounding structures.
7. When using the white anvil trocar tip accessory, avoid contact with the black release button until you are ready to
remove the tip from the anvil.
8. Sharp (only applicable to 21 mm and 25 mm staplers) and blunt anvil trocar tip accessories are provided. Verify tip
selection prior to introduction of the anvil to the surgical eld. If an anvil trocar tip accessory is not required for the
procedure, remove the blunt anvil trocar tip accessory from the anvil prior to use.
9. The device should not be used to staple tissue outside of the labeled limits for maximum and minimum tissue
thickness.
10. Visually inspect prior to ring for inclusion of unintended anatomic structures within the staple line.
11. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler ring.
NOTE: Anvil tips are small white plastic molded objects with tips that attach to the anvil. The
surgeon might select to use an anvil tip to pierce a stapled section of tissue when creating a circular
anastomosis. EEA™ staplers with Tri-Staple™ technology, sizes 21 mm, 25 mm, 28 mm, 31 mm, and
33 mm, come packaged with the blunt anvil tip accessory for heavier tissue punctures.
12. Avoid use of the device on the aorta.
13. Prior to attaching the anvil to the instrument, verify that the instrument integrated trocar has advanced fully through
the tissue and that the orange band is visible. If the orange band is not visible, proper assembly of the instrument and
anvil may be compromised.
14. When attaching the anvil to the instrument, hold the black twist knob rmly to prevent the integrated trocar from
moving back slightly into the head of the device. If the integrated trocar is pushed back into the bowel, the user may
not be able to visualize the orange band on the integrated trocar which may result in improper attachment of the anvil.
Improper attachment of the anvil can result in the anvil detaching when the stapler is being closed and/or red.
15. After attaching the anvil to the instrument, verify that the orange band on the instrument’s integrated trocar has been
completely covered by the anvil/center rod prior to approximating the anvil to ensure proper assembly of the anvil to
the instrument.
16. Applying gentle counter traction on the distal bowel during approximation may minimize excessive tissue incorporated
into the barrel of the stapler.
17. Do not use the stapler unless there is sucient tissue to allow anastomosis without tension.
18. Make certain the space between the cartridge and anvil is closed and ensure that the green bar is visible in the indicator
window prior to ring the stapler. The safety will not release if the green bar is not visible in the indicator window.
19. When ring the stapler, make sure to fully squeeze the instrument handle until the metal underside of the handle
contacts the stapler body to the fullest extent.
CAUTION: Failure to squeeze the instrument handle fully during ring (partial ring) may result in
unacceptable staple formation and/or an incomplete knife cut. This may result in leakage. Ensure
that the handle is fully squeezed when the metal underside of the handle contacts the stapler body
to the fullest extent.
20. When opening the stapler prior to removal, DO NOT TURN THE TWIST KNOB MORE THAN 2 FULL TURNS, as this may
allow the anvil assembly to separate from the instrument.
21. DO NOT try moving the stapler at the same time as opening it. Doing so may result in the anvil catching on the
anastomotic lip as it will not have fully tilted, which could cause diculty in removing the stapler from the patient.
22. After removing the stapler, always inspect the staple line for hemostasis and check the anastomosis for integrity. Minor
bleeding may be controlled by electrocautery or manual sutures. Minor leakage may be controlled by manual sutures.
23. Dispose of white anvil trocar tip accessory immediately after use. Following removal of tissue specimens (“donuts”) from the
shaft, dispose of the used instrument in accordance with the end-user’s medical and biological waste disposal requirements.
24. The tissue specimens (“donuts”) should be inspected to ensure that all tissue layers have been incorporated in the
anastomosis. If the specimens are not complete, leakage could result and cause narrowing.
25. Avoid handling the top rim of the cartridge to prevent possible injury from the circular knife.
26. Never reuse any components of disposable instruments.
27. Use of an improperly matched instrument and anvil combination will cause staple malformation or result in the failure
of the instrument to cut properly. Malformed staples may compromise the integrity of the staple line resulting in
leakage or disruption.
28. There is a risk of increased leak rates when staple lines are crossed, even if there may be clinical circumstances when a
surgeon may deem it necessary or appropriate to do so.
29. The Tilt-Top™ anvil cannot be detached from the anvil/center rod assembly.
30. Contact of the EEA™ circular stapler with Tri-Staple™ technology with mercuric chloride solutions may cause a chemical
reaction and should be avoided.
31. The titanium staples in this device are nonferromagnetic and may undergo MRI and/or NMR procedures at forces of 3.0
Tesla or less after implantation.
32. Compatibility of other manufacturer’s staple line reinforcement material for use with EEA™ single use stapler has not
been determined.
33. This device is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT
RESTERILIZE. The device is sterilized by ethylene oxide gas, which is identied by the Environmental Protection Agency
as a known Carcinogen.
MRI SAFETY INFORMATION
Non-clinical testing demonstrated that a representative titanium staple is MR Conditional. A patient with these titanium
staples can be scanned safely immediately after placement of the titanium staple under the following conditions:
• Static magnetic eld of 1.5T and 3.0T
• Maximum spatial gradient magnetic eld of 3000-Gauss/cm (30 T/m)
• Normal Operating Mode of operation for the MRI system (whole body averaged SAR, 2-W/kg) for 15 minutes of
scanning, per pulse sequence.
Under the scan conditions dened above, the titanium staple is expected to produce a maximum temperature rise of less
than 3.2°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 2.0 mm from the titanium staple
when imaged with a gradient echo pulse sequence and a 3.0T MRI system.
ADVERSE REACTIONS
While every attempt has been made to reduce patient and user risks, all surgeries using this device carry some residual
risk, even when used by trained physicians. The potential adverse reactions associated with the use of the EEA™ circular
stapler with Tri-Staple™ technology are: allergic reaction, foreign body reaction, foreign body in patient, anastomotic leak,
infection/peritonitis/sepsis, bleeding, tissue damage, perforation, stulas, hemothorax, obstruction, ischemia, and staple
migration. In the event that a serious incident has occurred related to device use, immediately report the event to Covidien,
the competent authorities, and any other regulators as required.
SCHEMATIC VIEW
A) Tilt-Top™ ANVIL/CENTER ROD ASSEMBLY
B) Tilt-Top™ ANVIL
C) GRASPING NOTCH
D) ANVIL TROCAR TIP ACCESSORIES
E) WHITE BLUNT ANVIL TROCAR TIP ACCESSORY
F) WHITE SHARP ANVIL TROCAR TIP ACCESSORY (Sharp Tip only applicable to 21 mm and 25 mm staplers)
G) BLACK RELEASE BUTTON
H) SUTURE HOLE
I) SHIPPING WEDGE
J) INTEGRATED TROCAR
K) CARTRIDGE
L) SHAFT WITH INTEGRATED TROCAR
M) INDICATOR WINDOW
N) TWIST KNOB
O) SAFETY RELEASE
P) INSTRUMENT HANDLE
INSTRUCTIONS FOR USE
Upon removal of the stapler from the package, separate the yellow shipping wedge, which contains radiopaque white anvil
trocar tip accessories and the Tilt-Top™ anvil, from the instrument and keep in the sterile eld for later use.
CAUTION: DO NOT touch the black twist knob when removing the stapler from the package.
Inadvertent turning of the black twist knob may result in the green bar showing in the indicator
window and the safety being released. This inadvertent release of the safety may result in
potential advancement of the handle, which in turn can advance the staples. Partially advanced
staples protruding from the cartridge during an attempted insertion through either the abdominal
wall or the rectum may cause problems with the insertion and also may cause unacceptable staple
formation after ring.
NOTE: The anvil and anvil/center rod assembly on each instrument are one piece and are nondetachable.
(Prior to introduction of the stapler, pursestring sutures must be placed no more than 2.5 mm from the cut edge of the
tissue to avoid excessive tissue within the closed anvil and cartridge, which could cause staple malformation or leakage.
And surgeons should determine that a tissue is appropriate for stapling by evaluating tissue properties (such as integrity,
blood supply, and thickness), patient pathological conditions, and associated comorbidities that may negatively impact the
quality of the staple line or may require adjustment in staple size selection prior to stapler use.)
Closed Lumen Technique:
1. The blunt anvil trocar tip accessory is pre-installed on staplers. If a closed lumen procedure (double stapling) is being
performed and the white anvil trocar tip accessory is not required, remove the blunt anvil trocar tip from the Tilt-Top™
anvil by pressing the black release button on the anvil trocar tip accessory and pulling it out of the anvil/center rod
assembly, insert the Tilt-Top™ anvil into the lumen. The pursestring suture must be tied securely above the pursestring
notch to secure proximal tissue over the Tilt-Top™ anvil.
2. Apply copious amounts of surgical lubricant to the stapler to ease insertion.
NOTE: If performing a triple stapling procedure, or one where a white anvil trocar tip accessory is
desired, select the appropriate anvil trocar tip accessory for the procedure.
3. If the sharp tip (only applicable to 21 mm and 25 mm staplers) is desired, remove the blunt tip (E) by pressing the black
release button (G) and pulling the anvil trocar tip accessory out of the anvil/center rod assembly (A). Attach the white
sharp anvil trocar tip accessory (F) to the hollow shaft on the Tilt-Top™ anvil/center rod assembly (A). The anvil trocar
tip accessory will lock into place.
A suture may be placed through the hole at the tip of the anvil trocar tip accessory and tied into a loop. Once the
structure has been pierced, unlock the white anvil trocar tip accessory by pressing the black release button on the anvil
trocar tip accessory with a grasper or nger. If performing the procedure laparoscopically, remove the white anvil trocar
tip accessory by grasping the suture loop and pulling the white anvil trocar tip accessory through the access cannula
with an inner diameter greater than 6.0 mm.
4. The stapler is supplied with the integrated trocar (J) in the fully retracted position and completely within the connes of the
cartridge (K).
CAUTION: Avoid handling the top rim of the cartridge to prevent possible injury from the circular knife.
5. To pierce tissue, the instrument is inserted up to the closed lumen to be anastomosed, and the integrated trocar (J) is extended
by turning the twist knob (N) counterclockwise until the tissue is pierced and the integrated trocar is fully extended. Ensure the
integrated trocar is extended closely adjacent to the existing staple line to avoid tissue bunching on the side of the integrated
trocar. The distance between the staple line and the piercing point of the integrated trocar should be close enough to ensure
transection of the staple line, but far enough to allow easy passage of the center rod of the anvil/center rod assembly through the
distal bowel during approximation.
CAUTION: When piercing tissue with the integrated trocar or anvil trocar tip accessory, keep the point and
puncture site visualized at all times to prevent inadvertent damage to surrounding structures. Additionally,
verify that the orange band on the integrated trocar is visible outside of the structure to be anastomosed. If
the orange band is not visible, the Tilt-Top™ anvil may not be properly attached to the instrument.
6. Once the integrated trocar (J) is fully extended, hold the Tilt-Top™ anvil/center rod assembly (A) at the grasping notch (C) with a
grasping device (Q) such as an Endo Clinch™ II or Endo Babcock™. Mate the Tilt-Top™ anvil center/rod assembly to the integrated
trocar by pushing rmly until the instrument shaft clicks into its fully seated position. This click will be tactile. Manually inspect
the attachment to ensure that the anvil/center rod assembly and integrated trocar are fully mated. When fully mated, the orange
band on the integrated trocar will be fully covered by the Tilt-Top™ anvil/center rod assembly. The anvil center rod has a laser
etched size indicator on one side which tells the user the lumen outer diameter of the anvil center rod. The stapler will always tilt
toward this indicator.
NOTE: DO NOT grasp/clamp on the legs (open end) of the anvil/center rod assembly. Doing so could bend the
legs and make it dicult to attach/detach the anvil to the integrated trocar of the stapler.
CAUTION: When attaching the anvil to the instrument, hold the black twist knob rmly to prevent the
integrated trocar from moving back slightly into the head of the device. If the integrated trocar is pushed
back into the bowel, the user may not be able to visualize the orange band on the integrated trocar which
may result in improper attachment of the anvil. Improper attachment of the anvil can result in the anvil
detaching when the stapler is being closed and/or red.
7. To approximate the tissue and to close the space between the cartridge (K) and Tilt-Top™ anvil (B), turn the twist knob (N) at
the rear of the stapler clockwise until it stops. Applying gentle counter traction on the distal bowel during approximation MAY
minimize excessive tissue incorporated into the barrel of the stapler. Proper approximation is veried when a green bar (R) is visible
in the indicator window (M) signifying that the stapler is ready to be red.
NOTE: The safety will not release if the green bar is not visible in the indicator window.
CAUTION: The instrument should not be used if unusual eort is required to turn the twist knob in order to
visualize at least a portion of the green bar in the indicator window.
CAUTION: Always select a stapler with the appropriate staple size for the tissue thickness. Overly thick tissue
may result in unacceptable staple formation and/or incomplete knife cut. Overly thin tissue may result in
unacceptable staple formation.
NOTE: When the stapler is upsized or downsized for its staple height only (upsized from purple to black
stapler or downsized from black to purple stapler) keeping the same lumen diameter, the anvil can be left
in the anatomy.
CAUTION: When the stapler is upsized or downsized to a dierent lumen diameter, the original anvil must be
removed from the anatomy and a new anvil whose lumen diameter matches the lumen diameter of the new
stapler should be utilized in its place. Ensure that the anvil lumen diameter (laser etched on the anvil center
rod) and stapler lumen diameter (written on the cartridge of the stapler) always match.
NOTE: While swapping the stapler in the above case, please ensure that you are again using EEA™ circular
stapler with Tri-Staple™ technology. Tri-Staple™ technology is written in blue color both on the handle as
well as on the cartridge of the stapler. You can also check the packaging of the stapler and the cartridge of
the stapler (which will be purple or black) to ensure the right stapler is being used.
8. If attempting the anastomosis with a purple stapler initially and if excessive resistance is experienced in reaching the green ring
zone, the stapler should be upsized to a black extra thick staples.
9. Pre-compression of tissues during use of the EEA™ circular stapler is recommended prior to stapler ring.
10. To re the instrument, release the red safety (O) above the instrument handle (P) and fully squeeze the instrument handle until
the metal underside of the handle contacts the stapler body to the fullest extent. An audible and tactile ring indicator will provide
additional feedback of ring completion; however, even at the presence of these indicators, it is important to fully squeeze the
handle to ensure complete ring.
CAUTION: Failure to squeeze the handle fully during ring may result in unacceptable staple formation and/
or an incomplete knife cut. An incomplete knife cut may result in diculty removing the stapler from the
patient, and unacceptable staple formation may result in leakage. Ensure that the handle is fully squeezed
when the metal underside of the handle contacts the stapler body to the fullest extent.
11. Following release of the handle, return the safety to the locked position.
12. To remove the instrument, create a space between the cartridge (K) and anvil (B) by turning the twist knob (N) counterclockwise
2 FULL TURNS.
CAUTION: When opening the stapler prior to removal, DO NOT TURN THE TWIST KNOB MORE THAN 2 FULL
TURNS, as this may allow the anvil assembly to separate from the instrument.
NOTE: The instrument has a tactile indicator that can be felt and heard at 2 turns. This may be used to
identify proper opening position for removal of the stapler.
CAUTION: DO NOT try moving the stapler at the same time as opening it. Doing so may result in the anvil
catching on the anastomotic lip as it will not have fully tilted, which could cause diculty in removing the
stapler from the patient.
13. Opening the twist knob 2 full turns will allow the anvil to tilt on its side for easy removal through the anastomosis. Gently remove
the instrument by pulling it straight out of the new anastomosis. Following removal, inspect the staple line for hemostasis and
check the anastomosis for integrity.
IMPORTANT: Relieve any tension by pushing the instrument slightly forward and then pulling
straight out
CAUTION: There is a risk of increased leak rates when staple lines are crossed, even if there may be
clinical circumstances when a surgeon may deem it necessary or appropriate to do so.
14. Inspect the tissue specimens (“donuts”) (S) to ensure that all tissue layers have been incorporated in the anastomosis.
Turning the twist knob in a counterclockwise direction will cause the integrated trocar to extend, permitting inspection
of the tissue specimens.
Open Lumen Technique:
15. Turn twist knob at rear of stapler counterclockwise until the orange band on integrated trocar is fully exposed. Remove
the white anvil trocar tip accessory from the Tilt-Top™ anvil/center rod assembly by pressing the black button and pulling
it out of the anvil/center rod assembly. Mate the Tilt-Top™ anvil center/rod assembly to the integrated trocar by pushing
rmly until the instrument shaft clicks into its fully seated position. This click will be tactile and audible. Manually inspect
the attachment to ensure that the anvil/center rod assembly and integrated trocar are fully mated. When fully mated, the
orange band on the integrated trocar will be fully covered by the Tilt-Top™ anvil/center rod assembly. Turn twist knob at
rear of stapler clockwise to retract anvil. The anvil center rod has a laser etched size indicator on one side which tells the
user the lumen outer diameter of the anvil center rod. Stapler will always tilt toward this indicator.
CAUTION: When attaching the anvil to the instrument, hold the black twist knob rmly to prevent
the integrated trocar from moving back slightly into the head of the device.
16. Introduce the instrument into the structure until the anvil protrudes.
17. Open the stapler by turning the twist knob counterclockwise until sucient space is available between the cartridge
and the anvil for the structures to be anastomosed. Tie the distal pursestring suture securely but not too tightly around
the integrated trocar to secure tissue over the cartridge. Ensure the pursestring suture is securely tied with sucient
space to enable the pursestring to smoothly slip over the center rod of the Tilt-Top ™ anvil/center rod assembly when
closing the stapler. Tie the proximal pursestring suture securely above the pursestring notch to secure proximal tissue
around the Tilt-Top™ anvil.
18. Apply copious amounts of surgical lubricant to the stapler to ease insertion.
19. FOLLOW STEPS 5-11 ABOVE.
STAPLE SPECIFICATION CHART
T) COLOR
U) SIZE OF STAPLE
V) APPROXIMATE CLOSED STAPLE HEIGHT (HEIGHT OF “B”)
W) STAPLE CROSS SECTION DIMENSIONS (WIRE SIZE)
X) SHELL OUTSIDE DIAMETER
Y) OUTSIDE KNIFE DIAMETER
Z) NUMBER OF STAPLES
Aa) TISSUE COMPRESSION REQUIREMENT
STORE AT ROOM TEMPERATURE.