Signia™
Small Diameter Reloads
PT00167983
A
C
B
H
G
I
J
K
L
M N O
Gray
2
mm
2.5
mm
2.5
mm
30 mm
30 mm
White
45 mm
White
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.
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, or death. 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
1. The Signia™ small diameter reloads place staggered rows of titanium staples and simultaneously divide the tissue so
that two staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the
selection of the single use reload.
2. The Signia™ small diameter reloads place two rows of titanium staples on either side of the cut line and are available in
multiple articulating configurations with following features:
• Open staple height: 2.0 mm (gray cartridge) and 2.5 mm (white car tridge)
• Car tridge length: 30 mm and 45 mm
• Anvil tip: cur ved tip
• Shaft length: shor t (15 cm) and long (24 cm)
3. Refer to the Instructions for Use for the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, and Signia™
platforms for articulation angles.
4. The curved tip on the distal-end of the curved tip reload can be used to aid in positioning the reload around target
tissue/vessels for subsequent firing and placement of staples.
5. The working length of the Signia™ small diameter reload will fit through an 8 mm trocar sleeve or larger and is
compatible with existing Endo GIA™ handles and Signia™ adapters.
6. The short shaft lengths (15 cm) are recommended for use in open, thoracoscopic and laparoscopic procedures and are
compatible with 8 mm diameter trocar sleeves.
7. The long shaft lengths (24 cm) are recommended for use in thoracoscopic and laparoscopic procedures and are
compatible with 8 mm diameter trocar sleeves.
8. Signia™ small diameter reloads are recommended for use with SHORT handles and adapters.
9. Signia™ small diameter reloads contain an intelligence chip. The intelligence chip has the ability to communicate with
Covidien powered stapler handles that have a compatible communications interface.
STAPLER HANDLE COMPATIBILITY
1. The Signia™ small diameter reloads can be used with the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra,
iDrive™, and Signia™ platforms. Some features of Signia™ are only compatible with Tri-Staple™ 2.0 reloads, Signia™
intelligent loading units.
2. Refer to the Instructions for Use for the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™
platforms for specific indications, contraindications, warnings, precautions, and operating instructions.
D
E F
P
.75 mm
1.0 mm
1.0 mm
INDICATIONS
1. The Signia™ small diameter gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for
resection and transection of vasculature using gray reloads and thin tissue and vasculature using white reloads.
CONTRAINDICATIONS
1. Do not use the Signia™ small diameter vascular reload (gray cartridge) on any tissue that compresses to less than 0.75 mm in
thickness, on any tissue that cannot comfortably compress to 1.0 mm or on the aorta.
2. Do not use the Signia™ small diameter vascular/thin reload (white cartridge) on any tissue that compresses to less than 1.0 mm in
thickness, on any tissue that cannot comfortably compress to 1.5 mm or on the aorta.
3. The Signia™ small diameter reloads should not be used on friable or delicate tissue and/or where the closure of the device might
be destructive to the tissues.
4. Do not use any linear cutter on major vessels without making provisions for proximal and distal control.
5. Do not use the instrument on ischemic or necrotic tissue.
6. The use of curved tip reloads is contraindicated on tissue or structures that cannot fit completely within the jaws proximal to the
transitional angle of the curved tip.
7. These devices are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT
RESTERILIZE.
8. Do not use in applications where staple line reinforcement may be applied.
WARNINGS
1. Ensure that the staple reloads are compatible with the staplers.
2. Depending upon the stapler handle used, also refer to the applicable Instructions for Use for the GIA™ Universal, Endo GIA™
Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings, precautions, and
operating instructions.
3. Surgeons should consider specific patient factors before deciding if the device is suitable for use. For 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.
4. Always select a reload with the appropriate staple size for the tissue thickness. Overly thick or thin tissue may result in
unacceptable staple formation.
5. Use added caution when applying stapler in variable/thick tissues such as lung parenchyma to ensure that no part of the tissue
within the jaws exceeds thickness indications or that closure of the stapler does not crush /damage tissue. The white / gray small
diameter stapling reloads may not be appropriate for all use conditions or cases.
6. Ensure tissue has not extended (extruded) beyond the tissue stop proximally. Tissue forced into the instrument beyond the tissue
stop may be transected without stapling.
7. The instrument will cut and staple any structure included in the jaws. Use caution to ensure that only structures to be cut and
stapled are within the instrument jaws.
8. Prior to firing, visually inspect the application site for the inclusion of unintentional anatomic structures within the staple line.
When positioning the stapler on the application site, ensure that no unintentional obstructions, such as clips, loose staples, or any
other obstructions are incorporated into the instrument jaws. DO NOT FIRE over any obstructions. Firing over an obstruction may
result in incomplete cutting action and/or improperly formed staples and/or the potential of the instrument jaws not opening
after firing.
9. There is an increased risk of leak when staple lines are crossed, even if there may be clinical circumstances when a surgeon may
deem it necessary or appropriate to do so.
10. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
11. Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic
techniques. Prior to performance of any endoscopic procedures, consult the medical literature relative to techniques, complications
and hazards.
12. A thorough understanding of the principles involved in laser and electrosurgical procedures is essential to avoid shock and burn
hazards to both patient and operator(s), and damage to the instrument.
13. When positioning the curved tip reload around tissue/vasculature, avoid exerting excessive pressure on fragile or delicate
structures with the curved tip of the reload.
14. The instrument will cut and staple any structure included in the jaws. Use caution to ensure that only structures to be cut and
stapled are within the instrument jaws.
15. Failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor
hemostasis and/or leakage.
16. Signia™ small diameter reloads are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE.
DO NOT RESTERILIZE. Reprocessing or resterilization may compromise the device integrity and could lead to patient injury, illness,
or death. Reuse, even after resterilization, may create a risk of contamination and lead to patient infection or the transmission of
infectious disease(s).
17. Compatibility of staple line reinforcement material with the Signia™ small diameter reloads has not been established.
PRECAUTIONS
1. Depending upon the stapler handle used, also refer to the applicable Instructions for Use for the GIA™ Universal, Endo GIA™
Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings, precautions, and
operating instructions.
2. Do not attempt to remove the shipping wedge until the reload is loaded into the instrument. The shipping wedge should be
retained until the completion of the case.
3. Do not clamp instrument prior to removing shipping wedge.
4. The jaws of the reload must be closed prior to introducing the instrument into the trocar sleeve or the incision. Do not attempt to
insert or remove the instrument from the incision, or trocar sleeve if the instrument is in the articulated position.
5. After firing and removal of the instrument, always inspect the staple line and the surrounding site for hemostasis and/or leakage.
Minor bleeding may be controlled by electrocautery or manual sutures. Minor leakage may be controlled by manual sutures.
6. Placement of tissue proximal to the tissue stops (on the reload) may result in stapler malfunction. Any tissue extending beyond
the cut line will not be transected.
7. The Signia™ small diameter reloads are single use and can only be fired one time. A safety interlock is provided that
prevents an empty single use reload from being fired a second time. Do not attempt to override the safety interlock.
Overriding the safety interlock will cause device malfunction.
8. The instrument will not cut tissue beyond the black cut line indicated on the single use reload. More than one
application of the stapler may be necessary for tissue exceeding the length of the reload (30 mm or 45 mm).
9. When endoscopic instruments and accessories from different manufacturers are employed together in a procedure,
verify compatibility and ensure that electrical isolation or grounding is not compromised.
10. The anvil must be completely visible, (past the trocar sleeve) prior to opening the reload within the body cavity.
11. Where practical, proximal control of blood vessels is recommended prior to stapling. Methods of blood vessel control
should be in place in the event of stapler failure. When dividing major vascular structures, be sure to adhere to the basic
surgical principles of proximal and distal control.
12. In case of a curved tip reload, ensure that the tissue/vessel to be transected does not extend beyond the black cut line
on the reload. The device will only cut to the black cut line. Tissue contained within the jaws distal to this line will not
be transected.
13. Dispose of used instruments and used reloads in accordance with the end-user’s medical and biological waste disposal
requirements.
14. The compatibility of other manufacturers’ staples and staplers has not been determined.
MRI SAFETY INFORMATION
Non-clinical testing demonstrated that the Signia™ small diameter reloads are 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 field of 1.5T and 3.0T
• Maximum spatial gradient magnetic field 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 defined 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 mm from the titanium staple when
imaged with a gradient echo pulse sequence and a 3.0T MRI system.
ADVERSE REACTIONS
Possible adverse reactions and potential complications are: bleeding/hematoma/hemorrhage that may lead to death,
staple line leak, fistula and infection which includes intra-abdominal abscesses, peritonitis, sepsis that may lead to death,
ischemia, chronic pain, allergic reactions, potential for staple migration, stenosis, inflammatory reaction, visceral adhesions,
small bowel obstruction, perforation, need for future re-operation.
SCHEMATIC VIEW
A) 8 mm SINGLE USE CURVED TIP RELOAD SHORT (30 mm length)
B) 8mm SINGLE USE CURVED TIP RELOAD LONG (45 mm length)
C) SHIPPING WEDGE
D) PROXIMAL END (12 mm diameter)
E) LOAD ALIGNMENT INDICATOR
F) INTELLIGENCE CHIP
G) ANVIL
H) TISSUE STOP
I) END OF CUT LINE
J) END OF STAPLE LINE
K) INCREMENT MARKINGS
L) STAPLE CARTRIDGE
NOTE : For environmental conditions of use with the Signia™ powered handle refer to the Signia™
powered handle package insert.
LOADING
1. The reload is packaged in the open position. Do not attempt to close the reload.
WARNING: Always select a reload with the appropriate staple size for the tissue thickness.
Overly thick or thin tissue may result in unacceptable staple formation, which may result in poor
hemostasis and/or leakage.
CAUTION: Do not attempt to remove the shipping wedge until the reload is loaded into the
instrument. The shipping wedge should be retained until the completion of the case.
CAUTION: Do not clamp instrument prior to removing shipping wedge.
2. Depending upon the stapler handle used, refer to the applicable Instructions for Use for the GIA™ Universal, Endo
GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings,
precautions, and operating instructions.
UNLOADING
1. Depending upon the stapler handle used, refer to the applicable Instructions for Use for the GIA™ Universal, Endo
GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings,
precautions, and operating instructions.
INSTRUCTIONS FOR USE
1. Depending upon the stapler handle used, refer to the applicable Instructions for Use for the GIA™ Universal, Endo
GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings,
precautions, and operating instructions.
2. In case of the curved tip reload, the curved tip of the anvil can be used to position the reload around target tissue and
target vasculature and will be clearly visible when the reload is clamped on the tissue/vessel that has to be transected.
WARNING: When positioning the curved tip reload around tissue/vasculature, avoid exerting
excessive pressure on fragile or delicate structures with the curved tip of the reload.
CAUTION: In case of a curved tip reload, ensure that the tissue/vessel to be transected does not
extend beyond the black cut line on the reload. The device will only cut to the black cut line. Tissue
contained within the jaws distal to this line will not be transected.
STAPLE SPECIFICATIONS
M) CARTRIDGE LENGTH
N) COLOR
O) OPEN STAPLE SIZE
P) FORMED STAPLE HEIGHT
en: Staple rows, staggered staple pattern
en: Open
54.9 kPa
-20.2°F
-29°C
63°F
17°C
Tissue
85%
140°F
60°C
94°F
34°C
101.3 kPa
en: Intended compressed tissue thickness
en: Sterilized using ethylene oxide
en: Single Use
en: Caution: U.S. Federal law restricts this device to sale by or on
the order of a physician.
en: Do not use if package is damaged
en: Consult instructions for use
en: Do not resterilize
en: MR Conditional
en: Transport atmospheric pressure
en: Transport humidity limitations
en: Transport temperature limitations
en: Storge temperature range
en: Type CF applied part
en: Package quantity
© 2017 Covidien.
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
www.covidien.com
+1 800 633 8766
+1 763 514 4000
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered
trademarks of Covidien AG. Other brands are trademarks of a Covidien company, ™* brands are trademarks of their
respective owner.
2022 - 06 / 01
Loading...