Medtronic Signia Stapler, Product Information Manual

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INSTRUCTIONS
FOR USE
Signia™
Linear Adapters
PT00048739
NOTE: The adapter is a reusable instrument and will deactivate after reaching the end of its service life. The number of uses remaining
is indicated on the power handle display. These indications are described in the Signia™ stapling system’s user manual.
MANUAL CLEANING
1. Remove the adapter from the assembled stapler according to the Instructions for Use provided with the Signia™ stapling system’s user manual.
2. Wipe down the adapter with a separate lint-free cloth soaked in a 32-40 °C pH-neutral detergent solution diluted per the manufacturer’s specifications.
3. Under 32-40 °C running water, scrub all reachable exterior surfaces with a general instrument soft nylon bristle brush for 1-2 minutes to remove surgical
debris. Hold the distal end of the adapter under running water and flush for 1-2 minutes. Do not insert the brush into the distal end shaft. While brushing, pay
particular attention to the grooves on the pin (A). Also pay particular attention to the grooves and sides of the reload unload button (D).
4a. For enzymatic detergents (Validated with Steris Prolystica™* 2X Concentrate): Hold the adapter at a slight angle to allow the detergent solution to flow into
the shaft from the bottom and air bubbles to release from the top. Once all air bubbles are released, immerse the adapter in a 32-40 °C enzymatic bath diluted as
specified by the manufacturer’s Instructions for Use and soak for 10-20 minutes.
4b. For alkaline detergents (non-enzymatic pH greater than 9.5 but less than 10.8) (Validated with neodisher MediClean forte™*): Hold the adapter at a slight
angle to allow the detergent solution to flow into the shaft from the bottom and air bubbles to release from the top. Once all air bubbles are released, immerse
the adapter in a 32-40 °C alkaline bath diluted as specified by the manufacturer’s Instructions for Use and soak for 10-20 minutes.
5. Manually agitate the adapter in the bath for 1-2 minutes.
6. Invert the adapter until all fluid has completely drained.
7. In a clean 32-40 °C water bath, hold the adapter at a slight angle to allow the water to flow into the shaft from the bottom and air bubbles to release from the
top. Once all air bubbles are released, immerse the adapter and soak for 2-3 minutes.
8. Manually agitate the adapter in the bath for 1-2 minutes.
9. Invert the adapter until all fluid has completely drained.
10. Repeat step 3.
11. Rinse under 32-40 °C running tap water for 1-2 minutes.
12. Perform a final rinse under purified water for 1-2 minutes.
13. Dry with a clean, soft, lint-free cloth.
14. Inspect the adapter. If not visibly clean, repeat the above steps.
PRECAUTION: Do not use instrument lubricant on the power handle or the adapter.
AUTOMATIC CLEANING
NOTE: The Signia™ adapter should be placed in such a manner to avoid contact with other devices to prevent damage from
occuring in result of movement during the wash cycle. It is recommended that the adapter be placed with reload unload button
(D) facing downward to assist drainage.
1. Remove the adapter from the stapler according to the Instructions for Use provided with the Signia™ stapling system’s user manual.
2. Wipe down the adapter with a lint-free cloth soaked in 32-40 °C pH-neutral detergent solution diluted per manufacturer’s instructions.
3. Under 32-40 °C running water, scrub all reachable surfaces with a general instrument soft nylon bristle brush for 1-2 minutes to remove surgical debris.
Hold the distal end of the adapter under running water and flush for 1-2 minutes. Do not insert the brush into the distal end shaft. While brushing, pay particular
attention to the grooves on the pin (A). Also pay particular attention to the grooves and sides of the reload unload button (D).
4. Rinse under 32-40 °C running tap water for 1-2 minutes.
5. Perform the automatic cleaning cycle, following the parameters in the table below:
NOTE: Place the adapter into the washer-disinfector in a manner that will protect it from unwanted motion or potential
mechanical damage during the automated wash cycle.
Treatment Time (MM:SS) Temperature Chemicals
Pre-Wash 00:45 Cold Tap Water N/A
Enzyme Wash 04:00 Hot Tap Water
Enzymatic 1 or Alkaline 2 Detergent
Diluted per the manufacturer’s
specifications
Rinse 0:15 Hot Tap Water N/A
Wash 03:00 Hot Tap Water
Enzymatic 1 or Alkaline 2 Detergent
Diluted per the manufacturer’s
specifications
Rinse 00:15 Hot Tap Water N/A
Thermal Rinse 05:00
Hot Purified Water heated to
203 °F (95 °C)
N/A
Dry 06:00 High Setting 203 °F (95 °C) N/A
1. Validated with Steris Prolystica™* 2x concentrate
2. Validated with neodisher MediClean forte™*
6. Dry with a clean, soft, lint-free cloth.
7. Inspect the adapter. If not visibly clean, repeat the above steps.
NOTE: The adapter has been tested for material compatibility with cleaners that have pH ranges from neutral to 10.8. Refer to the
cleaner’s manufacturer for information on the microbiological effectiveness of the cleaner.
DISINFECTION
See the instructions in the automatic cleaning section.
STERILIZATION
The following process parameter information are the sterilization methods recommended and qualified for the Signia™ adapter to achieve a minimum sterility
assurance level of 10
-6 .
STEAM STERILIZATION
The adapters are provided non-sterile. They may be sterilized by steam autoclave by placing the instruments in a standard hospital wrap or other suitable
container. Put the adapters and accessories into the inserts provided, on their side, in an approved sterilization tray. Follow the process parameters as described:
Steam Autoclave Sterilization:
132°C Pre-vacuum (Hi Vac) Steam Cycle
Exposure temperature: 270°F (132°C)
Exposure time: 4 minutes
Vacuum dry time: 20 - 40 minutes
134°C Pre-vacuum (Hi Vac) Steam Cycle
Exposure temperature: 273°F (134°C)
Exposure time: 3 minutes
Vacuum dry time: 20 - 40 minutes
Outside USA (OUS)
Minimum recommended
WHO¹
Cycle
Pre-vacuum Steam Cycle Cycle Cycle Cycle
Exposure temperature (°C) 132 134 134 134
Exposure time (minutes) 4 3 5 18
Vacuum dry time (minutes) 20-40 20-40 20-40 20-40
1. World Health Organization (WHO) steam sterilization cycle.
NOTE: When sterilizing multiple instruments in one autoclave cycle, ensure the sterilizer manufacturer’s stated maximum load is
not exceeded.
WARNINGS AND PRECAUTIONS
1. For steam autoclave sterilization, the Signia™ adapter has been tested to a maximum exposure temperature of 137°C and a maximum exposure time of 18
minutes without degradation in functional performance and service life of the device.
Therefore, do not expose the device to temperatures in excess of 279°F (137°C), and/or exposure time in excess of 18 minutes as this may shorten device service
life and/or lead to device failure.
2. Place the adapter on its side during sterilization.
3. Allow a 20 minute cool down period at room temperature post sterilization. Do not leave the instrument in the autoclave for cool down. Remove from the
autoclave immediately after the sterilization cycle completes.
4. Do not use flash steam sterilization. Use of flash steam sterilization will damage the device, and may lead to malfunction.
EtO Sterilization
EtO sterilization can be followed in replace steam sterilization methods using one of the following methods:
Hot Cycle:
• Temperature Set Point: 130 °F (54 °C)
• Ethylene Oxide Gas Concentration: 600-650 mg/L
• Relative Humidity: 40-60%
• Exposure Time: 2 hours minimum
• Condition: Wrapped
Cold Cycle:
• Temperature Set Point: 100 °F (38 °C)
• Ethylene Oxide Gas Concentration: 650-700 mg/L
• Relative Humidity: 40-60%
• Exposure Time: 6 hours minimum
• Condition: Wrapped
MAINTENANCE
Inspect the adapter for damage or wear prior to use, including bent electronic connectors or distal tip components, buildup of debris in electronic contacts or
cracking of the adapter housings.
A
B
C
D
E
LOAD
G
F
Box Size: 15.25 x 3.88
Overall Size: 8.5 x 14
Folds to: 4.25 x 3.5
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.
DESCRIPTION
The Signia™ linear adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™
stapler and enable functionality of compatible stapling reloads. The Signia™ linear adapters are composed of motor-mating connectors, sensor gauges and
device communications interfaces to provide functionality and communications between compatible stapling reloads and the power handle.
For system configuration information and Instructions for Use, see the Signia™ stapling system’s user manual. Refer to each system component’s Instructions for
Use for detailed product descriptions and associated indications, instructions, contraindications, warnings, precautions.
The product is to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The Signia™ stapling system is
intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
COMPATIBILITY
The Signia™ linear adapter is used with the Signia™ stapler. Refer to the Signia™ stapling system’s user manual for compatible single use stapling reloads,
loading units and cartridges including curved-tip reloads, radial reloads and reinforced reloads. The Signia™ linear adapter is also compatible with the Signia™
manual retraction tool. When using compatible stapling reloads or the Signia™ manual retraction tool, refer to individual Instructions for Use for indications,
instructions, contraindications, warnings and precautions.
INDICATIONS FOR USE
The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with
compatible single use staple reloads, reinforced reloads, loading units and cartridges has applications in abdominal, gynecological, pediatric, and thoracic
surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary
structures and for transection and resection of pancreas.
The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with
compatible curved tip single use reloads can be used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with
compatible single use radial reloads has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection
and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and
resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
CONTRAINDICATIONS
Refer to the Instructions for Use provided with the Signia™ stapling system’s user manual for specific indications, contraindications, warnings, and precautions.
SCHEMATIC VIEW
A) PIN
B) LOADING ALIGNMENT ARROW (for Covidien™ compatible stapling reloads)
C) SHAFT
D) SINGLE-USE RELOAD UNLOAD BUTTON
E) LOADING HUB
F) CENTER TRI-LOBE STAPLING DIRECTIONAL CONTROL
G) RIGHT TRI-LOBE ROTATIONAL CONTROL
INSTRUCTIONS FOR USE
Refer to the Instructions for Use provided with the Signia™ stapling system’s user manual for detailed information on power handle insertion techniques and set
up instructions. These instructions are not intended as a reference to surgical techniques.
WARNINGS AND PRECAUTIONS
1. The stapler and adapters are to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices.
Covidien™ stapling reloads are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
2. Refer to the Instructions for Use provided with the Signia™ stapling system’s user manual for specific indications, contraindications, warnings, and precautions.
3. Select the Covidien™ stapling reload with an indicated tissue range that is appropriate for the target tissue. Overly thick or thin tissue may result in
unacceptable staple formation.
4. The adapter is a precise instrument. Care should be taken to avoid dropping. Improper handling, cleaning, or sterilization may shorten device service life and/
or lead to device failure.
5. The adapter is provided non-sterile. Clean and sterilize before each use.
6. Do not flash sterilize (immediate-use sterilize) the adapter.
7. Use only the sterilization method that is recommended and qualified for the adapter, as described in this document. Do not use hydrogen peroxide gas plasma
technology (such as STERRAD™* systems) or gamma sterilization to sterilize the adapter.
8. Clean the adapter immediately after use to prevent blood and other biological materials from drying on the surface of the device. Do not use abrasive agents.
9. Do not hold or carry the stapler by the distal end of the adapter, or by the stapling reload when an adapter is attached to the stapler.
10. Do not attempt to load a stapling reload before the adapter has been attached to the stapler and calibration has been completed. Doing so may lead to
improper calibration and/or device damage.
11. Do not attach an adapter to the power shell prior to inserting a power handle into the power shell.
12. Do not load a reload onto the adapter prior to attaching onto a power handle. The stapler will not allow the stapling reload to fire until the reload is removed
and the adapter completes its calibration.
13. Do not use the adapter if the packaging or the device appears damaged.
14. 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.
15. Depending upon the potential failure mode for the stapler, an alternate opening procedure described in the Signia™ stapling system’s user manual may or
may not be successful in retracting the knife and opening the stapling reload. Professional experience should be used to assess patient status when deciding the
best course of action.
SET UP AND DISSASSEMBLY
Refer to the Instructions for Use in the Signia™ stapling system’s user manual for complete set up, operation, and disassembly instructions.
NOTE: If a stapling reload is attached to the adapter before the adapter is attached to the stapler, the adapter will not calibrate
for use.
SET UP
1. Align the proximal end of the adapter with the quick release button facing up and in the same orientation as the assembled stapling handle.
2. SIMULTANEOUSLY, PRESS THE TWO COMPONENTS TOGETHER UNTIL THE ADAPTER IS FULLY SEATED INTO THE STAPLING HANDLE AND TACTILE FEEDBACK IS
REGISTERED.
LOADING A STAPLING RELOAD
IMPORTANT: When using compatible stapling reloads, refer to the indications, contraindications, warnings, and precautions
described in the associated Instructions for Use.
1. Insert the pin located at the distal end of the adapter into the stapling reload. Ensure the LOAD alignment indicator on the reload aligns with the LOAD
alignment indicator on the shaft.
2. Lock the reload in place by pushing it in and twisting clockwise 45° (relative to the adapter).
NOTE: When the reload is loaded properly into the adapter, the reload unload button is seated in place without any red showing
underneath.
UNLOADING A STAPLING RELOAD
1. Once rotation and articulation is centered and the jaws are open, pull the blue UNLOAD button back to release the stapling reload, twist the reload
counterclockwise 45°, and pull the reload from the shaft of the adapter to remove it.
2. Dispose of the single use reload per local procedures and regulations for biohazard waste materials. Do not attempt to reuse or resterilize single use reloads.
CLEANING, DISINFECTION, AND STERILIZATION
NOTE: The adapter is made from metals and plastic.
WARNING AND PRECAUTIONS
1. The adapter is supplied non-sterile. It must be cleaned and sterilized prior to use.
2. Clean the adapter immediately after use to prevent blood and other biological materials from drying on the surface of the device. Do not use abrasive agents.
3. Remove and dispose of the stapling reload (if attached) from the adapter prior to cleaning and sterilizing as described in the Disassembly: Unloading a
Stapling Cartridge section of the Instructions for Use provided with the Signia™ stapling system’s user manual.
During Use
Remove excess soil on reusable instruments with disposable wipes.
After Use
The adapter should be cleaned thoroughly after every use to remove all traces of blood and debris. Reprocess as soon as possible following use. If reprocessing
cannot be performed immediately, cover the adapter with a moist towel.
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