Medtronic Signia Stapler, Руководство по эксплуатации товара

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INSTRUCTIONS
FOR USE
Signia™
Reusable Insertion Guide
PT00048741
PRECAUTION: Ensure the reusable insertion guide is properly seated onto the power shell
before inserting a power handle device.
3. CIRCULATING PERSON: Maintaining aseptic transfer techniques insert the power handle into the reusable
insertion guide and power shell handle.
E) SCRUBBED PERSON
F) CIRCULATING PERSON
G) POWER HANDLE
4. CIRCULATING PERSON: After the power handle is fully seated in the power shell, carefully remove the
reusable insertion guide using the extended handle.
B) EXTENDED HANDLE
E) SCRUBBED PERSON
F) CIRCULATING PERSON
5. SCRUBBED PERSON: Taking care not to touch the power handle, close the front portion of the power shell
until there is confirmation the base of the power shell is closed and the top secure clips are secured. This
confirms the power shell is fully closed and securely locked.
D) TOP SECURE CLIPS
CLEANING, DISINFECTION, AND STERILIZATION
NOTE: The reusable insertion guide is made from plastic.
Warnings
Detergents and solutions should have a pH between neutral and 10.8.
Sterilization temperature should not exceed 279 °F (137 °C).
The reusable insertion guide is supplied non-sterile. Prior to use it must be cleaned and sterilized.
Before Use
Clean and sterilize the reusable insertion guide prior to each use following the instructions provided.
During Use
Remove excess soil on reusable instruments with disposable wipes.
After Use
The reusable insertion guide 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 device with a moist towel.
MANUAL CLEANING
1. Wipe down the device with a lint-free cloth soaked in 32-40 °C pH-neutral detergent solution diluted per
manufacturer’s instructions.
2. Under 32-40 °C running water, scrub all reachable surfaces with an 11.9 mm soft nylon bristle brush for
1-2 minutes to remove surgical debris. Pay particular attention to the grooves on the extended handle and
indentations on the underside of the tool.
3a. For enzymatic detergents (validated with Steris Prolystica™* 2x Concentrate): immerse the device in a 32-
40 °C enzymatic bath diluted as specified by the manufacturer’s Instructions for Use and soak for 5-10 minutes.
3b. For alkaline detergents (non-enzymatic pH greater than 9.5 but less than 10.8) (validated with neodisher
MediClean forte™*): immerse the device in 32-40°C alkaline bath diluted as specified by the manufacturer’s
Instructions for Use and soak for 5-10 minutes.
4. Manually agitate the device in the bath for at least 1 minute.
5. Repeat step 2.
6. Rinse under warm running tap water (32-40 °C) for at least one minute.
7. Perform a final rinse under purified water for a minimum of one minute.
8. Dry with a clean, soft, lint-free cloth
9. Inspect the device. If not visibly clean, repeat the above steps.
AUTOMATIC CLEANING
NOTE: The Signia™ reusable insertion guide should be placed in the washer-disinfector
with the logo facing up to avoid water collecting in the crevices on the underside of the
tool.
NOTE: The Signia™ reusable insertion guide should be placed in the washer-disinfector
in such a manner to avoid contact with other devices (damage may occur as a result of
movement during the wash cycle).
1. Wipe down the reusable insertion guide with a lint-free cloth soaked in 32-40 °C pH-neutral detergent
solution diluted per manufacturer’s instructions.
2. Under 32-40 °C running water, scrub all reachable surfaces with an 11.9 mm soft nylon bristle brush for
1-2 minutes to remove surgical debris. Pay particular attention to the grooves on the extended handle and
indentations on the underside of the tool.
3. Rinse under running tap water (32-40 °C) for at least 1 minute.
4. Perform the automatic cleaning cycle, following the parameters in the table below:
Treatment Time (MM:SS) Temperature Chemical
Pre-wash 00:45 Cold tap water N/A
Wash 04:00 Hot tap water
Enzymatic 1 or Alkaline 2
Detergent diluted per the
manufacturer’s specifications
Rinse 00:15 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™*
5. Dry with a clean, soft, lint-free cloth.
6. Inspect the device. If not visibly clean, repeat the above steps.
NOTE: The reusable insertion guide 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 automatic cleaning section.
STERILIZATION
The following process parameter information are the sterilization methods recommended and qualified for the
Reusable Insertion Guide to achieve a minimum sterility assurance level of 10
-6 .
B
A
C
D
3
4
5
G
A
C
B
F
2
E
E
F
E
D
Box Size: 3.2 x 7.5
Overall Size: 8.5 x 11
Folds to: 2.83 x 5.5
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™ reusable insertion guide is designed for use with the Signia™ stapler, which is
composed of the Signia™ power handle, Signia™ power shell and Signia™ adapters. The reusable
insertion guide is intended to be used to help maintain the sterility of the Signia™ power shell
during insertion of the non-sterile Signia™ power handle. It is provided non-sterile and must be
sterilized prior to each use.
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, and 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.
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 reload, 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.
SCHEMATIC VIEW
A) REUSABLE INSERTION GUIDE
B) EXTENDED HANDLE
C) POWER SHELL
D) TOP SECURE CLIPS
INSTRUCTIONS FOR USE
Refer to the instructions for use provided with the Signia™ stapling system’s user manual, power
handle or power shell for detailed information on power handle insertion techniques and set-up
instructions. These instructions are not intended as a reference to surgical techniques.
INSERTING THE POWER HANDLE
PRECAUTION: Maintain aseptic transfer principles when inserting the power
handle into a sterile power shell with a sterilized reusable insertion guide. Use
caution not to contaminate the sterile shell during power handle insertion.
PRECAUTION: Ensure the power handle is sufficiently charged before use. See the
instructions for use provided with the power charger.
PRECAUTION: The reusable insertion guide is provided non-sterile. It must be
cleaned and sterilized prior to each use.
1. SCRUBBED PERSON: After aseptically removing the sterile power shell from the packaging,
carefully open the power shell by holding the back handle of the power shell so the front handle is
facing up and away from the back handle.
2. SCRUBBED PERSON: Align and fully seat a clean, sterilized reusable insertion guide onto the back
handle of the open power shell to provide an aseptic transfer guide when inserting the disinfected
power handle into the power shell.
A) INSERTION GUIDE
C) POWER SHELL
E) SCRUBBED PERSON
STEAM STERILIZATION
The Reusable Insertion Guide is provided non-sterile. It may be sterilized by steam autoclave by
placing it in a polyethylene breathable pouch, standard hospital wrap, or other suitable container.
Put the reusable insertion guide into the inserts provided, on its 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 Reusable Insertion Guide 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. 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.
3. Do not use flash steam sterilization. Use of flash steam sterilization will damage the device, and
may lead to malfunction.
EtO Sterilization
The following sterilization instructions apply to the use of EtO sterilization:
Hot Cycle Cold Cycle
Temperature Set Point 130 °F (54 °C) 100 °F (38 °C)
Ethylene Oxide Gas
Concentration
600-650 mg/L 650-700 mg/L
Relative Humidity 40-60% 40-60%
Exposure Time 2 hours minimum 6 hours minimum
Condition Wrapped Wrapped
MAINTENANCE
Inspect the reusable insertion guide for damage or wear prior to use. If the device is warped or
broken in any way, replace with a new reusable insertion guide.
STORAGE
Store at room temperature. Avoid prolonged exposure to elevated temperatures.
DISPOSAL
Discard or recycle as per local, state, and governmental regulations.
© 2016 Covidien.
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited, IDA Business & Technology Park, Tullamore.
www.covidien.com
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.
2016 / 06 - 1
Do not use if
package is opened
or damaged
Caution, consult
accompanying
documents
Consult
instructions
for use
18