Medtronic SIGADAPTSTND Instructions for Use

Signia™

Linear Adapters

PT00167990

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A

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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

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.

Signia™ linear adapters, when connected with compatible stapling reloads, can articulate from 0 degree to approximately
45 degrees in either direction unless otherwise specified in the reload indications for 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, 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) SINGLEUSE 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.

LOAD

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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 Signia™ linear 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 Signia™ linear adapter is provided non-sterile. Clean and sterilize before each use.

6. Powered Shell is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE

7. Do not flash sterilize (immediate-use sterilize) the adapter.

8. 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 gammasterilization to sterilize the adapter.

9. 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.

10. 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.

11. 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.

12. Do not attach an adapter to the power shell prior to inserting a power handle into the power shell.

13. 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.

14. Do not use the adapter if the packaging or the device appears damaged.

15. 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.

16. A thorough understanding of the principles involved in laser and electrosurgical procedures is essential to avoid shock and burn
hazards to both patient and operators and damage to the instrument.

17. 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.

18. Ensure that the staple reloads are compatible with the staplers.

19. 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 openinthe stapling reload. Professional experience
should be used to assess patient status when deciding the best course of action.

20. Compatibility of other manufacturer’s staples and staplers has not been determined.

21. For all adverse reactions related to the Signia™ stapling system, refer to the Signia™ user manual.

22. 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.

23. Avoid use of the device on the aorta.

LIMITATIONS ON PROCESSING

Covidien has reliability studies for these devices for up to 50 procedural uses. The power handle is a reusable device and will deactivate
after reaching the end of its service life.

The device will not deactivate during use. The device number of uses remaining indication is provided on the power handle OLED
display.

NOTE: Whenever a linear stapler is removed and then reinserted there is a chance of increased
contamination, and tissue trauma during insertion and placement. The same level of care should be used
when inserting the linear stapler for all insertions.

Performing subsequent firings in the same procedure:

Remove the stapler system from the surgical site, detach and discard the reload. Detach and then reattach the Signia™ linear adapter,
waiting five seconds between disconnecting and connecting so that the Signia™ stapler can register the change and reset. Repeat
setup procedures as defined in Step 2 of the setup section.

NOTE: When performing subsequent staple firing it is important to make sure that the adapter is clean of
debris. Debris can prevent the contacts between the adapter and the reload from properly connecting and
the system will not recognize the reload. If this happens, please remove the reload and try to clean the
adapter contacts and reconnect the reload. If the reload cannot be recognized, then the adapter is too dirty
and must be sent for a full cleaning and a new adapter must be used.

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.

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).

4. a. 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.

b. 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 occurring 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

Enzymatic1 or Alkaline2 Detergent Diluted per

the manufacturer’s specifications

Rinse 0:15 Hot Tap Water N/A

Wash 03:00 Hot Tap Water

Enzymatic1 or Alkaline2 Detergent Diluted per

the manufacturer’s specifications

Rinse 00:15 Hot Tap Water N/A

Thermal Rinse 05:00

Hot Purified Water heated to

95°C (203°F)

N/A

Dry 06:00 High Setting 95°C (203°F) 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.

PRESTERILIZATION DISINFECTION OPTIONAL:

In facilities that require disinfection before sterilization, the thermal cycle during the automatic cleaning process should be
programmed for 5 minutes at 95°C (203°F).

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: 132°C (270°F)
Exposure time: 4 minutes
Vacuum dry time: 20 - 40 minutes
134°C Pre-vacuum (Hi Vac) Steam Cycle
Exposure temperature: 134°C (273°F)
Exposure time: 3 minutes
Vacuum dry time: 20 - 40 minutes

Outside USA (OUS)

Minimum recommended

Pre-vacuum Steam Cycle Cycle Cycle Cycle

WHO¹ 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: Dynamic-air-removal steam sterilizers achieve air removal through a preconditioning phase.
Ensure to follow the sterilizer manufacturer’s instructions for proper preconditioning.

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
(279°F), 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 137°C (279°F), 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: 54°C (130°F)
Ethylene Oxide Gas Concentration: 600-650 mg/L
Relative Humidity: 40-60%
Exposure Time: 2 hours minimum
Condition: Wrapped

Cold Cycle:

Temperature Set Point: 38 °C (100 °F)
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.

STORAGE

Store at room temperatures 10-40°C (50-104°F) and relative humidity (30%-75%).

DISPOSAL

Discard or recycle as per local, state, and governmental regulations.

PRODUCT CLASSIFICATION PER IEC 606011

Type of protection against electric shock: Internally powered (battery)
Battery ratings: Lithium ion, 7.2 V, 2050 mAh
Degree of protection against electric shock: Type CF applied part
Not suitable for use in presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Mode of operation: Continuous mode

ELECTROMAGNETIC COMPATIBILITY GUIDANCE EN/IEC 6060112
PRECAUTION: The adapters are considered medical electrical equipment. Medical electrical equipment

requires special precaution regarding electromagnetic compatibility (EMC), and needs to be installed and
put into service according to the EMC information provided in this document.

PRECAUTION: Portable and mobile RF communication equipment can affect medical electrical equipment.

WARNING: The use of accessories other than those specified and sold by Covidien may result in increased
emissions or decreased immunity of the stapler and adapter.

WARNING: The adapter should not be used adjacent to other equipment. If adjacent use is necessary, the
stapler and adapter should be observed to verify normal operation in the configuration in which it will be
used.

Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

The adapter is intended for use in the electromagnetic environment specified below. The customer or

the user should ensure they are used in such an environment.

Emissions test Compliance Elec tromagnetic environment—guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

IEC 61000-3-2

Harmonic emissions

Voltage fluctuations /

flicker emissions

IEC 61000-3-3

Group 1 The adapter uses RF energy only for its internal function. Therefore, their

Class A The adapter is a low-voltage battery-operated device and is suitable for use in

Class A

RF emissions are very low and are not likely to cause any interference with

The Emissions characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential

environment (for which CISPR 11 class B is normally required) this equipment

N/A

might not offer adequate protection to radio-frequency communication

services. The user might need to take mitigation measures, such as relocating

nearby electronic equipment.

all establishments other than domestic buildings.

or re-orienting the equipment.

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The adapter is intended for use in the electromagnetic environment specified below. The

customer or the user should ensure they are used in such an environment.

Immunity test

Electrostatic discharge

(ESD)

IEC 61000-4-2

Electrical fast transient

/ burst

IEC 61000-4-4

Surge

IEC 61000-4-5

IEC 60601
test level

±8 kV contact

±15 kV air

±2 kV for power

supply lines

±1 kV for input/output lines

+/- 0.5 kV and 1 kV differential

mode

+/- 0.5 kV, 1 kV and 2 kV

common mode

Compliance

level

±8 kV contact

±15 kV air

N/A

N/A

Electromagnetic

environment—guidance

Floors should be wood, concrete,

or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be

at least 30%.

The power handle, adapter and

power shell are low-voltage

battery-operated devices

and are suitable for use in all

establishments.

The power handle, adapter and

power shell are low-voltage

battery-operated devices

and are suitable for use in all

establishments.

<0% UT (>100% dip in UT)

For 0.5 cycle at 0°, 45°, 90°,

Voltage dips, short

interruptions, and voltage

variations on power

supply input lines

IEC 61000-4-11

135°, 180°, 225°, 270°, 315°

40% UT (60% dip in UT)

For 5 cycles 70% U

(30% dip in UT)

T

For 25/30 cycles

N/A

The power handle, adapter and

power shell are low-voltage

battery-operated devices

and are suitable for use in all

establishments.

<0% UT (>100% dip in UT)

For 250/300 cycles

Power frequency (50/60

Hz) magnetic field

IEC 61000-4-8

30 A/m 30 A/m

The power handle, adapter and

power shell are low-voltage

battery-operated devices

and are suitable for use in all

establishments.

Note: UT is the AC mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The adapter is intended for use in the electromagnetic environment specified below. The

customer or the user should ensure they are used in such an environment.

Immunity test

Conducted RF

IEC 61000-4-6

IEC 60601 test

level

3Vrms

150 kHz to 80 MHz

Compliance

level

3 V

Electromagnetic Environment—Guidance

Portable and mobile RF communications equipment

should be used no closer to any part of the power
handle, adapter and power shell, including cables,

than the recommended separation distance

calculated from the equation applicable to the

frequency of the transmitting device.

Recommended separation distance

150 kHz to 80 MHz

d = 1.2√P

6 Vrms

ISM frequency bands

6 V

80 MHz to 800 MHz

d = 0.5√P

800 MHz to 2.7 GHz

d = √P

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.7 GHz

7 V/m

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a

should be less than the compliance level in each

frequency range.

Interference may occur in the vicinity of equipment

marked with the following symbol:

b