Signia™
Power Handle
PT00167989
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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™ power handle is a reusable, battery-powered stapling handle that is designed as part of the Signia™ stapler,
which is composed of the Signia™ power handle, Signia™ power shell and Signia™ adapters. The power handle includes a
microprocessor, electronics, motors, an OLED display screen and a rechargeable Li-ion battery in a sealed packet.
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.
COMPATIBILITY
The power handle, when combined with a power shell and adapter, becomes the Signia™ stapler. Refer to the Signia™
stapling system’s user manual for compatible single use stapling reloads.
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,
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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. Refer to the Instructions for Use provided with the compatible reloads for reload specific indications,
contraindications, warnings, and precautions.
PRECAUTIONS
1. Refer to the Instructions for Use provided with the Signia™ stapling system’s user manual for additional specific precautions.
2. The power handle is a precise instrument. Care should be taken to avoid dropping, improper cleaning, improper handling or
sterilizing the device. These actions may shorten device life and/or lead to device failure.
3. The power handle is provided non-sterile. DO NOT STERILIZE.
4. Ensure the battery is sufficiently charged prior to use. Refer to the Instructions for Use provided with the associated charger.
5. REMOVE the power handle from the used power shell after use.
6. Ensure the power handle is completely dry prior to inserting it into a sterile power shell or charger.
7. Do not hold or carry the stapler by the distal end of the adapter or stapling reload.
8. The Signia™ power handle should be cleaned when it appears dirty or contaminated and following each use the adapter or by
the stapling reload.
9. Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic
techniques. Prior to performing endoscopic procedures, consult the medical literature relative to techniques, complications, and
hazards.
10. A thorough understanding of the principles involved in laser and electrosurgical procedures is essential to avoid shock and burn
hazards to the patient and operators, as well as damage to the instrument.
WARNING: Avoid use of the device on the aorta.
SCHEMATIC VIEW
A) POWER HANDLE
B) DATA CONFIGURATION PORT
C) MOTORS
D) ELECTRONIC CONNECTORS
E) OLED DISPLAY SCREEN
INSTRUCTIONS FOR USE
Refer to the Instructions for Use provided with the Signia™ stapling system’s user manual for detailed instructions on set up and use.
SET UP
NOTE: The power handle unit is shipped in the OFF mode.
When receiving a new power handle, turn it on by placing the power handle into a charger terminal facing forward and the base of
the handle onto the terminal from back to front until a secure connection is established. The device will turn on and begin initializing.
CHARGING
NOTE: Refer to the charger Instructions for Use or the Signia™ stapling system’s user manual for complete
information related to charging power handle devices.
1. Insert the power handle into the battery charger, placing it into the battery charger bay facing forward and the base of the handle
onto the terminal from back to front until a secure connection is established.
2. Upon its first activation, charge the power handle for a minimum of three hours before clinical use.
3. Recharge the power handle after each use.
INSERTING THE POWER HANDLE
PRECAUTION: The non-sterile power handle must be inserted into a sterile power shell with a sterilized
reusable insertion guide while maintaining aseptic transfer principles. Use caution when inserting the
power handle so as not to contaminate the sterile shell.
PRECAUTION: Ensure the power handle is suciently charged before use. See the Instructions for Use
provided with the charger.
PRECAUTION: The reusable insertion guide is provided non-sterile. It must be cleaned and sterilized prior
to each use. Refer to the Instructions for Use provided with the reusable insertion guide for cleaning and
sterilization instructions.
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 power handle into the power shell.
F) REUSABLE INSERTION GUIDE
G) POWER SHELL
H) SCRUBBED PERSON
PRECAUTION: Ensure the reusable insertion guide is properly seated onto the power shell before inserting
the power handle.
3. CIRCULATING PERSON: Maintaining aseptic transfer techniques, insert the power handle into the reusable insertion guide and
power shell.
A) POWER HANDLE
H) SCRUBBED PERSON
I) CIRCULATING PERSON
4. CIRCULATING PERSON: After the power handle is fully seated in the power shell, carefully remove the reusable insertion guide
using the extended handle. J) EXTENDED HANDLE
H) SCRUBBED PERSON
I) CIRCULATING PERSON
5. SCRUBBED PERSON: Taking care not to touch the power handle, close the front portion of the power shell until there is
tactile confirmation the base of the power shell is closed and the top secure clips are secured. This confirms the shell is
fully closed and securely locked.
K) OP SECURE CLIPS
PRECAUTION: Ensure both top secure clips are secured before use.
Operational Use
Refer to the Signia™ stapling system’s user manual for complete information regarding controls and communications.
Removing the Power Handle
1. Release top secure clips, press the secure latch, and carefully open the power shell to expose the power handle.
2. Remove the power handle with a clean glove.
CLEANING THE POWER HANDLE
PRECAUTIONS AND WARNINGS
NOTE: The power handle is made from metal, electronics, and plastic.
NOTE: 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.
1. The power handle is provided non-sterile. Clean after each use. DO NOT STERILIZE.
2. Do not rinse under running water or submerge. Avoid moisture on the gold electrical contacts on the bottom and
front face.
3. Do not use alcohol, quaternary ammonium, and bleach based wipes as they may cause physical deterioration of the
handle housing such as discoloration, embrittlement, or cracking. Only use the cleaning methods described in this
manual to maximize the physical characteristics of the handle housing.
4. Do not use instrument lubricant on the power handle.
TO CLEAN THE POWER HANDLE
1. Wipe down all exposed surfaces with a slightly water dampened lint-free cloth to completely remove any gross debris
from the device.
2. If additional cleaning is required, use a hydrogen peroxide based wipe such as Oxivir™* Tb per the manufacturer’s
instructions.
3. Ensure the power handle is completely dry prior to inserting it into a sterile power shell or charger.
MAINTENANCE
Inspect the power handle for damage or wear prior to use including bent electrical connectors, buildup of debris in
electrical contacts or cracking of the power handle housings.
STORAGE
Return the power handle to a battery charger for charging and storage. Store at room temperatures (50 °F-104 °F or 10 °C- 40 °C)
and relative humidity (30%-75%).
DISPOSAL
NOTE: Contact Covidien customer service prior to recycling and disposing of to confirm contracted
recycling and disposal agreements. Contact customer service at http://www.covidien.com/
sales-support or by dialing 1-800-722-8772. Recycle the power handle by returning it to the
manufacturer.
PRODUCT CLASSIFICATION PER IEC 606011
Type of protection against electric shock: Internally powered (battery)
Battery ratings: Lithium ion, 14.8 V, 2150 mAh
Degree of protection against electric shock: Type CF applied part
Degree of protection against ingress of water: IPX4
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 6060112
PRECAUTION: The power handle is considered medical electrical equipment. Medical electrical
equipment requires special care 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 aect 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 power handle.
WARNING: The power handle should not be used next to other equipment. If adjacent use is
necessary, verify the power handle is operating normally.
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The power handle is intended for use in the electromagnetic environment specified below. The
customer or user should ensure they are used in such an environment.
Emissions test Compliance Electromagnetic Environment—Guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions IEC
61000-3-3
Group 1
Class B
N/A
N/A
The power handle uses RF energy only for its internal function.
Therefore, RF emissions are very low and not likely to cause any
interference with nearby electronic equipment.
The power handle is a low-voltage battery-operated device and is
suitable for use in all establishments.
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The power handle 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 IEC 60601 test level
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transient
/ burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential mode
±2 kV common mode
<5% U
(>95% dip in UT)
for 0.5 cycle
40% U
(60% dip in UT)
for five cycles
70% U
(30% dip in UT)
for 25 cycles
<5% U
(>95% dip in UT)
for five seconds
3 A/m N/A
Compliance
level
±6 kV contact
±8 kV air
N/A
N/A
T
T
T
T
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 is a low-voltage
battery-operated device and is suitable
for use in all establishments.
The power handle is a low-voltage
battery-operated device and is suitable
for use in all establishments.
The power handle is a low-voltage
battery-operated device and is suitable
for use in all establishments.
The power handle is a low-voltage
battery-operated device and is 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 power handle is intended for use in the electromagnetic environment specified below. The customer
Immunity
test
Conducted RF IEC
61000-4-6
or user should ensure they are used in such an environment.
IEC 60601
test level
150 kHz to 80
3 Vrms
MHz
Compliance
level
3V
Electromagnetic Environment—Guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the power handle, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitting device.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 1.2√P 800 MHz to 2.5 GHz
Radiated RF IEC
61000-4-3
3 V/m
80 MHz to
2.5 GHz
where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
3V/m
the recommended separation distance in meters (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
Note 1. At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless), telephones, and land mobile radios;
amateur radio; AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the power handle, adapter and power shell are used exceeds the applicable RF compliance
level above, the power handle, adapter and power shell should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the power handle, adapter and power shell.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and
The power handle is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the power handle, as recommended below, according to the maximum
Rated maximum
output power of
transmitter (W)
the Power Handle
output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 1.2√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer. Note 1. At 80 MHz and 800 MHz, the separation distance
for the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
en: Non sterile
en: Caution: U.S. Federal law restricts this device to sale by or
on the order of a physician.
en: Do not resterilize
en: Do not use if package is damaged
en: Consult instructions for use
en: Caution, consult accompanying documents
90%
en: Transport humidity limitation
101.3 kPa
en: Transport atmospheric pressure
54.9 kPa
140°F
-20.2°F
-29°C
60°C
en: Transport temperature limitations
en:
en: Type CF applied part
IPX3
16.8V/1.5A
en: Protection against uid ingress: Drip-proof
en: Direct current
en: TÜV mark (SÜD)
© 2016 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/ 03
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