Covidien Sonicision SCDA13 Mode D'emploi page 6

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Warning
Use the device with caution when operating
in close proximity to external or implanted
electronic medical devices. Electromagnetic
interference produced by the proximity of
the ultrasonic generator can potentially
cause a device to enter an unsafe mode.
There is also a possibility that a nearby
electronic device could alter the
performance of the Sonicision device.
Consult the manufacturer of the external or
implanted electronic device or responsible
hospital department for further information
when use is planned in close proximity to
such devices.
Infection hazard Non-sterile components
may contaminate the sterile field and place
the patient at risk for infection.
• Do not use the dissector if the sterile
package is opened, damaged, or has
exceeded the expiration date.
• Generators and battery insertion guides
are provided non-sterile and must be
cleaned and sterilized prior to first use and
for each reuse. Refer to the cleaning and
sterilization instructions in the Sonicision
Curved Jaw Cordless Ultrasonic Dissection
System User's Guide.
• Battery packs are non-sterile and cannot
be sterilized. The battery pack must be
aseptically inserted into the dissector
according to instructions. See Inserting the
Battery Pack on page 7.
Fire and Burn Hazard The clamping jaw,
active blade, and distal 6 cm of the shaft are
hot during, and for a period of time after
activating the device. Avoid the potential for
fire and unintended burns by always keeping
the distal end of the device in sight and away
from direct contact with adjacent tissue,
textiles, and other flammable materials
during and for a period of time after
activation.
Precaution
Ensure that the battery pack is sufficiently
charged before use. Refer to the Sonicision
Curved Jaw Cordless Ultrasonic Dissection
System User's Guide for charging instructions.
Use of a battery pack that is not full charged
can result in a procedural delay.
Use only Sonicision components listed in the
compatibility table on the front cover.
Components from other manufacturers are
not compatible with this system and may
cause injury to the patient and operator.
6
Important
Instructions provided in this document are
limited to the initial assembly, change of a
battery pack during a procedure, and
disassembly of the device. Refer to the
Sonicision Curved Jaw Cordless Ultrasonic
Dissection System User's Guide provided with
the Sonicision Reusable Generator for
complete information and important
warnings and cautions.
Medical equipment needs special
precautions regarding EMC and needs to be
installed and put into service according to
the EMC information provided in the
Sonicision Curved Jaw Cordless Ultrasonic
Dissection System User's Guide.
Contact Covidien to obtain additional or
replacement copies of the instructions for
use and Sonicision Curved Jaw Cordless
Ultrasonic Dissection System User's Guide if
needed.
Notice
This device is intended to be used with a
5mm trocar when used endoscopically.
Verify proper trocar size and compatibility
prior to using the device in a procedure.
Ensure the battery pack connector is dry.
Attaching a battery pack or inserting into the
battery charger when the connector is wet
may damage the components.
Battery packs are shipped with a low state of
charge and must be charged upon receipt.
To avoid electrostatic-damage to a battery
pack, do not touch the battery pack
connector.
Description
The Sonicision Curved Jaw Cordless Ultrasonic
Dissector is a sterile, singe-use component for
use with the Sonicision Reusable Generator
and Reusable Battery Pack. The dissector
provides control for device functions such as
power levels, blade placement and position,
grasping, coagulating, and dissecting tissue. It
is designed to be inserted and extracted
through a compatible 5 mm trocar, when used
endoscopically. Refer to the figure on page 5
for dissector features.
Assemble the Sonicision Curved Jaw
Cordless Ultrasonic Dissection
Device
Complete assembly of a working Sonicision
Curved Jaw Cordless Ultrasonic Dissection
Device requires the following components: