Cardica MicroCutter XCHANGE 30 Gebrauchsanleitung Seite 4

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CAUTION: Failure to completely fire the Stapler will result in an
incomplete cut and/or incomplete staple formation, which may
result in poor hemostasis and/or leakage.
3.3.3. Reset & Unclamp:
3.3.3.1. To unclamp the Stapler Jaws, pull the
Return Slide completely back towards the Rotation Knob.
3.3.3.2. Gently remove the Stapler from the tissue.
3.3.3.3. To remove the Stapler from the Trocar
approximate the Jaws, by partially pulling the Trigger.
3.3.3.4. Pull the Jaws up against the Trocar then
release the Trigger and continue pulling the Stapler through
the Trocar.
OK
MicroCutter XCHANGE
Control Number: 103234
Revision: H
2x
2x
Jaw Open
® 30
- Instructions For Use
Page 7 of 38
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3.3.4. Unload & Reload:
3.3.4.1. Carefully push upward (toward the Anvil) to
unsnap the used Cartridge from the Channel. A fine tip
forcep, Cartridge Retainer, or Cardica Unloader if supplied,
can be used to push the Cartridge tip out of the Channel.
Discard the used Cartridge. See below for instruction:
CAUTION: Failure to completely clear the Stapler Jaws of loose
Staples or obstructions prior to firing can cause an incomplete
cut and incomplete staple formation, and will result in poor
hemostasis that may require surgical intervention.
3.3.4.2. Prior to reloading the instrument, rinse the
Stapler Jaws in sterile solution and then wipe the Anvil and
Channel to clear any loose Staples.
WARNING: Do not use the Stapler until it has been visually
inspected to confirm there are no Staples on the Anvil and
Channel.
3.3.4.3. Refer for loading instructions in previous
section.
4. How Supplied
®
The MicroCutter XCHANGE 30 Stapler is provided STERILE and is intended for
SINGLE patient use. DISCARD AFTER USE.
The MicroCutter XCHANGE ® 30 Cartridges are provided STERILE and are
intended for SINGLE patient use. DISCARD AFTER USE.
5. Packaging/Storage
®
All MicroCutter XCHANGE 30 Staplers and Cartridges should be stored at room
temperature. Avoid prolonged exposure to elevated temperatures.
6. MRI Information
The MicroCutter Staple was determined to be MR-conditional according
to the terminology specified in the American Society for Testing and
Materials (ASTM) International, Designation: F2503-08. Standard Practice
for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment. ASTM International, 100 Barr Harbor Drive,
P.O. Box C700, West Conshohocken, PA, USA.
for further information.
7. Patent Information
Patents are pending in the United States and other countries.
MicroCutter XCHANGE
Control Number: 103234
Revision: H
Jaw Clamped
Contact Cardica, Inc.
® 30
- Instructions For Use
Page 8 of 38