Cardica MicroCutter XCHANGE 30 Gebrauchsanleitung

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INST TRUCTIONS F
Syste em Description
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The M MicroCutter XCHANGE E 30 Stapler is a s
loaded d with a MicroCutter XCHANGE
316L st tainless steel staples s while simultaneous
two, d double staple rows. T The MicroCutter XCH
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XCHAN NGE 30 Cartridge are e designed for intro
trocar cannula or larger. Th he staple line length
loaded d, fired, and reloaded d with the MicroCutt
the nu umber deployments indicated on pack
proced dure. The Stapler ca an fire different siz
staple indicated by the colo or of the MicroCutter
Shaft
A Anvil
Jaws
Ch hannel
Tissue St op
Cartridge (Sta
Cartrid dge (Curved Tip)
Note: O Other accessories ma ay be provided to assi
BEFO ORE USING MICRO OCUTTER PRODU
FOLL LOWING INFORMA ATION COMPLETE
MicroCutter
Control Number: 103234
Revision n: H
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FOR USE
ingle patient device e that, when
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30 Cartri dge, delivers two do ouble rows of
sly transecting tissue between the
®
ANGE 30 Stapler and d MicroCutter
duction and use thr rough a 5 mm
is 30 mm long. The S Stapler can be
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ter XCHANGE Cartri dge for up to
kage label in a si ingle surgical
ed staples, with the e size of the
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r XCHANGE Cartridge es.
Rotation Kno ob
Articulation
Retu urn Slide
Buttons
Mode
Selector
Button
Handle
Trigger T
Staple Slots
ndard)
ist with device usage
CTS, PLEASE REA AD THE
ELY AND THORO OUGHLY.
XCHANGE ® 30
- Instruc ctions For Use
Page 1 of 38
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Important
This booklet is designed to assist in using this product, providing detailed
instructions on the use of the MicroCutter XCHANGE
reference on surgical techniques.
Indications
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The MicroCutter XCHANGE 30 is intended for the transection, resection, and/or
creation of anastomoses. The instrument has applications in multiple general,
gynecologic, urologic, thoracic, and pediatric surgical procedures.
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MicroCutter XCHANGE system can be used to blunt dissect or separate target
tissue from other tissue.
Contraindications
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1. The MicroCutter XCHANGE 30 White Cartridge is designed for tissue
that is easily compressible to 1.0 mm.
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2. The MicroCutter XCHANGE 30 Blue Cartridge is designed for tissue that
is easily compressible to 1.5 mm.
3. Do not use the Stapler on ischemic or necrotic tissue.
4. Do not use the Stapler on the aorta.
5. The Stapler is not intended for use when surgical stapling is contraindicated.
Precautions
1. Do not load or fire the MicroCutter XCHANGE
on the package label.
2. The Staplers are shipped without a Cartridge and must be loaded prior to
use. Use only the indicated MicroCutter XCHANGE
®
MicroCutter XCHANGE 30 Stapler. Do not use MicroCutter XCHANGE
Cartridges in an instrument other than the designated MicroCutter
XCHANGE ® 30 Stapler.
3. Do not use a Cartridge if there is any portion of the staples exposed above
the surface. If the Cartridge is not replaced then the Stapler will not fire.
4. Always inspect tissue thickness and select the MicroCutter XCHANGE
Cartridge with the appropriate size Staples prior to firing. Consideration
should be given to existing pathological conditions, such as preoperative
radiotherapy, which may cause changes in tissue thickness that would fall
outside the indicated range of tissue for the standard choice of staple size.
5. When positioning the Stapler Jaws at the target site, ensure that no
obstructions are present such as Staples, clips, stents, guide wires, etc.
Firing over an obstruction may result in incomplete transection, improperly
formed Staples, and impact the release from tissue.
6. The Stapler will cut and staple any tissue clamped between the Jaws.
Use caution to ensure that only structures intended to be cut and
stapled are within the Stapler Jaws.
7. Attempting to grasp too much tissue between the Jaws will prevent the
Stapler from fully clamping and also prevent firing. Firing in excessively thick
or thin tissue may result in an incomplete deployment and / or poor staple
formation.
8. After the orange Mode Selector button is activated, pulling the Trigger
will fire the Stapler.
9. Failure to completely fire, or to fully reset the MicroCutter XCHANGE
30 System will result in an incomplete cut and/or incomplete staple
formation, which may result in poor hemostasis and/or leakage.
10. The compatibility of staple
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MicroCutter XCHANGE 30 System has not been determined.
MicroCutter XCHANGE
Control Number: 103234
Revision: H
®
30 System. It is not a
The
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30 Stapler more than indicated
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30 Cartridges in the
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30
®
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line reinforcement material with
® 30
- Instructions For Use
Page 2 of 38