Bard SORBAFIX Gebrauchsanweisung Seite 3

9. If the device locks and cannot be separated from a fastener that has been deployed into tissue, you may rotate
the device counter clockwise to free the device. The locked device should then be discarded and a new device
should be used.
10. If the fastener does not deploy properly, remove the device from the patient and test the device in air to ensure
proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into
the patient.
ADVERSE REACTIONS
Adverse reactions and potential complications associated with fixation devices such as the S
Fixation System may include, but are not limited to the following: hemorrhage; pain, edema and erythema at wound
site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.
INSTRUCTIONS FOR USE
1. Take the S F ™ Absorbable Fixation System out of the sterile package using sterile technique.
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2. Precaution: The S
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compatibility by inserting the device into the trocar prior to introduction into the patient. The S
Absorbable Fixation System should enter and exit the trocar easily without excessive force. The use of too
much force could damage the instrument.
3. Bring the prosthesis (mesh) or tissue into position.
4. Precaution: Do not use this device where hemostasis cannot be verified visually after application.
5. Place the tip of the S
apply adequate pressure.
6. Precaution: Counter pressure should be applied on the skin of the abdominal wall. Avoid placing hand/finger
directly over the area where fastener is being deployed to prevent injury.
7. Compress hand piece trigger in a single, complete and uninterrupted stroke to drive an absorbable fastener
through the mesh into the tissue. Keep consistent pressure on the tip of the device through the entire stroke.
Release the trigger allowing it to return completely to its resting position. Repeat this procedure until all
required fasteners are deployed.
8. Precaution: If the device locks, remove the device from the patient and lightly tap the trigger forward toward
the tip to release.
9. Precaution: Insertion of fasteners is possible into some collagenous structures such as ligaments and
tendons, but is NOT possible directly into bone or cartilage. This may damage the device.
10. Precaution: If the device locks and cannot be separated from a fastener that has been deployed into tissue,
you may rotate the device counter clockwise to free the device. The locked device should then be discarded
and a new device should be used.
11. Precaution: If the fastener does not deploy properly, remove the device from the patient and test the device
in air to ensure proper fastener deployment. Once proper fastener deployment is confirmed, the device may
be reinserted into the patient.
12. The device should be considered a sharp during handling and disposal. To minimize exposure of sharp or
unintended fastener delivery, do not actuate the trigger during removal from the trocar.
13. The fasteners should be placed entirely in tissue and the head of the fastener should be firm against the mesh
or tissue in order to achieve the best fixation performance. If the fastener head is not flush in mesh or tissue,
use a grasper to fully seat the fastener by turning the grasper clockwise. If the fastener still does not fully seat,
use a grasper to remove the fastener by turning the grasper counter clockwise and place another fastener in
the same area.
14. After successful deployment of all required fasteners, handle and dispose of in accordance with any local and
federal laws regarding medical waste and sharps disposal requirements to prevent sharps injury.
STORAGE
Store the S F ™ Absorbable Fixation System in a dry environment at a temperature less than 40°C (104°F). It
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is for single use only. Do not use if the package is damaged or open, or if the temperature indicator is black.
Copyright © 2009 C. R. Bard, Inc. All Rights Reserved.
Bard, Davol and SorbaFix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Contents
See package insert for
Instructions for use.
Sterile unless package is
damaged or open.
Patents Pending
Absorbable
F ™ Absorbable Fixation System can be used with most 5 mm trocars. Ensure
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F ™ Absorbable Fixation System at the desired location on the mesh or tissue and
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Laparoscopic 36CM
S F ™ Absorbable Fixation System
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30
Laparoscopic 36cm
36CM
30 Absorbable Fasteners
S F ™ Absorbable Fixation System
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15
Laparoscopic 36cm
36CM
15 Absorbable Fasteners
F ™ Absorbable
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F ™
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