en
Contents
Sterile unless package is
damaged or open.
Patents Pending
Non-absorbable
36cm
15
P
ERMA
F
IX
™ Fixation System
36cm / 15 Fasteners
36cm
30
P
ERMA
F
IX
™ Fixation System
36cm / 30 Fasteners
3.
The P
ERMA
F
IX
™
Fixation System can be used with most 5 mm trocars. Ensure compatibility by
inserting the device into the trocar prior to introduction into the patient. The P
ERMA
F
IX
™ Fixation
System should enter and exit the trocar easily without excessive force. The use of too much force
could damage the instrument.
4.
Counter pressure should be applied on the target area. Avoid placing hand/finger directly over the
area where fastener is being deployed to prevent injury.
5.
Insertion of fasteners is possible into some collagenous structures such as ligaments and tendons,
but the fasteners are not intended for use in bone or cartilage as this may damage the device.
6.
Avoid excessive trigger force as this may damage the device.
7.
If the device locks, remove the device from the patient and lightly tap the trigger forward toward the
tip to release.
8.
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.
9.
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 P
ERMA
F
IX
™
Fixation System may include, but are not limited to the following: hemorrhage, pain, edema, and erythema
at wound site; septicemia/infection; allergic reaction to acetal; hernia recurrence/wound dehiscence.
INSTRUCTIONS FOR USE
1.
Take the P
ERMA
F
IX
™ Fixation System out of the sterile package using sterile technique.
2.
Bring the prosthesis (mesh) or tissue into position. For tissue approximation, be sure that adequate
overlap of tissue exists.
3. For laparoscopic ventral hernia repair it is recommended to reduce the pneumoperitoneum
appropriately for better abdominal wall compliance and optimal fastener depth penetration.
4.
Place the tip of the P
ERMA
F
IX
™ Fixation System at the desired location perpendicular (90 degree
angle) to the mesh or tissue and apply adequate pressure. Different types of mesh may require
different amounts of counterpressure. Adjust angle and counterpressure appropriately.
5.
Compress handpiece trigger in a single, complete and uninterrupted stroke to drive a permanent
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.
6.
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.
7.
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.
8. Care should be taken to ensure that the prosthesis (mesh) is adequately fixated to the abdominal wall.
If necessary, additional fasteners and/or sutures should be used.
9.
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 P
ERMA
F
IX
™ Fixation System at room temperature. Avoid prolonged exposure to elevated
temperatures. It is for single use only. Do not use if the package is damaged or open.
Copyright © 2009, 2010 C. R. Bard, Inc. All Rights Reserved.
Bard, Davol and PermaFix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
PK3795440 BAW-12.indd 3
PK3795440 BAW-12.indd 3
3/11/2011 8:32:56 AM
3/11/2011 8:32:56 AM
