Integra Miltex Membrane Tack Kit Handbuch

Integra Miltex
™
®
Membrane Tack Kit
Directions For Use
Directions For Use
Integra™ Miltex® Membrane Tack Kit
Device Description
Integra™ Miltex® membrane tacks are small titanium alloy nails intended
to fixate or stabilize guided tissue regeneration membranes during the
healing process by providing an attachment mechanism for the membrane
to local and adjacent bone at the surgical site. Membrane tacks are
used in conjunction with membrane tack placement instruments and
accessories provided in a kit. Membrane tacks are not intended for long-
term implantation, but should be removed upon completion of the healing
process. Integra™ Miltex® membrane tack kit consists of membrane tacks
and membrane tack placement instruments and accessories. Membrane tack
kit is provided NON-STERILE.
Integra™ Miltex® Membrane Tack Kit Components
• Membrane Tack Probe
• Membrane Tack Applicator
• Perforation Raspatory
• Double-ended Sinus 7 Instrument
• Sinus Elevator
• Mixing Cup with Lid
• Membrane Tack Storage Box
• Wash Tray with Lid
Indications For Use
Integra™ Miltex® membrane tacks are intended to fixate or stabilize guided
tissue regeneration membranes to bone at the surgical site.
Contraindications
Contraindications customary to the use of bone grafts and membrane
techniques should be observed. These include, but are not limited to:
• current local infection
• vascular impairment at the implant site
• uncontrolled diabetes
• chronic high dose steroid therapy
• clotting disorders
• current anticoagulant therapy
• metabolic bone disease and other metabolic or systemic disorders which
affect bone or wound healing
Warnings
• DO NOT reuse Integra™ Miltex® membrane tacks once applied.
• Advise patients to report any unusual changes of the operative site.
• Select the appropriate length of membrane tack based on appropriate
bone width and/or height. Premature clinical failure or other
complications may occur.
Precautions
• Before each use, sterilize and inspect instruments.
• Membrane tacks are only for implantation during the healing period
during which tissue regeneration takes place.
• This product (tacks) must be disposed of per standard protocol for
biohazardous materials due to potential exposure to blood borne
pathogens.
Adverse Effects
• Osteoporosis inhibited revascularization, bone re-absorption and poor
bone formation can cause loosening, bending, cracking and fracturing of
the device
• Delayed union, nonunion and mal-union of the fracture site resulting from
improper alignment
• Increased fibrosis tissue response around fracture site
• Early and late infection, both deep and/or superficial
• Nerve damage may occur as a result of surgical trauma
• Metal sensitivity reactions in patients following surgery
Directions FOR USE
Tack Placement
1. Sterilize tacks in Integra™ Miltex® tack storage box.
2. Prepare implantation site for membrane following membrane manufacturer's Instructions for
Use. The Integra™ Miltex® membrane tack probe may be used for membrane placement.
3. Transfer tacks to surgical site by firmly pressing tip of Integra™ Miltex® membrane tack
applicator onto head of membrane tack. (Please remove the tack applicator cover by pulling off
cap before use)
4. Deliver membrane tack to desired position over membrane.
5. Seating Tack:
a) Cancellous or "soft" bone
1. Seat tack by gently tapping end of Integra™ Miltex® membrane tack applicator with a
surgical mallet.
b) Cortico-cancellous, cortical or "hard" bone
1. Pre-puncture a small guide hole in desired bone location by placing Integra® Miltex™
perforation raspatory immediately over membrane at desired tack attachment site.
2. Tap Integra™ Miltex® perforation raspatory with a surgical mallet to insert guide puncture
into membrane.
3. Following preparation of guide hole, use pre-sterilized Integra™ Miltex® membrane tack
applicator to deliver tack into guide hole.
4. Seat tack by gently tapping end of Integra™ Miltex® membrane tack applicator with a
surgical mallet.
6. Disengage tack by rolling Integra™ Miltex® membrane tack applicator to one side, away from
perpendicular to the bone.
NOTE: Place special tip protector over Integra™ Miltex® membrane tack applicator tip when not
in use.
7. Written and radiographic documentation of number and location of tacks should be obtained
for later removal.
Tack Removal
1. When tissue regeneration is complete, remove membrane tacks by exposing the surgical site.
2. Pry head of membrane tack away from the underlying bone using a scalpel blade, periosteal
elevator or other similar thin, flat surface.
3. Removed membrane tacks should be accounted for and discarded. DO NOT reuse membrane
tacks.
4. Re-suture surgical site.
Sterilization Instructions
• Integra™ Miltex® membrane tack kit is supplied NON-STERILE and must be sterilized prior to
use.
• Before each use, sterilize and inspect instrument.
• Performance testing has validated that the recommended cycle parameters are safe and
effective and able to achieve a 10-6 SAL when sterilizing Integra™ Miltex® membrane tack kit for
the following sterilization cycles:
Gravity steam
Temperature 250ºF (121ºC)
Exposure time 30.0 minutes
Pre-vacuum steam
Temperature 270ºF (132ºC)
Exposure time 4.0 minutes
• Avoid using cold sterilants.
Symbols
Manufacturer
EC REP
Authorized Representative in the European Community
Catalog number
Lot number
CAUTION: See warnings or precautions
Consult instructions for use
CAUTION: Federal (USA) law restricts this device to sale by or on
the order of a dentist or physician.
CE 0297 Complies with requirements of EU Directive 93/42/EEC
2
Do Not Reuse
Integra York PA, Inc. 589 Davies Drive, York, PA 17402
866-854-8300 USA 717-840-2763 outside USA
717-840-9347 fax
integralife.com/integra-miltex
Integra LifeSciences Services (France) SAS Immeuble Sequoia 2
EC REP
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
Fax: 33 (0) 4 37 47 59 29
Integra and the Integra logo are trademarks of, and Miltex is a registered trademark of, Integra LifeSciences Corporation or its subsidiaries.
©2011 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. 500 L76-DENTTACKITDFU Rev A 06/13