KometaBio Smart Dentin Grinder User manual

–
Smart Dentin
Grinder™
User Guide
Tissu
e
Engineerin
g
Bon
e
Graftin
g
P
rocess
Version
1.2

Smart Dentin Grinder User Guide
About This Guide
2
Thank you for purchasing the Smart Dentin Grinder™, which enables you to create a
patient’s own autologous bone graft within less than 15 minutes!
Thanks to this solution, extracted teeth are no longer considered to be clinical waste.
Extracted teeth can now be used as an autologous bone graft, which is the golden
standard of grafting. With Smart Dentin Grinder™, a few short steps easily transform
an extracted tooth into a sterile and clean dentin particulate ready for grafting.
We are certain that this autologous graft will provide you with optimal results.
This user guide is intended for dental practitioners. It describes how to use the Smart
Dentin Grinder.
•
Chapter 1, Introducing the Smart Dentin Grinder Process, page 7, introduces the
Smart Dentin Grinder and describes its components and how it works.
•
Chapter 2, Using the Smart Dentin Grinder, page 13, describes how to transform
an extracted tooth into a sterile and clean particulate dentin ready for grafting.
•
Appendix A, Specifications, page 27, describes the specifications for the Smart
Dentin Grinder.
•
Appendix B, Labeling, page 28, shows the label that appears on the Smart Dentin
Grinder.

Important Notice
3
Important Notice
Copyright © 2013 by Kometa Bio International. All rights reserved.
All intellectual property rights in this publication are owned by Kometa Bio International. and
protected by applicable copyright laws and international treaty provisions. Kometa Bio
International. retains all rights not expressly granted. No part of this publication may be reproduced
in any form whatsoever or used to make any derivative work without prior written approval by
Kometa Bio International.
Kometa Bio International. reserves the right to revise this publication, and/or make improvements or
changes in the product(s) and/or the program(s) described in this documentation at any time without
prior notice. The information in this document is provided in good faith. However, it is provided without
any
w
a
rra
n
ty
that it is accurate or complete and on the express understanding that Kometa Bio
International. shall have no liability whatsoever to other parties in any way arising from or relating to
the information or its use.
Any product described in this publication is furnished under its own license agreement.
All other trademarks or registered trademarks are the property of their respective owners.
Date: 05/2013
Document #: 13-10-01
Document Version: 1.0
Device Version: 1.1
Patent Pending No. US61/752,453
CE Representative: Mr. Kfir Atias
2 Devonshire Place W16HG
London, England
Telephone: 08000842417

4
Smart Dentin Grinder User Guide
Table of Contents
About This Guide.................................................................................................... 1
Important Notice.................................................................................................... 3
Table of Figures...................................................................................................... 5
Documentation Conventions ....................................................................... 5
Safety Information ................................................................................................. 6
Chapter 1: Introducing the Smart Dentin Grinder Process........................................ 7
What is the Smart Dentin Grinder? ................................................................. 7
Device Intended Use ................................................................................ 7
Indications for Use.......................................................................................... 7
Contraindications ........................................................................................... 7
Smart Dentin Grinder Components.................................................................... 8
Sterile Disposable Chamber ........................................................................ 9
Basic Cleansing Solution and Containers ................................................... 10
Hot Plate................................................................................... ................. 10
How Does the Smart Dentin Grinder Work? ..................................................... 11
Step 1, Using the Patient’s Own Teeth....................................................... 11
Step 2, Grinding the Teeth ......................................................................... 11
Step 3, Sterilizing the Particulate ............................................................... 12
Chapter 2: Using the Smart Dentin Grinder ............................................................13
Workflow Overview....................................................................................... 13
Step 1, Preparing the Teeth........................................................................... 14
Step 2, Preparing the Smart Dentin Grinder ................................................. 14
Step 3, Placing the Teeth in the Smart Dentin Grinder ................................. 17
Step 4, Configuring the Smart Dentin Grinder .............................................. 18
Step 5, Grinding the Teeth............................................................................. 20
Step 6, Cleansing the Particles ...................................................................... 21
Step 7, Drying the Particulate........................................................................ 23
Appendix A: Specifications ....................................................................................27
Appendix B: Labeling............................................................................................28

5
Table of Figures
Table of Figures
Figure 1: Smart Dentin Grinder Components ...............................................................................................8
Figure 2: Sterile Disposable
Chamber
...........................................................................................................9
Figure 3: Grinding Blade and Particulate Si
eve
.............................................................................................9
Figure 4: Particulate Drawer
Compartments
..............................................................................................10
Figure 6: Using the Smart Dentin Grinder –Workflow Dia
gr
a
m
.................................................................13
Figure 7: Attaching the
Chamber
................................................................................................................15
Figure 8: Aligning the Arrows......................................................................................................................15
Figure 9: Chamber is
Locked
.......................................................................................................................16
Figure 10: Switching On the Smart Dentin Grinder.....................................................................................16
Figure 11: Power Indicator..........................................................................................................................16
Figure 12: Removing the Chamber Cap ......................................................................................................17
Figure 13: Placing the Teeth in the Smart Dentin
Grinder
..........................................................................17
Figure 14: Closing the Chamber Cap...........................................................................................................18
Figure 15: Grinding for 3 S
ec
onds...............................................................................................................19
Figure 16: Sorting for 20 Seconds ...............................................................................................................19
Figure 17: Pulling Out the D
r
a
wer
s.............................................................................................................21
Figure 18: Pulling Out the Top Drawer
Compartment
................................................................................21
Figure 19: Harvesting the Implantable
Particles
.........................................................................................22
Figure 20: Hot Plate ....................................................................................................................................23
Figure 21: Smart Dentin Grinder Label .......................................................................................................28
Documentation Conventions
NOTE:
Notes provide additional important information.
TIP:
Tips provide shortcuts or special guidance that may enable optimal performance.
WARNING!
Warnings indicate conditions or practices that could result in death or serious injury.
It may also describe potential serious adverse reactions and safety hazards.
CAUTION:
Caution indications relate to conditions or practices that are potentially hazardous
that may result in minor or moderate injury to the user or damage to the equipment
or other property. Caution indications may also be used to indicate practices
necessary for effective use of the device.
Table of contents