Medtronic 6061006 Technical Manual
™
ACCELERATE
GRAFT DELIVERY
SYSTEM WITH
GRAFTON™ DBF
USER GUIDE
Graft material inside of Cannula shown for visual ization
TABLE OF
CONTENTS
3 Introduction
4 Instrument and Implant Information
4 Instruments and Implants
4 Technical Specifications
5 Procedure
5 Tips
6 Graft Preparation
™
7 Filling the Accelerate
8 Loading the Accelerate
9 Attaching the Accelerate
10 Delivery of the Bone Graft Mixture
11 Reloading and Disassembly
Cannula with the Bone Graft Mixture
™
Cannula into the Accelerate™ Funnel
™
Funnel to the Accelerate™ Body
12 Graft Recovery
13 Product Ordering Information
14 Instructions for Use (IFU)
2
INTRODUCTION
The Accelerate™ Graft Delivery System was developed and designed to empower the healthcare professional to leverage
the delivery of autograft combined with Grafton™ DBF. The seamless, simplified, and integrated delivery of bone graft with
the Accelerate™ Graft Delivery System enables controlled delivery in an efficient workflow. This User Guide is designed to
familiarize healthcare professionals with the use of Accelerate™ Instrument Set. Please carefully read this User Guide and
its appendix prior to use of the instruments and implants.
The development and design of the Accelerate™ Graft Delivery System revolved around a comprehensive solution to bone
grafting that focused on – the instrument, the implant, and the workflow.
Accelerate™ Design Pillars
LEVERAGE
AUTOGRAFT
EFFICIENT
WORKFLOW
Risks
See IFU for a full list of risks, warnings, and contraindications.
CONTROLLED
DELIVERY
3
INSTRUMENT AND IMPLANT
INFORMATION
Instruments and Implants
Distal end Proximal end
Accelerate
Cannula
Accelerate
™
Funnel
™
Graft Delivery Loading Platform
Pin
open
closed
Socket
Standard Bone Funnel
Accelerate
Accelerate
™
Graft Recovery Tool
™
Graft Recovery Platform
Clasp
Plunger
Release mechanism
Trigger Back handle
Accelerate
™
Funnel Pin
Technical Specications
Cannula
Cannula Bone Graft Capacity 6.0cc
Accelerate
Accelerate™ Funnel Outer Diameter 7.9mm
Accelerate
™
Funnel
™
Funnel Shaft Length 7.1"
Accelerate
4
™
Body
Standard Bone Funnel
Standard Bone Funnel Inner Diameter 6.85mm
Standard Bone Funnel Outer Diameter 8.5mm
Standard Bone Funnel Shaft Length 7.3"
PROCEDURE
Tips
1 The Accelerate™ Instrument will clog if the bone chip
size exceeds 3.2mm in diameter.
2 Use Accelerate™ Graft Delivery Instrument as intended
only with Grafton™ DBF. Use with other products
(mineralized allograft, synthetics, dierent bone
graft formulations, etc.) will likely result in decreased
performance, clogging, and possible permanent
malfunction.
™
3 Only use Accelerate
BG Set T502XX Grafton™
DBF. The original T501XX Grafton™ DBF will not be
compatible as it does not contain the Cannula.
™
4 The Accelerate
Graft Delivery Instrument will not
work eciently and clog if used without the Cannula.
™
5 The Accelerate
Graft Delivery Instrument may
not function as intended (and is likely to clog) if the
autograft content of the nal bone grafting mixture
exceeds 50% of the total volume.
6 Close and open the Cannula once or twice to make
the closing of the Cannula easier once it has been
loaded with bone graft mixture.
7 If the Cannula won’t completely close, redistribute or
remove small amounts of bone grafting mixture until
the Cannula completely closes. Overlling of Cannula
increases the likelihood of clogging.
™
8 Do not force the Cannula into the Accelerate
Funnel.
If you experience resistance loading the Cannula into
the Accelerate™ Funnel, redistribute or remove small
amounts of bone grafting mixture.
™
9 The Accelerate
Instrument Set contains two
Accelerate™ Funnels for simultaneous preloading
of Cannulas with bone graft mixture.
™
10 If the Cannula (inside of the Accelerate
Funnel) is
hitting the Body and preventing the Accelerate™
Funnel from properly engaging, ensure the Cannula
is fully seated.
11 The proximal tip of the Cannula should be aligned
with the Plunger.
12 It may take several Trigger squeezes prior to
delivery of the bone graft mixture. Typically, the
bone graft mixture in the Cannula rst compresses,
and then begins to ow through distal end of the
™
Accelerate
Funnel.
13 If there is increasing resistance/diculty in squeezing
™
the Trigger, remove the Accelerate
Graft Delivery
Instrument from the surgical site and disassemble in
accordance with the instructions in the Reloading and
Disassembly section of this User Guide.
14 If the Plunger is hard to pull back, conrm that the
Trigger has been fully reset, and sits ush with the
™
Accelerate
Body.
15 The Cannula is intended for SINGLE USE ONLY. If
additional bone graft is needed, repeat the loading
process with a new Cannula until the desired amount
of bone graft mixture is delivered.
16 If the Cannula is dicult to remove, simultaneously
™
twist the Accelerate
Funnel while pulling out the
Cannula.
17 For rapid bone graft delivery, it is recommended that
™
the spare Accelerate
Funnel is prepped and loaded
with a Cannula to allow for rapid Accelerate™ Funnel
exchange.
18 Be sure to remove the Cannula after use (and prior
to sterilization).
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