Zimmer Biomet AccuMix Operating manual

Sterile Inner Tray
• Outer peel pack, inner sterile tray
• Part of sterile mixing procedure
• Holds funnel upright for easy transfer
of BSM powder
• Hydrates and mixes AccuFill®Bone Substitute Material (BSM)
• Closed mixing system; closed transfer to injection syringes
– Controlled, consistent, reproducible mixing
– No loss of material
• User-friendly design, technique
–Alternative to open-bowl mixing techniques
Mixer converts back to syringeSyringe converts to mixer
Multifunction Syringe
AccuMix®Mixing System
Product Information Sheet
AccuMix Mixing System (P/N 331.100)
Kit includes:
• (5) 1 cc Syringes
• Luer Lock Cap and Blue Plug
• Mixing Syringe and Funnel
Components of AccuFill BSM Needed for AccuMix Mixing
P/N 201.150
1 – AccuFill BSM, 5 cc
2 – Saline Syringe with Adapter
3 – 0.9% Saline
P/N 201.130
1 – AccuFill BSM, 3 cc
2 – Saline Syringe with Adapter
3 – 0.9% Saline
Note: Spatula and Transfer Syringe may be discarded
1
2
3

AccuMix Mixing System: AccuFill Mixing Technique
1Transfer the tray to the
sterile field (back table).
Remove the mixing syringe
and set upright in the
tray groove; lift funnel to
extend syringe.
7Remove mixing syringe
from tray. Remove plunger
sleeve from plunger stem.
DO NOT DISCARD SLEEVE!
8Thoroughly mix powder
and saline for 60 strokes
(~60 seconds). Twist and
rotate while plunging
until mix takes “paste”
consistency.
9Remove blue plug.
Reattach sleeve to stem,
with stem fully extended.
10 Holding syringe with cap
upright, expel excess air
from syringe. Connect the
first 1 cc syringe. Inject
AccuFill BSM into syringe.
Repeat for remaining
syringes.
11 Transfer filled syringes
to operative field.
2Remove vial of AccuFill
powder from jar. Empty
powder into funnel;
tap until powder enters
syringe.
3Remove funnel; fully
tighten cap and plug.
Remove blue plug and
set in sterile tray. DO
NOT DISCARD PLUG!
SET UP MIX
HYDRATE TRANSFER
4Withdraw saline from vial using the saline
syringe and adaptor.
P/N 201.150 (5 cc AccuFill BSM)
• 3.0 cc Saline
• Alternative: 3.4 cc Blood
P/N 201.130 (3 cc AccuFill BSM)
• 2.0 cc Saline
• Alternative: 2.3 cc Blood
5Connect Saline syringe to white cap; tighten.
Inject Saline into powder; pull up on syringe
plunger to pull excess air into saline syringe.
Inject again, to ensure ALL SALINE FLOWS
INTO POWDER, then repeat to release
pressure.
6Remove saline syringe; set it in the sterile
tray. Attach blue plug to cap.
NOTE: Do not empty entire contents of saline vial into
AccuFill BSM powder. Measure and use only the exact
volume noted above.
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disclosed, in whole or in part, without the express written
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health care professionals and the Zimmer Biomet sales
force. Distribution to any other recipient is prohibited. Not
for distribution in France. For product information, including
indications, contraindications, warnings, precautions,
potential adverse eects and patient counseling information,
see the package insert and www.zimmerbiomet.com. Check
for country product clearances and reference product specific
instructions for use.
AccuFill®BSM is Manufactured by ETEX Corporation,
38 Sidney Street, Cambridge, MA 02139 USA • etexcorp.com
AccuMix®is Manufactured by: Zimmer Knee Creations,
841 Springdale Drive, Exton, PA 19341 USA
©2017 Zimmer Biomet1102.1-EMEA-en-REV0517
Authorized Representative
Zimmer GmbH
Sulzerallee 8
8404 Winterthur
Switzerland
Legal Manufacturer
ETEX Corporation
38 Sidney Street,
Cambridge, MA 02139
USA
Legal Manufacturer
Zimmer Knee Creations
841 Springdale Drive
Exton, PA 19341
USA
www.zimmerbiomet.com