Stryker 0306 Serie Manual De Instrucciones página 2

Stryker ACM ® (Advanced
Cement Mixing) System
0306-XXX-XXX Series
Instructions For Use
EN
ACM allows you to mix cement with a constant
high vacuum throughout the process. Air bubbles
are removed for the virtual elimination of porosity.
Cement is transferred directly from the mixing bowl
to the application cartridge while under vacuum.
User/Patient Safety
WARNINGS:
• Read and understand the instructions. If you
have questions, contact your Stryker sales
representative or Stryker customer service.
Outside the US, contact your nearest Stryker
subsidiary.
• Before use in the clinical environment, practice
using the system with acrylic bone cement.
Mixing time and proper application can be
technique dependent.
• Upon initial receipt and before use, inspect the
package for damage and confirm the integrity of
the sterile barrier. DO NOT use any equipment
if damage is apparent or the sterile barrier has
been compromised.
• DO NOT reuse, reprocess, or repackage a
single use device. A single use device is
intended for a single use only. A single use
device may not withstand chemical, chemical
vapor, or high temperature sterilization
reprocessing. Design features may make
cleaning difficult. Reuse may create a serious
risk of contamination and may compromise
the structural integrity of the single use device
resulting in operational failure. Critical product
information may be lost if the single use device
is repackaged. Failure to comply may lead to
infection or cross infection and result in patient
and/or healthcare staff injury.
• Use only Stryker approved accessories.
CAUTION: Mix enough cement to allow for losses
in the application tip and cement penetration,
especially in total hip procedures.
NEDERLANDS (NL)
ENGLISH (EN)
SVENSKA (SV)
ESPAÑOL (ES)
DANSK (DA)
DEUTSCH (DE)
SUOMI (FI)
FRANÇAIS (FR)
PORTUGUÊS (PT)
ITALIANO (IT)
Print Date: Aug 07, 2015 02:23:37 PM
2015-03
0000003965, Rev. P Effective Date: -
Prepare and Organize
Equipment
The ACM System is used in conjunction
with Stryker Dual Speed Cement Injection
Gun and High Vacuum Pump or Automatic
High Vacuum Pump.
Stryker Dual Speed
Injection Gun: Turn the
ram to the RELEASE
position, then pull all the
way back. Set aside until
ready to use.
Instructions
NOTE: Mixing times are approximate and may vary with room
temperature. Do not place the cement mixing components
where they will be warmed to above 70 °F.
1. Remove bowl assembly from blister
using proper sterile technique.
2. Attach vacuum tube to vacuum
pump.
3. Remove the lid from the bowl by
turning the lid counterclockwise.
Set the lid aside taking care not
to bend the paddles.
4. Pour bone cement powder into the
bowl followed by liquid monomer.
WARNING: DO NOT add foreign
substances to the cement's mix-
ture. The alteration of the mixture
with such substances can affect
the cement's mechanical proper-
ties and setting time during use.
5. Return the lid to the bowl; turn clockwise
to secure. Depress footswitch on the
Automatic High Vacuum Pump or
manually activate the Portable High
Vacuum Pump. Evacuate the bowl until
the gauge reads 20-22 inHg.
6. Mix back and forth until the powder and
liquid are blended. Tap unit on the work
surface to dislodge powder from sides of
bowl and into the mixture.
7. Once the mixture is blended, rotate the
paddles clockwise to further remove air
from the mixture.
8. When mixing is complete, firmly depress
the transfer rod.
NORSK (NO)
POLSKI (PL)
日本語 (JA)
中文 (ZH)
한국어 (KO)
Application Tips and Accessories: Select
appropriate tips and accessories. Remove
them from their packages using proper
sterile technique. Set aside until ready to
use.
Cement Media: Remove media components
from their outer packages using proper
sterile technique. Set aside until ready to
use.
Vacuum Pump: Place the vacuum pump
outside sterile field. If using the Stryker
Portable High Vacuum Pump, it may be
sterilized and placed on the sterile field.
Nitrogen Source:
WARNING: Reduce regulated
pressure on nitrogen source to
zero before connecting to Stryker
Automatic High Vacuum Pump.
0306-553-702 Rev-P
Connect nitrogen source to vacuum
pump.
Set pressure to 70-100 psi.
WARNING: Do not operate
pump outside the recom-
mended pressure range.
9. Rotate the paddles clockwise until the
cement is completely transferred into the
cartridge.
10. Peel vent tab (VACUUM RELEASE) from
lid to release vacuum from bowl.
WARNING: Never release the
vacuum by removing the vacuum
hose from the bowl or pump.
11. Grasp the cartridge and remove the
bowl and cartridge from base with a
counterclockwise turn. Keep the
cartridge upright.
12. With other hand, separate
cartridge from bowl with a
counterclockwise turn.
13. Set bowl into base and set
aside. These components may
be discarded.
14. Place desired application tip on
the cartridge.
NOTE: Align the tab with the
arrow on the cartridge then turn
the tip so that the tab slides
over the ramp and latches
to secure the tip.
15. Snap the cartridge into the Dual
Speed Injection Gun.
16. Hold the gun and cartridge vertically
and fill the tip. Turn the ram to the
INJECT position. The FILL setting
on the side of the gun will yield an
extrusion rate of 9 mL per stroke. The
PRESSURIZE setting will extrude 3 mL
per stroke with greater mechanical
advantage.
WARNING: The cartridge cannot
withstand the excessive pressure
that is created when doughy ce-
ment is extruded. DO NOT attempt
to extrude the cement if excessive
force is required. In this situation,
remove the application tip and
hand pack the cement. Excessive
force can cause the cartridge
to break. Pieces of the broken
cartridge can harm the patient
and staff.
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