INSTRUCTIONS FOR USE
MAGELLAN
®
Aspiration Kit
INTRODUCTION
Indications for Use
The MAGELLAN
®
Aspiration Kit is intended for use only with the MAGELLAN
Autologous Platelet Separator Instrument.
Note: Refer to the MAGELLAN
for Usage Instructions, Disclaimers, Warnings, Precautions, and Contraindications.
Contraindications for Use
•
Fracture
•
Excessive Tissue (Severe obesity and/or absence of adequate anatomical
landmarks)
•
Osteoporosis
•
Infection at the area of insertion
•
Previous, significant orthopedic procedure at the site, prosthetic limb or joint
•
Intraosseous at site in the past 48 hours
Cautions
•
Federal Law (USA) restricts this device to be sold by or on the order of a
physician.
•
Refer to the System Operator's Manual supplied with the instrument, as well
as Instructions for Use for components from other manufacturers inside this
convenience kit before performing the procedure.
•
Use only MAGELLAN
•
Inspect the kit prior to use. Do not use the kit if any component of the tray is
damaged or opened.
•
Treat all blood and fluids using universal precautions for bloodborne
pathogens.
•
All components of this kit are sterile fluid pathway single patient use. Do not
re-sterilize.
Precautions
•
Only Arteriocyte Medical Systems, Inc. sterilized disposable kits are approved
for use with the MAGELLAN
important that aseptic technique be used to minimize the possibility of
contamination of the disposable components and/or patient.
•
Store all disposable components in a dry place away from extremes of
environmental conditions.
•
Materials used in the MAGELLAN
chemicals (such as solvents and certain detergents).
•
Under certain adverse conditions, exposure to these chemicals (including
vapors) may cause the plastics to fail or malfunction. Visually inspect the
contents of the disposable kit. Should any evidence of damage to the
components be found during inspection or setup, do not use the disposable
components. Do not use silicone oils or greases near disposable components.
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English
®
Autologous Platelet Separator Operator's Manual
®
disposable accessories.
®
Autologous Platelet Separator Instrument. It is
®
Disposable Kit may be sensitive to
®