arteriocyte MAGELLAN Gebrauchsanweisung Seite 10

MAGELLAN®
Basic Platelet Separator Kit
INTRODUCTION
Indications for Use
Magellan® Basic Platelet Separator Kit is intended for use only with
1
the Magellan® Autologous Platelet Separator Instrument. See the
Magellan® Autologous Platelet Separator Indications for Use.
Contraindications
Use of the Magellan® Basic Platelet Separator Kit is contraindicated
for a hemodynamically unstable or hypercoagulable patient.
Use of this product for pediatric patients should be approached
carefully. Withdrawing blood from pediatric patients should be at a
physician's specific direction, avoiding any significant reduction in
the patient's blood volume.
Caution: Medications that adversely affect a patient's coagulation
system may inhibit the use of platelet separation system therapy.
Warning: Reprocessing may compromise the structural integrity of
the device and/or lead to device failure. Reuse of this single patient
use device creates a potential risk of patient or user infections.
Contamination of the device may lead to injury, illness or death of
the patient.
Precautions
1. Only Manufacturer-sterilized disposable kits are approved
for use with the Magellan® Autologous Platelet Separator
Instrument. It is important that aseptic technique be
used to minimize the possibility of contamination of the
disposable components and/or the patient.
2. Store all disposable components in a dry place away from
extremes of environmental conditions.
3. Materials used in the Magellan® Basic Platelet Separator
Kit may be sensitive to chemicals (such as solvents and
certain detergents). Under certain adverse conditions,
exposure to these chemicals (including vapors) may
1 Magellan® is a registered trademark of Arteriocyte Medical Systems, Inc.
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INSTRUCTIONS FOR USE