arteriocyte magellan Instructions For Use Manual

Complete Disposable Kit
Explanation of symbols on package labeling
l
Lot Number
j
Catalog Number
f
Use by
X
Quantity
k
Do Not Reuse
O
IQ
Fluid Path Sterilized Using Ethylene Oxide
O
IK
Fluid Path Sterilized Using Irradiation
O
IS
Fluid Path Sterilized Using Steam or Dry Heat
Not made with natural rubber latex
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Nonpyrogenic
U.S.P.
United States Pharmacopeia
H
This Way Up
M
Manufacturer
F
Fragile, Handle with Care
Consult Instructions for Use
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Caution, Consult Accompanying Documents
Caution: Federal law restricts this device to sale by or on
the order of a (licensed healthcare practitioner).
INTRODUCTION
Indications for Use
®
The Arteriocyte Medical Systems, Inc. MAGELLAN Complete Disposable Kit is intended
®
for use only with the MAGELLAN Autologous Platelet Separator Instrument. See
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Magellan Platelet Separator Indications for Use.
Contraindications
The Use of the Arteriocyte Medical Systems, Inc. MAGELLAN
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 with attention
given to 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 Arteriocyte Medical Systems sterilized disposable kits are approved for patient use
®
with the MAGELLAN Platelet Separator Instrument. It is important that aseptic
technique be used to minimize the possibility of contamination of the disposable
components and/or patient.
2. Store all disposable components in a dry place away from extremes of environmental
conditions.
3. Materials used in the Arteriocyte Medical Systems, Inc. MAGELLAN
may be sensitive to 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
© Arteriocyte Medical Systems, Inc.
All Rights Reserved
use the disposable components. Do not use silicone oils or greases near disposable
components.
System Description
The Arteriocyte Medical Systems, Inc. MAGELLAN
sterile fluid pathway single-patient-use components necessary for each platelet separation
procedure with the MAGELLAN
Cautions
1. Caution: Federal Law (USA) restricts this device to be sold by or on the order of
physician.
2. Refer to the System Operator's manual supplied with the instrument before performing
a platelet separation procedure using the components of this kit. Treat all blood and
fluids using Universal Precautions for bloodborne pathogens.
3. Each platelet separation procedure using the Arteriocyte Medical Systems Inc,
®
MAGELLAN Platelet Separator Instrument requires one MAGELLAN
Separator Disposable Kit. The separation chamber and associated tubing can be used
with the same patient for up to three complete separation cycles.
4. Use only Arteriocyte Medical Systems disposable accessories.
5. Inspect the kit prior to use. Do not use the kit if any component or the tray is damaged
or opened.
6. Throughout procedure, make certain all tubing is free of any kinks, twists, or flat areas.
All components of this kit are sterile fluid pathway single-patient-use. Do not resterilize.
Do not use the ACD-A anticoagulant unless the solution is clear and the seal is intact.
The ACD-A anticoagulant supplied in this kit is not for preparation of blood products for
transfusion or for direct intravenous infusion. Discard the unused portion. Do not reuse.
How Supplied
Contents of the Arteriocyte Medical Systems, Inc. MAGELLAN
(see Figure 1):
A. One (1) 50-mL bag ACD-A anticoagulant
B. One (1) 60-mL syringe (Syringe 2)
C. One (1) 10-mL syringe (Syringe 1)
D. One (1) 5-mL syringe
E. One (1) IV Site Prep Kit
F. One (1) Separation chamber with attached tubing
G. One (1) 18 gauge x 3.8 cm (1.5") needle
H. One (1) phlebotomy needle set with luer-lock connector
I. One (1) tubing clamp (For phlebotomy needle set)
J. Four (4) syringe tip caps
K. Instruction For Use
Note: If more than one separation cycle will be performed with the same patient, additional
1
10-mL and 60-mL BD™ syringes are required and can be purchased from Arteriocyte
Medical Systems.
®
Disposables Kit is
Figure 1. Contents of the Arteriocyte Medical Systems, Inc. MAGELLAN
Disposable Kit.
INSTRUCTIONS
Caution: All components of this kit are sterile fluid pathway single-patient-use. Do not
resterilize.
1. Remove the cover from the separator disposable kit tray.
®
Disposables Kit
2. Be certain that all components are present and undamaged.
Caution: Do not use the kit if any component or the tray is damaged or open.
3. Remove the separation chamber package from the tray.
4. Peel open the lid on the chamber package.
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Complete Disposable Kit consists of
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Autologous Platelet Separator Instrument.
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Platelet
®
Complete Disposable Kit
®
Complete
5. Holding the platelet separation chamber with the vent facing upward, thread the
attached tubing through the center of the chamber caddy (see Figure 2A and B).
Figure 2. Thread the separation chamber tubing through the center of the chamber
caddy.
6. Install the platelet separation chamber into the centrifuge caddy, making certain that
both ends of the chamber are properly located in the caddy notches (see Figure 3A).
Place T-connector in slot (see Figure 3B), and tubing under retainer on top surface of
caddy (see Figure 3C). Press tubing down into groove on outer edge of chamber caddy
(see Figure 3D).
Caution: Failure to install the separation chamber properly may result in error codes.
Figure 3. Install the separation chamber into the caddy and place tubing into slot and
under retainer.
7. Rotate the tubing collar so that its shape aligns with the opening in the support arm.
Slide the tubing collar into the support arm (see Figure 4A) and close the latch (see
Figure 4B).
Figure 4. Attach chamber tubing collar to the instrument tubing support arm.
8. Press tubing down into groove on support arm and place tubing through notch in
centrifuge ridge (see Figure 5).
Instructions for Use
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AMS95023LBL Rev8