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Instructions for Use

Page 1 of 2

AMS95023LBL Rev8

Arteriocyte Medical Systems, Inc.

Complete Disposable Kit

Explanation of symbols on package labeling

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

Magellan

Platelet Separator Indications for Use.

Contraindications

The Use of the Arteriocyte Medical Systems, Inc. MAGELLAN

Disposables 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 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

Disposables Kit

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

use the disposable components. Do not use silicone oils or greases near disposable
components.

System Description

The Arteriocyte Medical Systems, Inc. MAGELLAN

Complete Disposable Kit consists of

sterile fluid pathway single-patient-use components necessary for each platelet separation
procedure with the MAGELLAN

Autologous Platelet Separator Instrument.

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

Platelet

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

Complete Disposable Kit

(see Figure 1):

One (1) 50-mL bag ACD-A anticoagulant

One (1) 60-mL syringe (Syringe 2)

One (1) 10-mL syringe (Syringe 1)

One (1) 5-mL syringe

One (1) IV Site Prep Kit

One (1) Separation chamber with attached tubing

One (1) 18 gauge x 3.8 cm (1.5”) needle

One (1) phlebotomy needle set with luer-lock connector

One (1) tubing clamp (For phlebotomy needle set)

Four (4) syringe tip caps

Instruction For Use

Note:

If more than one separation cycle will be performed with the same patient, additional

10-mL and 60-mL

BD™ syringes are required and can be purchased from Arteriocyte

Medical Systems.

Figure 1

. Contents of the Arteriocyte Medical Systems, Inc. MAGELLAN

Complete

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.
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.

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.