arteriocyte magellan User manual

Instructions for Use
Page 1of 2
AMS95023LBL Rev8
©
Arteriocyte Medical Systems, Inc.
All Rights Reserved
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 systemtherapy.
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):
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
10-mL and 60-mL 1BD™ 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.
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 theinstrument tubing support arm.
8. Press tubing down into groove on support arm and place tubing through notch in
centrifuge ridge (see Figure 5).
l Lot Number
j Catalog Number
f
Use by
X
Quantity
k
Do Not Reuse
IQ
O
Fluid Path Sterilized Using Ethylene Oxide
IK
O
Fluid Path Sterilized Using Irradiation
IS
O
Fluid Path Sterilized Using Steamor Dry Heat
Not made with natural rubber latex
-
Nonpyrogenic
U.S.P.
United States Pharmacopeia
H
This Way Up
M
Manufacturer
F
Fragile, Handle with Care
Consult Instructions for Use
w
Caution, Consult Accompanying Documents
Caution: Federal law restricts this device to sale by or on
the order of a (licensed healthcare practitioner).

Instructions for Use
Page 2of 2
AMS95023LBL Rev8
©
Arteriocyte Medical Systems, Inc.
All Rights Reserved
Caution: Make certain all tubing is free of any kinks, twists, or flat areas.
Figure 5. Place tubing through notch in centrifuge ridge.
9. Prepare the syringe pumps on the front of the instrument by rotating the plunger drivers
to the open position (see Figure 6A), while sliding them to the lowest points (see Figure
6B).
Figure 6. Within the syringe receptacles, slide the open plunger drivers to the lowest
points.
10.Prepare the patient for venipuncture according to standard clinical practice using the IV
Site Prep Kit, if necessary.
11.Using aseptic technique, draw the appropriate volume of anticoagulant from the ACD-A
anticoagulant bag into syringe 2 (60 mL syringe) using the 18 gauge needle. Refer to
Table 1 for the appropriate volumes of ACD-A and blood.
Table 1. Volume of ACD-A and corresponding volumes of blood to achieve
anticoagulated blood containing ~7 parts blood: 1 part ACD-A.
Total Volume of Anticoagulated
Blood (mL)
Volume of ACD-
A
(mL)
Volume of Blood
Drawn (mL)
30 4.0 26.0
40
5.0
35.0
50 6.0 44.0
60
8.0
52.0
Caution: Do not use the ACD-A anticoagulant unless the solution is clear and the seal is
intact. Do not reuse the ACD-A supplied in this kit except for multiple separation cycles with
the same patient. Discard unused portion.
Note: Alternative methods can be used to collect patient blood. As appropriate, disregard
references to the phlebotomy needle set.
12.Hook the tubing clamp onto the tubing of the phlebotomy needle set. Do not clamp at
this time.
13.Attach the phlebotomy needle set with tubing clamp to the ACD-A primed 60 mL syringe
(syringe 2).
14.Prime the phlebotomy needle set by slowly pushing the plunger of syringe 2 until ACD-A
reaches the top of thetubing closest to the needle.
15.Slowly draw the appropriate volume of patient blood. Gently mix with ACD-A throughout
the blood draw for thorough distribution. Refer to Table1 for the appropriate volumes of
ACD-A and blood.
16.Once the appropriate amount of the patient’s blood is drawn into syringe 2, close the
tubing clamp prior to removing the phlebotomy needle set fromthe patient.
Note: Do not exceed 60 mL total volume.
Note: If multiple separation cycles are to be performed with the same patient, repeat
steps 11, 15 and 16 to prepare and fill syringes.
17.Disconnect syringe 2 from the IV tubing. Set aside the syringe and discard the needle
and IV tubing utilizing appropriate local procedures.
18.Remove the luer connector cap from the end of the shorter length of chamber tubing
and attach syringe 1 (10 mL syringe, see Figure 7A).
19.Evacuate all air from syringe 1 into the chamber tubing line.
20.Place syringe 1 into the appropriate syringe pump receptacle.
21.Rotate and slide the plunger driver to engage the syringe 1 plunger (see Figure 7B).
22.Ensure whole blood is thoroughly mixed using gentle agitation prior to placing in the
syringe pump receptacle.
23.Remove the luer connector cap from the longer length of chamber tubing and attach
syringe 2 (see Figure 7C).
24.Evacuate all air from syringe 2 into the chamber tubing line.
Note: Failure to remove air fromsyringes may compromise the quality of the product.
25.Place syringe 2 into the appropriate syringe pump receptacle.
24.Rotate and slide the plunger driver to engage the syringe 2 plunger (see Figure 7D).
Figure 7. Attach tubing, load syringes, and engage syringe plunger drivers.
Caution: Make certain all tubing is free of anykinks, twists, or flat areas.
25.Gently stretch the tubing attached to syringe 2 and slide it completely into pinch valve
opening (see Figure 8).
Figure 8. Stretch syringe 2 tubing and slide into pinch valve.
ARTERIOCYTE MEDICAL SYSTEMS INC. DISPOSABLES KIT LIMITED WARRANTY2
(U.S.)
THE FOLLOWING LIMITED WARRANTY APPLIES TO UNITED STATES CUSTOMERS
ONLY:
A. This Limited Warranty provides the following assurance to the customer who receives
the Arteriocyte Medical Systems, Inc. MAGELLAN®Complete Disposable Kit,
hereafter referred to as the “Product”:
1) Should the Product fail to function within normal tolerances due to a defect in
materials or workmanship prior to its “Use Before Date”, Arteriocyte Medical
Systems will at its option: (a) issue a credit equal to the Purchase Price, as defined
in Subsection A (2), against the purchase of the replacement Product or (b) provide
a functionally comparable replacement Product at no charge.
2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the
original, or current functionally comparable, or replacement Product.
B. To qualify for the Limited Warranty, these conditions must be met:
1) The Product must be used prior to its “Use By” date.
2) The unused portion of the Product must be returned to Arteriocyte Medical Systems
Inc. within 60 days after use and shall be the property of Arteriocyte Medical
Systems.
3) The Product must not have been altered or subjected to misuse, abuse or accident.
4) The Product may not have been used by any other customer.
C. This Limited Warranty is limited to its express terms. In particular:
1) Except as expressly provided by this Limited Warranty, ARTERIOCYTE MEDICAL
SYSTEMS IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR
MALFUNCTION OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON
WARRANTY, CONTRACT, TORT OR OTHERWISE.
2) This Limited Warranty is made only to the customer in whom the Product was used.
AS TO ALL OTHERS, ARTERIOCYTE MEDICAL SYSTEMS MAKES NO
WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY
IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW,
CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE
CUSTOMER SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE.
THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE
TO ANY PERSON.
3) The exclusions and limitations set out above are not intended to, and should not be
construed so as to contravene mandatory provisions of applicable law. If any part or
term of this Limited Warranty is held to be illegal, unenforceable or in conflict with
applicable law by a court of competent jurisdiction, the validity of the remaining
portions of the Limited Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Limited Warranty did not contain the
particular part or term held to be invalid. This Limited Warranty gives the customer
specific legal rights. The customer may also have other rights which vary from state
to state.
No person has any authority to bind Arteriocyte Medical Systems to any representation,
condition or warranty except this Limited Warranty.
DISPOSABLES LIMITED WARRANTY – ARTERIOCYTE MEDICAL SYSTEMS, INC.
(OUTSIDE U.S.)
THE FOLLOWING LIMITED WARRANTY APPLIES TO CUSTOMERS OUTSIDE THE
UNITED STATES.
A. This LIMITED WARRANTY provides assurance for the customer who receives an
Arteriocyte Medical Systems®(“AMS”) MAGELLAN®Complete Disposable Kit
“Product”, that should the Product fail to function to specification, AMS will issue a credit
equal to the original Product purchase price (but not to exceed the value of the
replacement Product) against the purchase of any AMS replacement Product used for
that customer. THE WARNINGS CONTAINED IN THE PRODUCT LABELLING ARE
CONSIDERED AN INTEGRAL PART OF THIS LIMITED WARRANTY. CONTACT
YOUR LOCAL AMS REPRESENTATIVE TO OBTAIN INFORMATION ON HOW TO
PROCESS A CLAIM UNDER THIS WARRANTY.
B. To qualify for the LIMITED WARRANTY, these conditions must be met.
1) The Product must be used prior to its “Use By” date.
2) The Product must be returned to AMS within sixty (60) days after use and shall be
the property of AMS.
3) The Product must not have been altered or subjected to misuse, abuse or accident.
4) The Product must not have been used more than one time for any customer.
5) The Product must be used in conformity with the Product, of which this LIMITED
WARRANTY is an integral part.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
1) In no event shall any replacement credit be granted where there is evidence of
improper handling,improper use or material alteration of the replaced Product.
2) AMS is not responsible for any incidental or consequential damages based on any
use, defect or failure of the Product, whether the claim is based on warranty,
contract, tort, patent infringement or otherwise.
D. This LIMITED WARRANTY does not cover those parts that, by their very nature, are
likely to deteriorate or which AMS considers should be periodically replaced consistently
with normal routine or preventative maintenance requirements.
E. The exclusions and limitations set out above are not intended to, and should not be
construed so as to, contravene mandatory provisions of applicable law. If any part to
term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be
illegal, unenforceable, or in conflict with applicable law, the validity of the remaining
portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations
shall be construed and enforced as if this LIMITED WARRANTY did not contain the
particular part or term held to be invalid.
F. No representative, agent, dealer, retailer, or intermediary of AMS shall have
authorization to amend the contents of this LIMITED WARRANTY.
G. The validity, interpretation and performance of the agreement for which this LIMITED
WARRANTY is issued, as well as any disputes relating or connected thereto is
controlled by and construed under thelaws of the State ofDelaware, USA.
Manufacturer:
Arteriocyte Medical Systems, Inc.
45 South St. Hopkinton, MA 01748 USA - Internet: www.arteriocyte.com
Toll-free USA: 1-866-660-AMSI (2674) Fax: [phone]
1BD™ is a trademark of Becton, Dickinson and Company.
2 This Limited Warranty is provided by Arteriocyte Medical Systems, Inc., 45 South St.,
Hopkinton, MA 01748 USA. It applies only in the United States. Areas outside the United
States should contact their local Arteriocyte Medical Systems representative for exact
terms of the Limited Warranty.

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English Instructions for Use 3
AMS Confidential
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INTRODUCTION
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English Instructions for Use 3
AMS Confidential
0
INTRODUCTION
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SECTION:
(for English section)
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.
(for French section)
Attention: Tout retraitement risque de compromettre líintÈgritÈ structurale du dispositif et/ou
díentraÓner la dÈfaillance du dispositif. Toute rÈutilisation de ce dispositif ‡ usage unique et
destinÈ ‡ un seul patient engendre un risque potentiel díinfection pour le patient ou líutilisateur.
Une contamination du dispositif risque díoccasionner des lÈsions ou une maladie au patient,
voire son dÈcËs.
(for German section)
Warnhinweis: Eine Wiederverwertung kann die strukturelle Integrit‰t des Instruments
beeintr‰chtigen und/oder zu einem Versagen des Instruments f¸ hren. Eine Wiederverwendung
dieses zur einmaligen Anwendung an einem Patienten konzipierten Instruments schafft ein
potenzielles Gesundheitsrisiko f¸ r den Patienten oder kann Infektionen des Anwenders nach
sich ziehen. Eine Kontaminierung des Instruments kann zu Verletzung, Erkrankung oder Tod
des Patienten f¸ hren.
(for Espanol section)
Advertencia: El reprocesado puede poner en riesgo la integridad estructural del dispositivo y/o
provocar un fallo del dispositivo. La reutilizaciÛn de este dispositivo para uso en un ˙ nico
paciente genera un riesgo potencial de infecciones del paciente o usuario. La contaminaciÛn
del dispositivo puede conducir a una lesiÛn, a una enfermedad o a la muerte del paciente.
(for Netherlands section)
Waarschuwing: Herverwerking kan de structurele integriteit van het apparaat aantasten en/of
falen van het apparaat veroorzaken. Hergebruik van dit apparaat dat voor gebruik bij een enkele
patiÎ nt bestemd is, schept een mogelijk risico van infecties bij de patiÎ nt of gebruiker.
Besmetting van het apparaat kan leiden tot letsel, ziekte of overlijden van de patiÎ nt.
(for Italian section)
Avvertenza: il ricondizionamento potrebbe compromettere líintegrit‡ strutturale del dispositivo
e/o portare a un guasto dello stesso. Il riutilizzo di questo dispositivo monouso costituisce un
rischio poichÈ potrebbero verificarsi infezioni nei pazienti o utenti. La contaminazione del
dispositivo puÚportare a lesioni, malattie o decesso nel paziente.
AMS95030LBL Rev. 2
AMS95125LBL Rev. 2

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4 English Instructions for Use
AMS Confidential
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AMS95030LBL Rev. 2
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AMS Confidential
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INTRODUCTION
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AMS Confidential
0
INTRODUCTION
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6 English Instructions for Use
AMS Confidential
0
ARTERIOCYTE MEDICAL SYSTEMS INC. DISPOSABLES
KIT LIMITED WARRANTY1(U.S.)
THE FOLLOWING LIMITED WARRANTY APPLIES TO UNITED STATES
CUSTOMERS ONLY:
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AMS95125LBL Rev. 2

English Instructions for Use 7
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AMS Confidential
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AMS95030LBL Rev. 2
AMS95125LBL Rev. 2

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8 English Instructions for Use
AMS Confidential
0
AMS95030LBL Rev. 2
G. The validity, interpretation and performance of the agreement for which this LIMITED
WARRANTY is issued, as well as any disputes relating or connected thereto is controlled by
and construed under the laws of the State of Ohio, USA.
FRENCH
GARANTIE LIMITÉE DES CONSOMMABLES – ARTERIOCYTE
MEDICAL SYSTEMS, INC. (EN DEHORS DES ÉTATS-UNIS)
LA GARANTIE LIMITÉE SUIVANTE S’APPLIQUE AUX CLIENTS SITUÉS EN DEHORS DES
ÉTATS-UNIS.
A. Cette GARANTIE LIMITÉE fournit au client qui reçoit un kit de consommables pour
séparateur de plaquettes autologues Magellan® (le « produit ») d’Arteriocyte Medical
Systems® (« AMS ») l’assurance qu’en cas d’incapacité du produit à fonctionner
conformément aux spécifications, AMS fournira un avoir d’un montant égal au prix d’achat
d’origine du produit (mais sans excéder la valeur du produit de remplacement) à valoir sur
l’achat de tout produit de remplacement AMS utilisé par ce client. LES AVERTISSEMENTS
CONTENUS DANS LA NOTICE DU PRODUIT SONT CONSIDÉRÉS COMME FAISANT
PARTIE INTÉGRANTE DE CETTE GARANTIE LIMITÉE. POUR DE PLUS AMPLES
DÉTAILS SUR LA FAÇON DE FAIRE VALOIR UNE RÉCLAMATION AU TITRE DE CETTE
GARANTIE, ADRESSEZ-VOUS À VOTRE REPRÉSENTANT AMS LOCAL.
B. Pour pouvoir bénéficier de la GARANTIE LIMITÉE, les conditions suivantes doivent être
remplies :
(6) Le produit doit être utilisé avant sa date « À utiliser avant le ».
(7) Le produit doit être renvoyé à AMS dans les soixante (60) jours qui suivent son
utilisation et demeurera la propriété d’AMS.
(8) Le produit ne doit pas avoir été modifié ou fait l’objet d’un usage impropre, d’une
utilisation abusive ou d’un accident.
(9) Le produit ne doit pas avoir été utilisé plusieurs fois par un client.
(10) Le produit doit être utilisé conformément au mode d’emploi figurant dans le « manuel
de l’utilisateur » remis au client avec le produit et dont cette GARANTIE LIMITÉE fait
partie intégrante.
C. Cette GARANTIE LIMITÉE se limite à ses modalités expresses. En particulier :
(3) En aucune circonstance, un avoir de remplacement ne sera fourni en cas de preuve de
manipulation incorrecte, d’usage impropre ou de modification matérielle du produit
remplacé.
(4) AMS décline toute responsabilité pour tous dommages accessoires ou consécutifs
reposant sur l’utilisation, la défectuosité ou la défaillance du produit, que la réclamation
se fonde sur la garantie, le droit contractuel, un acte délictuel, une contrefaçon ou autre.
D. Cette GARANTIE LIMITÉE ne couvre pas les pièces qui, par leur nature même, sont
susceptibles de se détériorer ou dont AMS considère qu’elles doivent être remplacées
périodiquement conformément aux exigences habituelles de la maintenance de routine ou
préventive.
ENGLISH
DISPOSABLES LIMITED WARRANTY – ARTERIOCYTE MEDICAL
SYSTEMS, INC. (OUTSIDE U.S.)
THE FOLLOWING LIMITED WARRANTY APPLIES TO CUSTOMERS OUTSIDE THE UNITED
STATES.
A. This LIMITED WARRANTY provides assurance for the customer who receives an
Arteriocyte Medical Systems ® (“AMS”) Magellan® Ratio Dispenser Kit “Product”), that
should the Product fail to function to specification, AMS will issues a credit equal to the
original Product purchase price (but not to exceed the value of the replacement Product)
against the purchase of any AMS replacement Product used for that customer. THE
WARNINGS CONTAINED IN THE PRODUCT LABELLING ARE CONSIDERED AN
INTEGRAL PART OF THIS LIMITED WARRANTY. CONTACT YOUR LOCAL AMS
REPRESENTATIVE TO OBTAIN INFORMATION ON HOW TO PROCESS A CLAIM
UNDER THIS WARRANTY.
B. To qualify for the LIMITED WARRANTY, these conditions must be met:
(1) The Product must be used prior to its “Use By” date.
(2) The Product must be returned to AMS within sixty (60) days after use and shall be the
property of AMS.
(3) The Product must not have been altered or subjected to misuse, abuse or accident.
(4) The Product must not have been used more than one time for any customer.
(5) The Product must be used in conformity with the user instructions in the “User Manual”
delivered to the customer together with the Product, of which this LIMITED WARRANTY
is an integral part.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
(1) In no event shall any replacement credit be granted where there is evidence of improper
handling, improper use or material alteration of the replaced Product.
(2) AMS is not responsible for any incidental or consequential damages based on any use,
defect or failure of the Product, whether the claim is based on warranty, contract, tort,
patent infringement or otherwise.
D. This LIMITED WARRANTY does not cover those parts that, by their very nature, are likely to
deteriorate or which AMS considers should be periodically replaced consistently with normal
routine or preventative maintenance requirements.
E. The exclusions and limitations set out above are not intended to, and should not be
construed so as to, contravene mandatory provisions of applicable law. If any part to term of
this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal,
unenforceable, or in conflict with applicable law, the validity of the remaining portion of the
LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed
and enforced as if this LIMITED WARRANTY did not contain the particular part or term held
to be invalid.
F. No representative, agent, dealer, retailer, or intermediary of AMS shall have authorization to
amend the contents of this LIMITED WARRANTY.
AMS95125LBL Rev. 2

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Manufacturer:
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MAGELLAN®
Aspiration Kit
Instructions For Use

Explanation of symbols on package labeling
wCaution, Consult Accompanying
Documents
lLot Number
jCatalog Number
pSterilized Using Ethylene Oxide
Latex Free
-Nonpyrogenic
kDo Not Reuse
fUse by
FFragile, Handle with Care
HThis Way Up
_ Quantity
 Phthalate
G Open Here
/For US Audiences Only
PHT
DEHP

INTRODUCTION
The Arteriocyte Medical Systems, Inc.’ MAGELLAN®Aspiration Kit
is a sterile convenience kit for aspirating bone marrow.
Intended Use:
The Arteriocyte Medical Systems, Inc. MAGELLAN®Aspiration Kit
is intended for use only with the MAGELLAN®Autologous Platelet
Separator Instrument.
Note: Refer to the MAGELLAN®Autologous Platelet Separator
Operator’s Manual for Usage Instructions, Disclaimers, Warnings,
Precautions, and Contraindications.
Cautions
• Federal Law (USA) restricts this device to sale by or on the
order of a physician.
• Kit components for single patient use only. Do not resterilize
• Refer to the System Operator’s Manual supplied with the
instrument, as well as Instruction for Use for components from
other manufacturers inside this convenience kit before per-
forming the procedure. Treat all blood, tissue and uids using
Universal Precautions for bloodborne pathogens.
• Use only Arteriocyte Medical Systems disposable accessories.
• Inspect the kit prior to use. Do not use the kit if any component
of the tray is damaged or opened.
Precautions
1. Only Arteriocyte Medical Systems, Inc. sterilized disposable
kits are approved for patient use with the MAGELLAN®Autolo-
gous 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.
MAGELLEN®Disposable Kit may be sensitive to chemicals
(such as solvents and certain detergents).
4. Under certain adverse conditions, exposure to these chemi-
cals (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 com-
ponents. Do not use silicone oils or greases near disposable
components.
How Supplied:

The MAGELLAN®Aspiration Kit consists of the following compo-
nents:
Two (2) 30 mL Syringes
One (1) 60 mL Syringe
One (1) 200 Micron Blood Component Filter
One (1) Bone Marrow Aspiration Needle
One (1) 3-Way Stopcock
One (1) 18-G Needle
Four (4) Syringe Tip Caps

200 Micron Blood Component Filter and Syringe Adapter
Instructions for use
Prime heparin ushed lter and syringes. Residual priming volume
of saline is 6 mL. Maximum volume of product is 300 mL.
Directions:
Use aseptic technique. Single patient use.
1. Close the pinch clamp on the distal end of lter tubing.
2. While holding adaptor upright, squeeze the lter chamber
and attach the syringe containing the blood component to the
proximal end.
3. Release hold on chamber allowing blood components to enter
lter chamber. Release pinch clamp and allow blood compo-
nents to ow into distal tubing just to luer connector to de-air
tubing and close pinch clamp.
4. Attach the collection syringe to distal tubing luer connector of
the lter and open pinch clamp.
5. Gently pull back on the plunger of the collection syringe until
resistance is met, or until the desired volume is reached. If re-
sistance is met before desired volume is reached, disconnect
proximal syringe and pull remaining blood components into
collection syringe. Repeat if more than one syringe of blood
component is drawn.
6. Disconnect the ltered blood component syringe from lter tub-
ing and attach a sterile syringe cap.
Follow AABB guidelines.
Manufacturer:
Arteriocyte Medical Systems, Inc.
45 South Street
Hopkinton, MA 01748
USA
Internet: www.arteriocyte.com
Toll-free: 1-866-660-AMSI (2674)
Fax: [phone]