arteriocyte magellan User manual

MAGELLAN®
Basic Platelet Separator Kit
Základní souprava pro separaci trombocytů
Basis trombocytseparationssæt
Thrombozytenseparator-Basisset
Βασικό κιτ διαχωριστή αιμοπεταλίων
Kit básico del separador de plaquetas
Verihiutale-erottimen perustarvikepakkaus
Kit de base pour séparateur de plaquettes
Osnovni komplet sustava za odvajanje trombocita
Kit di base per separatore di piastrine
Bloedplaatjesseparator-basisset
Conjunto de componentes básicos do separador de plaquetas
Set de bază pentru separarea trombocitelor
Osnovni komplet za odvajanje trombocita
Bastrombocytsepareringsset
Temel Trombosit Ayırıcı Kiti
Instructions for Use / Návod k použití / Brugsanvisning / Gebrauchsanweisung / Οδηγίες χρήσης /
Instrucciones de uso / Käyttöohjeet / Mode d’emploi / Upute za uporabu / Istruzioni per l’uso /
Gebruiksaanwijzing / Instruções de utilização / Instrucţiuni de utilizare / Uputstva za upotrebu /
Bruksanvisning / KullanmaTalimatı

1
EXPLANATION OF SYMBOLS ON PACKAGE LABELING / VYSVĚTLENÍ SYMBOLŮ NA ŠTÍTKU
OBALU / FORKLARING AF SYMBOLER PÅ EMBALLAGENS MÆRKATER / ERKLÄRUNG
DER SYMBOLE AUF DEM VERPACKUNGSETIKETT / ΕΠΕΞHΓΗΣΗ ΤΩΝ ΣΥΜΒOΛΩΝ ΣΤΗ
ΣHΜΑΝΣΗ ΤΗΣ ΣΥΣΚΕΥΑΣIΑΣ / EXPLICACIÓN DE LOS SÍMBOLOS EN EL ETIQUETADO
DEL ENVASE / PAKKAUKSEN SYMBOLIEN SELITYKSET / EXPLICATION DES SYMBOLES DES
ÉTIQUETTES SUR L’EMBALLAGE / ZNAČENJE SIMBOLA NA NALJEPNICI NA PAKOVANJU /
SPIEGAZIONE DEI SIMBOLI SULLE ETICHETTE DELLA CONFEZIONE / VERKLARING VAN DE
SYMBOLEN OP DE VERPAKKINGSLABELS / EXPLICAÇÃO DOS SÍMBOLOS NAS ETIQUETAS
DA EMBALAGEM / SEMNIFICAŢIA SIMBOLURILOR DE PE ETICHETELE DE PE AMBALAJ /
OBJAŠNJENJE SIMBOLA NA ETIKETI PAKOVANJA / FÖRKLARING AV SYMBOLER PÅ
FÖRPACKNINGSETIKETTEN / PAKET ETİKETİNDEKİ SEMBOLLERİN AÇIKLAMAS
Conformité Européenne (European
Conformity). This symbol means that the
device fully complies with European Council
Directive 93/42/EEC. / Conformité Européenne
(Evropská shoda). Tento symbol znamená,
že zařízení v plném rozsahu splňuje směrnici
Evropské rady 93/42/EHS. / Conformité
Européenne (Europæisk Standard). Dette
symbol betyder, at enheden fuldt ud
overholder det Europæiske Råds Direktiv
93/42/EØF. / Conformité Européenne
(Europäische Konformität). Dieses Symbol
besagt, dass das Gerät allen Vorschriften
der Richtlinie 93/42/EWG des Europäischen
Rates entspricht. / Conformité Européenne
(Ευρωπαϊκή Συμμόρφωση). Το σύμβολο
αυτό σημαίνει ότι το προϊόν συμμορφώνεται
πλήρως με την οδηγία του Ευρωπαϊκού
Συμβουλίου 93/42/ΕΟΚ. / Conformité
Européenne (Conformidad Europea). Este
símbolo indica que el dispositivo cumple
totalmente la Directiva 93/42/CEE del
Consejo Europeo. / Conformité Européenne
(eurooppalainen vaatimustenmukaisuus).
Tämä symboli tarkoittaa, että laite on
kaikilta osin Euroopan unionin neuvoston
direktiivin 93/42/ETY mukainen. / Conformité
Européenne. Ce symbole signifie que l’appareil
est entièrement conforme à la Directive
européenne 93/42/CEE. / Conformité

2
Européenne (Europska sukladnost). Ovaj
simbol označava da je uređaj potpuno u
sukladnosti s direktivom Europskog vijeća
93/42/EEZ. / Conformité Européenne
(Conformità Europea). Questo simbolo
significa che l’apparecchio è conforme alla
Direttiva del Consiglio Europeo 93/42/CEE. /
Conformité Européenne (Europese
Conformiteit). Dit symbool betekent dat het
apparaat volledig voldoet aan de Europese
Richtlijn 93/42/EEG. / Conformité Européenne
(Conformidade Europeia). Este símbolo
significa que o dispositivo está em total
conformidade com a Directiva do Conselho
Europeu 93/42/CEE. / Conformité Européenne.
(Conformitate europeană.) Acest simbol
înseamnă că dispozitivul este în deplină
conformitate cu Directiva 93/42/CEE
a Consiliului European. / Conformité
Européenne (Usklađeno sa evropskim
propisima). Ovaj simbol označava da je
uređaj u potpunosti usaglašen sa direktivom
Evropskog saveta 93/42/EEC. / Conformité
Européenne (Europeisk Standard). Denna
symbol betyder att utrustningen helt följer
rådets direktiv 93/42/EEG. / Conformité
Européenne (Avrupa Uygunluğu). Bu sembol,
cihazın Avrupa Konseyi Direktifi 93/42/EEC ile
tamamen uyumlu olduğu anlamına gelir.
l
Lot Number / Číslo šarže / Partinummer /
Losnummer / Αριθμός παρτίδας / Número
de lote / Eränumero / Numéro de lot / Serijski
broj / Numero di lotto / Partijnummer /
Número de lote / Număr de lot / Serijski broj /
Lotnummer / Lot Numarası

3
w
Caution, Consult Accompanying Documents /
Pozor, prostudujte přiložené dokumenty /
Forsigtig! Se medfølgende dokumentation /
Achtung, Begleitdokumentation beachten /
Προσοχή, συμβουλευτείτε τα συνοδευτικά
έγγραφα / Precaución, consulte la
documentación que se incluye / Huomio,
katso oheiset asiakirjat / Attention, se référer
aux documents joints / Oprez, pogledati
prateću dokumentaciju / Attenzione, vedere
i documenti allegati / Let op, zie bijgevoegde
documentatie / Atenção, consulte os
documentos anexos / Atenţie, consultaţi
documentele însoţitoare / Oprez, konsultujte
prateću dokumentaciju / OBS! Se medföljande
dokument / Dikkat, Beraberindeki Belgelere
Başvurun
j
Catalog Number / Číslo v katalogu /
Katalognummer / Katalognummer / Αριθμός
καταλόγου / Número de catálogo /
Luettelonumero / Numéro de référence /
Kataloški broj / Numero di catalogo /
Catalogusnummer / Número de catálogo /
Număr de catalog / Kataloški broj /
Katalognummer / Katalog Numarası
r
Sterilized Using Ethylene Oxide / Sterilizováno
etylenoxidem / Steriliseret med etylenoxid /
Sterilisiert mittels Äthylenoxid /
Αποστειρωμένο με αιθυλενοξείδιο /
Esterilizado mediante óxido de etileno /
Steriloitu etyleenioksidilla / Stérilisation
par oxyde d’éthylène / Sterilizirano etilen
oksidom / Sterilizzato con ossido di etilene /
Gesteriliseerd met ethyleenoxide / Esterilizado
com óxido de etileno / Sterilizat cu oxid
de etilenă / Sterilisano etilen oksidom /
Steriliserad med etylenoxid / Etilen Oksitle
Sterilize Edilmiştir

4
q
Sterilized Using Irradiation / Sterilizováno
ozářením / Steriliseret med stråling / Sterilisiert
mittels Strahlung / Αποστειρωμένο με
ακτινοβολία / Esterilizado mediante
irradiación / Steriloitu säteilyttämällä /
Stérilisation par irradiation / Sterilizirano
zračenjem / Sterilizzato mediante
irradiazione / Gesteriliseerd met straling /
Esterilizado por irradiação / Sterilizat prin
iradiere / Sterilisano zračenjem / Steriliserad
med strålning / Radyasyonla Sterilize Edilmiştir
q
t
Sterilized By Steam / Sterilizováno parou /
Steriliseret med damp / Sterilisiert mittels
Dampf / Αποστειρωμένο με ατμό / Esterilizado
mediante vapor / Steriloitu höyryllä /
Stérilisation à la vapeur / Sterilizirano parom /
Sterilizzato a vapore / Gesteriliseerd met
stoom / Esterilizado por vapor / Sterilizat cu
aburi / Sterilisano parom / Steriliserad med
ånga / Buharla Sterilize Edilmiştir
Latex Free / Neobsahuje latex / Uden latex /
Latexfrei / Χωρίς λάτεξ / Sin látex / Lateksiton /
Ne contient pas de latex / Ne sadrži lateks /
Senza lattice / Latex-vrij / Não contém látex /
Nu conţine latex / Ne sadrži lateks / Latexfri /
Lateks İçermez
-
Nonpyrogenic / Nepyrogenní / Non-pyrogen /
Nichtpyrogen / Μη πυροτογόνο / Apirógeno /
Pyrogeeniton / Apyrogène / Nezapaljivo / Non
pirogeno / Niet-pyrogeen / Não pirogénico /
Apirogen / Apirogeno / Pyrogenfri / Pirojenik
değildir

5
k
Do Not Reuse / Nepoužívejte opakovaně / Må
ikke genbruges / Nicht wiederverwenden /
Μην το επαναχρησιμοποιείτε / No reutilizar /
Kertakäyttöinen / Ne pas réutiliser / Nemojte
ponovno koristiti / Non riutilizzare / Voor
éénmalig gebruik / Não reutilizável / Nu
refolosiţi / Ne upotrebljavati ponovo / Får inte
återanvändas / Tekrar Kullanmayın
f
Use By / Datum použitelnosti / Kan anvendes
til og med / Zu verwenden bis einschließlich /
Χρήση έως / No utilizar después de /
Käytettävä viimeistään / À utiliser jusqu’au /
Upotrijebiti do / Data di scadenza / Te
gebruiken tot en met / Não utilizar depois de /
Data expirării / Rok upotrebe / Får användas till
och med / Son Kullanma Tarihi
_
Quantity / Množství / Antal / Menge /
Ποσότητα / Cantidad / Määrä / Quantité /
Količina / Quantità / Aantal / Quantidade /
Cantitate / Količina / Mängd / Adet
L
Open Here / Zde otevřete / Åbnes her / Hier
öffnen / Ανοίξτε εδώ / Abrir aquí / Avaa tästä /
Ouvrir ici / Ovdje otvoriti / Aprire qui / Hier
openen / Abrir aqui / Deschideţi de aici /
Otvoriti ovde / Öppnas här / Buradan Açın
/
For US Audiences Only / Pouze pro uživatele
v USA / Gælder kun i USA / Gilt nur für Leser
in den USA / Μόνο για πελάτες εντός των
ΗΠΑ / Sólo aplicable en EE.UU. / Koskee
vain Yhdysvaltoja / Ne s’applique qu’aux
États-Unis / Samo za korisnike u SAD /
Esclusivamente per il mercato statunitense /
Alleen van toepassing voor de VS / Apenas
aplicável aos E.U.A. / Numai pentru utilizatorii
din SUA / Samo za korisnike u SAD / Gäller
endast i USA / Sadece ABD Okuyucuları için

6
U.S.P.
United States Pharmacopeia / Lékopis
Spojených států amerických / United States
Pharmacopeia / United States Pharmacopeia /
Φαρμακοποιία των ΗΠΑ / United States
Pharmacopeia / United States Pharmacopeia
(Yhdysvaltojen farmakopea) / United
States Pharmacopeia / Farmakopeja SAD /
United States Pharmacopeia / United States
Pharmacopeia / United States Pharmacopeia
(Farmacopeia dos Estados Unidos) /
Farmacopeea Statelor Unite / Farmakopeja
SAD / United States Pharmacopeia / Amerika
Birleşik Devletleri Farmakopesi
Fragile, Handle with Care / Křehké, vyžaduje
opatrné zacházení / Fragil, skal håndteres
forsigtigt / Vorsicht, zerbrechlich / Εύθραυστο,
χειριστείτε με προσοχή / Frágil, manipular con
cuidado / Helposti särkyvä, käsittele varovasti /
Fragile, à manipuler avec précaution /
Lomljivo, rukovati pažljivo / Fragile,
maneggiare con cura / Breekbaar, voorzichtig
hanteren / Frágil, manusear com cuidado /
Fragil, manipulaţi cu atenţie / Lomljivo,
rukujte pažljivo / Ömtålig, hanteras varsamt /
Kırılabilir, Dikkatli Taşıyın
H
This Way Up / Touto stranou nahoru / Denne
side op / Diese Seite oben / Προς τα πάνω /
Esta cara hacia arriba / Tämä puoli ylöspäin /
Placer ce côté vers le haut / Ovom stranom
prema gore / Questa parte rivolta verso l’alto /
Deze zijde boven / Manter esta parte virada
para cima / Cu partea aceasta în sus / Ova
strana gore / Denna sida upp / Bu Taraf Yukarı
Manufacturer / Výrobce / Fabrikant /
Hersteller / Κατασκευαστής / Fabricante /
Valmistaja / Fabricant / Proizvođač /
Produttore / Fabrikant / Fabricante /
Producător / Proizvođač / Tillverkare / Üretici

7
MAGELLAN® Basic Platelet Separator Kit 8
INTRODUCTION 8
Indications for Use 8
Contraindications 8
Precautions 8
System Description 9
Cautions 9
How Supplied 10
INSTRUCTIONS 10
DISPOSABLES KIT LIMITED WARANTY – ARTERIOCYTE
MEDICAL SYSTEMS, INC. (OUTSIDE U.S.) 17
TABLE OF CONTENTS

8 English
MAGELLAN®
Basic Platelet Separator Kit
INTRODUCTION
Indications for Use
Magellan®1Basic Platelet Separator Kit is intended for use only with
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
INSTRUCTIONS FOR USE
1Magellan® is a registered trademark of Arteriocyte Medical Systems, Inc.

English 9
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.
System Description
The Magellan® Basic Platelet Separator Kit consists of sterile fluid
pathway single-patient-use components necessary for each
platelet separation procedure with the Magellan® Autologous
Platelet Separator Instrument.
Cautions
• /Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician.
• 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.
• Each platelet separation procedure using the Magellan®
Platelet Separator Instrument requires one Magellan®
Basic Platelet Separator Kit. The separation chamber and
associated tubing can be used with the same patient for
up to three complete separation cycles.
• Use only disposable accessories supplied by the
Distributor.
• Inspect the kit prior to use. Do not use the kit if any
component or the tray is damaged or open.
• Throughout the 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.

10 English
How Supplied
Contents of the Magellan® Basic Platelet Separator Kit (see
Figure 1):
a. One (1) 10-mL BD™2syringe (Syringe 1)
b. One (1) separation chamber with attached tubing
c. One (1) 60-mL BD™ syringe (Syringe 2)
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 the Distributor.
Figure 1. Contents of the Magellan® Basic Platelet Separator 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 disposables 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 and syringes
from the carton.
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).
2BD™ is a trademark of Becton, Dickinson and Company.

English 11
Figure 2. Thread the separation chamber tubing through the center
of the chamber caddy.
6. Install the platelet separation chamber into the centrifuge
caddy (verify audible snap), make certain that both ends
of the chamber are properly located in the caddy notches
(see Figure 3a). Place the T-connector into the slot (see
Figure 3b), and tubing under the retainer on top of the
caddy surface (see Figure 3c). Press the tubing down into
the groove on the outer edge of the 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 the tubing
into the slot and under the retainer.

12 English
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 the tubing down into the groove on the support
arm and through the notch in the centrifuge ridge (see
Figure 5).
Caution: Make certain all tubing is free of any kinks,
twists, or flat areas.
Figure 5. Place the tubing into the groove and through the notch.

English 13
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. Using aseptic technique, draw the appropriate volume
of anticoagulant into Syringe 2 (60-mL syringe). Refer to
Table 1 for the appropriate volumes of ACD-A and blood.
Table 1. Volumes 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

14 English
11. Attach Syringe 2 to the blood access site and slowly
draw the appropriate volume of blood. Gently mix with
ACD-A for thorough distribution. Refer to Table 1 for the
appropriate volumes of ACD-A and blood.
Note: Do not exceed 60 mL total volume.
Note: If multiple separation cycles are to be performed
with the same patient, repeat steps 10 and 11 to prepare
and fill syringes.
12. Disconnect Syringe 2 from the blood access site.
13. 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).
14. Evacuate all air from Syringe 1 into the chamber tubing
line.
15. Place Syringe 1 into the appropriate syringe pump
receptacle.
16. Rotate and slide the plunger driver to engage the
Syringe 1 plunger (see Figure 7b).
17. Ensure whole blood is thoroughly mixed using gentle
agitation prior to placing in the syringe pump receptacle.
18. Remove the luer connector cap from the longer length of
chamber tubing and attach Syringe 2 (see Figure 7c).
19. Evacuate all air from Syringe 2 into the chamber tubing
line.
Note: Failure to remove air from syringes may
compromise the quality of the product.
20. Place Syringe 2 into the appropriate syringe pump
receptacle.

English 15
21. 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 any kinks,
twists, or flat areas.

16 English
22. Gently stretch the tubing attached to Syringe 2 and slide
it completely into the pinch valve opening (see Figure 8).
Figure 8. Stretch Syringe 2 tubing and slide into pinch valve.
Refer to the operator’s manual provided with the Magellan®
Platelet Separator Instrument for further information on the
platelet separation procedure.

English 17
DISPOSABLES LIMITED WARRANTY – ARTERIOCYTE MEDICAL
SYSTEMS, INC. (OUTSIDE U.S.)1
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® Basic Platelet Separator 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
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.
1This Limited Warranty is provided by the Manufacturer, Arteriocyte Medical
Systems, Inc., 45 South Street, Hopkinton, MA, 01748, USA. It applies only
outside of the United States. Areas outside the United States should contact
their local Arteriocyte Medical Systems representative for exact terms of the
Limited Warranty.

18 English
(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 the laws of the State of Delaware, USA.