sorin SYNTHESIS C Ph.I.S.I.O User manual

GB – ENGLISH - INSTRUCTION FOR USE......................................................5
IT. – ITALIANO – ISTRUZIONI PER L’USO ....................................................10
FR – FRANÇAIS – MODE D’EMPLOI..............................................................15
DE - DEUTSCH - GEBRAUCHSANWEISUNG................................................20
ES. – ESPAÑOL - INSTRUCCIONES DE USO ...............................................25
NL – NEDERLANDS - GEBRUIKSAANWIJZING............................................30
011653/01 – 05/2010

2
Fig. 1
Fig. 1- References
1. Venous Return connector
2. Venous/Arterial sampling stopcock
3. Blood outlet (to main pump)
4. Arterial temperature probe
5. Gas scavenging connector with capnographport
6. Blood inlet (from main pump)
7. Arterial blood connector
8. Gasinlet
9. Venous temperature probe site
10. Recirculation/purge line
Fig. 1 - Riferimenti
1. Connettore del ritorno venoso
2. Rubinetto di campionamento venoso/arteriale
3. Uscita sangue (verso la pompa principale)
4. Sonda di temperatura arteriale
5. Connettore di recupero gas con ingresso
capnografo
6. Ingresso sangue (dalla pompa principale)
7. Connettore sangue arterioso
8. Ingressogas
9. Portasonda di temperatura venosa
10. Linea di ricircolo/spurgo
Fig. 1- Références
1. Raccord du retour veineux
2. Collecteur de prélèvement artériel/veineux
3. Sortie sanguine (vers la pompeprincipale)
4. Sonde de la température artérielle
5. Raccord de récupérationdes gaz avec raccord
pour capnographe
6. Entrée sanguine (de la pompe principale)
7. Raccord sanguin artériel
8. Admission du gaz
9. Porte-sondede températuredu sang veineux
10. Lignede purge/recirculation
Abb. 1- Detailpunkte
1. Konnektor des venösenRücklaufs
2. Hahn für venöse/arterielle Blutprobennahme
3. Blutauslass (zu Hauptpumpe)
4. Arterieller Temperaturfühler
5. Gassspülkonnektor mit Kapnographieanschluss
6. Bluteinlass(von Hauptpumpe)
7. Arterieller Blutanschluss
8. Gaseinlass
9. Sitz der venösen Temperatursonde
10. Rezirkulations/Spüllinie
Fig. 1 - Referencias
1. Conector de retorno venoso
2. Llavede muestreo venoso/arterial
3. Salida de sangre (a la bomba principal)
4. Sonda de temperatura arterial
5. Llavede ventilación con puerto de capnógrafo
6. Entrada de sangre (desde la bomba principal)
7. Acceso de la sangre arterial
8. Entrada de gas
9. Puntode la sonda de temperatura venosa
10. Tubodepurga/recirculación
Afb. 1- Referenties
1. Veneuze retourconnector
2. Veneuze/arteriële monsternemingskraan
3. Bloeduitgang (naar hoofdpomp)
4. Arteriële temperatuurvoeler
5. Gasafvoerconnector met capnograafaansluiting
6. Bloedingang (vanaf hoofdpomp)
7. Arteriële bloedconnector
8. Gasingang
9. Veneuze temperatuurmeetplek
10. Recirculatie-/aftaplijn

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Fig. 2
Fig. 2 Synthesis Holder
Fig. 2 Supporto Synthesis
Fig. 2 Support de Synthesis
Abb. 2 Synthesis-Halterung
Fig. 2 Soporte para SYNTHESIS
Afb. 2 Synthesis Houder
Fig. 3
Fig. 3 Synthesis C Holder with bag squeezer
Fig. 3 Supporto del Synthesis C con
stringisacca
Fig. 3 Support de Synthesis C avec serre-
poche
Abb. 3 Halterung für Synthesis C mit
Beutelpresse
Fig. 3 Soporte para Synthesis C con
compresor de bolsa
Afb. 3 Synthesis C Houder met zakknijper

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GB – ENGLISH 5
GB – ENGLISH - INSTRUCTION FOR USE
GB – ENGLISH
TABLE OF CONTENTS
A. DESCRIPTION
B. TECHNICAL FEATURES
C. INTENDED USE
D. SAFETY INFORMATION
E. PREPARATIONAND SETUP
F. PRIMING AND RECIRCULATION PROCEDURE
G. STARTING PERFUSION
H. DURINGPERFUSION
I. TERMINATING PERFUSION
J. BLOOD RECOVERY AFTERPERFUSION
K. DEVICE CHANGE-OUT
L. MEDICAL DEVICES FOR USE WITH SYNTHESIS C PH.I.S.I.O
M. RETURNOF USED PRODUCTS
N. LIMITEDWARRANTY
A. DESCRIPTION
SYNTHESIS C Ph.I.S.I.O is a new-concept microporous hollow fibre membrane
oxygenator It is composed of a gas exchange module connected to an integrated
heat exchanger, an arterial filter and a collapsible venous reservoir.
The self-debubbling arterial filteris made up ofa 40 µm filter screen.
SYNTHESIS C Ph.I.S.I.O is coated with Phosphorylcholine (Ph.I.S.I.O).
Devices coated with Ph.I.S.I.O are used when a coated blood path is desired. The
Ph.I.S.I.O coating improves the blood compatibility of the device byreducing platelet
adhesion on the coated surfaces.
The device is single-use, non-toxic, apyrogenic, supplied STERILE in individual
packaging. Sterilized by ethylene oxide.
The level of ethylene oxide residuals in the device is in conformity with the
provisionsofthe legislation in force in thecountry ofuse.
The device is available in the following version:
[A] SYNTHESIS C Ph.I.S.I.O with integrated arterial filter and collapsible
venousreservoir.
B. TECHNICAL FEATURES
- Suggested max. blood flow
8000ml/min
- Membrane type
Microporous polypropylene
- Membrane surface area
2.0 m
2
- Heat exchanger surface area
0.14 m
2
- Collapsible venousreservoir
Maxvolume
1200 ml
Filter area
120 µm
Filtering surface
0,01 m2
- Arterial filter
Filter screen:
40
µ
m
Type:
polyester
Useful surface area
0.04 m2
Static priming volume
500 ml
(oxygenatormodule + heat exchanger +
arterial filter)
- Connections:
Venous return
1/2" (12.7 mm)
Venous reservoir outlet
3/8" (9.53mm)
Oxygenator venous inlet
3/8"
Arterial filter outlet
3/8"
C. INTENDED USE
SYNTHESIS C Ph.I.S.I.O is intended for use in cardiopulmonary bypass circuits as
substitute for the lungs (transferof oxygen and removal of carbon dioxide), to control
the arterial/venous temperature, and as venous blood reservoir and filter element to
eliminate blood component aggregates larger than 40 µm. The blood to be treated
must contain anticoagulant.
SYNTHESIS C Ph.I.S.I.O is an ADULT oxygenator intended for use in operations on
adults patients.
SYNTHESIS C Ph.I.S.I.O must not be used for longer than 6 hours. Contact with
blood for longer periods is inadvisable.
SYNTHESIS C Ph.I.S.I.O must be used in combination with the medical devices
listed in sectionL (Medical devices for use with SYNTHESIS C Ph.I.S.I.O).
D. SAFETY INFORMATION
Information intended to attract the attention of the user to potentially dangerous
situations and to ensure correct and safe use of the device is indicated in the text in
the following way:
WARNING indicates serious adverse reactions and potential safety hazards for
the practitioner and/or the patient that may occur in proper use or misuse of
the device as well as the limitations of use and the measures to be adopted in
such cases.
CAUTION indicates any special care to be exercised by a practitioner for the
safe and effectiveuse of the device.
EXPLANATION OF SYMBOLS USED ON THE LABELS
For single use only(Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Date of manufacture
Manufactured by:
Sterile - Ethylene oxide sterilised
Non Pyrogenic
Contains PHTHALATE
Latexfree
Warning: Do not resterilize.
Contents sterile only ifpackage isnot opened, damaged
or broken
Catalogue (code) number
Attention, see instructions for use
Attention, see instructions for use
This wayup
ea Units
Fragile; handle with care
Keep away from heat
Keep dry
The following is general safety information with the aim of advising the operator in
preparing touse the device.
Specific safety information is also given in the instructions for use at locationsin the
text where that information is relevant forcorrect operation.
-The user should carefully check the device for leaks during set-up and
priming.. Do not use if any leak is detected.
-The device must be used in accordance with the instructions for use
provided in this manual.
-For use by professionally trained personnelonly.
-SorinGroup Italia isnot responsible for problems arising from inexperience
or improper use.
-FRAGILE. Handle with care.
-Keep dry. Store at room temperature.
-Always apply and maintain a correct dose and accurately monitor the
anticoagulant before, during and after the bypass.
-For single use and for single-patient use only. During use the device is in
contact with human blood, body fluids, liquids or gases for the purpose of
eventual infusion, administration or introduction into the body, and due to
its specific design it cannot be fully cleaned and disinfected after use.
Therefore, reuse on other patients might cause cross-contamination,
infection and sepsis. In addition, reuse increases the probability of product
failure (integrity, functionality and clinical effectiveness).
-The device must not undergo any further processing.
-Do not resterilize.