Spectrum Medical Quantum PureFlow HX32V-C0 Mode D'emploi page 5

Quantum PureFlow Cardioplegia Heat Exchangers
REF. DESCRIPTION
HX32V-C0 Cardioplegia Heat Exchanger High Flow 1/4
HX22V-C0 Cardioplegia Heat Exchanger Low Flow 3/16
HX22V-C1 Cardioplegia Heat Exchanger Low Flow 1/4
CONTENTS
A. WARNINGS
B. CONTRAINDICATIONS AND ADVERSE REACTIONS
C. DESCRIPTION
D. TECHNICAL CHARACTERISTICS
E. INTENDED USE
F. DEVICE PREPARATION AND SET-UP
G. DEVICE PRIMING PROCEDURE
H. DEVICE USE AND REMOVAL
I. DEVICE REPLACEMENT
J. MEDICAL DEVICES TO BE USED WITH THE DEVICE
K. RETURN OF USED DEVICES AND NOTIFICATIONS
L. LIMITED WARRANTY
M. SYMBOLS USED
A. WARNINGS
CAUTION
- Carefully read the instruc� ons before use.
- The device must be used in accordance with these instruc� ons for use. QURA cannot be held responsible for damages resul� ng from
incorrect use; the user is fully responsible for improper use or use diff erent from that indicated.
- The device may only be used by adequately trained and qualifi ed personnel.
- The device is sterilized by ethylene oxide and is sold STERILE. Sterility is guaranteed only when the package is intact. Do not use
the device if the package is damaged, tampered with, open or wet.
- Visually inspect and carefully check the device before use. Inappropriate transport and/or storage condi� ons not compliant with
the instruc� ons may have damaged the product.
- Fragile, handle with care.
- Keep dry. Store in a dry place between 0°C/32°F and 60°C/140°F.
- Single-use product to be used only once and on one single pa� ent. Reuse (on the same person or on other pa� ents) may result
in cross-contamina� on, infec� on and sepsis a� er the device comes into contact with blood/body fl uids or any substances infused into
the pa� ent during the procedure. Reusing the product could also compromise its characteris� cs in terms of performance and safety.
- Do not resterilize, subject to further processing or clean for reuse.
- The device is not made with natural rubber latex and does not contain phthalates.
- The device is non-toxic and non-pyrogenic.
- Check the expiry date printed on the label. Do not use the device beyond this date.
- In order to avoid product contamina� on, the device must be used immediately a� er opening the sterile packaging and handled asep� cally.
- The device must be used only in combina� on with the medical devices listed in sec� on J "Medical devices to be used with the device"
in these instruc� ons for use. Carefully read the user manuals of the medical devices listed in sec� on J before using the device.
- Do not allow alcohol, alcohol-based liquids, ethers, halogenated liquids (such as Halothane), or corrosive solvents (such as acetone)
to come into contact with the device. This would cause damage such as to compromise the integrity and func� onality of the device.
- The connec� on lines must be properly connected to prevent tube kinking or occlusion which could lead to a reduc� on in fl ow and/or
an increase in circuit pressure.
- It is advisable to externally secure the tubes on the herringbone connectors of the device using cable-� es.
- Con� nuously and carefully monitor perfusion.
- A spare device must always be available during the procedure.
- Follow an an� coagula� on protocol and monitor an� coagula� on throughout the procedure. The benefi t from using an extracorporeal
support must however be evaluated against the risk of systemic an� coagula� on and must be supported by a medical prescrip� on.
- Frequently monitor both the pa� ent and the device; do not leave the device una� ended while it is running.
- A� er use, dispose of the device in accordance with the applicable regula� ons in force in the country of use.
- In the event of a malfunc� on, always keep the defec� ve device and follow the instruc� ons given in sec� on J "Return of used devices
and no� fi ca� ons" if it needs to be returned.
- For further informa� on and/or in case of complaint, contact Qura S.r.l. or the distributor of the Qura product.
- For US market - Cau� on: Federal law restricts this device to sale by or on the order of a physician.
HX-C
CODE
HX32V-C4
HX22V-C4
HX22V-C5
Cardioplegia Heat Exchanger
Instruc� ons for use
DESCRIPTION
Cardioplegia Heat Exchanger High Flow 1/4 - PL
Cardioplegia Heat Exchanger Low Flow 3/16 - PL
Cardioplegia Heat Exchanger Low Flow 1/4 - PL
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