sorin APEX HP Instrucciones De Uso página 11

SORIN GROUP ITALIA warrants that the medical device is capable of functioning as
indicated in the current instructions for use when used in accordance with them by a
qualified user and before any expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will use the device
correctly, nor that the incorrect diagnosis or therapy and/or that the particular physical
and biological characteristics of an individual patient, do not affect the performance
and effectiveness of the device with damaging consequences for the patient, even
though the specified instructions for use have been respected.
SORIN GROUP ITALIA, whilst emphasizing the need to adhere strictly to the
instructions for use and to adopt all the precautions necessary for the correct use of
the device, cannot assume any responsibility for any loss, damage, expense,
incidents or consequences arising directly or indirectly from the improper use of this
device.
SORIN GROUP ITALIA undertakes to replace the medical device in the event that it is
defective at the time of placing on the market or whilst being shipped by SORIN
GROUP ITALIA up to the time of delivery to the final user unless such defect has
been caused by mishandling by the purchaser.
The above replaces all other warranties explicit or implicit, written or verbal, including
warranties of merchantability and fitness for purpose. No person, including any
representative, agent, dealer, distributor or intermediary of SORIN GROUP ITALIA or
any other industrial or commercial organization is authorized to make any
representation or warranty concerning this medical device except as expressly stated
herein. SORIN GROUP ITALIA disclaims any warranty of merchantability and any
warranty of fitness for purpose with regard to this product other than what is expressly
stated herein. The purchaser undertakes to comply with the terms of this Limited
Warranty and in particular agrees, in the event of a dispute or litigation with SORIN
GROUP ITALIA, not to make claims based on alleged or proven changes or
alterations made to this Limited Warranty by any representative, agent, dealer,
distributor or other intermediary.
The existing relations between the parties to the contract (also in the case that it is not
drawn up in writing) to whom this Warranty is given as well as every dispute related to
it or in any way connected to it as well as anything related to it or any dispute
concerning this Warranty, its interpretation and execution, nothing excluded and/or
reserved, are regulated exclusively by the Italian law and jurisdiction. The court
chosen is the Court of Modena (Italy).
PRODUCT SPECIFICATIONS
®
APEX HP HOLLOW FIBER MEMBRANE BLOOD
OXYGENATOR WITH HARDSHELL VENOUS RESERVOIR
System
Maximun Blood Flow
Priming Volume (static, 0 lpm)
Height
Maximum Diameter
Weight
VVR 4000i Venous Reservoir
Maximum Cardiotomy Flow
Minimum Operating Volume (During
cardiopulmonary bypass)
Maximum Volume Capacity
Max. Negative Reservoir Pressure
Defoamed and Unfiltered Ports
Venous Inlet Port
Rapid Prime Port
Recirculation Port
Filter Bypass Port
Luer Lock Ports
Venous Sampling Port
Defoamed and Filtered Ports
Cardiotomy Inlet Ports (5)
Luer Lock Ports
Other Ports
Venous Reservoir Outlet Port
Vent/Vacuum Port
Pressure Valve
Fittings
SAT/HCT Fitting
Venous Temperature Probe Fitting
8 liters/min
660 ml
21" (53.3 cm)
10" (25.4 cm)
4.0 lbs (1800g)
4 liters/min
100 ml up to 5 liters/min
200 ml for 5 to 8 liters/min
4000 ml
–90 mm Hg
1/2" (12.7 mm)
1/4" (6.4 mm)
1/4" (6.4 mm)
3/8" (9.5 mm)
3
Female Luer-lock
Four 1/4" (6.4 mm)
One 3/8" (9.5 mm)
2
3/8" (9.5 mm)
1/4" (6.4 mm)
Integral
Sorin Group Italia Bayonet
with Optical Window
YSI Series 400
GB – ENGLISH
Integral Cardiotomy Filter
Filtration Efficiency
Construction Materials
Defoamer
Construction Materials
APEX HP Hollow Fiber Membrane Blood Oxygenator with Integral Heat
Exchanger
Maximun Gas Flow
Priming Volume
Static Priming Volume:
(post use recovered)
Ports
Oxygenator Inlet Port
Oxygenator Outlet Port
Arterial Blood Access Port
Arterial Sampling Port
Fittings
Gas Inlet Fitting
Water Inlet & Outlet Fittings
Arterial Temperature Probe
Anesthetic Gas Scavenge
Heat Exchanger
Material
Surface Area
Membrane
Configuration
Membrane Surface Area
Membrane Material
Pressure Limitations
Blood Pathway
Gas Pathway
Water Pathway
Blood Access Connector
EXPLANATION OF THE 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
Latex free
90% at 30 microns
Polyurethane sponge
Polyester, nonwoven depth
material
Polyester screen
Polyester knit sock
Polyurethane sponge
Silicone antifoam
16 liters/min
250 ml
210 ml
3/8" (9.5 mm)
3/8" (9.5 mm)
pos-lock
Female Luer-lock
1/4" (6.4 mm)
Hansen 3ST
YSI Series 400
3/8" (9.5 mm)
Stainless steel
0.14 m
2
Hollow fiber
(Blood outside fiber)
1,87 m
2
Microporous polypropylene
750 mm Hg (100 kPa)
0 mm Hg at outlet
44 psi (300 kPa)
1/4" (6.4 mm) Barb
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