dideco 151E Manual De Usuario página 4

Carefully check that the collection bags are hung with the inlet line at the
top. If not, during some phases of the procedure (in particular during bowl
emptying) the blood components collected in the bags may flow back into
the bowl.
4. Connect the larger-diameter line of the 4-way adapter to the male connector located
at the end of the wash set waste line exiting from the bowl.
Open the red clamp on the collection bag line. Close the white clamp on the waste
bag collection line. Close the blue clamp on the free branch of the 4-way adapter.
•
The value indicated on the flow regulator should not be understood as
measured value, but only as reference for the user. Should the volume
values be considered significant for patient treatment purposes,
special measuring instruments must be used.
•
Check that the collapsing bag is positioned at the height of the trolley
base and placed in vertical position with the connection to the wash
set at the top.
•
Avoid simultaneously closing the clamps on the outlet lines of the bowl.
This would cause pressure increase in the bowl, detachment of the
safety ring and outflow of the fluid contained in the bowl.
5. In the case of procedures requiring only one bag (PPP or PRP1), close the clamp on
the unused line; in the case of procedures requiring two bags, connect the second
bag supplied with the blood component collection set to the Luer-lock connector on
the line identified by the orange clamp.
6. Open the yellow clamp on the connection line to one of the two collection bags (PPP
collection bag) and close the orange clamp on the other bag (PRP collection bag).
Close the white clamp on the connection line to the waste bag.
7. The sterile Luer-lock protective caps provided can be used to close the open ends of
the lines on the collection bags at the end of the procedure.
8. Extract the direct drawing circuit from the relevant container.
9. Close the red clamp on the anticoagulation line and set the regulator to OFF.
10. Hang the anticoagulant solution on the upper arm of the IV pole, connect it to the
anticoagulation line by means of the spike and fully extend the IV pole. Open the air
intake if necessary.
11. Close the roller clamp and the green clamp on the saline solution line.
12. Hang the saline solution bag on the lower part of the IV pole and connect it to the
saline solution line (identified by the green clamp) by means of the spike. Open the
air intake if necessary.
13. Connect the drawing line (identified by the blue tube) to the wash set filling line.
Close the white clamp positioned near the 4-way connector.
14. Secure the collapsing bag to the right-hand side of the trolley at the bottom of its
vertical wall with the connection to the wash set at the top.
•
The bag must be in vertical position to assure proper filling and
consequent functioning.
15. Get ready to carry out the circuit priming operations.
•
For a detailed description of the line priming operations and use of the
circuit, carefully read the instructions in the user manual of the SORIN
GROUP ITALIA ELECTA cell separator for the pre-operative apheresis
procedures with direct drawing from the patient.
•
The PRP or PPP collected must be administered on instructions and
under supervision of the responsible physician. Carefully evaluate the
haemocoagulative state of the patient following administration of the
collected PRP. The collected platelets must be stored at 20-24°C and
frequently stirred gently. The platelets may not be kept for more than 6
hours in accordance with international standards.
MEDICAL DEVICES FOR USE WITH THE BLOOD
COMPONENTS COLLECTION SET COD. 151E
The Code 151E Blood Components Collection Set must be connected to the
Wash Sets and to the SORIN GROUP ITALIA ELECTA unit.
The connections to the product must be of a diameter which is compatible with the
dimensions of the connectors on the device (3/8" or 1/4").
LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the Purchaser pursuant to
applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been taken in the manufacture
of this medical device, as required by the nature of the device and the use for which the
device is intended.
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.
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 expressedly 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 expressedly 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.
No person, including any