Intended Use; Safety Information - dideco 151E Manual De Usuario

PRODUCT DESIGNATION
Cod. 151E
DESCRIPTION
The Code 151E Blood Components Collection Set is made up of tubes and collection bags
for transfer and containment of the blood components separated from the patient's blood.
The products are single use, non-toxic, non pyrogenic, supplied STERILE and packaged
individually. Sterilized with ethylene oxide.
The level of ethylene oxide residuals in the product is within the limits established by
national regulations in the country of use.

INTENDED USE

The Code 151E Blood Component Collection Set must be used in combination with the
wash sets and the SORIN GROUP ITALIA ELECTA unit for separation of Platelet-Rich
Plasma (PRP) and Platelet-Poor Plasma (PPP) from the whole blood directly collected
from the patient. The product must be used in combination with the medical devices listed
in the paragraph "Medical devices for use with the Code 151E Blood Component Collection
Set".

SAFETY INFORMATION

Information intended to attract the attention of the user to potentially dangerous situations
and to ensure correct and safe use of the product is indicated in the text in the following
way:
Indicates serious adverse reactions and potential safety hazards for
practitioner and/or patient that can occur in the proper use or misuse of the
product, and also the limitations of use and the measures to be adopted in
such cases.
Indicates any special care to be exercised by a practitioner for the safe and
effective use of the product.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
For single use only
(Do not reuse)
Manufacturing batch
Batch code (reference for product
traceability)
Use by (Expiry date)
Sterile - Ethylene oxide sterilised
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Keep away from heat
Temperature limitation
0°C (32°F) ÷ 60°C (140°F)
BLOOD COMPONENTS COLLECTION SET
WITH DIRECT DRAW
PRODUCT DESCRIPTION
Blood components collection set with direct
connection
Keep dry
The following is general safety information that aims to advise the operator on how to use
the product.
Also, specific safety information is given in the instructions for use where that information
is relevant for correct operation.
•
The product must be used according to the instructions for use provided
in this manual.
•
The product is intended to be used by professionally trained personnel.
•
Sorin Group Italia is not responsible for problems arising from
inexperience or improper use.
•
FRAGILE, handle with care.
•
Do not expose the product to temperatures below 0 °C (32 °F) or above
60 °C (140 °F).
•
Avoid any condition which may cause the blood temperature to exceed
37 °C (98.6 °F).
•
Keep dry.
•
Always apply and maintain a correct dosage and an accurate monitoring
of the anticoagulant when used with blood.
•
For single use and for single patient use only.
•
The product must not undergo any further processing.
•
Do not resterilise.
•
After use, dispose of the product in accordance with applicable
regulations in force in the country of use.
•
For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorised local representative.
The use of medication not mentioned in this manual is on sole responsibility
of the user.
DISPOSABLE SET-UP PROCEDURE
•
Sterility is guaranteed only if the sterile packaging is not wet, opened,
damaged or broken. Do not use the product if sterility cannot be
guaranteed.
•
Check the expiry date on the label attached. Do not use the product
after the date shown.
•
The product must be handled aseptically.
•
Make all connections with a suitable sterile technique.
•
Carry out a visual inspection and carefully check the product before
use. Transport and/or storage conditions other than those prescribed
may have caused damage to the product.
•
Do not use solvents such as alcohol, ether, acetone, etc. to prevent
damage to the product.
•
Refer to the user manual of the SORIN GROUP ITALIA ELECTA cell
separator for the methods of connection and use with the relevant
disposable circuits.
•
During installation of the wash set, do not attach the waste bag and the
autotransfusion reservoir to the respective connection lines.
1. Extract the blood component collection set from the relevant container.
2. The collection bags contained in the package may be used to collect only Platelet-
Poor Plasma (PPP) or only Platelet-Rich Plasma (PRP) (single-bag procedure), or to
collect the PRP separately from the PPP (double-bag procedure). In the single-bag
procedure, the second collection bag may, if necessary, be used to change the
reinfusion bag on the wash set.
3. Hang the collection bags on the IV pole of the unit with the inlet line entering at the
top of the bag. Close the roller clamp on the outlet line of each collection bag. To
prevent blood fluid from accumulating at the top of the bags, it is recommended to
hang the relevant lines over the arm of the IV pole.