Intended Use; Contraindications; Safety Information - SORIN GROUP dideco RECOVERY 797 Mode D'emploi

INSTRUCTIONS FOR USE
DESCRIPTION
Kit Code Kit Designation
04085 Code 681-R Circuit for postoperative
drainage (without filter)
04096 Code 681-R Circuit for postoperative
drainage
04097 Code 681-P Circuit for preoperative
apheresis
04099 Code 681 Line for postoperative
recovery of blood
04128 Multidiameter adapter
04059 4 way adapter with female luer lock
For a detailed description of the sets, please
refer to the SORIN GROUP ITALIA RECOVERY
KIT Code KIT Designation
04085 Code 681-R Circuit for post-operative
drainage (without filter)
04096 Code 681-R Circuit for post-operative
drainage
04097 Code 681-P Circuit for preoperative
apheresis
04099 Code 681 Line for postoperative recovery
of blood
04128 Multidiameter adapter
04059 4 way adapter with female luer lock

CONTRAINDICATIONS

The above mentioned circuits are not associated
with any particular contraindications.
The only side effects that can result from the
circuit use are those related to all collecting
procedures.

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 practitioner and/or
797 user manual. The device is single use, non-
toxic, non pyrogenic, supplied STERILE and
packaged singly. Sterilised by ethylene oxide.
The level of ethylene oxide residual in the device
within the limits established by national regula-
tions in the country of use.

INTENDED USE

The disposable circuits SORIN GROUP ITALIA
cod. 04085, 04096, 04097, 04099, 04128 are
intended to be connected exclusively with the
blood collecting module SORIN GROUP ITALIA
RECOVERY 797 in order to carry out the col-
lecting procedures mentioned in the table.
Type of Procedure
Postoperative drainage
Postoperative drainage
Preoperative apheresis
Postoperative drainage
Any procedure
Post operative drainage
patient that can occur in the proper use or
misuse of the device, and also 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 effective use of
the device.
EXPLANATION OF THE SYMBOLS USED ON
THE LABELS
For single use only
(Do not reuse)
Batch code (number)
LOT (reference for product
traceability)
1