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Idiomas disponibles
Idiomas disponibles
GB - ENGLISH
CONTENTS
A. Description
G. Administration procedure
I.
D921, D924, D924S, D928S, D924P are circuits designed to administer cardioplegic
solution containing blood with a fixed blood/asanguineous cardioplegic solution ratio.
Cardioplegic solution is used for perfusion of the coronaries during cardiopulmonary
by-pass, when the aorta is clamped and the intention is to protect the myocardium
during the anoxic phase. The sets are disposable, non-toxic and non-pyrogenic and
are supplied STERILE in individual packs. They are sterilized with ethylene oxide.
The residual ethylene oxide level in the sets complies with the requirements of the
legislation in force in the country of use.
The sets comprise:
1)
Two delivery lines for the asanguineous cardioplegia solution and oxygenated
blood which also act as pump segments.
The asanguineous solution line is bifurcated to allow the use of two different
cardioplegic solutions (if only one type of cardioplegic solution is used, the
unused line must be clamped).
2)
VANGUARD heat exchanger with integrated bubble trap, pressure line (with
transducer protection) and temperature probe port.
3)
Delivery line.
4)
1 Three-way stopcocks (for pressure and vent lines).
5)
Shunt between the blood line and the asanguineous cardioplegic solution line
for administration of blood only and a luer connector on the blood line to allow
the provision of different ratios using an infusion pump (model D924S, D928S).
B. TECHNICAL SPECIFICATIONS
The sets differ in the ratios of blood to cardioplegic solution and whether or not they
are equipped with shunt and luer. More specifically:
-
D924 (4 parts blood and 1 part asanguineous cardioplegic solution).
-
D924S (4 parts blood and 1 part asanguineous cardioplegic solution); with
shunt between the blood line and the asanguineous cardioplegic solution line
for administration of blood only and a luer connector on the blood line.
-
D921 (1 part blood and 1 part asanguineous cardioplegic solution).
-
D928S (8 parts blood and 1 part asanguineous cardioplegic solution); with
shunt between the blood line and the asanguineous cardioplegic solution line
for administration of blood only and a luer connector on the blood line.
-
D924P (4 part blood and 1 part asanguineous cardioplegic solution).
-
VANGUARD heat exchanger:
-
Hansen connectors for connections to the thermocirculator
-
temperature monitoring port
-
cardioplegic solution inlet connector 1/4" (6.4 mm)
-
cardioplegic solution outlet connector 3/16" (4.8 mm)
-
luer connector for vent line
-
pressure monitoring line
-
bubble trap with 105 micron filter
-
priming valve
C. INTENDED USE
D921, D924, D924S, D928S, D924P are sets for the administration of cardioplegic
solution containing blood, with the aid of a low flow pump.
This set allows control of the flow, the temperature and infusion (line) pressure of the
cardioplegic fluid. The pump permits total control of the infusion parameters, flow
and quantity of solution delivered. The perfusion temperature depends on the
thermal parameters of the cold water source which supplies the VANGUARD heat
exchanger.
Sets must not be used for more than 6 hours. Contact with the perfusion solution for
longer periods is not recommended.
Sets must be used in combination with the medical devices listed in point I (Medical
devices for use with cardioplegia sets).
D. SAFETY INFORMATION
In the text, information intended to draw the user's attention to the need to prevent
hazardous situations and assure correct, safe use of the device are identified as
follows:
Indicates serious consequences and potential dangers for the user and/or the
patient deriving from the use of the device in normal conditions of use or
GB - ENGLISH - INSTRUCTIONS FOR USE
improper use, as well as limitations on its use and the measures to be taken if
these events should occur.
Indicates every possible precaution the user must take for safe, effective use
of the device.
KEY TO THE SYMBOLS USED ON THE LABELS
The following are items of general information about safety, intended to provide the
operator of the set with appropriate warnings. In addition, specific information about
safety is included in these instructions for use where they may affect the operation to
be performed.
- The device must be used in accordance with these instructions for use.
- The device is intended for professional use.
- SORIN GROUP ITALIA accepts no responsibility for problems caused by
negligence or improper use.
- FRAGILE: handle with care
- Do not exceed a inlet water pressure of 300 kPA (3 bar / 43.5 psi).
- Do not exceed a heat exchanger inlet water temperature of 42°C (108°F).
- Keep dry. Store at room temperature.
- For single use and for single-patient use only. During use the device is in
contact with human blood, body fluids, liquids or gases for the purpose of
eventual infusion, administration or introduction into the body, and due to
its specific design it cannot be fully cleaned and disinfected after use.
Therefore, reuse on other patients might cause cross-contamination,
infection and sepsis. In addition, the reuse increases the probability of
product failure (integrity, functionality and clinical effectiveness).
GB - ENGLISH
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
Warning: Do not resterilize.
Contents sterile only if package is not opened,
damaged or broken
Catalogue (code) number
Attention, see instruction for use
Attention, see instruction for use
This way up
Fragile; handle with care
Quantity
Keep away from heat
Keep dry
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