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Les langues disponibles
INSTRUCTIONS FOR USE
I. CONTENTS
I. Contents
G. Use of the cardiotomy for post-operative drai-
nage.
H. Venous reservoir replacement
I. Medical devices for use with the D762, D764
MIDICARD
A. DESCRIPTION
The D762, D764 MIDICARD is a cardiotomy reser-
voir composed of a filtering system made up of a
defoaming material and a filter which is mainly
intended to eliminate the microaggregates and the
microemboli coming from the suckers placed in the
operative field and from the ventricular vent.
The filtering system is contained in a polyester hou-
sing.
The device is single use, non-toxic, non pyrogenic,
supplied STERILE and packaged singly.
Sterilised by ethylene oxide. The level of ethylene
oxide residuals in the device is within the limits
established by national regulations in the country of
use.
The device is available in the following versions:
[A] D 762 MIDICARD (with 20 μm cardiotomy)
[B] D 764 MIDICARD (with 40 μm cardiotomy)
B. TECHNICAL FEATURES
- Cardiotomy maximum volume
- Defoaming system Material
- Filtering system Material
- Connections:
Inlets
1 filtered luer lock or pos lock
1/4" and 3/8" (quick prime)
Outlet
1/4" (air vent/vacuum conn.)
- Maximum blood flow
2000 ml
Polyurethane
Polyester
2x3/16"
3x1/4"
3 filtered luer locks
1 unfiltered luer lock
3/8"
4l/min
C. INTENDED USE
The D762, D764 MIDICARD is a cardiotomy reser-
voir which is devised to collect the blood aspirated
from the operating field during surgical procedu-
res. The D762, D764 MIDICARD is intended for
use in procedures on patients with a body weight
up to 55Kg (121 lb). The D762, D764 MIDICARD
should not be used longer than 6 hours. Contact
with blood for longer periods is not advised.
The D762, D764 MIDICARD should be used in
combination with medical devices listed in section
I (Medical devices for use with the D762, D764
MIDICARD ).
D. 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 indica-
ted in the text in the following way:
WARNING
Indicates serious adverse reactions and potential
safety hazards for practitioner and/or patient that
can occur in the proper use or misuse of the devi-
ce, and also the limitations of use and the mea-
sures 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)
Manufacturing batch
Batch code (number) (refe-
LOT
rence for product traceability)
Use by (Expiry date)
Sterile - Ethylene oxide
sterilised
STERILE
Non sterile
NON STERILE
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