Technical Features; Intended Use; Safety Information - sorin SYNTHESIS R Instrucciones De Uso

GB – ENGLISH
CONTENTS
A. DESCRIPTION
B.

TECHNICAL FEATURES

C.

INTENDED USE

D.

SAFETY INFORMATION

E. PREPARATION AND SET-UP
F. PRIMING PROCEDURE
G. INITIATING BYPASS
H. DURING BYPASS
I. SUSPENDING BYPASS
J. REINITIATING BYPASS
K. TERMINATING BYPASS
L. BLOOD RECOVERY AFTER BYPASS
M. USE OF ACTIVE VENOUS DRAINAGE WITH VACUUM
N. USE FOR POST-OPERATIVE CHEST DRAINAGE
O. DEVICE CHANGE-OUT
P. MEDICAL DEVICES FOR USE WITH SYNTHESIS R
Q. RETURN OF USED PRODUCTS
R. LIMITED WARRANTY
A. DESCRIPTION
SYNTHESIS R is a rigid shell venous reservoir with sequential
cardiotomy filter.
The device is single-use, non-toxic, apyrogenic, supplied STERILE in
individual packaging. Sterilized 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 version
1) SYNTHESIS R: hard-shell venous reservoir with sequential
cardiotomy filter.
B. TECHNICAL FEATURES
MAX. RESERVOIR VOLUME
MIN. OPERATING VOLUME
OUTER BODY
- Material
BLOOD COLLECTOR
- Material
VENOUS COLLECTOR
- Material
FILTERING PACK
- Defoaming body
- Defoaming agent
- Microfilter
- Retention barrier
FILTERING SURFACE AREA
- 30 m + depth filter
- 100 m
FILTERING ABILITY
- cardiotomy reservoir section
- venous reservoir section
MAX. BLOOD FLOW
- venous blood
- suction blood
PORT CONFIGURATIONS
- Venous inlet
- Suction inlets
- Quick prime
- Pos lock
- Luer locks
- Chest drainage
- Vent / vacuum
- Blood outlet
SAFETY VALVE
C. INTENDED USE
SYNTHESIS R has been specifically designed for cardiovascular
procedures requiring cardiopulmonary bypass. It collects venous
blood and defoams, filters and stores the blood from the operating
field through thoracic, intracardiac and general suction.
GB - ENGLISH- INSTRUCTIONS FOR USE
4300 ml
300 ml
Polycarbonate
Polycarbonate
Polycarbonate + PVC
Polyurethane sponge (30 ppi)
Silicone antifoam
30 m polyester net + depth
filter
100 m polyester net
330 cm
2
410 cm
2
30 m
100 m
8 l/min
4 l/min
1 x 1/2" rotating
3 x 1/4"
1 x 3/8"
1 x 1/4" filtered
1 unfiltered pos lock with direct
access to the bottom of the
venous reservoir
1 filtered
4 filtered
1 unfiltered
1 filtered x 3/8"
1 x 1/4" with overflow safety
valve
3/8"
vents P<-80 mmHg and P>5
mmHg
SYNTHESIS R can be used post-operatively for chest drainage.
It is suggested not to use SYNTHESIS R for more than 6 hours.
SYNTHESIS R can be used with the devices listed in paragraph P
(MEDICAL DEVICES FOR USE WITH SYNTHESIS R).
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 indicated in the text with the following symbols:
WARNING indicates serious adverse reactions and potential
safety hazards for the practitioner and/or the patient that may
occur in the proper use or misuse of the device as well as 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
The following is general safety information with the aim of advising
the operator in preparing to use the device.
Specific safety information is also given in the instructions for use at
locations in the text where that information is relevant for correct
operation.
- The user should carefully check the device for leaks during
set-up and priming. Do not use if any leak is detected.
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 instructions for use
Attention, see instructions for use
This way up
Fragile; handle with care
Units
Keep away from heat
Keep dry
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