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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.
- The device must be used in accordance with the instructions
for use provided in this manual.
- For use by professionally trained personnel only.
- SORIN GROUP ITALIA is not responsible for problems arising
from inexperience or improper use.
- FRAGILE, handle with care.
- Keep dry. Store at room temperature.
- Always apply and maintain a correct dose and accurately
monitor the anticoagulant before, during and after the
bypass.
- 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 at the end of use.
Therefore, reuse on other patients might cause cross-
contamination, infection and sepsis. In addition, reuse
increases the probability of product failure (integrity,
functionality and clinical effectiveness).
- The device must not undergo any further processing.
- Do not resterilize.
- After use, dispose of the device in accordance with
applicable regulations in force in the country of use.
- The device must only be used if STERILE.
- The device contains phthalates. Considering the nature of
body contact, the limited contact duration and the number of
treatments per patient, the amount of phthalates which might
be released from the device do not raise specific concerns
about residual risks. Further information is available on
request from Sorin Group Italia.
- The device should be used together with a membrane
oxygenator for collection and defoaming of venous blood and
for filtration and storage of blood aspirated during surgical or
therapeutic procedures implementing extracorporeal blood
circulation or cardiopulmonary bypass. It is also suitable for
postoperative chest drainage.
- The device and its accessories must be handled applying
sterile techniques.
- The maximum venous blood flow is 8 l/min, while the
maximum aspirated blood flow is 6 l/min.
- The venous manifold allows connection to the venous line, an
auxiliary cardiotomy reservoir and the venous blood sampling
system. It is provided with a temperature site.
- SYNTHESIS R should always be positioned above the
oxygenator used.
- During SYNTHESIS R operation constantly check that the
blood level does not fall below the safety limit.
- For higher safety use a blood level detector.
- "Filtered" and "unfiltered" ports allow the administration of
fluids and medicinal preparations.
- Drugs which must be administered at low doses should be
diluted with saline solution so that they can safely run into the
extracorporeal circuit.
- It is recommended to administer all fluids through the filtered
ports, even if this should result in a slight delay in the fluid
reaching the circulation.
- The SYNTHESIS R venous reservoir, applying the method of
active venous drainage with vacuum, must be used carefully
following the instructions "USE OF ACTIVE VENOUS
DRAINAGE WITH VACUUM" in this user's manual in
paragraph M.
- When using the venous reservoir for post-operative chest
drainage carefully follow the instructions in "USE FOR POST-
OPERATIVE CHEST DRAINAGE" in this user's manual at
paragraph N.
- The special positive and negative overpressure valve built
into the Sorin Group reservoirs ensures optimal intra- and
post-operative performance of the system. The valve is
activated and vents positive pressure higher than +5 mmHg
(0.7 KPa/ 0.007 bar / 0.1 Psi) and negative pressure lower than
-80 mmHg ( -10.4 KPa / -0.01 bar / -1.53 Psi). DO NOT
OCCLUDE THE EXTERNAL ENTRY PORT OF THE VALVE FOR
ANY REASON WHATSOEVER.
6
- SYNTHESIS R venous reservoirs can be used with their
special holder, RESERVOIR HOLDER.
- For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative.
- Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
E. PREPARATION AND SET-UP
Do not use if the sterile packaging is damaged, unsealed, or
-
has been exposed to moisture or other conditions that
would compromise the sterility of the device.
Check the expiry date on the label attached. Do not use the
-
device after the date shown.
-
The device must be used immediately after opening the
sterile packaging.
-
The device must be handled aseptically.
1. Remove the device from the sterile packaging
- Carry out a visual inspection and carefully check the device
before use. Transport and/or storage conditions other than
those prescribed may have caused damage to the device.
- Do not use solvents such as alcohol, ether, acetone, etc., as
contact may cause damage to the device.
- Do not allow halogenated liquids such as Halothane and
Fluothane to come into contact with the polycarbonate
housing of the device. This could cause damage which may
compromise the integrity and proper functioning of the
device.
2. Remove the yellow insert from the pressure relief valve.
3. Remove the unit from its external packaging but only remove it
from the sterile wrapper just before use.
4. Place the venous reservoir into its holder after positioning it on the
heart-lung machine. The holder can be located in different
positions on the pump. The venous reservoir and its holder should
be positioned so as to allow easy and practical access to the
connectors and easy reading of the blood level. Make sure that
SYNTHESIS R is positioned above the oxygenator to which it is
connected.
5. Secure the device to its holder simply by inserting it in the metal
half-ring, taking care that the lower part rests on the
corresponding striker of the holder. Alignment and attachment
require nothing other than positioning and pressing. The venous
reservoir will fit perfectly in place when it is in vertical axis.
6. Remove the protective caps of the connectors to be used and
connect them as soon as the corresponding cap has been
removed. The connectors are shown in Fig. 1 of this manual.
7. Remove the yellow cap which protects the gas venting vacuum
line connector.
8. Connect the venous line to the 1/2" venous manifold connector.
9. Three
administration: Luer, pos-lock and 1/4" I.D. For the corresponding
directions refer to Fig. 1 of this manual.
10. An additional cardiotomy reservoir should be connected to the
special connector as illustrated in Fig. 1 of this manual.
11. Connect the purge/recirculation lines to the relevant connectors
(Rif. 5 in Fig. 1).
12. Connect the venous sampling manifold to the venous Luer-lock
connector (Rif. 14 in Fig. 1).
13. Connect the Sorin Group Italia temperature probe to the venous
collector temperature site (Rif. 11 in Fig.1).
Use SORIN GROUP ITALIA temperature probes (code 09026) or
equivalent.
F. PRIMING PROCEDURE
1. Prime the extracorporeal circuit through the SYNTHESIS R
reservoir cardiotomy section. Make sure that the 3/8" blood outlet
connector is clamped during operation.
2. Prime the oxygenator by gravity or simply by pump flow, then the
arterial filter and the arterial/venous line. All the vents should be
opened. The other single devices will be operated according to
the relative instructions for use.
3. Debubble the extracorporeal circuit following the device sequence
according to the flow direction. For instance, first the line
upstream of the oxygenator, then the oxygenator, the connection
line to the arterial filter, the arterial filter, etc.
GB - ENGLISH
types
of
vertical
connectors
enable
quick
fluid
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