Medical Devices For Use With Synthesis; Return Of Used Products; Limited Warranty - sorin Synthesis Gebrauchsanweisung

- When there is the certainty or suspicion of large contaminations, tumours, intestinal
perforations, or lymphatic loss.
- If the patient undergoes another operation.
- Before use ensure that the SYNTHESIS venous reservoir has not been
polluted as a result of handling which has compromised sterility.
- The SYNTHESIS venous reservoir can function as chest drainage activated
by the line vacuum.
- The sterility of the system depends on the degree of asepsis resulting from
use of the venous reservoir and the care taken in connecting the kit during
the conversion to chest drainage.
- Prepare the vacuum regulating device with integrated valve for use,
following the instructions of the manufacturer provided with the device.
- Should negative pressure be applied to the system such that the
overpressure valve intervenes, the recovered blood will no longer be
suitable for transfusion since contaminated.
- Periodically check functioning of the vacuum regulating device.
- If the recovered blood exceeds the amount established by postoperative
routine, immediately notify the physician in charge.
- If the recovered blood is to be re-infused, an increase in vacuum will be
noted in the reservoir. A filtered venting system must therefore be arranged
in order to restore the original negative operating pressure.
- Using suitable tests, check the degree of "pollution" of the blood collected
related to the time of use of the drainage system. The results of these tests
must be taken into account for blood transfusion.
- The recovered blood must be re-transfused with a suitable volumetric
infusion pump or with the syringe and three-way stopcock technique used
manually as an alternative to the pump.
- To prevent air from entering the vein of the patient, ensure that the infusion
pump has an efficient stopping system in the event of air in the line;
likewise, be careful not to aspirate air during re-transfusion with syringe.
- If the reservoir used does not have an integrated microfilter, fit the re-
infusion line with a 25-40 micron blood filter.
USE WITH A VACUUM SOURCE
Immediately after intraoperative use of the SYNTHESIS reservoir, convert it to chest
drainage using the line sets/chest drainage kits, and operate in such a way as not to
compromise sterility of the system. In order to obtain the best out of the system, set up
the operational routine in such a way that the priming fluid of the extracorporeal circuit
generously wets the filter of the SYNTHESIS reservoir to the maximum possible level; do
not for any reason transfer to the reservoir blood that has not been suitably
uncoagulated.
1. Clamp all openings.
2. Set up the device for connection to the patient and to a possible vacuum source
fitted with a safety valve and suitable pressure regulator.
3. Position the SYNTHESIS venous reservoir suitably close to the patient and in any
case at a level lower than the patient: for this purpose use the RESERVOIR
HOLDER securing it to the bed frame.
4. After making the appropriate connections to the patient, connect to the vacuum line,
taking care to place a vacuum regulator and a safety valve between the vacuum line
and the SYNTHESIS reservoir. These two devices must be extremely reliable and
accurate.
5. Adjust the desired degree of negative pressure.
6. Ensure that the safety valve functions properly.
7. Start the drainage procedure and periodically check that the system functions
regularly.
- Use of the SYNTHESIS venous reservoir as chest drainage is the
responsibility of the intensive care staff.
- Its preparation is the joint responsibility of the person performing perfusion
and the intensive care staff.
- Its connection to the patient is the responsibility of the attending surgeon.
- Use by untrained and unqualified personnel is not permitted.
- All the connections to the Sorin reservoir should be carried out with the
utmost care and rapidity in order to prevent contamination.
- The connections and the caps should be checked to assure that the system
is tight.
- Always keep the device in a vertical position: do not incline it, not even
when the patient is being moved.
- The SYNTHESIS reservoir must always be placed at a subthoracic level so
that its drainage functions can properly be performed.
- Activate the line vacuum following the instructions provided by the
manufacturer of the vacuum regulator.
- Any re-infusion of recovered blood is on the responsibility and at the
discretion of the attending physician.
N. MEDICAL DEVICES FOR USE WITH SYNTHESIS
- HOLDER code 05046
- SYNTHESIS reservoir holder code 050119
- Stopcock holder (050134).
- Active drainage kit (code 096834).
The circuit connections must be made with tubes of a diameter compatible with the
dimensions of the connectors located on the device (3/8", 1/4", 1/2").
Temperature control must be carried out with SORIN GROUP ITALIA probes, code
050122 or YSI Series 400 compatible.
Use a Sechrist air/oxygen blender (Sorin Group Italia code 09046) or a system with
compatible technical features to control the blood gas concentration.
Any heating/cooling system (thermocirculator) may be used, provided that the connectors
to the oxygenator are the Hansen type (Sorin Group Italia code 09028).
SORIN GROUP ITALIA is currently not aware of any contraindications to the use of the
device with occlusive or non-occlusive pumps. The use of other types of pumps must be
agreed with SORIN GROUP ITALIA.
O. RETURN OF USED PRODUCTS
Should the user be dissatisfied with anything related to the quality of the product, the
product distributor or the authorized local SORIN GROUP ITALIA representative should
be notified.
All the parameters considered critical by the user must be reported with particular care
and urgency. The following is the minimum information that should be provided:
 Detailed description of the event and, if pertinent, the conditions of the patient;
 Identification of the product involved;
 Lot number of the product involved;
 Availability of the product involved;
All the indications the user considers useful in order to understand the origin of the
elements of dissatisfaction.
Sorin Group Italia reserves the right to authorize, if necessary, recall of the product
involved in the notification for assessment. If the product to be returned is contaminated,
it must be treated, packed and handled in conformity with the provisions of the legislation
in force in the country where the product was used.
- It is the responsibility of the health care institution to adequately prepare
and identify the product for return shipment. Do not return products that
have been exposed to blood borne infectious diseases.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a returned goods
authorisation (RGA) number is required from Sorin Group USA Inc. prior to shipping.
If the product has been in contact with blood or blood fluids, it must be thoroughly
cleaned and disinfected before packing. It should be shipped in either the original carton
or an equivalent carton to prevent damage during shipment, and it should be properly
labelled with an RGA number and an indication of the biohazardous nature of the content
in the shipment.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031.
P. LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the Purchaser
pursuant to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been taken in the
manufacture of this medical device, as required by the nature of the device and the use
for which the device is intended.
SORIN GROUP ITALIA warrants that the medical device is capable of functioning as
indicated in the current instructions for use when used in accordance with them by a
qualified user and before any expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will use the device
correctly, nor that incorrect diagnosis or therapy and/or that the particular physical and
biological characteristics of an individual patient, do not affect the performance and
effectiveness of the device with damaging consequences for the patient, even though the
specified instructions for use have been respected.
SORIN GROUP ITALIA, whilst emphasizing the need to adhere strictly to the instructions
for use and to adopt all the precautions necessary for the correct use of the device,
cannot assume any responsibility for any loss, damage, expense, incidents or
consequences arising directly or indirectly from the improper use of this device.
SORIN GROUP ITALIA undertakes to replace the medical device in the event that it is
defective at the time of placing on the market or whilst being shipped by SORIN GROUP
ITALIA up to the time of delivery to the final user unless such defect has been caused by
mishandling by the purchaser.
The above replaces all other warranties explicit or implicit, written or verbal, including
warranties of merchantability and fitness for purpose. No person, including any
representative, agent, dealer, distributor or intermediary of SORIN GROUP ITALIA or any
other industrial or commercial organization is authorized to make any representation or
warranty concerning this medical device except as expressly stated herein. SORIN
GROUP ITALIA disclaims any warranty of merchantability and any warranty of fitness for
purpose with regard to this product other than what is expressly stated herein. The
purchaser undertakes to comply with the terms of this Limited Warranty and in particular
agrees, in the event of a dispute or litigation with SORIN GROUP ITALIA, not to make
claims based on alleged or proven changes or alterations made to this Limited Warranty
by any representative, agent, dealer, distributor or other intermediary.
The existing relations between the parties to the contract (also in the case that it is not
drawn up in writing) to whom this Warranty is given as well as every dispute related to it
or in any way connected to it as well as anything related to it or any dispute concerning
this Warranty, its interpretation and execution, nothing excluded and/or reserved, are
regulated exclusively by the Italian law and jurisdiction. The court chosen is the Court of
Modena (Italy).
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