Blood Recovery After Bypass; Oxygenator Replacement; Module; Return Of Used Products (Only For Us Customers) - SORIN GROUP PrimO2X Instrucciones De Uso

– Verify that the cardioplegia circuit connected to the coronary outlet port is
properly clamped.
To eliminate air from the oxygenator, proceed as follows:
1) Turn the gas flow off.
2) Turn the arterial pump off.
3) Clamp the arterial line.
4) Restore the venous return so that the required volume of liquid is in the venous
reservoir.
5) Clamp the venous line.
6) Open the purging/recircualtion line and recirculate at a rate of 2000 ml/min until
complete air removal from the system.
7) Restart bypass by opening the arterial and venous lines.
8) Clamp the purging/recircualtion line.
J. BLOOD RECOVERY AFTER BYPASS
1) Recover as much blood as possible from the venous line, as soon as the surgeon
has removed the cannulae from the patient's vena cava.
Deliver blood into the aortic canulae as required by the patient's condition, slowly
2)
decreasing the level in the Venous Reservoir.
When the reservoir is nearly empty stop the arterial pump and clamp the arterial line.
3)
K. OXYGENATOR REPLACEMENT
A spare oxygenator must always be available during bypass in the unlikely event that the
oxygenator in use requires change-out. Procedures lasting longer than 6 hours or if
particular situations where the safety of the patient may be compromised, (insufficient
oxygenator performance, leaks, abnormal blood parameters etc.), could require change
out. Follow the steps below to change out the oxygenator.
Use a sterile procedure during the entire replacement phase.
1) Turn the gas flow off.
2) Double clamp, the venous line (5 centimetres apart).
3) Turn the arterial pump off and double clamp the arterial line (5 centimeters apart) next
to the arterial outlet port.
4) Turn the heater-cooler off, clamp and remove the water lines.
5) Disconnect the gas line, all monitoring and sampling lines.
6) Cut the venous return and the arterial lines in the section between the two clamps,
leaving a sufficient length of tubing to allow connection to the new oxygenator.
7) Remove the oxygenator from the holder.
8) Place a new oxygenator on the holder. Connect all lines (i.e. venous line to the
Venous Reservoir inlet port, arterial and gas to the oxygenator, pump line to Venous
Reservoir outlet and oxygenator inlet port).
In this phase, keep the venous and arterial lines clamped.
9) Open the water lines on the holder turn the heater-cooler on and check the integrity
of the new heat exchanger.
10) Prime the new oxygenator and remove the microbubbles, as described in the priming
and circulation procedure.
11) Verify all connections and secure with ties.
12) Remove clamps from the venous and the arterial line, close the purging/recirculation
line and start the bypass again.
Turn on the gas flow and adjust gas flow rate as required.
13)The blood contained in the oxygenating module and in the heat exchanger can be
recovered by connecting the arterial line to one of the venous reservoir inlets and by
gravity draining the PRIMO X MODULE replaced.
2
L. MEDICAL DEVICES FOR USE WITH THE PRIMO

MODULE

The user should observe the warnings and cautions and follow instructions for use
accompanying the separate device.
The device may be used in combination with a soft venous reservoir and an auxiliary
cardiotomy of no less than 2 l, to achieve a closed system.
The device may be used in combination with a hardshell venous/cardiotomy reservoir of
no less than 2l, to achieve an open system.
All tubing used to make the circuit connections must be of a diameter which is compatible
with the dimensions of the connectors on the device (3/8",1/4").
Temperature monitoring must be carried out using SORIN GROUP ITALIA probes (code
09026) or equivalent temperature probes (ref TMPMV) compatible to YSI Series 400.
Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 09046) or a system with
compatible technical features for control of the blood gas concentrations.
Any heating/cooling system may be used, provided that the water line connectors are
Hansen 3ST (SORIN GROUP ITALIA code 09028) or equivalent.
Currently SORIN GROUP ITALIA is not aware of any contraindications to the use of the
device with occlusive or non-occlusive peristaltic pumps or with centrifugal pumps. The
use of other types of pump must be agreed with SORIN GROUP ITALIA.
8
M. RETURN OF USED PRODUCTS (ONLY FOR US
CUSTOMERS)
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 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 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.
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.
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
N. 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 the 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,
X
2
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.
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 expressedly 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 expressedly 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).
GB - ENGLISH
No person, including any