Gb - English; Instructions For Use - sorin XRES T Instrucciones De Uso

5. At the sterile field, unwrap the assembly, remove the protective cover, and
attach the connector to a suction cannula.
6. Pass the other end (the split end) of the aspiration line back from the sterile field
to the XTRA Autotransfusion System operator.
7. Close the roller clamp on the small bore tubing.
8. Remove the protective cover on the large bore tubing of the aspiration and
anticoagulation line.
9. Attach the tubing to one of the inlet ports on the lid of the reservoir. The inlet
ports are 45° angled, orange-capped, marked SUCTION.
10. Hang the anticoagulant solution container on one of the holders of the IV pole.
11. Using aseptic technique, spike the container of the anticoagulant solution.
Set up of the VEL Vacuum Extension Line
1. Attach one end of the vacuum line to the XVAC Vacuum System (or another
vacuum source)
2. Attach the other end to the vacuum port (yellow capped, marked VACUUM) on
the lid of the XRES Blood Collection Reservoir.
Set up of the Cardio Kit (for Collection Set Cardio only, otherwise skip next
steps)
Connecting the Y adapter to the XRES Blood Collection Reservoir
1. Close the clamps on the Y adapter branches waiting for subsequent
connections.
NOTE: The branch ending with a male port is used to connect the
reservoir to the Bowl Set, the branch ending with a female port is used to
connect the XRES Blood Collection reservoir to a circuit or oxygenator for
ECC through the Oxygenator Extension Line.
2. Connect the Y adapter ¼'' port to the reservoir outlet port:
A. located on the reservoir lid, marked WASH and covered with a
blue cap on the XRES T Blood Collection Reservoir
B. located on the bottom of the XRES B Blood Collection Reservoir
Connecting the Oxygenator Extention Line to a circuit or oxygenator for
ECC
1. Before adding the priming liquid to the ECC circuit, connect the 1/4"
Adapter Tubing contained in the Cardio Kit to a 1/4" connector of the
circuit or oxygenator for ECC.
2. Close the ¼'' Adapter Tubing with a clamp, keeping the protective cap in
place to maintain sterility. During priming circulation remove the air from
the circuit.
3. Connect one end of the Oxygenator Extension Line to the free end of the
¼'' Adapter Tubing
4. Connect the other end to the female connector on the Y Adapter branch or
directly to the Bowl Set.

INSTRUCTIONS FOR USE

Blood collection and anticoagulation
1. Switch on the vacuum system, following below instructions according to the
system used
a) If using XVAC vacuum system linked to XTRA Autotransfusion System:
a.1. Make sure XVAC is connected to the XTRA and the power switch
on the back of the vacuum unit is on ON.
a.2. Turn on the XTRA Autotransfusion System and wait for system's
boot up
a.3. Regulate the vacuum level from the vacuum displet present on the
cell separator's screen
NOTE:
Once system's boot up is finished, the level of vacuum is controlled

from the vacuum displet present on the cell separator's screen
 If during an emergency XVAC is required while the XTRA OS boots
up, the aspiration can be controlled directly from the control panel
present on the XVAC vacuum system (refer to chapter 13 of XTRA
Operator's Manual for detailed information), until the boot up is
finished. Then, it will be controlled only from the XTRA screen.
b) If using XVAC vacuum system stand alone:
b.1. Make sure the power switch on the back of the unit is on ON.
b.2. Turn on XVAC using the ON/OFF switch present on the control
panel
b.3. Regulate the level of vacuum from the control panel
c) If using a vacuum regulator
c.1. Switch on the vacuum regulator
c.2. Close all the lines apart from the vacuum line with a clamp (the
aspiration line and the Y adapter if present) and regulate the
vacuum level.
c.3. Then, reopen the lines, keeping the vacuum on.
SORIN GROUP ITALIA recommends not to exceed a negative pressure of -
150 mmHg (20 Kpa/0,2 Bar/-2,9 psi) during recovery procedure as an
excess vacuum increases hemolysis of the recovered blood
2. Regulate the vacuum at a level no greater than 150 mmHg (20 kPa) in
accordance with the AABB guidelines.
3. Verify that the protective cover on the end of the suction line in the sterile field
has been removed and that the aspiration tip is open to the atmosphere (not
blocked).
4. With the vacuum system ON, open the roller clamp on the small bore tubing and
allow 200 ml of anticoagulant solution to be drawn into the reservoir before
starting blood collection. This volume should ensure adequate wetting of the
blood contact surfaces. Close the roller clamp if there will be any delay before
processing.
5. After the transfer of the anticoagulant solution to the reservoir, adjust the flow
rate of the anticoagulant solution to between 60 and 100 drops a minute. The
lower flow rate is suitable for ACD-A or CPDA-1 and the higher rate for heparin.
In case of heavy bleeding, appropriately increase the rate.
NOTE: The flow of anticoagulant into the reservoir is manually controlled by the roller
clamp on the anticoagulant line. This flow must be adjusted to the rate of blood
collection from the surgical field. If the rate of collection varies without adjusting the
flow of anticoagulant, the ratio of anticoagulant to blood can be too low or too high.
The blood in the reservoir may clot if there is too little anticoagulant.
In the event of excess heparin in collection reservoir due to inappropriate
ratios, the savaged blood may contain residual heparin.
In the event of decreased patient antithrombin III levels if using heparin
anti-coagulation, consult the physician in order to provide alternate
anticoagulation.
When in the need of tranferring into the reservoir unfiltered blood coming
from another source, use the filtered luer lock connection.
Failure to maintain adequate anticoagulation during blood collection can
cause excessive clotting and possible clogging of the collection reservoir
or centrifuge bowl.
Prior to collecting any blood, prime the reservoir with approximately 200
mL of the anticoagulant solution.
When an anticoagulant solution using ACD-A pr CPDA-1 is used during
blood recovery, do not use ringer lactate solutions in subsequent wash.
The XRES Blood Collection Reservoir is equipped with three graduated scales 180°
angled to allow the operator to monitor the level of fluid present inside the reservoir
from any position. The indication provided by the graduated scales must be
considered only as a gross indication of the fluid contained in the device.
The XRES Blood Collection Reservoir is equipped with a Safety level valve device for
interrupting aspiration and preventing the blood collected from entering the vacuum
line. Should this safety level valve activate, follow the instructions below to reset
aspiration to the operative field:
1. Temporarily switch off the vacuum and process the fluid contained in the
reservoir until the level ìis below the safety valve.
2. Pull the yellow tab located on the connector marked VACUUM and check that
the valve has dropped down in the guide.
3. Release the yellow tab and reset aspiration.
A pressure relief valve is provided to prevent implosion of the device if
exposed to a sudden, deep vacuum
The negative pressure inside the XRES Blood Collection Reservoir
o
must not exceed -300 mmHg (40 KPa/0.4 bar/5.7 psi).
Check the cap seals of the connectors not in use, pushing them fully
o
on.
Do not occlude the safety valve release present on the XRES Blood
o
Collection Reservoir with foreign bodies to prevent the potential
possibility of implosion
Using the XRES Blood Collection Reservoir connected to a Bowl Set
1. When ready to start processing, connect the Bowl Set inlet port (on the fill line,
blue color) to the XRES Blood Collection Reservoir outlet port:
a. marked WASH and covered with a blue cap, for a XRES T Blood
Collection Reservoir
b. located on the bottom of the XRES T Blood Collection Reservoir
2. In case a Y adapter is used (Collection Set Cardio), connect the Bowl Set inlet
port (on the fill line, blue color) to the Y adapter male branch and open the
corresponding clamp. Keep the clamp on the other branch of the Y adapter (for
connection to the Oxygenator Extention Line) closed.
3. Proceed with further steps for blood processing according to the instructions for
use contained in the operator's manual of the cell separator
Concentration of priming fluid during ECC (for Collection Set Cardio only)
1. Isolate the Y adapter from the reservoir, by closing the 1/4" tubing segment
connecting the Y adapter to the reservoir with a clamp. Open the clamps
located on the Y adapter branches.
2. Remove the clamp used on the 1/4" Adapter Tubing previously connected to
the ECC circuit and open any other clamp that may be present on the
GB – ENGLISH 5