Gb - English - Instructions For Use - SORIN GROUP WR4000I Instrucciones De Uso

GB – ENGLISH
VVR 4000i and VVR4000i SMAR
VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY
FILTER
DESCRIPTION
The VVR 4000i is a hardshell venous reservoir with integral cardiotomy filter
(hereinafter called "venous reservoir").
Blood contact surfaces of the VVR 4000i SMARxT have been modified to
improve blood compatibility, resulting in reduced platelet adhesion on the coated
surfaces.
This product has been sterilized by ethylene oxide gas and has nonpyrogenic
fluid pathways.
INDICATIONS FOR USE
The VVR 4000i is intended to be used in surgical procedures requiring
cardiopulmonary bypass for periods of up to six hours.
CONTRAINDICATIONS
There are no known contraindications for this product.
WARNINGS
1. Obstruction of the vent/vacuum port could result in pressurization of the
reservoir and potentially gaseous bubbles passing to the patient and/or
damage to the device.
2. Do not allow the venous reservoir to become over pressurized as this could
obstruct venous drainage, force air retrograde into the patient or cause air
to enter the blood path of the oxygenator.
3. Do not allow any VAVD vapor trap to become completely filled during use.
This may cause fluid to enter the vacuum controller or may prevent the
reservoir from being vented to the atmosphere when no vacuum is applied.
4. The cap must be removed from the vent/vacuum port to prevent
inadvertent pressurization of the reservoir. The vent/vacuum port must
remain open at all times during reservoir operation or be attached to a
regulated vacuum source not exceeding -90 mmHg in procedures that
utilize vacuum assisted venous return.
5. Ensure that the cap on any unused port is airtight prior to initiating vacuum
assisted venous return.
6. Do not let anesthetic agents, such as isofluorane, come into direct contact
with this device. These agents may jeopardize its structural integrity.
PRECAUTIONS
1. To aid the prevention of gas or particulate embolization, Sorin Group
recommends the use of safety devices, including level sensors, bubble
detectors, arterial filters, and prebypass filters for all cardiopulmonary
bypass procedures.
2. Read the Instructions For Use carefully before using this device.
3. This device is intended for one-time, single-patient use. Do not resterilize.
4. This device is intended for use by trained personnel only.
5. Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
6. The minimum operating volume in the venous reservoir for
cardiopulmonary use is 100-200 ml (see unit specifications paragraph).
However, to ensure an adequate response time in case of venous inflow
obstruction, it is recommended that an adequate volume in addition to the
100-200 ml minimum level be maintained. Do not exceed 4000 ml in the
venous reservoir.
7. Utilization of vacuum assisted venous return can lead to negative
pressures in the oxygenator and the potential for air to be pulled across the
oxygenator membrane into the blood pathway. The sample system, the
arterial purge line, a hemoconcentrator, a nonocclusive roller pump, a
centrifugal pump or any other connection between the patient arterial line
and the reservoir may provide a conduit for the vacuum to be applied to the
arterial side of the oxygenator.
8. Do not infuse fluids or drugs to the arterial side of the sample system.
9. Do not run more than 4 liters/min of combined blood and gas through the
filter bypass, recirculation, or rapid prime ports, except when it is necessary
to debubble the oxygenator.
10. The integral cardiotomy filter pressure should be monitored. If the pressure
exceeds 50 mmHg, the cardiotomy filter should be bypassed.

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11. Do not connect patient vent lines to the filtered ports of the venous
reservoir unless some means of preventing retrograde flow toward the
patient is located between the patient and the venous reservoir.
12. Do not use any filtered port as a return site when purging the arterial line
filter.
13. Do not add small-volume drugs through the Luer-lock ports.
14. Unused ports should be kept tightly capped.
15. Adequate anticoagulation is essential.
16. Use an aseptic technique when making all blood pathway connections.
17. Ensure that the venous reservoir outlet is positioned higher than the
highest point inside the membrane compartment. This will reduce the
possibility of pulling gas into the blood from the gas side of the membrane
compartment.
18. Sorin Group recommends use of the following in procedures utilizing
vacuum assisted venous return:
a) reliable wall suction and calibrated vacuum regulator
b) vapor trap in vacuum line
c) venous line pressure monitor
d) vacuum relief valve in vacuum line
e) one-way valves where necessary to prevent retrograde flow.
19. Attach the arterial sample line to the preferred arterial sample site of the
extracorporeal circuit.
20. Do not connect the arterial filter purge line to the filtered cardiotomy ports
or to the filtered Luer-lock ports.
21. Exercise caution when infusing drugs during vacuum assisted venous
return as they may be rapidly infused into the reservoir.
PROCEDURES FOR USE FOR CARDIOPULMONARY BYPASS
SETUP PROCEDURES
1. Place the venous reservoir in the bracket.
Ensure that the mounting bracket (catalog no. 050305400) is securely
fastened to the pump console and oriented to provide maximum visibility
during use. The bracket can be placed on either side of the pump.
Remove the venous reservoir from the shipping box and inspect the sterile
wrapper for damage. Do not use if sterility has been compromised. Record
the serial number located on the back underside of the reservoir.
Install the venous reservoir in the mounting bracket and ensure that the
reservoir is stable. (Refer to the instructions for use for the mounting
bracket for a description of bracket mounting and assembly).
For better orientation of the ports on the top of the venous reservoir, the
cover can be rotated to the desired orientation.
2. Blood Temperature Monitoring
If desired, insert a Sorin Group reusable (non-sterile) temperature probe
(catalog no. 042229000) into the venous temperature probe fitting. Lock the
temperature probe into place by twisting the connector sleeve clockwise
into the locked position. Attach the probe jack to any temperature monitor
that accepts Yellow Springs Instrument series 400 probes.
3. Connection of Sorin Group SAT/HCT
If desired, connect the SAT/HCT Monitor (catalog no. 050280000) to the
SAT/HCT fitting on the venous inlet of the venous reservoir. For connection
instructions, refer to the Operator's Manual for the SAT/HCT Monitor (cata-
log no. 050280700).
4. Vent/Vacuum Port
Remove the cap from the vent/vacuum port. If vacuum is to be used attach
the vacuum source.
5. Cardiotomy Return
Remove the protectors from the filtered cardiotomy ports and secure the
1/4" (6.4 mm) ID suction tubing to the ports. If a filtered cardiotomy port is
not going to be used, press in the self-sealing protector to form a liquid
seal. The protectors on the vertical filtered cardiotomy ports are sealed if
not removed.
Attach a monitoring line to the filtered Luer-lock port for pressure
monitoring.
6. Venous Blood Inlet
Rotate the venous inlet port to the optimal position and remove the large
Monitor
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