SORIN GROUP VVR 4000i Instrucciones De Uso página 4

VVR 4000i™ SEALED HARDSHELL VENOUS RESERVOIR WITH INTEGRAL
Catalog Number 050262400
DESCRIPTION
The VVR 4000i™ is a hardshell venous reservoir with integral car-
diotomy filter (hereafter called "venous reservoir").
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 adult 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 pressur-
ization 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 pressur-
ized as this could obstruct venous drainage, force air retro-
grade into the patient or cause air to enter the blood path of
the oxygenator.
3. Do not allow the vapor trap to become completely filled during
use. This may allow fluid to enter the vacuum controller or
may prevent the reservoir from being vented to atmosphere
when no vacuum is applied.
4. The cap must be removed from the vent/vacuum port to pre-
vent inadvertent pressurization of the reservoir. The vent/vac-
uum port must remain open at all times during the operation
of the reservoir or be attached to a regulated vacuum source
not to exceed -90 mm Hg in procedures that utilize vacuum
assisted venous return.
5. Ensure that the cap on any unused port is airtight prior to ini-
tiating 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 in the prevention of gas or particulate embolization,
Sorin Group Italia 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 200 ml. However, to ensure adequate
response time in case of venous inflow obstruction, it is rec-
ommended that an adequate volume in addition to the 200 ml
minimum level be maintained. Do not exceed 4000 ml in the
venous reservoir.
Sorin Group Italia
CARDIOTOMY FILTER
INSTRUCTIONS FOR USE
7.
8.
9.
10. The integral cardiotomy filter pressure should be monitored. If
11. Do not connect patient vent lines to the filtered ports of the
12. Do not use any filtered port as a return site when purging the
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 aseptic technique when making all blood pathway con-
17. Ensure that the venous reservoir outlet is positioned higher
18. Sorin Group Italia recommends use of the following in
19. Attach the arterial sample line to the preferred arterial sample
20. Do not connect the arterial filter purge line to the filtered car-
21. Use caution when infusing drugs during vacuum assisted
4
Utilization of vacuum assisted venous return can lead to neg-
ative 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.
Do not infuse fluids or drugs to the arterial side of the sample
system.
Do not flow 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.
the pressure exceeds 50 mmHg, the cardiotomy filter should
be bypassed.
venous reservoir unless some means of preventing retro-
grade flow toward the patient is located between the patient
and the venous reservoir.
arterial line filter.
nections.
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
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
site of the extracorporeal circuit.
diotomy ports or to the filtered Iuer lock ports.
venous return as they may be rapidly infused into the reser-
voir.
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