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VRV-100 Overpressure/Vacuum Relief Valve
Description
The Overpressure/Vacuum Relief Valve is an in-line, one-way valve designed to moderate both excessive negative
(vacuum) and positive pressures. The primary feature is an in-line, one-way silicone rubber valve that readily opens to
allow blood flow away from the patient and immediately closes to prevent reverse blood flow towards the patient. Silicone
rubber "umbrella" valves moderate excessive negative (vacuum) pressure and protect the valve by relieving excessive
positive pressure by opening to the atmosphere. The pressures required to open the "umbrella" relief valves at 0.5 liters
per minute blood flow are approximately -205 mmHg and 318 mmHg.
Indications for Use
This product is intended for use in procedures requiring moderation of excessive vacuum within the left ventricle of the
heart during left ventricular venting. The VRV-100 also protects against the possibility of pumping air or drainage into the
left ventricle should positive pressure build between the blood pump and the valve.
Contraindications
This product used for any other purposes than for the indicated use is the responsibility of the user.
Warnings
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Read all Warnings, Precautions, and Instructions for Use carefully prior to use. Failure to read and follow all
instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.
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Only persons thoroughly trained in cardiopulmonary bypass procedures should use this product. Operation of each
product requires constant supervision by qualified personnel for patient safety.
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Each product has been carefully manufactured, tested and packaged; however, the state of the art has not been
developed to the point that Medtronic
Perfusion must be carefully and constantly monitored.
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Each product is intended for single use only. Do not reuse or resterilize. EO sterilized.
•
The fluid pathway is sterile and nonpyrogenic. Inspect each product/package prior to use. Do not use if the package is
opened or damaged or if the product is damaged or the protective caps are not in place.
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Tubing should be attached in such a manner as to prevent kinks or restrictions that may alter blood or water flow.
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Use aseptic technique in all procedures.
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Do not allow alcohol, alcohol-based fluids; anesthetic fluids (such as isoflurane); or corrosive solvents
(such as acetone) to come into contact with the product as they may jeopardize the structural integrity.
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Air may be drawn into the blood in order to prevent excessive negative pressure. Blood that passes through this valve
must be returned to a cardiotomy reservoir with appropriate air removal capability.
•
Never agitate or invert the product once cardiopulmonary bypass is initiated.
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Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
Precautions
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Refer to package labeling for storage temperature requirements.
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A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all
procedures. The benefits of extracorporeal support must be weighed against the risk of systemic anticoagulation and
must be assessed by the prescribing physician.
Instructions For Use
Warning: The setup and use of this system is the responsibility of the attending clinician.
1.
Remove the product(s) from the packaging carefully to ensure sterile fluid pathway.
Warning: Ensure aseptic technique is used during all stages of setup and use of this product.
Warning: Before removing the product from the packaging, inspect the packaging and product for damage.
If the packaging or product is damaged, do not use as sterility of the product may have been compromised
and/or performance may be affected.
2.
Place the valve in the vent line between the left vent cannula and the blood pump in a location best determined by
the perfusionist and/or physician. Verify that all connections are secure. The raised arrow on the side of the one-way
valve indicates the direction of blood flow.
Warning: Leakage and/or separation at connections can cause blood loss or air embolism. Observe carefully
for leaks and/or loose interfaces before and during bypass. If leakage is noted or interfaces are loose,
appropriate clinical measures must be taken.
Warning: The pressure relief valve must remain clear of obstruction. Otherwise, this device may not function
properly.
Caution: The raised arrow must point towards the blood pump (away from the patient) in order to function
properly.
3.
Proper function of the valve can be verified by observing the valve through the clear housing. With suction flow, the
valve should be open. The higher the blood flow, the more the valve opens.
4.
Both the negative pressure moderation and positive pressure relief functions activate automatically should they be
needed without any action by the user.
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is able to ensure that the product will not leak, crack, or fail during use.
Instructions for use
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