Directions For Use - Medtronic DLP 1001 Guia De Inicio Rapido

Adaptador de llave de paso anterogrado/ retrogrado
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Directions for Use

Antegrade/Retrograde Stopcock Adapter
Model
13001
Description
The stopcock adapter provides a method for perfusion of cardioplegia alternately in either an antegrade or
retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the
cannulae. The delivery lines are color coded (red and blue for antegrade and retrograde, respectively) to enhance
stopcock positioning. The unit is backed with a towel clamp plate with sticky pad for placement on a drape in close
proximity to the open chest.
Sterile, Non-pyrogenic, Disposable.
Indications
This system is intended to be used during cardiopulmonary bypass surgery, specifically for the delivery of
cardioplegia into the myocardium through the desired retrograde coronary sinus perfusion cannula (e.g.DLP's
94115 or 94315) and aortic root cannula (e.g. DLP's 23009 or 24009).
Contraindications
This device is not intended for use except as indicated above.
Precautions
ALIGNING THE OFF PROJECTION ON THE STEM WITH THE CARDIOPLEGIA INPUT LINE WILL ALLOW
COMMUNICATION BETWEEN ANTEGRADE AND RETROGRADE LINES.
THE PUMP FLOW OF CARDIOPLEGIA MUST BE STOPPED PRIOR TO SWITCHING FROM ANTEGRADE TO
RETROGRADE OR FROM RETROGRADE TO ANTEGRADE TO PREVENT EXCESSIVE LINE PRESSURE
FROM BUILDING IN THE LINE AND SURGING INTO THE VESSELS.
MAKE CERTAIN THAT THE STOPCOCK IS FULLY "ON" PRIOR TO INITIATING PUMP.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Do not exceed the maximum pressures recommended by the manufacturers of the perfusion cannulae used with
this device.
Note: Proper surgical procedures and techniques are necessarily the responsibility of the medical profession. The
described procedure is furnished for information purposes only. Each surgeon must, of course, evaluate the
appropriateness of the procedure based on their own medical training and experience, the type of surgical
procedure, and the type of delivery system being utilized.
When infusing cardioplegia solution, use the lowest possible pressures consistent with surgical techniques to
minimize hemolysis, or damage to the vessels.
This adapter is designed and intended for single use only: DO NOT REUSE.
Adverse Effects
None known.
Directions for Use
1.
Inspect the package and product for damage and expiration date. If undamaged and unexpired, open the
package and transfer the product onto the sterile field utilizing an aseptic technique.
2.
Remove the band from the legs of the device and discard it. Note: To remove the band, grab each end and
peel apart. Tearing the band may create particulate matter.
3.
Connect the cardioplegia inlet leg of the device to the cardioplegia source. If applicable, connect the
pressure monitoring line to the monitor source.
4.
Prime each leg of the device just prior to connecting to the cannulae:
Antegrade: Cannulate the aortic root per instructions provided by the manufacturer of the cannula to be
employed. Select antegrade (red) flow on the stopcock and flush the line. Connect the cannula to the primed
line taking adequate precautionary measures to remove any entrapped air by back bleeding from the aortic
root.
Retrograde: Cannulate the coronary sinus per instructions provided by the manufacturer of the cannula to be
employed. Select retrograde (blue) flow on the stopcock and flush the line. Connect the cannula to the primed
line taking adequate precautionary measures to remove any entrapped air by back bleeding from the sinus.
Pressure Monitor (if applicable): Connect the distal end of the pressure monitoring line to the cannula
pressure monitoring line. The entire line should be primed and de-aired prior to connection.
5.
The system is now ready for use.
6.
Upon completion of the procedure, disconnect the adapter and dispose of properly according to hospital
policy with the other blood contaminated products.
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