Abiomed Impella 2.5, Instructions For Use Manual

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5.36 Instructions for Use & Clinical Reference Manual (US)
4. Flush the sidearm of the repositioning sheath prior to advancing the sheath.
5.
For the Impella
®
2.5 Catheter, place a deadend cap on the sidearm of the repositioning
sheath to prevent further usage. The sideport should not be used to give medication
or draw blood because the blood could potentially clot. Pressure bags should not be
connected to the sideport of the repositioning sheath. If a pressure bag is connected,
the sideport must have an infusion pump or flow limiting valve in place to control the
amount of fluid administered to the patient.
6.
Slide the repositioning sheath over the catheter shaft and advance it into the artery to
the blue suture pads. For the Impella CP
® Catheter, do
NOT
remove the stylet in the
guidewire access port.
7.
Secure the repositioning unit to the patient with the blue suture pads or a StatLock
®
stabilization device.
8. Evaluate the catheter position in the aortic arch and remove any excess slack. The
catheter should align against the lesser curvature of the aorta rather than the greater
curvature. Verify placement with fluoroscopy and with the placement signal.
9.
Attach the anticontamination sleeve to the blue section of the repositioning sheath.
Lock the anchoring ring in place by turning it clockwise. Secure the catheter shaft in
place by tightening the connected anchoring ring.
10.
Carefully extend the anticontamination sleeve to maximum length and secure the end
closest to the red Impella
®
plug by tightening the anchoring ring.
TRANSFER TO STANDARD CONFIGURATION
Abiomed recommends transitioning from the initial set-up configuration to the standard
configuration as soon as practical. The standard configuration ensures that purge solution
is delivered through the catheter to prevent blood from entering the motor. After 2 hours of
operation, if the system is still in the set-up configuration, a white, advisory alarm notifies the
operator to transfer to the standard configuration. Press
MUTE ALARM to silence the alarm for
30 minutes.
To transfer to the standard configuration, follow these steps.
1.
Press PURGE SYSTEM and select “Transfer to Standard Configuration” from the
menu.
2.
Set up a standard sodium chloride solution with pressure bag (pressurized to 300–350
mmHg) using straight tubing without injection ports.
3.
Clamp the red luer on the Y connector from the red pressure sidearm. Disconnect and
end cap the red luer.
4. Create a slow drip from the NaCl pressure bag to flood the luer connector of the red
pressure sidearm and make a wet-to-wet connection. Fully open the roller clamp. The
controller may alarm during this step.
5.
Select OK to confirm the transfer. You will no longer see the set-up icon on the bottom
of the screen. The advisory alarm message will be gray.
4. 4. Flush the sidearm of the repositioning sheath prior to advancing the sheath.
5. 5.
For the Impella
®
2.5 Catheter, place a deadend cap on the sidearm of the repositioning
sheath to prevent further usage. The sideport should not be used to give medication
or draw blood because the blood could potentially clot. Pressure bags should not be
connected to the sideport of the repositioning sheath. If a pressure bag is connected,
the sideport must have an infusion pump or flow limiting valve in place to control the
amount of fluid administered to the patient.
6. 6.
Slide the repositioning sheath over the catheter shaft and advance it into the artery to
the blue suture pads. For the Impella CP
® Catheter, do
NOT
remove the stylet in the
NOT NOT
guidewire access port.
7. 7.
Secure the repositioning unit to the patient with the blue suture pads or a StatLock
®
stabilization device.
8 8 . . Evaluate the catheter position in the aortic arch and remove any excess slack. The
catheter should align against the lesser curvature of the aorta rather than the greater
curvature. Verify placement with fluoroscopy and with the placement signal.
9. 9.
Attach the anticontamination sleeve to the blue section of the repositioning sheath.
Lock the anchoring ring in place by turning it clockwise. Secure the catheter shaft in
place by tightening the connected anchoring ring.
10. 10.
Carefully extend the anticontamination sleeve to maximum length and secure the end
closest to the red Impella
®
plug by tightening the anchoring ring.
Purge Pressure
When you transfer to the
standard configuration, the
purge pressure is no longer
regulated at 600 mmHg.
In the standard configuration,
purge flow can range from
2 to 30 mL/hr and purge
pressure can range from 300
to 1100 mmHg.
Handling Precaution
When connecting or
disconnecting the red luer
on the Y connector, do NOT
grasp the white flush valve or
apply force. Grasp the luer on
both sides beneath the white
flush valve while connecting
or disconnecting lines from
the red pressure sidearm.