Zeroing Pressurewire; Diagnostic Procedure; Interventional Procedure - St. Jude Medical PressureWire Aeris Instrucciones De Uso

complications. Note that use of PressureWire in conjunction with uncoated diagnostic catheters may reduce the perform-
ance of PressureWire.
CAUTION: If PressureWire gets stuck or is damaged during the procedure, immediately disconnect the transmitter and
then replace the damaged PressureWire, including the transmitter, with a new one. Damage may be but is not limited to
kinks, bends, sheared polymer coating, no pressure signal or inaccurate pressure signal. Incorrect use may result in ves-
sel/ventricle damage, arrhythmia induction, electric shock, inaccurate pressure signals or inaccurate torque response.
CAUTION: When PressureWire is disconnected from the transmitter during procedure make sure the male connector does
not come into contact with conductive surfaces, thus avoiding unintentional connection with other equipment or electric
shock.
Preparations
1. Open PressureWire packaging using aseptic technique.
2. Make sure that the packaging coil is flat on the table.
3. Fill the packaging coil with saline solution through the flush port. The saline shall cover the pressure sensor ele-
ment, approximately 20 cc.

Zeroing PressureWire

4. Activate the receiving instrument according to manufacturer's instruction.
5. Zero PressureWire by turning on the Aeris Transmitter.
CAUTION: Make sure to keep PressureWire stable at all time and avoid any excessive movement during zeroing.
The transmitter's function indicator shall display a stable green light when it is successfully zeroed. Please refer to
table 5 for further information.
6. Carefully remove PressureWire from the packaging coil.
7. The shapeable guidewire tip may be carefully shaped using standard tip shaping practices.
CAUTION: Do not use a shaping tool with a sharp edge.

Diagnostic procedure

8. Introduce PressureWire into the patient's blood vessels according to standard clinical practice.
CAUTION: Avoid turning off the transmitter during the procedure since PressureWire is automatically zeroed when
the transmitter is turned on and PressureWire requires zeroing outside of the body.
9. Use the torque device to slowly steer PressureWire. Position PressureWire sensor element just outside the guiding
catheter opening.
10. To ensure accurate pressure reading: Place the aortic pressure transducer at the same height as the patient's heart.
Pull back the insertion tool and tighten the hemostatic valve. Make sure that there is no remaining contrast fluid in
the catheter.
11. Verify that the pressures from the guiding catheter and PressureWire are equal.
12. If the pressures differ: Equalize the pressure signals according to manufacturer's instructions.
NOTE: If pressure difference before equalization is greater than 20 mmHg or limit according to equipment specifica-
tion whichever is lowest it is recommended to remove the wire, rezero and repeat from step 8.
13. Perform measurements. Use the torque device to slowly steer PressureWire to the desired position and perform
pressure measurement according to standard clinical procedures.
NOTE: If it is difficult to reach the desired position, PressureWire may be disconnected for better handling.
14. If applicable, considering the results from the measurements, proceed with interventional procedures.

Interventional procedure

15. Disconnect the transmitter.
16. Remove the torque device by loosening the screw and gently withdraw it.
17. Carefully advance the interventional device over PressureWire guidewire and proceed according to manufacturer's
instructions.
18. Put the torque device back on a suitable position on the guidewire.
19. Carefully wipe and dry the guidewire.
20. Take care to gently and fully insert the guidewire into the transmitter and secure the cap.
21. Treat the lesion according to manufacturer's instruction.
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