How To Pause Procedure; How To Verify Pressure Measurement; How To Finish Procedure; Handling And Disposal - St. Jude Medical PressureWire Aeris Instrucciones De Uso

How to pause procedure

Perform the following procedure if PressureWire is removed from the patient's blood vessels during any diagnostic or inter-
ventional procedure, in order to be reintroduced:
1. Carefully withdraw PressureWire. Make sure that the distal flexible part of the guidewire is kept wet.
2. Carefully wipe and dry the guidewire before it is reconnected to the transmitter.
3. Repeat the procedures from step 8 and forward.

How to verify pressure measurement

1. Carefully withdraw PressureWire until the sensor element is positioned just outside the catheter opening. Verify that
the pressures registered by the guiding catheter and PressureWire are equal.

How to finish procedure

1. Carefully withdraw PressureWire. Turn off the Transmitter.

Handling and disposal

1. Handle and dispose PressureWire as biohazardous material and in accordance with medical and applicable local,
state and federal law and regulations.
2. The battery can be removed by opening the end cap using e.g. forceps in the slits under the label.
CAUTION: The transmitter is powered by a standard Li-ion battery. Li-ion batteries can contain a small concentration of
1,2-Dimethoxyethane. Do not open the battery or disassemble it. Do not expose to fire or high temperatures (>60°C). Dis-
pose battery according to standard local practice for Li-ion batteries.
Technical specifications
Table 1. Pressure measurement
Operating pressure:
Accuracy 1) :
Temperature sensitivity:
Zero drift:
Operating time:
Table 2. Temperature measurement
Temperature range:
Table 3. Radio signal specification
Frequency range:
Type:
Radiated power:
Range:
Delay time:
1) The contribution to the error in average pressure from any external disturbance source will be ≤ 2 mmHg i.e. when a
disturbance source is applied in accordance with IEC 60601-1-2, the average pressure may change up to 2 mmHg.
The effect of electromagnetic noise on pressure signal is less than 3 mmHg peak to peak.
-30 to +300 mmHg
≤ 2 mmHg or ± 2%
0.3 % of pressure change per °C
< 7 mmHg/h
3 hours
34 – 42°C
2.4000-2.4835 GHz (ISM-band)
Frequency Hopping Spread Spectrum
1 mW peak, 70 µW average (EIRP)
Up to 5 m.
NOTE: Radio range is reduced by objects and walls, keep
transmitter and receiver in line of sight wherever possible.
<28 ms
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