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Biomedical Department Power Output Test
VNUS has created a Biomedical Department Inspection Procedure for the testing of the VNUS RF
Generator . This procedure outlines setting the VNUS Radiofrequency Generator up in concert with an ESU
analyzer to verify temperature measurement, power output, and measurement of impedance .
A special test cable from VNUS is provided for this purpose . Please contact VNUS Customer Service for
information on obtaining the Biomed Test Cable. (TL100-119-02 Cable, Biomed Test).
Set-up Procedure
• Check the RF Generator case exterior . The case exterior shall have no visible damage (e . g . dents,
scratches, scaled off paint) .
• Panel displays shall have no visible foreign material or damage .
• Inspect all external connectors/receptacles for bent pins, foreign objects, damaged case and/or
improper fit .
• The AC power cord shall have no obvious physical defects or damage .
• Connect the RF Generator to the appropriate AC power supply and turn on main power,
wait until the generator completes its self- test .
• Attach test cable to the generator .
• The front panel parameters should be:
Temperature:
~23°C (ambient temperature)
Impedance:
1999 Ω
Power:
0 W
• Clip ESU tester to red and black leads . Select 100 Ω impedance on ESU analyzer .
• Place red and yellow thermocouple wire in 37°C bath . Place reference thermometer in 37°C bath .
Test Method
• Verify that the bath temperature and ESU analyzer load impedance are indicated on the Temperature
and Impedance displays .
• Depress the "RF Power" switch to initiate RF power sequence .
• Verify that the bath temperature, ESU analyzer load impedance, and power indicated on the
Temperature, Impedance, and Power displays on the RF Generator are in agreement with the
reference thermometer and the ESU analyzer .
• Turn off main power to the generator . Remove the modified Instrument Cable from the RF Generator,
and AC power cord from the generator .
• In assessing the functionality of the RF Generator with any external measurement system such as an
ESU Analyzer, the measurement tolerances of the ESU Analyzer for a given test must be added to the
tolerances listed in the Tolerances section of this manual .
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VNUS Radio Frequency Generator
Power Delivery Verification
This test is intended to verify the ability of the VNUS RF Generator to deliver RF energy .
• Attach a ClosureFAST catheter (model CF7-7-60 or CF7-7-100) to the generator .
• Fill a glass container with 0.9% saline solution heated to 37 ±3 °C (this simulates the temperature
and impedance of blood in a blood vessel) .
• Place the distal end of the catheter in saline such that the entire RF coil is covered by the saline.
• Press the RF Power button on the generator to enter ready mode .
• Press the Start RF button on the catheter to start RF treatment . Insure that the catheter coil is
covered by the saline while RF power is being delivered .
• Verify that the generator delivers power and that the setpoint temperature is maintained during
delivery .
Alarm Priority
The RF Generator will generate a tonal alarm for an alarm condition based on the power, temperature,
and impedance feedback .
The RF Generator will enforce an alarm priority whereby an alarm message or tone takes priority over any
other type of message or tone (i . e . advisory and informational) .
During multiple message or tone conditions, the message or tone with the highest priority will take
precedence as shown in Tables 7 and 8 .
Table 7: Alarm Message Priority
Priority
Message
1 (Highest)
Alarm Message
2
Advisory Message
3
Informational Message
Service Manual
Table 8: Alarm Tone Priority
Priority
Tone
1 (Highest)
Button Acknowledge Tone
2
Invalid Tone
3
Alarm Tone
4
RF Stop Tone
5
Informational Tone
6
RF Start Tone
7
RF On Tone
8
RF Pullback Pause Tone
9
Power On Tone
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