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7.8.2.1 Display
• Red “error” indicator will display on screen.
• System Fault code will display in the center of the screen within the Status window.
7.8.2.2 Settings
• The main power On/Off switch needs to be cycled OFF then ON to attempt to clear the non-recoverable fault.
8 Technical
Specifications
8.1 Impedance
Measurement
• Range 1 to 3000 Ohms (Ω), 1 Ω resolution
• Before and during lesion in LESION mode
• Before STIMULATION mode
• During TRANSDISCAL Placement mode
• During Cooled RF Auto Temp mode
• During
TRANSDISCAL
Treatment
mode
• During RFA Placement mode
• During RFA Treatment mode
• During IDL mode
8.2 Stimulation
• Stimulation Amplitude Ranges: Voltage mode: 0.00-10 V, 0.01 V increment
Current mode: 0.00-10 mA, 0.01 mA increment
• Stimulation rate:
1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180 and 200 Hz
• Stimulation pulse duration:
0.1, 0.2, 0.5 and 1.0 ms
8.3 RF
Output
• RF energy :
460.8 kHz ± 1 %, Quasi-sinusoidal
• Maximum power:
50 W (available into an impedance range of 60 Ω - 520 Ω, resistive.) Outside this range, the Generator reduces available power to
comply with specified voltage and current limits.
• Applied part of patient circuit is not referenced to earth at high frequency.
• The maximum output of 50 W is restricted by:
• Maximum
voltage:
160
V
rms
• Maximum current:
0.9 A
rms
• Maximum peak voltage:
254 V (under normal operating conditions)
• Power output is available into loads of 25 Ω - 3000 Ω
• 100 Ω is the nominal “rated” load.
8.4 Measurement Accuracy (at time of manufacture)
• Power
±5 %, ± 0.25 W
• Impedance
• 25 – 1000 Ω:
± 10 %, ±10 Ω
• 1001 – 3000 Ω:
± 20 %±10 Ω
• Multi-RF Mode: Accuracy subject to condition that impedances of all other probes are within 100 – 1000 Ω; accuracy defined at ambient temperature of 25°C.
• Temperature:
± 3°C for thermocouple probes
• Elapsed Time:
± 1 s/min
8.5 Software Shutdown Limits During RF Delivery or Stimulation
• Measured Impedance:
< 25 Ω or > 3,000 Ω
• Measured Temperature:
< 15°C, > 100°C, or
> SET TEMPE5°C for 5 s, or
> SET TEMPE10°C for 1 s
• Measured RF Power:
> 55 W, or
> SET POWER + 50 % + 5 W for 100 ms, or
> SET POWER + 20 % + 5 W for 1 s
• Measured
RF
Voltage:
>
180
V
rms
• Measured RF Current:
> 0.9 A
rms
8.6 Hardware Shutdown Limits
• Measured RF Power:
> 60 W
• Measured RF Voltage:
> 200 V
rms
• Measured RF Current:
> 1 A
rms
• Stimulation Current:
> 40 mA
• Stimulation Voltage:
> 11 V
Avanos Exhibit 2069 Page 34
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089