9
5. Settings
Adjustment
Keys:
The up
V
and down
W
buttons located to the right of the SETTINGS Window
are used for adjusting treatment settings in the upper
4 locations of the SETTINGS Window.
6. Rotary
Encoder:
This encoder is used for adjusting the bottom parameter in the SETTINGS Window. The parameter in the window depends upon the current mode.
7.
OUTPUT ON/OFF Button and Indicator:
This button controls STIMULATION, LESION, COOLED RF, TRANSDISCAL, RFA and IDL outputs. In STIMULATION modes, this
button toggles the output on and off. In all other modes, this button control initiates or terminates RF output. The indicator is ON during RF delivery, and also when in
the STIMULATION: ON state.
8. POWER
Indicator:
This green LED indicates that system power is on.
9. FAULT
Indicator:
This red LED indicates a system fault has occurred. System faults include: self-test failure, hardware protection (such as short-circuit shutdown),
and software failure. Main power to the system must be cycled (off-on) to attempt recovery from a system fault.
10. MEASUREMENTS
Window:
Measured values for elapsed TIME, probe TEMPERATURE(S), RF POWER, RF VOLTAGE and/or IMPEDANCE are displayed during and after
RF output in both STIMULATION and LESION states and during treatment states for COOLED RF, TRANSDISCAL, RFA and IDL modes. During all READY states (prior to
RF output), TEMPERATURE and IMPEDANCE are displayed. In LESION READY states for AUTOTEMPERATURE, AUTOPULSED, MANUAL POWER, AND MANUAL PULSED,
IMPEDANCE is displayed according to LOW/OK/HIGH range. In PLACEMENT states for TRANSDISCAL and RFA modes, only the IMPEDANCE between the probe and the
dispersive return electrode will be displayed.
11. Graph
Window:
This window is used for graphing temperature, power and voltage data acquired during RF output in lesion states for ON states when in the LESION
mode and treatment states when in COOLED RF, TRANSDISCAL, RFA and IDL modes. The horizontal axis is time (
), corresponding to the treatment duration in the
SETTINGS Window. The display will rescale if the TIME duration in the SETTINGS Window is modified. The vertical axis represents temperature (°C) and either power
(W) or voltage (V).
12. Connector Cable Connection:
This patient-isolated connection is for attachment of the connector cable for
HALYARD*
Pain Management Thermocouple probes.
13. Dispersive Return Electrode Connection:
This patient-isolated connection is for attachment of a
HALYARD*
Pain Management Dispersive Electrode
(PMA-GP-BAY).
Figure 5-2 Generator rear panel
5.2 Rear Panel Displays, Controls, and Connections
• Descriptions of rear panel features and their functions are given below. Please refer to
Figure 5-2
for corresponding locations on the rear panel.
1. Volume
Adjustment:
This knob adjusts the volume of the system’s audio output.
2.
Device Label:
This label indicates the model number of the Generator and includes contact information for Halyard Health. The unique serial number of the
Generator is marked on this label.
3. Software
Version
Label:
This label indicates the PMG software version.
4.
AC MAINS SWITCH:
This switch controls the initial AC power input to the system, and is part of the power entry module, which integrates the AC power inlet and
Fuse Drawer.
5. Fuse
Drawer:
The proper fuses must be used, as indicated in the rear panel labeling.
6.
Equipotential Ground Connection:
This connector is attached to the chassis/earth ground. It is intended for earth reference connection in environments where
equipotential ground cabling is used.
7. Fan:
A brushless DC fan is used to exhaust warm air from the Generator. The direction of airflow is outward from the rear panel.
Avanos Exhibit 2069 Page 9
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089
