42
www.stryker.com
EN
0406-900-702 Rev-E
Inspection and Testing
See the
IVS Care Instructions
.
NOTE:
Maintenance documentation for this equipment is available upon
request to Stryker-authorized service personnel only.
To Perform Check-in Procedure (optional)
Perform these procedures to check the accuracy of the generator's
displayed values including temperature, impedance and power output.
Perform these procedures in addition to any existing facility check-in
protocol.
GENERAL
EQUIPMENT:
• Stryker RF MultiGen (generator)
• MultiGen cable
• Ground pad cable (monopolar return electrode cable)
• Ground pad (neutral electrode)
• Any size electrode
• Cannula (same length as electrode, any size active tip)
GENERAL SET-UP:
1. Connect the ground pad cable and electrode to the generator.
2. Turn the power on.
3. Remove the stylet from the cannula and place the electrode in the cannula.
TYPE CHECK
EQUIPMENT
PROCEDURE
RESULT
TEMPERATURE:
• Calibrated
Temperature
Measurement Device
• Warm Water,
37.0 °C to 47.0 °C
[98.6 °F to 116.6 °F].
• Hot Water,
85.0 °C to 95.0 °C
[185.0 to 203.0 °F].
1. Place the tip of the cannula/electrode and the calibrated temperature
measurement device in the warm water.
2. Record the temperature of the tip of the cannula/electrode and the
calibrated temperature measurement device.
3. Place the tip of the cannula/electrode and the calibrated temperature
measurement device in the hot water.
4. Record the temperature of the tip of the cannula/electrode and the
calibrated temperature measurement device.
5. Repeat the procedure for all four procedure tabs (two ports).
The temperature value
displayed on the generator
and the temperature value of
the calibrated temperature
measurement device should
be within
+4 °C/-2 °C from 37.0 °C to
95.0 °C.
IMPEDANCE:
500 Ohm resistors (1%)
1. Ensure the generator is in stimulation mode (either sensory or motor).
2. Carefully connect one side of the resistor to the exposed tip of the
cannula/electrode.
3. Lift the white tab on the blue ground pad clamp.
4. Place the other side of the resistor across both metal pads in the
ground pad clamp.
5. Return the white tab to the “closed” position to secure the connection.
6. Repeat the procedure for all four procedure tabs (two ports).
The impedance value displayed
on the generator should be
within 10% of the resistor value.
POWER OUTPUT:
• Gauze
• Saline
1. Remove the clear plastic from the ground pad.
2. Place the metal tab of the ground pad in the slot of the blue ground
pad clamp and secure the metal tab by lowering the white tab.
3. Moisten the gauze with saline and place the gauze on the sticky side of
the ground pad.
4. Place the electrode/cannula in the gauze.
5. Navigate to the lesion (RF output) screen on the generator.
6. Set the temperature for 80 °C for 10 seconds on procedure tab 1.
7. Press the START button to apply RF energy output.
The power output value should
not exceed 50 watts.
Cleaning
See the
Interventional Spine (IVS) Care Instructions
.
Storage and Handling
CAUTION:
ALWAYS store the equipment within the specified
environmental condition values throughout its useful life. See the
Specifications
section.
To ensure the longevity, performance and safety of this equipment, use
of the original packaging material is recommended when storing or
transporting this equipment.
Summary of Contents for RF MultiGen 0406-900-000
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