2019-01-23
M708348B458 Rev. D
*M708348B458-D*
OsteoCool™ Radiofrequency Generator
USER INTERFACE SYMBOLS AND EXPLANATION OF PACKAGE SYMBOLS
Alert icon
Completed icon
Decrease
Disabled
Download logs
Exit
Help
Increase
Ok
Caution
Date of Manufacture
Defibrillator-proof, patient isolated
connections
Dispersive return electrode
connection
Do not stack more than 2
Do not use if package is damaged
Electrical Hazard
Equipotentiality
Follow Instructions for Use
Reset
Sensor warning icon
Settings
Toggle
Touchscreen calibration
Update software
For US audiences only
CAUTION: Federal law (USA)
restricts these devices to sale by or
on the order of a physician.
Alternating Current
Atmospheric pressure range 700
hPa to 1060 hPa
-20 °C
Fragile, handle with care
Fuse
Humidity range 20% to 90%
Keep dry
Manufacturer
Non-ionizing radiation
OsteoCool™ Pump Cable
connection to connect the
OsteoCool™ Pump Unit to the
OsteoCool™ RF Generator
Serial Number
60°C
Temperature limit
This end up
OsteoCool™ Radiofrequency GeneratorENGLISH3
USB flash drive port
cTUVus Product Safety Mark
Consult instructions for use at this
website.
4ENGLISHOsteoCool™ Radiofrequency Generator
Table of contents
USER INTERFACE SYMBOLS AND EXPLANATION OF PACKAGE SYMBOLS.............................................................. 3
IMPORTANT INFORMATION ON THE OSTEOCOOL™ RADIOFREQUENCY GENERATOR.......................................... 7
INTRODUCTION................................................................................................................................................................7
PRODUCT DESCRIPTION................................................................................................................................................ 7
GLOSSARY OF TERMS.................................................................................................................................................... 7
INDICATED USE............................................................................................................................................................... 8
WARNINGS....................................................................................................................................................................... 8
PRECAUTIONS................................................................................................................................................................. 9
DIRECTIONS FOR USE.................................................................................................................................................... 9
Preparing the System................................................................................................................................................. 9
Compatible Accessories............................................................................................................................................. 9
When you get a New Generator............................................................................................................................... 10
Assembling the Mounting Bracket............................................................................................................................ 10
Preparing the Generator for Use...............................................................................................................................10
Mounting the Generator............................................................................................................................................ 10
Powering on the Generator.......................................................................................................................................10
Starting an Ablate Procedure.................................................................................................................................... 10
Shutdown Procedure................................................................................................................................................ 11
Generator Cleaning and Disinfection Instructions.....................................................................................................11
Generator Maintenance Schedule............................................................................................................................ 11
Disposal Instructions................................................................................................................................................. 11
USER INTERFACE.......................................................................................................................................................... 11
Front Panel Displays, Controls, and Connections.................................................................................................... 11
Rear Panel Displays, Controls, and Connections..................................................................................................... 12
Frequently Used Functions....................................................................................................................................... 12
FACTORY SET DEFAULTS............................................................................................................................................ 13
DISPLAYS........................................................................................................................................................................13
Startup State, Power-On-Self-Test (POST), Touchscreen Calibration..................................................................... 13
Device Connect State .............................................................................................................................................. 14
Ablate Standby and Ready State..............................................................................................................................15
Pump Priming State.................................................................................................................................................. 16
Active Ablate State....................................................................................................................................................17
Ablate Procedure Complete State............................................................................................................................ 18
Retract Standby and Ready State............................................................................................................................ 19
Retract Ramping and Active State............................................................................................................................ 20
Procedure settings.................................................................................................................................................... 21
Generator settings.................................................................................................................................................... 22
Fault state................................................................................................................................................................. 23
Touchscreen Calibration State..................................................................................................................................23
Help State................................................................................................................................................................. 24
TECHNICAL SPECIFICATIONS...................................................................................................................................... 24
Compliant Standards................................................................................................................................................ 24
Impedance Measurement......................................................................................................................................... 25
RF Output................................................................................................................................................................. 25
Measurement Accuracy (at time of manufacture)..................................................................................................... 25
Software Shutdown Limits During RF Delivery......................................................................................................... 25
OsteoCool™ Radiofrequency GeneratorENGLISH5
Hardware Shutdown Limits....................................................................................................................................... 25
Mechanical Specifications.........................................................................................................................................26
Environmental Specifications.................................................................................................................................... 26
Fuses........................................................................................................................................................................ 26
Line Input Ratings..................................................................................................................................................... 26
Rated Accessory Voltage (for associated equipment and active accessories).........................................................26
Power Output Graphs............................................................................................................................................... 26
Alert Limits................................................................................................................................................................ 26
Alert Tones................................................................................................................................................................ 26
Alert Condition Logging.............................................................................................................................................26
LIMITATION OF LIABILITY..............................................................................................................................................27
IEC EMC SPECIFICATIONS (EMISSIONS).................................................................................................................... 27
6ENGLISHOsteoCool™ Radiofrequency Generator
IMPORTANT INFORMATION ON THE OSTEOCOOL™ RADIOFREQUENCY GENERATOR
INTRODUCTION
The system presented in this user manual consists of the OsteoCool™ Radiofrequency Generator (RFG). For user
convenience, the OsteoCool™ Radiofrequency Generator will be referenced in this user manual as the “Generator” or “RFG”.
This user manual provides a description of the Generator, its controls and displays, and a sequence for its operation.
This user manual also supplies other information of importance to the user. Do not operate the Generator before thoroughly
reading this manual.
This user manual and the Generator screens can be made available in other languages. Contact Medtronic for further
information.
The Generator is rated as Class I, defibrillator proof, Type CF (rated for continuous operation), IPX0 as per IEC
60601-1:2005.
FOR US AUDIENCES ONLY
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PRODUCT DESCRIPTION
The OsteoCool™ Radiofrequency Generator is a coaxial, bipolar radiofrequency ablation platform. It is non-sterile and
reusable. RF energy is applied to the patient according to the selected or configured settings. The procedure is automatically
monitored, on a per-channel basis, for unexpected responses, which will cause messages to be displayed and RF energy
delivery cessation, if appropriate.
GLOSSARY OF TERMS
Term Definition
ABLATE mode A group of states designed for supplying RF energy to the patient through one or two probes to create
lesion(s). Real-time temperature, impedance, and power readings are displayed.
Active Ablate state State of the Generator where RF energy is applied to the patient in a temperature controlled manner
to create a lesion.
Active Tip Electrically active tip of the probe comprising bipolar electrodes through which RF energy is delivered
to the patient. The size of the active tip influences lesion size.
Cannula A metal tube electrically insulated along its length, with the exception of an exposed tip from which
electrical currents flow.
Cart Refers to the OsteoCool™ Cart on which the Generator can be mounted. It contains a shelf and two
bins for storage.
Connector Hub Refers to the OsteoCool™ Connector Hub which connects the Generator with up to 2 OsteoCool™
RF Ablation Probes and 2 OsteoCool™ Independent Thermocouples.
Desk Stand Refers to the OsteoCool™ Desk Stand on which the Generator can be mounted.
Lesion A localized pathological change in a bodily organ or tissue.
Mode A group of states (usually Ready, Active, and Complete) that comprise the machine steps to complete
a procedure. The modes for this Generator include ABLATE and RETRACT.
P.O.S.T. The state of the Generator when Power On Self Tests are performed.
Procedure Complete
state
Pump Refers to OsteoCool™ Pump Unit which works with the OsteoCool™ Tube Kits to pump water
Pump Priming state State of the Generator once a procedure is started in ABLATE mode where the Pump is priming the
Ready state State of the Generator where settings can be adjusted and other modes of operation can be chosen
RETRACT mode A group of states designed for supplying RF energy to ablate a thin strip of tissue along the path of
RF Radiofrequency.
Probe Refers to the OsteoCool™ RF Ablation Probe. A slender, flexible surgical instrument used to deliver
State of the Generator when RF energy has been terminated from ABLATE mode.
through the OsteoCool™ RF Ablation Probe.
flow of sterile water for the procedure.
prior to RF application.
the probe as it is removed from the patient.
stimulation and RF output to bodily organs or tissues.
OsteoCool™ Radiofrequency GeneratorENGLISH7
Term Definition
RFG OsteoCool™ Radiofrequency Generator.
Sensor Refers to the OsteoCool™ Independent Thermocouple which is connected to the OsteoCool™
Connector Hub to monitor temperature.
Standby state State of the Generator in which the Generator checks that a valid probe is connected and all
appropriate measurement conditions are met prior to the Generator entering Ready state.
State A function of the Generator where a basic task is performed. For instance, the Ready state for any
mode allows settings to be changed and allows RF energy to be initiated.
TEMP Temperature.
Thermocouple (TC) A thermoelectric device used to measure temperatures accurately, consisting of two dissimilar metals.
INDICATED USE
The OsteoCool™ Radiofrequency Generator is intended for use with the OsteoCool™ RF Ablation System for:
Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with
metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
Ablation of benign bone tumors such as osteoid osteoma.
WARNINGS
The safe and effective use of RF energy is dependent upon factors under the control of the Operator. There is no
substitute for a properly trained operating room staff. It is important the operating instructions supplied with the Generator be
read and understood before use.
Read before use: do not operate the Generator before thoroughly reading this manual.
Risk of Fire: do not use in the presence of flammable anesthetics, other flammable gases, near flammable fluids (such
as skin prepping agents and tinctures), flammable objects, or with oxidizing agents. Observe appropriate fire
precautions at all times.
Risk of Fire: do not use this device in oxygen-enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the
presence of other oxidizing agents.
Risk of RF burns: do not turn RF power on while touching any electrodes. RF energy may cause burns.
Risk of RF burns to the patient: while using this device during a procedure, the patient should not be allowed to come
into direct contact with grounded metal objects such as surgical table frame, the instrument table, etc. The use of
antistatic sheeting is recommended for this purpose.
Risk of RF burns to the patient: skin-to-skin contact (e.g. between the arms and body of the patient) should be avoided
(e.g. by insertion of dry gauze).
Risk of RF burns to the patient: failure of the Generator or accessories could result in an unintended increase of output
power.
Unintended neuromuscular stimulation: use of RF energy can produce unintended neuromuscular stimulation during
ablation. Appropriate precautions, including the use of lower power settings and continuous monitoring of the patient
during treatment, should be taken to minimize the risk of patient injury.
Interference with other equipment: use of electrosurgical generators on patients with internal or external pacemakers,
implantable defibrillators, or monitoring equipment may be affected. Qualified advice should be obtained as necessary to
minimize the risk of injury from implanted device malfunction.
Interference with other equipment: during RF output, the conducted and radiated electrical fields may interfere with other
electrical medical equipment.
Interference with other equipment: use only with approved devices and accessories. Use of accessories, transducers,
and cables other than those specifically approved by Medtronic for use with the RFG may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the RFG.
Risk of electric shock: to avoid the risk of electric shock, the Generator must only be connected to a supply mains with a
protective earth. Do not use extension cords or three-prong to two-prong adapters unless provided by Medtronic. The
mains power cord assembly should be periodically checked for damaged insulation or connectors.
Risk of electric shock: no modification of this equipment is allowed.
Risk of electric shock: the Generator is not intended for use with a multiple portable socket outlet.
Proper device use: the return electrode is not intended for use and the existing ground pads will not work with this
electrode.
Proper device use: do not operate the device if the display area has been damaged. Ship the unit back to the
manufacturer.
Proper device use: do not change the mechanical configuration of the OsteoCool™ Cart or OsteoCool™ Desk Stand.
Proper device use: lock the casters of all wheels of the OsteoCool™ Cart during operation of the Generator.
Non-Sterile: the Generator is non-sterile and should be placed outside the sterile field.
8ENGLISHOsteoCool™ Radiofrequency Generator
Storage: store the OsteoCool™ RF Generator, OsteoCool™ Connector Hub, and OsteoCool™ RF Ablation Kits at the
same temperature.
PRECAUTIONS
Do not activate the output of the Generator until the probes are properly positioned in the patient.
The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the
activation audible tone.
Do not wrap instrument cable around metal objects. Wrapping cables around metal objects may induce hazardous
currents.
The surgical electrode cables should be positioned to avoid contact with the patient or other leads. Unused active
electrodes should be stored in a location isolated from the patient.
Avoid high frequency output settings where the maximum output voltage (130 V
voltage.
The output power should be as low as possible for intended purpose.
Perform regular inspections of all accessories for damage to insulations, including electrosurgical cables and probes.
Only recommended cabling should be used with the Generator.
Use of smoke plume extraction is recommended to minimize the risk of surgical smoke inhalation by Operator.
For information on the connection and disconnection of detachable parts and accessories, refer to the Instructions for
Use (IFU) for the corresponding parts and accessories.
Care should be taken to avoid the danger of ignition of endogenous gases.
The RFG needs special precautions regarding EMC and needs to be installed and put into service according to the EMC
information provided in this document.
Electronic equipment, including portable and mobile RF communications equipment, can affect the operation of RFG.
Operating non-essential equipment in the vicinity of the RFG should be avoided if possible.
The position of the mounting bracket(s) on the OsteoCool™ Cart or OsteoCool™ Desk Stand should not be modified.
Altering the positions of the mounting brackets may cause decreased stability of the Cart or Desk Stand.
The RFG should not be used adjacent to or stacked with other equipment outside of its pre-set configuration on the Cart
or Desk Stand with the OsteoCool™ Pump Unit. If the RFG must be operated adjacent to or stacked with other
equipment outside of this configuration, the RFG should be observed to verify normal operation in that configuration.
When the Generator and physiological monitoring equipment are used simultaneously on the same patient, any
monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes
are not recommended. In all cases, monitoring systems incorporating high frequency current limiting devices are
recommended.
) may exceed the rated accessory
RMS
DIRECTIONS FOR USE
Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted in these
instructions. Failure to properly follow instructions may lead to improper functioning of the device and result in patient injury.
Refer to the next section for a User Interface Overview.
Preparing the System
1. Assemble all required equipment for the intended procedure per Figure 1.
2. Perform a visual check on all equipment and ensure all components are in good working order. Do not use damaged
equipment.
Figure 1: RF Ablation System equipment and connections
Compatible Accessories
The Medtronic RFG (1) is compatible with the following Medtronic accessories and/or applied parts:
Accessory/Applied Parts Applied Part Classification
OsteoCool™ Pump Unit and OsteoCool™ Pump Cable (2) N/A
OsteoCool™ Radiofrequency GeneratorENGLISH9
Accessory/Applied Parts Applied Part Classification
OsteoCool™ Connector Hub (3) Type CF
OsteoCool™ Cart (not shown) N/A
OsteoCool™ Desk Stand (not shown) N/A
OsteoCool™ RF Ablation Kit
Includes:
OsteoCool™ RF Ablation Probe(s) (5a)
OsteoCool™ Tube Kit(s) (5b)
OsteoCool™ Independent Thermocouples Kit (6)
Includes:
OsteoCool™ Independent Thermocouple
OsteoCool™ Independent Thermocouple Introducer
Type CF
Type CF
When you get a New Generator
When you open the box, you will find:
OsteoCool™ RF Generator
Hospital-Grade Power Cord
Assembling the Mounting Bracket
Follow the OsteoCool™ Cart or OsteoCool™ Desk Stand IFU for mounting bracket assembly instructions.
Preparing the Generator for Use
1. Inspect the Generator for any signs of damage to the display, metal trim, or rear panel. If any damage is found, do not use
the Generator. Contact Medtronic for further instructions.
2. Place the Generator on an OsteoCool™ Cart or OsteoCool™ Desk Stand using the provided mounting bracket. Do not
use the Generator without mounting on a Cart or Desk Stand. If the Cart has not been assembled, follow the OsteoCool™
Cart IFU for assembly instructions.
3. Check the mounting bracket on the back panel of the Generator to ensure it is firmly in place.
4. Ensure nothing is connected to the Generator prior to mounting.
Mounting the Generator
1. Ensure the OsteoCool™ Pump Unit is mounted first. Refer to the OsteoCool™ Pump Unit IFU for Pump mounting
instructions.
2. Once the Pump is mounted, lift the Generator so the Generator mounting bracket is level with the top mounting bracket.
3. Slide the Generator mounting bracket into the top mounting bracket. Ensure the Generator is secure.
4. Do not adjust the position of the mounting brackets on the Cart or Desk Stand.
5. Do not obstruct the vents underneath of the Generator. Under continuous use for extended periods of time, it is normal for
the outer housing to be warm to the touch.
Powering on the Generator
1. Connect the RFG power cord to the AC Power Inlet on the Generator and the other end to a power source. Position the
Generator so the power supply connection is easily accessible as a means of disconnecting power from the Generator.
2. Locate the AC Mains Switch on the rear panel of the Generator. Flip the switch to
"Startup State, Power-On-Self-Test (POST), Touchscreen Calibration" for reference to the startup screen. During start up,
the LCD, LEDs, and audible alarm will be cycled and should be observed before using the Generator. For an explanation
for each of the states the Generator will enter, refer to "Displays."
3. Once the Generator enters Device Connect state, refer to the OsteoCool™ Pump Unit IFU for instructions on connecting
the Pump with the Generator.
to turn the Generator on. Refer to
Starting an Ablate Procedure
1. Follow the OsteoCool™ RF Ablation Kit IFU to set up the remainder of the system.
2. If interference with an instrument outside of the system is suspected, move the instrument and its cables away from the
system.
3. Once the Generator has entered Ablate Ready state, press the RF ON/OFF button to start a procedure. Refer to
"Displays and Indicators for Startup State" for more detailed Generator state descriptions.
4. Monitor treatment progress throughout the procedure using the Generator display.
5. If a warning or error occurs at any point, a message displays along with instructions on resolving the issue.
10ENGLISHOsteoCool™ Radiofrequency Generator
Shutdown Procedure
1. Turn off the mains power using the AC Mains Switch on the rear panel of the Generator. Flip the switch to to turn off.
Ensure the LCD is off.
2. Disconnect the Generator power cord from the mains and the AC Power Inlet on the Generator.
3. Disconnect the Connector Hub and Pump Cable.
Generator Cleaning and Disinfection Instructions
Use a solution of 70% isopropyl alcohol (IPA) and 30% deionized water and a damp cloth to clean the Generator cover,
front panel, and power cable. The Generator cannot be sterilized. Do not allow fluids to enter the chassis. The
Generator may be disinfected using a standard hospital alcohol solution applied with a cloth.
Do not spray or pour liquids directly on the Generator.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
Flammable agents used for cleaning or disinfecting, or as solvents or adhesives, should be allowed to evaporate before
the application of high frequency surgery.
Generator Maintenance Schedule
The Generator verifies calibration integrity during the Power-On-Self-Test (POST). Maintenance is not required.
For cleaning and disinfection instructions, refer to the previous section.
Disposal Instructions
Do not dispose of in waste. Recycle in compliance with electronic recycling requirements.
USER INTERFACE
Front Panel Displays, Controls, and Connections
The Operator is expected to be positioned in front of the Generator, so the display is accessible and legible. The patient is
expected to be positioned so the Operator is able to view the display during treatment.
Figure 2: Generator front panel
1. Touchscreen Window: displays messages (e.g. errors, faults, settings, current state, etc.) and allows the Operator to
interact with the device through the touchscreen. Each key press should result in an audible tone. If a system fault occurs,
the Generator will enter Fault state. Power to the system must be cycled (OFF-ON) to attempt recovery from a system
fault.
2. Ablate/Retract toggle: button pressed to switch between ABLATE and RETRACT modes.
3. Help button: button pressed to access Help screens.
4. Settings button: button pressed to enter and modify Procedure Settings and Generator Settings.
5. Measurements Window: Measured values for elapsed ABLATE PROCEDURE TIME, PROBE TEMPERATURE, RF
POWER, and IMPEDANCE are displayed in ABLATE mode.
6. Graph Window: used for graphing temperature and power data acquired during RF output in Active Ablate state. The
horizontal axis is time, corresponding to the Ablate Time in Procedure Settings. The display will rescale if the Ablate Time
in Procedure Settings is modified. The vertical axis represents temperature (°C) in orange and power (W) in blue.
7. RF ON/OFF Indicator: LED around the RF ON/OFF button indicating if RF is being delivered. The indicator is on and blue
during RF delivery and off when RF is not delivered.
OsteoCool™ Radiofrequency GeneratorENGLISH11
8. RF ON/OFF button: toggles the RF output on if the system is in Ablate or Retract Ready state, or off if the system has
started a procedure.
9. Connection: patient-isolated connection for attachment of a Neutral Electrode. This is not intended for use for the
OsteoCool™ RF Ablation System.
10. Connector Hub Connection: patient-isolated connection for attachment of the Connector Hub for OsteoCool™ RF Ablation
Probes and OsteoCool™ Independent Thermocouples.
11. Front USB Port: allows for a USB flash drive to be connected to the front panel for updating software and downloading
logs. This port is only intended with the following USBs:
SanDisk Cruzer 8 GB
SanDisk Cruzer 16 GB
SanDisk Cruzer 32 GB
Rear Panel Displays, Controls, and Connections
Figure 3: Generator rear panel
1. Fuse Drawer: houses the fuses and allows for AC input voltages of 100-240 V.
2. AC Mains Switch: controls the initial AC power input. If the power is connected to the AC Power Inlet, flip the switch to
turn the RFG ON. Flip the switch to
3. AC Power Inlet: AC power cord is connected to the inlet to supply power to the system.
4. Equipotential Ground Connection: This connector is attached to the chassis/earth ground and is intended for earth
reference connection in environments where equipotential ground cabling is used.
5. Generator Mounting Bracket: for mounting to the OsteoCool™ Cart or OsteoCool™ Desk Stand.
6. Device Labels: indicate the model number of the Generator and includes contact information for Medtronic. The unique
serial number of the Generator is marked here.
7. Pump USB Port: intended to connect the Generator to the Pump through an OsteoCool™ Pump Cable, which is a USB A
to B cable. The USB B side connects to the pump while the USB A side connects to the Generator. The OsteoCool™
Pump Cable is provided with the OsteoCool™ Pump Unit.
8. Footswitch Connection: Footswitch is not provided as part of the OsteoCool™ RF Ablation System.
to turn the RFG OFF.
Frequently Used Functions
Frequently Used Function Section
RFG AC Power Switch activations Rear Panel Displays, Controls, and Connections: AC Mains
Switch
Connecting/disconnecting Connector Hub to/from RFG Front Panel Displays, Controls, and Connections: Connector
Hub Connection
Connecting/disconnecting Pump to/from RFG Rear Panel Displays, Controls, and Connections: Pump USB
Port
Connecting/disconnecting OsteoCool™ RF Ablation Probe to/
from Connector Hub
Connecting/disconnecting OsteoCool™ Independent
Thermocouple to/from Connector Hub
Reading RFG display (impedance, temperature, power,
procedure time, graphs, alerts, procedure summary)
Refer to the Connector Hub IFU
Refer to the Connector Hub IFU
Displays
to
12ENGLISHOsteoCool™ Radiofrequency Generator
Frequently Used Function Section
Verifying settings associated with the OsteoCool™ RF
Ablation Probe size
Pressing the RF ON/OFF button Front Panel Displays, Controls, and Connections: RF
Connecting/disconnecting USB device to/from RFG Front Panel Displays, Controls, and Connections: Front USB
Downloading procedure logs to USB device Generator Settings
Navigating to Retract mode using the touchscreen Front Panel Displays, Controls, and Connections: Ablate/
Navigating to Procedure Settings using the touchscreen Front Panel Displays, Controls, and Connections: Settings
Accessing Help screens Help State
Verifying end of procedure Ablate Procedure Complete State
Retracting OsteoCool™ RF Ablation Probe Retract Standby and Ready State and Retract Ramping and
Pressing touchscreen buttons Front Panel Displays, Controls, and Connections:
Cleaning Generator Cleaning and Disinfection Instructions
Ablate Standby and Ready State
ON/OFF button
Port
Retract toggle
button
Active State
Touchscreen Window
FACTORY SET DEFAULTS
FACTORY SET DEFAULTS
Mode Settings Probe Adjustment Range Default Value
Generator settings
Speaker volume All 1–10 5
Display brightness All 1–10 5
DISPLAYS
Startup State, Power-On-Self-Test (POST), Touchscreen Calibration
Figure 4: Startup state display
Startup state is initiated approximately 30 seconds after the AC Mains Switch is switched to on. The progress bar, blue
over grey, fills from left to right during POST.
During this state, the LCD, LEDs, and an audible tone will be cycled during POST, and should be observed before using
the Generator.
Once the Generator passes POST, a tone sounds and the screen transitions to Device Connect state.
If the Generator fails POST, the Generator will enter Fault state.
Press the screen for two seconds during the loading screen to transition to Touchscreen Calibration state.
OsteoCool™ Radiofrequency GeneratorENGLISH13
Table 1: Displays and indicators for Startup state
Parameter Status Description
RF Output OFF
RF Output ON/OFF Indicator
RF Audio Output
Cycled OFF and ON
No RF is generated.
Settings button N/A
Help button N/A
Perform the following checks before the patient is presented for the procedure:
1. Inspect the OsteoCool™ Pump Unit, power cord, and OsteoCool™ Pump Cable for damage.
2. Inspect the OsteoCool™ Pump Unit to see that all labels are present and legible. Contact Medtronic if any equipment or
label damage is found.
Device Connect State
Figure 5: Device connect state – no cable detected.
The Generator prompts the user to connect a Connector Hub.
When a Connector Hub is detected, the Generator will check the cable to see if it is valid. If a valid cable is detected, a
“success” tone will sound and the screen will transition automatically after 1-2 seconds to Ablate Standby state.
If an invalid Connector Hub is detected, an error tone will sound and the screen will display an Invalid Connector Hub
error.
Table 2: Displays and indicators for device connect state
PARAMETER STATUS DESCRIPTION
RF Output
OFF
No RF is generated.RF Output ON/OFF Indicator
RF Audio Output None
Settings button Available The Settings button is available with sub-access to both Generator Settings and
Procedures Settings available. Procedure settings for all devices are in N/A state as
none are detected.
Ablate/Retract toggle N/A The Ablate/Retract toggle is not available during Device Connect state.
Help button Available When accessed from Device Connect state, the Device Setup 1 tab will be
displayed.
14ENGLISHOsteoCool™ Radiofrequency Generator
Ablate Standby and Ready State
Figure 6: Ablate Probe A ready state and Probe B standby
Ablate Standby state is the default screen upon connection of a valid Connector Hub.
A probe will remain in Standby state if:
• The probe is not connected.
• An error is detected. Measurements are live in this state, if possible. Follow instructions on screen to resolve the
error.
• A warning is present. Measurements are live in this state, if possible.
Valid probes with no warnings or errors will be in Ablate Ready state. Measurements are live in this state.
• Pressing the RF button will lead to Pump Priming state as long as there are no other errors or warnings on screen.
• The probe active tip size is displayed in the graph area along with the current procedure settings.
Independent thermocouples can be plugged in to the Connector Hub during Ablate Standby and Ready state.
• The temperature will update live.
• If the sensor warning is triggered, the thermometer icon will appear full and turn orange.
Probes A and B can be in different states (e.g. Probe A can be in Ablate Ready state while probe B is in Ablate Standby
state).
Table 3: Displays and indicators for Ablate Standby and Ready state
PARAMETER STATUS DESCRIPTION
RF Output
OFF
No RF is generated.RF Output ON/OFF Indicator
RF Audio Output None
Settings button Available The settings button is available with sub-access to both Generator Settings and
Procedures Settings available. Procedure settings for any devices not connected are
in the N/A state.
Ablate/Retract toggle N/A Press this button to transition to Retract Standby state.
Help button Available When accessed from Ablate Standby and Ready state, the Ablate tab will be
displayed.
OsteoCool™ Radiofrequency GeneratorENGLISH15
Pump Priming State
Figure 7: Pump priming state
If the RF button is pressed during Ablate Ready state and there are no warnings or errors on screen, the Generator will
go to Pump Priming state if the pump lids are closed.
The Generator will start the pump heads(s) corresponding to the active probe(s), and will complete a 25 second pump
priming unless all of the following conditions are met:
1. No probes were disconnected that were included in a previous procedure.
2. The generator has remained powered since the previous procedure.
3. No pump lid openings were detected on a pump active during the previous procedure.
4. No pump alerts were observed since the previous procedure.
If all conditions are met, the Generator will complete a 5 seconds pump priming.
Pressing the RF button again in this state will stop the pumps and the Generator will return to Ablate Ready state.
The touchscreen is disabled in this state.
Table 4: Displays and Indicators for Ablate Pump Priming State
PARAMETER STATUS DESCRIPTION
RF Output
RF Output ON/OFF Indicator
RF Audio Output None
Settings button Disabled
OFF
No RF is generated.
Ablate/Retract toggle Disabled
Help button Disabled
16ENGLISHOsteoCool™ Radiofrequency Generator
Active Ablate State
Figure 9: Active Ablate state for Probe A, Procedure Complete state for Probe B, and Sensor A warning
Figure 8: Active Ablate state with Probe B disconnected
Once Pump Priming completes, ready probe(s) will enter Active Ablate state. RF will be delivered on the ready probe(s)
and the graph and measurement window will update live during the procedure.
If the procedure on one probe completes before the other probe during a two probe procedure, that probe will enter
Procedure Complete state while the other probe will continue with the procedure.
Pressing the RF button during Active Ablate state will stop the procedure and sound the “Procedure Complete” tone,
and the generator will enter Procedure Complete state.
The touchscreen is disabled in Active Ablate state.
If the sensor warning is triggered, the thermometer icon will appear full and turn orange and a warning tone will play.
Procedure will continue normally.
Table 5: Displays and Indicators for Active Ablate State
PARAMETER STATUS DESCRIPTION
RF Output
RF Output ON/OFF Indicator
RF Audio Output
Settings button Disabled
ON
RF power is delivered during Active Ablate state.
Ablate/Retract toggle Disabled
Help button Disabled
OsteoCool™ Radiofrequency GeneratorENGLISH17
Ablate Procedure Complete State
Figure 10: Ablate Procedure Complete state for both probes with Procedure Complete Note cleared on Probe B
Once the Ablate Procedure completes, the “Procedure Complete” tone will sound, the pumps will stop, and the
generator will enter the Ablate Procedure Complete state.
A procedure complete note will display that can be cleared to review the procedure graphs.
The procedure graphs will stay on screen until the Reset button is pressed.
Pressing the RF ON/OFF button in this state will not start an Ablate Procedure.
Temperature and impedance measurements are live in this state.
Table 6: Displays and Indicators for Ablate Procedure Complete State
PARAMETER STATUS DESCRIPTION
RF Output
OFF
No RF is generated.RF Output ON/OFF Indicator
RF Audio Output None
Settings button Available The settings button is available with sub-access to both Generator Settings and
Procedures Settings available. Procedure settings for any devices not connected are
in the N/A state.
Ablate/Retract toggle Available Pressing this button will cause the Generator to enter Retract Standby or Ready
state. The Reset button will disappear if the toggle switch is pressed.
Reset button Available If pressed, the Generator will return to Ablate Standby or Ready state and the Reset
button will disappear.
Help button Available When accessed from Ablate Procedure Complete state, the Ablate tab will be
displayed.
18ENGLISHOsteoCool™ Radiofrequency Generator
Retract Standby and Ready State
Figure 11: Retract Ready state (Probe A tab)
The Generator will enter Retract Standby or Ready state when the Ablate/Retract toggle is pressed in ABLATE mode.
Standby and Ready state differences are the same as in ABLATE mode.
The pump will not be running in RETRACT mode and no pump errors will be registered.
Independent thermocouples can be plugged into the Connector Hub during Retract, Standby, and Ready state.
The temperature will update live.
If the sensor warning is triggered, the thermometer icon will appear full, turn orange, and a warning tone will play.
Table 7: Displays and Indicators for Retract Standby and Ready State
PARAMETER STATUS DESCRIPTION
RF Output
OFF
No RF is generated.RF Output ON/OFF Indicator
RF Audio Output None
Settings button Available The settings button is available with sub-access to both Generator Settings and
Procedures Settings available. Procedure settings for any devices not connected are
in the N/A state.
Ablate/Retract toggle Available Pressing this button will cause the Generator to enter Ablate Standby or Ready
state.
Probe A/Probe B tab Available Pressing either tab will display the appropriate probe Retract information.
Help button Available When accessed from Retract Standby and Ready state, the Retract tab will be
displayed.
OsteoCool™ Radiofrequency GeneratorENGLISH19
Retract Ramping and Active State
Figure 12: Retract Ramping state (Probe A tab)
Figure 13: Retract Active state (Probe A tab)
If the RF ON/OFF button is pressed in Retract Ready state, the Generator will enter Retract Ramping state. RF delivery
starts in this state.
If the temperature reaches the sufficient ramp temperature at the end of Retract Ramping state, Retract Active state will
be entered.
Pressing the RF button in this state will stop RF delivery and Retract Standby or Ready state will be entered.
Temperature is updated live. The probe should be retracted once the Generator enters Retract Active state. In Retract
Active state, an arrow will rotate in response to changes in temperature, and the temperature should be maintained at
the target temperature and within the orange temperature range.
The touchscreen is disabled in this state.
The pump will not be running in RETRACT mode and no pump errors will be registered.
If the sensor warning is triggered, the thermometer icon will appear full, turn orange, and a warning tone will play.
20ENGLISHOsteoCool™ Radiofrequency Generator
Table 8: Displays and Indicators for Retract Ramping State
PARAMETER STATUS DESCRIPTION
RF Output
RF Output ON/OFF Indicator
ON
RF Audio Output
Settings button Disabled
RF is being delivered.
Ablate/Retract toggle Disabled
Probe A/Probe B tab Disabled
Help button Disabled
Procedure settings
Figure 14: Procedure Settings (Probe A tab)
Figure 15: Procedure Settings (Sensors tab)
If the Settings button is pressed, the Procedure Settings (Probe A Tab) will be displayed in a closable pop-up.
Settings specific to each device can be accessed through interactive folder tabs.
"+" and "-" buttons are used to increment/decrement each parameter. The slider bar will fill/empty as parameters are
changed.
• The buttons’ press-and-hold feature permits automatic, accelerated increment/decrement of each parameter.
Parameters will initially populate with default procedure settings based on the size of the connected probe.
OsteoCool™ Radiofrequency GeneratorENGLISH21
If procedure settings are manually changed, the Reset button will be activated and can be pressed to reset to the default
settings.
Always ensure the current settings are appropriate prior to use on each patient.
Table 9: Displays and Indicators for Procedure Settings
PARAMETER STATUS DESCRIPTION
RF Output
OFF
No RF is generated.RF Output ON/OFF Indicator
RF Audio Output None
Procedure/Generator settings toggle Available Pressing this button will switch to Generator Settings.
Probe A/Probe B/Sensors tab Available Pressing the tab will display the appropriate procedure settings for that
device.
Exit button Available Pressing this button will close the pop-up and return to the previous
Generator state.
Help button Available When accessed from Procedure Settings, the Procedure Settings tab will be
displayed.
Generator settings
Figure 16: Generator settings
If the Settings button is pressed, and the Generator Settings toggle is pressed, the Generator Settings will be displayed
in a closable pop-up.
"+" and "-" buttons are used to increment/decrement each parameter. The slider bar will fill/empty as parameters are
changed.
Touchscreen Calibration state can be accessed through the Touchscreen Calibration button.
If a valid USB device is plugged in to the front USB port, the procedure logs can be downloaded through the Download
Logs button.
Table 10: Displays and indicators for Generator Settings
PARAMETER STATUS DESCRIPTION
RF Output
OFF
No RF is generated.RF Output ON/OFF Indicator
RF Audio Output None
Touchscreen Calibration button Available Pressing this button will launch touchscreen calibration.
Download Logs button Available If valid USB is connected to the Generator, procedure logs can be
downloaded.
Disabled If no valid USB is connected to the Generator.
22ENGLISHOsteoCool™ Radiofrequency Generator
Table 10: Displays and indicators for Generator Settings
PARAMETER STATUS DESCRIPTION
Language Support button Available Pressing this button will open a pop-up screen, which allows for the generator
language to be changed between English, French, German, Italian and
Spanish.
Update Software button Available Pressing this button will allow software to be updated if valid software is
detected on connected USB.
Disabled If no valid USB device is connected to the Generator.
Procedure/Generator Settings
Available Pressing this button will switch to Procedure Settings.
Toggle
Exit button Available Pressing this button will close the pop-up and return to the previous Generator
state.
Help button Available When accessed from Generator Settings, the Generator Settings tab will be
displayed.
Fault state
If a non-recoverable fault is encountered, Fault state will be entered.
A fault code is displayed along with a description of the fault, and suggested Operator responses specific to each fault
condition. Follow instructions on screen. A medium priority alert tone will sound repeatedly in this state.
Mains power to the system must be cycled (OFF-ON) to attempt recovery from a system fault.
Table 11: Displays and indicators for Fault state
PARAMETER STATUS DESCRIPTION
RF Output
RF Audio Output None
Settings button N/A
Help button N/A
Alarm Audio Output Repeating Fault state triggers repeating alarm.
OFF
No RF is generated.RF Output ON/OFF Indicator
Touchscreen is disabled.Ablate/Retract toggle N/A
Touchscreen Calibration State
Figure 17: Touchscreen Calibration state
Press the touchscreen for two seconds to perform a Touchscreen Calibration during Startup state or access
Touchscreen Calibration through Generator Settings.
Instructions on screen indicate to press each button as they become enabled.
OsteoCool™ Radiofrequency GeneratorENGLISH23
• Once the button is pressed, it will stay depressed and the next button will appear. After the Operator has pressed 5
buttons (one in each corner of the window and one in the center), a note appears. After the note is cleared, the
Generator will return to its previous state.
If the touchscreen is miscalibrated, the two second screen press in Startup state is provided as an alternative.
Table 12: Displays and indicators for Touchscreen Calibration state
PARAMETER STATUS DESCRIPTION
RF Output
RF Output ON/OFF Indicator
OFF
No RF is generated.
RF Audio Output None
Settings button N/A
Ablate/Retract toggle N/A
Touchscreen Calibration removes all other buttons.
Help button N/A
Help State
Figure 18: Help state (Device Setup 1 tab)
If the Help button is pressed, the Help state will appear in a closable pop-up.
The Help state consists of 6 tabs which provide helpful, context-specific information to the Operator (Device Setup 1,
Device Setup 2, Ablate, Retract, Procedure Settings, and Generator Settings).
The tab initially displayed when the Help state is entered is context-specific, and depends on the state from which the
Help button was pressed.
Table 13: Displays and indicators for Help state
PARAMETER STATUS DESCRIPTION
RF Output OFF No RF is generated.
RF Output ON/OFF Indicator
RF Audio Output None
Settings button N/A
Ablate/Retract toggle N/A
Help button N/A
Exit button Available Pressing this button will close the pop-up and return to the previous state.
Help tabs Available There are 6 distinct Help tabs which the user can select to display context-specific
information.
TECHNICAL SPECIFICATIONS
Compliant Standards
EN/IEC 60601-1, 3rd Edition
24ENGLISHOsteoCool™ Radiofrequency Generator
EN/IEC 60601-1-2, 3rd Edition
EN/IEC 60601-2-2, 3rd and 5th Edition
EN/IEC 60601-1-6, 3rd Edition
Impedance Measurement
Range 40 to 1000 with 1 resolution.
Low Power Impedance Measurement delivers less than 10.0 mW as averaged over any 1 second period.
Low Power Impedance Measurement utilizes the same frequency as the RF output.
No greater than 24 V
Low Power Impedance Measurement provides impedance reading at least once every 0.1 s.
During Low Power Impedance Measurement, the impedance of the RF load applied to the RF Output Connector is
is applied to the RF Load during Low Power Impedance Measurement.
RMS
measured with an accuracy of ± 5 or 10% - whichever is greater - over impedances between 40 and 99 .
During Low Power Impedance Measurement, the impedance of the RF load applied to the RF Output Connector is
measured with an accuracy of ± 5% over impedances between 100 and 500 .
During Low Power Impedance Measurement, the impedance of the RF load applied to the RF Output Connector is
measured with an accuracy of ± 8% over impedances between 501 and 1000 .
RF Output
RF energy: 465.1 kHz ± 3%, Quasi-sinusoidal voltage waveform with harmonic
content < -15 dBc.
Maximum power: 40 W (into an impedance range of 100 - 400 ). 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 40 W is restricted by:
Maximum Voltage: 130 V
Maximum current: 1.0 A
Phase Angle: Between -30º (capacitive) and +30º (inductive)
Power output is available into loads of 40 - 1000
100 is the nominal “rated” load.
RMS
RMS
Measurement Accuracy (at time of manufacture)
Power:
Impedance = 40 – 99 ± 10% or ± 1 W, whichever is greater
Impedance = 100 – 500 ± 5% or ± 1 W, whichever is greater
Impedance = 501 – 1000 ± 8% or ± 1 W, whichever is greater
Impedance:
40 – 99 ± 10% or ± 5 , whichever is greater
100 – 500 ± 5%
501 – 1000 ± 8%
Temperature: ± 3°C between 20°C and 105°C
Elapsed Time: ± 1 s/min
Software Shutdown Limits During RF Delivery
Measured Impedance: < 40 or > 1,000
Measured Temperature: < 20°C, > 105°C
Measured RF Power: > 40 W
Measured RF Voltage: > 130 V
Measured RF Current: > 1.0 A
RMS
RMS
Hardware Shutdown Limits
Measured RF Power: > 60 W
Measured RF Voltage: > 200 V
RMS
OsteoCool™ Radiofrequency GeneratorENGLISH25
Measured RF Current: > 1.0 A
RMS
Mechanical Specifications
Size: 336 mm x 282 mm x 103 mm
Weight: 17 lb (7.7 kg) maximum (not including power cord or shipping box)
Moisture protection rating: IPX0 (ordinary)
Environmental Specifications
Operational temperature: 10°C to 40°C
Operational relative humidity: 30% - 70%
Storage temperature: -20°C to 60°C
Storage relative humidity: 20% to 90% non-condensing
Operational altitude: Up to 3000 m
After being stored in the storage environment and then undergoing a 2 hour acclimation period at 25°C ± 3°C, the Generator
will operate within the safety and performance specifications.
Fuses
100 – 240 V~ / 50-60 Hz configuration: Replace mains fuses as marked:
5A/250V, T-lag, 5 x 20 mm
When replacing fuses, ensure the integrity of the new fuses by inspecting for damage that could affect the function of the
fuse.
Use a precision slot drive screwdriver to remove the fuse drawer.
Replace the fuses and close the fuse drawer.
Line Input Ratings
The system operates from an AC source ranging from 90 to 264 V
The system operates from an AC source ranging from 47 to 63 Hz.
The system operates from an AC source capable of up to 125 W.
RMS
.
Rated Accessory Voltage (for associated equipment and active accessories)
160 V
for each active compatible accessory.
RMS
Power Output Graphs
Refer to figures 19 and 20.
Alert Limits
The alert limits during RF delivery are as follows:
A Low Priority Alert indication is raised if measured impedance exceeds 1,000 during RF delivery.
A Low Priority Alert indication is raised if measured impedance drops below 40 during RF delivery.
A Low Priority Alert indication is raised if measured temperature exceeds 100°C during RF delivery in Active Ablate
state or Retract Ramping state.
A Low Priority Alert indication is raised if measured temperature drops below 20°C during RF delivery in Active Ablate
state or Retract Ramping state.
A Low Priority Alert indication is raised if measured temperature exceeds 105°C during RF delivery in Retract Active
state.
A Low Priority Alert indication is raised if measured temperature drops below 80°C during RF delivery in Retract Active
state.
Alert Tones
When a Low Priority Alert indication is raised, the Generator will sound the Low Priority Alert Tone.
When a Medium Priority Alert indication is raised, the Generator will sound the Medium Priority Alert tone.
A Low Priority Alert tone consists of a single Alert Pulse.
A Medium Priority Alert tone consists of a single Alert Pulse repeated every 4-5 seconds.
Alert Tone volumes are always greater than 40 dBA and less than 90 dBA.
Alert Condition Logging
The Generator logs the occurrence and identity of alert conditions. The log file is maintained when the alert is acknowledged
and the system is powered down.
26ENGLISHOsteoCool™ Radiofrequency Generator
LIMITATION OF LIABILITY
In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or
in connection with the OsteoCool™ RF Generator based upon breach of contract (including breach of warranty).
If you have any problems with or questions about Medtronic medical equipment, contact Medtronic.
IEC EMC SPECIFICATIONS (EMISSIONS)
Table 14: Guidance and manufacturer’s declaration – electromagnetic emissions
The RFG is intended for use in the electromagnetic environment specified below. The customer or the user of the
RFG should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Table 15: Guidance and manufacturer’s declaration – electromagnetic immunity
The RFG is intended for use in the electromagnetic environment specified below. The customer or the user of the
RFG should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11
Group 1 The RFG uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
Class A
Class D
The RFG is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power
Complies
supply network that supplies buildings used for domestic purposes.
guidance
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
± 2 kV for power supply
lines
± 1 kV for input/output
± 2 kV for power supply
lines
± 1 kV for input/output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that of a
typical commercial or hospital
environment.
< 5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
< 5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the RFG
requires continued operation during
power mains interruptions, it is
recommended that the RFG be powered
from an uninterruptible power supply.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
70% U
T
(30% dip in UT)
for 25 cycles
< 5% U
T
(>95% dip in UT)
for 5 sec
70% U
T
(30% dip in UT)
for 25 cycles
< 5% U
T
(>95% dip in UT)
for 5 sec
3 A/m 3 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
OsteoCool™ Radiofrequency GeneratorENGLISH27
Table 15: Guidance and manufacturer’s declaration – electromagnetic immunity
The RFG is intended for use in the electromagnetic environment specified below. The customer or the user of the
RFG should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Note: U
Conducted RF
IEC 61000-4-6
is the AC mains voltage prior to application of the test level.
T
3 V
RMS
3 V
RMS
150 kHz to 80 MHz
Portable and mobile RF communications
equipment should be used no closer to
any part of the OsteoCool™
Radiofrequency Generator including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m Recommended separation distance:
d = [1.17] P
d = [1.17] P 80 MHz to 800 MHz
P = [2.33] P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,
a
should be less than the
compliance level in each frequency
b
range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1: at 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones, and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the OsteoCool™ Radiofrequency Generator including cables or any of
its components are used exceeds the applicable RF compliance level above, the OsteoCool™ Radiofrequency Generator
including cables should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the entire OsteoCool™ Radiofrequency Generator including cables.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
28ENGLISHOsteoCool™ Radiofrequency Generator
Table 16: Recommended separation distances between portable and mobile RF communications equipment and the
OsteoCool™ Radiofrequency Generator including cables
The OsteoCool™ Radiofrequency Generator (including cables) is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the OsteoCool™
Radiofrequency Generator (including cables) can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the OsteoCool™
Radiofrequency Generator including cables as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output power
of transmitter
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = [1.17] √P
80 kHz to 800 MHz
d = [1.17] √P
800 kHz to 2.5 GHz
d = [2.33] √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: at 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
Figure 19: Output Power Graphs - Power vs. Load Impedance
Figure 20: Output Power Graphs - Peak Voltage vs. Load Impedance
OsteoCool™ Radiofrequency GeneratorENGLISH29
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.
M708348B458 Rev. D
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