Medtronic OC01 Instructions for Use
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
Loading...