OsteoCool™ Pump Unit and
M708348B517E Rev. C
OsteoCool™ Pump Cable
2019-01-23
IMPORTANT INFORMATION ON THE OSTEOCOOL™ PUMP UNIT AND
OSTEOCOOL™ PUMP CABLE
Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted in these instructions.
Failure to do so may result in patient complications.
For US audiences only
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The OsteoCool™ Pump Unit is a non-sterile, reusable pump that circulates sterile water through a closed-loop system during
OsteoCool™ radiofrequency (RF) ablation procedures. The OsteoCool™ Pump Unit is suitable for continuous operation. The
OsteoCool™ Pump Unit is controlled by the OsteoCool™ RF Generator through the OsteoCool™ Pump Cable, a USB A to B
cable.
The OsteoCool™ Pump Cable is connected at the rear of the OsteoCool™ Pump Unit and OsteoCool™ RF Generator through
the indicated USB connectors. The OsteoCool™ Pump Unit is powered by a mains power cord connected to the rear and is
powered on by a mains power switch located on the rear panel (see Figure 1).
An equipotential connection (Figure 1) can be found on the rear panel. This connector is attached to the pump chassis/earth
ground. It is intended for earth reference connection in environments where equipotential ground cabling is used.
INDICATIONS
The OsteoCool™ Pump Unit and OsteoCool™ Pump Cable, in combination with other components of the OsteoCool™ RF
Ablation System, are intended 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.
CONTRAINDICATIONS
Use of the OsteoCool™ RF Ablation System device is contraindicated in vertebral body levels C1-C7.
WARNINGS
▪ Do not use in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified
professional (e.g. cardiologist). A possible hazard exists because interference with the action of the electronic implant may
occur, or the implant may be damaged.
▪ The OsteoCool™ Pump Unit should be used as stated in the Indications for Use and only with OsteoCool™ Tube Kits.
▪ Do not service the OsteoCool™ Pump Unit. If servicing is required, contact Medtronic.
▪ The OsteoCool™ Pump Unit shall be placed on an OsteoCool™ Cart or OsteoCool™ Desk Stand using the provided
mounting brackets. Do not use the OsteoCool™ Pump Unit without mounting on an OsteoCool™ Cart or OsteoCool™ Desk
Stand.
▪ Do not modify the OsteoCool™ Pump Unit. Any modifications may compromise the safety and efficacy of the device.
▪ The OsteoCool™ Pump Unit is non-sterile and should be placed outside the sterile field.
▪ The OsteoCool™ Pump Unit is not intended for use in oxygen rich environments (>25% O
at ambient pressure).
2
▪ Do not use in the presence of flammable anesthetics.
▪ The rear USB connector is only intended for the OsteoCool™ Pump Cable to connect the OsteoCool™ Pump Unit and the
OsteoCool™ RF Generator.
▪ The OsteoCool™ Pump Unit is not intended for use with a multiple portable socket outlet.
▪ Position the OsteoCool™ Pump Unit such that the power supply connection is easily accessible as a means of
disconnecting power from the OsteoCool™ Pump Unit.
▪ To avoid the risk of electric shock, the OsteoCool™ Pump Unit must only be connected to a supply mains with a protective
earth.
PRECAUTIONS
▪ Do not use the OsteoCool™ Pump Unit before thoroughly reading these Instructions for Use and the Instructions for Use for
the other OsteoCool™ RF Ablation System components required to perform the RF lesion procedure.
▪ Before starting ablation procedures, ensure the tubing of the OsteoCool™ Tube Kit is properly placed in the OsteoCool™
Pump Unit.
▪ Ensure the OsteoCool™ Pump Unit has completely stopped before inserting or removing tubing from the pump heads. Do
not unplug the OsteoCool™ Pump Unit during RF energy application.
▪ Only the power cord supplied with the OsteoCool™ Pump Unit, the OsteoCool™ Pump Cable supplied with the
OsteoCool™ Pump Unit, and the OsteoCool™ Tube Kit should be connected to the OsteoCool™ Pump Unit. Other items
should not be connected to the OsteoCool™ Pump Unit.
▪ The mains power cord of the OsteoCool™ Pump Unit must be connected to a properly grounded receptacle. Extension
cords and/or adapter plugs must not be used unless provided by Medtronic.
▪ Do not wrap instrument cable around metal objects. Wrapping cables around metal objects may induce hazardous currents.
▪ Perform regular inspections of all accessories, including the OsteoCool™ Tube Kit.
▪ The position of the mounting bracket(s) on the OsteoCool™ Cart or OsteoCool™ Desk Stand should not be modified by the
user. Altering the positions of the mounting brackets may cause decreased stability of the OsteoCool™ Cart or
OsteoCool™ Desk Stand.
▪ The OsteoCool™ Pump Unit should not be used adjacent to or stacked with other equipment outside of its pre-set
configuration on the OsteoCool™ Cart or OsteoCool™ Desk Stand with the OsteoCool™ RF Generator. If the OsteoCool™
Pump Unit must be operated adjacent to or stacked with other equipment outside of this configuration, the OsteoCool™
Pump Unit should be observed to verify normal operation in that configuration.
▪ Portable and mobile RF communications equipment can affect the OsteoCool™ Pump Unit.
ADVERSE EVENTS
The OsteoCool™ Pump Unit is used with other components of the OsteoCool™ RF Ablation System in RF lesion procedures.
Adverse events associated with the use of this device are similar to those indicated for medicated and anesthetic methods
utilized in other surgical procedures.
▪ As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury can occur.
▪ Nerve injury including thermal injury, or puncture of the spinal cord or nerve roots potentially results in radiculopathy,
paresis, and paralysis.
▪ Pulmonary embolism.
▪ Hemothorax or pneumothorax.
▪ Infection including deep or superficial would infection.
▪ Unintended puncture wound including vascular puncture and dural tear.
▪ Hemorrhage.
▪ Hematoma.
▪ Pain.
PRODUCT SPECIFICATIONS
Operational Environment 10ºC to 40ºC
Storage Requirements -20ºC to 60ºC
Steady State AC Power Input 125W
Electromagnetic Immunity Level Refer to the OsteoCool™ RF Generator User Manual
IP Classification IPX0
OsteoCool™ Pump Cable Length 1.00m±0.05m
Mains Power Cord Length 3.05 meters
Standards compliance
▪ EN/IEC 60601-1, 3rd Edition
▪ EN/IEC 60601-1-2, 3rd Edition
▪ EN/IEC 60601-1-6, 3rd Edition
INSPECTION PRIOR TO USE
When opening a new OsteoCool™ Pump Unit package, you will find:
▪ 1 OsteoCool™ Pump Unit
▪ 1 OsteoCool™ Pump Cable
▪ 1 Power cord
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.
EQUIPMENT
The Osteocool™ Pump Unit is for use in Osteocool™ RF procedures performed in specialized clinical settings. The equipment
in the OsteoCool™ RF Ablation System is as follows (Figure 2):
1. OsteoCool™ RF Generator.
2. OsteoCool™ Pump Unit and OsteoCool™ Pump Cable.
3. OsteoCool™ Connector Hub.
4. OsteoCool™ Cart or OsteoCool™ Desk Stand (not shown).
5. OsteoCool™ RF Ablation Probe Kit.
a. OsteoCool™ RF Ablation Probe.
b. OsteoCool™ RF Ablation Tube Kit.
6. OsteoCool™ Independent Thermocouple Kit.
a. OsteoCool™ Independent Thermocouple.
b. OsteoCool™ Thermocouple Introducer.
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.
Preparing the System
1. Assemble all required equipment for the intended procedure. Do not make connections yet.
2. Perform a visual check on all equipment and ensure all components are in good working order. Do not use damaged
equipment.
Preparing the Pump for Use
1. The OsteoCool™ Pump Unit must be mounted on an OsteoCool™ Cart or OsteoCool™ Desk Stand before use. Do not use
the OsteoCool™ Pump Unit without mounting on an OsteoCool™ Cart or OsteoCool™ Desk Stand. If the OsteoCool™ Cart
has not been assembled, follow the OsteoCool™ Cart’s Instructions for Use for assembly instructions.
2. Check the mounting bracket on the back panel of the OsteoCool™ Pump Unit to ensure it is fixed firmly in place. If the
mounting bracket is not installed, follow the assembly instructions (located in the OsteoCool™ Cart’s Instructions for Use) to
secure the mounting bracket and ensure it is installed properly.
3. Ensure nothing is connected to the OsteoCool™ Pump Unit prior to mounting.
Mounting the Pump
1. Ensure the OsteoCool™ RF Generator is not mounted prior to the OsteoCool™ Pump Unit.
2. Lift the OsteoCool™ Pump Unit so the OsteoCool™ Pump Unit mounting bracket is level with the OsteoCool™ Cart or
OsteoCool™ Desk Stand bottom mounting bracket.
3. Slide the OsteoCool™ Pump Unit mounting bracket into the OsteoCool™ Cart or OsteoCool™ Desk Stand bottom mounting
bracket. Ensure the OsteoCool™ Pump Unit is secure.
4. Do not adjust the position of the mounting brackets on the OsteoCool™ Cart or OsteoCool™ Desk Stand.
5. Mount the OsteoCool™ RF Generator according to the OsteoCool™ RF Generator Instructions for Use.
Directions for Operation
1. Once the OsteoCool™ RF Generator is mounted, connect the power cord to the AC Power Inlet on the rear panel of the
OsteoCool™ Pump Unit (Figure 1).
2. Locate the AC Mains Switch on the back of the OsteoCool™ Pump Unit (Figure 1). Flip the switch to turn the unit ON.
Ensure the indicator light on the front panel of the OsteoCool™ Pump Unit is turned ON.
3. Connect the OsteoCool™ Pump Unit to the OsteoCool™ RF Generator using the OsteoCool™ Pump Cable. Plug the USB
B side to the rear panel on the OsteoCool™ Pump Unit (Figure 1) and the USB A side to the rear panel of the OsteoCool™
RF Generator.
4. Set up the OsteoCool™ Connector Hub with the OsteoCool™ RF Generator as per the OsteoCool™ Connector Hub
Instructions for Use (Figure 2).
5. Set up the OsteoCool™ Tube Kit with the OsteoCool™ Pump Unit as per the OsteoCool™ RF Ablation Kit’s Instructions for
Use (Figure 2).
6. Set up the remainder of the system as per the OsteoCool™ RF Ablation Kit’s Instructions for Use (Figure 2).
7. The OsteoCool™ Pump Unit is controlled through the OsteoCool™ RF Generator. During Pump Priming and Active Ablate,
ensure the correct pump head of each probe connected is running throughout the procedure. Refer to the OsteoCool™ RF
Generator’s Instructions for Use for more information.
Shut Down Procedure
1. Turn off the mains power using the AC Mains Switch on the back of the OsteoCool™ Pump Unit (Figure 1). Flip the switch
to turn OFF. Ensure the indicator light on the front panel is OFF.
2. Disconnect the power cord from the mains and the AC Power Inlet on the OsteoCool™ Pump Unit.
3. Disconnect the OsteoCool™ Pump Cable from the OsteoCool™ RF Generator and the OsteoCool™ Pump Unit.
CLEANING INSTRUCTIONS
The OsteoCool™ Pump Unit is considered a noncritical environment surface (i.e. medical equipment surface) and does not
come in contact with patients. If cleaning is necessary, the surface of the OsteoCool™ Pump Unit can be cleaned with nonabrasive detergent prepared according to the manufacturer’s instructions, dilution recommendations, and temperature. Dry the
surface after wiping down. Never immerse the OsteoCool™ Pump Unit in water.
DISPOSAL INSTRUCTIONS
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations.
See http://recycling.medtronic.com for instructions on proper disposal of this product.
TROUBLESHOOTING
Problem Troubleshooting
▪ Immediately stop the procedure.
The OsteoCool™ Pump Unit
is not working when in
Ablate Mode.
▪ Check the OsteoCool™ RF Generator screen for error instructions.
▪ Check to ensure the OsteoCool™ Pump Unit is connected to the OsteoCool™ RF Generator.
▪ Check the power cord and OsteoCool™ Pump Cable for damage.
▪ Check that the pump lids are completely closed.
▪ Check for debris in the pump head.
The OsteoCool™ Pump Unit
will not accept the
OsteoCool™ RF Ablation
Tube Kit tubing.
▪ Fully open the cover for the OsteoCool™ Pump Unit and place the tubing coming from the
bottom of the burette of the OsteoCool™ RF Ablation Tube Kit into the L-shaped tube guides.
▪ Immediately stop the procedure.
▪ Check that the tubing is properly placed in the L-shaped tubing guides of the OsteoCool™
Pump Unit.
▪ Ensure the burette reservoir has been filled.
▪ Verify the float in the burette is not occluding the flow of water from the burette.
Fluid is not circulating during
Ablate Mode.
▪ Ensure the OsteoCool™ RF Ablation Tube Kit is correctly connected to the OsteoCool™ RF
Ablation Probes.
▪ Verify the OsteoCool™ RF Ablation Tube Kit is set up in the correct pump head
corresponding to the connected OsteoCool™ RF Ablation Probe.
▪ Ensure the tubing coming out of the bottom part of the burette is the portion that is in the
pump head.
▪ Check for leaks or occlusions in the OsteoCool™ RF Ablation Tube Kit.
The OsteoCool™ Pump Unit
is making abnormal noises.
Only one pump head is
rotating when both should be
▪ Ensure there is nothing in the OsteoCool™ Pump Unit that could be impeding motion.
▪ Check that the tubing is properly placed in the L-shaped tubing guides of the OsteoCool™
Pump Unit.
▪ Ensure there are two OsteoCool™ RF Ablation Probes connected to the OsteoCool™ RF
Generator.
FURTHER INFORMATION
For further information, contact Medtronic.
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™ Pump Unit or OsteoCool™ Pump Cable based upon breach of contract (including breach of
warranty).
©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Figure 1: OsteoCool™ Pump Unit Overview
a Power LED Indicator
b Burette Holder
c Mains Power Switch
d Pump Head
e Pump Lid
f Mains Power Connector
g Equipotential Connection
h OsteoCool™ Pump Cable
Figure 2: OsteoCool™ RF Ablation System equipment and connections (shown with optional second set of ablation equipment)
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
EXPLANATION OF SYMBOLS
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
For US audiences only
Alternating Current
Catalogue number
Date of Manufacture
Do not use if package is damaged
Equipotentiality
Follow Instructions for Use
Fuse
Humidity range 20% to 90%
Mains Power OFF
Manufacturer
A
Pump Head A
Serial Number
This end up
Atmospheric pressure range 700 hPa to 1060 hPa
Caution
Do not stack more than 2
Electrical Hazard
Fragile, handle with care
General Warning Sign
Keep dry
Mains Power ON
-20 °C
B
OsteoCool™ Pump Cable connection to connect the
OsteoCool™ Pump Unit to the OsteoCool™ RF Generator
Pump Head B
60°C
Temperature limit
Consult instructions for use at this website.
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