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).
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▪ 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.