Medtronic OCN001 Instructions for Use

OsteoCool™ Independent

M708348B460E Rev. C

Thermocouple Kit

2019-01-23

IMPORTANT INFORMATION ON THE OSTEOCOOL™ INDEPENDENT
THERMOCOUPLE KIT

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™ Independent Thermocouple Kit (sterile, single use) contains one OsteoCool™ Independent Thermocouple
and one OsteoCool™ Independent Thermocouple Introducer.

The thermocouple (sterile, single use) on the distal tip of the device measures tissue temperature throughout an RF ablation
procedure. The temperature measured is displayed through the OsteoCool™ RF Generator.

The introducer (sterile, single use) provides a path for the OsteoCool™ Independent Thermocouple. The introducer is to be
used with the OsteoCool™ Independent Thermocouple only.

INDICATIONS FOR USE

The OsteoCool™ Independent Thermocouple Kit, in combination with other components of the OsteoCool™ RF Ablation
System, is 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™ Independent Thermocouple Kit contains single use devices. They should not be re-sterilized or re-used.

Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another.

▪ Take appropriate precautions for patients with blood coagulation disorders, anticoagulant use, neurological deficit, or

systemic infection or local infection in area of the procedure.

▪ The procedure is to be performed with minimal to moderate sedation to allow the patient to remain in a communicative state

for patient feedback.

▪ Adequate measures must be taken to minimize x-ray exposure while using fluoroscopy. This exposure can result in acute

radiation injury as well as increased risk for somatic and genetic effects.

▪ Discontinue use if inaccurate, erratic, or sluggish temperature readings are observed. Use of damaged equipment may

cause patient injury.

▪ For safe use of the OsteoCool™ Independent Thermocouple Kit with the OsteoCool™ RF Ablation System, the physician

should have specific training, experience, and thorough familiarity with the use and application of this product.

▪ Do not use the device in fractures due to prostatic cancer or other osteoblastic metastases to the spine.
▪ Do not use the products in dense (sclerotic) bone including traumatic high energy fracture as device damage resulting in

patient injury may occur.

▪ Do not use this device in patients without metastatic malignant lesions in bone or in the vertebral body.

▪ When using this device in the vertebral body, do not use this device in patients with multiple myeloma, solitary

plasmacytoma, or primary malignant lesions in the index vertebra.

▪ Do not use this device in more than one vertebral body.
▪ Do not touch the electrode tip while power is being applied.
▪ Do not withdraw the OsteoCool™ RF Ablation Probe while power is being applied to ablate lesions.
▪ Use standard electrosurgical cautions when using the OsteoCool™ RF Ablation System in the vicinity of nerves and nerve

roots.

▪ Do not make physical contact between electrically conductive surfaces of the OsteoCool™ Independent Thermocouple Kit

and the OsteoCool™ RF Ablation Probe during the procedure when power is applied.

PRECAUTIONS

▪ Do not attempt to use the OsteoCool™ Independent Thermocouple Kit before thoroughly reading the accompanying

Instructions for Use and the Instructions for Use for the other OsteoCool™ RF Ablation System components required to
perform the RF lesion procedure.

▪ Only physicians familiar with RF lesion techniques should use the OsteoCool™ Independent Thermocouple Kit.
▪ Use care when handling the devices.
▪ Disconnect the OsteoCool™ Independent Thermocouple by pulling the connector, not the cable.
▪ Do not modify the OsteoCool™ Independent Thermocouple or OsteoCool™ Independent Thermocouple Introducer.
▪ Do not bend the OsteoCool™ Independent Thermocouple or OsteoCool™ Independent Thermocouple Introducer.
▪ The physician must determine, assess, and communicate to each individual patient all forseeable risks of the RF lesion

procedure.

ADVERSE EVENTS

The OsteoCool™ Independent Thermocouple Kit 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 could occur.
▪ Nerve injury including thermal injury, 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 wound infection.
▪ Unintended puncture wound including vascular puncture and dural tear.
▪ Hemorrhage.
▪ Hematoma.
▪ Pain.

PRODUCT SPECIFICATIONS

Connector 4-pin
Approximate dimensions Thermocouple Shaft: 8” length, 28G diameter

Introducer Needle: 8” length, 20G diameter
Cable length 48”
Protective sheath length 10”
Sterilization process Ethylene oxide (supplied sterile)
Storage environment Cool, dry environment
Max # of Sterilization Cycles Single Use

INSPECTION PRIOR TO USE

Prior to using the devices, inspect the packaging to ensure the package has not been damaged and sterility has not been
compromised. Do not use damaged or defective equipment in the procedure.

Inspect the device for any signs of physical damage on the shaft, handle, cable, or connector. Do not use damaged or defective
equipment in the procedure.

EQUIPMENT

The Osteocool™ Independent Thermocouple Kit is for use in Osteocool™ RF procedures performed in specialized clinical
settings. The equipment in the OsteoCool™ RF Ablation System is as follows (Figure 1):

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

The RF generator is capable of delivering significant electrical power. Patient or operator injury can result from improper
handling of the Probe, particularly when operating the device.

During power delivery, the patient should not be allowed to come in contact with ground metal surfaces. Refer to the
OsteoCool™ RF Ablation Kit Instructions for Use for RF ablation procedure instructions.

1. Open the package in the sterile field using appropriate sterile techniques. Inspect the devices visually to make sure there is

no damage. Do not perform the procedure with any damaged equipment.

2. With the stylet in the introducer and using fluoroscopic guidance, carefully advance the introducer through subcutaneous

tissue. The distal tip of the introducer should be placed at the desired monitoring site. After each advancement of the
introducer, review the introducer position carefully using fluoroscopic guidance. Do not reposition the introducer without the
stylet.

3. Insert the OsteoCool™ Independent Thermocouple into the tissue through the introducer. Never force the thermocouple if

significant resistance is felt.

4. Connect the 33-pin connector of the OsteoCool™ Connector Hub into the OsteoCool™ RF Generator.

5. Connect the OsteoCool™ Independent Thermocouple to the 4-pin connector on the OsteoCool™ Connector Hub.

6. Perform the procedure as described in the OsteoCool™ RF Generator User Manual.

Note: other than reproduction of their usual referred pain or irritation due to thermocouple introduction, monitor the patient for
unexpected symptoms that may indicate, for example, spinal cord or nerve root irritation. If these indications are suspected,
discontinue energy delivery.

7. After treatment, remove the Thermocouple and Introducer and discard as a biohazard. Disconnect the OsteoCool™

Connector Hub from the OsteoCool™ RF Generator. Follow standard hospital techniques to handle reusable items.

STERILIZATION

Devices are supplied in a sterile form. The OsteoCool™ Independent Thermocouple Kits are sterilized with ethylene oxide.

HOW SUPPLIED

The OsteoCool™ Independent Thermocouple Kits are supplied sterile in peel-open packaging. In the event of damage to the
sterile packaging, do not use and notify the manufacturer.

STORAGE

The thermocouple and introducer should be stored in their original shipping materials. Proper care should be taken to ensure
instruments will not be damaged. The devices should be stored in a cool dry environment.

TROUBLESHOOTING

The following table is provided to assist the user in diagnosing potential problems.

Problem Troubleshooting

Ensure all connections are made:

No temperature measurement.
or
Inaccurate, erratic, or sluggish
temperature reading.

Thermocouple connector does not
fit in Thermocouple plug-in.

▪ Thermocouple Monitor to Connector Hub.
▪ Connector Hub to the Generator.
▪ Generator to power outlet.

Check for an error message on the generator.
Visually inspect the thermocouple or cable for damage. Ensure devices are dry and at

room temperature. If problem persists, discontinue use.

▪ Verify the connector's keys are lined up in the proper orientation.
▪ Ensure the connectors are clean and unobstructed.

FURTHER INFORMATION

If you have any problems with or questions about Medtronic medical equipment, 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™ Independent Thermocouple Kit based upon breach of contract (including breach of warranty).

©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: RF Ablation System equipment and connections

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Manufacturer

50 °C

Batch code

Use-by date

Catalogue number

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

For US audiences only

Caution, Consult Accompanying Documents

Do not re-use

Do not use if package is damaged

Keep away from sunlight

Sterilized using ethylene oxide

Upper temperature limit 50°C

Non pyrogenic

Consult instructions for use at this website.