Medtronic OC04 Instructions for Use

OsteoCool™ Connector Hub M708348B518E Rev. C

2019-01-23

IMPORTANT INFORMATION ON THE OSTEOCOOL™ CONNECTOR HUB

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™ Connector Hub is a non-sterile, reusable cable which provides a path for delivery of radiofrequency (RF)
energy and temperature signals to/from OsteoCool™ RF Ablation Probes, OsteoCool™ Independent Thermocouple, and
OsteoCool™ Radiofrequency (RF) Generator.

The OsteoCool™ Connector Hub (Figure 1) is equipped with 5 connectors:

1. Two 8-pin female OsteoCool™ RF Ablation Probe connectors.

2. Two 4-pin female OsteoCool™ Thermocouple Monitor connectors.

3. One 33-pin male OsteoCool™ RF Generator connector.

INDICATIONS FOR USE

The OsteoCool™ Connector Hub, 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 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™ Connector Hub should be used by physicians familiar with RF lesion techniques.
▪ The OsteoCool™ Connector Hub is shipped non-sterile and should be used outside of the sterile field.
▪ The OsteoCool™ Connector Hub is a reusable device.
▪ Do not sterilize the OsteoCool™ Connector Hub.
▪ The OsteoCool™ Connector Hub must be used with OsteoCool™ RF Ablation Probe(s) and/or OsteoCool™ Independent

Thermocouple(s).

▪ Laboratory staff and patients can undergo significant x-ray exposure during RF procedures due to the continuous use of

fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic
effects. Therefore, adequate measures must be taken to minimize this exposure.

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

systemic infection or local infection in area of the procedure.

▪ If inaccurate, erratic, or sluggish temperature readings are observed, perform a visual inspection of the OsteoCool™

Connector Hub for damage. Discontinue use if any damage is observed.

▪ When the OsteoCool™ RF Generator is activated, the conducted and radiated electrical fields may interfere with other

electrical medical equipment.

▪ Do not modify any equipment. Any modifications may compromise the safety and efficacy of the device.
▪ The OsteoCool™ RF Generator is capable of delivering significant electrical power. Patient or operator injury can result

from improper handling of the OsteoCool™ Connector Hub, particularly when operating the device.

PRECAUTIONS

▪ Do not attempt to use the OsteoCool™ Connector Hub 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.

▪ Apparent low power output or failure of the equipment to function properly at normal settings may indicate failure to an

electrical lead. Do not adjust treatment parameters before checking for obvious defects or misapplication.

▪ In order to prevent the risk of ignition, ensure that flammable material is not present in the room during RF power

application.

▪ Medtronic relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of

the RF lesion procedure.

ADVERSE EVENTS

The OsteoCool™ Connector Hub 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 wound infection.
▪ Unintended puncture wound including vascular puncture and dural tear.
▪ Hemorrhage.
▪ Hematoma.
▪ Pain.

PRODUCT SPECIFICATIONS

Cable Length 96” ± 4”
Operational Environment 10 ºC to 40 ºC
Storage Requirements -20 ºC to 60 ºC

INSPECTION PRIOR TO USE

Perform the following checks before the patient is presented for the procedure:

1. Visually inspect the OsteoCool™ Connector Hub for damage. Look for damage to the insulation, connectors, plastic, cable,
and part labels. Ensure there is no visible damage, such as discoloration, cracks, label fading, or kinks. Do not use
damaged equipment. Contact Medtronic if any equipment or label damage is found.

2. Ensure the OsteoCool™ Connector Hub is dry. Residual moisture can cause improper function.

EQUIPMENT

The Osteocool™ Connector Hub 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 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™ Independent 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.

Prepare the System for Use

1. Assemble all required equipment for the intended procedure. Do not make system connections yet.

2. Perform a visual check on all equipment and ensure all components are in good working order. Do not use damaged

equipment.

3. Follow the OsteoCool™ RF Generator and OsteoCool™ Pump Unit’s Instructions for Use to power up the OsteoCool™ RF
Generator and OsteoCool™ Pump Unit.