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.

Directions for Use

1. Ensure the OsteoCool™ RF Generator and OsteoCool™ Pump Unit are mounted to an OsteoCool™ Cart or OsteoCool™

Desk Stand prior to use. Connect the OsteoCool™ Connector Hub to the front panel of the OsteoCool™ RF Generator
using the 33-pin male connector, as per Figure 2. Ensure an audible click is heard to confirm the connection is properly
secured.

2. Connect the 8-pin connector of OsteoCool™ RF Ablation Probe to either A or B slot of the OsteoCool™ Connector Hub, as
per Figure 2. Check the corresponding channel (A or B) on the OsteoCool™ RF Generator screen to ensure the correct
information is on screen. Ensure the corresponding OsteoCool™ Tube Kit is set up on the correct channel on the
OsteoCool™ Pump Unit. Another OsteoCool™ RF Ablation Probe can be connected to the unused probe channel as
required depending on physician preference and/or procedural needs.

3. When connecting an OsteoCool™ Independent Thermocouple, connect the 4-pin connector of the OsteoCool™
Independent Thermocouple to either the A or B slot of the OsteoCool™ Connector Hub, as per Figure 2. Check the
corresponding channel (A or B) on the OsteoCool™ RF Generator screen to ensure the correct information is on screen.
Another OsteoCool™ Independent Thermocouple can be connected to the unused thermocouple channel if necessary.

4. Refer to the OsteoCool™ RF Generator Instructions for Use for ablation procedure instructions.

Disassembly after Use

1. To disconnect the OsteoCool™ RF Ablation Probe or OsteoCool™ Independent Thermocouple from the OsteoCool™

Connector Hub, pull the OsteoCool™ RF Ablation Probe or OsteoCool™ Independent Thermocouple connector body away
from the OsteoCool™ Connector Hub. This will prevent damage to the connectors.

2. Disconnect the OsteoCool™ Connector Hub from the OsteoCool™ RF Generator by pulling the OsteoCool™ Connector
Hub 33-pin connector away from the OsteoCool™ RF Generator.

CLEANING INSTRUCTIONS

The OsteoCool™ Connector Hub is considered a noncritical environmental surface (i.e. medical equipment surface) and does
not come in contact with patients. If cleaning is necessary, the surface can be cleaned with non-abrasive detergent prepared
according to the manufacturer’s instructions, dilution recommendations, and temperature. Dry the surface after wiping down.
Never spray or pour liquids directly on the OsteoCool™ Connector Hub.

DISPOSAL INSTRUCTIONS

Discard the OsteoCool™ Connector Hub after 100 uses.

TROUBLESHOOTING

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

Problem Comment Troubleshooting

Connector does
not fit in plug-in.

Each connector is designed to connect in
a specific way for safety reasons. If the
connector “keys” are out of line the
connectors will not fit together.

▪ Check that the connector keys are lined up in the proper

orientation.

▪ Check that the connectors being connected have the same

number of pins and that the pins are not damaged.

▪ 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™ Connector Hub based upon breach of contract (including breach of warranty).

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

Figure 1: OsteoCool™ Connector Hub

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: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Manufacturer

A

B

Catalogue number

Batch code

Atmospheric pressure range 700 hPa to 1060 hPa

Channel A

Channel B

Do not stack more than 2

Do not use if package is damaged

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

Fragile, handle with care

Keep dry

Humidity range 20% to 90%

-20 °C

60°C

Temperature limit

This end up

Consult instructions for use at this website.