Medtronic OCA02 Instructions for Use

OsteoCool™ Stand and Cart M708348B463E Rev. C

2022-08-02

IMPORTANT INFORMATION ON THE OSTEOCOOL™ STAND AND CART

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.

DESCRIPTION

The OsteoCool™ Desk Stand is a non-sterile, reusable desk stand used to mount the OsteoCool™ Radiofrequency Generator
and OsteoCool™ Pump Unit for use during OsteoCool™ radiofrequency (RF) ablation procedures. It can be used as an
alternative to the OsteoCool™ Cart. The OsteoCool™ Desk Stand is suitable for operation in 10°C to 40°C environments.

The OsteoCool™ Cart is a non-sterile, reusable cart used to mount the OsteoCool™ Radiofrequency Generator and
OsteoCool™ Pump Unit for use during OsteoCool™ radiofrequency (RF) ablation procedures. The OsteoCool™ Cart also has 2
bins and a shelf for storage. The OsteoCool™ Cart is suitable for operation in 10°C to 40°C environments.

INDICATIONS

The OsteoCool™ Desk Stand and OsteoCool™ Cart are intended only for use in combination with other components of the
OsteoCool™ RF Ablation System.

CONTRAINDICATIONS

Use of the OsteoCool™ RF Ablation System is contraindicated in vertebral body levels C1-C7.

WARNINGS

▪ Do not operate the OsteoCool™ Desk Stand or OsteoCool™ Cart 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.

▪ Do not service the OsteoCool™ Desk Stand or OsteoCool™ Cart. If servicing is required, contact Medtronic.
▪ Do not modify the OsteoCool™ Desk Stand or OsteoCool™ Cart outside the mounting bracket positioning for the

OsteoCool™ Desk Stand. Any modifications may compromise the safety and efficacy of the accessory.

▪ The OsteoCool™ Desk Stand and OsteoCool™ Cart are non-sterile and should be placed outside the sterile field.
▪ Do not overload the OsteoCool™ Cart beyond what is identified in the labelling on the shelf and bins.

PRECAUTIONS

▪ Do not wrap instrument cable or power cables around metal objects. Wrapping cables around metal objects may induce

hazardous currents.

▪ The OsteoCool™ Desk Stand and OsteoCool™ Cart components should be inspected on a regular basis to ensure they are

securely fastened to the pole and they otherwise appear mechanically fit for the purposes of supporting a load.

▪ The mounting brackets on the OsteoCool™ Desk Stand should be properly positioned by the user as shown in Figure 1.

Altering the positions of the mounting brackets from those shown in Figure 1 may cause decreased stability of the
OsteoCool™ Desk Stand.

▪ The position of the mounting brackets (Figure 2a and 2b), shelf (Figure 2d), bins (Figure 2e), and handle (Figure 2c) on the

OsteoCool™ Cart should not be modified. Altering the positions of these components may cause decreased stability of the
OsteoCool™ Cart.

▪ The OsteoCool™ RF Generator and OsteoCool™ Pump Unit should not be used adjacent to or stacked with other

equipment outside of pre-set configurations on the OsteoCool™ Desk Stand and OsteoCool™ Cart. If the OsteoCool™ RF
Generator or OsteoCool™ Pump Unit must be operated outside of this configuration, they should be observed to verify
normal operation in that configuration.

▪ Move cart slowly, apply moving force only on the cart handle. Always push the cart. Do not pull the cart. Never apply force

at the top of the cart. Always push the cart near middle of handle.

ADVERSE EVENTS

The OsteoCool™ Desk Stand and OsteoCool™ Cart are 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, 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.

INSPECTION PRIOR TO USE

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

1. Inspect the OsteoCool™ Desk Stand or OsteoCool™ Cart for damage.

2. Inspect the OsteoCool™ Desk Stand or OsteoCool™ Cart components, such as the mounting brackets, shelf, and bins (cart

stand only) to ensure they are securely fastened to the pole and they otherwise appear mechanically fit for the purposes of
supporting a load.

3. Inspect the OsteoCool™ Desk Stand or OsteoCool™ Cart to see that all labels are present and legible.

Contact Medtronic if any equipment or label damage is found.

EQUIPMENT

The OsteoCool™ Desk Stand and OsteoCool™ Cart are for use in OsteoCool™ RF procedures performed in specialized
clinical settings. The equipment in the OsteoCool™ RF Ablation System is as follows:

1. OsteoCool™ RF Generator.

2. OsteoCool™ Pump Unit and OsteoCool™ Pump Cable.

3. OsteoCool™ Connector Hub.

4. OsteoCool™ Cart or OsteoCool™ Desk Stand.

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.

Preparing the OsteoCool™ Desk Stand and OsteoCool™ Cart for Mounting

1. Lock the OsteoCool™ Cart wheels prior to mounting. Press the wheel lock (Figure 2f) on the 2 front wheels to lock. To

unlock the wheels, flip the tab up on both wheels.

2. Do not adjust the position of the mounting brackets, shelf, bins, or handle on the OsteoCool™ Cart. For the OsteoCool™

Desk Stand, ensure the mounting brackets are positioned as shown in Figure 1.

3. Ensure the OsteoCool™ Cart shelf surface (Figure 2d) is clear of items.

Directions for Mounting

1. Mount the OsteoCool™ Pump Unit per the OsteoCool™ Pump Unit Instructions for Use.

2. Mount the OsteoCool™ RF Generator per the OsteoCool™ RF Generator Instructions for Use.

3. When using the OsteoCool™ Cart, utilize the built-in power cord extensions as they interconnect between the mounted

devices near the top of the cart and the power cord connection sockets exiting the pole near the base of the cart. Reference
Figures 2 and 3 to determine the correct version of your cart.

Preparing the System

1. Assemble 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.

Setting up the System

1. Continue setting up the OsteoCool™ Pump Unit and OsteoCool™ RF Generator according to their respective Instructions

for Use.

2. Ensure the OsteoCool™ Cart wheels are locked during use of the OsteoCool™ RF Ablation System.

CLEANING INSTRUCTIONS

The OsteoCool™ Desk Stand and OsteoCool™ Cart are considered non-critical environmental surfaces (i.e. medical equipment
surfaces) and do not come in contact with patients. If cleaning is necessary, the surfaces can be cleaned with a clean, soft cloth