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OCA02
Instructions for Use
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Medtronic OCA02 Instructions for Use

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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™ 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
(i.e. lint free cloth) dampened with a non-abrasive detergent or cleaning/disinfecting agent, prepared/used according to the manufacturer’s instructions, dilution recommendations, and temperature. Dry the surface after wiping down. Never immerse the OsteoCool™ Desk Stand or the OsteoCool™ Cart in water.
TROUBLESHOOTING
Problem Troubleshooting
Difficulty in mounting the OsteoCool™ RF Generator or OsteoCool™ Pump Unit
Difficulty in moving the OsteoCool™ Cart
▪ Check that the mounting brackets on the OsteoCool™ Desk Stand are installed properly
and are clear of debris or damage.
▪ Check that the mounting brackets on the OsteoCool™ RF Generator or OsteoCool™
Pump Unit are installed properly and are clear of debris or damage.
▪ Check the wheel lock to ensure it is not locking the wheel. ▪ Check the wheels for debris preventing movement.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
FURTHER INFORMATION
Recommended directions for use (surgical operative techniques) are available at no charge upon request. If further information is required, contact Medtronic.
After the EUDAMED website is launched, the Summary of Safety and Clinical Performance (SSCP) can be found at https:// ec.europa.eu/tools/eudamed.
©2022 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Figure 1: OsteoCool™ Desk Stand
Figure 2: OsteoCool™ Cart
Figure 3: OsteoCool™ Cart
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place Memphis, TN 38132 Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
Authorized representative in the European Community/ European Union
This device complies with applicable European Union regulations and directives.
Caution, Consult Accompanying Documents
Manufacturer
Catalogue number
CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Batch code
Do not dispose of the product in the unsorted municipal waste stream. Dispose of the product according to local regulations.
Medtronic B.V.
Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel: + 31 45 566 80 00
Consult instructions for use at this website.
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