Medtronic AI0001 Instructions for Use

Accurian™ Enhanced RF Probe Kit M708348B804E Rev. C

2022-04-05

IMPORTANT INFORMATION ON THE ACCURIAN™ ENHANCED RF PROBE KIT

Note: not all parts may be available in each geography.

PURPOSE

The Intended Purpose of the Accurian™ Single-Use RF Probe is the creation of radiofrequency lesions in nervous tissue.
Medtronic does not warrant use of instruments, accessories, or any component parts upon which repairs have been made or
attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.

For US audiences only

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

DESCRIPTION

The Accurian™ Enhanced Radiofrequency (RF) Probe Kit is supplied sterile for single use. The Accurian™ Enhanced RF Probe
Kit (sterile, single use) includes one Accurian™ Enhanced RF Probe, one Accurian™ Introducer, and one Accurian™ Tube Kit.

The Accurian™ Enhanced RF Probe (sterile, single use) comprises an electrically insulated shaft and an active electrode for RF
energy delivery, a handle, tubes with Luer locks and a cable with a 7-pin connector. It is inserted through the Introducer included
in the kit and positioned using Fluoroscopy or Ultrasound. Sterile water circulates internally to cool the probe while it delivers RF
energy. A thermocouple in the probe measures electrode temperature throughout the procedure. See Figure 1 for more details.

The Accurian™ Tube Kit (sterile, single use, non-body contact) comprises a burette and flexible tubing fitted with Luer locks.
The Luer locks connect to the Accurian™ Enhanced RF Probe to enable closed-loop circulation of sterile water through the
probe.

Each device in this bundle is intended to be a single-use disposable device, designed to be used once only and then discarded.
The duration of contact of the device with tissue is limited and is expected to never exceed 24 hours. Each device should not be
reused, resterilized, reprocessed, reconditioned, refurbished, repaired, or modified in any way to enable further use.

Surgeon note: although the surgeon is the learned intermediary between the company and patient, the important medical
information in this document should be conveyed to the patient.

INDICATIONS

The Accurian™ Enhanced RF Probe Kit is intended for the creation of radiofrequency lesions in nervous tissue.

CONTRAINDICATIONS

Use of the Accurian™ Enhanced RF Probe Kit is contraindicated in patients with systemic infection or local infection in area of
the procedure.

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.

▪ Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on

the patient while operating the Accurian™ RF Ablation System.

▪ If the patient has a spinal cord, deep brain, or other stimulator, contact the manufacturer to determine if the stimulator needs

to be in the OFF position.

▪ This procedure should be reconsidered in patients with any prior neurological deficit.
▪ The Accurian™ Enhanced RF Probe Kit contains single use devices. They should not be re-sterilized or re-used. Reuse

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

▪ Refer to the ASRA guidelines for recommendations on anti-coagulant use in combination with pain procedures.
▪ The procedure is to be performed with minimal to moderate sedation to allow the patient to remain in a communicative state

for patient feedback. The use of general anesthesia is not recommended.

▪ 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.

▪ Do not modify the equipment as this may compromise safety and efficacy.
▪ When the Accurian™ RF Generator is activated, electrical fields may interfere with other electrical medical equipment.
▪ During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces.

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

cause patient injury.

▪ For safe use of the Accurian™ RF Ablation System, the surgeon should have specific training, experience, and thorough

familiarity with the use and application of this product.

▪ Do not remove or withdraw the device while energy delivery is ongoing. There is a rare potential for localized skin burns if

the RF lesion is formed in insufficient subcutaneous tissue (<15mm) or near a shallow metal implant.

▪ Use standard electrosurgical cautions when using the Accurian™ RF Ablation System in the vicinity of nerves and nerve

roots.

▪ Do not touch the electrode tip while power is being applied.
▪ Ablation must be performed under fluoroscopic or ultrasonic guidance. Do not perform ablation without imaging as it can

result in severe injury to the patient.

▪ When using this device, the Accurian™ Enhanced RF Probe must be positioned such that when ablation is performed per

the lesion size equations (Equation 1), vessel and non-targeted nerve roots are beyond the ablation zone. Failure to follow
the thermal distribution equation may result in severe injury to the patient.

PRECAUTIONS

Do not attempt to use the Accurian™ Enhanced RF Probe Kit before thoroughly reading the accompanying Instructions for Use
and the Accurian™ RF Generator Instructions for Use (IFU).

▪ Only surgeons familiar with RF lesion techniques should use the Accurian™ Enhanced RF Probe Kit components.
▪ Do not modify the kit components, including bending and removing insulation.
▪ Use care when handling the devices.
▪ Proper sterile techniques must be used when assembling and filling the Accurian™ Tube Kit. Do not place the lid down on a

non-sterile surface.

Accurian™ Enhanced RF Probe

▪ The Accurian™ Tube Kit should never be disconnected from the Accurian™ Enhanced RF Probe when RF delivery is in

progress. The lumen of the tube kit should not be obstructed in any way during the procedure, as this will stop cooling of the
probe.

▪ Disconnect the Accurian™ Enhanced RF Probe from the Accurian™ Enhanced Connector Hub by pulling the connector,

not the cable.

▪ Handle the Accurian™ Enhanced RF Probe safely when it is in use due to electric currents and the hot tip.
▪ Do not bend the Accurian™ Enhanced RF Probe as this may damage the insulation.
▪ While inserting the Accurian™ Enhanced RF Probe through the introducer, watch the fluoroscope or ultrasound for any

buckling. Do not attempt to further insert the probe if any buckling is observed or significant resistance is felt.

▪ While moving the introducer, ensure that either the Accurian™ Enhanced RF Probe or the accompanying stylet is inserted

into the introducer prior to moving the introducer position.

Accurian™ Introducer

Introducers are supplied with the kit and have a length such that the proximal electrode on the probe extends beyond the distal
margin of the introducer. Do not use other introducers with the Accurian™ Enhanced RF Probe.

Accurian™ Tube Kit

▪ The Accurian™ Tube Kit can be connected to one or two Accurian™ Enhanced RF Probes.

▪ To connect a single Accurian™ Enhanced RF Probe, connect the female luer connector from the tube kit to the male luer

connector from the Accurian™ Enhanced RF Probe and the male luer connector from the tube kit to the female Luer
connector from the Accurian™ Enhanced RF Probe.

▪ To connect two Accurian™ Enhanced RF Probes in series, connect the female luer connector from the tube kit to the

male luer connector of the first Accurian™ Enhanced RF Probe. Connect the female luer connector of the first
Accurian™ Enhanced RF Probe to the male luer connector of the second Accurian™ Enhanced RF Probe. Close the
loop by connecting the female luer connector from the second Accurian™ Enhanced RF Probe to the male Luer
connector from the tube kit.

▪ Care must be taken to ensure all luer fittings are secure to prevent leaking. Do not disconnect luer fittings while the pump is

running.

▪ Arrange equipment to minimize tubing tripping hazards.
▪ Do not complete enhanced RF lesion procedures if water is not circulating through the tube kit, water is leaking, or air

bubbles are seen in the tubing. Immediately stop the procedure and correct circulation before restarting the procedure.

▪ Do not pinch the tubing of the Accurian™ Tube Kit.

ADVERSE EVENTS

The Accurian™ Enhanced RF Probe Kit is used with other components of the Accurian™ 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. Potential complications include but are not limited to:

▪ 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.

▪ Infection including deep or superficial would infection.
▪ Increased pain.
▪ Visceral injury.
▪ Failure of technique.

INSPECTION PRIOR TO USE

Prior to using the device, inspect the packaging to ensure the package has not been damaged and sterility has not been
compromised. Do not use the device if the package is damaged or defective.

EQUIPMENT

The Accurian™ Enhanced RF Probe is for use in Accurian™ RF procedures performed in specialized clinical settings. The
equipment in the Accurian™ RF Ablation System is as follows (Figure 2):

Accessory/Applied Parts Part Classification Part number

1. Accurian™ RF Generator with Desk Stand N/A AG1000

2. Accurian™ Pump Unit with Desk Stand and cable N/A AP1000

3. Accurian™ Enhanced Connector Hub N/A APH200

4. Accurian™ Enhanced RF Probe kit, consisting of:

▪ Accurian™ Enhanced RF Probe

Type CF (Defibrillation Proof
Applied Part)

APSCXX

▪ Accurian™ Introducer
▪ Accurian™ Tube Kit

a. Luer Locks for connection of Tube Kits to Accurian™ Enhanced Probe
b. Sterile water injection port
c. 70mL mark
d. Burette Reservoir

The ValleyLab™ dispersive electrode E7507 has been validated for use with this system.

DIRECTIONS FOR USE

Assemble all the equipment required for the procedure. Set up the Accurian™ RF Generator and the Accurian™ Pump Unit, as
directed in their IFU. Connect the Accurian™ Enhanced Connector Hub and the dispersive electrode to the Accurian™ RF
Generator as described in the corresponding IFU. Figure 2 is a schematic representation of the connections of the system.

Figure 3 is a schematic representation of the tube kit.
Open the package in the sterile field using appropriate sterile techniques.

Accurian™ Tube Kit Set-Up

Warning: leave the luer caps on the tubing until you are ready to connect the probes, so the inner pathway of the tube kit
remains sterile.

1. Place the burette into the burette holder on the side of the Accurian™ Pump Unit (Figure 4).

2. Fill the burette with room temperature sterile water. Use sterile handling techniques. Fill the burette to the 70mL mark

(Figure 3). Burette can be filled by injecting sterile water through a port in the lid (Figure 5), or by temporarily removing the
lid and pouring in sterile water (Figure 5).

Warning: be sure to fill the burette to the 70 mL mark. Not filling the burette to the 70mL mark will result in an inadequate
supply of water for circulation.

Use only sterile room temperature water.
Ensure the lid is secured to the body of the burette after filling.

3. Open the pump head lid and place the thick-walled tubing coming out of the bottom of the burette into the pump head of the
Accurian™ Pump Unit. Place the tubing between the notches and along the center channel of the L-shaped bracket
beneath the pump head to ensure the tubing is not obstructed while closing the pump head. Close the lid on the pump head
to clamp down on the tubing (Figure 6).

Warning: improper positioning of the tubing can pinch the tube and restrict water flow.

4. Remove the caps on the male and female luer locks. Connect the appropriate luer lock to the corresponding luer lock on the
probe. Do not over-tighten the connection (Figure 7).

5. At the end of the procedure, discard the Accurian™ Tube Kit appropriately.

Accurian™ Introducer

1. With the stylet in the Accurian™ Introducer, carefully insert the introducer into the patient using fluoroscopic or ultrasonic

guidance to place it at the desired lesion location.

2. Once the introducer is in the proper position, carefully remove the stylet from the introducer.

Accurian™ Enhanced RF Probe

1. Connect the probe(s) to the 7-pin connector on the Accurian™ Enhanced Connector Hub.