Medtronic AC0001 Instructions for Use

ACCURIAN™ RF Cannula M708348B807E Rev. A

2018-11-22

IMPORTANT INFORMATION ON THE ACCURIAN™ RADIOFREQUENCY CANNULA

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 ACCURIAN™ Radiofrequency (RF) Cannula is supplied sterile for single use.
The ACCURIAN™ RF Cannula (sterile, single use) comprises an electrically insulated shaft, an active electrode for RF energy

delivery, a hub with a female slip Luer fitting and a stylet with a color coded cap to indicate gauge size.

INDICATIONS FOR USE

The ACCURIAN™ RF Cannula is intended for the creation of radiofrequency lesions in nervous tissue.

CONTRAINDICATIONS

The use of the ACCURIAN™ RF Cannula 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™ RF Cannula is a single use device. It 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 American Society of Regional Anesthesia and Pain Medicine (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, including bending or removing insulation, 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 physician 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 (<15 mm) 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 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™ RF Cannula must be positioned such that when ablation is performed per the

lesion size graphs (Figure 2) and lesion size equation (Equation 1), vessel and non-targeted nerve roots are beyond the
ablation zone. Failure to consider the lesion size can result in severe injury to the patient.

PRECAUTIONS

Do not attempt to use the ACCURIAN™ RF Cannula before thoroughly reading the accompanying Instructions for Use and the
Instructions for Use for the ACCURIAN™ RF Generator.

▪ Only physicians familiar with RF lesion techniques should use the ACCURIAN™ RF Cannula.
▪ Disconnect the ACCURIAN™ RF Cannula from the ACCURIAN™ RF Probe by pulling the handle, not the cable.
▪ Handle the ACCURIAN™ RF Cannula safely when it is in contact with an active ACCURIAN™ RF Probe due to electric

currents and the active electrode.

▪ Do not kink the ACCURIAN™ RF Cannula as this may make it difficult to insert the probe or otherwise impair the function of

the cannula.

▪ The physician must determine, assess, and communicate to each individual patient all foreseeable risks of the RF

procedure.

ADVERSE EVENTS

The ACCURIAN™ RF Cannula 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:

▪ Infection including deep or superficial wound infection.
▪ Bleeding.
▪ Nerve damage.
▪ Visceral injury.
▪ Increased pain.
▪ Failure of technique.
▪ Paralysis and death.

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.

DIRECTIONS FOR USE

Lesion size is determined by Cannula selection. Refer to Equation 1 for relationship between lesion size and cannula choice.

1. Insert the ACCURIAN™ RF Cannula into the tissue under fluoroscopic or ultrasonic guidance.

2. Remove the stylet from the Cannula.

3. Follow the ACCURIAN™ Standard RF Probe Instructions for Use to deliver energy.

4. After the procedure, remove and disconnect the probes, then remove and discard the cannula.

Note: Maintain a minimum distance of 4 mm between the tip of the cannula and other metal objects.

STERILIZATION

Devices are supplied in sterile form. The ACCURIAN™ RF Cannula are sterilized with ethylene oxide.

HOW SUPPLIED

The ACCURIAN™ RF Cannula are supplied sterile in peel-open packaging. In the event of damage to the sterile packaging, do
not use and notify the manufacturer. The ACCURIAN™ RF Cannula are type CF defibrillation proof applied parts.

STORAGE

The cannula should be stored in their original shipping materials. Proper care should be taken to ensure the devices and sterile
packaging will not be damaged. The devices should be stored in a cool, dry environment.

TROUBLESHOOTING

PROBLEM TROUBLESHOOTING

No temperature measurement
OR
Inaccurate, erratic or sluggish temperature reading

Damage is observed to insulation, hub, or any part of device Do not use. Discard immediately.

▪ Ensure the probe is fully inserted into the cannula.
▪ Twist the probe to confirm it is fully inserted.

FURTHER INFORMATION

For further information, 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 ACCURIAN™ RF Cannula based upon breach of contract (including breach of warranty).