Accurian™ Single-Use RF Probe M708348B805E Rev. C
2022-04-05
IMPORTANT INFORMATION ON THE ACCURIAN™ SINGLE-USE RF PROBE
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™ Single-Use Radiofrequency (RF) Probe is supplied sterile for single use. The Accurian™ Single-Use RF Probe
(sterile, single use) comprises an active electrode for RF energy delivery, a handle, and a standard connector hub with a 7-pin
connector. It is inserted through an Accurian™ RF Cannula and positioned using fluoroscopy or ultrasound. It delivers
radiofrequency (RF) through the active tip of the Accurian™ RF Cannula. A thermocouple in the probe measures electrode
temperature throughout the procedure. See Figure 1 for more details.
DEVICE LIFETIME
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™ Single-Use RF Probe is intended for the creation of radiofrequency lesions in nervous tissue.
CONTRAINDICATIONS
The use of the Accurian™ Single-Use RF Probe 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 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™ Single-Use RF Probe 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 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 within 15mm of 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™ Single-Use RF Probe must be positioned such that when ablation is performed per
the lesion size graph (Figure 3) or 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™ Single-Use RF Probe before thoroughly reading the accompanying Instructions for Use
(IFU), and the IFU for the Accurian™ RF Generator and the dispersive electrode.
▪ Only surgeons familiar with RF lesion techniques should use the Accurian™ Single-Use RF Probe.
▪ Use care when handling the devices.
▪ Disconnect the Accurian™ Single-Use RF Probe from the Accurian™ Standard Connector Hub by pulling the connector, not
the cable.
▪ Handle the Accurian™ Single-Use RF Probe safely when it is in use due to electric currents and the hot electrode.
▪ Do not kink the Accurian™ Single-Use RF Probe as this may make it difficult to insert into the cannula or otherwise impair
the function of the electrode.
▪ The surgeon must determine, assess, and communicate to each individual patient all foreseeable risks of the RF procedure.
ADVERSE EVENTS
The Accurian™ Single-Use RF Probe 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 wound 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™ Single-Use 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™ Standard Connector Hub N/A APH100
3. Accurian™ Single-Use RF Probe Type CF (Defibrillation Proof Applied Part) APSDXXX
4. Accurian™ RF Cannula Type CF AC00XX
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 as directed in its Instructions for
Use (IFU). Connect the Accurian™ Standard Connector Hub and the dispersive electrode to the Accurian™ RF Generator as
described in its corresponding Instructions for Use (IFU). Figure 2 is a schematic representation of the connections of the
system.
Open the package in the sterile field using appropriate sterile techniques. Inspect the devices visually to make sure there is no
damage to them. Do not perform the procedure with any damaged equipment.
Accurian™ RF Cannula (supplied separately)
Follow the Instructions for Use (IFU) provided with the cannula to position it into the desired ablation site. Ensure the cannula tip
is in the correct position using fluoroscopy or ultrasound. Remove the stylet to create an access channel for the probe.
Loading...