Accurian™ Reusable RF Probe M708348B806E Rev. C
2022-04-05
IMPORTANT INFORMATION ON THE ACCURIAN™ REUSABLE RADIOFREQUENCY
PROBE
Note: not all parts may be available in each geography.
PURPOSE
The intended purpose of the Accurian™ Reusable 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™ Reusable RF Probe is an individual electrode used in combination with an RF Cannula for RF energy delivery. It
is comprised of an active electrode shaft, a handle, and a cable with a 7-pin connector. It is inserted through an RF Cannula and
positioned using fluoroscopy or ultrasound. It delivers radiofrequency (RF) through the active tip of the RF Cannula. A
thermocouple in the probe measures electrode temperature throughout the procedure. See Figure 1 for more details.
DEVICE LIFETIME
The devices have a finite lifetime that is determined based on the state of the device during the inspection and its ability to
perform its intended use. Users are instructed to complete visual checks prior to use to ensure device integrity.
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™ Reusable RF Probe is intended for the creation of radiofrequency lesions in nervous tissue.
CONTRAINDICATIONS
Use of the Accurian™ Reusable 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 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™ Reusable RF Probe is supplied non-sterile. It must be cleaned and sterilized prior to use as specified in the
Instructions for Use (IFU).
▪ The Accurian™ Reusable RF Probe is a reusable device. Failure to properly clean and sterilize can cause 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 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™ Reusable RF Probe must be positioned such that when ablation is performed per
the lesion size graphs (Figure 3) and 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™ Reusable RF Probe before thoroughly reading the accompanying IFU, and the IFU for the
Accurian™ RF Generator and the dispersive electrode.
▪ Do not modify the device.
▪ Use care when handling the devices.
▪ Disconnect the Accurian™ Reusable RF Probe from the Accurian™ Standard Connector Hub by pulling the connector, not
the connector cable.
▪ Handle the Accurian™ Reusable RF Probe safely when it is in use due to electric currents and the hot electrode.
▪ Do not bend, kink or otherwise stress the Accurian™ Reusable 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.
▪ Accurian™ Reusable RF Probes are supplied with a protective tube to prevent damage of the RF electrode during handling.
This tube must be removed for cleaning and replaced for sterilization.
ADVERSE EVENTS
The Accurian™ Reusable 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 probe for residual moisture. Ensure the RF Probes are dry before beginning procedure.
Residual moisture may cause malfunctions damage. Perform the following checks prior to the procedure. These steps will allow
you to verify that the equipment you will use is in proper working order. Do these tests in a sterile environment.
Visual Inspection: ensure RF Probes and RF Generator Connector Hub cables have no visible damage such as discoloration,
cracks, label fading, cable splice, or kinks. Do not use damaged or defective equipment.
EQUIPMENT
The Accurian™ Reusable 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™ Reusable RF Probe Type CF (Defibrillation Proof Applied Part) APSRXXX
APSNXXX
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 equipment required for the procedure. Set up the Accurian™ RF Generator as directed in its IFU. Connect the
Accurian™ Standard Connector Hub and the dispersive electrode to the Accurian™ RF Generator as described in its
corresponding IFU. Figure 2 is a schematic representation of the connections of the system.
Unwrap the sterilized probe 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 damaged equipment.
Accurian™ RF Cannula (supplied separately)
Follow the 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.
Accurian™ Reusable RF Probe
1. Connect the Accurian™ Reusable RF Probe(s) to the 7-pin connector on the Accurian™ Standard Connector Hub.
2. Insert the Accurian™ Reusable RF Probe(s) into the tissue, ensuring the probe handle is pushed fully into the Cannula.
Never force the probe if significant resistance is felt.
3. Using radiographic imaging or ultrasound, confirm the tip of the Accurian™ RF Cannula is in the desired location. If the
cannula position needs to be adjusted, ensure that either the Accurian™ Reusable RF Probe or the accompanying stylet is
inserted into the Cannula prior to moving the Cannula position.
4. Sensory Stimulation mode will be automatically selected in the Accurian™ RF Generator upon successful detection of a
valid Accurian™ Reusable RF Probe. Set advanced settings and the parameters for RF delivery in the Generator as
described in the Accurian™ RF Generator IFU.
5. Perform the procedure as described in the Accurian™ RF Generator IFU. The procedure comprises sensory and motor
stimulation and RF delivery, either via Lesion Mode for thermal ablation, or Pulsed Mode for Pulsed RF procedures.
Note: other than reproduction of their usual referred pain or irritation due to probe introduction, monitor the patient for
unexpected symptoms that may indicate, for example, spinal cord or nerve root irritation. If these indications are suspected,
discontinue energy delivery.
6. After treatment, remove the probes and cannula. Discard the cannula as biohazards. Discard the dispersive electrode
appropriately. Disconnect the Accurian™ RF Reusable Probe from the Accurian™ Standard Connector Hub. Process the
Reusable Probe per the CLEANING AND STERILIZATION section in the IFU.
DEVICE MODELS
The probe models in the Accurian™ Reusable RF Probe range are as follows:
▪ Stainless Steel
▪ 50mm length, compatible with 50mm long 16G-22G cannula
▪ 100mm length, compatible with 100mm long 16G-22G cannula
▪ 150mm length, compatible with 150mm long 16G-22G cannula
▪ Nitinol
▪ 50mm length, compatible with 50mm long 16G-22G cannula
▪ 100mm length, compatible with 100mm long 16G-22G cannula
▪ 150mm length, compatible with 150mm long 16G-22G cannula
CLEANING AND STERILIZATION
The manufacturer recommends the user implement a quality control program for each sterilization cycle that includes, but is not
limited to recording:
▪ Type of sterilizer and cycle used
▪ Lot control number
▪ Load contents
▪ Exposure time and temperature (if a recording chart is available, this may be sufficient)
▪ Operator’s name
▪ Results of sterilization process monitoring (i.e. biological, chemical, mechanical indicators)
INSTRUCTIONS – Instruments Only
Bringing a new
instrument into
service
▪ Devices are supplied non-sterile. Cleaning and sterilization are required prior to use.
▪ Remove all packaging material prior to cleaning and sterilization.
▪ Remove all visible soil from instruments using non-shedding wipes.
▪ Instruments should be thoroughly cleaned within 30 minutes of use to minimize the potential for drying.
▪ If the instruments cannot be reprocessed immediately, keep the devices moist during transport.
Point of use
Note: do not let the end connectors soak.
▪ Place instruments in a tray of softened tap water (except end connectors), if available, or cover with
damp towels.