Medtronic APSN050 Instructions for Use

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.

INSTRUCTIONS – Instruments Only

▪ Immediately transport the tray containing the covered instruments to a work area dedicated to further

Containment and
transportation

Preparation for
cleaning

reprocessing.

▪ Soiled instruments should be transported separately from non-contaminated instruments to avoid

contamination of personnel and surroundings.

▪ Remove the metal protective tube from the probe prior to cleaning.
▪ Instruments may be safely and effectively processed using manual (enzymatic) cleaning procedures as

outlined below.

▪ Rinse, flush, and scrub instruments under running cold tap water at a temperature of <110°F (<43°C)

for a minimum of 3 minutes. Scrub instruments with appropriately-sized, soft bristle brushes or pipe­cleaners to remove visible soil.

▪ Scrub until all visible soil is removed.

Note: do not let the end connectors soak. Wipe connectors with clean lint-free cloth until they are
visually clean.

Manual cleaning:
enzymatic

▪ Using tap water, prepare an enzymatic cleaning solution according to the manufacturer’s instructions,

dilution recommendations, and temperatures.

▪ Place probe and probe cable (except end connectors) in the enzymatic cleaner, submerge completely,

and soak 25-30 minutes. Ensure all surfaces, lumens, and components are in contact with the cleaning
solution.

▪ Scrub again with a soft bristle brush.
▪ Remove instruments from the enzymatic cleaning solution and flush for a minimum of 30 seconds

using de-ionized water.

▪ Visually inspect parts for debris. If any is present, repeat the cleaning process. Do not proceed with

reprocessing of a soiled instrument.

▪ Dry the devices using clean, absorbent, non-shedding wipes. Perform a visual inspection for dryness

Drying: manual

and repeat if necessary.

▪ Instruments should be completely dry before packaging for sterilization.
▪ Carefully inspect the instrument for damage by performing a thorough examination as referenced in the

Inspection and
reassembly

INSPECTION PRIOR TO USE and VISUAL INSPECTION section of this document.

▪ Replace the stainless steel protective sheath for protection of the delicate electrode.
▪ If the instrument is damaged, contact Medtronic immediately to arrange for disposal or replacement. Do

not proceed with reprocessing of a damaged device.

▪ A standard autoclave pouch must be used. Refer to manufacturer’s instructions for size and sealing

Packaging

requirements.

▪ Only instruments manufactured and/or distributed by Medtronic should be included.
▪ Proceed to the STERILIZATION INSTRUCTIONS section.

STERILIZATION INSTRUCTIONS: Instruments

▪ Place probes with protective tubes into surgical sterilization pouches. The protective tube should be loosely

mated with the handle.

▪ Inspect the pouch to ensure no rips, punctures, or seal failures are present in or on the pouch prior to loading

into the sterilizer.

▪ Load the pouches into the sterilizer by following the sterilizer manufacturer’s recommended loading

procedures and load configurations.

▪ Follow the sterilizer manufacturer’s recommended procedures to program the sterilizer with the sterilization

cycle parameters in the following table.

Sterilization

Cycle Temperature Exposure Time

Pre-vacuum 270°F (132°C) 4 minutes 30 minutes

1

Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using
ambient atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s
recommendations.

Chamber size and chamber load differences may exist between industrial and health care facility sterilizer
models. The sterilization parameters in the previous table can be achieved in both health care facility and
larger, industrial sterilizer models. Because of the many variables involved in sterilization, each health care
facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their
equipment.

Minimum Dry Time

1

STERILIZATION INSTRUCTIONS: Instruments

Note: steam for sterilization should be generated from water treated to remove total dissolved solids and
non-condensable gases, filtered to remove contaminates and water droplets, and supplied via piping without
dead legs or other stagnant zones where contamination may collect.

Caution: ethylene oxide (EO), gas plasma, gamma irradiation, chemical vapor, or dry heat sterilization
methods are not recommended for sterilization of these devices. Steam/moist heat is the recommended
method of sterilization.

Ensure the pouched probes are dry before storing. Store in dry, clean conditions at ambient room temperature.

Storage and
Shelf-Life

Temperature range recommended for storage is -20°C to 50°C or the temperature range specified by the legally
marketed sterilization pouch manufacturer. Shelf life of sterilized RF probes is dependent upon the legally
marketed sterilization pouch. The health care facility should establish a shelf life for sterilized instrumentation
based upon the type of sterilization pouch used and the recommendations of the sterile pouch manufacturer.

TROUBLESHOOTING

Problem Troubleshooting

▪ Ensure all connections are made.

No temperature measurement
OR
Inaccurate, erratic, or sluggish
temperature reading

Probe Connector does not fit in Probe
Plug-in

Probe is not recognized by
Accurian™ RF Generator

Damage is observed to handle,
connector, or any part of the device.

▪ Check for an error message on the generator.
▪ Ensure devices are dry and at room temperature. If devices are not at room

temperature, wait until they have reached temperature and retry.

▪ Visually inspect the probe or probe cable for damage. If problem persists,

discontinue use.

▪ Check that the connector's keys are lined up in the proper orientation.
▪ Check that the Connector hub is the Accurian™ Standard Connector hub.
▪ Ensure the connectors are clean and unobstructed.

▪ Check that the Connector hub is the Accurian™ Standard Connector hub.
▪ Check that the connector is not damaged.
▪ Check that the Accurian™ Reusable RF Probe has not been used before.

Do not use. Discard immediately.

PACKAGING

Packages for each of the components should be intact upon receipt. All components should be carefully checked for
completeness and to ensure there is no damage prior to use. Damaged packages or products should not be used and should
be returned to Medtronic. Contact Medtronic for return information.

VISUAL INSPECTION

Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return
information.

MRI INFORMATION

Medtronic instruments and accessories are not intended to be used in the magnetic resonance (MR) environment. As such,
Medtronic instruments and accessories were not evaluated for safety and compatibility in the MR environment. Therefore, safety
of Medtronic instruments and accessories in the MR environment is unknown.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.
Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the

competent authority of the Member State in which they are established.

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: Device components

Legend (See Figure 1)

A Thermocouple
BElectrode
C Handle

Figure 2: Diagram of system connections

Legend (See Figure 2)

1. Accurian™ RF Generator

2. Accurian™ Standard Connector Hub

3. Accurian™ Reusable RF Probe

4. Dispersive Electrode (Not included)

LESION SIZE

The size of a RF lesion is affected by the exposed surface area of the active tip (both the active tip length and cannula
diameter), the Set Temperature, and the Procedural Time (excluding the Ramp Time). Typical lesion size graphs over time are
shown for an 18G cannula at a Set Temperature of 80°C in Figure 3. The value of the Y coordinate for the graph on the left
represents lesion length (mm). The value for the Y coordinate for the graph on the right represents lesion width (mm).

Figure 3: Lesion size (Y) graph for 18G cannula at a Set Temperature of 80°C and Procedural time (X)

Y

XX

Y

To estimate the length (L) and Width (W) of lesion for any Probe, the following equations may be used:

Equation 1: Lesion size equations

L =-7.95 + 0.86D + 0.89A + 0.14T + 0.75t
W =-8.47 + 1.40D + 0.28A + 0.14T + 0.88t

Where A is the Cannula Active Tip Length in millimeter, D is the Cannula Diameter in millimeter, T is the Set Temperature in
degree C, and t is the Procedural Time (excluding the Ramp Time) in minute.

These equations are valid within the following ranges for the factors:

D = 16G (1.65mm), 18G (1.27mm), 20G (0.91mm), and 22G (0.72mm)
A = 5 and 10mm
T = 70, 80, and 90°C
t = 1, 2, and 3 min

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

EXPLANATION OF SYMBOLS

Authorized representative in the European Community/
European Union

Importer

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

This device complies with applicable European Union
regulations and directives.

For US audiences only

Manufacturer

Date of manufacture

Batch code

Catalogue number

Caution, Consult Accompanying Documents

-20 °C

Do not use if package is damaged and consult instructions
for use

Keep away from sunlight

50°C

Temperature limit -20°C to 50°C

Serial Number

Consult instructions for use at this website.

Medical device