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.
2. Insert the Accurian™ Enhanced RF Probe(s) into the tissue through the introducer(s), ensuring the probe handle is pushed
fully into the introducer handle. Never force the probe in if significant resistance is felt.
3. Using fluoroscopic or ultrasonic imaging, ensure the tip of the Accurian™ Enhanced RF Probe is in the desired location.
4. Ensure the Accurian™ Enhanced RF Probe is connected to the Accurian™ Tube Kit.
5. The Lesion mode will be automatically selected in the Accurian™ RF Generator upon successful detection of a valid
Accurian™ Enhanced RF Probe. Set advanced settings and the parameters for RF delivery in the Generator as described in
its Instructions for Use (IFU).
6. Perform the procedure as described in the Generator Instructions for Use (IFU). The procedure comprises pump priming
and treatment. Sensory and motor stimulation are also available.
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.
7. After treatment remove the probes and the introducer and discard as biohazards. Discard the dispersive electrode
appropriately. Disconnect the Accurian™ Enhanced Connector Hub from the Generator. Follow standard hospital
techniques to handle reusable items.
Note: maintain a minimum distance of 4mm between the probe active tip and other metal objects (disregarding the
introducer).
Ablation Size
See Equation 1 and Figure 8 for the mathematical relationship between procedure parameters and lesion length or width,
respectively. The nominal lesion sizes at the recommended Set Temperature of 80°C and Procedural Time (excluding the Ramp
Time) of 2 minutes are summarized below.
Probe Model Active Tip Length Nominal Lesion Length Nominal Lesion Width
APSC01 4mm 10mm 10mm
APSC02
APSC03
APSC04 5.5mm 12mm 12mm
APSC05
APSC06
STERILIZATION
Devices are supplied in sterile form. The Accurian™ Enhanced RF Probe Kits are sterilized with ethylene oxide.
PACKAGING
Devices are supplied sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile
package has been broken, the product should not be re-sterilized. Damaged or unintentionally opened sterile packages should
not be used and should be returned to Medtronic. Contact Medtronic for return information.
VISUAL INSPECTION
Visually inspect all sterile barrier packaging before use. If the integrity of the sterile barrier has been compromised, do not use
the product. 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.
HOW SUPPLIED
Accurian™ Enhanced RF Probe Kits are supplied sterile in peel-open packaging. In the event of damage to the sterile
packaging, do not use and notify the manufacturer.
STORAGE
The probe and tube kit should be stored in their original shipping materials. Proper care should be taken to ensure instruments
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
▪ Ensure all connections are made.
▪ 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 cable for damage. If problem persists, discontinue use.
▪ Stop the procedure immediately.
▪ Check that the burette has been filled past the 70mL mark.
Water does not flow through the
probe and tube kit
▪ Check the luer lock connections to ensure the tube kit is connected to the probe.
▪ Check the pump to ensure the pump heads are turning.
▪ Check the pump to ensure the lid is not open.
▪ Check the Accurian™ RF Generator for any error messages.
Probe Connector does not fit in
Probe Plug-in
Probe is not recognized by
Accurian™ RF Generator
Damage to Insulation on probe or
introducer
▪ Check that the connector's keys are lined up in the proper orientation.
▪ Check that the cable hub is the Accurian™ Enhanced Connector Hub.
▪ Ensure the connectors are clean and unobstructed.
▪ Check that the cable hub is the Accurian™ Enhanced Connector Hub.
▪ Check that the connector is not damaged.
▪ Check that the Accurian™ Enhanced RF Probe has not been used before.
Do not use. Discard immediately.
▪ Ensure the tube kit is correctly connected to the probe.
Water is not circulating through
tubing during pre-cooling, on and
post-cooling states.
Water is not dripping into the
burette.
The lid of the burette cannot be
removed.
Tube kit breaks, is leaking, or is
occluded
▪ Ensure the tube kit has been correctly placed in the pump head.
▪ Ensure the burette reservoir has been filled past the 70mL mark.
▪ Visually inspect the tube kit tubing and joints for leaks and occlusions.
▪ Ensure the pump tubing (thick-walled tubing that is coming directly out of the bottom
port of the burette) is placed in the pump head.
▪ Check to see if water is running down the wall of the burette.
▪ Check the luer connections to ensure water is not leaking out of any of the connections.
Inject sterile water through the port of the lid, rather than removing the lid.
Immediately discard the tube kit.
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
B Active Electrode
C Insulated Shaft
D Handle
E Water Tubes
F Luer Locks
G Connector
Figure 2: Diagram of system connections
Legend (See Figure 2)
1. Accurian™ RF Generator
2. Accurian™ Pump Unit
3. Accurian™ Connector Hub
4. Accurian™ Enhanced RF Probe
5. Accurian™ Tube Kit
6. Accurian™ Introducer
7. Dispersive electrode
Figure 3: Diagram of Tube Kit
Figure 4: Place burette into burette holder
Figure 5: Filling the burette
Figure 6: Installing tubing into Pump Unit
Figure 7: Connect tubing to Accurian™ Enhanced RF Probe
LESION SIZE
RF lesion procedures with the Enhanced RF probe is affected by the Active Tip Length, the Set Temperature, and the
Procedural time. Typical lesion growth graphs over time are shown for a 4mm Active Tip Enhanced Probe at a Set Temperature
of 80°C in Figure 8. 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 8: Lesion size (Y) growth graph for a 4mm Active Tip Enhanced Probe at a Set Temperature of 80°C and Procedural
time (X)
Y
X
Y
X
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 =-10.67 + 1.43A + 0.16T + 0.75t
W =-11.10 + 1.22A + 0.19T + 0.83t
Where A is the Probe Active Tip Length 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:
A = 4 and 5.5mm
T = 70, 80, and 90°C
t = 2, 3, 4, and 5 min
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
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
Use-by date
Catalogue number
Do not re-use
Do not use if package is damaged and consult instructions
for use
Keep away from sunlight
Sterilized using ethylene oxide
-20 °C
50°C
Temperature limit -20°C to 50°C
Non pyrogenic
Consult instructions for use at this website.
Medical device
*Single sterile barrier system
Double sterile barrier system
Single sterile barrier system with protective packaging
inside
Single sterile barrier system with protective packaging
outside
*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.
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