ACCURIAN™ Pump Unit and
M708348B808E Rev. A
ACCURIAN™ Pump Cable
2018-12-05
IMPORTANT INFORMATION ON THE ACCURIAN™ PUMP UNIT AND ACCURIAN™
PUMP CABLE
Carefully read all instructions prior to use.
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™ Pump Unit is a non-sterile, reusable pump that circulates sterile water through a closed-loop system during
ACCURIAN™ enhanced radiofrequency (RF) ablation procedures. The ACCURIAN™ Pump Unit is suitable for continuous
operation. The ACCURIAN™ Pump Unit is controlled by the ACCURIAN™ RF Generator through the ACCURIAN™ Pump
Cable, a USB A to B cable.
The ACCURIAN™ Pump Cable is connected at the rear of the ACCURIAN™ Pump Unit and ACCURIAN™ RF Generator
through the indicated USB connectors. The ACCURIAN™ Pump Unit is powered by a mains power cord connected to the rear
and is powered on by a mains power switch located on the rear panel (see Figure 1). An equipotential connection (Figure 1) can
be found on the rear panel. This connector is attached to the pump chassis/earth ground. It is intended for earth reference
connection in environments where equipotential ground cabling is used. The ACCURIAN™ Pump Unit must be used with the
ACCURIAN™ Enhanced Connector Hub.
The Pump is rated as Class I, rated for continuous operation, and IPX0.
INDICATIONS FOR USE
The ACCURIAN™ Pump Unit is intended for the creation of radiofrequency lesions in nervous tissue.
CONTRAINDICATIONS
Use of the ACCURIAN™ RF Ablation System is contraindicated in patients with systemic infection or local infection in the area
of the procedure.
WARNINGS
▪ For safe use of the ACCURIAN™ Pump Unit, the physician should have specific training, experience, and thorough
familiarity with the use and application of this product.
▪ The ACCURIAN™ Pump Unit should be used as stated in the Indications for Use and only with ACCURIAN™ Tube Kit.
▪ Do not service the ACCURIAN™ Pump Unit. If servicing is required, contact Medtronic.
▪ Do not modify the ACCURIAN™ Pump Unit. Any modifications may compromise the safety and efficacy of the device.
▪ The ACCURIAN™ Pump Unit is non-sterile and should be placed outside the sterile field.
▪ The ACCURIAN™ Pump Unit is not intended for use in oxygen rich environments (> 25% O2 at ambient pressure).
▪ Do not use in the presence of flammable anesthetics.
▪ The rear USB connectors are only intended for the ACCURIAN™ Pump Cable to connect the ACCURIAN™ Pump Unit and
the ACCURIAN™ RF Generator.
▪ Position the ACCURIAN™ Pump Unit such that the power supply connection is easily accessible as a means of
disconnecting power from the ACCURIAN™ Pump Unit.
▪ To avoid the risk of electric shock, the ACCURIAN™ Pump Unit must only be connected to a supply mains with a protective
earth.
▪ To avoid the risk of electric shock, do not disassemble this equipment.
PRECAUTIONS
▪ Do not use the ACCURIAN™ Pump Unit before thoroughly reading these Instructions for Use (IFU) and the Instructions for
Use for the other ACCURIAN™ RF Ablation System components required to perform the RF lesion procedure.
▪ Before starting ablation procedures, ensure the tubing of the ACCURIAN™ Tube Kit is properly placed in the ACCURIAN™
Pump Unit.
▪ Ensure the ACCURIAN™ Pump Unit has completely stopped before inserting or removing tubing from the pump heads. Do
not unplug the ACCURIAN™ Pump Unit during RF energy application.
▪ Only the power cord supplied with the ACCURIAN™ Pump Unit, the ACCURIAN™ Pump Cable supplied with the
ACCURIAN™ Pump Unit, and the ACCURIAN™ Tube Kit should be connected to the ACCURIAN™ Pump Unit. Other
items should not be connected to the ACCURIAN™ Pump Unit.
▪ The mains power cord of the ACCURIAN™ Pump Unit must be connected to a properly grounded receptacle. Extension
Cords, power strips and/or adapter plugs must not be used unless provided by Medtronic.
▪ Do not wrap instrument cable around metal objects. Wrapping cables around metal objects may induce hazardous currents.
▪ Perform regular inspections of all accessories, including the ACCURIAN™ Tube Kit.
▪ The position of the mounting bracket(s) on the ACCURIAN™ Pump Desk Stand should not be modified. Altering the
position(s) of the mounting bracket(s) may cause decreased stability of the Desk Stand.
▪ The ACCURIAN™ Pump Unit should not be used adjacent to or stacked with other equipment outside of its pre-set
configuration on the ACCURIAN™ Pump Desk Stand with the ACCURIAN™ RF Generator. If the ACCURIAN™ Pump Unit
must be operated adjacent to or stacked with other equipment outside of this configuration, the ACCURIAN™ Pump Unit
should be observed to verify normal operation in that configuration.
▪ Electronic equipment, including portable and mobile RF communications equipment, can affect the operation of the
ACCURIAN™ Pump Unit. Operating non-essential equipment in the vicinity of the ACCURIAN™ Pump Unit should be
avoided. If interference is suspected, the responsible equipment and associated cables should be moved away from the
ACCURIAN™ Pump Unit.
ADVERSE EVENTS
The ACCURIAN™ Pump Unit is used with other components of the ACCURIAN™ RF Ablation System. Adverse events
associated with the use of this device are similar to those indicated for medicated and anesthetic methods utilized in other
surgical procedures:
▪ As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury can occur.
▪ Nerve injury including thermal injury, or puncture of the spinal cord or nerve roots potentially results in radiculopathy,
paresis, and paralysis.
▪ Other possible adverse events include pain, pulmonary embolism, hemothorax or pneumothorax, infection, unintended
puncture wound including vascular puncture and dural tear, hemorrhage, and hematoma.
PRODUCT SPECIFICATIONS
Table 1: Product Specification
Operational Environment 10ºC to 40ºC, 30% to 70% relative humidity
Storage Requirements -20ºC to 60ºC, 20% to 95% non-condensing relative humidity
Operational Altitude Up to 3000m
Steady State AC Power Input 125W
AC Input Voltage
AC Input Frequency 50/60 Hz
AC Input Current 2.5A
Electromagnetic Immunity Level Refer to the ACCURIAN™ RF Generator IFU
IP Classification IPX0
ACCURIAN™ Pump Cable Length 1.00m ± 0.10m
Standards compliance
100 to 240 V
RMS
▪ EN/IEC 60601-1, 2005 + A1 2012
▪ EN/IEC 60601-1-2, 2014
▪ EN/IEC 60601-1-6, 2010 + A1 2013
INSPECTION PRIOR TO USE
When opening a new ACCURIAN™ Pump Unit package, you will find:
▪ ACCURIAN™ Pump Unit
▪ ACCURIAN™ Pump Cable
▪ Hospital-grade power cords
▪ The ACCURIAN™ Pump Unit box will contain the US power cord.
▪ Three other power cords, for use in other countries, will also be provided.
▪ ACCURIAN™ Pump Desk Stand
Perform the following checks before the patient is presented for the procedure:
1. Inspect the ACCURIAN™ Pump Unit, power cord, and ACCURIAN™ Pump Cable for damage.
2. Inspect the ACCURIAN™ Pump Unit to see that all labels are present and legible.
3. Contact Medtronic if any equipment or label damage is found.
EQUIPMENT
The ACCURIAN™ Pump Unit is for use in ACCURIAN™ RF procedures performed in specialized clinical settings. The
equipment in the ACCURIAN™ Enhanced RF Ablation System is as follows (Figure 3):
Accessory/Applied Parts Part Classification Part Number(s)
ACCURIAN™ RF Generator with Generator Desk Stand (1) N/A AG1000
ACCURIAN™ Pump Unit with Pump Desk Stand and Cable (2) N/A AP1000
ACCURIAN™ Enhanced Connector Hub (3) N/A APH200
ACCURIAN™ Enhanced RF Probe
(kit(s))
Dispersive Electrode* (7) Type CF N/A
*Disposable dispersive electrode meeting EN/IEC 60601-2-2, 2009 requirements for electrosurgical electrodes. The
ValleyLab™ dispersive electrode E7507 has been validated for use with this system.
The front and rear panels of the pump are shown in Figure 1. Different components of the pump unit, identified in Table 2, are
labeled in Figure 1.
Table 2: ACCURIAN™ Pump Unit components.
A Pump Head
B Pump Lid
C LED Indicators
D Burette Holder
E Mains Power Switch
F Mains Power Connector
G Equipotential Connection
H ACCURIAN™ Pump Cable Connectors
ACCURIAN™ Enhanced RF Probe
(4)
ACCURIAN™ Tube Kit (5) N/A
ACCURIAN™ Introducer (6) N/A
Type CF (Defibrillation
Proof Applied Part)
APSC01, APSC02,
APSC03, APSC04,
APSC05, and APSC06
DIRECTIONS FOR USE
Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted in these instructions.
Failure to properly follow instructions may lead to improper functioning of the device and could result in patient injury.
Preparing the System
1. Assemble all required equipment for the intended procedure. Do not make connections yet.
2. Perform a visual check on all equipment and ensure all components are in good working order. Do not use damaged
equipment.
Preparing the Pump for Use
1. The ACCURIAN™ Pump Unit must be mounted on a ACCURIAN™ Pump Desk Stand before use. Do not use the
ACCURIAN™ Pump Unit without mounting on a ACCURIAN™ Pump Desk Stand (Figure 2).
2. Check the mounting bracket on the back panel of the ACCURIAN™ Pump Unit to ensure it is fixed firmly in place.
3. Ensure nothing is connected to the ACCURIAN™ Pump Unit prior to mounting.
Mounting the Pump
1. Lift the ACCURIAN™ Pump Unit so the ACCURIAN™ Pump Unit mounting bracket is above the ACCURIAN™ Pump Desk
Stand bottom mounting bracket.
2. Slide the ACCURIAN™ Pump Unit mounting bracket onto the ACCURIAN™ Pump Desk Stand mounting bracket. Ensure
the ACCURIAN™ Pump Unit is secure (Figure 2).
3. Do not adjust the position of the mounting brackets on the ACCURIAN™ Pump Desk Stand.
4. Mount the ACCURIAN™ RF Generator according to the ACCURIAN™ RF Generator IFU.
Directions for Operation
1. Once the ACCURIAN™ Pump Unit is mounted, connect one end of the power cord to the AC Power Inlet on the rear panel
of the ACCURIAN™ Pump Unit and the other end to a power source. (Figure 1).
2.
Locate the AC Mains Switch on the back of the ACCURIAN™ Pump Unit (Figure 1). Flip the switch to to turn the unit ON.
Ensure the indicator lights on the front panel of the ACCURIAN™ Pump Unit are illuminated.
3. Connect the ACCURIAN™ Pump Unit to the ACCURIAN™ RF Generator using the ACCURIAN™ Pump Cable. Plug the
USB B side to the rear panel on the ACCURIAN™ Pump Unit (Figure 1) and the USB A side to the rear panel of the
ACCURIAN™ RF Generator.
4. Set up the ACCURIAN™ RF Generator as per the ACCURIAN™ RF Generator IFU (Figure 3).