Medtronic AP1000 Instructions for Use

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).

5. Set up the blue ACCURIAN™ Enhanced Connector Hub with the ACCURIAN™ RF Generator as per the ACCURIAN™

Connector Hub IFU (Figure 3).

6. Set up the ACCURIAN™ Tube Kit with the ACCURIAN™ Pump Unit as per the ACCURIAN™ Enhanced RF Probe Kit IFU
(Figure 3).

7. Set up the remainder of the system as per the ACCURIAN™ Enhanced RF Probe Kit IFU (Figure 3).

8. The ACCURIAN™ Pump Unit is controlled through the ACCURIAN™ RF Generator. During RF lesion procedures with the

ACCURIAN™ Enhanced RF Probe, ensure both pump heads are running throughout. Refer to the ACCURIAN™ RF
Generator IFU for more information.

Shutdown Procedure

1. Turn off the mains power using the AC Mains Switch on the back of the ACCURIAN™ Pump Unit (Figure 1). Flip the switch

to

to turn OFF. Ensure the indicator lights on the front panel are OFF.

2. Disconnect the power cord from the mains and the AC Power Inlet on the ACCURIAN™ Pump Unit.

3. Disconnect the ACCURIAN™ Pump Cable from the ACCURIAN™ RF Generator and the ACCURIAN™ Pump Unit.

4. After treatment remove the probes and the introducer and discard as biohazards. Disconnect the ACCURIAN™ Connector

Hub from the ACCURIAN™ RF Generator. Follow standard hospital techniques to handle reusable items.

CLEANING INSTRUCTIONS

The ACCURIAN™ Pump Unit is considered a noncritical environment surface (i.e. medical equipment surface) and does not
come into contact with patients.

Use a solution of non-abrasive detergent and water applied with a damp cloth to clean the ACCURIAN™ Pump Unit rear cover,
front panel, power cable and the ACCURIAN™ Pump Cable.

The ACCURIAN™ Pump Unit cannot be sterilized. Do not allow fluids to enter the chassis.
Do not spray or pour liquids directly on the ACCURIAN™ Pump Unit. Flammable agents used for cleaning, or as solvents or

adhesives, should be allowed to evaporate before operation.

DISPOSAL INSTRUCTIONS

Do not dispose of in waste. Recycle in compliance with electronic recycling requirements.

TROUBLESHOOTING

PROBLEM TROUBLESHOOTING

▪ Immediately stop the procedure.

The ACCURIAN™ Pump Unit
is not running during RF
lesion procedure with the
ACCURIAN™ Enhanced RF
Probe.

▪ Check the ACCURIAN™ RF Generator screen for error instructions.
▪ Verify the blue ACCURIAN™ Enhanced Connector Hub is attached to the Generator.
▪ Check to ensure the ACCURIAN™ Pump Unit is connected to the ACCURIAN™ RF

Generator.

▪ Check the power cord and ACCURIAN™ Pump Cable for damage. The ACCURIAN™ Pump

Unit indicator lights should be lit.

▪ Check that both pump lids are completely closed.

The ACCURIAN™ Pump Unit
will not accept the
ACCURIAN™ Tube Kit.

Fully open the pump head door covers for the ACCURIAN™ Pump Unit and place the tubing
coming from the bottom of the burette of the ACCURIAN™ Tube Kit into the L-shaped tube
guides.

▪ Immediately stop the procedure.
▪ Check that the tubing is properly placed in the L-shaped tubing guides of the ACCURIAN™

Pump Unit.

Fluid is not circulating during
Enhanced Lesion Mode.

▪ Ensure the burette reservoir has been filled.
▪ Ensure the ACCURIAN™ Tube Kit is correctly connected to the ACCURIAN™ Enhanced

Probes.

▪ Ensure the tubing coming out of the bottom part of the burette is the portion that is in the

pump head.

▪ Check for leaks or occlusions in the ACCURIAN™ Tube Kit.

The ACCURIAN™ Pump Unit
is making abnormal noises.

▪ Ensure there is nothing in the ACCURIAN™ Pump Unit that could be impeding motion.
▪ Check that the tubing is properly placed in the L-shaped tubing guides of the ACCURIAN™

Pump Unit.

FURTHER INFORMATION

For further information, contact Medtronic.

LIMITATION OF LIABILITY

In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or in
connection with the ACCURIAN™ Pump Unit based upon breach of contract (including breach of warranty).

©2018 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: ACCURIAN™ Pump Unit Overview

Figure 2: Mounting Brackets for the Generator and Pump

Figure 3: Diagram of system connections in enhanced procedures. A) Connections for one probe and B) connections for four
probes (Connector Hub is blue).

(A)

(B)

Legend (See Figure 3)

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

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

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

The device complies with European Directive MDD
93/42/EEC

For US audiences only

Manufacturer

Date of Manufacture

ACCURIAN™ Pump Unit USB port (to Generator)

Electrical Hazard

Medtronic B.V.

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

-20 °C

Do not stack more than 2

Do not use if package is damaged

Fragile, handle with care

Humidity range 20% to 95%

Keep dry

60°C

Temperature limit

This end up

Do not dispose of the product in the unsorted municipal
waste stream. Dispose of the product according to local
regulations.

Reference number

Serial Number

Atmospheric pressure range 700 hPa to 1060 hPa

E502967

Fuse

Alternating Current

Equipotentiality

Protective earth (ground)

cTUVus Product Safety Mark

Non pyrogenic

Consult instructions for use at this website.

MEDICAL – APPLIED CURRENT/ENERGY EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2 No.
60601-1 (2014), AND IEC 60601-2-2 (2009).