Medtronic AG1000 Instructions for Use
2019-03-27
M708348B803 Rev. A
*M708348B803-A*
ACCURIAN™ Radiofrequency Generator
EXPLANATION OF SYMBOLS
Alert icon
Completed icon
Increase/Decrease
Disabled
Help
Stimulation Auto Ramp play/pause
OK
Reset
ON/OFF Button
Date of Manufacture
Defibrillator-proof, patient isolated
connections
Dispersive electrode connection
Do not stack more than 2
Do not use if package is damaged
Electrical Hazard
Equipotentiality
CAUTION: Federal law (USA)
restricts these devices to sale by or
on the order of a physician.
Follow Instructions for Use
Stimulation Flag
Bipolar
Stimulation Dial
Profile Manager Mode
Settings
Toggle
Authorized representative in the
European Community
The device complies with European
Directive MDD 93/42/EEC
Alternating Current
-20 °C
Fragile, handle with care
Fuse
Humidity range 20% to 90%
Keep dry
Manufacturer
Non-ionizing radiation
Serial Number
60°C
Temperature limit
This end up
Atmospheric pressure range 700
hPa to 1060 hPa
USB port
ACCURIAN™ Radiofrequency GeneratorENGLISH3
E502967
HDMI Connection
cTUVus Product Safety Mark
Consult instructions for use at this
website.
Protective earth (ground)
WEEE Directive
Footswitch
Reference number
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).
4ENGLISHACCURIAN™ Radiofrequency Generator
Table of contents
EXPLANATION OF SYMBOLS............................................................................................................................................. 3
IMPORTANT INFORMATION ON THE ACCURIAN™ RADIOFREQUENCY GENERATOR.............................................. 7
INTRODUCTION................................................................................................................................................................7
DESCRIPTION...................................................................................................................................................................7
INDICATIONS.................................................................................................................................................................... 7
CONTRAINDICATIONS..................................................................................................................................................... 7
WARNINGS....................................................................................................................................................................... 7
PRECAUTIONS................................................................................................................................................................. 8
ADVERSE EVENTS...........................................................................................................................................................9
DIRECTIONS FOR USE.................................................................................................................................................... 9
Preparing the System................................................................................................................................................. 9
Compatible Accessories........................................................................................................................................... 10
When you get a New Generator............................................................................................................................... 11
Preparing the Generator for Use...............................................................................................................................11
Mounting the Generator............................................................................................................................................ 11
Powering on the Generator.......................................................................................................................................11
Standard Procedure Setup....................................................................................................................................... 11
Enhanced Procedure Setup...................................................................................................................................... 12
Treatment Modes...................................................................................................................................................... 12
Shutdown Procedure................................................................................................................................................ 12
Generator Cleaning Instructions............................................................................................................................... 12
Generator Maintenance Schedule............................................................................................................................ 12
USER INTERFACE.......................................................................................................................................................... 13
Front Panel Display, Controls, and Connections...................................................................................................... 13
Rear Panel, Controls, and Connections....................................................................................................................14
Touchscreen Calibration........................................................................................................................................... 14
Frequently Used Functions....................................................................................................................................... 15
TECHNICAL SPECIFICATIONS...................................................................................................................................... 15
Compliant Standards................................................................................................................................................ 15
Impedance Measurement......................................................................................................................................... 15
RF/Stimulation Output...............................................................................................................................................15
Measurement Accuracy (at time of manufacture)..................................................................................................... 16
Software Shutdown Limits During RF/Stimulation Delivery...................................................................................... 16
Hardware Shutdown Limits....................................................................................................................................... 16
Mechanical Specifications.........................................................................................................................................16
Environmental Specifications.................................................................................................................................... 16
Fuses........................................................................................................................................................................ 17
Line Input Ratings..................................................................................................................................................... 17
Rated Accessory Voltage (for associated equipment and active accessories).........................................................17
Disposal Instructions................................................................................................................................................. 17
Alert Limits................................................................................................................................................................ 17
Alert Tones................................................................................................................................................................17
Alert Condition Logging.............................................................................................................................................17
Fault State.................................................................................................................................................................17
FURTHER INFORMATION.............................................................................................................................................. 17
LIMITATION OF LIABILITY..............................................................................................................................................17
ACCURIAN™ Radiofrequency Generator
ENGLISH5
IEC EMC SPECIFICATIONS (EMISSIONS).................................................................................................................... 17
IEC EMC SPECIFICATIONS (IMMUNITY)...................................................................................................................... 18
6ENGLISHACCURIAN™ Radiofrequency Generator
IMPORTANT INFORMATION ON THE ACCURIAN™ RADIOFREQUENCY GENERATOR
INTRODUCTION
The system presented in this Instructions for Use (IFU) consists of the ACCURIAN™ Radiofrequency (RF) Generator. For
convenience, the ACCURIAN™ Radiofrequency Generator will be referenced in this IFU as the “Generator.” This IFU
provides a description of the Generator, its controls and displays, and a sequence for its operation.
This IFU also supplies other information of importance to the Operator. Do not operate the Generator before thoroughly
reading this IFU.
The Generator is rated as Class I, rated for continuous operation, and IPX0.
For US Audiences Only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
DESCRIPTION
The Generator is a four-channel radiofrequency ablation platform that allows monopolar deliveries with a dispersive electrode
as well as bipolar deliveries between probes. RF energy is applied to the patient according to the configured settings to create
lesions in tissue. The generator is capable of stimulating nerve cells by delivering low frequency stimulation pulses. It is nonsterile and reusable.
INDICATIONS
The ACCURIAN™ RF Generator 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
The safe and effective use of RF energy and stimulation energy is dependent upon factors under the control of the
Operator. There is no substitute for a properly trained operating room staff. It is important the operating instructions supplied
with the Generator be read and understood before use.
Risk of Fire: do not use in the presence of flammable anesthetics, other flammable gases, near flammable fluids (such
as skin prepping agents and tinctures), flammable objects, or with oxidizing agents. Observe appropriate fire
precautions at all times.
Risk of Fire: do not use this device in oxygen-enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the
presence of other oxidizing agents.
Risk of RF burns and unintended stimulation: do not turn RF or stimulation power on while touching any electrodes.
Risk of RF burns and unintended stimulation to the patient: while using this device during an RF or stimulation
procedure, the patient should not be allowed to come into direct contact with grounded metal objects such as the
surgical table frame, the instrument table, etc. The use of antistatic sheeting is recommended.
Risk of RF burns and unintended stimulation to the patient: skin-to-skin contact (e.g. between the arms and body of the
patient) should be avoided (e.g. by insertion of dry gauze).
Risk of RF burns and unintended stimulation: failure of the Generator or accessories could result in an unintended
increase of output power.
RF energy can produce unintended neuromuscular stimulation during ablation. Appropriate precautions, including the
use of lower power settings and continuous monitoring of the patient during treatment, should be taken to minimize the
risk of patient injury.
Interference with other equipment: use of electrosurgical generators on patients with internal or external pacemakers,
implantable defibrillators, or monitoring equipment may be affected. Qualified advice should be obtained as necessary to
minimize the risk of injury from implanted device malfunction.
Interference with other equipment: use of electrosurgical generators on patients with conductive implants can cause the
implants to heat up and damage tissue. Qualified advice should be obtained as necessary to minimize the risk of injury
from conductive implant heating.
Interference with other equipment: during RF or stimulation output, the conducted and radiated electrical fields may
interfere with other electrical medical equipment.
Interference with other equipment: use only with approved devices and accessories. Use of accessories, transducers,
and cables other than those specifically approved by Medtronic for use with the Generator may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the Generator.
Risk of electric shock: to avoid the risk of electric shock, the Generator must only be connected to a supply mains with a
protective earth. Do not use extension cords or three-prong to two-prong adapters unless provided by Medtronic. The
mains power cord assembly should be periodically checked for damaged insulation or connectors.
Risk of electric shock: do not modify this equipment.
ACCURIAN™ Radiofrequency GeneratorENGLISH7
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