KIRWAN AURA 28-2000 User manual

IFU-70WGEN-5 Rev. K (11-2018)
Kirwan Surgical Products LLC
OPERATING INSTRUCTIONS AND SPECIFICATIONS FOR
THE
®
70 WATT BIPOLAR ELECTROSURGICAL GENERATORS
28-2000 - 70W Coagulator
28-2600 - 70W Coagulator w/Irrigation

IFU-70WGEN-5 Rev. K (11-2018)
TABLE OF CONTENTS
English 1
Français 13
Deutsch 25
Italiano 37
Español 49
Português 61

IFU-70WGEN-5 Rev. K (11-2018) 1
English
APPLICATION
This manual applies to the AURA®70 watt bipolar electrosurgical generators (Model Numbers
28-2000 and 28-2600) produced by Kirwan Surgical Products LLC
INDICATIONS
The AURA®70 watt bipolar electrosurgical coagulator is a general purpose solid state bipolar
coagulator used to supply the RF signal to electrosurgical handpieces used on soft body tissues
where a wide range of tissue types, patient conditions, and load impedances are encountered.
WARNINGS AND CAUTIONS
This device is restricted to use by a qualified, licensed practitioner. Federal (USA) law restricts
this device to sale by or on the order of a physician.
Read this entire manual prior to use of this product.
Do not remove cover. Refer servicing to qualified service personnel.
Do not use in the presence of flammable gasses.
Use of this device in the presence of patients with pacemakers or active implants is not
recommended. Approved qualified advice should be obtained prior to any such use.
If the AURA®70 is used simultaneously with any physiological monitoring equipment,
monitoring electrodes should be placed as far from surgical electrodes as possible. Needle
monitoring electrodes are not recommended. Monitoring systems incorporating high frequency
current limiting devices are recommended.
Connect the generator power cord to a properly grounded receptacle. Do not use adapters or
extension cords.
Connect only bipolar accessories to the bipolar receptacles. Improper connection of accessories
may result in inadvertent accessory activation or other potentially hazardous conditions.
Use only accessories whose voltage rating is greater than the maximum output voltage of the
AURA®70 (210 Vpeak). Accessories, including cables, should be routinely inspected for any
damage prior to use. Refer to the instructions for use of each individual accessory as needed.
Temporarily unused active accessories shall be stored in a location that is isolated from the patient.
Accessory cables shall be positioned in such as way as to avoid contact with the patient or other
leads.

IFU-70WGEN-5 Rev. K (11-2018) 2
The lowest possible output setting necessary to achieve the desired effect should be used at all
times.
Special precautions regarding electromagnetic compatibility (EMC) should be exercised prior to
installing and putting the AURA®70 into service. Refer to technical service manual IFU-
70WSERV-5 for further information.
The AURA®70 complies with standard EMC requirements when used with bipolar handpieces up
to 10.5 inches (26.7cm) in length and bipolar cables up to 12 feet (3.7m) in length produced by
Kirwan Surgical Products LLC (refer to product catalog L-GENCAT-6 or www.ksp.com for
additional accessory information). The use of longer handpieces and/or cables, or those produced
by other manufacturers, could adversely affect the EMC performance of the unit.
The AURA®70 produces high frequency energy that may adversely affect the operation of other
electronic equipment in its vicinity.
Portable or mobile communications equipment used in the vicinity of the AURA®70 could
potentially cause slight disturbances in the function of the device.
Any use of this device for tasks other than for which it is indicated, may result in damaged
equipment or possible injury to the user or patient.
ESSENTIAL PERFORMANCE
The AURA®70 shall not change output power settings during use. Unintended HF energization is
not allowed.
ON-SCREEN ERROR MESSAGES
Color Message
System
Operation
Stopped Cause Action
Yellow “Hot! Decrease Power” No Internal temperature of the unit exceeds 40°C Decrease power setting.
Yellow
“Pump Stopped.
Release pedal for
reset” No
Maximum pump motor
current limit is reached Release pedal.
Yellow “Pump Error. Refer for service” No Problem with irrigation pump Contact service.
Red “Error. Refer for service. Code XX.” Yes Internal malfunction
Contact service.
Reference "XX" error
code.

IFU-70WGEN-5 Rev. K (11-2018) 3
CONTROLS AND INDICATORS
Figure 1
Pump Tube Slot - Accepts standard Kirwan irrigation cords
Pump Module – Accepts silicone pump tube on standard Kirwan irrigation cords
HF Out LED – Lit when bipolar output is activated
Bipolar Output Receptacles – Accept standard 4mm banana pins
Flow Rate Display – Displays flow rate setting of pump module in cubic centimeters per
minute (cc/min)
Flow Rate Adjust – Adjusts flow rate of pump module up or down
Irrigation ON/OFF – Enables irrigation pump module ON in tandem with bipolar output
Active/Inactive Display – Indicates status of bipolar output
Power Level Display, Watts – Displays output power level setting in watts
Power Level Adjust – Adjusts output power level up or down
Time Display – Displays total elapsed time bipolar output is activated during procedure
Reset – Resets time display to 00:00
Options – Accesses controls for screen brightness, speaker volume, and tube priming
Power Level Display, Neuro – Displays output power level setting in Neuro units

IFU-70WGEN-5 Rev. K (11-2018) 4
Figure 2
Power On/Off Switch
Fuse Holder
Mains Power Cord Connector
Equipotentiality Connection
Slot for IV Pole – Located at top right corner of heat sink
Footswitch Connector
SETUP
Connect the power cord to the power cord connector on the rear panel of the unit. Ensure the main
power switch is in the off (0) position prior to connecting the cord.
Connect the footswitch to the footswitch connector on the rear panel of the unit.
Connect the banana pins of the bipolar cord into the bipolar output connectors.
If irrigation is to be used, refer to the figure below and load the silicone pump tube as follows:
Form the silicone pump tube into a semi-circle and loop it around the roller wheel of the
pump module, proximal end (closest to the spike) on top.
Pull the plastic connectors on either end of the pump tube along the slots toward the rear
of the unit, until the flanges on the connectors can be secured into place in the recesses
located at the midpoint of the slots. Avoid over-stretching the tube.
Insert the spike at the proximal end of the irrigation line into the appropriate container.
Figure 3 – Loading Silicone Pump Tube

IFU-70WGEN-5 Rev. K (11-2018) 5
Connect the appropriate bipolar handpiece to the instrument end of the bipolar cord. Refer to the
specific instructions for use provided with the accessory before using.
OPERATION
Turn the unit on via the main power switch on the rear panel. After a brief diagnostic routine, the
unit should come up in the state shown in Figure 1 (flow and power will be set to 00).
To adjust the volume level of the audible tone:
Touch the OPTIONS button on the main screen
Touch the SOUND VOLUME adjustment button and slide it left or right as needed, or
touch the right or left arrows to increase or decrease the volume.
Touch the EXIT button to return to the main screen
Adjust the output power level to achieve the desired effect by touching the power level adjustment
arrows on the display screen. The power level will be displayed simultaneously in both watts and
Neuro units.
Depress the footswitch pedal to activate the bipolar output to the accessory handpiece. An
audible tone will sound indicating that the bipolar output is activated. Units will also provide
visual indication via a blue “Active” indicator on the screen.
To reset the elapsed time display to 00:00, press the RESET button.
IRRIGATION OPERATION (Model 28-2600 only)
To prime the irrigation line with irrigating solution:
Touch the OPTIONS button on the main screen
Touch the PRIME button. The pump motor will run continuously while this button is
touched. Observe distal end of handpiece for presence of irrigant.
Touch the EXIT button to return to the main screen
Adjust the flow rate as necessary by touching the flow rate adjustment arrows on the display
screen. Note - Flow rates indicated on-screen are approximations. Variations in tubing durometer,
solution container types, etc., may cause variations in actual flow output rates.
Touch the Irrigation ON/OFF button on the screen in order to allow flow of irrigating solution to
the accessory handpiece via footswitch activation.
To return to activation of the bipolar output only, touch the Irrigation ON/OFF button again.

IFU-70WGEN-5 Rev. K (11-2018) 6
SPECIFICATIONS
Input: 90-240VAC, 50/60Hz, max 200VA
Class: I
Applied Part: Type BF, Defibrillation-proof
Output: 512KHz, max 70W at 100-300 ohms load
Rated load: 200 ohms
Maximum output voltage: 210 V
peak
Fuses: 2 x T2.5A 250V
Weight: 15 lbs. (6.8 kg)
Footprint: 11 ½ in W x 8 in H x 11 in D (height does not include IV pole)
(29.0 cm x 20.5 cm x 28.0 cm)
EXPLANATION OF EXTERNAL MARKINGS
CE Mark
Caution! Consult Accompanying Documents (rear panel)
Footswitch connection (rear panel)
Equipotentiality (rear panel)
Any accessories and all replaced parts must be disposed
of and recycled in accordance with local environmental
regulations regarding the disposal of used equipment and
waste (rear panel)
Warning! Dangerous voltage (front panel)
Date of Manufacture (rear panel)
Defibrillator-proof type BF applied part (front panel)
High Frequency current output (front panel)
Non-ionizing radiation (rear panel)
Consult the Instructions for Use (label)

IFU-70WGEN-5 Rev. K (11-2018) 7
MAINTENANCE
CLEANING INSTRUCTIONS
Use a mild detergent and damp cloth to clean the generator cover, power cord, and footswitch. In
the presence of significant amounts of splashed liquids, protecting the footswitch with a disposable
plastic bag may be desirable in order to simplify cleaning and ensure optimum performance of the
switch over the life of the product.
Use only a soft damp cloth to clean the touch screen display. No chemicals should be used. Clean
the display only when the unit is turned off to avoid any inadvertent activation.
The generator and all components must be completely dry before use.
Do not sterilize the generator.
PREVENTIVE MAINTENANCE
At least once per year, the following inspections should be performed:
Visually check the condition of the AC power cord and footswitch cord (fraying of cables,
loosening of connector ends, damaged insulation or contact pins, etc.). See the service parts list
below if replacements are required.
Test the actual output power of the unit compared to the front panel setting, and the RF leakage
current to ground, via an ESU analyzer or other appropriate method. The measured output power
should not vary from the set power by more than 20%. The RF leakage current should not exceed
30mA. If the unit fails to comply with either of these requirements, it should be returned to Kirwan
Surgical Products LLC as per the last page of this document for further evaluation.
SERVICE/ACCESSORY PARTS LIST
Description Part Number
Fuse, T2.5AL/250V 28-2000-70
Detachable Power Cord, Hospital Grade, 12 ft (3.7m) 26-2535
Square Pedal Footswitch w/ 15 ft (4.6m) Cord & 4 Pin Connector 28-2000-61
IV Pole 28-2600-40
Testing & Service Manual IFU-70WSERV-5
All other components of this product are NOT field-replaceable. Contact Kirwan Surgical Products
LLC as per the last page of this document if servicing of other components is required.

IFU-70WGEN-5 Rev. K (11-2018) 8
TROUBLESHOOTING GUIDE
Symptom Possible Cause(s) Correction
Unit does not power up Power cord not plugged in correctly Check power cord connection.
Blown fuse(s) Check/replace fuse(s)
Bad power cord Check/replace power cord
Fault in internal power supply Refer to qualified personnel for
servicing
No RF output Bipolar cord not plugged in correctly Check bipolar cord-ESU connection
Instrument not plugged into bipolar
cord correctly Check instrument-bipolar cord connection
Footswitch cord not plugged in
correctly Check footswitch cord connection.
Faulty footswitch Check/replace footswitch
Bad bipolar cord Check/replace bipolar cord
Eschar build-up on instrument tip Check/clean instrument tip
Fault in internal circuitry Refer to qualified personnel for
servicing
No irrigation flow Irrigation tube not installed correctly Check irrigation tubing installation
Leak or blockage in irrigation tubing Check/replace bipolar irrigation cord
Debris in pump roller assembly Refer to qualified personnel for
servicing
Fault in pump motor assembly Refer to qualified personnel for
servicing
LCD Display Screen
goes blank Excessive Electrostatic Discharge (ESD) from operator to screen Cycle Power switch off and on again. Refer to qualified personnel for
servicing if necessary
RF power drops
unexpectedly Transient Voltage on Mains Line Release footswitch pedal and depress again
Eschar build-up on instrument tip Check/clean instrument tip
Touch screen not
functioning Software error Cycle Power switch off and on again. Refer to qualified personnel for
servicing if necessary
Fault in screen and/or other internal
circuitry Refer to qualified personnel for servicing
LCD Display too dim Incorrect brightness/contrast
adjustment Adjust brightness/contrast control
Fault in internal circuitry Refer to qualified personnel for
servicing
Audible tone too low Incorrect volume adjustment Adjust volume control
Fault in internal circuitry Refer to qualified personnel for
servicing