AtriCure ASU2-115 User manual

ABLATION AND SENSING UNIT
(ASU)
SERVICE MANUAL
Model ASU2-115
ASU3-230
AtriCure, Inc.
6033 Schumacher Park Drive
West Chester, Ohio 45069
USA
Telephone: [phone]
Technical Support: 866-349-2342
P000050.F

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Table of Contents
Section
1. INTRODUCTION.........................................................................................................................2
1.1. System Description .........................................................................................................2
2. WARNINGS AND PRECAUTIONS..........................................................................................3
2.1. WARNINGS...................................................................................................................3
2.2. PRECAUTIONS ............................................................................................................. 3
2.3. Responsibility of the Manufacturer ................................................................................ 4
3. TECHNICAL SPECIFICATIONS.............................................................................................4
3.1. RF Output........................................................................................................................ 4
3.2. Mechanical Specifications .............................................................................................. 4
3.3. Environmental Specifications ......................................................................................... 4
3.4. Electrical Specifications..................................................................................................4
3.5. Fuses ............................................................................................................................... 4
3.6. Footswitch Specifications ............................................................................................... 4
3.7. Power and Voltage Output Restrictions.......................................................................... 5
4. THEORY OF OPERATION.......................................................................................................7
5. POWER ON SELF-TEST............................................................................................................8
6. OPTIONAL PERFORMANCE VERIFICATION PROCEDURE ....................................10
6.1. Tools Needed ................................................................................................................ 10
6.2. Indicators....................................................................................................................... 10
6.3. Maximum Power Output............................................................................................... 11
6.4. Errors and Fault Mode .................................................................................................. 12
6.5. Thermocouple and Temperature Display...................................................................... 12
6.6. Visual Inspection of ASU ............................................................................................. 12
7. TROUBLESHOOTING .............................................................................................................14
7.1. No ASU Power ............................................................................................................. 14
7.2. No RF Power Output .................................................................................................... 14
7.3. Error Codes ................................................................................................................... 15
7.4. Electromagnetic or Other Interference.......................................................................... 15
8. REPLACING FUSES .................................................................................................................17
8.1. Tools Needed ................................................................................................................ 17
8.2. Procedure ...................................................................................................................... 17
9. CLEANING AND DISINFECTING ........................................................................................18
9.1. ASU Cleaning and Disinfection Instructions................................................................ 18
9.2. Footswitch Cleaning and Disinfection Instructions...................................................... 18
10. ATRICURE CONTACT INFORMATION............................................................................18

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1. Introduction
This Service Manual is designed to provide instructions for the servicing of the AtriCure
Ablation and Sensing Unit (ASU). It is not a reference to surgical technique. A separate
manual, the “Ablation and Sensing Unit (ASU) User’s Manual,” is designed to provide
instructions for use.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Please read all information carefully. Failure to properly follow the instructions may lead to
serious consequences.
For the user’s convenience, the AtriCure Ablation and Sensing Unit will be referred to in
this Service Manual as the “ASU”. The AtriCure Bipolar Handpiece will be referred in this
Service Manual as the “Handpiece”.
This manual is intended as a Service Manual only. For a complete description of the ASU,
its controls, displays, indicators, tones and a sequence for its operation with the Handpiece
please refer to the User’s Manual. The User’s Manual also supplies other information of
importance to the user.
Do not operate the ASU before thoroughly reading the User’s Manual.
1.1. System Description
The system is comprised of the following:
•AtriCure Bipolar Handpiece with integral cable
•AtriCure Ablation and Sensing Unit (ASU)
•Footswitch
•Power cord

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2. Warnings and Precautions
The safe and effective use of RF energy is highly dependent upon factors under the
control of the operator. There is no substitute for a properly trained operating room
staff. It is important that the operating instructions supplied with the ASU be read,
understood and followed before use.
2.1. WARNINGS
•Fire Hazard: Electrosurgical accessories that are activated or hot from use can cause
a fire. Do not place them near or in contact with flammable materials.
•Fire Hazard: Do not use extension cords.
•Fire Hazard: To avoid igniting cleaning agents, use only non-flammable agents to
clean and disinfect the ASU. If flammable agents are inadvertently used on the
ASU, allow these substances to evaporate completely before operating.
•Trip Hazard: Standard care should be used to reduce the risk of tripping on the
Footswitch cable.
The voltage selector is factory set and should not be changed by the user. The voltage
selector and the power entry module must be set to the same voltage setting to prevent
ASU malfunction and potential instrument damage.
Electric Shock Hazard: Connect the ASU Power Cord to a properly grounded
receptacle. Do not use power plug adapters.
Electric Shock Hazard: Do not connect wet accessories to the generator.
Electric Shock Hazard: Ensure that the Handpiece is correctly connected to the ASU
and that no wires are exposed from the cable, connector or Handpiece.
2.2. PRECAUTIONS
•Do not disable the audible tone.
Do not remove the ASU cover, as there is a potential for electrical shock. Refer to
authorized personnel for service.
•Use only the Footswitch provided with the ASU.
•The Power Cord of the ASU must be connected to a properly grounded receptacle.
Extension cords and/or adapter plugs must not be used.
Do not wrap instrument cable around metal objects. Wrapping cables around metal
objects may induce hazardous currents.
•Failure of the ASU and Handpiece could result in unintended power output
increases.
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2.3. Responsibility of the Manufacturer
AtriCure is responsible for safety, reliability, and performance of the equipment only if:
•Installation procedures in the User’s manual are followed.
•Other than fuse replacement, only persons authorized by AtriCure carry out
modifications or repairs.
•The electrical installation of the relevant room complies with local codes and
regulatory requirements such as UL, IEC and BSI.
•The equipment is used in accordance with the AtriCure User’s Manual.
3. Technical specifications
3.1. RF Output
•Frequency: 460.8 kHz ±5%, Quasi-sinusoidal
•RF Power Output: Refer to the Power vs. Load Impedance output curve, Figure 1.
•RF Voltage Max: 57 Vrms ±10% (Device Code A, D, E, F, G, and H)
77.5 Vrms ±10% (Device Code B, C, J, K, and L)
3.2. Mechanical Specifications
•Size: 13″x 13.75″x 6″(32.5 cm x 34.4cm x 15 cm) maximum
•Weight: 15 lb. (9 kg) maximum
3.3. Environmental Specifications
•Operational temperature: 10oC to 40oC
•Storage temperature: –35°C to +60°C
•Humidity: 15% to 90% relative humidity
3.4. Electrical Specifications
•100V – 120V ~ 50/60 Hz
•220V – 240V ~ 50/60 Hz
3.5. Fuses
•100V – 120V, 220V – 240V, ~50 / 60 Hz
Replace fuses as marked:
1.25A/250V, T-lag, 5x20mm, UL Recognized, IEC Approved. AtriCure P/N C000322.
3.6. Footswitch Specifications
•Moisture protection rating: IPX8

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3.7. Power and Voltage Output Restrictions
•Power output is available over a 20Ω- 1,000Ωrange.
•The maximum power and voltage output,
Device Code Maximum Output Power Maximum Output Voltage
A 28.5 W at 114Ω57.0 Vrms
B 15.0 W from 26.3Ωto 400Ω77.5 Vrms
C 20.0 W from 31.3Ωto 300Ω77.5 Vrms
D 25.6 W at 127Ω57.0 Vrms
E 22.8 W at 143Ω57.0 Vrms
F 28.5 W at 114Ω57.0 Vrms
G 28.5 W at 114Ω57.0 Vrms
H 28.5 W at 114Ω57.0 Vrms
J 12.0 W from 20.0Ωto 500Ω77.5 Vrms
K 25.0 W from 39.1Ωto 240Ω77.5 Vrms
L 30.0 W from 46.9Ωto 200Ω77.5 Vrms
At other load impedances, the ASU will reduce the available power to comply with the
specified voltage and current limits. See Figure 1 and Figure2 below.
Note: Device code F is programmed into the STK1 test cable, which is displayed in
the upper right hand corner of the ASU screen.

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ASU2 & ASU3 POWER OUTPUT
0
5
10
15
20
25
30
0 100 200 300 400 500 600 700 800 900 1000 1100 1200
Load Impedance (Ohms)
Power (Watts)
Device Code A and F
Device Code H
Device Code G
Device Code D
Device Code E
Figure 1 – Power vs. Load (clamp algorithm)

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ASU2 & ASU3 POWER OUTPUT
0
5
10
15
20
25
30
35
0 100 200 300 400 500 600 700 800 900 1000 1100 1200
Load Impedance (Ohms)
Power (Watts)
Device Code L
Device Code K
Device Code B
Device Code C
Device Code J
Figure 2 – Power vs. Load (pen algorithm)
4. Theory of Operation
This unique system is not just another radio frequency generator. Using discreet field bi-
polar radio frequency, the AtriCure ASU delivers targeted ablative energy while
simultaneously measuring the change in conductive properties of the lesion as it is created.
The ASU produces and delivers RF energy, in a bipolar mode, at a frequency of
approximately 460 kHz, with a maximum power as indicated in Section 3.7. The
AtriCure ASU is designed to operate with the AtriCure Handpiece. The ASU and
Handpiece are designed for use without a neutral electrode. The Footswitch is the input
device used to activate RF energy delivery.

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5. Power on Self-Test
The ASU goes through a Power On Self Test (POST) every time the power switch is turned
on. The POST is software driven; it is a comprehensive test of the generators components. If
an Error is generated during this test, the ASU goes into FAULT Mode. This Mode is
entered upon detection of any unrecoverable error condition during any Mode of operation.
The system is inoperable in this Mode until the power is cycled off, then on.
At startup the Self-Test generates two quick beeps, the temperature display lights up, and
indicator lights come on. The operator must verify that the beeps are generated and that all
the temperature and indicator lights come on during the test.
Below is a comprehensive list of the tests that are performed during the Power On Self Test:
Power Measurement and Delivery Test:
This test connects an internal 350test load to the RF power generation circuit and
delivers 15 Watts into the test load.
The error codes are:
•Code P01: the measured power and the power set point differ more than 1.5
Watts,
•Code P02: the measured impedance and the test load impedance differ more
than 35Ω,
•Code P03: the measured voltage and the expected voltage differ more than 7
Volts,
•Code P04: the measured current through the test load and the expected current
differ more then 20 mA.
RF Watchdog Shutdown Test:
The RF Watchdog timer is tested by allowing it to timeout and shutoff the RF power.
•Code P05 is generated if the RF power is still ON after 500 ms without RF
Watchdog strobe.
ROM Test Error :
The ROM CRC is computed and verified against the pre-installed CRC and ensures the
ROM data integrity.
•Code P06 is generated if the computed CRC does not match the pre-installed
CRC.
RAM Test Error:
The entire RAM space is tested using the “walking bit pattern” test and ensures the
RAM addressing and data integrity.
•Code P07 is generated if the written data does not match the data read back.

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Configuration Register Error
•Code P08 is generated if a configuration register error is detected.
MCU COP Error
•Code P09 is generated if the COP watchdog timer expires.
Switch Stuck Test
•Code P10 is generated if the Footswitch is depressed during the POST.
Real Time Clock Test
•Code P11 is generated if the date and time of the Real Time Clock are not valid.
Reference Voltage Test
•Code P12 is generated if one of the three reference voltages is not with in a
given range when compared against the corresponding nominal voltage.

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6. Optional Performance Verification Procedure
The ASU does not have any customer serviceable parts. The manufacturer does not
require or recommend routine calibration/output verification.
As stated in Section 5, the ASU performs is own maintenance check every time it is
powered ON. The check is called the Power On Self Test (POST). This test is software
driven and is a comprehensive test of the generators components. No calibration is needed;
the unit will generate an unrecoverable error if further maintenance is needed.
If an organization determines that more system tests are required, then an optional
performance verification procedure can be performed per this section. The ASU should
perform as indicated; any deviation should be a cause for concern. These tests are optional,
but should be performed as indicated to insure accuracy.
6.1. Tools Needed
Tools needed to complete optional performance verification procedure:
•ASU Service Test Cable. Available through AtriCure. Part Number A000075.
•50, 100, and 200Load
•Oscilloscope, capable of reading both Voltage and Current
6.2. Indicators
These tests are to confirm that the indicator lights are functioning properly.
1. Plug in AC power cord into a grounded receptacle and power ON the ASU.
NOTE: Do not use extension cords or three-prong to two-prong adapters.
•The ASU will perform a Self-Test, the contents of which are covered in
Section 5 of this manual. The Self-Test generates two quick beeps at
startup. The operator must verify that the beeps are generated.
2. Plug in footswitch and Service Test Cable.
•The ready light will illuminate and temperature display will show a numerical
temperature reading.
3. Unplug footswitch.
•The ready will light turn off and temperature display will go blank.
4. Plug in footswitch.
•The ready light will turn on and temperature display will show a numerical
temperature reading.
5. Unplug Service Test Cable.
•The ready light will turn off and temperature display will go blank.
6. Plug in Service Test Cable.
•The ready light will turn on and temperature display will show a numerical
temperature reading.
7. Connect the 100to the RF electrode alligator clips on the Service Test Cable, and
depress the footswitch.
•The RF ON light will turn on and Constant medium-pitched tone will sound.
8. Deactivate the footswitch.
•The RF ON light will turn off.

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6.3. Power Output
This test is to confirm the ASU is putting out the correct power.
NOTE: It is assumed that the one performing these tests has a basic knowledge of how to
operate the Oscilloscope in use. The accuracy of the measurement will vary with the test
equipment used.
1. With footswitch and Service Test Cable plugged in and the ASU in STANDBY, connect
the load impedance of interest as identified below to the Service Test Cable.
2. Place the Voltage leads from the Oscilloscope on either side of the load impedance.
3. (Optional) Clip the Current lead from the Oscilloscope on to either of the RF wires
connected to the banana jacks.
4. Depress the footswitch and take the Voltage and Current readings from the
Oscilloscope.
5. Using the Voltage and/or Current measurements calculate the power output using
P=I2Ror P=IV or P=V2/R
Device
Code
Load
Impedance
Power
Output
Measured
Current
Measured
Voltage
5015.0W 0.55A 27.4VA
10025.0W 0.50A 50.0V
500.55A 27.4VB
10015.0W 0.39A 38.7V
500.63A 31.6VC
20020.0W 0.32A 63.2V
5012.0W 0.49A 24.5VD
10020.3W 0.45A 45.0V
5010.0W 0.45A 22.4VE
10016.0W 0.40A 40.0V
5015.0W 0.55A 27.4VF
10025.0W 0.50A 50.0V
5015.0W 0.55A 27.4VG
10025.0W 0.50A 50.0V
5015.0W 0.55A 27.4VH
10025.0W 0.50A 50.0V
500.45A 22.4VJ
20010.0W 0.22A 44.7V
500.71A 35.4VK
20025.0W 0.35A 70.7V
500.77A 38.8VL
20030.0W 0.39A 77.5V

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6.4. Errors and Fault Mode
These tests are to confirm that errors are being detected properly.
6.4.1. Error Generation Test
1. With footswitch and service test cable plugged in and no load connected to cable, turn
on the ASU.
2. Depress the foot switch.
•This will cause the ASU to go into ERROR mode.
•“Replace Handpiece” and Code E02 will appear at the lower left corner of the
display screen and a Constant low-pitched tone will sound.
3. Turn Off the ASU.
6.4.2. Fault Generation Test
1. Depress the footswitch.
2. Turn On the ASU.
•This will cause the ASU to go into FAULT mode.
•FAULT and Code P10 will appear at the lower left corner of the display screen
and a rapid succession of low-pitched beeps will sound for a two second
duration.
3. Deactivate the footswitch and turn the ASU off and then back on again.
•This resets the ASU and puts it back into STANDBY mode.
6.5. Thermocouple and Temperature Display
These tests are to confirm the Thermocouple and the Temperature display are functioning
properly.
NOTE: Do not depress the footswitch at any time during this test. Doing so may result in
injury.
1. A thermocouple is embedded in the cable near the terminal box. With footswitch and
Service Test Cable plugged in and the ASU in STANDBY, gently warm the
thermocouple by placing your hand directly over the shrink sleeve of the Test Cable
near the terminal box. Other means of gently warming the thermocouple may also be
effective.
•The temperature display will show an increase in temperature as your hand warms
the thermocouple.
2. Release the shrink sleeve.
•The temperature display will show a decrease in temperature as the thermocouple
approaches room temperature.
6.6. Visual Inspection of ASU
These tests confirm that the external components of the ASU are functioning properly.
1. Inspect the connectors for the Footswitch and Handpiece.
•Connectors should not be damaged or cracked and should latch when plug is
inserted.

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2. Do a visual inspection of the Footswitch and electrical power cords.
•Cords should not be frayed or damaged and electrical power cords should have
proper grounding.
3. Verify that the ASU is stable when placed on a flat level surface.
4. Inspect the carrying handle and confirm its ability to latch and rotate.
5. Inspect the LCD display and confirm that it is not cracked or damaged.

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7. Troubleshooting
Use the following sections to help troubleshoot possible problems with the ASU.
7.1. No ASU Power
If the ASU does not Power ON, confirm that the ASU is firmly plugged into a grounded
receptacle. Verify that the ON/OFF switch is in the ON position.
NOTE: Do not use extension cords or three-prong to two-prong adapters. The power cord
assembly should be periodically checked for damaged insulation or connectors.
If the lack of ASU Power persists, replace the fuses using the instructions in Section 8.
7.2. No RF Power Output
If there is no RF power output, attempt to correct this problem using the checklist below.
Possible Cause Solution
ASU not turned on Turn power on
ASU not plugged in Confirm electrical connections and then turn power on
No Handpiece connected Connect Handpiece
No Footswitch connected Connect Footswitch
ASU in FAULT mode Turn Power off and then on
ASU in STANDBY mode Ensure that Handpiece and Footswitch are properly connected
Broken Handpiece cable Replace Handpiece
Fault in Footswitch Replace Footswitch
Fault in Handpiece Replace Handpiece
Internal ASU failure Contact AtriCure Technical Support
If the lack of ASU RF power output persists, contact AtriCure Technical Support.

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7.3. Error Codes
If a fault condition should occur, the numeric displays on the front panel will display an
error code. If an Error Code of E07 through E09, PO1 through P11, or F01 through F14
appears, try turning the ASU power off, then on. If the problem persists, contact AtriCure
Technical Support.
Use the table below to attempt to resolve the following recoverable application errors.
LCD DISPLAY MESSAGE DESCRIPTION SOLUTION
Replace Handpiece H01 Invalid Handpiece Version Replace Handpiece
Replace Handpiece H02 Time Expired Error: The Handpiece
expiration date has been exceeded Replace Handpiece
Replace Handpiece H03 Handpiece Electrical Problem Replace Handpiece
Replace Handpiece H04 Invalid Handpiece Version Replace Handpiece
Check Electrodes E01 Low Impedance Error:
Handpiece electrodes touch Check Electrodes or reposition jaws
Close Jaws E02 High Impedance Error:
Handpiece jaws are open Close Handpiece Jaws
Check Electrodes E03 Low Impedance Error:
Handpiece electrodes touch Check Electrodes or reposition jaws
Check Electrodes E04 Low Impedance Error:
Handpiece electrodes touch Check Electrodes or reposition jaws
HiTemp or Handpiece E05 Open or defective thermocouple, or
high sensor temperature Replace Handpiece, or wait for temperature to
drop below 75˚C
Check Footswitch E06 Switch Stuck Test Error Replace Footswitch
Check Footswitch P10 Footswitch closed at power up Check Footswitch
7.4. Electromagnetic or Other Interference
The ASU has been tested and found to comply with the limits for medical devices in
IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation.
The ASU generates and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in the
vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If the ASU does cause harmful interference to other devices, which can be
determined by turning the ASU off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•Reorient or relocate the receiving device(s).
•Increase the separation between the ASU and the receiving device(s).
•Connect the ASU into an outlet on a circuit different from that to which the
receiving device(s) are connected.

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•Contact AtriCure Technical Support for help.
Use the following sections to troubleshoot specific types of interference, including monitor
(display) interference, neuromuscular stimulation, and pacemaker interference.
7.4.1. Monitor (Display) Interference
7.4.1.1. Continuous Interference
1. Check the Power Cord connections for the ASU.
2. Check all other electrical equipment in the operation room for defective
grounds.
3. If the electrical equipment is grounded to different objects, rather than a
common ground, voltage differences can appear between the two-
grounded objects. The monitor may respond to these voltages. Some
types of input amplifiers can be balanced to achieve optimum common
mode rejection and may possibly correct the problem.
7.4.1.2. Interference Only When ASU is Activated
1. Check all connections to the ASU, and active accessory to look for
possible metal-to-metal sparking.
2. If interference continues when the ASU is activated and while the
electrode is not in contact with the patient, the monitor is responding to
radio frequencies. Some manufacturers offer RF choke filters for use in
the monitor leads. These filters reduce interference while a generator is
activated. RF filters minimize the potential for an electrosurgical burn at
the site of the monitor electrode.
3. Check that the ground wires in the operating room are electrically
consistent. All ground wires should go to the same grounded metal with
wires that are as short as possible.
4. If the above steps do not remedy the situation, contact AtriCure Technical
Support to arrange evaluation of the ASU.
7.4.2. Neuromuscular Stimulation
1. Stop the surgery.
2. Check all connections to the ASU and active electrodes to look for a possible
metal-to-metal spark.
3. If no problems are found, contact AtriCure Technical Support to arrange
evaluation of the ASU for abnormal 50/60 Hz AC leakage current.
7.4.3. Pacemaker Interference
1. Check all connections.
2. Always monitor pacemaker patients during surgery.
3. Always keep a defibrillator available during electrosurgery on patients with
pacemakers.
4. Consult the pacemaker manufacturer for specific recommendations.

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8. Replacing Fuses
If the ASU does not Power ON and you have gone through the Troubleshooting Section 7.0
of this manual, replace the fuses. There are no other user replaceable parts.
8.1. Tools Needed
Tools needed to complete Replacement of the Fuses:
•Small flat headed screwdriver.
•Two (2) fuses. Available through AtriCure. Part Number C000322 or as described
under Section 3.5.
8.2. Procedure
The ASU unit has been pre-set at the factory to either 110V – 120V or 220V – 240V. The
Input Voltage Selector Switch on the back panel of the ASU indicates the selected Input
Voltage for this unit. The operator should not adjust The Input Voltage Selector Switch.
This setting should only be adjusted by the manufacturer or by an authorized AtriCure
technical service representative.
NOTE: ASU should be powered off and unplugged before continuing with the fuse
replacement procedure.
1. Determine the voltage selected for this unit by looking at the Input Voltage Selector
Switch. The voltage that has been selected will be indicated by a dot above the
voltage.
2. Note the orientation of the two voltages written on the back of the fuse box before
removing it. The one that is on the lower right, indicated with an arrow, should
correspond with the voltage indicated by the Input Voltage Selector Switch.
3. Insert the Screw Driver into the access strip along the top seam of the fuse box. Use
this to pry the fuse box from the power entry module on the back panel of the ASU.
4. Replace the (2) two fuses located in the fuse box. Make sure the fuses are lined up
straight.
5. Line up the fuse cartridge so the voltage on the fuse box that is pointing down at the
indication arrow in the lower right corresponds with the Input Voltage for this unit.
6. Put fuse box back into power entry module.
7. Confirm operational status by plugging in the ASU and powering it up. Check to see
that the self-test is completed without errors.

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9. Cleaning and Disinfecting
9.1. ASU Cleaning and Disinfection Instructions
Use a mild detergent and damp cloth to clean the ASU cover, front panel, and power cable.
The ASU cannot be sterilized. Do not allow fluids to enter the chassis. The ASU may be
disinfected using a standard hospital alcohol solution applied with a cloth.
NOTE: Do not spray or pour liquids directly on the unit.
WARNING: To avoid igniting flammable vapors, use only non-flammable agents to
clean and disinfect the ASU. If flammable agents are inadvertently used on the ASU,
allow these substances to evaporate completely before operating.
9.2. Footswitch Cleaning and Disinfection Instructions
Use a mild detergent (prepared to the manufacturer’s specifications) and a damp cloth to
clean the exterior of the Footswitch and cord. Do not allow fluids to enter the chassis. Take
care not to wet the electrical connector on the cable. Do not use caustic, corrosive, or
abrasive cleaning materials. The Footswitch cannot be sterilized. The Footswitch may be
disinfected using a standard hospital alcohol solution applied with a cloth.
10. AtriCure Contact Information
If further assistance is needed, please contact AtriCure Technical Support.
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