AtriCure ASU2-115 Ablation and Sensing Unit User Manual
- June 10, 2024
- AtriCure
Table of Contents
AtriCure ASU2-115 Ablation and Sensing Unit
ABLATION AND SENSING UNIT (ASU)
USER’S MANUAL
Model ASU2-115 Model ASU3-230
AtriCure Incorporated 7555 Innovation Way Mason, Ohio 45040 USA Customer
Service: 1-866-349-2342 (toll free)
1-513-755-4100 (phone) P000463 Rev. H |
2022/07
USER’S MANUAL
Getting Started
This manual, and the equipment, it describes are for use only by qualified
medical professionals trained in the particular technique and surgical
procedure to be performed.
Federal Law (US) 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 surgical consequences.
Important: This manual is designed to provide instructions for use of the
AtriCure Ablation and Sensing Unit (ASU) with the AtriCure Bipolar Handpiece
(Isolator clamp, Isolator Transpolar pen, or CoolRail linear pen) and AtriCure
Accessory Devices (ASB 3). It is not a reference to surgical technique.
The AtriCure ASU produces and delivers RF energy, in a bipolar mode, at a
frequency of approximately 460 kHz, with a maximum output power ranging from
22.8 Watts up to 28.5 Watts for the Isolator clamps, 12.0 Watts up to 30.0
Watts for the Isolator Transpolar pen or CoolRail linear pen devices depending
on the mode of operation The AtriCure ASU is capable of producing a maximum
output power of 32.5 Watts under a 100 Ohm load, although no current AtriCure
Bipolar Handpiece uses power above 30 Watts. The operating mode is a function
of the handpieces or pen and is set by the ASU. The AtriCure ASU is designed
to operate only with an AtriCure Bipolar Handpiece, AtriCure Isolator Pen, or
AtriCure CoolRail linear pen. The Footswitch is the input device used to
activate RF energy delivery. Please refer to the handpiece and pen
Instructions for Use for complete description of the indications and use of
these devises.
For the user’s convenience, the AtriCure Ablation and Sensing Unit will be
referred to in this User’s Manual as the “ASU”. The AtriCure Bipolar Handpiece
will be referred in this User’s Manual as the “Handpiece”.
This User’s Manual provides a description of the ASU, its controls, displays,
indicators, tones and a sequence for its operation with the Handpiece. This
User’s Manual also supplies other information of importance to the user. This
manual is intended as a User’s Manual only. Do not operate the ASU before
thoroughly reading this manual.
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1.1. System Description As shown in Figure 1, the system is comprised of the following: · AtriCure Bipolar Handpiece with integral cable (not shown) · AtriCure Ablation and Sensing Unit (ASU) · Footswitch · Power cord. Accessory devices are described in paragraph 10.
Figure 1 ASU, Footswitch, and Power Cord
1.2. Unpacking Lift the ASU, Footswitch, and Power Cord from the box and
remove the protective wrapping. It is recommended that the original shipping
box and protective wrapping be saved for future storing and/or transporting of
the device.
1.3. 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.
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USER’S MANUAL
WARNINGS
· Do not operate the ASU before thoroughly reading this manual.
· Do not use electrosurgical equipment unless properly trained to use it in
the specific procedure being undertaken. This manual, and the equipment, it
describes are for use only by qualified medical professionals trained in the
particular technique and surgical procedure to be performed.
· Do not use this device 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.
· Do not use this device in oxygen-enriched atmospheres, nitrous oxide (N2O)
atmospheres, or in the presence of other oxidizing agents.
· 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 (such as gauze or surgical drapes). Avoid igniting endogenous gases.
· 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.
· Contact of the Handpiece with any metal (such as hemostats, clamps, staples,
etc.) can result in unintended burn injuries.
· When not using the Handpiece, place it in a clean, dry nonconductive, and
highly visible area not in contact with the patient. Inadvertent contact by an
active Handpiece with the patient may result in burns.
· When the ASU is activated, the conducted and radiated electrical fields may
interfere with other electrical medical equipment. Refer to Section 5 for more
information regarding potential electromagnetic or other interference, and
advice regarding avoidance of such interference.
· Electrosurgery should be used with caution in the presence of internal or
external pacemakers. Interference produced with the use of electrosurgical
devices can cause devices such as a pacemaker to enter an asynchronous mode or
can block the pacemaker entirely. Consult the pacemaker manufacturer or
hospital Cardiology department for further information when use of
electrosurgical appliances is planned in patients with cardiac pacemakers.
· Trip Hazard: Standard care should be used to reduce the risk of tripping on
the Footswitch cable.
· The use of accessories, transducers and cables other than those specified in
accordance with the instructions or supplied by AtriCure, may result in
increased emissions or decreased immunity of the equipment.
· The ASU should not be used adjacent or stacked with other equipment, except
for intended stacking with AtriCure’s equipment in accordance with the
instructions. The ASU normal use configuration should be observed to verify
normal operation.
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· 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.
PRECAUTIONS
· Use only with the AtriCure Handpieces intended for use with the ASU.
· Do not activate the ASU until the Handpiece is properly positioned in the
patient.
· The activation tone and indicator are important safety features. Do not
obstruct the activation indicator. Ensure that the activation tone is audible
to personnel in the operating room prior to use. The activation tone alerts
personnel when the Handpiece is active. Do not disable the audible tone.
· Do not remove the cover of the ASU 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.
· To avoid shock, do not allow patients to come into contact with earth metal
parts of the ASU. The use of antistatic sheeting is recommended.
· Studies have shown that smoke generated during electrosurgical procedures
can be potentially harmful to surgical personnel. These studies recommend
using surgical masks and adequately ventilating the smoke by using a surgical
smoke evacuator or other means.
· When the ASU and Handpiece are used on a patient simultaneously with
physiological monitoring equipment, ensure that the monitoring electrodes are
placed as far as possible from the surgical electrodes. Be sure to position
the Handpiece cables so that they do not come in contact with the patient or
the other leads.
· Needle monitoring electrodes are not recommended for use when operating the
ASU and Handpiece.
· Monitoring systems that incorporate high frequency current-limiting devices
are recommended for use with the ASU and Handpiece.
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USER’S MANUAL
· Failure of the ASU and Handpiece could result in unintended power output
increases.
1.4. EMC Guidance and Manufacturer’s Declaration
1.4.1. Electromagnetic Requirements
The AtriCure Ablation and Sensing Unit (ASU) has been tested and found to
comply with the limits for medical devices in IEC 60601-1-2:2007. These limits
are designed to provide reasonable protection against harmful interference in
a typical medical installation.
The ASU can radiate radio frequency energy and, if not installed, used, and serviced in accordance with electromagnetic compatibility information provided in the instructions, may cause harmful interference to other devices in the vicinity.
Portable and mobile RF communications equipment can also affect ASU performance and care should be taken to minimize such interference. 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.
· Increase the separation between the ASU and the other devices.
· Connect the ASU into an outlet on a circuit different from that to which the
other device(s) are connected.
· Contact the AtriCure service representative for help.
1.4.2. Electromagnetic Emissions
Guidance and manufacturer’s declaration electromagnetic emissions
The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified below. The customer or the user of the ASU unit should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment guidance
RF emissions CISPR 11
Group 1
The ASU unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Class A Class A
The ASU unit is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Complies
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1.4.3. Electromagnetic Immunity
Guidance and manufacturer’s declaration electromagnetic immunity
The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified below. The customer or the user of the ASU unit should assure that it is used in such an environment.
IMMUNITY test
Electrostatic discharge (ESD) IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input
lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
IEC 60601 test level
Compliance level
± 6 kV contact
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<5 % UT (>95 % dip in UT) for 0,5 cycle
± 1 kV for input/output lines ± 1 kV differential mode
± 2 kV common mode <5 % UT (>95 % dip in UT) for 0,5 cycle
40 % UT (60 % dip in UT) for 5 cycles
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
70 % UT (30 % dip in UT) for 25 cycles
<5 % UT (>95 % dip in UT) for 5 s
<5 % UT (>95 % dip in UT) for 5 s
3 A/m
3 A/m
Electromagnetic environment guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital
environment.
Mains power quality should be that of a typical commercial or hospital
environment.
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the ASU unit requires continued operation during
power mains interruptions, it is recommended that the ASU unit be powered from
an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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1.4.4. EMC Guidance and Manufacturer’s Declaration
Guidance and manufacturer’s declaration electromagnetic immunity
The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified below. The customer or the user of the ASU should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 TEST LEVEL
Compliance level
Electromagnetic environment guidance
Portable and mobile RF communications equipment should be used no closer to
any part of the ASU, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter.
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
Recommended separation distance d = 1.2 P
Radiated RF IEC 3 V/m
61000-4-3
80 MHz to 2.5 GHz
3 V/m
d = 1.2 P 80 MHz to 800 MHz
d = 2.3 P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,a should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects,
and people.
a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the ASU is used exceeds the
applicable RF compliance level above, the ASU should be observed to verify
normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the ASU.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
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1.4.5. Recommended Separation Distance
Recommended separation distances between portable and mobile RF communications
equipment and the AtriCure Ablation and Sensing Unit
The AtriCure Ablation and Sensing Unit (ASU) is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the ASU can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ASU as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz d = 1.2 P
80 MHz to 800 MHz d = 1.2 P
800 MHz to 2.5 GHz d = 2.3 P
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
1.5. Responsibility of the Manufacturer AtriCure is responsible for safety, reliability, and performance of the equipment only if: · Installation procedures in this manual are followed. · 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 IEC and BSI. · The equipment is used in accordance with the AtriCure User’s Manual.
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USER’S MANUAL
2. The AtriCure Ablation and Sensing Unit (ASU) This section provides a
detailed description of the ASU including its function and operating features.
2.1. Device Description The AtriCure ASU produces and delivers RF energy, in a
bipolar mode, at a frequency of approximately 460 kHz, with a maximum output
power ranging from 12 Watts up to 30 Watts depending on the operating mode.
The AtriCure ASU is capable of producing a maximum output power of 32.5 Watts
under a 100 Ohm load although no current AtriCure Bipolar Handpiece uses power
above 30 Watts. The operating mode is a function of the handpiece and is set
by the ASU. 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.
2.2. ASU Front Panel Illustration and Nomenclature An illustration of the
ASU front panel is shown in Figure 2, below.
Figure 2 ASU Front Panel
1. Tissue Conductance/ Power Graph Display 2. Ready Indicator 3. RF ON
Indicator
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5. Transmurality Indicator 6. Fault Indicator 7. Power Indicator 8. Handle
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4. Handpiece Receptacle
9. Handle Adjustment Knobs
Front Panel Displays
There is one display on the front panel of the ASU: the Tissue Conductance /
Power Graph Display. This display is described below.
Display
Description
Tissue Conductance Graph Display Isolator clamp (Default):
During the ablation cycle the ASU displays a graph of tissue conductance
(Current/Voltage) versus Time. The y-axis is Tissue Conductance and the x-axis
is Time.
When the Footswitch is disconnected or reconnected, the display of the tissue
conductance graph is not affected. Refer to Section 4.4.3.
Power Graph Display Isolator Transpolar pen or CoolRailTM linear pen:
During the ablation cycle the ASU displays a graph of power (Current ×
Voltage) versus Time. The y-axis is Power and the x-axis is Time.
When the Footswitch is disconnected or reconnected, the display of the power
graph is not affected. Refer to Section 4.4.3.
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Front Panel Indicators Indicator
Front Panel Receptacle Receptacle
Description
POWER Indicator A Green LED indicates that the AC power is present and the
ASU has been switched on.
FAULT Indicator This Red lamp indicates that a fault has occurred and
requires that the power be cycled.
READY Indicator This Green lamp indicates that the Footswitch and Handpiece
are connected and the ASU is ready for use
RF ON Indicator A Blue LED indicates that RF power is being output to the
Handpiece.
The RF power output is initiated by pressing the Footswitch.
TRANSMURALITY Indicator A Blue flashing LED indicates that the Transmurality
Algorithm has been satisfied indicating that the user may terminate the
ablation cycle.
Description
HANDPIECE or ASU Accessory Receptacle This 12-pin receptacle accepts the
AtriCure Handpiece or connection cable to an accessory device. This connection
is patient-isolated.
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2.3. ASU Rear Panel Illustration and Nomenclature An illustration of the ASU
rear panel is shown in Figure 3, below.
Product Labeling
Figure 3 ASU Rear Panel
1. Data Port 2. Speaker Volume Control 3. Power Entry Module 4. Fuse Box
5. Equipotential Ground Stud 6. Input Voltage Selector Switch 7. Footswitch Receptacle 8. Service Access
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Rear Panel Functions Graphic
Description Equipotential Ground Stud Provides a means of
securely linking the earth grounds of the AtriCure ASU to other grounded
equipment.
Data Port For manufacturing and test purposes.
Power Entry Module This module contains both the ON/OFF switch and the
fuses. The voltage is selected by the orientation of the fuse drawer as
marked.
Fuse Box The Fuse Box contains fuses selected for the input voltage. See
Technical Specifications in Section 7 of this manual.
Input Voltage Selector Switch The input voltage selector switch is pre-set
at the factory to either 110V or 220V and should not be adjusted by the
operator. This setting should only be adjusted by the manufacturer or by an
authorized service representative.
Speaker Volume Control The audible volume level is adjustable via a rotary
dial.
The ASU includes a speaker for producing audible feedback to the user.
Footswitch Receptacle This receptacle accepts the Footswitch connector. The
single momentary actuation pedal provides for the activation of RF power
output.
Service Access For manufacturing and test purposes.
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3. Installing the ASU Inspect the ASU for any signs of physical damage to the
front panel, chassis or cover.
NOTE: If any physical damage is found, DO NOT USE THE UNIT. CONTACT AtriCure
for a replacement.
All returns must be approved by AtriCure.
3.1. Transporting the ASU The handle may be used to carry the ASU. To change
the positioning of the handle, depress both handle adjustment knobs
simultaneously and move the handle to the desired location. Do not change the
handle position when a Handpiece or Accessory Device is connected to the
Handpiece receptacle.
3.2. Adjusting the Viewing Angle To change the viewing angle of the ASU
Conductance Graph Display, adjust the handle position using the directions in
Section 3.1., above.
3.3. Preparing the ASU For Use The ASU may be placed on a mounting cart or on
any sturdy table or platform. It is recommended that carts have conductive
wheels. Refer to hospital procedures or local codes for detailed information.
Provide at least four to six inches of space around the sides and top of the
ASU for convection cooling. Under continuous use for extended periods of time,
it is normal for the top and rear panel to be warm.
3.4. Power Cord The ASU is shipped with an approved hospital grade power cord.
Plug the ASU into a grounded receptacle.
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.
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3.5. Connecting and Disconnecting the Handpiece Connect the Handpiece directly
to the ASU. Insert the Handpiece cable connector into the receptacle on the
front panel of the ASU, ensuring that the arrow symbol on the connector is
facing upward and oriented to the arrow symbol on the ASU receptacle.
NOTE: Typically, you will connect the Handpiece to the ASU when the ASU has
been powered up and is in STANDBY operating mode (see Section 4.2 regarding
the STANDBY mode). However, the Handpiece may be connected when powered up, or
prior to powering up the ASU.
NOTE: Once you have connected the Handpiece, it cannot be disconnected from
the ASU by pulling on the cable. To disconnect the Handpiece, pull back on the
cable connector body and remove it from the ASU receptacle.
NOTE: Refer to the Handpiece instruction sheet for more detailed information
about connecting the Handpiece to the ASU in a sterile environment.
3.6.Installing the Footswitch
3.6.1. Inspect the Footswitch Inspect the Footswitch for any signs of physical
damage to the cable and connector. If physical damage is found or the
Footswitch does not perform within specification, notify AtriCure. All returns
must have approval from AtriCure.
3.6.2. Connecting and Disconnecting the Footswitch With the connector
alignment arrow in the 12 o’clock position, push the Footswitch Connector into
the Footswitch Receptacle on the rear panel of the ASU, shown in the Figure 4.
NOTE: Typically, you will connect the Footswitch to the ASU when the ASU has
been powered up and is in STANDBY operating mode (see Section 4 regarding the
STANDBY mode). However, the Footswitch may be connected when powered up, or
prior to powering up the ASU.
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Product Labeling
Figure 4 Connecting the Footswitch to the ASU 3.6.3. Preparing the
Footswitch for Use
The Footswitch should be placed on a flat floor. It is recommended that the
area near the Footswitch be kept dry to reduce the risk of slippage.
Appropriate precautions should be taken to ensure that the cable connecting
the Footswitch to the ASU does not create a hazard in the operating room.
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Instructions For Use
Powering Up the ASU
1. Ensure that the ASU has been plugged into a grounded receptacle. 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.
2. Turn the power on using the ON/OFF switch located on the power entry
module on the rear panel. When power is turned on; the system performs the
System Self-Tests. See Figure 5. If all Self-Tests pass, the system
transitions to the STANDBY mode. If any Self-Test fails, the system
transitions to the FAULT mode. The Self-Test generates two quick beeps at
startup. The operator must verify that the beeps are generated. NOTE: Refer to
Section 4.2., below, for a full description of the STANDBY and FAULT modes, as
well as all the other operating modes.
Figure 5 Display Indicating SELF-TEST
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4.2. Operating Modes
The ASU operates in one of five modes: STANDBY, READY, RF ON, ERROR and FAULT
modes. These modes are shown on the lower left corner of the Conductance
Display Graph. See Figure 6, below.
· STANDBY Mode This mode is entered automatically after the ASU is
successfully turned on or from READY Mode upon detection of a Handpiece or
Footswitch disconnection. The LCD display message indicates the system is in
the STANDBY Mode.
· READY Mode This Mode is entered upon connecting both Handpiece and
Footswitch while in the STANDBY Mode or from the ON Mode if the Footswitch has
been depressed and released. The LCD display message indicates the system is
in the READY Mode.
· RF ON Mode This Mode is entered when the Footswitch is depressed while in
the READY Mode. The system transitions from the RF ON Mode to the READY Mode
upon 40-second time expiration or if the Footswitch is released.
· ERROR Mode This Mode is entered upon detection of any recoverable error
conditions during any Mode excluding the FAULT Mode. The system displays the
corresponding error message, and upon Footswitch release, transitions to the
READY Mode.
· FAULT Mode This Mode is entered upon detection of any unrecoverable error
condition during any Mode. The system is inoperable in this Mode until the
power is cycled off, then on.
Figure 6 Conductance and Power Display Graph Indicating STANDBY Mode
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4.3. Audio Tones
The ASU uses 5 possible audio tones during its operation: Start Tone, Error Tone, Fault Tone, RF ON Tone, and the Transmurality Tone, You may control the volume of these tones using the Speaker Volume Control on the rear panel of the ASU (See Figure 3). Each of these 5 audio tones is described below.
Tone Name Start Tone Error Tone Fault Tone RF ON Tone
Transmurality Tone
Tone Description Two quick beeps
Constant low-pitched tone Rapid succession of low-pitched beeps for 2 seconds
duration Constant mediumpitched tone
Varying mediumpitched tone
Intermittent mediumpitched tone
Meaning for Operator: This tone is generated when the power switch is placed
in the “ON” position. This tone occurs while an error is present.
This tone occurs upon entering a fault mode.
This tone is generated when RF energy is being delivered to the Isolator
clamp. This tone has a higher pitch than the Error tone. A discrete,
decrementing tone in 10 second intervals is generated when RF energy is being
delivered to the Isolator Transpolar pen. This tone has a higher pitch than
the Error tone. This tone is generated in the RF ON mode when Transmurality is
achieved. The Transmurality tone will continue, and RF energy will continue to
be applied, until the Footswitch is released or until 40 seconds has elapsed.
This function is not applicable to the Isolator Transpolar pen.
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4.4. Delivering RF Energy
4.4.1. Connect the Handpiece and Footswitch Connect the Handpiece and
Footswitch as described in Sections 3.5. and 3.6.,and note the display to
ensure connections are made. The display screen and Ready Indicator of the ASU
should indicate that the RF generator is in the READY mode. See Figure 7.
Figure 7 Tissue Conductance Display Graph Indicating READY Mode for Isolator
Handpieces(above) and Power Display Graph for Isolator Transpolar pen and
CoolrailTM linear pen device (below).
NOTE: When the READY mode is entered from the RF ON mode, the previous plot is
shown.
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4.4.2. Position the Handpiece To position the Handpiece, follow the
Instructions for Use provided with the Handpiece.
4.4.3. Deliver RF Energy Press the Footswitch to initiate RF energy output. RF
energy output is terminated by releasing the Footswitch or at the end of 40
continuous seconds of energy delivery. The display screen of the ASU will
indicate that the generator is in the RF ON mode. See Figures 8 and 9.
During the Isolator clamp operation, a real-time graph of measured tissue
conductance is displayed on the LCD graphics screen with a +/- 20% tolerance.
Using measurements of conductance, the ASU will determine when a transmurality
condition has been achieved.
When this condition has been achieved, the Blue Transmurality indicator will
flash and the audible tone emitted from the ASU will change from constant to
intermittent, thus signaling to you that transmurality has been achieved. If
you do not release the Footswitch within 40 seconds, the system will
automatically time-out and stop the ablation.
Figure 8 Conductance Display Graph Indicating RF ON Mode
With the Isolator Transpolar pen and CoolrailTM linear pen, a real-time graph
of measured power delivered to the tissue is displayed on the LCD graphics
screen with a +/20% tolerance. The ASU will not indicate when a transmurality
condition has been achieved in this mode. Furthermore, if you do not release
the Footswitch within 40 seconds, the system will automatically time-out and
stop the ablation.
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Figure 9 Power Display Graph Indicating RF ON Mode
Both the conductance and the power graphs are on a 20-second scale. In some
cases, the transmurality condition will not be achieved within the 20 seconds
shown on the Tissue Conductance Display Graph (not valid for Isolator
Transpolar pen device or CoolrailTM linear pen). In such cases, the Graph will
wrap to a second screen, which will display a continuation of the conductance
for a maximum of 20 additional seconds. Figure 10, below, shows an example of
this wrapping feature for an ablation requiring more than 20 seconds.
Similarly, for the Isolator Transpolar pen and CoolrailTM linear pen the power
graph will wrap to a second screen for ablations lasting longer than 20
seconds for a maximum of 20 additional seconds.
Figure 10 Display Graph Wraps For An Ablation Lasting More Than 20 Seconds
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Troubleshooting
Use the following sections to help troubleshoot possible problems with the ASU.
5.1. No RF Power Output If there is no RF power output, attempt to correct this problem using the checklist below.
Possible Cause ASU not turned on ASU not plugged in No Handpiece connected No Footswitch connected ASU in FAULT mode ASU in STANDBY mode Broken Handpiece cable Fault in Footswitch Fault in Handpiece Internal ASU failure
Solution Turn power on Confirm electrical connections and then turn power on Connect Handpiece Connect Footswitch Turn Power off and then on Ensure that Handpiece and Footswitch are properly connected Replace Handpiece Replace Footswitch Replace Handpiece Contact AtriCure Customer Service
If the lack of ASU RF power output persists, contact the AtriCure service representative.
5.2. Error Codes
If a fault condition should occur, the Power Graph display on the front panel
will display an error code. If an Error Code of E07 through E09, P01 through
P10, P12 or F01 through F14 appears, try turning power off, then on. If the
problem persists, contact AtriCure Customer Service.
Use the table below to attempt to resolve the following recoverable application errors.
LCD DISPLAY MESSAGE Replace Handpiece H01
DESCRIPTION Invalid Handpiece Version
SOLUTION Replace Handpiece
Replace Handpiece H02 Replace Handpiece H03 Replace Handpiece H04 Check Electrodes E01 Close Jaws E02 Check Electrodes E03 Check Electrodes E04 Replace Handpiece E05
Time Expired Error: The Handpiece expiration date has been exceeded
Handpiece Electrical Problem
Invalid Handpiece Version
Low Impedance Error: Handpiece electrodes are shorted
High Impedance Error: Handpiece jaws are open
Low Impedance Error: Handpiece electrodes are shorted
Low Impedance Error: Handpiece electrodes are shorted
Open or defective thermocouple
Replace Handpiece
Replace Handpiece Replace Handpiece Check Electrodes or reposition jaws Close
Handpiece Jaws
Check Electrodes or reposition jaws Check Electrodes or reposition jaws
Replace Handpiece
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LCD DISPLAY MESSAGE Check Footswitch E06
Check Electrodes E10
Check Footswitch P10
DESCRIPTION Switch Stuck Test Error: Footswitch closed while connecting
Handpiece electrodes are shorted
Footswitch closed at power up
SOLUTION Replace Footswitch
Check electrodes or reposition jaws Check Footswitch
5.3. Electromagnetic or Other Interference The ASU has been tested and found
to comply with the limits for medical devices in IEC 60601-12:2001. 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.
· Increase the separation between the ASU and the other devices.
· Connect the ASU into an outlet on a circuit different from that to which the
other device(s) are connected.
· Contact the AtriCure service representative for help.
Use the following sections to troubleshoot specific types of interference,
including monitor (display) interference, neuromuscular stimulation, and
pacemaker interference.
5.3.1. Monitor (Display) Interference
5.3.1.1. 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.
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5.3.1.2. 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, qualified service
personnel should check the ASU.
5.3.2. Neuromuscular Stimulation
1. Stop the surgery.
2. Check all connections to the ASU and active electrodes to look for a
possible metal-tometal spark.
3. If no problems are found, the ASU should be checked by qualified service
personnel for abnormal 50/60 Hz AC leakage current.
5.3.3. 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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6. Symbols Used
Alternating Current Attention: consult accompanying documents
Dangerous Voltage Type CF Defibrillation-Proof Applied Part READY RF ON
Transmurality Equipotential Footswitch Fuses Non-Ionizing Radiation Power OFF
Power ON Volume Non-Sterile Manufacturer Page 29 of 40
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Refer to Instruction Manual
Humidity Storage Limit
Temperature Storage Limit Waste of electrical and electronic equipment (WEEE):
Contact AtriCure for return and recycling information at the end of useful
life Catalogue Number Serial Number UL Classification Mark
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Technical specifications
7.1. RF Output
· Frequency:
460 kHz ±5%, Quasi-sinusoidal
· ASU Maximum Power Output: 32.5 W at 100
· HF Power and Voltage Output:
Device Code
Maximum Output Power
Maximum Output Voltage
Handpiece Type
A
28.5 W at 114 57.0 Vrms
Isolator clamp
B
15.0 W from 20 to 400
77.5 Vrms
Isolator Transpolar pen
C
20.0 W from 31 to 300
77.5 Vrms
Isolator Transpolar pen Isolator linear pen
D
25.6 W at 127 57.0 Vrms
Isolator clamp
E
22.8 W at 143 57.0 Vrms
Isolator clamp
F
28.5 W at 114 57.0 Vrms
Isolator clamp
G
28.5 W at 114 57.0 Vrms
Isolator clamp
H
28.5 W at 114 57.0 Vrms
Isolator clamp
J
12.0 W from 20 to 500
77.5 Vrms
Isolator Transpolar pen
K
25.0 W from 39 to 240
77.5 Vrms
Isolator Transpolar pen, or CoolrailTM linear pen
L
30.0 W from 47 to 200
77.5 Vrms
Isolator Transpolar pen, or CoolrailTM linear pen
7.2. Mechanical Specifications
· Size:
13 × 13.75 × 6 (32.5 cm × 34.4 cm × 15 cm) maximum.
· Weight:
15 lb. (9 kg) maximum.
7.3. Environmental Specifications · Operational temperature: 10oC to 40oC
· Storage temperature:
35°C to +54°C
· Humidity:
15 to 90% relative humidity
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7.4. Electrical Specifications · 100-120V ~ 50/60 Hz
· 220-240V ~ 50/60 Hz
7.5. Fuses · 100 -120V, 220-240V, ~50 / 60 Hz,: Replace fuses as marked:
1.25A/250V, T-lag, 5 × 20 mm, UL Recognized, IEC Approved
7.6. Footswitch Specifications · Moisture protection rating: IPX8
7.7. Power and Voltage Output Restrictions The maximum power output of 28.5 W
for the Isolator clamp is available at 114 load for devices operating under
device code “A, F, G, and H”. Lower maximum output powers are available
depending on the system operating mode. See Section 7.1. The maximum power
output of 15.0 W for the Isolator Transpolar pen is available between 40 to
400 load for device operating under device code “B”. Lower maximum output
powers are available depending on the system operating mode. See Section 7.1.
The maximum power output of 30.0 W for the CoolrailTM linear pen is available
between 47 to 200 load for device operating under device code “L”. Lower
maximum output powers are available depending on the system operating mode.
See Section 7.1. The maximum power output of 20.0 W for the IsolatorTM linear
pen is available between 31 to 300 load for device operating under device code
“C”. Lower maximum output powers are available depending on the system
operating mode. See Section 7.1. At other load impedances, the ASU will reduce
the available power to comply with the specified voltage and current limits.
See Figure 11 and Figure 12. The ASU is capable of producing a maximum output
power of 32.5 Watts under a 100 Ohm load although no current AtriCure Bipolar
Handpiece uses power above 30 Watts. The maximum output voltage depends on the
device code, and can be either 57 Vrms or 77.5 Vrms. See Section 7.1.
7.8. Equipment Type / Classification · Class 1 Equipment
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Figure 11 Power vs. Load (clamp algorithm)
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Power (Watts)
35 Device Code L
30
ASU2 & ASU3 POWER OUTPUT
25 Device Code K
20
15
10 Device Code J
Device Code B
5
Device Code C
0
0
100
200
300
400
500
600
700
800
900
1000 1100 1200
Load Impedance (Ohms)
Figure 12 Power vs. Load (pen algorithm)
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Preventive Maintenance and Cleaning of ASU
8.1. Preventive Maintenance Perform annual preventative maintenance procedures
to ensure all ASU components are functioning as defined within this manual.
Pay particular attention to operational and safety features, including but not
limited to:
· Electrical power cords for fraying, damage, and proper grounding
· AC power switch
· Indicator damage (Power On, Fault, Ready, RF ON, Transmurality)
· LCD display damage or loss of graphic information
· Handpiece connector damage, cracking or inability to insert and latch
Handpiece plug
· Carrying handle damage, inability to latch or rotate
· Rubber feet damage, cracking or inability for the ASU to remain stabile on a
flat surface.
· Footswitch cord fraying or damage
· Footswitch connector damage cracking or inability to insert and latch
footswitch plug
· Footswitch pedal damage check activation by pressing and releasing the pedal
Other medical equipment that may be used simultaneously with the ASU should
also be inspected for damage. Specifically, check for insulation damage of
monitoring electrode cables and endoscopically used accessories.
Visually inspect the footswitch for fluids or other infectious hazards. Clean
as necessary using the instructions in Section 8.2.
The ASU does not have any serviceable parts. For servicing issues, contact
AtriCure, Inc. at:
AtriCure Incorporated 7555 Innovation Way Mason, Ohio 45040 USA
Customer Service: 1-866-349-2342 (toll
free) 1-513-755-4100 (phone)
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USER’S MANUAL
8.2. Cleaning and Disinfecting
NOTE: Do not spray or pour liquids directly on the unit. NOTE: The unit and/or
accessories cannot be sterilized. WARNING: Ensure Isopropyl Alcohol (IPA) is
completely dry before operating the unit. CAUTION: Avoid caustic or abrasive
cleaners
Guidelines The following guidelines are recommended for cleaning the unit. It
is the user’s responsibility to qualify any deviations from these processing
methods. 1. Disconnect the unit or cart from the outlet before cleaning. 2. If
the unit and/or accessories are contaminated with blood or other body fluids,
they shall be cleaned before the contamination can dry (within two hours of
contamination). 3. The outer surfaces of the unit and/or accessories shall be
cleaned with 70% -90% Isopropyl alcohol (IPA) wipes for a minimum of two
minutes. Do not allow fluids to enter the chassis. 4. Pay attention to all
areas where fluids or soil may gather, such as under/ around the handles or
any tight crevices/ grooves. 5. Dry the unit and/or accessories with a dry,
white lint-free cloth. 6. Conduct a final confirmation of the cleaning process
by visually inspecting the white cloth for remaining soil. 7. If soil remains
on the white cloth, repeat steps 3 through 6. 8. After cleaning is complete,
turn the unit on to perform Power On Self-Test (POST). If any errors are
received, contact AtriCure to begin return process.
9. Disposal Follow local governing ordinances and recycling plans regarding
disposal or recycling of device components.
10. Accessories
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10.1. ASB3, Switch Matrix Accessory
The Switch Matrix provides a means of connecting multiple handpieces to the
ASU and a means of selecting the input to the handpiece electrodes. The input
is selected with the Switch Matrix knob. A cable with is provided to connect
the Switch Matrix to the ASU. WARNING: Do not connect the ASB3 auxiliary
device cable to supply mains (line voltage) operated equipment without
evidence that the safety certification of the Accessory has been performed in
accordance to the appropriate EN60601-1 and/or EN60601-1-1 harmonized national
standard. Supply mains operated equipment may introduce dangerous leakage
currents into the heart.
An auxiliary device (other than those listed in paragraph 10.2.2) may have an
adverse effect on nearby radio or TV or medical equipment. There may also be
cases when nearby electrical appliances adversely influence the auxiliary
device, causing data errors or malfunction. Auxiliary devices compatible for
use with the Switch Matrix include:
Any AtriCure IsolatorTM Handpiece
Any AtriCure TranspolarTM Pen
Any AtriCure CoolrailTM linear pen
OSCOR Model PACE 203H TM
MicroPace ORLabTM Stimulator/EP Recorder System
WARNING: Read auxiliary device manual and observe warnings.
Any AtriCure handpiece or pen device may be connected to the Switch Matrix.
AtriCure Devices will be functional when the device is connected to the
correct receptacle and the Switch Matrix switch knob is turned to indicate the
device for use.
Settings and procedures for the auxiliary device are determined according to
the instructions for use provided with the auxiliary device.
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ASB3, Switch Matrix Unit is shown below with the ASU.
Product Labeling
Product Labeling
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Switch Matrix set up is shown in the following figures.
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USER’S MANUAL
Accessories and Cables
· ASU/ASB Power Cord · ASU/ASB Interface Cable · Auxiliary Cable · ASU Footswitch · ASU/ASB Footswitch Interface Cable
Warranties
Limitation on Liability
This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Ohio, U.S.A.
AtriCure, Inc. warrants this product to be free from defects in material and workmanship under normal use and preventive maintenance for the respective warranty period shown below. AtriCure’s obligation under this warranty is limited to the repair or replacement, at its option, of any product, or part thereof, which has been returned to AtriCure, Inc. or its Distributor within the applicable time period shown below and which examination disclosed, to AtriCure’s satisfaction, to be defective. This warranty does not apply to any product, or part thereof, that has been: (1) adversely affected due to use with devices manufactured or distributed by parties not authorized by AtriCure, Inc. (2) repaired or altered outside AtriCure’s factory in a way so as to, in AtriCure’s judgment, affect its stability or reliability, (3) subjected to improper use, negligence or accident, or (4) used other than in accordance with the design and use parameters, instructions and guidelines for the product or with functional, operational or environmental standards for similar products generally accepted in the industry. AtriCure has no control over the operation, inspection, maintenance or use of its products after sale, lease or transfer, and has no control of the selection of Customer’s patients.
AtriCure’s products are warranted for the following periods after shipment to the original purchaser:
AtriCure Ablation and Sensing Unit ………………………………………………………………….. One (1) Year
AtriCure Switch Matrix……………………………………………………………….. One (1) Year AtriCure Source
Switch……………………………………………………………….. One (1) Year AtriCure Footswitch
………………………………………………………………………………………… One (1) Year Grounded Electrical
Cord…………………………………………………………………………………. One (1) Year
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING THE WARRANTIES OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF ATRICURE,
INC. AND IS A PURCHASER’S EXCLUSIVE REMEDY. IN NO EVENT SHALL ATRICURE, INC.
BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING, WITHOUT
LIMITATION, DAMAGES RESULTING FROM LOSS OF USE, PROFITS, BUSINESS OR GOODWILL.
AtriCure, Inc. neither assumes nor authorizes any other person to assume for
it any other liability in connection with the sale or use of any of AtriCure
Inc. products. There are no warranties that extend beyond the terms presented
unless an extended warranty is purchased before the original warranty expires.
No agent, employee or representative of AtriCure has any authority to change
any of the foregoing or assume or bind AtriCure to any additional liability or
responsibility. AtriCure, Inc. reserves the right to make changes to products
built and/or sold by them at any time without incurring any obligation to make
the same or similar changes on products previously built and/or sold by them.
DISCLAIMER
Users assume responsibility for approving the acceptable condition of this
product before it is used, and for ensuring that the product is only used in
the manner described in these instructions for use. Under no circumstances
will AtriCure, Inc. be responsible for any incidental, special or
consequential loss, damage, or expense, which is the result of the deliberate
misuse of this product, including any loss, damage, or expense which is
related to personal injury or damage to property.
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