AtriCure ACM1 User manual

AtriCure Cryo Module
(ACM)
USER’S MANUAL
Model ACM1 – 115 VAC
Model ACM2 – 230 VAC
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll
free)
1-513-755-4100 (phone)
P000669 Rev. J

European Representative:
Herbert Köntges
Köntges SPRL
Avenue Hellevelt 35
B-1180 Brussels Belgium
Tel: [phone]
FAX: [phone]
email: [email protected]

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Table of Contents
1. GETTING STARTED....................................................................................................................4
1.1. System Description .........................................................................................................5
1.2. Unpacking.........................................................................................................................6
1.3. Warnings and Precautions.............................................................................................6
1.4. EMC Guidance and Manufacturer’s Declaration........................................................7
1.5. Responsibility of the Manufacturer .............................................................................11
2. THE ATRICURE CRYO MODULE (ACM) .............................................................................12
2.1. Device Description.........................................................................................................12
2.2. ACM Front Panel – Illustration and Nomenclature...................................................13
2.3. ACM Rear Panel – Illustration and Nomenclature ...................................................20
3. INSTALLING THE ACM ............................................................................................................23
3.1. Transporting of ACM.....................................................................................................23
3.2. Preparing the ACM For Use.........................................................................................23
3.3. Installing Power Cord....................................................................................................23
3.4. Installing the Footswitch...............................................................................................23
3.5. Installing Cylinder Heater Band...................................................................................24
3.6. Installing N2O Gas Line Hose......................................................................................25
3.7. Installing N2O Exhaust Hose........................................................................................27
3.8. Connecting and Disconnecting the Handpiece.........................................................28
4. INSTRUCTIONS FOR USE.......................................................................................................30
4.1. Powering Up the ACM..................................................................................................30
4.2. Operating Modes...........................................................................................................31
4.3. Delivering Cryo Energy.................................................................................................33
4.4. Parameter Entry Mode / Adjusting the System Default Parameter Values..........37
5. TROUBLESHOOTING...............................................................................................................38
5.1. No ACM Power / Display Function .............................................................................38
5.2. ACM Fault Codes..........................................................................................................38
5.3. ACM Error Codes..........................................................................................................39
5.4. Handpiece Error Codes................................................................................................41
6. SYMBOLS USED........................................................................................................................42
7. TECHNICAL SPECIFICATIONS..............................................................................................45
7.1. Mechanical Specifications............................................................................................45
7.2. Environmental Specifications.......................................................................................45
7.3. Electrical Specifications................................................................................................45
7.4. Mains Fuses...................................................................................................................45
7.5. Footswitch Specifications.............................................................................................45
7.6. Equipment Type / Classification..................................................................................45
8. PREVENTIVE MAINTENANCE AND CLEANING OF ACM..............................................46
8.1. Preventive Maintenance...............................................................................................46
8.2. Cleaning and Disinfecting.............................................................................................47

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9. SERVICING OF ACM UNIT......................................................................................................48
9.1. Replacement of AC Mains Fuses...............................................................................48
9.2. Inspection and Replacement of In-Line N2O Filter...................................................49
9.3. Replacement of Gas Line Desiccant Filter and Tip Washer...................................51
9.4. Other Replacement Components ...............................................................................53
10. ACCESSORIES...........................................................................................................................54
10.1. CMH15, Cryo Module Cylinder Heater Band............................................................54
10.2. CMH22, Cryo Module Cylinder Heater Band............................................................54
10.3. CMF1, Cryo Module Footswitch..................................................................................54
11. DISPOSAL....................................................................................................................................54

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1. 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.
Caution: 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 surgical consequences.
Important: This manual is designed to provide instructions for use of the AtriCure
Cryo Module (ACM) with the AtriCure Cryo Handpiece (CRYO1 and cryoICE) and
AtriCure Accessory Devices (CMF1, CMH15, CMH22). This manual is not a reference
to surgical technique.
The AtriCure Cryo Module (ACM) unit is an electro-mechanical and pneumatic cryogenic
surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to create
lines of ablation through cardiac tissue. The ACM is part of a system which includes the
nitrous oxide gas, N2O gas line hose, N2O exhaust hose, cylinder heater band, a
footswitch, and single-use cryo handpiece with integrated electronics cable / gas hoses.
The system provides controlled lesion forming temperature that is below -40°C, with
typical operating ranges between -50°C to -70°C. The system is also equipped with the
ability to tune or set the terminal handpiece temperature.
The ACM is designed to operate only with AtriCure designed and developed handpieces.
Along with the Ablation Activation Switch on the front panel of the ACM, a footswitch can
also be used to activate the ablation cycle. Refer to the handpiece Instruction for Use for
a complete description of the indications and uses of these devices.
For the user’s convenience, the AtriCure Cryo Module will be referred to in this User’s
Manual as the “ACM”. The AtriCure Cryo Handpiece will be referred in this User’s
Manual as the “Handpiece”.
This User’s Manual provides a description of the ACM, its controls, displays,
indicators, 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 ACM 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:
•A: AtriCure Cryo Module Cylinder Heater Band (CMH15 or CMH22)
•B: AtriCure Cryo Footswitch (CMF-1)
•C: ACM N2O Exhaust Hose
•D: ACM N2O Gas Line Hose Module
•E: AtriCure Cryo Module (ACM)
•ACM Power Cord (not shown)
•AtriCure Cryo Handpiece with integral cable (not shown)
Accessory devices are described in Section 10.
Figure 1 – ACM, Footswitch, N2O Gas Line Hose Module, N2O
Exhaust Hose, and Cylinder Heater Band
A
E
D
C
B

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1.2. Unpacking
1.2.1. ACM Unit
Lift the ACM unit from the box and remove the protective wrapping and side caps.
Note: The ACM unit is packed upside down for transit purpose.
Note: Take precautions when lifting the unit as it weighs approx 45 lbs (20 kg).
1.2.2. Accessories
ACM accessories are shipped separately from the ACM unit. The accessory box
contains the following items:
•ACM Power Cord
•N2O Gas Line Hose
•N2O Exhaust Hose
•ACM Cylinder Heater Band
•ACM Footswitch
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 the cryo device and equipment 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 ACM unit be read, understood, and followed before use.
1.3.1. WARNINGS
•Do not operate the ACM unit before thoroughly reading this manual.
•Do not use cryo surgical equipment unless properly trained 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.
•Fire Hazard: Do not use extension cords.
•Trip Hazard: Standard care should be used to reduce the risk of tripping on the
Footswitch cable, as well as the N2O exhaust hose.
•No modification of this equipment is allowed.
The voltage selector is factory set and should not be changed by the user. The
voltage setting and the fuse rating must be appropriate as identified to prevent ACM
malfunction and potential instrument damage.
Electric Shock Hazard: Connect the ACM Power Cord to a properly grounded
receptacle. Do not use power plug adapters.
Electric Shock Hazard: Do not connect wet accessories to the generator.

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Electric Shock Hazard: Ensure that the Handpiece is correctly connected to the
ACM and that no thermocouple wires are exposed from the cable, connector, or the
Handpiece.
1.3.2. PRECAUTIONS
•Use only with the AtriCure Handpieces intended for use with the ACM.
•Do not activate the ACM unit until the Handpiece is properly positioned at the
ablation site.
•The system status indicators and displays are important safety features. Do not
obstruct either the ablation or the system status indicators.
Do not remove the ACM cover, except for the in-line gas filter access port, as
there is a potential for electrical shock. Refer to authorized personnel for service.
•Use only the Footswitch provided with the ACM.
•The Power Cord of the ACM must be connected to a properly grounded
receptacle. Extension cords and/or adapter plugs must not be used.
•Do not contact AtriCure Handpieces with a RF device.
•Compressed Air Hazard: Do not operate N2O tanks with a pressure greater than
1000 PSIG (6900 kPa).
1.4. EMC Guidance and Manufacturer’s Declaration
1.4.1. Electromagnetic Requirements
1.4.1.1. The AtriCure Cryo Module (ACM) 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.
1.4.1.2. The ACM 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.
1.4.1.3. Portable and mobile RF communications equipment can also affect ACM
performance and care should be taken to minimize such interference.
However, there is no guarantee that interference will not occur in a
particular installation.
1.4.1.4. If the ACM does cause harmful interference to other devices, which can be
determined by turning the ACM 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 ACM and the other devices.
•Connect the ACM into an outlet on a circuit different from that to which
the other device(s) are connected.
•Contact the AtriCure service representative for help.

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1.4.2. Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The AtriCure Cryo Module (ACM) is intended for use in the electromagnetic environment specified below.
The customer or the user of the ACM unit should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1
The ACM 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
Class A
The ACM 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.
Harmonic emissions IEC
61000-3-2 Class A
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 Cryo Module (ACM) is intended for use in the electromagnetic environment specified below.
The customer or the user of the ACM unit should assure that it is used in such an environment.
IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output lines
±2 kV for power
supply
Lines
±1 kV for
input/output
lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % U
T
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
ACM unit requires continued
operation during power mains
interruptions, it is recommended
that the ACM unit be powered from
an uninterruptible power supply or
a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
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 Cryo Module (ACM) is intended for use in the electromagnetic environment specified below.
The customer or the user of the ACM should assure that it is used in such an environment.
IMMUNITY
test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Portable and mobile RF communications
equipment should be used no closer to any part of
the ACM, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2 √P
Radiated RF
IEC 61000-4-3
3 V/m
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 ACM is used exceeds the applicable RF compliance level above, the ACM
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the ACM.
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 Cryo Module
The AtriCure Cryo Module (ACM) is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the ACM can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the ACM 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 √P80 MHz to 800 MHz d = 1.2 √P800 MHz to 2.5 GHz d = 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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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2. The AtriCure Cryo Module (ACM)
This section provides a detailed description of the ACM including its function and
operating features.
2.1. Device Description
•The AtriCure Cryo Module (ACM) unit is an electro-mechanical and pneumatic
cryogenic surgical system that delivers a cryogenic source, Nitrous Oxide, to
create lines of ablation through cardiac tissue.
•The ACM is part of a system which includes the nitrous oxide gas and its cylinder,
N2O gas line hose, N2O exhaust hose, cylinder heater band, a footswitch, system
power cord, and single-use cryo handpiece with integrated electronics cable / gas
hoses.
•The system provides a controlled lesion forming temperature that is below -40°C,
with typical operating ranges between -50°C to -70°C for the treatment of cardiac
arrhythmias, creating an inflammatory response (cryonecrosis) that blocks the
cardiac electrical conduction pathway.
•The system is also equipped with the ability to tune or set the terminal handpiece
temperature.
•Along with the Ablation Activation Switch on the front panel of the ACM, the ACM
Footswitch can also be used as the input device to activate and terminate the cryo
ablation cycle.
•The presence of the ACM Footswitch is not a requirement for the ACM unit to
operate and is made available as a secondary means of interfacing with the ACM
unit, and to provide control of the ablation cycle to the surgeon.
•The ACM is designed to operate only with AtriCure designed and developed
handpieces.
•Refer to the Handpiece Instruction for Use for complete description of the
indications and uses of these devices.

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2.2. ACM Front Panel – Illustration and Nomenclature
An illustration of the ACM front panel is shown in Figure 2, below.
Figure 2 – ACM Front Panel
1. Ablation Activation Switch
7. Ablation Timer Increase Button
2. Ablation Status Indicator 8. Handpiece Probe Temperature
3. N2O Gas Gauge Display 9. Handpiece Thermocouple Port
4. System Status Indicator 10. Handpiece Electronic Interface Port
5. Ablation Timer Decrease Button 11. Handpiece Gas Connection Port
6. Ablation Timer Display 12. Handpiece Probe Temperature Control
2.2.1. Ablation Status Indicators
There are three indicators on the front panel of the ACM: READY, FREEZE,
and DEFROST. These indicators are described below.
Figure 3 – ACM Ablation Status Indicators
1
5
7
12
11
6
3
8
2
4
10
9
1
2
3

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Indicator Symbol Description
1
READY – Green LED
This status indicates the ACM is in
stand-by mode and is ready to start the
cryo ablation cycle.
2
FREEZE – Blue LED
This status indicates the ACM is in cryo
freeze state and the N2O gas is allowed
to flow through the Handpiece causing
drop in probe temperature.
3
DEFROST – Amber LED
Constant:
This status indicates the ACM is in
defrost state, N2O gas flow is ceased,
Handpiece is back pressurized, and the
Handpiece probe is warming back up to
the ambient temperature.
Blinking:
Indicates the ACM is now ready to
transition to the next state. Upon
activation of either the Ablation Activation
Switch or the Footswitch, the ACM unit
will transition into the next state
depending on the ACM model as
described below.
International – ACM
•Transitions to Ready state only
US – ACM
•Press and release – Freeze state
•Press and hold – Ready state

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2.2.2. System Status Indicators
There are six system status indicators on the front panel of the ACM: SYSTEM
POWER, SYSTEM FAULT, MAINTENANCE NEEDED, LOW CYLINDER
PRESSURE, CYLINDER HEATER BAND ACTIVE, and FOOTSWITCH
ACTIVE. These indicators are described below.
Figure 4 – ACM Status Indicators
1
2
3
4
6
5

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Indicator Symbol Description
1
SYSTEM POWER – Green LED
This status indicates system logic power
for the ACM is available.
2
SYSTEM FAULT – Red LED
This status indicates ACM has
encountered a system fault condition and
has halted all operation. The ACM unit will
not operate until the fault condition has
been addressed.
3
MAINTENANCE NEEDED – Amber LED
This status indicates the ACM system is still
in normal, functional, and safe operating
mode. However, maintenance is being
requested to address such items as
replacing in-line N2O gas filter to optimize
system performance.

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Indicator Symbol Description
4
LOW CYLINDER PRESSURE – Amber
LED
This status indicates the N2O cylinder gas
pressure into the ACM unit is below (initial
system power up) or is dropping below
(during usage) the optimal operating level.
Two LED indication modes are available.
Initial Power Up:
Constant:
Indicates the cylinder pressure is still
below the optimal operating level.
Blinking:
Indicates cylinder valve is closed, or if
the valve is open, the cylinder
pressure is well below the operating
level or is empty of N2O gas.
•In both of these cases, the cylinder
heater band will be active to raise the
cylinder pressure to its recommended
operating level as long as the cylinder
valve is in the open position.
•The cylinder heater band will not be
active if the cylinder valve is in the
CLOSED position.
•The indicator LED will extinguish when
the cylinder pressure has reached its
optimal operating level.
During Usage:
Constant:
Indicates the cylinder pressure has
dropped below the optimal operating
level, and the cylinder heater band will
be activated. The indicator LED will
extinguish when the cylinder pressure
has risen back to the optimal
operating level.
Blinking:
Indicates the cylinder pressure is well
below the recommended operating
level, and the cylinder has less than
10 minutes of functional gas left.

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Indicator Symbol Description
5
CYLINDER HEATER BAND ACTIVE –
Amber LED
This status indicates ACM unit has
energized the N2O cylinder heater band
and it is active. The indicator LED will
extinguish when the cylinder heater band
is turned off by the ACM unit (when
optimal cylinder pressure is reached).
6
FOOTSWITCH ACTIVE – Blue LED
This status indicates the ACM footswitch
pedal is depressed and is in activate state.
The indicator LED will extinguish when the
footswitch pedal is released.
2.2.3. Front Panel Functions
Item Description
HANDPIECE THERMOCOUPLE
Receptacle
This 2-pin receptacle accepts the AtriCure
Handpiece thermocouple connectors. This
connection is patient-isolated.
HANDPIECE ELECTRONIC
INTERFACE Receptacle
This 14-pin receptacle is reserved for
future release of AtriCure Handpiece. This
connection is patient-isolated.
HANDPIECE PNEUMATIC Receptacle
This 2 port pneumatic receptacle provides
the N2O interface with the AtriCure
Handpiece. The ports are sized differently
to prevent cross-coupling of the
connections.

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Item Description
HANDPIECE PROBE TEMPERATURE
ADJUST Knob
This control knob provides the operator
with the ability to adjust the terminal
temperature of the handpiece probe.
Turning the knob in the counter-clockwise
rotation lowers the probe temperature,
while turning the knob in clockwise rotation
raises the probe temperature. In normal
operation the knob will be adjusted to
provide maximum negative temperature.
2.2.4. Front Panel Displays
2.2.4.1. N2O Gas Gauge
•This display indicates, in minutes, the approximate amount of useable
N2O gas remaining in the cylinder. As the gas is being consumed, this
value will adjust based on the actual gas flow time and the cylinder
pressure. As a result, the displayed value may decrease quicker than
anticipated.
•This time value should not be taken as an absolute measurement, but
only as a reference in gauging the amount of gas remaining in the
cylinder.
•The display value will start to blink when there is approximately 10
minutes or less of anticipated useable gas left in the cylinder.
NOTE: Replacement of the N2O cylinder at this point is highly
recommended.
NOTE: Along with the blinking gas gauge, the Low Cylinder
Pressure indicator LED may also be blinking indicative of
empty or near empty N2O cylinder.
•Typical usage time for a new cylinder is between 30 to 40 minutes
depending on the type and size of the cylinder when used with the ACM
cylinder heater band.The usage time will be less when the cylinder
heater band is not used.
•The gas gauge value can be reset upon replacement of the N2O
cylinder by pressing down on the Timer Increase and Timer Decrease
key simultaneously and releasing.
•Secondary function of the gas gauge is to display the N2O cylinder gas
pressure during the ablation cycle. This provides the user with
additional real-time information regarding the gas status within the
cylinder during system operation in psi x10.