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.