AtriCure cryoICE BOX ACM1 User manual

cryoICE BOX
Version 6
USER’S MANUAL
AtriCure cryoICE BOX, model ACM1 – 115 (100-120)VAC, 4A, 50/60 Hz
BR REP
Technical Name: Cryogenic Surgical Unit
Commercial Name: AtriCure Cryosurgical System
ANVISA n°: 80117580971
Importer: Emergo Brazil Import Importação e Distribu-
ição de Produtos Médicos Hospitalares Ltda. Avenida
Francisco Matarazzo, 1.752, Salas 502/503, Agua Branca,
São Paulo-SP, CEP – 05001-200 CNPJ: 04.967.408/0001-
98
Email: [email protected]om
Technical Manager: Luiz Levy Cruz Marns, CRF-SP:
42415
Manufacturer:
AtriCure, Inc.
7555 Innovaon Way,
Mason, Ohio 45040 USA
[phone] (toll free)
[phone] (phone)
2022/04 | IFU-0229.A
EN

II

FOREWORD.............................................................................IV
CAUTION ...............................................................................IV
IMPORTANT ............................................................................IV
INDICATIONS FOR USE/INTENDED PURPOSE ...............................................IV
PATENT INFORMATION ..................................................................IV
WARNINGS AND CAUTIONS ..............................................................V
WARNINGS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .V
CAUTIONS ....................................................................V
Meanings of Symbols on AtriCure cryoICE BOX .....................................VI
Classicaon in accordance with IEC, EN, ANSI/AAMI, CSA 60601-1 ....................VII
1. SYSTEM OVERVIEW ................................................................... 1
The AtriCure cryoICE BOX........................................................1
AtriCure cryoICE BOX Front and Rear Panels – Illustraons and Nomenclature ............1
Operang Modes ..............................................................2
READY Mode ................................................................2
FREEZE Mode ...............................................................2
DEFROST Mode..............................................................2
FAULT Condion .............................................................2
2. TECHNICAL SPECIFICATIONS ............................................................ 2
Mechanical Specicaons .......................................................2
Electrical Specicaons .........................................................3
Mains Fuses...................................................................3
Footswitch Specicaons........................................................3
Equipment Type / Classicaon...................................................3
3. ATRICURE CRYOICE BOX, DETACHABLES, AND ACCESSORIES .................................. 3
N2O Gas Coupling Installaon ....................................................4
AtriCure cryoICE BOX Set-Up and Preparaon .......................................4
N2O Cylinder Installaon ........................................................4
Exhaust Tubing ................................................................5
Heater Band Installaon.........................................................5
Turning On the AtriCure cryoICE BOX ..............................................6
Reseng the N2O Gas Gauge.....................................................6
System Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
4. DEVICE USE.......................................................................... 7

III 2022/04 | IFU-0229.AEN
Install AtriCure cryoICE Probe ....................................................7
Set Ablaon Time ..............................................................9
Start Ablaon .................................................................9
5. SPECIAL CASES ....................................................................... 9
Abort FREEZE..................................................................9
Change Ablaon Time during Ablaon .............................................9
Emergency Stop ...............................................................9
Set Default Ablaon Time .......................................................9
Operate Without Temperature Reading ...........................................10
6. SYSTEM DISASSEMBLY AFTER USE ...................................................... 10
Disconnecng the AtriCure cryoICE Probe .........................................10
N2O Cylinder Removal..........................................................10
7. PREVENTIVE MAINTENANCE AND CLEANING OF THE ATRICURE CRYOICE BOX ................. 10
Cleaning and Disinfecng Instrucons ............................................10
Prevenve Maintenance .......................................................11
AtriCure Address / Toll Free Telephone Number ....................................11
Corporate Website ............................................................11
Customer Service/ Product Inquiries..............................................11
Replacement of AC Line Fuses ...................................................11
Procedure to Replace AC Mains Fuses ............................................12
Tank Hose Assembly without canisters – Standard ..................................12
Tank Hose Assembly with canisters – Alternate (Replacement of Desiccant Filter) ........13
Table 3: Atricure Accessory Devices ..............................................14
Table 4: AtriCure Component Devices ............................................15
Disposal .....................................................................15
8. TROUBLESHOOTING ................................................................. 16
AtriCure cryoICE BOX Error Codes ................................................18
9. ELECTROMAGNETIC COMPATABILITY TABLES ............................................. 19
Electromagnec Emissions......................................................19
Electromagnec Immunity – Enclosure Port .......................................19
Electromagnec Immunity – Input A.C. Power Port .................................20
Electromagnec Immunity – Input D.C. Power Port – Not Applicable ...................22
Electromagnec Immunity – Paent Coupling Port..................................22
WARRANTIES .......................................................................... 23
DISCLAIMER ........................................................................... 23

IV
FOREWORD
This manual and the equipment it describes are for use only by qualied medical professionals trained in the
parcular technique and surgical procedure to be performed. The AtriCure cryoICE BOX also referred to as the
AtriCure Cryo Module (ACM) : ACM1.
Please read all informaon carefully. Failure to properly follow the instrucons may lead to serious surgical
consequences including paent and caregiver harm.
IMPORTANT
This user manual is designed to provide instrucons for use of the AtriCure cryoICE BOX (A000896-4 assembly/
A000898-4 packaged assembly) with the AtriCure cryoICE probes and AtriCure Component and Accessory De-
vices (See pages 12 through 15 of this manual for specic part numbers informaon.) This user manual is not a
reference to surgical technique.
INDICATIONS FOR USE/INTENDED PURPOSE
The AtriCure cryoICE BOX is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous
oxide, to AtriCure’s cryo-ablaon probes.
The intended purpose of the ACM Exhaust Hose Connector is an oponal accessory of the AtriCure cryoICE
BOX, providing a method to connect the AtriCure cryoICE BOX exhaust to a hospital medical vacuum or waste
anesthesia gas disposal (WAGD) system. It is intended only to be used together with the AtriCure cryoICE BOX
to enable meeng its intended purpose.
The ACM footswitch is used to acvate the AtriCure cryoICE BOX as an alternave to using the Acvaon But-
ton on the front panel of the generator.
The AtriCure cryoICE BOX unit is an electro-mechanical cryogenic surgical unit that delivers a cryogenic Nitrous
Oxide (N2O) energy source to a cryoICE probe to create lines of ablaon through ssue. The AtriCure cryoICE BOX
is part of a system which includes the N2O gas cylinder, N2O gas line hose, N2O exhaust hose, cylinder heater band,
an oponal footswitch, and single-use cryoICE probes. The system provides controlled lesion forming tempera-
tures below -40°C (-40°F), with typical operang ranges between -50°C to -70°C (-58°F to -94°F).
The AtriCure cryoICE BOX is designed to operate only with AtriCure designed and developed cryoICE probes. The
AtriCure cryoICE probe will be referred in this User’s Manual as the “cryoICE probe”.
This User’s Manual provides a descripon of the AtriCure cryoICE BOX, its controls, displays, indicators, and a
sequence for its operaon with the cryoICE probe. This User’s Manual also supplies other informaon of impor-
tance to the user. For informaon about the cryoICE probes, please refer to the cryoICE probe Instrucons for Use.
Do not operate the AtriCure cryoICE BOX before thoroughly reading this manual.
PATENT INFORMATION
May be covered by one or more patents.
WARNINGS AND CAUTIONS
The safe and eecve use of the cryo device and equipment is highly dependent upon factors under the control of
the operator. There is no substute for a properly trained operang room sta. It is important that the operang
instrucons supplied with the AtriCure cryoICE BOX unit be read, understood, and followed before use.

V2022/04 | IFU-0229.AEN
WARNINGS
• Do not operate the cryoICE BOX unit before thoroughly reading this manual.
• Do not use cryo surgical equipment unless properly trained in the specic. procedure being undertaken.
This manual and the equipment it describes are for use only by qualied medical professionals trained in
the parcular 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 modicaon of this equipment is allowed.
• The voltage selector is factory set and should not be changed by the user. The voltage seng and the
fuse rang must be appropriate as idened to prevent cryoICE BOX malfuncon and potenal instru-
ment damage.
• Electric Shock Hazard: Connect the cryoICE BOX 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 cryoICE probe is correctly connected to the cryoICE BOX and that
no thermocouple wires are exposed from the cable, connector, or the cryoICE probe.
• Use of accessories, transducers and cables other than those specied or provided by AtriCure could re-
sult in increased electromagnec emissions or decreased electromagnec immunity of the cryoICE BOX
and result in improper operaon
• Use of the cryoICE BOX adjacent to or stacked with other equipment should be avoided because it could
result in improper operaon
• Portable RF communicaons equipment (including peripherals such as antenna cables and external an-
tennas) should be used no closer than 30 cm (12 inches) to any part of the cryoICE BOX, including cables
specied by the AtriCure. Otherwise, degradaon of the performance of this equipment could result.
• The Emissions characteriscs of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residenal environment (for which CISPR 11 class B is normally required)
this equipment might not oer adequate protecon to radio-frequency communicaon services. The user
might need to take migaon measures, such as relocang or reorienng the equipment.
• The ACM Exhaust Hose connector requires a dedicated Vacuum or WAGD port to prevent back pressure
into the paent’s breathing line, which may result in Pneumothorax.
CAUTIONS
• Use only with the cryoICE probes intended for use with the cryoICE BOX.
• Do not transion into FREEZE mode unl the cryoICE probe is properly posioned at the ablaon site.
• The system status indicators and displays are important safety features. Do not obstruct either the
ablaon or the system status indicators.
• Do not remove the cryoICE BOX cover as there is a potenal for electrical shock. Refer to authorized
personnel for service.
• The Power Cord of the cryoICE BOX must be connected to a properly grounded receptacle. Extension
cords and/or adapter plugs must not be used.
• Do not contact cryoICE probes with a RF device.
• Compressed Air Hazard: Do not operate N2O cylinders with a pressure greater than 1000 PSIG (6900 kPa).
• Nitrous Oxide connecons should only be unplugged when the cryoICE BOX is in the READY mode and
properly vented.

VI
Meanings of Symbols on AtriCure cryoICE BOX
Power O Cylinder Valve On/O
Cauon N2O Gas Gauge Reset
Alternang Current
~
Gas Exhaust
Equipotenal Terminal Maintenance Needed
Type CF Applied Part
(cryoICE Probe) Cylinder Heater Band
READY Footswitch
FREEZE Maximum Pressure
DEFROST Thermocouple/Probe
N2O Gas Gauge Gas Inlet
Timer Gas Outlet
Timer Increase Buon Non-Sterile
Timer Decrease Buon Manufacturer
cryoICE Probe Temperature Catalog Number
Temperature
Storage, Transit, and
Operaonal Limits
100°F
(37
°C)
-20
°F
(-28
°C)
Serial Number
Humidity
Storage, Transit, and
Operaonal Limits
90%
15%
%
Cauon: Federal Law (US)
restricts this device to sale by or on
the order of a physician
Authorized representave in the
Brazillian Community
BR REP
Follow Instrucons for Use
Date of Manufacture US Does not contain phthalates PHT
Not made with dry natural rubber
or natural rubber latex
Waste Electrical and Electronic
Equipment (WEEE)
Importer Model Number
Naonal Instute of Metrology
Standardizaon and Industrial
Quality

VII 2022/04 | IFU-0229.AEN

SAFETY INFORMATION
E509985
MEDICAL — GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA C22.2 No. 60601-1 (2014) E509985
Cryogenic Ablaon Device, Model AtriCure Cryo Module, ACM1, cord connected/ appliance coupler / transportable,
rated: 115VAC, 4A, 50/60 Hz
1. Type of protecon against electric shock: Class I
2. Degree of protecon against electric shock: Type CF
3. Degree of protecon against ingress of water: IPX0
4. Equipment not suitable for use in the presence of a ammable anesthec mixture with air or with oxygen or nitrous oxide
5. Mode of operaon: Connuous
6. Environmental Condions: Normal:
10-40°C (50°F-104°F), 15-90% rH, 980-1050mb (14.2 to 15.2 psi)

1
1. SYSTEM OVERVIEW
The AtriCure cryoICE BOX
This secon provides a detailed descripon of the cryoICE BOX including its funcon and operang features.
• The cryoICE BOX unit is an electro-mechanical cryogenic surgical unit that delivers a Nitrous Oxide (N2O)
cryogenic energy source to a cryoICE probe to create lines of ablaon through ssue. The cryoICE BOX
is part of a system which includes the N2O cylinder, N2O gas line hose, N2O exhaust hose, cylinder heat-
er band, an oponal footswitch, and single-use cryoICE probes. The system provides controlled lesion
forming temperature that is below -40°C (-40°F), with typical operang ranges between -50°C to -70°C
(-58°F to -94°F).
• Along with the Acvaon Buon on the front panel of the cryoICE BOX, an oponal Footswitch can also
be used to acvate and terminate the cryo ablaon cycle.
• The cryoICE BOX is designed to operate only with AtriCure cryoICE probes. Refer to the cryoICE probe
Instrucon for Use for complete descripon and indicaons for use of these devices.
AtriCure cryoICE BOX
Illustraons of the cryoICE BOX front panel (Figure 1) and rear panel (Figure 2) are shown below.
Figure 1: AtriCure cryoICE BOX Front Panel
1. Acvaon Buon 9. cryoICE Probe Gas Outlet Port
2. N2O Gas Gauge Indicator Display 10. cryoICE Probe Gas Inlet Port
3. N2O Gas Gauge Indicator Display Reset 11. Ablaon Status Indicator
4. Ablaon Timer Display 12. Cylindexr Heater Band Indicator
5. Ablaon Timer Decrement 13. Maintenance Needed Indicator
6. Ablaon Timer Increment 14. System Fault Indicator
7. cryoICE Probe Temperature 15. Thermocouple Open Indicator
8. Future Probe Connecon 16. cryoICE Probe Thermocouple Ports
Figure 2: AtriCure cryoICE BOX Rear Panel
17. N2O Exhaust Port 23. Power Plug Receptacle
18. N2O Manual Exhaust Knob 24. Power Switch
19. N2O Inlet Port 25. Mains Fuse Locaon
20. N2O Exhaust Switch 26. cryoICE BOX Voltage Rang Label
21. Acvaon Footswitch Connecon Port 27. Equipotenal Terminal
22. Heater Band Cord Receptacle 28. RS232 Data Connecon

22022/04 | IFU-0229.AEN

The cryoICE BOX operates in one of three modes: READY, FREEZE, and DEFROST. These modes are idened by the
system status indicator LEDs and the ablaon status indicator LEDs located on the front of the cryoICE BOX unit.
READY Mode
This mode is entered automacally upon successful execuon of Power-on-self -test when the unit is rst
turned on or following DEFROST Mode upon the cryoICE probe reaching approximately 10°C (50°F) and
automatically venng. This indicates that the system is ready for the next cryo ablaon run.
FREEZE Mode
This Mode is entered from the READY Mode when the user iniates the cryo ablaon cycle by pressing
and releasing the Acvaon Switch or the Footswitch. In this mode, the N2O gas is allowed to cycle
through the cryoICE probe causing a temperature drop to take place at the cryoICE probe.
DEFROST Mode
This Mode is entered automacally from FREEZE Mode upon expiraon of the ablaon mer, or manually
by the operator when the Acvaon Switch or the Footswitch is actuated while in the FREEZE Mode. In
this mode, the cryoICE probe temperature is acvely forced towards the ambient temperature.
Once the cryoICE probe temperature is above approximately 10°C (50°F), the cryoICE BOX unit will transion back to
the READY Mode.
Note: cryoICE BOX does allow early transion out from the DEFROST Mode into either the READY Mode or the
FREEZE Mode by pressing the Acvaon Buon.
Note: cryoICE probe temperature may drop temporarily upon transion from DEFROST to READY state.

This is entered upon detecon of any unrecoverable error condion during any Mode. The system
is inoperable in this Mode unl the unit is rst power cycled, and only if the fault condion no
longer exists or has been remedied.
2. TECHNICAL SPECIFICATIONS

Size: 17.5 in (44.5 cm) - (W) ×27.0 in (68.6 cm) - (D) ×4.5 in (11.4 cm) - (H) maximum
Weight: 45 lb. (20.4 kg) absolute maximum
Environmental Specications
Temperature Humidity Atmospheric pressure
Operaonal +10°C to +40°C
+50°F to +104°F
15% to 90% relave humidity 980mb to 1050mb
(14.2 to 15.2 psi)
Storage -28°C to +37°C
-20°F to +100°F
15% to 90% relave humidity 980mb to 1050mb
(14.2 to 15.2 psi)
Transit -28°C to +60°C
-20°F to +140°F
30% to 85% relave humidity

3

AtriCure cryoICE BOX, model ACM1 – 115 (100-120)VAC, 4A, 50/60 Hz
Mains Fuses
AtriCure cryoICE BOX, model ACM1 – 115 (100-120)VAC, 4A, 50/60 Hz
Replace fuses as marked: 4.0A/250V, T-lag, 5 × 20 mm, UL Recognized, IEC Approved

Resoluon: 1°C (increments)
Temperature > or = -40°C Accuracy of +3°C/-6°C (-40°F Accuracy of +2.4°F/-4.8°F )
Temperatures<-40°C Accuracy of +5°C/-8°C (-40°F Accuracy of +4°F/-6.8° F)

Moisture protecon rang: IP68

Class 1 Equipment
3. AtriCure cryoICE BOX, COMPONENTS, AND ACCESSORIES
As shown in Figure 3, the system is comprised of the following:
A: AtriCure cryoICE BOX Cylinder Heater Band (CMH15) - Component
B: AtriCure cryoICE BOX Tank Hose Assembly, without Canister Set, Standard - Component
C: AtriCure cryoICE BOX N2O Exhaust Hose - Component
D: AtriCure cryoICE BOX Exhaust Hose Connector - Component
E: AtriCure cryoICE BOX Tank Hose Assembly, with Filter Canister Set (Oponal) -Component
F: AtriCure cryoICE BOX
G: AtriCure cryoICE BOX Footswitch (Oponal – not shown) - Accessory
H: AtriCure cryoICE BOX Power Cord (not shown) - Component
I: AtriCure cryoICE probe with integral tube set (not shown) - Type CF Applied Part
J: AtriCure cryoICE BOX Heater Band Extension Spring (not shown) – Component
Figure 3: AtriCure cryoICE BOX, Components, and Accessories
D
F

42022/04 | IFU-0229.AEN
N2
• Use Teon tape (not provided) to wrap around the ¼”-18 NPT connector of the N2O gas coupling.
• Connect the N2O gas coupling to the Tank Hose Assembly angled connector.
• Secure this connection as tight as possible only

This secon will outline the preliminary set-up for the cryoICE BOX, including cylinder installaon, heater band
installaon, turning on the cryoICE BOX, and reseng the cylinder gauge on the cryoICE BOX user interface.
Note: The cryoICE BOX should be set up at least 15-minutes prior to the procedure to allow me for the
heater to warm the N2O cylinder to operang temperature.
N2
• Use only nitrous oxide gas with a water content not exceeding 3 ppm. Automove grade nitrous ox-
ide should not be used due to the inclusion of hydrogen sulde.
• The cryoICE BOX is designed to use 20-pound (9-kg.) cylinders.
• Always install a completely full cylinder so the cylinder volume can be indicated correctly.
• To install a new N2O cylinder, rst nd the N2O gas line receptacle on the rear panel and connect this
end into the corresponding end of the N2O gas line. Insert and push in the connector unl you hear it
“click” in place and the connecon is fully seated and secured from unlatching as seen below in Figure 4.
Figure 4: N2O Inlet Connection
• Next, match the opposite black knob end of the N2O gas line with the threaded connecon port of a new
N2O gas cylinder.
• Screw the cryoICE BOX gas line into place by hand ghtening the country specic coupler as shown in
Figure 5.
Over ghtening this ng with a wrench may cause damage, allowing N
2O gas to leak.
• To open gas cylinder valve, slowly turn the knob on the top of the cylinder counter-clockwise as seen in
Figure 6.

5
Figure 5: Attach country specic coupler to
Threaded Connection Figure 6: Turn Valve Counter-Clockwise to Open
• Listen for leaks. If a leak is detected, ghten the black knob with a wrench if needed.
• If the Low-Pressure indicator, as seen in Figure 7, illuminate’s amber this indicates that the cryoICE BOX
is not detecng proper pressure. Check to ensure that the gas cylinder valve is open fully and that the
cylinder you have aached is not empty.
Figure 7: Low Pressure Indicator
Exhaust Tubing
Note: Ensure the Exhaust tubing (hose) is rmly aached to the cryoICE BOX N2O exhaust port, see Figure 2 item 17.
• Be sure to route the N2O vent tubing to a safe area prior to use.
• If a scavenger system is used, it must be able to accommodate a connuous ow of 60 LPM (16 GPM).

• Ensure the cryoICE BOX is properly connected to an N2O gas cylinder.
• Place heater band with the cord facing upward.
• Secure all tensioning spring retainers around the gas cylinder, starng with the very boom and very top
retainers and then proceed to secure the middle retainers as shown in Figure 8.
• The Heater band must be posioned less than 2-inches (5-cm) from boom of the cylinder to ensure that
the N2O is heated eciently.
• Plug heater band cord into the appropriate indicated receptacle located on the rear panel of the cryoICE
BOX unit as shown in Figure 9.
• Verify that the Cylinder Heater Band Icon on the front of the unit is not illuminated.

62022/04 | IFU-0229.AEN
Figure 8: Secure All Tensioning Spring Retainers Figure 9: Plug Heater Band Cord into Receptacle
Turning On the AtriCure cryoICE BOX
• Plug in the cryoICE BOX unit into an approved hospital outlet.
• Turn-On the cryoICE BOX unit with the switch located on the back as seen in Figure 10. The power switch
is used to connect mains power (Turn-On) or disconnect mains power (Turn-O) to the cryoICE BOX unit.
• Aer powering up, the Acvaon Buon on the front of the cryoICE BOX interface will be illuminated. If
no light is observed, check for proper power cord connecon and switch posion
Figure 10: Turn-On AtriCure cryoICE BOX with Switch
2O Gas Gauge
• Only reset the gauge when a new full cylinder has been installed.
• Ensure cryoICE BOX is powered on.
• Ensure the unit is in READY mode.
• Find the gas cylinder display on the front of the cryoICE BOX and note the RESET buon to the right of
this display, see Figure 11.
• Press and hold the RESET buon for one second.
Note: Once the N2O gas gauge is reset, the display can take up to several minutes to display the remaining
volume in the tank.
• The gauge can only be reset to full aer a system power cycle or following a cylinder swap out. If RESET
buon is pressed following usage the gauge will reset to the esmated cylinder volume.

7
Figure 11: N2O Gas Gauge RESET Button
• Meaning of gas gauge indicators seen in Figure 12
Figure 12: N2O Gauge Indicators
3-Segments On = Approximately 20-40 minutes remaining
2-Segments On = Approximately 15-20 minutes remaining
1-Segment On = Approximately 5-10 minutes remaining
1-Segment Flashing = Approximately 5 minutes or less remaining – CHANGE TANK
System Check
• Verify neither the Maintenance Needed or System Fault icons are illuminated.
4. DEVICE USE
Install AtriCure cryoICE Probe
1. Ensure cryoICE BOX is properly connected to a N2O gas cylinder.
2. The cryoICE probe may be connected before the cryoICE BOX has been turned on, while the cryoICE BOX
is being turned on, or when the cryoICE BOX unit is on and in READY mode.
3. Insert the corresponding connecons on the pneumac connectors as shown below in Figure 13. The
sliding ring will need to be manually pushed-in on the orange connector.

82022/04 | IFU-0229.AEN
Figure 13: Color Coded Pneumatic Connectors
4. Ensure each pneumac connecon is fully seated by listening for an audible “click” as each connector
engages its receptacle. Gently tug on each tube to ensure proper engagement with connector.
5. Insert the corresponding red and black colored connecons into the thermocouple connectors, see Figure 15.
Figure 14 Figure 15
6. The cryoICE probe icon, seen above in Figure 14, will exnguish if the cryoICE probe is funconing prop-
erly and the approximate room temperature will be displayed on the temperature display (typically 10 to
25° C [50°F to 77°F]). An example of this is shown in Figure 16.
Figure 16: Probe Temperature Display
7. A test run is advised to ensure the cryoICE probe and system is working properly prior to the case.
8. Pneumac connectors should only be unplugged when the cryoICE BOX is in the READY mode.

9

1. The me of ablaon is displayed in the middle of the interface of the cryoICE BOX and is indicated by a
clock underneath the display. The display shows the me of ablaon in seconds, see Figure 17.
Figure 17: Ablation Time Display
2. To change the duraon of the ablaon, press either of the up or down arrows to the right of the me
display. The display will change in increments of ten seconds. The mer will reset to the default seng
aer a single cycle has been run.

1. Ensure cryoICE BOX is powered on and the cryoICE probe and N2O is connected properly.
2. Check that desired ablaon me is displayed, change if needed.
3. Press and release the Acvaon Buon at the le of the device to begin the ablaon.
4. The temperature display on the front panel displays the cryoICE probe temperature. A double-beep will
indicate that the therapeuc temperature has been reached (typically -40°C [-40°F]), and the ablaon
mer will begin to count down. A short beep will sound every 30 seconds. A series of beeps will indicate
the last 5-seconds of the Ablaon cycle.
5. At the conclusion of the Ablaon cycle, the cryoICE BOX will automacally transion into the DEFROST
mode. The DEFROST indicator will illuminate indicang probe warming unl it has reached the transion
temperature which ends DEFROST, then the unit will automacally transion into READY and vent the
probe. During the DEFROST cycle, a triple-beep will alert the user that the temperature of the probe has
transioned above 0°C (32°F) degrees.
5. SPECIAL CASES
Abort FREEZE
To stop ablaon during a FREEZE cycle, press and release the Acvaon Buon during the ablaon. The sys-
tem will then transion into DEFROST mode.

To change the current ablaon me, the up and down arrows can be used to add or decrease me in 10 sec-
ond increments.
Emergency Stop
To stop ablaon and depressurize the cryoICE probe during a FREEZE or DEFROST push the Acvaon Buon
to vent cryoICE probe unl the cryoICE BOX system has sequenced into READY mode.
The unit can also be stopped by turning o power in the back of the unit or unplugging it from the AC power
outlet. The ow of N2O will stop, however gas will be trapped within the cryoICE probe and the cryoICE BOX.
This gas will be vented the next me the cryoICE BOX is powered on.

1. Ensure cryoICE BOX is powered on.
2. Press and hold both up and down arrows simultaneously for one second to iniate the mode that allows
a change to the default ablaon me.

10 2022/04 | IFU-0229.AEN
3. The me display will ash and the default me can now be changed by using the up or down arrows. The
me will change in increments of 10 seconds. The me cannot be set lower than 20 seconds, nor higher
than 270 seconds.
4. To save the set default me, the display will stop ashing aer 5 seconds and the new default will be set.
Operate Without Temperature Reading
If the cryoICE BOX does not display a temperature and the cryoICE probe is properly plugged in (red and black connec-
tors) the cryoICE probe should not be used. If the Acvaon Buon is pressed with this condion, the cryoICE BOX will
ash and beep for 5-seconds. If the Acvaon Buon is pressed again within 5-seconds, the cryoICE BOX will sequence
into FREEZE mode and the counter will start the countdown immediately. This should only be done at the discreon of
a physician as there will not be temperature feedback.
6. SYSTEM DISASSEMBLY AFTER USE
Check to see that the service icon is not illuminated. If so, nofy AtriCure service to correct the problem.
cryoICE Probe
1. The cryoICE probe can only be removed in the READY mode.
2. Remove the cryoICE probes pneumac connecons by pushing in the sliding ring on the receptacle while
pulling out the cryoICE probe side of the connector.
3. Remove the black and red connecons for the thermocouples.
N2O Cylinder Removal
1. Turn-O the N2O cylinder by turning the knob clockwise.
2. Purge the N2O from the system by pressing and holding the N2O Exhaust Switch in the back of the unit.
Watch the pressure gauge on the cylinder to see that all the pressure has been released. If the cryoICE
BOX is powered o, pull and hold the N2O Manual Exhaust Knob unl the pressure is relieved.
3. Disconnect the gas cylinder inlet ng on the back of the cryoICE BOX by sliding the collar back.
4. Disconnect the hose from the N2O cylinder by unscrewing the black knob.
5. Turn-O power and unplug the cryoICE BOX.
7. PREVENTIVE MAINTENANCE AND CLEANING OF THE AtriCure cryoICE BOX

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 operang the unit.
CAUTION: Avoid causc or abrasive cleaners to avoid damage to ACM chassis.
Guidelines
The following guidelines are recommended for cleaning the unit. It is the user’s responsibility to qualify any
deviaons 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 uids, they shall be cleaned
before the contaminaon can dry (within two hours of contaminaon).
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 uids to enter the chassis.
4. Pay aenon to all areas where uids or soil may gather, such as under/ around the handles or any ght
crevices/ grooves.
5. Dry the unit and/or accessories with a dry, white lint-free cloth.
6. Conduct a nal conrmaon of the cleaning process by visually inspecng the white cloth for remaining soil.
7. If soil remains on the white cloth, repeat steps 3 through 6.
8. Aer 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.

11

AtriCure service representaves or the hospital biomed personnel shall conduct annual preventave mainte-
nance procedures to ensure all cryoICE BOX components are funconing as dened within this manual. Pay
parcular aenon to operaonal and safety features, including but not limited to:
• Electrical power cords for fraying, damage, and proper grounding
• AC power switch
• Any front panel display damage including switches, numeric displays and indicator lights.
• cryoICE probe electronic interface connector damage, cracking or inability to insert and latch cryoICE probe
connector.
• cryoICE probe pneumac interface connector damage or inability to insert and latch cryoICE probe pneu-
mac connector.
• Carrying handle damage or inability to fold.
• Rubber feet damage, cracking or inability for the cryoICE BOX to remain stable on a at surface.
• Rubber alignment cup damage, cracking or inability for the ASB/ASU to remain stable atop cryoICE BOX and
within the alignment cup.
• Listen for leaks when pressurized.
• Other medical equipment that may be used simultaneously with the cryoICE BOX should also be inspected
for damage. Specically, check for insulaon damage of electrical cables and associated connectors.
The cryoICE BOX does not have any customer serviceable parts aside from mains fuses and gas line desiccant
lter for cryoICE BOX units so equipped. For servicing issues, contact AtriCure, Inc. at:
AtriCure Address / Toll Free Telephone Number
AtriCure, Inc.
7555 Innovaon Way,
Mason, Ohio 45040 USA
1.866.349.2342
Corporate Website
www.atricure.com
Customer Service/ Product Inquiries
Telephone: [phone]
866-349-2342 Toll Free
Fax: [phone]
Replacement of AC Line Fuses
Tools and Parts
• Needle Nose Pliers
Table 1: Fuses
AtriCure cryoICE BOX
Model Fuse Type Manufacturer Part Number
ACM1 T 4A L 250V Schurter 0034.5049
The cryoICE BOX unit has been pre-set at the factory to a nominal voltage of 115V (ACM1). The Rang Label below the
Power Entry Module on the back panel of the cryoICE BOX indicates the selected Input Voltage for this unit. This seng
should only be adjusted by the manufacturer or by an authorized AtriCure technical service representave.
Note: cryoICE BOX unit should be powered o and unplugged before connuing with the fuse replacement procedure.
Procedure to Replace AC Mains Fuses
1. Determine the fuse type by looking at the cryoICE BOX Model Number or the cryoICE BOX Rang Label.
2. Using the needle nose pliers, carefully extract the fuse box from the power entry module by
squeezing down on the fuse box tabs in the slots as shown in Figure 18.

12 2022/04 | IFU-0229.AEN
Figure 18: Fuse Box Tabs
3. Replace the (2) two fuses located in the fuse box. Make sure the fuses are aligned properly.
Figure 19: Guide Tab Location
4. Align the fuse cartridge so the guide tab is towards the power entry side.
5. Return the fuse box to the power entry module and push in rmly.
6. Conrm operaonal status by plugging in the cryoICE BOX and turning power on. Ensure that the self-
test is completed without errors.

A001054-4 Packaged, ACM Components - Brazil

A001399 Packaged, Tank Hose Assembly - Brazil

13
Figure 20: AtriCure cryoICE BOX Tank Hose Assembly without canisters

This secon only applies to cryoICE Box Systems equipped with the Tank Hose Assembly which contains the canister set.
Table 2: Tank Hose Assembly with Canisters Replacement Parts
Item Supplied By Part Number
Filter Cartridge AtriCure F021720
Filter O-ring AtriCure F010924
O-Ring Lubricant AtriCure C002502
Figure 21: Gas Line Components
• Desiccant Filter Cartridge (A)
Note: Replace desiccant lter cartridge every me the N2O tank is replaced.
• Filter Housing (B)
• Filter O-Ring (D)
Note: Replace lter O-Ring with replacement of the desiccant lter cartridge.
Procedure
1. Prior to changing the Desiccant Filter Cartridge, assure that the cryoICE probe is disconnected from the
paent and the cryoICE Box is turned o.
2. Unscrew the lter cartridge housing by rotang it counter-clockwise. Refer to Figure 22 below.
D