cryoICE BOX
Version 6
USER’S MANUAL
AtriCure cryoICE BOX, model ACM1 – 115 (100-120)VAC, 4A, 50/60 Hz
AtriCure cryoICE BOX, model ACM2 – 230 (220-240)VAC, 2A, 50/60 Hz
European Representative:
Herbert Köntges
Köntges SPRL
Avenue Hellevelt 35
B-1180 Brussels Belgium
Tel: +32 (0) 2 375 51 63
FAX: +32 (0) 2 375 89 06
email: herbert.kontges@skynet.be
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Manufactured by: AtriCure, Inc.
7555 Innovation Way,
Mason, Ohio 45040 USA
1.866.349.2342
P001323 Rev A
Table of Contents
FOREWORD .................................................................................................................................... IV
CAUTION ......................................................................................................................................... IV
IMPORTANT ................................................................................................................................... IV
INDICATIONS FOR USE .............................................................................................................. IV
DISCLAIMER .................................................................................................................................. IV
PATENT INFORMATION .............................................................................................................. V
WARNINGS AND CAUTIONS ....................................................................................................... V
WARNINGS ...........................................................................................................................v
CAUTIONS .......................................................................................................................... vi
SAFETY CSA MARK INFORMATION ............................................................................. ix
1. SYSTEM OVERVIEW ............................................................................................................... 1
The AtriCure cryoICE BOX ...................................................................................................1
AtriCure cryoICE BOX Front and Rear Panels – Illustrations and Nomenclature ................1
Operating Modes .....................................................................................................................3
READY Mode .................................................................................................................... 3
FREEZE Mode.................................................................................................................... 3
DEFROST Mode ................................................................................................................ 3
FAULT Condition ............................................................................................................... 3
2. TECHNICAL SPECIFICATIONS ........................................................................................... 4
Mechanical Specifications ......................................................................................................4
Electrical Specifications..........................................................................................................4
Mains Fuses ............................................................................................................................4
Footswitch Specifications .......................................................................................................4
Equipment Type / Classification .............................................................................................4
3. ATRICURE CRYOICE BOX, DETACHABLES, AND ACCESSORIES ........................... 5
AtriCure cryoICE BOX Set-Up and Preparation ....................................................................6
N2O Cylinder Installation .......................................................................................................6
Exhaust Tubing .......................................................................................................................8
Heater Band Installation .........................................................................................................8
Turning On the AtriCure cryoICE BOX .................................................................................9
Resetting the N2O Gas Gauge ...............................................................................................10
System Check........................................................................................................................11
4. DEVICE USE ............................................................................................................................. 11
Install AtriCure cryoICE Probe ............................................................................................11
Set Ablation Time .................................................................................................................13
Start Ablation ........................................................................................................................13
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5. SPECIAL CASES ...................................................................................................................... 14
Abort FREEZE......................................................................................................................14
Change Ablation Time during Ablation ...............................................................................14
Emergency Stop ....................................................................................................................14
Set Default Ablation Time ....................................................................................................14
Operate Without Temperature Reading ................................................................................14
6. SYSTEM DISASSEMBLY AFTER USE ............................................................................... 15
Disconnecting the AtriCure cryoICE Probe .........................................................................15
N2O Cylinder Removal .........................................................................................................15
7. PREVENTIVE MAINTENANCE AND CLEANING OF THE ATRICURE CRYOICE
BOX ............................................................................................................................................. 16
Cleaning and Disinfecting Instructions .................................................................................16
Preventive Maintenance ........................................................................................................17
AtriCure Address / Toll Free Telephone Number ................................................................18
Corporate Website ................................................................................................................18
Customer Service/ Product Inquiries ....................................................................................18
Replacement of AC Line Fuses ............................................................................................18
Tank Hose Assembly without canisters – Standard ..............................................................20
Tank Hose Assembly with canisters – Alternate (Replacement of Desiccant Filter) ...........21
Disposal.................................................................................................................................22
8. TROUBLESHOOTING ........................................................................................................... 23
AtriCure cryoICE BOX Error Codes ....................................................................................27
9. ELECTROMAGNETIC COMPATABILITY TABLES ..................................................... 28
Electromagnetic Emissions ...................................................................................................28
Electromagnetic Immunity – Enclosure Port ........................................................................28
Electromagnetic Immunity – Input A.C. Power Port ............................................................29
Electromagnetic Immunity – Input D.C. Power Port – Not Applicable ...............................30
Electromagnetic Immunity – Patient Coupling Port .............................................................30
WARRANTIES ................................................................................................................................. 31
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FOREWORD
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. The AtriCure cryoICE
BOX also referred to as the AtriCure Cryo Module (ACM) consisting of two model units: ACM1 and
ACM2.
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 including patient and caregiver harm.
IMPORTANT
This user manual is designed to provide instructions for use of the AtriCure cryoICE BOX
(A000896-3 & A000897-3 assembly/A000898-3 & A000899-3 packaged assembly) with the
AtriCure cryoICE probes and AtriCure Detachable and Accessory Devices (See page 22 of this
manual for specific part numbers information.) This user manual is not a reference to surgical
technique.
INDICATIONS FOR USE
The AtriCure cryoICE BOX is a non-sterile, reusable device which delivers cryogenic energy,
namely nitrous oxide, to AtriCure’s cryo-ablation probes.
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 ablation through
tissue. 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 optional footswitch, and single-use cryoICE
probe. The system provides controlled lesion forming temperatures below -40°C, with typical
operating ranges between -50°C to -70°C.
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 description of the AtriCure cryoICE BOX, its controls, displays,
indicators, and a sequence for its operation with the cryoICE probe. This User’s Manual also
supplies other information of importance to the user. For information about the cryoICE probes,
please refer to the cryoICE probe Instructions for Use.
Do not operate the AtriCure cryoICE BOX before thoroughly reading this manual.
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
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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.
PATENT INFORMATION
May be covered by one or more patents.
WARNINGS AND CAUTIONS
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 AtriCure cryoICE BOX unit be
read, understood, and followed before use.
WARNINGS
• Note: Do not operate the cryoICE BOX unit before thoroughly reading this manual.
• Note: 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 cryoICE BOX
malfunction and potential instrument 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 specified or provided by
AtriCure could result in increased electromagnetic emissions or decreased
electromagnetic immunity of the cryoICE BOX and result in improper operation
• Use of the cryoICE BOX adjacent to or stacked with other equipment should be avoided
because it could result in improper operation
• Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
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the cryoICE BOX, including cables specified by the AtriCure. Otherwise, degradation of
the performance of this equipment could result.
• Note: The Emissions characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment
(for which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or reorienting the equipment.
CAUTIONS
• Use only with the cryoICE probes intended for use with the cryoICE BOX.
• Do not transition into FREEZE mode until the cryoICE probe 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 cryoICE BOX cover as there is a potential 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 connections should only be unplugged when the cryoICE BOX is in the
READY mode and properly vented.
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Meanings of Symbols on AtriCure cryoICE BOX
Power Off
Caution
Alternating Current
Equipotential Terminal
Type CF Applied Part (cryoICE Probe)
READY
FREEZE
DEFROST
N2O Gas Gauge
Timer
Timer Increase Button
Timer Decrease Button
cryoICE Probe Temperature
Thermocouple/Probe
Cylinder Valve On/Off
N2O Gas Gauge Reset
Gas Exhaust
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Maintenance Needed
Fault Condition
Cylinder Heater Band
Footswitch
Maximum Pressure
Gas Inlet
Gas Outlet
Non-Sterile
Manufacturer
Catalog Number
Serial Number
Prescription Only
Follow Instructions for Use
Humidity and Temperature Storage Limits
Waste Electrical and Electronic Equipment (WEEE)
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Classification in accordance with EN 60601-1
SAFETY CSA MARK INFORMATION
CLASS 8750 01 - MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS
CLASS 8750 81 - MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to US
Standards
Cryogenic Ablation Device, Model AtriCure Cryo Module, ACM1 & ACM2, cord connected/ appliance
coupler / transportable, rated: 115/230Vac, 4/2A, 50/60 Hz
1. Type of protection against electric shock: Class I
2. Degree of protection against electric shock: Type CF
3. Degree of protection against ingress of water: IPX0
4. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide
5. Mode of operation: Continuous
Environmental Conditions: Normal: 10-40°C, 15-90% rH, 980-1050mb
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1. Activation Button
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. Ablation Status Indicator
4. Ablation Timer Display
12. Cylinder Heater Band Indicator
5. Ablation Timer Decrement
13. Maintenance Needed Indicator
6. Ablation Timer Increment
14. System Fault Indicator
7. cryoICE Probe Temperature
15. Thermocouple Open Indicator
8. Future Probe Connection
16. cryoICE Probe Thermocouple Ports
1. SYSTEM OVERVIEW
The AtriCure cryoICE BOX
This section provides a detailed description of the cryoICE BOX including its function and
operating 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
ablation through tissue. The cryoICE BOX is part of a system which includes the N2O
cylinder, N2O gas line hose, N2O exhaust hose, cylinder heater band, an optional
footswitch, and single-use cryoICE probe. The system provides controlled lesion forming
temperature that is below -40°C, with typical operating ranges between -50°C to -70°C.
• Along with the Activation Button on the front panel of the cryoICE BOX, an optional
Footswitch can also be used to activate and terminate the cryo ablation cycle.
• The cryoICE BOX is designed to operate only with AtriCure cryoICE probes. Refer to the
cryoICE probe Instruction for Use for complete description and indications for use of
these devices.
AtriCure cryoICE BOX Front and Rear Panels – Illustrations and Nomenclature
Illustrations of the cryoICE BOX front panel (Figure 1) and rear panel (Figure 2) are shown
below.
Figure 1: AtriCure cryoICE BOX Front Panel
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17. N2O Exhaust Port
23. Power Plug Receptacle
18. N2O Manual Exhaust Knob
24. Power Switch
19. N2O Inlet Port
25. Mains Fuse Location
20. N2O Exhaust Switch
26. cryoICE BOX Voltage Rating Label
21. Activation Footswitch Connection Port
27. Equipotential Terminal
22. Heater Band Cord Receptacle
28. RS232 Data Connection
Figure 2: AtriCure cryoICE BOX Rear Panel (Domestic & International)
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Operating Modes
The cryoICE BOX operates in one of three modes: READY, FREEZE, and DEFROST. These
modes are identified by the system status indicator LEDs and the ablation status indicator
LEDs located on the front of the cryoICE BOX unit.
READY Mode
This mode is entered automatically upon successful execution of Power-on-self test when the unit is first turned on or following DEFROST Mode upon the
cryoICE probe reaching approximately 10°C and automatically venting. This
indicates that the system is ready for the next cryo ablation run.
FREEZE Mode
This Mode is entered from the READY Mode when the user initiates the cryo
ablation cycle by pressing and releasing the Activation 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 automatically from FREEZE Mode upon expiration of the
ablation timer, or manually by the operator when the Activation Switch or the
Footswitch is actuated while in the FREEZE Mode. In this mode, the cryoICE
probe temperature is actively forced towards the ambient temperature.
Once the cryoICE probe temperature is above approximately 10°C, the cryoICE
BOX unit will transition back to the READY Mode.
Note: cryoICE BOX does allow early transition out from the DEFROST Mode into
either the READY Mode or the FREEZE Mode by pressing the Activation
Button.
Note: cryoICE probe temperature may drop temporarily upon transition from
DEFROST to READY state.
FAULT Condition
This is entered upon detection of any unrecoverable error condition during any
Mode. The system is inoperable in this Mode until the unit is first power cycled,
and only if the fault condition no longer exists or has been remedied.
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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
Temperature
Humidity
Atmospheric
Operational
+10°C to +40°C
15% to 90%
980mb to 1050mb
Storage
-28°C to +37°C
15% to 90%
980mb to 1050mb
Transit
-28°C to +37°C
15% to 90%
980mb to 1050mb
2. TECHNICAL SPECIFICATIONS
Mechanical Specifications
Environmental Specifications
pressure
Temperature
+50°F to +104°F
-20°F to +100°F
-20°F to +100°F
relative humidity
relative humidity
relative humidity
Electrical Specifications
AtriCure cryoICE BOX, model ACM1 – 115 (100-120)VAC, 4A, 50/60 Hz
AtriCure cryoICE BOX, model ACM2 – 230 (220-240)VAC, 2A, 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
AtriCure cryoICE BOX, model ACM2 – 230 (220-240)VAC, 2A, 50/60 Hz
Replace fuses as marked: 2.0A/250V, T-lag, 5 × 20 mm, UL Recognized, IEC Approved
Footswitch Specifications
Moisture protection rating: IP68
Equipment Type / Classification
Class 1 Equipment
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A
E
D
C
B
3. AtriCure cryoICE BOX, DETACHABLES, AND ACCESSORIES
As shown in Figure 3, the system is comprised of the following:
A: AtriCure cryoICE BOX Cylinder Heater Band (CMH15 or CMH22) - Detachable
B: AtriCure cryoICE BOX Tank Hose Assembly, without Canister Set, Standard - Detachable
C: AtriCure cryoICE BOX N2O Exhaust Hose - Detachable
D: AtriCure cryoICE BOX Tank Hose Assembly, with Filter Canister Set (Optional) -
Detachable
E: AtriCure cryoICE BOX
F: AtriCure cryoICE BOX Footswitch (Optional – not shown) - Accessory
G: AtriCure cryoICE BOX Power Cord (not shown) - Detachable
H: AtriCure cryoICE probe with integral tube set (not shown) - Type CF Applied Part
I: AtriCure cryoICE BOX Heater Band Extension Spring (not shown) – Detachable
Figure 3: AtriCure cryoICE BOX, Detachables, and Accessories
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AtriCure cryoICE BOX Set-Up and Preparation
This section will outline the preliminary set-up for the cryoICE BOX, including cylinder
installation, heater band installation, turning on the cryoICE BOX, and resetting 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 time for the heater to warm the N2O cylinder to operating temperature.
N2O Cylinder Installation
• Use only nitrous oxide gas with a water content not exceeding 3 ppm. Automotive
grade nitrous oxide should not be used due to the inclusion of hydrogen sulfide.
• 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, first find 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 until you hear it “click” in place and the connection 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
connection port of a new N2O gas cylinder.
• Screw the cryoICE BOX gas line into place by hand tightening the knob as shown in
Figure 5. Over tightening this fitting with a wrench may cause damage, allowing N2O
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.
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Figure 5: Attach Black Knob to Threaded Connection
Figure 6: Turn Valve Counter-Clockwise to Open
• Listen for leaks. If a leak is detected, tighten 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 detecting proper pressure. Check to
ensure that the gas cylinder valve is open fully and that the cylinder you have
attached is not empty.
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Figure 7: Low Pressure Indicator
Exhaust Tubing
• Note: Ensure the Exhaust tubing (hose) is firmly attached 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 continuous flow of
60-liters per minute.
Heater Band Installation
• 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, starting with the very
bottom and very top retainers and then proceed to secure the middle retainers as
shown in Figure 8.
• The Heater band must be positioned less than 2-inches (5-cm) from bottom of the
cylinder to ensure that the N2O is heated efficiently.
• 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.
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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-Off) to the cryoICE BOX unit.
• After powering up, the Activation Button on the front of the cryoICE BOX interface will
be illuminated. If no light is observed, check for proper power cord connection and
switch position.
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Figure 10: Turn-On AtriCure cryoICE BOX with Switch
Resetting the N2O 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
button to the right of this display, see Figure 11.
• Press and hold the RESET button 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 after a system power cycle or following a cylinder
swap out. If RESET button is pressed following usage the gauge will reset to the
estimated cylinder volume.
Figure 11: N2O Gas Gauge RESET Button
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• 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 connections on the pneumatic connectors as shown below in
Figure 13. The sliding ring will need to be manually pushed-in on the orange
connector.
Figure 13: Color Coded Pneumatic Connectors
11
Figure 15
4. Ensure each pneumatic connection 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 connections into the thermocouple
connectors, see Figure 15.
Figure 14
6. The cryoICE probe icon, seen above in Figure 14, will extinguish if the cryoICE probe is
functioning properly and the approximate room temperature will be displayed on the
temperature display (typically 10 to 25° C). 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. Pneumatic connectors should only be unplugged when the cryoICE BOX is in the READY
mode.
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Set Ablation Time
1. The time of ablation 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 time of ablation
in seconds, see Figure 17.
Figure 17: Ablation Time Display
2. To change the duration of the ablation, press either of the up or down arrows to the
right of the time display. The display will change in increments of ten seconds. The
timer will reset to the default setting after a single cycle has been run.
Start Ablation
1. Ensure cryoICE BOX is powered on and the cryoICE probe and N2O is connected
properly.
2. Check that desired ablation time is displayed, change if needed.
3. Press and release the Activation Button at the left of the device to begin the ablation.
4. The temperature display on the front panel displays the cryoICE probe temperature. A
double-beep will indicate that the therapeutic temperature has been reached
(typically -40°C), and the ablation timer 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
Ablation cycle.
5. At the conclusion of the Ablation cycle, the cryoICE BOX will automatically transition
into the DEFROST mode. The DEFROST indicator will illuminate indicating probe
warming until it has reached the transition temperature which ends DEFROST, then
the unit will automatically transition into READY and vent the probe. During the
DEFROST cycle, a triple-beep will alert the user that the temperature of the probe has
transitioned above 0°C degrees.
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5. SPECIAL CASES
Abort FREEZE
To stop ablation during a FREEZE cycle, press and release the Activation Button during the
ablation. The system will then transition into DEFROST mode.
Change Ablation Time during Ablation
To change the current ablation time, the up and down arrows can be used to add or
decrease time in 10 second increments.
Emergency Stop
To stop ablation and depressurize the cryoICE probe during a FREEZE or DEFROST push the
Activation Button to vent cryoICE probe until the cryoICE BOX system has sequenced into
READY mode.
The unit can also be stopped by turning off power in the back of the unit or unplugging it
from the AC power outlet. The flow of N2O will stop, however gas will be trapped within
the cryoICE probe and the cryoICE BOX. This gas will be vented the next time the cryoICE
BOX is powered on.
Set Default Ablation Time
1. Ensure cryoICE BOX is powered on.
2. Press and hold both up and down arrows simultaneously for one second to initiate the
mode that allows a change to the default ablation time.
3. The time display will flash and the default time can now be changed by using the up or
down arrows. The time will change in increments of 10 seconds. The time cannot be
set lower than 20 seconds, nor higher than 270 seconds.
4. To save the set default time, the display will stop flashing after 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 connectors) the cryoICE probe should not be used. If the
Activation Button is pressed with this condition, the cryoICE BOX will flash and beep for 5-
seconds. If the Activation Button 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 discretion of a physician as there will not be temperature
feedback.
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6. SYSTEM DISASSEMBLY AFTER USE
Check to see that the service icon is not illuminated. If so, notify AtriCure service to correct
the problem.
Disconnecting the AtriCure cryoICE Probe
1. The cryoICE probe can only be removed in the READY mode.
2. Remove the cryoICE probes pneumatic connections 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 connections for the thermocouples.
N2O Cylinder Removal
1. Turn-Off 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 off, pull and hold the N2O Manual
Exhaust Knob until the pressure is relieved.
3. Disconnect the gas cylinder inlet fitting 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-Off power and unplug the cryoICE BOX.
15
7. PREVENTIVE MAINTENANCE AND CLEANING OF THE AtriCure cryoICE BOX
Cleaning and Disinfecting Instructions
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.
16
Preventive Maintenance
AtriCure service representatives or the hospital biomed personnel shall conduct annual
preventative maintenance procedures to ensure all cryoICE BOX 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
• 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 pneumatic interface connector damage or inability to insert and latch
cryoICE probe pneumatic connector.
• Carrying handle damage or inability to fold.
• Rubber feet damage, cracking or inability for the cryoICE BOX to remain stable on a
flat 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. Specifically, check for insulation damage of
electrical cables and associated connectors.
17
AtriCure cryoICE
ACM1
T 4A H 250V
Schurter
0001.2510
ACM2
T 2A H 250V
Schurter
0001.2507
The cryoICE BOX does not have any customer serviceable parts aside from mains fuses and
gas line desiccant filter for cryoICE BOX units so equipped. For servicing issues, contact
AtriCure, Inc. at:
AtriCure Address / Toll Free Telephone Number
AtriCure, Inc.
7555 Innovation Way,
Mason, Ohio 45040 USA
1.866.349.2342
Corporate Website
www.atricure.com
Customer Service/ Product Inquiries
Telephone: 513-755-4100
866-349-2342 Toll Free
Fax: 513-755-4567
Replacement of AC Line Fuses
Tools and Parts
• Needle Nose Pliers
Fuses
BOX Model
The cryoICE BOX unit has been pre-set at the factory to a nominal voltage of 115V (ACM1)
or 230V (ACM2). The Rating Label below the Power Entry Module on the back panel of the
cryoICE BOX indicates the selected Input Voltage for this unit. This setting should only be
adjusted by the manufacturer or by an authorized AtriCure technical service
representative.
Note: cryoICE BOX unit should be powered off and unplugged before continuing with the
fuse replacement procedure.
Fuse Type Manufacturer Part Number
Procedure to Replace AC Mains Fuses
1. Determine the fuse type by looking at the cryoICE BOX Model Number or the cryoICE
BOX Rating Label.
18
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.
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.
Return the fuse box to the power entry module and push in firmly.
5.
Confirm operational status by plugging in the cryoICE BOX and turning power on.
6.
Ensure that the self-test is completed without errors.
19
A001053
Packaged, ACM Accessories- Domestic
A001054
Packaged, ACM Accessories- International
A001056
Packaged, Gas Line Hose Module Assembly- Domestic
A001055
Packaged, Tank Hose Assembly- International
Component “C”
Tip Washer
AtriCure
F021837
Tank Hose Assembly without canisters – Standard
New AtriCure cryoICE BOX Installation
Existing AtriCure cryoICE BOX Upgrade
Figure 20: N2O Cylinder Interface Figure 21: AtriCure cryoICE BOX Tank Hose
Assembly without canisters
Replacement Part
20
Item
Supplied By
Part Number
Filter Cartridge
AtriCure
F021720
Filter O-ring
AtriCure
F010924
Tip Washer
AtriCure
F021837
O-Ring Lubricant
AtriCure
C002502
D
Tank Hose Assembly with canisters – Alternate (Replacement of Desiccant Filter)
This section only applies to cryoICE Box Systems equipped with the Tank Hose Assembly
which contains the canister set.
Tank Hose Assembly with Canisters Replacement Parts
Figure 22: Gas Line Components
•
Desiccant Filter Cartridge (A)
Note: Replace desiccant filter cartridge every time the N2O tank is replaced.
Filter Housing (B)
•
Tip Washer (C)
•
Filter O-Ring (D)
•
Note: Replace filter O-Ring with replacement of the desiccant filter cartridge.
Procedure
1. Prior to changing the Desiccant Filter Cartridge, assure that the cryoICE probe is
disconnected from the patient and the cryoICE Box is turned off.
2. Unscrew the filter cartridge housing by rotating it counter-clockwise. Refer to Figure
23 below.
Figure 23: Filter Housing Removal
21
Item
Supplied
USA
International
ACM Footswitch
AtriCure
A000708
A000708
Tank Hose Assembly with canisters
AtriCure
A000837
A000838
Tank Hose Assembly without canisters
AtriCure
A001056
A001055
Heater Band Extension Springs (Qty. 6)
AtriCure
A000836
A000836
N2O Exhaust Hose (50ft./15.2m.)
AtriCure
C002051
C002051
Cylinder Heater Band (CMH15)
AtriCure
A000728
A000728
Watlow
120150509 or
120150509 or
Cylinder Heater Band (CMH22)
AtriCure
A000727
A000727
Watlow
120220507 or
120220507 or
AC Power Cord
AtriCure
C000262
C002090
3. Remove the desiccant filter cartridge by rotating it counter-clockwise using hand force
only. Refer to Figure 24 below.
Figure 24: Desiccant Filter Cartridge Removal
4. Remove the old black O-ring from the top of the filter housing fixture.
5. Slide the new O-ring onto the filter housing fixture, making sure that it is fully seated
in the groove at the top.
6. Apply a thin film of O-Ring Lubricant around the new O-Ring.
7. Replace the desiccant filter cartridge with the new cartridge.
8. Replace the filter housing by screwing on clockwise using hand force only.
9. Remove the old Tip Washer and replace it with the new washer.
Other Detachable and Accessory Devices
International
Domestic
By
Part Number
SK025877-DWG7
SK025877DWG10
125 VAC, 10A.
(10ft./3.3m.)
Part Number
SK025877-DWG7
SK025877-DWG10
250 VAC, 10A.
(11.5ft./3.5m.)
Disposal
The cryoICE BOX does not contain hazardous substances. Follow local governing
ordinances and recycling plans regarding disposal or recycling of device components. The
used cryoICE probe is considered bio-hazardous. Follow facility procedures for disposal.
22
Problem
Possible Cause
Action
Front displays
• No power.
• Check power switch on back of
• cryoICE BOX electrical failure.
• Call AtriCure Service.
Cylinder Heater
• Heater not plugged in.
• Check connection on back of
• N2O cylinder valve closed.
• Ensure N2O valve is open.
• Empty N2O cylinder.
• Replace N2O cylinder.
• Extremely cold N2O cylinder.
• Allow 15 minutes to warm up.
• Heater not attached to N2O
• Attach Heater Band to cylinder.
• Heater malfunctioning.
• Call AtriCure Service.
Temperature
• cryoICE probe not plugged in.
• Ensure cryoICE probe
• Malfunctioning cryoICE probe.
• Replace cryoICE probe.
• cryoICE BOX malfunctioning.
• Call AtriCure Service.
cryoICE BOX has
• cryoICE probe not plugged in.
• Plug in cryoICE probe.
• N2O cylinder empty.
• Replace N2O Cylinder.
• N2O cylinder valve closed.
• Open cylinder valve.
• Inlet Gas Connection not secure.
• Ensure Inlet Gas Connection is
8. TROUBLESHOOTING
not lit.
Band Icon
Illuminated.
cryoICE BOX.
• Check plug connection on back
of cryoICE BOX.
• Check AC plug in wall socket.
• Ensure power is available at wall
socket.
unit.
cylinder.
Not Displayed.
power but will
not go into
FREEZE mode.
thermocouple leads are firmly
seated within their receptacles.
completely seated.
23
Problem
Possible Cause
Action
cryoICE probe
• Heater Band not properly
• Check heater installation and
• N2O cylinder low or out of gas.
• Replace N2O cylinder.
Temperature
• cryoICE probe plugged in
• Ensure cryoICE probe black and
• Malfunctioning cryoICE probe.
• Replace cryoICE probe.
• cryoICE BOX malfunctioning.
• Call AtriCure Service.
Bottom segment
• N2O cylinder empty.
• Replace with full cylinder.
• N2O cylinder cold.
• Make sure heater blanket is
• Indicator not reset when
• Press Reset when cylinder is
N2O Gas Gauge
• N2O cylinder pressure is below
• Make sure heater blanket is
• N2O cylinder empty.
• Replace with full cylinder.
not getting cold
enough.
Display indicates
incorrect values.
installed.
• Exhaust filter is clogged.
incorrectly.
• Electromagnetic interference
heater icon.
• Exhaust connector (orange) is
frosting/ freezing ice (liquid
condensate is not uncommon)
call AtriCure Service.
red plugs are in correct
receptacles.
• Relocate or Reorient cryoICE
BOX
on N2O icon
flasing.
flashing.
cylinder was replaced.
650psi.
installed and working. Allow
time for the cylinder to warm
up if it is cold.
replaced.
installed and working. Allow
time for the cylinder to warm
up if it is cold.
24
Problem
Possible Cause
Action
Amber Low
• N2O cylinder not turned on.
• Ensure the N2O cylinder is fully
Difficulty
• Trapped N2O within the system.
• Power-On the cryoICE BOX
Wrench Icon
• Heater band over temperature
• Unplug heater band if clicking
Pressure
Indicator on N2O
icon flashing.
connecting a
cryoICE probe to
the cryoICE BOX.
• Quick connector out of
sequence, sleeve on blue
connector is forward.
• Quick connector O-ring dried
out and/or swelling.
turned on.
which clears trapped gas
exerting pressure on the
connector.
• Push the sleeve toward the
cryoICE BOX
until it locks back.
(usually clicks)
• Lubricate the connector inside
with silicon-based O-ring.
lubrication such as AtriCure Part
No. C002502.
flashing and
clicking heard
inside cryoICE
BOX, may also
include display
flashing.
• Heater band over temperature
due to empty N2O Cylinder.
due to loose fit on N2O cylinder.
stops and/ or display flashing
stops, check if tank is warm to
the touch – If so, tank is likely
empty, replace tank with full
tank. Power-off, then Power-on
cryoICE BOX to reset wrench
Icon.
• Heater band is to be tight and
positioned at bottom of tank,
cord at top edge. If problem is
not corrected by above two
actions, return cryoICE BOX and
heater band to AtriCure.
25
Problem
Possible Cause
Action
cryoICE probe
• The cryoICE BOX and probe
• If probe does not reach desired
• The N2O quality is not adequate
• Medical grade nitrous oxide,
• N2O cylinder contains a siphon
• Verify the N2O cylinder does not
getting colder
than -75°C and
not defrosting.
system are flooded with liquid
N2O.
defrost temperature, apply
warm sterile saline to the tissue
and probe area as necessary.
• Replace the Tank Hose Assembly
which has canister set with Tank
Hose Assembly without canister
set.
A001056 – Domestic Tank Hose
Assembly without canisters
A001055 – International Tank
Hose Assembly without canisters
• Power-On cryoICE BOX within a
few minutes of cryoICE probe
use to minimize N2O condensing
in system.
to be used as a refrigerant.
tube or a dip tube.
26
3ppm water maximum, is
preferred for use with AtriCure
cryogenic Devices.
contain a siphon tube or dip
tube. Cylinder valve body
should be blank (no mark of: S,
DT, or D.)
AtriCure cryoICE BOX Error Codes
If an error condition should occur, the Maintenance Needed Indicator or the System Fault
Indicator will illuminate. The probe Temperature display on the front panel will temporarily
display one of the following error codes during the power-up sequence. Contact AtriCure
Service if one of these conditions occurs.
Error ID Error Likely Cause
001 No 24 VDC Fuse (F2)
002 Cylinder Over Temperature Heater blanket
003 probe Overpressure Pressure regulator
004 Unwanted probe Pressure Leaky inlet valve
005 No 230 VAC Fuse (F1)
008 Cylinder Over Pressure/Temperature Overheated Cylinder
PPP Power On Self-Test Error
Activation Button/Footswitch
Pressed during power up
27
Harmonic distortion
See IEC 61000-3-2 b) (Class A)
a) Professional healthcare facility environment.
Guidance and manufacturer’s declaration – Enclosure Port Immunity
The AtriCure cryoICE BOX is intended for use in the electromagnetic environment specified below. The customer
or the user of the AtriCure cryoICE BOX unit should assure that it is used in such an environment.
Immunity Test Levels
Professional healthcare facility
environment
± 8 kV contact
± 2kV, ± 4kV, ± 8kV, ± 15 kV air
3 V/m f)
80% AM at 1kHz c)
Refer to Table 9 in IEC 60601-1-
equipment
Rated power frequency magnetic
fields
30 A/m g)
50 Hz or 60 Hz
a) The interface between the PATIENT physiological signal simulation, if used, and the AtriCure cryoICE BOX shall
for the minimum expected distance.
9. ELECTROMAGNETIC COMPATABILITY TABLES
Electromagnetic Emissions
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The AtriCure cryoICE BOX is intended for use in the electromagnetic environment specified below. The customer
or the user of the AtriCure cryoICE BOX
Phenomenon Professional healthcare facility environment a)
Conducted and radiated RF EMISSIONS CISPR 11 (Group 1, Class A)
Voltage fluctuations and flicker IEC 61000-3-3 b)
b) This test is not applicable in this environment unless the AtriCure cryoICE BOX used there will be connected to
the PUBLIC MAINS NETWORK and the power input Is otherwise within the scope of the Basic EMC standard.
Electromagnetic Immunity – Enclosure Port
unit should assure that it is used in such an environment.
Phenomenon Basic EMC standard or test method
ELECTROSTATIC DISCHARGE IEC 61000-4-2
Radiated RF EM fields a) IEC 61000-4-3
Proximity fields from RF wireless
communications equipment
d) e)
be located within 0.1 m of the vertical plane or the uniform field area in one orientation of the AtriCure cryoICE
BOX.
b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for its operation shall be
tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the
RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an
intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve
normal reception during the test.
c) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
d) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
e) During the test, the AtriCure cryoICE BOX may be powered at any NOMINAL input voltage, but with the same
frequency as the test signal.
f) Before modulation is applied.
g) This test level assumes a minimum distance between the AtriCure cryoICE BOX and sources of power frequency
magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the AtriCure cryoICE BOX will be used closer than
15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate
IEC 61000-4-3
IEC 61000-4-8
80 MHz – 2.7 GHz b)
2:2014 – Test specification for
Enclosure Port Immunity to RF
wireless communication
28
Guidance and manufacturer’s declaration – Input A.C Power Port Immunity
The AtriCure cryoICE BOX is intended for use in the electromagnetic environment specified below. The customer
or the user of the AtriCure cryoICE BOX unit should assure that it is used in such an environment.
Immunity Test Levels
Professional healthcare facility
environment
Electrical fast transients / bursts
a)
± 2 kV
100 kHz repetition frequency
Surges
a) b) j) o)
Line-to-line
± 0.5 kV, ± 1 kV, ± 2 kV
3 V/m m)
80% AM at 1kHz e)
0% UT; 0.5 cycle g)
270° and 315° q)
0% UT: 1 cycle
Single phase: at 0°
Voltage interruptions
f) i) o) r)
IEC 61000-4-11
0% UT: 250/300 cycle h)
a) The test may be performed at any one power input voltage within the AtriCure cryoICE BOX’s RATED voltage
q) At some phase angles, applying this test to ME EQUIPMENT with transformer mains power Input might cause
Electromagnetic Immunity – Input A.C. Power Port
Phenomenon Basic EMC standard or test method
l) o)
IEC 61000-4-4
IEC 61000-4-5 ± 0.5 kV, ± 1 kV
a) b) j) k) o)
Surges
Line-to-ground
Conducted disturbances
Induced by RF fields
c) d) o)
IEC 61000-4-5
IEC 61000-4-6
0.15 MHz - 80 MHz
6 V/m
0.15 MHz and 80 MHz
At 0°, 45°, 90°, 135°, 180°, 225°,
Voltage dips
f) p) r)
IEC 61000-4-11
And
70% U
range. If the AtriCure cryoICE BOX is tested at one power input voltage, It Is not necessary to re-test al additional
voltages.
b) All AtriCure cryoICE BOX cables are attached during the test.
c) Calibration for current injection clamps shall be performed in a 150 Ω system.
d) If the frequency stepping skips over an ISM or amateur band, as applicable, an additional test frequency
shall be used In the ISM or amateur radio band. This applies to each ISM and amateur radio band within the
specified frequency range.
e) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
f) ME EQUIPMENT and ME SYSTEMS with a D.C. power input intended for use with A.C.-to-D.C. converters shall be
tested using a converter that meets the specifications of the MANUFACTURER of the ME EQUIPMENT or
ME SYSTEM. The IMMUNITY TEST LEVELS are applied to the A.C. power input of the converter.
g) Applicable only to ME EQUIPMENT and ME SYSTEMS connected to single-phase A.C. mains.
h) E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
i) ME EQUIPMENT and ME SYSTEMS with RATED Input current greater than 16 A/phase shall be interrupted once
for 250/300 cycles at any angle and at all phases at the same time (if applicable). ME EQUIPMENT and ME
SYSTEMS with battery backup shall resume line power operation after the test. For ME EQUIPMENT and
ME SYSTEMS with RATED input current not exceeding 16 A, all phases shall be interrupted simultaneously.
j) ME EQUIPMENT and ME SYSTEMS that do not have a surge protection device in the primary power circuit may
be tested only at ± 2 kV line{s) to earth and ± 1 kV line(s) to line(s).
k) Not applicable to CLASS 11 ME EQUIPMENT and ME SYSTEMS.
I) Direct coupling shall be used.
m) R.M.S., before modulation Is applied.
n) The ISM (Industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to
6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz The
amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz
to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz,
21.0 MHz lo 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
o) Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A/phase and
ME EQUIPMENT and ME SYSTEMS with RATED Input current greater than 16 A/phase.
p) Applicable to ME EQUIPMENT and ME SYSTEMS with RATED Input current less than or equal to 16 A/ phase.
m)
in ISM bands between
: 25/30 cycles h)
T
n)
29
an overcurrent protection device to open. This can occur due to magnetic flux saturation of the transformer
RATED input voltage within the range.
Guidance and manufacturer’s declaration – Patient Coupling Port Immunity
The AtriCure cryoICE BOX is intended for use in the electromagnetic environment specified below. The customer
or the user of the AtriCure cryoICE BOX unit should assure that it is used in such an environment.
Immunity Test Levels
Professional healthcare facility
environment
± 8 kV contact
± 2kV, ± 4kV, ± 8kV, ± 15 kV air
3 V b)
80% AM at 1 kHz
a) The following apply:
PERFORMANCE.
core after the voltage dip. If this occurs, the AtriCure cryoICE BOX shall provide BASIC SAFETY during and after the
test.
r) For ME EQUIPMENT and ME SYSTEMS that have multiple voltage settings or auto ranging voltage capability, the
test shell be performed at the minimum and maximum RATED input voltage. ME EQUIPMENT and ME SYSTEMS
with a RATED input voltage range of less than 25 % of the highest RATED input voltage shall be tested at one
Electromagnetic Immunity – Input D.C. Power Port – Not Applicable
Electromagnetic Immunity – Patient Coupling Port
Phenomenon Basic EMC standard or test method
ELECTROSTATIC DISCHARGE c) IEC 61000-4-2
Conducted disturbances induced
by RF fields
- All PATIENT-COUPLED cables shalt be tested, either Individually or bundled
- PATIENT-COUPLED cables shall be tested using a current clamp unless a current clamp is not suitable. In
cases were a current clamp is not suitable, an EM clamp shall be used.
- No intentional decoupling device shalt be used between the injection point and the PATIENT COUPLING
POINT in any case.
- Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
- Tubes that are intentionally filled with conductive liquids end intended to be connected to a PATIENT shalt
be considered to be PATIENT-COUPLED cables.
- If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test
frequency shall be used In the ISM or amateur radio band. This applies to each ISM and amateur radio
band within the specified frequency range.
- The ISM (Industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to
6.795 MHz: 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The
amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz,
5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to
18.17 MHz, 21.0 MHz lo 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to
54.0 MHz.
b) R.M.S., before modulation Is applied
c) Discharges shall be applied with no connection to an artificial hand and no connection to PATIENT simulation.
PATIENT simulation may be connected after the test as needed in order to verify BASIC SAFETY and ESSENTIAL
a)
IEC 61000-4-6
0.15 MHz - 80 MHz
b)
6V
in ISM bands between
0.15 MHz and 80 MHz
30
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 cryoICE BOX Unit ............................................................................................. One (1) Year
AtriCure Cylinder Heater Band ..................................................................................... One (1) Year
AtriCure Gas Line Hose Assembly……………………………………………… ................................ One (1) Year
Grounded Electrical Cord .............................................................................................. One (1) Year
AtriCure Cryo Footswitch .............................................................................................. 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.
31
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