Cautions - AtriCure cryoICE BOX Instructions For Use Manual

No modifications of this equipment are allowed to prevent risk of serious injury to patient or user.
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Equipment malfunction may occur.
Electric Shock Hazard: Connect the cryoICE BOX power cord to a properly grounded receptacle. Do not use
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power plug adapters to prevent risk of serious injury to patient or user.
• 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
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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
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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
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antennas) should be used no closer than 30 cm (12 inches) to any part of the cryoICE BOX, including cables
specified by the AtriCure. Otherwise, degradation of the performance of this equipment could result.
• The ACM Exhaust Hose connector requires a dedicated Vacuum or WAGD port. Connecting multiple lines to
a single WAGD port may result in serious injury to patient.
Do not transition into FREEZE Mode until the cryoICE probe is properly positioned at the ablation site to
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prevent cryoablation of unintended tissue or structures.
Do not remove the cryoICE BOX cover as there is a potential for electrical shock. Refer to authorized
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personnel for service.

CAUTIONS

• Do not use the cryoICE BOX and Accessories if visible damage is observed.
Use only with the cryoICE probes intended for use with the cryoICE BOX. Use of other PROBES may result in
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improper device performance.
The system status indicators and displays are important safety features. Do not obstruct either the ablation
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or the system status indicators.
• Do not contact cryoICE probes with a RF device to prevent risk of electrical noise/interference with OR
equipment.
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• Compressed Air Hazard: Do not operate N O cylinders with a pressure greater than 1000 PSIG (6900 kPa) to
• prevent overpressure condition.
Nitrous Oxide connections should only be unplugged when the cryoICE BOX is in the READY Mode and
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properly vented to prevent gas from being trapped in inlet line and prohibiting handpiece connection.
• Trip Hazard: Standard care should be used to reduce the risk of tripping on the Footswitch cable, Power Cord,
as well as the N2O exhaust hose.
• 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.
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• 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.
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V 2023-04 | IFU-0093.A | en