AtriCure cryoICE BOX ACM1, User Manual, Page: 4 / 62

IV
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 cryo ICE BOX also referred to as the
AtriCure Cryo Module (ACM) : ACM1.
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 cryo ICE BOX (A000896-4 assembly/
A000898-4 packaged assembly) with the AtriCure cryo ICE probes and AtriCure Component and Accessory De-
vices (See pages 12 through 15 of this manual for specific part numbers information.) This user manual is not a
reference to surgical technique.
INDICATIONS FOR USE/INTENDED PURPOSE
The AtriCure cryo ICE BOX is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous
oxide, to AtriCure’s cryo-ablation probes.
The intended purpose of the ACM Exhaust Hose Connector is an optional 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 meeting its intended purpose.
The ACM footswitch is used to activate the AtriCure cryoICE BOX as an alternative to using the Activation But -
ton on the front panel of the generator.
The AtriCure cryo ICE BOX unit is an electro-mechanical cryogenic surgical unit that delivers a cryogenic Nitrous
Oxide (N
2
O) energy source to a cryo ICE probe to create lines of ablation through tissue. The AtriCure cryo ICE BOX
is part of a system which includes the N
2
O gas cylinder, N
2
O gas line hose, N
2
O exhaust hose, cylinder heater band,
an optional footswitch, and single-use cryo ICE probes. The system provides controlled lesion forming tempera-
tures below -40°C (-40°F), with typical operating ranges between -50°C to -70°C (-58°F to -94°F).
The AtriCure cryo ICE BOX is designed to operate only with AtriCure designed and developed cryo ICE probes. The
AtriCure cryo ICE probe will be referred in this User’s Manual as the “ cryo ICE probe”.
This User’s Manual provides a description of the AtriCure cryo ICE BOX, its controls, displays, indicators, and a
sequence for its operation with the cryo ICE probe. This User’s Manual also supplies other information of impor -
tance to the user. For information about the cryo ICE probes, please refer to the cryo ICE probe Instructions for Use.
Do not operate the AtriCure cryo ICE BOX before thoroughly reading this manual.
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 cryo ICE BOX unit be read, understood, and followed before use.