4
Introduction
The Frigitronics
®
CE-2000
TM
is a
completely non-electric,
(Battery Operated Display) low-pressure, fully exhausted
cryosurgical system that uses readily available nitrous
oxide gas.
INDICATIONS FOR USE: The CE-2000 CryoSurgery
System is designed to perform procedures in
Ophthalmology, as well as Otolaryngology, Gynecology
and Proctology. It is intended to destroy tissue during
surgical procedures by applying extreme cold. The system
provides controlled freezing temperature down to a
maximum of -89 ºC. The complete CE-2000 Cryosurgical
System consists of a control console with foot pedal,
mobile equipment carrier, nitrous oxide cylinders and
cryosurgical probes.
The system operates on the Joule-Thomson principle
where pressurized gas expands through a fine orifice,
producing a rapid drop in temperature.
Rapid freezing of the probe tip is started by depressing the
foot pedal. Release of the foot pedal causes warm low
pressure gas to flow through the probe for defrosting. The
backlight display activates automatically when the foot
pedal is depressed.
An
automatic shut-off
built into the system will stop the
flow of nitrous oxide gas and will shut off the backlight
and display approximately 4 minutes after the probe has
been set aside. The system can be reactivated by simply
depressing the foot pedal. A
wide range of probes
are
available for use with the CE-2000 and are outlined on
page 9.
Caution Statements
Rx ONLY: CAUTION: U.S. Federal law restricts this
device to sale by or on the order of a physician.
Only health care professionals trained in use of
Cryosurgical technique in the medical application in the
field of Ophthalmology, Gynecology, Otorhinolaryngology
and Proctology should use this device. Use only MEDICAL
GRADE Nitrous Oxide in this Device. This device is
supplied with indexed cylinder connectors specifically
designed to prevent inadvertent use with other gases. This
device is designed and shipped with cylinder fittings and
yokes specified for Nitrous Oxide. Use of this device
results in Nitrous Oxide gas exhaust, which must be
properly vented. Do not restrict or limit the flow of gas in
any way. The hand-piece probe socket is intended to fit
CooperSurgical probes. No others should be substituted.
There are a number of probe tip configurations. It is highly
recommended that the user consider the intended
application and select from the options to achieve the
desired outcome. Always ensure that the safety latch is
engaged when inserting the probe plug into the probe jack
on the front of the unit. Use CSI part number 20566 Front
Exhaust Tube only for connection to probe. The foot pedal
must be released to allow the tip to defrost before
removing from tissue. The manufacturer has validated
sterilization parameters. However, it is recommended that
the user validate specific conditions under local protocol.
Information Statements
This device operates by achieving rapid frost/defrost
without directly exposing the surgeon or the surgical team
to electrical or high pressure. It is recommended that the
user pre-pressure test the device, prior to patient contact.
The control console is equipped with a pressure regulator
that cannot exceed 625 psi (44 kg/cm
2
). The control
console is equipped with a safety latch, which locks the
probe tube in place. All probes are pressure tested to
specifications far exceeding normal operating conditions.
The equipment contains two 9-volt batteries. There is no
EMI interference, certified to IEC60601-1-2:2001. The
patient contact material is coin silver. Silver has been used
successfully in medical devices for many years,
and is a proven anti-microbial agent. The CE-2000 is
Latex-Free.
Unpacking and Set-up
Unpacking
The CE-2000 console is packaged with the following
items: console with attached foot pedal (boxed), a delivery
line, a front and rear exhaust hose, and two 9-volt
batteries. The mobile equipment carrier is packaged with
four locking casters, mobile equipment frame with attached
cylinder harness, and two cylinder handles (“E” cylinders
only). Check all packing material for accessories and
components.
Please read this operation manual carefully
before using the system.
Set-up
1.
Unwrap foot pedal and affix the CE-2000 console (5) to
top of carrier by aligning the four pads on bottom of
console to the pads on the top of the carrier, pushing
down firmly on top corners to secure console.
2.
Install two 9-volt batteries for backlight display: one for
display, and one for backlight.
Summary of Contents for frigitronics CE-2000
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