Pentax C2 CryoBalloon Mode D'emploi page 8

displayed does not resolve the fault condition, do not use the
system. Contact PENTAX Medical.
Cleaning and Disinfection
The reprocessing instructions are based on recommendations
found in the "Guideline for Disinfection and Sterilization in
Healthcare Facilities, 2008" by the USA Centers for Disease
Control (CDC).
This section provides guidelines for cleaning and disinfecting
the C2 CryoBalloon™ Controller. The Controller has a reuse
life of 1 year. Use EPA-registered disinfectant wipes and
provided brushes/swabs wetted by EPA-registered disinfectant
spray.
Caution: The Controller is rated for IPX0 (it has no protection
against ingress of liquids) – do not allow any fluid to enter t he
Controller.
1. Remove the Controller Cap and soak it in warm water for
at least 5 minutes.
2. Wipe all accessible surfaces on the Controller and the
Cap. Repeat until visible soils are removed.
3. Spray the Controller to adequately wet the external
surfaces. Brush all the external surfaces and swab the
inner exhaust ports.
Caution: Do not spray liquid disinfectant directly into the
catheter insertion port, the receptacle for the Cartridge, and the
cable receptacle.
4. Leave the Controller undisturbed for at least 4 minutes.
5. Wipe the Cap and all accessible surfaces on the
Controller. Use multiple wipes.
6. Allow the Controller assembly to dry prior to use.
This section provides guidelines to clean the C2
CryoBalloon™ Foot Pedal. The Foot Pedal has a reuse life of
3 years.
Caution: The Foot Pedal is rated for IPX6 (protection against
splashing of liquids; no protection against submersion) – do
not fully submerge the Foot Pedal.
1. Clean any visible soils with a mild soap and water
solution if necessary. Wipe clean.
2. Allow the Foot Pedal to dry prior to use.
Operation, Storage and Disposal
Operate and store the C2 CryoBalloon™ Ablation System as
follows:

Controlled room temperature environment with ambient
temperature from +10°C to +40°C

Relative humidity from 30% to 75%

Atmospheric pressure from 700 to 1060 hPa
Dispose of the C2 CryoBalloon™ System components in
accordance with standard hospital guidelines and local codes
for the disposal of medical waste and electronic waste.
EMC Compliance and Warning Statement
This equipment has been tested and found to comply with the
limits of the standard for medical devices, IEC 60601-1-2. The
LBL-1045 Rev 12
limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This
equipment generates, uses and can radiate radio frequency
energy, and, if not installed and used in accordance with the
manufacturer's instructions may cause harmful interference to
other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. If
this equipment causes interference with other devices, which
may be determined by turning the equipment off and on, the
user should notify the hospital safety personnel and try to
correct the interference by one or more of the following
measures:

Reorient or relocate the device receiving the interference.

Increase the separation between the equipment.

Consult the manufacturer for help.
FCC/IC Compliance and Warning Statement
Changes or modifications not expressly approved by the
manufacturer could void the user's authority to operate the
equipment.
NOTE: This equipment has been tested and found to comply
with the limits for a Class A digital device, pursuant to part 15
of the FCC Rules
designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct
the interference at their own expense.
EMC Guidance and Declaration
The CryoBalloon Ablation System is intended for use in t h e
electromagnetic environments described in the tables below.
The customer or user of the system should assure that is used
in such an environment.
Immunity Test
Test Level
Electrostatic ± 6 kV
Discharge contact
(ESD)
IEC 61000-4- ± 8 kV
2
Power
Frequency
(50/60 Hz)
3 A/m
magnetic
field
IEC 61000-
4-8
Radiated
3 V/m
RF
80 MHz
IEC 61000-
to 2.5
4-3
GHz
PENTAX Medical
and Canada ICES-003. These limits are
ELECTROMAGNETIC IMMUNITY
Compliance Electromagnetic environment
Level
Floors should be wood, concrete
± 6 kV or ceramic tile. If floors are
covered with synthetic material,
contact
the relative humidity should be at
± 8 kV air least 30%
air
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
3 A/m commercial hospital environment
P ortable and mobile RF
communications equipment should be
used no closer to any part of the
3 V/m
CryoBalloon Ablation Controller, than
80 MHz to 2.5
the recommended separation distance
GHz
calculated from the equation
applicable to the frequency of the
transmitter.
guidance
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