Breg VPULSE Manual Del Usuario página 10

Never drop or insert any object into any
opening
Excessive lint or dust may impede the flow
of water through the system. To minimize this
occurrence, keep the handle properly installed
and fully engaged when not filling or emptying
the device.
DO NOT stand on or in the appliance.
DO NOT place the appliance or operate the
appliance while it is on a surface more than 1 foot
above the floor.
Unplug this product before filling or
cleaning. Fill with water and ice or water and Ice
Bottles provided by Breg only. DO NOT use any
Ice Bottles other than those provided by Breg.
`DO NOT place the tubing set, power cord
or use any pad around the neck to avoid the
possibility of strangulation.
Electrical Safety
When using an electrical appliance, especially
when children are present, basic safety
precautions should always be followed.
Electromagnetic Interference
This device has been tested and found to
comply with the limits for Medical Devices
according to IEC 60601-1-2:2014+AMD1:2020.
These limits are designed to provide
reasonable protection against harmful
interference in typical medical installations.
This equipment generates and radiates radio
frequency energy and, if not installed and used
in accordance with the instructions, may cause
harmful interference to other devices in the
vicinity. There is no guarantee that interference
does cause harmful occurrence in a particular
installation.
If this equipment does cause harmful
interference to other devices, which can be
determined by turning the equipment off and
on, the user can try to correct the interference
by one or more of the following measures:
• Reorient or relocate this device.
• Increase the physical separation between this
device and the other devices(s).
• Connect the equipment into an outlet or
circuit different from the one where the other
device(s) are connected.
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Essential Performance
This device contains Essential Performance per
IEC 60601-1, Edition 3.2 and IEC 60601-1-2,
Edition 4.1
The VPULSE system notifies the user through
audible/visual alarms when the sequential
therapy mode ceases to function or delivers a
pressure out of the specified range.
Environmental Conditions
This device has been tested and found to
comply with the environmental conditions
for Medical Devices according to IEC
60601-1-2:2014+AMD1:2020 and IEC
60601-1-6:2010+AMD1:2013+AMD2:2020.
These conditions are designed to provide
reasonable environmental operating ranges
for the equipment. Extreme changes in
the environmental conditions or operating
outside the specific operating ranges, such as
temperatures, pressure and humidity, may impact
the performance of this device. The user can try
to correct these conditions by relocating this
device to a more moderate environment.
Interference From Other Products
If this equipment is interfered with by other
devices, which can be determined by turning that
equipment off and on, the user can try to correct
the interference by one or more of the following
measures:
• Reorient or relocate this device.
• Increase the physical separation between this
device and the other devices(s).
Electromagnetic Interference and Emissions
Use of this equipment adjacent to or
stacked with other equipment should be
avoided because it could result in improper
operation.
Use of accessories, transducers and cables
other than those specified or provided by the
manufacturer of this equipment could result
in increased electromagnetic emissions or
decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment
(including peripherals such as antenna cables
and external antennas) should be used no closer
that 30 cm (12 inches) to any part of the VPULSE
including cables specified by the manufacturer.
Otherwise, degradation of the performance of
this equipment could result.
DANGER – TO REDUCE THE RISK OF
ELECTRICAL SHOCK, DO NOT DISASSEMBLE
THE UNIT. REFER SERVICING TO THE
MANUFACTURER:
1. Always unplug this appliance from the
electrical outlet immediately after using and
before cleaning.
2. DO NOT use while bathing or in a shower.
3. DO NOT place or store appliance where it can
fall or be pulled into a tub or sink. DO NOT
place in or drop into water or other liquid.
4. DO NOT reach for a product that has fallen
into water. Unplug immediately.
Only use the power supply provided with the
unit. Failure to do this could damage the unit,
power supply, and/or create a potential injury to
the patient. Please contact Breg Customer Care if
a replacement wall adapter is required.
Never operate this appliance if it has a
damaged cord, plug or wall adapter, if it is not
working properly, if it has been dropped or
damaged, or dropped into water.
Keep the power cord away from heated
surfaces.
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