baxter Colleague 3 CXE, Руководство оператора

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9
Electromagnetic Compatibility Statement
9-14
COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL 071960491
Electromagnetic Compatibility Statement
This statement and the information provided in Tables 9-3 through 9-6
are required by IEC 60601-1-2, second edition. The tables can be used to
identify the electromagnetic compatibility (EMC) standards the pump
was subjected to, the minimum test level identified in the standard, the
level that the pump meets and general guidance on the EMC
environment. The pump is intended for use in the electromagnetic
environment specified in the following tables. As with most
microprocessor-based electronic products, the pump creates RF (radio
frequency) energy as a side effect of its internal functions. The essential
performance of the pump is volumetric accuracy.
Precautions should be taken to avoid exposing the pump to powerful
sources of electromagnetic radiation such as MRI (magnetic resonance
imaging).
Note that portable and mobile communications equipment such as
cellular phones can affect medical electrical equipment such as the
pump.
! WARNING !
The use of accessories and cables other than those specified in this manual, with
the exception of cables sold by Baxter as replacement parts for internal
components, may result in increased emissions, decreased immunity or may
result in operation that is not within the constraints and parameters of the device.
Use only accessory equipment complying with the device's safety requirements;
failure to do so may lead to reduced safety levels of the resulting system.
Consideration relating to accessory choice shall also include:
•
Use of the accessory in the patient vicinity
•
evidence the safety certification of the accessory has been performed in
accordance with the appropriate UL 60601-1 or IEC/EN 60601-1 harmonized
national standard.
! WARNING !
The pump should not be used adjacent to or stacked with other electrical
equipment. If adjacent or stacked use is necessary, the pump should be observed
to verify normal operation in the configuration in which it will be used.
! WARNING !
As with all medical electronic equipment, care must be exercised to avoid
exposing this device to powerful sources of electromagnetic interference. This
device design has been tested to current U.S. and European standards and
guidelines for medical devices. The device was not found to be affected
adversely by these susceptibility tests and will perform safely. The device's
emissions also were found to be acceptable. Using the pump near operating
equipment which radiate high energy radio frequencies (such as electrosurgical/
cauterising equipment, two-way radios, or cellular telephones) may cause false
alarm conditions. If this happens, reposition the pump away from the source of
interference; or turn off the pump and, if clinically necessary, manually regulate
the flow with the regulating clamp according to your facility's guidelines.