BD Alaris Directions For Use Manual page 27

Alaris™ Gateway Workstation v1.3.x
Operating Precautions
Electromagnetic Compatibility and Interference
This Workstation is protected against the effects of external interference, including high energy
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radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated
by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones
etc .) and has been tested to EN/IEC 60601-1-2 and ETSI EN 301 489-17 (where applicable) .
The Workstation is a CISPR II Group 1 Class A device . When Alaris™ Infusion Pumps are attached
and operational, the system becomes a CISPR II Group 1 Class A system .
This Workstation is a CISPR II Group 1 Class A equipment and uses RF energy only for its internal
function in the normal product offering . Therefore, its RF emissions are very low and are not likely
to cause any interference with the nearby electronic equipment . However, this Workstation emits
a certain level of electromagnetic radiation which is within the levels specified by EN/IEC 60601-
2-24, EN/IEC 60601-1-2 and ETSI EN 301 489-17 (where applicable) . If however the Workstation
interacts with other equipment, measures should be taken to minimise the effects, for instance by
repositioning or relocation .
Therapeutic Radiation Equipment: Do not use the Workstation in the vicinity of any Therapeutic
Radiation Equipment . Levels of radiation generated by the radiation therapy equipment such as
a Linear Accelerator, may severely affect functioning of the Workstation . Consult manufacturer's
recommendations for safe distance and other precautionary requirements . For further
information, contact your local BD representative .
Magnetic Resonance Imaging (MRI): The Workstation contains ferromagnetic materials which
are susceptible to interference with magnetic field generated by the MRI devices . Therefore,
the Workstation is considered not to be MRI compatible . If use of the Workstation within an
MRI environment is unavoidable, then BD highly recommends securing the Workstation at a
MR
safe distance from the magnetic field outside the identified 'Controlled Access Area' in order to
evade any magnetic interference to the Workstation; or MRI image distortion . This safe distance
should be established in accordance with the manufacturers' recommendations regarding
electromagnetic interference (EMI) . For further information, refer to the product Technical Service
Manual (TSM) . Alternatively, contact your local BD representative for further guidance .
Modifications: The Workstation is tested and compliant with the relevant EMC claims only with the
recommended products . Use of any product , transducer or cable other than those specified by BD
may result in increased emissions or decreased Workstation immunity .
In some circumstances the Workstation may be affected by an electrostatic discharge through
air at levels above 15kV; or by radio frequency radiation above 10V/m . If the Workstation is
affected by this external interference, it remains in a safe mode and alerts the user by generating
a combination of visual indicators and audible tones . Should any encountered alarm condition
persist, even after user intervention, it is recommended to replace that particular Workstation and
quarantine for the attention of Qualified Service Personnel .
Portable RF Communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30cm (12 inches) to any part of the
Workstation including cables specified by the manufacturer. Otherwise degradation of the
performance of this Workstation could result.
The Workstation should not be used in close proximity to High Frequency (HF) surgical equipment .
Direct contact between HF surgical equipment and the Workstation and/or associated
components and cabling must be avoided .
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