Electromagnetic Compatibility & Interference - BD Alaris 8002TIG03 Directions For Use Manual

Electromagnetic Compatibility & Interference
• The Pump is protected against the effects of external interference, including high energy radio frequency
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emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and
cauterising equipment, large motors, portable radios, cellular telephones etc .) and is designed to remain
safe when unreasonable levels of interference are encountered .
• Therapeutic Radiation Equipment: Do not use the Pump in the vicinity of any Therapeutic Radiation
Equipment . Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator,
may severely affect functioning of the Pump . Please consult manufacturer's recommendations for safe
distance and other precautionary requirements . For further information, please contact your local BD
representative .
• Magnetic Resonance Imaging (MRI): The Pump contains ferromagnetic materials which are susceptible
to interference with magnetic field generated by the MRI devices . Therefore, the Pump is not considered
an MRI compatible Pump as such . If use of the Pump within an MRI environment is unavoidable, then BD
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highly recommends securing the Pump at a safe distance from the magnetic field outside the identified
'Controlled Access Area' in order to evade any magnetic interference to the Pump; or MRI image distortion .
This safe distance should be established in accordance with the manufacturers' recommendations
regarding electromagnetic interference (EMI) . For further information, please refer to the product
Technical Service Manual (TSM) . Alternatively, contact your local BD representative for further guidance .
• Accessories: Do not use any non-recommended accessory with the Pump . The Pump is tested and
compliant with the relevant EMC claims only with the recommended accessories . Use of any accessory,
transducer or cable other than those specified by BD may result in increased emissions or decreased
Pump immunity .
• This Pump is a CISPR 11 Group 1 Class A device 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 Pump emits a certain level of
electromagnetic radiation which is within the levels specified by IEC/EN60601-1-2 and IEC/EN60601-2-24 . If
the Pump interacts with other equipment, measures should be taken to minimise the effects, for instance
by repositioning or relocation .
• In some circumstances the Pump may be affected by an electrostatic discharge through air at levels close
to or above 15kv; or by radio frequency radiation close to or above 10v/m . If the Pump is affected by
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this external interference the Pump will remain in a safe mode; the Pump will duly stop the infusion and
alert the user by generating a combination of visual and audible alarms . Should any encountered alarm
condition persist even after user intervention, it is recommended to replace that particular Pump and
quarantine the Pump for the attention of appropriately trained technical personnel . (Consult Technical
Service Manual for further information) .
BDDF00001 Issue 5 13/56
Alaris™ Syringe Pumps
Operating Precautions