CareFusion Alaris PK Plus MK4 8005PK201 Directions For Use Manual page 16

Electromagnetic Compatibility and 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
CareFusion 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
CareFusion highly recommends securing the Pump at a safe distance from the magnetic field outside
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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 manufacturer's
recommendations regarding electromagnetic interference (EMI). For further information, please refer to
the product Technical Service Manual (TSM). Alternatively, contact your local CareFusion 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 CareFusion 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 Qualified Service Personnel. (Consult Technical Service Manual
for further information).
1000DF00741 Issue 5
Alaris™ PK Plus Syringe Pump
Operating Precautions
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