CareFusion Alaris GP Directions For Use Manual page 10

Alarm Conditions
• Several alarm conditions detected by this pump will stop the infusion and generate visual and audible
alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no
alarms are operating.
Alaris®
GP
Electromagnetic Compatibility and Interference
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• This pump is protected against the effects of external interference, including high energy 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 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
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 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.
• 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
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.
• This pump is a CISPR 11 Group 1 Class B 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
Alaris®
GP
interference with the nearby electronic equipment. However, this pump emits a certain level of
electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24 and IEC/EN60601-
1-2. If the pump interacts with other equipment, measures should be taken to minimise the effects, for
instance by repositioning or relocation.
Earth Conductor
• The pump is a Class I device, therefore must be earthed when connected to an AC power supply.
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• This pump also has an internal power source.
• When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used.
If the integrity of the external protective conductor on the AC power cable has been compromised, the
pump should be disconnected from the AC power source and operated utilising the internal battery.
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Alaris™ GP (Guardrails™) Volumetric Pump
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Operating Precautions