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Operating Environment
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When using any infusion pump in conjunction with other pumps or devices requiring vascular access,
extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation in
pressures created within the local vascular system by such pumps. Typical examples of those pumps are used
during dialysis, bypass or cardiac assist applications.
•
This pump is suitable for use in Hospital and clinical environments other than domestic establishments and
those directly connected to the public single phase AC mains power supply network that supplies buildings
used for domestic purposes. However, it may be used in domestic establishments under the supervision of
Medical professionals with additional necessary appropriate measures. (Consult Technical Service Manual,
appropriately trained qualified service personnel or CareFusion for further information).
•
This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen
or nitrous oxide.
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 qualified service 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 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.
•
For further information on electromagnetic compatibility, please consult Technical Service Manual,
1000SM00006.
1000DF00430 Issue 4
Alaris® GW Volumetric Pumps
Operating Precautions
7/36
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