Electromagnetic Compatibility And Interference; Hazards - BD Alaris GW 800 Series Directions For Use Manual

Electromagnetic Compatibility and Interference

• This 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
MR
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 .
• 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
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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,
BDTM00006 .

Hazards

• An explosion hazard exists if the Pump is used in the presence of flammable anaesthetics . Exercise care to
locate the Pump away from any such hazardous sources .
• A fire hazard may exist if the Pump is used in the presence of high oxygen concentrations .
• Dangerous Voltage: An electrical shock hazard exists if the Pump's casing is opened or removed . Refer all
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servicing to Qualified Service Personnel .
• Electrostatic discharge (ESD) precautions are required when connecting RS232/Nurse Call . Touching the pins
V
of the connectors may result in ESD protection failure . It is recommended that all actions must be taken by
appropriately Qualified Service Personnel .
• If this Pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or
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otherwise suspected to have been damaged, remove it from service for inspection by Qualified Service
Personnel . When transporting or storing the Pump, use original packaging where possible, and adhere to
temperature, humidity and pressure ranges stated in the Specifications section and on the outer packaging .
• Warning: Alaris GW 800 Volumetric Pumps should not be modified or altered in any way, except where
explicitly directed or authorised by BD . Any use of Alaris GW 800 Volumetric Pumps which have been altered
or modified otherwise than in strict application of directions provided by BD, is at your sole risk, and BD
does not provide any warranty for or endorsement on any Alaris GW 800 Volumetric Pump that has been so
modified or altered . BD product warranty shall not apply in the event the Alaris GW 800 Volumetric Pump
has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of
unauthorised modification or alteration of the Alaris GW 800 Volumetric Pump .
BDDF00160 Issue 1
Alaris™ GW Volumetric Pumps
Operating Precautions
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