CareFusion Alaris GP Guardrails Directions For Use Manual page 10

Volumetric pump
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This pump is protected against the effects of external interference, including high energy radio frequency
M
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 interference with the
nearby electronic equipment. However, this pump emits a certain level of electromagnetic radiation which
Alaris®
GP
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.
The Alaris® GP Guardrails® Volumetric Pump is a Class I device, therefore must be earthed when connected to an
d
AC power supply.
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.
B
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.
m
Dangerous Voltage: An electrical shock hazard exists if the pump's casing is opened or removed. Refer all servicing
to qualified service personnel.
Do not open the RS232/Nurse Call protective covering when not in use. Electrostatic discharge (ESD) precautions
V
are required when connecting RS232/Nurse Call. Touching the pins of the connectors may result in ESD protection
failure. It is recommended that all actions must be taken by appropriately trained personnel.
If this pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise
suspected to have been damaged, remove it from service for inspection by a qualified service engineer. 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.
If this pump behaves abnormally, remove from service and contact a qualified service engineer.
Care should be taken to ensure power leads and RS232 cables do not present a trip hazard.
Care should be taken in the placement of power leads and RS232 cables to prevent accidental tugging.
Operating Precautions (Continued)
Electromagnetic Compatibility and Interference
Earth Conductor
1000DF00498 Issue 3
9/42
Hazards

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