1000DF00480 Issue 2 8/48
Operating
Pressure
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The pumping pressure alarm system is not designed to provide protection against, or detection
of, extravasation or tissuing complications which can occur.
•
The pump is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be
performed to ensure the infusion is proceeding as expected. It is a positive displacement delivery system,
capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered
in practice, including resistances to flow imposed by small gauge catheters, filters and intra-arterial infusion.
It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions.
Alarm Conditions
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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.
Electromagnetic Compatibility and Interference
M
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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.
•
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 A device when the model 180 (Flow Sensor) is used and a
CISPR 11 Group 1 Class B device without the use of the model 180 (Flow Sensor). The pump uses
RF energy only for its internal function in the normal product offering. In a domestic environment,
this system may cause radio interference. Reorienting, relocating or shielding the system, or
filtering the connection to the public mains network, are examples of steps that can be taken
to reduce or eliminate interference. 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.
•
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.
Earth Conductor
d
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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.
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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.
Operating Precautions (continued)
