Cardinal Health Alaris PK Directions For Use Manual page 14

Syringe pump
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Operating Precautions (continued)
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.
This pump is a CISPR 11 Group 1 Class A 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.
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. (Consult Technical
Service Manual for further information).
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.
Dangerous Voltage: An electrical shock hazard exists if the pump's casing is opened or removed. Refer all
servicing to qualified service personnel.
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 in the installation or its arrangement is in doubt, the pump
should be operated from the battery.
Do not open the RS232/ Nurse Call protective covering when not in use. Electrostatic discharge
(ESD) precautions 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.
The embedded pump software incorporates limits and pump configuration parameters. Qualified personnel
must ensure the appropriateness of the limits, the compatibility of the drugs, and the performance of each
pump, as part of the overall infusion. Potential hazards include drug interactions, and inappropriate delivery
rates and pressure alarms.
The Alaris® PK Syringe Pump does not contain any Latex.
1000DF00005 Iss. 2
Electromagnetic Compatibility & Interference
Hazards
Latex Content
13/44

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