Operating Pressure; Alarm Conditions; Guardrails Safety Software; Hazards - BD Alaris 8002TIG03 Directions For Use Manual

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Operating Pressure

This is a positive pressure Pump designed to achieve very accurate fluid administration by automatically
compensating for resistance encountered in the infusion system .
The pumping pressure alarm system is not designed to provide protection against, or detection of, IV
complications which can occur .

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 .
Alarm tone settings are preserved in the case of power loss, however some system faults will result in loss
of alarm settings . The new alarm tone settings will be stored when powering down from tech mode after
a change . The settings will be lost if a cold-start is performed, but should be saved for faults that don't
require a cold start .

Guardrails Safety Software

Guardrails
The Guardrails Safety Software incorporates soft dosing limits and Pump configuration parameters based
on hospital protocol . The software adds a test of reasonableness to drug programming based on the
limits defined by the hospital . Qualified personnel must ensure the appropriateness of the drug dosing
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 .
When loading a data set with the Guardrails Safety Software, the user must ensure the correct profile is
selected prior to starting an infusion .

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 .
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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)
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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 the 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 Qualified Service
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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 Syringe Pumps should not be modified or altered in any way, except where explicitly
directed or authorised by BD . Any use of Alaris Syringe 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 Syringe Pump that has been so modified or
altered . BD product warranty shall not apply in the event the Alaris Syringe Pump has suffered damage
or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised
modification or alteration of the Alaris Syringe Pump .
Care must be taken when removing covers or handling moving mechanisms .
All pumps in a single care area should be configured with the same alarm tones to avoid User confusion .
BDDF00001 Issue 5
12/56
Alaris™ Syringe Pumps
Operating Precautions

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