Creating A Data Set - CareFusion Alaris CC Guardrails 80033UND1-G Directions For Use Manual

To use the Alaris® CC Guardrails® Syringe Pump a Data Set will need to be developed, reviewed, approved, released, uploaded and verified
according to the following process. Refer to the Guardrails® Editor Directions For Use (1000PB01398) for further details and operating
precautions.
1. Create Master Lists (Using Guardrails® Editor)
Master Drugs*
Syringe Library
2. Create Care Area Profiles (Using Guardrails® Editor)
Drug Library*
Configuration**
3. Review, Approve and Release Data Set (Using Guardrails® Editor)
Review and Approve
Release
4. Upload Data Set to Alaris® CC Guardrails® Syringe Pump enabled (Using Guardrails® Editor Transfer Tool)
Data Set transfers should only be performed by qualified technical personnel.
5. Verify Data Set Upload
First or Individual Pump Verification
Subsequent Pumps Verification
* Note: Drug parameters have to be in accordance to local regulation and prescribed information.
** See important note in Configured Options section.

Creating a Data Set

A list of drug names and standard concentrations. The Software can store an
unlimited number of entries depending on disk space. Note: When using a
combination of two or more drugs, the dose rate can only be configured for one
drug. Up to 19 characters are available to name the drug or the combination.
Configure syringes enabled for use.
Drugs and concentrations for a Profile with minimum & maximum limits and
occlusion alarm level. Up to 100 drug set-ups can be entered for each of the
available 10 Profiles.
Pump configuration settings, General Options and Units for Dosing Only.
Entire Data Set Report to be printed, reviewed and signed as proof of approval by
an authorised person, according to Hospital protocol. Signed printout to be kept
safe by hospital for use during verification procedure.
Data Set status to be promoted to Released (Password is required).
On completion of upload, record CRC (Cyclic Redundancy Check) number shown
on the Alaris® CC Guardrails® Syringe Pump. Download the Data Set from the
pump using the Verification Tool. Compare Data Set downloaded with approved
signed Data Set printout. Reviewer should sign the printout and also record the
CRC number on the printout as a record.
On subsequent uploads of the Data Set compare CRC number on pump with CRC
number recorded in First Pump Verification.
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