Creating A Data Set - Cardinal Health Alaris PK Directions For Use Manual

To fully utilise the Alaris® PK Syringe Pump a Data Set will need to be developed, reviewed, approved, released, uploaded and verified
according to the following process. Refer to the Alaris® PK Editor Software Directions for Use (1000CH00016) for further details and operating
precautions.
1. Create Master Lists (Using Alaris® PK Editor Software)
Master Drugs*
Alaris® PK Syringe Library
2. Create Profile (Using Alaris® PK Editor Software)
Drug Library*
Configuration**
3. Review, Approve and Release (Using Alaris® PK Editor Software)
Review and Approve
Release
4. Upload Data Set to Alaris® PK Syringe Pump (Using Alaris® PK Editor Transfer Tool)
Data Set transfers should only be performed by qualified technical personnel.
5. Verify Data Set Upload
First or Individual Instrument Verification
Subsequent Instruments 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. These may be for TIVA use or may have an
associated PK/PD model for TCI use.
Configure syringes enabled for use.
Drugs and concentrations for this profile with defaults, minimum & maximum limits and targets and
occlusion level.
Instrument configuration settings and general options.
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 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® PK
Syringe Pump.
Download the Data Set from the pump using the Alaris® PK Verification Tool.
Compare Data Set downloaded with the approved signed Data Set printout. Reviewer should sign the
printout and also record the CRC number on the printout as record.
On subsequent uploads of the Data Set compare CRC number on the instrument with CRC number
recorded on First Instrument Verification.
1000DF00005 Iss. 2
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