Exigo H400 - Quality Assurance Functions

© Boule Medical AB, March 2018. Article no. 1504496 Page 39
5. Quality Control
Quality Assurance Functions
Quality Assurance Functions
The Exigo H400 system includes numerous Quality Assurance functions to ensure that the analyzer
and reagents are working properly and that the operator procedures are performed correctly.
The Exigo H400 system has been designed and manufactured according to Boule Medical ISO 13485
quality system procedures.
Analyzer Quality Assurance
 Before and during each measurement the analyzer performs a self-test to verify correct
operation on both the sub-system and system levels.
 A system check using blood control is recommended on a daily basis to assure the system is
functioning properly. The system uses barcodes to identify that the control materials are Boule
certied products.
 The analyzer has been factory calibrated prior to shipment, and has calibration functionality, if
necessary.
Reagent Quality Assurance
 Each lot of reagents have specic lot information assigned to them with the information
encoded in the barcode.
Software Quality Assurance
 The software has been designed with a variety of control features such as:
− Result memory storage – Allowing results to be stored, reviewed, printed, and sent to USB
devices and hosts.
− Barcodes – Restricting only Boule certied consumables and accessories to be used with
the analyzer.
− QC agging – If expired reagents, controls and/or calibrators are used, results will be
agged.
− Blocked results – Possible erroneous results cannot be viewed by operator if specied QC/
analysis conditions are not met.
 The software has several parameter and system information messages related to the measured
parameters and the analyzer. These messages alert the operator of possible pathologic samples
and parameter value and analyzer errors.
 For information on Third-party software see Appendix C.