GEM Hemochron 100 User Manual

5 - Quality Control(QC)
52 / 112
000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
5.1 Electronic Quality Control(EQC) Testing
CAUTION: If the EQC test feature is required (Yes), the instrument will be required to perform
validation testing at regular intervals. The factory default setting for this feature is required (Yes) but
can be changed using CCM. The manufacturer recommends that it be required (Yes). The decision to
require (Yes) or not require (No) this feature shall be determined by and is the responsibility of the
each institution.
When manually or automatically started, EQC testing will initiate 3 phases (ESV, EQC Level 1, and
EQC Level 2) of instrument validation. The rst phase, Electronic System Verication (ESV), begins the
testing sequence. Once ESV is complete and passes specic component checks, further comprehensive
validation tests immediately follow with EQC Level 1 and then EQC Level 2. Once all validation tests
successfully pass, the display will indicate EQC Pass, including the subtests evaluated. This information is
also stored in the instrument database.
If the EQC testing is aborted by the user, the test result will be displayed as Aborted. To view details of the
test result, select (Result Details). Pass or Aborted will be displayed next to each phase indicating
when the test was aborted.
If ESV fails during the course of EQC testing, neither EQC Level 1 or EQC Level 2 testing will begin. Similarly,
if ESV passes but EQC Level 1 fails, EQC Level 2 will not start. The display will indicate EQC Fail if ESV,
EQC Level 1, or EQC Level 2 testing does not meet ALL validation criteria. See “Troubleshooting” (page 65)
for assistance or contact Technical Support.
In addition to the EQC, an ESV test is automatically performed under the following conditions:
● After powering on the instrument.
● During EQC test.
● Before patient and LQC test (for patient test, the ESV is not shown on the display screen).
Table 8: ESV and EQC Tests
ESV EQC Level 1 EQC Level 2
Instrument
Component
• Internal Voltages
• Analytic Firmware CRC
• Assay Denition File CRC
• Calibration and Factory CRC
• Battery Health
• Real-Time Clock
• Processor Communication
• Heater ESV
• Pump ESV
• Camera
• Illumination
• Heater Level 1
• Pump Level 1
• Heater Level 2
• Pump Level 2
Test Run Time 3 seconds 120 seconds
Congured for 300 seconds,
total time = 180
Congured for 500 seconds,
total time = 380
Total elapsed time to perform an EQC test is approximately 5 or 8.5 minutes
(conguration dependent)

GEM Hemochron 100 Specifications

General

Brand	GEM
Model	Hemochron 100
Category	Measuring Instruments
Language	English