Technical Specifications - A.MENARINI GLUCOFIX TECH User Manual

Blood sample error. The blood sample did
not fill the sample area of the strip during the
measurement because the sample was not
applied correctly or the volume was insufficient.
Repeat the test with a new strip after correctly
puncturing your finger (§4.1).
The strip was removed or disturbed during the
countdown. Repeat the test with a new test strip.
NFC disconnection during transmission. Repeat
the NFC transmission. If the problem persists,
please contact the customer service.
Low battery. Change the batteries according to
the instructions (§7.3).
The temperature was not within the recommended
range. Repeat the measurement after at least 30
minutes, when the operating temperature has
been restored.
8.3. Unexpected test results
If the test result is unusual compared to your previous test results:
1. Repeat the measurement using a new test strip (§4.2).
2. Perform a control measurement using the GLUCOFIX® TECH Control
control solution (§4.3).
3. Change the test strip vial and repeat the measurement using a new
test strip (§4.2).
4. If you are still uncertain about the test results, contact your doctor or
healthcare professional.
WARNING
● In case of an unexpected reading, consult your doctor or healthcare
professional before altering your treatment.
● If the test results continue to be unusual, please, contact the
A. Menarini Diagnostics customer service.

9. Technical specifications

Product: GLUCOFIX® TECH
Manufacturer: A. Menarini Diagnostics srl
Tested item: Blood Glucose level
Unit of mg/dL (mmol/L)
measurement:
Test Range: 20 – 600 mg/dL (1.1 – 33.3 mmol/L)
Haematocrit range: 10 – 70% (haematocrit compensated)
Test strip: GLUCOFIX® TECH Sensor
Test strip coding: No coding required
Sample: Fresh capillary whole blood
Sample size: Minimum 0.5 µL
Test time: 5 seconds
Assay Method: Electrochemical,
Aspergillus niger
Mediator: Hexacyanoferrate(III) ion.
6
Glucose Oxidase (GOD,
sourced) based method.
Calibration and The results are equivalent to the plasma glucose
traceability: concentration (capillary plasma referenced).
The GLUCOFIX® TECH system is calibrated using
capillary plasma values determined with a Yellow
Springs 2300 analyser (YSI). The YSI analyser is
calibrated (as a secondary reference measurement
procedure) using a series of YSI standards (primary
calibrators) which are taken from the NIST
(National Institute of Standards and Technology,
USA).
Temperature Automatic compensation using a built-in thermo
compensation: sensor.
Batteries: Two 3.0 V lithium batteries (CR2032).
Battery life: A minimum of 1000 tests or about 1 year (2-3
tests/day).
Memory: 730 test results with markers, dates and times.
When the memory is full, the new results will
replace the oldest ones.
Data Before/after meals, exercise, check markers
management: available.
Alarms: Up to three settable acoustic alarms.
Data transfer: Via dedicated data cable, NFC, or a Bluetooth
device.
Averages: Over 1, 7, 14, 30, 60, 90 days.
Automatic turn - After 90 seconds of inactivity before the test
off: (sensor strip inserted into the meter, drop
iconflashing).
- After 60 seconds of inactivity after the test and
Error messages Err2, Err3, Err4, HI and LO.
- After 5 seconds for Error messages Err1, Err5,
Temperature icon and Battery icon.
Dimensions: 85.5 mm (L) x 56 mm (W) x 18.2 mm (H)
Weight: 46 g (without batteries)
Meter Operating - Temperature: 5 - 45 °C (41 - 113 °F).
Conditions: - Relative Humidity: 20 - 90% (no dew condensation).
Meter Storage - Temperature: -20 – 50 °C (-4 – 122 °F).
Conditions: - Relative Humidity: 20 - 90%.
Test strip Storage - Temperature: 4 - 30 °C (39.2 - 86 °F) (both for
Conditions: unopened vial and after opening).
- Relative Humidity: 20 - 90% (both for unopened
vial and after opening).
Control Solution 4 - 30 °C (39.2 - 86 °F)
Storage
Temperature:
Operating The meter
environment: electromagnetic emission requirements (EMC).
EU directive/ 98/79/EC / Annex II, List B
classification:
Device Standard: EN ISO 15197:2015
complies with applicable