Limitations Of Use; Warnings And Precautions - EKF Diagnostics Quo-Test A1C Test Kit Gebrauchsanleitung

Limitations of Use

For hemoglobin concentrations outside of the range of 6.5 g/dL to
20.4 g/dL (4.0 to 12.7 mmol/l) or for HbA1c values outside the range
of 4.0 to 15.0 % DCCT (20 to 140 mmol/mol IFCC), a result will not
be reported and an error message will be displayed. Consult the
Quo-Test Analyzer System User Manual for further details.
eAG values may differ significantly from a patient's glucose
concentration if checked at the same time.
As with all HbA1c analyses, the results obtained are dependent upon
the patient's clinical history and having red blood cells with a typical
lifespan.

Warnings and Precautions

For in vitro diagnostic use only.
Do not use Test Cartridges after the expiry date or if the Test
Cartridges have not been stored in accordance with the
recommendations.
Do not use the Test Cartridge if the foil pouch, Test Cartridge or
silica gel sachet have been damaged or if the silica gel in the sachet
is completely green.
The Test Cartridge contains sodium azide as a preservative. The
concentration is < 0.1 %, which is below the level considered to be
hazardous in normal use. In case of leakage, avoid contact with eyes
and skin. In case of contact, wash with plenty of water.
Do not re-use any part of the Test Cartridge.
Use Gloves – Used Test Cartridges, sampling equipment, patient
samples and controls are potentially infectious. Used Test Cartridges
should be disposed of immediately as clinical waste in accordance
with local / national regulations.
Operate the Quo-Test Analyzer System according to the User
Manual.
Sample Preparation and Collection
Finger Prick Blood Sample
The patient's finger must be warm, dry and clean, including being
free of substances such as hand cream.
Use a single use lancet (not provided) to prick the finger.
Allow a droplet of blood to form, about the width of the Blood
Collector, before sampling.
Fill the Blood Collector, avoiding air bubbles and excess sample on
the outside of the tip of the Blood Collector. Do not wipe excess
blood from the collector.
Place the Blood Collector into the Test Cartridge and the Test
Cartridge into the Quo-Test Analyzer within 1 minute.
Operate the Quo-Test Analyzer System according to the User
Manual.
5 EN 3121-9101-0255_ML1_02.01_QT Test Kit - 05/2017