IDS IDS-iSYS, Руководство пользователя

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1-6- Precautions for Use
The is a multiparameter selective analyser for in vitro assays in clinical biology.
The analyser is intended for professional use and must only be used by trained personnel in compliance with
the following safety precautions and good laboratory practice (GLP).
1-6-1-
General precautions
•
When installing Immunoassay cartridges into the reagent compartment, each reagent rack must be properly
inserted as shown on the sticker displayed on the reagent compartment cover (see 3-2- Installation of
reagents, page 38). Incorrect positioning of the rack onto its rail may cause either an insu
ffi cient mixing of
magnetic particles in their vial or incorrect pipetting of reagents.
•
After start up or installation of a new reagent, a waiting period is necessary before using the reagent in an
assay. For Immunoassay cartridges this should be 40 minutes for temperature equilibration and magnetic
particle re-suspension (for biochemistry this should be 20 minutes to allow temperature equilibration). The
waiting period is automatically managed by the system through a count-down displayed on each reagent
position. Interrupting a count-down may impair the quality of analytical results.
•
When the lid of the analyser is not equipped with a locking system, do not lift the lid while the analyser is
running (i.e. during the run cycle). Opening the lid during the run cycle interrupts the movements of the
pipetting arm. Should this occur, analyses under way may be interrupted and restarted (recycled).
•
An activation key is provided with the accessories for analysers equipped with a locking system. The use of
the activation key is strictly restricted to the adjustment of probe position described in Section 5,
5-4-10-2-
Adjustment procedure for analyser with lid locking system
, page 136.
•
Do not place bottles of reagent on the surface of the analyser.
•
While the analyser is in operation, do not touch the analyser stop/start button, do not remove the solid
waste. The solid waste tray must be present to enable the analyser to function.
•
The solid waste can contain 400 cuvettes. The waste can be emptied during operation. It is recommended to
empty the solid waste before starting the run cycle
•
Make sure that the reagent and sample racks are clean at all times.
•
During sample programming (either from the interface software or via the centralised computer system),
verify that the appropriate sample type is selected. The type «
Serum/Plasma»
must be selected for each
blood sample, whether collected in a dry tube (serum) or collected in a tube containing anticoagulants
(plasma). The type «
Urine»
must be used only when defined in the assay setup (refer to the reagent IFU). The
type «
Other»
must be used when specified in the reagent IFU.
•
The validity of results obtained depends on the correct programming of the sample type.
•
Verify that the barcode reader can recognize the barcode symbology used for sample tubes (see Appendix
A-5, page A7). The character «%» is not recognized and must not be used. It is recommended to use a
symbology containing a check character.
•
When installing a sample tube, check that the barcode number corresponds to the sample identification.
•
Do not expose the eyes to the beam of barcode readers.
•
The database is automatically backed up once a week when opening the application. Operators should store
back-ups from the computer onto CD or USB flash drive.
•
To ensure confidentiality of results, patient demographic information (name, birth date, ...) are encrypted in
the database. An encryption key is generated in the first installation of the software. A copy is kept on the
Windows desktop. Keep a backup of the encryption key, outside the computer.
•
Keep documentation of the set-up programmed on the analyser.
•
Only Immunoassay and ancillary reagents supplied by IDS and its partners, can be used on the analyser
(catalogue available on request).
•
To ensure that the cuvette loader functions correctly, only use full cubes of cuvettes. Never install isolated
layers in the loader.
•
In the event of maintenance or an intervention by IDS Service & Support Personnel, the analyser and its
various components must first be cleaned and decontaminated as defined in the Maintenance section (see
Section 5).
Operating principle
1-6- Precautions for Use
IDS-iSYS User Manual - Revision M1
Operating principle 1-6
15
Software version V 14