Human Elisys Quattro User manual

HUMAN -
ELISYS QUATTRO
User Manual
Elisys Quattro
| User Manual
|
Cat.No. 16300/1

Edition:
System Manufacturer:
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Software-copy-
rights
The ELISYS QUATTRO software is the intellectual property of HUMAN GmbH .
Intellectual property rights shall remain with
HUMAN GmbH
You are entitled to use the ELISYS QUATTRO software and the printed accompany-
ing material at your place of work only.
Any violations of property rights or copyright or trademark may be subject to legal
action.
Rev. /DATE. REVISION DESCRIPTION
01/2004-12 First edition
02/2011-01 Update cover and back page
Copyright © 2010, HUMAN GmbH . All rights reserved.
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21
D-65205 Wiesbaden, GERMANY
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written
approval of
HUMAN GmbH .

ELISYS QUATTRO - User Manual HUMAN TOC-1
Table of Contents
1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 Typographical Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1.1 Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1.2 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.1.3 Symbol Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.1.4 Special Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.2.1 General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.2.2 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.2.3 Laser Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.2.4 Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.2.5 Biological Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.2.6 Cleaning the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.2.7 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.3 Positions of Safety Labels and Type Label. . . . . . . . . . . . . . . . . 1-7
1.3.1 General Warning Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.3.2 Biological Hazard Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.3.3 Electrical Hazard Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.3.4 Laser Hazard Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.3.5 Type Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
2 System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Top Level Instrument Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.2.1 Tray for Tip Racks and Pre-dilution . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2.2 Patient Sample and Reagents Unit with Bar Code Reader . . . . 2-4
2.2.3 Tip Ejection Station, Pipettor Wash Station, Pipetting Station. . . 2-4
2.2.4 Test Plate Compartment with Bar Code Scanner . . . . . . . . . . . . 2-5
2.3 Drawer Instrument Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.3.1 Wash Buffer Container and Waste Bottles . . . . . . . . . . . . . . . . . 2-6
2.3.2 Wash Unit for Test Plates with Window . . . . . . . . . . . . . . . . . . . 2-6
2.3.3 Incubator Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.3.4 Photometer (Back of Bottom Drawer). . . . . . . . . . . . . . . . . . . . . 2-7
2.4 Other Instrument Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2.4.1 Guide Rail for Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2.4.2 Pipettor (Z-Direction) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.5 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.6 LED Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
2.7 Principles of Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.7.1 Absorbance Photometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.7.2 Bichromatic Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
3 Software Structure and Operation . . . . . . . . . . . . . . . . . . . 3-1
3.1 Basic Information about Operation . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Menu Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.2.1 General Menu Guidance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.2.2 Worklist Menu Guidance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.2.3 Result Menu Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3.3 File Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
4 Performing a Test Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

TOC-2 ELISYS QUATTRO - User Manual HUMAN
4.1 System Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Input of Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2.1 Manual Input of Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2.2 Input of Bar Coded Patient Samples . . . . . . . . . . . . . . . . . . . . . . 4-4
4.3 Worklist Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.3.1 Create New Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.3.2 Defining Several Assays per Plate. . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.3.3 Defining Several Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
4.3.4 Input of Reagent Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
4.4 Start a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
4.4.1 The Worklist Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
4.4.2 Loading Samples and Reagents . . . . . . . . . . . . . . . . . . . . . . . . 4-12
4.4.3 Loading other Required Resources . . . . . . . . . . . . . . . . . . . . . . 4-15
4.4.4 Reagent Volume Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
4.4.5 Plate Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
4.4.6 Starting and Processing a Run . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
4.4.7 Pausing or Cancelling a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
4.5 Results of a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
4.5.1 Results Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
4.6 Re-Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
4.7 Quality Control Analysis Report (Levey Jennings Plot) . . . . . . 4-25
4.8 Patient Result Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
5 Loading - Unloading - Disposal . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 Loading (Instrument at Hold). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.1 Refill System Liquid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.2 Refill Wash Liquid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.3 Position Dilution Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.4 Load Tip Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.5 Load Sample and Reagent Racks . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.1.6 Load Test Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.2 Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.2.1 Remove Dilution Tubes / Take Tip Racks off . . . . . . . . . . . . . . . . 5-6
5.2.2 Remove Racks with Patient Samples and Reagents. . . . . . . . . . 5-6
5.2.3 Remove Test Plate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.3 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
5.3.1 Liquid Waste from Pipettor and Wash Unit . . . . . . . . . . . . . . . . . 5-7
5.3.2 Disposable Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
5.3.3 Replace Waste Container for Disposable Tips . . . . . . . . . . . . . . 5-7
5.3.4 Disposal of Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
5.3.5 Disposal of Packaging Material . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
6 Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1.1 Daily Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1.2 Weekly Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1.3 Monthly Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2 Service Plan (to be performed by authorised Service Engineers)6-
2
6.3 Cleaning and Disinfecting the Instrument . . . . . . . . . . . . . . . . . . 6-4
6.3.1 Cleaning and Disinfecting the Housing Surface. . . . . . . . . . . . . . 6-5
6.3.2 Cleaning and Disinfecting the Interior of the Instrument . . . . . . . 6-5
6.3.3 Maintenance of Pipettor System . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3.4 Maintenance of Washer System . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.4 Cleaning the Wash Head Needles . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
6.5 Replacement of Mains Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.6 Backup of Result Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.7 Putting System Out of Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

ELISYS QUATTRO - User Manual HUMAN TOC-3
7 Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 General Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Error Messages of Components. . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
8 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

TOC-4 ELISYS QUATTRO - User Manual HUMAN

Intended Use
ELISYS QUATTRO - User Manual HUMAN 1-1
1 Intended Use
The ELISYS QUATTRO system consists of the ELISYS QUATTRO instrument and
the Phoenix software. It is a fully automated microplate analyzer performing the
complete sample processing (sample dilutions, sample and reagent dispensing, in-
cubations, wash processes, plate transports) as well as the photometric measure-
ment and evaluation.
For in Vitro Diagnostics only!
Prior the use of the ELISYS QUATTRO system for IVDs, any test methods (assays)
and kits must be validated by the user in combination with the system according to
common clinical laboratory practice, local legislation, and the state of the art.
1.1 Typographical Conventions
Please consider the following typographical conventions.
1.1.1 Warning Messages
Warning messages are indicated with a safety symbol and printed in special types.
For special situations the following security symbols were used.
Caution, risk of danger! Consult instructions for use!
Biohazard!
Electrical hazard!
Caution, hot surface!
Mechanical hazard!
Automatic start-up!
Laser hazard!

1-2 ELISYS QUATTRO - User Manual HUMAN
Intended Use
1.1.2 Notes
Notes are indicated with a symbol and printed in special types. For special situations
were used the following symbols.
Consult instructions for use!
Notes are indicated by this symbol and printed in special types.
Disconnect mains power connector before servicing!
1.1.3 Symbol Keys
1.1.4 Special Types
Manufactured by
In Vitro Diagnostic Medical Device
Lot Number
Expiration Date
Storage Temperature
CE Mark
Catalogue Number
Serial Number
LEDs LEDs (light emitting diode) are printed in spe-
cial type.
Example:
PWR LED, ERR LED

Intended Use
ELISYS QUATTRO - User Manual HUMAN 1-3
1.2 Safety Instructions
Read all of these instructions! Save these instructions for later use!
Please always act according to the following safety instructions, before as
well as during operation of the system!
The operating manual must be kept near the system and must be accessible
for the user at any time.
ELISYS QUATTRO is a fully automated microplate analyzer including functions such
as sample preparation, test performance, photometric measurement and data eval-
uation.
ELISYS QUATTRO is designed and manufactured in accordance with the safety re-
quirements for electronically and IVD measuring devices. If the local law lays down
regulations on the installation and/or operation of microplate analyzers, then it is the
operators responsibility to adhere to them.
The manufacturer has done everything possible to guarantee that the equipment
works safely, both electrically and mechanically. The systems are tested by the man-
ufacturer and supplied in a condition that allows safe and reliable operation.
The user has to observe the information and warnings contained in this operating
manual in order to ensure safe operation of the instrument.
1.2.1 General Safety
Follow all warnings and instructions marked on the instrument and in this
manual.
The instrument must only be operated by personnel who have been trained on
the use of the system.
It is strongly recommended that all first time personnel read this manual prior to use.
Use the system only for the designated application.
Use only the consumables and accessory prescribed herein (e. g. microplates,
tubes, disposable tips etc.).
The manufacturer assumes no liability for any damages, including those to third par-
ties, caused by improper use or handling of the system.
Menu items and fields Menu items and fields are printed in bold type.
Example:
File Menu
Buttons Buttons are printed in spaced type.
Example:
Open button.
Keys Keys are printed in slanted type.
Example: Press Enter

1-4 ELISYS QUATTRO - User Manual HUMAN
Intended Use
The operator may only perform the maintenance work described in this manu-
al.
Use only the parts prescribed in this manual for servicing.
The tests and maintenance work defined by the manufacturer should be performed
to make sure that the operator remains safe and that the instrument continues to
function correctly.
Any service and maintenance work not described in this manual must be performed
by authorised service personnel and technicians.
Any changes on the system which are not authorised by the manufacturer lead to the
loss of guarantee obligation.
The system was developed and tested according to the regulations of the IvD
directive
Any changes on the system which are not authorised by the manufacturer lead to the
loss of the validity of the conformity with the applicable regulations the manufacturer
has declared. In this case, the customer is responsible for the fulfilment of the appli-
cable regulations.
The instrument should be opened, serviced and repaired by qualified and au-
thorised service personnel only.
1.2.2 Electrical Safety
Country-specific regulations regarding safe electrical operation of the in-
stalled system have to be observed.
Check that the operating voltage is set correctly on all system components be-
fore you connect the system to the mains supply.
This product must be operated from the type of power source indicated on the type
label. If you are not sure of the type of power available, consult an authorised sales
person or your local electric power company.
Use a 3-wire grounding type plug to connect all instrument and peripherals to
mains supply.
Use only extension cables with a protective conductor and grounded contact.
Grounding of the instrument, computer and its peripheral devices to the same pro-
tective earth potential must be ensured.
Never knowingly interrupt the grounding contacts.
There is the risk of an electrical shock if the protective conductor is interrupted within
or outside the device, or has been disconnected.
The instrument must be connected with a delivered connection cable to dedi-
cated socket. The use of a multi plug is not allowed!
Do not allow anything to rest on the power cord.
If you can see that the instrument has become unsafe to use, switch it off and
disconnect it from the mains supply.