Elisys Uno: - User Manual

Elisys Uno
| User Manual
REF 17350/1
REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2006-06 First Edition
02/2008-02 Adaptation to new corporate design
03/2009-05 Performance check kit added
04/2011-09 Correction dimensions
05/2022-05 Reworked - IVDR IP added, QR Code for software and settings added
06/2022-07 IVDR minor text adjustment
SYSTEM VERSION
COPYRIGHT
Copyright 2022, Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden,
Germany. All rights reserved.
No part of this documentation may be reproduced in any form, nor processed, copied or
distributed by means of electronic systems, without prior permission of HUMAN in
writing. Since all precautionary measures were taken into account in producing these operating
instructions, the manufacturer accepts no responsibility for any errors or omissions. This
includes any liability for damage that could arise from possible incorrect operation based on this
information. Subject to changes without notice as result of technical development.
SERVICE AND SUPPORT

CONTENTS
TABLE OF CONTENTS
1 SAFETY INSTRUCTIONS 5
1.1 INTRODUCTION 5
1.2 USER WARRANTY 5
1.3 USE OF THE INSTRUMENT 5
1.4 GENERAL SAFETY WARNINGS 6
1.5 DISPOSAL MANAGEMENT CONCEPT 6
1.6 BIOHAZARD WARNING 7
1.7 INSTRUMENT DISINFECTION 7
2 INTRODUCTION 9
2.1 INTENDED PURPOSE ELISYS UNO 9
2.2 DETAILED DESCRIPTION 9
3 INSTALLATION 11
3.1 INSTRUMENT SETUP 11
3.2 INSTRUMENT CHECK OUT 16
4 PRINCIPLES AND SPECIFICATIONS 17

4.1 TECHNICAL SPECIFICATIONS 18
5 ELISYS UNO MANAGER 21

5.1 OPENING THE SOFTWARE AND SECURITY 21
5.1.1 Opening the ELISYS UNO program 21
5.1.2 Password security and logging in 21
5.1.3 Security menu options 22
5.2 ALIGNMENT SETUP 23
5.2.1 Alignment 23
5.2.2 Rack2 dispense height 28
5.2.3 Filter voltages 29
5.2.4 Channel blanks 30
5.2.5 Display instrument parameters 32
5.2.6 Restore instrument parameters 33
5.2.7 ELISYS UNO manager toolbar icons 33
5.3 ELISYS UNO MANAGER TABS 34
5.3.1 Layout tab 34
5.3.2 Sample tab 37
5.3.3 Test list tab 38
5.3.4 Report tab 39
5.4 MAIN MENU SELECTIONS AND FEATURES 40
5.5 MANAGEMENT MENU 41
5.5.1 Laboratory information system (LIS) 42
5.6 ROUTINES MENU 44
5.7 LOT # REGISTRATION 45
5.8 QC TRACKING 45
5.8.1 Sample DB 46
5.8.2 Settings 46
5.8.3 Utilities 48
5.8.4 Security 54
5.8.5 Help: About 54
6 RUNNING ELISYS UNO 55

6.1 GENERAL SETTINGS 55
6.1.1 Software settings 55
6.2 START OF DAY 59
6.2.1 Run start of day 59
6.2.2 Sample database setup 60
6.2.3 Calibrators 65
6.3 RUNNING SAMPLES 70
6.4 END OF DAY 72
7 ASSAY EDITOR 73
7.1 MAIN MENU AND TOOLBAR 74
7.1.1 Assay 75
7.2 CREATING ELISA ASSAYS 82
7.2.1 Absorbance mode 83
7.2.2 Point-to-point mode 83
7.2.3 Regression mode 84
7.2.4 Cubic spline (constrained) mode 86
7.2.5 Cut-off standard mode 86
7.2.6 Cut-off standard mode 88
7.2.7 Dose response mode 88
7.2.8 Polynomial modes 88
7.2.9 Parameter logistic 89
7.2.10 %Absorbance 89
7.3 QC CRITERIA 89
7.4 ASSAY STEPS 91
7.4.1 Select step 91
7.4.2 Edit step 102
CONTENTS
7.4.3 Arrow buttons 102

7.4.4 Delete step 102
7.4.5 Copy step 103
7.5 INTERPRETATION SETTINGS 103
7.6 SPECIAL GROUPS ASSAY EDITOR 105
7.7 STANDARDS 107
7.8 BLANK 111
7.9 CONTROLS 112
8 QUICK GUIDE 115

8.1 ELISA TESTS 115
8.2 ACCEPTING AND ADJUSTING STANDARD CURVES 119
9 TROUBLESHOOTING 127
9.1 FLAGS AND ERROR MESSAGES 127
9.1.1 Flags 127
9.1.2 Error messages 129
9.1.3 Rackfile – Troubleshooting 135
10 HUMAN SOFTWARE AND SETTINGS UPDATE 137
11 SAFETY DETAILS 139

11.1 WARNING MARKINGS 139
11.1.1 Safety symbols 139
11.2 SAFETY PRECAUTIONS 140
11.3 HAZARD STATEMENTS 141
11.4 PRECAUTIONARY STATEMENTS 142
11.5 OPERATING PRECAUTIONS 142
Safety Instructions 5
1 SAFETY INSTRUCTIONS
1.1 Introduction
This manual is considered part of the instrument and must be available to the
operator and the maintenance personnel. For accurate installation, use and
maintenance, please read the following instructions carefully.
In order to avoid damage to the instrument or personal injury, carefully read the
”GENERAL SAFETY WARNINGS”, describing the appropriate operating procedures.
Please contact your HUMAN authorised local Technical Service in the event of
instrument failure or other difficulties with the instrument.
1.2 User warranty

HUMAN warrants that instruments sold by one of its authorised representatives
shall be free of any defect in material or workmanship, provided that this
warranty shall apply only to defects which become apparent within one year
from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item within this
warranty period at no charge, except for transportation expenses to the point
of repair.
This warranty excludes the HUMAN representative from liability to replace any
item considered as expendable in the course of normal usage, e.g.: lamps,valves,
syringes, glassware, fuses, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty
if the product is not used in accordance with the manufacturer‘s instructions,
altered in any way not specified by HUMAN, not regularly maintained, used
with equipment not approved by HUMAN or used for purposes for which it was
not designed.
1.3 Use of the instrument

The instrument must be used for its intended purpose (see chapter 2). It must
be operated in perfect technical conditions, by qualified personnel, in such
[IVD]
working conditions and maintained as described in this manual, in the GENERAL
SAFETY WARNINGS. This manual contains instructions for qualified professional
operators.
6
1.4 General safety warnings

Use only chemical reagents and accessories specified and supplied by HUMAN
and/ or mentioned in this manual. Place the product so that it has proper
ventilation. The instrument should be installed on a flat, stationary working
surface, that is free of vibrations.
Do not operate in area with excessive dust. Operate at temperature and at a
humidity level in accordance with the specifications listed in this manual. Do not
operate this instrument with covers and panels removed. Use only the power
cord specified for this product, with the grounding conductor of the power cord
connected to earth ground.
Use only the fuse type and rating specified by the manufacturer for this
instrument. The use of fuses with improper ratings may pose electrical and fire
hazards. To avoid fire or shock hazard, observe all ratings and markings on the
instrument. Do not power the instrument in environments that are potentially
explosive or at risk of fire.
Prior to cleaning and/or performing maintenance on the instrument, switch off
the instrument and remove the power cord.
Only cleaning materials described in this manual may be used, as other materials
may damage parts. It is recommended to always wear protective clothing and
eye protection while using this instrument.
All warning symbols that appear in this manual must be carefully observed.
See Chapter 11 Safety details.
1.5 Disposal management concept

The applicable local regulations governing disposal must be observed. It is the
user‘s responsibility to arrange for proper disposal of the individual components.
All parts which may contain potentially infectious materials must be disinfected
by suitable, validated procedures (autoclaving, chemical treatment) prior to
disposal. Applicable local regulations for disposal must be carefully observed.
The instruments and electronic accessories (without batteries, power packs
etc.) must be disposed of according to the applicable local regulations for the
disposal of electronic components.
Batteries, power packs and similar power sources must be removed from
electric/ electronic parts and disposed of in accordance with applicable local
regulations.
Elisys Uno | User manual

Safety Instructions 7
1.6 Biohazard warning

Analytical instruments for in vitro diagnostic application involve the handling
of human samples and controls which should be considered at least potentially
infectious. Therefore every part and accessory of the respective instrument
which may have come into contact with such samples must equally be
considered as potentially infectious.
The „BIOHAZARD“ warning label must be affixed to the instrument prior to first
use with biological material!
Figure 1
Biological hazard symbol
1.7 Instrument disinfection

Before performing any servicing on the instrument it is very important to
thoroughly disinfect all possibly contaminated parts. Before the instrument is
removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination must be performed by authorised well-trained personnel, and
in observance of all necessary safety precautions.
8

Introduction 9
2 INTRODUCTION
2.1 Intended purpose ELISYS Uno

ELISYS Uno is an automated colorimetric immunoassay (ELISA) analyzer
intended for quantitative, semi-quantitative and qualitative automated
measurements of physiological or pathological parameters in human serum or
plasma depending on the performed test design. It is intended to be used in
combination with various ELISA reagents as an aid in diagnosis, for screening
and monitoring of different medical conditions. The instrument is an open
system and can be used with HUMAN ELISA reagents as well as with other ELISA
kits. For laboratory professional use only.
2.2 Detailed description
Fluid handling Aspirates and dispenses from 5 µl to 1,95 ml

Incubating Heating temperatures - coil heats to 37°C, plate heats to
25°C or 37°C, or no temperature control (ambient)
Mixing Reaction plate only
Timing From 1 second to 24 hours
Optical reading UV/ visible range
Calculating Uses numerous pre-programmed equations
Data storage Unlimited capacity
Data reporting Many options and customisations to choose from
The system allows one to define and program an unlimited number of

customised protocols by selecting displayed menu options from a Microsoft
Windows® software program (see Chapter 11.5 Operating precautions).
ELISYS UNO may also be used in production processes involving micro volume
dispensing, diluting, incubating and reading.
ELISYS UNO is an unique automatic system. Reactions occur in standard plastic

microwells. Reagent bottles and sample tubes are placed into the removable
instrument racks. The instrument is programmed to pick up from one place,
dispense to another, wash the probe, read the wells, incubate, mix, etc.
10

Installation 11
3 INSTALLATION
How to unpack, set up, and check out your ELISYS UNO instrument.
ELISYS UNO is carefully packaged in a custom-made container to assure its safe
arrival. If upon receipt the outer packaging is damaged report damage to your
freight carrier immediately.
When shipping, it is important that the instrument be anchored and packaged in

the original manner to prevent shipping damage. Therefore, retain all shipping
screws and packaging in the event the instrument requires future relocation.
The details how to unpack the instrument once it is removed from its crate can
be found in the Unpacking Instructions Manual (Cat. No. 17350/4).
3.1 Instrument setup

1. After placing instrument on the selected surface, check that there are at
least 3in. (8- 10 cm) of clearance behind and to the sides of the instrument
to allow for proper ventilation..
2. Connect one end of the drain tubing to the drain outlet located on the bot-
tom of the instrument. Push the tubing over the fitting as far as possible,
ideally flush with the plastic nut. The waste drain tubing may be routed
! Note: Do not allow the end of
the tubing to rest in the drain
container below the expected lev-
through an access hole on the lab bench or routed to the front or back of the el of the waste liquid.
instrument as desired towards the waste drain container.
12
3. At the edge of the table or above a lab table access hole, cut the drain tube
and connect it to the barb tee, as shown in Figure 2. One of the other ends
of the barb tee should connect to the remaining drain tube, leading down-
wards to the waste drain container.
Figure 2
Figure 3
The upright barb will act as an air vent as shown in Figure 4 so that the waste
fluid will not develop an air pocket preventing the fluid from flowing into the
waste container below.
Figure 4
A Serves as air vent

B Tubing attached to the drain
outlet on the bottom of the
instrument
C Tubing leading to waste con-
tainer
4. Place the waste drain container at a level lower than the instrument to allow
the fluid to flow into the waste drain container. A 2l bottle should be suffi-
cient for drainage (waste container is not supplied with the instrument). Cut
the end of the drain tube diagonally as shown in figure (below) and place the
diagonally cut end into the drainage container. The diagonally cut tube pre-
vents the tubing from resting on the bottom of the waste container, which
may cause the waste fluid to back up into the instrument.
Figure 5

Installation 13
5. Match the colour-coded connectors on the three bottle cap assemblies to

the coloured connectors on the right side of the instrument. Turn each con-
nector about 1/4 turn clockwise to lock it in place. Insert the sensor cable
jacks, matching the coloured tie wrap with the colour-coded connectors.
Figure 6
Connectors
6. Put de-ionised water into the bottle marked Rinse. Put wash buffer provided
into the bottle marked Wash for ELISA tests. Leave the Waste bottle empty.
Check that each bottle cap is securely fastened and that no sensor wires are
! Note: The hydrophobic filter
on the waste bottle is de-
signed to protect the pump from
crossed. Note that the Waste bottle has short sensor leads in order to detect liquid and may become clogged
when waste is nearly full. Rinse and Wash bottles have long leads in order to when wet. Arrange the tubing so
sense when bottles are nearly empty. that the filter hangs down below
the connecter on the side of the
7. Fill the Prime bottle with fresh, clean de-Ionised water. This should be done ELISYS UNO to prevent clogging.
each day - This water enters the precision calibrated syringe pump and
therefore must be very pure to avoid damage and prolong the life of these
components. Prime bottle installed as shown in Figure 7.
Figure 7
Install prime bottle
14
8. Using the USB cable provided, connect the computer’s USB A port to the
ELISYS UNO USB B port (see Figure 8).
Figure 8
Back of instrument
3
1 Power cord connection

2 USB-B port 1
3 Power switch
4 Reset button
2
4
9. Turn on the computer and insert the installation USB stick. The installer
should automatically start, if not, select Run from the Windows® Start Menu,
run USB stick drive:\setup, and follow the prompts for installing the program.
Execute the ELISYS UNO program after installation. Enter Admin as the user
ID and Admin as the password.
Figure 9
Figure 10
Figure 11
Figure 12

Installation 15
Figure 13
Figure 14
Figure 15
10. Connect the power cord to the instrument, then to an approved power
source. It is strongly advised that a UPS (Uninterruptible Power Supply) be
used to avoid power interruptions to the ELISYS UNO and to the computer.
11. Place a rack onto each of the two rack holders. The default positioning places
the reagent rack on the left and the Sample rack on the right. Place the plate
loaded with microwells into the plate carrier at the right.
12. The program default is to use COM1 for communication with the instrument.
If connecting the instrument to a different port, go to the Settings Menu and
select Software. Select a communications port and click OK.
Figure 16
16
3.2 Instrument check out

With the instrument connected to a computer, start the ELISYS UNO software,
and switch on the instrument. When the instrument powers up, note the
following actions:
- All racks move to the front (home) positions;
- The probe moves to its home position (to the left), over the plate, and then
to the wash cup;
- The syringe pump primes;
- The instrument and the optical system lights come on.
These events are controlled by firmware installed in your instrument however,

the software must be running for proper operation.
If the instruments power comes on, but these actions do not occur and the beep
sound continues, there is a problem with the communications setup. Check the
USB cable connections and COM port settings.
At this time, the wash arm is raised from its shipping position. Install the wash
head (found in the accessories carton) to the wash arm using the two attached
thumbscrews. The luer fittings must face outward (towards the user), and the
colour-coded fittings on the tubing should be fastened finger-tight to the wash
head. See Figure 17.
Figure 17
Wash head installation

Principles and specifications 17
4 PRINCIPLES AND SPECIFICATIONS

The syringe pump is used to make precise dilutions. The syringe measures
volumes of 2.5 ml or less. The single probe moves left and right as well as
vertically. It is equipped with a liquid surface detection mechanism that stops
the probe automatically when the tip is sufficiently submerged. Probe washing
uses de-ionised H2O from the prime bottle and drains to the bottle below.
Each of the two racks and the plate move independently toward the front and
back of the instrument. Commonly referred to as a reagent rack, a sample rack,
and a Reaction plate. However, reagents can be placed in the sample rack, or
two racks can be used to perform pre-dilutions. Each rack has an arrangement
of holes or grooves configured to hold different types of tubes, bottles, micro
tubes, microwells, and other containers. Racks are identified in the software in
order to tell the instrument which configuration is to be used. They are also
displayed graphically.
The incubator plate/ well can be set to heat to 25°C, 37°C, or remain at ambient
room temperature. The plate/ well will heat to 25°C providing the ambient room
temperature is below 25°C (it should be noted that the option of heating the
plate/ well to 25°C should only be used when the ambient room temperature is
consistently below 20°C).
When the probe carries a reagent to an incubated reaction plate, the temperature-
controlled coil can be set to pre-warm the liquid before dispensing. Reagent
racks can be loaded and unloaded with bottles from run to run. The location
of each reagent is indicated using a colour-coded computer screen. Alternately,
preferred reagent rack setups can be stored in panels. For convenience, multiple
pre-loaded racks can be stored in the refrigerator ready to load and use.
When taking an optical reading, the reaction plate automatically positions itself
under the 4-channel optical system. Four lamps are aligned to simultaneously
shine down through four wells. A filter wheel with eight filters rotates constantly
below the plate. The filter wheel is designed so that four filters align with the
four lit wells for absorbance readings. Depending on the setup, reports may be
displayed or printed to create permanent lab records and physician reports.
18
4.1 Technical specifications

Overall
Dimensions (W x D x H)
Instrument without 102 x 55 x 47 cm
any components:
Space required for 170x 80x 80 cm
routine use
Packaging 63 x 105 x 78 cm
Weight Gross 70.0kg, Net 35.0 kg
Reagent and sample dispensing

Capabilities Dilutions, predilutions, single or multiple reagents
Pumps One syringe pump, sized: 2.5 ml
Probe 316 stainless steel for maximum reagent compatibili-
ty, level sensing
Minimum and 5 μl – 1.95 ml
maximum volume
Maximum number 96 (including calibrators and controls)
of specimens
Maximum number Typically 27 or 44
of reagents - Assorted replaceable racks and custom designed
racks are available for various bottle sizes.
- Reagents can also be programmed to go to the sam-
ple rack.
Reaction vessel Standard microwells, strips
Instrument bottles 1 l Priming bottle, 2 l Wash bottle w/ low volume warn-
ing sensor, 1l Rinse bottle (or 2nd wash) w/ low volume
warning sensor
Incubation, timing and temperature control:

Thermal control Plate/ well 25 °C, 37 °C, or ambient temperature
- Temperature controlled to 25 °C providing the ambi-
ent room temperature is below 25 °C
- Sample rack is not temperature controlled.
Washing
Wash head 8-probe, automatic prime and rinse
Programs Create and run user programmable protocols (aspirate,
dispense, soak). Can wash wells for re-use as applicable

Principles and specifications 19
Reading
Optical design Reads absorbance in four simultaneous channels; NIST
traceable calibration; user selects monochromatic or
bichromatic results
Light source Tungsten-Xenon lamp
4 position filter 405, 450, 490, 630
wheel
Interference filters Long life, hard coat, ion-assisted deposition, +/- 2 nm,
10 nm typical half band pass
Linear range -0.2 to 3.0 A
Photometric ± (1% of the reading +0.005 A from 0 to 1.5 A)
accuracy ± (2% of the reading +0.005 A from 1.5 to 3.0 A)
Software
Format USB drive or via Web download
Operating systems Windows(R) 7 and 10
Minimum system Processor 1Ghz, 1 GB Ram, USB-B Port, 800x600
Recommended Core i3 2,2Ghz, 8GB Ram, 512GB SSD, USB-B
system
Secondary menu Create/ edit protocols, import/ export data, etc., Con-
options trol, Run, Setup
Calculation modes Absorbance, single standard, factor, fixed time kinetics,
kinetics by standard or factor, multi-calibrator point-
to-point, linear regressions, log-logit, cubic spline, and
nonlinear regressions (curve fit).
Self monitoring Lamp, bottle volume, filters, pressure, vacuum, me-
modes chanical function, and more
QC options Store control data, print Levey-Jennings or QC range
plots, calculate SDs
USB port Standard USB A to B, connection via COM port auto-
matically established
20
Power
Voltage range 100- 250 VAC
Frequency range 50- 60 Hz
Power maximum 160 W
Environmental conditions for safe operation

Mains supply Fluctuations not to exceed ±10% of the nominal voltage
voltage
Altitude Up to 2000 m
Humidity 80% for temperatures up to 31°C decreasing linearly to
50% humidity at 40°C
Temperature 5°C to 40°C
Recommended environmental conditions

Operating 18-35°C recommended
temperature
Operating Less than 85% recommended
humidity

Elisys uno manager 21
5 ELISYS UNO MANAGER
5.1 Opening the software and security

ELISYS UNO uses the standard Windows® controls, windows, and dialogues.
Refer to your Windows® documentation to become familiar with these controls
and how to use them
5.1.1 Opening the ELISYS UNO program

- Power on the instrument;
- Double-click on the ELISYS UNO icon
ager software.
to open the ELISYS UNO Man- ! Note: It is not necessary to
turn the instrument off when
restarting the software.
5.1.2 Password security and logging in

- When either the ELISYS UNO Manager or Assay Editor software are opened
for the first time, a user name and a password must be entered;
- For user name, type Admin;
- For password, type Admin.
There are three security access levels: Administrator, Manager and Operator.
See Table 1 for security levels.
Security level Administrator Manager Operator Table 1

Disable security Y N N Security levels
Enable security Y N N
Create manager Y N N
Create operator Y Y N
Remove manager Y N N
Remove operator Y Y N
Change password Y Y Y
View log file Y N N
22
5.1.3 Security menu options

- Enabled when Enabled is checked, the password protection and security re-
strictions are being used;
- ELISYS UNO can be set up with or without a password security system;
- To remove the password security system so that a login is no longer required,
go to the Security menu (see Figure 18) and uncheck Enabled;
- With Enabled checked, the security system is on. Only Administrators have
access to this option.
Figure 18
Security menu options
- Login as different user: Displays the Login screen and allows you to login
with a different name and password.
- Log out: Logs current user out of the system.
- Create new user: Creates a new user with ID, password, and security level.
The manager can create users, but will only be able to give them operator
level security.
- Remove user: Administrators can remove any user. Managers can only re-
move operators.
- Change password: Any security level can use this feature. Enter the old pass-
word followed by the new password.
- Who is logged in: Security access window appears to show who is logged in
and their access level (see Figure 19).
Figure 19
Security access window
- View log file: Opens a log of every user name that has logged on, including a
time and date stamp and a running count of entries.

5.2 Alignment setup

Before running any tests or jobs, the instrument must be aligned and setup. Use
the procedures in this section to ensure that the ELISYS UNO is ready to work.
When the software is first opened, a prompt will ask if the ELISYS UNO has a
washer. If no, select No and again at confirmation.
5.2.1 Alignment
Figure 20
Under the Utilities menu,
Utilities menu
select Alignment
Select Probe vs. Rack1 Figure 21

Adjust probe position for Rack 1
To check the current alignment,

click the probe button:
24
Use the arrow buttons to position the probe correctly. The probe tip should be
centred about 3 mm above the rear pin, as shown:
Figure 22
1 Side-to-side (blue) 1
2 Up and down (green)

3
3 Forward and backward (red) 2
2
3
To check new alignment, select Test.

When finished click Save, then click Close.
Next, select Probe vs. Rack2. from the menu.
Figure 23

click the Probe button:

Use the arrow buttons to position the probe correctly.

Figure 24
To check new alignment, select Test. When finished click Save, then click Next
to continue with Step 2 of 2.
The next step prompts to replace

Figure 25
Rack2 and place a sample cup in
Step 2 adjust probe depth for
position number 96 in the back of
the sample rack (view Figure 25). Rack2
! Note: Select “Close” to pass

the option to set an alternate
depth.
Otherwise, select the Probe

button:
Use the arrow keys to move the probe until it almost reaches the bottom of the
sample cup. When the correct depth has been reached click Save and then the
Close button.
26
Figure 26 Select Probe vs. Plate from the

menu.
Figure 27 Insert a plate or strip tray into

Adjust probe position for plate z-position when prompted.

click the Probe button:
Use the arrows to move the probe into the correct position.
The probe tip should be centred in well H01 and almost touching the bottom.
Press Test to confirm. When finished, click Save and then the Close button.
Figure 28 Select Probe vs. Wash Cup from

the menu.

Figure 29
Press the button. Adjust probe position with
Wash Cup
The probe will move to the

centre wash position and low-
er into the cup. The probe tip
should be centred in, and at
the surface of the small, cen-
tre wash cup. If it is not in po-
sition, use the arrow keys to
move the probe into position.
When finished, click Test to check new alignment.

If aligned, click Save, then Close.
Choose Washer vs. Plate from

Figure 30
the menu.
Insert a plate or strip tray when

prompted. Click the Probe button.
The plate will move under

the wash head and the wash
head will lower into the wells.
The plate and wash head
should be positioned so that
the aspiration needles are
centred left to right, toward
the back of the wells; touch-
ing but not pressing on the
bottoms of the wells. Use the
arrows to position the wash
head correctly.
28
When finished, click Test to check new alignment. If aligned, click Save, then
Close.
5.2.2 Rack2 dispense height

Used to select the dispense height when dispensing to a sample rack for pre-
dilution purposes (see Figure 32).
- Use the top set of three buttons to select the High dispense height, and the
bottom set of three buttons to select the Low dispense height - the up and
down arrows will adjust the probe up and down, the button will
move the probe to its actual position setting.
- Low is normally used for dispensing small volumes such as serum to a pre-
dilution.
- High is normally used for dispensing a large volume of diluent (these set-
tings are specified when programming the assay in Assay Editor
- Low should be set inside the tube to eliminate splashing and loss of sample;
- High should be set as high as possible to thoroughly mix the sample/diluent,
but not high enough to cause reagent foaming.
Test with your particular reagents for appropriate dispense heights. Click Save
on each to save the new settings, then click Close.
Figure 32
Adjust probe dispense height

5.2.3 Filter voltages

Select Filter Voltages from the Utilities menu.
Figure 33
Press the Test Current Voltages button to view the filter voltage readings for all
four channels at each of the eight wavelengths (if nothing happens, wait for the
automatic lamp warm-up time).
Figure 34
Current voltages test results
All filter voltages should be between 2.00 and 10.00 (see Figure 34). Lower
readings might indicate that a lamp is misaligned or partially blocked. The data
storage buttons on this window are for troubleshooting and are only used when
instructed to do so by service engineers. Click Close to exit.
If abnormally low voltage is detected, the user will be prompted to mark the
wells read by that lamp as unavailable. If not able to immediately replace the
lamp at that time, allow the software to mark the wells as unavailable until it
can be replaced.
30
5.2.4 Channel blanks
! Note: See chapter 6.2 and run

Start of Day before perform-
ing Channel Blanks for the first
Select Channel Blank... from the Utilities  Alignment menu dialogue.
time if this has not already been

done with the Quick Start Guide.
Figure 35
Select Channel Blank...
from Utilities menu
This will allow the user to blank the four photometer channels on a wetted
optically-clear solution (example blanking solution included, 0.5 N NaOH with
100 µl Triton X-100/ l). The ELISYS UNO software will show which wells it will be
using for channel blanks (preferably, use a new set of wells), and then prompt to
put Blanking Solution in position 1 of Rack 1 (never use plain water).
Figure 36
Load the wetted blanking
material into position

The ELISYS UNO will then pipette the four blank wells, read, and store them,
then do a confirmatory reading. The absorbance values of the readings will
be displayed and should be 0 ± 0.0050 A. These blanks will automatically be
subtracted from absorbance readings. See Figure 37; notice at the bottom of the
window the Result is displayed.
Figure 37
Reset channel blank results
If one of the values is not between 0 ± 0.0050, follow the instructions and try
doing channel blanks again. Do make sure there are clean wells in the positions
indicated to run channel blanks again.
32
5.2.5 Display instrument parameters

Choose Display Instrument Parameters in the Utilities  Alignment menu.
Notepad opens and the following text is shown:
Figure 38
Figure 39
Notepad file
This file can be saved and/ or printed or filed for future reference.

5.2.6 Restore instrument parameters

Select Restore Instrument Parameters to restore parameters from the copy
saved at the last initialization.
Figure 40
5.2.7 ELISYS UNO manager toolbar icons
Figure 41
1 2 3 4 5 6 7 8 9
1 Initialize 6 Calibration event

2 Pause or resume engine 7 Lot # registration
3 Pause or resume probe 8 QC tracking
4 Reload assay files 9 Sample database
5 Communication window
34
5.3 ELISYS UNO manager tabs
5.3.1 Layout tab

The default window, which is open when the user starts the software, is the
Layout Tab.
Figure 42
Layout tab
2 3 4 5
This window displays the current status of the instrument including the
temperatures. Also shown are the currently loaded racks and plate. The software
automatically keeps track of which wells in the reaction plate have been used.
Table 2
Feature: Description: Item No.:
Status The temperatures of the probe/coil and reaction plate 1
window are continually displayed in the ELISYS UNO Status Win-
dow. The temperature reading of the probe coil and
plate are only accurate near 37 °C.
At normal ambient temperatures, the reported temper-
atures are not accurate and often the displayed temper-
ature of the probe coil and plate do not agree and may
report higher than the actual temperature. When plate
heating is turned off, so is probe coil heating. When run-
ning room temperature assays, disregard the displayed
temperature values.

Home Use these buttons to return to the home positions. 2

buttons
Reset Press the Reset buttons in Rack 1 and Rack 2 to reset rack 3
buttons as clean.
Press Reset under Plate to reset wells as clean.
If using this button, make sure that the positions are
clean.
Any tests running that are waiting for clean well posi-
tions will continue.
Save Press the Save button to save the rack layout. 4
Load Press the Load button to load a previously saved rack 5
layout.
Calibration tab
Figure 43
Calibration tab
1. Choose assay: Use the drop-down menu to choose one of the assays from
the list. Press the Print Report button, to print for the selected assay.
2. Add calibration test information: Lists the calibrators and controls by name,
copies required, and whether or not they are valid.
Selections:
- Select the Curve option to insert a blank and a calibrator for the assay into
the work list. Select multiple times to add more copies of each. This button
is not active if the user is running an assay that does not require calibrators.
! Note: The user may also se-
lect calibrators, controls, and
blanks individually.
- Select the Control option to add all of the controls specified in the assay.
Press the button multiple times to add multiple copies of the controls.
36
3. View results: View the calibration and control results in this area.
4. Work list buttons:

• Click Save to save the current work list.
• Press the Load button to load a previously saved work list.
• Choose any or all of the items in the work list and click the Remove but-
ton to delete them from your worklist.
• Press the Request button to go to the layout tab to load and verify the
locations of the reagents, calibrators, etc.
5. Activate selected button: To edit the curve, check the curve records (choose
part of curve records which look good to user), then click the Activate Select-
ed button. This button will be enabled once the software calculates (based
on time, logic, math, etc.) a valid curve. After activating new curve records,
the current curve is changed. The software will look at the test list to recal-
culate all finished tests of this assay.
6. Discard recent: Upon accepting the new adjusted curve with the settings in
Strategy Settings set to Auto, the option to ‘discard recent’ is no longer avail-
able (reference Accept Curve and Control Results Menu in chapter 6.1.1.2
ELISA strategy.) However, if Strategy Settings remain defaulted to ‘manual’,
the user has the option to ‘discard recent’ and return to the previous curve.
With Strategy Settings set to Manual, the new concentration values will
display, however, the original values remain, allowing the user to ‘discard
recent’.
7. Print preview: Preview calibration and control results before printing statis-
tics such as %CV, %Dif, and mean values are also shown.
8. Print report
9. Curve button: Toggles between substances selected (calibrators, controls)

and calibration curves.
• Curve based on selected records: The curve based upon the calibrators
selected in the “Curve” box. Select calibrators by clicking on the box to
the left of the calibrator name.
• Current curve: When the desired calibrators have been selected (as
shown above), click on the Activate Selected button to accept. The curve
is displayed in the window. The current curve will then be used for sam-
ple calculations.

5.3.2 Sample tab
Figure 44
Sample tab
This tab can be used to set up a quick and easy work list.
1. Enter sample IDs: Press the Add Numerical ID button to enter samples by
number. After pressing the button, follow the instructions in the pop-up.
Press Add Patient ID to choose a patient from the Patient Database. Refer-
! Note: The ‘drag and drop’ fea-
ture allows reagents and sam-
ple racks to be changed within
ence 6.2.2.8 Choose patient record for more information. their rack location and between
racks as well.
2. Choose tests: Click on one or more of the patient ID’s on the left. With the
patient(s) highlighted, choose the assay or assays to run with the chosen
patients. Click on the test and press Add test. Click on the same test again
to deselect it.
3. Work list: Lists the IDs and assays assigned to each and requested copies. To
add more copies to a test, highlight that row and use the hidden pull down
to change the number. To remove a patient, click the row and press the Re-
move button. If you click Calibrate, all registered calibrators are loaded to
the worklist as well (not visible in this list). You can then print the work list
and/or press the Request button. When you choose Request and confirmed
the schedule and the wash bottle loading, the layout tab opens. Verify the
location of all samples and press Start Run when done loading the racks. The
test will now begin.
38
5.3.3 Test list tab
1 2
Figure 45
Test list tab
3 4
1. List: Use Highlight by Name/ ID drop down menu to highlight a patient, or

use Highlight by Assay drop down menu to highlight by type of assay. All of
the assays are listed and the Current Step that is running is shown to the
right of the drop down menus.
2. Layout: Indicates the location of patient samples, reagents, and pertinent
assays. For more information on a particular substance, highlight it with the
mouse cursor.
3. Select all and buttons: Select All selects all patient ID’s, or patients may also
be selected individually. Check the box next to the ID’s that you are choosing.
When at least one of the ID’s is checked, the row of buttons at the bottom
is highlighted. Click Accept to accept the results of the selected ID, Rerun
to run the selected ID again, or Delete to discard the selected ID. Choose
Resume All to continue the tests. Results must be accepted to allow you to
view them in the Report tab.
4. Legend used by software: Used to identify the processes and results being
used.

5.3.4 Report tab
2 3
Figure 46
4 1 5 5 6 7 8
By default, the Report tab shows the information from the most recent test run.
In Figure 46, the Report tab shown is displaying information after running for
example TSH, T3 and T4.
Results are organised based on the time they are run. Select all or individual
tests using the checkboxes.
1. Select Sorting option from drop down menu to change the way your results
are displayed.
2. Select the History checkbox to begin searching for results by date, substance
type, name/ID or test name.
40
Past results may also be searched for this way. Input as much search criteria
as possible for more precise search results.
• Search by Date: Use the drop down menus to select the dates to search
for results.
• By Name/ ID: Search for results for a specific patient.
• By Assay: Use this menu to search for results from a specific assay.
3. Select the magnifying glass to display the kinetic trend (absorbance vs. sec-
onds) of the selected sample.
4. Select All: Check this box to select all Names/IDs. Only selected results will
be printed.
5. Print: Print all selected Results. Print Preview shows a preview of the print-
out.
6. Export: Export selected reports to a text file (*.txt), MS Excel file (*.xls), or
XML file (*.xml). Save for future reference.
7. Remove: Remove all selected Results.
8. Retest (add to Sample Tab): Add the selected items to the sample tab to be
retested.
5.4 Main menu selections and features
This section will introduce you to the items located in the ELISYS UNO Manager’s
main menu.

5.5 Management menu
Figure 47
Management menu options
Option Description
Initialize Establish or re-establish communication between the soft-
ware and the instrument without restarting the software.
Pause engine Pauses the process that your ELISYS UNO is doing at that
time. Resume allows ELISYS UNO to resume the previous
task from the point it paused.
Reload assay Use this feature after editing or creating new assays with
files Assay Editor. The new or edited assays are then added to
the list of available assays in ELISYS UNO Manager.
Change Change the temperature for specific tests. For instance,
temperature when running the Performance Check, change to Room
Temperature.
Change rack1 Change the rack style
Change rack 2 Select another rack type for sample tubes.
Multi-plate test Used when running a plate that contains long incubation
times. Other tests, even entirely different modes, can be
run by loading a different plate. There is a reminder to re-
load the plates when time is almost expired.
Communication Used for service purposes ONLY
window
Calibration event See Chapter 6.2.3 Calibrators for more information.
LIS Import Read the information that follows this table explaining the
LIS Import Option and examples of import and export files.
Exit Exit the ELISYS UNO Manager Software.
42
5.5.1 Laboratory information system (LIS)

The ELISYS UNO Laboratory Information System (LIS) provides a method, or
protocol, to allow for ease of information exchange between two systems.
The patient information from external sources can be easily uploaded into our
patient database. This database will contain patient information and tests
requested.Upon job completion the patient information and assay results can
be downloaded into a text file following the same protocol. The protocol for
data exchange is listed below.
- Import process:
• Select Management  LIS Import
• Choose a file containing LIS requests.
• Requested tests are added automatically to request list in the Sample
tab.
- Export process:
• In the Report tab, user will select records and press Export button.
• In the Save-As Type drop down list, the user will select LIS files (*.lis). User
types in a file name, and a folder, for the file and presses Save button.
Record definitions and specifications

Record type definitions:
H| Indicates a Header Record, primarily for informational purposes.

P| Indicates a Patient Record and is patient specific information.
OBR| Indicates a Requested Assay to be run for the preceding patient.
OBX| Results from the Requested Assay preceding.
L| Indicates the end of the file.
A| Append this information to the preceding record; may be used on any
record.

A carriage return is used to indicate the end of the line (220 is the maximum).
Record Layout Specifications Minimum Requirements
Figure 48
! Note: A solid bar (|) indicates

the field is for future use. The
bar delimiter is necessary for cor-
rect formatting within the record.
Figure 49 Figure 50
Import file example (.LIS file extension) Export file example (.LIS file extension)
44
5.6 Routines menu

Figure 51
Routines menu
Option Description
Start of Day See Chapter 6.2.1 Run start of day for more information.
End of Day See Chapter 6.4 End of day for more information.
Wash Probe Select Wash the Probe and reset syringe positions.
Prime Syringe Primes the fluid handling system with the liquid in the
Prime bottle.
Prime Washer - Primes the wash system with the solution in the Wash
Wash Bottle bottle.
Prime Washer - Primes the wash system with the solution in the Rinse
Rinse Bottle bottle.
Temperature On / Enable and disable temperature control.
Temperature Off
Read Wells... Enables selection of wells to be read; selection of filters
(primary and differential); number of reads; and to use,
or not use, a stored blank. Select the Clear button to re-
move all of the results. Select Export to send the results
to a text (.txt) file.
Custom Script... Allows scripts to be run consisting of a series of com-
mands. Recommended for advanced users.

5.7 Lot # registration

See chapter 6.2.3 Calibrators for more information.
5.8 QC tracking
Enables Controls and Calibrators to be tracked using a Levy-Jennings chart. In
past versions, QC tracking could be accessed at the assay level through the QC
tab. With ELISYS UNO this feature is accessed by selecting QC Tracking from QC
on the main menu.
Figure 52
Tracking menu page
Figure 53
Tracking example
46
Enter the assay, control, and lot number information in the drop down menus
to select the control that you wish to review. The curve can be viewed by
absorbance or by concentration results.
Lot numbers are entered in the tab labelled „Lot # Registration“.
Points in the Levey-Jennings Chart can be edited. Unselect the points which shall
not be displayed in the graph. Make sure to click Save QC Points afterwards.
The QC Report can be printed.
5.8.1 Sample DB
See Chapter 6.2.2 Sample database setup for details.
5.8.2 Settings
See Chapter 6 Running ELISYS UNO for details on software settings.
5.8.2.1 Software
See Chapter 6 Running ELISYS UNO for details on software settings.
5.8.2.2 Custom report

In the Custom Report, you can define general reports based on:
Results report templates

- Sorted by request time
- Sorted by name/ ID
- Sort by assay

Assay mode calibration templates

- Absorbance
- Factor
- Standard
- Point to point
- Regression
- Cubic spline (constrained)
- Dose response
- Polynomial 2nd order
- Polynomial 3rd order
- Polynomial 4th order
- Cut off
- Cut off standard
Or Assay specific calibration templates (have the preference over assay mode
templates).
Figure 54
48
5.8.2.3 Language
Choose between available languages. Restart the software after changing a
language. The instrument does not need to be restarted.
5.8.3 Utilities
5.8.3.1 Alignment
See Chapter 5.2 Alignment setup.
5.8.3.2 Channel blank

See Chapter 5.2.4 Channel blanks.
5.8.3.3 Self test

Self Test presents the user with the status of the instrument by recording
data into the Self Test log in Notepad. The self test requires the ELISYS UNO
Performance check kit Cat. No. 17350/11. Refer also to the corresponding
leaflet page 47. The Performance check kit is used for blanking the instrument
and to verify the instrument‘s pipetting precision, reading reproducibility and
photometer accuracy.
Content of the kit:
[SOL1] 120 ml Performance/ Blanking Solution

NaOH 0.1 M
Triton X-100 0.01%
[SOL2] 23 ml Performance/ Blanking Solution
NaOH 0.1 M
Triton X-100 0.01%
[PNP] 7 ml PNP Solution
Para-nitrophenol (PNP) 3 mM
NaOH 0.1 M
Triton X-100 0.01%
It is necessary to supply an empty sample vial for [PNP] to be used when self
test is running. [SOL1] is intended to refill [SOL2] if required.

Figure 55
Figure 56
Self test
To begin the test the user selects Self Test from the Utilities menu. The user then
places the bottle containing 23ml of [SOL1] in position 1 of the reagent rack and
puts an aliquot of the [PNP] in a sample vial placed in position 1 of the sample
rack. After loading the solutions and inserting a clean plate into the instrument,
the Start button is pressed and the self test is performed. The Test Progress bar
will display the progress of the test. After the self test completes the instrument
displays Pass/ Fail results on the screen. Clicking the Details button will display
the complete self test report.
Pressing the Details button once the Self Test is completed will open the Self
Test log in Notepad.
50
The Self Test log in Notepad displays the date, time, status of Lamps, Blank,
Pipetting Accuracy, Photometer/ Plate Positioning, Temperature, Blank Abs,
Filter Volts, etc.
Figure 57
Self test failure checklist

Self test failure is defined as follows:
Type CV Criteria
Large (18 μl sample) > 2%
Medium (10 μl sample) > 2%
Small (2 μl sample) > 3%
Please note:
- Verify start and ending temperatures are room temperature;
- All blanks should be between -0.005 and +0.005;
- If not, repeat setting blanks;
- Filter Voltages must be between 2 and 10;
- Make sure the plate position has passed.

If running the Self Test yields poor results, attempt the following steps:
1. If small (2 μl) CV% results are within specifications but medium (10 μl) and
large (18 μl) are out of range, failure is likely not with pipetting accuracy but
rather with photometer/ plate positioning.
! Note: [PNP] is temperature
sensitive. Make sure the in-
strument temperature is set to
2. If small (2 μl) CV% results are not within specifications, check the following: OFF and the temperature has sta-
• Check for diluter system leaks bilized. [PNP] irritates eyes, skin
• Check syringes for freedom of movement and mucous membranes. Upon
• Check that probe tip is not partially bent contact, rinse thoroughly with co-
• Rerun channel blanks pious amounts of water and con-
• Recheck photometer alignment. If this is adjusted, check plate X/Y parms. sult a doctor.
• Recheck probe alignments
5.8.3.4 Filter voltages

See Chapter 5.2.3 Filter voltage.
5.8.3.5 Launch assay editor

The Assay Editor will open when the Launch Assay Editor option is selected from
the Utilities Menu. See Chapter 7 Assay editor for more information.
Figure 58
52
5.8.3.6 Launch pack

The Pack application is used by technical support to troubleshoot problems.
Type in a description of the problem before packing the data.
Figure 59
Select Pack options from the drop down menu. Options include packing assay
files, root files, lot# files, and rack files. An individual file may be selected by
clicking in the check box next to the file name, or all files may be selected by
clicking on the Select all checkbox.
Figure 60

Figure 61
The screen will display a message when the pack file operation has completed.
Figure 62
The packed file will be located in the directory with the file name shown in the
To display box on the screen.
54
5.8.3.7 Launch report creator
5.8.4 Security
See Chapter 5.1.2 Password security and logging in for more information.
5.8.5 Help: About
Figure 63
The About selection will open a window and display the version of the ELISYS
UNO Manager installed in your instrument.
Figure 64

Running ELISYS UNO 55
6 RUNNING ELISYS UNO

This section will take you through the steps necessary to prepare for the day’s
work and set up a run using the ELISYS UNO Manager.
6.1 General settings

When you first open the ELISYS UNO Manager, there are several settings to
choose from and a few tasks that must be performed before running samples.
6.1.1 Software settings

Choose Software under the Settings menu.
Figure 65
Selected database option
Figure 66
Software settings
56
You may choose to keep the records of numerical ID records from 1 to 10 years;
choose to keep sample IDs from 1 to 30 days. However, whatever preferences
you choose, all sample test records are backed up monthly to an archive
database. The communication port can be changed. The default temperatures
are displayed for ELISA mode. Press OK when finished.
6.1.1.1 Sample database
Option
Sample Database
Figure 67 Description
Customize sample database field
names, uncheck field name from
the list displayed if you do not want
to use it.
! Note: The Sample ID field and

the Keyword field must be used.

6.1.1.2 ELISA strategy
Option
EIA Strategy
Description Figure 68
Set parameters for how to run the
tests and how to handle the results
in ELISA mode.
Save reagent
Sacrifices some instrument per-
formance in exchange for reagent
economy.
Auto accept curve (default)

The curve generated is automatical-
ly accepted.
Manual accept curve

When tests are complete, they remain in the test list. The user can review the
step log to see if there are timing errors, etc. The user should check the curve
set and click the accept button. Curve records will be written into the data-
base and displayed in the Calibration tab.
Manual activate curve

After accepting the curve, the curve records go to the Calibration tab. They are
available for the user to activate. After user activates a curve, Sample Results
are calculated. This setting is helpful when a user chooses Auto Accept Sam-
ple and Auto Print Report.
58
6.1.1.3 Report appearance
Option
Report Appearance
Specify your preferences on the re-
port appearance.
6.1.1.4 Report output
Option
Report Output
Specify optional data to print for
different report types. You can also
specify if report should be printed
jointly.
Specify settings, press OK when fin-

ished to save and exit.

6.2 Start of day

Running Start of Day at the beginning of every workday is recommended.
6.2.1 Run start of day

Check the bottle volume levels: Empty the Waste bottle if necessary; empty the
Prime bottle and refill it with fresh deionised water.
Start of day procedure:

From the Routines Menu, select Start of Day.
Figure 71
The sample handling system will be primed with deionised water. The washer (if
applicable) will be primed with wash solution and the lamps will turn on. After
running the Start of Day program, visually check the sample handling tubing
! Note: Observe the fluid han-
dling system and ensure there
are no leaks.
and the syringe for the presence of any bubbles.
If bubbles are present, repeat the Start of Day program, tapping the tubing
where the bubbles are present. If this does not eliminate the trapped bubbles,
perform the Weekly alcohol cleaning procedure, see Chapter 6.2.1.1.
60
6.2.1.1 Weekly alcohol cleaning

Perform this procedure to purge the tubing of trapped air bubbles. Replace the
prime bottle with a bottle containing 70% Isopropyl Alcohol. From the Routines
Menu, select Prime Syringe
Figure 72
When the cycle is complete, replace the bottle containing 70% Isopropyl Alcohol
with the prime bottle containing fresh deionised water and repeat the Prime
Syringe procedure.
6.2.2 Sample database setup
6.2.2.1 Add sample ID

1. Select Sample DB from the menu.
2. When first opened, the Sample Database window will not have any records
to display.
Figure 73

3. Select the Edit button to enter Sample ID, Family Name, Given Name, etc.
This will be helpful as search criteria when searching the database. Press the
Done button when finished.
4. An instructional dialogue box will open.
• Navigate through the fields on the screen by using the Tab or arrow keys
on the keyboard.
• Create a Sample ID by typing in the Sample ID field.
! Note: The Edit button toggles
to Done
• Modify a Sample ID record by clicking on the field to edit and typing.

• Delete a Sample ID by highlighting the record to delete and press the
Delete key on the keyboard.
Figure 74
5. Additional criterion includes Keyword or Custom. Information that can be

useful in either Keyword or Custom can include, but is not limited to, medi-
cal issuer, study ID numbers, or chronic diagnosis.
Figure 75
Information entered in the keyword field will be matched to keywords entered

in Special Interpretation Groups (see Figure 149 Special group in Chapter 7.6).
62
6.2.2.2 Modify sample ID

1. Select Edit to edit an existing patients information or create a new one.
Figure 76
2. Modify the information and then press the Done button to save the changes.
6.2.2.3 Delete sample ID

Highlight the items to be deleted then press the Delete key on the keyboard. A
dialogue box will open prompting the user to confirm the deletion of the record.
Press Yes to delete, press No to cancel the deletion process.
Figure 77
Press the Close button to close the Sample DB window.

6.2.2.4 View log

Select the View Log button to view the Patient.DB.log in Notepad. The log will
display the modification date, time and the change that was made:
Figure 78
6.2.2.5 Import patient record

Click on Import to open the Import Sample Records window. Browse for the
sample record to be imported via Open. It is necessary to match the information
in the sample record and the database format. For this, the selected Text File
Field should contain the information which fits to the respective Database Field.
Click on Start to import the sample record.
Figure 79
64
6.2.2.6 Export patient record

1. Click to highlight the Sample ID to export. Select the Export button to send
the selected record to the Sample Record text file in Notepad.
Figure 80
2. Click on File and select Save. Close the window when finished.
6.2.2.7 Search patient record

Enter criteria into Search Database area, press OK. All records containing the
specified criteria will display.
Figure 81
Search result
displayed

6.2.2.8 Choose patient record

Select the Choose button to add a selected patient to the Sample ID list in the
Sample tab.
Figure 82
6.2.3 Calibrators
Before Samples can be read, Calibrators must be registered and read. Open the
Calibration tab and choose “TSH calibrator A” as an example from the Choose
Assay drop down menu. Entering the lot numbers for calibrators is optional,
since the calibrator concentrations are set in the Assay Editor.
Lot # Registration
1. Open Lot Registration from the top menu.
Figure 83
Choose the corresponding name
3
2
66
2. Click the Substance in the left column you would like to register.
3. Click on Register New Lot#
Figure 84
Enter Lot # and optional
description
Enter the Lot # and a description (optional). Click OK to Save.
Concentration range
Figure 85
Entering concentration range
Specify standards concentration for curve calculation; specify range to monitor

the quality (optional). Highlight the field to change, type in new value.
Press the Close button to save.

New curve and new control

In the Calibration tab, add the New Curve and New Control to the Work List
by selecting the corresponding option from the drop-down menu. In the above
example (see Figure 85 Entering concentration range) [ALL] has been selected. All
programmed Calibrators and Controls will be added to the Work List. You may
run more than one of each of the calibrators. In Figure 86 Select Curve, we are
only running one of each. Change the numbers by using menu options
Figure 86
Select curve
CC
NC
PC
Use drop down menu to change the number of copies.

Select Curve from the drop-down menu. Press the New Curve button once for
each blank and calibrator you intend to run. Select Controls to add controls.
If you wish to save this as a Work List for validating your calibrators in the future,
press Save, choose a location, enter a name, and press OK.
68
Press Request; the Layout tab will open.

1. Verify location;
2. Make sure your reagents are loaded properly;
3. Press Start Run if placements are OK.
1 1 2 3
Figure 87
Verify reagent, calibrator and
controls are properly loaded
The volume given in the loading instructions is a recommendation and includes

a generous dead volume for safety. Load Sample and Reagent racks as instructed
and press the Start Run button (see Figure 87 Verify reagent, calibrator and
controls are properly loaded). The Test List tab opens and the ELISYS UNO begins
the run. The status and current step are both shown.
Figure 88
Test List tab shows the status of
the current run

When ELISYS UNO is finished reading, the Calibration Event window opens. This
window shows whether the new curves and controls were accepted. If the curve
is not accepted, this procedure must be repeated.
The controls will be accepted even if they read out of range if the Control Properties
are set to Warn and Continue. To check your Control Properties or change this
setting, see Chapter 7 Assay editor. If you do not want to see this window every
time, click the Do not automatically show up box in the bottom left corner of the
window (see Figure 89 Calibration event). If checked, the Calibration Event can
only be viewed by selecting it from the Routines window or by pressing the F8
key on your keyboard at any time.
Figure 89
Calibration event
When selected, Calibration Event will display the blank, calibrator, and controls
valid for 7 days. After they expire, you will have to re-run the Calibrators to use
that assay. You may run more frequent recalibrations and control checks as often
as you like. To change the time valid, you must edit the assay using Assay Editor.
70
6.3 Running samples

At this point, you are ready to begin running samples.
Click on the Sample tab (see Chapter 5.3.2 ‘Sample tab‘).
Figure 90
Sample Tab
Press Add Numerical ID. Type in the First ID and the total number of patients
(see Chapter 5.3.2 Sample tab). Click OK to add the IDs.
! Note: Press Add Sample ID to

access IDs from the Sample
Database.
Refer to Figure 91 Assigned assays and click on each patient(s) and add tests for
them to the Work List. After pressing Request the Layout tab opens.
Use loading positions to correctly load the racks (refer to Figure 92 Layout tab
with load positions).
1. Click on Patient to select.

2. Click Test or Tests to be added. Then click Add Test.
3. Press Request to begin.
Figure 91
Assigned assays
1 2 3

1. Locations for samples outlined.

2. Use these Instructions to load the racks.
3. When all are correctly loaded, press the Start Run button.
Figure 92
Layout tab with load position
! Note: Use the ‘drag and drop’

feature to change reagent
or sample locations within their
rack location and between racks
as well.
1 1 2 3
The Test List tab opens as shown in Figure 93.
Figure 93
Test List tab opens
After the tests are complete, you must Accept, Delete or Rerun the tests. Tests
must be accepted before they can be viewed in the Report tab. Click the Report
tab to get reports on all of the results (see Chapter 5.3.4 Report tab).
72
6.4 End of day
! Note: It is important that you

place deionised water in the
Rinse bottle prior to running End
At the end of the day, place deionised water in the rinse bottle, if it does not
already contain it. Place a bottle of approximately 5.25% Sodium Hypochlorite
in Rack1 Position1. Select End of Day from the Routines menu and follow the
of Day. prompts. This will completely bleach the sample handling system, re-prime it
with deionised water, and rinse the wash head (if applicable) with deionised
water. It is optional whether you turn the unit off or not.

Assay Editor 73
7 ASSAY EDITOR
Assay Editor works in conjunction with ELISYS UNO Manager. Although all
HUMAN Methods are included and pre-programmed in the ELISYS UNO Manager
software it is possible to add new methods by choosing Launch Assay Editor in
the Utilities menu.
Figure 94
Welcome screen
Figure 95
User software menu
Access the Assay Editor via the shortcut, or click Launch Assay Editor in the
Utilities drop down menu within the user software.
There are eight main parts to the Assay Editor.

74
Figure 96
Working screen
Item Section Location

1 Main menu and toolbar Chapter 7.1
2 Creating ELISA assays Chapter 7.2
3 Assays steps Chapter 7.4
4 Interpretation settings Chapter 7.5
5 Special groups assay editor Chapter 7.6
6 Standards Chapter 7.7
7 Blank Chapter 7.8
8 Controls Chapter 7.8
7.1 Main menu and toolbar

Assay Editor 75
7.1.1 Assay
New ELISA: Clears all entries and allows building of a new Assay.
Open ELISA: Opens an existing Assay.
7.1.1.1 View
Figure 97
View menu
Toolbar: Uncheck to close.

Status Bar: Closed by default.
7.1.1.2 Substances
Use this menu to choose one of the Substances and manage the list. Managing
the list refers to adding: New, Edit or Delete Current Substances.
Figure 98
Substances menu
Figure 99
Manage reagents
76
Figure 100 Figure 101

Manage controls Manage standards
7.1.1.3 Panels
This feature allows you to set up and save panels of assays to be run as a group.
Use New EIA to create a new Panel Assay list. Select an assay from All Assays and
add it to the Panel list by pressing the arrow buttons. Assays can belong to more
than one panel. Click Open EIA to open an existing Panel Assay list.
Figure 102
Panel menu
Figure 103
Select an existing or newly
created panel

Assay Editor 77
7.1.1.4 Indices
Sometimes a test result is not a measurement, but a calculation made from
other measurements. To create an equation that calculates a test result, select
New ELISA.
See Figure 104 Create a new index that follows.
1. Index Name: Give the New Index a name.

2. Assays: Click an Assay twice to add it to the Index Formula Editor (7).
3. Operators: Click once to insert into the equation.
4. Numbers: Click to add numbers to the equation.
5. Backspace: Click to remove last action.
6. Interpretation Settings: See Chapter 7.5 for more information.
7. Index Formula Editor: Displays the equation you built. Be sure the formula is
correct before saving.
8. Index Description (optional): Type a description of your Index.
When making a Patient Report, the Index is reported only if there was a valid
test result for that patient for each of the Assays required to calculate the Index.
1 3 4 5 7 8
Figure 104
Create a new index
2 6
78
7.1.1.5 Security
Figure 105
Security menu
Security allows the Administrator to designate other users as Operators or

Managers. The user’s security level will decide what they are authorized to use.
Table 3
Security level Administrator Manager Operator
Disable security Y N N
Enable security Y N N
Create manager Y N N
Create operator Y Y N
Remove manager Y N N
Remove operator Y Y N
Open assay Y Y Y
Save assay Y Y N
Open panel Y Y Y
Save panel Y Y N
Open index Y Y Y
Save index Y Y N
Create substance Y Y N
Edit substance Y Y N
Delete substance Y Y N

Assay Editor 79
Enabled: When Enabled is checked, the password protection and security

restrictions are being used.
Login as Different User: Shows the login screen and allows you to login with a
different name and password.
Logout: You are logged out and the Login screen appears and waits for next user.
Press Cancel to quit Assay Editor.
Create New User: Create a new user with ID, password, and security level. The
manager can create users, but will only be able to give them operator level
security.
Remove User: Administrators can remove any user. Managers can only remove
operators.
Change Password: Any level can use this feature. Enter your old password
followed by the password you want to change it to.
Who Is Logged In: Security access window appears to show who is logged in and
their security access.
Figure 106
Who Is Logged In
View Log File: Displays a text file listing logins, anything that has been modified,
date, time and by whom.
80
7.1.1.6 Settings
Figure 107
Settings
Printout Font: Allows user to select a font style for printouts
Figure 108
Printout Font selection
Filters: Displays the currently installed filters in a particular instrument.
Figure 109
Installed Filters (may vary)

Assay Editor 81
7.1.1.7 Icons
To see the function each icon has, place the mouse cursor over the icon in Assay
Editor. A description will appear.
Create a new ELISA Assay.
Open an existing ELISA Assay.
Save: Saves the current Assay under the name entered in the “As-
say Definition” Section.
See Chapter 7.4 for more information.
Save As: Allows the Assay to be saved under a different name or

to save another copy of the Assay.
Print Assay: Prints the current Assay.
Manage Reagents: Same function as selecting Reagents under the

Substances menu. See Chapter 7.1.1.2 for details.
Manage Controls: Same function as selecting Controls under the

Manage Standards: Same function as selecting Standards under the

Help: Opens the Help window. See Chapter 5.8.5 for details.
82
7.2 Creating ELISA assays

This section gives a broad overview of creating a new assay. See Chapter 7 for
detailed information.
Figure 110
For ELISA Assays
1. Assay name: Enter a name for the new Assay.

2. Assay type: Indicates ELISA Assay is being programmed.
3. Temperature: Room temperature, 37°C or 25°C selection
4. Assay description: Entering a description for the Assay is optional. However,
a short description of the edited or newly created Assay is recommended.
5. Assay mode: There are ten ELISA Modes.
Figure 111
Assay Definition
section

Assay Editor 83
Figure 112
7.2.1 Absorbance mode

ELISYS UNO reads and prints the monochromatic or bichromatic differential
absorbance at the user-selected wavelengths. Blanking is optional. Most Assays
require a mode other than Absorbance Mode. In this mode, no calculations are
made - only absorbance values are reported.
Figure 113
Assay definition
7.2.2 Point-to-point mode

ELISYS UNO accepts a number of calibrators and calculates concentrations
based on the point-to-point calibration curve. Calibrator materials of known
concentrations are used to calibrate ELISYS UNO so that concentrations of
unknown samples may be calculated. The resulting calibrator curve is a series
of lines connecting the calibrator points, which may be entered in ascending
or descending order of absorbance. The direction of slope between the first
and second calibrators determines the direction of the curve. If the direction of
the curve changes direction, the curve will be flagged as being invalid and no
interpretations will be printed.
84
Unknown samples are calculated as follows:

- The unknown sample’s absorbance is read and compared to the absorbance
of the calibrator.
- The line selected as the calibration curve used to determine the concentra-
tion of the unknown Sample is the line that connects the pair of Calibrators
with absorbance values closest above and below the value of the unknown
absorbance of the Sample.
- An unknown Sample, with absorbance higher than the calibrator with the
highest absorbance value, is calculated using a line that passes through the
two Calibrator points with the highest absorbance value. An unknown Sam-
ple with absorbance lower than the lowest Calibrator absorbance is calcu-
lated from the line that passes through the two calibrators with the lowest
absorbance values.
Figure 114
7.2.3 Regression mode

ELISYS UNO accepts a number of calibrators and calculates concentration values
based on a best-fit curve (linear regression).
Figure 115
Regression mode

Assay Editor 85
Data may be entered for linear-linear, ln (= natural log)-linear, linear-ln, or ln-ln

calculations. A logit-log calculation is also available. Absorbance, or ln of (1000
* absorbance), is always on the Y axis. Concentration, or ln of concentration, is
always on the X axis.
1. “Y= ABS, X=CONC”:

Both the absorbance data (y) and the concentration data (x) are linear.
2. “Y=Ln (1000*ABS), X=Conc”:
The natural log of the absorbance is plotted against the concentration. The
absorbance values are multiplied by 1000 before taking the logs.
3. “Y=ABS, X=Ln(Conc)”:
Absorbance is plotted against the natural log of the concentration.
4. “Y= Ln (1000*ABS), X=Ln(Conc)”:
The natural log of the absorbance is plotted against the natural log of the
concentration.
5. “Y= Logit(Abs), X= Log(Conc)”:
To calculate unknowns using the equation: Abs Logit = Ln [(sample/0 cal) /
1-(sample/0 cal)]
6. “Y=Log (1000*ABS), X=Conc”:
The common log of the absorbance is plotted against the concentration. The
absorbance values are multiplied by 1000 before taking the logs.
7. “Y=ABS, X=Log(Conc)”:
Absorbance is plotted against the common log of the concentration.
8. “Y= Log (1000*ABS), X=Log(Conc)”:
The common log of the absorbance is plotted against the common log of the
concentration.
When using the Logit calculation, the 0 calibrator is not plotted as part of the
curve; it is used only for the calculations.
In the Linear Regression mode, resulting concentrations will be the same no

matter what base is used (ln or log). However, slopes and intercepts will vary.
When using a format which calculates the ln of the concentration, (do not
use 0.0 for the concentration, since ln 0 is not defined. If a 0.0 concentration
Calibrator is used, it will be ignored when the regression is calculated.) Note that
in the logarithmic modes, any values which require the log of a zero or negative
number are invalid, and will either invalidate the curve (if in the Calibrators) or
invalidate the specimen. Likewise, when using ln of 1000*Abs, the absorbance
values must be nonzero and positive.
86
7.2.4 Cubic spline (constrained) mode

ELISYS UNO accepts a number of Calibrators and calculates concentrations
based on the Cubic Spline (Constrained) calibration curve. Calibrator materials of
known concentrations are used to calibrate ELISYS UNO so that concentrations
of unknown Samples are calculated from the generated curve. The resulting
calibrator curve is a smooth curve connecting the Calibrator points, which may
be entered in ascending or descending order of absorbance. A constraining
algorithm is applied to prevent curve overshoot.
Figure 116
7.2.5 Cut-off standard mode

Within the Cut-off mode, ELISYS UNO offers four (4) equations to choose from:
Figure 117

Assay Editor 87
COV = X*mean(CC + F = Cut-off control

- COV = Cut-off value for positive or negative interpretation
- X = A variable provided in the Assay Kit package insert. Note: X will equal 1 if
no value or variable provided.
- mCC = The calculated mean of the absorbance values of the cut-off controls
when test is running.
- Blanking is optional, dependent upon the Assay Kit
- F= Factor added to the mCC. If needed, this value is provided in the Assay Kit
package insert. If none provided, use zero for the value of F.
- Positive and/ or negative controls may be used for OC criteria.
COV = X*mean(NC) + Y*mean(PC) + F

- Use this equation when ELISYS UNO must calculate the cut-off value based
upon readings or positive and/ or negative controls.
- In this equation, NC and PC are used to determine the COV (cut-off value).
- Enter the variables provided in the package insert.
- ELISYS UNO calculates the mean of the positives and the mean of the neg-
atives.
COV = X*mean(NC) + F
- Use this equation if only a negative control is used to determine the COV.
COV = Y*mean(PC) + F
- Use this equation if only a positive control is used to determine the COV.
Reverse Cut-off mode: With the Reverse Cut-off option, the samples with
values lower than the cut-off are labelled as positive. If you choose this
option, be careful to follow the < and > signs in the prompts for entering
cut-offs and ranges.
88
7.2.6 Cut-off standard mode

ELISYS UNO reads a calibrator, then calculates concentrations based on a single-
point standard curve passing through the point (0,0). A blank is required to
determine the (0,0) point. A factor (equal to the concentration of calibrator ÷
the absorbance of calibrator) is generated in this mode, and then multiplied
by subsequent absorbance readings to determine concentrations. In the Cut-off
Standard mode, you may assign a concentration value to one of the controls
to be treated as a calibrator and select cut-offs based upon the concentrations
7.2.7 Dose response mode

This mode uses non-linear regression (Levenberg-Marquardt method) to fit the
calibration curve to a four-parameter logistic equation defined by:
Y = Bottom + (Top-Bottom) / (1 + 10 ^ ((LogEC50-X) * HillSlope)).
This yields a sigmoid curve. The parameter Bottom is the absorbance value at
the bottom of the plateau, Top is the absorbance value at the top of the plateau,
and LogEC50 is the concentration value halfway between the Bottom and
Top. The parameter HillSlope describes the steepness of the curve. When the
Hillslope is less than 1.0 the curve is shallower, when the Hillslope is greater
than 1.0 the curve is steeper.
7.2.8 Polynomial modes

These modes use non-linear regression to fit the calibration curve to polynomial
equations. The order of the polynomial equation tells you how many terms are
in the equation. Higher order equations have more inflection points.
Second order is defined by: Y = A + B * X + C * X^2.
Third order is defined by: Y = A + B * X + C * X^2 + D * X ^3.
Forth order is defined by: Y = A + B * X + C * X^2 + D * X ^3 + E * X ^4.

Assay Editor 89
7.2.9 Parameter logistic

These mode is used if a sigmoidal curve is used acc 4 parameter Logistic (4PL).
The calibration window shows 4PL and the printout for the calibration curve
includes the values for A,B,C,D, the formula of 4PL and the R².
Figure 118
4PL Curve
7.2.10 %Absorbance
These mode used to show absorbance ratio %.
7.3 QC Criteria
Clicking the QC Criteria button brings up the QC Criteria window shown in
Figure 119. From this window one can add new control criteria, delete, edit or
change the checked order of the control criteria defined in the Assay
! Note: There must be substanc-
es (standards, controls, blank)
in the assay before selecting QC
Criteria.
Figure 119
Assay editor – QC
Criteria
90
Figure 120
QC Criteria over-
view
Pressing the New button brings up the window shown in Figure 122 Cut-off QC
general criterion. By clicking on the Substances, Operators, and Numbers you
can enter any QC equation that you would like. This General Formula option is
also accessible from the QC button in assay modes “other than cut-off mode”.
Figure 121
QC Criteria tem-
plate (for other than
Cutoff)
Figure 122
QC Criteria general
criteria (for Cut Off)

Assay Editor 91
7.4 Assay steps
Figure 123
Assay steps dialogue box
An ELISYS UNO Assay is constructed of several successive steps. They are:

- Select step (Chapter 7.4.1)
- Edit step (Chapter 7.4.2)
- Arrow buttons to change the order of the various steps (Chapter 7.4.3)
- Delete step (Chapter 7.2.4)
- Copy step (Chapter 7.4.5)
7.4.1 Select step

Figure 124
Select step dialogue box
! Note: For advanced users

“Additional Parameters” (Ad-
vanced Button) may be altered.
Otherwise, default parameters
will be used.
92
7.4.1.1 Add sample
Figure 125
Add sample step
parameters dialogue
1. Enter the Sample volume to be added to a well.

2. If predilution is needed, enter the dilution ratio, or manually enter the vol-
ume of Sample to volume of diluent being used. When entering the dilution
ratio, the total predilution volume must be specified.
! Note: Dilution ratios and total

volume being specified must
result in a Sample volume of
3. If a clean/ rinse step between each pre-dilution is needed, choose the option
to dilute in the sample rack, and clean/rinse after dilution.
4. Press OK or click the Advanced button for Advanced Parameters such as as-
greater than 2µL piration speed, air gap, dispense speed, dispense height.

Assay Editor 93
Figure 126
Pre-dilute parameters
Figure 127
94
1 1
Figure 128 Figure 129

Advanced parameters for Sample Advanced parameters for Diluent
Volume Volume
Click the Advanced button (optional).
Feature: Description: Item No.:

The acceptable range is 0 to 4, where 4 is the fastest
Aspiration
speed. Default speed is 2. Slower speeds result in bet- 1
speed
ter precision, but decreased throughput.
Amount of air (in micro litres) that will separate the
substance aspirated from the de-ionized (DiH20) wa-
Air gap 2
ter in the system. Default values are automatically
selected based on the aspiration volume.
The acceptable range is 0 to 4, where 4 is the fastest
Dispense
speed. Default speed is 2. Slower speeds result in bet- 3
speed
ter precision, but decreased throughput.
Dispense There are two levels of dispensing - High or Low. The
4
height default is Low for a Sample and High for a Reagent.

Assay Editor 95
A. Main settings
Dilution ratio: Ratio of sample volume to total volume
Total volume: Total predilution volume
Sample volume: Sample volume to be added to the diluent to make the
dilution.
Advanced button (optional): Opens the advanced parameter dialogue,
where the Aspiration Speed and Air Gap can be changed.
Dilute to plate (instead of sample rack): Check this option if you want the
dilution to be sent directly to the well.
Set the volumes manually: Manually specify the volume of Sample and
diluent to be used for the predilution.
Diluent volume: Amount of diluent to be added to a Sample.
B. Aspiration settings
Aspirate separately: If this option is not checked, both the diluent and the
Sample are aspirated in a single step, and then dispensed together to the
vial on the sample rack.
Separation air pocket:
What should be diluted (in addition to samples):
• Dilute standards: Check this option if you want to dilute both samples
and standards.
• Dilute controls: Check this option if you want to dilute both samples
and controls.
• Use diluent for blank: Check this option if you want to use the diluent
for blanking.
C. Dilution mixing in Rack2
Mix by aspirate/ dispense
• Mixes the dilution before loading by repetitive aspiration and dispensing.
• The number of times and the percentage of volume can be set.
96
7.4.1.2 Add reagent
Figure 130
Select or create a
substance (reagent)
Select Add Reagent from the list. Select an existing Substance or Reagent, or,
create a new one.
Figure 131
Add reagent step parameters

Assay Editor 97
Change button: Enables changing the reagent for this step.

Volume: Desired reagent volume to be added to a well.
Exclude blanks when dispensing: In common practice, Blank wells contain a
reagent only. If you do not want to dispense the reagent into the Blanks, check
this option.
Dispense one by one: ELISYS UNO tries to be as efficient as possible and aspirates
the reagent for several samples at once. If you want the reagent to be aspirated
for only one Sample, resulting in better precision for small reagent volumes,
check this option.
Advanced button (optional):
Figure 132
Add reagent step advanced
parameters
Aspiration speed: The acceptable range is 0 to 4. The fastest speed is 4. Default

speed is 2.
Airgap: Amount of air (in microliters) that will separate the substance being
aspirated from the de-ionized (DiH20) water in the diluter system. Default
values are automatically selected based on the aspiration volume.
Pre-warm time: Most kinetic tests require the reagent to be pre-warmed after
aspiration and before it is added to the well. The pre-warm time can be set up to
59 minutes and 59 seconds.
Dispense speed: The acceptable range is 0 to 4. The fastest speed is 4. Default
speed is 2.
Dispense height: There are two levels of dispensing - High or Low. The default is
Low for a Sample and High for a reagent.
98
7.4.1.3 Incubate (lag time)
Figure 133
Incubate step parameters
! Note: For rate mode test, this

is where the lag time is set.
Time to incubate: Enables an incubation (lag) time in hh:mm:ss format, where
hh=hours, mm=minutes, ss=seconds.
Figure 134
Incubate step parameters

Assay Editor 99
7.4.1.4 Read
Read step parameters:
Figure 135
Figure 136
! Note: If using a differential

blank or sample, a Read step
must be added both before and
after the Incubation step.
Primary filter: Select a primary filter to be used for readings. There is no default
value. A primary filter must be selected before continuing.
Differential filter: Select a differential filter that should be used for readings, if
any. There is no default value. One of the options from the list must be selected
to continue. One of the options is None. The differential filter cannot be the
same as the primary filter.
Some assay inserts do not specify to use a differential filter, but when running
assays in microplates as in ELISYS UNO, a differential reading filter usually
improves results.
! Note: A differential filter
should always be used if at all
possible when running assays in
ELISYS UNO
It is important to choose a differential wavelength which is at an absorbance
minimum in the absorbance spectrum of your reacted reagent. If your assay
insert does not specify a differential wavelength to use for your reagent and
there is no corresponding ELISYS UNO example to use, contact the reagent
manufacturer for the best wavelength choice.
100
When the checkbox Kinetic Read is checked,

The menu show additional informations:
- Kinetic Time
• Read time
• Fixed time mode (only two readings)
• Interval in seconds
• Number of reads
Also Kinetic Ranges can be defined

- Initial Absorbance Range
- Delta Abs/ Min Range
- or/ and Maximum S.D. of the Delta Abs/ Min
The results are shown as abs/min.
Figure 137
Kinetic read
windows
! Note: Some reading time delays can occur especially with large assay bat-
ches, but the abs/ min rate is calculated based on the actual reading time
interval not the programmed interval.

Assay Editor 101
7.4.1.5 Clean probe

The Clean Probe step aspirates the cleanser from the bottle in the rack and
dispenses it to waste. This is a special step for cleaning the probe with 1N HCl or
5.25% sodium hypochlorite.
! Note: The probe is washed au-
tomatically with water after
each dispense – no user defined
step is needed.
Clean probe parameters:
Choose or create cleanser:
Figure 138
Figure 139
Volume: Desired cleanser volume to be aspirated by the probe.
Figure 140
102
7.4.1.6 Rinse probe

Rinse probe step parameters:
Enables Rinse Probe
Figure 141
Figure 142
7.4.2 Edit step

1. Select the Edit Step button to change settings in an existing step. See Figure
143.
7.4.3 Arrow buttons

2. Select a step in the list to the right and use the arrows to move that step
higher or lower in the sequence. See Figure 143.
7.4.4 Delete step

3. Select a step from the list on the right and click Delete Step to remove it from
the list. See Figure 143.

Assay Editor 103
7.4.5 Copy step

4. Select the Copy Step button to copy an existing step.
Figure 143
7.5 Interpretation settings

Figure 144
Interpretation Settings
1. Units: Use this drop down menu to select the units of measure for an assay.
Figure 145
Select units
2. # of Decimals: Choose the number of decimal places needed for results.

3. Normal Range: Choose this option to set the range, which identifies that a
Sample is normal. If a result is out of normal range, it will be interpreted as
High or Low.
104
You can also define the linear (valid) test range.
If a result is out of linear (valid) range, it will be interpreted as Above linear

range or Below linear range.
Figure 146
Normal range
Choose this option to set the range, which identifies that a Sample is normal. If
a result is out of normal range, it will be interpreted as High or Low.
4. Positive / Negative
Figure 147
Positive / Negative
Choose this option to set Positive and Negative limits. Results will be interpreted
as Positive or Negative. Samples in a range between the Positive and Negative
limit are interpreted as Equivocal.
Check the Reversed box to switch the settings (see below).

Figure 148
Positive / Negative reversed

Assay Editor 105
7.6 Special groups assay editor

Figure 149
Special group
Special groups can be defined based on age, gender, or keyword. In Figure 151
Special Group Edit Menu, Adult is defined as a patient who is greater than 18
years old.
To access Special Groups, click on Normal Range (see diagram box 1) in the
Interpretation Settings section of the screen. The Special Groups button (see
diagram box 2) will appear in the lower left hand corner of the screen.
106
The Special Groups Interpretation window will open. A list of defined groups
will display. Defined groups may be added, edited, and deleted.
Figure 150
If Edit Group is chosen, the Special Group Edit window will open. The Group
ID is the group definition. Age range and gender may be selected. Keywords
should be separated by a comma. The keyword characterizes the group. It may
be matched with a keyword in the Sample ID database or entered (for numerical
ID) when assigning tests for a sample. Example: Pregnant, non-smoker.
Figure 151
Special group edit menu
Keywords can also be used to determine the group assignment. When the
keyword is found in the patient database keyword field that patient will be
automatically assigned to the defined group. It is important to note that the text
used to name the Group ID is not searched by the database; the user must enter
the keyword(s) used to define the group in the Keyword text box. Figure 152

Assay Editor 107
‘Special group edit using keyword(s)‘ is an example of a special group definition

for a pregnant patient.
Figure 152
Special group edit
using keyword(s)
Refer to the ELISYS UNO Manager section for entering keywords in the Patient
Database. When running samples with numerical IDs the group can be manually
assigned at run time.
7.7 Standards
Standards are used to create the curve for calculating concentration from
absorbance. Standards are available in all calculation modes except Absorbance
and Factor. Assay editor has one standard predefined called Standard.
Figure 153
Add standard
1
1 Add button
2
2 Properties
3 3 Arrow keys
4 Remove
4
5 Curve valid time
5
! Note: The “Add” button is disabled when the chosen assay mode does not
use a Standard. It also becomes disabled when the maximum number of
Standards for a selected mode has been added to the assay.
108
1. Add: Select an existing Standard or create a new one.
Figure 154
Select or create a standard
Figure 155
Standard selected
2. Standard properties
Figure 156
Standard properties
! Note: To enter the concentra-

tion, register a lot number for
this standard in the ELISYS UNO
2.1
The Standard Properties dialogue shows possible Advanced parameters (for

Manager. special cases).

Assay Editor 109
2.1 Advanced button (optional): This should only be used if you need to set up
different parameters than in the Add Sample step.
Figure 157
Advanced button
Needs different volume: Check this box if the Standard needs a volume that is
different that the volume defined in the Add Sample step. When checked, the
Volume field is enabled.
Needs different advanced parameters (optional): Check this box if the Standard
needs advanced parameter(s) different than those defined in the Add Sample
step. When checked, the Advanced button is enabled.
Figure 158
Advanced parameters
Aspiration Speed: The acceptable range is 0 to 4, where 4 is the fastest speed.

Default speed is 2.
110
Air gap: Amount of air (in microliters) that will separate the substance being
aspirated from the de-ionized (DiH20) water aspirated. It separates prime bottle
substance from the aspirated substance. Default values are automatically
Pre-warm time: Some tests require you to pre-warm the standard after
aspiration, before it is added to the well. The pre-warm time can be set here.
Dispense speed: The acceptable range is 0 to 4, where 4 is the fastest speed.

Default speed is 2.
Dispense height: There are two different levels of dispensing you can choose
from: High or Low.
3. Arrow buttons: Select a Standard in the list to the left and click the arrow for
the direction in which to move it in the list.
4. Remove: Select a Standard from the list on the left and click Remove to elim-
inate it from the list.
5. Curve valid time:
Figure 159
Curve info menu
! Note: Follow the IFU for the

curve validity, typical for ELISA
is to set it to 0, and run a calibra-
tion with each run.
Set the amount of time, in days, hours, or both, that the Standard Curve should
remain valid. Default is (7) days.

Assay Editor 111
Figure 160
If the calibration is expired and tests are requested within the Sample menu of
the user software, calibrators will be loaded automatically to the Test list.
7.8 Blank
Figure 161
Blank
Using a Blank is optional in all modes except Standard mode. To use a Blank,
check the box next to Blank Used (Figure 161).
Blank Properties: Set up the Absorbance Range, Out of Range Action, and the
Valid Time for the Blank (Figure 162).
Figure 162
Blank properties
112
Absorbance range: Expected absorbance range of the blank.
Action to take when result is out of range:

1. Warn and Continue – Continue the test when absorbance is out of the range,
but put a warning to the report.
2. Invalidate Tests – Invalidate the Assay results.
Valid time: Blank result valid time in days and hours. Default value is 7 days.
7.9 Controls
Figure 163
Controls menu
1
Controls are used to validate tests (see Figure 163). Assay editor has two controls
predefined: Normal Control and Abnormal Control. New controls can be defined
if needed.
1. Add: Select an existing Control or create a new one.
Figure 164
Select or create controls

Assay Editor 113
2. Properties
Figure 165
Control properties
Action to take when result is out of range:

- Warn and continue: Continue the test when absorbance is out of the range,
but put a warning to the report.
- Invalidate tests: Invalidate the assay results.
Valid Time: Blank result valid time in days and hours. Default value is 7 days.
Advanced button (optional): This should only be used if you need to set up
different parameters than in the Add Sample step.
Figure 166
Need different parameters
than add sample step
114
Needs different volume: Check this box if the standard needs a volume that is
different that the volume defined in the Add Sample step. When checked, the
Volume field is enabled.
Needs different advanced parameters (optional): Check this box if the standard
needs advanced parameter(s) different than those defined in the Add Sample
step. When checked, the Advanced button is enabled.
Figure 167
Advanced aspiration
and dispense
Aspiration speed: The acceptable range is 0 to 4, where 4 is the fastest speed.

Default speed is 2.
Air gap: Amount of air (in microliters) that will separate the substance being
aspirated from the de-ionized (DiH20) water aspirated. It separates prime bottle
substance from the aspirated substance. Default values are automatically
Pre-warm time: Some tests require you to pre-warm the standard after
aspiration, before it is added to the well. The pre-warm time can be set here.
Dispense speed: The acceptable range is 0 to 4, where 4 is the fastest speed.
Default speed is 2.
Dispense height: There are two different levels of dispensing you can choose
from: High or Low.
3. Arrow buttons: Select a Standard in the list to the left and click the arrow for
the direction in which to move it in the list (reference Figure 130).
4. Remove: Select a Standard from the list on the left and click Remove to elim-
inate it from the list (see Figure 130).

Quick guide 115
8 QUICK GUIDE
8.1 ELISA tests

1. Open the Calibration tab to add the curve(s) necessary for the Assay(s) being
run. Controls should also be selected at this point. Next go to the Sample tab
to enter the patient samples to be run. Clicking Request will then process the
standards, control and samples together as a batch.
For ELISAs, standard values are set in the assay editor and entering lot
numbers for standards is optional.
2. Click on the Sample tab in order to enter the patient samples.
3. Click on the Request button. You will be asked to confirm addition of the
calibration standards and asked whether to use a new plate.
If defined Special Interpretation Groups are in the Assay(s) being run, the
Interpretation Group window (Figure 168 Interpretation group) is displayed;
otherwise the Work Schedule (Figure 169 Work scheduler) is displayed. Using
Special Groups Interpretation, unique normal ranges are used for different
Group definitions.
Figure 168
Interpretation
group
116
When multiple Assays are run simultaneously, the software will automatically
generate the best run order based on the shortest total completion time. The
desired run order can be changed by selecting an alternate schedule. The
software will delay the start of certain assays so that conflicts do not occur.
Figure 169
Work scheduler
4. After reviewing the work schedule, click on OK. The Wash bottle selection
window (Figure 170 Select wash bottle) will be displayed. Select whether the
Assays will use the Wash or the Rinse bottle for the plate washing steps.
Click the OK button.
Figure 170
Select wash bottle
5. Place all the needed reagents and samples into the correct rack locations,
place the proper-coated ELISA strips into a plastic strip tray, and click Start
Run. The assay processing will begin. The time remaining for completion of

Quick guide 117
each Calibrator/Standard, Control and Sample is displayed on the screen

(see Figure 171).
Figure 171
Test list
Right clicking on any of the Sample rows will display the Step Log (see Figure
172) for that sample. This can be helpful for verifying that all the Assay events
have occurred reasonably on time. For example: If a reagent runs out during
a test and has to be refilled, the timing in this window can help determine
whether to accept a result or delete it.
Figure 172
Step log
118
Check the Assay processing status by clicking on View Schedule button. This will
display an approximated time line of the Assay processing (see Figure 173 ELISA
work schedule).
Figure 173
ELISA work schedule
When Assays are complete the curve can be accepted (see Figure 174 Statistics).
Patient concentrations will be calculated. If controls are run in an Assay, the
Statistics can be displayed. Select the Controls with the left mouse button and
hold down the Ctrl key.
Figure 174
Statistics

Quick guide 119
8.2 Accepting and adjusting standard curves

A. Deleting calibrators
In the picture below, a TSH standard curve is displayed. This assay uses a 2nd
order polynomial curve fit. Moving the mouse pointer over the plotted curve
will display the fit parameters.
Figure 175
Unedited curve
Clicking on the Test List tab will display the patient results (sample shown
below.)
Figure 176
Un-edited results
This data shows that the first copy of standard 5 appears incorrect. By checking
the boxes to the left of each standard, a corrected curve can be generated.
120
Once a satisfactory curve is generated, clicking on the Activate Selected button

will cause this curve to be the current standard curve in use and will update the
concentration values of the samples in the Sample tab. The corrected curve is
shown below in Figure 177 TSH results, edited. The patient sample results are
now updated, which you can see by clicking on the Test List tab.
Figure 177
TSH results, edited
Figure 178
TSH results, activated

Quick guide 121
You can now choose to accept or delete any of the sample results by clicking on
the buttons. In Figure 179 Accepted results, all samples are selected.
Figure 179
Accept results
B. Adjusting curves by a percentage factor:

Curves can also be adjusted by a percentage factor. This is set by the factor
setting in the calibration tab. Normally this value is set to 0%, and the actual
standard curve absorbance values are used with no adjustment.
Figure 180
TSH Curve 0% Factor
122
The resulting concentration values for the samples run are shown below in
Figure 181.
Figure 181
TSH results
In Figure 182 TSH Curve -10% Factor below the calibration curve is adjusted by
-10%. Factor adjustments occur immediately and do not require clicking on the
Activate Selected button.
Figure 182
TSH curve -10% factor

Quick guide 123
The new concentration values are displayed in the Sample tab as shown below
in Figure 183 TSH Results:
Figure 183
TSH results
The percent adjust feature can be used when stored curves are used and there is
evidence that the current run has resulted in increased or decreased absorbance
levels than what is expected.
! Note: Decreasing the standard
curve by a percentage will re-
sult in increasing the sample con-
centration values.
C. Adjusting curves by running less than all the calibrator values:
Less than all the calibrators used in an assay can be run and the stored curve can
be adjusted accordingly. The adjustment factor will be calculated based on the
average percent change of all the new calibrators run compared to their stored
absorbance values.
The new curve will be generated from the new calibrator(s) absorbance values
which are currently run and the adjusted absorbance values of the remaining
calibrators from the stored curve. This feature can be used to control for changes
in reagent activity when using stored curves.
124
In the Figure 184 TSH Adjusted with Standard 5, TSH Standard 5 is used to adjust
the stored curve shown in Figure 180 TSH Curve 0% Factor. Instead of requesting
an entire new curve, Standard 5 is requested individually.
Figure 184
TSH Adjusted with Standard 5
In this example, TSH Standard 5 yielded an absorbance value of 1.366. This is an

absorbance drop compared to the Standard 5 absorbance values of the stored
curve. By selecting this standard and all the stored standards the new adjusted
curve can be activated.

Quick guide 125
Figure 185
TSH adjusted curve
Once activated the original absorbance values remain, but the new calculated
concentration values of the standards are displayed.
Figure 186
Activated TSH adjusted curve
Even though the samples show decreased absorbance values similar to the one
adjustment standard run, the resulting concentration values for the samples
are the same as when they were run with the original complete standard curve
(see Figure 181 TSH results).
126
Figure 187
TSH Standard 5 Results

Troubleshooting 127
9 TROUBLESHOOTING
9.1 Flags and error messages

Flags are warning messages to the user of a possible problem condition that
will need to be corrected. The instrument will continue to operate under these
conditions. An example of a Flag is Wash Bottle is Low.
Error Messages indicate a condition that causes the instrument to be unable
to proceed, and must be corrected before the instrument is used further. An
example of an Error Message is Probe Z axis is jammed.
9.1.1 Flags
Possible insufficient aspiration:
This flag may appear:
- If incorrect bottle sizes are used in the reagent rack.
- If reagent bottles are filled past the neck.
Volume calculation:
ELISYS UNO automatically detects liquid surfaces and makes approximate
volume calculations based upon the diameters of the rack cut-outs and the
distance between the detected surface and the bottom of the rack. Hanging
! Note: Conical containers and
containers narrower than the
rack openings will always result
containers that do not rest on the bottom of the rack will introduce error to the in volume calculation errors.
volume approximation if the container bottom level is not set to a new value.
These types of containers can only be used provided the new container bottom
level is properly set using Rack2 setup (see Chapter 3.1 ‘Instrument setup‘).
Possible insufficient aspiration (continued):

Probe insertion depth:
For reagents, it is important to choose straight-walled bottles that snugly fit the
rack hole cut-outs. (Refer to Figure 188 Probe Insertion Depth Illustration.)
Sample volumes are usually so small that the vessel configuration is not a factor.
Reagent handling, however, can be adversely affected by significantly tapered or
under-sized vessels.
This is why: the probe detects the liquid surface at the start then ELISYS UNO
calculates the proper insertion depth for the probe so that the probe tip will
remain just below the liquid surface when the aspiration is finished.
128
! Note: Pipette errors may oc-

cur if reagent bottles are used
which have a smaller diameter
This calculation is based on the diameter of the rack hole cut-out, and it assumes
a straight-walled bottle. If a much smaller diameter bottle or a conical vessel is
used, the liquid surface will descend faster and could result in the aspiration of
than that for which the rack was some air and less than the desired reagent volume.
designed. This can result in in-
accurate volumes or no reagent
being dispensed to some reaction
wells.
Figure 188
Probe insertion depth illustration
Wash/ rinse bottle low:

When the wash or rinse bottle is low, you will be warned as appropriate.
The software will automatically check the status of the bottles when preparing
to run assays. Refill the bottle(s) before starting the assays.
- If one of the bottles becomes low during the run, the Error Status Board will
display a message Wash bottle empty or Rinse bottle empty and will contin-
ue to perform the wash with the remaining solution.
- To refill the wash bottle, select Pause Engine from the Management Menu.
Refill the wash bottle. Select Resume Engine from the Management Menu.
! Note: Although the software

only checks the Wash, Rinse,
and Waste bottles when neces-
Waste bottle full:
- When the waste bottle becomes full during a run the software will prompt
Waste Bottle Full.
sary for assays, the instrument - If the message appears to be in error, wipe out the inside of the bottle cap
checks itself periodically. If the in- with a dry cloth. It is very important not to run the instrument when the
strument is beeping periodically Waste bottle is full to avoid damage. The software does not check the drain
during periods of inactivity, check waste container.
the bottle volume levels.

Troubleshooting 129
9.1.2 Error messages
Error code(s)/ problem: Solution:

001 Unknown Command Check command for spelling and va-
002 Parameter exceeds allowed range lidity.
003 Too few or wrong parameters
004 Command has not been implement-
ed
005 Fluid not detected in range. Add more fluid to the container and
Not enough Sample or Reagent press Resume All.
When setting up a run, be sure to
have about 100 µl of extra volume in
each serum vial. It is also important
to place more reagent volume in the
reagent bottles than is actually nec-
essary in the assay.
If the reagent volume is limited, the
reagent bottle position should be as-
signed in the assay or in the run to
use one of the smaller rack positions.
006 Probe Z axis is jammed When a jam message appears, look
007 Probe X axis is jammed for a physical obstruction to remove,
and verify correct instrument set-up
(alignments). Make sure the probe is
properly seated with the retention
hook over the collar.
008 Rack 1 is jammed Possible causes are bottles that are
009 Rack 2 is jammed too tall or have too small of a diame-
ter for the rack cut-out.
Make sure bottle caps have been re-
moved, correct rack files are being
used, and the setup alignment pa-
rameters including probe depth and
wash head depth are correct.
If normal operation does not resume
after clearing the obstruction, select ! Note: The service report
should be made BEFORE re-
starting the software so that im-
Initialize from the Management tab
on the ELISYS UNO Manager menu.If portant information will not be
the problem is not solved by re-ini- lost.
tializing, make a service report. Turn
the instrument off and restart it. If
the jam has not cleared send the ser-
vice report.
130
010 Diluter not acknowledging Check the cable that plugs in the back
of the diluter
011 CSI/O Inactive Unable to communicate with coproc-
essor.
013 Timeout waiting for coprocessor Make sure that the serial cable is
message firmly connected to both the com-
puter and the instrument. Use the ca-
ble (and adapter, if needed) provided
with the instrument.
Make sure the ELISYS UNO is pow-
ered up.
014 Diluter not responding See Error Code 010
015 Timeout waiting for completion See Error Code 013
of last coprocessor command
016 Check reagent/sample level! Check levels
018 Probe sensor malfunction A problem exists with fluid sensing
circuitry.
019 Parameter checksum error See Error Code 013
020 Probe jammed while trying to Make sure you have the proper size
detect the liquid surface bottle (not too small or tapered).
Check that the cap has been removed
from the bottle.
Try adding more reagents. Check the
probe depth setting for the rack in In-
strument Setup.
022 Large syringe stroke error Check the assay programs to make
sure that the 2.5 ml maximum has
not been exceeded.
Select the Routines tab from the
ELISYS UNO Manager menu, and click
on the Wash Probe option to reset
the syringe position.
504 Plate X axis is jammed Check for physical obstructions
blocking the path of the plate in the
X direction.
505 Plate Y axis is jammed Check for physical obstructions
blocking the path of the plate in the
Y direction.

Troubleshooting 131
506 Wash axis is jammed Select Initialize from the Manage-

ment tab on the ELISYS UNO Manag-
er menu. If the wash head does not
lift free, loosen the two thumbscrews
that connect the wash head to the
wash arm (Figure 189).
Figure 189
Possible causes include setting the

washer depth too low or setting it
such that the wash head tubes hit
the edge of the reaction plate wells.
(See Instrument Set Up).
The Set Up should be re-checked so
that the long tubes of the wash head
just lightly touch the microwells and
are set toward the back of the centre
of the wells.
Make sure that the wash head ap-
pears level after installation and that
the screws are snug.
511 Wash movement errors. Wash Check for physical jams blocking the
aborted. path of the wash head.
132
! Note: Protect yourself from

contact with hazardous waste.
512 Waste bottle is full Pause the engine by clicking on the
Pause Engine icon
(Click on icon again when finished to

Resume Engine.)
Carefully unscrew the cap and empty
the waste bottle.
Make sure the aerosol filter does not
get wet in the process (replace if this
happens).
If the Waste bottle is already empty
when the error message is observed,
check that the sensors are not short-
ed by foam, or touching each other.
Clean the inside of the cap with a pa-
per towel. Close the cap tightly and
assure that the coloured luer locks
and sensor are plugged in before re-
suming operation.
513 Wash bottle is empty Wash/Rinse bottles are low. The in-
strument detected an empty condi-
tion on the wash or rinse bottle. If
the bottle is full, check that the sen-
sor’s lead is securely connected to the
bottle cap and plugged in properly.
Check the sensor leads for continuity.

Troubleshooting 133
514 Rinse bottle is empty The instrument detected an empty

condition on the wash or rinse bot-
tle. If the bottle is full, check that the
sensor’s lead is securely connected to
the bottle cap and plugged in prop-
erly.
Wrong cap has been used. Make sure
the cap with the long wires is insert-
ed into the bottle and closed snug.
The black plastic separator should
be at the bottom of the wires and
the wires should not be crossed or
touching each other. Check that the
sensors are submerged in the liquid.
Pause/resume the engine by clicking
on icon.
Unscrew and refill the bottle.

Close the caps tightly and assure that
the coloured luer locks and sensors
remain plugged in before resuming
operation.
515 Filter Wheel ErrorWheel is not Check filters wheel pulleys for free-
rotating dom of movement.
516 Pressure System Error Select the option Pause Engine from
517 Vacuum System Error the Management Tab on the menu.
Pressure not building rapidly enough (Select Resume Engine when fin-
ished.)
Open and re-close each bottle cap to
flatten and reset each gasket.
Check all of the bottle caps and con-
nections for tightness.
Make sure there are no cracks in the
caps, tubing, or connections.
Check the operation of the pinch
valves. If the valve opens but the
tubing remains pinched, move the
tubing so that a different area gets
pinched.
Open the tubing by stretching it and
rolling it between your fingers.
If the aerosol filter on the waste bot-
tle gets wet it will no longer function;
try changing this filter assembly.
134
518 Possible aspiration failure To prevent accidental flooding of

the plate during washing, the ELISYS
UNO automatically verifies adequate
aspiration before beginning a wash
cycle by moving down and blocking
the aspiration probes against a foam
test strip. If the foam is worn away or
if the wash head is not level, air may
leak into the system and cause this
message.
Check that the wash head is properly
installed. Check the wash head align-
ment, setting the wash head height
to a lower setting usually solves this
problem (see Chapter 5.2 Alignment
setup). Check that all tubing is con-
nected and not pinched. If this does
not solve the problem, replace the
foam strip.
519 Vacuum over range Check for obstruction in the head or
tubing. A clogged aerosol filter may
also be the cause; try replacing this
assembly.
520 Y slot not detected Y Slot flag not properly situated. Phys-
ical obstructions in path of Plate Y.
Malfunctioning Y slot sensor.
521 X slot not detected X Slot flag not properly situated.
Physical obstructions in path of Plate
X. Malfunctioning X slot sensor.
522 Lamp X failure Look for all four lights and replace
any burned out bulbs. Always contact
your Instrument Service Provider first.
If all the lamps are lit, check for fluid
spillage.
Spillage or an obstructed or dam-
aged optical filter may also cause this
message due to decreased detection
of light. Clean spills immediately and
wipe chemical residue away with re-
peat cleanings using fresh water.

Troubleshooting 135
523 Channel blanks are not valid!! Under Settings, select Alignment,
click on Channel Blanks option. Run
Channel Blanks using the blanking
material provided with ELISYS UNO
and new clean and clear-flat bottom
microwells. Follow the instructions
as prompted.
9.1.3 Rackfile – Troubleshooting

If for a new parameter a predefined rack file should be used, us the open Rackfile.
Otherwise the Rackfile need to be edited for autofilling.
136

Human software and settings update 137
10 HUMAN SOFTWARE AND SETTINGS UPDATE

Information about the latest software and settings are accessible via
https://www.human.de/sw-euno
or by scanning the following QR Code with a mobile device supporting QR Codes.
This QR code can also be found as a label on the device.
If the information are not accessible via internet, they can be obtained free of
charge from your local distributor.
If you installed software or settings are not the latest one, please contact your
local distributor.
138

Safety details 139
11 SAFETY DETAILS
11.1 Warning markings
11.1.1 Safety symbols

Symbols that may appear on the product:
Warning Protective ground Caution

Risk of shock (Earth) Terminal Refer to manual
Fuse: For continued protection against risk of fire, replace fuse only with one
of the specified type and current rating. Disconnect equipment from supply
before replacing fuse.
These terms may appear on the product:

Danger Indicates an injury immediately accessible as you read this
marking.
Warning Indicates an injury hazard not immediately accessible as you
read this marking.
Caution Indicates a hazard to property, including the product.
These terms may appear in this manual:

Warning Warning statement identify conditions or practices that
could result in injury or loss of life. Warning indicates an
injury hazard not immediately accessible as you read this
marking.
Caution Caution statements identify conditions or practices that
could result in damage to this product or other property.
140
11.2 Safety precautions

To assure operator safety and prolong the life of your instrument, carefully
follow all instructions outlined below.
- Read instructions: Please take the time to read this manual carefully before
using this instrument. Review the following safety precautions to avoid in-
jury and prevent damage to this instrument or any products connected to
it. To avoid potential hazards, use this instrument only as specified. For best
results, familiarise yourself with the instrument and its capabilities before
attempting any clinical diagnostic tests. Refer any questions to your instru-
ment service provider.
- Servicing: There are no user-serviceable parts inside the instrument. Refer
servicing to qualified service personnel. Use only factory-authorised parts.
Failure to do so may void the warranty.
- Wear protective apparel: Many diagnostic assays utilise materials that are
potential biohazards. Always wear protective apparel and eye protection
while using this instrument. Always operate this instrument with the aer-
osol shield lowered.
- Follow operating instructions: Do not use this instrument in a manner not
specified by the manual, or the protection provided by the instrument may
be impaired.
- Use proper power cord: Use only the power cord specified for this product
and certified for the country of use.
- Ground the product: This product is grounded through the grounding con-
ductor of the power cord. To avoid electric shock, the grounding conduc-
tor must be connected to earth ground. An optional method is to attach a
ground strap from the external grounding terminal on the rear panel of the
instrument to a suitable ground such as a grounded pipe or some metal sur-
face to earth ground.
- Observe all terminal ratings: To avoid fire or shock hazard, observe all rat-
ings and markings on the instrument. Consult this manual for further rat-
ings information before making connections to the instrument.
- Install as directed: Install the instrument on a sturdy, level surface capable
of safely supporting the instrument’s weight (45 kg). The mounting surface
should be free of vibrations. The instrument does not require fastening to
the bench top.

Safety details 141
- Provide proper ventilation: Refer to the installation instructions for details

on installing the product so it has proper ventilation. The instrument should
be surrounded by the following clearances: 46 cm on each side, 117 cm on
top, 15 cm in front and 18 cm in back.
- Do not operate without protective covers: Do not operate this instrument
with covers and panels removed.
- Do not operate without probe shield: Do not operate this instrument with
shield removed. Doing so risks the operator to biohazard injury from the
probe.
- Use proper fuse: Use only the fuse type and rating specified by the manufac-
turer for this instrument.
- Avoid exposed circuitry: Do not touch exposed connections and components
when power is present.
- Avoid excessive dust: Do not operate in an area with excessive dust.
- Do not operate with suspected failures: If you suspect there is damage to
this instrument, have it inspected by a qualified service person.
- Do not operate in wet/ damp conditions!
- Do not operate in an explosive atmosphere!
Keep instrument surfaces clean and dry!

Solvents such as acetone or thinner will damage the instrument. Do not use
solvents to clean the unit. Avoid abrasive cleaners; the aerosol shield is liquid-
resistant, but easily scratched. Clean the exterior of the instrument with a soft
cloth using plain water. If needed, a mild all-purpose or nonabrasive cleaner
may be used. Use as a disinfectant a 10% solution of chlorine bleach (5.25%
Sodium Hypochlorite) or 70% isopropyl alcohol. Take special care not to spill
liquid inside the instrument.
11.3 Hazard statements

The following hazard statements are valid for the respective REF numbers.
[REF] 17350/11 Performance Check Kit [SOL1] [SOL2]
Danger
Causes severe skin burns and eye damage.
H314
142
11.4 Precautionary statements

The following precautionary statements apply to the following REF numbers.
[REF] 17350/11 Performance Check Kit
P303 + P361 + P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin
with water/ shower.
P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing.
P310
Immediately call a POISON CENTRE/ doctor.
P405
Store locked up.
P501
Dispose of contents/container in accordance with local/ regional/ national/
international regulations.
11.5 Operating precautions

Warning: Insufficient RAM will adversely affect the performance of your
instrument Follow the requirement recommendation in Chapter 4.1.
- Watch the instrument during Start of the day operation to ensure that the
probe and wash head dispense functions are operating properly.
- Be sure to run a sufficient number of controls in each assay. If controls are
not within their acceptable limits, or if incomplete, or non-uniform washing
is suspected, disregard the test results.
- Since the ambient light may interfere with the optical sensors used to mon-
itor mechanical movements, always operate the instrument with the top
cover down.
- Do not operate the instrument if the probe is damaged or the pressure is
unstable.

Safety details 143
- Do not operate the instrument if the wash head probes are damaged.
- If the waste bottle is overturned during operation, set it upright. When the
run has finished, check that the filter has not become wet and replace it if
necessary. If the hydrophobic filter becomes wet due an overturned waste
bottle, it will be blocked. Continued use of the instrument with a blocked
filter will impair washer effectiveness and may result in damage to the in-
strument.
- Do not fill reagent bottles past the neck. Doing so may cause the system to
inadvertently aspirate air.
- Do not fill wash or rinse bottles into the neck to prevent fluid from entering
the pressure tube.
- The wash and rinse bottles are pressurised during normal operation and the
waste bottle is under vacuum.
- Do not remove bottle caps or tubing connections while the bottles are pres-
surised/ evacuated.
- Turn the instrument off or click Pause Engine in the Management menu be-
fore adding more solution, changing bottles or connecting tubing.
The quality of washing often affects the validity of test results. To assure
adequate washing follow these precautions:
- Perform End of the day to clean probe with bleach and wash head with H2O.
- Handle and store the wash head carefully to prevent damage.
- Use the prime cycle before each wash.
144

HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 • 65205 Wiesbaden • Germany
Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100
eMail: human@human.de • www.human.de

Elisys Uno: - User Manual

Uploaded by

Copyright:

Available Formats

Elisys Uno: - User Manual

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Elisys Uno: - User Manual

Uploaded by

Copyright:

Available Formats

Elisys Uno

SERVICE AND SUPPORT

4 PRINCIPLES AND SPECIFICATIONS 17

5 ELISYS UNO MANAGER 21

6 RUNNING ELISYS UNO 55

7.4.3 Arrow buttons 102

8 QUICK GUIDE 115

10 HUMAN SOFTWARE AND SETTINGS UPDATE 137

11 SAFETY DETAILS 139

1.2 User warranty

1.3 Use of the instrument

1.4 General safety warnings

1.5 Disposal management concept

Elisys Uno | User manual

1.6 Biohazard warning

1.7 Instrument disinfection

Elisys Uno | User manual

2.1 Intended purpose ELISYS Uno

2.2 Detailed description

Fluid handling Aspirates and dispenses from 5 µl to 1,95 ml

The system allows one to define and program an unlimited number of

ELISYS UNO is an unique automatic system. Reactions occur in standard plastic

Elisys Uno | User manual

When shipping, it is important that the instrument be anchored and packaged in

3.1 Instrument setup

A Serves as air vent

Elisys Uno | User manual

5. Match the colour-coded connectors on the three bottle cap assemblies to

1 Power cord connection

Elisys Uno | User manual

3.2 Instrument check out

These events are controlled by firmware installed in your instrument however,

Elisys Uno | User manual

4 PRINCIPLES AND SPECIFICATIONS

4.1 Technical specifications

Reagent and sample dispensing

Incubation, timing and temperature control:

Elisys Uno | User manual

Environmental conditions for safe operation

Recommended environmental conditions

Elisys Uno | User manual

5 ELISYS UNO MANAGER

5.1 Opening the software and security

5.1.1 Opening the ELISYS UNO program

5.1.2 Password security and logging in

Security level Administrator Manager Operator Table 1

5.1.3 Security menu options

Elisys Uno | User manual

5.2 Alignment setup

Select Probe vs. Rack1 Figure 21

To check the current alignment,

2 Up and down (green)

To check new alignment, select Test.

To check the current alignment,

Elisys Uno | User manual

Use the arrow buttons to position the probe correctly.

The next step prompts to replace

! Note: Select “Close” to pass

Otherwise, select the Probe

4 PRINCIPLES AND SPECIFICATIONS 17

5 ELISYS UNO MANAGER 21

6 RUNNING ELISYS UNO 55

7.4.3 Arrow buttons 102

8 QUICK GUIDE 115

10 HUMAN SOFTWARE AND SETTINGS UPDATE 137

11 SAFETY DETAILS 139