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This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the
maintenance operator’s availability. For accurate installation, use and maintenance, please read the following
In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY
WARNINGS”, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
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 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, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in
ith 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.
HUMAN shall be relieved of any obligation under this war
ranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re
e freight carrier for settlement or claim.
INTENDED USE OF THE INSTRUMENT
The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as descri
bed in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.
Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in
Place the product so that it has proper ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to
the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conductor of the power cord connected to
nd rating specified by the manufacturer for this instrument, 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 potenti
ally explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
ommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.
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DISPOSAL MANAGEMENT CONCEPT
The currently valid local regulations governin
g disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
g, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the di
sposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
Analytical instruments for in
vitro diagnostic 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.
Before doing 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
econtaminated/disinfected. Decontamination/disinfection should be performed by a authorised well
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the
responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non
acceptance of the instrument
by the servicing centre, or from authority’s interventions.
ry effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become avai
lable. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
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Opening the Software and Security
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Opening the ELISYS UNO Program
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Password Security and Logging In
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Display Instrument Parameters
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Restore Instrument Parameters
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ELISYS UNO Manager Toolbar Icons
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Main Menu Selections and Features
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Special Groups Assay Editor
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1077Enzyme Immuno Assay Editor
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1188ELISYS UNO Manager and ELISAs
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Accepting and Adjusting Standard Curves
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is a computer controlled instrument system, capable of automating any or all stages of ELISA assay
processing that involve these functions
aspirates and dispenses from 5 µL to 1.95 ml
s-coil heats to 37°C, plate heats to 25°C or 37°C,
or no temperature control (ambient).
from 1 second to 24 hours
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 Operatin
g Precautions, Section 1.4).
may also be used in production processes involving micro volume dispensing, diluting, incubating, and
is a unique automatic system. Reactions occur in standard plastic microwells Reagent bottles
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.
s designed for use in processing ELISA tests for in vitro diagnostic application. It is an instrument
intended to be used by trained laboratory professionals who are capable of selecting the appropriate features and
options for each specific cli
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To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined below.
Please take the time to read this manual carefully before using this instrument. Review the
wing safety precautions to avoid injury 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 capabilitie
s before attempting any clinical diagnostic tests. Refer any questions to
your instrument service provider.
serviceable parts inside the instrument. Refer servicing to qualified service personnel.
rts. Failure to do so may void the warranty.
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
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.
Cord Use only the power cord specified for this
product and certified for the country of use.
This product is grounded through the grounding conductor of the power cord. To avoid
electric shock, the grounding conductor must be connected to earth ground. An optional method is to 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 surface 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 ratings information before making connections to the instrument.
Install the instrument on a sturdy, level surface capable of safely supporting the instrument’s
ight (45 kg). The mounting surface should be free of vibrations. The instrument does not require fastening
Provide Proper Ventilation
Refer to the installation instructions for details on installing the product so it has
lation. The instrument should be surrounded by the following clearances: 46cm on each side,
cm in front, and 18cm in back.
Do Not Operate Without Protective Covers
Do not operate this instrument with covers and panels removed.
perate Without Probe Shield
Do not operate this instrument with shield removed. Doing so risks the
operator to biohazard injury from the probe
Use only the fuse type and rating specified by the manufacturer for this instrument.
Do not touch exposed connections and components when power is present.
Do not operate in an area with excessive dust
Do Not Operate With Suspected Failures
If you suspect there is damage to this instrument,
a qualified service person.
perate in Wet/Damp Conditions
rate In An Explosive Atmosphere
Keep Instrument Surfaces Clean and Dry
Solvents such as acetone or thinner will damage the instrument. Do not
s 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
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Insufficient RAM will adversely affect the performance
of your instrument. Therefore, if using
Windows® ME, the minimum RAM required is 96 MB. For Windows® XP, the minimum RAM required is 128 MB.
Watch the instrument during "Start of Day" operation to ensure that the probe and wash head dispense
Be sure to run a sufficient number of controls in each assay. If controls are not within their acceptable limits; or if
uniform washing is suspected, disregard test results.
Since the ambient light may interfere with
the optical sensors used to monitor 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.
Do not operate the instrument if the wash head probes are d
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 to an overturned
Continued use of the instrument with a blocked filter will impair washer
effectiveness and may result in damage to the instrument.
Do not fill reagent bottles past the neck. Doing so may cause the system to inadvertently aspirate air.
l 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 bo
ttles are pressurised/evacuated.
Turn the instrument off or click the Pause Engine in the Management menu before adding more solution,
changing bottles, or connecting tubing.
The quality of washing often affects the validity of test results. To assure ad
equate washing follow these
Perform “End of Day” to clean probe with bleach and flush wash head with H2O
Handle and store the wash head carefully to prevent damage.
Use the prime cycle before each wash.
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How to unpack, set up, and check out your ELISYS UNO instrument.
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 imm
When shipping, it is important that the instrument be anchored and packaged in the original manner to prevent
Therefore, retain all shipping screws and packaging in the event the instrument requires future
s how to unpack the instrument once it is removed from its crate can be found in the
Unpacking Instructions Manual (Cat. No. 17350/4).
Connect the drain tube to the drain tube connector on the bottom of the instrument by pushing the
ng over the fitting on the connector.
Place the other end of the drain tube into a drain container (at least 2L
not included). Next, the bottle
must be placed at a level below the instrument, either by using an access hole on the lab bench, or by
the tubing to the front or the back of the instrument as desired. The drain line may also be
connected to an approved permanent drain.
CAUTION: Do not allow the end of the tubing to rest in the drain container below the expected level of the waste
coded connectors on the three bottle cap assemblies to the colo
right side of the instrument. Turn each connector about 1/4 turn clockwise to lock it in place. Insert the
sensor cable jacks, matching the colo
CAUTION: The hydrophobic filter on the waste bottle is designed to protect the pump from liquid and may become
clogged when wet. Arrange the tubing so that the filter hangs down below the
connecter on the side of the
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Principles and Specifications
The syringe pump is used to make preci
se 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.
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
eagent rack, a Sample rack, and a React
ion 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 con
identified in the software in order to tell the instrument which configuration is to be used. They are also displayed
The incubator plate/well can be set to heat to 25°C, 37°C, or remain at ambient room temperature. The
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
rries 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
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 automa
tically positions itself under the 4
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
Depending on the setup, reports may be displayed or printed to create permanent lab records and physician
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86cm W x 51cm L x 40cm H, approx. weig
Reagent and Sample Dispensing:
Dilutions, predilutions, single or multiple reagents
One syringe pump, sized: 2.5 ml
316 stainless steel for maximum reagent compatibility, level
Minimum and Maximum Volume:
Maximum number of specimens:
96 (including calibrators and controls)
Maximum number of reagents:
Assorted replaceable racks and custom designed racks
are available for various bottle sizes.
Reagents can also be programmed
Standard microwells, strips
1L Priming bottle, 2L Wash bottle w/ low volume warning
sensor,1L Rinse bottle (or 2nd wash) w/ low volume
Incubation, timing and temperature cont
Plate/Well 25°C, 37°C, or ambient temperature
Temperature controlled to 25°C providing the ambient
room temperature is below 25°C
Sample Rack is not temperature controlled.
8-probe, automatic prime and rinse
Create and run user programmable protocols (aspirate,
dispense, soak). Can wash wells for re
Reads absorbance in four simultaneous channels; NIST
traceable calibration; user selects monochromatic or
Long life, hard coat, ion
± (1% of the reading +0.005A from 0 to 1.5A)
± (2% of the reading +0.005A from 1.5 to 3.0A)
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CD-Rom and Internet upgrades
Windows® 98, 2000, ME, NT 4.0, or XP
Pentium®/133 MHz, 64 MB RAM, SVGA moni
or USB port with Serial adapter
PentiumII®/333 MHz, 128 MB RAM, CD drive, Windows® 98
Create/edit protocols, import/export data, etc., Control,
single standard, factor, fixed time kinetics,
kinetics by standard or factor, multi
point, linear regressions, log
nonlinear regressions (curve fit).
Lamp, bottle volume, filters, pressure
Store control data, print Levey
Jennings or QC range plots,
RS232 output only, 19200 Baud,1 start bit, 8 data, 1 stop,
no parity, no handshake, Serial cable provided
Environmental Conditions for Safe Operation:
Fluctuations not to exceed ±10% of the nominal voltage
80% for temperatures up to 31°C
decreasing linearly to 50%
Recommended Environmental Conditions:
Less than 85% recommended