InCCA 2015 User's Manual v2.09.05 PDF

USER’S MANUAL
v2.09.05
InCCA User’s Manual

IUMv2.09.05
1 TRANSPORTATION, STORAGE AND UNPACKING ----------- 1-1
1.1 TRANSPORTATION AND STORAGE ------------------------------------------------------------ 1-1
1.2 UNPACKING INSTRUCTIONS ------------------------------------------------------------------- 1-1
2 INSTALLATION AND CONNECTIONS OF THE ANALYZER--- 2-1

2.1 ELECTRICAL REQUIREMENT ------------------------------------------------------------------- 2-1
2.2 DIMENSIONS ---------------------------------------------------------------------------------- 2-1
2.3 ENVIRONMENTAL REQUIREMENTS ----------------------------------------------------------- 2-1
2.4 MOVING THE INSTRUMENT ------------------------------------------------------------------- 2-1
2.5 PC MINIMUM REQUIREMENTS --------------------------------------------------------------- 2-1
2.6 INSTRUMENT PLACEMENT AND PREPARATION ----------------------------------------------- 2-2
2.7 WIRES AND TUBINGS CONNECTION ---------------------------------------------------------- 2-3
2.7.1 WASHING SOLUTION --------------------------------------------------------------------------------------------2-5
2.8 INSTALLATION --------------------------------------------------------------------------------- 2-6
2.8.1 PC CONFIGURATION ---------------------------------------------------------------------------------------------2-6
2.8.2 ANALYZER SETUP-------------------------------------------------------------------------------------------------2-7
3 ANALYZER TECHNICAL SPECIFICATIONS----------------------- 3-1
3.1 GENERAL SPECIFICATIONS -------------------------------------------------------------------- 3-1

3.2 SAMPLE/REAGENT TRAY --------------------------------------------------------------------- 3-2
3.3 CUVETTES/REACTION TRAY ------------------------------------------------------------------ 3-2
3.4 DISPENSING ARM AND HYDRAULIC SYSTEM ------------------------------------------------- 3-2
3.5 CUVETTE WASHER ----------------------------------------------------------------------------- 3-2
3.6 PHOTOMETER --------------------------------------------------------------------------------- 3-3
3.7 ISE MODULE (OPTIONAL)--------------------------------------------------------------------- 3-3
3.8 SOFTWARE ------------------------------------------------------------------------------------ 3-3
3.9 POWER REQUIREMENT------------------------------------------------------------------------ 3-3
3.10 DESCRIPTION OF ELECTRONIC CIRCUITS ----------------------------------------------------- 3-4
3.11 TYPES OF SAMPLES -------------------------------------------------------------------------- 3-4
3.12 TYPES OF REACTIONS------------------------------------------------------------------------ 3-4
3.13 TYPES OF METHODS------------------------------------------------------------------------- 3-4
4 GENERAL FUNCTIONS ---------------------------------------------- 4-1
4.1 MAIN PARTS OR MODULES ------------------------------------------------------------------- 4-1

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4.1.1 SAMPLE/REAGENT TRAY ----------------------------------------------------------------------------------------4-1
4.1.2 DISPENSING ARM AND PROBE ----------------------------------------------------------------------------------4-2
4.1.3 CUVETTE/R EACTION TRAY --------------------------------------------------------------------------------------4-3
4.1.4 CUVETTE WASHER -----------------------------------------------------------------------------------------------4-4
4.1.5 HYDRAULIC SYSTEM ---------------------------------------------------------------------------------------------4-5
4.1.6 OPTICAL SYSTEM-------------------------------------------------------------------------------------------------4-6
4.1.7 ISE MODULE (OPTIONAL) --------------------------------------------------------------------------------------4-7
4.2 DESCRIPTION OF THE OPERATING CYCLE ----------------------------------------------------- 4-8
4.2.1 REACTION PREPARATION CYCLE --------------------------------------------------------------------------------4-8
4.2.2 INCUBATION AND READING CYCLE ------------------------------------------------------------------------------4-8
4.2.3 CUVETTE WASHING CYCLE --------------------------------------------------------------------------------------4-8
4.2.4 ISE PROCESSING CYCLE (OPTIONAL) ----------------------------------------------------------------------------4-8
5 BASIC OPERATIONS ------------------------------------------------- 5-1

5.1 INITIAL CONFIGURATION OF THE PROGRAM -------------------------------------------------- 5-1
5.2 DAILY OPERATION----------------------------------------------------------------------------- 5-1
5.3 PROGRAMMED MAINTENANCE --------------------------------------------------------------- 5-2
6 SOFTWARE TABS ---------------------------------------------------- 6-1
6.1 MAIN WINDOW OF THE SOFTWARE ---------------------------------------------------------- 6-1

6.2 OPERATIONS TAB ----------------------------------------------------------------------------- 6-2
6.3 REAGENTS TRAYS TAB ------------------------------------------------------------------------ 6-5
6.3.1 REAGENT POSITION ----------------------------------------------------------------------------------------------6-5
6.4 PAT RESULTS TAB ---------------------------------------------------------------------------- 6-8
6.4.1 PATIENT RESULTS SEARCH ---------------------------------------------------------------------------------------6-9
6.4.2 ADVANCED SEARCH --------------------------------------------------------------------------------------------6-12
6.5 CAL RESULTS TAB -------------------------------------------------------------------------- 6-16
6.6 CON RESULTS TAB-------------------------------------------------------------------------- 6-18
6.7 SAMPLE POSITIONS TAB -------------------------------------------------------------------- 6-19
7 OPERATIONS MENU ------------------------------------------------ 7-1
7.1 ADD SAMPLES AND METHODS --------------------------------------------------------------- 7-1

7.1.1 ADD SAMPLE-----------------------------------------------------------------------------------------------------7-2
7.1.2 ADD METHODS --------------------------------------------------------------------------------------------------7-6
7.2 MODIFY SAMPLE------------------------------------------------------------------------------ 7-7
7.3 DELETE SAMPLES AND METHODS ------------------------------------------------------------ 7-9
7.3.1 DELETE SAMPLE------------------------------------------------------------------------------------------------7-10
7.3.2 DELETE SELECTED METHOD -----------------------------------------------------------------------------------7-11

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7.4 PENDING: SAVE, LOAD AND IMPORT PENDING REQUESTS --------------------------------- 7-12
7.4.1 SAVE PENDING-------------------------------------------------------------------------------------------------7-13
7.4.2 LOAD PENDING ------------------------------------------------------------------------------------------------7-13
7.4.3 IMPORT FROM CSV--------------------------------------------------------------------------------------------7-14
7.5 SAMPLES TO TRAY -------------------------------------------------------------------------- 7-14
7.6 SAMPLES TO TRAY (BARCODE) (OPTIONAL) ----------------------------------------------- 7-18
7.7 WASH CUVETTES --------------------------------------------------------------------------- 7-22
7.8 START --------------------------------------------------------------------------------------- 7-23
7.9 STOP----------------------------------------------------------------------------------------- 7-23
7.10 PAUSE ------------------------------------------------------------------------------------- 7-24
7.11 PRINT RESULTS ---------------------------------------------------------------------------- 7-25
7.12 REPEAT RESULTS -------------------------------------------------------------------------- 7-28
7.13 RELOAD SAMPLES ------------------------------------------------------------------------- 7-29
7.14 EXPORT RESULTS -------------------------------------------------------------------------- 7-30
8 METHODS MENU ---------------------------------------------------- 8-1
8.1 SETTINGS: METHODS CONFIGURATION ------------------------------------------------------ 8-1

8.1.1 GENERAL TAB ----------------------------------------------------------------------------------------------------8-2
8.1.2 FACTOR TAB -----------------------------------------------------------------------------------------------------8-4
8.1.3 REFERENCE VALUES TAB ----------------------------------------------------------------------------------------8-7
8.1.4 SPECIALS TAB ----------------------------------------------------------------------------------------------------8-8
8.1.5 ADVANCED TAB ------------------------------------------------------------------------------------------------8-16
8.2 ISE METHODS SETTINGS (OPTIONAL) ----------------------------------------------------- 8-20
8.2.1 GENERAL TAB (ISE) -------------------------------------------------------------------------------------------8-20
8.2.2 FACTOR TAB (ISE) ---------------------------------------------------------------------------------------------8-22
8.2.3 SPECIAL TAB (ISE)---------------------------------------------------------------------------------------------8-23
8.2.4 ADVANCED TAB (ISE) -----------------------------------------------------------------------------------------8-24
8.3 REAGENTS IN USE AND PROFILES----------------------------------------------------------- 8-26
8.4 SAVING METHODS -------------------------------------------------------------------------- 8-28
8.5 LOADING METHODS ------------------------------------------------------------------------ 8-29
8.6 SAVING PROFILES --------------------------------------------------------------------------- 8-30
8.7 LOADING PROFILES ------------------------------------------------------------------------- 8-30
9 CALIBRATORS MENU ----------------------------------------------- 9-1
9.1 SETTINGS -------------------------------------------------------------------------------------- 9-1

9.2 SAVING CALIBRATORS FILES ------------------------------------------------------------------ 9-2
9.3 LOADING CALIBRATORS FILES ---------------------------------------------------------------- 9-3

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10 CONTROLS MENU-------------------------------------------------10-1
10.1 SETTINGS ---------------------------------------------------------------------------------- 10-1
10.2 SAVING CONTROLS FILES------------------------------------------------------------------ 10-2
10.3 LOADING CONTROLS FILES ---------------------------------------------------------------- 10-2
11 STATISTICS MENU ------------------------------------------------11-3
11.1 LEVY-JENNINGS OF PATIENTS ------------------------------------------------------------- 11-3

11.2 LEVY-JENNINGS OF CALIBRATORS -------------------------------------------------------- 11-5
11.3 LEVY-JENNINGS OF CONTROLS ------------------------------------------------------------ 11-6
11.4 QUALITY CONTROL ------------------------------------------------------------------------ 11-7
12 MAINTENANCE MENU-------------------------------------------12-1
12.1 SETTINGS ---------------------------------------------------------------------------------- 12-1

12.1.1 SERIAL PORT TAB --------------------------------------------------------------------------------------------12-1
12.1.2 FILES TAB -----------------------------------------------------------------------------------------------------12-2
12.1.3 DATABASE TAB -----------------------------------------------------------------------------------------------12-3
12.1.4 AGES TAB-----------------------------------------------------------------------------------------------------12-5
12.1.5 REPORTS TAB-------------------------------------------------------------------------------------------------12-6
12.1.6 MEMORY TAB ------------------------------------------------------------------------------------------------12-9
12.1.7 LANGUAGE/ STYLE TAB --------------------------------------------------------------------------------------12-9
12.1.8 ACCESS CONTROL TAB ------------------------------------------------------------------------------------- 12-10
12.2 CUVETTES STATUS ------------------------------------------------------------------------ 12-11
12.3 CONTAINERS STATUS---------------------------------------------------------------------12-12
12.4 PROGRAMMED WASHING ---------------------------------------------------------------- 12-13
12.5 TIP CLEANING ---------------------------------------------------------------------------- 12-13
12.6 COMMUNICATIONS ---------------------------------------------------------------------- 12-14
12.6.1 COMMANDS CONSOLE------------------------------------------------------------------------------------- 12-14
12.6.2 SERIAL PORT LOG ------------------------------------------------------------------------------------------ 12-15
12.7 VALIDATIONS ----------------------------------------------------------------------------- 12-16
12.7.1 STRAY LIGHT------------------------------------------------------------------------------------------------ 12-16
12.7.2 PHOTOMETER PRECISION ---------------------------------------------------------------------------------- 12-17
12.7.3 PHOTOMETRIC ACCURACY --------------------------------------------------------------------------------- 12-18
12.7.4 PHOTOMETRIC LINEARITY---------------------------------------------------------------------------------- 12-19
12.7.5 DILUTER PRECISION ---------------------------------------------------------------------------------------- 12-21
12.8 INSTRUMENT ----------------------------------------------------------------------------- 12-22
12.8.1 CALIBRATION ----------------------------------------------------------------------------------------------- 12-23
12.8.2 DILUTER PURGE -------------------------------------------------------------------------------------------- 12-24
12.8.3 WASHER PURGE -------------------------------------------------------------------------------------------- 12-24

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12.8.4 INITIALIZE --------------------------------------------------------------------------------------------------- 12-25
12.8.5 ISE (OPTIONAL)-------------------------------------------------------------------------------------------- 12-25
13 ADVANCED OPERATIONS---------------------------------------13-1
13.1 CONFIGURATION OF THE PRINTING FORMATS -------------------------------------------- 13-1

13.2 FILE EXCHANGE ---------------------------------------------------------------------------- 13-3
13.3 IMPORTING SAMPLES FROM AN ADMINISTRATION PROGRAM --------------------------- 13-4
13.4 EXPORTING RESULTS TO THE ADMINISTRATION PROGRAM ------------------------------ 13-5
13.5 DETERMINATION OF PRECISION OF AN ANALYTIC METHOD ------------------------------ 13-7
13.6 DIRECT READING OF THE SOLUTION ABSORBANCE---------------------------------------- 13-7
14 ISE MODULE: DESCRIPTION AND OPERATION (OPTIONAL)

-----------------------------------------------------------------------------14-1
14.1 ELECTRODES ------------------------------------------------------------------------------- 14-2

14.2 FLUID MANAGEMENT --------------------------------------------------------------------- 14-2
14.3 SAMPLE TYPE ------------------------------------------------------------------------------ 14-3
14.3.1 SAMPLE HANDLING AND COLLECTION ----------------------------------------------------------------------14-3
14.3.2 MATRIX EFFECTS ---------------------------------------------------------------------------------------------14-4
14.3.3 REAGENT KIT ELECTRONIC KEY ------------------------------------------------------------------------------14-4
14.4 SAMPLE ASPIRATING AND DISPENSING -------------------------------------------------- 14-4
14.5 CALIBRATION CYCLE ----------------------------------------------------------------------- 14-5
14.6 CLEAN CYCLE ------------------------------------------------------------------------------ 14-6
14.7 PURGE A CYCLE --------------------------------------------------------------------------- 14-6
14.8 PURGE B CYCLE --------------------------------------------------------------------------- 14-6
14.9 SIP CYCLE ---------------------------------------------------------------------------------- 14-7
14.10 OFF CYCLE (UNDER ELECTRODE REPLACEMENT COMMAND) -------------------------- 14-7
14.11 PUMP CALIBRATION CYCLE-------------------------------------------------------------- 14-7
14.12 BUBBLE CAL CYCLE ---------------------------------------------------------------------- 14-7
14.13 MAINTENANCE -------------------------------------------------------------------------- 14-8
14.13.1 BEFORE STARTING DAILY OPERATION ----------------------------------------------------------------------14-8
14.13.2 DAILY MAINTENANCE --------------------------------------------------------------------------------------14-8
14.13.3 SHUTDOWN PROCEDURE ----------------------------------------------------------------------------------14-8
14.13.4 ISE MODULE RE-ACTIVATION------------------------------------------------------------------------------14-9
14.14 TROUBLESHOOTING --------------------------------------------------------------------- 14-9
15 MAINTENANCE PROGRAM----------------------------------- 15-14

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15.1 DAILY MAINTENANCE --------------------------------------------------------------------15-14
15.1.1 BEFORE STARTING DAILY OPERATION---------------------------------------------------------------------- 15-14
15.1.2 DURING THE DAILY OPERATION---------------------------------------------------------------------------- 15-14
15.1.3 UPON FINISHING WITH THE DAILY OPERATION------------------------------------------------------------ 15-14
15.2 WEEKLY MAINTENANCE -----------------------------------------------------------------15-14
15.3 MONTHLY MAINTENANCE --------------------------------------------------------------- 15-15
15.3.1 EXTERNAL WASHING OF CUVETTES ------------------------------------------------------------------------ 15-15
15.3.2 GENERAL WASHING OF THE INSTRUMENT----------------------------------------------------------------- 15-15
15.3.3 BACK-UP OF FILES IN USE ---------------------------------------------------------------------------------- 15-16
15.4 ISE MODULE MAINTENANCE PROGRAM (OPTIONAL) ---------------------------------15-16
15.4.1 RECOMMENDED COMPONENT REPLACEMENT SCHEDULE (LOW VOLUME USER)----------------------- 15-16
15.4.2 RECOMMENDED REPLACEMENT SCHEDULE (HIGH VOLUME USER)-------------------------------------- 15-17
15.5 MAINTENANCE ACCORDING TO PROGRAMMED ALARMS ------------------------------- 15-17
15.5.1 MAINTENANCE LEVELS ACCORDING TO CYCLES OF USE COUNTERS -------------------------------------- 15-17
15.5.2 MAINTENANCE LEVEL 1 ----------------------------------------------------------------------------------- 15-18
15.5.3 MAINTENANCE LEVEL 2 ----------------------------------------------------------------------------------- 15-20
15.6 MAINTENANCE ACCORDING TO NEED ---------------------------------------------------- 15-21
15.6.1 DATABASE INITIALIZATION (EVERY 10.000 DETERMINATIONS) ----------------------------------------- 15-21
15.6.2 REPLACING THE LIGHT BULB ------------------------------------------------------------------------------- 15-22
15.6.3 CUVETTES REPLACEMENT (SEE ITEM 15.5.3.8)---------------------------------------------------------- 15-24
15.6.4 INTERFERENTIAL FILTERS REPLACEMENT ------------------------------------------------------------------ 15-24
15.6.5 SAMPLE / REAGENT PROBE REPLACEMENT --------------------------------------------------------------- 15-24
15.6.6 REPLACING THE IGNITION FUSES--------------------------------------------------------------------------- 15-28
15.6.7 SPECIAL WASH --------------------------------------------------------------------------------------------- 15-28
15.6.8 REPLACING O-RINGS OF PISTON PUMP -------------------------------------------------------------------- 15-29
15.6.9 REPLACING FILTERS OF WASHING SYSTEM ---------------------------------------------------------------- 15-29
15.6.10 ELECTRODE REPLACEMENT (FOR ANALYZERS WITH ISE MODULE INSTALLED) ------------------------ 15-29
15.6.11 REPLACING ISE PERISTALTIC PUMPS TUBINGS (FOR ANALYZERS WITH ISE MODULE INSTALLED) ---- 15-30
16 PREPARING SOLUTIONS ----------------------------------------16-1

16.1 WASHING SOLUTION ---------------------------------------------------------------------- 16-1
16.1.1 WASHING SOLUTION FOR PROBE AND CUVETTES -----------------------------------------------------------16-1
16.1.2 WASHING SOLUTION FOR PROBE AND CUVETTES WHEN RUNNING TURBIDIMETRIC METHODS -----------16-1
16.2 TIP CLEANING SOLUTION------------------------------------------------------------------ 16-2
16.3 SPECIAL WASHING SOLUTION FOR MAINTENANCE ACCORDING TO NEED ---------------- 16-2
16.4 SPECIAL WASHING SOLUTION FOR TURBIDIMETRIC TECHNIQUES WITH LATEX ----------- 16-2
16.5 DISINFECTING SOLUTION ------------------------------------------------------------------ 16-2
17 TROUBLESHOOTING ---------------------------------------------17-1
17.1 INTRODUCTION ---------------------------------------------------------------------------- 17-1

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17.2 CHEMICAL PROBLEMS --------------------------------------------------------------------- 17-3
17.2.1 HIGH RESULTS ------------------------------------------------------------------------------------------------17-3
17.2.2 LOW RESULTS ------------------------------------------------------------------------------------------------17-4
17.2.3 ERRATIC R ESULTS --------------------------------------------------------------------------------------------17-5
17.2.4 ONLY ONE AFFECTED SAMPLE FOR ALL OF THE METHODS --------------------------------------------------17-6
17.2.5 ONLY ONE AFFECTED METHOD FOR ALL OF THE SAMPLES --------------------------------------------------17-6
17.3 INSTRUMENTAL PROBLEMS --------------------------------------------------------------- 17-7
17.3.1 CONNECTIONS AND SUPPLIES--------------------------------------------------------------------------------17-8
17.3.2 HYDRAULIC SYSTEM ------------------------------------------------------------------------------------------17-8
17.3.3 DILUTER ------------------------------------------------------------------------------------------------------17-9
17.3.4 WASHER ------------------------------------------------------------------------------------------------------17-9
17.3.5 SAMPLE/REAGENT PROBE -----------------------------------------------------------------------------------17-9
17.3.6 REACTION CUVETTES TRAY -------------------------------------------------------------------------------- 17-10
17.3.7 SAMPLE/REAGENT TRAY ---------------------------------------------------------------------------------- 17-10
17.3.8 SOFTWARE ------------------------------------------------------------------------------------------------- 17-10
17.4 HARDWARE MESSAGES ------------------------------------------------------------------17-11

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INTENDED USE OF THE ANALYZER
InCCA is a photometric analyzer for clinical chemistry, it is meant to perform automated
analytic procedures for “in vitro” diagnosis.
TERMS OF USE
1. The instrument must be installed by trained personnel.
2. This instrument is Class 1, Type b, IPX0.
3. The instrument must be used by trained personnel
4. Operation room requirements: Room temperature 20-25ºC; Humidity: 20- 85% (no
condensation).
5. The instrument must be connected to a supply line according to current national regulations.
6. This instrument must not be used for purposes other than the ones it has been built for.
7. After switching on the instrument, wait 10 minutes before beginning analysis.
8. After powering off, wait at least 20 seconds before restarting.
9. If line variations are higher than 10%, a ferroresonant voltage regulator or a 1500 VA
uninterruptible power supply (UPS) is recommended.
10. Read the entire User’s Manual before using the instrument
11. The laboratory must count on a special residues collection service, to handle wastes.
12. Do not discard the analyzer, neither its accesories, along with domestic residues.Check the
local terms for its correct elimination. Is the user’s responsability to deliver the analyzer in
the indicated pickup point for recycling of electric and electronic devices, otherwise get in
contact with Diconex or its authorized agent to proceed to its removal in a safe and
ecological way.
13. Use only expendables and spare parts provided by Diconex or its authorized agent.
14. If any failure occurs, contact your local authorized technical serive, or contact Diconex:
Torcuato de Alvear 46
B1878DMB - Quilmes - Buenos Aires
Argentina
Tel/Fax 54 11 4252 - 2626
www.diconex.com

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PRECAUTIONS
Electrical Risks
As with any electronic equipment, electric shock is always a potential threat. Extreme caution should
be used when working around the instrument to avoid contact with any electrical wire or components.
DO NOT attempt to work in any electronic compartment while the power is ON.
Mechanical Risks
Keep lids closed when the instrument is working.

Do not touch mechanical arms or other moving parts while the instrument is working.
Do not wear rings, bracelets, necklaces, etc. as they may get caught in operating mechanical systems.
Do not try to change or touch sample tubes, reagents, etc. when the instrument is running to prevent
breakage and/or an accident when the Reagent Sample Tray moves.
Make sure that the instrument is paused to add reagents, samples, etc.
Chemical risks
Always wear protective apparel when operating the analyzer (gloves, safety glasses, etc.).
Follow specific recommendations on the bottles of each reagent or washing solution.
Read safety information of materials provided by manufacturers to be aware of possible danger and to
learn how to prevent it.
Biological risks
Rings and long nails can easily break gloves and increase exposure to biological risks.
Always treat samples and reagents as potentially infectious.
Waste and waste deposits must be treated as toxic and biologically hazardous. Handle them and
eliminate them in accordance with routine laboratory protocols.
Follow in force standards given by local sanitary authority.
Eye risks
Do not look straight at barcode detector light beams.

Do not look straight at the light source of spectrophotometers since they can emit ultraviolet rays.

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WARNINGS ABOUT THE INSTRUMENT AND
LABORATORY PRACTICES
The use of calibrators is recommended; refer to reagent manufacturer instructions for specific
calibration instructions.
The use of controls, as indicated by good laboratory practices, is also recommended.
Carry out the maintenance plan as indicated in this manual.
Read all warning messages.
Results may or may not be validated by the user depending on the validation criteria.
Symbols used in the manual and the instrument
Warning
Ground Connection
Manufacturing Date
Consult instructions for use
“In vitro” diagnostics device
Biological risk
Serial number
Fuse

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Warranty Terms
Diconex S.A. warrants the instrument for a period of 12 months as of the date the instrument leaves
the factory. This warranty is only effective as long as the pertinent warranty card together with the
installation record with all the data is duly completed and sent to us by certified mail.
Warning: This warranty only covers defective materials or manufacturing defects, according to
examination carried out in the factory and shall be limited to the replacement of defective materials.
Accessories which are not provided by Diconex S.A., such as: wash solutions, standards, controls,
reagents and consumables are not covered by the warranty. Furthermore, costs arising from
mishandling the instrument and/or damage to the instrument are not covered by this warranty.
This warranty shall not be valid if personnel not authorized by Diconex S.A. attempt to repair the
instrument.
WARRANTY SERVICE: Without charge at Diconex S.A. Otherwise, transport and traveling expenses of a
technician to the place where the instrument is to be repaired shall be paid. Such costs shall not be
born by Diconex S.A.
DICONEX S.A. RESERVES THE RIGHT TO MODIFY THE INSTRUMENTS WITHOUT AFFECTING THEIR
OPERATING PARAMETERS.
NOTE: The following elements are not covered by warranty terms: halogen lamps, fuses, cuvettes,
reagents bottles, tubes and tubings.

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1 TRANSPORTATION, STORAGE AND UNPACKING
1.1 Transportation and storage
Do not pile up more than four wooden boxes
Keep dry, protect from humidity and rain
Fragile
Handle with care
Store at 0 C - 50 C
Gross mass 67 Kg.

Move using an automatic or a manual lift
1.2 Unpacking instructions
Warning: Unpacking shall be carried out by trained personnel. Carefully unpack the
instrument to prevent damage.
Labels indicating this operation are found on each side of the packaging box.

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1-1
Figure 1-1
Remove the wooden box lid by unscrewing the eight screws located in the front, back and sides.

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Figure 1-2
NOTE: Instrument remains fastened to the bottom.
Remove the instrument from the bottom of the box as shown in Figure 1-2 and as explained below.
On the upper part of the instrument you will find an Allen wrench Nº 6, which will be used to remove
the screws joining the bottom to the instrument.

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Figure 1-3
Unscrew the four screws located on the sides.
Figure 1-4
Screws are placed this way:

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Figure 1-5
Once the screws have been removed and the instrument is released, the protective Styrofoam is
removed and the instrument can be placed on the working surface.

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2 INSTALLATION AND CONNECTIONS OF THE ANALYZER
Installation must be carried out by trained personnel.
2.1 Electrical requirement

A standard 110 Volts 60 Hz or 220 Volts 50 Hz socket for 400 VA consumption. The supply line has a
third terminal to ensure proper ground connection. If line variations are higher than 10%, a
ferroresonant voltage regulator, or a 1500 VA uninterruptible power supply (UPS sine wave output) is
recommended.
2.2 Dimensions
Width: 80 cm, Height: 45 cm, Depth: 65 cm
2.3 Environmental requirements

Room temperature: 20 – 25 °C
Humidity: 20 – 95% (no condensation)
2.4 Moving the instrument

Avoid hitting the instrument as well as subjecting it to any kind of vibration while moving it.
2.5 PC minimum requirements

The PC must have the following:
-2 GHz Pentium IV
-RAM Memory, 512 MB
-Independent video card
-40 GB Hard Drive
-CD Rom
-CD Reader
-Windows XP
-Printer (optional)
The PC must comply with safety regulations IEC 60950 and have a certified source.

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2-1
2.6 Instrument placement and preparation
Warning: Avoid hitting the instrument as well as subjecting it to any kind of vibration while
moving it.
The instrument must be placed on a counter in a room free from dust and corrosive vapors to ensure
its proper operation.
The instrument must not be subject to vibrations or sudden changes of temperature.
Leave a 20 centimeter separation between the equipment and the wall to ensure proper ventilation.
Liquid containers must be under the counter. Avoid collapsing and/or curving of waste exit tubing.
Avoid any centrifuge, lifts or x-ray supply lines or any other kind of noise-generating equipment in
the supply line.
Avoid direct sun light or illumination on the instrument.
The supply line has a third ground conductor for protection purposes.
Connect the instrument to the computer and its peripherals before connecting to the supply line.
If the above requirements are not met, the quality of results may be affected.
Warning: Make sure that ground connection in the line meets the standard requirements for
its operating power. Not performing ground connection poses significant safety risk for the
operator and may damage one or several parts of the equipment or the computer.
Warning: Waste solution tubings must be placed correctly so that it drains by gravity. They
must not be curved and/or collapsed.
Warning: The instrument must be connected to a PC which meets the requirements

previously mentioned.
Warning: The instrument has been tested with a tensioactive solution which is added to the
distilled water. Not using or altering the product or its dilution will affect the operation of the
instrument.

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2.7 Wires and Tubings Connection
Communication cable RS 232
Power cord
Tubbings connections
Figure 2-1
1. Connect the interlock to 110-220 V, 50-60 Hz supply.
If line variations are higher than 10%, a ferroresonant voltage regulator or a 1500 VA uninterruptible
power supply (UPS sine wave output) is recommended.
2. Connect the RS-232 wire to the PC before switching on the instrument.
For analyzers with ISE Module installed continue with step (3). Otherwise go to step (8).
3. Connect the ISE module connector to the reagent Kit.
4. Remove all electrodes from sealed bags.
5. Remove tape from K+ and Li+ electrode.
If necessary, soak the reference electrode in warm water until the lumen of the electrode has been
cleared of salt build-up.
6. Depress the compression tray to install electrodes in position (as shown in Figure 2-2)

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Figure 2-2
7. Press the lock stick and move down the ISE module to put in place
Warning: Do not turn off the analyzer by pressing general button unless maintenance cycle has
been done and electrodes removed.
NOTE: ISE module must be power on all time that the electrodes are in it. Purge cycles are performed
by the ISE module automatically every 30 minutes.
8. Connect tubings to the appropriate containers.
Figure 2-3

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Warning: The tubing with the biggest diameter (waste funnel) must be kept straight
downwards without curves to allow free drain of fluids.
2.7.1 Washing solution
Warning: Containers must be placed under the analyzer.
Warning: Container must not be placed on the same analyzer level.
2.7.1.1 Washing solution for probe and cuvettes
First wash concentrate solution has to be prepared from Triton X-100 Solution. Then, use wash
concentrate solution to prepare washing solution for probe and cuvettes.
Wash Concentrate: dilute 1 part v/v of Triton X-100 in 9 parts of distilled water, Ex: 100 ml Triton X-
100 in 900 ml of distilled water.
The Triton X-100 is extremely viscous. It is suggested to pour the desired quantity into a graduated
cylinder and gradually add the water. Heat the distilled water to 70 – 80 ºC to help dissolve the Triton
X-100.
Washing solution for probe and cuvettes: dilute 7 ml of wash concentrate in 1 liter of distilled water.
Ex: 140 ml of wash concentrate per 20 liters of distilled water.
2.7.1.2 Washing solution for probe and cuvettes when running turbidimetric
methods
In those cases where latex reagents are used (most turbidimetric methods), is highly
recommended to use the following washing solutions:
Washing solution for probe: use only DI water
Washing solution for cuvettes: dilute 3 ml of wash concentrate in 1 liter of distilled water. Ex: 70 ml
of wash concentrate per 20 liters of distilled water.
Warning: not following the instructions given above will affect the results.

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2.8 Installation
2.8.1 PC configuration
Open Control Panel  Display  Settings  into Screen Resolution field set 1024x768 pixels
Control Panel  Date and Time  Internet Time  unselect Automatically synchronize with an
Internet time server
Uninstall antivirus
Uninstall Scren Saver
2.8.1.1 Install analyzer software.
1. Open “Computer”.
2. Find the device where the software installer is.
3. Double Click on the analyzer software installer executable.
4. Press Next to continue with the installation or Cancel to exit.
5. Choose between “Everyone or Just Me” option (see NOTE).
6. Press Next to continue with the installation or Cancel to exit. In this step the file folder path can
be changed.
7. Press Next to start installation process.
8. Press Close to close the window.
NOTE: “Everyone” option means that the software will be installed in all the user accounts existing at
the moment of installation. “Just Me” option means that the software will be installed in the account
that the installer is being executed (if a new account is created then the analyzer software must be
installed in the new account)
If “Just Me” option is chosen the other users can not use analyzer software, unless they install the
analyzer software too, but they have to change the path of all the files when the software is being
installed.
Maintenance Settings  Files tab: all path must be changed for a different location in this user
account.

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9. Open analyzer software from desktop.
2.8.2 Analyzer setup
Place the cuvettes in the reaction tray.
Warning: Do not touch the external surface of the cuvette.
Warning: avoid dropping the metal nuts into the interior of the instrument during this
procedure.
Turn on the instrument by the General Power button in the back of the analyzer, and then by
pressing the Power button in the frontal panel from the analyzer (lower button) The button in the
middle of the frontal panel turns on/off the reagents cooling system.
Let the instrument warm up for ten minutes.
Home Button
Reagents Cooling System

Power
General Power Power
NOTE: ISE module must be power on all time that the electrodes are in it (General Power button in
the back of the analyzer must be ON) Purge cycles are performed by the ISE module automatically
every 30 minutes.
10. Run several diluter purge cycles, visually checking that there are no bubbles present
in the diluter’s body (Maintenance  Instrument  Diluter Purge)
11. Run several wash cycles with the first 10 cuvettes, verifying the flow of wash solution
into the cuvettes and that there is no overflow. (Operations  Wash cuvettes  Cuvette range  1
to 12  Wash
Warning: during this procedure visually check the wash station; if due to the great
amount of aire there is overfilling of the cuvettes, it’s advisable to remove the affected strips and

IUMv2.09.05 2-7
wash with plenty DI water, dry the outside gently with a tissue, and put back on the strips. Verify
this before moving on to the next step.
12. Wash all cuvettes (Operations  Wash cuvettes  All cuvettes  Wash)
13. Run two diluter purge cycles (Maintenance  Instrument  Diluter Purge)
14. Calibrate the photometer and all the cuvettes (Maintenance  Instrument  Calibration
 select Calibrate photometer  select Calibrate cuvettes  Range 1 to 100  select the position
of the solution to use ex: Use container  OK)
For instruments that don’t have ISE Module installed, the analyzer is now ready to use. Otherwise go
to step 15.
15. Run Reagent Kit Replacement command. (Maintenance Instrument  ISE Reagent
Kit Replacement)
16. Run Calibrant A and B purge if necessary. (Maintenance Instrument  ISE Calibrant
A Purge/Calibrant B Purge)
17. Run Bubble Sensor Calibration. (Maintenance Instrument  ISE Bubble Sensor
Calibration)
18. Allow the electrodes to be exposed to fluid for 15 minutes.
19. Run Calibration command (Maintenance  Instrument  ISE  Calibration)
20. Instrument is ready to use.
Warning: Do not turn off the analyzer by pressing general button unless maintenance cycle had
been done and electrodes removed.

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3 ANALYZER TECHNICAL SPECIFICATIONS
Figure 3-1
3.1 General specifications

Average throughput with ISE: 450 test/hour
Average throughput without ISE: 300 test/hour
Automatic: Sample and reagents are taken and dispensed without the user's intervention. This also
applies to the reading of reactions.
Random access: Processing order is determined by the user and may be interrupted to allow the
input of stats.
Discrete: The reaction takes place in the same cuvette in which the reading will be performed. The
use of separate cuvettes for every reaction reduces crossover contamination among samples. The
Analyzer has 100 cuvettes for the reactions and readings to be carried out. Cuvettes are continuously
and automatically washed by the instrument while it is running, as required by dispensing.
Photometric: The Analyzer uses 10 optical filters. An eleventh filter may be added.

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3-1
3.2 Sample/Reagent Tray
Number of positions for reagent bottles: 30 positions for single or double-reagent bottles, allowing
60 reagents.
Volume of bottles: Single-reagent bottles 60ml, double-reagent bottles 28ml and 31ml.
Number of positions for samples: Physical capacity for 60 tubes or sample cups.
Positions become available and new samples can be added after the readings of the programmed
methods have been completed.
12 or 13 x 75mm primary tubes, test tubes and/or sample cups may be used.
Refrigeration of reagent tray is operated independently from main power switch.
Bar-code ID samples reader: Optional
3.3 Cuvettes/Reaction Tray

Number of cuvettes: 100 PMMA cuvettes placed in 10 different segments.
Reaction volume: minimum reading volume: 220 µl; maximum reaction volume (physical capacity of
the cuvette): 600 µl
Incubation: warm air thermal incubation
Working temperature: 37ºC
3.4 Dispensing Arm and Hydraulic System

Samples and reagents preheated to 37ºC.
High precision diluter
Maximum aspiration volume: 500 µl (physical capacity of the diluter)
Internal and external washing of the probe through liquid diaphragm pump
Volume detection
Probe impact sensors
3.5 Cuvette washer

Water consumption: 2.4 ml/cuvette
Uninterrupted washing and drying of cuvettes as required by dispensing or maintenance process.

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3.6 Photometer
Interferential filters: 340, 380, 405, 450, 505, 546, 578, 600, 650 and 700 nm and an extra filter as
optional
Krypton-halogen lamp: 12 volts 20 watts
Optical path: 6 mm
Photometric range: -0.100 to 3.600 A.
Type of measurement: monochromatic and bichromatic
3.7 ISE module (optional)

Electrodes: four ion-selective electrodes Li+, Na+, K+, Cl- and one Reference electrode
Peristaltic pumps: three
Reagent Kit: Calibrant A, Calibrant B, Waste storage.
3.8 Software
Easy access menu, with buttons and icons.
Continuous loading of patients, calibrators, controls and reagents during work sequence.
Stat samples
Unlimited number of methods in memory
Statistics for controls, calibrators and patients
Levy-Jennings plots
Linear and non linear multipoint calibration
Interpolation and adjustment of curves
Calibration curve graph
Extra washing option to avoid interference and self-interference
Automatic sample re-dilution
Verification of reagent condition
Data import and export to interface with administration program
Reagent consumption statistics
Print outs of technical reports and patient reports
QC graphics
3.9 Power requirement

100- 240 VAC and 50- 60 Hz. 400 VA

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3.10 Description of electronic circuits
The Analyzer is a completely micro-controlled instrument. The fundamental concept regarding its
operating way is that it carries out commands it receives through communication port. These
commands are simple operations sent by the user’s software on a PC, and the instrument decides
when they are to be carried out.
In order to carry out all the commands received from the PC, the Analyzer has thirteen
microcontrollers. The main microcontroller receives commands through the communication port
and it sends the operations that correspond to the other twelve microcontrollers. Within the other
microcontrollers, there are seven whose function is to operate the seven engines in the instrument,
two which control temperature and three which communicate with internal devices of the
instrument.
The Analyzer has four power supplies: a 24 Volt power supply that provide power to the power
circuits; a ±15 Volt power supply for supplying power to the lamp and the analogical circuits; a 15
Volt power supply for the refrigerated tray, a 24 Volt power supply with output of 24 volt for the ISE
module and 5 volt for digital circuit.
3.11 Types of Samples

The samples to be analyzed may be:
Plasma
Serum
Whole blood
Urine
Spinal Fluid
Puncture Fluid
Different biological fluids
Chemical solutions
3.12 Types of Reactions

End point reagent blank
End point sample blank
Kinetics
Fixed time kinetics
Ion Selective Electrode (ISE) (Optional)
3.13 Types of Methods

Colorimetric
Kinetics
Turbidimetric
Ion Selective Electrode (ISE) (Optional)

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4 GENERAL FUNCTIONS
4.1 Main parts or modules
InCCA Autoanalyzer can be divided into the following main parts:
Sample/ Reagent Tray

Dispensing Arm and Probe
Cuvette/Reaction Tray
Cuvette Washer
Hydraulic System
Optical System
ISE module (optional)
4.1.1 Sample/Reagent Tray
Figure 4-1

IUMv2.09.05
4-1
This tray can hold up to 60 refrigerated reagents, in 30 tray positions. Each reagent bottle can be
single or double-mouthed. Only one tray position is occupied in methods with two reagents.
The normal operating temperature of the reagent tray is 15ºC below room temperature, i.e. if room
temperature is 25ºC, then the reagent temperature is 10ºC. The minimum temperature of the
reagent tray is 10ºC; refrigeration is interrupted below that limit.
The refrigeration system has a separate power on/off button
The Sample/Reagent tray can hold up to 60 samples in one loading. The software allows the
continuous loading of samples once the requested tests have been finished.
Primary tubes can be used since the capillary of the probe only reaches 1 mm below the sample
level. This increases laboratory biosafety. Cups for pediatric samples can also be used.
4.1.2 Dispensing Arm and Probe
Figure 4-2
The dispensing arm transports the reagents and samples through the probe to a cuvette in the
reaction tray. Reagents and samples are preheated in this arm before being dispensed.
IUMv2.09.05 4-2
The probe has a conductivity detection system. When the probe is 1 mm below the surface of a
conductive liquid, it stops its movement. Due to this characteristic, it is important that samples do
not have bubbles since the level would be detected and only air would be aspirated, producing an
inaccurate result. It is also essential that samples are free of clots and fibrin.
4.1.3 Cuvette/Reaction Tray
Figure 4-3
This is where the reactions are carried out and read.
It has 100 separate cuvettes, grouped in 10 strips of 10 cuvettes. The cuvettes are made of PMMA,
which allows a good transmittance in the UV range.
The tray is heated by an air bath to 37ºC. All reactions are carried out at 37ºC.
Each cuvette has a minimum reading volume of 220 µl, and a maximum reaction volume (physical
capacity of the cuvette) of 600 µl.

IUMv2.09.05 4-3
4.1.4 Cuvette Washer
Figure 4-4
Its function is to wash cuvettes once the reactions have been measured. This washing is also
performed as required by dispensing: each time a new sample is dispensed by the probe, the
washing system operates, and cuvettes are washed automatically and sequentially.
The washer is divided into 4 double capillaries: one to aspirate, another to dispense liquid, and two
drying capillaries. They carry out the cuvette washing and drying process.
Washers: Four stainless steel capillaries which aspirate and dispense washing solution. The first
capillar will aspirate the pure reaction.
Dryers: Two stainless steel capillaries covered with silicone tubings that are placed on the left of the
cuvette washer to dry the cuvettes which have already been washed. They work with two separate
pumps.
Each cuvette is washed by 2400 µl.
This circuit operates sequentially, acting on the cuvette to be cleaned in six stages:
- In the first stage, the reaction liquid is aspirated and wash solution is dispensed into the
cuvette.
- In the second, third and fourth stages; the wash solution dispensed in the previous stage is
aspirated and new wash solution is dispensed.

IUMv2.09.05 4-4
- In the fifth stage, the wash solution dispensed in the fourth stage is aspirated, leaving the
cuvette empty.
- In the sixth stage, the final drying is done, and the residual wash solution remaining from the
previous stage is completely removed.
4.1.5 Hydraulic System
Figure 4-5

IUMv2.09.05 4-5
Its main components are the liquid diaphragm pump, the solenoid valve and the diluter, the washing
station and the tubing that connects the wash solution container to the probe.
The diluter aspirates the reagent and a sample volume required, and dispenses them into the
reaction cuvette.
The liquid diaphragm pump conveys the wash solution from the wash solution container to the end
of the probe capillary. This allows the washing and purging of the tubing, the diluter and the probe.
It is important to highlight that reagents never reach the diluter’s body.
4.1.6 Optical System
Light source: a 12-Volt 20-Watt krypton-halogen lamp is used which has a high emission in the UV
range (320 nm-380 nm)
Collimating lenses: 3 plane-convex lenses are used.
Wavelengths: 340-380-405-450-505-546-578-600-650 and 700 nm and an extra filter as optional.
Beam splitter: Divides the primary beam into two secondary beams: one goes towards the sample
channel and the other goes to the reference channel.
Sample channel: The sample channel beam passes through the cuvette to the sample photosensor,
where the signal is read.
Reference channel: The reference channel beam is read by the reference photosensor. The reference
channel compensates possible light source fluctuations.
Photometric Graph

IUMv2.09.05 4-6
Figure 4-6
1. LAMP
2. PLANE-CONVEX LENS
3. STOPPER
4. FILTER WHEEL
5. BEAM SPLITTER
6. SAMPLE CUVETTE
7. SAMPLE PHOTOSENSOR
8. REFERENCE PHOTOSENSOR
4.1.7 ISE Module (Optional)
Figure 4-7

IUMv2.09.05 4-7
ISE Module includes ion selective electrodes and three peristaltic pumps.
The ISE module measures the concentration of Li+, Na+, K+, Cl- in serum, plasma, and diluted urine.
The module requires a minimum sample size of a 70 µl for serum samples and 140 µl for urine
samples (urine samples must be diluted 1 urine part + 9 urine diluent part)
4.2 Description of the Operating Cycle

The operating cycle can be divided into four parts:
Reaction Preparation Cycle
Incubation and Reading Cycle
Cuvette Washing and Reaction Dispensing Cycle
ISE processing cycle
4.2.1 Reaction Preparation Cycle
The dispensing arm moves to the sample/reagent tray, and the probe places itself over the reagent
to be aspirated. The arm lowers until the sensor of the probe finds liquid level and it aspirates the
programmed reagent volume.
The arm moves to the wash station, and the external washing of the probe capillary is carried out.
The arm moves to the sample/reagent tray and it places itself over the sample to be aspirated. The
arm lowers until the sensor of the probe finds liquid level and it aspirates the programmed sample
volume.
The arm moves to the cuvette/reaction tray and places itself over the cuvette where the reaction is
going to be dispensed. It dispenses the sample and the reagent together.
The dispensing arm moves to the washing station, and the internal washing of the tubing and the
probe is carried out by the liquid diaphragm pump.
4.2.2 Incubation and Reading Cycle
In this cycle, incubation and photometric readings of the reaction are carried out at the appropriate
wavelengths.
The incubation and reading cycle occurs while a new reaction preparation cycle is beginning.
4.2.3 Cuvette Washing Cycle
While the cuvette tray is stopped and the next reaction is being dispensed, the cuvettes where
reactions have already been measured are washed. As this is a continuous cycle, clean cuvettes will
always be available and there is no need to interrupt the process.
4.2.4 ISE processing cycle (Optional)
The sample is aspirated by the analyzer from a sample cup and dispensed into the sample entry port
on top of the ISE Module. The sample is then positioned in front of the electrodes for measurement.
Four solutions are required to operate the ISE Module: Calibrant A, Calibrant B, Cleaning solution and
Diluent for Urine samples.

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5 BASIC OPERATIONS
In this chapter, the necessary steps for operating the instrument are described, including initial
configuration, daily operation and programmed maintenance.
5.1 Initial configuration of the program

Before beginning with the operation of the equipment, it is necessary to configure the following
items:
1. Methods (Methods Menu)

a) Settings
b) Reagents in use and Profiles
2. Calibrators (Calibrators Menu)
3. Controls (Control Menu)
4. Reagent Tray (Tabs)
Each of these steps is explained in the corresponding chapter.
The methods configuration is run according to the instructions given by the reagent manufacturer
and by following the guidelines in this manual.
It is recommended to verify each configured method before reporting the patients’ results
(Advanced Operations)
5.2 Daily operation

For the daily operation, follow the steps below:
1) Turn on the instrument by pressing analyzer frontal panel button and let it warm up for 10
minutes.
2) Prepare the wash solution and place it in wash solutions containers (Maintenance Program).
3) Empty the waste container.
4) Purge the diluter 2 times.
5) Wash the first 10 cuvettes.
For analyzer with ISE Module follow the steps below. Otherwise go to step 7.
6) Run Start up commands for ISE module.

IUMv2.09.05
5-1
7) Verify macroscopically the absence of impurities and/or precipitates in the reagents bottles.
8) Check the reagent volume to be used, refill reagents if necessary.

9) Calibrate the methods to be used, verifying reagent blanks.
10) Verify calibration by running QC material. The use of two levels is recommended.
11) Enter the samples to be processed.
12) Send the entered samples to tray.
13) Run the programmed washing each time the “Programmed Process” screen appears on
the instrument.
For analyzers with ISE Module follow the steps below, otherwise go to step 15.
14) Run the ISE calibration and ISE cleaning each time the system ask to (every 8 hours or every 50
samples).
15) Evaluate the obtained results.
16) Print results and/or reports.
For analyzers with ISE Module follow the steps below, otherwise go to step 18.
17) Run clean procedure for ISE module at the end of the work day.
18) Run a cleaning TIP procedure at the end of the work day.
19) Wash the cuvettes.

20) Turn the instrument off by pressing analyzer frontal panel button.
Warning: For analyzer with ISE Module: do not turn off the analyzer by pressing general button
unless maintenance cycle had been done and electrodes removed.
5.3 Programmed maintenance

In addition to the maintenance processes run during daily operation, there are other weekly and
monthly maintenance operations performed by the user, which are part of the instrument
Maintenance Program.
They are the following:
1) Calibration cuvettes once per week.

2) Manual washing of the exterior and calibration of the cuvettes and photometer once per month.
3) General cleaning of the instrument once per month.
4) Back-up of files in use once per week, or per month, or after making modifications.

IUMv2.09.05 5-2
5) Initialization of the results base after every 10,000 determinations.
It is important to follow these maintenance instructions in order to ensure optimum performance

and maximum life of the instrument.
Other options reserved for a Service Technician, or those that are run according to need, are also
described in the Maintenance Program Chapter.
As additions to this Manual, the user will find a series of Quick Guides which will help in running the
following procedures:
- Method configuration
- Calibration and Control
- Daily Operation
- Entering and Processing Samples
- Backing-up Files

IUMv2.09.05 5-3
6 SOFTWARE TABS
6.1 Main window of the software
The following window will be displayed when opening the software.
Figure 6-1
The menu will be accessed by the mouse or from the keyboard with the help of shortcut keys. These
become active by pressing Alt on the keyboard.
As shown in the following figure, a dash appears under some letters indicating which letter must be
pressed to access the appropriate menu.
Figure 6-2
For example: to enter the Operations menu press Alt+ letter p. the Operations Menu will be
displayed. All menus work in the same way.
The Title bar identifies the software and the software version number. Versions are constantly
updated and modified, so the user must install current software updates.
The Menu bar allows access to each menu by selecting the menu from this bar. When the menu is
displayed, select the name of the command or submenu. There is a chapter for each menu.
The Tools bar is a row of icons or keys that allow quick access to commonly used menu commands.
For quick selection, each icon has an image which shows its function and name. By placing the mouse
on each icon, text will appear with a description of the function of the icon.
The Tab bar allows access, by selecting each “tab”, to different windows of the software as reagents
Trays, Patient Results, etc.

IUMv2.09.05
6-1
6.2 Operations Tab
The software has tabs in which patients’ results, calibrators and/or controls, as well as samples and
reagent positions will be observed.
It has a main tab Operations, where process and status of determinations will be shown. These tabs
can be accessed by selecting them with the mouse.
Figure 6-3
Figure 6-4
Added processes, patients, calibrators and/or controls which are part of the working lists are shown
in the frame “Entered Samples”.
“Samples to be processed”, where pending processes remain, such as processes with a method
which was not programmed in the reagent tray.
Samples to be processed are those which are part of the working sequence and are being added to
the lower frame by the program.
“Samples in process”, are those samples which are being processed. This is where you can observe
process characteristics, such as information of the cuvette where the reaction is being developed,
results, reagents, status signs, etc.
Status of sample processing is shown in this tab. In Figure 6-5, important parts of this window or tab
are shown.
Each column has a name, process #, type of sample, name, ID, etc., and are described below.

IUMv2.09.05 6-2
Figure 6-5
Process Number
This symbol represents the number assigned by the software to each sample when requested. This
number corresponds to the time when the request is made. It is unique and it cannot be changed
and has the following format:
yy/mm/dd/hh/mm/ss/msmsms
05 10 05 12 41 34 672
This process was carried out:
Year: 2005
Month: 10
Date: 05
Hour: 12
Minutes: 41
Seconds: 34
Milliseconds: 672
Within this column a + sign and a – sign is shown next to the process number.
A + sign means that this process has method(s) selected to be processed. By clicking on this sign you
can see all methods requested.
A – sign means that information of requested methods is being shown.

IUMv2.09.05 6-3
Absence of any of these signs means that there are no selected methods for the process, and the
frame will be Pending Samples.
Type
In this column are the types of process like samples, patients, calibrators and/or controls. They are
identified with different symbols for a quick reference. Red symbols correspond to samples entered
as stat.
This symbol represents a patient.
This symbol represents a calibrator. It is in red because it is urgent (stat),

Calibrators are stat by default.
This symbol represents a control.
Name
First and last names of patients are shown in this column if they have been entered. If you click on
the + sign, the names of selected methods will be shown.
ID
This column shows the number previously assigned to the sample.
Status
This column shows the status of the selected method. The status shows the percentage of the total
process of the method which has been completed so far, taking into account the elapsed reaction
time and the reading(s) which have already been done. The number in brackets on the right of this
percentage is the number of cuvette where the reaction was dispensed. There are also warning signs
indicating lack of reagent, reagent deterioration, etc.
Concentration
Samples results obtained, as well as warning signs referring to that reaction, such as deteriorated
reagent, No sample, repeated, re-diluted, re-dilute manually appear in the concentration column.

IUMv2.09.05 6-4
Figure 6-6
6.3 Reagents Trays Tab
6.3.1 Reagent position
Reagent tray positions are configured in this tab.
Figure 6-7
Numbers 1 to 30 on the left of each box correspond to the reagent positions on the tray.
R1 is for the bottle located in the outer part of the tray, and R2 is for the bottle located in the inner
part.

IUMv2.09.05 6-5
When placing reagents on the tray, select on the right if it is a single reagent bottle (single mouth) or
two reagents (double mouth) by indicating 1 or 2 respectively. If you selected 1 (single mouth), you
will only be able to access the list to be displayed corresponding to reagent 1 column “R1”, if you
selected 2 (double mouth), you will be able to access both columns “R1” and “R2”. Within those lists,
select the reagent(s) to be positioned.
Figure 6-8
Once all reagents have been positioned, type a name within the Tray File field and press Save. An
indefinite number of tray files may be created, each with difference names, and then press Save.
To load a stored reagent tray configuration, select from stored trays displayed in Tray File and then
press Load. The tray file will be loaded and new reagent positions will appear on screen.
To delete a reagent tray, it must first be loaded by means of the Load key and then deleted by means
of the Delete key.
Figure 6-9
When the volume in a reagent bottle is low, an error message “lack of reagent” will be displayed
indicating which reagent(s) must be reloaded. This error windows has to be closed after reloaded
process

IUMv2.09.05 6-6
Figure 6-10
When a lack of reagent message is displayed, the working sequence must be paused.
Press Pause for a few seconds until the instrument is paused.
Figure 6-11
Reload the volume reagent bottle(s), press Reloaded button in the Tray and then press Pause again
to continue with the pending work.
Figure 6-12
Warning: probe arm robot will move if reagent 2 has to be dispensed.

To prevent any human injury be careful with this procedure.

IUMv2.09.05 6-7
6.4 PAT Results Tab
Figure 6-13
Within this tab you have access to all processed patients’ results.
It is divided in two parts. In the upper part you can find process numbers, ID, name and other data
entered to identify that patient and in the lower part you can find results of all processed methods
for each patient and the cuvette number on which each reaction was performed.
When you open the software and you access this tab, results will not be shown until you press the
key
With the following keys, different search processes of patients’ results, methods, calibrators and
controls can be carried out.
The following keys have the same functions in the PAT Results tab, CAL Results tab and CON Results
tab.

IUMv2.09.05 6-8
Figure 6-14
Press this key to access the patients list saved in the results base of the program.
By pressing this key, the processed samples list will be shown.
6.4.1 Patient results search
To see patients’ results follow these steps:
When the software is opened, results will not be shown. The screen will look like this:
Figure 6-15

IUMv2.09.05 6-9
First: Press the key “Make a new search” so that all saved patients are shown.
200 patients can be seen in this window. To see the next 200 patients press the key
To see the previous 200 patients press the key
Figure 6-16
Second: To see results corresponding to each patient, first select the patient in the box on the upper
part of the window.
Results corresponding to the selected patient can be seen in the box on the lower part of the
window.

IUMv2.09.05 6-10
Figure 6-17
Third: Double click on the result of a method to access “Extended information” for that analyte.
Figure 6-18
This “Extended Information” box will appear differently depending on the type of reaction. It will
show whether the technique is bichromatic and/or if it is reagent blank.
Main and bichromatic wavelength absorbance will be reported.
Number of sample re-dilutions will also be reported.
Figure 6-19 corresponds to an End Point Reagent Blank method.

IUMv2.09.05 6-11
Figure 6-19
Figure 6-20 corresponds to a Kinetics method.
Figure 6-20
Absorbances, time of measurements, readings plot, delta abs/min, redilutions, will be reported
6.4.2 Advanced search
Patients can be searched in different ways, such as:
By process date:
Figure 6-21
Select from the box Process Date and select a date and time range From/To, then press the key

IUMv2.09.05 6-12
Search results will be shown on the upper box
Figure 6-22
Advanced search parameters are shown or hidden by pressing this key both for a patient’s name and
a method result.
It has the same function in the CAL Results and CON Results tab.
By pressing the same key these parameters will be hidden.

IUMv2.09.05 6-13
Figure 6-23
The search keys in the lower part of the page work in the same way in the upper part and allow for
the search for a specific assay or patient result.
Advanced searches for patients can be carried out through the following search parameters:
Process number, Name, Last Name, Age, Sex, ID, Doctor, and Bed.
Each of these parameters can be simplified through a more precise selection such as: Same, Range,
Contains Phrase, Similar, Contains Words, Contains Words in Order and Any word.
Check the box of the search parameter that will be used to search for the patient.
An example is shown in figure 6-24. A search of a patient whose last name is Stuart was made. The
box corresponding to last name was checked. Same last name was searched and the exact name was
typed (case sensitive). After completing the information, press

IUMv2.09.05 6-14
Figure 6-24
Search results will be shown in the window box. Other advanced search parameters will operate in
the same way.
Warning: When the advanced search is not being used, REMOVE the check mark from the
search parameter box. If it is not removed, and parameters are hidden, the advanced search will still
operate and all results in the ordinary patients’ search will not be shown.

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Patient data from the upper window and/or results from the lower window can be exported by using
this key, with no connection between them, are two different exported lists. The following window
will be displayed:
Figure 6-25
Name the file to be exported.
By pressing Browse you can see the location where the file to be exported will be saved or you can
change the location.
You can select save All or Selection, which will allow you to select the columns that you would like to
save (consecutive number from 0)
6.5 CAL Results Tab
Figure 6-26
Calibration results and factors are shown in this tab.
They can be sorted by process number, alphabetically (by calibrator name), or by method.

IUMv2.09.05 6-16
To sort the calibrators, click on the name of the appropriate column and the calibrators will be listed
in ascending order. By clicking again, they will be listed in descending order.
The keys work as previously described.
Within this screen, two types of results will be shown.
1. Reagent blank absorbance which corresponds with the calibrator point it was processed with.
2. Calibrator absorbance is shown In the Report column:
By double clicking on any result line, you can open the extended information box, as previously
described.
Press Hide/Show search parameters key. The following screen will be displayed:
Figure 6-27
Searches can be made by process date, name of calibrator, method, or by patient report.

IUMv2.09.05 6-17
Warning: Remove check marks from search parameters before closing advanced searches.
6.6 CON Results tab
Figure 6-28
Controls results will be shown in this tab.
They can be sorted by process number, alphabetically (by control name), or by method.
To sort the controls, click on the name of the appropriate column and the controls will be listed in
ascending order. By clicking again, they will be listed in descending order.
The keys work as previously described.

Within this screen two types of results will be shown.
Figure 6-29
2. Result in control concentration is shown In the Report column
Results will be reported with the text Right if the result is within the programmed control range, or
Error if the result falls outside the programmed control range.
The limits are the minimum (-2SD) and maximum (+2SD) programmed data.
Warning: Limits has to be programmed in the same units as method and calibrator

IUMv2.09.05 6-18
By double clicking on any result line, you can open the extended information box, as previously
described.
Press Hide/Show search parameters key. The following screen will be displayed.
Figure 6-30
Searches can be made by process date, name of control, method, or by report.
Warning: Remove check marks from search parameters before closing advanced searches.
6.7 Sample Positions Tab
Figure 6-31

IUMv2.09.05 6-19
This tab corresponds to the positions on the sample tray. Positions of tubes can be found here and
identified by ID number or name.
Processing status is shown with different colors
Green: the position is available for samples or new samples

Yellow: all processing for the sample has been completed
Red: sample is in process
Figure 6-32
Figure 6-33 shows that patients with ID number 47885, 33698, and 21556 are in position 3, 4 and 5,
respectively.
All processes have Ended. The sample in position 6 is in process, so the position is Busy.
This tab allows for a quick view of patient position and working status.

IUMv2.09.05 6-20
7 OPERATIONS MENU
Basic functions for the operation of the instrument are described in the Operations Menu, which can
also be accessed from shortcut icons (Figure 7-1)
Figure 7-1
7.1 Add Samples and Methods
The entering of samples to be processed by the instrument as well as the addition of methods to
samples already requested can be carried out from the submenu Add on the Operations Menu
(Figure 7-2)

IUMv2.09.05
7-1
Figure 7-2
7.1.1 Add Sample
Patients, Calibrators and Controls samples can be carried out in two ways: from the Operations
Menu (Figure 7-2) or from the icon Add New Sample (Figure 7-3)
Figure 7-3
On the Operations Menu select Add  Sample or click on the icon Add New Sample. The screen
Add Process is displayed (Figure 7-4), where the kind of sample to be requested is selected: Patient,
Calibrator or Control.

IUMv2.09.05 7-2
Figure 7-4
7.1.1.1 Add Patient
Select Patient on the screen Add Process. The fields Name, Surname, PID (Personal Identification),
Age, Sex, ID, Tube, Doctor and Bed will appear.
ID is the only mandatory field that has to be completed in order to save the request. The other fields
can be completed so that patients’ data appear in the patients report, or for them to be saved in the
database.
Warning: ID name can be alphanumeric.
The field Age can be completed with a number representing the age or by selecting the age group of
the patient, configured according to Chapter 12 section 12.1.4 (Figure 7-5).
The options Male or Female are configured in the field Sex. If no option is selected, Male will appear
by default.

IUMv2.09.05 7-3
Figure 7-5
Use the mouse to select the methods to be processed. The methods in use appear on the screen.
A method profile can also be selected in the drop-down menu under the field Special (Figure 7-6).
Only one profile can be selected for each request. Additional methods can be added from the list
appearing on the Add Process screen. Also methods from a selected profile can be substracted.
Figure 7-6
Press Add to save the request, or Cancel if the operation is not carried out.
If the Clear After Adding box is selected, the Add Process screen will be cleared after clicking on the
Add button. If this option is not selected, all entered data and requested methods will remain on the
screen to be modified upon the next request after pressing Add.
ID increase box is useful when the requested methods are the same for different samples or when
patients’ data is similar, for example: consecutive ID numbers. This option is alphanumeric.
You can add several processes at the same time. In the box next to Add button you can choose
between 1 and 99999 for differents groups of patients
Each added request will appear in the Operations tab with a process number that indicates the time
when the request was made and the symbol that represents a patient sample.
The entered patient can be checked as Stat. If the Stat option is selected, this symbol
will appear in red on the list of requested samples (Figure 7-7).

IUMv2.09.05 7-4
Figure 7-7
7.1.1.2 Add Calibrator
Select Calibrator on the Add Process screen. All calibrators configured according to Chapter 9 point
9.1 will be displayed. Select the desired calibrator on the left column. The methods to be calibrated
with the selected calibrator will appear in the right column since they have a configured
concentration (Figure 7-8). Select the methods to be calibrated and press Add.
Each calibrator that has been added will appear on the Operations tab with a process number
indicating the time when the request was made and a symbol representing a calibrator .
Figure 7-8
7.1.1.3 Add Control
Select Control on the Add Process screen. All controls configured according to Chapter 10, section
10.1 will be displayed. Select the desired control on the left column. The methods for the selected

IUMv2.09.05 7-5
control will appear in the right column since they have minimum and maximum configured
concentrations (Figure 7-9). Select the methods to be run and press Add.
The requested control can be selected as Stat.
Each control that has been added will appear on the Operations tab with a process number
indicating the time the request was made and a symbol representing a Control
If the option Stat is selected, this symbol will appear in red on the requested samples list.
Control
Calibrator
Patient
Figure 7-9
7.1.2 Add Methods
Methods can be added to samples already requested, Patients, Calibrators or Controls. This can be
carried out in two ways: from the Operations Menu (Figure 7-2) or from the Add New Method to
Sample icon (Figure 7-10). This option is only available for samples already entered, not for those
pending or in process.

IUMv2.09.05 7-6
Figure 7-10
Select the sample to be modified on the Operations Tab, press Operations  Add  Method or
click on the Add New Method to Sample icon. A screen with all the available methods and profiles to
be added will be displayed (Figure 7-11).
Select the method/s you want to add, press Add to add them to the original sample, or Cancel if you
do not wish the operation to be carried out.
Warning: These processes can only be carried out before the entered samples are on the
sample tray. Once in process, or when the process has finished, it is not possible to add new
methods; the methods will have to be added in a new request for the sample.
Figure 7-11
7.2 Modify Sample
Patients’ data that has already been requested can be edited in two ways: from the Operations
Menu (Figure 7-12) or from the Edit Sample icon (Figure 7-13)

IUMv2.09.05 7-7
Figure 7-12
Figure 7-13
Select the sample to be modified on the Operations Tab, press Operations  Modify  Sample or
click on the Edit Sample icon. A screen with the patient’s data available to be modified or added will
be displayed, included the Stat status (Figure 7-14). Press Add to save the modifications, or Cancel if
data is not saved. The Stat status for calibrators and/or controls can be modified following the same
procedure (Figure 7-15)
Warning: These processes can only be carried out before the entered samples are on the sample
tray. Once in process, or when the process has finished, it is not possible to modify patients’ data or
the Stat condition.

IUMv2.09.05 7-8
Figure 7-14
Figure 7-15
7.3 Delete Samples and Methods
Entered, pending or in-process samples and / or methods can be deleted from the submenu Delete
in the Operations Menu (Figure 7-16)
Figure 7-16

IUMv2.09.05 7-9
7.3.1 Delete Sample
An entered sample can be deleted in two ways: from the Operations Menu (Figure 7-16) or from the
Delete Sample icon. (Figure 7-17)
Figure 7-17
Select the sample to be deleted on the Operations Tab and press Operations  Delete  Sample or
by clicking on the Delete Sample icon. To delete more than one sample, hold the Control key on the
keyboard and select all the samples to be deleted (Figure 7-18). Before deleting all the requests, a
screen will appear to confirm the operation (Figure 7-19). Press Yes to confirm the deletion, or No to
cancel it.
To delete samples which have been sent to tray and which appear as pending on the Operations Tab,
the instrument must not be working. Press Stop to cancel the operation and then delete the selected
pending samples.
Samples that have already been processed can be deleted from the Operations Tab following the
same procedure. However, the obtained results will be saved in the results database until it is
initialized.
Warning: It is not possible to delete results of samples that have already been processed and
deleted from the Operations Tab. Results will be deleted only when the results database is
initialized.

IUMv2.09.05 7-10
Figure 7-18
Figure 7-19
7.3.2 Delete Selected Method
A requested method for a Patient, Calibrator or Control sample can be deleted in two ways: from the
Operations Menu (Figure 7-16) or from the Delete Method icon (Figure 7-20)
Figure 7-20

IUMv2.09.05 7-11
Display the requested methods to the sample on the Operations tab by pressing the symbol next
to the request process number. Select the method to be deleted and press Operations  Delete 
Delete Selected Method or press the Delete Method icon (Figure 7-20).
To delete more than one method, hold the Control key on the keyboard and select all the methods to
be deleted (Figure 7-21). Before deleting the method/s, a screen will appear to confirm the operation
(Figure 7-22). Press Yes to confirm or No to cancel it.
To delete methods which have been sent to tray and which appear as pending on the Operations
Tab, the instrument must not be working. Press Stop to cancel the operation and then delete the
selected pending methods
Warning: It is not possible to delete a method of a sample once results have been obtained.
Figure 7-21
Figure 7-22
7.4 Pending: save, load and import pending requests
Pending requests lists can be loaded, saved and imported from the Pending submenu in the
Operations Menu. This operation is unavailable while patients, calibrators and/or controls are in
process.

IUMv2.09.05 7-12
Figure 7-23
7.4.1 Save Pending
Samples which are not processed in the current run remain pending and can be saved in a file with
the extension *.aop. This file can later be used in a new run to enter new requests into the system
without the need to create them again (see 7.4.2). This can be carried out in two ways: from the
Operations Menu press Pending Save (Figure 7-23) or press the icon Save Pending List Samples
(Figure 7-24).
Figure 7-24
In the save window, select the location where the file will be saved. Name it and press Save or
Cancel. This way, all the data of pending requests is saved in a file with extension *.aop.
Warning: During this process, all requests that hasn’t been processed will be saved (including
pending or in process samples with pending results)
7.4.2 Load Pending
Pending sample lists saved in files with extensions *.aop (see 7.4.1) can be entered into the system
again to be processed in a new run. This can be done in two ways: from the Operations Menu (Figure
7-23) and pressing Pending Load or by pressing the Load Samples in Pending icon (Figure 7-25).

IUMv2.09.05 7-13
The exploration window will then be displayed to select the file with extension *.aop to be loaded.
Press Open or Cancel.
All pending sample saved in the file are now available in the Operations Tab to be processed by the
instrument.
Figure 7-25
Warning: When sample requests are re-loaded from a saved file, the system will assign a new
process number to each sample.
7.4.3 Import from CSV
Sample requests can be entered in the software from a laboratory information system software
through a file with a standard CSV (comma, space, value) format. To accomplish this, a
communication protocol between both programs must be created, which includes the requirements
of this kind of file. The description of the data format of this file can be found in Chapter 13 Point
13.3
To import data from this file, select Pending  Import from CSV on the Operations Menu (Figure 7-
23). The exploration window will then be displayed to select the file with extension *.csv to be
loaded. Press Open or Cancel.
All sample requests made by the laboratory information system software are now available on the
Operations Tab to be processed by the instrument.
NOTE: The import of a work list in a csv format can be performed automatically. This has to be
configured along with the laboratory information system software. For further information contact
technical support.
7.5 Samples to Tray

Processing of samples requested on the Operations tab (Figure 7-26) can be started from Samples to
Tray submenu or from the Samples to Tray icon.

IUMv2.09.05 7-14
Figure 7-26
To start processing samples, follow these steps:
1) Select the samples to process on the Operations tab (Figure 7-27). Samples can be selected in
two ways:
-Correlative samples: place the cursor on the first sample and go to the bottom of the list, holding
the left bottom of the mouse.
-Non-correlative samples: Holding the Control key on the keyboard, select each sample with the
mouse.
Either all or some of the requested samples can be selected; the remaining samples can be left for
later process.
Warning: Verify that the methods have been calibrated and controls have been run to determine
validation of the calibration. After reagent blank values, calibrator absorbances and controls have
been validated; continue with the processing of patients.
Figure 7-27

IUMv2.09.05 7-15
2) Press the Samples to Tray icon. The Samples Position screen will be displayed (Figure 7-28),
where Type of requested sample (patient, calibrator, control: PAT, CAL, CON), Name, ID and
Position are indicated.
3) Check that the actual positioning of samples on the tray corresponds to what appears on the
Samples Position screen. Sample positions can be modified by using the drop down window in
the Position column.
Figure 7-28
If the same position number is used by mistake for two different samples in the same run, an error
message will be displayed requesting to correct the repeated positions (Figure 7-29).
Figure 7-29
4) Select the execution options: by Selection, by Patients or by Reagents:
Selection: This is the fastest option. The software organizes and establishes the work sequence,
ordering of the methods and samples, optimizing processing speed.
Patients: Processes samples in the order in which they were requested.
Reagents: All tests of the same method are run before it continues with the tests for the next
method. The user cannot select the methods’ processing order. The software establishes the
optimal processing order. Processing is grouped as New Group by default.

IUMv2.09.05 7-16
5) Press Send to continue or Cancel send if the operation is not carried out.
6) Select the methods for reagent verification on the Reagents Verification screen (Figure 7-30)
After sending samples to be processed, the Reagent Verification screen is displayed. In this screen,
all methods where the verification time (configured in the Verification Time field) has elapsed are
indicated with a check mark. It is recommended that the selected reagents are verified to ensure the
integrity of the reagents before processing samples.
Methods where the verification time has not elapsed can also be verified by selecting them on this
screen. It is recommended that methods are verified after changes have been made. Some examples
of changes that require verification are: when a new reagent is placed, when configuration of certain
method parameter is modified, etc.
Figure 7-30
7) Press Verify Selected or Do not verify. If the option Do Not Verify is selected, the methods that
are checked will not be verified.
Warning: This is the last screen where processing of requested samples can be cancelled.
8) Press Start on the screen to put the samples in the tray (Figure 7-31)
Warning: It is not possible to cancel processing of selected samples in this step.

IUMv2.09.05 7-17
Figure 7-31
7.6 Samples to Tray (Barcode) (Optional)
Processing of samples with barcodes can be initialized from the Samples to Tray (Barcode) submenu
or from the Samples to Tray (Barcode) icon when the instrument is installed with the optional
barcode reader (Figure 7-32)
Figure 7-32
To begin processing samples, follow the next steps:

1) Add the daily work list of samples (either manually or imported from a pending file or a .csv)
Warning: First methods should be calibrated and controlled, once the values for reagent blank,
calibrators absorbances and quality controls are validated, then proceed to process patients samples.
2) Press Samples to Tray (Barcode)

The analyzer will scan every sample position in the SR tray until it finds all the samples added in the
work list, meaning, if the samples in the work list are in the first ten positions then the analyzer will
find the samples and stop the scanning process after finishing in position 10. If a barcode can’t be
read by the analyzer, the sample corresponding to that barcode won’t be found, therefor the
analyzer will continue scanning until it reaches position 60.

IUMv2.09.05 7-18
Figure 7-33
Figura 7-34
Once the detecting process is finished, the window for Sample Positions will appear. Verify that the
positions shown in the list match the ones in the SR tray.
NOTE: Those samples with barcodes that can’t be read by the analyzar will remain in the work list
(Entered Samples), not being sent to tray, the rest of the samples whose barcodes were read OK will
be moved to tray. The samples that remain in the work list can be sent to tray manually or,
previously correcting the barcode (positioning correctly, label, etc), using the barcode reader.
If a new list of samples is scanned in positions that still have pending tests the following message will
show:
Figura 7-35
By pressing OK Position 2 will be scanned again until the original tube is detected. The analyzer won’t
allow to move on until the original tube is placed in its position.

IUMv2.09.05 7-19
3) Check that the actual positioning of samples on the tray corresponds to what appears on the
Samples Position screen. Sample positions can be modified by using the drop down window in the
Position column.
Figure 7-34
If the same position number is used by mistake for two different samples in the same run, an error
message will be displayed requesting to correct the repeated positions (Figure 7-29).
Figure 7-35
4) Select the execution options: by Selection, by Patients or by Reagents:
Selection: This is the fastest option. The software organizes and establishes the work sequence,
ordering of the methods and samples, optimizing processing speed.
Patients: Processes samples in the order in which they were requested.
Reagents: All tests of the same method are run before it continues with the tests for the next
method. The user cannot select the methods’ processing order. The software establishes the
optimal processing order. Processing is grouped as New Group by default.
5) Press Send to continue or Cancel send if the operation is not carried out.
6) Select the methods for reagent verification on the Reagents Verification screen (Figure 7-30)

IUMv2.09.05 7-20
After sending samples to be processed, the Reagent Verification screen is displayed. In this screen,
all methods where the verification time (configured in the Verification Time field) has elapsed are
indicated with a check mark. It is recommended that the selected reagents be verified to ensure the
integrity of the reagents before processing samples.
Methods where the verification time has not elapsed can also be verified by selecting them on this
screen. It is recommended that methods be verified after changes have been made. Some examples
of changes that require verification are: when a new reagent is placed, when configuration of certain
method parameter is modified, etc.
Figure 7-36
7) Press Verify Selected or Do not verify. If the option Do Not Verify is selected, the methods
that are checked will not be verified.
Warning: This is the last screen where processing of requested samples can be cancelled.
8) Press Start on the screen to put the samples in the tray (Figure 7-31)
Warning: It is not possible to cancel processing of selected samples in this step.

IUMv2.09.05 7-21
7.7 Wash Cuvettes
Cuvette washing processes are carried out from the Operations Menu, Wash Cuvettes submenu or
from the Wash Cuvettes icon on the main screen of the system (Figure 7-33)
Figure 7-37
The different options to wash cuvettes are:
All cuvettes: it washes all 100 cuvettes.
Dirty cuvettes: it only washes dirty cuvettes which have just been used and which have been partially
washed.
Cuvettes range: select the range of cuvettes to wash. In the left box put the number of the initial
cuvette and in the right box put the number of the final cuvette to be washed.
Special Wash: A special wash solution is placed in a reagent bottle and is assigned a position in the
Reagent Pos. box. During this wash cycle, the instrument starts washing cuvettes from 1 to 10 and
then dispenses 300 µl special washing solution and 300 µl washing solution in each of the 100
cuvettes. This wash solution mixture remains in the cuvettes for approximately 10 minutes, and then
it is automatically washed. A diluted solution of sodium hydroxide is used for the special wash.
NOTE: This procedure must be performed after using latex reagents using a 2N NaOH solution. It can
also be performed when needed using a 0.2N NaOH solution as a preventive maintenance of the
cuvettes.
From the Operations Menu, Wash Cuvettes submenu or by pressing the Wash Cuvettes icon, select
the desired washing option on the Wash Cuvettes screen (Figure 7-34). Press Wash or Cancel.

IUMv2.09.05 7-22
Figure 7-40
7.8 Start
Operation of the instrument can be started from the Start submenu of the Operations Menu or from
the Start icon (Figure 7-35)
Figure 7-41
Start is used:
-to initialize the instrument.

-to repeat a result when the instrument has already finished the run.
-to restart the processing of samples after having stopped the instrument by pressing Stop (see 7.9)
7.9 Stop
The instrument can be completely stopped by pressing Stop on the Operations Menu or the Stop
icon (Figure 7-36). The processing of samples and the reading of reagents in process will stop
completely as a result.

IUMv2.09.05 7-23
Figure 7-42
Stop is used:
-When there is a mechanical error. For example, if there is a problem with the probe, cuvettes tray
cover is out of place, washing solution is needed, etc.
-When there is an error in the processing. For example: a reagent has been positioned in the wrong
place, samples are missing or they have been incorrectly placed, reagent deterioration index is out of
range, etc.
-When there is an error sign on the screen that indicates Retry or Stop the process.
When the instrument is running tests and the option Stop is pressed, a warning sign will appear
(Figure 7-37) to confirm the operation by pressing Yes or No.
Figure 7-38
7.10 Pause
The instrument can be paused by pressing Pause on the Operations Menu or the Pause icon (Figure
7-38). Dispensing of samples will stop but reactions in process will continue, including R2 dispensing.

IUMv2.09.05 7-24
Figure 7-39
Pause is used:
-to add samples on the samples tray

-to refill reagents bottles
-to refill the washing solution container or to empty the waste container
After the desired operation has been carried out, restart processing of samples by pressing Pause
again. Pause or not paused is evidenced by the icon:
Paused Instrument: the key is pressed in the icon
Not Paused Instrument: the key is not pressed in the icon
7.11 Print Results
Patients, calibrators and controls results can be printed from the Operations Menu, Print PAT, CAL
or CON Results or from the Icon Print View (Figure 7-45).

IUMv2.09.05 7-25
Figure 7-40
Results to be printed must be first selected on the appropriate Tabs: PAT Results Tab, CAL Results
Tab, CON Results Tab. Data can be grouped and ordered in each tab according to different criteria
before printing.
Once ordered and selected, results are printed by pressing Print View or from the Operations Menu,
selecting the submenu corresponding to the type of results: Print PAT, CAL or CON Results. The Print
View icon only prints the results selected on the tab in view at the time the print button is pressed.
A screen will then appear to select the type of printout: Patient Report or Technical Report, and to
filter the results that the user does not want in the printout (Figure 7-46)
Figure 7-41
The Patient Report has an easy-to-read format designed to be delivered directly to patients or
doctors. The report is printed on a separate sheet of paper for each patient.
The Technical Report has a more compressed format and is used to generate a printed record of
results. Results from multiple patients are printed on the same report.
Patient and technical reports are configured in HTML format (Chapter 12 Point 12.1.5)
By pressing Preview the Patient Report or Technical Report format can be viewed on screen.
By pressing Filter a new window will appears, through this window some results can be remove from
printout process.

IUMv2.09.05 7-26
Figure 7-427
To see all processed methods double click on the ID patient field.

Uncheck the checkbox next to the methods name and press “Filter”, the preview will show only the
results that remains checked.

IUMv2.09.05 7-27
Figure 7-43
Press Preview, Print or Cancel.
7.12 Repeat Results
A method with a result already reported by the instrument can be repeated by pressing Repeat
under the Operations Menu or the Repeat icon (Figure 7-41)

IUMv2.09.05 7-28
Figure 7-44
The results to be repeated are selected from the Operations tab or the Samples in Process window
and the Repeat icon is pressed. This option is used while the instrument is running.
To repeat results when the instrument has already finished the complete operation, select them and
press Repeat. Then, to initialize the new process press Start (see Chapter 7 point 7.8)
Warning: Results of samples which do not appear on the Operations tab or which have been
removed from their original position on the samples tray cannot be repeated.
The last result obtained for each method is reported on the Operations Tab. All the results obtained
for each sample are reported on the PAT, CAL or CON Results Tabs.
7.13 Reload Samples

Upon detection of insufficient sample an error notice will appear. The sample process identification
is provided.
Figure 7-50

IUMv2.09.05 7-29
Figure 7-51
A No Sample notice can be seen on the Operation Tab, Status field (Figure 7-43).
Figure 7-52
When insufficient sample has been detected, the empty sample tube/cup must be refilled, press
Pause button, refill sample tube, the patient must be selected on the Operations Tab then press the
Reload Sample button and press Pause button again.
7.14 Export Results
Results obtained in the software can be exported to the laboratory information system software
through a standard CSV file (comma, space, value). The file is created according to the process
described in Chapter 12, section 12.1.3, and a description of this file data format can be found in
Chapter 13, section 13.3
The process can be performed automatically along with the laboratory system software, for further
information contact technical support.

IUMv2.09.05 7-30
8 METHODS MENU
In the menu bar select “Methods” to display the Method Menu (Figure 8-1)
Figure 8-1
8.1 Settings: Methods Configuration
Test parameters are programmed in this menu, including: reaction types, wavelengths, sample and
reagent volumes, incubation times, etc. This operation is unavailable while processing patients,
calibrators and/or controls.
Select Settings and enter the access code (provided at installation).
To complete a method configuration, enter the information in all the fields of the respective Tabs.
These tabs are: “General”, “Factor”, “Reference Values”, “Specials” and “Advanced”.
IMPORTANT: After all the corresponding information for a method has been entered, press the
Modify button. If the Modify button is not pressed before selecting another method, the following
message will show:
Figure 8-2

IUMv2.09.05
8-1
By clicking on Discard modifications the changes made to the method will be lost, if Back to method
is pressed, it will return to the method configuration allowing to click on Modify to save changes. Exit
the Methods Configuration by clicking on OK, otherwise the same message from above will appear.
8.1.1 General Tab
Figure 8-3
Write the method’s name in the blank field on the top of the window (to the left of the Add button)
then press Add. The method will appear in the field to the left of the Delete button, included in the
general list of methods.
NOTE: Do not change the size of the method name into the general list for one big. Software will
cut the method name if you change to another one too big.
For a new methods file, the name will appear in the field to the left of the Add button. For an already
existing methods file, you have to overwrite the name of any method in the field left of the Add
button, enter the new name and finally press Add
Warning: When the first method is programmed, it will be displayed with the default values.
When a new method is created, be sure to enter all of the desired parameter values, since the
software will default to those values of the currently displayed method.
Fill in different fields in the “General” Tab:
Name: Enter the generic method name; this name will appear in the printed reports exactly as it’s
been written in this field.

IUMv2.09.05 8-2
Brand: Enter the name of the reagent manufacturer.
Type: In this field, the methods are programmed according to the type of reaction.
Software has five types of reactions, and each has its own options and characteristics. Each one will
be explained in detail later.
 End Point Reagent Blank

 End Point Sample Blank
 Kinetics
 Fixed Time Kinetics
 ISE (Parameters at the end of this Chapter) (Optional)
Main Wavelength: Enter the main wavelength for the proper reaction, as provided by the reagent
manufacturer. The software will select the filter that is closer to that value.
Bichromatic Wavelength: Enter the bichromatic wavelength for the proper reaction, as provided by
the reagent manufacturer. The software will select the filter that comes closest to that value. For
monochromatic mode, enter “0”.
Unit: Enter the units of measurement desired for the calculation and printout of the results.
Decimals: Enter the number of decimal points desired for the calculation and printout of the results.
Sample Volume: Enter the sample volume according to the reagent/sample ratio provided by the
reagent manufacturer. The volume sample should not be less than 2 µl.
R1 Volume: Enter the volume of reagent 1 according to the reagent/sample ratio provided by the
reagent manufacturer.
R2 Volume: Enter the volume of reagent 2 according to the reagent 1/reagent 2/sample ratio given
by the reagent manufacturer if it corresponds. Leave it at “0” for single reagent methods.
Warning: The total volume (R1+ R2 + sample) must be less that 500 µl. The minimum reading
volume should be 220 µl. The maximum cuvette capacity is 600 µl.
Time to Dispense Reagent 2: Enter the time to dispense the second reagent after the dispensing of
reagent 1 and the sample. If 0 sec is entered the sample + R1 + R2 will be dispensed at the same
time.
Reagent Deterioration Index: The instrument checks the state of the reagents according to the
reagent manufacturer’s instructions. This value corresponds to the reagent blank’s absorbance. If the
measured absorbance value is outside the programmed range, a “deteriorated reagent” message will
be shown in the operations tab beside each result.
Min.: Enter the minimum absorbance value for the reagent blank according to the reagent
manufacturer’s instructions. If a minimum absorbance is not given, enter 0 as the value.

IUMv2.09.05 8-3
Note: With some bichromatic methods, a negative result is obtained for the reagent blank; in this
case enter an absorbance value less than 0.
Max.: Enter the maximum absorbance value for the reagent blank as indicated by the reagent
manufacturer. If a maximum absorbance is not given, enter 2 as the value.
Verification time: Enter the time (in hours) that is desired for checking the reagent deterioration
index. Sixteen hours is recommended.
NOTE: Always press the Modify and OK buttons if any change is made in the method configuration. If
no parameter is changed, exit by pressing the OK button.
If this is not done, the methods will not be programmed correctly and the results may be affected.
8.1.2 Factor Tab
Figure 8-4
In the Factor tab (Figure 8-3), select the Decreasing method option for reagents in which the
absorbance decreases upon increasing the analyte concentration. If this option is programmed
incorrectly, a Warning: Sign error message along with the calibrator concentration will appear during
the method calibration. This will also be reflected in negative results.
Select from the available methods for results calculation: Factor or Calibrator curve.
If Factor option is selected, enter the corresponding value in the field to the right.

IUMv2.09.05 8-4
If calibration curve option is selected, select Calibrator and complete the fields below.
In the Point field assign a number for each point (starting from 1)
Complete calibrator and absorbance field with the value “0”, since the concentration is taken from
the input value in the concentration field of the calibration parameters, and the absorbance value
will be adjusted automatically to the obtained value during the calibration.
If the calibration curve has more than one point repeat the previous steps until reaching the desired
number of points.
This step connects in the software the “Methods” window with the “Calibrators” window, where the
calibrator concentration must be entered. There will be as many calibrators as points entered in the
method settings. For that, go to the “Calibrator Parameters” section.
If only one calibration point is programmed, the system will assume the second point of reference
is“0”.
If two or more points are programmed, the system stops using “0” as a point of reference, and a
point of concentration “0” should be programmed.
Possible Interpolation types are:
Linear:
Conc = a • Abs + b
Potential:
(a • log (Abs) + b)
Conc = 10
Exponential:
(a • Abs + b)
Conc = e
Polynomial:
2 n
Conc = a0 + a1 • Abs + a2 • Abs + … + an • Abs
where n is the number of programmed calibrators.
Cubic Spline
Multilinear

IUMv2.09.05 8-5
When a method uses a calibration curve with more than 2 points, it’s recommended to evaluate the
best interpolation for that set of calibrators. For example, notice the following set of concentrations
and absorbances that constitute a calibration curve:
Figure 8-5
To know which interpolation suits the best for that set of calibrators, clic on Curve and you’ll see the
following chart, where each coloured curve represents each type of interpolation and in black circles
are marked the calibration points. The curve that best fits these points must be selected. In this case
it would be the Cubic Spline (in violet), a second option could be the Polynomial (in blue).

IUMv2.09.05 8-6
Figure 8-6
8.1.3 Reference Values Tab
In the Reference Values tab (Figure 8-4) complete the fields with the corresponding values given by
the reagent manufacturer or a population mean obtained from each laboratory. These reference
values are listed in the patient and technical reports.

IUMv2.09.05 8-7
Figure 8-7
Click in each of the lower fields and enter the corresponding values for Min Age, Max Age, Sex,
Minimum Value and Maximum Value. Once all the information has been entered, press the “Enter”
button and the whole data will appear in the upper field.
More than one range of reference values can be entered for age and sex. These values will be shown
in each case related to the age and sex data entered for each patient. If neither is entered as part of
the information for the patient, the software will default to adult male.
NOTE: Always press the Modify and OK buttons if any change is made in the method configuration, if
8.1.4 Specials Tab
In the Specials tab enter the incubation times, minimum repetition and maximum re-dilution values,
etc.
The fields shown in this tab will depend on the type of reaction selected in the General tab. Each
method has four different options (Figure 8-5).
Figure 8-8

IUMv2.09.05 8-8
8.1.4.1 End Point Reagent Blank
In this type of reaction, the instrument does a reagent blank in a separate cuvette from the test
cuvette. The blank absorbance is stored and substracted from each test absorbance. The same blank
absorbance will be used until the reagent blank is measured again.
Only one absorbance reading is taken at the end of the incubation period (end point).
This type of measurement is mostly used for colorimetric tests such as Glucose, Cholesterol, etc.
Figure 8-9
8.1.4.1.1 Times and values to enter
Time for Reagent Blank: Enter the total time in seconds required for reading the reagent blank.
Usually this value is the same as the Incubation Time.
Incubation Time: Enter the total time in seconds required for reading the reaction. Generally this
value is the same as the Time for Reagent Blank. The reagent blank is given priority, and therefore
the incubation time can be the same.
Interval between blanks: Enter the maximum possible time interval for the run of the reagent blank.
72 hours is recommended. The reagent blank should be run each time the reagent bottle is refilled,
the reagent batch is changed, or the method is calibrated.
Repetition: Enter a minimum concentration value, below which the Autoanalyzer will repeat the test
under identical sample and reagent(s) conditions, and will show that this result has been repeated.
Linear Limit: Enter the upper linearity limit provided by the reagent manufacturer. If this value is
exceeded, the instrument will dilute the sample to obtain a value within the linear range. The
instrument will run the dilution using half the sample volume programmed in the General tab. The
software will show that the sample has been rediluted. The result will be calculated using a dilution
factor for compensation. If the new result is still not within the programmed values, the sample will
be diluted again until the minimum volume indicated in the Advanced tab is used.

IUMv2.09.05 8-9
8.1.4.1.2 Calculations
Monochromatic Reading
Ab = Reagent Blank Absorbance

As = Sample Absorbance
F= Factor programmed or obtained by the method calibration
C= Concentration
C= (As – Ab) • F
Bichromatic Reading
AB = Reagent Blank Absorbance

A B’ = Reagent Blank Bichromatic Absorbance
Ab = Reagent Blank Calculated Absorbance
As’ = Sample Bichromatic Absorbance
Am = Sample Calculated Absorbance
C= Concentration
Ab = AB - AB’
Am = As - As’  C = (As – Ab) • F
8.1.4.2 End Point Sample Blank
In this type of measurement, the instrument takes a blank reading for each sample to be measured
and the result is subtracted from the absorbance of the final reaction. The sample blank reading and
reaction reading are run in the same cuvette.
This type of reaction is used for methods like Bilirubin, where the sample itself absorbs at the
wavelength being used for the assay.

IUMv2.09.05 8-10
Figure 8-10
8.1.4.2.1 Entering Times and Values
Time for Reagent 1 + Sample: Enter the total time in seconds required for reading the absorbance of
Reagent 1 + sample which is the value for the sample blank. This time can not be more than the time
program in General Tab for Time to Dispense Reagent 2
Incubation Time: Enter the total time in seconds required for reading the reaction absorbance. The
sample blank absorbance will be deducted from this value for each sample.
software will show that the sample has been rediluted. The result will be calculated using a dilution
Ab = Sample Blank Absorbance

C= Concentration
VS = Sample Volume
VR1 = Reagent 1 Volume
FD = Dilution Factor
FD = (VM + VR1) / (VM + VR1 + VR2)

IUMv2.09.05 8-11
C = (Am – Ab • FD) • F
Bichromatic Reading
AB = Sample Blank Absorbance

A B’ = Sample Blank Bichromatic Absorbance
Ab = Sample Blank Calculated Absorbance
As’ = Sample Bichromatic Absorbance
As = Sample Calculated Absorbance
C= Concentration
VS = Sample Volume
FD = Dilution Factor
FD = (VM + VR1) / (VM + VR1 + VR2)
Ab = AB - AB’
As = As - As’  C = (Am – Ab • FD) • F
8.1.4.3 Kinetics
In this type of reaction, a set of readings through a specified period is taken by the instrument, as
programmed by the user.
This method monitors the initial substrate consumption, and calculates by least squares the slope of
the straight line that the abs/min determines.
This type of reaction is used for tests like AST, ALT, etc., where the speed of production or
consumption of NADH, etc. is measured.

IUMv2.09.05 8-12
Figure 8-11
T. BDT (Bubble Dispersion Time): Time from the start of the reaction until the first absorbance
reading.
This absorbance will be used for the initial substrate consumption calculation, but not for the
calculation of the end result. This absorbance is compared with the Time to start Readings
absorbance. A T. BDT of 20 seconds is suggested.
Time to start Readings: Time from the T.BDT, at which the absorbance reading should be started,
according to the instructions given by the reagent manufacturer.
Time to end Readings: Time from the T.BDT, at which the absorbance readings should be ended.
N° of Measurements: Number of readings to be taken in the time between the Time to Start
Readings and the Time to end Readings. 3 readings are recommended. 10 readings maximum.
Initial Consumption: Maximum value permitted in abs/min for the method indicated by the
reagent manufacturer. If the substrate initial consumption (abs/min) of the reaction is greater than
the value entered here, the instrument will dilute the sample automatically. The absorbances used
for this calculation are those measured between the “T.BDT” and the “Time to start Readings” and
its value is extrapolated to abs/min. It is recommended to enter the reagent manufacturer’s
suggested value.
Linearity: This is the linear correlation coefficient of the absorbance readings according to the time of
the reaction. If the coefficient is less than that programmed, the instrument will dilute the sample. It
is recommended to enter a value between 0.8 and 0.95
Linear Limit: Enter a maximum concentration value. The reagent linear limit value given by the
manufacturer is one option. Another option is the higher laboratory limit for the test. However, if
this value is exceeded, the instrument will dilute the sample to obtain a value within the linear limit.

IUMv2.09.05 8-13
The instrument will run the dilution using half the sample volume programmed in the General Tab.
The software will show that the sample has been rediluted. The result will be calculated using a
volume factor for compensation. If the new result is still not within the programmed values, the
sample will be diluted again until the minimum volume indicated in the Advanced tab is used.
Example for method configuration
Figure 8-12
BDT: Bubble dispersion time = 20”
TSR: Time to start readings = 100”
TER: Time to end readings = 320”
Measurements= 3
A1 = 1st Absorbance reading of the Sample

A2 = 2nd Absorbance reading of the Sample
AN = nth Absorbance reading of the Sample
ΔA/min = change per minute of the sample absorbance calculated by linear regression over “n”
Absorbance readings
C= Concentration
C= ΔA/min • F

IUMv2.09.05 8-14
Bichromatic Reading
A1 = 1st Absorbance Reading of the Sample

A2 = 2nd Absorbance Reading of the Sample
AN = nth Absorbance Reading of the Sample
ΔA/min = change per minute of the sample absorbance calculated by linear regression over “n”
Absorbance readings
st
A1 = 1 Bichromatic Absorbance Reading of the Sample
A2 = 2nd Bichromatic Absorbance reading of the Sample
AN = nth Absorbance reading of the Sample
ΔA/min = change per minute of the sample bichromatic absorbance calculated by linear regression
over “n” Absorbance readings
C= Concentration
C= (ΔA/min - ΔA’/min) • F
8.1.4.4 Fixed Time Kinetics
In this type of measurement the instrument makes only two readings, and calculates the abs.
between both for the end result (Figure 8-10). This type of measurement is used for kinetic methods
such as Urea, Creatinine, etc.
Figure 8-2
Time to start Readings: Enter the total time in seconds for the first absorbance reading.
Time between Readings: Enter the total time in seconds after the first absorbance reading, for the
second absorbance reading.

IUMv2.09.05 8-15
software will show that the sample has been diluted. The result will be calculated using a dilution
Ai = Initial Absorbance Reading of the Sample

Af = Final Absorbance Reading of the Sample
C= Concentration
C= (Af – Ai) • F
Bichromatic Reading
AI = Initial Absorbance Reading of the Sample
AI’ = Initial Bichromatic Absorbance Reading of the Sample
Ai = Initial Calculated Absorbance Reading of the Sample
AF = Final Absorbance Reading of the Sample
AF’ = Final Bichromatic Absorbance Reading of the Sample
Af = Final Calculated Absorbance Reading of the Sample
C= Concentration
Ai = AI - AI’
Af = AF - AF’  C = (Af – Ai) • F
8.1.5 Advanced tab
Warning: Changes should only be made in this tab under supervision or only by trained
personnel in advanced options.

IUMv2.09.05 8-16
Figure 8-14
The purpose of modifying this part of the Methods Settings is to improve the performance of a
certain reagent
Within these options are found:
Initial Air Gap: A volume of air drawn in the diluter. It is used to minimize contact between the
reagent and the liquid inside the probe. The default value is 0 µl and it is recommended not to
exceed a value of 20 l. 2 l are recommended.
Initial Gap Speed: The speed with which the diluter draws in the initial air gap. The default value is
500 1/6 l / second.
Gap Reagent/Sample: A volume of air drawn in by the diluter. It is used to minimize contact
between the reagent and the sample. The default value is 0 µl. 2 l are recommended.
Reagent/Sample Gap Speed: The speed with which the diluter draws in the air gap. The default
value is 500 1/6 l / second.
Reagent 1 + Sample Dispensing Speed: If bubbles are formed in the reaction cuvette during the
dispensing, this speed can be reduced.
The default value is 2500 1/6 l / second. The minimum value is 1600 1/6 l / second.
Reagent 2 Dispensing Speed: If bubbles are formed in the reaction cuvette during the dispensing,
this speed can be reduced. The default value is 2500 1/6 l / second. The minimum value is 1600 1/6
l / second.
Reagent 1 Aspiration Speed: If a viscous reagent is used, the aspiration speed can be reduced. The
default value is 2500 1/6 l / second. The minimum value is 1600 1/6 l / second.

IUMv2.09.05 8-17
Dilution with: The dilution of the sample can be performed using half volume of sample or double
volume of reagent. Only sample option is available at the moment.
Dilutions with sample will be done when the result exceeds the maximum concentration value or
linear limit, when the initial substrate consumption is exceeded, or when the linearity is not met.
The instrument will use half volume sample than that programmed until reaching the Minimum
Volume of Sample programmed in the Advanced tab.
The diluter will only aspirate volumes in whole numbers.
Minimum Volume of Sample: The minimum volume of sample required to make the re-dilutions.
This value must be lower than the Sample Volume value programmed in the General Tab .
Sample Aspiration Speed: The default value is 500 1/6 l / second
Extra volume: The default value is 0 l. You can add some extra volume (for ISE methods this extra
volume corresponds to sample, for other methods this extra volume correspond to Reagent 1)
Mixing: This is performed inside the cuvette where the reaction was dispensed, it’s performed by the
probe and the diluter (they aspire different volumes of the reaction and then dispense them back in
the cuvette) The mixing can be programmed after dispensing R1 + Sample (if the value is written in
the upper field) and/or after dispensing R2 (if the value is written in the bottom field)
It’s recommended not to add more than 2 mixings.
Figure 8-15

IUMv2.09.05 8-18
Washings to avoid Interference: Extra wash cycles of the probe can be programmed to prevent
interference between reagents of different methods. This extra wash can be up to 2.
Select from the general list of methods, the method that is being interfered. Select the Advanced
tab, under Washings to avoid interference column, the interfering method. Then click in the number
field to the right of the method name, and enter the extra number of washes. Press the Enter key.
Washings to avoid self-interference: Self-interference washings can be added.

If the method that presents self interference is a single reagent method, the extra wash of the probe
will be added between consecutive dispensing of the reagent. For example, if calcium presents self
interferences, and two calcium are performed in a row, the extra washing will be between both
calciums. (The washing solution for this extra washing is taken from the 10 liters container by the
liquid diaphragm pump)
If the method that presents self interference is a double reagent method, an extra wash of the probe
will be added between the dispensing of both reagents, and between consecutive methods (as in the
previous example). (The washing solution for this extra washing is also taken from the 10 liters
container by the liquid diaphragm pump)
This extra wash can be up to 2.
Self Inference Wash Solution: if a different solution from the one in the containers wants to be
used, write a solution name, this solution name will now appear available in the drop down lists from
the reagents tray, the reagent tray position has to be programmed for this solution.
Self Inference Wash Time: write a number in seconds that the wash solution will be inside the
probe.
The same options are available for washings between different reagents. Select from the general list
of methods the one that is causing the interference. Then click in the Washing field, enter the extra
number of washes, press Enter. It is recommended to enter 1 or 2 extra washes and no more than 3.
After that, click on Solution column and write the wash solution name, press the Enter key.
Finally click on Time column enter a number in seconds that the wash solution will be inside the
probe, press the Enter key.
NOTE: The method that’s being interfered is the one that has to be programmed. For instance, let’s
assume the glucose is interfering calcium. Go to methods’ configuration, select calcium from the list,
and go to Advanced tab, in the list on the right search for glucose and add the number of extra
washings and solution to use. This way each time a calcium is made after a glucose, and extra wash
will be performed before running the calcium. (If the sequence is Glucose->Calcium, there will be an
extra wash, if the sequence is Glucose-> method x-> Calcium, there won’t be an extra wash)

IUMv2.09.05 8-19
Figure 8-16
8.2 ISE Methods Settings (Optional)

ISE Module measures the potentials developed when the sample is positioned in the electrodes.
Next, Calibrant A is positioned in the electrodes. The difference in the two potentials is related
logarithmically to the concentration of the measured ions in the sample divided by their respective
concentrations in the calibrant solution.
8.2.1 General Tab (ISE)
Write the method’s name (Ex: ISE) in the blank field on the top of the window (to the left of the Add
button) Select in the drop down list ISE type. Fill in the Name field (Ex: ISE) and complete Brand
fields. Press Add. The method will appear in the field to the left of the Delete button, included in the
general list of methods.

IUMv2.09.05 8-20
Figure 8-17
After adding the ISE type method a new check box and drop down list with the new ISE methods (Li,
Na, K, Cl) appears.
Figure 8-18
To complete each ion programming process follow this steps:
In Name field erase the name that you wrote (Ex:ISE) and write the name of the ion shown in the
drop down list (Li, Na, K, Cl), in this case write Lithium.
Press Modify button
Complete the next fields (most of them are disabled):
Unit: Enter the units of measurement desired for the calculation and printout of the results.

IUMv2.09.05 8-21
Decimals: Enter the number of decimal points desired for the calculation and printout of the results.
Sample Volume: For serum sample is 70 µl for urine sample is 140 µl (diluted urine)
Press Modify button
NOTE: Always press the Modify and OK buttons if any change is made in the method configuration, if
8.2.2 Factor tab (ISE)
ISE Module performs an internal calibration using its own reagents, nevertheless it has to be
considered that there might be some dilution of the sample while aspirating and dispensing, and this
is not contemplated during the internal calibration. So it’s recommended that each method be
calibrated externally also, as in general methods.
If Factor option is selected, enter the corresponding value in the field to the right.
If calibration curve option is selected, select Calibrator and complete the fields below.
In the Point field assign a number for each point (starting from 1)
Complete calibrator and absorbance field with the value “0”, since the concentration is taken from
the input value in the concentration field of the calibration parameters, and the absorbance value
will be adjusted automatically to the obtained value during the calibration.
If the calibration curve has more than one point repeat the previous steps until reaching the desired
number of points.
This step connects in the software the “Methods” window with the “Calibrators” window, where the
calibrator concentration must be entered. There will be as many calibrators as points entered in the
method settings. For that, go to the “Calibrator Parameters” section.
If only one calibration point is programmed, the system will assume the second point of reference
is“0”.
If two or more points are programmed, the system stops using “0” as a point of reference, and a
point of concentration “0” should be programmed.
Possible Interpolation types are:
Linear:
Conc = a • Abs + b
Potential:
(a • log (Abs) + b)
Conc = 10

IUMv2.09.05 8-22
Exponential:
(a • Abs + b)
Conc = e
Polynomial:
2 n
Conc = a0 + a1 • Abs + a2 • Abs + … + an • Abs
where n is the number of programmed calibrators.
Cubic Spline
Multilinear
8.2.3 Special Tab (ISE)
Figure 8-19
Select sample type between Serum/Plasma and Urine.

Serum/Plasma: 70 µl
Urine (diluted): 140 µl
Remember each sample type has different sample volume parameter. Must be programmed in the
General tab.
8.2.3.1.1 Calculations (ISE)
Since the difference in potentials and the concentration of lithium, sodium, potassium, and chloride
ions in the calibrant solution are known, the computer can calculate the concentration of the ions in
the sample, in accordance with the Nernst equation, rewritten as:

IUMv2.09.05 8-23
Ex - Es = S log (Cx / Cs) or Cx = Cs x 10^ [ (Ex-Es)/S ]
where: Ex = ISE potential developed in sample solution
Es = ISE potential developed in the calibrant solution
S = Electrode slope calculated during calibration
Cx = Concentration of ion in the sample
Cs = Concentration of ion in the calibrant solution
“S”, the slope, is determined during calibration using Calibrants A and B, which have known levels of
lithium, sodium, potassium, and chloride.
When a two-point calibration is initiated, the slope is calculated from the difference between each
Calibrant A and Calibrant B reading. Excessive drift or noisy readings will be flagged and the
appropriate error message will be shown.
8.2.4 Advanced tab (ISE)
Warning: Changes should only be made in this tab under supervision or only by personnel
trained in advanced options.

IUMv2.09.05 8-24
Figure 8-20
The purpose of modifying this part of the Methods Settings is to improve the performance of a
certain reagent (Figure 8-15)
Within these options are found:
Initial Air Gap: A volume of air drawn in the diluter. It is used to minimize contact between the
reagent and the liquid inside the probe. The default value is 0 µl and it is recommended not to
exceed a value of 20 l. 2 l are recommended.
Initial Gap Speed: The speed with which the diluter draws in the initial air gap. The default value is
500 1/6 l / second.
Gap Reagent/Sample: A volume of air drawn in by the diluter. It is used to minimize contact
between the reagent and the sample. The default value is 0 µl. 2 l are recommended.
Reagent/Sample Gap Speed: The speed with which the diluter draws in the air gap. The default
value is 500 1/6 l / second.
Reagent 1 + Sample Dispensing Speed: If bubbles are formed in the reaction cuvette during the
dispensing, this speed can be reduced.
The default value is 2500 1/6 l / second. The minimum value is 1600 1/6 l / second.
For ISE we recommend 1700 1/6 l / second.
Reagent 2 Dispensing Speed: If bubbles are formed in the reaction cuvette during the dispensing,
this speed can be reduced. The default value is 2500 1/6 l / second. The minimum value is 1600 1/6
l / second.

IUMv2.09.05 8-25
Dilution with: The dilution of the sample can be performed using half volume of sample or double
volume of reagent. Only sample option is active.
Dilutions with sample will be done when the result exceeds the maximum concentration value or
linear limit, when the initial substrate consumption is exceeded, or when the linearity is not met.
The instrument will use half volume sample than that programmed until reaching the Minimum
Volume of Sample programmed in the Advanced tab.
The diluter will only aspirate volumes in whole numbers.
Minimum Volume of Sample: The minimum volume of sample required to make the re-dilutions.
This value must be lower than the Sample Volume value programmed in the General Tab .
Sample Aspiration Speed: The default value is 500 1/6 l / second
Extra volume: The default value is 0 l. You can added some extra volume (for ISE methods this extra
volume correspond to sample, for other methods this extra volume correspond to Reagent 1)
Washings to avoid Interference: Refer to section 8.1.5
8.3 Reagents in Use and Profiles
Figure 8-21
Within the Methods menu, select Reagents in Use and Profiles (Figure 8-16). Every time a method is
programmed, it will appear on the In Use listing.
Here is where the programmed methods should be set ‘in use’.
The programmed methods can be:

IUMv2.09.05 8-26
Available: They are seen in the column headed ‘Available’, and they will not appear in the selection
options (when adding a sample, calibrator or control, in the reagents tray)
In use: They are seen in the column headed ‘In Use’ and they will appear in the selection options
(when adding a sample, calibrator or control, in the reagents tray)
To change an Available method to In Use, select the chosen method from the Available list and press
the key:
To change an In Use method to Available, select the chosen method from the In Use list and press
the key:
After the change has been made, press the OK key.
In the Profiles column, groups of methods called Profiles can be created. (Figure 8-17)
Within the column, select the methods desired for the profile; enter a name in the field under this
column as shown in the example, and then press the Add and OK keys.
Note: If methods file is deleted, profiles will be shown anyway

IUMv2.09.05 8-27
Figure 8-22
8.4 Saving Methods
The configured methods in the software can be saved in a file or location different from that which
the software uses.
They are saved with the extension *.amf. This extension is only used for the InCCA program, and is
not able to be opened with any other application. This operation is unavailable while processing
patients, calibrators and/or controls.
Open the menu Methods and select Save (Figure 8-18)
An explorer window will open. Select or create the location where the file will be saved.
Give the file a name and press the Save button, or press the Cancel button if saving is not the desired
operation.

IUMv2.09.05 8-28
Figure 8-23
8.5 Loading Methods
Methods are loaded from a different location than that used by the program. Only files with the
*.amf extension are able to be loaded. This operation is unavailable while processing patients,
calibrators and/or controls.
Open the menu Methods and select Load (Figure 8-19)
Figure 8-24
An explorer window will open. Select the desired *.amf file. Only files with this extension are able to
be loaded.
Press the Open button, or press the Close button if opening a file is not the desired operation.
When loading a new file, it is added to the currently loaded file. The software saves this information
when it is closed.
Warning: The software saves certain information when it is closed. The method files are not
replaced, but added together during the loading of a new file, giving a combined methods file as a
result.
To replace the method file in use by a new one (see Chapter 13 Point 13.2)

IUMv2.09.05 8-29
8.6 Saving Profiles
The created profiles can be saved in a different location than that used by the program. They are
saved with the extension *.aef. This extension is used for the InCCA program. This operation is
unavailable while processing patients, calibrators and/or controls.
Open the menu Methods and select Save Profiles (Figure 8-20)
Figure 8-25
An explorer window will open. Select or create the location where the file will be saved.
Give the file a name and press the Save button, or press the Cancel button if saving is not the desired
operation.
8.7 Loading Profiles
Created profiles can be loaded from a different location than that used by the program. Only files
with the *.aef extension are able to be loaded. This operation is unavailable while processing
Open the menu Methods and select Load Profiles (Figure 8-21)
An explorer window will open. Select the desired *.aef file.
Press the Open button, or press the Close button if opening a file is not the desired operation.
Figure 8-26

IUMv2.09.05 8-30
9 CALIBRATORS MENU
Calibrator parameters settings as well as calibrator files handling can be carried out from the
Calibrators Menu. There is also a shortcut to parameters setting from the icon Calibrators
Parameters (Figure 9-1)
Figure 9-1
9.1 Settings
Calibrators parameters are set on the Settings submenu. This operation is unavailable while
processing patients, calibrators and/or controls.
Press Settings on the Calibrators Menu or the Calibrators Parameters shortcut icon. The
configuration screen will then be displayed (Figure 9-2) and the Name, Brand, Lot and Expiration date
(dd/mm/yyyy) for the calibrator is entered. Press Add to add the calibrator.
NOTE: Do not enter a name too big. Software will cut the name.
Once the calibrator has been entered, concentration values for each analyte have to be
programmed. In order to do this, select the calibrator in the column: Calibrator; select the method in
the column Method and select the concentration fields in the column Conc. Type the concentration
value assigned to the calibrator for the analyte and press Enter from the keyboard.
To the right of the Concentration value, a number for repetitions can be added, in the column
Repetitions (for example, if you write “1” in the repetition column, that method of that calibrator
will be processed twice, an average of those results will be used later in the calibration cuve)
Finally, select in the column Point the related calibration curve point. When the method has different
calibration points with different concentrations, a calibrator must be configured for each point. Press
OK to save the data previously entered.
Warning: Calibrator concentration values entered for each method must be expressed in the
same units used in the method configuration to express the results.

IUMv2.09.05
9-1
Figure 9-2
The remove a calibrator already entered, select the calibrator in the column Calibrator and press
Delete and then OK.
To modify a concentration already entered, place the cursor on the data and modify it. Then press
Enter on the keyboard and OK to save modifications.
When the calibration of a method is requested, the software uses the calibrator in use configured
concentration for the calculation of the results.
Figure 9-3
9.2 Saving Calibrators Files
Calibrators configuration data in use can be saved through the submenu Save. By pressing
Calibrators Menu  Save, an exploration window is displayed. Select the folder or location where
the data will be saved. Name the file and press Save or Cancel if the operation will not be carried out.
A file with extension *.acf will be created which can be used as a back up or to be installed in another
PC.

IUMv2.09.05 9-2
9.3 Loading Calibrators Files
Calibrators configuration data can be obtained through the submenu Load from a different file than
the file in use. By pressing Calibrators Menu  Load, an exploration window is displayed. Select the
folder or location from where the data will be obtained. Select the file with extension *.acf and press
Open or Cancel if the operation will not be carried out.
All the data of the calibrators that appear in the selected file will then be entered.
Warning: By entering configuration data of new calibrators through the submenu Load, all the
data of calibrators in use will be deleted. Additionally, if the methods configured in the loaded file
are different from the methods in use, the calibrator value will appear as -1.
Before this operation, back up the calibrators in use as indicated in Chapter 9 Point 9.2

IUMv2.09.05 9-3
10 CONTROLS MENU
Controls parameters setting as well as controls files handling can be carried out from the Controls
Menu. There is also a shortcut to parameters setting from the icon Controls Parameters (Figure 10 -
1)
Figure 10-1
10.1 Settings
Controls parameters are set on the Settings submenu. This operation is unavailable while processing
Press Settings on the Controls Menu or Controls Parameters shortcut icon. The configuration screen
will then be displayed (Figure 10-2) and the data of the control is entered first in the pertinent fields:
Name, Brand, Lot and Expiration date, in this format: dd/mm/yyyy. Press Add to add the new
control.
NOTE: Do not enter a name too big. Software will cut the name.
Figure 10-2

IUMv2.09.05
10-1
Once the control has been entered, minimum and maximum concentration values are assigned. In
order to do this, select the control in the column Control; select the method in the Method column
and select the minimum concentration field in the column Min. C. Add the minimum concentration
value assigned to the control and press Enter. Then select the maximum concentration field in the
column Max. C. and enter the maximum concentration value and press Enter. Finally, press OK to
save the data previously entered.
During the controls process the software verifies that the results obtained are within the
programmed ranges and the control results are reported as Correct or Error.
Warning: Minimum and maximum concentration values entered for each method must be
expressed in the same units used to express results in the general method configuration.
Warning: Every time the control lot in use and its concentration values are changed, enter the
new lot as a new control.
To remove a control that has been entered, select the control in the column Control and press
Delete and then OK.
To modify a concentration that has been entered, place the cursor on the data and modify it. Then
press Enter on the keyboard and OK to save modifications.
10.2 Saving Controls Files
Controls configuration data in use can be saved from the submenu Save. By pressing Controls Menu
 Save, an exploration window is displayed. Select the folder or location where the data will be
saved. Name the file and Save or Cancel if the operation will not be carried out.
A file with extension *.aof will be created which can be used as a back up or to be installed in
another PC.
10.3 Loading Controls Files
Controls configuration data can be obtained through the submenu Load from a different file than the
file in use. By pressing Controls Menu  Load, an exploration window is displayed. Select the folder
or location from where the data will be entered. Select the file with extension *.aof and press Open
or Cancel if the operation will not be carried out. All the data of the controls that appear in the
selected file will then be entered.
Warning: By entering configuration data of new controls from the submenu Load, all the data of
controls in use will be deleted.
Before this operation, it is recommended to back up the controls in use as indicated in Chapter 10,
section 10.2

IUMv2.09.05 10-2
11 STATISTICS MENU
The Statistics Menu (Figure 11-1), which is accessed from the main screen, is where patients,
calibrators and controls statistical analysis is carried out. There is also a shortcut to the statistical
analysis of data from the Levy-Jennings Plot icon.
Figure 11-1
11.1 Levy-Jennings of Patients
Levy-Jennings plots can be made to represent values obtained in the same patient for a certain
analyte. To do this, data must be previously ordered in the PAT Results Tab, performing an advanced
search by Last Name and Name, so that all processes for the same patient are shown together.
The following steps must be carried out:
1. Select the Process Date from/to which the search will be performed.
2. Perform an advanced search of the data of the same patient (Figure 11-3): For example: Name:
Juan, Last Name: Osores. The search can also be performed by Age, Sex, Protocol, Doctor or Bed
3. Select the data obtained, press Statistics Menu  Levy-Jennings of Patients or press the
shortcut Levy-Jennings Plot icon.
4. A screen will then appear to display all the methods performed to the selected processes (Figure
11-2). Select the method to be plotted and press OK or Cancel to cancel the operation.
Figure 11-2

IUMv2.09.05 11-3
Figure 11-3
The graph is a Levy-Jennings Plot where the results obtained for each point are shown. The CV% and
the Average for the data are also reported. In the plot different lines can be observed, which show
the values corresponding to the average and +/- SD per line (Figure 11-4). The plotted data can be
edited: place the cursor on the appropriate box, enter the new value and press Enter on the
keyboard. By pressing Calculate, the statistical parameters will be calculated and a new graph will be
obtained.
Warning: Data can be temporarily edited, but will not be saved by the program.

IUMv2.09.05 11-4
Figure 11-4
11.2 Levy-Jennings of Calibrators
Levy-Jennings plots can be made to represent values obtained in the same calibrator for a certain
analyte. To do this, data must be previously ordered in the CAL Results Tab, performing an advanced
search by Calibrator and Method.
2. Perform an advanced search of a particular calibrator data (Figure 11-5): For example: Calibrator:
CAL 1, Method: GLUCO-DICO. The search can also be performed by Report that means by
obtained result.
3. Select the data obtained, press Statistics Menu  Levy Jennings of Calibrators or press the

IUMv2.09.05 11-5
Figure 11-5
The graph obtained is a Levy-Jennings Plot where the results obtained for each point are indicated.
The CV% and the Average for the data are also reported. In the plot, different lines can be observed,
which show the values corresponding to the average and +/- SD per line (Figure 11-4). The plotted
data can be edited: place the cursor on the appropriate box, enter the new value and press Enter on
the keyboard. By pressing Calculate, the statistical parameters will be recalculated and a new graph
will be obtained.
Warning: Data can be temporarily edited, but will not be saved by the program.
11.3 Levy-Jennings of Controls
Levy-Jennings plots can be made to represent values obtained in the same control for a certain
analyte. To do this, data must be previously ordered in the CON Results Tab, performing an advanced
search by Control and Method, so that all results for the same method are shown together.
2. Perform an advanced search of the data of a level or kind of control and a certain method:
Example: CONTROL N, Method: ALBU-DICO (Figure 11-6).

IUMv2.09.05 11-6
3. Select the data obtained, press Statistics Menu  Controls Levy-Jennings Plot or press the
Figure 11-6
The graph obtained is a Levy-Jennings Plot where the results obtained for each point are indicated.
The CV% and the Average for the data are also reported. In the plot, different lines can be observed,
which show the values corresponding to the average and +/- SD per line (Figure 11-4). The plotted
data can be edited: place the cursor on the appropriate box, enter the new value and press Enter on
the keyboard. By pressing Calculate, the statistical parameters will be calculated and a new graph
will be obtained.
Warning: Data can be temporarily edited but will not be saved by the program.
11.4 Quality Control

This function allows a quality control graph of controls to be viewed and printed from the CON
Results tab.

IUMv2.09.05 11-7
Figure 11-7
The results of the controls will have to be selected before being drawn.
Figure 11-8
If more than one method is selected, a method selection window will appear.
Figure 11-9
In the same way, if more than one control is selected, a control selection window will appear.
Figure 11-10
Observe between brackets the number of lot that was entered during control programming (in
Controls Menu), and that it’s added to the name of the control. Thus, the controls of different lots
are considered to be different controls for the quality control chart.
NOTE: Control settings must be programmed with lot number

IUMv2.09.05 11-8
Figure 11-11
In the upper side of the graph, control settings are shown.
Figure 11-12
To the right side, the statistical information and the concentrations of the selected controls are
shown.
Figure 11-13

IUMv2.09.05 11-9
In the lower left side, the quality control graph is shown. Programmed control values are shown in
solid line:
Gray = Mean value (this value is the average value between the programmed maximum and
minimum control values)
Green = ± 1SD (these values are obtained by considering the programmed maximum and minimum
control values as ± 2SD)
Yellow = ± 2SD (this values are obtained from the programmed maximum and minimum control
values)
Red = ± 3SD (these values are obtained by considering the programmed maximum and minimum
control values as ± 2SD)
Selected controls statistics are shown in dotted line
Gray = Mean value

Green = ± 1SD
Yellow = ± 2SD
Red = ± 3SD
Figure 11-14
Lines can be individually hidden by pressing the related upper side reference. For example, by
pressing on the -3SD Cont text, the bottom red line will be hidden.

IUMv2.09.05 11-10
12 MAINTENANCE MENU
The Maintenance Menu is accessed from the main screen of software (Figure 12-1). In this menu
general configuration options of the system, maintenance operations and validation tests are
separately described.
Figure 12-1
12.1 Settings
12.1.1 Serial Port Tab
Figure 12-2

IUMv2.09.05
12-1
Communication port configuration data is preset in the Serial Port Tab (Figure 12-2).
Available Serial Port: the PC Communication Port is accessed by the software and communication is
established between them. The message appears on a green frame.
Warning: Do not make changes in the preset communication port configuration.
12.1.2 Files Tab
The names and addresses of the files the software uses to work on a daily basis appear on the Files
tab (Figure 12-3). There are Methods, Calibrators, Trays, Tests and Log files. Each of them has a
particular extension.
The log files are communication reports between the instrument and the PC. They contain a history
of actions that have occurred every time there is an error message in the system. They have HTML
format and they are used by technical support to determine the causes of errors whenever there is a
failure. A log file is generated automatically on a daily basis.
Figure 12-3
File locations: By pressing Browse, the explorer window displays the folder where the file in use is
located. By using this command, the files that appear on screen are only those with the same
extension as the pertinent file. For example, if Browse is pressed for Methods File and a folder is
selected, the files that appear on screen when it is opened are only those with *.amf extension.
File modification: The names of the files in use and/or their path on the PC may be modified in this
screen. If such modifications will not be made, go back to the original name by pressing Reset. To

IUMv2.09.05 12-2
save modifications, press OK or press Cancel. Modifications to the name and path of the files are
automatically saved by the software every time it is closed.
Warning: method files are not replaced. They are added with the change of name, creating as a
result an integral method file.
12.1.3 Database Tab
Figure 12-4
The name and address of the results file in use with the extension *.adb appear in the Database tab
(Figure 12-4)
File location: by pressing Browse the exploration window will be displayed, and the file in use folder
is shown. If another location is selected, the files shown when each folder is opened will only be
those with *.adb extension.
If you wish to see the results saved in another file, select it and press Save, the new name and
address will appear on screen. To save modifications press OK or otherwise press Cancel.
File modification: the name of the file in use and/or its addresses on the PC may be modified on this
screen. If such modifications will not be made, go back to the original name by pressing Reset. To
save modifications, press OK or otherwise, press Cancel.
Modifications to the name and location of the file are automatically saved by the software every time
it is closed.
Export Results: the database may be saved in .csv format. Press Export Results and select the folder
where the data will be saved. Name the file and press Save. A screen where the type of results to be

IUMv2.09.05 12-3
saved can be selected appears: Patients, Controls and/or Calibrators results. Also Technical
Information and/or Kinetics Points can be added (Figure 12-5). Choose the option/s and then press
Export.
Figure 12-5
The next screen allows selecting date and time or process numbers from/to save information range
(Figure 12-6). Choose the required option/s, complete the initial and final data to be saved and then
press Selection. To save all the available information of the file in use, press All.
Then a file with *.csv extension will be created, and it can be read using Excel. This option allows to
save separately every type of data or to make statistics, searches, etc., using Excel functions.
Figure 12-6
Database Copy: This button will allow saving *.adb files that contain results in the database. The
entire database is saved; no range or type can be individually selected.
It is recommended that a back-up copy of the database be made before it is initialized.
Initialize: Before initializing the database a Results Back-up and a Results Export should be made (see
Results Export and Results Back-up).
Once the results back-up and the results export have been carried out, press Initialize, all Patients
results, calibrators, controls and methods are deleted from the system. The following message will
show:

IUMv2.09.05 12-4
Figure 12-7
Press Yes to confirm or No to go back to the previous window.

The latest calibration is saved in the configuration of methods and configuration data regarding
calibrators, controls and method is not modified.
Statistics: The number of Patient, Calibrator and Control results that have accumulated in the
database in use is displayed. The total number of test results obtained with current run is shown to
the left of the main window.
In the adjacent box the number of test results obtained with every available method can be seen. In
this box Total represents the Grand Total of all tests in the database in use. This counting is refreshed
by pressing Refresh Statistics.
Warning: The database must be initialized regularly so that the working speed of the software is
not affected. This process should be carried out on a monthly basis or when the number of total
determinations reaches 10,000 determinations.
12.1.4 Ages Tab
Figure 12-8

IUMv2.09.05 12-5
The age groups are configured in the Age Tab (Figure 12-7). To enter a new age group, press Add,
and fill in name of the group under Type, and the minimum and maximum ages (in years) in the From
and To fields. This data is used in the Add Process screen to assign the appropriate age group to
each patient. Operations  Add  Sample  Patients Age  select the age group (Figure 12-8).
To delete an age group, click inside that box and press Delete.
It is possible to set the printout of the Patient Report and/or Technical Report to show the reference
values of every patient according to their age group (See Chapter 8, section 8.1.3, Reference Values
Tab).
Figure 12-9
12.1.5 Reports Tab
The printout formats of Patient Reports and Technical Reports are configured in this tab (Figure 12-9)

IUMv2.09.05 12-6
Figure 12-10
The Patient Report has an easy-to-read format designed to be delivered directly to patients or
doctors. The report is printed on a separate sheet of paper for each patient.
The Technical Report has a more compressed format and is used to generate a printed record of
results. Results from multiple patients are printed on the same report.
By clicking on the box Patient’s Report/Page Heading, the different sections of the Patient’s
Report/Technical Report to be configured are displayed (Figure 12-10).
The configuration language is HTML. The final format appears at the bottom of the screen. The
configuration is written in the text box in the middle of the page. If no modification is made, press
Reset to go back to the original format. To save modifications press OK, otherwise press Cancel.

IUMv2.09.05 12-7
Figure 12-71
By clicking on Configure Printer, a list of the available printers and their properties are shown.
By clicking on Print Test Page, select the number of samples and methods to be printed (Figures12-
11 and 12-12). This allows test prints of the printer configuration. Then, select the printout format:
Patient Report or Technical Report. The configured format can be seen on screen by pressing
Preview or by printing it, by pressing Print (Figure 12-13)
Figure 12-12
Figure 12-8

IUMv2.09.05 12-8
Figure 12-9
12.1.6 Memory Tab
The technical data in the internal memory of the instrument can be viewed and modified in the
Memory tab (Figure 12-14)
In this tab the status of the variables related to each module of the instrument is shown. By pressing
Get from Instrument, the software reads all the data saved in the internal memory of the
equipment. This process takes several minutes and can be seen in the Status Bar.
Warning: These processes are carried out only by Technical Support or personnel trained in
advanced operations.
Figure 12-10
12.1.7 Language/ Style Tab
In this tab the language and the style are selected (Figure 12-15).

IUMv2.09.05 12-9
Language: Click on the desired language and press OK. For the language changes to be loaded in the
system, close the software and open it again.
Style: By displaying the Style menu, all the possible screen design style options appear on the screen.
Select the desired style, and press OK. For changes of style to be loaded in the system, close the
software and open it again.
Warning: Do not make Language/Style changes while the instrument is running. Remember to
close and open the software after making changes.
Figure 12-11
12.1.8 Access Control Tab
Access control can be changed by the software administrator.

Admin: password to enter in Settings of Maintenance menu.
Methods: password to enter in Settings of Methods, Calibrators and Controls menu.
Service: password to enter in Commands Console of Maintenance Menu
Select on the left side the option that one to be changed and the right side fill in with the new
password, repeat new password and finally press Change Password button.

IUMv2.09.05 12-10
Figure 12-12
Warning: in case of losing or forgetting passwords contact technical support
12.2 Cuvettes Status
By clicking on Maintenance and selecting Cuvettes Status, a screen will appear (Figure 12-17) which
shows the number and status of each cuvette, represented by different colors:
Green: Clean
Light Red: Dirty
Dark Red (6 different shades): In washing process and drying process:
-Washing 1: Aspiration of liquid and dispensing of washing solution

-Washing 5: First drying step
-Washing 6: Second drying step
Light Blue: In Use

Gray: Unknown status
Cuvettes status is constantly refreshed as operations are carried out in the cuvettes tray.

IUMv2.09.05 12-11
Warning: Every time the software is unexpectedly closed in unusual way, the instrument shows
the status of the cuvettes as all dirty, this is a preventive action.
Therefore, it is necessary to start sessions by washing dirty cuvettes or by carrying out the
programmed washing. Otherwise, start the new session by washing the entire cuvettes tray (Wash
cuvettes  range of cuvettes  1 to 100  wash)
Figure 12-18
12.3 Containers Status
By clicking on Maintenance and selecting Containers Status, a screen will appear which shows the
volume of liquid in each container, expressed as a percentage of its total capacity.
When the level of waste liquid is above 90% and/or that of the washing solution is below 10%, a red
warning sign will automatically appear on this screen (Figure 12-18)
Figure 12-19
To make changes in level of liquid of the bottles, the instrument must not be working. Once the
waste bottle has been emptied, the instrument can work again. Once new washing solution has been
added, make five purge cycles of the diluter
(Maintenance  Instrument  Diluter Purge)

IUMv2.09.05 12-12
Then wash cuvettes from 1-10 five times
(Operations menu wash cuvettes  Range 1-10 Wash)
Warning: The level of liquid is only refreshed when processes that require the aspiration or
dispensing of liquid are carried out.
12.4 Programmed washing
The Programmed Washing option appears on screen two minutes after the working sequence has
finished and all the results have been shown (Figure 12-19)
This process washes dirty cuvettes which have just been used and those which have not been fully
washed, being executed in the indicated remaining time. If Execute is selected, the washing is carried
out at that moment.
If it were left some samples pending of process, passed 10 minutes an autostop will take place
automatically; after that the sequence of programmed washing will be carried out.
Warning: DO NOT cancel the programmed washing since it may affect next washings as well as
cuvettes lifespan.
Figure 12-20
12.5 TIP Cleaning
This process consists in the internal and external washing of the TIP or probe which aspirates and
dispenses samples and reagents.
Select Cleaning TIP from the Maintenance Menu and place a tube containing 30% Sodium
Hypochlorite in the chosen position. On the screen, position 60 appears as preset option. Click OK.

IUMv2.09.05 12-13
This cleaning must be carried out after finishing work on a daily basis.
Figure 12-21
12.6 Communications
By clicking on Maintenance and selecting Communication, two communication options between the
PC and the instrument are displayed: Commands Console and Serial Port Log (Figure 12-21)
Figure 12-22
12.6.1 Commands Console
This screen allows selecting working commands. The different commands allow for individual
movements of the instrument components, reading of parameters, writing of parameters, working
sequences, etc. The desired command can also be straightly written on the Terminal window
through the initials of each operation.
Warning: These operations should be carried out by Technical Support, but may be done by
users in some particular cases by following precise instructions.

IUMv2.09.05 12-14
Figure 12-23
12.6.2 Serial Port Log
All the operations between the instrument and the PC are registered by the Serial Port Log screen
(Figure 12-23). This registration only occurs when the screen is open and the command AutoRef is
active.
The following options appear:
Close: It closes the screen

Highlight: the different operations carried out by the instrument are differentiated with colors for a
better view.
Refresh: it updates data
AutoRef: data is constantly updated
Save: it allows saving all the data obtained in the PC in HTML file format. This data may then be used
to analyze processes, to determine causes of failure, etc. It is used by Technical Support.
Clean: it deletes all data obtained until that moment.
Figure 12-24

IUMv2.09.05 12-15
12.7 Validations
By clicking on Maintenance and selecting Validations, some validation tests are displayed which are
used to control how the components of the instrument are working (Figure 12-24). The
spectrophotometer, the diluter and the washer are controlled through these tests. Each user can
create an internal quality control program of their Autoanalyzer by using these tests.
Warning: A Special Washing cycle with Sodium Hydroxide 0.2 N is recommended before making
the Validation Tests (see Chapter 7 point: 7.7)
Figure 12-25
12.7.1 Stray Light
Stray light is any electromagnetic radiation of a different wavelength from that selected wavelength
reached by the detector and which is registered by the instrument.
This test is based on the absorbance measurement of a Sodium Nitrite solution. The solutions of this
substance absorb all wavelength radiation lower than 390 nm, that is why they are called optically
opaque to UV light.
Necessary materials:
Sodium Nitrite Solution 50 g/l

Automatic pipette
Procedure:
1. Dispense manually 300 µl of the solution in cuvette 1 or in any cuvette, indicating it on the
screen (Figure 12-25)

IUMv2.09.05 12-16
2. Wait for 5 minutes to reach thermal stability of the solution in the cuvette
3. Select Maintenance  Validations  Stray Light Cuvette number  OK  Filter  OK
4. The instrument reads at the selected wavelenght, informing the value in absorbance units
AU.
5. Perform the reading in duplicate.
Acceptable stray light: Abs. Higher tan 3AU
Figure 12-26
Figure 12-27
12.7.2 Photometer Precision
Photometric precision is the measurement of the dispersion of absorbance measurements around

the mean and it is expressed as a variation coefficient. This measurement is always made in the same
cuvette.
Copper Sulfate Solution 30 g/l in Sulfuric Acid 0.45 N

Automatic Pipette
Procedure:
1. Dispense manually 300 µl of the solution in cuvette 2 or in any cuvette, indicating it on the
screen (Figure 12- 27)
2. Wait for 5 minutes to reach thermal stability of the solution in the cuvette
3. Select Maintenance  Validations  Photometer Precision  Cuvette Number  OK 
Filter  OK
4. The instrument makes 30 correlative readings of the solution at the selected wavelenght,
reporting the obtained values in absorbance units AU, the arithmetic mean and the
coefficient of variation CV% for this data.

IUMv2.09.05 12-17
5. Perform the test in duplicate.
Acceptable photometric precision: CV% lower than 1.0%
Figure 12-28
Figure 12-29
12.7.3 Photometric Accuracy
Photometric Accuracy means similarity between the absorbance unit and the real absorbance of a
specific certified solution measured using reference standards.
The error while reading the absorbance of this solution regarding the certified value is called
photometric inaccuracy.
2 solutions of Potassium Dichromate in Perchloric Acid 0.001 N of different concentration and with
known and certified absorbance, measured using NIST Reference Standards Certificates (National
Institute of Standards and Technology). Example: solution A and B
Automatic pippete
Procedure:
1. Dispense manually 300 µl of the solution A in cuvette 3 or in any cuvette, indicating it on the
2. Dispense manually 300 µl of the solution B in cuvette 4 or in any cuvette, indicating it on the
3. Wait for 5 minutes to reach thermal stability of the solutions in the cuvette
4. Select Maintenance  Validations  Photometric Accuracy  Cuvette number  OK
 Cuvette Number  OK  Filter  OK

IUMv2.09.05 12-18
5. The instrument makes the readings of both solutions at the selected wavelenght, reporting
the value in absorbance units AU.
6. Make the reading duplicate.
7. Calculate the % of photometric inaccuracy according to the following formula:
% Photometric inaccuracy=[measured abs – reference abs] x 100

Reference abs.
Acceptable photometric inaccuracy: lower than 5.0%
Figure 12-30
Figure 12-31
Figure 12-32
12.7.4 Photometric Linearity
Photometric linearity means the photometric capacity to make absorbance readings proportional to
concentration changes for solutions of increasing concentrations of a substance which follows Beer’s
law.

IUMv2.09.05 12-19
Potassium Dichromate solutions in Perchloric Acid 0.001 N of increasing concentrations and known
and certified absorbance measured using NIST Reference Standards Certificates (National Institute of
Standards and Technology). Example: 25, 50, 100 and 200 mg/l (solutions A, B, C and D respectively).
Automatic Pipette.
Procedure:
1. Dispense manually 300 µl of solution A in cuvette 5 or in any cuvette, indicating it on screen

(Figure 12-32)
2. Dispense manually 300 µl of solution B in cuvette 6 or in any cuvette, indicating it on screen
(Figure 12-33)
3. Dispense manually 300 µl of solution C in cuvette 7 or in any cuvette, indicating it on screen
(Figure 12-34)
4. Dispense manually 300 µl of solution D in cuvette 6 or in any cuvette, indicating it on screen
(Figure 12-35)
5. Wait for 5 minutes to reach thermal stability of the solutions in the cuvette
6. Select Maintenance  Validations  Photometric Linearity  Cuvette Number  OK 
Cuvette Number  OK  Cuvette Number  OK Cuvette Number  OK Filter  OK
7. The instrument makes the reading of four solutions at the selected wavelenght, informing
the values in absorbance units AU.
8. Perform the test in duplicate.
9. With the results obtained, make a graph of absorbances found (y) in relation to reference
absorbances (x) and calculate the correlation coefficient by linear regression.
Acceptable photometric linearity: higher tha 0.9995
Figure 12-33
Figure 12-34

IUMv2.09.05 12-20
Figure 12-35
Figure 12-36
Figure 12-37
12.7.5 Diluter Precision
This test allows to determine volume precision of the diluter hydraulic system by making repeated
dilutions and readings of the same reaction at 340 nm.
Sample solution: Potassium Dichromate solution 5g/l in Perchloric Acid 0.001 N

Reagent solution: Potassium Dichromate solution 0.25 g/l in Washing Solution (Triton X-100 diluted).
It is prepared by diluting 5 ml of Sample Solution in one liter of Washing Solution.
Procedure:
1. Set a new method with the parameters shown in Figure 12-38 Methods  Settings
3. Place the Sample Solution in a sample tube and the Reagent Solution in a reagent bottle and assign
a position in the reagents tray.
4. Make the Diluter Precision test Maintenance  Validations  Diluter Precision  select the
method Dichromate Test  assign a position to the Sample Solution: 1 define the number of
replicates to be made, minimum 10  OK
Make the test duplicate.
Acceptable diluter precision: CV% lower than 1.5%

IUMv2.09.05 12-21
Note: this test can also be used to validate methods in use, determining each test CV% at different
concentration values.
Figure 12-38
ADAPTATION
GENERAL SPECIALS
Name Dichromate Time for Reagent blank 60
Type End Point R.Blank Interval between blanks 72
Main Wavelength 340 Incubation Time 60
Bicrom. Wavelength 700 Repetition 0,4
Units -- Linear Limit 2,0
Decimals 4
Sample Vol. 6 ADVANCED
R1 Vol. 300 Initial Air Gap 2
R2 Vol. 0 Initial gap Speed 500
Time to Disp R2 0 Gap Reagent/Sample 2
Min. Abs 0 Reagent/Sample Gap Speed 500
Max. Abs 2 R1+ Sample Dispensing Speed 2500
Verification time 16 R2 Dispensing Speed 2500
FACTOR R1 Aspiration Speed 2000
Decreasing method No R2 Aspiration Speed 2000
Factor Yes/ 1 Dilution with Sample
Calibrator No Minimum sample volume 2
Interpolation Linear Sample aspiration Speed 500
Figure 12-39
12.8 Instrument
By clicking on Maintenance and selecting Instrument, the options Calibration, Diluter Purge, Washer
Purge, Initialize and ISE are displayed (Figure 12-39)

IUMv2.09.05 12-22
Figure 12-40
12.8.1 Calibration
This option allows to calibrate the optical system, both photometer and cuvettes.
12.8.1.1 Photometer calibration
Choose Calibrate Photometer and select the position for the solution to be used for the calibration in
Use Solution in reagent pos.
The photometer can be calibrated with new washing solution placed in a reagent bottle, or using the
one in the probe washing container, in which case select Use container. Then press Calibrate.
Photometric gain for each wavelength on the readings made in the cuvette which appears in the field
Initial Cuvette on the screen.
0% and 100% T. data is also obtained, which will be later used for the Absorbance readings
calculations.
Warning: Make a diluter purge cycle before calibrating the photometer to make sure there are
no bubbles in the circuit.
Warning: Do not remove the cuvettes tray lid during this process.

IUMv2.09.05 12-23
12.8.1.2 Cuvettes calibration
Choose Calibrate Cuvettes and select the Initial Cuvette and Final Cuvette range to be calibrated.
Also select the position of the solution to be used for the calibration in Use solution in reagent pos.
Cuvettes can be calibrated with new washing solution placed in a reagents bottle, or using the
washing solution from the probe washing container, in which case select Use container. Then press
Calibrate.
During this process, the instrument reads blank absorbances of each cuvette and refreshes the value
in the instrument memory to use it later in the calculation of reaction absorbances.
Warning: It is recommended to calibrate all cuvettes tray (1 to 100) and not to make partial
calibrations by sectors.
Warning: Do not remove the cuvettes tray lid during this process.
Figure 12-41
12.8.2 Diluter purge
During this cycle, a volume of approximately 6 ml washing solution is pumped through the diluter.
This procedure eliminates bubbles from the tubing and does the internal and external washing of the
probe.
This cycle is carried out:
- every time the daily work starts

- after cleaning the TIP
- after adding washing solution to the container
- before photometer and cuvettes calibration
- as part of other maintenance operations
- every time it is necessary to purge tubings and/or clean the probe
12.8.3 Washer purge

IUMv2.09.05 12-24
The washing of the first 10 cuvettes is carried out during this cycle, which allows the filling of all
tubings of the washer circuit and the elimination of bubbles.
This cycle is carried out:
- after adding washing solution to the container

- every time it is necessary to purge tubings
12.8.4 Initialize
By clickin this command an individual initialization of each and every module will be executed,
following a certain order: photometer, probe, probearm, SR tray, diluter, washer and cuvettes tray.
This cycle is performed:

- At the beginning of daily work
- Automatically after an auto-stop sequence
12.8.5 ISE (Optional)
Through this menu different ISE maintenance options can be run.
Figure 12-42

IUMv2.09.05 12-25
Figure 12-43
12.8.5.1 Start up
During this cycle, a volume of Calibrant A and Calibrant B is pumped through the ISE module. This
procedure eliminates bubbles from the tubing. Then pumps calibration will be done (place a tube
with pumps calibration solution and indicate the position).
Finally Start up procedure ends with the Calibration of the module.
Figure 12-44
This cycle must be carried out:
- every time the daily work starts

- every 8 hours
12.8.5.2 Calibrant A purge
During this cycle, a volume of Calibrant A is pumped through the ISE module. This procedure
eliminates bubbles from the tubing.

IUMv2.09.05 12-26
Figure 12-45
12.8.5.3 Calibrant B purge
During this cycle, a volume of Calibrant B is pumped through the ISE module. This procedure
eliminates bubbles from the tubing.
Figure 12-46
12.8.5.4 Calibration
This cycle is used to calibrate the electrodes of the ISE Module. The ISE Module then cycles Calibrant
B and Calibrant A solutions in front of the electrodes and measures the millivolt output of the
electrodes for each of the respective solutions.
The ISE Module Calibration Cycle performs two successive calibrations.

IUMv2.09.05 12-27
Figure 12-47
- every 8 hours
- after each Clean Cycle
- if the QC sample results do not repeatedly fall within the proper ranges
12.8.5.5 Clean
Place a tube with cleaning solution in the required position, then press ok.
This cycle is used to remove protein build-up from the ISE Module electrodes.
Figure 12-48
- once per 24-hour period

- after every 50 samples
12.8.5.6 Pumps Calibration
Place a tube with saline solution in the required position, and then press ok.
This cycle is used to calibrate the peristaltic pumps of the ISE Module.

IUMv2.09.05 12-28
Figure 12-49
- once per day
12.8.5.7 Bubble Sensor Calibration
The Bubble Cal command is used to allow the module to reestablish a baseline for detecting air-liquid
interfaces.
Figure 12-50
- Monthly
12.8.5.8 Electrode replacement
This cycle is used to clear fluid from the flow path of the ISE Module and to pause the Sip Cycle.
Warning: This cycle is required before any electrode(s) is removed from the ISE Module. Failing
to run this cycle will cause the fluid in the flow path to leak when electrodes are removed.
Spilled fluid (or electrodes that are wet on the outside) can cause sporadic and/or erroneous results.
Always dry each electrode when changing electrodes.

IUMv2.09.05 12-29
It should be noted that every 30 minutes, a Sip Cycle is initiated, and 100 μL of Calibrant A is
dispensed. If the electrodes are removed without initiating this maintenance Cycle (Electrode
Replacemente), a Sip Cycle may occur and the 100 μL of Calibrant A will flow into the empty module.
This can cause significant damage to the ISE Module and/or other surrounding components.
Never leave the Module in this status with the reference electrode in place for more than an hour
after a Maintenance Cycle is initiated, as KCl will diffuse out of the reference electrode. Over time,
the KCl will clog the flow path. As soon as the electrodes are reinstalled, run a Calibration command.
 Press Electrode Replacement command (module will be off and the lock stick will be
released)
 Press the lock stick
 Move up the ISE module
 Depress the compression tray.
 Remove or/and install electrodes in positions
 Install electrodes into the ISE Module (electrode position as shown in Figure 12-51)
 Move Down the ISE module to put in place
 Run reconnect command
 Run Start Up procedure
Figure 12-51
12.8.5.9 Reagent Kit Replacement
Reagent kit should be replaced any time the system asks to, when controls do not fall within the
range and/or when the calibration of the module shows error.
A pop up window will appear, replace the reagent kit and press Accept.

IUMv2.09.05 12-30
Figure 12-52
The system will start purgigong to eliminate bubbles from the tubings.
Place a tube with saline solution in the required position, and then press Ok.
Figure 12-53
Finally Start up procedure starts automatically.
Figure 12-54
12.8.5.10 Reconnect
This cycle is used to power on ISE module after maintenance procedure (Electrode Replacement)
Figure 12-55

IUMv2.09.05 12-31
13 ADVANCED OPERATIONS
In this chapter are described a series of operations reserved for advanced users. These include the
configuration of the printing formats, the exchange of methods in use files, the description of
communication files, the validation of analytical methods, and the solution absorbance readings,
among others.
13.1 Configuration of the printing formats
The printing of results can be done using two different formats: Technical Report o Patient’s Report.
The configuration of these two formats and the type, text, size and distribution of the data can be
done from the Maintenance Menu  Settings  Reports.
Patient’s Report and Technical Report consist of five fields to be programmed in HTML language.
Fields are:
Page Heading
Results Heading
Result
Result’s Imprint
Page’s Imprint
The difference between Patient’s Report and Technical Report is that the first one prints the results
corresponding to the selected patients as a constant list, whereas the second one does it printing a
patient per sheet.

IUMv2.09.05
13-1
Patient’s Report Technical Report
Page Heading
Page Heading
Results Heading Results Heading
Result Result
Last Last
Method? Method?
Result’s Imprint Result’s Imprint
Page’s Imprint
Last
Patient?
Last
Patient?
Page’s Imprint
End End
In both cases, the following variables can be printed:
datetime
time
timeiso
timetext
date
dateiso
datetext
protocol
name
lastname
age
sex
dr
bed
methodname
methodtecname
unit
limdown

IUMv2.09.05 13-2
limup
limflag
pid
comment
result
concentration
redilutions
id
id_date
id_dateiso
id_datetext
id_time
id_timeiso
id_timetext
13.2 File Exchange
When the software is installed for the first time on the PC, the method files, calibrators, controls, and
results, will be automatically generated in the start-up register, each with its own characteristic
extension.
In Maintenance Menu  Settings  Files are shown the locations of the method files, calibrators
and controls.
In Maintenance Menu  Settings  Database is shown the location of the result files.
The calibrators and controls files are replaced one by the other with the Load command in each of
the menus.
The method files however, are additive, meaning that when loading a new method file using the
Method  Load, both files will be combined.
For using a new method file discarding the file in use, follow the steps below:
1) Create a backup of the method file in use, sending it to another location in the computer or to a
removable unit
2) Go to Maintenance  Settings  Files and see the exact location of the method file in use
3) Close the program
4) Go to the location of the method file in use and delete it
5) Open the software and verify that in Methods  Settings there is no configured method.
6) Load the new method file going to Methods  Load  select the new file in the explorer
window  Open
7) Verify in Methods  Settings, that the new methods have been loaded and press OK
Caution: Whenever a new file is being used it is necessary to recalibrate all the configured
techniques.

IUMv2.09.05 13-3
Caution: Verify that the new methods have the calibrator and controller concentrations
configured.
13.3 Importing samples from an administration program
From a laboratory central administration software sample requests can be entered into the software
through a standard CSV (comma, space, value) formatted file.
To do this, a communication protocol between both programs must be designed that takes into
account the requirements of this file type.
The file is a text-type separated by commas; each line of the file must contain a Patient, a Calibrator
or a Control along with all the methods to be used for the process.
The format of each line should be the following:
for Patients:
PAC,protocol,Patient name,Patient surname,Age,SEX*,Doctor,Cama,TYPE*,

PID,comment,Method1,Method2,...,MethodN
for Controls:
CON,Control name,TYPE*,Method1,Method2,...,MethodN
for Calibrators:
CAL,Calibrator Name,TIPO*,Method1,Method2,...,MethodN
*SEX: one character (F or M)

*TYPE: 0=Normal 1=STAT

IUMv2.09.05 13-4
To import the information in this file, go to Operations Menu, then go to the option Pending 
Import form a CSV. The explore window will appear and select the file with the desired *.csv
extension, and press Open, or press Cancel if this is not the desired operation.
Following this, all the requested samples generated by the laboratory central administration
software are now available in the Operations tab for being processed by the equipment.
The import of the information can be done automatically. Contact Technical Support for more
information.
13.4 Exporting results to the administration program
The results obtained in the equipment can be exported form the software to the laboratory central
administration software through a standard CSV (comma, space, value) formatted file.
The file will be generated following the procedure described in the Chapter12 point 12.1.3
Description of the exported results file:
The results are exported in a text file separated by commas (*.csv) with each of the fields in
quotations and with escape sequences for the “ (quotation marks) and the \ (inverted bars).
Therefore, the values of the fields:
- Will always be in quotations (“ ”)

Example: “Value1”,”Value2”,…,”ValueN”
- The quotation marks (“”) should be replaced by the sequence \”
Example: “this is a value that have \”quotationmarks\”,”Value1”,”Value2”,…,”ValueN”
- The inverted bars (\) should be replaced by the sequence \\
Example: “this is an \\inverted\\ bar”
The exported fields are the following ones:
(The values in quotation are fixed data)
Patients:
Process number
Order number
Method’s name
PID
Patient’s name
Patient’s surname
Age
Sex
ID
Doctor
Bed

IUMv2.09.05 13-5
Report
Blank (1 blank, 0 determination)
Number of re-dilutions
Controls:
Process number
Order number
Method’s name
Control name
“CON”
“”
“”
“”
“”
“”
Report
Calibrators:
Process Number
Order number
Method’s name
Calibrator Name
“CAL”
“”
“”
“”
“”
“”
Report
Technical Information:
"TEC"
Process Number
Order number
Method’s name
Determination Type ("PAC", “CAL” or “CON”)
Method Type (“EPRB”, “EPSB”, “K” or “FTK”)
Concentration
Main Absorbance
Bichromatic Absorbance

IUMv2.09.05 13-6
Bichromatic (1 bichromatic, 0 monochromatic)
Maximum Value
Minimum Value
Unit
Kinetics Points:
"TEC K"
Process Number
Order number
Method’s name
Determination Type ("PAC", “CAL” or “CON”)
Main Absorbance reading Time
Main Absorbance
Bichromatic Absorbance reading Time
Bichromatic Absorbance
The export of the results can be done automatically. Contact Technical Support for more information.
13.5 Determination of precision of an analytic method
For the validation of an analytic method, one of the parameters that should be stipulated is the CV%
that estimates the imprecision of the methods for a given concentration.
This parameter can be measured easily using the program. Go to Maintenance  Validations 
Diluter precision  Select the method  indicate the position of the tube to use  Indicate the
number of repetitions (10 minimum, 20 optimum)  OK.
It is recommended to choose the imprecision of the method for various concentrations levels, or at
least, for the medical decision level for each analyte
Caution: Do not process other samples while this procedure is being done.
Caution: Use sample tubes with a total volume greater than 800 µl for the precision tests.
13.6 Direct reading of the solution absorbance
From the Maintenance menu  Communications  Commands console it is possible to read the
solution absorbance without the intervention of the instrument’s hydraulic and the dispensing
systems.
In order to do this, the number of the cuvette should be recognized. Cuvette number 1 is located in
cuvette strip aligned with the acrylic cuvettes tray positioning guide, and it’s indicated with a label.
Following the direction of the arrow on the label (clockwise) you can identify the correlative
numeration for all the other cuvettes.

IUMv2.09.05 13-7
The procedure described below is used as an example for the reading of the instrumental control
solutions, or for adapting analytic techniques and monitoring reactions.
To make an absorbance reading, it is recommended to use externally washed cuvettes calibrated
with washing solution.
These are the steps to follow:
1) Start up the instrument Maintenance  Instrument  Initialize

2) Using an automatic pipette, dispense 250 to 500 µl of solution to be read, avoiding the formation
of bubbles.
3) Place the lid on the cuvettes tray
4) Go to Maintenance  Communications  Commands console and in the terminal window
write the following command (exactly as it’s written):
disableVars A1 R
Press the button on the right that says Execute
5) Select photoSetFilter (Figure 13-1) from the commands list, enter in the Parameters field the
desired filter for carrying out the reading and press Execute. This way the photometer will be
positioned in the chosen filter.
Figure 13-1
6) Select the ReactionGoPhoto command and enter in the Parameters field, the cuvette number in
which the solution was dispensed. Press Execute. Using this command the selected cuvette will be
positioned in front of the photometer.

IUMv2.09.05 13-8
7) Select the command photoRead and press Execute. The absorbance value obtained for that
cuvette and that filter will be shown in the screen above
8) For consecutive readings, press Execute several times. The time in which each operation is
completed appears in the screen and corresponds to the hours, minutes, seconds and milliseconds
from the moment the instrument was turned on.
9) Execute again the command written in the terminal window (disableVars A1 R)
10) Once all the readings have been made, wash the used cuvettes specifying in the program, the
initial and final cuvettes to wash Operations  Wash Cuvettes  Cuvette range  Wash
Figure 13-2

IUMv2.09.05 13-9
14 ISE MODULE: DESCRIPTION AND OPERATION (OPTIONAL)
ISE Module includes ion-selective electrodes and three peristaltic pumps.

The ISE Module measures the concentration of Li+, Na+, K+, and Cl- in serum, plasma
and diluted urine.
The ISE Module contains the ion-selective electrodes and the reference electrode. A bubble detector
is also included at the top of the electrodes.
The three pumps that position the sample and wash/calibrating solutions.
A waste storage is included in the reagent module. Calibrant A and Calibrant B are packaged in foil
pouches within the reagent module.
Figure 14-1

IUMv2.09.05
14-1
14.1 Electrodes
Electrodes are maintenance-free. In their package the user will find the “Install-by date.”
A pump calibration should be performed each day.

Perform a two-point calibration every 8 hours. If the user is running more than 50 serum samples a
day, both, cleaning and two-point calibration, must be performed after every 50 samples. To ensure
reliable operation, the ISE Module performs calibrant sipping every 30 minutes, beginning after the
last sample is run.
The ISE Module uses a double-junction reference electrode. The reference electrode is filled with
saturated KCl.
The reference electrode contains a small red sphere in the reservoir which normally resides on top of
the filling solution.
If the sphere begins to sink, the reference electrode must be replaced.
Cleaning solution should be used at least once a day at the end of the work day to minimize protein
build-up in the fluid lines and electrodes.
14.2 Fluid Management
The sample is aspirated by the analyzer from the sample tube and dispensed into the sample entry
port on top of the ISE Module. The sample is then positioned in front of the electrodes for
measurement.
Four solutions are required to operate the ISE Module.
1. Calibrant A is used in both two-point and single-point calibrations for serum sample analysis.
Calibrant A is pumped into the sample entry port by the Calibrant A pump and then
positioned in front of the electrodes by the waste pump. Calibrant A solution is also used for
Pump and Bubble Calibration.
2. Calibrant B is used in two-point and single-point calibrations for urine sample analysis.
Calibrant B is pumped into the sample entry port by the Calibrant B pump and then
positioned in front of the electrodes by the waste pump.
3. Cleaning Solution is used once a day to prevent protein buildup on the electrodes and fluid
path. It must be used more frequently if the ISE Module performs greater than 50 sample
measurements per day. 100 μL of cleaning solution must be aspirated by the host analyzer
from a sample cup on the host analyzer and dispensed into the sample entry port. The
sample cup must be covered to eliminate evaporation.
NOTE: Medica pepsin/HCl cleaning solution must be prepared every four weeks and stored at 4º C.

IUMv2.09.05 14-2
4. Medica Urine Diluent. Urine samples must be diluted to perform urine measurement: 1 part
urine sample to 9 parts urine diluent. The diluted specimen must be thoroughly mixed before
aspirating a sample.
14.3 Sample type

Sample: Serum, Plasma, or Urine (Urine requires dilution)
Minimum Sample Size: 70 μL serum; 140 μL diluted urine
When measuring urine, the sample must be accurately diluted (1 part sample to 9 parts Medica urine
diluent). The dilution must be performed before the sample is dispensed into the sample entry port.
Warning: Sample volumes should never exceed 150 μL. Volumes greater than 150 μL will result
in the sample mixing with the Calibrant B in the inlet tube.
14.3.1 Sample Handling and Collection
14.3.1.1 Serum
Serum may be analyzed immediately, stored at 4°C for 24 hours, or frozen at -20°C for up to one
week.
Samples must be brought to room temperature and homogenized well before assaying.
To obtain accurate results, samples should be free of any clots, fibrin, etc., which would obstruct
sample flow and affect results. The use of a serum clearing agent is strongly recommended.
If a serum separator tube is utilized, care must be taken to avoid inserting the sample probe into the
gel layer. This can create obstructions in the sample probe and the fluid path.
14.3.1.2 Plasma
Plasma samples offer an advantage over whole blood specimens when short term storage is a factor.
If the sample is to be stored, serum specimens are preferable.
Collect the specimen by venipuncture into a Sodium-Heparin evacuated blood collection tube. The
heparin level should not exceed 15 IU per mL of tube volume. Note the time of collection.
Warning: DO NOT USE AMMONIUM HEPARIN, LITHIUM HEPARIN, EDTA, OR NaF TUBES.
Mix the specimen by inverting the tube. Do not shake.
When using Sodium-Heparin collection tubes, collect a full tube of specimen to minimize the effect of
sodium heparin on the ISE Module sodium measurement.

IUMv2.09.05 14-3
14.3.1.3 Urine Samples
The required minimum sample volume for a urine sample diluted (1 part urine and 9 parts diluent)
with urine diluent is 140 μL (2 x 70 μL), two 70 μL dispensings.
Warning: Significant carryover into the subsequent serum sample will occur if a urine sample is
inadvertently analyzed in an undiluted form. Potassium errors may exceed 1 mmol/L.
Results are multiplied by 10, so the reported results will be multiplied by ten.
Never dispense a volume greater than 150 μL because it may come in direct contact with the
Calibrant B port on the side of the sample entry port.
Contamination of subsequent samples and Calibrant B will result.
38
14.3.2 Matrix Effects
Sample Matrix. The ISE Module is designed to analyze human serum, plasma and diluted urine.
Surfactants. Virtually all surfactants can irreversibly harm ISE electrodes. Most oils, emulsions, many
organic chemicals, as well as certain inorganic chemicals and buffers, can also harm the electrodes
(sometimes irreversibly).
QC Materials. Caution must be exercised when selecting quality control materials. QC materials
specifically designed for use with ion-selective electrodes usually perform suitably, but we can only
guarantee that QC materials it has validated are compatible with its electrodes. QC materials should
be run after each calibration to ensure the integrity of sample results.
14.3.3 Reagent Kit Electronic Key
The ISE reagent kit uses a memory device in order to store module information. Update information
will be stored in the device. Information includes such data as: expiration date, distributor code,
module size, lot number, security key. The update information includes the install date, a means to
calculate a count down of reagent kit usage, and information about why a kit was designated as no
longer acceptable (expiration, no remaining reagent, wrong distributor code).
14.4 Sample Aspirating and Dispensing
The sample delivered to the ISE Module must not be contaminated or further diluted. The wash
solution, usually deionized water, is the most serious contaminant. Sample pickup and delivery to the
ISE Module must be highly controlled and consistent.
Samples and calibrators are positioned in front of the electrodes by three peristaltic pumps. Two
separate pumps move Calibrant A and Calibrant B into the ISE Module’s sample entry port and a
waste pump positions samples and calibrants in front of the electrodes. The sample is deposited into
the sample entry port. After each sample measurement, calibrant is positioned in front of the
electrodes for a single-point calibration.

IUMv2.09.05 14-4
The removal of protein build-up on the electrodes and fluid path is accomplished by the use of
cleaning solution. Cleaning solution is placed in a cup on the host analyzer sample tray, aspirated,
and deposited into the sample entry port by the host analyzer.
14.5 Calibration Cycle

These millivolt readings are then used to set up a relationship between sample concentration and
electrode millivolt output. The change in millivolts per change in concentration is the slope of the
electrode. The slope of the electrodes is reported in mv/dec (millivolts per decade change in
concentration), and should be within the following limits:
Li+ 47-64 mV/dec

Na+ 52-64 mV/dec
K+ 52-64 mV/dec
Cl- 40-55 mV/dec
The ISE Module Calibration Cycle performs two successive calibrations. The slopes should be
repeatable within 1.5 mV/decade change; if not, a message error will be shown.
Typical slopes are approximately 55 mV/decade for Li+, Na+ and K+ and 45 mV/decade for Cl-.
In practice, electrode slopes may be higher than the ideally predicted value of 59.2 mV/decade at 25°
C. Higher operating temperatures, interfering ions and other factors can raise the observed slope
significantly.
The slope changes with temperature.
The slope of the electrodes is equal to (RT/nF) = 59.2 at 25° C, where R is the gas constant, T is the
temperature in degrees K, n is the valence of the ion, and F is Faraday constant. If all of the factors
are constant except T, one can calculate the ideal slope of the electrodes based on the temperature.
Some examples of predicted slopes vs. temperature are listed below.
Temp. (in deg. C) Slope (mV/decade)
20 58.2
22 58.6
24 59.0
26 59.4
28 59.8
30 60.2
32 60.6
If the module is calibrated at any temperature within its specification, and the same temperature is
maintained during sample analysis, no error in the measurement will occur. Errors will occur only
when calibration and sample analysis are performed at different temperatures.

IUMv2.09.05 14-5
As electrodes age, slopes will decrease. Lower limits for acceptable slopes are set at the lowest value
that insures good analyzer precision.
The values of slopes between calibrations performed successively (one after the other) should not
differ by more than 1.5 mV/decade for any of the channels, (Li+, Na+, K+, or
Cl-).
The calibration frequency should be once every 8 hours. A calibration should be performed after
each Clean Cycle, or if the QC sample results do not repeatedly fall within the proper ranges. The
analyzer will flag ISE results after the 8-hour interval is exceeded. Additionally, QC materials should
be run after each calibration to ensure the accuracy of sample results.
14.6 Clean Cycle
This cycle is used to remove protein build-up from the ISE Module electrodes. The ISE Module
positions cleaning solution in front of the electrodes for a period of time which will allow the enzyme
to remove protein build-up on the electrodes.
Once this is done, the ISE Module is then flushed with Calibrant A.
The Clean Cycle should be performed once per 24-hour period.
We strongly recommend that a Calibration Cycle be run after a Clean Cycle. We also recommend that
the Clean Cycle be run at the end of the day to give the electrodes extra time to stabilize after the
Clean Cycle. This is not required. However, users will experience slightly better performance if they
give the electrodes some time to stabilize after the Clean Cycle. It is also recommended that high
volume users run a Clean Cycle after every 50 serum samples.
14.7 Purge A Cycle

This cycle is used to purge Calibrant A solution through the tubing from the reagent kit to the ISE
Module.
The ISE Module pumps Calibrant A from the reagent kit through the ISE Module to wash out the flow
path.
14.8 Purge B Cycle

This cycle is used to purge Calibrant B solution through the tubing from the reagent kit to the ISE
Module.
The ISE Module pumps Calibrant B from the reagent kit through the ISE Module to wash out the flow
path.

IUMv2.09.05 14-6
14.9 Sip Cycle
Every 30 minutes after the last sample is run, the ISE Module will automatically run a Sip Cycle. The
Sip Cycle is used to keep the calibrants in the tubing fresh, and to refresh the Calibrant A in front of
the electrodes.
14.10 Off Cycle (Under Electrode replacement command)

This cycle is used to clear fluid from the flow path of the ISE Module, and to pause the Sip Cycle.
The ISE Module then runs the waste pump until the electrode flow path is cleared of fluid.
dispensed. If the electrodes are removed without initiating a Maintenance Cycle, a Sip Cycle may
occur and the 100 μL of Calibrant A will flow Cycle may occur and the 100 μL of Calibrant A will flow
into the empty module. This can cause significant damage to the ISE Module and/or other
surrounding components.
the KCl will clog the flow path. As soon as the electrodes are reinstalled, run a Purge A, Purge B or
Calibration cycle.
Warning: Do not turn off the analyzer by pressing general button unless maintenance cycle had
been done.
14.11 Pump Calibration Cycle

We recommend performing a Pump Calibration Cycle once per day. The Pump Calibration values of A
and B should be within the range 1500 to 3000.
14.12 Bubble Cal Cycle

The Bubble Cal command is used to allow the module to reestablish a baseline for detecting air-liquid
interfaces. It can also be used as a diagnostic tool to see if the bubble detector is functioning
properly.

IUMv2.09.05 14-7
14.13 Maintenance
Maintenance Schedule
The ISE Module has been designed to require very little operator maintenance.
14.13.1 Before starting daily operation
Allow the electrodes to be exposed to fluid for 15 minutes before calibrating.
Calibrate the ISE Module by clicking on the Bubble Cal button.

Click on the Pump Cal button.
If the results from the Module are unacceptable, refer to the Troubleshooting
Guide for assistance.
14.13.2 Daily Maintenance
The only daily maintenance required is to run the cleaning solution after the last sample of the day or
after 50 patient samples, whichever is first.
Clean the sample inlet port with a cotton swab and DI water once per month. All other parts and
expendables are replacement items (see schedule below). Use only Diconex approved components.
14.13.3 Shutdown Procedure
Preparing the ISE Module for Storage if the laboratory plans to store the ISE Module, the following
steps should be performed:
Before removing the electrodes, they should be cleaned using the cleaning solution and then 3 Purge
A cycles should be run.
Enter the Maintenance Cycle of the analyzer to purge the ISE Module fluid path.
Maintenance  Instrument  ISE Electrode replacement.
• Depress the compression tray and remove all electrodes, including the reference electrode from
the ISE Module.
• Place the Na+ and Cl- electrodes into individual sealed bags.
• Reinsert the Reference Electrode flow path line with yellow flag, if available, and then put into
individual sealed bags.

IUMv2.09.05 14-8
• Aspirate a small volume of Calibrant A from the top port of the reagent kit into a syringe fitted with
a blunt needle.
• Inject sufficient Calibrant A into the lumen of the K+ and Li+ electrodes until fluid fills the lumen.
• Cover both ends of the lumen (both sides of the K+ and Li+ electrodes) with tape to hold the
Calibrant A in place.
• Insert the K+ and Li+ electrodes into a sealed bag.
• Remove the reagent kit from the analyzer and discard.
• Remove all fluidic tubing and thoroughly rinse with DI water.
14.13.4 ISE Module re-activation
• Remove all electrodes from sealed bags.

• Remove tape from K+ and Li+ electrode.
• If necessary, soak the reference electrode in warm water until the lumen of the electrode
has been cleared of salt build-up.
• Install electrodes into the ISE Module.
• Connect new reagent kit to the ISE Module.
• Use Reagent Kit Replacement to prime the calibrants. Maintenance Instrument ISE 
Reagent Kit Replacement
• Calibrate ISE module. Maintenance  Instrument  ISE  Calibrate
14.14 Troubleshooting
Overview
To enhance trouble-free operation of the ISE Module, it is important to follow the recommended
component replacement schedule listed in the maintenance section of this manual.
When the ISE Module is not operating properly, approach troubleshooting as a logical sequence of
events. Isolate the problem area to avoid unnecessary component replacement and down time.
Troubleshooting can be categorized into three main areas.
These areas are:
fluid delivery, electrode stability, and communication.
Once your chemistry system is developed to a point that the communication is stable and the data
transmission is properly interpreted, troubleshooting should focus primarily on fluid delivery and
electrode stability. As these are related, sometimes the same symptoms can have different causes.
Most problems can be corrected while the ISE Module is still installed in your chemistry system.
Fluid Delivery

IUMv2.09.05 14-9
It is necessary to perform a Pump Calibration cycle each day. This cycle will calibrate the pumps that
dispense Cal A and Cal B, and position fluid in front of the electrodes. The waste pump moves
solution from the Sample Entry port to the electrode area for measurement. As the tubing ages and
samples are passed through the system, the positioning of the solution will change. The pump uses a
stepper motor that counts how many steps it takes to move the solution to the correct position.
By calibrating the pump each day, the ISE Module can now calculate the relationship between
volume and pump steps. This will enable the pumps to dispense an accurate volume of calibrant, and
for the solution to be accurately placed in the proper location for analysis.
Problems can be caused by a partial obstruction from a clot in the tubing from the exit tube to the
waste pump, a sharp bend in the waste tubing that restricts the flow, a misalignment of the
electrodes, or from too great a length of tubing from the exit tube to the waste pump. As the pump
tries to pull the fluid from the sample entry port into the electrodes, a vacuum develops because of
the restriction. The bubble detector detects the trailing edge of the solution (sample, calibrant, etc.)
and stops the waste pump so that the solution is in front of the electrodes. The vacuum will cause
the solution to travel after the pump stops.
One of the first indications of a flow problem will be the lithium electrode response.
If, however, the solution slowly moves out of the electrodes when the pump has not been activated,
there is either a leak between the electrodes, or along the flow path. This can be tested by placing
solution into the sample entry port by hand and watch to see if the fluid level changes. In either case,
the symptoms would be similar—the lithium or sodium millivolts would experience noise errors and
the bubble detector would trigger an error.
Electrode Stability
Errors associated with electrode instability typically include drift, noise, and slope failures. While
these errors may be caused by a failure of a particular electrode, it is necessary to explore other
causes as well. Proper operation on a daily basis is the key to keeping the electrodes stable and the
system working properly. Each day, it is necessary to perform a Cleaning Cycle. The cleaning solution
removes protein build-up in the flow paths of both the electrodes and the tubing. In high sample
volume instances, it may be necessary to perform this cycle more than once in a single day.
It is also necessary to replace the Reference Electrode every six months or when the red ball
indicator no longer floats in the internal electrode solution, whichever comes first. Failure to replace
the Reference Electrode at this interval will cause all three of the errors mentioned.
Ensure that the ISE Module is properly grounded.
Flow problem
Observation Probable cause Action

Low Slope Na+ or K+ Misalignment of the electrodes Remove electrodes.
<52 mV/decade
Cl- <40mV/decade, Inspect o-rings. Reassemble
Li+<47mV mV/decade or properly.
High Slope Na+, Calibrator solutions Replace Reagent Pack.
K+, or Li+>64 mV/decade

IUMv2.09.05 14-10
Cl- >55 mV/decade Electrode (low slope). Replace electrodes.
Air bubble on reference Remove electrode, tap to

electrode membrane. dislodge
bubble, replace, and
recalibrate.
Reference electrode. Replace reference electrode

and retest.
ISE Module or fluid temperatures Decrease the environment

exceed temperature.
32° C. (high slope).
Noise Error Flag Single Electrode. Replace problem electrode and
electrode. recalibrate.
Noise Error Flag Multiple Electrode. Replace reference electrode

electrode. and recalibrate.
Electrical noise spike from Contact Technical Support

environmental source.
Component failure on ISE Module Contact Technical Support

board.
Drift Error Flag Single May occur when new electrode Purge the Calibrant A and
Electrode or Calibrant A is installed. recalibrate the ISE Module.
If the electrode is new it may
initially drift as it rehydrates
over the course of 15 minutes.
Electrode. Replace the electrode and
recalibrate.
Drift Error Flag Multiple May occur when new electrode Purge Calibrant A and
electrodes or Reagent Kit is installed on recalibrate.
system.
Reference electrode. Replace reference electrode
and recalibrate.
Electrical spike from Contact Technical Support

Contact Technical Support
board.
Air in Sample Insufficient sample pipetted into Probe with some blocked
ISE Module sample entry port.
Bubbles in Sample. Sample must be free of bubbles.

IUMv2.09.05 14-11
Fluid leaks Contact Technical Support
Sample not positioned. Electrodes not seated properly.

Remove electrodes.
Inspect o-rings and reassemble.
Replace pump tubing.
Pump tubing obstructed. Replace pump tubing.

Air in Sample and Sample and Calibrant A are Electrodes are not properly
Calibrant A segmented with air. seated or compressed. Check
compression tray, spring, and
seal. Remove and reassemble
electrodes.
Fibrin or salt is plugging the Use Cleaning procedure.

electrode flow path.
Bubble detector is Remove electrodes and
malfunctioning. clean or replace electrode
with plugged flow path.
Reinstall electrodes and
recalibrate.
Waste pump is malfunctioning. Contact Technical Support
Air in Calibrant B and Air in Calibrant B and Calibrant A are Electrodes are not properly
Calibrant A segmented with air. seated. Check compression
tray, spring and seal.
Ensure that all electrodes and
o-rings are properly installed.
Ensure tubing between
reagent kit and sample
entry port is connected
properly.
Replace tubing between
reagent kit and sample
entry port.
Reagent low or out.
Fibrin or salt is plugging the Use Cleaning procedure.

IUMv2.09.05 14-12
electrode flow path. Remove electrodes
and clean or replace electrode
with plugged flow path.
Reinstall electrodes and
recalibrate.
Waste pump malfunction. Contact Technical Support
Bubble Detector malfunction. Contact Technical Support
Air in Calibrant A Calibrant A. Replace reagent kit with a new

one, prime, and recalibrate.
Tubing from reagent module is Reconnect or replace tubing.
disconnected,
plugged, or crimped.
Calibrant A pump is not working Contact Technical Support
properly.

IUMv2.09.05 14-13
15 MAINTENANCE PROGRAM
In order to ensure optimal performance and maximum useful life of the Autoanalyzer, it is important
to follow the cleaning and maintenance instructions outlined in this section.
15.1 Daily Maintenance

15.1.1 Before starting daily operation
1. Verify that the levels of the waste and washing solution containers are adequate to start with
the daily operation.
2. Run two diluter purge cycles, visually checking the absence of bubbles in the diluter body
Maintenance  Instrument  Diluter Purge
3. Run one wash cycle of the first 10 cuvettes, checking the absence of bubbles, and overflow of
the liquid in the cuvettes Operations  Wash cuvettes  Cuvette range  1 to 10  Wash
15.1.2 During the daily operation
1. Run the washing program every time the message appears on the instrument. Programmed
Washing  Execute
15.1.3 Upon finishing with the daily operation
1. Run one wash cycle of all the cuvettes: Operations  Wash cuvettes  All cuvettes 
Wash
Caution: If the daily work included turbidimetric techniques that utilize latex in the composition
of their reagents, perform a Special wash cycle of the cuvettes using special wash solution described
in chapter 16.
2. Run the cleaning of the TIP using a 30% commercial sodium hypochlorite solution in the
selected tube Maintenance  TIP Cleaning  OK
15.2 Weekly Maintenance
1. Run one wash cycle of all the cuvettes: Operations  Wash cuvettes  All cuvettes 
Wash
2. Run two diluter purge cycles Maintenance  Instrument  Diluter Purge

IUMv2.09.05 15-14
3. Calibrate all the cuvettes Maintenance  Instrument  Calibration  select Calibrate
cuvettes  Range 1 to 100  select the position of the solution to use ex: Use container 
OK
15.3 Monthly Maintenance

15.3.1 External washing of cuvettes
1. Turn off the instrument.

2. Remove all the cuvette strips, unscrewing the metal nuts.
Caution: avoid dropping the metal nuts into the interior of instrument during this procedure.
3. Wash the external part of the cuvettes under the faucet with detergent and plenty of water.
Rinse with plenty distilled water.
4. Dry the external part of the cuvettes gently with paper towel.
Caution: avoid scratching or leaving traces of paper inside the cuvettes during this procedure.
5. Place the cuvette strips on the tray, tightening securely the metal nuts.
6. Turn on the instrument.
7. Run one wash cycle of all the cuvettes Operations  Wash cuvettes  All cuvettes  Wash
8. Run two diluter purge cycles Maintenance  Instrument  Diluter Purge
9. Calibrate the photometer and all the cuvettes Maintenance  Instrument  Calibration 
select Calibrate photometer  select Calibrate cuvettes  Range 1 to 100  select the
position of the solution to use ex: Use container  OK
15.3.2 General washing of the instrument
1. Washing the containers: disconnect the waste and washing solution tubes and clean the
containers with plenty of water. Washing solution container: rinse with distilled water.
Waste container: rinse with commercial sodium hydrochloride 30% solution and plenty of
water.
2. Cleaning the reagent tray: turn off the instrument and the reagent refrigeration. Remove all
the reagent bottles and clean the reagent tray and sample tray with a damp cloth.
3. Cleaning the cuvette tray: clean the black surface of the cuvette tray with a damp cloth.
4. Cleaning externally: with a damp cloth, clean the external covers, lids, hood of the pipetting
arm.
Caution: the instrument needs to be turned off during this procedure. Take care not to spill
liquids on the instrument.
5. Cleaning the tip externally: clean the tip from top to bottom with paper towel dipped in
isopropyl alcohol.

IUMv2.09.05 15-15
Caution: When performing this procedure, avoid removing the PTFE cover of the volume
sensor probe.
15.3.3 Back-up of files in use
1. Select Methods  Save  an explore window will open  select the back-up file
destination for a removable drive, ex. USB (E:)  name the method file in use as methods
yymmdd.adb, where yy is the year, mm the month and dd the day for the date of the back-up
 Save
2. Repeat the same procedure for the calibrator and control files by going to the Calibrator and
Control menus.
3. Back-up methods, calibrators and controls files when these are configured for the first time
or whenever configuration changes are made.
4. Select Maintenance Menu  Settings  Enter password  Database tab  press Database
Copy  select the folder where the data will be saved  Copy
Figure 15-1
15.4 ISE Module Maintenance Program (Optional)
15.4.1 Recommended Component Replacement Schedule (low volume user)
Li+ Electrode
Pump Tubing
Na+ Electrode
K+ Electrode
Cl- Electrode
Reference Electrode

IUMv2.09.05 15-16
Fluidic Tubing 12 months
15.4.2 Recommended Replacement Schedule (high volume user)
(Greater than 100 samples per day)
Li+ Electrode 3,000 samples

Pump Tubing 6 months
Na+ Electrode 10,000 samples
K+ Electrode 10,000 samples
Cl- Electrode 10,000 samples
Reference Electrode 10,000 samples
Fluidic Tubing 12 months
15.5 Maintenance according to programmed alarms

15.5.1 Maintenance Levels according to cycles of use counters
The analyzer has implemented a system that keeps track of the its own cycles of use. These systems
keep record of the work performed by certain parts of the analyzer. This inteligent system allows to
have a maintenance program based on the type of user and not on a time schedule. So once a
certain limit is reached the system will show a window on the screen posting that a maintenance
level has been reached. At this moment the user must call technical service to perform the necessary
maintenance procedures.
The system involves three independent cycles of use counters: one for the hours of work, other for
cycles of use or tests performed, and a third one for lamp hours of use.
This allows the maintenance program to be acorrding to the volume of work that each user in
particular handles.
Figura 15-2
Warning: This message will continue showing until the established maintenance is done, if
they’re not properly done the performance of the analyzer will be affected, and failures may occur.
Warning: The maintenance must be done by Diconex trained personnel. Contact authorized
technical support for this purpose.

IUMv2.09.05 15-17
There are two maintenance levels: 1 and 2. Next we detail the procedures carried out during these
maintenances.
15.5.2 Maintenance Level 1
15.5.2.1 Disinfecting the reagent tray
1. Turn off the instrument and the refrigeration of the reagent tray
2. Remove all the reagent flasks
3. Pour a 30% Sodium Hypochlorite solution in all the compartments of the reagent tray
4. Leave the solution for 30 minutes
5. Wash with water, avoiding splatters
NOTE: If necessary, repeat step 5.
15.5.2.2 Disinfecting the tubings and cleaning of the containers
1. Remove the tubings from the probe and cuvettes containers (NOTE: do not
disconnect the tubings from the plastic connector, remove the filters)
2. Place the filters in a container with 30% Sodium Hypochlorite solution and leave for
one hour
3. Place the filters back into the tubings and place the tubings in a container with 30%
Sodium Hypochlorite solution
4. Purge the diluter twenty times
5. Wash all cuvettes twice (1 to 100)
6. Leave for one hour
7. Cleaning of the containers:
Washing solution containers: rinse with plenty DI water
Waste container: rinse with a 30% Sodium Hypochlorite solution and then rinse with
plenty DI water.
8. Prepare new probe and cuvettes washing solutions
9. Remove the tubings from the Sodium Hypochlorite solution and rinse the extremes
with DI water
10. Remove the filters from the Sodium Hypochlorite solution and rinse with plenty DI
water
11. Connect the tubings back to the washing solution containers (make sure probe
tubings go to probe container, and cuvettes tubings go to cuvettes container)
12. Purge the diluter thirty times
13. Wash all cuvettes three times (1-100)
14. Calibrate photometer and cuvettes

IUMv2.09.05 15-18
15.5.2.3 General cleaning of the instrument
1. Cleaning of the SR tray: turn off the analyzer and the reagent cooling system,
remove all reagent bottles and clean with a dump cloth.
2. Cleaning of the cuvettes tray: using a dump cloth clean the black surface of the
cuvettes tray.
3. External cleaning: with a dump cloth clean the external covers of the analyzer (gray
and orange covers)
Warning: the analyzer must be off during this procedure. Do not spill fluids on
the instrument.
4. External cleaning of the tip: with a tissue embed in isopropilic alcohol clean the
exterior of the probe from up to down.
Warning: avoid removing the teflon covering the volumen sensor of the probe
during this procedure.
15.5.2.4 Axes lubrication
15.5.2.5 Cleaning of the washer circuit filter
15.5.2.6 Replacement of the teflon seals in the piston pump
15.5.2.7 Flushing Pump Membrane replacement
15.5.2.8 Diluter Liquid Diaphragm Pump Membrane replacement

IUMv2.09.05 15-19
15.5.3 Maintenance Level 2
15.5.3.1 Disinfecting the reagent tray (see item 15.5.2.1)
15.5.3.2 Disinfecting the tubings and cleaning of the containers (see item 15.5.2.2)
15.5.3.3 General cleaning of the instrument (see item 15.5.2.3)
15.5.3.4 Axes lubrication
15.5.3.5 Cleaning of the washer circuit filter
15.5.3.6 Replacement of the teflon seals in the piston pump
15.5.3.7 Flushing Pump Membrane Replacement
15.5.3.8 Diluter Liquid Diaphragm Pump Membrane Replacement
15.5.3.9 Cuvettes replacement
1. Turn off the analyzer.

2. Remove the metal nuts that hold the cuvette strips. Remove all cuvette strips.
Warning: avoid the metal nuts fall inside the analyzer during this procedure.
3. Place the new cuvette strips and adjust the metal nuts properly.
4. Turn on the analyzer.
5. Purge the Diluter(Maintenance  Instrument  Diluter Purge)
6. Calibrate all cuvettes (Maintenance  Instrument  Calibration  select Calibrate
Cuvettes  Range 1 a 100  select the position of the solution that will be used for
calibration Ex.: Use Container  Calibrate)

IUMv2.09.05 15-20
15.6 Maintenance according to need
15.6.1 Database Initialization (every 10.000 determinations)
1. Select Maintenance Menu  Settings  Enter password  Database Refresh Statistics

In the lower part of the tab, are shown the numbers of patients, calibrators, and controls
samples for the database in use. The Total is also shown, with the inclusion of the previous
results. In the adjacent box the Total value corresponds to the sum of all the determinations in
the database in use. These numbers are updated with the Refresh Statistics command
Before the total number of determinations reaches the 10.000, the database must be initialized:
steps 2), 3) and 4)
Figure 15-3
2. Select Maintenance Menu  Settings  Enter password  Database Export results 

select the folder where the data will be saved. Name the file as results yymmdd.csv, where yy
is the year, mm is the month and dd is the day for the date of the back-up. Press Save and a
window will open for selecting the type of results to be saved: patient, calibrator and control
results. Select all the options and press Export. The next window allows the selection of the
entire database or just a range given by the date and the hour, or the process numbers
(initial and terminal) to use for saving the information. For the entire database select the
option All.
3. Select Maintenance Menu  Settings  Enter password  Database tab  press Database
Copy  select the folder where the data will be saved  Copy (this process may take

IUMv2.09.05 15-21
several minutes, the interruption of the process may cause the corrumption of the file
created)
4. Select Maintenance Menu  Settings  Enter password  Database  Initialize: this is

where the Patient results, Calibrators and Controls results are all erased
The last calibration is saved in the methods configuration, and the configuration dates of the
calibrators, controls and methods are not modified.
5. Press Yes in this tab, close and open software.
15.6.2 Replacing the light bulb
1. Turn off the instrument.

2. Remove the lids of the trays.
3. Remove the main cover
4. Remove the dissipater, removing the two screws manually.
5. Disconnect the lamp from the air connector by loosening the fastening screw. Remove the
light bulb.
6. Install the new light bulb, positioning the filament horizontally.
Caution: hold the light bulb by the base and don’t touch the glass of the bulb. Tighten the screw
slightly and proceed with the adjustment of the focal distance.
Caution: the filament should always be in a horizontal position. Once the proper adjustment has
been made, secure the position of the light bulb with the fastening screw.
7. Reconnect the lamp to the air connector.

8. Place back the dissipater
9. Turn on the instrument.
10. Start up the photometer Maintenance  Communications  Console of commands 
select photoInit  Execute
11. Select a visible wavelength range, ex. 546 nm Maintenance  Communications  Console
of commands  select photoSetFilter  Parameters enter 546  Execute
Remove the part of the cuvette in the optical path and place a white piece of paper against
the lens of the photometer. Adjust the position of the lamp such that the filament can be
seen sharply against the paper. In case of being necessary to fit the focal length moving the
lamp, without rotating it (to be able to maintain the filament in horizontal position), It must

IUMv2.09.05 15-22
look for to focus the beam in the center of the optical path of the cuvette. Once obtained the
adjustment, fix the lamp.
12. Place back the main cover and lids
13. Run a calibration of the photometer and all the cuvettes Maintenance  Instrument 
Calibration  select Calibrate photometer  select Calibrate cuvettes  First cuvette 1 
Last cuvette 100  select the position of the solution to use for the calibration ex: Use
container  Calibrate
Dissipater
screws
Dissipater
Figure 15-4
Silicon Grease
Light bulb
Fastening screw
Air Connector
Figure 15-5

IUMv2.09.05 15-23
15.6.3 Cuvettes Replacement (see item 15.5.3.8)
15.6.4 Interferential filters replacement
a. Turn off the analyzer, remove the lids and the main cover of the autoanalyzer to have access
to the photometer, located on the right back side.
b. Remove the photometer’s dissipater.
c. Spot the interferential filter to be replaced and manually turn the filter’s wheel clockwisely to
find and to easily remove the interferential filter holder from the filter wheel.
d. Place the holder with the new filter in the filter wheel.
Filter holder
Figure 15-6
e. Place back the lids and main cover, switch on the equipment.
f. Run a calibration of the photometer and all the cuvettes Maintenance  Instrument 
Calibration  select Calibrate photometer  select Calibrate cuvettes  First cuvette 1 
Last cuvette 100  select the position of the solution to use for the calibration ex: Use
container  Calibrate
15.6.5 Sample / Reagent probe replacement
a. Keep the equipment off, remove the hood of the probe arm.
b. Disconnect the Teflon tubing from the hydraulic connector.

IUMv2.09.05 15-24
Teflon tubing
Fixing screws
Figure 15-7
c. Disconnect the connector from PCB and remove the fixing screws on the PCB. To remove the
Sample / Reagent probe remove the PCB
Figure 15-8
d. Replace the Sample / Reagent probe. The new probe has a polarizing pin to make assembly
easier.

IUMv2.09.05 15-25
Pin
Figure 15-9
e. Assembly the PCB and connect the Teflon tubing.

f. Perform several purge cycles and check that there is no leak.
Caution: when assembling check the following items for proper replaces
Check distance I is the same as distance II

IUMv2.09.05 15-26
Figure 15-10
Check angle of 90 º
Figure 15-11
Correct form

IUMv2.09.05 15-27
Figure 15-12
Incorrect form
Figure 15-13
15.6.6 Replacing the ignition fuses
1. Turn off the instrument

2. Remove the feed cable from the line filter
3. Remove the lid of the fuse-box located in the upper part of the line filter
4. Remove the burnt fuses and replace them with new ones
5. Replace the lid of the fuse box
6. Reconnect the feed cable to the line filter
7. Turn on the instrument
15.6.7 Special Wash
1. Fill a single mouth reagent container with special washing solution (see chapter 16 point 16.3
and 16.4)
2. Place the container in the reagent tray
3. In the Wash cuvettes screen, select Special Wash and enter in Reagent Pos. the position of
the container
4. Press Wash

IUMv2.09.05 15-28
5. Once the special wash is finished, the cuvettes are ready to be used as usual
15.6.8 Replacing o-rings of piston pump
15.6.9 Replacing filters of washing system
15.6.10 Electrode replacement (For analyzers with ISE Module installed)
This cycle is used to clear fluid from the flow path of the ISE Module and to pause the Sip Cycle.
dispensed. If the electrodes are removed without initiating this maintenance Cycle, a Sip Cycle may
occur and the 100 μL of Calibrant A will flow into the empty module. This can cause significant
damage to the ISE Module and/or other surrounding components.
the KCl will clog the flow path. As soon as the electrodes are reinstalled, run a Calibration command.
 Press electrode replacement command (module will be off and the lock stick will be release)
 Press the lock stick
 Move up the ISE module
 Depress the compression tray.
 Remove or/and install electrodes in positions
 Install electrodes into the ISE Module (electrode position as shown in Figure 15-9)
 Run reconnect command
 Run Start Up procedure
 Calibrate the module

IUMv2.09.05 15-29
Figure 15-14
15.6.11 Replacing ISE peristaltic pumps tubings (For analyzers with ISE Module
installed)
Figure 15-15
1- Remove the reaction Tray cover.

2- Visualize the front black plate supporting the three peristaltic pumps and remove the tubing
connection from the yellow connectors.
3- Remove the Peristaltic Pumps to release the Peristaltic Tubing.

IUMv2.09.05 15-30
16 PREPARING SOLUTIONS
16.1 Washing solution
Warning: Containers must be placed under the level of the analyzer, never on the same
level.
16.1.1 Washing solution for probe and cuvettes
First, Wash Concentrate Solution (mother solution) has to be prepared from Solution of Triton X-
100, this concentrate solution will be used to prepare washing solution for probe and cuvettes.
Wash Concentrate (mother solution): dilute 1 part v/v of Triton X-100 in 9 parts of distilled water,
Ex: 100 ml Triton X-100 in 900 ml of distilled water.
The Triton X-100 is extremely viscous. It is suggested to pour the desired quantity into a graduated
cylinder and gradually add the water. Heat the distilled water to 70 – 80 ºC to help dissolve the Triton
X-100.
Washing solution for probe and cuvettes: dilute 7 ml of the mother solution in 1 liter of distilled
water. Ex: 140 ml of wash concentrate for 20 liters of distilled water.
16.1.2 Washing solution for probe and cuvettes when running turbidimetric
methods
In those cases where latex reagents are used, is highly recommended to use the following
washing solutions:
Washing solution for probe: use distilled water alone
Washing solution for cuvettes: dilute 3 ml of wash concentrate in 1 liter of distilled water. Ex: 70 ml
of wash concentrate for each 20 liters of distilled water.
Warning: not following the instructions given above will affect the results.

IUMv2.09.05
16-1
16.2 TIP cleaning solution
Use a 30% commercial sodium hypochlorite solution (bleach solution)
16.3 Special washing solution for maintenance according to need

Use 0.2 Normal sodium hydroxide. Weigh out 8 gr. of dry sodium hydroxide and dissolve it in 1 liter
of distilled water.
16.4 Special washing solution for turbidimetric techniques with latex

Use 2 Normal sodium hydroxide. Weigh out 80 gr. of dry sodium hydroxide and dissolve it in 1 liter of
distilled water.
16.5 Disinfecting solution

Use a 30% commercial sodium hypochlorite solution

IUMv2.09.05 16-2
17 TROUBLESHOOTING
17.1 Introduction
This chapter gives instructions and guides for isolating and identifying problems quickly. In the
majority of cases the users will be able to find and fix the problem themselves, and resume the daily
workload. When this is not possible, contact the Technical Support.
For identifying and solving problems, the user should be familiar with the theory of the instrument
operation, the operating procedures, the maintenance procedures, and the fundamentals of the
chemical test methods described in this Manual.
The primary responsibility of the operator in the resolution of problems falls into the following
categories:
- Preparation and storage of reagents

- Preparation and location of samples
- Basic operation of the instrument
- General operation of the software
- General maintenance and replacement of basic components
Problems can be divided into two major groups:
Chemical problems
Instrumental problems
If it becomes necessary to call the Technical Support in order to solve a chemical or instrumental
problem, have ready the following information:
Chemical problems:
- Serial number of the instrument

- Methods affected
- Description of the problem
- Expiration date for the reagents, calibrators and controls in use
- Absorbance information for the last run calibration
- Absorbance information for the last run blank
- Patient results affected
- Error messages reported by the instrument for the methods affected
Instrumental problems:
- Serial number of the instrument

- Description of the problem
- Error messages reported by the instrument

IUMv2.09.05
17-1
- Information about the last maintenance procedures run on the instrument
- Log file for the day
Having this information ready will help solve the problem more quickly.
How to find the log file for the day
Log files are located in a particular folder in the computer, and they’re named by the date the file
was created.
To know which folder is keeping the log files go to Maintenance -> Settings -> Files and look for the
path indicated under Log File Folder.
Figure 17-1
Once located the path, minimize InCCA software. Search for the folder indicated in the path. Once
located the folder, look for the type of files log.html. They are identified by year, month and day (for
example, the file from day 21 of August 2007 will have the name: 2007-08-21.log.html).
Figure 17-2

IUMv2.09.05 17-2
Once the file is located, send it by mail to technical support or follow the instructions by them
given.
17.2 Chemical Problems

Chemical problems may appear with an error message along with the results, or by unexpected
results for the processed samples. They may appear in the following situations:
- Calibration errors
- Alarms with control or patient results
- Quality control results outside the defined ranges
- Unexpected patient results
From the results obtained from the method calibration, quality controls, and patient samples tested,
decide which of the following conditions best describe the problem encountered and run the checks
and actions associated with each case:
- High results
- Low results
- Erratic results
- Only one affected sample for all the methods
- Only one affected method for all the samples
17.2.1 High results

Incubation temperature > High cuvette tray temperature Contact Technical Support
37ºC High ambient temperature Reduce the ambient temp to <
25 ºC
Low calibrator absorbance Incorrect preparation of the Use a calibrator reconstituted
results calibrator dilution correctly
Presence of bubbles or fibrin in Use a calibrator free of bubbles
the calibrator tube and/or fibrin
High blank reagent absorbance Verify the blank reagent
Insufficient calibrator volume Use a minimum volume of 200
µl
Samples concentrated by Insufficient sample and control Use a minimum volume of 200
evaporation volumes µl
Inadequate sample and control Use fresh samples and controls
storage
Deteriorated reagent Inadequate reagent preparation Prepare new reagent
Refilled reagent not Mix the reagent gently and

IUMv2.09.05 17-3
homogenized, or not checked verify the blank
Avoid foaming
Physical and/or chemical Prepare new reagent
deterioration of the reagent
Incorrect information in Calibrator concentration Configure the calibrator
the cc of the calibrator configured incorrectly concentration correctly
Incorrect aspiration or Losses in the diluter circuit Adjust connections and purge
dispensing of samples and connections the diluter
reagents Obstruction of the TIP Purge the diluter
Run a TIP cleaning
Bubbles in the tubing or diluter Adjust connections and run a
TIP cleaning
Sensing failure See error solving 109
Insufficient reagent Reagent volume less than 2 ml or Refill the reagent bottle or
volume or bubbles into more than 55 ml change it without any bubbles
the reagent bottle Inadequate purge of the Purge the diluter
hydraulic system Purge the washer
17.2.2 Low Results

Incubation temperature < Low cuvette tray temperature Contact Technical Support
37ºC Low ambient temperature Increase the ambient temp to >
15 ºC
High calibrator absorbance Incorrect preparation of the Use a calibrator reconstituted
results calibrator dilution correctly
Low blank reagent absorbance Verify the blank reagent

Inadequate samples Insufficient sample and control Use a minimum volume of 200
volumes µl
Presence of bubbles or fibrin in Use samples free of bubbles
the sample tubes and/or fibrin
Absence of the sample in the Place the samples in the correct
assigned position positions
homogenized, or not checked verify the blank
Avoid foaming
Physical and/or chemical Prepare new reagent and verify
deterioration of the reagent the blank
Incorrect information in Calibrator concentration Configure the calibrator
the configuration of the configured incorrectly concentration correctly
calibrator

IUMv2.09.05 17-4
reagents Obstruction of the TIP Purge the diluter
Run a TIP cleaning
TIP cleaning
17.2.3 Erratic Results

Incorrect information in Incorrect type of reaction chosen Select the correct type of
the method configuration for each method reaction
Method parameters configured Configure the parameters
incorrectly adequately
Incorrect calibration Calibrator concentration Configure the calibrator cc
configured incorrectly correctly
Inadequate samples Sample volumes less than 200 µl Use a minimum volume of 200
µl
Presence of bubbles or fibrin in Use samples free of bubbles
the sample tubes and/or fibrin
Absence of the sample in the Place the samples in the correct
assigned position positions
Presence of air in the Incorrect purge of the diluter Purge the diluter
hydraulic system circuit
Incorrect purge of the washer Purge the washer
circuit
Insufficient washing solution Refill the washing solution and
purge the hydraulic system
completely
Dirty cuvettes Maintenance program did not Run the remaining maintenance
finish completely operations
Contamination of the cuvettes Run a special wash cycle with
NaOH
0.2 N (See Chapter 7 point 7.7)
Failure of the washing and/or Contact Technical Support
drying of the cuvettes
Failure of the optical Burned lamp Replace the lamp
system Deteriorated cuvettes Replace the cuvettes

IUMv2.09.05 17-5
Inadequate calibration of the Calibrate the photometer
optical system Calibrate the cuvettes
Contamination of the Prolonged non-use of the Run a decontamination process
circuits instrument
Erratic incubation Erratic cuvette tray temperature Contact Technical Support
temperature
reagents Obstruction of the probe and/or Purge the diluter and run a TIP
of the pre-heater cleaning
TIP cleaning
17.2.4 Only one affected sample for all of the methods

Incorrect sample position Sample incorrectly positioned Place the sample in the correct
position
Incorrect control Incorrect assignment of the Configure the controls
configuration concentrations limits to the concentrations limits correctly
controls
Incorrect selection of Selection of methods inadequate Select the correct methods for
methods for the type of sample the type of sample
Incorrect preparation of Sample reconstituted with an Reconstitute a new vial
the sample inadequate volume or poorly correctly
homogenized
Sample diluted incorrectly Dilute the sample correctly
Inadequate sample Insufficient volume Use a minimum volume of 200
integrity µl
Inadequate storage Use fresh or well preserved
samples
Presence of bubbles and/or fibrin Use a sample free of bubbles
in the sample tubes and fibrin
Presence of sample Use a new sample free of
interferences: hemolysis, interferences
jaundice, lipemic specimen,
turbidity
17.2.5 Only one affected method for all of the samples

IUMv2.09.05 17-6
the reagent bottle
Inadequate reagent Incorrect positioning of the Assign the reagent position
reagent in the tray correctly
Inadequate reagent container Use only the reagent bottles
designed for the instrument
Dirty reagent bottles Wash the reagent bottles
periodically
Insufficient reagent volume Refill the reagent bottle
homogenized, or not verified verify the blank
Avoid foaming
Physical and/or chemical Prepare new reagent and verify
deterioration of the reagent the blank
Incorrect information in Incorrect type of reaction chosen Select the correct type of
the configuration for the method reaction
Method parameters configured Configure the parameters
incorrectly adequately
Incorrect assignment of the Configure the controls
concentrations limits to the concentrations limits correctly
controls
Inadequate calibration Calibrator concentration Configure the calibrator cc
configured incorrectly correctly
Incorrect preparation of the Use a calibrator reconstituted
calibrator dilution correctly
Incorrect blank reagent Verify the blank reagent
absorbance
Incorrect calibrator absorbance Calibrate the method
Message of a re-diluted Linearity configured incorrectly Configure the linearity
result or re-dilute correctly: a value between 0.80
manually with results y 0.95
within the linear limit Initial consumption configured Configure the method’s initial
incorrectly consumption correctly
17.3 Instrumental Problems
Instrumental problems may appear with visible failures in its components or by malfunction errors
that are shown up in the software. As well, instrumental problems may often be inferred from the
analysis of observed chemical problems.

IUMv2.09.05 17-7
Based on these observations, instrumental problems can be grouped according to the affected
module or component of the instrument. Decide which of the following components is probably
affected and run the associated checks and actions in each case:
- Connections and supplies

- Hydraulic system
- Washer
- Diluter
- Sample/Reagent probe
- Reaction cuvette tray
- Sample/Reagent tray
- Software
If this does not solve the problem, contact Technical Support
17.3.1 Connections and supplies

Failure in the start up of Instrument disconnected Plug the cable into the power
the instrument source
Burnt out start up fuse Replace the fuses
No electricity from the power Reestablish the electricity
source
Damaged start-up button Contact Technical Support
Failure in the PC- Instrument turned off Turn on the instrument
instrument Instrument turned off and on Run initialization procedure
communication without initialization procedure
Invalid communication port Close all open applications that
might be using the
communication port and re-
open the software
PC disconnected from the Connect the PC-instrument
instrument communication cable
17.3.2 Hydraulic system

Presence of bubbles/air in Connections adjusted Adjust the connections
the tubing inadequately Purge the diluter
Partial obstruction of the probe Purge the diluter
Run a TIP cleaning cycle
Incorrect purge of the diluter Purge the diluter
circuit

IUMv2.09.05 17-8
Incorrect purge of the washer Wash cuvettes
circuit
Insufficient washing solution Refill the wash solution and
purge the diluter five times and
wash cuvettes
Overflowing of the probe Drain hose bent or obstructed Straighten or un-obstruct the
wash station drain hose
Presence of water under
the instrument
17.3.3 Diluter

Presence of bubbles or air Connections adjusted Adjust the connections
in the diluter inadequately Purge the diluter
Damaged tubing Contact Technical Support
Blocked probe Run a TIP cleaning cycle
Purge the diluter
17.3.4 Washer

Colored dryer tips Washer failure Contact Technical Support
Horizontal movement of Washer head adjusted incorrectly Contact Technical Support
the washer head
Dripping washer tips Washer failure Contact Technical Support
17.3.5 Sample/reagent probe

Dripping probe Blocked probe Run a TIP cleaning cycle
Purge the diluter
Pre-heater failure Contact Technical Support
Faulty connections Contact Technical Support
Unusual noise with Presence of bubbles between the Clean the probe tips with paper
upward movement two ends of the probe towel dipped in ethyl alcohol
Purge the diluter
Damaged probe: Collision of the probe Contact Technical Support
aspiration tip and sensor
tip of the same length
Probe and its capillary Adhesion of remains of samples Clean the exterior of the probe
dirty and/or reagents with paper towel dipped in
ethyl alcohol

IUMv2.09.05 17-9
Purge the diluter
17.3.6 Reaction Cuvettes Tray

Formation of crystals in Incomplete run of the wash Run an external wash and
the upper part of the program calibration of the cuvettes
cuvettes
Presence of water on the Inadequate purge of the washer Purge the washer 5 times
cuvette strips Insufficient washing solution Refill the washing solution
Presence of bubbles in the container and purge the diluter
cuvettes during the wash and washer five times
Air entering the tubing Check the connection of the
hoses to the washing solution
container
Purge the washer
Damaged/opaque Prolonged use Change the cuvettes and
cuvettes calibrate them
Cuvettes still dirty after Washer failure Contact Technical Support
washing
17.3.7 Sample/Reagent Tray

No refrigeration of the Refrigeration unit turned off Turn on unit
reagents
Refrigeration system failure Contact a Technical Support
Presence of dark stains in Fungal contamination Disinfect with 33% sodium

the reagent tray hypochlorite for 30 minutes
Unusual noises Mechanical failures Contact Technical Support
17.3.8 Software

Error message: Processing Attempt to make an operation Press Retry, if this does not
error # Process outside of the specified time correct the error, press Cancel
xxxxxxxxxxx (Time out) Retry the operation
Retry/Cancel Contact Technical Support

IUMv2.09.05 17-10
Results expressed as a nan Error in the calculation of the Verify settings methods, the
(not a number) calibration or the sample result blank reagent and recalibrate
the method
Failure to update a Calibration made with the Recalibrate with the method
calibration method setting screen open setting screen closed or edit the
value obtained for the
calibration
Error message: The Instrument turned off Turn on the instrument
instrument cannot be Instrument turned off and on Run initialization procedure
initialized without initialization procedure
Burnt out start up fuse Replace the fuses
No electricity from the power Reestablish the electricity
source
Damaged Analyzer on/off button Contact Technical Support
Instrument disconnected Plug the cable into the power
source
Invalid communication port Close all open applications that
might be using the
communication port and re-
open the software
PC disconnected from the Connect the PC-instrument
instrument communication cable
Mechanical failure Contact Technical Support
For any problem other than those described here, contact exclusively the Technical Support
authorized by Diconex S.A.
17.4 Hardware Messages

Error messages will be displayed on the screen like this:
Figure 17-1

IUMv2.09.05 17-11
+
Figure 17-2
There are two types of messages:
 Error messages, this error stops the running (Figure 17-1)

 Warning messages, this is just a warning, it will not stop the running (Figure 17-2)
This kind of flags report the Message ID number (the number between (xxxx)) and a brief description
of the problem.
Below, there’s a list with all the Hardware Messages, including a probable cause and a possible
solution.
NOTE: This tool is useful in most cases, but it is not a definitive solution for all the problems.
START UP
Message ID Number and Probable cause Possible Solution

Description
(0001) The Analyzer has The analyzer has been powered on Execute the command to initialize
been powered on. An with software session active. or wait for software automatic
initialization sequence initialization sequence.
will be required
(0002) A general power The Analyzer general power has Long term general power
down happened to the been interrupted. interruptions will affect the ISE
Analyzer, it could affect electrodes life expectancy and
the ISE module performance. Avoid using the
performance. Please general power key. Purge,
purge, calibrate and calibrate and control the ISE
control it module.
EEPROM

Description
(0031) EEPROM writing Wrong direction or defective Contact Technical Support.
error EEPROM

IUMv2.09.05 17-12
(0032) EEPROM reading Wrong direction or defective Contact Technical Support.
error EEPROM
(0033)EEPROM writing Enabling command not executed Contact Technical Support.
disabled
(0034) EEPROM erasing Defective EEPROM Contact Technical Support.
error
(0035) EEPROM Defective EEPROM Contact Technical Support.
absorbances clearing
error
(0036) EEPROM writing Wrong Direction Contact Technical Support.
error (variable does not
exist)
(0037) EEPROM reading Wrong Direction Contact Technical Support.
error (variable does not
exist)
VERTICAL

Description
(0101) Probe Impact Physical impact Verify possible obstacles along the
(Vertical Movement) path of header movement.
Impact switches failures Contact Technical Support.
(preheater board)
Poor contacts Contact Technical Support.
(0102)Probe Vertical Home sensing Failure Contact Technical Support.
Movement not initialized
Mechanical failure Contact Technical Support.
or initialization error
(Home active) Vertical movement not initialized. Execute the commands to initialize
the movement
(0103)Probe Vertical Sensing failure home Contact Technical Support.
or initialization error Mechanical failure Contact Technical Support.
(Home inactive) Vertical movement not initialized Execute the commands to initialize
the movement
(0104) Probe Vertical Home sensing failure Contact Technical Support.
Movement error (Home Mechanical failure. Contact Technical Support.
not found)
(0105) Probe vertical Home sensing failure Contact Technical Support.
movement error (Home
active)
(0106) Upgrade Vertical Controller old version. Contact Technical Support.
Movement Controller
(0107) Probe level not Wiring failure Contact Technical Support.
detected(level inactive) Probe failure. Contact Technical Support.

IUMv2.09.05 17-13
Preheater PCB failure Contact Technical Support.
(0108) Probe Impact See error solving 101 and 109.
(Vertical Movement) and
incorrect Probe Level
Detection (Level active)
(0109) Incorrect Probe Sensing failure Clean the probe in case of possible
Level Detection (Level dirtiness or a drop between the
active) auxiliary and the main capillary.
Probe failure Contact Technical Support.
Module preheater failure Contact Technical Support.
Wiring failure Contact Technical Support.
HORIZONTAL

Description
(0151) Probe impact Physical impact Verify possible obstacles in the
(Horizontal Movement) movement
Impact switches failures Contact Technical Support.
(preheater board)
(0152) Probe Horizontal Home Sensing failure Contact Technical Support.
or initialization error
(Home active) Horizontal movement not Execute the command to initialize.
initialized
(0153) Probe Horizontal Home sensing failure Contact Technical Support.
or initialization error Mechanical failure Contact Technical Support.
(Home inactive) Horizontal movement not Execute the command to initialize.
initialized

Movement error (Home
active) Mechanical failure Contact Technical Support.

Movement error (Home
inactive)
(0156) Upgrade Old Controller version. Contact Technical Support.
Horizontal Movement
Controller
REACTION TRAY

IUMv2.09.05 17-14
Description
(0201) Probe Impact Physical impact Verify possible obstacles in the
(Reaction Tray) movement.
Impact switches failure (preheater Contact Technical Support.
board)
(0202) Reaction Tray not Home sensing failure Contact Technical Support.
initialized or initialization Mechanical failure Contact Technical Support.
error (Home active) Reaction tray not initialized Execute the command to initialize.
(0203) Reaction Tray not Home sensing failure. Contact Technical Support.
initialized or initialization
error (Home inactive) Mechanical failure Contact Technical Support.
Reaction tray not initialized. Execute the command to initialize.
(0204) Reaction Tray not Module not initialized. Execute the command to initialize.
initialized
(0205) Reaction Tray Home sensing error. Contact Technical Support.
error (slotted tray
counting error) Mechanical failure. Contact Technical Support.
Sensor P out of counting position. Contact Technical Support.
(0206) Reaction Tray Mechanical failure Contact Technical Support.

error (Home active) Sensing failure Contact Technical Support.
(0207) Reaction Tray Mechanical failure. Contact Technical Support.
error (Home inactive) Sensing failure. Contact Technical Support.
(0208) Reaction Tray Mechanical failure. Contact Technical Support.
movement inadequate Sensing failure of W-UP and W- Contact Technical Support.
safety conditions DOWN.
(Washer) NOTE: the equipment verifies the state of the washer before moving
the reaction tray.
(0209) Reaction Tray Same values for dispensed offset Contact Technical Support.
programming error and photometer offset.
(Dispensing and
Photometer offset)
SAMPLES-REAGENT TRAY

Description
(0251) Probe Impact Physical impact. Verify possible obstacles in the
(Samples and Reagents movement.

IUMv2.09.05 17-15
Tray) Impact switches failures Contact Technical Support.
(preheater board)
(0252) Samples and Home sensing failure. Contact Technical Support.
Reagents Tray not Mechanical failure Contact Technical Support.
initialized or initialization Sample-reagent tray not Execute the command to initialize.
error (Home active) initialized.
(0253) Samples and Home sensing failure Contact Technical Support.
Reagents Tray not
initialized or initialization Mechanical failure. Contact Technical Support.
error (Home inactive) Reagent and samples tray not Execute the command to initialize.
initialized.
(0254) Samples and Module not initialized Initialize module.
Reagents Tray not
initialized
(0255) Samples and Home sensing failure Contact Technical Support.
Reagents Tray error
(slotted tray counting Mechanical failure. Contact Technical Support.
error)
Sensor- P out of the counting Contact Technical Support.
position.
(0256) Samples and Mechanical failure. Contact Technical Support.
Reagents Tray error Sensing failure. Contact Technical Support.
(Home active)
(0257) Samples and Mechanical failure Contact Technical Support.
Reagents Tray error Sensing failure Contact Technical Support.
(Home inactive)
FILTER WHEEL

Description
(0302) Filter Wheel not Home sensing failure. Contact Technical Support.
initialized or initialization Mechanical failure. Contact Technical Support.
error (Home active)
Filter wheel not initialized. Execute the command to initialize.
(0303) Filter Wheel not Home sensing failure Contact Technical Support.
error (Home inactive) Mechanical failure Contact Technical Support.
Filter wheel not initialized. Execute the command to initialize.
(0304) Filter Wheel not Module not initialized. Initialize module

initialized

IUMv2.09.05 17-16
(0305) Filter Wheel error Home sensing failure. Contact Technical Support.
(slotted tray counting
error) Mechanical failure Contact Technical Support.
Sensor F out of the counting Contact Technical Support.

position.
(0306) Filter Wheel error Poor contacts. Contact Technical Support.

(Home active) Mechanical failure Contact Technical Support.
Sensing failure Contact Technical Support.

(0307) Filter Wheel error Poor contacts Contact Technical Support.
(Home inactive)
Sensing failure. Contact Technical Support.
READING (AMPLIFIERS)

Description
(0321) The time is not A reading was performed before Wait .(it is recommended at least
enough for thermal reaching the time of thermal 10 minutes)
stabilization. Please stabilization.
repeat the test after
some minutes
(0322) Reaction Tray It has been intended to carry out a Place the cover of the reaction
uncovered. Please place reading operation without placing tray.
the cover the cover of the reaction tray.
Light sensor failure. Contact Technical Support.

(0323) Lamp error Lamp burned out. Replace the lamp.
(burned, unconnected or
power failure)
Lamp disconnected or without any Contact Technical Support.
supplies.
(0324) Lamp powered off The lamp turned off and the Contact Technical Support.
analyzer attempts to read.
(0325) Internal CRC error Communication error between Contact Technical Support.
(Amplifier) amplifier controller and Main
controller.
(0326) Low energy in Lack of calibration. Run photometer calibration.

IUMv2.09.05 17-17
Reference Beam. Exit Lens of the reference channel Contact Technical Support.
Calibrate Photometer
Defective Lamp Contact Technical Support.
Defective Beam Filter Contact Technical Support.

(0327) Low energy in Lack of calibration. Run photometer calibration.
Sample Beam. Check Scratch Cuvette or not aligned. Contact Technical Support.
Sample absorbance
Exit Lens of the reference channel Contact Technical Support.
Defective Lamp Contact Technical Support.
Defective Beam Filter Contact Technical Support.

(0328) Saturated Reaction tray uncover Place the cover of the reaction
Reference Amplifier tray.
Reference amplifier disconnected. Contact Technical Support.
Reference amplifier failure. Contact Technical Support.
Filter missing. Contact Technical Support.
Incorrect positioning of a Beam Contact Technical Support.

Filter.
(0329) Saturated Sample Reaction tray uncovered Place the cover of the reaction
Amplifier tray.
Reference amplifier disconnected Contact Technical Support.
Reference amplifier failure. Contact Technical Support.
Filter missing Contact Technical Support.

Filter.
(0330) High energy Reaction tray lid not placed. Place the lid of the reaction tray.
Reference Beam
Amplifiers disconnected. Contact Technical Support.
Filter missing Contact Technical Support.

Filter.
(0331) High energy Lamp failure Contact Technical Support.
Sample Beam
Filter.
Defective filter Contact Technical Support.
(0332) Saturated Sample Lamp failure Contact Technical Support.

IUMv2.09.05 17-18
and Reference Amplifiers Incorrect positioning of a Beam Contact Technical Support.
Filter.
PHOTOMETER CALIBRATION

Description
(0351) Photometer Filter ID values set on the EEPROM Contact Technical Support.
Calibration error (no
filters programmed in
EEPROM)
(0352) Photometer Possible failure in filter wheel Contact Technical Support.
Calibration error (Filter controller.
Wheel Controller
communication)
(0353) Photometer Possible failure in amplifier IC Contact Technical Support.
Calibration error controller.
(Amplifier Controller
communication)
(0354) Photometer Calibration logic error. Contact Technical Support.
Calibration error
(0355) Photometer Scratched cuvette or not aligned. Replace the cuvette or try to
Calibration error (low calibrate another cuvette.
energy in Sample Beam) (Anyway, it is recommended to
replace defective cuvettes)
Contact Technical Support.
Exit lens of the reference channel. Contact Technical Support.
Amplifier sample Failure. Contact Technical Support.
(0356) Photometer Exit lens of the reference channel. Contact Technical Support.
Calibration error (low
energy in Reference Failure in the amplifier reference. Contact Technical Support.
Beam)
(0357) Photometer Defective lamp Contact Technical Support.
Calibration error (low
energy in Sample and Exit lens. Contact Technical Support.
References Beams)
Filter.
(0358) Photometer Alignment failure in the optical Contact Technical Support.
Calibration error (high path

IUMv2.09.05 17-19
energy in Sample Beam) Sample Amplifier Failure. Contact Technical Support.
(0359) Photometer Reference Amplifier Failure. Contact Technical Support.

Calibration error (high
energy in Reference
Beam)
(0360) Photometer Incorrect positioning of a Beam Contact Technical Support.
Calibration error (high Filter.
energy in Sample and Lamp failure Contact Technical Support.
Reference Beams)
Amplifiers failure Contact Technical Support.
(0361) Photometer Stray light. Contact Technical Support.
Zero in Sample Amplifier)
Sample Amplifier Failure. Contact Technical Support.
(0362) Photometer Stray light. Contact Technical Support.

Reference Amplifier Failure. Contact Technical Support.
Zero in Reference
Amplifier)
(0363) Photometer Incorrect positioning of a Beam Contact Technical Support.
Calibration error (high Filter.
Zero in Sample and Lamp failure Contact Technical Support.
Reference Amplifiers)
Missing filter Contact Technical Support.
Amplifiers failures Contact Technical Support.
(0364) Photometer Defective EEPROM Contact Technical Support.
Calibration error
(EEPROM writing error)
(0365) Photometer Scratched cuvette or not aligned. Replace the cuvette or try to
Calibration (High gain calibrate another cuvette.
Sample Amplifier) (Anyway, it is recommended to
replace defective cuvettes)
Exit lens of the reference channel. Contact Technical Support.
(0366) Photometer Exit lens of the reference channel. Contact Technical Support.
Calibration (High gain
Reference Amplifier)
(0367) Photometer Defective lamp Contact Technical Support.
Calibration (High gain
Exit lens.
Sample and Reference
Amplifiers) Incorrect positioning of a Beam

IUMv2.09.05 17-20
Filter.
Defective filter
Cuvettes calibration

Description
(0381) Cuvettes Filter ID values set on the EEPROM Contact Technical Support.
Calibration error (no
filters programmed in
EEPROM)
(0382) Cuvettes Possible failure in IC filter-wheel Contact Technical Support.
Calibration error (Filter controller.
Wheel Controller
communication)
(0383) Cuvettes Possible failure in IC controller Contact Technical Support.
Calibration error (Amplifier).
(Amplifier Controller
communication)
(0384) Cuvettes Error in the logic of calibration. Contact Technical Support.
Calibration error
(0385) Cuvettes Lack of calibration. Run photometer calibration.
Calibration error (low Scratched cuvette or poorly Contact Technical Support.
energy in Sample Beam) aligned.
Replace the cuvette.(it is
recommended to replace the
defective cuvettes)
Exit lens of the sample channel Contact Technical Support.
(0386) Cuvettes Lack of calibration. Run photometer calibration.

Calibration error (low Exit lens of the reference channel. Contact Technical Support.
energy in Reference
Beam)
(0387) Cuvettes Scratched cuvette or poorly Replace the cuvette.(it is
Calibration error (Cuvette aligned. recommended to replace the
absorbance too high, defective cuvettes)
replace the cuvettes) Contact Technical Support.
Lack of calibration Run photometer calibration
(0388) Cuvettes Lack of calibration Do photometer calibration
Calibration error (Cuvette Cuvette not aligned. Replace the cuvette.(it is
absorbance too low, recommended to replace the
Calibrate Photometer in a defective cuvettes)
different cuvette or Contact Technical Support.
replace de cuvettes)

IUMv2.09.05 17-21
(0389) Cuvettes Striped cuvette or misaligned Check the alignment of the beam
Calibration (Cuvette with the cuvette.
absorbance too high, Replace the cuvette.(it is
replace the cuvettes recommended to replace the
when possible) defective cuvettes)
Lack of calibration Run photometer calibration
(0390) Cuvettes Lack of calibration Run photometer calibration
Calibration (Cuvette Cuvette poorly aligned. Replace the cuvette.(it is
absorbance too low, recommended to replace the
Calibrate Photometer in a defective cuvettes)
different cuvette or Contact Technical Support.
replace de cuvettes when
possible)
(0391) Cuvettes Defective EEPROM. Contact Technical Support.
Calibration error
(EEPROM writing error)
HEATER AND PRE-HEATER

Description
(0401) Temperature Wiring failure Contact Technical Support.

reading error (can't read
Reaction Tray A/D A/D defective
converter)
(0451) Temperature Wiring failure Contact Technical Support.
reading error (can't read
Preheater A/D converter) A/D defective Contact Technical Support.
DILUTER

Description
(0501) Diluter Wiring failure Contact Technical Support.
Initialization error
(0502) Diluter invalid Contact Technical Support. Contact Technical Support.
command
(0503) Diluter invalid Incorrect Volume Verify the aspiration Volume in
operand the Method parameters.
(0504) Diluter invalid Contact Technical Support. Contact Technical Support.
command sequence

IUMv2.09.05 17-22
(0505) Diluter not Diluter not initialized. Execute initialization commands.
initialized
(0506) Diluter Plunger Mechanical failure Check possible obstacles in the
overload movement of the diluter plunger.

(0507) Diluter Valve Mechanical failure Contact Technical Support.
overload
(0508) Diluter Plunger Wrong position of the valve. Contact Technical Support.
move not allowed
(0509) Diluter command Contact Technical Support. Contact Technical Support.
overflow
WASHER

Description
(0552) Washer not Sensing failure. Contact Technical Support.
error (Up active) Mechanical failure. Contact Technical Support.
(0553) Washer not Sensing failure. Contact Technical Support.
error (Up inactive) Mechanical failure Contact Technical Support.
(0554) Washer Header Sensing failure. Contact Technical Support.
movement error (Down
active) Mechanical failure. Contact Technical Support.
(0555) Washer Header Home sensing failure. Contact Technical Support.

movement error (Down
inactive) Mechanical failure. Contact Technical Support.
FLUSHING PUMP

Description
(0571) Washer Flushing HOME sensing failure Contact Technical Support.
Pump initialization error
Electrical failure Contact Technical Support.
(Home active)
0572) Washer Flushing HOME sensing failure Contact Technical Support.
Pump initialization error
(Home inactive) Mechanical failure Contact Technical Support.
(0573) Washer Flushing Wiring failure. Contact Technical Support.
Pump moving error
Mechanical failure. Contact Technical Support.
(Home active)

IUMv2.09.05 17-23
(0574) Washer Flushing Wiring failure. Contact Technical Support.
Pump moving error
(Home inactive)
(0575) Washer Flushing Wiring failure or sensing home Contact Technical Support.
Pump error (Home active)
Electrical failure. Contact Technical Support.

(0576) Washer Flushing HOME sensing Failure Contact Technical Support.
Pump error (Home
inactive)
FILLING PUMP

Description
(0581) Washer Filling HOME sensing Failure Contact Technical Support.

Pump moving error
(Home active) Electrical failure. Contact Technical Support.
(0582) Washer Filling Wiring failure or sensing home Contact Technical Support.
Pump moving error
(Home inactive) Electrical failure. Contact Technical Support.

Pump error (Home active)
Pump error (Home
inactive) Electrical failure Contact Technical Support.
ISE

Description

IUMv2.09.05 17-24
(0701) mV Out in Salt is plugging the electrode flow Remove electrodes and clean or
Serum/Plasma path. replace electrode with plugged
flow path. Reinstall electrodes and
recalibrate.
If single electrode is flagged Replace problem electrode and
recalibrate.
If multiple electrode are flagged Replace reference electrode and

recalibrate.
Electrical noise spike from Contact Technical Support.

Calibrant A path. replace electrode with plugged
recalibrate.
If single electrode is flagged: May Purge Calibrant A and recalibrate
occur when new electrode or the ISE module. If the electrode is
Calibrant A are installed. new it may initially drift as it
rehydrates over the course of 15
minutes.
If single electrode is flagged Replace the electrode and
recalibrate.
If multiple electrode are flagged Purge the Calibrant A and

May occur when new electrode or recalibrate the ISE module.
Reagent Kit is installed.
Reference electrode. recalibrate.
(0703) Noise in If single electrode is flagged Replace problem electrode and

Serum/Plasma recalibrate.
recalibrate.


board.
(0704) Noise in Calibrant If single electrode is flagged Replace problem electrode and
A recalibrate.
recalibrate.

IUMv2.09.05 17-25
board.
(0705) Drift in If single electrode is flagged: MayPurge the Calibrant A and
Serum/Plasma occur when new electrode or recalibrate the ISE module. If the
Calibrant A is installed. electrode is new it may initially
drift as it rehydrates over the
course of 15 minutes.
If single electrode is flagged: Replace the electrode and
recalibrate.
If multiple electrode are flagged: Purge the Calibrant A and
If multiple electrode are flagged: Replace reference electrode and
board.
(0706) Out of range in Samples results are out of range Check quality of sample.
Serum/Plasma limits:
Whole blood, serum, plasma Run Calibration procedure, run

Li+ 0.20 – 3.50 mmol/L control samples and retest.
Na+ 100.0 – 200.0 mmol/L
K+ 1.00 – 10.00 mmol/L
Cl- 50.0 – 150.0 mmol/L
(0707) mV Out in Urine Salt is plugging the electrode flow Remove electrodes and clean or
path. replace electrode with plugged
recalibrate.
If single electrode is flagged Replace problem electrode and
recalibrate.
If multiple electrodes are flagged Replace reference electrode and
recalibrate.
(0708) mV Out in If single electrode is flagged: MayPurge Calibrant B and recalibrate
Calibrant B occur when new electrode or the ISE module. If the electrode is
Calibrant A/B are installed. new it may initially drift as it
minutes.
recalibrate.
If multiple electrodes are flagged Purge the Calibrant A and

IUMv2.09.05 17-26
(0709) Noise in Urine If single electrode is flagged Replace problem electrode and
recalibrate.

recalibrate.


board.
(0710) Noise in Calibrant If single electrodes is flagged Replace problem electrode and
B recalibrate.
recalibrate.
board.
(0711) Drift in Urine If single electrode is flagged: May Purge the Calibrant B and
occur when new electrode or recalibrate the ISE module. If the
Calibrant B is installed. electrode is new it may initially
recalibrate.
If multiple electrodes are flagged: Purge the Calibrant A and

If multiple electrodes are flagged: Replace reference electrode and
(0712) Out of range in Samples results are out of range Urine diluted must be used.
Urine limits:
Urine Check quality of sample.
Na+ 10 – 500 mmol/L
K+ 5 – 200 mmol/L
Run Calibration procedure, run
Cl- 15 – 400 mmol/L
control samples and retest.
(0713) mV Out in If single electrode is flagged: May Purge Calibrant B and recalibrate
Calibrant B occur when new electrode or the ISE module. If the electrode is
Calibrant B are installed. new it may initially drift as it

IUMv2.09.05 17-27
minutes.

recalibrate.
If multiple electrode are flagged Purge the Calibrant B and
Calibrant A path. replace electrode with plugged
recalibrate.
If single electrode is flagged: May Purge Calibrant A and recalibrate
occur when new electrode or the ISE module. If the electrode is
Calibrant A are installed. new it may initially drift as it
minutes.
recalibrate.
B recalibrate.
recalibrate.
board.
A recalibrate.
recalibrate.
board.
(0717) Drift in Calibration Salt is plugging the electrode flow Remove electrodes and clean or
path. replace electrode with plugged
recalibrate.
If single electrode is flagged: May Purge Calibrant A/B and
occur when new electrode or recalibrate the ISE module. If the

IUMv2.09.05 17-28
Calibrant A/B are installed. electrode is new it may initially
recalibrate.
(0718) Out of Range in Acceptable slope limits are: Replace the electrode and
Calibration Slope (mV/decade) recalibrate.
Li+ 47–64
Na+ 52–64
K+ 52–64
Cl- 40–55
(0731)ISE Module - Air in Insufficient sample pipette into ISE Check method settings (Sample
Sample/Urine module sample entry port volume must be 70 µl for
(automatically repeated) serum/plasma and 140 µl for
diluted urine)
Bubbles in sample Sample must be free of bubbles.
Fluid leaks Contact Technical Support.
Sample not positioned Electrodes not seated properly.
Remove electrodes. Inspect o-
rings and reassemble.
Pump tubing obstructed Contact Technical Support.
(0732) ISE Module - Air in Calibrant A Replace reagent kit with a new
Calibrant A (automatically one. Purge, and recalibrate.
repeated) Tubing from reagent module is Contact Technical Support.
disconnected, plugged, or
crimped.
Fibrin or salt is plugging the Remove electrodes and clean or
electrode flow path. replace electrode with plugged
recalibrate.
Calibrant A pump is not working Contact Technical Support.
properly.
(0733) ISE Module - Air in Calibrant B is segmented with air Electrodes are not properly
Calibrant B (automatically seated. Check compression plate,
repeated) spring and seal.
Ensure that all electrodes and o-
rings are properly installed.
Ensure tubing between reagent kit
and sample entry port is

IUMv2.09.05 17-29
connected properly.
Replace tubing between reagent
kit and sample entry port.
Reagent low or out.
Fibrin or salt is plugging the Use cleaning procedure.
Remove electrodes and clean or
replace electrode with plugged
recalibrate.
Waste pump malfunction Contact Technical Support.
Bubble detector malfunction Contact Technical Support.
(0734) ISE Module ISE Module Temperature higher Room temperature must be
Temperature higher than than 32ºC. reduced.
32ºC. Please decrease the
environment
temperature, otherwise
the Electrodes life
expectancy could be
reduced
(0735) ISE Module Processing temperature is +/- 4ª Calibrate the ISE Module and
Temperature drift higher since last calibration. repeat the test.
than 4ºC. Please Calibrate
the Module and repeat
the test
(0751) ISE Module - Internal error. Contact Technical Support.
Invalid Answer
Unknown Error
(0753) ISE Module - Air in See possible solution for 0731.
Sample
Calibrant A
Calibrant B
(0756) ISE Module - Air in Insufficient cleaning solution Check cleaning solution tube
Cleaner pipette into ISE module sample
entry port.
Waste peristaltic pump failure. Contact Technical Support.
recalibrate.

IUMv2.09.05 17-30
(0757) ISE Module - Air in Sample cup contamination. The A cotton tip applicator dipped in
Segment sample cup may become dirty (i.e. DIH20 to clean around and in the
possible protein buildup, salt from sample cup, being careful not to
reagent, dust falling in from dislodge any particles that may
above) during normal use. obstruct the flow path.
Air bubble in sample – if the Contact Technical Support.

sample probe delivering the
sample or any reagent is to fast or
forceful air bubbles can be created
and drawn into the flow path.
(0758) ISE Module - Pump Insufficient saline solution pipette Check saline solution tube
Calibration error into ISE module sample entry port.
Waste peristaltic pump failure. Contact Technical Support.
recalibrate.
(0759) ISE Module - No Pump tubing obstructed Contact Technical Support.
Flow
Peristaltic pump failure Contact Technical Support.
(0760) ISE Module - Fluid leaks Contact Technical Support.
Bubble Detector
Pump tubing obstructed Contact Technical Support.
Reagents Kit Electronic
Key Read
Reagents Kit Electronic
Key Write
Invalid Command
(0764) ISE Module Calibration time expired (more Run a calibration procedure.
calibration out of time. than 8 hours from last)
Please Calibrate it
(0765) ISE Module Module has been turned off. Run a calibration procedure.
uncalibrated. Please
Calibrate it ISE module has been under Mant
command
Calibration ended with errors
Electrode has been enabled by
hardware option

IUMv2.09.05 17-31
(0766) ISE Module Internal error Contact Technical Support.
communication
Checksum error
(0767) ISE Module answer Internal error Contact Technical Support.
parsing error
(0768) ISE Module Cleaning time expired (more than Run cleaning procedure.
cleaning out of time. 8 hours or 50 samples from last)
Please Clean it
(0769) ISE Module out of ISE module in a wrong position. Reposition module.
position. Please
reposition the Module
(0770) ISE Pack changed ISE Reagent Kit has been change. Run Reagent Kit replacement.
(0771) ISE Pack Security Kit electronic key failure Change ISE reagent kit.
Code error
(0772) ISE Pack Wrong Invalid Reagent Kit 5420-0104 ISE reagent kit must be
Distributor Code used.
(0773) ISE Pack Expired ISE Reagent Kit expired. Change ISE reagent kit. Run
Reagent Kit replacement
(0774) ISE Pack Not Good Kit electronic key failure Change ISE reagent kit. Run
Reagent Kit replacement
(0775) ISE Module in ISE module in Maintenance Mode. Run Calibrant A Purge or
Maintenance Mode. Run Calibration procedure.
a Purge Cycle or a
Calibration Cycle
(0776) ISE Module Off. ISE module is off. Run Reconnect procedure and
Position the module then Star up.
properly and Reconnect it
(0777) ISE Pack not ISE Reagent Kit is not connected. Connect ISE reagent kit
connected
ISE Reagent Kit connector out of Check ISE reagent Kit connector.
place.
(0778) ISE Pack no more Lack of Calibrant Replace ISE reagent kit.
Calibrant
(0779) ISE Module ISE Calibration finished No action is required
Calibration successful successfully
(0780) Last ISE Module Last ISE Calibration ended with Check last ISE Calibration warning
Calibration finished with warnings messages, correct them and
warnings recalibrate the ISE Module.

IUMv2.09.05 17-32
Torcuato de Alvear 46
B1878DMB - Quilmes - Buenos Aires
Argentina
Tel/Fax +54 11 4252 - 2626
www.diconex.com

IUMv2.09.05 17-33

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USER’S MANUAL

InCCA User’s Manual

2 INSTALLATION AND CONNECTIONS OF THE ANALYZER--- 2-1

3 ANALYZER TECHNICAL SPECIFICATIONS----------------------- 3-1

3.1 GENERAL SPECIFICATIONS -------------------------------------------------------------------- 3-1

4 GENERAL FUNCTIONS ---------------------------------------------- 4-1

4.1 MAIN PARTS OR MODULES ------------------------------------------------------------------- 4-1

InCCA User’s Manual

5 BASIC OPERATIONS ------------------------------------------------- 5-1

6 SOFTWARE TABS ---------------------------------------------------- 6-1

6.1 MAIN WINDOW OF THE SOFTWARE ---------------------------------------------------------- 6-1

7 OPERATIONS MENU ------------------------------------------------ 7-1

7.1 ADD SAMPLES AND METHODS --------------------------------------------------------------- 7-1

InCCA User’s Manual

8 METHODS MENU ---------------------------------------------------- 8-1

8.1 SETTINGS: METHODS CONFIGURATION ------------------------------------------------------ 8-1

9 CALIBRATORS MENU ----------------------------------------------- 9-1

9.1 SETTINGS -------------------------------------------------------------------------------------- 9-1

InCCA User’s Manual

11 STATISTICS MENU ------------------------------------------------11-3

11.1 LEVY-JENNINGS OF PATIENTS ------------------------------------------------------------- 11-3

12.1 SETTINGS ---------------------------------------------------------------------------------- 12-1

InCCA User’s Manual

13.1 CONFIGURATION OF THE PRINTING FORMATS -------------------------------------------- 13-1

14 ISE MODULE: DESCRIPTION AND OPERATION (OPTIONAL)

14.1 ELECTRODES ------------------------------------------------------------------------------- 14-2

15 MAINTENANCE PROGRAM----------------------------------- 15-14

InCCA User’s Manual

16 PREPARING SOLUTIONS ----------------------------------------16-1

17.1 INTRODUCTION ---------------------------------------------------------------------------- 17-1

InCCA User’s Manual

InCCA User’s Manual

InCCA User’s Manual

Keep lids closed when the instrument is working.

Do not look straight at barcode detector light beams.

InCCA User’s Manual

The use of controls, as indicated by good laboratory practices, is also recommended.

Carry out the maintenance plan as indicated in this manual.

Read all warning messages.

Symbols used in the manual and the instrument

Consult instructions for use

“In vitro” diagnostics device

InCCA User’s Manual

InCCA User’s Manual

Do not pile up more than four wooden boxes

Keep dry, protect from humidity and rain

Handle with care

Gross mass 67 Kg.

1.2 Unpacking instructions

InCCA User’s Manual

InCCA User’s Manual

NOTE: Instrument remains fastened to the bottom.

InCCA User’s Manual

Unscrew the four screws located on the sides.

Screws are placed this way:

InCCA User’s Manual

InCCA User’s Manual

Installation must be carried out by trained personnel.

2.1 Electrical requirement

2.3 Environmental requirements

2.4 Moving the instrument

2.5 PC minimum requirements

InCCA User’s Manual