AMS Ellipce User Manual
ELLIPSE
User Manual
Via E. Barsanti 17/A
00012 Guidonia – ROME (ITALY)
www.ams-analyzers.com
CONFIGURATION SHEET
CHAPTER DESCRIPTION REVISION
INDEX TABLE OF CONTENTS 02
01 INSTALLATION
02 GENERAL DESCRIPTION
03 SOFTWARE DESCRIPTION
04 DAILY ROUTINE
05 METHODOLOGY
06 CALIBRATION CURVES
07 MAINTENANCE
08 FORMULAS AND CALCULATION MODELS
09 ERROR SIGNALING AND TROUBLESHOOTING
10 HOST COMMUNICATION
11 PACKING LIST
02
02
02
01
01
01
02
01
02
01
01
12 DIAGNOSTIC PROGRAM
02
Ellipse User Manual Rev.02 19 October 2005 Page 1
TABLE OF CONTENTS
Chapter 01 INSTALLATION
Chapter 02 GENERAL DESCRIPTION
Chapter 03 SOFTWARE DESCRIPTION
Chapter 04 DAILY ROUTINE
INDEX
Chapter 05 METHODOLOGY
Chapter 06 CALIBRATION CURVES
Chapter 07 MAINTENANCE
Chapter 08 FORMULAS AND CALCULATION MODELS
Chapter 09 ERROR SIGNALING AND TROUBLESHOOTING
Chapter 10 HOST COMMUNICATION
Chapter 11 PACKING LIST
Chapter 12 DIAGNOSTIC PROGRAM
Ellipse User Manual Rev.02 19 October 2005 Page 1
Chapter 01 - INSTALLATION
CHAPTER 01 - INSTALLATION
INDEX
1.1 UNPACKING .......................................................................................................................... 2
1.2 INSTALLATION..................................................................................................................... 4
1.2.1 INSTALLATION SITE SPECIFICATIONS........................................................................... 4
1.2.2 ELECTRIC CURRENT REQUIREMENTS ........................................................................... 4
1.2.3 CONNECTION OF THE ACCESSORIES ............................................................................. 5
1.2.3.1 POWER SUPPLY .................................................................................................................... 5
1.2.3.2 COMPUTER - INSTRUMENT CONNECTION .................................................................... 6
1.2.3.3 HYDRAULIC CONNECTIONS …....……………………………………………………….6
1.2.4 ATTENTION .......................................................................................................................... 6
1.2.5 SYMBOLS ............................................................................................................................. 7
1.2.6 REGULATORY COMPLIANCE.......................................................................................... 8
1.2.7 LIMITATION OF USE........................................................................................................... 8
1.2.8 BARCODE READER............................................................................................................. 8
1.2.9 WARRANTY ……...……………………………………………………………...…………8
1.2.10 CONSUMABLES AND ACCESSORIES PARTS LIST OUT OF WARRANTY…………9
Ellipse User Manual Rev.02 19 October 2005 Page 1
Chapter 01 - INSTALLATION
t
n
y
1.1 UNPACKING
The ELLIPSE is packed and delivered in two separate wooden crates: one contains the analyzer itself
and the other the computer, along with its accessories. In the event that the order does not include the
PC component, the packing and delivery will involve one wooden crate plus a corrugated cardboard
box. The packing has been expressly studied and designed to insure maximum protection of the
contents during shipping and handling. It is therefore extremely important that the crate(s)/box be
carefully examined upon delivery in order to ascertain their integrity. Special attention should be
dedicated to examining the color of the “Shock Watch” glued to the crates, which must show the color
‘white’. A ‘red’ “Shock Watch” indicates that the crate(s) have experienced some sort of ‘shock’
during handling, transport and/or delivery. This fact must be noted by the courier on the delivery note,
as must any and all visible external damage (for example: holes, dents, rips or tears, water marks, etc.)
evident at the moment of delivery. This will simplify matters in the event of any future claims for
damages.
Upon arrival of the crate(s)/box, take out the
delivery note and make sure that all the items
on the packing list are included in the crates
and are undamaged. Make sure the series
number on the delivery note/packing lis
corresponds to that impressed on the plate o
the left side of the instrument.
Open the crate(s)/box from the top and ver
carefully take out:
- the instrument;
- the computer and accessories.
ELLIPSE
S/N
P/N
100 ÷ 230Vac 47 ÷ 63Hz
Analyzer
Medical
System
300W
Rome-Italy
MAKE SURE THAT THE UNPACKING IS CARRIED OUT BY TWO PEOPLE.
Ellipse User Manual Rev.02 19 October 2005 Page 2
Chapter 01 - INSTALLATION
Do not discard the delivery crate(s)/box or the packing material until the correct functioning of the
instrument has been ascertained.
Remove all the items from the crate(s)/box very carefully.
Before connecting the "Ellipse", remove the protective packing material placed under the sampling
arm and under the wash station group.
Warning: in the event that it is necessary to repack any or all of the delivered item(s), the following
procedures must be carefully followed:
Reposition the protective packing material under the sampling arm and under the wash station
group.
Tape down (using masking tape if possible) the cover of the samples and reagents housing, the
front panels, and the samples and reagents racks.
Remove the probe from the sampling arm and place it inside a primary tube. Then cap the tube
and tape the cap down.
Be very careful to not bend the wash station cannulas when repositioning the protective packing
material.
Fill the empty spaces around the accessories packed in the crate using “pluriballs” or other
suitable packing material.
Ellipse User Manual Rev.02 19 October 2005 Page 3
Chapter 01 - INSTALLATION
1.2 INSTALLATION
The ELLIPSE must only be installed by a qualified technician who has been authorised and trained to
do so. During its installation the system will be checked once again to ensure correct functioning. The
persons who are required to operate the ELLIPSE system must have received the adequate training.
This should also include the "know-how" of the normal maintenance for the instrument. A description
of the maintenance will be found in Chapter 7 of this manual.
ELLIPSE is a complex system, and it is therefore extremely important that it is correctly installed in
order to fully guarantee fine performance. If the installation and use directions, given in this manual,
are not correctly followed and/or safety indications are not respected, AMS cannot guarantee correct
functioning of the instrument. Apart from this, the safety of the operator could be placed at risk.
1.2.1 INSTALLATION SITE SPECIFICATIONS
Ascertain that the ELLIPSE system is not exposed to direct sunlight, draughts, dust or strong magnetic
fields. In addition, please take note of the following conditions required for the location of the
installation:
USE
DEGREE OF POLLUTION
INSULATION CLASS
INSTALLATION CATEGORY
TEMPERATURE
HUMIDITY
ALTITUDE
In covered and dry place
2
I
II
Between 18°- 30°C
20% ÷ 85%
Max 3000 m
Shelf or table with a minimum surface of 75 x 60 cm stable
LOCATION
and free of vibration
Leave a minimum distance of 10 cm around the instrument to
VENTILATION
permit air circulation. Make sure that the front and rear holes
are not blocked by any object
1.2.2 ELECTRIC CURRENT REQUIREMENTS
The power voltages to which the instrument is adapted are indicated on the left-hand side
(see fig. 1). It must be plugged into a plug of the correct voltage.
VOLTAGE
FUSES
100÷ 230 Vac 47/63 Hz ± 10%
6.3 A /T - 5 x 20
Ellipse User Manual Rev.02 19 October 2005 Page 4
Chapter 01 - INSTALLATION
NOTE: IT IS ADVISABLE TO MAINTAIN THE MAXIMUM STABILITY OF THE ELECTRICAL CURRENT IN THE
LABORATORY
SUPPLEMENTARY DEVICES IS RECOMMENDED
. WHERE THIS IS NOT POSSIBLE OR ASCERTAINABLE, USE OF THE FOLLOWING
:
ELECTRONIC STABILIZER
Used to stabilise the electric voltage in the laboratory. Any stabiliser with a power potential
greater than 0.5 KW, currently available on the market, can be used.
NO-BREAK MODULE UPS - (Uninterrupted Power Supply)
This module provides two important functions:
- stabilises the main-line power
- supplies current to the instrument in case of a main-line power failure.
1.2.3 CONNECTION OF THE ACCESSORIES
1.2.3.1 POWER SUPPLY
Fig. 1 – Plug (use the feeder cable supplied with the instrument).
The sticker below the plug in indicates the power supply voltage and the values of the fuses.
Ellipse User Manual Rev.02 19 October 2005 Page 5
Chapter 01 - INSTALLATION
1.2.3.2 COMPUTER - INSTRUMENT CONNECTION
The instrument and the Personal Computer are connected by one serial RS232 standard cable
(Cod. 9-35-0055-01), which provides the hardware support for the communication.
1.2.3.3 HYDRAULIC CONNECTIONS
The instrument uses Cleaning solution and distilled water for reaction cuvettes cleaning; it uses Rinse
solution for sampling probe cleaning and cuvette blank determination (WBL). A second Rinse
hydraulic line is used for cuvettes quality control checking after washing.
For connecting said solution there are four inlet on the instrument left side identified by roman
numbers as here below specified:
• I Rinse solution (green color)
• II Rinse solution (yellow color)
• III Distilled water (blue color)
• IV Cleaning solution (red color)
The waste hydraulic lines are located on the instrument right side
Further information can be taken on the Hydraulic diagram (SI 16 00571 01 Service manual -chapter
04).
1.2.4 ATTENTION
The following label is found at the rear of the instrument.
CAUTION
TO PREVENT ELECTRIC SHOCK
DO NOT REMOVE BACK PANEL.
NO USER-SERVICEABLE PARTS INSIDE.
REFER SERVING TO QUALIFIED
SERVICE PERSONNEL
NOTE: THE REAR PANELS OF THE INSTRUMENT MUST NEVER BE OPENED WITHOUT HAVING FIRST
SWITCHED THE INSTRUMENT OFF AND DISCONNECTED THE ELECTRICITY CABLE
Ellipse User Manual Rev.02 19 October 2005 Page 6
.
Chapter 01 - INSTALLATION
THE MAINTENANCE AND CLEANING PROCEDURES FOUND IN CHAPTER 07 OF THIS MANUAL MUST BE
RESPECTED AT ALL TIMES
BEFORE INSTRUMENT MAINTENANCE OPERATION
. REMEMBER TO FOLLOW THE DECONTAMINATION PROCEDURE WHEN REQUIRED
(SEE CHAPTER 07).
1.2.5 SYMBOLS
ATTENTION: READ THE INSTRUCTIONS IN THE USER MANUAL
TERMINAL OF TOTAL MASS PROTECTION (CONDUCTOR)
BIOLOGICAL HAZARD
(LOCATED NEAR THE REACTION PLATE AREA)
Carefully manipulate all the consumables and the wastes produced during the
analysis routines. Use appropriate protective garment. Disposal of wastes must
be done in compliance with applicable regulation. It is recommended to
periodically check the level in the waste container, in order to avoid overflow.
INDICATES THE BOTTLES CONNECTION
I RINSE SOLUTION
II
III
IV
STAND-BY BUTTON
RINSE SOLUTION
DISTILLED WATER
CLEANING SOLUTION
BUZZER FORCE OFF BUTTON
Ellipse User Manual Rev.02 19 October 2005 Page 7
Chapter 01 - INSTALLATION
BARCODE READER BUTTON
1.2.6 REGULATORY COMPLIANCE
The ELLIPSE instrument complies with:
• European Directive 98/79/CE for In Vitro Diagnostic Devices
1.2.7 LIMITATION OF USE
The ELLIPSE can not be used by blind operators because the user interface with the system requires a
monitor.
Furthermore the ELLIPSE must be used with particular caution by color blind operators because the
graphic interface displays different colors with different meaning.
1.2.8 BARCODE READER
A bar code reader can be optionally installed on the ELLIPSE. The barcode reader has a laser micro-
scanner classified as Class II laser device. It is compliant with applicable safety regulations.
WARNING TURN OFF ALWAYS THE INSTRUMENT before removal of those panels and
covers that protect from any interference and/or exposure to the laser beam active during sample
identification.
1.2.9 WARRANTY
AMS guarantees the substitution of all defective components and/or materials for a period of time not
above of fourteen months starting from the date of invoicing. Saying warranty, as well as Technical
Assistance, generally is intended furnished as net ex factory Rome.
This warranty does not include consumable and instrument parts in contact with liquids. All
components not covered by the warranty are reported in the table on the next page.
Besides warranty does not cover damage caused by:
- improper use of the ELLIPSE instrument (or however not according to the Producer or Seller
instructions)
- bad transport
- insufficient (or missing) preventive maintenance by the User
In particular any damages due to the transport must be immediately reported to the carrier when he
delivers.
Ellipse User Manual Rev.02 19 October 2005 Page 8
Chapter 01 - INSTALLATION
1.2.10 CONSUMABLES AND ACCESSORIES PARTS LIST OUT OF WARRANTY
Description Type
Quantity
(Pieces)
Code
Reagents containers 35 ml 12 C101-00190-00
Reagents containers 6 ml 12 C101-00191-00
Samples cups 0.8 ml 1000 AS650002
Short samples cups 1 ml 1000 AS650100
Adapter for short samples cups 1 9-01-0609-00
Reaction sectors 6 C101-00217-00
Washing solution bottle 2 lt 1 9-35-0041-00
Bottle level sensor 1 9-05-0078-00
Tubing Kit for peristaltic pump 2 65-01835-00
Tubing Kit – complete 1 65-01836-00
Cleaning solution 250 ml 2 ASRN0020
Rinse solution 50 ml 1 ASRN0021
Sampling probe (internal needle) 1 05-00707-00
Complete Sampling probe 1 10-00703-00
Drying Pad 1 01-01920-00
Halogen Lamp (6 V - 10 W) 1 9-35-0016-00
Interferential filters Kit (Stablife) 1 65-02017-00
Fuse 6,3 A-T 5x20 10 C132-01238-08
Inlet/outlet fitting for Rinse & Clean conts 1 01-01224-00
Cuvettes protection cover 1 05-01249-00
Reagent protection cover 1 10-00584-00
Reagent plate 1 10-00585-00
Samples rack 1 05-01829-00
Washing station, first or second cannulas (A) 1 05-01633-00
Washing station, third cannula (B) 1 05-01633-01
Washing station, fourth cannula (C) 1 05-01638-00
Washing station, fifth cannula without pad (D) 1 05-01919-00
Diluter Micro-Pump 1 05-01710-40
Air Micro-Pump (µP 6) 1 05-01711-20
Micro-Pump (µP 2 ÷5) 1 05-01826-16
Predilution rack 1 05-01735-00
Solenoid Valve –2 way 1 9-35-0035-00
Solenoid Valve –3 way 1 9-35-0036-00
Ellipse User Manual Rev.02 19 October 2005 Page 9
Chapter 02 - GENERAL DESCRIPTION
CHAPTER 02 – GENERAL DESCRIPTION
INDEX
2.1 INTENDED USE AND SYSTEM DESCRIPTION........................................................... 2
2.2 ANALYSES CYCLE .......................................................................................................... 3
2.2.1 REACTION PLATE ........................................................................................................... 3
2.2.2 REACTION PLATE CYCLE ............................................................................................. 3
2.2.3 SAMPLING ARM - OPERATIONAL SEQUENCE ......................................................... 4
2.2.4 SAMPLING SYSTEM........................................................................................................ 5
2.2.5 WASH STATION ............................................................................................................... 6
2.2.6 WASH STATION CYCLE ................................................................................................. 6
2.3 TECHNICAL-OPERATIVE SPECIFICATIONS............................................................... 7
2.3.1 SOFTWARE AND COMPUTER SPECIFICATIONS....................................................... 8
2.3.2 OPTIONAL MODULES .....................................................................................................9
2.3.3 DIMENSIONS, WEIGHT AND OPERATING ENVIRONMENT.................................... 9
2.3.4 INSTALLATION SPECIFICATIONS................................................................................9
Ellipse User Manual Rev.02 19 October 2005 Page 1
Chapter 02 - GENERAL DESCRIPTION
2.1 INTENDED USE AND SYSTEM DESCRIPTION
The “Ellipse” is a random access, computer controlled, counter-top, clinical analysis instrument.
The system can perform 138 tests per hour and has a machine cycle of 26 seconds. Its execution
time ranges from a minimum of 18 seconds to a maximum of 1040, depending on the analysis
method chosen.
The first time the system is used for laboratory analyses, the operator must configure the system
based on the specific needs of that laboratory; i.e.: the chemistry parameters and the reagents racks,
along with the normal, calibrated and control values, must all be defined.
The “Ellipse” is an “OPEN” system that allows configuration with different reagents selected by
the customer in order to fit his needs.
NOTE:
In order to assure the analytical performances of the system “instrument + reagents”, it is
responsibility of the laboratory staff to use reagents, controls and calibrators validated on the
“Ellipse”, or in alternative, to qualify other reagents, controls and calibrators in compliance with
the applicable regulations.
The daily routine analyses will be carried out according to patient sample arrival in a sequential and
continuous, non-stop manner.
The work list is organized using a loading rack holding up to 8 patient samples. Rack loading is
non-stop.
The racks can accommodate test tubes or micro caps. The bar code for primary tubes and reagent
containers is an optional feature.
When the system, the analytical unit and the computer, is turned on the color-meter lamp is supplied
with low voltage power (1.2 volts), the sampling arm pre-heater remains turned off, while instead
the reaction plate heater, the reagents refrigerating unit (optional module) and the electronic
components are turned on.
In this phase, the "Stand-by" light, placed on the front panel, will flash until the reaction plate
reaches a temperature of 36° C. When this temperature is reached, the "Stand-by" light will stop
flashing and will remain constantly lit.
In the case of system failure or malfunction, the "Ready" light, situated on the front panel of the
instrument, will light up red.
In order to access the main program, double click on the "Analyzer" icon on the computer desktop.
Ellipse User Manual Rev.02 19 October 2005 Page 2
Chapter 02 - GENERAL DESCRIPTION
The main menu - "System Monitor" - will appear.
Whenever any system function is launched, the color-meter lamp and the sampling arm pre-heater
will receive regular power.
2.2 ANALYSES CYCLE
2.2.1 REACTION PLATE
The reaction plate of the "Ellipse" system contains 6 disposable racks with 20 reaction cuvettes
each.
The racks can be removed individually.
The basic operating cycle of the reaction plate takes 26 seconds. This cycle includes: optic reading
of the cuvettes in incubation, aspiration and dispensing of the reagents and the samples by the arm,
along with the relative positioning of the plate.
The reactions take place at 37° C. This temperature is maintained constant by a controlled heating
unit placed under the reaction plate.
2.2.2 REACTION PLATE CYCLE
After reagents and samples have been placed in cuvette #1, the reaction plate will rotate 40
positions counter-clockwise, so as to bring the first cuvette to be analyzed in front of the color-
meter for reading with either one or two wavelengths, if required.
The plate will then, moving clockwise, carry out all the readings of any other prepared cuvettes.
After having effectuated all the readings, the plate will move counter-clockwise to its initial
position minus one cuvette, ready for a new dispensing.
In this manner, the reaction cuvettes move clockwise 1 - 2 - 3 - 4 for dispensing, washing and the
relative readings.
Ellipse User Manual Rev.02 19 October 2005 Page 3
Chapter 02 - GENERAL DESCRIPTION
2.2.3 SAMPLING ARM - OPERATIONAL SEQUENCE
1. The sampling arm lifts up from the wash well and carries out a wash cycle;
2. The arm moves toward the specific reagent container, while the diluter aspirates an air bubble
to separate the rinse column from the reagent;
3. The arm lowers itself into the reagent, below the level indicated by the sensor, and aspirates the
required quantity of reagent. If the method requires a Rinse (used in order to reduce the
possibility of negative contamination between the water column and the reagent) an extra
amount of reagent (not used in the analysis) will be aspirated before the quantity of reagent
necessary for the analysis, along with another air bubble for their separation;
4. While the diluter aspirates a second air bubble, the arm rises and then lowers into the wash well
so that it can be washed externally, to minimize cross contamination;
5. The arm moves to the specified sample and aspirates a third air bubble;
6. Once the level sensor has indicated the presence of the liquid, the arm stops and aspirates the
sample;
7. The arm once again is raised, while the diluter aspirates a fourth air bubble to prevent sample
loss;
8. At this point, the arm returns to the wash well in order to clean the outside of the probe and
aspirates a fifth air bubble;
9. The arm moves to the reaction plate, dispenses, and mixes the reagent and sample in the
reaction cuvette for incubation and reading;
10. The arm returns to the wash well and carries out a probe wash cycle.
Ellipse User Manual Rev.02 19 October 2005 Page 4
Chapter 02 - GENERAL DESCRIPTION
(
)
2.2.4 SAMPLING SYSTEM
Aspiration of Air
Aspiration of Reagent
Aspiration of Air
To separate reagent from serum
To wash well to clean the
probe
Aspiration of air
Aspiration of serum
Aspiration of air
To wash well to clean the
probe
Aspiration of air
Dispensing and mixing in
cuvette
To wash well for final
wash
H2O
AIR
RGT
AIR
AIR
SERUM
AIR
Ellipse User Manual Rev.02 19 October 2005 Page 5
Chapter 02 - GENERAL DESCRIPTION
2.2.5 WASH STATION
The reaction plate wash station is made up of a series of five small needles situated on one side of
the reaction plate. Said needles are opportunely connected to the valve and pump system for
emptying, washing and drying operations (please see the hydraulic diagram).
2.2.6 WASH STATION CYCLE
The wash station carries out its operations alternating upward and downward movement. In its
downward movement phase the needles are guided in such a manner as to carry out the following
operations:
• The first needle, using the central cannula, removes the reaction mix while the external cannula
dispenses, shower-like fashion, the wash solution; after that the external cannula dispenses
wash solution and then the liquid is aspirated from the central cannula;
• The second needle operates exactly like the first but uses distilled water instead;
• The third needle operates exactly like the first but dispenses rinse solution into the cuvette so
that an optics check can be performed (if the results are negative, the cuvette is discarded);
• The fourth needle aspirates the Rinse solution used for the optic check.
• The fifth needles dries the sides.
All these operations are part of the routine operation of the instrument. Every reaction cuvette is
washed at the end of each round of analysis.
The reusability (optical integrity) of each reaction cuvette is always tested before the next round of
analysis.
Ellipse User Manual Rev.02 19 October 2005 Page 6
Chapter 02 - GENERAL DESCRIPTION
2.3 TECHNICAL-OPERATIVE SPECIFICATIONS
♦ Completely automatic, random access, computer
DESCRIPTION
REACTION TYPES
TEST SELECTION MODES
PRODUCTIVITY
OPERATING TEMPERATURE
IN LINE REAGENTS
SAMPLE CONTAINERS
controlled, counter-top, non-stop loading clinical
chemistry and immunoturbidimetric analysis
instrument
♦ End Point, Fixed Time, Kinetic, Bichromatic,
Differential
♦ Selective, Batch, Profile, STAT
♦ 138 tests per hour
♦ 37° C
♦ 24 removable containers (capacity 35 and 6 ml)
♦ Reagent plate cooling unit (Optional)
♦ 12 positions for Controls and Standards
♦ Positive Bar Code Reader (Optional)
♦ Primary tubes (diameter from 8 to 16 mm; height
up to 100 mm) cups from 1 to 4 ml
SAMPLE LOADING
MINIMUM REACTION
VOLUME
MAXIMUM REACTION
VOLUME
SAMPLING ARM
DILUTER
♦ 4 racks, each having 8 positions for non-stop
sample loading
♦ Positive Bar Code Reader (Optional)
♦ 220 µl
♦ 550 µl
♦ A single mechanical arm performs all the sampling
operations and is equipped with:
• A volume level sensor
• Pre-heating of the reagent(s) to 37 °C
• Automatic probe washing
♦ Integrated syringe-free module having the
following specifications:
• Sample volume: 2 µl ÷ 99 µl (1 µl incr.)
• Reagent 1 volume: 3 µl ÷ 500 µl (1 µl incr.)
• Reagent 2 volume: 3 µl ÷ 330 µl (1 µl incr.)
• Reagent 3 volume: 3 µl ÷ 330 µl (1 µl incr.)
Ellipse User Manual Rev.02 19 October 2005 Page 7
Chapter 02 - GENERAL DESCRIPTION
PRECISION
READING SYSTEM
OPTIC SYSTEM
CUVETTE OPTIC LENGTH
WASHING STATION
REACTION PLATE
♦ CV < 1 % at 2 µl
♦ Direct reading
♦ Photometer: double ray, interferential filters
♦ Wavelength: 8 narrow band – from 340 nm to 620
nm – interferential filters plus one available
optional filter position
♦ Light source: 6V/10W halogen bulb
♦ Linearity range: up to 3,500 Abs
♦ Resolution: 0.0005 Abs
♦ 6 mm
♦ Composed of five probes that empty, wash and dry
the reaction cuvettes.
♦6 individually replaceable racks with 20 cuvettes
each
♦Incubation temperature: 37°C
2.3.1 SOFTWARE AND COMPUTER SPECIFICATIONS
TYPE
CPU
♦ IBM Compatible
♦ Pentium IV 500 MHz, 512 Kb Cache or plus
♦ RAM 256 Mb or plus
MEMORY
♦ Hard Disk 20 Gb or plus
♦ Floppy Disk 3 1/2” 1.44 Mb
Colour SVGA 15’’ low radiation
MONITOR
Resolution 800 x 600 pixels;
max number of colors 65536 (16 bit)
PRINTER
♦ 80 Columns impact graphic (EPSON LX 300)
KEYBOARD AND MOUSE
INTERFACE
♦ PS2
♦ One Bi-directional RS 232C serial ports and one
parallel (one second serial port for the Host link)
♦ Multitasking WINDOWS XP Home edition
SOFTWARE
AVAILABLE LANGUAGES
Ellipse User Manual Rev.02 19 October 2005 Page 8
♦ Italian, English, Chinese, Czech. Software to be released
soon in these languages: Russian, Portuguese, French,
Polish. Upon request it is possible to release the software
in other languages.
Chapter 02 - GENERAL DESCRIPTION
♦ Disable all the energy saving options
SETTINGS
♦ Disable the screen saver
♦ Select English “USA” as language, dot as decimal
symbol and date and time in Regional setting
NOTE: Even though the computers demonstrate the same technical and operative characteristics,
some of these could have different hardware installed.
This could cause problems for the Ellipse software when running tests (A message appears
indicating “Random” error or blocks the program).
Therefore, if the PC is bought separately/locally, it is highly recommended to test the system before
proceeding with the installation at customer laboratories.
Consequently, AMS denies any responsibility for software problems that are due to buying the
computer separately from the instrument.
2.3.2 OPTIONAL MODULES
♦ POSITIVE BAR CODE READER
2.3.3 DIMENSIONS, WEIGHT AND OPERATING ENVIRONMENT
♦Height: 53 cm
DIMENSIONS
♦Width: 57 cm
♦Length: 75 cm
WEIGHT
OPERATING
ENVIRONMENT
♦35 kilos
♦Temperature: 18 °C ÷ 30 °C
♦ Relative Humidity: 20% ÷ 85%
2.3.4 INSTALLATION SPECIFICATIONS
♦Input voltage: 100 ÷ 230 Vac
♦Input frequency: 47 ÷ 63 Hz
POWER SUPPLY
♦Power consumption:
♦300 W for the analysis unit
♦400 W for the work station
Ellipse User Manual Rev.02 19 October 2005 Page 9
Chapter 02 - GENERAL DESCRIPTION
Warning: in order to assure proper instrument functioning, the manufacturer strongly advises the
use of a stable tension supply outlet (+/-10%). If it is not possible to guarantee said stability, the
manufacturer suggests the use of:
♦ UPS (Uninterrupted Power Supply)
♦ ELECTRONIC STABILIZER
Ellipse User Manual Rev.02 19 October 2005 Page 10
Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
CHAPTER 03 - DESCRIPTION OF INSTRUMENT
SOFTWARE
INDEX
3.1 SYSTEM MONITOR………………………………...……………..…………………….………..3
Warning Lights.................................................................................................................................... …….5
Legends ........................................................................................................................................................ 7
Status Line.................................................................................................................................................... 8
Menus available under System Monitor: ..................................................................................................... 9
Command Buttons………………………………………………………………………..……………....10
Check button ..............................................................................................................................................11
Order button ............................................................................................................................................... 11
Print button................................................................................................................................................. 13
Graph button............................................................................................................................................... 13
Rerun button............................................................................................................................................... 14
Edit Results button ..................................................................................................................................... 15
Move to Archive button ............................................................................................................................. 16
Unload button............................................................................................................................................. 16
3.1.1 START WORK................................................................................................................................ 17
Wash all cuvettes........................................................................................................................................ 17
Water Blank Level ..................................................................................................................................... 18
Calibration & Quality Control.................................................................................................................... 18
Work List ................................................................................................................................................... 19
Start Running ............................................................................................................................................. 19
3.2 CHECKS ........................................................................................................................................... 20
WBL........................................................................................................................................................... 21
Main Area.............................................................................................................................................. ….21
Reagent Volume......................................................................................................................................... 23
Main Area................................................................................................................................................... 23
Details Area……………………………………………………….……………………………………...24
Reagent Configuration ............................................................................................................................... 25
Predilution Rack......................................................................................................................................... 27
3.3 ROUTINE ......................................................................................................................................... 31
Work List Setup .........................................................................................................................................32
Unassigned Sample .................................................................................................................................... 33
Saving data for more than one patient........................................................................................................ 37
Deleting a Patient………………………………………………………………………………….……...37
Ellipse User Manual Rev.02 19 October 2005 Page 1
Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
Deleting a rack…………………………………………………………………….……………………...38
Result by Patient ........................................................................................................................................ 40
Printing Data ..............................................................................................................................................43
Main Area................................................................................................................................................... 44
Precision check........................................................................................................................................... 46
Calibration & Quality Control Setup ......................................................................................................... 47
Calibration Programming........................................................................................................................... 49
Editing Calibration ..................................................................................................................................... 50
Calibration Results ..................................................................................................................................... 51
Quality Control Results.............................................................................................................................. 58
Quality Control Graphs .............................................................................................................................. 60
Receive from Host...................................................................................................................................... 61
3.4 ARCHIVE ......................................................................................................................................... 62
Patients ....................................................................................................................................................... 63
Main Area................................................................................................................................................... 63
Details Area................................................................................................................................................ 64
Calibration.................................................................................................................................................. 65
Main Area................................................................................................................................................... 66
Details Area................................................................................................................................................ 68
Backup........................................................................................................................................................ 69
Restore........................................................................................................................................................ 70
Tests Counter ............................................................................................................................................. 71
Event Log................................................................................................................................................... 72
3.5 PARAMETERS ................................................................................................................................ 73
Inserting the Password ............................................................................................................................... 74
Profiles ....................................................................................................................................................... 75
Ratio ........................................................................................................................................................... 77
Standards.................................................................................................................................................... 82
Controls...................................................................................................................................................... 87
Options ....................................................................................................................................................... 91
Print Order.................................................................................................................................................. 92
Report Options ........................................................................................................................................... 93
Password Setting ........................................................................................................................................ 94
3.6 HELP................................................................................................................................................. 96
Guide F1.................................................................................................................................................... 97
Software versions ....................................................................................................................................... 98
3.7 SHUT DOWN................................................................................................................................... 99
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3.1 SYSTEM MONITOR
Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
Warning Lights
Operative
Buttons
Reagent tray
Sample tra
Reaction tray
Desk Top area
Operative
View Data/Details Area
The system’s management software is extremely user-friendly and, moreover, allows maximum
flexibility in its use.
The operator can access the management software by simply turning on the instrument. If the last
instrument Shut Down was due to a Fatal Error or if the Analyzer is at the time turned off, the user
must double click on the Analyzer icon located on the computer Desk Top.
The user interface screen is subdivided into two main areas:
the Desk Top area
the View Data/Details Area
The Desk Top area is a graphic illustration of the instrument that allows the operator to easily
identify each
single item and its status. It includes:
√ A reagent tray with twenty-four reagents and twelve Standards and Controls positions;
√ A Samples tray composed by four racks with eight positions each.
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Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
√ A reaction tray composed by six racks with twenty cuvettes each.
View Data/Details Area
Located in the lower section of the System Monitor mask, the View Data/Details Area contains
precise, detailed information concerning the item selected (Cuvette, Samples, Reagents, Standards
and Controls).
It is possible to view data details regarding single items by clicking on them whenever the mouse
pointer turns into a question mark as it passes over that particular element.
• If the operator selects a given position on the Reaction Plate, by placing the mouse pointer
over the required item:
a table containing the WBL values of the cuvette selected (both the main channel and the
reference channel values) will be viewed. The Print button will also be activated.
• If the operator selects a given position on the Samples Rack, by placing the mouse pointer
over the required item:
a table listing the tests programmed to be run on that sample will appear in the lower
portion of the window and information regarding the sample itself (patient name, sample
ID, rack and position) will appear in the upper portion of the window.
• If the operator selects a given position on the Reagents Rack, by placing the mouse pointer
over the required item, the below-illustrated table will appear allowing the user to view
information regarding the selected Reagent.
• If the operator selects a given position on the Controls or Standards, by placing the mouse
pointer over the required item, the below-illustrated table will appear allowing the user to
view information regarding the selected Control or Standard.
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Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
WARNING LIGHTS
There are two types of alarms:
• The first type is a brief visual text message, which appears in the lower, left-hand portion
of the screen, up to the operative buttons. It can inform the operator that either there is “no
instrument connection”, or the “cover is open”, or that a “remote link” is in operation.
• The second are Warning Buttons (located in the upper, right portion of the mask) and they
can be:
- either a “Warning” represented by a triangle that lights up yellow. If the operator clicks
on this button, it is possible to view in the Details Area those events which caused the
warning (e.g.: liquid(s) finished).
- or a “Fatal Error” represented by an X that lights up red. Whenever a fatal error is
signalled, only those readings that have already been carried out will be saved; those
operations being carried out at the time are interrupted (e.g.: incubation). After every
“Fatal Error”, the user must have the instrument carry out a Wash cuvette cycle. If the
operator clicks on this button, it is possible to view in the Details Area those events that
caused the warning (e.g.: temperature error).
At this point, it can be useful for the operator to consult Event Log, listed under the
Archive menu, where all instrument status information is memorized, in order to have
more information regarding the occurrence.
Operative Buttons “Actions”:
START (green triangle): allows the operator to access the Start Work mask
where it is possible to start the running of the various tests and of any other operation regarding
the instrument.
PAUSE: temporarily interrupts only the sampling process. It does not interrupt
incubation, nor the reading of already dispensed samples. To restart, press START
.
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Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
STOP: halts instrument functioning - the sampled tests are lost.
Operative Buttons “Racks Replacement”:
Change cuvettes: allows the operator to change cuvettes rack. Clicking on it, the
following dialog box will automatically open and rack selection to be replaced can be done
clicking on the pull-down menu from 1 to 6.
Clicking on “OK” the instrument pass to the Priming and then in Stand-By condition while the
reaction plate turns up to bring the selected position in front of the operator to allow the cuvette
rack replacement.
Click on “OK” into the message that appears after reaction plate positioning to confirm the
happened replacement.
Cuvettes rack can be changed only when the instrument is not performing any operation or
procedure. In such condition, the button is made disable.
Whenever one or more cuvettes illustrated in the Reaction Plate are coloured Red, it is because the
instrument cannot perform the required readings on them due to the fact that they are not perfectly
transparent, or rather; their transparency is below the minimum or above the maximum limit
acceptable to the instrument program. If the operator wishes to view the filter readings, he/she can
do so from within the Details Area.
Whenever a cuvettes rack is inserted for the first time in the Reaction Plate, it is indicated in red
under System Monitor because the instrument does not have that data necessary for the
mathematical equations needed to calculate test results. Therefore, it is necessary to carry out a
WBL for that cuvettes rack (auto-zeroing) in order to be able to use it.
Load Sample/s: allows the operator to load samples rack. Clicking on it, the following
dialog box will automatically open and rack selection to be replaced can be done on the pull-down
menu, among those programmed, in the reported position A, or B, or C or D, defined by the
instrument.
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Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
Clicking on “OK”, the sample plate turns up to bring the selected position in front of the operator,
to allow the sample rack loading.
Click on “OK” into the message that appears after sample plate positioning to confirm the
happened loading.
Samples rack can be loaded at any time, even if the instrument is in running condition.
In this case, pushing the loading operative button, the instrument pass from the Running to the
Pausing and then to the Pause condition, to allow the selected rack loading.
Click on “OK” into the message that appears after sample plate positioning to confirm the
happened loading; click on the START button and confirm pushing OK in order to restart the
running.
Load Reagents: allows the operator to load reagents. The button is able in Running
condition only. Clicking on it, the following dialog box will automatically open and ALL
selection to load reagents can be done on the pull-down menu.
Clicking on “OK” the instrument pass from the Running to the Pausing and then to the Pause
condition the allow the refill of one or more then one used reagents, or one new reagent
configuration loading.
Click on “OK” into the message that appears after reagent plate positioning to confirm the
happened loading; click on the START button and confirm pushing OK in order to restart the
running.
LEGENDS
There are three legends and one symbol to be found under System Monitor and they are the
following:
• A Legend regarding the colours associated with certain visual text messages
concerning reagent and sample status: (upper right)
Reag./Samples:
White (absent)
Sky blue (present)
Yellow (in use)
Green (completed)
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Chapter 03 - DESCRIPTION OF INSTRUMENT SOFTWARE
Magenta (low level)
Red (error - no sample or reagent)
• A legend regarding the various types of reagent bottles having different volume
capacities, that can be selected for use by the operator (medium right)
white 35 ml
sky blue 6 ml
magenta 6 ml
blu 6 ml
• A legend regarding the various types of test-tubes having different volume capacities,
that can be selected for use by the operator (lower right)
white (short – approximately 1 ml)
sky blue (conic– approximately 2 ml)
magenta (primary tube)
By clicking on “Options” under the “Parameters” menu, the operator can select the reagent
bottle to be used by default. The reagent code will be written in the colour of the bottle that
contains that reagent.
• A symbol regarding STAT
Samples having this symbol will be processed first of all the other programmed
and loaded samples.
STATUS LINE
The Status Line, lower left, contains information regarding the functioning condition of the
instrument. Said information allows the operator to follow and check the status of instrument
operation.
Stand By
Stop
Washing
Running WBL
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