This manual has been written in order to supply the technical staff, the persons who are responsible
for the maintenance and for resolving instrument failures, a complete and detailed guide of the
Ellipse analyzer, in accordance with the standard UNI EN591 (which requires a manual to be
supplied with vitro diagnostic instruments for professional use).
1.1.2 MANUAL OUTLINE
The technical manual is composed of 10 chapters that not only describe the operative technical
characteristics of the system, but also the reparation and maintenance procedures to use for the
modules that they are composed of.
. Chapter 1 INTRODUCTION
The manual structure is described, and recommendations are given regarding the general
use of the analyzer. The technical characteristics of the operative system are given in this
chapter.
. Chapter 2 DESCRIPTION OF THE SYSTEM
Describes the system, in particular, the analytical cycle of the single modules and
electronic boards.
. Chapter 3INSTALLATION
Describes the unpacking procedures and the required characteristics for the place of
installation.
. Chapter 4ELECTRONICS SCHEMES AND DRAWINGS
Gives the electronics schemes and assembly drawings of the electronics board and the
assembly drawings of the modules that the system is composed of.
Ellipse Service Manual Rev. 03 01June 2009 Page 2
Chapter 01 – INTRODUCTION
. Chapter 5DIAGNOSTIC PROGRAM
Describes the folders in the Diagnostic Program that are responsible for the checks and the
calibration of the modules in the system.
. Chapter 6SETTINGS AND ADJUSTMENTS
Gives the procedures for replacement, adjustment and check of the system modules.
. Chapter 7MANTENANCE
Describes the routine maintenance that needs to be done on a regular basis in order to
guarantee the correct functioning of the analyzer.
. Chapter 8COMUNICATION WITH HOST
Describes the communication protocol between the analyzer and the Host computer.
•Chapter 9ERROR CODES AND GUIDE TO RESOLVE ANOMALIES
Lists the system’s error codes, describes the errors in the results and gives a guide for how to
implement corrective actions.
The technical staff responsible for resolving the structural anomalies is highly suggested to
thoroughly examine the contents of this manual before operating the system.
Ellipse Service Manual Rev. 03 01June 2009 Page 3
Chapter 01 – INTRODUCTION
1.2 SYSTEM INTRODUCTION
The “Ellipse” system is a continuous-loading, random access, bench top instrument for performing
chemical and Immunoturbidimetric clinical analysis. It is totally automatic and computer
controlled.
Via E. Barsanti 17/A
00012 Guidonia – ROME (ITALY)
Ellipse Service Manual Rev. 03 01June 2009 Page 4
Chapter 01 – INTRODUCTION
1.3 PRECAUTIONARY MEASURES
1.3.1 CHEMICAL RISKS
The individual operator is responsible for assuring that all possible precautionary measures are
taken against eventual risks associated with the use of the “Ellipse” instrument in clinical laboratory
settings. The manufacturer will provide the reagents kit and specific written information on the use
of each of the reagents.
It is important that the samples be well coagulated and then carefully centrifuged.
Samples which contain fibrinogen clots can obstruct the probe and lead to inexact sampling.
If blood samples containing gel are used, it is suggested that the manufacturer’s recommendations
be followed.
Immediately clean and remove any accidental leakage of reagent or other liquid.
1.3.2 ELECTRICAL RISKS
As with any electrical device, the risk of electric shock exists.
Is therefore necessary to take every precautionary measure possible when working with this, or any
other, electrical instrument to avoid contact with power supply wires, electrical components or
electronic boards.
1.3.3 MECHANICAL RISKS
Several precautionary measures should be taken when operating the analyzer:
avoid wearing very loose clothing or jewelry that could become tangled in the instrument’s moving
parts (e.g. the sample probe); whenever possible, operate the instrument with the main cover panel
lowered.
WARNING: Never attempt to service or substitute any part(s) of the analyzer when the
instrument is turned on.
Any and all technical repairs or servicing must be performed by specialized personnel only.
Ellipse Service Manual Rev. 03 01June 2009 Page 5
Chapter 01 – INTRODUCTION
1.4 WARRANTY
AMS guarantees the replacement of all defective components and/or materials for a period of time
not above of 14 months starting from the date of invoicing. Saying guarantee, as well as Technical
Assistance, generally is intended furnished as net ex factory Rome.
This guarantee does not include consumable and instrument parts in contact with liquids. All
components not included in the guarantee are reported in the following table.
Besides guarantee 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.
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Chapter 01 – INTRODUCTION
CONSUMABLES AND ACCESSORIES PARTS LIST OUT OF GUARANTEE
Description
Type QuantityCode
Reagents containers 35 ml 12 pieces C101-00190-00
Reagents containers 6 ml 12 " C101-00191-00
Samples cups 0.8 ml
1000 "
AS-65-0002
Short samples cups 1 ml 1000 " AS-65-0100
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 " 10-01920-00
Halogen Lamp (6 V - 10 W)1 " 9-35-0016-00
Interferential filters Kit 1 " 9-65-0029-00
Fuse 6,3 A-T 5x20 10 " C130-01238-08
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 Service Manual Rev. 03 01June 2009 Page 7
Chapter 01 – INTRODUCTION
1.5 TECHNICAL OPERATING FEATURES
DESCRIPTION
ASSAY TYPE
TEST ENTRY MODE
THROUGHPUT
♦ Fully automatic, random access, continuous loading,
benchtop analyzer for clinical chemistry and
immunoturbidimetric assays;
♦ End Point, Initial Rate, Kinetic, Bichromatic, Differential;
♦ Selective, Batch, Profiles, STAT
♦ 138 tests per hour
WORKING TEMPERATURE ♦ 37° C
♦ 24 removable containers by 40 ml and 6 ml;
ON LINE REAGENTS
♦ 12 positions for Controls and Standards;
♦ Positive identification by a Bar Code Reader
♦ Primary tubes (diameter from 8 to 16 mm; height up to
100 mm) cups from 1 to 4 ml;
SAMPLE CONTAINERS
♦ 4 racks, each having 8 positions for continuous sample
loading
SAMPLE LOADING
♦ Positive identification by a Bar Code Reader
MINIMUM REACTION VOLUME
MAXIMUM REACTION VOLUME
SAMPLING ARM
DILUTER
PRECISION
♦ 220 µl
♦ 550 µl
♦ A single mechanical arm provides all the sampling
operations and is equipped with:
• Capacitive liquid level sensing
• Reagent pre-warming at 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.)
♦ CV < 1 % at 2 µl
READING SYSTEM
♦ Direct reading
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Chapter 01 – INTRODUCTION
♦ Photometer: double beam, interferential filters
♦ Wavelength: 8 narrow band interferential filters
OPTIC SYSTEM
from 340 nm to 620 nm , plus one available
optional filter position
♦ Light source: 6V/10 W halogen bulb
♦ Linearity range: up to 3,500 Abs
♦ Resolution: 0.0005 Abs
OPTICAL PATH
WASHING STATION
REACTION PLATE
1.5.1. COMPUTER & SOFTWARE FEATURE
TYPE
CPU
MEMORY
♦ 6 mm.
♦ Composed of five probes that empty, wash and
dry the reaction cuvettes.
♦ 6 singular replaceable racks with 20 cuvettes
each
♦ Cuvettes Q.C. continuously computer controlled
♦ Incubation temperature: 37°C
MINIMUM REQUIREMENTS
♦ IBM Compatible
♦ Pentium IV 500 MHz, 512 Kb Cache
♦ RAM 256 Mb
♦ Hard Disk 20 Gb
♦ 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
INTERFACE
SOFTWARE
AVAILABLE LANGUAGES
♦ 80 Columns impact graphic (EPSON LX 300)
♦ One Bi-directional RS 232C serial ports and one
parallel (one second serial port for the Host link)
♦ Multitasking WINDOWS XP Home edition
♦ 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.
♦ 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
Ellipse Service Manual Rev. 03 01June 2009 Page 9
Chapter 01 – INTRODUCTION
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 at
your offices before preceding with the installation at the final client’s.
Consequently, AMS denies any responsibility for software problems that are due to buying the
computer separately from the instrument.
1.5.2 OPTIONAL MODULES
♦ POSITIVE BARCODE READER
1.5.3 DIMENSIONS, WEIGHT & OPERATING ENVIRONMENT
DIMENSIONS
WEIGHT
OPERATING ENVIRONMENT
1.5.4 INSTALLATION REQUIREMENTS
POWER REQUIREMENTS
♦ Height: 53 cm
♦ Depth: 57 cm
♦ Length: 75 cm
♦ 35 Kilos
♦ Temperature: 18°C ÷ 30°C.
♦ Relative humidity: 20% ÷ 85%
♦ Input Voltage 90 ÷ 250 Vac
♦ Input Frequency: 47 ÷ 63 Hz
♦ Power consumption:
♦ 300 W for the analytical unit
♦ 400 W for the work station
♦ EN 61010-1:1993 +A2:1995
(IN COMPLIANCE WITH THE MAIN
SAFETY REGULATIONS
EUROPEAN DIRECTIVES 73/23/CEE AND
93/68/EEC REGARDING SAFETY)
Ellipse Service Manual Rev. 03 01June 2009 Page 10
Chapter 01 – INTRODUCTION
♦ EMC 89/336/EEC – 92/31/EEC Directives
♦ EN 55011, Class B, Group 1
♦ EN 50081-1:1992 EMC
ELECTROMAGNETIC
COMPATIBILITY
♦ EN 55022
♦ ENV 50140 – ENV 50141
♦ EN 60601-1-2
♦ EN 61000-4
Warning: A steady power supply (+ 10%) must be provided for the instrument.
If it is not, the manufacturer highly recommends the use of:
♦ UPS Uninterruptible Power Supply ( No-break module)
♦ ELECTRONIC STABILIZER
Ellipse Service Manual Rev. 03 01June 2009 Page 11
Chapter 02 – SYSTEM DESCRIPTION
CHAPTER 02
– SYSTEM DESCRIPTION -
INDEX
2 DESCRIPTION OF THE SYSTEM ................................................................................................ 2
Ellipse Service Manual Rev. 03 01 June 2009 Page 1
Chapter 03 - INSTALLATION
3.1 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
not include the PC component, 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 list
corresponds to that impressed on the plate on
the right side of the instrument.
S/N
P/N
ELLIPSE
90 - 250Vac 47 - 63Hz
Analyzer
Medical
System
Rome-Italy
300W
Open the crate(s)/box from the top and very
carefully take out:
- the instrument;
- the computer and accessories.
MAKE SURE THAT THE UNPACKING IS CARRIED OUT BY TWO PEOPLE.
Ellipse Service Manual Rev. 03 01 June 2009 Page 2
Chapter 03 - 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.
Remove the adhesive tape from the cover of the samples and reagents housing, from the front
panels and from the samples and reagents racks.
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:
¾ Reposition the protective packing material under the sampling arm and under the wash
station group.
¾ Tape down (using masking tape if possible) the cover of the samples and reagents housing,
the front panels, and the samples and reagents racks.
¾ Remove the probe from the sampling arm and place it inside a cuvette. Then cap the
cuvette and tape the cap down.
¾ Be very careful to not bend the wash station cannulas when repositioning the protective
packing material.
¾ Fill the empty spaces around the accessories packed in the crate using “pluriballs” or other
suitable packing material.
Ellipse Service Manual Rev. 03 01 June 2009 Page 3
Chapter 03 - INSTALLATION
3.2 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 security indications are not respected,
AMS cannot guarantee correct functioning of the instrument. Apart from this, the security of
the operator could be placed at risk.
3.2.1 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
LOCATION
In covered and dry place
2
I
II
between18°- 30°C
20% ÷ 85%
Max 3000 m
Shelf or table with a minimum surface of 75 x 60 cm
stable and free of vibration
VENTILATION
Leave a minimum distance of 10 cm around the
instrument to permit air circulation . Make sure that
the front and rear holes are not blocked by any object
3.2.2 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 Amp/T - 5 x 20
Ellipse Service Manual Rev. 03 01 June 2009 Page 4
Chapter 03 - INSTALLATION
NOTE: IT IS ADVISABLE TO MAINTAIN THE MAXIMUM STABILITY OF THE ELECTRICAL CURRENT IN
THE LABORATORY
FOLLOWING SUPPLEMENTARY DEVICES IS RECOMMENDED
. WHERE THIS IS NOT POSSIBLE OR ASCERTAINABLE, USE OF THE
:
ELECTRONICSTABILIZER
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.
3.2.3 CONNECTION OF THE ACCESSORIES
3.2.3.1 POWER SUPPLY
Fig. 1 - – Plug (use the feeder cable supplied with the instrument).
The sticker indicates the power supply voltage and the values of the fuses.
Ellipse Service Manual Rev. 03 01 June 2009 Page 5
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