Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
Tel.+39/065127161 – Fax +39/065127550
email edif@edif.it
EI1121A – Echo PC User manual - Rel. 1.1
i. INTRODUCTION
i.1. Identification Data
This document represents the User’s Manual of the ECHO, an automatic multiparameter analyzer for clinical chemistry.
The document has to be intended as a functional part of the ECHO analyzer instrument
and the user must read carefully all the sections of this manual, before operate with the
instrument.
The manufacturer doesn’t take any responsibility related to partial or unauthorized copy
of its contents.
i.1.1. Document
•Document Part Number
•Document Revision
•Dated
•Software Version
•Release Date
i.1.2. Instrument
•Instrument Part Number
: EI1121A
: Rel. 1.1
: 03/07/2008
: Rel. 4.23
: 2008
EI0002A
i.1.3. Manufacturer
Edif Instruments s.r.l.
Via Ardeatina, 132
00179 Roma – ITALY
Tel.+39/065127161
Fax +39/065127550
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
Tel.+39/065127161 – Fax +39/065127550
email edif@edif.it
EI1121A – Echo PC User manual - Rel. 1.1
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i.2. Copyright
This document is property of Edif Instruments S.r.l.
Unauthorized copies or alterations of its content could cause legal actions in order to
preserve manufacturer’s interests.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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EI1121A – Echo PC User manual - Rel. 1.1
i.3. International and European Norms Compliance
This document was written according to UNI EN 591: 1996 standard.
The ECHO equipment meets the following directives:
EN 55001
EN 61326-1
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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i.4. Patents
Currently there are not patents for this instrument.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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i.5. Document Intended Purpose
This document represents the User’s Manual of the ECHO automatic multi-parameter
analyzer.
It is forwarded to laboratory technical personnel that have experience in laboratory
practice and in laboratory automated equipments handling.
NOTE: The Manufacturer declares that the information inside this manual have to
be considered sufficient to perform a proper use of the referred equipment only in
case of readers who have previously followed a manufacturer’s specific training
course.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
Tel.+39/065127161 – Fax +39/065127550
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EI1121A – Echo PC User manual - Rel. 1.1
i.6. How to Use this Manual
The Manufacturer recommends to read this User’s Manual in any of its parts; in
particular it is necessary to take care of notes, used to specify or to probe concepts
previously treated, and of warnings, used to emphasize potentially risks or hazards.
All the notes and warnings, written in bold print, must be read carefully, paying
particular attention to the following sections:
•Safety (Chapter 1)
•Installation (Chapter 3)
•Maintenance (Chapter 8)
During Laboratory daily operation, it is also suggested by the Manufacturer not to keep
this User’s Manual too far from the ECHO instrument.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
Tel.+39/065127161 – Fax +39/065127550
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EI1121A – Echo PC User manual - Rel. 1.1
i.7. Index of Contents
Section i - INTRODUCTION
i.1 Identification Data .............................................................................................. pag. 1
12.1 List of Acronyms and Abbreviations.................................................................. pag. 1
12.2 List of Terms ...................................................................................................... pag. 2
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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EI1121A – Echo PC User manual - Rel. 1.1
1. SAFETY
The safety precautions and regulations included in this section must be strictly observed
by the User.
The use of the Instrument for purposes other than those specified in Chapter 5 will
automatically invalidate any warranty agreement.
The user must not carry out any kind of alteration on the Instrument, included software
manipulations. Every unauthorized change or modification and not observance of the
maintenance procedures will immediately invalidate warranty agreements.
1.1. General Warnings
All notes and warnings in this Manual which are in bold and/or underlined must be read
carefully, paying particular attention to the following sections:
•Installation (Section 3)
•Disinfections Procedures (Section 8)
All assay methods must be validated on the analyzer before carrying out any laboratory
routine. Such validation must include:
•Make sure that the instrument correctly handling the various reagents, with
reference to:
oAspiration, transfer and distribution of the liquid
oLiquid mixing (if required) without bubble or froth formation, which may
create problems in later stages of the process.
•Reliability of materials used for the procedure (sample tubes, reagent and/or
control vials, microplates, etc).
•Accurate calculation: ensure that the software calculations give results
comparable to those obtained using the methods specified by the assay
manufacturer.
These procedures are normally validated by the distributor: if the required data are not
available for any particular assay, the user must validate these procedures himself.
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Any modification made to pre-validated procedures must be validated again.
The User should always check the proper closure of the Instrument covers, during the
use of the instrument.
The User must always assure himself that all Instrument technical activities related to
installation, performance verification and repair are carried out by qualified personnel.
All precautions and recommended practices normally used in the laboratory (Good
Laboratory Practice) must be followed: this is particularly important because the
diagnostic tests are carried out automatically by the analyzer.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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1.2. Safety Labels
Infective tank warning
This label is placed on the external tank for the waste and near the peristaltic pumps. It
informs the user about the contamination risk for the part where it is placed.
ATTENZIONE
SERBATOIO POTENZIALMENTE INFETTO
WARNING
POTENTIALLY INFECTIVE TANK
Electrical risk warning
This label is placed on the back of the instrument and it informs the user about electrical
risk.
WARNING
HIGH VOLTAGE INSIDE DO
NOT OPEN CABINET, REFER
TO QUALIFIED PERSONNEL
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1.3. Safety Warnings
To reduce the risk of electric shock, keep away from live circuits. The instrument must
be connected to a ground point. The instrument is equipped with a three-core cable to be
connected to a 220 Vac or 110 Vac power socket.
1.3.1. Installation
On customer demand, the installation, verification and calibration of the instrument,
will be carried out by qualified technical personnel. They should take reasonable steps
to ensure that the location in which the equipment is to be installed meets the
environmental and electromagnetic specifications for the analyzer. Any significant
movement of the equipment should be carried out by qualified personnel.
If the instrument has the refrigerated plate option, a free air space of at least 10 cm is
necessary to allow air-cooling inlet, placed on the bottom of the instrument, on the left
side.
1.3.2. Operations
If the ECHO is used for automated clinical chemistry analysis; the Manufacturer
reminds the Users that failures following safety precautions and regulations could
produce false negative results reporting.
For these reasons, particular care must be carried out by the operator to the following
points:
•Use only test procedures or assays pre-validated by the Manufacturer or its
distributor;
•Don’t introduce any modification on pre-validated procedures or assays;
•Avoid to use vials other then Manufacturer suggested types;
Particular care must be observed for the instructions provided by the Manufacturer in
order to perform correct switching on and off procedures.
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NOTE: The Manufacturer reminds to the User that safety precautions failure
could produce human hazard, risk or damages both for operator and patient.
1.3.3. Maintenance
The User must carry out the maintenance procedures quoted in Chapter 8, in order to
assure a correct operation of the instrument and the reliability of the assay results.
NOTE: The Manufacturer remarks to the User that continuous Instrument visual
inspection is the first and easier way to guarantee the best equipment
performances.
User’s maintenance tasks must observe the following safety recommendations:
•Read carefully the instruction on Chapter 8 before starting with maintenance;
•Clean every part of the Instrument only using soft cloths;
•Remove immediately spills or sketches from the working planes, if any;
•Use only non corrosive solutions;
All User maintenance tasks must be carried out with the Instrument in OFF state
and with the main power cable disconnected from the power socket.
1.3.4. Transport and Storage
Take care during the transport and the unpacking of the instrument.
To store the instrument read carefully Section 10.6 ‘Storage Environmental
Requirements’.
WARNING
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1.4. Risks Related to the Use
The Manufacturer reminds that the use of the Instrument doesn’t assure the absence of
exposure to BIOHAZARD so the Instrument must be always handled as potentially
infected device.
The Manufacturer declares that information provided through this manual have to be
consider sufficient to perform a “free of risk” usage of the referred equipment only in
case of readers that previously exceed a manufacturer’s specific training course.
To reach the full throughput condition of the Instrument and to assure at the same time
the user safety, the Manufacturer recommends, considering both the operator and the
patient point of view that the daily operators have to be also previously trained to the
operating system basic usage.
The Manufacturer also assumes that all precautions and recommended practices
normally used in the laboratory (Good Laboratory Practice) must be applied by the
Instrument operators.
NOTE: To avoid running additional risks, do not make any unauthorised
modifications; any kind of alteration should be made with the prior authorisation
of the manufacturer.
1.4.1. Human Hazards
Particular safety items against human hazards are the following:
•Do not eat, drink or smoke in the laboratory;
•Wear the lab coats at all time and particularly near the Instrument placement
point.
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Tel.+39/065127161 – Fax +39/065127550
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1.4.2. Personal Safety Aspect
The Manufacturer declares that the Instrument and all its internal parts were designed
and manufactured to prevent any possible risk for the operator safety.
It is mandatory, for the operator safety, to install an emergency breaker at not more than
one meter from the Instrument.
1.4.3. Information on Infectious Liquids and Parts
The use of the instrument doesn’t assure the absence of exposure to biohazard.
The Manufacturer remarks to the User that all parts of the Instrument that could come
into direct contact with blood or sera, including positive controls, and/or reagent must
always be treated as potentially infected materials.
The instrument must be always handled as potentially infected device.
1.4.3.1. Handling
When handles potentially contaminated sera, the operator must wear:
•Lab coat
•Disposable gloves
•Safety glasses
in order to avoid splashes and/or spilling of the infectious liquids that could come into
contact with any exposed part of the body.
Take special care when you handle the following parts of the instrument:
WARNING
•Metal needles
•Waste tank
because they could be contaminated: they come in contact with sera and reagents.
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Eventual tools and instruments used during technical intervention must be sterilised,
before putting them back into their cases.
1.4.3.2. Dismantling
All waste materials, including both liquids and solid, must be dismantled according with
regional laws and local regulations.
The Manufacturer remarks to the user that all waste materials must always be
treated as potentially infected materials.
In case of replacement of faulty parts, each broken parts, dismounted from the
Instrument just by manufacturer or local distributor qualified personnel, must be
handled as potentially infected materials.
WARNING
The Manufacturer declares that all technical personnel have exceed a specific training
course related to infected materials treatment.
All parts dismounted from the Instrument that could have been entered in direct
contact with possible contamination sources must be subjected to a valid
decontamination process before leaving the User’s medical laboratory.
The dismantling of the product should be carried out by applying the national
regulations, referring to the local environment authority, taking into consideration that
the instrument is manufactured with no noxious materials for the environment.
1.4.3.3. Contamination
Risks of contamination exist only during the operations of loading/unloading; with
regard to this, see section 1.4.3. (Information on Infectious Liquids and Parts). During
the instrument operation there are not contamination risks because the instrument, in
this step, doesn’t need the user intervention.
WARNING
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1.5. Recommendations for Optimal Performance
The User must observe the following recommendations in order to get the specified
performance from the instrument.
•Fill sample vials out of the instrument, in order to avoid spilling of liquids on
the ECHO working area.
•The user must ensure that, when placing test tubes or vials into the analyzer,
these are properly seated.
•If the laboratory does not have back up power supplies, a standby system
(UPS) providing at least 1.5 kW, should be used to provide power during shortterm cuts.
WARNING
Use of the instrument for purposes other than specified, indicated or agreed upon
with the manufacturer, will automatically invalidate all warranties. The
manufacturer reserves the right to take any legal action to protect all its interests.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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2. SYMBOLS
No symbols are applied on this version of ECHO.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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EI1121A – Echo PC User manual - Rel. 1.1
3. INSTALLATION
3.1. Equipment Overview
The ECHO is provided with internal LCD screen, that allows to control all its functions
and operation. Its working area is planned to work in safety and with maximum
productivity; it enclose the reagent plate, where are placed the reagent tubes, the sample
plate, that contains the sample vials, ant the incubation plate.
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3.1.1. Supplied Materials
In the following sections are listed the supplied materials, subdivided in a standard
supply list and in a list of options.
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3.2. Installation Constrains
During the installation of the ECHO, the operator has to observe mechanical and
environmental constrains in order to assure a correct instrument operation.
3.2.1. Mechanical
ECHO should be positioned on a working bench, at least 1 meter long, free of vibrations
and far from electromagnetic sources (big electrical motors, elevators, therapeutic
equipment, X rays etc.) and with a good ground connection.
The working bench must be a robust table, to prevent the oscillation of the instrument: the
table should be as flat as possible and capable of bearing the weight of the instrument.
3.2.2. Environmental
The place where the instrument will be installed should be possibly an air-conditioned
room, to have a firm temperature and a correct degree of humidity. Avoid the direct
exposure to the sunbeam.
Allow a working space around the instrument of at least 50cm. However, if space
facilities are restricted and the instrument has the refrigerated plate option, the air intake
located on the bottom of the instrument, on the left side, must have a free air space of at
least 10 cm.
3.2.3. Software
The ECHO software is a firmware multitask application purposely realized for this
instrument; it has characteristics of reliability and use facility. It is recorded on the two
EPROMS mounted on the CPU board.
An internal mini-PC with a DOS Terminal program is used for the video, keyboard,
external printer and host interface.
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3.3. Storage
To store in the right way the instrumentation, it is recommended to store it in a dry area
and to observe the storage environmental requirements listed in section 10.6.
Remember that the instrument must be stored exclusively in its original wood packing
and that the operations for the storage must be carried out only by authorized personnel.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
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3.4. Unpacking
Before proceeding to unpacking the instrument, check that all constrains and
environmental conditions are met – refer to section 10 Technical Specifications.
3.4.1. Package Characteristics
ECHO is normally despatched in a box made of cardboard studied to give the best
protection to the instrument, during transportation in normal conditions. The original
packing can be re-used if the instrument has to be moved or sent back.
3.4.2. Transport Damages Check
Check the package carefully for damages. The eventual damages caused by the
transport should be contested immediately to the shipping company and noted on the
delivery note.
Once the goods are delivered to the shipping company, the responsibility for its integrity
is his until the delivery of the goods.
If you find some anomalies:
1) Do not refuse the shipment
2) On the receipt of delivery, write a note on the fact
3) Do not remove the package! Leave the instrument in the original package, and request
immediate inspection from carrier within 15 days from delivery – if the delivery is
international, the inspection must be requested within 3 days from delivery.
NOTE: Check if the above procedure is in conformity with local regulations and/or
special agreements with the shipper.
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
Tel.+39/065127161 – Fax +39/065127550
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3.4.3. Removal from Package
Open the boxes and extract the instrument carefully.
Verify that all the parts described in the delivery note are present, including the
welcome kit as well.
Control the serial number of the instrument, if the same corresponds to the one indicated
in the delivery note.
Remove the lid and then remove the two lateral elements that secure the instrument.
At least two persons are needed to move the instrument from its box to the working table.
Lift the instrument up and place it on the working bench (the one on which the
instrument is destined to be operated upon).
Edif Instruments s.r.l. – Via Ardeatina, 132 – 00179 Roma – ITALY
Tel.+39/065127161 – Fax +39/065127550
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