A.MENARINI ARKIVE SL User manual

“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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ELECTRONIC-MECHANICAL DEVICE
FOR LOADING SLIDES TO BE ARCHIVED AND
THE RETRIEVAL OF ARCHIVED SLIDES
Operator’s Manual
10/2019 - Rev. 1.1
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
- 2 of 58 -
11/2019 - Rev. 1.3
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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DOCUMENT
Name: Operator’s Manual
Revision: 1.1 –November 2019
REFERENCE STANDARDS
Directive 98/79/EC, European CE Marking for In Vitro Diagnostic (IVD) devices
Directive 2012/19/EU, Waste Electrical and Electronic Equipment Directive (WEEE)
IDENTIFICATION OF THE DEVICE
Name: FINDER for SLIDES
Version: 01
MANUFACTURED FOR Menarini Diagnostic S.r.l.
BY:
Logicon S.r.l. Via Galilei 245 - 29010 Alseno (Pc) –Italy –www.logicon.it / www.logibiotech.com
Operating headquarters: Via Galilei 245 –29010 Alseno (Pc) - Italy
TECHNICAL ASSISTANCE –CUSTOMER SERVICE
www.menarinidiagnostics.it
This document cannot be copied in whole or in part, reproduced, or translated into other languages on any other
media without the written permission of “Menarini Diagnostics S.r.l.”.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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11/2019 - Rev. 1.3
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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The FINDER for SLIDES, which from now on will be referred to simply as FINDER, is
an electronic-mechanical device that serves for assisting the operator in carrying out
the slide archiving and retrieval operations as described in the following paragraphs.
The FINDER has been designed exclusively for the procedures of archiving,
cataloguing, retrieving and storage of cyto-histological slides.
The FINDER is intended for the exclusive use by appropriately trained professional
users, such as laboratory technicians and physicians who are experts in the archiving
techniques of cyto-histological slides.
This manual is an important and integral part of the device, as it indicates its operation
and maintenance in total safety.
The instructions must always be read before the installation, maintenance or use of
the device.
A copy of this manual must always be kept near the device.
The device is supplied already tested at the manufacturer's factory.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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Nevertheless, an operational verification is foreseen after installation at the customer’s
site with the drafting of the final test report.
All users will be trained at specific theoretical-practical training courses held by the
technicians of “Menarini Diagnostics S.r.l.”, with mandatory attendance by the
personnel in charge of using the device.
All users are qualified to use the device after demonstrating that they are familiar with
the device's features. When successfully completed, a specific theoretical-practical test
establishes the qualification to use the device.
The device must only be used by trained personnel holding the relative certification.
Only the personnel who have attended the specific training course and successfully
passed the final evaluation test are authorised to use the device.
Users who successfully complete the final theoretical-practical examination at the end
of the training course will receive a certificate for use of the device.
Directive 98/79/EC, European CE Marking for In Vitro Diagnostic (IVD) devices.
Directive 2012/19/EU, Waste Electrical and Electronic Equipment Directive (WEEE).
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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The device is identified with the following label:
Symbol
Meaning
Hazard/Immediate or potentially hazardous situation
High voltage/Danger of serious injury or death
CE marking of in vitro medical diagnostic devices
Read the instructions before carrying out any operation
Correct disposal of electrical and electronic devices (WEEE –Waste
Electrical and Electronic Equipment Directive)
Residual risk of electrocution
Residual risk of crushing of limbs
Residual risk of fire
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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To make it easy to understand this document, a glossary of the technical terms that
are used is provided below. It is recommended to refer to this glossary in case of
doubts or misunderstandings, and should they persist further, to contact the Technical
Assistance –Customer Service on www.menarinidiagnostics.it to receive appropriate
clarifications.
TERM
DESCRIPTION
Arkive_Server
Cabinet with the hardware unit installed inside that acts as a
server
Arkive_Std
Cabinet not containing a server
DHT
Wi-Fi temperature and humidity sensor
Rack
Loader-collector of slides to be inserted inside a cabinet container
Pc_Server
Hardware unit that acts as a server and includes the operating
system and MAPS (Mitsubishi Adroit Process Suite) management
and communication software
Finder
Electronic-mechanical device that automatically loads and
unloads the slides, identifying them before inserting them or
removing them from the racks
Cartridge
Slide container to be inserted into the Finder for the slides’
transfer to and from the racks
Mission
The task of archiving or retrieval of the slides transmitted by the
head of the laboratory from the terminal to the operators’
smartphones.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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In order to ensure correct operation, the installation of the device must be carried out
exclusively by qualified and authorised technicians.
The following requirements must be complied with before, during and after
installation:
It is forbidden for unauthorised persons (including children, the disabled, or
individuals with reduced physical, sensory and mental capacities) to carry out
any operations.
Read these instructions before carrying out any operation.
Wear appropriate protective equipment for the operations to be performed. As
regards the personal protective equipment (PPE), the European Community
has issued directives to which operators must strictly adhere. Airborne noise
≤70 dB
Exclude all forms of power supply upstream from the device whenever it is
necessary to operate in conditions of safety.
The installation operations must be carried out by qualified and authorised
technical operators, in compliance with the laws in force in this sector and
with the use of the appropriate and described materials.
If necessary, the operator authorised for the handling and installation
operations of the device must organise a "safety plan", for protecting the
safety of the persons involved in the operations. In addition, the laws and
regulations relating to mobile construction sites must be strictly and
scrupulously followed.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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The device must be handled with lifting equipment that is suitable to bear its weight.
If the device needs to be transported, it must be on its original pallet and under no
circumstances must it be stacked on top of other devices. If it is necessary to move
the device without its original pallet, it must first be adequately protected and then
lifted. The device must never be pushed or dragged, causing it to scrape along the
floor.
The device must be installed in a suitable room according to the specifications
indicated below:
•the room temperature must be between 15°C and 25°C;
•the floor must be non-slip;
•the device must be positioned perfectly level;
•the room must have load-bearing characteristics of at least 6 kN/m2;
•the room must have ventilation and lighting systems as prescribed by the
regulations in force in the user’s country;
•the room must be clean and free of moisture;
•the room must have switches to cut off any form of electricity upstream if
necessary (emergency shut-off);
•the room must have a preferential electricity line in “absolute continuity” coming
from a UPS to which the system can be connected;
•the room must have Ethernet or Wi-Fi coverage for access to internet, which
will be used for remote control of the system, for data backup and for connecting
to the Laboratory Information System (LIS);
•the walls immediately behind the device must be fireproof and isolated from
possible heat sources.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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Particular attention and care must be taken in positioning the device, which must be
conserved with the utmost diligence as though it were a personal possession.
The device must be powered from the mains and must therefore be connected to the
same according to the regulations in force.
Upon completion of the installation, all the operators must receive appropriate training
from a qualified and authorised technician. Under no circumstances should the device
be used by untrained personnel.
All qualified and authorised technicians must perform the installation and any other
changes or repairs to the device in a workmanlike manner.
The device must be installed with sufficient ventilation according to the previously
specified environmental requirements.
The device is not designed to operate in an explosive atmosphere. For this reason, it
must not be installed in an area subject to the ATEX directive 2014/34/EU
(ATmosphères & EXplosives).
If the device is to be positioned against a wall or partition, these must be made of
non-combustible materials.
Under no circumstances must the device be installed near heat sources.
The manufacturer certifies that the packaging complies with Directive 2018/852, which
amends Directive 94/62/EC on the management of packaging and packaging waste;
at the same time the manufacturer also requires that the final installer and the user
observe the rules regarding the removal of the packaging in terms of recycling or
reuse.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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The methods of storing the materials must foresee containers and devices suitable for
preventing damage due to vibrations, bumping, abrasions, corrosion, out-of-range
temperatures or other environmental conditions that could harm the device.
The stored parts must be checked from time to time to detect any deterioration.
The device is protected on the external surfaces with a film that must be removed
manually after completing the positioning phase.
Before installation, remove all protective parts. Carefully clean the device, manually
removing all the material used to protect the components.
Take great care with steel surfaces in order to prevent damaging them; in particular,
avoid the use of corrosive products and do not use abrasive materials or sharp tools.
Do not use pressurised or direct water jets.
Do not use aggressive materials such as cleaning solvents.
Carefully read the instructions on the label of the cleaning products before using them.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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Position the device in the room intended for its use after having verified that the
suitability conditions exist (see permitted operating and environmental limit
conditions).
In the absence of the required conditions, the premises must previously be made
suitable.
The levelling and anchoring requires the adjusting of the device as a single unit
independently of any other adjacent devices:
•assemble and adjust the levelling feet;
•place a spirit level on the structure and follow the indications provided by the
level;
•perfect levelling is obtained by regulating the level and feet according to the
width and depth of the structure.
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
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“ARKIVE SL FINDER” OPERATOR’S MANUAL
THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION, EVEN PARTIAL, IS PROHIBITED.
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96 cm (width) x 25 cm (height) x 40 cm (depth).
In the basic configuration, the FINDER can have a maximum of 1 rack and 1 slide-
holder cartridge on board.
When empty, its weight is equal to 30 kg, while with a full load, its weight is 32
kg.
The FINDER is a microprocessor device powered with low voltage, 12 Volt DC, via an
external 220-Volt AC power supply.
The FINDER is equipped with an electronic circuit that makes it possible to control
the electric motors, manage the sensors and photocells for safety purposes, and
display information or alarms for the operator on the display.
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