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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

 

 

 

ELECTRONIC-MECHANICAL DEVICE 

FOR LOADING SLIDES TO BE ARCHIVED AND  

THE RETRIEVAL OF ARCHIVED SLIDES 

 

Operator’s Manual

 

 

10/2019 - Rev. 1.1

 

Approved

Содержание ARKIVE SL

Страница 1: ...IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 1 of 58 11 2019 Rev 1 3 ELECTRONIC MECHANICAL DEVICE FOR LOADING SLIDES TO BE ARCHIVED AND THE RETRIEVAL OF ARCHIVED SLIDES Operator s Manual 10 2019 Rev 1 1 Approved ...

Страница 2: ... 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 Approved ...

Страница 3: ... 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 who...

Страница 4: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 4 of 58 11 2019 Rev 1 3 Approved ...

Страница 5: ... OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 5 of 58 11 2019 Rev 1 3 9 9 9 9 10 10 11 11 12 13 13 15 17 17 18 19 20 20 20 20 20 20 21 22 22 Approved ...

Страница 6: ...TOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 6 of 58 11 2019 Rev 1 3 22 22 23 23 23 23 23 25 27 27 28 29 33 33 33 39 42 42 43 43 43 43 44 44 45 46 46 46 Approved ...

Страница 7: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 7 of 58 11 2019 Rev 1 3 46 46 49 51 53 Approved ...

Страница 8: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 8 of 58 11 2019 Rev 1 3 Approved ...

Страница 9: ...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 main...

Страница 10: ...e 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 authorise...

Страница 11: ...aning 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 ris...

Страница 12: ...nstalled 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 aut...

Страница 13: ...ipment 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 technica...

Страница 14: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 14 of 58 11 2019 Rev 1 3 Approved ...

Страница 15: ... 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 ...

Страница 16: ...allation 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 ...

Страница 17: ...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 ...

Страница 18: ...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 obta...

Страница 19: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 19 of 58 11 2019 Rev 1 3 Approved ...

Страница 20: ...nd 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 dis...

Страница 21: ...s All the slide archiving retrieval phases are tracked and stored within local and cloud databases In the event of any anomalies it is possible to reconstruct the entire itinerary and the archiving retrieval process of each individual slide The room must possess all the features required for its installation as follows the room temperature must be between 15 C and 25 C the floor must be non slip t...

Страница 22: ... must be fireproof and isolated from possible heat sources The device emits noise below 80 decibels dB therefore there is no risk of exposure to noise for any of the operators As reported in Legislative Decree 81 2008 hearing PPE is not required An emergency stop button is installed on the right hand side of the FINDER that can be easily reached from any position in which the operator finds him he...

Страница 23: ...tarted There are no power circuits and all circuits are control circuits These circuits do not therefore require any protection There is no fire protection system on the machine or in the rooms where the device is installed and no particular precautions are necessary apart from those required by current legislation since the risk of fire is a residual risk The installation of the device must be ca...

Страница 24: ...vent of improper use the manufacturer cannot be held liable for any possible damage to objects or injury to persons When in operation the device must always remain connected to the power supply line regardless of whether it is in operating or stand by state the connection must be carried out in full compliance with the electrical regulations in force On the other hand the system must be disconnect...

Страница 25: ... the manufacture and trade of the product there are still residual risks which due to the nature of the device itself it was not possible to eliminate These risks include the following Residual risk of electrocution this risk exists if it is necessary to operate electrical and or electronic devices in the presence of voltage as non compliance can cause serious injury or death Residual risk of crus...

Страница 26: ... 2019 Rev 1 3 Keeping the device and all ancillary equipment in order and functional is the responsibility of the operator It is prohibited for individuals not expressly or officially authorised to carry out operations on the device including children people with disabilities or those with reduced physical sensory or mental capacities Approved ...

Страница 27: ... Without this authentication the FINDER will not move After being authenticated the operator takes care of loading the full cartridge in the appropriate housings of the FINDER Once the cartridge has been loaded the operator clicks the start button on the FINDER display and the device starts to transfer the slides from the cartridge onto the rack Once the transfer is complete the FINDER is ready to...

Страница 28: ...ator accepts the same by clicking on the relative button The operator is directed on the smartphone display to the ARKIVE cabinets where the racks containing the slides to be retrieved are located The operator goes to the area of the cabinets which are illuminated with the put pick to light technology in order to make it easier for the operator to identify where the racks with the slides to be ret...

Страница 29: ...eans of the usual barcode identification procedure in this way ending the retrieval procedure When the operator accepting the slide archiving or retrieval mission goes to the FINDER he she must first and foremost be recognised by the FINDER In order to be recognised the operator must bring the smartphone provided in the vicinity of the FINDER display as in this case it acts as an identification ba...

Страница 30: ...here is then the FINDER is ready to go otherwise it signals the absence of a rack or a full rack The FINDER positions the cartridge in correspondence of the first free compartment on the rack picks up the slide using an electronically controlled pincer reads the barcode on the slide and if compliant moves it from the cartridge into the free compartment in the rack If the process is successful the ...

Страница 31: ... one If it is then the FINDER is ready to go otherwise it signals the absence of a cartridge or an incorrect cartridge The FINDER positions the cartridge near the compartment of the rack from which the slide must be withdrawn picks up the slide using an electronically controlled pincer reads the barcode on the slide and if compliant moves it from the rack into the free compartment of the cartridge...

Страница 32: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 32 of 58 11 2019 Rev 1 3 Approved ...

Страница 33: ...he use of all the functions of the software and the devices connected to it management of the system preparation and uploading of cyto histological samples slides insertion replacement of slides and troubleshooting The slide holder tray is placed on the table of the pathologist who starts off the slide archiving mission from the terminal The mission is broadcast to all operators smartphones The fi...

Страница 34: ... a rack to complete in the Finder in which case one cartridge is inserted into the Finder at a time so that the Finder transfers the slides from the cartridge into the rack after having read the relative barcode If there are no racks in the Finder an empty rack must be inserted into the Finder and the previous steps followed by inserting one cartridge at a time into the Finder for transferring the...

Страница 35: ...ated in the Finder reads the QR Code on the rack and memorises the code which will be used for future missions When the slide is withdrawn from the cartridge the Finder takes charge of it before depositing it inside the rack the camera detects the barcode on the slide If the code is not legible the slide is taken out of the Finder so that the pathologist or operator Approved ...

Страница 36: ...ct and congruous the slide will be positioned inside the rack and only then will the rack code slide code association be made with the relative transmission to the database In case of lack of communication with the database the information will be kept in the Finder which will transmit it at the first rebooting Once the rack is full the operator must manually carry it to the area of the cabinet or...

Страница 37: ...or who has taken charge of the archiving mission Using the camera on the smartphone the operator reads the QR Code of the cabinet Once the operator has been identified the electro lock unlocks and the LED strip lights up on the door to be opened manually The operator opens the door positioning him herself in front of the cabinet and firmly gripping the handle It will be necessary to pull the handl...

Страница 38: ...S MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 38 of 58 11 2019 Rev 1 3 To close the door the operator holds the handle and pushes it up to the stop to allow the system to close properly Approved ...

Страница 39: ...erator to accept the mission goes to the room where the cabinets are kept The cabinet from which the rack must be withdrawn lights up yellow LED strip Using the camera in the smartphone the operator identifies him herself by reading the QR Code of the cabinet The door to be opened will unlock and light up The operator opens the door positioning him herself in front of the cabinet and firmly grippi...

Страница 40: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 40 of 58 11 2019 Rev 1 3 Approved ...

Страница 41: ...ER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 41 of 58 11 2019 Rev 1 3 The operator then carries the withdrawn rack to where the Finder is located and inserts it into the relative housing taking care to also load the cartridge in which the slides are to be transferred Approved ...

Страница 42: ...he previous and following pages To facilitate the effectiveness of the device each operator is assigned a personal smartphone univocally associated with him her The operator uses the smartphone to take charge of the missions to be carried out receive instructions about the sequence of the operations to be performed be recognised and authorised by the system software read the barcodes present on th...

Страница 43: ...s In the event of any emergency situations arising the operator must activate the emergency pushbutton and if necessary disconnect the mains power supply The device does not contain any hazardous substances The operators are not obliged to use Personal Protective Equipment as the noise levels are below 80 dB During the installation and use of the device the operators must wear suitable personal pr...

Страница 44: ...R S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 44 of 58 11 2019 Rev 1 3 The FINDER has a touchscreen display via which the operator accesses all the functions Approved ...

Страница 45: ...rator personalises his her user account with his her credentials username and password necessary for connecting to the server At the end of the registration ArkiveApp will be connected to the system software at any time the operator can receive slide archiving and retrieval missions view alarms deriving from malfunctioning or be accompanied step by step in an interactive way during the slide loadi...

Страница 46: ... for inserting the cartridges and racks for the archiving and retrieval missions The on off buttons are located on the touchscreen display on board the device The procedure for restoring operation after a fault or jamming entails 1 the opening of the front or rear safety guards 2 the pressing of the emergency button 3 a check of the cause of the fault or jamming 4 removal of the block by activatin...

Страница 47: ...CTION EVEN PARTIAL IS PROHIBITED 47 of 58 11 2019 Rev 1 3 The procedure for restoring operation after an emergency stop entails 1 the pressing of the emergency button 2 the restarting from the panel that automatically restores the conditions existing immediately prior to the fault or jamming Approved ...

Страница 48: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 48 of 58 11 2019 Rev 1 3 Approved ...

Страница 49: ...this device must therefore contact the manufacturer and follow the procedures the latter has adopted to allow for differentiated collection of the device at the end of its working life Adequate differentiated collection for subsequent recycling treatment and environmentally compatible disposal helps to avoid any possible negative effects on the environment or on health and promotes the reuse and o...

Страница 50: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 50 of 58 11 2019 Rev 1 3 Approved ...

Страница 51: ...CTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 51 of 58 11 2019 Rev 1 3 The structure of the device is in anodised aluminium with plexiglass parts It is therefore necessary to clean with specific detergents removing any accumulated residues such as dust by hand Approved ...

Страница 52: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 52 of 58 11 2019 Rev 1 3 Approved ...

Страница 53: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 53 of 58 11 2019 Rev 1 3 Figure 1 Empty SLIDE HOLDER RACK Approved ...

Страница 54: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 54 of 58 11 2019 Rev 1 3 Figure 2 Full SLIDE HOLDER RACK Approved ...

Страница 55: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 55 of 58 11 2019 Rev 1 3 Figure 3 ARKIVE slTM CABINET Approved ...

Страница 56: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 56 of 58 11 2019 Rev 1 3 Figure 4 Full SLIDE HOLDER CARTRIDGE Approved ...

Страница 57: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 57 of 58 11 2019 Rev 1 3 Approved ...

Страница 58: ... ARKIVE SL FINDER OPERATOR S MANUAL THIS MANUAL IS THE PROPERTY OF THE MANUFACTURER AND ANY REPRODUCTION EVEN PARTIAL IS PROHIBITED 58 of 58 11 2019 Rev 1 3 powered by Approved ...

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