Bee Robotics RB01 User Manual Download Page 64

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BRDoc209

RoboBlot - User Manual [en-GB]

Rev: 2 | CRF: 2665

Bee Robotics Ltd

CONFIDENTIAL

Pg. 64 of 64

16.5

Appendix VI – REVISION HISTORY

Issue

Date

Comment

Details

11/03/2020

First release

First release of User Manual

26/05/2022

Updates for IVDR

Include:
-

Catalogue number and Basic UDI

Intended Use

Residual Risks

Removal of X Transit Clamp (Unpacking)

Additional Labelling

Consumables

Serious Incidents Section

Synopsis of labels updated

Cybersecurity

Updated Declaration of Conformity

Summary of Contents for RB01

Page 1: ...this manual will void the manufacturer s warranty and may pose a risk to the user Only trained personnel shall use this instrument Ensure all users are conversant with the instrument contact Bee Robotics for any further instrument or training requirements if in any doubt before using the instrument Consult User Manual where symbol left is seen on the instrument For In Vitro Diagnostic Use RoboBlot...

Page 2: ...ce Dublin 7 Ireland eurep cslifesciences com Bee Robotics reserves the right to modify its products and services at any time This guide is subject to change without notice Although prepared to ensure accuracy Bee Robotics assumes no liability for errors or omissions or for any damages resulting from the application or use of this information The content of this manual is the property of Bee Roboti...

Page 3: ...nitial Setup _________________________________________________________________14 5 6 1 Lubricate grease the Probe O Ring _______________________________________________14 5 6 2 Mount and Connect the Touchscreen _______________________________________________14 5 6 3 Powering the Instrument ___________________________________________________________15 5 6 4 System Start Up__________________________...

Page 4: ...NG THE INSTRUMENT __________________________________________51 11 DISPOSAL GUIDELINES ________________________________________________52 12 TECHNICAL SUPPORT __________________________________________________53 13 SERIOUS INCIDENTS ___________________________________________________53 14 LIMITED WARRANTY ___________________________________________________54 15 DECLARATION OF CONFORMITY____________...

Page 5: ...or processing samples of all groups of people It is to be used by trained personnel with samples and reagents diagnostics kit that are appropriate for the RoboBlot The Product is intended for professional use in a Laboratory 1 2 Purpose The purpose of this document is to provide end users with a complete overview of the RoboBlot instrument to such an extent that once the document has been read the...

Page 6: ...the instrument prewashing strips inside a plastic tray then automatically transferring barcoded samples from the Sample Carousel using its novel pressure detection system for liquid levels and or blockages to the tray for further processing The instrument then provides full XYZ automation for the addition and aspiration of subsequent reagents using disposable tips to dispense the required amount o...

Page 7: ...ing Processing volumes Samples 10 L to 1000 L Processing volumes Reagents 100 L to 5000 L Dispensing mode accuracy Piston Pump Reagents 0 5 Samples 10 Peristaltic pumps 0 10 Software Embedded software Voltage frequency Earthed electrical power source at AC 100 to 240 V AC 10A 50 60Hz Fuses 5A UL Approved Ø5x20mm Dimensions 600 H x 620 D x 820 W mm Weight 70 kg Consumption value energy 400 W max Ac...

Page 8: ...llowing items Accessories Quantity Touch Screen with Mounting Arm and Attached Cables 1 Touch Screen Screw Set Keys 1 Spare fuses 5A pack of 2 1 Reagent Bottle Holder 1 Wash Water Bottle Holder 1 Wash Bottle Lid 1 Water Bottle Lid 1 Reagent Bottle Set 1 Priming Trough 1 Waste Tip Trough 1 Tip Rack Holder 1 Sample Carousel 1 Mains Lead 1 User Manual 1 Set of spare packaging tape 1 Ethernet Cable 1 ...

Page 9: ...sable trays Carousel Sample tubes which sizes range between Height 75 102mm Diameter 12 17mm These will be provided by the laboratory As the instrument has been designed for use with specific disposable tips you SHOULD NOT attempt to use any tips other than what is provided by the Distributor Not adhering to this could result in the failure of the instrument and will invalidate the warranty Compat...

Page 10: ...6 Two people are required to lift the instrument off the base one positioned at the front of the instrument and one person positioned at the back of the instrument Lift one side of the instrument and at the same time remove the foam side cheek and gently rest the instrument down repeat this procedure for the other side of the instrument Remove any protective bubble wrap and foam top protectors 7 R...

Page 11: ... INSTRUMENT with wet hands and DO NOT attempt to disassemble the INSTRUMENT In either case electrical shock may result and in both cases the warranty will be invalidated The INSTRUMENT will automatically stop when the Cover is opened Never attempt to manipulate or run the instrument with the Cover opened It is recommended to wear eye protection a laboratory coat and protective gloves when operatin...

Page 12: ...g the security protocols are that of your own The default configuration of the instrument comes without anti virus software and with the fire wall disabled In order to guard the instrument against malicious software or behaviour it s recommended that your I T department install the relevant protection software as well as update the fire wall to a configuration that s appropriate for your policies ...

Page 13: ...ection in an emergency particularly any object to the right side panel of the instrument 5 5 3 Ventilation Do not place the instrument in line with a direct draft such as an air vent Otherwise there are no specific ventilation requirements for the instrument Allow a space of 100 mm between the instrument and any wall or other instruments 5 5 4 General Keep free of dust harsh solvents and acidic va...

Page 14: ...he probes and not the o rings clean with tissue so that there is no grease left on the probes themselves Figure 1 probe o ring 5 6 2 Mount and Connect the Touchscreen a touchscreen rear clamp mounting b touchscreen to instrument mounting To attach the support arm and thus the touch screen to the instrument you must retrieve the following from the accessory collection 4x screws 3x washers and 2x Al...

Page 15: ... of the instrument This connection is illustrated within the top most blue circle in image b To enable touch support the USB cable of the unit must be attached to a USB port on the instrument s on board computer This connection is illustrated within the central green circle in image b 5 6 3 Powering the Instrument With the switch state set to off O attach the mains leads to the power inlet socket ...

Page 16: ...the display unit after which a number of initialization routines will automatically start The Z axis will move upwards to its HOME position The Y axis will move to its HOME position The X axis will move to its HOME position The Carousel drive will rotate to its HOME position The Table will rock The XY arm will move to be above the tip waste trough the Z will eject and XYZ will then return to its H...

Page 17: ...Ltd CONFIDENTIAL Pg 17 of 64 After robotic initialisation is complete press START button to navigate to the Main Screen A successful initialisation The main menu Once you ve reached the main menu the initialisation of the instrument and on board software is complete ...

Page 18: ...older Tip Waste Trough Sample Carousel Tray Strip Holder Barcode Scanner Priming Trough Scanning Head Tip Picker Level Sensor Tip Rack Holder Embedded PC at side Peri Pumps behind scanner Piston Pump 6 2 Instrument Deck Layout Sample Carousel Barcode Scanner Pump Assembly Priming Trough Tray Strip Holder Wash Water Bottle Holder Tip Waste Trough Reagent Bottle Holder Tip Rack Holder ...

Page 19: ...tray table it will only fit one way Tip Rack Holder Position tip rack holder on the dimples in front of the Reagent Bottle Holder it will only fit one way Tip Waste Trough Position waste tip trough on the dimples to the immediate right of the Reagent Bottle Holder and Tip Rack Holder it will only fit one way Wash Bottle Holder Position wash bottle to the right of the trayholder in its dedicated ho...

Page 20: ...uration that is used 7 1 Running the Instrument Standalone 7 1 1 Setting up an Assay 1 From the main menu that is entered following initialisation click on the circular button that is labelled Start Assay 2 The first task that s required is to assign an identifiable name to the assay worklist that you re creating You don t need to worry about making this unique but it s recommended that you assign...

Page 21: ...e PROT G02 has been selected Once you re happy with your selection navigate to the next screen by clicking on the button with the forward arrow 4 If the selected protocol supports multiple assay kits or strips then you will be presented with a menu to choose which kits and conjugates you want to run You select a kit type by selecting at least one conjugate option from the right hand side Mixing di...

Page 22: ...stic tray it s possible to start the test from another well For this example we ll start from well number 10 6 In the next steps you ll be asked to specify the number of samples for each test conjugate pair along with any optional controls that are needed It s worth nothing that depending on the kit there may be different additional or no control options In the image below we ve chosen 1 positive ...

Page 23: ...to make sure everything is correct and then continue ahead when ready 8 The instrument comes equipped with a tip rack with a total capacity of 96 tips As each tip is used the instrument records where the next free tip can be found When setting up a new work list you may set the instrument to use the last position by using the button highlighted in green or if you wish you can manually set a starti...

Page 24: ... menu is active take the time to prepare the reagent bottles with at least the amounts specified Failure to load sufficient volumes may result in a failed test 10 As positive controls have been chosen in these examples the next screen is a loading guide that instructs you where to place each bottle relative to the control bottle holder If no controls are chosen for a work list this menu is skipped...

Page 25: ...owed to proceed to the next screen Note that the content of the list may change depending on the selection test or protocol so always read them carefully To complete the action of loading samples place the sample tubes into the sample carousel Start from position 1 and ensure that the barcodes point outwards When the sample carousel contains all of the samples to be processed load the carousel ont...

Page 26: ... holders You should load the appropriate amount of 5ML tips Note that the instrument picks these up in column wise order starting from top left and working down The instrument will always start picking 5ML tips from the top left With the tips inserted place the holder onto the mounting points on the deck You may refer to Section 4 2 for location details Check off the action on screen when done To ...

Page 27: ...les with the labels on the holder The 2x5 smaller positions are designed to hold control bottles the insert order of which is outlined in an earlier on screen menu Check off the action on screen when done To complete the action of loading the wash buffer and DI water fill each bottle with the amount of liquid that was specified in an earlier on screen menu if you re ever in doubt always fill the b...

Page 28: ...lete the action of emptying the tip waste will depend on the instrument configuration If the instrument is configured with a waste basket located on the deck then remove any tips from earlier runs and wipe down any residue outside of the instrument when placing it back ensure that the basket is placed back firmly on the mounting points If the instrument is configured with a tip chute however then ...

Page 29: ...where in the carousel but you should ensure that there are an amount equal to the target value While the scan is taking place the progress will be shown on the display indicating what barcodes have been found and where Once a sufficient amount of barcodes have been detected a button highlighted blue will become active to allow you to start the assay In the event that a barcode is present but damag...

Page 30: ...at the instrument is doing See below for a reference of each control item 1 Work list name This is the name that has been assigned to the work list 2 Protocol name This is the name of the protocol that is being processed by the instrument 3 Current step This is the description of the step that is currently being performed by the instrument 4 Event log This is a list of all the steps that have been...

Page 31: ...is action 6 Skip incubation This button is enabled during certain incubations steps and only on certain protocols Pressing this when it s active will cause the incubation timer to be immediately reduced to zero E g if samples are meant to be incubated for 60 minutes and the user presses this after 5 minutes it will cancel the remaining 55 minutes and proceed to the next protocol steps 7 Run summar...

Page 32: ...ion and Handling In a standard protocol implementation there will be a transfer of samples controls and reagents from their containers into tray wells In most cases these transfers will be done with added intelligence to make sure that the instrument doesn t continue with an incorrect configuration such as missing tips or missing samples With regards to samples the instrument will request user int...

Page 33: ... instrument gives up on automatically retrying the transfer the screen will change to what s depicted in the graphic below while also playing an audiable alarm to get someone s attention 1 Cause and description In this region the instrument will display information about what problem has been detected and during which transfer attempt specifically which carousel position to which tray position If ...

Page 34: ...rt assay When a problem has been identified and it s clear that it cannot be resolved potentially due to a mechanical issue it s possible to exit from the assay by clicking on this button Note that all the progress of the protocol will be lost 5 Skip transfer When a problem has been identified and it appears that the sample cannot be transferred for any reason it s possible to abandon that transfe...

Page 35: ... gives up on automatically retrying the transfer the screen will change to what s depicted in the graphic below while also playing an audiable alarm to get someone s attention 1 Cause and description In this region the instrument will display information about what problem has been detected and during which transfer attempt specifically which control bottle position to which tray position If the c...

Page 36: ...y clicking on this button Note that all the progress of the protocol will be lost 5 Skip transfer When a problem has been identified and it appears that the sample cannot be transferred for any reason it s possible to abandon that transfer and continue with the rest of the assay by pressing this button to skip it The next transfer will continue as normal Note that the tray well itself will still b...

Page 37: ...e alarm to get someone s attention 1 Cause and description In this region the instrument will display textual information about what problem has been detected If the cause is related to insufficient volume Open the door Check that a 5ml tip is present on the tip picking probe Check that the target bottle has the minimum amount of reagent If the cause is related to a tip blockage Open the door Chec...

Page 38: ...dispose of the current tip nor will it attempt to pick up a new tip Instead the tip that s currently on the probe will be used again and the instrument will attempt to detect a sufficient amount of reagent once again 7 1 4 End of Assay Scanning While dependent on the protocol assay configuration the typical work flow is that imaging of the strips with the on board scanner is done automatically at ...

Page 39: ...you to the primary cleaning menu where you only have the options of starting or going back home Immediately upon starting the cleaning routine a pop up as below will be shown The instruction states that you should fill the Wash and Water bottles with you preferred cleaning solution The steps for this are Remove the standard wash and water bottle set from instrument ones used for the assay Locate t...

Page 40: ...s with the cleaning solution then soak the lines for a few minutes The progress onscreen will display thus After the soaking stage the screen will prompt the user for further intervention The steps for this are Discard any remaining cleaning solution Fill the wash and water bottles with DI Water and press OK onscreen Close door and press OK onscreen to start the cleaning process ...

Page 41: ... again flush soak and now back prime the DI Water in the system After this step which takes a few minutes again the following screen will appear Close the pop up to return back to the main menu and then remember to unload the spare Water and Wash bottles from the instrument and replace them with the standard set ...

Page 42: ... on Assay worklists Depending on your edition you may be taken directly to the records or be presented with a sub menu If it s the latter select the Assay worklist history option Once you ve accessed the right menu you will be shown a list of the most recent runs that were performed on the instrument The most recent always appears at the top of the list From this menu you have a few options You ca...

Page 43: ...ed above the power switch and then click on the Save button With a USB connected and after pressing Save you should see a screen similar to the below Highlight your USB device and once again click Save This will begin the process of copying any images and text files over to your device If successful a pop up will appear indicating where the files have been stored ...

Page 44: ...rst option under the Imaging tab Upon accessing the feature it s possible to specify two parameters the first well to start scanning from and the number of wells to scan Once the selection is confirmed the scanning progress screen will keep you updated while it s active before returning to the main menu After returning to the main menu at the end of the scan the output can be saved to USB by click...

Page 45: ... power switch and then choose your preferred image format JPEG PNG or BMP Next click on the Save button Choose your USB device from the list and press Save once again If successful a pop up will appear indicating where the image has been stored A hidden option is also the ability to delete images All that is required for this is to press and hold your finger over an entry in the list for approxima...

Page 46: ...rd in accordance with country federal state and local regulations 4 Remove the Tip Waste Trough Chute and empty contents into general hazardous waste 5 Remove the Priming Trough and empty any contents into general hazardous waste 6 Remove the Tip Rack from the deck 7 Remove Strip Holder Remove strips and keep or dispose of as required 8 Wipe down interior with microsol or alcohol wipes 9 Clean the...

Page 47: ...ain a record of all run information user inputs and error codes that have happened in the most recent runs Gaining access to the logs is a straight forward procedure but you will need a USB storage device at hand 1 Navigate to the main menu of the application 2 Open the system menu flyout and select the Logging tab 3 Press the primary button that will copy the logs to USB 4 When the new window app...

Page 48: ...the system menu flyout and select the Information tab Here you will find information about a Application version and install date b Master controller firmware version and install date 3 Select the Installed Scripts tab Here you will find information about the protocol routines that are installed Details include a The installed sector b The name of the protocol entry c The version d The date at whi...

Page 49: ...there are no kinks visible along the Y and X axis which could affect the sample processing Pay particular attention to the connections at the tip picking ejection mechanism Remove all the accessories from the base and clean with a lint free cloth 9 2 Mechanical Inspection When the visual inspection doesn t highlight any obvious issues it s best to then move onto the mechanical components to inspec...

Page 50: ...ill rotate to its HOME position The Table will rock The XY arm will move to be above the tip waste trough the Z will eject and XYZ will then return to its HOME position If the instrument fails to perform any or all of these tasks then there is a fault which needs to be rectified Please contact your local representative or Bee Robotics for further assistance 9 4 Error messages If there are any prob...

Page 51: ...Wear protective gloves prior to cleaning Use an appropriate detergent to clean surrounding surfaces Dampen a cloth in detergent and wipe all areas in and around the base and the reagent area Use the same technique to wash all parts that may come in contact with any accidental spillage Clean all the reagent bottles at the end of each run Ensure that the waste bottle is emptied Ensure that the tip w...

Page 52: ...performed and the decontamination certificate as per appendix section 14 4 must be completed prior to shipping the instrument Instrument Disposal As part of the WEEE EU directives this instrument should be returned to the manufacturer for dismantling at the end of its life Decontamination must be performed and the decontamination certificate as per appendix section 14 4 must be completed Packaging...

Page 53: ...t 32 33 Cibyn Industrial Estate Caernarfon Gwynedd LL55 2BD Wales UK Tel 44 0 1286 672744 Fax 44 0 1286 678322 info beerobotics com w www beerobotics com Servicing and authorised repairs may only be carried out by Bee Robotics or associated trained service personnel 13 SERIOUS INCIDENTS Any serious incident relating to the use of this device must be reported to Bee Robotics as the Manufacturer and...

Page 54: ...ion mistreatment or neglect 3 damage caused by equipment or system with which the product is used 4 damage caused by modification or repair not made or authorised by Bee Robotics 5 theft vandalism fire water or other peril The product may not be returned without proper authorisation from Bee Robotics cost of transportation removal or reinstallation of the equipment will be paid by the purchaser Th...

Page 55: ...BRDoc209 RoboBlot User Manual en GB Rev 2 CRF 2665 Bee Robotics Ltd CONFIDENTIAL Pg 55 of 64 15 DECLARATION OF CONFORMITY ...

Page 56: ...kground Yellow Symbol Outline Black IEC 60417 5032 Caution Hot Surface On Heater LED Background Yellow Symbol Outline Black IEC 60417 5007 Caution Risk of Danger On Caution Labels Background White Yellow Symbol Outline Black ISO 7010 W004 Warning Laser Beam On Caution Labels Background White Yellow Symbol Outline Black ISO 7000 0659 Biological Risks On Caution Labels User Manual Symbol Outline Bla...

Page 57: ...cturer Instrument Serial Label User Manual Symbol Outline Black IEC 60417 6414 WEEE Waste Electrical and Electronic Equipment Instrument Serial Label User Manual Symbol Outline Black ISO 7000 1641 Consult Instructions for Use Instrument Serial Label User Manual Symbol Outline Black N A Unique Device Identifier Instrument Serial Label ...

Page 58: ...dalone Scan Main Screen Imaging Saved Images Main Screen Imaging Start Cleaning Main Screen Cleaning Reduce value Various Process Screens Increase value Various Process Screens Not started incomplete Various Process Screens Completed Various Process Screens In progress Various Process Screens Access Flyout Menu Main Screen Power Off Flyout Menu Restart Flyout Menu Back to previous screen in proces...

Page 59: ...BRDoc209 RoboBlot User Manual en GB Rev 2 CRF 2665 Bee Robotics Ltd CONFIDENTIAL Pg 59 of 64 Proceed to next screen in process All Process Screens Skip Incubation Assay Running Screen ...

Page 60: ...emselves can be a point of vulnerability to viruses the INSTRUMENT control software comes with a firewall implementation that should block the transfer of rogue software over the network User Access Controls 1 Access to an INSTRUMENT is first and foremost restricted behind access to a laboratory where it is standard practice to have restricted personnel policies After this point access to the inst...

Page 61: ...MENT SERIAL NUMBER CUSTOMER NAME ADDRESS TELEPHONE NUMBER FAX NUMBER E MAIL ADDRESS Did the instrument arrive in good condition Yes No If no provide details Were all of the accessories present see SECTION 3 If no provide details Did the instrument initialise correctly refer to SECTION 5 6 3 in User Manual Yes No If no provide details ...

Page 62: ...esentative Address Representative Signature Date Customer Signature Date Customer Print Name Position Customer to retain original copy Distributor must send copy to Bee Robotics Ltd Unit 32 33 Cibyn Industrial Estate Caernarfon Gwynedd LL55 2BD Wales UK Tel 44 0 1286 672744 Fax 44 0 1286 678322 info beerobotics com W www beerobotics com ...

Page 63: ...ve procedure or been in contact with blood other body fluids or pathological samples It has been cleaned in preparation for inspection service or repair or This equipment has been cleaned and decontaminated The decontamination method is outlined below or This equipment could not be decontaminated The nature of risks and safety precautions to be adopted are as follows Signed Date Position Held Full...

Page 64: ...Comment Details 1 11 03 2020 First release First release of User Manual 2 26 05 2022 Updates for IVDR Include Catalogue number and Basic UDI Intended Use Residual Risks Removal of X Transit Clamp Unpacking Additional Labelling Consumables Serious Incidents Section Synopsis of labels updated Cybersecurity Updated Declaration of Conformity ...

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