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Related Manuals for R-Biopharm RIDA qLine autoBlot
Summary of Contents for R-Biopharm RIDA qLine autoBlot
- Page 1 RIDA qLine autoBlot ® User Manual https:/ /clinical.r-biopharm.com...
- Page 2 RIDA qLine® autoBlot | User manual...
- Page 3 Version 2.00 (2022-03-30) Pegasus Revision 1.6.1 Copyright 2022 by R-Biopharm AG © R-Biopharm AG 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, R-Biopharm AG assumes...
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Page 4: Table Of Contents
RIDA qLine® autoBlot | User manual Inhalt Introduction 4.7.4 System Start-up Intended purpose and Initialisation Check Purpose oft the document 4.7.5 Critical Errors Product Overview System Overview Glossary AutoBlot Component Guide Installation of Accessories Technical Specifications System Operation Safety & General The System Menu Information 6.1.1 Information Tab... - Page 5 Technical Support Obtaining Work-list Information Directly from Conformity the Instrument IEC 61326-2-6 Standalone Imaging and RoHS3 7.6. Accessing Stored Images Automated Cleaning Limited Warranty Routine Version Number QC test using RIDA qLine® Soft Appendix 19.1 Appendix II: Synopsis Instrument Shutdown of Symbols used in manual &...
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Page 6: Introduction
Failure to comply with the instructions in this manual will void the manufacturer’s warranty and may pose a risk to the user. Ensure all users are conversant with the instrument - contact R-Biopharm AG for any further instrument or training requirements if in any doubt before using the instrument. -
Page 7: Product Overview
The combination of all these features result in the ability to completely automate the processing of R-Biopharm RIDA qLine® Allergy for detection of specific IgE in allergy diagnostic. - Page 8 RIDA qLine® autoBlot | User manual The typical work-flow of the instrument would go as follows: i. A user sends 1 or more work-list from RIDA qLine® Soft to the instrument. ii. The user walks over to the instrument and selects a work-list they wish to process. Following onscreen instructions, the user is told how to prepare the instrument.
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Page 9: Glossary
2.1 Glossary Definitions Meaning autoBlot The name of the instrument that this document is discussing. Instrument Synonymous with “autoBlot”. User The person who is using the autoBlot in its standard operation. Operator Synonymous with “User”. 3 Technical Specifications Instrument type: Standalone bench top Processing Capability: 1 to 36 samples per run... -
Page 10: Safety & General Information
RIDA qLine® autoBlot | User manual Consumption value 150 W (max) (energy): Acoustic noise level (dB): ~ 60 dB Electromagnetic emissions: Class A 30 MHz to 1000 MHz Radiated field immunity: 10 V/m 80 MHz to 1000 MHz 3V/m 1.4 GHz to 2 GHz 1V/m 2 GHz to 2.7 GHz 4 Safety &... -
Page 11: Accessories Provided With The Instrument
be positioned at the back of the instrument. To remove the foam side cheek, lift one side of the instrument and have a third person remove it from the raised side. Gently lower the instrument back down and repeat this for the other side. Remove any protective bubble wrap and the foam top protectors that remain. - Page 12 RIDA qLine® autoBlot | User manual Priming Trough Tip Rack Holder Touchscreen Screws & Keys 5A Fuse Instrument Mains Lead Ethernet Cable Spare Packing Tape Set Accessory Box B Item Description Quantity 1000 mL spare Nalgene Rect. Bottle* *Labelled “A. bidest” Touchscreen, Mounting Arm, Cables Waste Tip Trough Tray (Strip Holder)
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Page 13: Consumables Required But Not Provided With The Instrument
The supplied RIDA qLine® Allergy reagents must be transferred into the glass bottles for the autoBlot before use. The tips and glass bottles for the reagents can be directly ordered from R-Biopharm, as well as the corresponding screw caps. Product Art. -
Page 14: Instrument Labeling
RIDA qLine® autoBlot | User manual 4.4 Instrument labeling Please observe and respect all caution labels shown on instrument & consumables: 4.5 Detailed Personal Safety Information Symbol Description Warning! Avoid touching the instrument with wet hands, and do not attempt to disassemble the instrument. -
Page 15: Environmental Conditions
4.6 Environmental Conditions 4.6.1 Bench Space Always place the instrument on a flat and solid surface while ensuring that there are no obstruction to the Touch Screen on the right-hand side of the instrument. The minimum bench space that required is a width of 1000 mm and a depth of 700 mm - The depth constraint is required to ensure there is no overhang on the front of the instrument. -
Page 16: General
RIDA qLine® autoBlot | User manual 4.6.4 General The instrument should be kept free of dust, harsh solvents and acidic vapours. The instrument should not be exposed to vibrations, harsh sunlight or unduly large variations in temperature and humidity. Failure to abide could affect the correctness of the result. The instrument is designed and intended for in-door use only: located on a flat surface within a typical laboratory environment, i.e.: Altitude:... -
Page 17: Lubricate (Grease) The Probe O-Ring
4.7.1 Lubricate (grease) the Probe O-Ring Apply a small amount (approx 1mm ‘blob’) of silicone grease to the o-ring - illustrated in Figure 1. Place a 1000 mL tip onto the tip-picking probe, rotate the tip on the probe twice over in order to spread the grease over the whole o-ring, then remove the tip. - Page 18 RIDA qLine® autoBlot | User manual To attach the support arm, and thus the touch screen to the instrument, 4 screws, 3 washers and two Allen keys must be retrieved from the accessory collection. Using the longest M6x75 screw from the screw set (and appropriate M6 washer), secure the Touchscreen rear clamp to the arm.
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Page 19: Powering The Instrument
4.7.3 Powering the Instrument To power on the instrument, insert a mains lead into the side of the instrument while the switch state is set to off (as denoted by the marker) as shown in Figure 4. Note that the instrument must be powered by an earthed mains supply, and it is recommended to power the instrument through an appropriate RCD device. - Page 20 RIDA qLine® autoBlot | User manual 3. The X axis will move to its home position; this consists of moving to the left hand side. 4. The carousel drive will rotate to its home position; this consists of ensuring position 1 is infront of the barcode reader.
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Page 21: Critical Errors
4.7.5 Critical Errors The robotic side of the instrument has its own error handler that is separate from the global software controller. This means that it has its own way of generating and displaying errors. Any time a robotics error is detected, a screen as shown in Figure 7 will be shown that contains error sequences that are vital for ensuring that the service provider is able... -
Page 22: System Overview
RIDA qLine® autoBlot | User manual 5 System Overview 5.1 AutoBlot Component Guide Figure 8: A guide that details the components and locations which are vital to the instrument 5.2 Installation of Accessories Figure 9: An illustration of the deck layout for the instrument... - Page 23 Figure 9 illustrates the positioning of all the accessories on the deck of the instrument. Further notes on the assembly and placement of the accessories can be found below. Accessory I. Priming Trough Position on the dimples in front of the pump assembly. There is only one way in which it can fit.
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Page 24: System Operation
RIDA qLine® autoBlot | User manual Accessory IX. Wash Bottle and Lid Position the bottle into the holder and place the green lid onto the bottle. Connect the tubing from the wash pump. Accessory X. Tray Place the strip holder (also known as the tray) onto the table. There is only one way it can fit. -
Page 25: The System Menu
6.1 The System Menu At any point while within the main menu, the system menu button can be found in the bottom right corner of the screen (shown in Figure 10 and highlighted in Figure 11). This button opens a system menu, a menu which contains information about the system, as well as some important features. -
Page 26: Logging Tab
RIDA qLine® autoBlot | User manual The engineering tab can be deactivated by repeating the above steps until a similar ‘engineering has been deactivated’ message is shown. If the back button is pressed while engineering is set to active, an additional entry will be found next to the ‘Cleaning’... -
Page 27: Installed Scripts Tab
6.1.3 Installed Scripts Tab The installed scripts tab can be found to the right of the logging tab (see Figure 15). This tab contains the names, version numbers and build dates of all the scripts that the software executes in-order to carry out the strip processing protocols. -
Page 28: Determining The Ip Address Of The Instrument
RIDA qLine® autoBlot | User manual 6.2 Determining the IP address of the instrument As the use of the instrument is heavily dependent on receiving work-lists from the third party software application, one of the first tasks a user should perform is determine the IP address of the instrument. -
Page 29: Viewing The Internet Protocol (Ip) Address
Selecting the ‘General Settings’ option will show all the engineering options which don’t require authentication. Figure 18 shows what should be seen upon clicking this option. 6.2.3 Viewing the Internet Protocol (IP) address Figure 18: The engineering menu for In the engineering section, select the ‘Networking’... -
Page 30: Connecting To The Instrument To Rida Qline® Soft
In addition to RIDA qLine® Soft, the RLink_AutoBlot.exe program will be copied into the directory C:\Program Files (x86)\R-Biopharm\qLine. It is recommended to create a shortcut to this file on the desktop since the RLink_autoBlot program does not start automatically, but is needed to connect to the RIDA qLine®... -
Page 31: Device Settings For Rida Qline® Soft
RIDA qLine® Soft the parameters of the other devices (in maximum 4) must be entered manually into the qsoft.ini-file. In order to find the qsoft.ini file please enter %appdata%\R-Biopharm\qsoft into the address bar of the windows explorer and confirm with the enter key. -
Page 32: Full Automatic Processing
RIDA qLine® autoBlot | User manual Fig. 23: Autoblot protocolversion The AutoBlotProtocolversion may not be changed. The AutoBlotSoftwareversion corresponds with the Application version and the AutoBlotFirmwareversion corresponds with the FirmwareVersion shown in the Information tab (see section 6.1.1). Make sure that the device is connected to the power supply during all update processes. 6.3.2 Full automatic processing When the RIDA qLine®... -
Page 33: Assay Processing
7 Assay processing 7.1 Creating a Worklist Upon connecting to the instrument and performing successful calibration scans, the environment is set for using the instrument for strip processing and analysis. From the main menu and within the worklists tab, the option called ‘Start Worklist’ takes the user to the menu from which they can select a work-list to run. -
Page 34: Running A Work-List
RIDA qLine® autoBlot | User manual 7.2 Running a Work-list If the user is able to see a screen similar to what is shown in Figure 21, then they are ready to start a worklist. By highlighting a selected work-list and pressing start, the user will be taken into the first screen on the work-list set-up menu;... - Page 35 Figure 24: A completed check-list that Figure 25: The pop-up that is shown if results in the progression button any of the expected panels are missing becoming visible After confirming that everything is located correctly within the instrument, pressing ‘navigate forward’ will immediately trigger the panel verification scan. This is a procedure where the on-board software verifies that all of the panels are present and in the correct order - see Figure 25.
- Page 36 RIDA qLine® autoBlot | User manual becomes empty, the verification passes and automatically navigates to the next screen. If the instrument scans the entire carousel but still has entries in the ‘missing’ list at the end, the sample verification will fail. This will result in the instrument sounding an alarm and showing an error pop-up.
- Page 37 to abort the work-list and a time control which can be used to determine the remaining time, as well as the current time and what time the processing will complete. If there are no issues with the work-list, instrument or samples, then the user should not need to interact with Figure 29: The time control this screen at all.
- Page 38 RIDA qLine® autoBlot | User manual will not take place and the work-list will be invalidated. This feature should only be used if the user has made a drastic mistake in the work-list and would like to start it from scratch later on. Figure 32: The button When the strip processing completes, the imaging will automatically start.
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Page 39: Transfer Exception Handling
7.3 Transfer Exception Handling Thus far, it has been assumed that the processing of the samples has not experienced any issues. A summary of the potential issues that could arise during the sample transfer phase are listed below: 1. The barcode of the sample being transferred does not match the barcode that was detected during sample verification 2. - Page 40 RIDA qLine® autoBlot | User manual the sample tube for the instrument to pick up. If inspection results in no issues being detected, the user should verify that tips of the correct specification are being used. If the transfer issue states [BarcodeIncorrect], it means the instrument has rotated the carousel to the position that it found the target sample tube in from the verification run, but somehow the barcode no longer matches what is expected.
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Page 41: Obtaining Work-List
7.4 Obtaining Work-list Information Directly from the Instrument The analysis of the work-list images can only be done from the RIDA qLine® Soft, but a copy of the images and event logs from the last 8 work-lists can always be accessed via the instrument. -
Page 42: Standalone Imaging
RIDA qLine® autoBlot | User manual 7.5 Standalone Imaging The premise of the instrument revolves around obtaining images following the comple- tion of a work-list, but it’s noted that sometimes users may want to perform a scan that isn’t directly tied to a work-list. This can be achieved by navigating to the ‘Imaging’ category within the main menu and selecting ‘Standalone Scan’. -
Page 43: Automated Cleaning Routine
Figure 39 shows the screen that contains the latest stored images. By selecting an entry, meta-data are shown on the right- hand side, as well as options to save the image to a USB device in either .JPEG, .PNG or .BMP format. Similarly to the other features within the instrument software, entries from this list can be deleted by pressing and holding... - Page 44 RIDA qLine® autoBlot | User manual 2. Load a cleaning solution (e.g. 4 % bleach or 4 % SDS) into the wash bottle and fastening the caps back on correctly. 3. Place the wash bottle back inside the instrument and close the door 4.
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Page 45: Qc Test Using Rida Qline® Soft
4. Place the wash bottle back in the instrument and close the door. Once the pop-up is closed, the instrument will once more flush and soak, while also back-priming the DI water in the system; the task is reflected on screen, as shown in Figure 44. - Page 46 RIDA qLine® autoBlot | User manual Measurement of the QC strips will start automatically. Measuring will take several seconds. After the measurement, the following image will be displayed in the RLink_ AutoBlot program: Next click “Image”.
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Page 47: Instrument Shutdown
The scanned QC strips will be displayed for you. Next, open RIDA qLine® Soft and start the QC measurement. 10 Instrument Shutdown This section describes the procedure that must be followed when the user wishes to shut down the instrument. The user is strongly advised to follow this routine during every shutdown. - Page 48 RIDA qLine® autoBlot | User manual found, as shown in Figure 45. To shut down the instrument, the user should press the ‘Power Off’ option and confirm their selection when the pop-up appears. If done correctly, the touch-screen should show a ‘Shutting down…’ message. Once the touch-screen has turned off, the mains power inlet should be switched off.
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Page 49: Troubleshooting
Remove the Strip Holder from the tray. Remove strips and store or discard as required. 8. Wipe down the interior with microsol or alcohol wipes. 9. Clean the Sample Carousel, Tip Rack and Strip Holder with microsol or alcohol wipes and reinsert into the instrument. 10. -
Page 50: Mechanics
RIDA qLine® autoBlot | User manual 11.1.2 Mechanics Ensuring that the tip picking/ejection system is in the HOME position, move the X and Y axes by hand to ensure that there are no obstructions. If obstructions are encountered, look for mechanical obstructions, such as loose screws. Ensure that the aspirating needles are clean and in good condition. -
Page 51: Critical Error Messages
(6) The Touch Screen Display to the right of the instrument should be ON. 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 R-Biopharm AG for further help. 11.1.5 Critical Error Messages... -
Page 52: Disposal
If in any doubt about the compatibility of decontamination or cleaning agents, please contact your local agent, or R-Biopharm AG. 13 Disposal All reagents and materials must be disposed of properly and responsibly after use. -
Page 53: Corrective Action/Notification To Authorities
+49 (0) 61 51 - 8102-0 info@r-biopharm.de www.r-biopharm.com Only by R-Biopharm AG or associated trained service personnel may authorized repairs and servicing be carried out. For further details of instrument or to arrange for training to be given on the instrument, contact R-Biopharm AG at the above address. -
Page 54: Limited Warranty
(4) damage caused by modification or repair not made or authorized by R-Biopharm AG, or (5) theft, vandalism, fire, water or other peril. Product may not be returned without proper authorization from R-Biopharm AG;... -
Page 55: Version Number
18 Version Number Version Number Chapter and Description Version 1.0 (2017-12-14) Previous version Version 2.0 (2022-03-30) IVDR Adaptation: Accessories provided with the instrument Consumables required but not provided with the instrument Connecting to the instrument to RIDA qLine® Soft Disposal Corrective action/Notification to authorities Version Number 19.1 Symbols used in manual &... - Page 56 RIDA qLine® autoBlot | User manual Symbol Colour Publication Description Placement Symbol & Outline: IEC 60417 – Alternating Instrument Black 5032 Current Serial Label Symbol & Outline: IEC 60417 – On (Supply) Inlet Filter Black 5007 Symbol & Outline: IEC 60417 – Off (Supply) Inlet Filter Black...
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Page 57: Touchscreen Icons
19.2 Touchscreen Icons Icon Function Location View, select then run a work-list Home Screen (Worklist Tab) Access the work-list history menu Home Screen (Worklist Tab) Initiate the standalone imaging Home Screen (Imaging Tab) View latest standalone images Home Screen (Imaging Tab) Initiate the automated cleaning procedure Home Screen (Cleaning Tab) Access the general engineering settings... -
Page 58: Appendix Iii - Cyber Security Statements
INSTRUMENT. 2. R-Biopharm AG anticipates that laboratories have network technicians who configure the buildings to only have specific internet access points. As such, it’s our recommendation that the INSTRUMENT never be connected to the internet where it could potentially be exposed to viruses –... - Page 59 When a release becomes available, R-Biopharm contact the customer with the update files and release notes indicating the defects or flaws that were found, along with a severity rating for each defect.
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Page 60: Appendix Iv - Rida Qline
RIDA qLine® autoBlot | User manual 19.4 Appendix IV – RIDA qLine® autoBlot INSTALLATION CHECKLIST Instrument serial number: ..............Customer name: Address: Telephone number: Fax number: E-mail address: Did the instrument arrive in good condition? If no, provide details:... - Page 61 Were the following accessories present?: 1 x Touch Screen, Mounting Arm & Attached Cables 1 x Touch Screen Screws & Keys 1 x Spare fuses 5A (pack of 2) 1 x Reagent Bottle Holder 1 x Wash Bottle Holder 1 x Waste Bottle Holder 1 x Priming Trough 1 x Waste Tip Trough 1 x Tip Rack Holder...
- Page 62 RIDA qLine® autoBlot | User manual Any other comments: Representative Name: Representative Address: Representative Date: Signature: Customer Date: Signature: Customer Position: Print Name: Customer to retain original copy. Distributor must send copy to: R-Biopharm AG An der neuen Bergstraße 17 64297 Darmstadt Germany...
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Page 63: Appendix V - Rida Qline
19.5 Appendix V – RIDA qLine® autoBlot DECONTAMINATION CERTIFICATE Institute Name Make of Instrument Model Number Tick: This equipment has not been used in an invasive procedure or been in contact with blood, other body fluids or pathological samples. It has been cleaned in preparation for inspection, service or repair. - Page 64 RIDA qLine® autoBlot | User manual Signed: Date: Position Held: Full Official Address: Telephone number:...
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Page 65: Assay Protocol
19.6 Assay protocol This test is a nitrocellulose membrane-based enzyme immunoassay (immunoblot assay) for the quantitative detection of allergen-specific IgE antibodies in human serum and plasma (citrat). Test procedure: The test procedure is designed for 36 membranes in the RIDA qLine® autoBlot Allow the Membranes, reagents and patient sera to come to room temperature (20 - 25 °C). - Page 66 RIDA qLine® autoBlot | User manual The washing is performed as described in item 5. But the washing step is repeated as much as 7 times. 10 400 μL of Substrate are dispensed to the membranes each and incubated on the orbital shaker for 15 minutes.
- Page 68 RIDA qLine® autoBlot | User manual R-Biopharm • An der neuen Bergstraße 17, 64297 Darmstadt, Germany E-mail: orders@r-biopharm.de • clinical.r-biopharm.com...