Instructions for Use RPI MRN-184-EN Version 6 (05-01-2022)
Contents Contents - Document history overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1 - Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.1 - - About this manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.2 - - Used symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents 8.1 - - User Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 8.2 - - Access levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 8.3 - - Operator level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 8.4 - - Supervisor level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents 12 - Error list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 13 - System temporarily out of use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 14 - Decommissioning and disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 15 - Glossary of Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents Manufacturer: RR Mechatronics Manufacturing B.V. Phone: +31 229 291 129 Fax: +31 229 241 534 E-mail: support@rrmechatronics.com Internet: www.rrmechatronics.com Postal address: P.O. Box 225 1620 AE Hoorn The Netherlands Office address: De Corantijn 13 1689 AN Zwaag The Netherlands © Copyright RR Mechatronics Manufacturing B.V. All rights reserved. Subject to changes without prior notice.
Document history overview Document history overview MRN-184-EN Issue No Date Revised Section(s) 6 jan. 2021 Disclaimer Safety 5 dec.2021 Calibration procedures Metrology traceability addition Decommissioning Decommissioning only by FSE remark 4 nov. 2021 All General update including software version 2.14 and changes due to wording intended use of RPI-Check HSR 3 jun. 2021 All General update and changed chapter sequence according FDA regulations HSR 2 jan.
Introduction 1 Introduction Read this manual, especially the standard operation procedure and Safety instructions , before using the instrument. 1.1 - About this manual This manual describes all necessary procedures and information required for the correct and successful use of the RPI, covering normal operation, user maintenance and troubleshooting. When instrument is mentioned, it is used for the complete instrument, the RPI including the AFS-24 unit.
Introduction These symbols are used to indicate that proper safety equipment has to be used. Protective glasses and gloves must be worn This UV RADIATION sticker is used to refer to a position on or inside the water system cabinet where exposure to UV light is possible This ELECTRICAL GROUND sticker is used to refer to a position on the water system Cabinet or inside where an electrical ground connection is made.
Introduction 1.4 - Disclaimer Operate and maintain this instrument according to this manual and other instructions from the manufacturer. Failures and defects as result of unspecified use will void the product warranty. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Intended use RPI 2 Intended use RPI The RPI is a general purpose instrument intended to dilute a concentrated reagent to a usable fluid for in vitro laboratory testing.
Installation procedures and requirements 3 Installation procedures and requirements Users are not allowed to install and connect the instrument. The RPI must be unpacked, installed and checked by a trained engineer prior to first operation. Installation procedures and requirements are described in the Installation manual. 3.1 - Feed water requirements The provided feed water quality will affect the performance of the RPI and is required to be within the specifications mentioned below.
Principles of operation 4 Principles of operation The RPI (Reagent Production Instrument) is an automated reagent preparation instrument. It produces a ready-to-use reagent out of a concentrated reagent and lab water to a predetermined target conductivity. The instrument is a single unit, housing all necessary parts inside a closed frame. The frame is covered with easily removable, coated, sheet metal panels. The instrument is operated with a user interface with multiauthority levels.
Performance characteristics and specifications 5 Performance characteristics and specifications 14 MRN-184-EN Version 6 (05-01-2022)
Performance characteristics and specifications 5.
Performance characteristics and specifications 1x John Guest PM Acetal fitting 8 mm Input water connection Clinical laboratory reagent water, conductivity ≥ 1MΩ/cm Produced water quality Installation by Merck-Millipore Field Installation Engineer is required Installation requirement Waste RPI Waste connection AFS-24 Waste connection 1x John Guest PM Acetal fitting 10mm (OD) 1x John Guest PM Acetal fitting 6 mm (OD) Concentrate cubitainers Cubitainer positions Cubitainer orientation Cubitainer volume
Performance characteristics and specifications Reagent delivery port details: Number of output ports Output port outer diameter End point filtration Expected priming vacuum 4 John Guest PM Acetal 6 mm (OD) 0.
Performance characteristics and specifications Deep cleanse cycle Deep cleanse medium Exterior sanitation Yearly maintenance+ incidentally Chloride cleaning tablet Common lab practice Maintenance Preventive maintenance calls per year 1, by qualified field service engineer Consumables replacement frequency RPI: Every 3 months, WPU: Every 3 months Consumables RPI-Check / Progard / Q-gard / end point filters / peristaltic pump tubing and pickup tubes Electrical requirements Mains voltage 120 or 230V
Performance characteristics and specifications Environment Sound level Environment temperature Operating temperature Relative humidity Operational altitude Indoor/outdoor use Less than 62 dBA 5-40 °C 15.5 – 32 °C 35-75% non-condensing 0 – 2000 m AMSL Indoor use Total dimensions Instrument size Empty weight L 775 x W 620 x H 750 mm 107 kg, including WPU Chemical compatibility Wetted surface materials PFA / HDPE / PP / PPS (40%GFR) / LLDPE / EPDM / AlO / ANSI-316 / Pyrex 3.
Performance characteristics and specifications 5.2 - User level description The software has four access levels from basic functionality for the operator up to full access for the Field Service Engineer. The four levels are: 1. Operator: ▪ Basic functionality 2. Supervisor: ▪ Basic functionality ▪ Retrieve performance data ▪ Environmental settings 3. Technician: ▪ all previous ▪ Basic maintenance 4.
Performance characteristics and specifications 5.3 - Application The instrument is used as part of an automated laboratory logistical system and can be connected to a maximum of 4 analyzers or similar reagent consuming instruments. These combined instruments are expected to have a continuous consumption of <17 L/hr / ~20 L/hr peak (for 3 hours). The instrument will be standing on the laboratory floor.
Performance characteristics and specifications 5.6 - Identification and Labelling Example of type plate This label indicates the voltage configuration / used fuses in which the instrument is delivered. The voltage cannot be changed.
Standard operation procedures 6 Standard operation procedures 6.
Standard operation procedures The operator can start production by pressing "Start Production". The instrument start producing ready-to-use reagent. The main screen shows the consumption of the reagents.
Standard operation procedures 6.3 - Cubitainer Status It is advised to replace the empty Cubitainer prior to the active Cubitainer reaching 50% of the fill level to ensure continuous production of ready-for-use reagent. The color changes when a cubitainer has <20% concentrate reagent remaining. The color changes to red when a cubitainer is empty (<5%), production switches to other cubitainer and an audible and visual warning is given.
Standard operation procedures When both cubitainers are empty, an audible and visual warning is given and production stops until new cubitainers are placed. 6.4 - Replacement of the cubitainers and RPI-Check bottle Wear protective clothing, gloves and safety glasses during replacement. Clean immediately in case of spilling or splashing.
Standard operation procedures Both cubitainers are positioned inside the RPI in designated drawers. The upper position is indicated as the "Top" concentrate cubitainer (1). The lower position is indicated as the "Bottom" concentrate cubitainer (2). The RPI-Check bottle can be found inside the door at the right side of the instrument (3). During normal operation it is possible to produce reagent until both cubitainers are empty.
Standard operation procedures 6.4.1 - Placement of a new cubitainer Always use concentrated reagent cubitainers that has been acclimatized for at least 24 hours to environment temperature. 1. Prior to use, inspect the cubitainer for any damage. 2. When the following screen appears, select ‘Log in’ and enter credentials. 3. Select the 'Manual' tab from the left side column of the screen.
Standard operation procedures 4. Select ‘Replace cubitainer’. The following message appears: 5. Prepare a new cubitainer, remove the cardboard cover to expose neck and cap. Do not extend the neck. 6. For replacement of top cubitainer: Open door, lift drip tray sensor and pull out the drip tray.
Standard operation procedures Open drawer Place new cubitainer nearby and disconnect peristaltic pick-up tube cubitainer from old cubitainer. Remove old cubitainer, remove cap from new container, transfer pick-up tube from old to new container. Place new cubitainer. Ensure the pick-up tube is clean and undamaged.
Standard operation procedures Ensure the cubitainer is placed correctly. Place pickup tube on the new the container and connect peristaltic pump tube. Place cap on the old cubitainer. Discard the old cubitainer according to local regulations. Wipe drip tray in case of leaking fluids. Push drawer and drip tray in (mind the drip tray sensor).
Standard operation procedures Open drawer. Place new cubitainer nearby. Exchange cap and pickup tube from both cubitainers. Place new cubitainer in the drawer. Ensure the pick-up tube is clean and undamaged. Remove spilled liquid immediately.
Standard operation procedures Ensure the cubitainer is placed and connected correctly. Discard the old cubitainer according to local regulations. Push drawer in The GUI will indicate if the NFC tag was read correctly. If the NFC tag is not orientated in the correct way or not readable, the reagent information has to be entered manually, see Manual insert cubitainer ID .
Standard operation procedures Enter new or existing user information and press Submit. Note: After a lot switch, production can be low and F67 occurs. This will be automatically solved by the instrument (RPI). 6.4.2 - Concentrated reagent lot switch When both concentrated reagent cubitainers have the same lot number, reagent production continues without interruption. If a new lot is used, a visual and audible warning is given that availability will pause soon.
Standard operation procedures ▪ ▪ ▪ Produce 3 batches Provide a "Ready for production" message Add a new lot number Press Start Production to start production from concentrated reagent with a new lot Progress of the Prime storage step is shown on the screen: 6.4.
Standard operation procedures 1. Open the door. 2. Remove empty bottle from the instrument and replace with a new one. Always use a bottle that has been acclimatized to room temperature for at least 24 hours. 3. Place the bottle with the NFC-tag facing the NFC-reader to enable the RPI to read the NFC properly. 4. Close the door. The NFC is automatically read to import batch information. If the NFC tag is not read correctly it can be manually entered.
Standard operation procedures 6.5 - Checks during operation Pay attention for the status of the cubitainers on the main screen. It is advisable to replace the empty cubitainer prior to the active one reaching it’s 50% level.
Calibration procedures 7 Calibration procedures The RPI is not calibrated but monitored with a control cycle. 7.1 - Control cycle With the control cycle the measurement accuracy is validated. This cycle will take a maximum of 20 minutes and uses RPI-Check (conductivity range of 16.5-17.5 mS/cm @25˚C). The accuracy of RPI-Check is guaranteed through RR Mechatronics measurement and quality control procedures, and based on a Certified Reference Material produced by the Danish National Metrology Institute.
Calibration procedures MRN-184-EN Version 6 (05-01-2022) 39
User interface and software menu 8 User interface and software menu The Graphical User Interface or GUI is featured on a touch operated screen located on the front of the instrument. The following program description is valid for software from version 2.15 and up.
User interface and software menu 8.1 - User Menu The following tabs are available: Home Maintenance Manual Settings Information Depending on the access level one or more functions are available. On each screen is shown: active tab (1), menu level (2) and the active access level (3). Available functions are indicated in dark blue (4). Not activated functions, due to access level restrictions, are indicated in light blue (5).
User interface and software menu 8.
User interface and software menu 8.3 - Operator level The lab operator has to login to be able to operate the touch screen. 1. Select Log In 2. Enter the Lab employee credentials on the-screen keypad, to operate the graphical user interface: 3.
User interface and software menu On the home screen, information for the available cubitainers is given, indicated which cubitainer is used and which container is the spare. This screen shows if one the cubitainers is empty (<5%) and has to be replaced. If one cubitainer is empty and the other is <10% filled, a warning is given to replace the empty cubitainer. For the RPI-Check bottle the first warning (almost empty) is given if the level is <40% and an urgent replace warning if the level is <20%.
User interface and software menu 8.4 - Supervisor level 1. Select Log In 2. Enter the Supervisor credentials on the-screen keypad, to operate the graphical user interface: 3.
User interface and software menu ▪ ▪ ▪ Performance data Instrument state Instrument information It is not possible to use items on the Maintenance tab On tab Settings the following functions are activated: 46 MRN-184-EN Version 6 (05-01-2022)
User interface and software menu ▪ ▪ ▪ General settings Audio settings Lab settings MRN-184-EN Version 6 (05-01-2022) 47
User interface and software menu 8.5 - Technician level The Lab technician is allowed to replace regular items in the instrument and can confirm these actions in the software to be able to start production again after the required replacement of parts. The Lab technician has to be trained by a qualified Field Service Engineer. See chapter Maintenance screen for all functions which are available on Technician level. 8.
User interface and software menu The status of the current used concentrated reagent. The status of the concentrated reagent not currently in use. The status of the RPI-Check. Concentrated reagent or RPI-Check has to be replaced. Concentrated reagent level is almost empty (indicated if concentrate level is <10%). Production is switched to other cubitainer or control cycle cannot be performed.
User interface and software menu Concentrated reagent or RPI-Check has to be replaced immediately. Concentrated reagent level is empty. (indicated if concentrate level is <5%). By pressing on one of the circles more information is visible with specific data: Warnings are indicated with an orange frame, errors are indicated with a red frame on the screen, including a message. This message can be minimized by pressing on the message or enlarged by pressing the warning sign.
User interface and software menu 8.7 - Manual screen Select Manual . On this tab reagent production can be started or stopped or to start a Control cycle . The other options are: Replace cubitainer (and adding users ) Replace RPI-Check Manual ID entry If the button "Start production" is grey, it has been more than 24h since a control cycle has been performed. During operation, production can be stopped, press "Stop production".
User interface and software menu 8.7.1 - Manual Control cycle his option can be used if an additional control cycle has to be performed. A control cycle will take maximum 20 minutes. For this step the door has to be closed. 1. Select ‘Log in’ 2. Enter credentials 3. Select tab 'Manual’ 4. Select "Start Control cycle", initiating the control cycle. The instrument will start the control cycle once the current process is finalized. Once the cycle is done, production is continued automatically. 5.
User interface and software menu Press Yes, the following screen appears, enter new or existing user information. Click on "new entry" to add a new user. The following screen appears: The next time, this user can be selected from the list.
User interface and software menu Press Submit and it will be confirmed that all the concentrate information has been stored correctly: 8.7.3 - Manual insert cubitainer ID Disclaimer This is not the recommended process. “By manually entering the cubitainer ID the instrument is unable to determine and track the consumption from that cubitainer. The user accepts all performance and potential legal consequences that this action may have” 1. Select ‘Log in’, in the right side of the screen. 2.
User interface and software menu 4. Select ‘Manual ID entry’. 5. Select applicable "top" or "bottom" concentrated reagent. 6. Enter applicable data, exactly as printed on the cubitainer label and press Next.
User interface and software menu Manual entered data is marked in grey, the liquid level of a cubitainer with manual entered data is not tracked by the software, production is stopped in case of insufficient level of concentrated reagent. Press Submit to enter the data. In case the entered cubitainer ID is not accepted by the instrument, repeat the process. 7. Log out or otherwise log-out will occur automatically after 5 minutes of inactivity. 8.7.4 - Manual insert RPI-Check ID 1.
User interface and software menu 6. Log out or otherwise log-out will occur automatically after 5 minutes of inactivity. Disclaimer “By manually entering the cubitainer ID the instrument is unable to determine and track the consumption from that cubitainer.
User interface and software menu 8.8 - Information screen Select Information . Three options are available: Performance data To retrieve data from a specific batch of concentrate, RPI-Check and traceabilty. Instrument state To see the status of the instrument. Instrument information For general information about the instrument configuration.
User interface and software menu 8.8.1 - Retrieve performance data Use an empty, virus-free, USB stick, formatted with FAT32. 1. Select ‘Login’ 2. Enter access level credentials 3. Select "Information"tab 4. Select 'Performance Data'. 5. Data can be shown on screen with Search, data can be exported with Export. Search option: On screen can be seen: End time, Result, Conductivity, Temperature, Pulse count and Duration.
User interface and software menu After using the table button: The available data is shown as a graph. Export option: 1. Select "Performance Data”. 2. 3. 4. 5. 6. Insert an empty USB stick in the slot located at the front of the instrument, near the GUI screen. Choose which data type has to be exported: batch data, control data or traceability data. Select the period of which data is to be downloaded. Press “Export” to copy the data (.CSV format) on the USB-stick.
User interface and software menu 8.8.2 - Instrument state This screen only indicates in which lines is an active water flow (in blue). The lines in black are not containing water at that moment. The overflow lines are only indicated in red, meaning an inactive water flow. 8.8.3 - Instrument information On this screen general information, several software status and serial numbers are displayed.
User interface and software menu 8.9 - Maintenance screen In the Maintenance screen, two options are available on Technician access level: WPU , with maintenance functions for the WPU (filter replacement and cleaning). RPI , with maintenance functions for the RPI (cleaning, replacement of standard parts and shut down). 8.9.1 - WPU maintenance The filter packs in the WPU requires replacing or cleaning (Cl or pH). The WPU display provides an indicator for required actions.
User interface and software menu Confirm finishing the WPU Maintenance actions after they are performed. The RPI will go back to online. 8.9.2 - RPI maintenance On the level Technician are options available for regular replacement items: ▪ ▪ ▪ Replace Vent filter Replace Peristaltic pump tubes Replace pick-up tubes / End point filters ▪ Note: During these actions, production of ready-to-use reagent is paused.
User interface and software menu 8.10 - Settings General settings: Change language: Select your language (if available) Set the time zone, date and time with the next options. To apply Time and timezone settings a restart is required. Note: Daylight saving time has to be set manually, the RPI is not connected with an external network.
User interface and software menu Audio settings: After enabling the the silent mode, the timer can be refreshed for one hour. With adjusting the sound volume., the normal sound level can be set. Only error messages signals will stay at the same level. Lab settings: Set control cycle time: For setting the time for the automatic control cycle.
Operational precautions, limitations and hazards 9 Operational precautions, limitations and hazards The RPI and the incorporated WPU should be operated according to the instructions in this manual and the manual of the WPU (AFS24). In particular, the hydraulic and electrical specifications should be followed and met. It is important to use this equipment as specified in this manual; using this equipment in a different manner may impair the safety precautions of the instrument.
Operational precautions, limitations and hazards Power Supply ▪ ▪ ▪ ▪ ▪ The power connection has to be accessible at any time, the power cord is functioning as disconnecting device. Should the instrument emit unusual smell or smoke, turn the main switch OFF immediately and unplug the power cable. Using the instrument further carries the risk of fire, electric shock or personal injury. Contact your Service Representative. Do not disconnect the power for any other reason.
Troubleshooting 10 Troubleshooting In case of errors, the system will generate an error message on the GUI. Also, the (optional) status light will be changed from green to orange in the case of warning, or to red in the case of a production error. Warnings and errors of the WPU are displayed on the AFS-display (visible from the outside) Occurring errors are indicated on the screens with red outlines and error codes with descriptions. These messages can be minimized if these errors can be solved later.
Troubleshooting If more errors are active, it will be indicated: 10.1 - No water -Possible stop of water supply, check water connection/supply. -WPU-error, check display of the WPU-unit, in case of no water, check tubing and water supply. 10.2 - Concentrated reagent information is not recognized If after placing a new concentrated reagent cubitainer the data is not recognized (error F55), the instrument will not start production. This data has to be manually added in the cubitainers menu.
Troubleshooting 10.3 - Reagent errors Check the cubitainer connection or replace the cubitainer if this error persists.
Troubleshooting Press No to cancel or Yes to execute the control process: 10.4 - Control cycle does not start or fails If the automatic control and manual control does not start: ▪ ▪ ▪ Check if the door is closed. DI-vessel is not filled (enough), check water supply and WPU-unit. Check/replace RPI-Check Peristaltic pump tube T30 .
Maintenance 11 Maintenance Required maintenance items will be indicated by messages, which only can be removed after correct replacement and confirmation by a trained Lab Technician (quarterly maintenance) or Field Service Engineer (quarterly maintenance/yearly maintenance. Inform the Lab Technician or your Field Service for performing maintenance as soon as possible. We recommend performing the maintenance in time to be sure the instrument will produce reagent as required.
Maintenance 11.1 - Maintenance items & Maintenance schedule RPI Item Order nr.
Maintenance Chloride cleaning tablet Merck ZWCL01F50 / Merck 5874316024 (US only) / Merck 5874316024C (Canada only) 1 year + on repairs FSE O-ring Vent filter A0020832 1 year FSE Other parts: External tubing set A0020393 Concentrate tubing kit (Beckman Coulter) A0019376 For replacing complete assembly consists of A0019806 Pick up tube A0019392 Peristaltic pump tube A0019520 Harness 11.2 - Removing and replacing cover panels Remove top panel 1.
Maintenance Remove side panels 1. Undo the latches from a side panel on the inside of the RPI. 2. Now gently push the side panel outwards. 3. Lift the side cover up out of the lower supports with use of the grip. Place the side cover in a suitable location until it is placed back. 4. Repeat Steps 1 to 4 for the other side panel. Reverse the steps to put the panels back. 11.3 - Replacing the Vent filter Only to be performed by a trained Lab Technician or FSE.
Maintenance 1. Enter software and log in with the applicable credentials. 2. Go to Maintenance and select 'RPI" 3. Press Replace vent filter, the following message is given: 4. Press YES to confirm and start actual replacement. 5. Press YES after the message "Instrument will be offline." 6. Remove the top panel by loosening (with Torx T10) the three M4 bolts at the back, lifting up and fully removing from the instrument. a.Unscrew the old filter, b.Check O-ring c.Replace it with a new filter.
Maintenance 8. Confirm that replacement is correctly performed. Production is started again. 9. Log out or otherwise log-out will occur automatically after 5 minutes of inactivity. 10. Dispose of removed parts according to local regulations. 11.4 - Replacing peristaltic pump tubes Only to be performed by a trained Lab Technician or FSE. Be aware of liquid spilling, use a cloth to prevent liquid dripping in the instrument. The peristaltic pump tubes T28 and T29 have to replaced every 3 months.
Maintenance 1. Remove the top panel by loosening the three M4 bolts(with Torx T10) at the back, lifting up and fully removing from the instrument. 2. Undo the latches from the side panel on the inside of the RPI (1) and remove side panel (2) with use of the handle inside the panel, remove side panel completely (3). 3. Enter software and log in with the applicable credentials. 4. Go to Maintenance and select "RPI" 5. Press Replace peristaltic pump tubes, the following message is given. 6.
Maintenance 8. Remove the strain relief from the frame. 9. Disconnect the pump tubes from the cubitainers. 10. Disconnect the pump tubes from the mix vessel. Use the John Guest connection tool to remove the tube coupling.
Maintenance 11. Remove the old tubes from the pumps. Lift the lever to open the clamp system, remove old tube 12. Guide the new pump tubes to the holes, push the strain relief in the hole.
Maintenance 13. Connect the pump tubes with the "quick connect" to the cubitainers and close the drawers. 14. Mount new tube in the pumps, close the clamp system again. 15. Connect the new pump tubes to the mix vessel. C1 for top cubitainer (T28), C2 for bottom container (T29). 16. After replacement of the peristaltic pump tubes: confirm the replacement, the instrument primes tubing and rinses the mix vessel. 17. Monitor for leaks prior to replace the panels. 18.
Maintenance 11.5 - Replacing Pickup tubes/End point filters Only to be performed by a trained Lab Technician or FSE. Be aware of liquid spilling, use a cloth to prevent liquid dripping in the instrument. Replacing Pickup tubes: 1. Enter software and log in with the applicable credentials. 2. Go to Maintenance and select "RPI". 3. Press Replace Pickup tubes/End filter, the following message is given. 4. Press YES to confirm and start actual replacement. 5.
Maintenance 6. Replace T30 from RPI-Check bottle to V6 connection. Replacing endpoint Replacing endpoint Replacing Endpoint filters and tubing (4xA0017999): The end point filter module is positioned at the left upper side.
Maintenance 1. Ensure connected analyzers are placed in an operational mode where reagent consumption will not occur. 2. If not done yet: Remove the top panel by loosening the three M4 bolts(with Torx T10) at the back, lifting up and fully removing from the instrument. 3. Detach the end filter tubing, take care of leaking fluids and remove the old filters. 4. Place new A0017999 End point filter assemblies (filters+tubing), connect tubes according the numbers. 5.
Maintenance 7. Confirm that replacement is correctly performed. Production will resume. 8. Log out or otherwise log-out will occur automatically after 5 minutes of inactivity. 9. Dispose of removed parts according to local regulations. Note: Optional can the complete end filter assembly be demounted after removing the old tubing by loosening the knurled knobs. 11.6 - Maintenance WPU Needed actions are shown on the screen of the WPU.
Maintenance For maintenance of the WPU: See AFS24 User manual (Merck). Remove top and right side panel first. 11.7 - Cleaning The concentrate and reagent tubing are automatically rinsed before each control cycle. As needed a manual rinse cycle can be performed by the Field Service Engineer. Annually, Service will perform additional internal cleaning during the PM visit. 11.7.1 - Cleaning of the drawers and casing Remove spilled liquid inside the drawers and drip tray immediately.
Maintenance The outer casing of the instrument and the inside of the drawers can be cleaned with any standard (nonabrasive) cleaning agent or soap solution and a microfiber cloth. The LCD screen and the light box can be cleaned with a clean soft cloth, slightly damped. Do not use organic solvents. 11.8 - Replacing main fuses The instrument is delivered for 230VAC or 120VAC. Place only the applicable fuses, the voltage rate may not be changed (see Type-plate ).
Maintenance Replace both fuses with the appropriate type, as indicated on the type label and in the Technical specifications . Push the fuse holder back into the power entrance module.
Error list 12 Error list Description Possible cause(s) How to solve? F01 Mix vessel will not fill (process error) Issue with WPU LT: Check WPU, drain mix vessel, restart process, if not solved: Fatal error, call for service Instrument failure F02 Mix vessel will not fill (hardware error) Issue with WPU Instrument failure LT: Check WPU, drain mix vessel, restart process, if not solved: Call for service F03 Mix vessel will not empty Instrument failure Call for service F05 Internal test ECT unit t
Error list F12 Three failed batches in a row Wrong estimation of cubitainer contents Peristaltic pump broken Cubitainer pickup tube broken/ bend F13 Wrong order floats in storage vessel Float switch(es) broken Try other cubitainer Re-attach pickup tube Check peristaltic pump tubing on pinching Call for service Not correctly connected F14 Wrong order floats in lab water vessel Float switch(es) broken Call for service Not correctly connected F15 Power to wpu on, but it takes too long for vessel to be
Error list F26 CAN address error Wiring incorrect or electronics failure Call for service F27 ECT measurement precision too low ECT error Call for service F28 ECT module doesn't have valid control data Fluid bottle is empty (re)start Control cycle ECT module issue Place RPI-Check bottle Call for service F29 No conductivity detected after starting control cycle Pickup tube/Peristaltic pump tube issue Replace the peristaltic tubing F50 Temperature of 1x reagent in the storage vessel out of range
Error list F59 RPI-Check bottle open life expired Open life expiration is detected Replace RPI-Check bottle F60 When starting control, open life expired After start of control step shelf life expiration is detected Replace RPI-Check bottle F61 Shelf life one concentrate cubitainer expired Shelf life expiration is detected Replace cubitainer F62 Shelf life both concentrate cubitainers expired Shelf life expiration is detected Replace cubitainers F63 RPI-Check bottle shelf life expired Shelf life
Error list F72 Error: Expiration date of manual barcode has already passed Placed concentrate is out of date Replace cubitainer with correct expiration date F73 An unexpected error has occurred in the NFC reader failure tagreader Call for service F74 Tag is write protected and cannot be used Replace cubitainer with a writable tag Unusable tag on place cubitainer F75 Maintenance: Cleaning procedure is required Call for service F76 Maintenance: Replace the cubitainer pickup tubes LT: Replace Cubita
System temporarily out of use 13 System temporarily out of use Als het instrument niet gebruikt wordt (inclusief 's nachts) dient de watertoevoer afgesloten te worden om incidenten met waterverspilling te voorkomen. Activeer de "LAb gesloten"modus van de WPU-eenheid. If the RPI is shut off for a long period of time: Call for service, this can only be performed by a Field Service Engineer.
Decommissioning and disposal 14 Decommissioning and disposal Only to be performed by a trained FSE. In case of permanent removal of the instrument 1. Remove all data from the memory. 2. Perform a complete shut of procedure to remove all fluids from the instrument. 3. Remove the battery from the touch screen unit. 4. Dispose of the instrument and its parts according national or local regulations.
Glossary of Terms 15 Glossary of Terms Cell constant: A cell constant converts the measured conductivity value of a fluid with known conductivity (= a control fluid) into the known conductivity value of that control fluid. Cl2 cleaning: Cleaning of the inside of the membranes of the AFS-24 with chlorine CLRW: Clinical Laboratory Reagent Water ECT: Electronic Conductivity and Temperature End point filter: 0.
Index Instrument state. . . . . . . . . . . . . . . . . . . . . 61 A About this manual. . . . . . . . . . . . . . . . . . . . . 8 Intended use RPI. . . . . . . . . . . . . . . . . . . . Access levels. . . . . . . . . . . . . . . . . . . . . . . . 42 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . 8 Application. . . . . . . . . . . . . . . . . . . . . . . . . 21 Avoidance of infection. . . . . . . . . . . . . . . . . 67 M Maintenance. . . . . . . . . . . . . . . . . . . . . . . .
S Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Standard operation procedures. . . . . . . . . . . 23 Supervisor level. . . . . . . . . . . . . . . . . . . . . 45 System temporarily out of use. . . . . . . . . . . 94 Technical specifications. . . . . . . . . . . . . . . . 15 T Technician level. . . . . . . . . . . . . . . . . . . . . . 48 Troubleshooting. . . . . . . . . . . . . . . . . . . . . 68 U Used symbols. . . . . . . . . . . . . . . . . . . . . . . .
