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Document history overview

MRN-184-EN

Issue No

Date

Revised Section(s)

Changes

Authorised

jan. 2021

Disclaimer
Safety

Modification claim
Exposure limits / USB-port use

HSR

dec.2021

Calibration procedures
Decommissioning

Metrology traceability addition
Decommissioning only by FSE remark

HSR

nov. 2021

All

General update including software

version 2.14 and changes due to

wording intended use of RPI-Check

HSR

jun. 2021

All

General update and changed chapter

sequence according FDA regulations

HSR

jan. 2021

All

General update

HSR

oct. 2020

All

General update

HSR

Document history overview

MRN-184-EN Version 6 (05-01-2022)

Содержание RPI

Страница 1: ...Instructions for Use RPI MRN 184 EN Version 6 05 01 2022...

Страница 2: ......

Страница 3: ...ication 21 5 4 Output performance characteristics 21 5 5 Waste 21 5 6 Identification and Labelling 22 6 Standard operation procedures 23 6 1 Check before starting up after inactive period 23 6 2 Norma...

Страница 4: ...RPI maintenance 63 8 10 Settings 64 9 Operational precautions limitations and hazards 66 9 1 Avoidance of infection 67 10 Troubleshooting 68 10 1 No water 69 10 2 Concentrated reagent information is n...

Страница 5: ...12 Error list 89 13 System temporarily out of use 94 14 Decommissioning and disposal 95 15 Glossary of Terms 96 Index 97 Contents MRN 184 EN Version 6 05 01 2022 5...

Страница 6: ...rmechatronics 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...

Страница 7: ...oning Metrology traceability addition Decommissioning only by FSE remark HSR 4 nov 2021 All General update including software version 2 14 and changes due to wording intended use of RPI Check HSR 3 ju...

Страница 8: ...is important for proper usage and maintenance in compliance with the manufacturer specifications Your RPI is delivered with these documents An Instruction for Use which describes all specifications o...

Страница 9: ...useful information not related to any specific danger 1 3 Installation The instrument must be installed in a dry and dust free location on a solid and stable surface Do not expose the instrument to e...

Страница 10: ...zers according local quality specifications Do not disconnect the RPI s prior to completion of the shut down cycle The manufacturer disclaims any liability for any direct indirect incidental special o...

Страница 11: ...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 Intended use RPI MRN 184 EN Version 6 05 01 2022 1...

Страница 12: ...in the specifications mentioned below RR Mechatronics recommends that a Merck Millipore representative performs a water analysis prior to the installation of the RPI to ensure your water supply meets...

Страница 13: ...interface with multi authority levels All external connectors are situated on the rear side of the instrument including the ON OFF switch All user serviceable and replaceable parts are accessible thr...

Страница 14: ...5 Performance characteristics and specifications Performance characteristics and specifications 14 MRN 184 EN Version 6 05 01 2022...

Страница 15: ...hange and service Number of concentrate cubitainers 2 x 10L hot swappable Result monitoring method RPI Check Intended use The RPI is a general purpose instrument intended to dilute a concentrated reag...

Страница 16: ...ion Upright Cubitainer volume 10L Maximum Cubitainer dimensions H 245 x W 245 x D 245 mm Cubitainer detection identification NFC Location RFID at cubitainer Rear Concentrate pick up tube To be determi...

Страница 17: ...talian German Spanish Intended use Use environment In Vitro Diagnostic laboratories Intended operators Trained IVD lab personnel Cubitainer switching Intra lot cubitainer switching Uninterrupted produ...

Страница 18: ...al requirements Mains voltage 120 or 230V 10 50 60 Hz 3 Fuse EU 230V 2x 3 15A T Slow blow Hollyland 31 50T 032H or equivalent according IEC 60127 250V temp range 55 C to 125 C Fuse USA 120V 2x 6 3 A T...

Страница 19: ...16 Pyrex 3 3 POM Pt Tygon Data storage Storage medium Onboard memory data export storage USB 4 GB Stored data Batch production information and reagent traceability information Data on Cubitainer NFC t...

Страница 20: ...c functionality 2 Supervisor Basic functionality Retrieve performance data Environmental settings 3 Technician all previous Basic maintenance 4 Field Service Engineer these functions are not described...

Страница 21: ...ment typically 15 32 C Relative Humidity 35 75 non condensing for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C The instrument is designed for an operational altitude of...

Страница 22: ...g Example of type plate This label indicates the voltage configuration used fuses in which the instrument is delivered The voltage cannot be changed Performance characteristics and specifications 22 M...

Страница 23: ...eral and lab settings by the Lab Manager check if End filter connections are correct by the Lab Technician During startup the instrument is automatically checked and if all start conditions are met th...

Страница 24: ...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 24 MRN 184 EN Vers...

Страница 25: ...o 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 switch...

Страница 26: ...on 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 spi...

Страница 27: ...al operation it is possible to produce reagent until both cubitainers are empty After placing a new cubitainer the data of this specific cubitainer is stored in the instrument The ID of the cubitainer...

Страница 28: ...d 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...

Страница 29: ...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 Replacement of top cu...

Страница 30: ...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 und...

Страница 31: ...staltic 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 sen...

Страница 32: ...rby 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...

Страница 33: ...l 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 manua...

Страница 34: ...w lot is used a visual and audible warning is given that availability will pause soon If no action is taken all further steps are automatically performed the remaining reagent will be used Press Drain...

Страница 35: ...centrated reagent with a new lot Progress of the Prime storage step is shown on the screen 6 4 3 Placement of a new RPI Check bottle It is shown on the screen if the RPI Check bottle fluid has to be r...

Страница 36: ...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 i...

Страница 37: ...ters see display of the AFS visible from the outside If optional external warning light is installed the status of the instrument is indicated as Green instrument in operation mode Orange warning inst...

Страница 38: ...ck and compares it to limits based on the conductivity value stored in the NFC tag on the RPI Check bottle If the measured conductivity is within the limits the control cycle is passed and the control...

Страница 39: ...Calibration procedures MRN 184 EN Version 6 05 01 2022 39...

Страница 40: ...interface has four levels of access Operator with basic user functionality Supervisor For the lab manager supervisor with full user functionality Technician For the local technician with some mainten...

Страница 41: ...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 acc...

Страница 42: ...eck bottle x x x Start Manual Control cycle x x x Manual ID entry x x x Info Performance data x x Instrument state x x Instrument information x x x Maintenance WPU maintenance items x RPI Maintenance...

Страница 43: ...ble 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 The menu for the lab operator is visible User interf...

Страница 44: ...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 At...

Страница 45: ...the Supervisor credentials on the screen keypad to operate the graphical user interface 3 The menu for the Supervisor is visible More screens are activated at Information tab User interface and softw...

Страница 46: ...Instrument state Instrument information It is not possible to use items on the Maintenance tab On tab Settings the following functions are activated User interface and software menu 46 MRN 184 EN Ver...

Страница 47: ...General settings Audio settings Lab settings User interface and software menu MRN 184 EN Version 6 05 01 2022 47...

Страница 48: ...ailable on Technician level 8 6 Home screen The Home screen provides relevant information for available cubitainers and indication of the status of the concentrated reagent cubitainers and RPI Check T...

Страница 49: ...e 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 cubit...

Страница 50: ...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 pre...

Страница 51: ...er 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 op...

Страница 52: ...ycle The instrument will start the control cycle once the current process is finalized Once the cycle is done production is continued automatically 5 Log out or otherwise log out will occur automatica...

Страница 53: ...pears 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 MR...

Страница 54: ...y 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 a...

Страница 55: ...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 MRN 184 EN Version 6...

Страница 56: ...inactivity 8 7 4 Manual insert RPI Check ID 1 Select Log in in the right side of the screen 2 Enter access level credentials 3 Select Manual tab 4 Select Manual ID entry Follow the instructions on the...

Страница 57: ...laimer 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 tha...

Страница 58: ...a 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 instrume...

Страница 59: ...s 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 Co...

Страница 60: ...After confirmation that the data is copied successfully remove the USB stick The Batch CSV contains the following data Duration batch id temperature conductivity production total date end time end Th...

Страница 61: ...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 softwa...

Страница 62: ...ut 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 This display is visible through the sight g...

Страница 63: ...ntenance 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 action...

Страница 64: ...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 exter...

Страница 65: ...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 automat...

Страница 66: ...osure limits and has been evaluated in compliance with mobile exposure conditions The equipment must be installed and operated with minimum distance of 20 cm of the human body The USB port on the outs...

Страница 67: ...ed to a power outlet of the correct voltage Please note that the instrument must be earthed Use only the original delivered main power cord or exact equivalent with wire thickness of 3x1 0 mm2 AWG 18...

Страница 68: ...reens with red outlines and error codes with descriptions These messages can be minimized if these errors can be solved later Indication messages are also displayed when there are multiple errors at t...

Страница 69: ...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...

Страница 70: ...errors Check the cubitainer connection or replace the cubitainer if this error persists Press confirm to continue Press confirm and solve other errors if needed Troubleshooting 70 MRN 184 EN Version...

Страница 71: ...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 P...

Страница 72: ...l produce reagent as required Delayed maintenance can result in poor quality instrument failure and downtime Replacing Vent Filter Peristaltic pump tubes Pick up tubes and End filters can be performed...

Страница 73: ...022758 ECO 3 months Lab technician Replace Concentrate pickup tubes 2 pcs A0022751 ECO 3 months Lab technician Vent filter SQWLV040002 3 months Lab technician Maintenance of WPU unit Replacement WPU f...

Страница 74: ...y consists of A0019806 Pick up tube A0019392 Peristaltic pump tube A0019520 Harness 11 2 Removing and replacing cover panels Remove top panel 1 Loosen the three M4 torx screws with torx key T10 stored...

Страница 75: ...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 Be aware of liquid spilling...

Страница 76: ...placement 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...

Страница 77: ...ity 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...

Страница 78: ...e 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 per...

Страница 79: ...f 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 MRN 184 EN...

Страница 80: ...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 80 MRN 184 EN Version 6 05...

Страница 81: ...r 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 Replace the...

Страница 82: ...ickup 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...

Страница 83: ...ck 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 MRN 184 E...

Страница 84: ...ly 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 acco...

Страница 85: ...fter 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 kn...

Страница 86: ...trol 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 a...

Страница 87: ...he instrument is delivered for 230VAC or 120VAC Place only the applicable fuses the voltage rate may not be changed see Type plate The main power entrance is located on the rear side Move the instrume...

Страница 88: ...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 Maintenance 88 MRN 184 EN Version 6 05...

Страница 89: ...RPI Check bottle is almost empty RPI Check tubing pickup is broken Replace RPI Check bottle Check pick up tube If not solved Call for service F07 Temperature is out of range Temperature too high or l...

Страница 90: ...in overflow vessel Float switch es broken Not correctly connected Call for service F18 Leak detection triggered Leak Accidental spilling of e g RPI Check fluid Check vessels and tubes and replace leak...

Страница 91: ...ck content too low for next cycle After control cycle too little RPI Check for next control cycle Place new control bottle F53 Automated cycle not completed due to insufficient content Not sufficient...

Страница 92: ...in Please close the door or log in by pressing confirm Unauthorized action Close door drawer or log in F66 Internal communication error Menu not found Navigate to other menu Retry action that caused t...

Страница 93: ...itable tag F75 Maintenance Cleaning procedure is required Call for service F76 Maintenance Replace the cubitainer pickup tubes LT Replace Cubitainer pickup tubes F77 Maintenance Replace the peristalti...

Страница 94: ...oer 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 on...

Страница 95: ...ment 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 i...

Страница 96: ...GUI Graphical User Interface IVD is short for In Vitro Diagnostic This kind of diagnostic is performed on biological samples in a test tube or more generally in a controlled environment outside a liv...

Страница 97: ...state 61 Intended use RPI 11 Introduction 8 M Maintenance 72 Maintenance items Maintenance schedule RPI 73 Maintenance screen 62 Maintenance WPU 85 Manual Control cycle 52 Manual insert cubitainer ID...

Страница 98: ...45 System temporarily out of use 94 T Technical specifications 15 Technician level 48 Troubleshooting 68 U Used symbols 8 User interface and software menu 40 User level description 20 User Menu 41 W...

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