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EUROIMMUN Medizinische Labordiagnostika AG MERGITE!, Инструкция по эксплуатации

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2 Safety 

Instructions for use 

• 

MERGITE! 

25/84 

2.8  Environmentally hazardous 

substances/materials 

Dispose of the used materials, e.g. slides,  glass plates  or cover 

glasses and the  waste liquid  in accordance with the statutory 

regulations for hazardous biological substances. 
The glass plates are suitable for multiple use. For the disinfection, 

cleaning and regeneration of the glass plates properties, please refer 

to the instructions for use

  General Instructions for  EUROIMMUN 

indirect immunofluorescence tests

 (FI_0001_A_UK_CXX). 

Содержание MERGITE!

Страница 1: ...EUROIMMUN Medizinische Labordiagnostika AG 23560 L beck Germany Seekamp 31 Tel 49 451 5855 0 Fax 49 451 5855 591 Instructions for use MERGITE Wash system for Titerplane slides MERGITE 10 MERGITE 50...

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Страница 3: ...iquid flow is gently applied to every substrate field providing for a substrate preserving and efficient washing Thus the MERGITE washing technology in combination with standardized washing protocols...

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Страница 5: ...o pay compensation All rights are reserved in the case of a patent being granted or the design being registered Document number YG_0064_A_UK_C04 Version 01 08 2018 Software version 4 5 0 X Translation...

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Страница 7: ...7 1 6 Warranty 17 1 7 Limitation of liability 17 1 8 Transport and storage requirements 18 1 9 Disposal 19 1 10 Customer Support 19 2 Safety 20 2 1 Intended purpose 20 2 2 Validity 20 2 3 Technical sa...

Страница 8: ...3 1 MERGITE 10 26 3 1 1 Scope of delivery MERGITE 10 26 3 1 2 Accessories MERGITE 10 27 3 2 MERGITE 50 27 3 2 1 Scope of delivery MERGITE 50 27 3 2 2 Accessories MERGITE 50 28 3 3 Spare parts 28 3 4...

Страница 9: ...Titerplane incubation with MERGITE 45 6 4 Filling or draining the containers 49 Draining the waste liquid container 49 Filling the container for distilled water 50 Filling the wash buffer container 50...

Страница 10: ...maintenance 65 8 2 Maintenance schedule 66 8 3 Maintenance and cleaning tasks 67 Filling the system with distilled water 67 8 3 1 Cleaning of the liquid system 67 Cleaning the liquid system 67 8 3 2 C...

Страница 11: ...GITE xi 9 Troubleshooting 74 9 1 Switching on the device 74 9 2 Liquid system 74 9 3 Power failure 76 10 Technical data 77 10 1 Mechanical data 77 10 2 Environmental conditions 77 10 3 Electrical and...

Страница 12: ...structions for use These instructions for use explain connecting the system components connection diagram operation care and maintenance disposal Installation and commissioning is carried out by the T...

Страница 13: ...erved Avoidance of hazard or WARNING TYPE OF HAZARD ALTERNATIVE TYPE OF HAZARD Possible consequences if the instructions are not observed Avoidance of hazard The gravity of the hazard is classified by...

Страница 14: ...serve the associated safety information Symbol Explanation General hazard sign Warning of dangerous biological substances Warning of dangerous electric voltage Tab 2 Warning symbols Mandatory action s...

Страница 15: ...ge for storage and transport Chapter 10 2 Environmental conditions p 77 storage Permissible humidity for storage and transport Chapter 10 2 Environmental conditions p 77 This side up Tab 4 Symbols on...

Страница 16: ...that the product complies with the applicable guidelines in Canada and the US Pay attention to the safety information warnings and precautions in the instructions for use In vitro diagnostic or IVD me...

Страница 17: ...s applicable in the Federal Republic of Germany where the product was manufactured apply 1 7 Limitation of liability The validation carried out by the EUROIMMUN Medizinische Labordiagnostika AG herein...

Страница 18: ...MUN AG or provided in another manner use of spare parts or accessories of other manufacturers or use of hardware or software configurations of other manufacturers i e lack of compatibility of the EURO...

Страница 19: ...RoHS Reach The products and processes of EUROIMMUN comply with the following guidelines with regard to the labelling of substances as well as the restriction of use of certain hazardous substances Ro...

Страница 20: ...d may only be used by trained professional staff All results have to be checked by trained medical staff The diagnosis or ruling out of an illness as well as an assessment of its likelihood require a...

Страница 21: ...ith biological material and have technical knowledge of dealing with laboratory equipment This also includes the maintenance work listed in these instructions for use Typical qualification levels for...

Страница 22: ...andling these reagents If liquids such as e g biological substances or reagents have been spilled on the device the contaminated areas must be immediately cleaned and disinfected using a validated met...

Страница 23: ...ions Internal hose connectors could become loose or components could become damaged Do not expose the device to strong magnetic fields Electronic components could become impaired or damaged Comply wit...

Страница 24: ...ug the mains plug in order to disconnect the device from the power supply A dangerous situation is for example the leakage of liquid from the device 2 7 Foreseeable incorrect use MERGITE must not be u...

Страница 25: ...asses and the waste liquid in accordance with the statutory regulations for hazardous biological substances The glass plates are suitable for multiple use For the disinfection cleaning and regeneratio...

Страница 26: ...0064 0101 1 5 Titerplane set for the incubation of slides with 10 fields The set includes 1 x MERGITE slide carrier 1 x MERGITE cover glass carrier 1 x MERGITE carrier plate 2 Containers for distille...

Страница 27: ...livery MERGITE 50 Number Explanation 1 MERGITE 50 MERGITE for 1 slide with 50 fields Order no YG 0064 0101 2 5 Titerplane set for the incubation of slides with 50 fields The set includes 1 x MERGITE s...

Страница 28: ...MERGITE ZZ 9999 0550 16 5 coded glass plates For the incubation of slides with 50 fields Tab 10 Accessories MERGITE 50 3 3 Spare parts for MERGITE 10 and MERGITE 50 Order no Article ZG 006f 0101 018...

Страница 29: ...slides with 5 or 10 fields ZZ 3001 0112 1 Cover glasses 12 pieces for mounting the slides with 50 or 10 fields Cleaning ZG 0009 0505 Setup Clean 500 ml Cleaning and disinfection of the liquid system...

Страница 30: ...wash basin via the washing columns and directed onto the substrate fields of the slide Every substrate field is positioned above one washing column that provides for a defined wash buffer liquid flow...

Страница 31: ...ash basin is for washing the slides Depending on the device model one 50 field or up to five 10 field Titerplane slides can be placed on the wash basin in a slide carrier An integrated sensor detects...

Страница 32: ...ontainer Out Hose connector for container with distilled water In 1 Sensor connector for container with distilled water In 1 Hose connector for wash buffer container In 2 Sensor connector for wash buf...

Страница 33: ...ss check that there is sufficient wash buffer distilled water and capacity in the container for waste liquid Number Description Cap with connectors for liquid supply Liquid supply container Cap with c...

Страница 34: ...th a glass plate is called a reagent tray Number Description Positioning aid for placement of the slide carrier Anti twist prevention for placement of the slide carrier Slide carrier The slide carrier...

Страница 35: ...e reagent tray or cover glass carrier Position number Cover glass carrier The cover glass carrier takes up the cover glasses Cover glass carriers are available in 10 field or 50 field format Number De...

Страница 36: ...ed water Connector for wash buffer container Service connector only intended for service work by EUROIMMUN AG Assay connector for installing new washing programs with external data carriers Power supp...

Страница 37: ...the containers 1 Fill a cleaned container with distilled water 2 Connect the container with distilled water to the connector In 1 3 Fill a cleaned container with wash buffer 4 Connect the container wi...

Страница 38: ...applied This prevents increased bubble formation during washing The containers and liquids are prepared and connected to the device Switching the device on 1 Remove the wash basin cover from the wash...

Страница 39: ...rinsing process if needed Pressing NO activates the START view Fig 15 The device is switched on and ready to wash slides 6 2 Washing The following describes the washing of Titerplane slides in the ME...

Страница 40: ...ts standing time in the liquid system has been exceeded Chapter 6 5 Rinsing with the wash buffer p 51 In this case you will be prompted to rinse the liquid system again The WASH window appears for sel...

Страница 41: ...0 substrate fields are always placed on the slide carrier from left to right For MERGITE 10 The selection for the number of slides to be washed appears For MERGITE 50 Continue with 11 10 Select the nu...

Страница 42: ...ides begins 12 At the beginning of the washing process make sure that all substrate fields have contact with the washing liquid If necessary you can establish the contact by tapping on the correspondi...

Страница 43: ...sh basin Note A washing process that is not performed according to the assay cancelled or repeated washing can lead to incorrect analysis results Slides that were not washed according to the assay hav...

Страница 44: ...Instructions for use MERGITE The wash basin is rinsed automatically and the wash columns are refilled with wash buffer The assay selection view appears Fig 22 Remove slide carrier from the wash basin...

Страница 45: ...ITE 10 The procedure with MERGITE 50 is carried out analogically with the respective carriers and carrier plates You will need Titerplane slides up to five 10 field slides Titerplane glass plates 2 gl...

Страница 46: ...accordingly e g 1 5 3 Insert the slide from left to right in the slide carrier Make sure that the substrate fields of the slides are facing downwards 4 Pipette the prepared samples onto the reaction f...

Страница 47: ...iod and drop the fluorescence marker FITC onto the fields The required amount is specified in the test kit instructions 7 Wash the slides on MERGITE after the end of the incubation period Washing Tite...

Страница 48: ...er glasses in the cover glass carrier The positions are marked with numbers on the cover glass carrier 11 Wash the slides on MERGITE after the end of the incubation period Washing Titerplane slides p...

Страница 49: ...l is reached you will be prompted to fill or drain the container Draining the waste liquid container If the fill level of the waste liquid container reaches its upper limit it must be drained You can...

Страница 50: ...er finish the process by pressing OK The waste liquid container has been drained Filling the container for distilled water Filling the container for distilled water is necessary when the fill level of...

Страница 51: ...nnect the filled container 5 If you were prompted by the system to fill the wash buffer container finish the process with OK 6 Rinse with the new wash buffer Rinsing with wash buffer p 51 You filled t...

Страница 52: ...2 84 Instructions for use MERGITE 3 Press START to rinse with wash buffer The rinsing process begins 4 Afterwards you will be asked if you want to repeat the rinsing Fig 34 RINSE view Fig 35 Rinsing i...

Страница 53: ...ions for use MERGITE 53 84 Repeat the rinse by pressing YES as long as foam build up can be seen on the wash columns Press NO to end the rinsing The liquid system has been rinsed with wash buffer Fig...

Страница 54: ...buffer residue from the wash basin Aspirating wash buffer residue 1 Open the PURGE view START MAINTENANCE PURGE 2 Press START to aspirate the wash buffer 3 Wait until the aspiration process has ended...

Страница 55: ...case of visible contamination clean the wash basin with a moist lint free cloth Use a disinfectant for this purpose e g Meliseptol New Formula 2 Press the On Off switch o If the device is already rin...

Страница 56: ...evice Volume for audio signals Playing a test audio signal Mute Sound on Sound off DISPLAY Settings for brightness contrast and saturation of the screen INFO Device information Chapter 7 1 Information...

Страница 57: ...iquid system rinsing required Distilled water is in the liquid system Status of the liquid system not determined The liquid system is empty IN 1 Sensor IN 1 reports a sufficient fill level Sensor IN 1...

Страница 58: ...from the device on the flash drive DELETE Delete assays from the device SHOW Show existing assays on the device Note Assay Only assays approved by EUROIMMUN AG can be saved on the device Note Externa...

Страница 59: ...2 Select IMPORT in the ASSAY MANAGER view The assays located on the flash drive are displayed on the left side of the screen 3 Select the assays you want to import or press SELECT ALL 4 Press IMPORT T...

Страница 60: ...ce are displayed 2 Select the assays you want to export or press SELECT ALL 3 Press EXPORT The selected assays are saved on the flash drive 4 Press OK to complete the export You have exported one or s...

Страница 61: ...n the device are displayed 2 Select the assays you want to delete or press SELECT ALL 3 Press DELETE 4 Confirm the deleting process with YES The selected assays are deleted from the device 5 Press OK...

Страница 62: ...of the liquid is performed 1 Press DRAIN MERGITE in the DEVICE MANAGER 2 Follow the instructions of the software step by step Note If you don t have a second container at hand you can put both suction...

Страница 63: ...by the Technical Customer Support of EUROIMMUN AG is required for MERGITE WARNING BIOLOGICAL SUBSTANCES Potential risk of infection skin irritation Device may have been in contact with infectious mate...

Страница 64: ...r PURGE Purging wash buffer residues out of the wash basin FULL RINSE Thorough rinsing of the system with wash buffer duration of approx 1 minute MONTHLY MAINTENANCE Performing the monthly maintenance...

Страница 65: ...ntainer p 70 Replacement of wash buffer Cleaning the surfaces of the device and accessories Chapter 8 3 3 Cleaning the device and accessories p 71 8 1 4 Monthly maintenance Cleaning of the liquid syst...

Страница 66: ...55 automatic Cleaning the device and accessories Chapter 8 3 3 Cleaning the device and accessories p 71 X X Disinfection of the containers Cleaning and or disinfecting the containers p 70 X Cleaning a...

Страница 67: ...eposits in the hoses pumps etc Cleaning the liquid system The following instructions describe the cleaning of the liquid system step by step ATTENTION DAMAGE FROM CLEANING AGENTS The liquid system can...

Страница 68: ...n which to place the container cap and to mop up any dripping liquid residues 5 Press START The system is filled with SETUP CLEAN 1 5 and the progress indicator for the exposure time appears After the...

Страница 69: ...1 5 in the liquid system can damage the device or damage the substrates by accidental washing with the cleaning solution Make sure that distilled water is connected to In 1 Make sure that SETUP CLEAN...

Страница 70: ...They apply to all containers 1 Make sure that the device is not running any processes 2 Have a paper towel at the ready on which to place the container cap connector hose and sensor line from the con...

Страница 71: ...lint free cloth o Outside of the container o Container cap with connector hose and sensor line o Suction or discharge tube 10 Rinse the container 2 x with tap water to remove residues from the cleanin...

Страница 72: ...DAMAGE TO THE CARRIERS The carriers and wash basin cover can become warped Do not use excessive force when cleaning The carriers and wash basin cover are not suitable for the autoclave or dishwasher...

Страница 73: ...rking solution The working solution SETUP CLEAN 1 5 can be used immediately 8 4 Measures for storage or transport Carry out the following steps before you store or transport the device a Empty the liq...

Страница 74: ...e 9 2 Liquid system Effect Cause and troubleshooting There are many air bubbles or foam forming on the wash columns of the wash basin Air in the liquid system Air in the liquid system can be introduce...

Страница 75: ...that the waste liquid container is correctly connected to connector Out Pressure compensation on the waste liquid container is not possible Check that the pressure compensation hole on the container...

Страница 76: ...k the correct connectivity of the sensor cables if necessary by removing and reconnecting them Technical defect Contact Technical Customer Support Chapter 1 10 Customer Support p 19 With IGNORE you ca...

Страница 77: ...emperature 15 C to 25 C 59 F to 77 F Permissible relative humidity without condensation 30 to 80 Installation height up to 2000 m above sea level Installation area dry level clean Place of operation d...

Страница 78: ...Overvoltage installation category II EN 61010 1 Contamination level 2 EN 61010 1 Maximum pump pressure connector In 1 In 2 Out 1 bar The product satisfies the requirements regarding interference emiss...

Страница 79: ...MERGITE 79 84 11 Glossary Term Meaning IFA Indirect immunofluorescence assay Titerplane technique Process in which all BIOCHIPs of the slide are simultaneously in contact with the liquid and the react...

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Страница 84: ...YG_0064_A_UK_C04 Version 01 08 2018 EUROIMMUN Medizinische Labordiagnostika AG E Mail euroimmun euroimmun de Internet www euroimmun de...

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