Thermo Scientific BRAHMS KRYPTOR compact PLUS User Manual
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Thermo Scientific BRAHMS KRYPTOR compact PLUS User Manual

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Summary of Contents for Thermo Scientific BRAHMS KRYPTOR compact PLUS

  • Page 10 B·R·A·H·M·S KRYPTOR compact PLUS User Manual | Version R08 106172 I SW 7.06.00 I Date 21.02.2018...
  • Page 11 B . R . . H . M . S KRYPTOR compact PLUS: Instrument and consumables Name B . R . . H . M . S KRYPTOR compact PLUS 106172 B . R . . H . M . S KRYPTOR compact PLUS Reading Module 106174 B .

  • Page 12: Table Of Contents

    Contents Labelling ................................. 4 Safety Instructions ..............................6 Introduction ................................8 Instrument Components ............................9 Description of the System Status Window ....................... 11 Main Menus ................................12 The Tool Palette ..............................13 Work Surface Colour Codes ..........................14 Sample Carousel ..............................14 Reagent rea .................................

  • Page 13: Labelling

    Labelling Symbol Explanation Symbol Explanation Laser, danger to eyes Serial number Location: on fluidic hood, of Reading Module on barcode readers Serial number Electrical risk of Pipetting Module Location: high voltage power supply, inside electronic boxes Identification Biohazard of the machine Location: waste bottle plug, wash station, waste pump, clot detection board lternative current ( C)
  • Page 14 Symbol Explanation Product reference number 106172 of the assembly Barcode that provides UDI information according to FD regulations Federal law restricts this device US : Rx only to sale by or on the order of a licensed healthcare practitioner (applicable to US classification only) cTUVus logo Labelling of...

  • Page 15: Safety Instructions

    Long term storage 50 °C … environmental contamination. It is mandatory for users of Thermo Scientific™ Input and output connections B . R . . H . M . S™ KRYPTOR™ compact PLUS to pay Caution: particular attention to S FETY INSTRUC TIONS written On the serial communication ports, connect only a in the B .
  • Page 16 B·R· ·H·M·S GmbH, the protection provided by the Class 2 lasers are limited to a maximum output power of 1 milliwatt and the beam must have a wavelength equipment may be impaired. be tween 400 and 700 nm. person receiving an eye Biohazardous exposure from a Class 2 laser beam, either accidentally When working with human serum, controls and cali-...

  • Page 17: Introduction

    Introduction Intended use Reliable prevention of interference B . R . . H . M . S KRYPTOR compact PLUS is a fully auto- Non-specific signals are eliminated by the internally mated system for in vitro diagnostic. B . R . . H . M . S calc ulated ratio of the intensities at these wavelengths KRYPTOR compact is an autoanalyser which can (665/620 or 707/620).

  • Page 18: Instrument Components

    Instrument presence. Levels of buffer and distilled water are managed by float switches within the main body of Components the instrument. When the bottle becomes red on the VDU screen, it is possible to refill the bottles without interruption to the current run. There is no fluid sensor This instrument has two parts: pipetting module on these two bottles.
  • Page 19 SOLUTIONS 1, 2, 3 and 4 (order code B . R . . H . M . S Reagents tray This accessory contains up KRYPTOR compact SOLUTION 1-4) to 4 reagent kits. The cool - The SOLUTIONS 1 and 2 are used for reconstitution ing system (2...8 °C) is ope- of freeze dried reagents.

  • Page 20: Description Of The System Status Window

    Description of the System Status Window CCESS TO M IN MENUS Waste B . R . . H . M . S KRYPTOR compact PLUS Distilled or demineralized water: Liquid system TOOL B R Buffer PBS: Phosphate Buffer Saline: Wash WINDOWS COMM ND B R liquid B .

  • Page 21: Main Menus

    Main Menus These menus are available by clicking on: The main menus bar appears To close it, click again on: SYSTEM INSTRUMENT REGISTR TION DMINISTR TION HELP * Logon * Worklist * Rescan Carousel * Calibrator/Standard * Panels * User Manual * Shutdown * Results * Start Processing...

  • Page 22: The Tool Palette

    The Tool Palette ICON COMM ND FUNCTION MENU OPTION DESCRIPTION Scan Carousel Instrument Identification of samples without starting a run Rescan Carousel Start Processing Instrument This icon disappears after click on it to give access Start Processing to Pause processing. Pause Processing Instrument This icon appears after Processing has started.

  • Page 23: Work Surface Colour Codes

    Work Surface Colour Codes Sample Carousel t the end of carousel scan, all samples with a barcode and tests in the worklist will be shown in green, blue, yellow or red. If the system is connected to LIS, there are different colours for the sample status (see dministration Menu/ LIS interface in B .

  • Page 24: Reagent Rea

    Reagent rea Each reagent cassette has its own identification. n information area appears by clicking (left button of the mouse) on reagent tray screen image, this shows cassette ID and temperature in degrees of the kit. colour code on the circle portion exists as a quick visual check of the right temperature in the reagent area or a reagent cassette’s fan fault.

  • Page 25: Reaction Rea

    Reaction rea Each reaction plate is barcode labelled to allow the loading of the plate. The reaction plate has to be loaded to activate its preheating and to allow the dispensing of samples. Click on the plate to view the exact number of tests dispensed and completed. When the reaction plate is full, there is no automatic unloading, it is necessary to request by clicking on reaction plate.

  • Page 26: Fluidic System

    B . R . . H . M . S KRYPTOR compact SOLUTIONS 1 to 4 For SOLUTIONS 1 and 2, the dead volume has been defined to finish a reconstitution started even if red level is detec t ed; it is normal to have around 12 mL in SOLUTION 1 and approximately 8 mL in SOLUTION 2 when red status appears on the interface screen.

  • Page 27: Routine Work

    Routine Work fter an automatic change of day The automatic change of day procedure is launched every day, on the first ready or intialized stage after midnight. This will perform automatically all the initializations (init pipetor + init reader). Start-up Nevertheless, the user will have a logon to perform Fill the appropriate bottles with distilled or deminerali- manual maintenances and database maintenance.

  • Page 28: Reagent Registration

    - Backup Log Files. Backup of log of run and main - Control tenance log files. - Click on: - Remove messages from box office. This action - Click on: enables the purge of the box office and avoid the - Click on Register new Controls.

  • Page 29: Run Controls

    Results Run controls - Open results list: ontrol - Select a test. dding a Control through Worklist - It is possible to Cancel tests in detecting, or counting - Select dd control in the Data, Worklist: step or in pending, only in “Ready/…” status. - Select a control from the list, press dd to worklist, - Results needing resolution can be: ccepted, Re-run Close, Close.

  • Page 30: Nalytes With Pre-Incubation

    nalytes with Pre-incubation The padlock is removed when the reagent kit has no The assay of an analyte with a pre-incubation is com- posed of two phases: tests remaining in Phase I, however the RED square Pre-incubation or Phase I: the system aspirates one can remain active if other tests in Phase I are under- of the 2 conjugates and the antigen (sample).
  • Page 31 During Phase I, tests appear in blue with the message pre-incubating: The start time of a test is given after the start of Phase II. If the test is failed during Phase I, the test is indicated in red with an alarm: “System error: Pre-incubation has failed.”...

  • Page 32: Important User Information

    Important User Information Detailed information about consumables and When a consumable is loaded by manual entry, it is patient samples marked by a symbol (not reaction plate) and on By clicking and holding the left mouse button an infor- session log. mation window appears.
  • Page 33 Pipetting / Reading sequence Tip cleaning after fatal clot detection • Open fluidic hood, place tip on Zhome position. During pipetting / reading sequence it is forbidden to close interface to avoid to lose samples results or to • Clean point of tip. have bad behavior of results list management.

  • Page 34: Barcodes Specifications

    Barcodes Specifications vailable symbologies on KRYPTOR instruments: Tube positioning: The tube must be straight and the • Code 128 bars must visible throughout the window width. • Code 39 • Codabar • Code 2/5 interleaved • Code UPC/E N Other specifications: •...

  • Page 35: Troubleshooting Guide

    Troubleshooting Guide Result Window Messages FL G NO. RESULT WINDOW MESS GE WH T TO DO “System Warning: Low Laser Power” • Call the Hot Line “System Error: Reaction Plate position” • Request a reader initialization in Daily Maintenance or restart the system completely.
  • Page 36 FL G NO. RESULT WINDOW MESS GE WH T TO DO “System Warning: Heated Tip • Prime the system to remove bubbles. Out of Range” • If the problem persists, call the Hot Line. “System Error: Interrupted” • Reboot the system. •...

  • Page 37: Degraded Mode

    Degraded Mode Plexi Door: The Plexi door is the clear flap which is lowered when loading a new reaction plate. The soft- When one of the following sensors has a malfunction ware no longer identifies if it is open or closed. Check the local hotline can disable it to finalize the ongoing that the plexi door is closed before loading the reaction measurement protocol.
  • Page 39 B·R·A·H·M·S GmbH Neuendorfstr. 25 16761 Hennigsdorf Germany +49-3302-883-0 +49-3302-883-100 fax info.brahms@thermofisher.com www.thermoscientific.com/brahms www.thermoscientific.com/copeptin www.thermoscientific.com/proadrenomedullin www.thermoscientific.com/procalcitonin www.thermoscientific.com/kryptor International Product Support CEZANNE SAS Allée Graham Bell Parc Scientifique Georges Besse 30035 Nîmes Cedex 01 France +33-466-365-246 +33-466-365-261 fax productsupport.brahms.frnim@thermofisher.com Date: 21.02.2018 This version supersedes all earlier User Manuals. Software 7.06.00 Clinical Diagnostics Thermo Fisher Scientific...
  • Page 41 Santé Health Therapeutic Products Directorate 96541 LN/NH: Canada Canada Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Medical Device Licence Homologation d'un instrument médical * MODIFIÉE * * AMENDED * 96541 Licence Number: No d'homologation: 2016/02/12 First Issue Date: Première date de délivrance: 2017/01/16 Amended Date:...
  • Page 42 Direction des produits thérapeutiques Bureau des matériels médicaux Components/Parts/Accessories/Devices for this Licence Les composantes, parties, accessoires et instruments médicaux pour cette homologation BRAHMS KRYPTOR COMPACT PLUS Device ID/No de l'instrument: 813302 Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/Catalogue):...
  • Page 43 Santé Health Therapeutic Products Directorate LN/NH: 96541 Canada Canada Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux 83991 BRAHMS CGA II KRYPTOR QC Device ID/No de l'instrument: 815672 Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/Catalogue): 83992 BRAHMS ANTI-TGN KRYPTOR Device ID/No de l'instrument: 823274...
  • Page 44 Santé Health Therapeutic Products Directorate LN/NH: 96541 Canada Canada Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux BRAHMS HTG SENSITIVE KRYPTOR Device ID/No de l'instrument: 823279 Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/Catalogue): 832.075 BRAHMS HTG SENSITIVE KRYPTOR CAL Device ID/No de l'instrument: 823280 Device Identifier / Identificateur de l'instrument...
  • Page 56 Australian Register of Therapeutic Goods Certificate Issued to Microgenics Diagnostics Pty Ltd for approval to supply Instrument/analyser IVDs ARTG Identifier 190292 Class 1 ARTG Start date 7/10/2011 Product Category: Medical Device Included - IVD Class 1 GMDN CT943 GMDN Term Instrument/analyser IVDs Intended Purpose Instruments / Analysers used as an in vitro diagnostic medical device...
  • Page 57 This entry: does not contain System(s)/Procedure Pack(s) Product Specific Conditions No specific conditions have been recorded against this entry. Therapeutic Goods Administration ARTG Identifier: 190292 PO Box 100, Woden ACT 2606 Australia ARTG Start Date: 7/10/2011 Phone: 1800 020 653 Email: info@tga.gov.au...

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