Roche cobas p 512 Operator's Manual
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Roche cobas p 512 Operator's Manual

Pre-analytical instrument
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Operator's Manual

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Summary of Contents for Roche cobas p 512

  • Page 1 512 pre-analytical instrument Operator’s Manual...
  • Page 2 512 Operator's Manual - Version 1.6 - 10/2015...
  • Page 3 They further include modules for registration of barcoded sample tubes, liquid level and sample quality detection. In case of standalone use of the cobas p 512 pre-analytical system, the transfer of tubes, processed on the cobas p 512 pre-analytical system, to any other workstation within the laboratory is subject of validation performed by the laboratory itself.
  • Page 4 512 Norms and standards The cobas p 512 sorting system conforms to the currently applicable directives of the European Union. Compliance with all standards and legal obligations is guaranteed. CE labeling corresponds to the EU directives 98/79/EU (IVD Directive).

  • Page 5: Table Of Contents

    512 Table of contents General information ................1-1 1.1. Preface ......................1-1 1.2. Using the Operator’s Manual ..............1-1 1.3. Screen graphics, signs and symbols ............1-1 1.4. Abbreviations ....................1-1 1.5. Hazards and precautionary measures ........... 1-1 1.5.1...
  • Page 6 512 2.2.10 Laser liquid level detection (Laser-LLD) .............. 2-1 2.2.11 Decapping module ....................... 2-1 2.2.12 Recapping module (optional) ................... 2-1 2.2.13 Output sorter ........................2-1 2.2.14 Signal lamp ........................2-1 2.2.15 Operating modes ......................2-1 2.2.16 Mains connection and system interfaces ............2-1 2.2.17...
  • Page 7 512 2.7.9 Routine menu – Clear Data ..................2-1 2.7.10 Routine menu – Statistics ..................2-1 2.7.11 Maintenance menu ...................... 2-1 2.7.12 Maintenance menu – Error history ................. 2-1 2.7.13 Maintenance menu – Daily Backup ............... 2-1 2.7.14 Maintenance menu –...
  • Page 8 512 4.4. Weekly device care ..................4-1 4.4.1 Cleaning the decapper module ................4-1 4.5. Monthly device maintenance..............4-1 4.5.1 Cleaning system components .................. 4-1 4.5.2 Cleaning the barcode reader ..................4-1 4.5.3 Cleaning the sensors on the RT-Transport ............4-1 4.5.4...
  • Page 9 5.3.2 Informative messages ....................5-1 Appendix ....................6-1 6.1. Included in delivery ..................6-1 6.2. cobas p 512 system, technical data ............6-1 6.2.1 Dimensions and weight ....................6-1 6.2.2 Current and voltage supply ..................6-1 6.2.3 Compressed air supply....................6-1 6.2.4...
  • Page 10 512 Operator's Manual - Version 1.6 - 10/2015...

  • Page 11: General Information

    512 Part A - General information Part A General information Operator's Manual - Version 1.6 - 10/2015...
  • Page 12 Part A - General information cobas p 512 Operator's Manual - Version 1.6 - 10/2015...
  • Page 13 512 Part A - General information General information ................1-1 1.1. Preface ......................1-5 1.2. Using the Operator’s Manual ..............1-6 1.3. Screen graphics, signs and symbols ............1-7 1.4. Abbreviations ....................1-9 1.5. Hazards and precautionary measures ..........1-11 1.5.1...
  • Page 14 Part A - General information cobas p 512 Operator's Manual - Version 1.6 - 10/2015...

  • Page 15: Preface

    Part A - General information 1.1. Preface The cobas p 512 sorting system is a computer-controlled stand-alone device for sorting barcoded sample tubes. It has an online connection to a laboratory computer (host). It consists of the following components: Input sorter with sorting unit •...

  • Page 16: Using The Operator's Manual

    1.2. Using the Operator’s Manual This Operator's Manual is valid for cobas p 512 sorting system. It contains information for system operators at the application level. The information contained in this manual is not intended for administrators or service technicians.

  • Page 17: Screen Graphics, Signs And Symbols

    512 Part A - General information 1.3. Screen graphics, signs and symbols Screen displays are presented in the Operator's Manual as shown in the following example: Figure 1-1: Screenshot Command entries A 15" touch screen monitor mounted on a swivel arm between the input sorter and the output sorter is used to enter commands in the system.
  • Page 18 Part A - General information cobas p 512 Signs and Symbols Various symbols are used in this manual for the localization and interpretation of information. They are explained below. [Tab] Key (keyboard) [OK] Button (screen) 'Menu 1  Menu hierarchy in the software...

  • Page 19: Abbreviations

    512 Part A - General information 1.4. Abbreviations The table below contains an explanation of the abbreviations used in this manual. Abbreviation Meaning Ampere Alternating current Ampere-hour ASTM American Society for Testing and Materials Communauté Européenne Central Processing Unit...
  • Page 20 Part A - General information cobas p 512 Abbreviation Meaning Random Access Memory RAST Radio-alergo-sorbent-Test RJ45 Registered Jack 45 RS232/422 Recommended Standard 232/422 Transport conveyor for primary tubes Standard Interface TCP/IP Transmission Control Protocol/Internet Protocol Volt Volt-Ampere 1-10 Operator's Manual - Version 1.6 - 10/2015...

  • Page 21: Hazards And Precautionary Measures

    512 Part A - General information 1.5. Hazards and precautionary measures 1.5.1 Safety instructions To avoid potentially dangerous situations from the start, you should familiarize yourself with all precautionary measures and regulations concerning the operation of the system. Pay particular attention to the safety instructions when handling samples.
  • Page 22 Part A - General information cobas p 512 Figure 1-3: Warning labels on the rear D Interface block and mains voltage (caution) A Decapping module (caution / laser radiation) B Tube type identification module E Waste container (biohazard) (laser radiation / hazardous voltage)
  • Page 23 512 Part A - General information Figure 5 Input sorter (front) WARNING Risk of infection! This warning label on the sorting areas (Input- and Output sorter) advises you of potentially infectious contents. Operator's Manual - Version 1.6 - 10/2015...
  • Page 24 Part A - General information cobas p 512 Figure 1-6: Warning labels on subassembly WARNING Risk of injury! Never look directly into the laser beam! These warning labels on the case of the barcode scanner and on the RT- Transport advise you of the risk posed by the laser light.
  • Page 25 512 Part A - General information Figure 1-7: Recapper module (optional) WARNING Risk of injury! This warning label on the cover of the recapper module advises you that it may be dangerous to touch the housing here during operation.
  • Page 26 Part A - General information cobas p 512 Figure 1-9: Tube type identifcation, input sorter and output sorter and decapping module Located on the rear side on the tube type identification module: Located on the rear side of the input sorter. (If recapping module is available, also located on...
  • Page 27 512 Part A - General information Located on the rear side of the input sorter. (If Laser-LLD module is available, also located on the decapping module): Located on the rear side of the tube type identification module. Operator's Manual - Version 1.6 - 10/2015...
  • Page 28 Part A - General information cobas p 512 WARNING Electrical Shock! Do not touch the components or connectors! This can cause burning, electrical shock or fatal injury. Completely disconnect the mains connection before working inside the device. Only authorized and trained service technicians should conduct work on or near live current-carrying components.
  • Page 29 512 Part A - General information Figure 1-11: Permissible range for the compressed air CAUTION The compressed air supply must comply with specifications: between min. 6 bar and max. 8 bar! Higher air pressure will cause damage to the system and may endanger you.

  • Page 30: Notes On Safety

    Part A - General information cobas p 512 1.5.3 Notes on safety Safety regulations IEC 61010-1 and the applicable national electrical safety guidelines must be observed! Safe operation and reliability of the system can only be ensured if the electrical installation of the system meets appropriate IEC requirements.

  • Page 31: Laser Exposure

    The liquid level detection with laser (Laser-LLD) can be integrated into the sorting system of cobas p 512 . The Laser-LLD is a computer controlled system designed to detect the liquid level of centrifuged serum or plasma and urine samples. The module is equipped with an class 3B laser beam.

  • Page 32: Preconditions For Scanning A Barcode

    Part A - General information cobas p 512 1.6. Preconditions for scanning a barcode In order for the system to process the sample tube, the barcode must be placed correctly on the tube and it must be easily readable. Therefore there are basic prerequisites which must be met.

  • Page 33: Specifications For The Barcode Labels

    Code128 Modulus 103 The use of check digits can reduce the frequency of errors when reading barcodes. Roche PVT claims no responsibility for read errors resulting from missing check digits, poor quality labels or insufficient maintenance. Definition of barcode to...
  • Page 34 Part A - General information cobas p 512 Maximum and minimum gaps on the label a: min. 3 mm (quiet zone) b: max. 50 mm c: min. 3 mm (quiet zone) d: min. 8 mm e: min. 3 mm Calculating the quiet zone The dimensions must be at least fifteen times larger than the module width b.

  • Page 35: Placement Of The Barcode Label

    512 Part A - General information 1.6.3 Placement of the barcode label The following requirements must be met when placing a printed barcode label on a sample tube. The label should run the length of the tube. It should be placed as parallel as possible to the tube edge.
  • Page 36 Part A - General information cobas p 512 Scanning area Label placement on the sample tube Bar code label must be within the scanning area. Primary tube Distance a (Label to tube opening, cap or plug) 5 - 8 mm...

  • Page 37: Sample Images Of Correct And Incorrect Barcode Labels

    512 Part A - General information 1.6.4 Sample images of correct and incorrect barcode labels correct incorrect incorrect Error-free placement of a Tube has multiple barcode The window for serum barcode label labels on it. The label is analysis is too small.

  • Page 38: Disposal Of Device

    The obligation on the part of the producer to take back equipment does not apply to equipment from Roche PVT GmbH. The owner of the equipment supplied by Roche PVT must ensure appropriate disposal. It is the responsibility of the owner to ensure disposal in compliance with the respective national and international laws and regulations.

  • Page 39: System Description

    512 Part B - System description Part B System description Operator's Manual - Version 1.6 - 10/2015...
  • Page 40 Part B - System description cobas p 512 Operator's Manual - Version 1.6 - 10/2015...
  • Page 41 512 Part B - System description System description ................2-1 2.1. Introduction ....................2-5 2.1.1 Operator training ......................2-5 2.1.2 Customer configuration ....................2-5 2.1.3 Specifications ........................2-5 2.1.4 Level of automation ...................... 2-6 2.1.5 Device reliability ......................2-6 2.2.
  • Page 42 Part B - System description cobas p 512 2.6.1 Structure of the software ..................2-40 2.6.2 QNX operating system ..................... 2-40 2.6.3 Communication with the laboratory host computer ........2-40 2.6.4 Graphic user interface ....................2-42 2.6.5 How to use the menu system ................2-43 2.6.6...

  • Page 43: Introduction

    2.1.1 Operator training A service technician is present when the cobas p 512 is being installed to provide operator training. This training is designed to prepare the future user to perform daily routine operations without close supervision and work safely with the system by observing safety instructions.

  • Page 44: Level Of Automation

    2.2. Hardware description The cobas p 512 is an automatic pre- and post-analytic system for the acquisition and sorting of sample tubes. The cobas p 512 offers many processing steps and the capability for customization to the customer's location. This makes it an efficient and reliable tool for preparing sample tubes.
  • Page 45 512 Part B - 0BSystem description Figure 2-1: cobas p 512 system A Control unit F Signal lamp B Tube type recognition G Sorter unit C Decapping module H Recapping module (optional) D Input sorter I Output sorter...

  • Page 46: Schematic Diagram

    Part B - System description cobas p 512 2.2.1 Schematic diagram Figure 2-2: Schematic diagram of the cobas p 512 system 2.2.2 System safety devices Areas that present a hazard during operations are secured by a protective door. The operating area of the movable sorting unit is secured with protective doors on the input and output sorters.

  • Page 47: Control Unit

    512 Part B - 0BSystem description 2.2.3 Control unit The system control unit consists of the screen, keyboard and stick. The user enters all commands using the control unit. Figure 2-3: Monitor with keyboard and stick A Touch screen monitor...

  • Page 48: Qnx Computer

    Part B - System description cobas p 512 2.2.4 QNX Computer The computer is housed in the lower area of the input sorter (left system side). The computer has a QNX operating system. Figure 2-4: QNX computer in the lower area of the input sorter...

  • Page 49: Qs I Computer (Optional)

    512 Part B - 0BSystem description 2.2.5 QS I computer (optional) The QS I image processing computer is only available with the QS I module. The computer with Windows® operating system for the QS I camera is located in the right output sorter enclosure.

  • Page 50: Input Sorter

    Part B - System description cobas p 512 2.2.6 Input sorter The sample tubes are fed to the system (loaded) by the input sorter. It is possible to load the output sorter by replacing the complete rack trays or by inserting individual racks or tubes.

  • Page 51: Tube Transport (Rt-Transport)

    A RT-Transport in the input sorter 2.2.8 Tube recognition The cobas p 512 is equipped with a camera system for tube recognition. The tube recognition module processes sample tube information. The camera system for tube recognition is available in two different versions: Camera system with BlueLYNX-220CX camera for tube recognition via cap recognition.
  • Page 52 Part B - System description cobas p 512 2.2.8.1 BlueLYNX-220CX camera for tube recognition The camera system with BlueLYNX-220CX camera for tube cap recognition is located in the camera enclosure in the input sorter. Figure 2-7: Camera – BlueLYNX-220CX A Camera for tube type recognition The camera system recognizes tube types (manufacturer and dimension) by examining the cap color and the cap geometry.
  • Page 53 The QS I quality system is a computer controlled system for tube type recognition (of closed tubes), for the calculation of the serum volume of centrifuged samples and for the classification of the serum. The cobas p 512 system can be equipped with different QS I quality systems, depending on the laboratory needs: QS I full version with Sample Image •...
  • Page 54 Part B - System description cobas p 512 Detection principle Figure 2-10: Measurement principles of the QS I system A Laboratory Information system (host) E 3rd step: fill-level detection on white background B control computer F sample tube C 1st step: cap identification on black...
  • Page 55 512 Part B - 0BSystem description The quality system operated in two steps: First step: cap recognition The cap recognition is carried out with the same operating principles as the BlueLYNX 220CX camera system. An image is created of the tube cap with black background. The image is then analyzed in the QS I PC.
  • Page 56 Part B - System description cobas p 512 NOTICE To toggle to live image press keys in short sequence [Fn] + 2x[Scroll] (black keyboard) [Ctrl.] – [Ctrl.] – [Enter] (white keyboard) CAUTION In the screenshots shown below, use the button found only on the keyboard and stick! Do not use the touch screen.

  • Page 57: Infrared Liquid Level Detection (Ir-Lld)

    512 Part B - 0BSystem description QS I-LLD (Liquid level detection) The quality system QS I is only used to detect the tube fill level and to calculate the serum volume. The serum will not be classified. QS I-LLD + Sample Image Sample Image is part of the QS I full version and optionally available with QS I-LLD.
  • Page 58 Part B - System description cobas p 512 means of infrared light. It then transmits the upper and lower level of the respective sample material to the system's control computer. In the second step, the camera module determines the tube's type (and thus its dimensions) via cap color identification.

  • Page 59: Laser Liquid Level Detection (Laser-Lld)

    512 Part B - 0BSystem description 2.2.10 Laser liquid level detection (Laser-LLD) General The Laser-LLD module is integrated into the input sorter of the cobas systems. When a tube is sorted into the tube transport, data are collected by the sensor technology of the Laser-LLD system.
  • Page 60 Part B - System description cobas p 512 Measurement principle The location of liquid within the tube is performed using an optical device which is able to detect material transitions in the tube. The system comprises two infrared lasers of different wavelengths which pass through the tube.
  • Page 61 512 Part B - 0BSystem description Barcode scanner The barcode scanner is located in the same enclosure as the cap/tube recognition unit. The barcode scanner reads the barcode from the tube label. The inquiry processing for this sample is performed after the barcode has been read. (Tests are requested by the laboratory host computer.) If it was not possible to read the barcode or the sample could not be...

  • Page 62: 2.2.11 Decapping Module

    Part B - System description cobas p 512 2.2.11 Decapping module When necessary, the decapping module automatically removes the caps of the sealed tubes. The decapping module is located in the input sorter housing. The sample tubes are first raised by the lifting gripper and then opened with the aid of the rotary gripper. This is accompanied by a simultaneous downwards movement of the lifting gripper.

  • Page 63: Recapping Module (Optional)

    512 Part B - 0BSystem description Figure 2-21: Rear view with waste container A Waste tube B Waste container 2.2.12 Recapping module (optional) The Recapping module in the output sorter is capable of sealing opened primary tubes with an aluminum foil.

  • Page 64: 2.2.13 Output Sorter

    Part B - System description cobas p 512 2.2.13 Output sorter The tubes from the conveyor belt are sorted into racks at the output sorter. These racks are also referred to as target racks. Figure 2-23: Output sorter with sorting unit and racks...

  • Page 65: 2.2.14 Signal Lamp

    512 Part B - 0BSystem description 2.2.14 Signal lamp A signal lamp is mounted at the top of the system indicating the current operating mode of the system: Lamp color System mode of operation STANDBY Intervention by the operator or service technician is necessary.

  • Page 66: 2.2.16 Mains Connection And System Interfaces

    Part B - System description cobas p 512 2.2.16 Mains connection and system interfaces The interface block of the system is located on the bottom left-hand side at the rear of the device. Figure 2-24: Interface block A Service port (Ethernet)

  • Page 67: 2.2.17 Compressed Air Connection

    The cobas p 512 requires dry, oil-free air and an air pressure of min. 6 to max. 8 bar. It connects via a snap-on hose coupling NW 7.2 (G ¼').
  • Page 68 Part B - System description cobas p 512 2.2.17.2 Disconnecting the compressed air connection Proceed as follows if the connection to the compressed air supply needs to be disconnected: 1. Turn off the connected air compressor or the building's compressed air supply.

  • Page 69: 2.2.18 The Waste Container For The Decapping Module

    512 Part B - 0BSystem description 2.2.18 The waste container for the decapping module The decapping module's waste container is located on rear side of the input sorter, directly underneath the decapping module. Figure 2-29: The decapping module's waste container...

  • Page 70: Air Pressure Maintenance Unit (Interior)

    Part B - System description cobas p 512 2.2.19 Air pressure maintenance unit (interior) The compressed air maintenance unit with pressure control valve for the system pressure, a compressed air filter with automatic emptying of condensation, and two manometer switches are all mounted in the interior by the compressed air connection. The manometer switches monitor the pressure of the compressed air supply and report to the system if there is insufficient pressure or the pressure is set too high.

  • Page 71: Consumable Material

    The sealing foils for the optional Recapping module are refilled at the rear of the system. For further information please refer to chapter 3 'Operation'. 2.4. Accessories The components listed below are available as accessories. Please see the Roche PVT accessories list for the corresponding order numbers. 2.4.1 Carriers, racks and rack trays Various carriers, racks and rack trays are available for configuring the sorting area with the individual workplaces.

  • Page 72: Cleaning Brush

    A cleaning fluid and cloth is included in scope of supply to clean the camera lens of the tube recognition module. Figure 2-27: cobas p 512 cleaning set Figure 2-28: Cleaning kit, camera To clean the sensors, a cleaning kit – comprising a lint-free cloth, compressed air spray and 10 cotton swabs –...

  • Page 73: Sample Flow And Sample Processing

    2.5.1 The route that the sample takes through the system The cobas p 512 system provides an optimized and efficient flow of samples in the laboratory. Unsorted samples are transported by the system, decapped or recapped if necessary, and sorted into defined workplaces. These workplaces can be sample racks for analysis devices or archive racks for storage.

  • Page 74: Processing Profiles And Priorities

    Part B - System description cobas p 512 2.5.2 Processing profiles and priorities To process the samples, the system checks all pending tests for a patient sample. The selection is made based on certain rules and priorities. 2.5.2.1 Rules for sample processing The individual sorting targets (rack trays and racks for the analyzers or manual work places) are specified in profiles.

  • Page 75: Defining Sorting Racks

    512 Part B - 0BSystem description 2.5.3 Defining sorting racks The system allows you to setup a very flexible arrangement of the sorting area in both the input and output sorters. The number and size of the drawers are very configurable to the customer requirements on-site.

  • Page 76: Processing Recursive Sample Tubes

    Part B - System description cobas p 512 2.5.5 Processing recursive sample tubes During routine operations, it may be necessary to set a tube which has been already processed back into the input sorter (for example, because of a processing error or an additional test requirement).

  • Page 77: Processing Multiple Patient Samples With The Identical Barcode

    The samples are processed to end, and all tests are then run on the analyses. Subsequently, the sample is put back into the cobas p 512 input sorter. It is then transported through the system without processing, recapped if necessary and sorted into the archive rack.

  • Page 78: Basic Information About The Software

    2.6.3 Communication with the laboratory host computer Normally, the cobas p 512 system is connected to the host computer via a serial interface (RS232) or via a TCP/IP network. Data can be transferred in both directions. 2.6.3.1 Dynamic interface The data flow is controlled by the lab computer, and the existing data processing rules of the cobas p 512 system are changed by the lab host computer.
  • Page 79 512 Part B - 0BSystem description 2.6.3.3 Data transfer Testing requirements (query mode) The requirements for each barcode that is read are queried from the lab host computer. Data is transferred first when the data is needed. Transmission of sorting lists to the host computer.

  • Page 80: Graphic User Interface

    Part B - System description cobas p 512 2.6.4 Graphic user interface The graphic user interface (GUI) is divided into different functional sections. The tab buttons contained in the main and sub menus have a light-gray background color. Figure 2-32: Operator interface...

  • Page 81: How To Use The Menu System

    512 Part B - 0BSystem description 2.6.5 How to use the menu system The system is operated by touching the buttons on the touch screen monitor or by using the stick and its hardware buttons. Commands can also be entered using the keyboard.
  • Page 82 Part B - System description cobas p 512 Hotkeys [Shift] + [Tab] Jump to the previous field. [CTRL] + underlined letter Select the corresponding main or submenu item. [Alt] + underlined letter Select the corresponding buttons in the active window.

  • Page 83: Online Help

    512 Part B - 0BSystem description 2.6.6 Online Help Each entry field is linked to a help mask of the online help system; to call up the online help right-click in the field. The context-sensitive Help provides an exact description of the respective field.

  • Page 84: System Status And Messages

    Part B - System description cobas p 512 2.6.7 System status and messages Extensive system monitoring makes it easier to react to malfunctions and error messages. Each step made by the system can be logged. Thus, it is possible to reconstruct operating procedures in detail at a later point in time.
  • Page 85 512 Part B - 0BSystem description Buttons in pop-up message windows Acknowledge the message and close the message window. Many potential errors are only temporary. Thus pressing the [Repeat] button should be the very first action before undertaking any further steps in troubleshooting. It will restart the procedure that led to the error message being issued.

  • Page 86: Software Description

    Access to these menus items requires separate access rights which are made available to specially trained personnel, laboratory administrators, or Roche PVT service technician. When the system is switched on via the main switch, the operating system is booted and the login screen is displayed.

  • Page 87: System Test

    512 Part B - 0BSystem description 2.7.2 System test After the system software is loaded and a work cycle has been activated, the system carries out a self-diagnosis and all movable elements position themselves at their reference points. If errors occur during this procedure, the corresponding error messages are displayed in pop- up windows on the screen.

  • Page 88: Structure Of The Menus

    Part B - System description cobas p 512 2.7.4 Structure of the menus The following graphic provides a schematic overview of the menu structure of the graphic user interface (GUI) when accessed via the [User-Login] button. Submenu 'Routine ▶ Control' Submenu 'Routine ▶...

  • Page 89: Routine Menu

    512 Part B - 0BSystem description 2.7.5 Routine menu The 'Routine' tab on the main menu includes the control elements which are required to operate and control the system on a daily basis. Program overview: 'Routine ▶ Control' (see 2.7.6 for more details) •...
  • Page 90 Part B - System description cobas p 512 Figure 2-38: 'Routine' - 'Control' A Buttons (menu-specific) E Status field B Input sorter drawers F Progress of tube transport C Active work cycle G Output sorter drawers D [Logout] button (global)
  • Page 91 512 Part B - 0BSystem description If the system is programmed with more than one routine work cycle then the required work cycle must be selected before sample processing is started. The [Work cycle] button is active if operations have not yet been started or the system is in standby mode.
  • Page 92 Part B - System description cobas p 512 Each target rack displayed on the screen can be used as a button for a rack change. In the upper right corner, it contains a sequential digit (0-9, a-z, ...). This digit complies to...
  • Page 93 512 Part B - 0BSystem description 2.7.6.5 Input sorter In the input sorter, the gripper takes the tubes out of the racks and puts them into the RT- Transport. They are then transported to the next module. You can follow the processing status of the samples when they are in the input sorter.
  • Page 94 Part B - System description cobas p 512 Racks and workplace areas on the drawer Depending on the customer configuration, one or multiple workplaces can be assigned for a single drawer. A workplace can be a part of a single rack, a single rack or multiple racks.
  • Page 95 512 Part B - 0BSystem description 2.7.6.6 Tube transport The transport positions and the processing status of every sample tube is shown on screen. Each sample tube is represented by a small square symbol. Recognition, process and transport status of the sample tubes are indicated by the different colors of the individual small squares.
  • Page 96 Part B - System description cobas p 512 2.7.6.7 Output sorter In the output sorter, the tubes are removed from RT-Transport and distributed to the targets (racks). During operation the sorting unit checks for rack presence on inserting a tube. Only then the tube is released.
  • Page 97 512 Part B - 0BSystem description Racks and workplace areas on the drawer Depending on the customer configuration, one or multiple workplaces can be assigned for a single drawer. A workplace can be a part of a single rack, a single rack or multiple racks.
  • Page 98 Part B - System description cobas p 512 Individual tube positions A small square is used to represent an individual tube position in the racks. Color Meaning White Empty position Yellow Tube identified through barcode Erroneous tube After (re)booting the system, all tubes located inside default work places are depicted in red, regardless of their former coloring.

  • Page 99: Routine Menu - Sorting Lists

    512 Part B - 0BSystem description 2.7.7 Routine menu – Sorting lists The 'Sorting lists' menu item is used to display the sorting files. The sorting racks in the output sorter are the individual work places, for each of which a sorting list can also be maintained.
  • Page 100 Part B - System description cobas p 512 Example [Display]: 1. Press the [Display] button. Figure 2-48: Routine menu – Display of sorting lists 2. In the overview, click on a list in order to display it. Figure 2-49: Routine menu – Display of sorting list details 2-62 Operator's Manual - Version 1.6 - 10/2015...
  • Page 101 512 Part B - 0BSystem description [Display] By pressing the [Display] button, you can access the file listing of the existing sorting and exceptions lists. The file name corresponds to the work place abbreviation. If subracks are used, their abbreviations will be displayed as well.

  • Page 102: Routine Menu - Information System

    Part B - System description cobas p 512 2.7.8 Routine menu – Information system All the patient data available in the system is displayed. Also, the corresponding orders are listed. Sorter Targets and stored sample images from the Camera (only on systems equipped with QS I or QSI-LLD-SI) can be displayed by clicking the appropriate button.
  • Page 103 512 Part B - 0BSystem description 2.7.8.1 Information system – Orders (Standard Interface) The Orders screen of the Information system menu displays all available barcode related patient information and assigned tests. The display of a patient flag before each test indicates whether a test is still in progress or has been completed.
  • Page 104 Part B - System description cobas p 512 [Forward] Use the [Forward] button to display the next data record (ascending barcode number). This function is specifically available for every screen of the Information system menu (Orders, Targets, Camera, Errors). [Backward] Use the [Backward] button to display the previous data record (descending barcode number).
  • Page 105 Append the requested test to the existing ones. New requests are added, existing ones are overwritten. Cancel request and delete from Roche PVT order database. The second character of the flag represents the number of the rack whereto the sample has been sorted.
  • Page 106 Part B - System description cobas p 512 2.7.8.2 Information system - Orders (Dynamic Interface) All the patient data available in the system is displayed. Also, the corresponding orders are listed. This data is displayed as transmitted by the host and does not necessarily reflect the...
  • Page 107 512 Part B - 0BSystem description Target Target rack for the sample tube. Volume The volume specified here is added up from all tests that the laboratory EDP (host) has ordered for this sample tube. It does not render the actual volume of the sample inside the tube.
  • Page 108 Part B - System description cobas p 512 2.7.8.3 Information system – Targets The 'Targets' screen displays the distribution information of all tubes related to the entered barcode, for example sorting time, target name and rack position. The information here is visible after the tubes have been processed on the system and can be sent to the host.
  • Page 109 512 Part B - 0BSystem description Name Abbreviation of the sorting target for this tube. When using virtual work place names (submenu 'Reference Data' ▶ 'Work places' ▶ 'Virtual work place name' = "1"), the system will use the name scanned by the operator on sorting of the first tube.
  • Page 110 Part B - System description cobas p 512 2.7.8.4 Information system – Camera (QS I) All the patient data available in the system is displayed in the head part of the screen the same way it is displayed above the Orders and Targets views you can switch to using the appropriate buttons.
  • Page 111 512 Part B - 0BSystem description Material no. The material ID as configured for the identified tube type. Quantity Sample volume in the tube in µl. The sample volume is calculated by the system based on fill level, sample liquid color and tube dimensions.
  • Page 112 Part B - System description cobas p 512 'Sample Image' software 'Sample Image' is a software process for preparing tube images and storing them in a separate access area. They are created within the QS I serum analysis and can be used for additional processing tasks.
  • Page 113 512 Part B - 0BSystem description Zoom in/ out for image view Click once on the image in order to enlarge your view of the sample tube. Note that when the data set is switched, the image is reset to its original output size. Scrolling backwards or forwards with full sized images is only possible when dealing with multiple or recursive samples.
  • Page 114 Part B - System description cobas p 512 2.7.8.5 Information system - Camera (cap recognition) All the patient data available in the system is displayed in the head part of the screen the same way it is displayed above the Orders and Targets views you can switch to using the appropriate buttons.
  • Page 115 512 Part B - 0BSystem description Material no. The material ID as set within the configuration data of the identified tube type. Quantity Volume of the remaining sample material inside the tube (in microliter µl). This value is initially derived from the measuring result of the IR-LLD module (if available).
  • Page 116 Part B - System description cobas p 512 2.7.8.6 Information system – Errors The 'Errors' screen displays all error messages related to the selected tube that occurred during tube processing (for example a failed tube recognition). It is not displayed by default when accessing the 'Routine' ▶ 'Information system' menu. To switch to the Errors view, touch the [Errors] button.
  • Page 117 512 Part B - 0BSystem description Date The date the erroneous tube has been sorted. Example: 20030623 = YYYYMMDD (Y = year, M = month, D = day) Name Name of the sorting rack for erroneous tubes. Example: DEFAULT.

  • Page 118: Routine Menu - Clear Data

    Part B - System description cobas p 512 2.7.9 Routine menu – Clear Data With this program the system is prepared for a restart. All data such as sorting lists and order files are archived (stored into another directory). Depending on the number of 'Archive Days' (configured in 'Customer Configuration'), outdated order data older than that, such as patient data and sorting positions, is deleted.

  • Page 119: 2.7.10 Routine Menu - Statistics

    512 Part B - 0BSystem description 2.7.10 Routine menu – Statistics This menu can be used to display statistical information about the amount of work processed by the system on a daily basis. The system provides statistical data of the past 31 days.
  • Page 120 Part B - System description cobas p 512 Figure 2-60: Processing statistics detailed view for the selected date File name Path and file name of the current statistics file. Customer Name of the owner of the system. Start processing Day time of the processing start of the system (HH:MM:SS).

  • Page 121: 2.7.11 Maintenance Menu

    512 Part B - 0BSystem description Total primary samples Total number of samples that have been processed by the system during the processing time. Number of samples decapped Total number of samples that have been decapped by the system during the processing time.

  • Page 122: 2.7.12 Maintenance Menu - Error History

    Part B - System description cobas p 512 2.7.12 Maintenance menu – Error history This program is used to display log files containing information about host communication events and errors that occurred during the operation of the system. Log files can be helpful for system diagnosis and troubleshooting procedures.
  • Page 123 Name of the program that issued the error 0122 Error message number Internal error number QNX 0000 Internal error number Roche PVT 122 Task <comm_astm0> not started Error description NOTICE The error log file information can be helpful to trace errors during installation and system setup and for general troubleshooting.
  • Page 124 Part B - System description cobas p 512 2.7.12.2 Error history – Host communication The Host communication log view displays all available log file information concerning communication with the host. Select "Host communication“ from the drop-down menu to display the log file information.

  • Page 125: 2.7.13 Maintenance Menu - Daily Backup

    512 Part B - 0BSystem description 2.7.13 Maintenance menu – Daily Backup This program stores relevant data (such as sorting lists, order files, patient data) to removable storage media (e.g. Floppy disk(s), USB memory stick). Figure 2-63: Maintenance menu – Daily Backup Insert the first floppy disk into the drive or connect a USB memory stick to the computer.

  • Page 126: 2.7.14 Maintenance Menu - Date, Time, Day

    Part B - System description cobas p 512 2.7.14 Maintenance menu – Date, time, day This program is used to set the date, time and weekday in the system. As a precaution, the system automatically checks the entries in the 'Date' and 'Day of the week' fields.
  • Page 127 512 Part C - Operation Part C Operation Operator's Manual - Version 1.6 - 10/2015...
  • Page 128 Part C - Operation cobas p 512 Operator's Manual - Version 1.6 - 10/2015...
  • Page 129 512 Part C - Operation Operation ....................3-1 3.1. Commissioning the system ..............3-5 3.2. Daily routine ....................3-5 3.2.1 Trouble-free operating procedures ................ 3-6 3.3. Preparation ....................3-10 3.3.1 Emptying the waste container ................3-11 3.3.2 Emptying the condensation container ............... 3-11 3.3.3...
  • Page 130 Part C - Operation cobas p 512 Operator's Manual - Version 1.6 - 10/2015...

  • Page 131: Commissioning The System

    Make sure that there is sufficient free space for movement in front and behind of the system. The cobas p 512 floor plan is available in chapter 6 'Appendix'. Operator training for the system is given on location, in order to prepare the future operator to be able to use the system safely and reliably without supervision.

  • Page 132: Trouble-Free Operating Procedures

    Part C - Operation cobas p 512 3.2.1 Trouble-free operating procedures Using the list below, you can review the complete work flow of the system, point by point: 1. Connections: Check that the mains plug, compressed-air supply and network connection are correctly connected.
  • Page 133 10. Switching on the system: Switch on the power supply for the system. NOTICE If a Silver Server from Roche PVT is used for communication with the LIS, switch this on first. For additional information, please refer to section 3.3.4. 11. Logging on: You can log on once the system has started.
  • Page 134 Part C - Operation cobas p 512 15. Feeding in primary samples: When all primary tubes of one drawer in the input sorter have been moved from their racks into the tube transport, the empty drawer is automatically ejected and can be re- loaded during system operations.
  • Page 135 NOTICE Then switch off the connected centrifuge module, if one is present. If a Silver Server from Roche PVT is used for communication with the LIS, switch this off last. 26. Checking the sorting area and the work area: Check the sorting area and rack conveyor for objects such as sample tubes, caps, spilt fluids or samples that may have gathered during operations.

  • Page 136: Preparation

    Part C - Operation cobas p 512 3.3. Preparation Inspecting connections and the sorting area Check that the mains plug, compressed air supply and network connection are correctly connected. Carefully check the sorting area and rack conveyor belt for foreign objects such as sealing foil or sample tubes (including parts of tubes).

  • Page 137: Emptying The Waste Container

    Part C - Operation 3.3.1 Emptying the waste container Empty the cobas p 512 waste container daily, either before or after the daily routine. For hygienic reasons, you should use plastic bags within the waste container. WARNING Risk of infection! Wear protective gloves! The waste container for caps is located on the rear of the system.
  • Page 138 512 2. Pull out the locking pin upwards. 3. With one hand, take hold of the foil roll (Roche PVT No. 32100500050) (Figure 3-5/ 3). NOTICE Sealing foils can be used for twelve months after their production date. Make sure to read the production date on the packaging.
  • Page 139 512 Part C - Operation Figure 3-5 Refill help for the foil storage Operator's Manual - Version 1.6 - 10/2015 3-13...

  • Page 140: Switching The System On

    Switching the system on NOTICE If a Silver Server from Roche PVT is used for communication with the LIS, switch this on first. If a centrifuge module is connected to the cobas p 512 system, also switch this on. Switch the system on. The main switch must be in the ON position. The system may take a few minutes to start.

  • Page 141: Login

    512 Part C - Operation 3.3.5 Login The user login is pre-configured. Press the [Log in] button on the login screen to load the control program. Figure 3-8: Login screen NOTICE If system messages are shown during the login (maintenance instructions and error messages are possible), make a note of them and confirm the messages by pressing the [OK] button.

  • Page 142: Performing A Reorganization

    512 3.3.7 Performing a reorganization Before beginning with a new work cycle, a 'Clear data' reorganization of the cobas p 512 must be carried out. All status and position information pertaining to sample processing procedures remaining in the memory of the system are deleted during the reorganization process, if they are older the time span included within the configured number of 'Archive days'.

  • Page 143: Selecting The Work Cycle (Optional)

    512 Part C - Operation 3.3.8 Selecting the work cycle (optional) Several work cycles can be programmed for the system. When you want to use a cycle other than the currently active work cycle (for example "Archive"), then you must select the new work cycle before starting the sample processing.
  • Page 144 Part C - Operation cobas p 512 3.3.9.1 Loading the input sorter with tubes, racks and rack trays The system can be configured to accept a wide variety of racks and rack trays from different manufacturers. The following descriptions each show one of the many possible rack and rack tray types.
  • Page 145 512 Part C - Operation 3.3.9.2 Loading the output sorter with sorting racks 1. Remove the full or partially-full sorting racks and rack trays from the holders in the drawers of the output sorter. 2. Put the empty sorting racks in the appropriate positions in the sorting area.
  • Page 146 3.3.9.4 Racks Example: Roche PVT rack Racks are available in different sizes and shapes. Roche PVT racks have been designed especially for the system. Loading and unloading the system with these racks is very easy. In order to fasten the rack onto its tray, it must be engaged from above into pins, pushed forward against a spring, lowered and snapped in place.

  • Page 147: Operation

    512 Part C - Operation 3.4. Operation Closing the protective doors Close the protective doors. The protective doors must be closed before you can begin with processing samples. Starting sample processing In the submenu 'Routine ▶ Control', press the [Run] button.

  • Page 148: Start Sample Processing

    Part C - Operation cobas p 512 3.4.1 Start sample processing After the login, the 'Routine ▶ Control' menu always appears. This is where the current system status is displayed. Detailed information about operating the touch screen, keyboard and stick, and information about the meaning and functions of button and key combinations is found in chapter 2 'System description' in section 2.6.5.

  • Page 149: React To Error Messages

    512 Part C - Operation 3.4.2.2 Main switch ON/OFF The system is halted immediately when the main switch is turned to OFF. The QNX (and QS I computer) are also shut down. CAUTION Switching off the system by means of the main switch can lead to loss of data, contamination and may also lead to damage to the system.

  • Page 150: Input Sorter During Operation, With Loaded Samples, Racks And Trays

    Part C - Operation cobas p 512 2. If necessary, open the protective door to allow access to the sorting area. This can be required by a troubleshooting instruction or if foreign objects or (parts of) sample tubes are lying in the wrong place in the sorting area.

  • Page 151: Emptying And Replacing Full Sorting Racks

    512 Part C - Operation 3.4.5 Emptying and replacing full sorting racks 3.4.5.1 Automatic ejection of the output sorter drawer If the racks belonging to a workplace in an output sorter drawer are full, then the drawer is automatically ejected.

  • Page 152: Processing Urgent Samples

    Part C - Operation cobas p 512 3.4.6 Processing urgent samples Urgent/emergency samples can be fed into the system while it is operational. The protective door remains closed during this procedure. Figure 3-15: Position 1 for urgent samples A Position 1 for urgent samples...

  • Page 153: Processing Recursive Samples

    512 Part C - Operation 3.4.7 Processing recursive samples The processing of recursive samples does not differ in principle to the processing of first-pass sample processing. The recursion varies, depending on the system configuration, the installed camera, the barcodes being used, and the tube types (open or closed).
  • Page 154 Part C - Operation cobas p 512 The exact meanings of the numbers and characters are found in chapter 2 'System description' in section 2.7.8. Figure 3-16: Searching for patients in submenu 'Routine' – 'Information system' (Standard Interface) Figure 3-17: Searching for patients in submenu 'Routine' – 'Information system'...
  • Page 155 512 Part C - Operation 4. Click the [Targets] button. The positions of the samples with processed test requirements are here listed with their sorting time, date, name, rack number, rack position and tube type. Figure 3-18: Display of the sorted samples of the desired patients 5.
  • Page 156 Part C - Operation cobas p 512 3.4.8.1 Incorrect tubes Lists can be viewed for a few days until they are finally deleted. When tubes are sorted into the error section, the reason can be viewed via the submenu 'Routine ▶ Sorting lists'. The reason can also be reconstructed after changing the work cycle or after performing a 'Clear data' reorganization.

  • Page 157: Archive Samples

    3.4.9.1 The 'archive' work cycle After all tests have been executed (after manual analysis in the laboratory or on external analysis devices), the samples go back into the cobas p 512 input sorter. The routine work cycle is completed. 1. Press the [Standby] button in the submenu 'Routine ▶ Control'.

  • Page 158: Terminating Routine Operation After Daily Routine

    Part C - Operation cobas p 512 3.5. Terminating routine operation after daily routine Ending operations Ensure that all samples have been processed and that no samples are located in the system. Press the [Standby] button in the submenu 'Routine ▶...

  • Page 159: Perform Data Backups

    Due to the risk of infection, always wear gloves when working on the system! 3.5.4 Emptying the waste container Empty the cobas p 512 waste container daily, either before or after the daily routine. For hygienic reasons, you should use plastic bags within the waste container. WARNING Risk of infection! Wear protective gloves! The waste container for caps is located on the rear of the system.

  • Page 160: Care And Maintenance Procedures

    Part C - Operation cobas p 512 3.5.5 Care and maintenance procedures Perform care and maintenance procedures as necessary. WARNING Always switch off the system before performing care and maintenance work. Always remove the mains plug of the system from the mains supply!
  • Page 161 512 Part D - Maintenance Part D Maintenance Operator's Manual - Version 1.6 - 09/2015...
  • Page 162 Part D - Maintenance cobas p 512 Operator's Manual - Version 1.6 - 09/2015...
  • Page 163 512 Part D - Maintenance Maintenance ..................4-1 4.1. Device care and maintenance ..............4-5 4.2. Cleaning agents and equipment ............. 4-6 4.3. Care and maintenance schedule ............4-7 4.3.1 Preventative maintenance ..................4-7 4.4. Weekly device care ..................4-8 4.4.1...
  • Page 164 Part D - Maintenance cobas p 512 Operator's Manual - Version 1.6 - 09/2015...

  • Page 165: Device Care And Maintenance

    512 Part D - Maintenance 4.1. Device care and maintenance Care and maintenance procedures include all activities to be performed periodically by the user. These serve to ensure trouble-free operation of the system. Adhering to the maintenance measures will help to ensure a trouble-free work flow.

  • Page 166: Cleaning Agents And Equipment

    Part D - Maintenance cobas p 512 4.2. Cleaning agents and equipment The surfaces of the module are made to ensure that the system can be cleaned with common disinfection agents (for example Meliseptol, Barrycidal 36 from Biohit, or Helipur H plus N from Braun Melsungen).

  • Page 167: Preventative Maintenance

    512 Part D - Maintenance 4.3. Care and maintenance schedule Interval Weekly Monthly / Every six Task as required months Clean and disinfect the gripper arms Clean and disinfect the housing and component surfaces Clean and disinfect the decapper...

  • Page 168: Weekly Device Care

    Part D - Maintenance cobas p 512 4.4. Weekly device care CAUTION Switch off the device before cleaning! Always wear protective clothing when cleaning! There is a risk of infection! 4.4.1 Cleaning the decapper module The decapper module is fastened to the housing so that it can be swung out or also reached through a door.
  • Page 169 512 Part D - Maintenance Figure 4-3: Inner view of decapper module Connecting piece for cylinder Funnel Knurled screws Loosen the connecting pieces on the cap-removal cylinder. NOTICE Hold on tight to the connecting pieces. When loosening, compressed air can escape! Loosen the knurled screws.
  • Page 170 Part D - Maintenance cobas p 512 10. Clean the waste tube, the funnel and the cap removal unit with water and the cleaning brush included in the delivery. WARNING Risk of infection! Always wear complete protective clothing (lab gown, gloves and eye...
  • Page 171 512 Part D - Maintenance 11. Clean the sensors pictured here, first with a moist cloth. Then, if necessary, wipe them dry. Figure 4-8: Sensors on the cap removal Figure 4-9: Sensors on the waste tube device (from below) 12.
  • Page 172 Part D - Maintenance cobas p 512 4.4.1.2 Cleaning the gripper In order to clean the lifting and turning grippers, you must wipe off their gripping surface with a cloth soaked with ethyl alcohol. Use a brush on the gripper when it is very dirty.

  • Page 173: Monthly Device Maintenance

    512 Part D - Maintenance 4.5. Monthly device maintenance 4.5.1 Cleaning system components The following components should be cleaned with a disinfectant at least once a month, since they come into contact with sample material. Racks • Drawers •...

  • Page 174: Cleaning The Barcode Reader

    Part D - Maintenance cobas p 512 4.5.2 Cleaning the barcode reader Loosen the fastening screws on the front of the cap-recognition unit. Remove the cover at the front. Clean the barcode reader window, first with a damp cloth and then wipe it dry.

  • Page 175: Cleaning The Sensors On The Rt-Transport

    512 Part D - Maintenance 4.5.3 Cleaning the sensors on the RT-Transport Clean the sensors pictured here, first with a moist cloth. Then wipe them dry. Figure 4-13: Sensors on the RT-Transport A Sensors Operator's Manual - Version 1.6 - 09/2015...

  • Page 176: Cleaning The Infrared Liquid Level Detection (Ir-Lld)

    Part D - Maintenance cobas p 512 4.5.4 Cleaning the infrared liquid level detection (IR-LLD) Clean the reflector with a moist cloth, then wipe it dry. When cleaning the area around the IR emitters/sensors, make sure to touch neither the emitters nor the sensors directly.

  • Page 177: Cleaning The Laser Liquid Level Detection (Laser-Lld)

    512 Part D - Maintenance 4.5.5 Cleaning the laser liquid level detection (Laser-LLD) Clean the reflector with a moist cloth, then wipe it dry. When cleaning the area around the laser emitters/sensors, make sure to touch neither the emitters nor the sensors directly.

  • Page 178: Device Care, As And When Required

    Part D - Maintenance cobas p 512 4.6. Device care, as and when required 4.6.1 Cleaning the housing and component surfaces Clean the surfaces of the housing with a cloth and disinfectant when soiled, for example, by spilt fluids. 4.6.2 Cleaning the display When soiled, clean the touch screen monitor with a damp cloth only.

  • Page 179: Cleaning The Sensors On The Feed-In And Output Modules

    512 Part D - Maintenance 4.6.4 Cleaning the sensors on the feed-in and output modules Wipe off the sensors on the input and output sorter with a soft lint-free cloth damped with demineralized water with disinfectant. Figure 4-18: Sensor rack output tray full (A)

  • Page 180: Emptying The Condensation Container

    Part D - Maintenance cobas p 512 4.6.5 Emptying the condensation container Empty the condensation container as necessary or during monthly maintenance procedures at the latest. The container is found inside the output sorter. Switch off the compressed air supply for the system.

  • Page 181: Cleaning The Tube Type Identification Module (Bluelynx Camera)

    512 Part D - Maintenance 4.6.6 Cleaning the tube type identification module (BlueLynx camera) When required, clean the camera lens using a slightly damp micro-fiber cloth. NOTICE Store the cleaning cloths for the camera lens separately so as to avoid contamination by foreign bodies.

  • Page 182: Cleaning The Quality Module (Qs I, Qs I-Lld)

    Part D - Maintenance cobas p 512 4.6.7 Cleaning the quality module (QS I, QS I-LLD) When required, clean the camera lens using a slightly damp micro-fiber cloth. NOTICE Store the cleaning cloths for the camera lens separately so as to avoid contamination by foreign bodies.

  • Page 183: Cleaning The Recapper Module

    512 Part D - Maintenance 4.6.8 Cleaning the recapper module Clean the recapper module housing with a cloth soaked in a disinfectant. CAUTION The heating block on the recapper module is very hot! It can take up to two hours to cool down after operation! Deposits and dirt on the heating surface can possibly become hardened.

  • Page 184: Replacing Parts

    Part D - Maintenance cobas p 512 4.7. Replacing parts 4.7.1 Replacing the mains fuse The mains fuse is located above the mains connection at the rear of the system. WARNING Electric Shock! Do not replace the fuse until you have unplugged the power cable!
  • Page 185 512 Part D - Maintenance Figure 4-29: Removing the mains supply cable Using a thin-blade screwdriver, push up the tab (on the lower part of the fuse holder) and pull out the fuse holder. Figure 4-30: Push up the tab ...

  • Page 186: Replacing The Lighting Of Tube Type Identification Module

    Part D - Maintenance cobas p 512 4.7.2 Replacing the lighting of tube type identification module The lighting (consisting of three bulbs) in the tube type identification module must be replaced once a year. CAUTION The bulbs are very hot! They can take up to 15 minutes to cool down! 4.7.2.1 Replacement parts...
  • Page 187 512 Part D - Maintenance Figure 4-35: Cap-recognition unit, rear view Figure 4-36: Cap-recognition unit, front view A Light bulbs Carefully pull out the bulbs. Insert the new bulbs into the sockets. Close the housing panels. Tighten the fastening screws.
  • Page 188 Part D - Maintenance cobas p 512 4-28 Operator's Manual - Version 1.6 - 09/2015...
  • Page 189 512 Part E - Troubleshooting Part E Troubleshooting Operator's Manual - Version 1.6 - 10/2015...
  • Page 190 Part E - Troubleshooting cobas p 512 Operator's Manual - Version 1.6 - 10/2015...
  • Page 191 512 Part E - Troubleshooting Troubleshooting ..................5-1 5.1. What do I do if...? ..................5-5 5.1.1 ... the system is not working? ................... 5-5 5.1.2 ... the control unit (computer) is not working? ..........5-5 5.1.3 ... the touch screen monitor is not working? ............5-5 5.1.4...
  • Page 192 Part E - Troubleshooting cobas p 512 Operator's Manual - Version 1.6 - 10/2015...

  • Page 193: What Do I Do If

    512 Part E - Troubleshooting 5.1. What do I do if...? 5.1.1 ... the system is not working? Check: if the main switch is in the correct ON/OFF position. • if the protective door is correctly closed. •...

  • Page 194: A Power Failure Has Occurred

    Part E - Troubleshooting cobas p 512 5.1.6 ... a power failure has occurred? The QNX PC and also the QS I PC (if present) must be rebooted after a power outage. The system can be started as usual. After the system is started, any tubes that are still in the RT- Transport are recognized and sorted into the specified default rack.

  • Page 195: Problems Occur When Reading A Barcode

    512 Part E - Troubleshooting 5.1.10 ... problems occur when reading a barcode? If tube barcodes are not recognized, a number of causes are possible: The tube is misaligned. • The label is not readable (defective, crumpled or too slanted).

  • Page 196: A Tube Is Set Down Into An Already-Occupied Position On The Rack

    Part E - Troubleshooting cobas p 512 5.1.12 ... a tube is set down into an already-occupied position on the rack? The system has false assignment information in regards to the racks in the output sorter. Possible causes for this are: After a reorganization and clear there are still racks with tubes in the sorting area.

  • Page 197: The Recapping Module Isn't Working

    512 Part E - Troubleshooting 5.1.13 ... the recapping module isn’t working? Power may be down or the pneumatics system may be defective. Check if sufficient air pressure is available. Notify the service technician if the problem persists.

  • Page 198: The Qs I Camera Fails To Classify The Sample

    Part E - Troubleshooting cobas p 512 5.1.15 ... the QS I camera fails to classify the sample? (only for systems equipped with a QS I camera module) In case the camera's classification of the serum has failed, a return code is sent representing the error that has occurred.
  • Page 199 512 Part E - Troubleshooting Return code Error Reason -305 Plausibility check Serum's upper edge detected just below • failed. Falsified result the label's lower edge, but ... of liquid level ... due to a narrow viewport beside the •...

  • Page 200: Important Questions For Customer Service

    Part E - Troubleshooting cobas p 512 5.2. Important questions for customer service 5.2.1 General information It is important that customer service receives a detailed description of the error. For that reason, ensure that the following information is available before calling customer service: Was the error caused when an entry was being made in the computer or was something •...

  • Page 201: System And Error Messages

    512 Part E - Troubleshooting 5.3. System and error messages All messages that may be displayed are described below. These messages are made up of both strictly informative messages as well as error messages to which the user must react.

  • Page 202: Error) Messages Which Require Intervention

    Part E - Troubleshooting cobas p 512 5.3.1 (Error) messages which require intervention The following table lists all messages which require intervention. Some of their causative errors or malfunctions however cannot be remedied by the operator alone. In such cases, the intervention of the lab administrator or service technician is necessary, since only they have the necessary software access rights, and only they should deal with mechanical or electrical problems.
  • Page 203 512 Part E - Troubleshooting Error message Description Remedy The day of the week has to be Enter the correct date, day of the week and Bad date or time entered additionally to ensure time. (not stored) that the data is entered correctly.
  • Page 204 Part E - Troubleshooting cobas p 512 Error message Description Remedy Error standstill monitoring for Press the [Repeat] button. Error standstill positioning commands. Axis Contact a service technician if the error monitoring deflection at standstill in excess persists. of the tolerance. The buffer does not change when this error occurs.
  • Page 205 512 Part E - Troubleshooting Error message Description Remedy No execution command for the Try to circumvent the error by pressing No execution DMS control board in the [Repeat]. If this proves to be in vain, reboot command in the buffer.
  • Page 206 Part E - Troubleshooting cobas p 512 Error message Description Remedy (L) Initialization error. If this error occurs repeatedly, contact a L Initialization During initialization, an axis' service technician: Make sure the axes are error limit switch hasn't been running smoothly. Check belt tension (if reached or the monitored time applicable for the affected axis).
  • Page 207 512 Part E - Troubleshooting Error message Description Remedy Error: Initialization error Contact a service technician. Error: Initialization (motor controller). Check the 5V voltage and the 5V fuse. error After any reset (hardware or Check 'Initstring' in the log file.
  • Page 208 Part E - Troubleshooting cobas p 512 Error message Description Remedy In a system of this size there are Follow the sequence listed below if you General internal hundreds of potential software encounter this error: software error errors that are not worth Search for an entry in the log file.
  • Page 209 512 Part E - Troubleshooting Error message Description Remedy The actuator <%1> has left the Check whether the sensor is active. Check Start position not start position. the sensor logic. Check whether the sensor active '%' Sensor's I/O channel: <%2>...
  • Page 210 Part E - Troubleshooting cobas p 512 Error message Description Remedy The actuator <%1> is still in Check whether the sensor is active. Check Start position is still start position. whether the sensor has been properly active '%' Sensor's I/O channel: <%2>...
  • Page 211 512 Part E - Troubleshooting Error message Description Remedy The gripper <%1> has lost a Remove the tube from the sorting area and Gripper has lost tube during sorting. place it in the work place provided for this tube '%' purpose.
  • Page 212 Part E - Troubleshooting cobas p 512 Error message Description Remedy No rack is in position in the If an empty rack is in the sorting area, you No rack in sorting sorting area where the tube is can sort the tube by pressing [Skip]. Place area supposed to be sorted.
  • Page 213 512 Part E - Troubleshooting Error message Description Remedy Manually remove the cap in Cap did not fall case it is located within the area through the waste of operations or stuck inside the tube gripper. Use the forceps if necessary.
  • Page 214 Part E - Troubleshooting cobas p 512 Error message Description Remedy One or more tests are listed in a You should check the following under Test not found profile but have not been 'Reference Data ' main menu item: created in 'Reference Data ->...
  • Page 215 512 Part E - Troubleshooting Error message Description Remedy Rack did not arrive at sensors of Move the rack up close to the stopper and Rack has not RUS. press [Repeat]. Check if the sensors are still passed sensors at working.
  • Page 216 Part E - Troubleshooting cobas p 512 Error message Description Remedy The system cannot be started Close the protective cover. Protective cover while the input sorters You will have to check the door sensors if input sorter not protective cover is open.
  • Page 217 512 Part E - Troubleshooting Error message Description Remedy You are trying to use invalid Read the position again. Teachin: coordinates. Please read the Coordinates position again. invalid The file <%1> was not found. Check your entry or create the file.
  • Page 218 Part E - Troubleshooting cobas p 512 Error message Description Remedy The rack %1 was not found Select a rack or check the correct spelling. % Teachin: You have not selected a rack You cannot start Teachin. The Change to standby mode by pressing the...
  • Page 219 512 Part E - Troubleshooting Error message Description Remedy The number of positions is not Enter the correct number of positions and TEACH_Q_NUM correct. Only racks which read the coordinates again. consist of complete rack-rows are allowed. If you are trying to...
  • Page 220 Part E - Troubleshooting cobas p 512 Error message Description Remedy The camera detected soiling in Try to continue operation by pressing Soiling in the the image window. This may be 'Repeat'. Open the housing of the tube type image window...
  • Page 221 512 Part E - Troubleshooting Error message Description Remedy The door of the corresponding Close the door. Door not closed module is not closed. After pressing [Repeat], the sequence of sensor % Sensor (%1) operation is re-launched. The sealing temperature of the...
  • Page 222 Part E - Troubleshooting cobas p 512 Error message Description Remedy Reference position check failed. If the error occurs very often and regularly, Error reference The current positioning has a service technician should check the motor, switch monitoring immediately been aborted.
  • Page 223 512 Part E - Troubleshooting Error message Description Remedy Transfer error (parity) Check the cabling to the motor control Transfer error % (address=%1). Communication board. See Service Manual -> Electronics. error from the computer to the DMS/SMS control boards. Red fail LED is blinking.
  • Page 224 Part E - Troubleshooting cobas p 512 Error message Description Remedy End-amplifier power supply. Upon repetition, check the voltages (24V, Motor Insufficient or excess voltage. 42V, 35V). See Service Manual -> undervoltage % The error is not reset after status Electronics.
  • Page 225 512 Part E - Troubleshooting Error message Description Remedy Error at motor control board Press the [Repeat] button. PID-Filter error % DMS (address=%1): Contact a service technician if the error PID filter error in the internal persists. Check the regulation parameters.
  • Page 226 Part E - Troubleshooting cobas p 512 Error message Description Remedy The sealing temperature of the Check the sealing temperature and the error Temp sensor RT: recap module is out of range notification on the temperature control sealing (180<>190C). Possible reasons:...
  • Page 227 512 Part E - Troubleshooting Error message Description Remedy Cylinder %1 did not reach the As the case may be, remove the obstacle. As Cylinder sensor in the working position the case may be, turn on the valve. As the movement error % (channel %2).
  • Page 228 Part E - Troubleshooting cobas p 512 Error message Description Remedy WARNING: Before you put the Check the drop tube into the drop container, container check if the container is empty. If not, clear the container and afterwards confirm the message by pressing [OK] to continue operation.
  • Page 229 512 Part E - Troubleshooting Error message Description Remedy Both IR-LLD module signal Check to make sure that the insort position IR-LLD module levels (emitter and receiver) are is empty. Restart the system. Contact a signal levels too too low.
  • Page 230 Part E - Troubleshooting cobas p 512 Error message Description Remedy A tube is to be placed in a Waiting for tube position of the transfer module. holder for sorting However, the module is not yet in the output ready. The transfer module has...
  • Page 231 512 Part E - Troubleshooting Error message Description Remedy The read coordinates are located Coordinates are within the recapper module's inside restricted restricted area. Check the read area coordinates and those of the restricted area. The system uses a Slip-Off of General Slip-Off <%1>.
  • Page 232 Part E - Troubleshooting cobas p 512 Error message Description Remedy The tube orientation sensor was Check the tube's position on the tube BLM: Detection of unable to detect a cap and is transport. It might be tilted or jammed.
  • Page 233 512 Part E - Troubleshooting Error message Description Remedy In order to allow the Before you execute "terminate all racks" Procedure failed termination of all racks, the RT anew, the system must have processed all to execute transport must be empty. On...
  • Page 234 Part E - Troubleshooting cobas p 512 Error message Description Remedy An unknown error occurred at When in contact with the service technician, Unknown CCM the CCM. Please inform a report the error group and number as stated error service technician. Error group: above.
  • Page 235 512 Part E - Troubleshooting Error message Description Remedy An error occurred at the CCM This particular error can be due to a large CCM error during during initialization. Check the variety of reasons. Please check the system's initialization error history for details.

  • Page 236: Informative Messages

    Part E - Troubleshooting cobas p 512 5.3.2 Informative messages The system can also display messages which are purely informational in nature or which are requesting a confirmation for a selected process. These messages are listed in the following table.
  • Page 237 512 Part E - Troubleshooting Message Description Remedy ISAM: Record '%' locked You have reached the last (first) Select [Back] ([Next]) if you have reached ISAM: End of file or data record in the general the last (first) data record.
  • Page 238 Part E - Troubleshooting cobas p 512 Message Description Remedy The selected sorting list is This message is only provided for your Start transferring transferred to the host. information. list '%' to host used as text. User-ID The input module initializes.
  • Page 239 512 Part E - Troubleshooting Message Description Remedy You have selected a square Teachin: Square rack. You can decide whether rack selected the rack is sorted line by line or column by column. The coordinates of the rack file...
  • Page 240 Part E - Troubleshooting cobas p 512 5-52 Operator's Manual - Version 1.6 - 10/2015...
  • Page 241 512 Part F - Appendix Part F Appendix Operator's Manual – Version 1.6 - 10/2015...
  • Page 242 Part F - Appendix cobas p 512 Operator's Manual – Version 1.6 - 10/2015...
  • Page 243 512 Part F - Appendix Appendix ....................6-1 6.1. Included in delivery ..................6-5 6.2. cobas p 512 system, technical data ............6-6 6.2.1 Dimensions and weight ....................6-6 6.2.2 Current and voltage supply ..................6-6 6.2.3 Compressed air supply....................6-6 6.2.4...
  • Page 244 Part F - Appendix cobas p 512 Operator's Manual – Version 1.6 - 10/2015...
  • Page 245 Part F - Appendix 6.1. Included in delivery Article Amount cobas p 512 (customer configured system) Power cord Tool set (special forceps, fuses, bulbs, etc.) System software on CD-ROM including updates Compressed-air hose including couplings (NW 7.2 / G ¼“), 3 meters Operator’s Manual...

  • Page 246: Cobas P 512 System, Technical Data

    Depth Height Weight cobas p 512 system 2.40 m 1.86 m 2.00 m 805 kg cobas p 512 system (with QS I and 2.40 m 1.86 m 2.00 m 1,116 kg recapper) 6.2.2 Current and voltage supply 230 V version...

  • Page 247: Operating Conditions

    512 system with recapper Approx. 2,880 kJ/h / 688 kcal/h / 2,730 BTU/h 6.2.8 Color of module The cobas p 512 system is available in the device colors RAL 7035 and RAL 6027. Operator's Manual – Version 1.6 - 10/2015...

  • Page 248: Barcode Scanner, Technical Data

    The use of check digits can reduce the rate of read errors. NOTICE Roche PVT accepts no liability for read errors resulting from missing check digits, poor quality labels or insufficient maintenance. 6.3.3...

  • Page 249: Maximum Number Of Digits

    Tested storage conditions for sealed tubes: • Up to three months in refrigerator (+ 4 °C / 39.2 °F), when foil is properly sealed. 6.7. System interfaces The external cobas p 512 interfaces are used to connect with: Power supply • Printer •...

  • Page 250: Device Reliability

    Longer average operating times will also shortened the guarantee and warranty period. 6.9. Accessories The following optional accessories are available for the cobas p 512 system: Oil-free compressor with membrane drying (230 V or 115 V) • Compressor in reduced-noise housing (for systems with a recapper) (230 V or 115 V) •...

  • Page 251: 6.11. Sample Tubes

    NOTICE Your distributor has a current list with the information on all allowable tube types for the cobas p 512 system. He can answer all additional questions you may have concerning the use of other tube types. 6.11.1 Dimensions of allowed tube types:...

  • Page 252: 6.12. Floorplan

    Part F - Appendix cobas p 512 6.12. Floorplan Figure 6-1: cobas p 512 floorplan 6-12 Operator's Manual – Version 1.6 - 10/2015...
  • Page 253 512 Part F - Appendix Figure 6—2: Floor load without options Operator's Manual – Version 1.6 - 10/2015 6-13...
  • Page 254 Part F - Appendix cobas p 512 Figure 6—3: Floor load with options 6-14 Operator's Manual – Version 1.6 - 10/2015...

  • Page 255: 6.13. Glossary

    512 Part F - Appendix 6.13. Glossary Term Explanation Aliquot A portion aspirated from a primary sample scheduled for a specific analytical test or group of tests. Analyzer device / system Lab device or system which analyses samples.
  • Page 256 Part F - Appendix cobas p 512 Term Explanation Delete Physical removal of data or files from the hard disk. Depth of drive in The aliquoter system calculates the depth of drive in according to the total pipetting volume and the tube diameter.
  • Page 257 512 Part F - Appendix Term Explanation Kernel generation Basic program of the operating system, which is customer-specifically generated for the system. A new kernel is generated as well when changing the RAM disk or node numbers (network).
  • Page 258 Part F - Appendix cobas p 512 Term Explanation Program parameters Definition of the parameters to be delivered on starting a certain program. Program type Classification of different programs by types. Protective cover Lockable doors on the barcode printing module and the sorting area.
  • Page 259 512 Part F - Appendix Term Explanation Standby System status: system operations have been halted; user intervention in the sorting area is possible. Button on the screen which causes the system to switch to Standby status. Startup file File (program) that is executed during the startup of the computer.
  • Page 260 Part F - Appendix cobas p 512 6-20 Operator's Manual – Version 1.6 - 10/2015...

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