Summary of Contents for Analyticon Urilyzer 500 Pro
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Urilyzer 500 Pro ® User Manual Analyzer for CombiScreen ® 11SYS Plus and CombiScreen ® 11SYS urine test strips Analyticon Biotechnologies GmbH Am Muehlenberg 10 35104 Lichtenfels - Germany info@analyticon-diagnostics.com www.analyticon-diagnostics.com agile - affordable - accurate...
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Germany info@analyticon-diagnostics.com www.analyticon-diagnostics.com The information in this manual was correct at the time of printing. However, Analyticon continues to improve its products and reserves the right to change specifications, equipment and mainte- nance procedures at any time without notice. Companies, names and data used in examples are fictitious unless otherwise noted. No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical or otherwise, for any purpose, without the express written permission of Analyticon.
Contents Contents Introduction ....................... 3 1.1 Intended Purpose ....................3 1.2 Indications for use ....................3 1.3 Limitation of use ....................3 1.4 How to use this manual ..................4 1.5 Safety precautions ....................4 1.6 Approvals ......................5 Quickstart ........................6 System description ....................
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Contents 9.1 QC Options ......................43 9.2 QC Testing ......................45 9.3 Recalling QC results ................... 46 10. Main Menu options ....................47 10.1 Strip LOT ......................47 10.2 View Settings ....................48 10.3 User Options ....................48 11. Instrument Settings ....................49 11.1 Language ......................
CombiScreen ® 11SYS PLUS and CombiScreen ® 11SYS urine test strips manufactured by Analyticon Biotechnologies GmbH. CombiScreen ® multiparameter urine test strips The system indicates the pH and Specific Gravity (SG) of the urine samples and performs the semi-quantitative measurement of relevant properties of the following urine analytes: Bilirubin (Bil), Urobilinogen (Ubg), Ketones (Ket), Ascorbic Acid (Asc), Glucose (Glu), Pro- tein (Pro), Blood (Bld / Ery), Nitrite (Nit), Leukocytes (Leu).
Introduction 1.4 How to use this manual The User Manual contains all instructions to unpack the analyzer, for safely use during daily urinalysis and to keep it in good working condition. Symbols and formatting conventions This manual uses the following symbols to highlight important information: Symbol Explanation CAUTION: This symbol indicates maintenance procedures, operations and...
Introduction 1.6 Approvals The Urilyzer ® 500 Pro system meets the requirements laid down in: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
Quickstart 2. Quickstart 1. Unpack the instrument and place it on an even, hard surface (for detailed installation instructions see 4. Unpacking & Setup). Insert the drop tray, the strip timer rake and the test strip tray. 2. Connect the power supply and turn the analyzer on with the On/Off-switch (See Figure 12: Powering up).
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Quickstart Figure 2: The Result menu Refer to 8.5 Further actions with selected items to delete measurement records. – Tap the Printer symbol to print the displayed record – Tap the Transfer button to transfer the displayed record to an external analyzer accord- ing to the current transfer settings –...
System description 3. System description 3.1 Principle of operation The test strip is moved below a moving measurement unit along the test strip tray by the strip timer rake. The photometer unit has an embedded reference pad. The analyzer reads the reference pad, followed by each of the test pads on the strip.
System description 3.2 Components & Functions Figure 4: Analyzer front Figure 5: Analyzer back Component Function 1. Printer cover Flips up to receive printer paper 2. Printer cover button Opens the printer cover when pressed 3. Capacitive touch screen Serves as interface with the user 4.
System description Always connect external devices to their designated connector only. If any ex- ternal device is connected to a connector it was not intended for, the device or the analyzer may be damaged e. g. because of wrong voltage. Check all cables to make sure they are operational.
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System description Temperature limitation DC Adaptor Polarity Centre Positive Atmospheric pressure limita- This way up tion Direct current Caution, consult accompanying documents MAC address...
Unpacking & Setup 4. Unpacking & Setup 4.1 Unpacking ® Read the Urilyzer 500 Pro User Manual carefully before installation to ensure proper operation of the analyzer from the outset. Follow the specified installation instructions carefully. Otherwise, inaccurate results or damage to the analyzer may occur. Check the carton and instrument for visible signs of damage;...
Unpacking & Setup 4.2 Setting up The analyzer should only be used indoors. – Set up and operate the analyzer on a solid level surface in an environment with fairly constant temperature and humidity. – Do not operate the analyzer in close proximity to sources of intense electromagnetic radiation (such as unshielded intentional RF sources).
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Unpacking & Setup 4.2.2 Inserting the drop tray Handle the drop tray by its handle. Insert the pan with its hollow side up into the opening under the touch screen from the right. Slide the drop tray inside the analyzer until it is held tight by its friction fit flap.
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Unpacking & Setup 4.2.4 Inserting the test strip tray/waste bin Figure 10: Inserting the test strip tray Handle the test strip tray/waste bin by the handle on the right-hand side of the analyzer, below the LCD touch screen. Insert the strip tray with the waste bin cavity facing up into the opening under the LCD touch screen from the right.
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Unpacking & Setup sure that the paper is aligned properly. Let a few centimeters (about an inch) of paper hang over the edge of the compartment, and close the printer cover until click. To remove the printed test report, tear off the paper by pulling it towards the front across the edge.
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Unpacking & Setup To power on the analyzer, firmly press down the ON/Standby button in front of the touch screen. Keep pressing down the button for a few seconds. The system starts up with an audible beep and runs a self-check. 4.2.8 Powering down Do not remove the power cable while the analyzer is in operation, otherwise the data may be corrupted or the system may be compromised.
Unpacking & Setup Figure 14: Powering down (2) 4.3 Analyzer software updates Only Administrator and higher access level operators can run a software update. ® The manufacturer is continuously upgrading the Urilyzer 500 Pro user software, add- ing new features and improving usability. From time to time the manufacturer will send a software update for the device.
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Unpacking & Setup 3. On the Settings » Update screen, wait for the Update button to light up and tap it to start the automatic update process. The system detects the software update package and verifies its contents before the Update button becomes active.
Interacting with the analyzer 5. Interacting with the analyzer 5.1 Screens The system displays messages, instructions and options to choose from the touch screen to operate the analyzer. Figure 15: Touch screen layout The screen layout can be divided into three main areas: (1) Header: Displays important system information such as the date and time, the current operator ID, queue, and status line messages.
Interacting with the analyzer 5.2 Touchscreen operation How to touch the display The touchscreen can be operated with bare fingers or gloved fingers. Tap the touch screen gently but firmly in a touch-sensitive area to get a response. Generally, the screen areas that have frames around them respond to tapping: buttons, check boxes, radio buttons, and text boxes.
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Interacting with the analyzer To confirm the performed changes on the User options or a Settings screen first tap Apply and leave the screen with the Back. Drop Apply Back Changes are still not saved No changes or changes are saved Check boxes Check boxes are used when an option can be enabled or disabled (e.g.
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Interacting with the analyzer Figure 16: The touch screen keyboard character sets 5.2.3 Entering data via a barcode reader or a keyboard A barcode reader can not only speed up the sample management process, but the ac- curate data entry also reduces transcription errors. Using a barcode reader Make sure that the external barcode reader supports ALT (alternate) mode, and select the ALT input mode before connecting the reader to the analyzer.
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Interacting with the analyzer Press ‘Ctrl’ to display the keyboard shortcuts on the screen. The relevant shortcuts will appear in the top left corner of the buttons. Figure 17: The Main screen with keyboard shortcuts displayed above the onscreen buttons Another option is to cycle through the onscreen buttons using the ‘Tab’...
Start-Up Wizard 6. Start-Up Wizard ® The first time the Urilyzer 500 Pro device is switched on, a Start-up Wizard is displayed. Here the user is able to customize the basic options of the device. The Start-up Wizard can be skipped on the second screen. It is recommended that a supervisor-level user ( 11.15 Operators) should com-...
Analyzing samples 7. Analyzing samples Depending on the needs of the laboratory, there are a number of workflows the user can choose from. – Quick analysis using automatically generated sample IDs ( 7.1 Quick analysis) – Analyzing samples using user-entered sample IDs Analyzing individual samples Analyzing samples from a worklist –...
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Analyzing samples Touch test strips by their handles – do not touch the analyte pads. 3. Blot by touching the edge of the strip to 4. When a continuous green light comes on a paper towel to remove excessive urine. at the strip delivery zone, place the test strip on the test strip tray, inside the strip delivery zone, with the test pads facing...
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Analyzing samples 7.1.1 Adding Color and Clarity data – Color: To select the visually determined color of the urine sample tap the appropriate button. After selection the next screen is displayed. Figure 18: Sample color options – Clarity: To select the visually determined clarity of the urine sample tap the appropriate button.
Analyzing samples 7.1.2 Strip checking events Errors in the sample handling and testing procedure may lead to false results. In order to further improve the diagnostic decision-making process, Urilyzer ® 500 Pro offers ad- vanced strip-detection features. The results of mechanical analysis failures fall into three categories: R1.
Analyzing samples 2. Prepare the samples from the worklist and make sure to prepare enough fresh ® ® CombiScreen 11SYS Plus or CombiScreen 11SYS test strips for each of them. 3. Refer to 7.1 Quick analysis, dip a test strip into the first urine sample on the worklist and start a measurement by placing the test strip inside the strip delivery zone.
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Analyzing samples These features can be modified by any operator and stored separately for each op- erator. – Change password: by tapping the Change password button the user can modify the password. 7.4.2 Customizing the analysis process Figure 21: Settings»Measurement On the Settings »...
Analyzing samples 7.5 Worklist management Figure 22: The Worklist menu The worklist is a predefined sequence of samples and contains the sample IDs and patient IDs in the sequence of planned evaluation. Tap the Worklist button on the Measurement screen to go to the worklist management. On the Worklist menu following settings are available: –...
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Analyzing samples the editing process can be speeded up considerably. The new item will be added to the end of the list. Use the Modify button to modify an already existing record. To change the position of the active item in the list, tap the Move button. The button background is changed to orange and the item can be moved up and down in the list by using the arrows on the right side.
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Analyzing samples field empty. Tap Apply&Next after entering the patient ID and proceed to the next screen. To abort and go back to the Sample ID screen, tap Drop&Back. Figure 24: Patient ID input For further instruction regarding barcode reader usage see 5.2.2 Entering data via a barcode reader or a keyboard 7.5.2 Worklist window in the Measurement menu...
Recalling results 8. Recalling results ® The Urilyzer 500 Pro has memory for 5000 measurements. Every result is automatical- ly saved after the analysis in an indexed database. Using the database, results can be searched, reviewed, printed or transferred to an external device. By default the analyzer warns the user to free up memory (erase data) 30 records be- fore the limit.
Recalling Results Figure 26: The Last Result menu displaying the record for a failed measurement If the measurement was successful, all data stored with the record in question is displayed. If the measurement failed for some reason, only the reason for the failure is displayed (usu- ally an error message), and the background of the menu is highlighted in yellow.
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Recalling results Figure 27: The Database menu Key to Figure 27 1. Currently selected result details 2. Results list 3. Further actions with selected records 4. Set up filters 5. Move up 100 records in the list 6. Move up 1 record in the list 7.
Recalling Results 8.3 Result view Figure 28: Database»Result menu Using the buttons in the top right-hand corner of the menu, selected records can be printed, modified and transferred to LIS. The Edit button is only available if the record has not been printed or transferred yet. 8.4 Modifying the active selection of results If a record is selected: –...
Recalling results Remove selection To remove all selections, tap the Remove selection button on the Database » Selected screen. 8.5 Further actions with selected items If no record is selected, the action buttons on this menu are dimmed. Delete To delete the selected records, tap the Delete button on the Database » Selected screen. In order to prevent accidental deletion, a confirmation dialog appears on the screen.
Recalling Results Select all Tap this button to select all the records in the database. An information message (“I102: All samples are selected”) is displayed to confirm the action. Remove selection Tap this button to cancel the selection. The screen will be automatically moved back to the Database menu.
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Recalling results On the first page of the Filter screen, the active filters from the second page are listed above the navigation buttons. To switch off filtering tap the Filter OFF button. To return to the list of results, tap Return. Selecting the Date&Time To select the filtering period, define the start and end Date&Time separately on the Filter »...
Several commercial controls are available. Control solutions may vary in the number of levels or components, the necessity for reconstitution or readiness for use or the type and volume of container. Analyticon Biotechnologies GmbH recommends the use of ® CombiScreen Dip Check (Ref.: 93010) or Drop Check (Ref.: 93015) controls as these...
Quality Control Testing 9.1 QC Options Figure 31: QC Options menu On the Main Menu » Settings » QC Options screen the analyzer Quality Control settings can be configured: – enable/disable QC lockout, – set the QC lockout interval in days, –...
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Quality Control Testing Figure 32: An example of a forced L2 quality check setting The lockout mode can be – warning If the limit is passed, the status bar background is changed to orange and a warning mes- sage is displayed. –...
Quality Control Testing 3. On the next screen set the LOT code (and the expiry date) and tap the Next button. If a LOT code is already stored for the current level, its value will be displayed as the default in the input box.
Quality Control Testing green: valid measurement was performed within the time limit red: invalid measurement was performed within the time limit The QC can start either with a negative or with a positive control. Apply the control to the strip according to the instructions of the control solutions and the CombiScreen ®...
Main Menu options 10. Main Menu options Figure 34: Main Menu options The Main Menu screen displays the following information: – Software version – Serial number – Test strip type and LOT code information – QC LOT information – Data Count The following functions can also be reached from this screen: –...
Main Menu options 10.2 View Settings The View settings screen shows all settings including user options as well. Use the down and up buttons to scroll through the settings. The analyzer settings can be printed out using the button. 10.3 User Options Most of the settings on the User options screen are related to the testing procedure ex- cept Sound and LCD brightness.
Instrument Settings 11. Instrument Settings Figure 35: The Settings menu ® The Urilyzer 500 Pro allows to change settings to suit individual workplace require- ments. Instrument settings can be reached from Main » Settings. The list of available settings may vary according to authenticated user level. To navigate between settings pages use the back and forward arrows.
Instrument Settings The settings can be restored based on the settings of supervisor user, if the ‘Default by “supervisor” settings’ switch is active on Manage settings page. Saving and restoring set of settings Figure 36: Manage Settings menu Supervisor level users can download settings to a USB flash drive and upload to one or multiple other analyzer/analyzers with this feature.
Instrument Settings 11.2 Date, time Figure 37: The Date/Time menu The date and time are displayed on the header and are recorded with the test results. To Modify which field is active use the up and down arrows. To change the value of the active field use the + and – buttons. Available date formats: YYYY-MM-DD (default, ISO 8601 standard) MM-DD-YYYY (US format)
Instrument Settings Printout Header custom string Patient ID If ON, ~ appears on the printout Operator ID If ON, ~ appears on the printout Analyzer S/N If ON, ~ appears on the printout Sediment rec: If ON, sediment recommendation information appears on the print- Strip LOT If ON, ~ appears on the printout Print blank:...
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Instrument Settings Serial (RS232) TCP/IP Ethernet File USB B Bidir:LIS2 (ASTM+) Bidir: HL7 Unidir: CSV Unidir: UTF8 text – For the serial port: The selectable baud rates are 2400, 4800, 9600, 19200, 38400, 57600, and 115200 bits per second. The value defines the speed of the serial commu- nication.
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Instrument Settings The two-way digital transmission protocol of Urilyzer ® 500 Pro regarding remote requests ® and results between Urilyzer 500 Pro and information systems is base on the NCCLS LIS2A2 approved standard. It enables Urilyzer ® 500 Pro and any standard LIS system, to establish a logical link for communicating text to send results and requests in a standardized and interpretable form.
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Instrument Settings 11.4.3 Comma-separated value output Figure 42: CSV export options If this output protocol is selected, the system will transfer the analysis results as plain text with a .csv file extension. In the text file, each result record is separated by a line break and each field in a record is separated by a predefined separator character (Options: tabula- tor, semicolon, comma) The resulting file can be opened by a spreadsheet editor such as Microsoft Excel.
Instrument Settings ter’ (ETX) at the end of the transferred string, as well as a two-digit checksum so that the transferred data can be verified. 11.5 Measurement The detailed description of the Measurement screen can be found in 7.4.2 Custom- izing the analysis process 11.6 Strip options The strip options screen shows the available strip types and the various analyte pads on...
Instrument Settings lease it. To exclude a specific pad from the results view, move the pad below the —Invisible— line. The pads below this line will not be listed in the results. The system will only measure and store results for invisible analytes when they are restored above the ---Invisible--- line.
Instrument Settings 11.9 Power management Figure 46: The Power management menu On the Power Management screen the following options can be enabled and set: – LCD off time (starts screensaver) – Logout time (logs out the active user) – Power off time (switches off the analyzer) The analyzer will perform these activities if it has been inactive for the given time.
Instrument Settings Always export and send log files to service in case of unresolvable errors. 11.11 Editing the color and clarity list The Urilyzer ® 500 Pro units allow the possibility to customize the urine color and clarity list values according to standard lists determined by your facility’s policy. The color list can be edited at the Settings »...
Instrument Settings For automatic configuration select the Automatic (DHCP) checkbox. By using DHCP, TCP/IP configuration is done dynamically and automatically when the analyzer is started. Dynamic configuration requires a properly configured DHCP server on your network. For manual configuration uncheck the Automatic (DHCP) checkbox and manually as- sign –...
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Instrument Settings ton. A status text will be displayed below the name of the network. When the status tet reads COMPLETE, the analyzer is connected to the selected wireless network. For functional bidirectional data transfer, a receiving server is needed. 11.14.2 Add a new connection 1.
Instrument Settings 3. Tap the Delete or the Edit button (numbered 1 and 5, respectively, in Figure 48), as necessary. Follow the instructions and messages that are displayed. 11.15 Operators The Operators screen is used to manage the system security settings and to manage the active operators.
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Instrument Settings 11.15.1 Managing operator accounts Figure 49: The operator account management menu Adding operator accounts Only users with administrator- and supervisor-level operator accounts can add new operator accounts. 1. On the Operators menu, tap the Add new operator button. 2.
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Instrument Settings Customizing operator accounts Apart from the user rights associated with them, operator accounts can be further cus- tomized by users with administrator- and supervisor-level operator accounts on the Set- tings » Operators » Rights menu ( Figure 49). The following additional settings are available for each operator account: –...
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Instrument Settings – To download the list enter a USB flash drive into its socket at the back of the analyzer. Go to Settings » Operators » Data Exchange screen, and click on Save. The analyzer saves the operator list in a .txt format with details of the analyzer and the date. –...
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Instrument Settings 8. Print the current list of operators 9. Delete the selected operator account 10. Go to the Data Exchange menu 11. Go back to the Settings menu 11.15.2 Predefined operator accounts The user rights of the “autologin” and the “self add” operators can be modified only by users with a supervisor-level operator account.
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Instrument Settings Figure 52: The Self-add with password preset security level screen 1. Open system Automatic login without identification or password, free modification of settings. No se- curity applied: Anyone can perform tests and modify the settings using the ‘autologin’ operator.
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Instrument Settings Open system Anonymous Self-add Self-add with Secure usage password auto login auto login admin user rights self add self add user user user rights password not re- quired perform anyone anyone anyone anyone registered test users (anonymous) (anonymous) modify anyone admins...
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Instrument Settings does not already exist in the database). When this option is enabled, the account level can be set for all such self-added operator accounts, as well as customize them ( Custom- izing operator accounts). Password not required: If this option is enabled, users are not prompted to enter passwords when setting up new operator accounts.
Cleaning & Maintenance 12. Cleaning & Maintenance ® As a general preventive action, always keep the outside of the Urilyzer 500 Pro clean and free of dust. 12.1 Cleaning the analyzer When the analyzer is turned off, wipe the outside (including the display) with a damp (not wet) cloth and a mild detergent.
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Cleaning & Maintenance Figure 54: Rinsing the strip timer rake Figure 55: Rinsing the drip tray The parts of the analyzer that may come into contact with urine samples must be cleaned regularly. Always wear protective gloves when handling the test strip tray, the strip timer rake or the drop tray.
Troubleshooting 13. Troubleshooting ® The Urilyzer 500 Pro will operate properly if the directions for using and cleaning the instrument are followed. Advisory messages will be displayed when the user’s attention is required on any disorder or result of a performed action. The user interface messages can be categorized into the following groups: 1.
Troubleshooting 13.1 Troubleshooting chart In case of an error, try to solve it according to the below troubleshooting guide first. If the failure remains, please contact your service representative. The certified service personnel is allowed to perform further troubleshooting, repair serviceable parts and configure the system according to the service manual.
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Troubleshooting Problem Cause Corrective action more external con- connection with the con- nectors nector board. personnel. 6.2 The connector panel is defective The LED is blocked by dirt or dried urine build-up. is very faint Check the Autoprint function on 8.1 Autoprint is not en- the Main Menu»Settings»User abled.
file name or (re)insert only, and ensure that the USB USB pendrive. flash drive is connected prop- erly and recognized by the system. If required, re-initialize the USB port by tapping the Analyticon logo in the top right corner.
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USB flash drive is connected properly and recognized by the system. If required, re- initialize the USB port by tap- ping the Analyticon logo in the top right corner. Output link Output link lost. Please wait a The system continuously tries minute.
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Troubleshooting Mes- Status line Full text Recommended action sage text Door open Printer door is open. Please Check if the paper roll is cor- close it! rectly loaded in the printer bay and close the printer door. Paper out Paper out. Please replace the Open printer door and load a printer paper! fresh paper roll in the printer.
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Ensure the USB flash drive is connected properly and rec- ognized by the system. If re- quired, re-initialize the USB port by tapping the Analyticon logo on the top right corner. E170 E Sample ID already exists, Verify and repeat the input or please change it.
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Troubleshooting Mes- Status line Full text Recommended action sage text W140 W Due to changes lockout time Tap inside the message win- was decreased to %d day(s). dow to confirm the new QC (Touch to confirm.) lockout period. W139 W Previous “strip pads”...
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Troubleshooting Mes- Status line Full text Recommended action sage text W130 W DB is recreated. All previous All existing data was lost. If data is lost! problem occurs multiple times, contact your service representative. I117 Due to changes lockout time The active QC lockout time is was increased to %d day(s).
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Troubleshooting 13.2.1 Testing/Measurement Result Errors These error codes are stored together with the results in the database permanently and are also displayed after the testing procedure. Status line Full text Testing: Error Source & text Action E299 E Head HW Head HW error: some LEDs Head hardware error.
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Troubleshooting Status line Full text Testing: Error Source & text Action E267 E Mechanical Home position error. Strip Contact your service repre- error: home failure detected after mea- sentative. position error surement E266 E Measure- Strip type mismatch while Not the proper test strip type ment error: calculating the results of mea- was used.
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Troubleshooting 13.2.2 Software Update Errors Full text Corrective action date E596 E Update was failed. Check and verify the software update sources on the media. Restart update. E597 E Internal configuration failure! Restart update. (Please call Service) E572 E Failed install: …… Corrupted or missing files.
Appendices Appendices Appendix A: Results table The Urilyzer ® 500 Pro prints the results in the following gradation of concentration: Parameter Conventional Units SI Units (SI) Arbitrary Units (Conv.) (Arb.) (Bilirubin) 1 mg/dl 17 µmol/l 2 mg/dl 35 µmol/l 4 mg/dl 70 µmol/l norm norm...
(See “Appendix D.2 Disposal information”) D.1 Incident reporting Inform Analyticon Biotechnologies GmbH service representative and your local compe- tent authority about any serious incidents which may occur when using this product. D.2 Disposal information Do not dispose of an used Urilyzer ®...
°C (270 °F) or for 20 minutes at 121 °C (250 °F). Appendix E: Support & ordering E.1 Support Analyticon Biotechnologies GmbH offers full service support for its products. Feel free to contact our service staff by phone during office hours at the service hotline or at the support e-mail address...
Appendices Appendix F: Modification history Version Software Changes Version 1.0 (01.05.2017) 1.0.10 First release 1.1 (01.11.2017) 1.0.10 Implementation of CombiScreen 11SYS 1.2 (01.01.2018) 1.0.10 Implemenation of the Reference number on page 86 1.3 (01.08.2018) 1.0.10 Korrektur der Tabelle in Anhang A (Seite IU500_GB_26_001_01.04_20191205 1.0.10 Implementation of CombiScreen Dip...
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