Urilyzer 500 Pro User Manual May 2022

Analyticon Biotechnologies GmbH Am Muehlenberg 10 35104 Lichtenfels Germany [email protected] 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 maintenance 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. Analyticon may have patents or pending patent applications, trademarks, copyrights or other intellectual or industrial property rights covering this document or subject matter in this document. The furnishing of this document does not give a license to these property rights except as expressly provided in any written license agreement from Analyticon. If this instrument is used in a manner differently than specified in this manual, the protection provided by the equipment may be impaired.

UL0500Pro IU500_en_26_001_07.01_20220520

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Contents

Contents 1.

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

2.

Quickstart ... 6

3.

System description ... 8 3.1 Principle of operation ... 8 3.2 Components & Functions ... 9 3.3 Instrument and Labeling Symbols ... 10

4.

Unpacking & Setup ... 12 4.1 Unpacking ... 12 4.2 Setting up ... 13 4.3 Analyzer software updates ... 18

5.

Interacting with the analyzer ... 20 5.1 Screens... 20 5.2 Touchscreen operation ... 21

6.

Start-Up Wizard ... 25

7.

Analyzing samples ... 26 7.1 Quick analysis ... 26 7.2 Analyzing samples with user-entered sample IDs ... 29 7.3 Analyzing samples downloaded from a LIS ... 30 7.4 Customizing the analysis workflow ... 30 7.5 Worklist management ... 32

8.

Recalling results ... 35 8.1 Last result ... 35 8.2 List view... 36 8.3 Result view ... 38 8.4 Modifying the active selection of results ... 38 8.5 Further actions with selected items ... 39 8.6 Filtering: Finding specific results ... 40

9.

Quality Control Testing ... 42

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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 ... 50 11.2 Date, time ... 51 11.3 Printout ... 51 11.4 Output (Connectivity: Transfer/Export) ... 52 11.5 Measurement... 56 11.6 Strip options ... 56 11.7 Database management ... 57 11.8 QC Options... 57 11.9 Power management ... 58 11.10 Log export ... 58 11.11 Editing the color and clarity list ... 59 11.12 Ethernet interface configuration ... 59 11.13 Update ... 60 11.14 Wi-Fi settings... 60 11.15 Operators ... 62 12. Cleaning & Maintenance... 70 12.1 Cleaning the analyzer ... 70 12.2 Cleaning the internal elements ... 70 13. Troubleshooting ... 72 13.1 Troubleshooting chart ... 73 13.2 Error Messages ... 75 Appendices ... 84 Appendix A: Results table ... 84 Appendix B: Specifications ... 85 Appendix C: Analyzer Default settings ... 85 Appendix D: Safety information ... 87 Appendix E: Support & ordering ... 88 Appendix F: Modification history ... 89

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Introduction

1. Introduction 1.1 Intended Purpose The Urilyzer® 500 Pro is a semi-automatic urine test strip analyzer and provides semiquantitative parameter concentration values in human urine. The analyzer evaluates dedicated CombiScreen® system urine test strips for preliminary screening. The product is designed for professional use as an in vitro diagnostic medical device.

1.2 Indications for Use The Urilyzer® 500 Pro urine test strip analyzer is a bench top IVD designed to be used exclusively with 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), Protein (Pro), Blood (Bld / Ery), Nitrite (Nit), Leukocytes (Leu). The system provides a screening test for the early detection of the following conditions: UʈÛiÀÊ`ˆÃi>Ãi UÊ ˆˆ>ÀÞÊ>˜`Ê i«>̈VʜLÃÌÀÕV̈œ˜Ã UÊ >ÀLœ Þ`À>ÌiʓiÌ>LœˆÃ“Ê`ˆÃœÀ`iÀÃʈ˜VÕ`ˆ˜}Ê ˆ>LiÌiÃÊiˆÌÕà UÊ>i“œÞ̈VÊ`ˆÃi>Ãi UÊ1Àœœ}ˆV>Ê>˜`ʘi« Àœœ}ˆV>Ê`ˆÃi>ÃiÃÊ>ÃÜVˆ>Ìi`ÊÜˆÌ Ê >i“>ÌÕÀˆ>ʜÀÊ >i“œ}œLˆ˜ÕÀˆ> UÊ ˆÃi>ÃiÃʜvÊÌ iʎˆ`˜iÞÃÊ>˜`ÊÌ iÊÕÀˆ˜>ÀÞÊÌÀ>VÌ UÊ*>Ì œœ}ˆV>Êà ˆvÌÃʈ˜ÊÌ iÊ«ÊÛ>Õi°

For more detailed information about the urine test strips, please refer to the test strip’s instructions for use.

1.3 Limitation of use Do not use the semi-quantitative results, that the device provides to make diagnostic or therapeutic decisions without additional analysis. The device was developed and manufactured for human diagnostics use only (original function). The manufacturer excludes all liability arising from or in connection with any use of the device, that is different from its original function.

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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 other processes that can cause personal harm or equipment malfunction, equipment failure or damage to the equipment if the instructions are not followed carefully. This symbol is also used to highlight situations that can compromise results. Caution text appears in bold type. BIOHAZARD: This symbol indicates maintenance procedures, operations and other processes where hazardous biological agents are present. Instructions are to be followed carefully to avoid personal injury and/or adversed health effect. Warning text appears in bold type. NOTE: This symbol indicates important information or useful tips on servicing the device. Notes appear in italic type.

1.5 Safety precautions Before operating the Urilyzer® 500 Pro, it is essential that the operator reads and understands the warnings, cautions, and safety requirements contained in this manual. Detailed safety information can be found in )Appendix D: Safety information section. User qualification: Only appropriately trained operators are qualified to operate the analyzer. Correct use: Any disregard of the instructions in the User Manual may result in a safety risk. Use the Urilyzer® 500 Pro to analyze urine samples only. It is not intended for any other application. Environmental conditions: The Urilyzer® 500 Pro is approved for indoor use only. See ) 4. Unpacking & Setup and the labelling symbols on the exterior of the analyzer for further environmental limitations. Handle with care during shipping, the analyzer may be heavy. All components of the urine test strip analyzer may come into contact with human urine and are therefore possible sources of infection. Urine specimens should be handled at Biosafety Level 2. To prevent accidental contamination in a clinical laboratory, always wear disposable surgical gloves when handling reagents, fluids, or any part of the analyzer. Use universal precautions, and consult your facility’s infection control policy.

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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. Restriction of hazardous substances The Urilyzer® 500 Pro system meets the requirements laid down in: Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Compliance with the applicable regulation and directive(s) is provided by means of the Declaration of Conformity.

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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). After the first boot-up procedure and self-test the StartUp Wizard will appear (See ) 6. Start-Up Wizard). After all further powering on the Measurement screen will show up on the display.

Figure 1: The Measurement menu 3. Dip a CombiScreen® 11SYS Plus or CombiScreen® 11SYS test strip into the urine sample for approximately one second. Do not touch the test pads on the test strip. 4. Blot by touching the edge of the strip to a paper towel to remove excess urine. Place the strip on the Test Strip Tray in the strip entry area. The instrument automatically detects the placed strip, and the strip timer rake will drag it towards the photometer, starting the measurement cycle. 5. Repeat steps 3–4 with each of the urine samples. The real-time progress of each of the strips in the list is monitored on the left of the Measurement screen. 6. The last result can be checked by tapping the Last Result button or by accessing the Database screen.

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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 according to the current transfer settings

– Tap the Measure button to return to the Measure screen. Start further measurements at any time by placing a test strip dipped in a urine sample.

– Tap the Edit button to modify the details of the record

The Edit button is only active if the result has not yet been printed or transferred. – To access the last test result tap the Last Result button on the Measurement screen.

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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. The photometer unit contains four LEDs that emit light at discrete wavelengths. Figure 3 summarizes the electro-optical pad reading process.

Figure 3: Principle of measurement Each LED (1) emits light of a predefined wavelength onto the surface of the test pad (2) from directly above the test zone. The test zone is a 3 mm circle in the center of each pad where the reaction is optimal. The light from the LEDs is reflected back from the test zone with more or less intensity. The intensity of the light is directly related to the concentration of the particular analyte in the urine that the pad absorbed. Photodiode detectors (3) positioned at optimum angles pick up the reflected light. The analogue electrical signals from the detectors are first boosted by an amplifier (4) before they arrive at the microcontroller (5). Here the A/D converter in the microcontroller changes the analogue signal into digital values. The microcontroller converts the digital data into an absolute reflectance value by comparing it to a calibration standard. Finally, the system calculates an evaluation value from the reflectance values, compares it to the predefined range limits, and produces a semi-quantitative result (6). A lead (incubation) time of about 55-65 seconds between the test strips coming into contact with the urine and the start of the measurement produces the most accurate results. The movement pattern of the strip timer rake is calibrated to delay the transport of the strips, and thereby to automatically ensure an optimal lead time.

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System description

3.2 Components & Functions 1

2

3

5 4

Figure 4: Analyzer front

6

7

8

9

10

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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. Test strip tray

Keeps the test strips in position during incubation timing and photometry

5. On/Standby switch

Switches the unit on and off

6. Power socket

Allows connection to the AC adapter

7. Type B USB socket

Allows connection to various USB-B peripherals

8. Type A USB socket

Allows connection to various USB-A peripherals

9. Ethernet socket

Allows connection to an Ethernet network

10. PS/2

Allows connection to a keyboard or a barcode reader

11. Serial interface

Allows connection to a PC or a host computer

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System description

Always connect external devices to their designated connector only. If any external 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. Verify the proper connection.

3.3 Instrument and Labeling Symbols The following symbols appear on the device, its AC Adapter and its packaging:

*7%

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Double insulated product or transformer. May also identify class 2 equipment (power supply only)

Indoor use only

Catalogue number

The CE mark indicates that the product complies with the applicable directives of the European Union

Indicates that this product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, second edition, including Amendment 1, or a later version of the same standard includes the same level of testing requirements

Indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive. It must be recycled or disposed of in accordance with applicable local requirements

Indicates that the instrument is listed by Underwriters Laboratories as meeting U.S. and Canadian requirements for safety

Stack no more than four (4)

Unique Device Identifier

Humidity limitation

Protect from sunlight and heat

Keep away from rain

Ethernet port symbol

Caution, consult accompanying documents

In vitro diagnostic medical device

Consult instructions for use

Manufacturer

Serial number

Country of origin of the goods

Date of manufacture

Handle with care

USB port symbol

System description

Temperature limitation

DC Adaptor Polarity Centre Positive

Atmospheric pressure limitation

This way up

Direct current

Caution, consult accompanying documents

MAC address

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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; if seen, contact the carrier immediately. Carefully remove the contents of the shipping carton, remove each of the wrappings and check for the following items:

List of delivered parts: 1

3

7

2

5 6

4

Figure 6: Delivered parts – Urilyzer® 500 Pro (1) Urilyzer® 500 Pro is tamper-evident: There is a tamper-evident sticker on a screw on the bottom of the device. Operational elements of the device cannot be accessed without breaking the sticker. If the tamper-evident sticker is broken, the warranty your company provides for the device is cancelled. Follow your company’s guidelines. – Power supply (IN: 100V–240V AC, 50-60Hz, OUT: 12V DC; 5A) (2) – Power supply cord (3) If the power cord is not the style needed, contact your service representative – Quick Reference Guide – Drop tray (4) – Strip timer rake (5) – Test strip tray/waste bin (6) – Roll of printer paper (7) – Grey check strip Do not touch the test area of the check strip. Only touch it by its handle.

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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). – Do not expose the measuring head to intense light such as direct sunlight. – Do not set up and operate the analyzer in an environment with vibration sources. Make sure that the strips sit and travel smoothly and stay level on the test strip tray at all times. Make sure the instrument is allowed to acclimatize to room temperature prior to use. Make sure that there is enough room at the back of the analyzer for easy connection and disconnection of power supply and peripherals. Do not put anything on top of the analyzer while it is in operation. Objects placed on top of the analyzer may damage the touchscreen and block the printer cover.

4.2.1 Plugging in the analyzer

Figure 7: Plugging in the analyzer

Use only the AC adapter provided and always plug it into a grounded socket. 1. Plug the cable of the power supply into the power inlet socket located on the rear of the Urilyzer® 500 Pro. 2. Plug the appropriate end of the power cord into the power supply. 3. Plug the other end of the power cord into a readily accessible AC electrical wall outlet. The instrument is easy to connect and disconnect to the power supply because of the simple standard connectors of the power supply adapter.

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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.

Figure 8: Inserting the drop tray Always insert the drop tray first, before the strip timer rake and the test strip tray/waste bin.

4.2.3 Inserting the strip timer rake

Figure 9: Inserting the strip timer rake Touch the strip timer rake by the two fingerholes in the middle, and place it on the metal bracket inside the cavity to the left of the touch screen. Make sure that the tines of the comb are facing up and that the end with the pointed tines is facing towards the LCD touch screen. Position the comb so that it sits snugly on the metal bracket, held tight by the two rubber pins on the bracket. Always insert the strip timer rake before the test strip tray/ waste bin.

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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. Push the test strip tray inside the opening until its handle panel is flush with the analyzer casing panel. Make sure that the strip timer rake and its bracket is in a low enough position so that it does not prevent the insertion of the test strip tray. If necessary, push down on the bracket to make room for the test strip tray.

4.2.5 Loading the printer

Figure 11: Loading the printer paper Press the printer cover button to open the printer cover. Do not touch the printer head. It may be hot. Place a roll of thermal printer paper into the printer roll compartment. The roll should sit straight inside the depression in the bottom. Position the loose end of the roll so that it comes up towards the printer head, not towards the rear of the analyzer. This should en-

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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. The analyzer is set up to print the results automatically (to turn off the automatic print function see ) 7.4.2 Customizing the analysis process

4.2.6 Interfacing with a computer The instrument can send results to a computer via the serial port located on the back of the analyzer. This requires a D-sub 9-pin serial cable (male on instrument side, female on PC side). It is even possible to transmit data via an Ethernet cable which connector is located on the back of the analyzer.

Connections: ®

Urilyzer 500 Pro

Host (PC pinout 9-pin)

1 -------------------------------------------------------------------------1 2 ----------------------------------- TxD---------------------------------2 3 -----------------------------------RxD --------------------------------3 4 -------------------------------------------------------------------------4 5 ---------------------------------- GND --------------------------------5 6 -------------------------------------------------------------------------6 7 -------------------------------------------------------------------------7 8 -------------------------------------------------------------------------8 9 -------------------------------------------------------------------------9 Connected PC must satisfy the electrical safety requirements laid down in EN 60950.

4.2.7 Powering up

Figure 12: Powering up

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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. Before turning the analyzer off, always ensure that there is no strip on the test strip tray and that the tray is clean. The analyzer is switched off by tapping the button on the Main Menu , the Measurement or on the Login screen.

Figure 13: Powering down (1) We recommend to switch off the analyzer and unplug the mains adapter from the AC wall socket at the end of each day.

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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, adding new features and improving usability. From time to time the manufacturer will send a software update for the device. The following sections describe the software update procedure: The update process will not overwrite or delete the existing database or the active settings on the analyzer.

4.3.1 Preparation of the USB flash drive 1. Create an ’update’ directory in the root folder of the USB flash drive. 2. Unzip the software update package and copy it into the ’update’ directory. The device will not be able to access the update files unless they are located in the root folder of the USB flash drive in a folder named ‘update’. The file names will be similar to these: ur5_x.x.x.tar.gz, ur5_x.x.x.tar.gz.chk (x are replaced with numbers). The file types have to be like this after unpacking the zip-file: .tar. gz and .tar.gz.chk, otherwise the Urilyzer® 500 Pro device won’t be able to recognize the update files.

4.3.2 Procedure of the software updates 1. Switch on the Urilyzer® 500 Pro and wait until the system is ready. 2. Plug the USB flash drive with the software update into one of the USB A connectors at sof of the back of the analyzer. Wait for a (disk) icon to appear in the top right hand corner of the touchscreen. The yellow disk icon indicates that the system recognized the USB device.

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