Urilyzer 100 Pro User Manual V1.03 Nov 2012

V1.03 (GB) (2012-11)

Analyticon Biotechnologies AG 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 Biotechnologies AG 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.

Table of Content

Table of Contents 1.

Introduction 1.1 How to use this manual

5 5

2.

Quickstart

8

3.

System description 3.1 Measuring principle 3.2 Components and Functions 3.3 Instrument and Labeling Symbols

10 10 11 12

4.

Unpacking & Set Up 4.1 Unpacking 4.2 Setting up 4.3 Analyzer software updates

14 14 14 18

5.

Use of the instrument 5.1 Screens 5.2 Interacting with the touch screen 5.3 Data input: Barcode reader, keyboard 5.4 Flow-chart of the menu structure

20 20 20 23 25

6.

Start-Up Wizard

27

7.

Testing 7.1 Quick Test 7.2 Test features and customization 7.3 Full Test 7.4 Latest result 7.5 Worklist management

28 28 31 34 36 36

8.

Recall Results 8.1 List view 8.2 Result view 8.3 Filtering: How to find specific results 8.4 Modifying the active selection of results 8.5 Action with selected items

39 39 40 40 41 42

9.

Quality Control Testing 9.1 QC Options 9.2 QC Testing 9.3 Recall QC Results

43 44 46 47

3

Table of Content 10. Options menu 10.1 Strip LOT 10.2 View Settings 10.3 User Options

48 48 48 48

11. Instrument Settings 11.1 Language 11.2 Date, time 11.3 Printout 11.4 Output (Connectivity: Transfer/Export) 11.5 Measurement 11.6 Strip options 11.7 Database management 11.8 QC options (Pro only) 11.9 Power management 11.10 Log export 11.11 Editing color and clarity list (Pro only) 11.12 Ethernet interface configuration (Pro only) 11.13 Update 11.14 Operators (Pro only)

50 51 51 51 52 54 54 55 55 56 56 56 57 57 58

12. Cleaning & Maintenance 12.1 Cleaning the analyzer 12.2 Cleaning the test strip tray

64 64 64

13. Troubleshooting 13.1 List of Errors and Information Messages 13.2 Problem Checklist

66 67 78

14. Appendices 14.1 Appendix A: Results table 14.2 Appendix B: Specifications 14.3 Appendix C: Analyzer Default settings 14.4 Appendix D: Safety information 14.5 Urilyzer 100 Intended Use and Indications for Use

79 79 81 82 83 85

4

Introduction

1

Introduction

 Due to software changes, some screens on the instrument may appear slightly different from those in this manual. What does the analyzer do? The Urilyzer 100 analyzer is a lightweight instrument for reading CombiSceen Plus urinalysis strips (CombiScreen 11SYS Plus, CombiScreen 7SYS Plus and CombiScreen 5SYS Plus). It is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of the strip. It is designed for In Vitro Diagnostic (IVD) use by qualified physicians and laboratory staff; however no special training is required to operate the instrument. The analyzer can be set up to be as simple or sophisticated as you prefer. You may simply insert a dipped urinalysis strip into the analyzer and the result will be reported. By modifying the user options the measurements can be automatically started, printed and transferred. Alternatively, you have the option to enter the Sample ID, Patient ID, and color, clarity of the specimen manually. This added information will be reported along with the test results. The system also allows full customization to determine which fields appear on the printouts. You can also enable the user management features, thus the Operator ID is also recorded with the test results. The advanced security functions may also prevent unauthorized use through configurable settings. Remember, these features can be set independently. The touch screen displays instructions and prompts you through the operation of the analyzer. In addition, you enter information through the touch screen. The optional barcode reader and external keyboard are also available for accurate data entry to reduce transcription errors. Do I have to calibrate? You do not have to do anything to calibrate. The instrument performs a system test each time it is turned on. Then, each time a test is run, the instrument automatically checks and corrects its performance through the independent internal sensor.

1.1

How to use this manual

The Operator’s Manual contains the directions you need to unpack the analyzer, safely use it for your daily urinalysis and keep it in good working condition. Symbols Symbols are used to help quickly locate and interpret information in this manual. This section explains the formatting conventions used in this manual. The following symbols are used throughout this document:

5

Introduction Symbol/Sign

Explanation CAUTION: Indicates a potentially hazardous situation that if not avoided could result in personal injury or damage to the instrument. This symbol is also used to highlight situations that can compromise results. Cautions appear in bold type. BIOHAZARD: Indicates a potentially dangerous situation involving the presence of biohazardous material. All safety precautions must be taken to prevent personal injury or damage to the equipment.



NOTE: Contains important information or useful tips on using the analyzer. Notes appear in italicized type.

The  sign labels a cross-reference inline the text. In the manual, you will notice some text is in bold/italic or bold. The bold/italic text identifies screen names, while simple bold text identifies a button (touch sensitive area) on the screen. Safety precautions Before operating the Urilyzer 100 analyzer, it is essential that the warnings, cautions, and safety requirements contained in this manual are read and understood by the user. Detailed safety information can be found in  14.4 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 Operator’s Manual may result in a safety risk. Use the Urilyzer 100 analyzer to analyze urine samples only. It is not intended for any other application. Environmental conditions: The Urilyzer 100 analyzer is approved for indoor use only. Strip waste is potentially biologically hazardous. Always wear personal protective equipment when handling and disposing of samples of human origin. Use universal precautions. Consult your facility’s infection control policy. See  14.4.1 Protecting yourself from biohazards section for more information.

6

Introduction Abbreviations The following abbreviations are used: Abbreviation Definition AC arb ASTM conv csv DC EN ID LED neg norm pos

Alternating Current arbitrary American Society for Testing Material conventional comma separated values Direct Current European Standard Identification number Light Emitting Diode negative normal positive

SI

Standard International

7

Quickstart

2.

Quickstart

Unpack the instrument and place it on an even, hard surface (for detailed installation instructions see  4. Unpacking & Set Up). Load the strip tray and the printer paper. Connect the power supply and turn the reader on with the On/Off-switch (See  4.2.5: Powering up). After the boot-up procedure and self-test the Measurement screen will appear on the display. Strip waste is potentially biologically hazardous. Always wear personal protective equipment when handling and disposing of samples of human origin. Use universal precautions. Consult your facility’s infection control policy. See  14.4.1 Protecting yourself from biohazards section for more information.

Measurement

• Dip a test stick (CombiScreen 11SYS Plus) into the urine sample for approx. one second. • Blot by touching the edge of the strip to a paper towel to remove excess urine. • Place the strip on the strip holder • Slide or push the strip to the end of the channel. Do not touch the reagent pads on the test strip. The instrument will automatically detect an applied strip. The measurement cycle will be started. A progress bar on the display shows the remaining incubation time.  If „Autostart“ (see  7.2.1 Features: Autostart-, print-, transfer- and fast mode) is deactivated, the measurement must be started by pressing the Start button.

8

Quickstart After approx. 60 seconds the pad results will be displayed on the screen. If Autostart is ON: The result screen will be displayed until you remove the test strip from the tray. Once the strip is removed, the display automatically returns to the Measurement screen. If Autostart is OFF: The result screen will be displayed for approximately 5 seconds –while displaying a circle animation – then the display will return to the Measurement screen (if no error occurred during the readout). If you touch the display while the circle animation is running, the system will not automatically return back. Result (1) On the Result screen: • By pressing the

Delete button the result can be deleted

• By pressing the

Printer symbol the result can be printed

• By pressing the

Transfer button the result can be transferred

• By pressing the

Meas. button the system goes back to the measurement

arrow the additional fields • By pressing the right of the result are showed – Color, clarity, Patient ID, Strip LOT and comment – On the second result screen the result can Edit button (if it be edited by pressing the wasn’t printed or sent already)

Result (2)

At the Measurement screen another analysis may be started by applying the next test strip. Latest button on the The latest result can be reviewed by selecting the Measurement screen.

9

System description

3.

System description

3.1

Measuring principle

The test strip is moved below a fixed measurement unit on a slide called test strip tray with an embedded reference pad. The analyzer reads the reference pad, followed by each of the test pads on the strip. The optical unit contains four LEDs that emit light at various wavelengths. Reading is done electro-optically, as follows:

Principle of measurement

The LEDs (1) subsequently emit light of a defined wavelength onto the surface of the test pad (2) from directly above the test zone. The light hitting the test zone is reflected more or less intensely depending on the degree of color change of the test pad (directly related to the concentration of the particular constituent in the urine), and is picked up by the detectors, photodiodes (3) positioned at optimum angles. The phototransistors send analogue electrical signal to an A/D converter (4), which changes it to digital form. The microprocessor (5) then converts this digital reading to a relative reflectance value by referring it to a calibration standard. Finally, the system compares the reflectance value with the defined range limits (reflectance values that are programmed into the analyzer for each parameter) and outputs a semi-quantitative result (6). Each test pad is read photometrically after a lead (incubation) time of about 55– 65 seconds.

10

System description 3.2

Components and Functions

1 2 3

4 5 Front view

6

7

8

9 10

11

Rear view

Component Function 1. Printer cover Flips up for insertion of printer paper 2. Printer cover button Push to open the printer cover 3. Display LCD touch screen for interfacing with the user 4. Test strip tray Holds the strip 5. Power inlet socket Socket used to connect the analyzer to the mains adapter 6. PS2 socket For connecting a barcode reader or a keyboard 7. Serial interface For connecting a personal or host computer 8. USB B socket Socket used for serial-USB 9. Ethernet socket (Pro) Socket used to connect the analyzer to an Ethernet network 10. USB A sockets Multifunctional socket used to connect USB devices 11. On/Off switch Powers the unit on. May be used to power the unit off. The standard power off procedure should be started from the user interface. Only connect the intended devices to the corresponding interface. If you connect another device to the corresponding interface, the device or the analyzer may be damaged e. g. because of wrong voltage. Be sure to check all cables you are using to make sure they are operational. Verify the proper connection.

11

System description 3.3

Instrument and Labeling Symbols

This section describes the symbols that appear on the exterior of the Urilyzer 100 analyzer, the power supply provided with the instrument, the packaging in which the instrument was delivered and the supplies of reagent strips which you will use with the instrument. Double insulated product or transformer may also identify class 2 equipment (power supply only)

Indoor use only

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

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

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 incorporating the same level of testing requirements.

12

This system contains certain toxic or hazardous substances or elements. The environmental protection use period for this system is 10 years. The system can be used safely during its environmental protection use period. The system should be recycled immediately after its environmental protection use period has expired.

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.

In vitro diagnostic medical device

Caution, consult accompanying documents

Manufacturer

Catalog number

Consult instructions for use

Serial number

System description Indicates a power on/off button

USB port symbol

Ethernet port symbol

DC Adaptor Polarity Centre Positive

Do not use if package is damaged

Keep this way up

4

Handle with care

60°C Temperature limitation (140°F) -25°C (-13°F)

%

Stack no more than 4

85%Humidity limitation

10% 106Atmospheric kPa

���

pressure limi-

tation

70 kPa

Batch code

Use by date

The number of items that the contents of the pack is sufficient for

Do not reuse

Protect from sunlight and heat

Keep dry

13

Unpacking & Set Up

4.

Unpacking & Set Up

4.1

Unpacking

Read the Urilyzer 100 Operator’s Manual carefully before installation, so as 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: • Urilyzer 100 analyzer • Power supply (AC Adapter 100V–240V, 50/60 Hz) • Power supply cord  If the power cord is not the style you need, contact your service representative • Operator‘s Manual CD • Quick Reference Guide • Test strip tray (2 x)

Contents

Do not touch the reference pad • Roll of printer paper • Check strip (1 x) Do not touch the check area, hold it by the handle

4.2

Setting up

Place the instrument on a solid, level surface where the temperature and humidity are fairly constant.  Make sure the instrument is allowed to acclimatize to room temperature prior to use. Make sure that you • Do not place the instrument in close proximity to sources of strong electromagnetic radiation or vibration sources • Do not place the instrument near heater devices, ovens or air conditioners 14

Unpacking & Set Up • Do not expose the instrument to strong light sources (e.g. direct sunlight) 4.2.1

Plugging analyzer in

Only use the power supply adapter included with the unit. Connect the analyzer to grounded power outlets only. 1. Plug the cable of the power supply into the power inlet socket located on the rear of the Urilyzer 100 analyzer. 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. Analyzer plugged in

4.2.2

Inserting test strip tray

Do not touch the reference pad. Insert the test strip tray into the analyzer by holding it by the end with the opening (opposite the reference pad) and with the channel facing up. Push the test strip tray into the analyzer, pushing it in until the reference pad disappears into the housing.

Loading test strip tray

15

Unpacking & Set Up 4.2.3 Loading the paper roll Open the printer cover by pushing the printer cover button. The cover can then be lifted back. The printer head may be hot, do not touch it. Place the paper roll in the compartment and pull out the first few centimeters of paper just beyond the edge of the compartment. The thermosensitive side of the paper (the outer surface of the paper roll) should be facing downwards. Close the cover again by pressing until it locks audibly into position.

Opening the printer cover

Loading the printer paper

Analyzer loaded with paper

 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  7.2.1 Features: Autostart-, print-, transfer- and fast mode).

16

Unpacking & Set Up 4.2.4 Interfacing to 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). Connections: Urilyzer 100 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. 4.2.5 Powering up Press the On/Off button located at the rear of the instrument. The system starts with an audible beep.

Picture 9: Powering up

17

Unpacking & Set Up 4.2.6 Powering down Do not remove the power cable while the instrument is operating, 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.

Powering down

button on the Main or on the The analyzer is switched off by pressing the Login (Pro) screen. The test strip tray will retract into the analyzer. We recommend that the analyzer be switched off at the end of each working day and that the mains adapter be unplugged from the AC wall socket.  If necessary, the analyzer can also be switched off by holding down the On/Off button for at least 5 seconds. Please note that this feature should be used in case of system freeze or LCD failure. In this case the test strip tray will not be retracted.

4.3

Analyzer software updates

From time to time Analyticon will add new features and make improvements to the Urilyzer 100 analyzer software. Updating the software is a simple procedure, but for the upgrade to work properly, it is important to follow the instructions below precisely. A previously prepared USB flash drive is required for the upgrade.  Either you will receive an already prepared USB flash drive from your local distributor or you will have to upload the update files manually to a USB flash drive if you received the software update in electronically distributed package. Instructions for preparation of the USB flash drive can be found in the next chapter.  Power on the instrument and wait until the system is ready to use.

18

Unpacking & Set Up  Plug the USB flash drive into one of the USB A connectors on the back of the disk icon appears in the status line. The icon shows that device. Wait until the the USB flash drive was recognized by the system.  Go to Settings (2)»Update screen. The analyzer recognizes that a software update package is available and verifies the integrity of the package. If the package is verified, the Update button will be available.  If no update source was found by the system, the button name is changed to Refresh. Push the Refresh button to force the system to check again all update peripherals.  To start the process, press the Update button. The update will be performed automatically.  After the update is finished successfully, press the Restart button and remove the USB flash drive.  Please note that the update process will not overwrite or delete the existing database or your settings. 4.3.1 Preparation of the USB flash drive If you received the software update in electronically distributed format, please follow these instructions for preparation of the USB flash drive.  To copy the update package on the USB drive you will need a PC and some basic knowledge of the operating system. 1) Create an ’update’ directory in the root of the USB drive. 2) Unzip and copy the content of the whole package into the ’update’ directory.  The file names will be similar to these: udr2base_x.x.x.tar.gz, udr2base_x.x.x.tar. gz.chk, iUD2vX, iUD2vX.chk (x, X are replaced with numbers). In case of Urilyzer 100 Pro ‚base‘ is replaced with ‚pro‘. 4.3.2 Available sources for software updates The software update is possible from various sources: • USB flash drive, • microSD card, • code chip. If you receive an updated description with the software update, please follow those instructions. The sockets for external microSD card and code chip are located under the printer cover and are on the right-hand side of the printer when you face the front of the instrument. The code chip socket is above the microSD card socket.  Special instructions for updating the software on your instrument from microSD card or code chip will be supplied with them.

19

Use of the intrument

5.

Use of the instrument

All inputs are done via the touch screen (if no external keyboard or barcode reader is attached).

5.1

Screens

The touch screen guides you through the operation of the Urilyzer 100 analyzer. The screen displays messages, instructions and options to which you respond by touching the appropriate area on the screen. The screen layout can be divided into three main areas: (1) Header: Displays important system information, like date&time, user ID (Pro), queue and status line messages.  The color background of the status bar changes with the state of the system. Yellow means warning, red means error.  The active errors and warnings can be listed by pressing the status bar area. (2) Content navigation: Indicates the main and subsections in which you are working. It gives you a way to keep track of your location within the program. The sign serves as hierarchy separator. Layout (3) Content area: Main operation area The first main screen you see is the Measure screen. In the work area you can facilitate a measurement, review the last result, handle the worklist, cycle through the worklist items and go to the QC, Main and Data screens. In some cases, the screen will also display instructions, messages or error messages.

»

5.2

Interacting with the touch screen

How to touch the display The screen needs to be touched gently, but firmly in the touch-sensitive area to activate a response. The touch-screen can be operated while wearing gloves. Never use a hard or sharp object to operate the touch screen as they can damage the screen.  A separate foil layer is attached to screen in order to prevent liquid leakage into the system.  By default the sound is switched on. A successful touch event is also confirmed with a short beep signal. 20