Mindray UA-66 Operator's Manual

i Copyright © 2005-2010 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2010-05. Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. , , , , BeneView, WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners. Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: � all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; � the electrical installation of the relevant room complies with the applicable national and local requirements; and � the product is used in accordance with the instructions for use.

ii WARNING: It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury. NOTE: This equipment must be operated by skilled/trained clinical professionals. Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: � Malfunction or damage caused by improper use or man-made failure. � Malfunction or damage caused by unstable or out-of-range power input. � Malfunction or damage caused by force majeure such as fire and earthquake. � Malfunction or damage caused by improper operation or repair by unqualified or � unauthorized service people. � Malfunction of the instrument or part whose serial number is not legible enough. � Others not caused by instrument or part itself. Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. E-mail Address: [email protected] Tel: +86 755 26582479 26582888 Fax: +86 755 26582934 26582500 EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, Hamburg 20537, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726

iii Labels Labels are used to indicate potential hazards in operating the system. The following table explains the labels used on the system. Serial number. Risk of electric shock Biohazard Warning: Risk of potentially biohazardous infection Date of manufacture. Manufacturer. In vitro diagnostic equipment. Storage temperature. Atmospheric pressure for storage. Relative humidity for storage.

- I - Contents 1 Introduction........................................................................................................... 1 1.1 Specifications ......................................................................................................................1 1.2 Displayed/Printed Results...................................................................................................2 2 Installation ............................................................................................................ 5 2.1 General................................................................................................................................5 2.2 Environment Factors ...........................................................................................................5 2.3 Unpacking............................................................................................................................5 2.4 Outline of the Instrument.....................................................................................................6 2.5 Connect to a Computer.......................................................................................................7 2.6 Power On.............................................................................................................................7 2.7 Install Paper Roll .................................................................................................................7 2.8 Adjust the Display................................................................................................................8 2.9 Introduction of Software ......................................................................................................8 2.10 Turn the Instrument Off ...................................................................................................10 3 Setup.................................................................................................................. 12 3.1 Reagent Strip.....................................................................................................................12 3.2 Critical Value......................................................................................................................12 3.3 Grade.................................................................................................................................13 3.4 Realtime Clock ..................................................................................................................13 3.5 Printer................................................................................................................................14 3.6 RS-232C............................................................................................................................15 3.7 Serial No............................................................................................................................16 4 Testing................................................................................................................ 18 4.1 Decide Testing Mode.........................................................................................................18 4.2 Decide Sample No. ...........................................................................................................18 4.3 The Single Mode ...............................................................................................................19 4.4 The Batch Modes ..............................................................................................................20 4.5 Stop Testing.......................................................................................................................20 5 Reports............................................................................................................... 22 5.1 Date List ............................................................................................................................22 5.2 Report................................................................................................................................24 6 Troubleshooting.................................................................................................. 26 7 Maintenance....................................................................................................... 28 7.1 General Cleaning ..............................................................................................................28 7.2 Daily Cleaning ...................................................................................................................28 7.3 Disinfection........................................................................................................................29 7.4 Periodic Cleaning ..............................................................................................................30

-1- 1 Introduction 1.1 Specifications Power Required AC 220V 50/60Hz (AC 110V 50/60Hz) Line Leakage Current ≤ 0.5 mA Dimensions Width: 360 mm (14.2 in.) Depth: 300 mm (11.8 in.) Height: 100 mm (3.94 in.) Weight 3.8 Kg Ambient Operating Temperature range 10 ℃ to 30 ℃ Ambient Operating Humidity range ≤80% Atmospheric pressure 76kPa-106kPa Transport and storage conditions Temperature: 0℃-40℃ Relative humidity: ≤80% Testing Type Reflectance Photometer Light Source LED Wavelength R (red), G (green), B (blue) Work Flow 60 seconds( single step mode ) 60 seconds( slow batch mode ) 30 seconds( fast batch mode ) Printer External printer 、micro thermo printer, width 57 mm, diameter<50mm. Display Liquid Crystal Display with back light, 240*128 dots Interface RS-232C, DB9 female Testing items Leukocytes, Urobilinogen, Bilirubin, Nitrite, pH, Specific Gravity, Blood, Glucose, Protein, Ketone, Ascorbic Acid Usable Strip U-10 Para. & 11 Para Table 1.1

- 2 - 1.2 Displayed/Printed Results Arbitrary Conversional SI LEU - ± 1+ 2+ 3+ neg. 15 Leu/µL 70 Leu /µL 125 Leu /µL 500 Leu /µL NIT Neg. + URO norm. 1 mg/dL 2 mg/dL 4 mg/dL 8 mg/dL Norm. 17 µmol/L 35 µmol/L 70 µmol/L 140 µmol/L PRO - ± 1+ 2+ 3+ 4+ Neg. 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL 2000 mg/dL PH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 BLD - ± 1+ 2+ 3+ Neg. 5-10 Ery 25 Ery 80 Ery 200 Ery SG 1.000 1.005 1.010 1.015 1.020 1.025 1.030 KET Neg. 5 mg/dL 15 mg/dL 40 mg/dL 80 mg/dL 160 mg/dL Neg. 0.5 mmol/L 1.5 mmol/L 4.0 mmol/L 8.0 mmol/L 16 mmol/L BIL Neg. 1+ 2+ 3+ Neg. 1 mg/dL 2 mg/dL 4 mg/dL Neg. 17 µmol/L 35 µmol/L 70 µmol/L

-3- Arbitrary Conversional SI GLU Neg. 100 mg/dL 250 mg/dL 500 mg/dL 1000 mg/dL 2000 mg/dL Neg. 5 mmol/L 15 mmol/L 30 mmol/L 60 mmol/L 110 mmol/L VC 0 mmol/L 0.6 mmol/L 1.4 mmol/L 2.8 mmol/L 5.6 mmol/L Table 1.2

-5- 2 Installation 2.1 General This chapter provides detailed installation instructions for the UA-66 Urine Analyzer. The installation steps must be followed correctly to ensure proper installation, operation and service. Read this section carefully before attempting to operate the instrument. The UA-66 is a precision instrument and must be handled accordingly. Rough handling or dropping of the instrument will disturb internal calibrated optics and cause other damage. Always handle the instrument with care. 2.2 Environment Factors As with all sensitive electronics instruments, prolonged exposure to excessive humidity and temperature should be avoided. Temperature should be held relatively constant to obtain the highest degree of operating stability. The ambient temperature range for instrument operation is 10 ℃ to 30 ℃; The maximum ambient humidity is 80% relative humidity. Before operating, allow the instrument to equilibrate to the environment conditions. Make sure that the instrument is placed stably on a level platform. If the 4 feet of the instrument cannot contact the platform properly, adjust the feet. Turn the feet counterclockwise to raise them, or turn the feet clockwise to lower them. Place the instrument where it will not be subjected to extreme temperature variations. Avoid proximity to open windows, ovens, hot plates, open burners, radiators, dry ice baths, and in particular, to direct sunlight. The UA-66 should not be used in an explosive atmosphere. 2.3 Unpacking Carefully remove the instrument and accessory package from the shipping carton. Inspect the carton and instrument for visible signs of damage. If damage to the instrument exists, immediately file a complaint with the carrier. The following parts and accessories should be included with the instrument: ♦ Operating Manual ( 1 ) ♦ Paper Roll ( 1 ) ♦ Line Cord ( 1 ) ♦ Replacement Fuses( 2 ) ♦ RS-232C Communication Cable ( 1 ) Make sure all these items have been included with your instrument, and keep them for future use. After the instrument has been unpacked, place it on a firm work surface in the designated work area. Make sure there is nothing in front of the instrument that will obstruct the reagent strip feed table when it moves out to the load position.

- 6 - NOTE: Retain the UA-66 shipping carton for future use. If the instrument ever needs to be shipped, the shipping carton will afford the best protection. 2.4 Outline of the Instrument Feed Table Insert Printer Cover Display Keyboard Feed Table Figure 2.1 Figure 2.1 shows the top view of the instrument. Pay attention to the feed table and the feed table insert components. The reagent strip is held and moved in and out by these two components while being tested. The feed table is mounted on the instrument and cannot be removed from the instrument. The feed table insert is mounted on the feed table and can be removed from the feed table when need to be cleaned or disinfected (see 7. Maintenance). ` Serial port Parallel port Power jack Fuse Power switch Figure 2.2

-7- Figure 2.2 shows the rear view of the instrument. White Plastic Calibration Chip Reagent Strip Holding Channel Figure 2.3 The reagent strip holding channel is used to hold the strip while being tested. The white plastic calibration chip is used to afford a calibration standard for photo metering. It must be treated carefully during the whole life of the instrument (see 7. Maintenance). 2.5 Connect to a Computer The UA-66 can also be connected to a host computer via the RS-232C serial port. Plug one end of the RS-232C communication cable into the RS-232C port on the rear panel of the instrument; plug the other end into the appreciate port on the host computer. 2.6 Power On The UA-66 is designed as an instrument can be used at either 110VAC or 220VAC. NOTE: Incorrect input of voltage will cause damage. Plug the instrument line cord into the instrument and into a appropriate grounded AC electrical outlet, then turn the instrument power on by placing the power switch to the “|” position. After the power is on, the instrument shows the logo immediately on the displayer and begins to perform a self diagnosis and calibration process. If any error occurred during the progress, refer to 5 Troubleshooting. Once the self diagnosis and calibration process completed, the instrument will show the system main menu including the logo, the software version, operating items, date and time. 2.7 Install Paper Roll There is no paper roll in the printer when being shipped. Install a paper roll before using the

- 8 - instrument. 1. Be sure that the instrument is in idle state, press ESC until the display return to the main menu. 2. Lift the printer cover on the top of the instrument. 3. Remove the used paper roll core. 4. Place a new roll of paper into the printer, with the paper unrolling from the beneath. 5. Feed the paper under the roller, and to advance the paper through the printer press ►. If the paper does not catch immediately, gently feed the paper into the roller while continuing to press ►. To make insertion easier, be sure the leading edge is a clean, straight cut; trimming the paper to a point may also assist in easier insertion. 6. Allow 4-5 cm of paper to advance through the roller, the feed the paper through the opening on the printer cover. Place the lip of the cover under the ledge on the instrument opening and close the cover. Press down firmly on the back of the cover until it snaps into place. 2.8 Adjust the Display 1. Open the printer cover on the top of the instrument. 2. Adjust the potentiometer (see Figure 2.6 ) using a suitable driver, scroll to find a position where the contrast of the screen is the most suitable. Potentiometer Figure 2.4 3. Replace the printer cover. 2.9 Introduction of Software Figure 2.5 shows the main menu of the instrument. The main menu is the entry of a multi-level menu system, from which all the user-selectable functions can be accessed. The main menu displays the date, time and the software version. The main menu lists 3 menu items, “Test”, “Reports” and “Options”. The item surrounded by a shadowed box is the item being selected.

-9- The content of the menu is the following: Single Mode Slow Batch Mode Test Fast Batch Mode Reports Strip Critical Value Grade Displayer Date Realtime Clock Time Option Shade Printer Diagnosis 9600 19200 38400 Serial Port 57600 Options Serial No Table 2.1 The operator executes the designated functions using the keyboard. The Keyboard consists of 3 arrow keys and 3 function keys. Key Function FUN Used to show or close a pop-up menu or mark a specimen during testing. ▲ Used to select the previous menu or option, or increase the selected digit while a number is being edited. ▼ Used to select the next menu or option, or decrease the selected digit while a number is being edited. ► Used to select the next digit while editing an integer, to feed paper at the main menu or to select the menu in the next column while multi column being displayed. ESC Used to stop current operation; Used to exit from current menu to upper menu level. START Used to begin a reagent test or to make new settings accepted; Table 2.2 When any menu under the main menu being displayed, the menu title is shown at the top of the

- 10 - displayer to indicator the location of the current menu, for example: Options>Realtime Clock>Date 2002.06.03 2002.06.03 Figure 2.5 Sometimes pop-up menu is used to accept instructions from the operator. Press FUN to show a pop-up menu, for example: Move Out Move In Figure 2.6 The highlighted item is the item being selected. Press START to execute the corresponding function, ESC or FUN to close the pop-up menu. When a parameter need is to be input, the software will show an input box, for example: Select Date 2002-05-23 Figure 2.7 If the parameter being edited has several segments, use ► to change the select fields and press ▲ / ▲ to modify. Press START to validate the input. When an error occurs, the software will show a notice box with a short and a long buzz, for example: E21 Printer Paper Empty! Figure 2.8 When a long process being done, the software will show a notice box to indicate the status, for example: Printing… Figure 2.9 2.10 Turn the Instrument Off 1. Be sure that the instrument is in idle state, press ESC until the display return to the main menu. 2. Press FUN to show a pop-up menu:

-11- Move Out Move In Figure 2.10 3. Select “Move In” by ▲ and ▼, and press START, the feed table begins to move in until the storage position. 4. Place the power switch to the “0” position. NOTE: It is strongly recommended that the feed table should be moved to the “storage” position before turning the instrument off.

- 12 - 3 Setup At the main menu( See Figure 2.5 ), use ▲ and ▼ as necessary to select “Options” , and press START to enter “Options” menu: Options Strip Printer Critical Value Serial Port Grade Serial No. Realtime Clock Figure 3.1 Using this menu, the operator can: ♦ Correct the system clock; ♦ Set the options for printer and serial port; ♦ Select the reagent strip , testing results output unit and critical values; ♦ Show serial No. of the instrument. 3.1 Reagent Strip NOTE: The name of the reagent strip being used must be the same as the reagent strip selected by the “Options>Strip” menu. Use of any other strip will cause erroneous results. At the “Options” menu( See Figure 3.1 ), use ▲ and ▼ to select “Strip”, press START to enter the “Options>Strip” menu: Options>Strip 10 Para. 11 Para. Figure 3.2 Use ▲ and ▼ as necessary to select the designated reagent strip, press START to validate the new selection. 3.2 Critical Value Critical values are a set of values to be compared with the testing results. If the result of a certain parameter is the same as or higher than the corresponding critical value, a “*” will be inserted in front of the corresponding row while the report being displayed and printed. At the “Options” menu, use ▲ and ▼ to select “Critical Value”, press START to enter the

-13- “Options>Critical Value” menu: Options>Critical Value LEU neg. NIT neg. URO norm. PRO + PH 7.0 BLD 3+ SG 1.015 KET neg. BIL neg. GLU 10 Figure 3.3 Use ▲ and ▼ to select a parameter to be modified, press START to show a pop-up window: LEU 75 /uL Figure 3.4 Use ▲ and ▼ to change the value, press START to validate the modification or press ESC to abandon. 3.3 Grade The “Options>Grade” menu is used to select the grade unit system in which the results being displayed and printed. The selectable unit systems are Arbitrary, Conversional and SI. For detail, refer to Table1.1. At the “Options” menu( See Figure 3.1 ), use ▲ and ▼ to select “Grade”, press START to enter “Options>Grade” menu: Options>Grade Arbitrary Conversional SI Figure 3.5 Use ▲ and ▼ as necessary to select the designated unit system, press START to validate the new selection. 3.4 Realtime Clock The instrument equipped a realtime clock chip to afford date/time information while a report is generated. After the instrument was unpacked, the realtime clock should be corrected according to the local time immediately. At the “Options” menu( See Figure 3.1 ), use ▲ and ▼ to select “Realtime Clock”, press START to enter the “Options>Realtime Clock” menu:

- 14 - Options>Realtime Clock 2002-06-03 12:03:45 Figure 3.6 Use ▲ and ▼ to select the date, press START to modify the date: Options>Realtime Clock 2002-06-03 2002-06-03 Figure 3.7 Press ► to move highlighted block among the year, month and day fields. Press ▲ and ▼ to modify the value of the current field. Press START to validate the new date, and press ESC to return to the “Options>Realtime Clock” menu. At the “Options>Realtime Clock” menu( See Figure 3.2 ), use ▲ and ▼ to select the date, press START to modify the date: Options>Realtime Clock>Time 13:45:28 13:44:03 Figure 3.8 Press ► to move highlighted block among the hour, minute and second fields. Press ▲ and ▼ to modify the value of the current field. Press START to validate the new time, and press ESC to return to the “Options>Realtime Clock” menu. NOTE: The testing reports stored in the Flash ROM of the instrument are organized by date, time and sample No. Incorrect modification to the realtime clock will cause confusions. 3.5 Printer The “Options>Printer” menu used to set auto print option and print shade or perform a test print. At the “Options” menu( See Figure 3.1 ), use ▲ and ▼ to select “Printer”, press START to enter

-15- “Options>Printer” menu: Options>Printer Option Shade Diagnosis Figure 3.9 Use ▲ and ▼ to select “Auto Print”, press START to modify the auto print option: Options>Printer>Option Not Print Print Figure 3.10 Press ▲ and ▼ to select “Yes” or “No”, press START to validate the new option. If “Yes” is selected, the instrument will print a report after a urine sample was tested. At the “Option>Printer” menu( see Figure 3.3 ), use ▲ and ▼ to select “Shade”, press START to modify the print shade: Options>Printer>Shade Figure 3.11 A bar shows the relative value of the print shade. Press ▲ to increase the shade and ▼ to decrease the shade. Press START to validate the new value. The print shade varies in different seasons. In cold seasons, the print shade should be set to higher values. In warm seasons, the print shade should be set to lower values. 3.6 RS-232C The instrument equipped a RS-232C serial port for communication with a host computer. The “Options>Serial Port” menu is used to set the baud rate of the serial port. At the “Options” menu( See Figure 3.1 ), use ▲ and ▼ to select “Serial Port”, press START to select the baud rate:

- 16 - Options>Serial Port 9600 19200 38400 57600 Figure 3.12 Press ▲ and ▼ to select the designated baud rate, press START to validate the new value. 3.7 Serial No. At the “Options” menu( See Figure 3.1 ), use ▲ and ▼ to select “Serial Port”, press START to view the serial No. of the instrument: Options>Serial No. 01234 Figure 3.13

- 18 - 4 Testing The instrument supports 3 testing modes: single mode, slow batch mode and fast batch mode. Under the single mode, the operator is required to press START every time to start a test and can do 60 tests per hour. Under the slow or fast batch modes, once the operator presses START, the instrument will start to test strips continuously unless the operator presses ESC to terminate the procedure. The instrument can test 60 tests per hour under the slow batch mode and 120 tests under the fast batch mode. The software of the instrument manages the testing reports by the sample No. and the date. The sample No. is a 3 digits number from 000 to 999 used to identify a particular sample. That is to say, the instrument can do up to 1000 tests and save all the 1000 reports in its Flash ROM. At the main menu( See Figure 2.5 ), use ▲ and ▼ to select “Test”, and press START to enter “Testing” menu. The instrument will then prompt the operator to decide the testing mode and the sample No. 4.1 Decide Testing Mode Test>Test Mode Single Mode Slow Batch Mode Fast Batch Mode Figure 4.1 3 testing modes are listed on the displayer and the mode used recently is automatically selected. Using ▲ and ▼ to select the desired mode, then press START , the display goes to the next step to decide the sample No. If the mode selected by the operator differs from the recently used mode, the software will save this new setting to the Flash ROM. 4.2 Decide Sample No. Test>Sample No. 010 --:--:-- 011 --:--:-- 012 --:--:-- 013 --:--:-- 014 --:--:-- 015 --:--:-- 016 --:--:-- 017 --:--:-- 018 --:--:-- 019 --:--:-- Figure 4.2

-19- 5 samples are listed on the displayer and the sample No. next to the latest sample is automatically selected. Sample No. and the time when being tested are used to identify a sample. A prefixed “*” indicates that the sample has at least a result higher than the corresponding critical value, and a prefixed “ ” indicates a sample marked by the operator during the testing. “--:--:--” indicates no testing was done under this No. Press ▲ and ▼ to change the selection. The list will scroll when operator try to select the sample previous to the sample listed on the top or next to the sample listed on the bottom. The operator can also enter the desired sample No. directly by pressing FUN to pop up an input box: Sample No. 013 Figure 4.3 Press ► to change the select digit and press ▲ / ▲ to modify. Press START to validate the input. When the sample No. selection is done, press START to start testing under the mode selected before. 4.3 The Single Mode 012 013 LEU ------------------- NIT ------------------- URO ------------------- PRO ------------------- PH ------------------- BLD ------------------- SG ------------------- KET ------------------- BIL ------------------- GLU ------------------- Press ’START’ Figure 4.4 Figure 4.1 shows the display of single mode testing. The display area is divided into 4 blocks. The top-left is the sample number area, the bottom-left is the report area, the top-right is the progress area, and the bottom-right is the user prompt area. Press START to start testing. The internal timer of the instrument begins to count down and a progress bar is shown under the sample number at the progress area. With 3 short noises from the buzzer, and the message “Dip 012” shown at the prompt area, the operator is prompted with immerse all reagent areas of the reagent strip in the urine; following the long noise from the buzzer and a “Place 012” prompt, place the reagent strip on the feed table. Then the feed table will move to the inside of the instrument. The instrument will test the stripe block by block when the feed table moving outside. When the feed table return to the original position the entire test cycle is over, and the result of the test is displayed at the report area, and output via the thermo printer. Press START to start a new test cycle.

- 20 - 4.4 The Batch Modes If “Slow Batch Mode” was selected, the instrument will prompt operator to dip the reagent strip 60 seconds after the first strip test started. If “Fast Batch Mode” was selected, the instrument will prompt operator to dip the reagent strip 30 seconds after the first strip test started. 012 09:12:36 013 █████ 014 ██ LEU - NIT - URO normal PRO +- PH 7.0 BLD 1+ SG 1.010 KET 8.0 mmol/L BIL 3+ GLU 3+ Press ’START’ Figure 4.5 At any moment during the test cycle, operator can browse the reports generated recently using ▲ and ▼. Operator can mark a report by press FUN. The mark can be seen later in the report menu. 4.5 Stop Testing At any moment during the test cycle, operator can stop the testing process by pressing ESC, the display will return to the main menu ( see Figure 2.5. ).

- 22 - 5 Reports The instrument can store up to 1000 reports in its Flash ROM. A report is saved to the Flash ROM immediately after a test is done. When the storage overflows, the oldest 333 reports will be dropped. All the reports can be recalled via the “Reports” menu. 5.1 Date List At the main menu( see Figure 2.5 ), use ▲ and ▼ to select “Reports” and press START, the instrument begins to search through the report storage, then lists all the date in ascending order. The most recent date is listed at the bottom of the display. Reports 2002-05-18 2002-05-19 2002-05-21 2002-05-22 2002-05-23 2002-05-24 2002-05-25 2002-05-26 2002-05-28 2002-05-30 Figure 5.1 Use ▲ to select the previous date and ▼ to select the next date. At this moment, the operator can ♦ Change the selected date by input a date directly. ♦ Delete the reports generated between two specified dates; ♦ Transmit reports of the selected date; ♦ Print reports of the selected date; Press FUN to show a pop-up menu. Select Date Delete Transmit Print Figure 5.2 Use ▲ and ▼ to select “Select Date” and press START, the instrument prompts the operator to input a new date: Select Date 2002-05-23 Figure 5.3 Use ► to move the high lightened block among the year, month and day fields, use ▲ and ▼ to modify the highlighted field and press START when done. The date list in Figure 5.1 will scroll to the specified date. If the specified date does not exist in the list, The date list will scroll to the

-23- nearest date. Select “Delete” item of the pop-up menu (See Figure 5.2) and press START to delete reports generated between 2 specified dates. First the instrument asks the operator to enter the start date. From 2002-05-23 Figure 5.4 Use ► to move the high lightened block among the year, month and day fields, use ▲ and ▼ to modify the highlighted field and press START when done. Then the instrument asks the operator to enter the end date. To 2002-05-23 Figure 5.5 Use ► to move the high lightened block among the year, month and day fields, use ▲ and ▼ to modify the highlighted field and press START when done. At last the instrument prompts the operator to confirm. Delete the reports from 2002-05-19 to 2002-05-23 ? Yes No Figure 5.6 Select “Yes” and press START to delete the reports. Select “No” and press START to abandon. Select “Transmit” item of the popup menu (See Figure 5.2) and press START to transmit reports of the selected date. First the instrument asks the operator to enter the start sample No. Start No. 000 Figure 5.7 Modify the start sample No. using ▲, ▼ and ►, and then press START when done. The instrument asks the operator to enter the end sample No. End No. 999 Figure 5.8 Modify the end sample No. using ▲, ▼ and ►, and then press START when done. The instrument begins to transmit the reports between the start No. and the end No. to the host computer via RS-232C serial port. A message box will be shown during the transmission.

- 24 - Transmitting… Figure 5.9 Press ESC to stop the transmission. Select “Print” item of the pop-up menu (see Figure 5.2 ) and press START to print reports of the selected date. Just as the transmitting process described above, the instrument will ask the operator to enter the start No. and the end No. Press START to print the reports between the start No. and the end No. when the end number was entered. A message box will be shown during the printing process. Printing… Figure 5.10 Press ESC to stop the printing process. 5.2 Report On the date list (See Figure 5.1), press START to browse the reports of the specified date. Reports>2002-05-23 *052 08:12:40 LEU neg. NIT neg. URO norm. *PRO + PH 7.0 *BLD +++ SG 1.015 KET neg. BIL neg. *GLU 10 Figure 5.11 If the date is today, the report of the most recently testing will be first displayed, otherwise the report with the smallest sample No. will be first displayed. Press ▲ to view the previous report and ▼ to view the next report. Press FUN to show a pop-up menu. Mark Select No. Transmit Print Figure 5.12 Note that the “Mark” item will be shown only if the report of today is shown. Use ▲ and ▼ to select the designed item, press START to perform the corresponding function. Select “Print” and press START to print the report. Select “Transmit” and press START to print to the host computer via the RS-232C serial port. Select “Mark” and press START to mark the report. The mark can be seen at the

-25- “Testing>Sample No” menu. If the report being currently displayed has already been marked, “Remove Mark” will be shown instead of “Mark”. Select “Select No.”, the instrument prompt the operator to enter a new sample No.. Sample No. 012 Figure 5.13 Modify the end sample No. using ▲, ▼ and ►, and then press START when done. The report with the specified sample No. will be shown if exists, otherwise the report with the nearest sample No. will be shown.

- 26 - 6 Troubleshooting If the instrument is in an abnormal condition, or being operated incorrectly, an error will occur. Table 6.1 lists all the errors and corresponding solutions. Error ID Message Solution E01 System Memory failure The system memory failed and the instrument can’t work. Please contact the customer service. E02 System Data Failure The calibration data lost and the instrument can’t work. Please contact the customer service. E03 Feed Table Failure The instrument can’t find the mechanical origin of the feed table. Please turn off the power off and retry for few more times. If not succeeded, please contact the customer service. E04 Calibration Error Clean the white plastic calibration chip as instructed in 7.2 Daily Cleaning, and turn the instrument once more. If not succeeded, contact with the customer service. E05 Feed Table Polluted If any foreign material is in the reagent strip holding channel, remove it; If the feed table insert is heavily polluted by the urine specimen, clean it as instructed in 7.2 Daily Cleaning. E10 Stray Light Error Confirm if the instrument is located under direct sunlight, or there is a strong light source working near the instrument. Please place the instrument as instructed in 5 Environment Factors. E11 Positioning Error The urine sample being tested should be tested once more. If this error usually occurs, contact the customer service. E12 Strip Placement Error Confirm if a reagent strip is placed on the feed table and the tip of the strip touches the end of the strip holding channel. If not, replace the strip in 10 seconds and press START. E21 Printer Paper Empty Please install a new paper roll. E22 Printer Handle Put the handle of the printer to the “down” position. Table 6.1

- 28 - 7 Maintenance Note: Materials of the strip are subject to contamination regulations. Dispose of a waste strip in accordance with your local or national guidelines for waste disposal. 7.1 General Cleaning Keep the exterior of the instrument free from dust all the time. If needed, the exterior may be cleared using a damp cloth and a mild detergent. Do not use any type of solvent on any part of the instrument. Do not use any type of lubrication on the instrument. Use of oil, grease, silicon spray, or any other lubrication may cause damage. 7.2 Daily Cleaning The feed table and feed table insert must be kept clean to obtain the best result with the UA-66 instrument / reagent strip system. At the end of each daily use, the instrument‘s white plastic calibration chip, located on the feed table insert, and the reagent strip holding channel should be cleaned. To clean the feed table insert, perform the followings: 1. Turn the instrument on. The feed table will move out from the “storage” position to the “load” position. 2. Grasp the front end of the insert on each side with the thumb and one finger. Apply a counter pressure with the palm of the hand against the feed table and gently pull the insert outward. After the insert is completely exposed, lift the front end of insert up and off the table. Figure 7.1 3. Clean the insert using a cotton-tipped applicator stick or other suitable absorbent material wetted with distilled water. Thoroughly swab the strip holding channel area until it is clear. Inspect the surface of the white plastic calibration chip for dust, foreign material, scratches or scuffs. If necessary, gently wipe the calibration chip with a cotton-tipped applicator stick wetted with distilled water. Allow the calibration chip to air dry before using. Make sure no foreign particles remain on its surface. If the calibration chip cannot be cleaned or is scratched

-29- or scuffed, contact the customer service for replacement. NOTE: Do not use any material that will scratch the feed table insert or the white plastic calibration chip. Do not use solvents of any kind to clean the calibration chip. 4. Wipe the feed table surface and feed table mounting groove with a damp cloth. Wipe the feed table dry with an absorbent tissue. NOTE: Residual water or solution on the feed table or feed table insert will cause damage to the electronic components inside the instrument. 5. To replace the feed table insert in the feed table: Hold the feed table insert in the same manner as when it was removed( holding it by the end opposite the calibration chip ). With the front end angled upwards, insert the calibration chip end about midway onto the feed table. Slide the insert in while lowering the front end until the insert is laying flat against the table and resistance is felt. Then place the thumb against the front edge of the insert and two fingers against the underside of the feed table. Apply a counter-pressure to the feed table while pressing the insert firmly inward. The insert is properly positioned in the feed table when the front edge is flush with the retain rails of the feed table. 6. After replacing the feed table insert, the LEDs must be recalibrated. To ensure this occurs, turn the instrument off, wait several seconds, and then turn it on again before testing additional samples. 7.3 Disinfection The only part of the UA-66 instrument that comes into contact with the urine specimen is the feed table insert. To disinfection the insert, perform the followings: 1. Remove, clean and dry the feed table insert as instructed in 7.2. 2. Prepare one of the following solutions for use in disinfection: a. 2% glutaraldehyde solution - CidexPTM (use full strength) is a commercially available product that is acceptable for use. Refer to the labeling accompanying this disinfection product for complete instructions on its use. b. 0.05% sodium hypochlorite solution – dilute 1 mL of 5% sodium hypochlorite (e.g., Clorox® Bleach) into 99 mL of water for a 1:100 dilution. c. Isopropyl alcohol (70% - 85%), undiluted. 3. Fill a tall, narrow container to a depth of 4 inches (10 cm) with the disinfection solution. 4. Immerse the feed table insert into the disinfection solution. So the white plastic calibration chip must be above the liquid level. NOTE: Do not allow the disinfection solution to come into contact with the white plastic calibration chip, located on the feed table insert, or with any other portion of the feed table or instrument. 5. Allow the feed table insert remain in the solution for 10 minutes.

- 30 - 6. Remove the feed table insert and rinse thoroughly with distilled water to remove any residual solution. 7. Wipe the feed table insert in dry with an absorbent tissue. 8. Replace the feed table insert in the feed table, as instructed in 7.2 Daily Cleaning. 7.4 Periodic Cleaning If the feed table insert becomes excessively dirty and cannot be adequately cleaned as described in 7.2 Daily Cleaning, the following procedure should be used: 1. Remove the feed table insert from the table, as described in 7.2 Daily Cleaning. 2. Wipe the strip holding channel of the feed table insert with 0.1N sodium hyndroxide (NaOH) using a cotton-tipped applicator stick or other suitable absorbent material. Thoroughly swab the channel area until it is clean. NOTE: Do not wipe the white plastic calibration chip with the NaOH. Do not use any material that will scratch the feed table insert. Do not allow the NaOH to come into contact with the white plastic calibration chip or with any other portion of the feed table or instrument. 3. Rinse the feed table insert channel thoroughly with water to remove any residual NaOH. 4. Wipe the feed table surface and feet table mounting groove with a damp cloth. Wipe the feed table dry with an absorbent tissue. 5. Replace the feed table insert in the feed table, as instructed in 7.2 Daily Cleaning.