Olympus AU600, AU1000, AU5200, PK7100, AU640 User Manual

December 10, 1999

* YEAR 2000 READINESS DISCLOSURE STATEMENT *

TO OLYMPUS CUSTOMERS PRESENTLY USING:

∙OLYMPUS DEMAND®, OLYMPUS® AU5000, OLYMPUS REPLY®, OLYMPUS® AU560, OLYMPUS® AU5200, OLYMPUS® AU800, OLYMPUS® AU1000, OLYMPUS® AU600, OLYMPUS® AU640, and OLYMPUS® AU400 Automated Chemistry Analyzers

∙OLYMPUS® PK7100 and OLYMPUS® PK7200 Automated Microplate Systems

∙OLYMPUS® Aliquotting System (OASYS)

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This Year 2000 Readiness Disclosure Statement revises, supplements, and/or restates important information previously disseminated in our Year 2000 Readiness Disclosure Statement dated February 12, 1999 (the “February 1999 Statement”). Revised and supplemental paragraphs and sections are so noted in this new Year 2000 Readiness Disclosure Statement. Those systems described in this Statement as “year 2000 compliant” are year 2000 compliant in accordance with the attached Year 2000 Compliance Limited Warranty.

∙OLYMPUS DEMAND Automated Chemistry Analyzer:

REVISED STATUS: A four-digit year code must be entered in the date. Entering a two-digit year code in the date may generate an input error and prevent analysis.

∙ OLYMPUS AU5000 Automated Chemistry Analyzer:

REVISED STATUS:

• A four-digit year code must be entered in the date. Entering a two-digit year code in the date may generate an input error and prevent analysis.

‚A parameter save/load function performed using the Parameter Floppy Disk after December 31, 1999 will result in the date stamp indicating the “Last Modified” status as the year “1900”.

∙OLYMPUS REPLY and OLYMPUS AU560 Automated Chemistry Analyzers:

The OLYMPUS REPLY and OLYMPUS AU560 will display a year of “1900” upon transition to January 1, 2000. OLYMPUS REPLY systems with operating software versions 2.4 and above and OLYMPUS AU560 systems will require a special software tool to ensure year 2000 compliance.

Olympus is preparing a special software disk that must be installed in these systems. This disk will be provided to you at no charge during the first half of 1999. Customer installation of the special software must be performed upon initial use of the system AFTER 12:00 a.m. on January 1, 2000. No action should be taken prior to 12:00 a.m. on January 1, 2000. Please follow the Year 2000 Conversion Instructions and Test Procedures attached to this Year 2000 Readiness Disclosure Statement. Upon complete and correct installation of the special software provided by Olympus, OLYMPUS REPLY and OLYMPUS AU560 units will be year 2000 compliant. NOTE: OLYMPUS

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REPLY systems with operating software versions below version 2.4 cannot be upgraded using the special software disk.

SUPPLEMENTAL INFORMATION: After December 31, 1999, a four-digit year must be used to define the date in the OLYMPUS AU560 “SET DATE & ROUND” and OLYMPUS REPLY “SET DATE & CAROUSEL” menus. If existing data indexes have a two-digit year entry they must be searched separately from those data indexes having a four-digit year entry.

∙OLYMPUS AU5200 Automated Chemistry Analyzer:

To ensure the year 2000 compliance of the OLYMPUS AU5200, the system MUST be powered off (by performing an “END PROCESS”) prior to midnight on December 31, 1999. The system must remain off during the brief transition from December 31, 1999 to January 1, 2000. If this process is followed completely and correctly, the date field will be correctly displayed as “01/01/2000” upon initial power on after 12:00 a.m. on January 1, 2000, no further corrective action will be necessary, and the system will be year 2000 compliant. However, if the OLYMPUS AU5200 is not powered off during the transition from December 31, 1999 to January 1, 2000, the date displayed in the upper right-hand corner of the monitor will be incorrectly listed as “01/01/1900” on January 1, 2000. In such event, you must follow the steps set forth in the attached Year 2000 Conversion Instructions and Test Procedures to correct the displayed date.

∙ OLYMPUS AU800 and OLYMPUS AU1000 Automated Chemistry Analyzers:

Much of the information contained in the following paragraph has been gleaned from HewlettPackard and certain independent test laboratories. Olympus has relied upon the information provided by Hewlett-Packard and these independent test laboratories.

The OLYMPUS AU800 and OLYMPUS AU1000 utilize a number of different Hewlett-Packard computers. If the computer installed with a system is a Hewlett-Packard Vectra VL 5/133 or higher clock speed unit, no corrective action will be required. OLYMPUS AU800 and OLYMPUS AU1000 units which utilize these higher clock speed computers are year 2000 compliant. Within the OLYMPUS AU800 and OLYMPUS AU1000 software program, on systems utilizing HewlettPackard computers with slower clock speeds (all 386, 486, 5/75, and 5/120 units), the display date, data index, and printout date appear to change properly from “12/31/1999” to “01/01/2000”. However, upon powering off, the computer’s internal clock will revert to 1980 when the system is next powered on. Therefore, those Hewlett-Packard computers with slower clock speeds will require manual updating of the current date by using the MS-DOS® “DATE” command to set the date to 2000 upon initial use AFTER 12:00 a.m. on January 1, 2000. No action should be taken prior to 12:00 a.m. on January 1, 2000. Please follow the Year 2000 Conversion Instructions and Test Procedures attached to this Year 2000 Readiness Disclosure Statement. This update MUST be performed on all Hewlett-Packard computers with clock speed slower than the Hewlett-Packard Vectra VL 5/133.

SUPPLEMENTAL INFORMATION:

¨The OLYMPUS AU800 and OLYMPUS AU1000 incorporate features that allow data to be stored on floppy disk. The “OFFLINE FLOPPY DATA OUTPUT” menu stores data in a form that can be used offline for functions such as spreadsheet applications. When performing the “OFFLINE FLOPPY DATA OUTPUT” function using a Data Floppy Disk initialized after

January 1, 2000, program execution will be interrupted. As a result, program status information may appear on the PC monitor. Patient data residing in the system hard drive is not affected and operation can be easily resumed by re-booting the system.

It is recommended that a sufficient quantity of Data Floppy Disks be initialized prior to January 1, 2000 in order to support offline floppy data output for a period of one month. In the event

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that there are no initialized Data Floppy Disks available upon transition to January 1, 2000, the system date can be set to a date prior to January 1, 2000 in the “AUXILIARY/CURRENT DATE AND TIME” menu. Disks can then be initialized using the “FLOPPY INITIALIZE” menu. Should this procedure be required, the date must be returned to the then-current date and time prior to analysis in the “AUXILIARY/CURRENT DATE AND TIME” menu. In addition, pre-initialized Data Floppy Disks will be available from Olympus after January 15, 2000. An updated version of software will be provided at no charge by June 1, 2000.

­Re-using a Data Floppy Disk containing data stored after December 31, 1999 will result in an interruption in program execution. As a result, program status information may appear on the PC monitor. Patient data residing in the system hard drive is NOT affected. Furthermore, operation can be easily resumed by re-booting the system. Disks can be re-used; however, disks containing data stored after December 31, 1999 must be initialized using the “FLOPPY INITIALIZE” menu and using a system date earlier than January 1, 2000. An updated version of software will be provided at no charge by June 1, 2000.

ÆThe “DATA DOWN LOAD TO FD” menu saves data onto a floppy disk in a form that will allow review or editing on the OLYMPUS AU800 and OLYMPUS AU1000 systems. This method will function using disks initialized before and after January 1, 2000. This is the recommended action for data archive purposes.

ØFloppy disk file date stamps will be recorded on the disk as “53” during the year 2000. In addition, years subsequent to 2000 will be displayed as “54”, “55”, etc. Information stored on the disks will not be affected. File date stamps are displayed only when viewed outside the AU800/AU1000 application. There will be no software update available to resolve this condition; however, this condition has no impact on system functionality.

°The impact of the aforementioned conditions on overall system operation is limited and only applies to the operating conditions described above.

∙OLYMPUS AU600 Automated Chemistry Analyzer:

Much of the information contained in the following paragraph has been gleaned from HewlettPackard and certain independent test laboratories. Olympus has relied upon the information provided by Hewlett-Packard and these independent test laboratories.

The OLYMPUS AU600 utilizes a number of different Hewlett-Packard personal computers. If the computer installed with a system is a Hewlett-Packard Vectra VL 5/133 or higher clock speed unit, no corrective action will be required. OLYMPUS AU600 units which utilize these higher clock speed computers are year 2000 compliant. Within the OLYMPUS AU600 software program, on systems utilizing Hewlett-Packard computers with slower clock speeds (5/75 and 5/120 units), the display date with two-digit year code located in the upper right-hand portion of the screen changes from “12/31/99” to “01/01/00”. The date display is for convenience purposes only and does not affect the system’s functionality. However, the data index and printout dates within the system program software contain a four-digit year code. Consequently, upon powering off, the computer’s internal clock will revert to 1980 when the system is next powered on. Therefore, those Hewlett-Packard computers with slower clock speeds will require manual updating of the current date by using the MSDOS® “DATE” command to set the date to 2000 upon initial use AFTER 12:00 a.m. on January 1, 2000. No action should be taken prior to 12:00 a.m. on January 1, 2000. Please follow the Year 2000 Conversion Instructions and Test Procedures attached to this Year 2000 Readiness Disclosure Statement. This update MUST be performed on all Hewlett-Packard computers with clock speed slower than the Hewlett-Packard Vectra VL 5/133.

SUPPLEMENTAL INFORMATION:

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•Offline Output and Data floppy disk file date stamps will be recorded on the disks as “53” during the year 2000. In addition, years subsequent to 2000 will be displayed as “54”, “55”, etc. Information stored on the disks will not be affected. File date stamps are displayed only when viewed outside the AU600 application. This condition has no impact on system functionality.

‚In the “Periodic Maintenance” menu, the “Next” date, indicating the next scheduled due date for a maintenance item, will be displayed one day late when February 29, 2000 falls between the “Executed” date (i.e., the date periodic maintenance was last performed) and the “Next” date (i.e., the calculated date the next periodic maintenance is due). Manual tracking of periodic maintenance must be conducted under these conditions. The “Periodic Maintenance” function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

ƒIntegrity of patient data is not affected by the aforementioned conditions. An updated version of software will be provided at no charge by June 1, 2000.

∙ OLYMPUS AU400 and OLYMPUS AU640 Automated Chemistry Analyzers:

REVISED STATUS:

•The “Consumable Management” menu displays an interval of time (i.e., days, weeks, months, years) since a consumable was last changed. In cases where the unit of time has been defined as “Day” or “Week” and February 29 falls between the then-current date and the next consumable change date, the indicated number of days or weeks since the last consumable change date will be reduced by one unit (i.e., day or week). Manual tracking of consumable management must be conducted under these conditions. The “Consumable Management” function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

­In the “Periodic Maintenance” menu, the color of maintenance items should change to yellow when the then-current date coincides with the “Next” maintenance due date. The color should change to red when the current date exceeds the “Next” maintenance due date. However, when the “Next” maintenance due date is February 29, the “Next” maintenance due date will be displayed in yellow on March 1 and red on March 2. Manual tracking of periodic maintenance must be conducted under these conditions. The “Periodic Maintenance” function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

ÆIn the “Periodic Maintenance” menu, the grid corresponding to the date when maintenance was last performed should be marked with an “o” symbol and the “Next” maintenance due date should be displayed in yellow in the “Grid Display” menu. However, symbols indicating last performed (“o”) and “Next” due (yellow) dates for the month of January will not be displayed in the “Grid

Display” menu from December 1 through December 30. Manual tracking of periodic maintenance must be conducted under these conditions. The “Periodic Maintenance” function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

ØIn the “Grid Display” menu, the color of grids for maintenance items should change to yellow when the then-current date coincides with the “Next” maintenance due date. However, when the “Next” maintenance due date is February 29, the grids for both February 29 and March 1 will be displayed in yellow. In addition, printing of the “Grid Display” using the “Report/Schedule” menu will assign an “*” mark (indicating maintenance due date) for both February 29 and March 1. Manual tracking of periodic maintenance must be conducted under these conditions. The “Grid Display” function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

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°The “Cuvette Status” menu displays a yellow color to alert the operator when 8 or more days have elapsed since the last W2/Photocal operation was performed. When a W2/Photocal is performed between February 22 and February 29, the yellow color alert will not be displayed until 9 days following the date of such W2/Photocal operation. The scheduling of W2/Photocal operations during this period must be manually tracked.

±The printout generated by the “Report/Schedule” menu should include the “o” and “*” symbols for the “Executed” maintenance date and the “Next” maintenance due date, respectively. However, from December 31 through January 30, the printout generated by the “Report/Schedule” menu will not include the “o” and “*” symbols for the portion of the month of January after the then-current date. Information prior to and including the then-current date will be printed. Manual tracking of periodic maintenance must be conducted under these conditions. The “Report/Schedule” function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

²The print function for maintenance activities will indicate a status of 31 days in all months. Please disregard maintenance marks for all dates that do not exist (e.g., February 30, April 31). This print function is provided as a convenience and, therefore, in no way impacts system functionality except as described above.

³ An updated version of software will be provided at no charge by June 1, 2000.

∙OLYMPUS PK7100 Automated Microplate System:

REVISED STATUS: When a single digit (“0” – “9”) or two-digit (“00” – “09”) year is entered in the date, dates contained in printed reports and on monitor screens will indicate a one-digit year, “0” to “9”, for the 2000 to 2009 year period. A four-digit year, 2000 – 2009, must be entered in the date.

∙OLYMPUS PK7200 Automated Microplate Systems:

The OLYMPUS PK7200 program only updates the last two digits of the displayed year. Therefore, the OLYMPUS PK7200 will display “01/01/1900” upon transition to January 1, 2000. Manual resetting of the date and time utilizing the “Maintenance” software menu of the system will be required. To ensure year 2000 compliance, the date and time fields MUST be updated upon initial use of the system AFTER 12:00 A.M. on January 1, 2000. No action should be taken prior to 12:00 a.m. on January 1, 2000. Please follow the Year 2000 Conversion Instructions and Test Procedures attached to this Year 2000 Readiness Disclosure Statement.

∙OLYMPUS Aliquotting System (OASYS):

The OLYMPUS Aliquotting System (OASYS) uses the date stamp for internal error log display only. The year will be displayed as “00” upon transition to January 1, 2000. The date is not associated with any instrument functions other than the error log display. The OASYS is year 2000 compliant.

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Included with this Year 2000 Readiness Disclosure Statement are Year 2000 Conversion Instructions and Test Procedure documents for the REPLY, AU560, AU600, AU800, AU1000, AU5200, and PK7200 systems. If you have any questions, please do not hesitate to contact Olympus’s Technical Services Department at [phone].

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Olympus appreciates your continued patronage and support, and we look forward to serving you in the future.

Glenn Mann

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Director of Service

Olympus America Inc.

Diagnostic Systems Division

Notice: This Statement contains proprietary information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without the prior written consent of Olympus America Inc.

MS-DOS® is a U.S. registered trademark of Microsoft Corporation.

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YEAR 2000 COMPLIANCE LIMITED WARRANTY

OF

OLYMPUS AMERICA INC.

DIAGNOSTIC SYSTEMS DIVISION

EXCEPT AS DESCRIBED IN THE YEAR 2000 READINESS DISCLOSURE STATEMENT TO WHICH THIS LIMITED WARRANTY IS ATTACHED, Olympus America Inc.’s Diagnostic Systems Division (“OAI-DSD”) warrants that it will deliver either (a) products that do not process date information or (b) 21st century compliant products that, provided that all other products used with the OAI-DSD products properly exchange accurate data, (i) will function and operate in accordance with applicable product specifications and logic in the year 2000, (ii) correctly process date fields and internal date field dependent logic to accurately process and utilize dates beyond December 31, 1999, (iii) store and represent dates in a manner which allows for identification or use of the century portion of any date fields without any special processing, and (iv) correctly process dates for leap years. OAI-DSD’s sole responsibility and your exclusive remedy for breach of this Limited Warranty shall be the offer of an update for or the repair or replacement of such products. Notwithstanding the foregoing, certain products listed on the Year 2000 Readiness Disclosure Statement (to which this Limited Warranty is attached) may require corrective action to ensure full year 2000 compliance.

EXCEPT FOR THE LIMITED WARRANTY SET FORTH ABOVE, OAI-DSD MAKES NO AND DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR CONCERNING ANY PATENTS OR TECHNOLOGY. OAI-DSD DOES NOT WARRANT THAT SOFTWARE WILL BE ERROR-FREE AND/OR UNINTERRUPTED. MOREOVER, OAI-DSD DOES NOT WARRANT THE YEAR 2000 COMPLIANCE OF PRODUCTS MANUFACTURED BY THIRD PARTIES OR PRODUCTS NOT SHIPPED FROM OAI-DSD INVENTORY. OAI-DSD DISCLAIMS RESPONSIBILITY AND LIABILITY FOR ENSURING THE YEAR 2000 COMPLIANCE OF INTEGRATED SYSTEMS COMPRISED OF OLYMPUS AND NON-OLYMPUS PRODUCTS. ALL GUARANTIES, WARRANTIES, CONDITIONS, AND REPRESENTATIONS WHATSOEVER, EITHER EXPRESS OR IMPLIED, WHETHER ARISING UNDER ANY STATUTE, LAW, COMMERCIAL USAGE OR OTHERWISE, ARE HEREBY EXPRESS EXCLUDED. IN NO EVENT SHALL OAI-DSD BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND (INCLUDING WITHOUT LIMITATION LOSS OF PROFITS OR LOSS OF USE), WHETHER OR NOT OAI-DSD SHALL BE OR SHOULD BE AWARE OF THE POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE.

Representations and warranties made by any person, including dealers and representatives of OAI-DSD, which are inconsistent with, in conflict with, or in addition to, the terms of this

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Limited Warranty, shall not be binding upon OAI-DSD unless reduced to writing and approved by an expressly authorized officer of Olympus America Inc.

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