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There is much discussion and concern today about the Year 2000 (Y2K) problem and its effects on computer controlled devices and systems. PharmaNetics has been working to ensure that all Y2K issues related to its Thrombolytic Assessment System (TAS) have been reviewed, investigated for potential problems and that all these issues have been resolved and documented.

The letters below address Y2K issues related to TAS and are designed to address any concerns of our customers, vendors or service providers. If, after reviewing these letters however, you still have questions please contact our technical service department, ext. 6085.

Dear Year 2000 Coordinator:

PharmaNetics Inc. is working to ensure that the year 2000 date change will not interfere with our ability to continue providing a high level of service to all of our customers. We have initiated internal programs to identify any systems that that may be adversely effected by the year 2000 issues. We are also reviewing the activities of our critical vendors to determine their ability to provide uninterrupted service after January 1, 2000. Finally, we have verified that the testing of our own software products adequately addressed the year 2000 scenarios. The company has assembled a core team of employees to develop and implement these plans to ensure a smooth transition into the twenty first century.

The first component of our year 2000 plan is to fully catalog the software used in the various departments within the company that are critical to the ongoing operation of the company. From this list, a hazard analysis will be performed to determine the effect each of these software applications would have if any one of them were to fail. Test plans will be developed to test the software applications with special emphasis on the most critical applications.

The second component of the plan is a survey of our vendors. Again, an analysis will be performed to determine the effect of a failure in each vendor’s ability to deliver products and services. Factors we will consider include, but are not limited to single source issues, lead times, and inventory levels. Surveys will be sent to the critical vendors to determine their readiness for the year 2000. Vendors that are not found to be preparing adequately will be replaced.

Two of our currently marketed products contain software. These products are the TAS analyzer and the TRAQS software application for Windows 95. The validation effort for version 3.53 of the TAS Analyzer software and for version 1.57 of the TRAQS software included significant testing of the year 2000 issues. Careful testing demonstrates that the software is Year 2000 Compliant, which we define as follows. Year 2000 Compliance means that the software:
  1. Utilizes dates calculations that process dates prior to and after January 1, 2000 with no adverse affect on the functionality of the software or accuracy of the date data;

  2. accurately sets the time and date in the year 2000 and beyond;

  3. accurately handles leap year calculations in the year 2000 and beyond;

  4. printing and reporting results in and around the year 2000 and beyond; and

  5. sorting results using dates for prior to and after January 1, 2000.

Our Year 2000 Compliance test results have been documented and reviewed and are accurate for the software as provided. Year 2000 Compliance does not apply to our software that has been altered or modified in an unauthorized manner. All future versions of our software will also be tested for compliance with these requirements as part of our ongoing testing program.

To conserve space on the display of the TAS analyzer, the instrument’s software was written to show two digit years. The software always interprets years between 85 and 99 as 1985 to 1999 respectively. Years between 00 and 84 are interpreted as 2000 through 2084 respectively. Since the TAS analyzer only uses the year as part of the current date ( for example: the TAS does not store patient date of births ), we have found this approach to be satisfactory. As mentioned above, the TAS software handles the transition to the year 2000 without any problems.

This letter does not constitute a guarantee, representation or warranty of any kind whatsoever and relies on information provided by our vendors and suppliers that has been reviewed by us prior to August 31, 1998. Regarding our software, the warranties provided are as set forth in the applicable license agreement under which you make use of the software.

We believe that the plan outlined in this letter will allow us to maintain and grow our business across the year 2000 boundary without any interruption. Please contact our Technical Service Department at 800-247-4234 should you wish to discuss any of these issues or other concerns you may have.

Sincerely,
Greg Godlevski
Director of Software Development

 

SUPPLEMENT TO THE YEAR 2000 STATEMENT LETTER FOR USERS OF TAS ANALYZERS WITH VERSION 3.16 SOFTWARE

Dear Year 2000 Coordinator:

Some customers of Cardiovascular Diagnostics, Inc., who purchased TAS analyzers before June of 1997, may have an analyzer with software version 3.16 or earlier. Analyzers with these earlier software versions will function properly with respect to Year 2000 concerns with one exception. Analyzers with software version 3.16 or earlier do not allow the date or time to be manually set to February 29, 2000 which is a valid, leap year date. The problem only occurs if the operator selects the Set Date/Time option from the user menu and tries to set the date to February 29, 2000. The effect of trying to set the date to February 29, 2000 is that an error message is displayed indicating that this is not a valid date.
The date and time display will function properly if the date and time are not modified on February 29, 2000. If the date is correctly displayed on the analyzer screen prior to February 29, 2000 then the date display will transition correctly into February 29, 2000 and also will transition correctly into March 1, 2000. There are no other known Year 2000 issues with analyzers with software version 3.16 or earlier, and they are otherwise Year 2000 compliant.

Sincerely,
Greg Godlevski
Director of Software Development

 

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