Laboratory Diagnostics Document Library

Access virtual tours below to get an interactive demonstration of the Document Library:

If you are on the Document Library Log In page click the “register" link to initiate the registration process. If you are on the SDS tab please click on the "register" link in the upper right area.

The verification of your account may take up to 5 business days. You will receive an email once your account has been activated. If you don't receive any notification please use our Online Contact Form for technical documents or send an email to us: diagnostics-lab-docs.healthcare@siemens.com.

On the Document Library Log In page click the "Forgot Password" link and enter your email address in the prompts to reset your password. An email including a new temporary password will be sent to you immediately.

First, log in to the Document Library. Go to your user profile by clicking on "My Account" in the upper right area. Then click the link "Document Library Profile" and activate the checkboxes for any additional items you would like to see. To confirm your request, click the "Save Profile" button. Once your updates have been saved your request will be reviewed and you will receive an email once the permissions have been updated.

First, log in to the Document Library. Go to your user profile by clicking on "My Account" in the upper right area. Then click the link "Document Library Profile" and deactivate the checkboxes for any items you would like removed. The changes will become effective with your next log in.

Your personal settings can be changed via your user profile. To access your user profile, please click on "My Account" in the upper right area. Once in “My Account,” click the "Edit" buttons to make profile changes.

The Document Library is designed for Microsoft Internet Explorer, Mozilla Firefox and Google Chrome internet browsers. In order to use this application correctly, please make sure to have JavaScript activated and cookies accepted.

"Browse" allows you to browse by product line and product, or by document category, and document type. If you select a specific product line or product, the document type box will be refreshed to only display those documents and document types for the selected product line or product. If you browse by document category and document type, the product box will refresh to only display product lines and products where you can find documents for the selected document category or document type. The filters can be removed by clicking again on the category. The number of available documents per category is available via the “Browse” box. Browsing can be useful if you cannot find the documents through the “Search” tabs. Please note that SDS (Safety Data Sheets) documents are only available through the tab “SDS.”

If you are looking for SDS (Safety Data Sheets) documents please use the tab "SDS." For reagent IFUs (Instructions for Use/Package Insert Sheets) please select the tab "IFU." In the IFU tab you can either use the "product code search" or the "keyword search." "Product code search" allows you to enter the product code into the field "REF," the lot number in the field "LOT," and the revision information in the third box (if available). Note, all fields are not required, but is recommended to help achieve a more specific results list. The "keyword search" functionality allows you to type in any keyword. The Advanced Search section allows you to specify a language and/or date range. The tab "Lot Specific Data" (Tables of Assigned Values, TAV) can be used for these special type of documents. There you can enter the product code into the field "REF" and/or the lot number into the field "LOT." You do not need to complete both fields, but it is recommended to help achieve a more specific results list. The Advanced Search section allows you to input a language and/or date range selection. The tab "General Search" allows you to enter one or more keywords in the white box. You can also set additional search criteria in the Advanced Search section. For example, you can select a specific language from the drop-down box and/or enter a lot number into the LOT field. The "Select Date Range" is helpful to ensure that the results displayed will only be based on the specified time frame. Note, "Refine" will replace the "Browse" boxes where you can apply additional filter(s) to further refine your result list.

This is dependent on the documents you are looking for. With browsing you can see all documents for a specific product line/product and/or document category and type. Please note that many documents will come up in the results list, which may require more time to load. Searching is recommended if you have specific documents in mind. "SDS" documents are only available through the tab "SDS." The tab "IFU" is a special search form for reagent IFUs (Instructions for Use/Package Insert Sheets). "Lot Specific Data" simplifies the search for TAVs (Tables of Assigned Values). The "General Search" tab is recommended if you would like to enter specific search terms, such as a product name or method. Note: "Refine" will replace the "Browse" boxes where you can apply additional filter(s) to further specify your result list.

The following document categories and document types are available:

Instrument and Software Information

• Instructions
• Maintenance Log Sheets
• Manuals/Guides
• Release Notes
• MDS2 (Manufacturer Disclosure Statement for Medical Device Security)

Reagent/Consumable Information

• Assay Rollouts
• Data Summary
• Instructions for Use/Package Inserts
• Panel Layouts
• QC Report Form
• Tables of Assigned Values (TAVs)/Lot Card
• Worksheet

System Application/Parameter Sheets

• Application Sheets/Parameter Sheets
• Assay Protocols

Product Quality Documents

• Certificates of Analysis/Compliance
• Declarations of Conformity
• Declarations of Traceability and Uncertainty
• Lot Release Certificates

Technical/ Reference Documents

• FAQ's
• Rapid Information/For Your Information (FYI)
• Technical Papers

Bulletins

CLSI Procedures

Click on the "SDS" tab and follow the steps listed to access the SDS you need. From here select the language/format needed from the drop-down menu in the Language/Country field. Then either select the product line needed from the drop-down menu in the View Product Line field, or enter a product name in the open text Description field. Finally, hit the Enter key or “Show Documents” button to return a table of your search results. You can view the results on the screen or download to your desktop.

SDS files can only be found through the "SDS" tab.

Please see answer to question "What is the difference between the "Browse" and "Search" methods? What is best to use?"

Please see answer to question "How can I request permissions for additional products, product lines, document types or languages?".

If you have tried both “Search” and “Browse” to locate the document and still cannot find the document, please contact Siemens using our Online Contact Form for technical documents, or send an email to: diagnostics-lab-docs.healthcare@siemens.com.

Simply click on the document title to open the document. If you do not have Adobe Acrobat Reader to view PDF files, you can download it from the following website:

Select the documents by checking the boxes in front of the title and click “Download” on the bottom of the page.

Mark all documents you want by checking the boxes and click "add to my selected documents". The documents will be added to your "My Selected Documents" cart which you can access later by clicking the link "My Selected Documents" in the upper right section. The number of selected documents and size of your collection is displayed in brackets next to the link.

This feature can be used if you intend to collect different documents on various pages and download at a later time. This feature allows you to download your complete list of documents quickly after you have finished collecting various documents. While browsing or searching, identify the documents you would like to add by checking the boxes in front of the document title and click the link "add to my selected documents". The documents will be added to your "My Favorites" cart which you can access later by following the link "My Favorites" in the upper right section. The number of selected documents and size of your collection is displayed in brackets next to the link.

FCA registration is a two-step process. First, under your user profile, enter the correct combination of sold-to number, serial number, and product. Then select the sites for which you are responsible. Once registered, you will receive FCA Letters for your products, and be able to return effectiveness checks, as appropriate.

Yes. Only registered Document Library users can register to receive FCA Letters, linked via email, and return effectiveness check responses electronically.

While Document Library registration is separate from FCA registration, FCA registration follows immediately after Document Library registration.

If you are already registered for Document Library, access your user profile and scroll to the bottom. There you will see fields to provide your sold-to number, product, and an associated equipment serial number. You only need to select one serial number from a Siemens instrument in your lab. Once you submit your registration and it is approved, your user profile is updated.

For new customers, upon completion of Document Library registration, the option is available to register to receive Field Corrective Actions (FCA) Letters via an email link, and return effectiveness forms electronically. During Document Library registration, the user is asked to provide their sold-to number, the name of a Siemens product in their lab, and an associated serial number, which must match for approval. Otherwise, Siemens will contact the user to obtain the information to validate registration. Upon verification and approval, your user profile is updated. You may complete the FCA registration by going into My Settings and complete the FCA Registration section.

Siemens needs to validate registration with a valid combination of a sold-to number, product, and associated equipment serial number. This information is needed to associate all products and sites associated with your company’s account with Siemens.

A sold-to number is a unique identifier for your company’s account with Siemens. It links your company’s account to all purchases. If your facility manager does not have this information your Siemens account representative will.

Click on the check box on the registration screen that states: I do not know my sold-to number, serial number, and/or product. Please assist with my registration.

If the information is invalid, one of our country administrators will contact you for additional information and provide assistance.

Please use our Online Contact Form for technical documents or send an email to: diagnostics-lab-docs.healthcare@siemens.com.

Upon verification and approval, your user profile is updated, and you can complete the FCA registration by going into the FCA Registration section under My Settings.

This information is not required but is recommended. It will facilitate verification.

Your organization may have multiple locations. These are what are referred to as ship-to accounts where a product was received by your company.

Please select those ship-to accounts you are responsible for. For each ship-to account selected, you will receive FCA Letters for the products running at that location.

If a FCA Letter applies to your affected product (hardware, software version, assay, lot, etc.), you will receive an email from Siemens with a link to view the FCA letter, as well as a link to the Effectiveness Check form.

Only select the site(s) for which you are responsible.

Please use our Online Contact Form for technical documents or send an email: diagnostics-lab-docs.healthcare@siemens.com.

FCA stands for Field Corrective Action. However, you may be more familiar with UMDC, UMDR, or UFSN as common terms.

Field Corrective Actions (FCAs) can be accessed several ways.

1. From a Siemens email notification, click on the FCA link, sign into Document Library, and open the FCA Letter.
2. From the Customer FCA portal on the Siemens Document Library site, navigate to All FCA link, find the appropriate FCA document, and click on the FCA Letter link.
3. From Document Library, click on the Field Corrective Actions tab, search/browse by product to find the appropriate FCA document, and click on the FCA Letter link.

Effectiveness Check Form can be accessed several ways. To complete the Effectiveness Check form, ensure you are registered as a “Primary” user.

1. From a Siemens email notification, click on the Effectiveness Check Form link, sign into Document Library, and complete and submit the form.
2. From the Customer FCA portal on the Siemens Document Library site, navigate to All FCA link, find the appropriate FCA document, and click on the Effectiveness Check Response Form link.
3. From Document Library, click on the Field Corrective Actions tab, search/browse by product to find the appropriate FCA document, and click on the Effectiveness Check Form link. Upon submission of the completed effectiveness form, other “Primary” users within your organization will receive an email notification that form has been submitted.

Field Corrective Actions (FCAs) can be accessed in two ways.

1. From the Customer FCA portal on the Siemens Document Library site, navigate to All FCA link, find the appropriate FCA document, and click on the FCA Letter link.
2. From Document Library, click on the Field Corrective Actions tab, search/browse by product to find the appropriate FCA document, and click on the FCA Letter link.

Emails from Siemens should not be blocked by you or your organization.

You should be registered on Document Library, and be registered to receive Field Corrective Action letters. Ensure your user profile is up to date to reflect all products within your facility.

You should have Adobe Reader (or equivalent PDF viewer) to view FCA Letters.

Go to Adobe Download Center

To delegate, ensure you are registered as a “Primary” user. From the Customer FCA Portal menu, select Delegation and follow the prompts.

Have them register on Document Library, and register to receive FCA letters. They should also update their user profile to reflect all products within their facility.

Each person who needs to receive FCA letters must be registered on Document Library, and registered to receive Field Corrective Action letters. They should also ensure their user profile is up to date to reflect all products within their facility.

“Primary” users have permission to remove individuals from receiving FCA emails. Go to the Customer FCA portal on the Siemens Document Library site, navigate to User Administration, select the email address of the person to be removed, change Status to Inactive, and click Update.

“Primary” users have permission to change individuals from General to Primary. Go to the Customer FCA portal on the Siemens Document Library site, navigate to User Administration, select the email address of the person to be changed, and under User Type change General to Primary and click Update.