Frequently Asked Questions

How do I find the patient information guide or Instructions for Use (IFU) for a specific product?

For Professional IFUs:

  1. 1. Select the Continent > Country > Language(s).
  2. 2. Enter product name or model number, or filter by Segment, Category and Family.
  3. 3. Select Search

The IFU(s) approved for the country and product selected are displayed.

 

For Patient Manuals:

  1. 1. Select the Continent > Country > Language(s).
  2. 2. Enter product name or model number and select Search.
  3. 3. Or select a category.

The patient manuals approved for the country and product are displayed.

 

Why is my country not listed?

Your country might not be approved for electronic IFUs at this time. The product will be provided with a paper IFU. If you require a copy of the IFU, please contact us using the appropriate Global Locations and Contacts | Abbott U.S..

Why is the product not listed in my country?

The product may not be approved in the country selected and/or may not be approved for electronic Instructions for Use at this time. The product will be provided with a paper Instructions for Use. If you require a copy of the Instructions for Use, please contact us using the appropriate Global Locations and Contacts | Abbott U.S..

Can I use the patient information guide or Instructions for Use from another country?

No, patient information guides and Instructions for Use approved for each country must be used.

How do I view an electronic patient information guide or Instructions for Use?

Adobe Reader 6.0 or later is required to view PDF files.

Click on the pdf name in the search results. The file will display in your web browser. The file can be saved, searched, or printed using Adobe Reader functionality. A free pdf reader is available here via Adobe Systems.

Recommended web browsers are:

  • Chrome. Please visit Google to download.
  • Mozilla Firefox. Please visit Mozilla to download.
  • Microsoft Edge. Please visit Microsoft to download.
  • Safari. Please visit Apple to download.

How do I view previous versions of a patient information guide or Instructions for Use?

For customers outside of the United States, the search results will display a feature to expand and show previous versions, document numbers, and published dates.

How do I know if the patient information guide or Instructions for Use have been revised?

Patient information guides or Instructions for Use documents may be revised from time to time, so please refer to this Web page for the most current version.

How will I be notified if the Instructions for Use have been revised for safety reasons?

Abbott has a formal process for determining when Field Safety Corrective Actions (FSCA) are necessary. Occasionally, an FSCA may include urgent revisions to prescribed instructions for use. In these cases, Abbott’s process requires the distribution of a Field Safety Notice to every Health Care Provider (HCP) that has received the affected product to inform them of the revised prescribed instructions for use. If an IFU on the website has been updated for safety reasons, the reason displays under the RevisionType field.

How do I download an electronic patient information guide or Instructions for Use?

For the latest version, click on the pdf name in the search results. The file will display in your web browser. The file can be saved, searched, or printed using Adobe Reader functionality. A free pdf reader is available here via Adobe Systems.

How do I print the electronic patient information guide or Instructions for Use?

For the latest version, click on the pdf name in the search results. The file will display in your web browser. The file can be saved, searched, or printed using Adobe Reader functionality. A free pdf reader is available here via Adobe Systems.

Where can I find the definitions of label symbols?

Every patient information guide and Instruction for Use contains the label symbol definitions. For the most used harmonized symbols, click here.

How do I request a paper copy of the patient information guide or Instructions for Use?

Contact customer service by phone, fax, or email.

For an online request form, access the specific IFU using the instructions under How do I find the patient information guide or Instructions for Use (IFU) for a specific product?

Then, select Order a Copy under the name of the pdf.

How quickly will customers receive a paper copy of the patient information guide or Instructions for Use?

Customers in the European Union will receive a printed patient information guide or Instructions for Use at no additional cost within 7 calendar days. In other locations, delivery will be is accordance with local regulations.

How do I find the Unique Device Identification (UDI) for the device?

Refer to the product label. The UDI is made up of two parts: the first 16 digits are the UDI-DI and the last 18 digits are the UDI-PI.

Unique Device Identification *Device Identifier = first 16 digits

You can use the UDI-DI on the EUDAMED site to access device-related information, such as the Summary of Safety and Clinical Performance (SSCP).