Important Safety Information

U.S. Important Safety Information

Indication for Use: The Histolog® Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

Intended Users: The Histolog® Scanner and its accessory devices are intended to be operated by trained healthcare professionals.

Clinical Utility: The Histolog® Scanner offers an additional source of information to the user by providing rapid, automated visualization of excised tissue microstructure. This information is an adjunct to visual observation of the surface of an excised tissue sample and tissue histopathology assessment.

Warnings:

• The Histolog® Scanner and its accessory devices are intended to be used for the ex vivo examination of specimens. They are not intended for use on patients (in vivo).

• The Histolog® Scanner and the Histolog® Dish are non-sterile devices. For use in an intraoperative setting, the Histolog® Scanner and its accessory products shall be located outside the sterile surgical area.

• When handling potentially infectious tissue specimens, avoid skin contact by wearing appropriate personal protective equipment such as, e.g., medical grade gloves.

• This device is not compatible with magnetic resonance (MR) or explosive environments.

• Handles [H] are not provided for lifting the device, but exclusively have a function for pushing/pulling.

• Do not operate the Histolog® Scanner in case of damage to the imaging window [G].

Cautions:

• Only use compatible accessories and parts supplied by SamanTree Medical or by an authorized distributor.

• Do not re-use a Histolog® Dish. A new Histolog® Dish shall be used for every new medical procedure.

• Do not use a Histolog® Dish, if it is damaged or if its optical interface is visibly dirty.

• If the information about the tissue specimen orientation is critical, the tissue specimen should be marked for orientation before starting the imaging procedure with the Histolog® Scanner.

• Do not apply tissue marking dyes on the tissue specimen before imaging it with the Histolog® Scanner. Tissue marking dyes prevent proper imaging with the Histolog® Scanner.

• The Histolog® Scanner is designed for use in a professional healthcare facility environment. It is likely to perform incorrectly if used in a home healthcare environment.

Laser safety

The Histolog® Scanner is a Class 1 laser product, as per IEC 60825-1:2014-05.

Laser radiation in the visible wavelength range is emitted from the imaging window [G] during imaging.

The Histolog® Scanner embeds a Class IIIB laser component with the following characteristics:

Wavelength: 488 (+0/-4) nm

Max output power: 100 mW (CW)

Refer to the full Histolog Instructions for use for additional information.

United States
SamanTree Medical Inc
50 Milk Street, Floor 16
Boston, MA 02109
+1 866.993.1441
[email protected]
www.samantree.com

This document is intended solely for healthcare professionals.

For distribution only in markets where Histolog has been regulatory cleared or approved.

Histolog is a registered trademark in the US and internationally for SamanTree Medical SA.

A&P-00981 V1-US