US Important Safety Information
United States
SamanTree Medical Inc
50 Milk Street, Floor 16
Boston, MA 02109
+1 866.993.1441
contact@samantree.com
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.
©2025 SamanTree Medical SA.
All rights reserved.
A&P-00426 V1 - WW
US Important Safety Information
The Histolog® Scanner Indications 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 in vitro for the examination of specimens. They are not intended for use on patients.
■ 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 gloves or other protective equipment.
■ This device is not compatible with magnetic resonance (MR) or explosive environments.
■ Handles are not provided for lifting the device, but exclusively have a function for pushing/pulling.
■ The Histolog® Scanner imaging window is fragile. Avoid impact with foreign objects. Do not load with mass above 1 kg.
■ Do not operate the Histolog® Scanner in case of damage to the imaging window.
■ The protective earthing connection of the Histolog® Scanner is performed through the power cord connection. If this cable is damaged, the device must not be connected to the mains power.
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 surgical 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.
■ Do not use disinfecting products that contain glycolic acid. These disinfecting products may damage the Histolog® Scanner.
■ The Histolog® Scanner is intended for use in the electromagnetic environment specified in the Histolog Scanner Instructions for use §16.2 and §16.3.
■ Do not use this device in proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional radio frequency (RF) sources), as these can interfere with proper operation.
■ Do not use this device in proximity of active HF surgical equipment, as these can interfere with proper operation.
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 during imaging. The Histolog® Scanner embeds a Class IIIB laser component with the following characteristics: Wavelength: 488±4 nm Max output power: 200 mW (CW); Beam divergence: < 0.7 mrad
