Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 48 of 101
Table 15 Symbols on PSC Device Label
# Symbol Meaning Source
7.
Consult the instructions for use ISO 7000 - 1641
8.
Unique Device Identifier N/A
5. Cleaning and Disinfection
Warning
Failure clean, disinfect, and sterilize the Eagle V1.2 Imaging System may result in
cross-contamination, and patient or user exposure to microbiological
contamination.
Warning
Do not clean, disinfect, or sterilize the Eagle V1.2 Imaging System when energized.
Power off the device before cleaning, disinfecting, or sterilizing. Cleaning,
disinfecting, or sterilizing when energized may be hazardous to the operator
and/or destructive to the system.
Warning Use only approved cleaning and sterilization procedures
Warning
Do not reuse the Eagle Custom Sterilize Sleeve or Dark Imaging Sheet. They are
single use only accessories.
Caution Improper cleaning/sterilization may reduce image quality.
Caution
Prior to disinfection or sterilization, ensure surfaces are cleaned to remove organic
matter as described in the sections below.
Note
The user should dispose of the cleaning, disinfection, and sterilization materials
according to biohazard waste control processes at their Institution.
Note
Follow precautions established in your facility when handling any medical device
that has been used intraoperatively and has been in contact with body fluids,
tissues, or blood.
In accordance with the Spaulding Classification scheme, the Handheld Fluorescence Camera is classified
as a critical medical device that is intended to contact normally sterile tissue, thereby introducing a
likelihood of microbial transmission and risk of infection if the device is not sterile. Therefore, it is essential
that the Handheld Fluorescence Camera be cleaned, sterilized, and rinsed before use or reuse to prevent