LIT-246 CUDA
®
Surgical
Rev. E (English)
Page 3 of 80
1. INTENDED USE
The LLS-LLX is the next generation of battery-operated LED headlights. It features an efficient,
modern headlight module design made from robust aluminum, which leads to greater durability
during transport and handling. The headlight boasts a 3hr runtime at full output with the standard
battery pack and up to 6hr runtime with the extended life battery pack at full output. This new
battery-operated LED headlight provides unmatched light output and spot quality.
1.1. Indications for Use
The intended use for the LLS-LLX is to provide general illumination to a surgical site. The
device is not intended to diagnose, prevent, monitor, treat or alleviate disease, injuries, or
handicaps, nor for the investigation, replacement, or modification of the anatomy or of a
physiological process.
There are no known contraindications.
The LLS-LLX headlight is intended to be used in a controlled operating room environment with
compatible devices by qualified medical personnel. The LLS-LLX Headlight is provided non-
sterile.
1.2. Functions of Design
The LLS-LLX
comprises a headlight module, headband, smart battery pack, and battery
holster. Light intensity is controlled via a knob located on the holster, and users can control
the light spot size via a lever located on the headlight module. Additionally, the holster control
module will signal the user via audible beep that the battery charge is low.
Summary of Contents for LLS-LLX
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