
4Amico Clinical Solutions Corp.
Introduction
Thank you for acquiring our new iCE 30m LED Series Surgical Light.
The Amico iCE 30m LED Series Surgical Lights provide high intensity and shadow free illumination to the patient surgical
eld during surgical procedures.
The iCE LED Surgical Lighting System brings the newest LED technology to the Operating Room. The iCE LED Surgical
Lights are designed for superior shadow control, increased depth of eld and light intensity. They have a CRI OF 97 and
a R9 greater than 90, allowing surgeons to easily dierentiate between tissues. The standard 4500 K color temperature
provides a crisp white light ensuring the surgical eld remains clearly illuminated. Amico‘s multicolor light allows users
to adjust the color temperature from 3500K to 5000K. The adjustable color temperature ensures the light can match the
unique requirement of any procedure while also having the ability to adjust to surgeon’s preference.
Intended User Prole:
• The iCE 30m Surgical Lights are intended to be used by trained medical practitioners in operating rooms, procedure
rooms, emergency departments and intensive care units.
• User has to be able to read the words in the mylar control and wall control to operate the light.
• User has to be able to understand the instructions for use (IFU) and the training provided by Amico sta (or other
designated personnel)
• User has to be able to position the iCE 30m Light by holding the light through the openings.
Intended Use:
• The iCE 30m LED Surgical Lightning System is designed to illuminate the surgical eld with a cool, bring white light and
an adjustable pattern size.
Patient Population:
• Age: newborn, bariatric and geriatric
• Weight: not relevant
• Health: not relevant
• Nationality: Multiple
• Patient State: patient is not a user
Application:
• Environment: The iCE 30m Surgical Lamp is intended to be used in the operating rooms, procedure rooms, emergency
departments and intensive care units.
• Physical – see Environmental Conditions Section
• Frequency of use: Several times a day
• Mobility: Central Axis is xed to the supporting structure but the extension arm and spring arm can be moved so as to
position the surgical light to illuminate the operating eld.
Training:
• Training provided by Amico Sales sta (or other designated) via hands-on demonstration of the equipment along with
the Instructions for Use and the Quick Reference Card (File: “IcelightsTrainingCard”).