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General| Brand | LiteCure Medical |
|---|---|
| Model | LightForce FX |
| Category | Health Care Products |
| Language | English |
Alerts the reader to specific or potential danger. Ignoring can lead to injury or death.
Alerts the user to potential problems, device malfunction, or damage.
Offers guidance for acceptance or trial to optimize utilization.
Describes conditions or exceptions that may apply to the subject matter.
Designates a supervisor responsible for training on operating and safety procedures.
Details safety features like the Emergency Laser Stop and Power Switch.
Outlines unattended protection, internal monitoring, and eye protection requirements.
Classifies the LightForce FX laser according to various safety and regulatory standards.
Lists compliance with FDA regulations and EU/CAN medical device directives.
Specifies the device's intended use for pain relief and circulation.
Lists conditions and patient types where the device should not be used.
Provides critical safety warnings for operation to prevent burns and eye damage.
Details safety considerations related to fire and explosion risks.
Identifies key components visible on the front of the device.
Highlights components located on the bottom of the device.
Details the ports and connectors found on the back of the device.
Guidance on inspecting and unpacking the device upon receipt.
Recommendations for user training and facility safety programs.
Instructions for selecting a suitable location and setting up the device.
Step-by-step instructions for connecting the optical fiber to the device.
Steps for preparing the patient and treatment area before therapy.
Details the hand piece and interchangeable treatment heads.
Instructions for installing the optical fiber into the emission port.
Mandates wearing safety eyewear for all personnel during operation.
Procedure for turning on the LightForce FX device.
Overview of options available on the device's main menu.
How to adjust settings like aiming beam, volume, and switch overrides.
Guidance on selecting patient characteristics and treatment protocols.
Instructions for creating custom treatment protocols based on patient data.
Explanation of the device's standby mode functions and settings.
Description of the ready mode for laser emission activation.
Details on laser output monitoring, power tolerance, and emission conditions.
Description of the single intensity finger switch for laser control.
Details the optional single intensity foot switch accessory.
Identification of the AC power cord for device operation.
Identification of the power adapter used with the device.
Guidance on wearing protective eyewear for laser safety.
Steps for performing power calibration by certified personnel.
Warning that unauthorized calibration voids the manufacturer's warranty.
Detailed procedure for testing and verifying laser power output.
Outlines the 24-month warranty coverage and exclusions.
Steps to follow for initiating a warranty claim and returning the product.
EMC emissions guidance for ME equipment and systems.
EMC immunity guidance for ME equipment and systems.
Separation distances for RF equipment to maintain EMC.
Explains the laser classification and radiation hazard warning label.
Details the information contained on the identification label.
Description of the safety label for the protective housing.
Information regarding the warranty void seal.
Identification of the optical fiber applicator label.
Identification of the laser emission label.
Identification of the emergency stop button label.
Identification of the finger/foot switch label.
Identification of the remote interlock connector label.
Identification of the CE mark label and authorized representative.
Identification of the DC power input label.
Identification of the protective earth label.
Identification of the power switch label.
