EasyManua.ls Logo

Solta Medical Fraxel DUAL 1927 User Manual

Default Icon
92 pages
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Page #1 background imageLoading...
Page #1 background image
Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 1 of 92
Fraxel
®
1550, Fraxel 1927 and
Fraxel DUAL 1550/1927
Laser Systems Operator Manual
Fractional Resurfacing with IOTS
Intelligent Optical Tracking
®
System
Manufactured by
Solta Medical, Inc.
25881 Industrial Blvd
Hayward, CA 94545 U.S.A.
Phone: +1 510-782-2286
Customer Service +1 510-782-2286; or
Authorized Distributor

Table of Contents

Question and Answer IconNeed help?

Do you have a question about the Solta Medical Fraxel DUAL 1927 and is the answer not in the manual?

Solta Medical Fraxel DUAL 1927 Specifications

General IconGeneral
Wavelength1927 nm
Electrical Requirements100-240 V, 50/60 Hz
FDA ClearedYes
Treatment DepthUp to 200 μm
IndicationsPigmentation, acne scars, skin resurfacing
Cooling Systemcontact cooling
Pulse DurationVariable

Summary

Fraxel Laser Systems Operator Manual

System Operation

Routine Precautions Before Treatment

Outlines essential steps before operating the system.

Safety Guidelines

Covers safety considerations, hazards, and precautions.

Pre-Treatment Precautions

Essential steps before starting treatment.

Warnings, Cautions, and Notes

Interpreting Safety Messages

Explains how to recognize and interpret safety messages in the manual.

Indications for Use

Device Overview

Control Features

Emergency Stop Button

Explains the operation of the emergency stop button.

Treat Mode Operation

Treatment Parameter Adjustments

Pattern Preview Test

Measurement-Guided Dosimetry

Measurement Process

Facial Surface Area Measurement Example

Estimated kJ Value Interpretation

Parameter Selection

Total Treatment Density

Handpiece Tracking (IOTS)

IOTS Functionality and Use

How the IOTS senses motion and direction for treatment.

Tip Management Procedures

Tip Cleaning and Disinfection

Pre-cleaning and Disinfection Procedures

High Level Disinfection Process

Normal Shut-down Procedure

Safety Information

Laser Classification and Hazards

Explains laser classification and associated hazards.

General Safety Precautions

Emphasizes reading manual and proper use.

General Hazards and Fire Precautions

Flammable Substances and Fire Risk

Warnings about using flammable materials near the laser.

Fire Safety Practices

Patient Oxygen and Fire Safety

Precautions when using oxygen with the laser.

Optical Safety

Laser Safety Roles and NOHD

Roles in enforcing safety and calculating NOHD.

NOHD Calculation Formula

Formula and definition for calculating NOHD.

Laser Output Parameters and Eyewear

Laser Output Specs and NOHD Eyewear

Details on laser output specs and required eyewear optical density.

Eyewear and Treatment Room Safety

Eyewear Care and Room Safety

Guidelines for eyewear care and room safety.

Eye Protection and Laser Beam Hazards

Eye Protection Limitations

Warning against using contact lenses/spectacles for protection.

Caution When Treating Near Eyes

Extra caution when treating near the eyes.

Operation of the Laser System

Operator Training and Procedures

Recommends training and references standards for operation.

Laser Treatment Operation Rules

Footswitch and Handpiece Handling Rules

Rules for footswitch and handpiece during treatment.

Electrical Safety

Power Connection Safety

Safety measures for plugging in the unit.

Protective Housing and Servicing Safety

Warnings about opening panels and servicing.

Laser Treatment Controlled Area (LTCA)

Laser Suite Access and Interlocks

Laser Routine Maintenance and Handling

Post-Treatment Handpiece Cleaning

Steps for cleaning the handpiece after treatment.

Storage and Handling Precautions

Regulatory Compliance and Safety

Remote Interlock and Protective Housing

Regulatory Compliance Labels

System Labeling and Symbols

Physician Information

Indications for Use

Refer to Section 1.1 for approved uses.

Contraindications

Pre-Treatment Patient Recommendations

Medication and Sun Exposure Guidelines

Recommendations for stopping certain activities before treatment.

Patient Preparation

Post-Operative Care Information

Expected Treatment Responses

Edema, Erythema, and Itching

Expected swelling, redness, and itching post-treatment.

Treatments and Intervals

Potential Complications

Skin Complications: Burns, Discoloration, Scarring

Potential complications like burns, discoloration, and scarring.

Infection, Eye Injury, and Bruising Risks

Risks of infection, eye injury, and bruising.

Maintenance and Warranty

Cleaning Procedures

Decontamination of Returned Equipment

Decontamination Certificate Requirements

Requirements for decontaminating equipment before return.

Safety Standards and Regulatory Classifications

Compliance with Standards

Compliance with FDA, CDRH, IEC, and EN standards.

Laser System Specifications

Treatment Beam Specifications

Details on product, classification, wavelength, and power.

Laser Safety Eyewear and Cart

Operating Environment and Storage

Electromagnetic Compatibility and Immunity

Electromagnetic Emissions Guidance

Electromagnetic Immunity Requirements

RF Communications Equipment Separation

RF Transmitter Separation Tables

External Factory Calibration

External Calibration Procedure

Step-by-step guide for external factory calibration.

Shipping, Installation, and Setup

Environmental and Electrical Requirements

System Movement and Parking Procedures

Labeling Symbols Guide

Device Symbols and Port Identification

Related product manuals