Introduction

Safe operation of your xTool P2 requires a trained Laser Safety Officer (LSO). xTool has consulted with professional organizations to design these xTool P2 LSO Training Materials to help you in complying with your LSO responsibilities and ensure that you operate your xTool P2 safely.

The first document, the xTool P2 LSO training, has three parts:

● The first section, "xTool P2 Safe Operation", describes the procedures to ensure safe operation.

● The second section, "Laser Safety Officer Responsibilities", describes your role as the Laser Safety Officer for your xTool P2.

● The third section, "About Lasers and Laser Safety", describes general information about lasers and laser safety as well as regulations on lasers.

The second document, "xTool P2 Laser Safety Program", is a laser safety program document that you, as the LSO for your xTool P2, may adopt.

The third document, "xTool P2 Laser Standard Operating Procedure", is an SOP document that you may adopt that is a part of the xTool P2 Laser Safety Program.

The fourth document, "Warning Sign", is a sign you may choose to use as a compliance measure described in the SOP, if you decide not to operate your xTool P2 in Class 1 conditions.

xTool P2 safe operation

Class 1 operating conditions

Your xTool P2 is a Class 4 laser. However, some safety precautions may create "Class 1 operating conditions" around the laser. Class 1 operating conditions mean that these conditions cannot produce damaging radiation levels during normal operation.

This means that if you choose to use the Safety Drawer and Raiser Base described below, you do not need additional protective measures, such as safety glasses, signs, and warning lights.

However, even under Class 1 operating conditions, everyone using xTool P2 must read and follow all instructions in the user manual and XCS.

Safety Drawer

Your xTool P2 will provide Safty Drawer. It is a drawer used to close the bottom. When xTool P2 is used in "Class 1 operating conditions", it is necessary to install it at the corresponding position at the bottom of the machine and make the sensor at this position sense that the drawer is closed. When Safety Drawer is installed and all instructions in the manual and xTool application are followed, there are Class 1 operating conditions. In addition to the manual and xTool application, no further laser safety precautions are required.

Raiser Base accessories

When the Safety Drawer is not at the corresponding position at the bottom of the machine, use the Railer Base accessory, follow all instructions in the manual and xTool application, and close the door panel of the Railer Base accessory. There are Class 1 operating conditions. The laser operator must prevent children and untrained users from accessing xTool P2.

Operation other than Class 1 condition

If your xTool P2 does not run under Class 1 operating conditions, you are responsible for ensuring safe operation. The SOP provided does not allow safe operation under Class 4 operating conditions, so LSO must create an SOP. Finally, the LSO is responsible for defining the required content, describing and implementing it according to the SOP, and the laser operator is responsible for ensuring compliance and safe operation. Some key elements of Category 4 SOP may include:

Appropriate safety glasses

xTool P2 does not provide safety glasses. xTool will sell relevant glasses; Contact xTool.com for more information. Note that these eyes only protect against the diffuse reflection of the laser, so be sure to avoid direct laser light.

Laser prompt

Put appropriate laser safety signs at the entrance to remind people of the dangers inside. xTool provides an example flag (below).

Light and visual indication

The light and visual indicators on the outside of the machine are opened by the user before starting to use the laser to indicate that the laser is in use.

Laser Interlock

The physical switch on the door will make the laser unable to be turned on in the operation state. Only after confirming that the laser stops working, the system will actively turn on the physical switch and make the machine in an accessible state. When the laser is in operation, the laser output laser has no direct line of sight at and outside the machine;

Laser Safety Officer Responsibilities

The LSO and Your Laser Safety Program

ANSI Z136.1 describes guidelines for a safety program that will minimize the hazards of a Class 4 laser like the xTool P2. Primary safety responsibility rests with someone designated as the Laser Safety Officer, or LSO. This document is designed to assist you in acting as the LSO for one or more xTool P2 units. It does not provide sufficient information to advise you on acting as the LSO for any other laser.

The LSO verifies the classification of the laser. The LSO determines the level of hazard by considering the details of the laser and creates a standard operating procedure (SOP) that determines what control measures (like additional interlocks, training, and safety glasses) should be used.

The LSO is then responsible for helping and training other laser users, ensuring safety compliance, analyzing any possible hazards, providing safety equipment, ensuring all regulations are complied with including (in the US) CDRH, OSHA, and state regulations, and auditing the use of the laser to make sure it’s used safely.

Beyond these responsibilities, the LSO must also recommend and approve signs, labels, protective equipment, facilities, equipment, and any modifications, maintain records, approve laser system operation, and investigate accidents should one occur. The LSO is ultimately the one responsible for determining if and how a laser may be safely operated.

Hazard Analysis

The LSO must analyze the hazards present in the lasers for which they are responsible. xTool has created a hazard analysis (provided below) of the xTool P2 that you may choose to use in your laser safety program.

Standard Operating Procedure

Based on Hazard Analysis, the LSO must create a Standard Operating Procedure (SOP) that describes the control measures required to minimize hazards. xTool has also created a sample SOP (provided below) that you may use or adapt to your xTool P2 laser safety program.

About Lasers and Laser Safety

How Lasers are Different

Lasers are a special kind of light source. Most light is made of many different colors, all shining out in lots of directions at once. Laser light is different in three ways.

First, laser light is monochromatic - just one color. Sometimes that color is visible, like the low-power red laser that you can see your xTool use to measure material when it’s focusing. Sometimes it's invisible, like the high-power infrared laser beam your xTool uses to cut and engrave material.

In technical discussions, people describe lasers as producing "nonionizing electromagnetic radiation". That describes a broad category that includes everything from sunshine to radio waves. Instead of talking about color, they use the term "wavelength". The wavelength of the low-power measuring laser on your xTool is 650 nanometers, which is red. The wavelength of the powerful printing laser is 10,600 nanometers, which is invisible infrared.

The second difference between laser light and regular light is that laser light is directional. That means that it can be made to travel in a straight line, in a beam, without spreading out much.

The third difference is that laser light is coherent. That means that each lightwave is synchronized with the others.

It’s very hard to get light to move in a straight line, without spreading out. If the waves aren't lined up, or if there's a mix of colors and directions, the beam will spread out. Lasers, however, can stay lined up for a long distance - and, importantly, can be focused down to a point.

Lasers' greatest effectiveness and danger, as compared to ordinary light, comes from lasers' ability to be focused.

Laser Background

The very first laser used a strobe light and a ruby crystal. The light from the strobe was amplified in the ruby crystal, stimulating it to emit nonionizing electromagnetic radiation at 694 nanometers. The acronym "LASER" comes from this experiment - light amplification through stimulated emission of radiation.

These first lasers were called "solid-state" lasers because the action parts were solid crystals. Shortly after the development of solid-state lasers came gas lasers, which can resemble neon signs. Electricity causes gas in a tube to glow. Specially tuned mirrors amplify the light, and the laser beam emerges. The infrared printing laser in your xTool is a gas laser. It uses a mixture of gases, but the gas that actually creates the beam is Carbon Dioxide, also known as CO2.

One of the most recent lasers to be invented is the diode laser. Diode lasers are small electrical devices that are made of microchips and LEDs. They turn power directly into laser light. You may have seen one before on a laser pointer. The low-power red measuring laser in your xTool is a diode laser.

Measurements

There are four measurements used to describe the effect of a laser.

Joules measure energy. If you shine a light on a gram of water until it absorbs 1 joule of energy, the water will heat by about a quarter of a degree Celsius.

Watts measures power. If you turn on a one-watt light for a second, it will put out 1 joule during that time.

Joules per square centimeter measures radiant exposure. If you focus down that one-watt light to a square centimeter of paper and shine it for a second, that one joule will spread over the paper, and it will heat up slightly, just like the water. However, if you focus it down to 1/100th the size, the paper may singe and turn brown.

Finally, watts per square centimeter measure irradiance. If you keep shining that one-watt light on the paper, it will keep adding joules of energy. If it’s focused to one square centimeter, it will slowly warm. If it’s focused to 1/100th the size, the paper may catch fire.

Laser Beam Hazards

Laser beams can be hazardous because the energy of the laser can damage the eyes and skin. If the main infrared laser in your xTool P2 strikes tissue, it will heat the tissue. This can cause damage to both eyes and skin. The risk is higher if the laser is more powerful if it is more focused, and if it stays in one place for a longer time, so all of these factors are considered when assessing safety.

The laser beam can strike a person in one of three ways. First, the laser can be pointed at the person directly. Second, in specular reflection’, the laser can be reflected toward a person. Third, in diffuse reflection’, the laser strikes a surface that is not a mirror and scatters the light in all directions. Because the light from a diffuse reflection is scattered, it is not as hazardous as direct or reflected light, but there may still be enough intensity to cause damage.

While any part of the body may be damaged by a laser beam, the eye is particularly sensitive and vulnerable. The far-infrared like the beam from CO2 lasers is absorbed by the cornea in front of the eye; therefore, unlike many other lasers, it is not a retinal hazard.

Laser Hazard Classes

Lasers are classified by the level of radiation that may be encountered during normal operation.

Class 1 lasers are incapable of causing injury during normal operation. Class 1M lasers are the same, except unless magnifying optics are used. The red measuring laser in the xTool P2 is a Class 1 laser.

Class 2 lasers are incapable of causing injury in less than 0.25 seconds. Class 2M lasers are the same, except unless magnifying optics are used.

Class 3R lasers are marginally unsafe if the beam is directed at the eye. Class 3B lasers are hazardous if the beam is directed at the eye, but are usually not an eye hazard if the beam is scattered.

Class 4 lasers are eye and skin hazards for both direct and scattered exposure. The infrared printing laser in the xTool P2 is a Class 4 laser.

Laser Regulations

In the US, laser manufacturers like xTool are regulated by the Center for Devices and Radiological Health (CDRH), and are required to follow 21 Care FR 1040.10 and 1040.11, which are federal law. In many other countries (but not the US), both laser manufacturers and laser users are required to follow IEC60825.

ANSI Z136.1 is a voluntary standard that describes how to use lasers safely. OSHA (a US federal law that applies to workplaces but not to private homes) requires a safety program like that described in the ANSI standard.

The CDRH requires that Class 4 laser devices have a defined set of safety features. The case of the xTool P2 prevents access to excess laser radiation and serves as the protective housing. Safety interlocks disable the laser if the lid is opened. A remote interlock connector on the back of the xTool P2 allows you to connect a separate interlock, such as a switch on the door to the room, that disables the laser and requires the laser to be restarted before it can be used again. The password to your account serves as the master key control for your xTool P2 that prevents unauthorized laser operation. The button of the xTool P2 serves as the emission indicator; if it is illuminated, laser light may be present. The controls are located so that laser exposure is not required to operate them, and all viewing optics limit exposure to Class 1 levels. There are also certain labels present required by the US and some international laws.

There may be other laser regulations depending on your country, state, and even city, and regulations may change. This information is provided to assist you in creating a safety program as described by ANSI Z126.1, but cannot advise you on legal compliance.

Non-Beam Hazards

There are additional hazards to your xTool P2. Always operate your xTool P2 in accordance with the manual and follow all instructions in the XCS to minimize hazards.

Electrical

Your xTool P2 uses a high-voltage power supply. Overriding the safety interlocks, operating a laser where the case is damaged, unauthorized service, or any other use in violation of the manual may expose you to hazardous and even lethal voltages.

Laser GeneratedAir Contaminants

When using a laser to process materials, a variety of air contaminants may be produced that can be hazardous. The air must be filtered to remove those contaminants. Follow the user manual in your xTool P2 to ensure that all exhaust is either properly treated or discharged outdoors where it can safely dissipate.

Process Nonionizing Radiation

Processing metals with a laser may result in the release of ultraviolet light. If your xTool P2 produces a bright light that cannot be viewed comfortably, look away.

Collateral Nonionizing Radiation

The material that produces the laser beam may emit harmful levels of UV and/or IR light. The xTool P2 has been tested to ensure that harmful levels are not present outside the case or when viewed through the glass lid.

xTool P2 Laser Safety Program

SCOPE

This program applies to xTool P2 Laser operated by xTool P2 Owner. This program is based on the guidance of ANSI Z136.1-2014, the American National Standard for Safe Use of Lasers. The proper implementation of this program will assure that laser exposures are always below the maximum permissible exposure (MPE) limits.

LASER SAFETY OFFICER

An individual designated as the Laser Safety Officer (LSO) shall have the responsibility and authority to assure compliance with this program. The LSO shall:

Provide hazard evaluations for xTool P2 laser

Specify control measures for the xTool P2 laser and assure implementation

Approve procedures, SOPs, protective equipment, signs, and labels

Assure that all laser personnel receive appropriate safety training

Monitor the program and assure compliance

Maintain program records

The LSO shall have final authority in determining xTool P2 laser control measures and may approve alternate controls when these are appropriate based on the judgment of the LSO. xTool P2 laser shall be operated only with the approval of the LSO. The LSO shall have the authority to terminate laser operations at any time.

LASER CLASSES

Class 1 laser systems are incapable of producing damaging radiation levels during normal operation and are exempt from any control measures. Class 1 laser systems may contain higher class lasers and may produce laser hazards if operated with interlocks defeated. Only authorized personnel may operate class 1 laser systems with interlocks defeated. Operators of class 1 laser systems with embedded class 3B or class 4 lasers shall receive a laser safety briefing.

Class 1M laser systems are incapable of producing hazardous exposure conditions during normal operation unless the beam is viewed with optical instruments. Operators of Class 1M laser systems shall receive a laser safety briefing.

Class 2 laser systems emit visible light only at a power level of 1 milliwatt or less. The normal aversion response to bright light is adequate protection. Staring into the beam of a class 2 laser is hazardous. Operators of class 2 laser systems shall receive a laser safety briefing.

Class 2M laser systems emit visible light only. The normal aversion response to bright light is adequate protection for unaided viewing. However, viewing the beam with optical aids is potentially hazardous. Operators of Class 2M laser systems shall receive a laser safety briefing.

Class 3R laser systems are potentially hazardous under some viewing conditions, but the probability of an actual injury is small, and the control measures for safe use are straightforward. Most laser pointers fall in this class. Operators of class 3R laser systems shall receive a laser safety briefing. (Most lasers previously classified as class 3a fall in this category.)

Class 3B laser systems are eye hazards for intrabeam viewing and specular reflections, even for momentary exposures, but diffuse reflections are not usually hazardous. Class 3B laser systems shall be operated only in laser-controlled areas by authorized operators. Operators of class 3B laser systems shall receive approved laser safety training.

Class 4 laser systems are eye hazards and skin hazards for intrabeam exposures, specular reflections, and diffuse reflections. They are also fire hazards and may produce laser-generated air contaminants. Class 4 laser systems shall be operated only in laser-controlled areas by authorized operators. Operators of class 4 laser systems shall receive approved laser safety training. Written Standard Operating Procedures (SOP) are required for class 4 laser operation. The xTool P2 Laser is certified by the FDA under the Code of Federal Regulations Title 21 as a class 4 laser system.

TRAINING REQUIREMENTS

When operating in Class 1 conditions, all users will read and obey the safety manual and XCS software. When operating in Class 4 conditions, additional laser safety training is required and must be prepared and administered by the LSO.

If there are bystanders or children, or if the xTool P2 Laser is used in a public setting where untrained individuals may be present, feed-through beam blocks must be securely installed.

CONTROL MEASURES

The requirements for the xTool P2 Laser-controlled area shall be determined by the LSO. The minimum requirements considered by the LSO for the xTool P2 Laser controlled area are:

·If needed entryway controls to allow only authorized personnel or approved spectators to enter the xTool P2 Laser control area. (Administrative controls are acceptable.)

Laser safety eyewear available and used in accordance with the SOP for the xTool P2 Laser.

Beam control (barriers and beam blocks) to limit laser hazards within the controlled area.

Written SOP for the xTool P2 Laser.

Training of the xTool P2 Laser operators.

EYEWEAR POLICY

Laser safety eyewear is not normally required for the operation of the xTool P2 when operating in Class 1 conditions as described in the SOP. The LSO will require eyewear or approve laser operation without eyewear based on a hazard evaluation performed by the LSO or the LSO may choose to delegate this responsibility.

RESPONSIBILITIES OF EMPLOYEES WORKING WITH LASERS

Employees who work with the xTool P2 Laser with the beam exposed shall: Energize or work with lasers only when authorized to do so.

Comply with laser safety rules and work procedures.

Notify their supervisor or the LSO in case of potential accident or injury or suspected unsafe condition.

LASER SAFETY AUDIT

At an interval determined by the Laser Safety Officer, the xTool P2 Laser will be audited for safety:

1) It will be visually inspected for damage.

2) The most recent user version of the manual will be re-read.

3) The laser will be powered on and self-checked to confirm whether the safety settings are invalid.

4) The Laser Safety Program will be reviewed to ensure that the program is current and compliant.

A record of this audit will be completed, printed, signed, dated, and retained.

RECORDS

The LSO shall maintain records that document the Laser Safety Program. These records shall include:

Laser hazard analysis reports for the xTool P2 Laser

A list of operators who have been trained and permitted to use the xTool P2 Laser

Standard Operating Procedures for the xTool P2 Laser

Approvals of alternate laser control measures, if implemented

Laser Safety Audit checklist

xTool P2 Laser Standard Operating Procedure (SOP)

Scope: This SOP applies to the normal operation of the xTool P2 Laser as specified by the manufacturer.

System Description: Three-axis carbon dioxide laser material processing system. This is a class 4 laser system that is normally operated under class 1 conditions (ANSI Z136.1, 4.4.2.7.2.1).

Wavelength: 10.6 µm

Maximum Power: 55 W

Operating Mode: Continuous Wave

Beam Diameter: 5 mm

Beam Divergence: 2.7 mrad (M2 =1)

Potential Hazards

A. Eye hazard from the direct, reflected, or scattered beam.

B. Skin hazard and fire hazard.

C. Electrical hazard inside the power supply.

D. Laser Generated Air Contaminants.

Control Measures

A. The LSO will only allow physical access to the laser to users who have been enrolled in the XCS software and thereby received safe operating instructions.

B. All users of the xTool P2 Laser will comply with the user manual and all instructions in the XCS software at all times.

C. The xTool P2 Laser shall be operated in class1 condition per ANSI Z136.1, 4.4.2.7.2.1 (reference Hazard Analysis Report). Class 1 conditions shall be considered fulfilled when operating under the following guidelines.

A. The laser system shall be operated with all manufacturer safety features fully functional.

B. When material passthrough is not used, the Safety Drawer shall be firmly in place.

C. When utilizing the material without Safety Drawer, use Raiser Base.

D. Do not place an unprotected eye at the Safety Drawer opening.

E. Keep all combustibles, tools, and reflective surfaces away from the beam path. Make sure you know where the beam is and stay clear.

F. Work involving access to the power supply shall be done by the manufacturer with no exceptions.

G. Maintenance shall be done with the laser system turned off.

H. When functioning normally, the exhaust system will remove LGACs to maintain levels that are not hazardous or irritating.

Required Training: When operating in Class 1 conditions, all users will read and obey the safety manual and XCS software. When operating in Class 4 conditions, additional laser safety training is required and must be prepared and administered by the LSO.

For emergency medical response call ____. Report all incidents to the LSO.

Authorized Personnel

Notes:

The worst case Optical Density (OD) requirement for laser-protective eyewear is 3.67. The eyewear provided by the laser manufacturer is rated at a minimum of OD 4. The exposure duration used to determine the OD is the ANSI default duration for an accidental exposure of 10 seconds.

With all the manufacturer safety features fully functioning and the laser operating per the SOP the only source for a possible exposure above the Maximum Permissible Exposure (MPE) is a diffuse reflection that could scatter the laser output through the feed-through opening. Very conservative assumptions are made in this analysis. The exposure duration used is 600 seconds which assumes intentional viewing. The scattered power is assumed to be 45 watts which is an absolute worst-case. The viewing angle is assumed to be 80 degrees. Greater viewing angles create a smaller hazard distance. The viewing angle in this case is closer to 85 degrees or more so a conservative assumption is 80 degrees. Given the assumptions, the diffuse nominal hazard zone (NHZ) is about 5 centimeters or just under 2 inches. This NHZ is insignificant. Operating per the SOP, the laser system fulfills the ANSI 4.4.2.7.2.1 requirement for operation under class 1 conditions.

Warning Sign

Disclaimer:

This training document is based on existing searchable documents, including but not limited to 21 CFR Part 1040.10, 1040.11, ANSI Z136.1 Standard - Guidance for Implementing a Safe Laser Program, OSHA, the U.S. Occupational Safety and Health Alliance, the U.S. Laser Protocol: the Laser Regulators and the Center for Devices and Radiological Health, and other publicly available documents and standards issued by the above agencies at the time of this document's development. The documents and standards issued by these organizations and available in the public domain have been prepared, and the courses and presentations of some laser safety experts in the public domain have also been taken into account. The final right of interpretation of this document belongs to XTOOL.