WeCreat Vision Laser Safety Program

WeCreat Vision Laser Safety Program

last updated on Sep 15th, 2023.

SCOPE

This program is applicable to the WeCreat VISION Laser, owned and operated by WeCreat VISION. It adheres to the guidelines outlined in ANSI Z136.1-2014, the American National Standard for the Safe Use of Lasers. Rigorous implementation of this program ensures that laser exposures consistently remain 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 WeCreat VISION laser

· Specify control measures for the WeCreat VISION 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 WeCreat VISION laser control measures and may approve alternate controls when these are appropriate based on the judgment of the LSO. WeCreat VISION 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 intra-beam 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 intra-beam 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) is required for Class 4 laser operation.

TRAINING REQUIREMENTS

In Class 1 conditions, all users must adhere to the safety manual and WeCreat appliance software. However, when operating in Class 4 conditions, additional laser safety training is mandatory and will be organized and overseen by the Laser Safety Officer (LSO).

In situations where bystanders, children, or untrained individuals may be present in a public setting where the WeCreat VISION Laser is utilized, feed-through beam blocks must be securely installed. This precautionary measure is crucial to enhance safety and prevent inadvertent exposure. 

CONTROL MEASURES

The requirements for the WeCreat VISION Laser controlled area shall be determined by the LSO. The minimum requirements considered by the LSO for the WeCreat VISION Laser controlled area are:

· Entryway controls, if necessary, to permit access only to authorized personnel or approved spectators. (Administrative controls are acceptable.)

· Availability and use of laser safety eyewear in accordance with the Standard Operating Procedure (SOP) for the WeCreat VISION Laser.

· Implementation of beam control measures, such as barriers and beam blocks, to restrict laser hazards within the controlled area.

· A written SOP specifically for the WeCreat VISION Laser.

· Training for operators of the WeCreat VISION Laser to ensure safe and proper usage.

EYEWEAR POLICY

Laser safety eyewear is not normally required for the operation of the WeCreat VISION 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 WeCreat VISION Laser with the beam exposed shall:

· 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 intervals determined by the Laser Safety Officer, safety audits will be conducted for the WeCreat VISION Laser:

· Visual Inspection for Damage:

The laser will undergo a visual inspection to identify any signs of damage or wear.

· Review of User Manual:

The most recent user version of the manual will be thoroughly reviewed to ensure comprehensive understanding of safety protocols.

· Power-On Self-Check:

The laser will be powered on and subjected to a self-check mechanism to verify the validity of safety settings.

 These periodic safety audits are crucial to maintaining the integrity and functionality of the WeCreat VISION Laser, ensuring that it consistently meets safety standards.

RECORDS

The Laser Safety Officer (LSO) is responsible for maintaining comprehensive records documenting the Laser Safety Program. These records shall include:

1. Laser Hazard Analysis Reports:

Detailed reports analyzing the hazards associated with the WeCreat VISION Laser.

2. List of Trained Operators:

A roster containing the names of operators who have undergone training and received permission to use the WeCreat VISION Laser.

3. Standard Operating Procedures (SOP):

The documented SOP for the WeCreat VISION Laser outlining operational protocols.

4. Approvals of Alternate Control Measures:

Records indicating the LSO's approvals of any implemented alternate laser control measures.

5. Laser Safety Audit Checklist:

Documentation from the laser safety audits, including checklists and findings.

Maintaining these records ensures a transparent and accountable Laser Safety Program, providing a foundation for ongoing safety and compliance.

WeCreat VISION Laser Standard Operating Procedure (SOP)

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

1. System Description: Semiconductor laser material processing system.

A. Potential Hazards

1. Eye Hazard:

Risks related to direct, reflected, or scattered laser beams that may pose a threat to the eyes.

2. Skin and Fire Hazard:

Risks involving potential harm to the skin and the risk of fire.

3. Electrical Hazard:

Hazards associated with the electrical components inside the power supply.

4. Laser Generated Air Contaminants:

Risks related to contaminants generated by the laser, potentially affecting the air quality.

Identifying and addressing these hazards is crucial for implementing effective safety measures and ensuring the secure operation of the WeCreat VISION Laser.

Control Measures

A.  Controlled Access:

The Laser Safety Officer (LSO) will restrict physical access to the laser, permitting entry only to users who have completed enrollment in the WeCreat application software and received appropriate safety instructions.

B. Compliance with Instructions:

All users of the WeCreat VISION Laser are required to adhere strictly to the user manual and follow all instructions provided in the application software.

C. Class 1 Conditions:

The WeCreat VISION Laser will be operated under Class 1 conditions in accordance with ANSI Z136.1, 4.4.2.7.2.1, as outlined in the Hazard Analysis Report. Fulfillment of Class 1 conditions will be determined by adherence to specified guidelines during operation.

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

o Do not utilizing the laser without Bottom tray.

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

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

o Maintenance shall be done with the laser system turned off and power cable unplug.

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

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

E. Report all incidents to the LSO.

F. Authorized Personnel

By checking the box or reading this LSO document, we will consider you to be qualified or authorized.

Notes:

The laser-protective eyewear must meet a worst-case Optical Density (OD) requirement of 3.67. The eyewear provided by the laser manufacturer exceeds this requirement with a minimum OD rating of 4. The exposure duration used to determine the OD is based on the ANSI default duration for an accidental exposure, which is set at 10 seconds.

With all manufacturer safety features fully functioning and the laser operating in accordance with the Standard Operating Procedure (SOP), the only potential source for exposure above the Maximum Permissible Exposure (MPE) is a diffuse reflection that could scatter the laser output through the feed-through opening. The analysis takes very conservative assumptions into account. The exposure duration used is 600 seconds, assuming intentional viewing. The scattered power is assumed to be 45 watts, an absolute worst case. The viewing angle is assumed to be 80 degrees, with greater viewing angles creating a smaller hazard distance. Although the actual viewing angle is closer to 85 degrees or more, a conservative assumption of 80 degrees is made. Given these assumptions, the diffuse nominal hazard zone (NHZ) is approximately 5 centimeters or just under 2 inches. This NHZ is considered insignificant. Operating in accordance with the SOP ensures that the laser system meets the ANSI 4.4.2.7.2.1 requirement for operation under Class 1 conditions.

Warning Sign

Disclaimer:

This training document is crafted based on existing searchable documents, encompassing, but not limited to, 21 CFR Part 1040.10, 1040.11, ANSI Z136.1 Standard - Guidance for Implementing a Safe Laser Program, OSHA (Occupational Safety and Health Administration), the U.S. Occupational Safety and Health Alliance, the U.S. Laser Protocol: the Laser Regulators, and the Center for Devices and Radiological Health. Additionally, other publicly available documents and standards issued by these agencies at the time of developing this document have been considered. The preparation of documents and standards by these organizations, along with courses and presentations by laser safety experts in the public domain, have been considered. It is crucial to note that the ultimate right of interpretation for this document lies with WECREAT.