This document discusses the requirements that apply to companies who purchase a Savasto Catheter Bonding Machine for use in their facility. Recommendations for users are provided in the ANSI laser safety standard as discussed below, but in most states there are no legal regulations on laser safety installations. Please note, however, that OSHA inspectors can be called in and can cite facilities as part of their overall regulations to provide a safe workplace.
Since Savasto Catheter Bonding Machine is a Class I Laser, facilities are exempt from most of the laser safety control measures. There are a few exceptions during maintenance or service where the Class IV laser energy is accessible. This will be discussed where appropriate in this manual.
Laser Hazards – There are two main concerns when evaluating the hazard from a CO2 laser. The collimated beam direct from the laser head or a mirror (without any focusing optics) contains sufficient heat energy to damage eyes, skin or flammable materials for a considerable distance (100s of feet or more) from the source. The focused beam contains much higher power density for marking, cutting or welding, but it is present only in a very localized area near the beam focus. Past the focus, the beam pattern expands significantly, and there is a distance beyond which the power spreads over an area that is so large that the laser beam is no longer hazardous.
Fumes generated from bonding some plastics and other materials can be highly toxic. Any materials being processed should be evaluated to determine what fume collection and filtering are needed to ensure that the Threshold Limit Values (TLVs) for the byproducts are not exceeded.
ANSI Standard – Most user laser safety documents are based on the ANSI Z136 series of standards, particularly ANSI Z136.1 Standard for the Safe Use of Lasers. That document includes: a discussion of laser hazard evaluation with limits for Maximum Permissible Exposures (MPEs); administrative, engineering, and procedural control measures; requirements for laser safety officers (LSOs); a discussion of non-beam hazards; and outlines for training and medical surveillance programs.
U.S. State Requirements – In the U.S., user safety regulations are up to the individual states, and they are primarily based on the ANSI Z136.1 safety standard. Those states with active laser safety control programs (and the telephone numbers for contact) are: Arizona (602) 255-4845, Florida (904) 487-1004, Illinois (217) 785-9975, Massachusetts (617) 727-6214, New York State (718) 797-7641, and Texas (512) 834-6688. Most of those state user regulations exempt facilities with Class I systems, but they place registration and control requirements on facilities with Class IV systems or with Class I systems that allow access to Class IV energy during maintenance or service. States that require registration usually charge annual registration fees.
OSHA – The Occupational Safety & Health Administration does not have specific laser safety requirements. However, if they are called into a facility, the inspectors follow published guidelines (OSHA Instruction PUB 8-1.7 Guidelines for Laser Safety and Hazard Assessment) that are based on an earlier (1986) ANSI Z136.1 standard.
References and Resources
CDRH – Center for Devices and Radiological Health – An agency within the U.S. Food and Drug Administration which publishes and enforces legal requirements on laser product manufacturers. For copies of the CDRH regulations, contact: CDRH (HFZ-312), 2098 Gaither Road, Rockville, MD 20850, Telephone (301) 594-4654.
ANSI/OSHA – ANSI (American National Standards Institute) is a U.S. organization that publishes standards for laser users. Their laser safety standards are not laws, but they form the basis for state and OSHA requirements for the use of lasers. For copies contact ANSI in New York at (212) 642-4900 or the Laser Institute of America, at Telephone (407) 380-1553, Fax (407) 380-5588.
Labels
In various locations of the Savasto Catheter Bonding Machine, special labels are placed for identification and safety. These include the four labels on the top of the laser unit (Figure 1). There is also a safety warning label for the red diode laser on the side of the diode laser generator (Figure 2).
Figure 1. Laser Safety Labels
Figure 2. Diode Laser Warning Label
