Class 3B Responsibilities

LMI Technologies has filed reports with the FDA to assist customers in achieving certification of laser products. These reports can be referenced by an accession number, provided upon request. Detailed descriptions of the safety items that must be added to the system design are listed below.

Remote Interlock

A remote interlock connection must be present in Class 3B laser systems. This permits remote switches to be attached in serial with the keylock switch on the controls. The deactivation of any remote switches must prevent power from being supplied to any lasers.

Key Control

A key operated master control to the lasers is required that prevents any power from being supplied to the lasers while in the OFF position. The key can be removed in the OFF position but the switch must not allow the key to be removed from the lock while in the ON position.

Power-On Delays

A delay circuit is required that illuminates warning indicators for a short period of time before supplying power to the lasers.

Beam Attenuators

A permanently attached method of preventing human access to laser radiation other than switches, power connectors or key control must be employed.

Emission Indicator

It is required that the controls that operate the sensors incorporate a visible or audible indicator when power is applied and the lasers are operating. If the distance between the sensor and controls is more than 2 meters, or mounting of sensors intervenes with observation of these indicators, then a second power-on indicator should be mounted at some readily-observable position. When mounting the warning indicators, it is important not to mount them in a location that would require human exposure to the laser emissions. User must ensure that the emission indicator, if supplied by OEM, is visible when viewed through protective eyewear.

Warning Signs

Laser warning signs must be located in the vicinity of the sensor such that they will be readily observed.

Examples of laser warning signs are as follows:

FDA warning sign example

IEC warning sign example