33
Regulatory Compliance
THIS DEVICE DOES NOT COMPLY WITH 21 CFR 1040. USE ONLY AS COMPONENT.
The IS4800 Series Laser Scan engines are designed to meet the requirements of IEC Class 2 in accordance
with IEC 60825-1:1993+A1:1997+A2:2001. IEC Class 2 is defined as follows:
Emission Duration: Greater than 0.25 seconds
Accessible Emission Limit: Less than 0.001 W (1.0 milliwatt) average radiant power
The IS4800 laser scan engine series is registered with the Center for Devices and Radiological Health as a
laser “component”. The addition of shutdown controls, labeling and informational requirements are necessary
to achieve compliance with the performance standard published in the Code of Federal Regulations (CFR),
Title 21 Parts 1040.10 and 1040.11.
It is the responsibility of the manufacturer who incorporates the
scan engine into their product to provide the additional performance, labeling, and informational
requirements necessary to comply with all federal laser safety regulations.
The specifications required for agency approval are not obtainable until the IS4800 engine is used in its final
configuration. Metrologic is unable to fulfill these requirements because the scan engine will operate differently
depending upon where it is used as a component. The following information concerning the scan engine
appears on the shipping label:
THIS DEVICE DOES NOT COMPLY WITH 21 CFR 1040.
USE ONLY AS A COMPONENT.
Manufacturers incorporating unmodified IS4800 engines into their product may reference the following
accession number on items in their Laser Product Report that request information concerning features inherent
in the IS4800 engine design.
Accession Number: 0620138-00
It is the responsibility of the manufacturer who incorporates the scan engine into their product to
obtain country specific regulatory compliance prior to the sale of the product. Refer to one of the
following sections for further explanation.
United States: Refer to page 34 for more information.
Canada: Refer to page 35 for more information.
Europe: Refer to page 35 for more information.
