18
LASER AND PRODUCT SAFETY
Regulatory Requirements
THIS DEVICE DOES NOT COMPLY WITH 21 CFR 1040.
USE ONLY AS COMPONENT.
The IS4800 Series microQuest 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 milliwatts)
average radiant power
The IS4800 series laser scan engine is registered with the Center for Devices
and Radiological Health as a laser “component”. The addition of shut-down
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. Therefore, 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
microQuest 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 microQuest 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 microQuest
engine design.
Accession Number: Pending
If the product is to be used in another country, it is the responsibility of the
manufacturer who incorporates the scan engine into their product to fulfill
any regulatory compliance requirements for that country. Refer to one of the
following sections for further explanation.
(68 pages)
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