Safe use specifications and compliance, Regulatory compliance, Hazards – Bio-Rad S3™ Cell Sorter User Manual

Page 6: Biohazards

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iv | S3 and S3e Cell Sorters

Safe Use Specifications and Compliance

Laser Product Hazard Classification

The intent of the laser hazard classification is to identify hazards to users posed by the laser, and provide appropriate protective
measures. The S3 or S3e laser is a Class 1 laser product that complies with 21 CFR 1040.10 and 1040.11, except for deviations
pursuant to Laser Notice No. 50, dated June 24, 2007 stating that operators are not exposed to harmful levels of laser radiation
during normal operation, maintenance and/or service. During times of repair and/or major service by a trained technician, laser safety
controls for Class 3B lasers must be followed.
WARNING! Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous
laser radiation exposure.

Electrical Safety Information and Classification

The S3 and S3e Systems conform to international regulations encompassing the accessibility of high voltages by the user. Use all
protective housings, interlocks, and shields as identified in this manual. Further information about specific electrical hazards is listed in
the hardware description.
AC Fuse Requirements
Remove power cord before replacing fuses.
Fuses are 5 x 20 mm and must be rated to 250 VAC, 4 A slow blow such as Schurter 0034.3123
AC Power Cord Requirements
Power cord must be IEC 60320-1 compliant with a C13 plug on the instrument end. The power cord must be rated at minimum
250 VAC, 10 A at 60ºC minimum. In the U.S. and Canada, the power cord must be rated at minimum 125 VAC, 10 A at 60ºC minimum.
Position the instrument for easy access to the power switch and the power cord.

Regulatory Compliance

This instrument has been tested and found to be in compliance with all applicable requirements of the following safety and
electromagnetic standards:

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IEC 61010-1:2010 (3rd Ed.), EN61010-1:2010 (3rd Ed). Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1:

General Requirements.

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UL/CSA 61010-1:2012 (3rd Ed.), Standard for Safety Electrical Equipment for Electrical Safety (USA, Canda, NRTL)

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IEC 60825-1:2007(2nd Ed.), EN 60825-1:2007(2nd Ed). Safety of laser products - Part 1: Equipment classification and requirements

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Class 1 laser product per CDRH requirements and regulations

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IEC 61010-2-081:2001+A1, EN61010-2-081:2002+A1. Safety requirements for electrical equipment for measurement, control and

laboratory use. Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other
purposes (includes Amendment 1)

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EN 61326-1:2006 (Class A) Electrical equipment for measurement, control and laboratory use. EMC requirements, Part 1: General

requirements

This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely
to cause harmful interference, in which case the user will be required to correct the interference at his own expense.

Hazards

The S3 and S3e Cell Sorters are designed to operate safely when used in the manner prescribed by the manufacturer. If the S3 or
S3e Cell Sorter or any of its associated components are used in a manner other than prescribed, or if modifications to the instrument
are not performed by a Bio-Rad or other authorized agent, then the warranty on the system will be voided. Service of the S3 or
S3e Cell Sorter should be performed only by Bio-Rad personnel.

Biohazards

The S3 and S3e Cell Sorters are laboratory products. However, if biohazardous samples are present, adhere to the following
guidelines and comply with any local guidelines specific to your laboratory and location.

General Precautions

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Always wear laboratory gloves, coats, and safety glasses with side shields or goggles

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Keep your hands away from your mouth, nose, and eyes

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Completely protect any cut or abrasion before working with potentially infectious materials

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