Bio-Rad Personal Molecular Imager™ (PMI™) System User Manual

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1.2.2 General Warnings

Warning: There are hazardous voltages inside the PMI scanner. Do not attempt to defeat
the door interlock or remove the instrument's cover. These are designed to prevent user
injury.

1.2.3 Power Safety Information

The PMI system is designed and certified to meet both IEC 61010 safety standards and
Center for Devices, Radiological Health (CDRH) laser safety standards. Certified products
are safe to use when operated in accordance with the instruction manual. This safety
certification does not extend to uncertified equipment or accessories, even when connected
to the PMI system.

This instrument and its accessories should not be altered or modified in any way. Alteration
of the PMI or its accessories will void the manufacturer's warranty, void the IEC 61010 and
CDRH certification, and create a potential safety hazard for the user.

Bio-Rad Laboratories is not responsible for any injury or damage caused by the use of this
instrument for purposes other than for which it is intended or by modifications of the
instrument not performed by Bio-Rad or an authorized agent.

Figure 1.1 shows two serial number certification labels. These are found at the rear of the
PMI system and the rear of the External Laser. This label provides manufacturing data
about the instrument, its voltage settings and CDRH compliance information.
.

Note: For easy customer access, serial number information for the PMI scanner is also
located on the right hand side of the overlay located behind the scanner door.

Fig. 1.1a. Instrument serial number information on the rear of the PMI scanner.

1.2.4 Laser Safety Information

This instrument and its accessories are certified according to 21 CFR 1040 of the CDRH,
as a Class I laser device and IEC/EN 60825-1+A1+A2 as a Class 1 Laser Device
(Figure 1.1a).

The laser contained within the PMI and PharosFX™ Plus scanning unit is configured with a
laser that generates energy up to 10 MW at 635 nm. The cover of the scanner has redundant
interlocks and is designed to protect the user.

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