INTRODUCTION
1.14
ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual
approved for safety by an appropriate agency should be connected to the ThinPrep 5000 pro-
cessor with AutoLoader.
Safety, EMI and EMC Standards
The ThinPrep 5000 processor with AutoLoader has been tested and certified by a U.S. nationally
recognized testing Laboratory (NRTL) to comply with current Safety, Electro-Magnetic Interference
(EMI) and Electro-Magnetic Compatibility (EMC) standards. Refer to the model/rating label, located
on the rear of the instrument, to see the safety certification markings (see Figure 1-7). This equipment
meets the IEC 61010-2-101 particular safety requirements for IVD equipment.
This equipment meets the emission and immunity requirements of IEC 61326-2-6. This equipment
has been tested and found to comply to CISPR 11 Class A emission limits.
In a domestic environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference. The electromagnetic environment should be evaluated prior to
operation of the equipment. Do not use this device in close proximity to sources of strong
electromagnetic radiation (e.g., unshielded RF sources), as these may interfere with the proper
operation.
This product is
in vitro
diagnostic (IVD) medical equipment.
If this equipment is used in a manner not specified by the manufacturer, then the protection provided
by the equipment may be impaired.
Laser Product Safety
This product contains a laser device, used to etch the sample accession ID onto the glass microscope
slide.
During operation, this laser equipment functions as a Class 1 laser product pursuant to the United
States Code for Federal Regulation, Title 21, Sub-Chapter J, Part 1040. This Class 1 laser product
conforms to CEN ELEC EN 60825-1:2007. During normal operation the laser beam and its reflections
are completely enclosed and there is no laser hazard to persons in the immediate area. There is,
however, a Class 4 laser inside this product and caution should be taken whenever the access door or
panels are open.
CAUTION:
Use of controls and adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
The slide laser printing system safety enclosure is interlocked and labeled to ensure safe operation.
Labels should not be removed. Interlocks should not be defeated by an operator. Service and repair
of this system must only be performed by trained Hologic personnel.
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