Part Number: 0160-6411, Rev A, 02/2019 Page 277 of 314
Software Release: cOS 5.00
4 Mobile Patient Bed Safety and Regulatory
This chapter addresses the following major topics:
• 4.1 General Safety and Regulatory Information, page 277
• 4.2 Electrical Hazards, page 278
• 4.3 Fire Hazards, page 279
• 4.4 Additional Safety Considerations, page 279
• 4.5 Regulatory Compliance Safety Features, page 281
• 4.6 System Labels and Symbols, page 282
4.1 General Safety and Regulatory Information
The Mobile Patient Bed complies with the following standards:
• EN/IEC 60601-1 2nd, 3rd and 3.1 ed
• EN/IEC 60601-1-4 1.1 ed
• EN/IEC 60601-1-6 1st and 3rd ed
• EN/IEC 60601-2-46 3rd ed
• EN/IEC 62366 1st ed
• EN/IEC 62304 1st and 1.1 ed
• EN/IEC 60601-1-2 4th ed
• ETSI EN 301 489-1 V1.9.2 (2011-09)
• ETSI EN 301 489-17 V2.2.1 (2012-09)
• CSA STD. C22.2 #60601-1
The essential performance for the Mobile Patient Bed is the lack of unintended bed movement
during laser surgery in any single fault condition or any combined fault conditions. When
essential performance degrades, the operator can expect unintended bed movement.
WARNING
If you experience unintended bed movement, press the emergency stop button and contact
OPTIMEDICA Service.
NOTE
This section includes safety and regulatory information for the Mobile Patient Bed. For safety and
regulatory information related to the use of the Mobile Patient Bed with the CATALYS® System,
refer to the Safety and Regulatory chapter on page 221.
The Mobile Patient Bed is a precision medical instrument that has undergone extensive testing.
With proper handling, it is a useful and reliable clinical instrument. To protect operating
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