Life support devices or systems are devices or systems that support or sustain life, and
whose failure to perform can be reasonably expected to result in a significant injury or
death to a person. A critical component is any component of a life support device or
system whose failure to perform can be reasonably expected to cause the failure of the
life support device or system, or to affect its safety or effectiveness.
Laser Warning
WARNING This device emits CDRH/IEC Class 2 laser and IEC Class 1M light. Do not stare
into beam.
Serial Number, Configuration, Date Code, and Modification
Codes
The serial number label is placed onto the safety and compliance label.
The serial number label includes the following information:
The serial number (SN), which uniquely identifies the unit.
The configuration number (CN), which details the build configuration.
The modifications codes, which are to the right of the CN number and are a
series of 20 numbers. When any of these numbers are blocked out, that identifies a
modification that was made to the unit.
Potential for Radio Frequency Interference on Device Operation
Both portable and mobile RF communications equipment can affect medical electrical
equipment, including SLS PCS. SLS PCS is intended for use in the electromagnetic
environment specified in the guidance and manufacturer’s declaration section.