RESUMEN

OBJECTIVE: This study evaluated the completeness and accuracy of information in LCU instruction manuals from 40 manufacturers. MATERIALS AND METHODS: Instruction manuals from 40 LCUs (20 from leading manufacturers and 20 budget units) were reviewed. Twenty-eight parameters across five categories were assessed using a binary scale (0=incorrect/missing, 1=correct). The categories and their respective evaluation scores were: LCU characteristics (43%), instructions for use (7%), safety precautions (14%), maintenance recommendations (29%), and regulatory certification (7%). These scores were combined to produce a final score. RESULTS: Scores from leading manufacturers ranged between 46-86%, while the budget category ranged from 18-68%. All manuals provided information about the wavelength/spectrum of the LCU. Only Valo X and Valo Cordless reported power values and used the term "irradiance" instead of "intensity." Details such as LED type and active tip emission area were often missing. Instructions on how to use the LCU to photo-cure resins were frequently limited. Although most manuals addressed safety precautions, several lacked details on heat issues and general health precautions. All manuals included maintenance instructions, though information on replacement parts was often missing. Among the LCUs, 85% stated they were CE certified, 32% held both FDA and CE certification, and 63% claimed compliance with ISO and/or IEC standards. CONCLUSIONS: There were notable differences in the completeness and accuracy of the instruction manuals. Manuals from major manufacturers generally provided more comprehensive information than their budget counterparts. CLINICAL SIGNIFICANCE: Instruction manuals should contain accurate information to help clinicians deliver the highest standard of care. The lack of important information about the LCUs in the manuals is concerning.