Olympus EVIS EXERA II - Page 6

Contents
iv
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix A: System Chart........................................................... 221
Appendix B: Inspection of the endoscope after cleaning,
disinfection or sterilization in accordance with
IEC 60601-2-37 ......................................................... 228
Appendix C: EMC Information ..................................................... 230
Appendix D: Acoustic Output Information in Accordance
with the FDA Guidance:
“Information for Manufacturers Seeking
Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers” .................................... 236
Symbol key ............................................................................................... 236
Acoustic output table with Hitachi or FUJIFILM Healthcare
diagnostic ultrasound system .................................................................... 238
Acoustic output table when combined with Olympus universal
endoscopic ultrasound center EU-ME1 .................................................... 241
Clinical measurement accuracy with Hitachi or FUJIFILM Healthcare
diagnostic ultrasound system .................................................................... 242
Clinical measurement accuracy when combined with Olympus
universal endoscopic ultrasound center EU-ME1 .................................... 242
Appendix E: Acoustic Output Information Accordance with
IEC 60601-2-37 ......................................................... 243
Acoustic output table with Hitachi or FUJIFILM Healthcare diagnostic
ultrasound system .................................................................................... 243
Acoustic output table with Olympus universal endoscopic ultrasound
center EU-ME1 ......................................................................................... 254