Norlase Leaf - Page 4

Leaf User Manual
P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 4 of 85
TROUBLESHOOTING GUIDE ....................................................................................................................................................... 41
PAIRING AN UNPAIRED TABLET WITH LASER CONSOLE ............................................................................................................................... 45
PAIRING A PAIRED TABLET TO A DIFFERENT LASER CONSOLE ........................................................................................................................ 45
ERROR MESSAGES ..................................................................................................................................................................... 46
ERROR STATES ................................................................................................................................................................................... 46
CALIBRATION CHECK PROCEDURE ............................................................................................................................................. 53
DISCLAIMER WARNING ........................................................................................................................................................................ 53
CALIBRATION CHECK INSTRUCTIONS ....................................................................................................................................................... 53
SYSTEM RELOCATION INSTRUCTIONS ........................................................................................................................................ 54
ROOM PREPARATION ................................................................................................................................................................ 54
GENERAL SAFETY AND REGULATORY INFORMATION ................................................................................................................ 55
OCULAR PROTECTION .......................................................................................................................................................................... 55
LASER SAFETY EYEWEAR ...................................................................................................................................................................... 56
ELECTRICAL HAZARDS .......................................................................................................................................................................... 58
FIRE HAZARD ..................................................................................................................................................................................... 59
PROTECTING NON-TARGET TISSUES........................................................................................................................................................ 59
OPERATIONAL SAFETY ......................................................................................................................................................................... 60
ADDITIONAL SAFETY CONSIDERATIONS ................................................................................................................................................... 62
REGULATORY COMPLIANCE SAFETY FEATURES .......................................................................................................................................... 63
Key Lock Switch ......................................................................................................................................................................... 63
Laser Emission Indicator ............................................................................................................................................................ 63
Door Interlock / External Emission Indicator ............................................................................................................................. 63
Emergency Stop ......................................................................................................................................................................... 64
Protective Housing .................................................................................................................................................................... 64
Safety Interlocks ........................................................................................................................................................................ 64
Safety Shutter ............................................................................................................................................................................ 64
LOCATION OF CONTROLS ...................................................................................................................................................................... 64
MANUAL RESET ................................................................................................................................................................................. 64
ELECTRICAL FAULT DETECTION CIRCUITRY ............................................................................................................................................... 64
LOCATION OF REGULATORY AND OTHER SYSTEM LABELS ............................................................................................................................ 64
Console Labels ........................................................................................................................................................................... 65
Slit Lamp Adapter (SLA) Labels .................................................................................................................................................. 68
Additional Labels ....................................................................................................................................................................... 69
ELECTROMAGNETIC COMPATIBILITY........................................................................................................................................................ 70
INDICATIONS FOR USE ......................................................................................................................................................................... 74
USAGE PRECAUTIONS (BEFORE USE) ...................................................................................................................................................... 74
USAGE PRECAUTIONS (DURING USE) ..................................................................................................................................................... 75
USAGE PRECAUTIONS (AFTER USE) ........................................................................................................................................................ 76
CONTRAINDICATIONS .......................................................................................................................................................................... 76
PRECAUTIONS IN PATIENT SELECTION ..................................................................................................................................................... 77
PRECAUTIONS IN PHOTOCOAGULATION ................................................................................................................................................... 77
ADVERSE EFFECTS AND COMPLICATIONS ................................................................................................................................................. 79
Posterior Segment Laser Procedures ......................................................................................................................................... 79
Anterior Segment Laser Procedures .......................................................................................................................................... 79
Rarely, severe iritis may occur, related to either an unusual patient response or improper spot location. .............................. 80
Residual Risk .............................................................................................................................................................................. 80
OPHTHALMOLOGY REFERENCES ............................................................................................................................................................. 81
WARRANTY INFORMATION ................................................................................................................................................................... 82
WARRANTY SHIPMENTS, RETURNS, AND ADJUSTMENTS ............................................................................................................................. 82
DECONTAMINATION OF RETURNED EQUIPMENT ....................................................................................................................................... 83
US TECHNICAL SERVICE INFORMATION ................................................................................................................................................... 83
DECONTAMINATION CERTIFICATION ....................................................................................................................................................... 84
WEEE DISPOSAL ................................................................................................................................................................................ 85