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Indications for Use, Contraindications, Warnings, and Precautions
Part Number: 0160-6411, Rev A, 02/2019
Page 13 of 314
Software Release: cOS 5.00
Purposeful misuse of custom fit adjustments to ocular surface(s) can result in patient
injury and complication(s) and therefore must be avoided.
• If a laser capsulotomy is interrupted, the system will not allow you to re-initiate the
capsulotomy, as precise co-registration with the initial capsulotomy cannot be assured.
Instead, use standard continuous curvilinear capsulorrhexis (CCC) surgical technique to
complete the treatment.
• If at any point during laser delivery the patient becomes undocked (e.g., due to vacuum
loss), the treatment will be interrupted and cannot be continued. Do not resume
treatment afterwards. Revert to traditional cataract surgery.
• If the treatment is interrupted by a “Critical Error”, the system will go to a safe state and
be disabled. Do not resume treatment afterwards. Revert to traditional cataract surgery.
• Never look directly into the laser aperture or scattered laser light from reflective surfaces
when the treatment beam is activated. Severe eye damage could occur.
• Standard continuous curvilinear capsulorrhexis (CCC) surgical technique must be used for
surgical removal of the capsulotomy disc. The capsulotomy may have residual uncut
areas that should be completed by advancing the capsule through the incompletely cut
area in a circumferential fashion, rather than pulling it radially. The use of improper
capsulotomy disc removal technique may potentially cause or contribute to anterior
capsule tear and/or a noncircular, irregularly shaped capsulotomy.
• Verify that the suction ring is correctly connected to the disposable lens component of
the
LIQUID OPTICS™
Interface during the initial patient docking procedure.
• To prevent unanticipated performance which may adversely impact patients, no
modification of this equipment is allowed.
• If the Mobile Patient Bed battery drops to the critically low level while paired to the
CATALYS®
System (as indicated by a solid red battery status icon on the control pendant
and a partially filled red Bluetooth connection status icon on the touchscreen), the bed
will maintain connection to the system but will not have adequate power to articulate all
motors. The user must connect the bed to an AC wall outlet and then disconnect and
reconnect the bed to the
CATALYS®
System before full motor function is re-enabled.
1.4 Precautions
• The system should be used only by qualified physicians who have extensive knowledge of
the use of this device and have been trained by
OPTIMEDICA
-certified personnel.
• Use of controls or adjustments or performance of procedures other than those specified
herein (System Misuse) may result in hazardous radiation exposure.
• Users should be aware of general laser warnings, precautions, and adverse effects. Read
this operator manual thoroughly and be familiar with its contents prior to using this
equipment.
• The key should not be turned to the start position for more than two seconds. If the key is
held at the start position for more than two seconds, the system will do a hard shutdown
Содержание Catalys OptiMedica
Страница 1: ...Part Number 0160 6411 Rev A 02 2019 Page 1 of 314 Software Release cOS 5 00 Operator Manual ...
Страница 237: ...Part Number 0160 6411 Rev A 02 2019 Page 237 of 314 Software Release cOS 5 00 System Labels and Symbols 282 ...
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Страница 287: ...Part Number 0160 6411 Rev A 02 2019 Page 287 of 314 Software Release cOS 5 00 Appendix B Patient Chair Instructions ...
Страница 299: ...Part Number 0160 6411 Rev A 02 2019 Page 299 of 314 Software Release cOS 5 00 Appendix D Software Error Code Table ...