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AMO Catalys OptiMedica Скачать руководство пользователя страница 225

Chapter 6 Safety and Regulatory

Part Number: 0160-6411, Rev A, 02/2019

Page 225 of 314

Software Release: cOS 5.00

6.7 Regulatory Compliance Safety Features

The

CATALYS®

System has been designed to comply with 21 CFR subchapter J as administrated

by the Center for Devices and Radiological Health of the Food and Drug Administration (FDA).
The following compliance safety features are included:

Key Lock Switch

The system can be activated only with the proper key to operate the master key switch. The key
cannot be removed in the

(on) position, and the system will operate only with the key in

place. When treatments are complete, always remove and secure the key to prevent
unauthorized use of the system.

Laser Emission Indicator

The

(laser emission) indicator is displayed on the touchscreen control panel at all times the

laser is energized to warn the user that the system is capable of emitting laser energy.

Door Interlock

A  door  interlock  may  be  used  in  conjunction  with  a  remote  switch  to  disable  laser  and  OCT
emission  in  case  of  certain  external  events  (e.g.,  the  opening  of  a  treatment  room  door).  A
remote switch or interlock can be wired to the door interlock plug and connected to the system
interlock receptacle on the system rear panel. If a remote switch is used, the system can deliver
laser  energy  only  when  the  remote  switch  is  closed.  Breaking  the  connection  by  opening  the
switch (door) or removing the plug disables laser and OCT emission, and the system displays a
clearable “Door Interlock” error message on the control panel.

Emergency Stop

The system has an emergency laser stop button that, when pressed, rapidly disables all laser
emission, disables the Mobile Patient Bed or patient chair, and disables the

LIQUID OPTICS™

Interface vacuum system.

Protective Housing

The

CATALYS®

System has a protective housing that prevents unintended human access to laser

radiation. This housing is to be opened only by trained

OPTIMEDICA

personnel.

Safety Interlocks

The protective housing is not designed to be removed by anyone other than an

OPTIMEDICA

-

certified technician. Therefore, the system does not have, and is not required to have, any safety
interlock within the meaning of US FDA 21 CFR, Section 1040, or European EN 60825-1.
However, the protective housing cannot be opened without use of special tools.

Safety Shutter

The

CATALYS®

System includes a safety shutter, which prevents any laser radiation from exiting

the system. The safety shutter is activated when the system is off, during the self-test at turn-on,
in STANDBY mode, or when the safety monitor detects a fault.

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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 2: ...Page 2 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 3: ...ions tables specifications and schematics contained herein are subject to change without notice CATALYS OPTIMEDICA INTEGRAL GUIDANCE and LIQUID OPTICS are trademarks of AMO Manufacturing USA LLC All other trademarks are the intellectual property of their respective owners The term cOS is defined as cataract operating system and is followed by a numeric version number e g cOS 5 00 For Technical Sup...

Страница 4: ...Page 4 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 5: ...ce GUI 24 Docking Keypad 24 LIQUID OPTICS Interface 24 LIQUID OPTICS Interface Circular Label Reader 25 Mobile Patient Bed or Patient Chair 25 Emergency Laser Stop Button 26 Key Switch 27 Vacuum and Laser Footswitches 27 Door Interlock Connector 28 Treatment Laser 28 Optical Coherence Tomography 28 Video Subsystem 29 Monitoring and Control Systems 29 Bench Testing 30 Animal and Cadaver Testing 30 ...

Страница 6: ...1 All Treatments Reports Screen 62 Treatment Results Screen 63 Printing the Treatment Report s 64 Saving the Treatment Report s 66 Sample Report 69 Surgeon Templates Overview Screen 75 Surgeon Template Screens 76 Overlay Settings Screens 78 General Preferences Screen 80 Settings Screen 81 Software Info Window 82 Help Screen 82 Planning Screens 83 Planning Screen Conventions 83 Default Details Scre...

Страница 7: ...ck Panel 127 Verify Fluid Panel 129 Treatment Screens 131 Surface Mapping Review Screen 131 Customizing Surface Fits 133 INTEGRAL GUIDANCE System Dimensions 138 Incision Review Screens 139 Incision Adjustment Screens 142 Adjust Capsulotomy Screens 142 Adjust Lens Fragmentation Screens 145 Adjust Arcuate Incisions Screens 147 Adjust Cataract Incisions Screens 148 Final Review Screen 152 Treatment P...

Страница 8: ...tem Imaging 193 Performing Laser Treatment 198 Instructions for Interrupted Treatments 200 Treatments Interrupted Prior to Initiating Laser Delivery 200 Treatments Interrupted During Laser Delivery 200 Postoperative Instructions 202 Releasing the Patient 202 Disconnecting the Mobile Patient Bed from the CATALYS System 203 Removing the Suction Ring and Disposable Lens 204 Maintenance 205 System Cle...

Страница 9: ... Regulatory Compliance Safety Features 225 Key Lock Switch 225 Laser Emission Indicator 225 Door Interlock 225 Emergency Stop 225 Protective Housing 225 Safety Interlocks 225 Safety Shutter 225 Location of Controls 226 System Reset 226 Electrical Fault Detection Circuitry 226 Location and Definition of Regulatory and Other System Labels 226 System Labels 227 Appendix A Mobile Patient Bed Instructi...

Страница 10: ...Table of Contents Page 10 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 11: ...e cornea each of which may be performed either individually or consecutively during the same procedure 1 2 Contraindications The CATALYS System is contraindicated in patients with corneal ring and or inlay implant s The CATALYS System is contraindicated in patients with severe corneal opacities corneal abnormalities significant corneal edema or diminished aqueous clarity that obscures OCT imaging ...

Страница 12: ...en if required Prior to INTEGRAL GUIDANCE System imaging and laser treatment the suction ring must be completely filled with sterile buffered saline solution such as Alcon BSS Alcon P N 351 55005 1 or equivalent Use the video image to verify that no air bubbles are entrapped within the sterile buffered saline solution after the suction ring is captured The video image should provide a sharp and cl...

Страница 13: ...se 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 ...

Страница 14: ... Clearable Error message press the OK button to clear the error and continue the treatment Alternatively when in doubt always choose the safest approach and shut down the system and abort the treatment The CATALYS System has not been adequately evaluated in patients with a cataract greater than Grade 4 via LOCS III therefore no conclusions regarding either safety or effectiveness are presently ava...

Страница 15: ...o prevent unintended dissection Full thickness corneal cuts or incisions should be performed with instruments and supplies on standby to seal the eye in case of anterior chamber collapse or fluid leakage Patients who will undergo full thickness corneal incisions with the CATALYS System should be given the same standard surgical preparation as used for patients undergoing cataract surgery for the r...

Страница 16: ...ing phacoemulsification capsulotomy lens fragmentation or cut incision decentration cells in anterior chamber choroidal effusion choroidal hemorrhage conjunctival hyperemia injection erythema che mosis conjunctivitis allergic viral corneal abrasion deepithelization epithelial defect cor neal edema cystoid macula edema Descemet s detachment decentered or dislocated intraocular lens implant diplopia...

Страница 17: ...e curriculum will cover Plan template driven treatment planning Engage the LIQUID OPTICS Interface docking and vacuum controls Visualize Customize INTEGRAL GUIDANCE System 3 D OCT imaging automated surface detection and laser exclusion zones and Treat parameter choices and patterns for all treatments The curriculum and hands on training are divided according to user roles Overall the curriculum ad...

Страница 18: ...tified as competent according to the defined user roles in the operation and use of the CATALYS System and ancillary equipment as well as being well informed about indications for use contraindications warnings precautions and laser safety Users who successfully complete the certification will receive a signed certificate from OPTIMEDICA personnel 1 7 Target Patient Profile Male or female age 22 y...

Страница 19: ...0 30 Hearing Mildly impaired but corrected to 85 of normal hearing Mobility No impairment must be able to assist with positioning the patient loading unloading the patient and moving the patient bed chair Hand eye coordination No impairment Technician operator Education 2 year associate degree high school education and certificate from hospital vocational or military school and or on the job train...

Страница 20: ...Indications for Use Contraindications Warnings and Precautions Page 20 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 21: ... registration of the two optical subsystems Each FS laser pulse creates a highly localized plasma and subsequent cavitation event that disrupts only microns of tissue per pulse The treatment consists of applying user defined laser patterns to the crystalline lens lens capsule and cornea of the eye to create incisions by applying FS laser pulses guided by the OCT data Intended treatment patterns ar...

Страница 22: ...rocedure is complete the operator will undock the patient using the docking control keypad reposition the patient from under the laser aperture and then provide any remaining post operative care 2 2 CATALYS System Components The CATALYS Precision Laser System consists of the following components Touchscreen control panel Graphical User Interface GUI Docking keypad LIQUID OPTICS Interface LIQUID OP...

Страница 23: ... monitoring and controls are contained within the system enclosure and are not accessible to the user Touchscreen Control Panel Graphical User Interface GUI Laser Emission Indicator Docking Control Keypad Mobile Patient Bed with Headrest Joystick Control On System Rear Panel Network Video Output Footswitch Door Interlock and AC Power Connections LIQUID OPTICS Interface Circular Label Reader Emerge...

Страница 24: ...e minute and then restart the system If the screen is still blank turn off the system and contact OPTIMEDICA Service Docking Keypad The docking keypad is located on the system front panel directly above the patient It contains the controls for capturing and releasing the suction ring including the patient vacuum capture and patient lock on off buttons Press buttons firmly when selecting on or off ...

Страница 25: ...e used with either the Mobile Patient Bed or patient chair Both the Mobile Patient Bed and patient chair incorporate an articulating headrest backrest seat and footrest that are individually adjustable as well as a precision movement joystick that adjusts the bed position in three axes x y and z Additionally the Mobile Patient Bed can be wirelessly connected to the CATALYS System via Bluetooth1 to...

Страница 26: ...page 233 Refer to Appendix B Patient Chair Instructions on page 287 for instructions on using the patient chair Emergency Laser Stop Button The system is equipped with a latching emergency laser stop button Pressing the emergency laser stop button stops emission of all laser output by closing the safety shutter releases the patient vacuum and disables the Mobile Patient Bed or patient chair Rotate...

Страница 27: ...quipped with two footswitch assemblies a vacuum footswitch and a laser footswitch The vacuum footswitch is a dual footswitch assembly containing two footswitches The left footswitch is a Vacuum OFF footswitch that disables the vacuum that attaches the LIQUID OPTICS Interface suction ring to the patient s eye The right footswitch is a Vacuum ON footswitch that enables the vacuum that attaches the L...

Страница 28: ...tion of precision scanners under computer control patterns may be pre planned and exactly positioned for precise capsulotomy lens fragmentation and corneal cuts incisions Optical Coherence Tomography The CATALYS System uses an Optical Coherence Tomography OCT subsystem to create a three dimensional model of the anterior portion of the eye to guide the laser treatment The OCT system employs an 820 ...

Страница 29: ...hree integrated optical subsystems each controlled and monitored by dedicated electronics A dedicated computer controls and monitors the Graphical User Interface GUI and provides convenient storage and retrieval of system data files The GUI is displayed on a flat panel touchscreen located to the right of the physician The GUI is used to display magnified video of the patient s eye from the on boar...

Страница 30: ...fragmentation patterns within specified limits for accuracy and precision Bench testing of the CATALYS System was conducted to demonstrate the system s ability to deliver a variety of laser patterns intended for corneal incisions with corresponding accuracy and precision In this test the system s entire suite of corneal incision patterns was bracketed to test the full spectrum of physician selecta...

Страница 31: ...assigned treatment with the current gold standard surgical technique of continuous curvilinear capsulorrhexis CCC and standard ultrasound phacoemulsification CATALYS System treatment times for the combined capsulotomy and laser phacofragmentation were found to be less than one minute in all subjects Total procedure time defined as the total time the subject was under suction and docked to the syst...

Страница 32: ...d complications and adverse events were found to be comparable between the two cohorts Device related complications ascribed to the CATALYS System were limited to petechiae 72 of eyes and subconjunctival hemorrhage 5 of eyes All device related complications were determined to be mild and transitory in nature as all resolved in less than 30 days without the need for additional medical intervention ...

Страница 33: ...ass 21 CFR 1040 ANSI Z136 1 Class 3R Class 1 Patient Interface Aqueous Contact LIQUID OPTICS Interface Contact element Sterile buffered saline solution such as Alcon BSS Alcon P N 351 55005 1 or equivalent not supplied Inner diameter 14 1 mm LIQUID OPTICS Interface 12 0 mm LIQUID OPTICS Interface 12 Fixation method Annular vacuum flange onto sclera Suction ring seal material Medical grade silicone...

Страница 34: ...lectrical codes to ensure proper grounding of the AC wall power outlet An appropriate location for the CATALYS System must be selected such that it can accommodate the system size and allow for easy access by the patient physician nurse and or assistant and OPTIMEDICA Service Personnel The rear of the system must remain clear after installation to provide access to the system power cord circuit br...

Страница 35: ...pletely isolated from mains AC power Make sure adequate space is available during system installation to allow access to the AC power cord the system circuit breakers the remote interlock connector and other rear panel connections Do not simultaneously touch accessible contacts on any conductors and the patient Do not replace the AC power cord laser footswitch cable and vacuum footswitch cable The...

Страница 36: ...lepresenter video recording system or equivalent user supplied video recording equipment as follows 1 Connect the video cable to the video output cable receptacle HDMI or Display Port HDMI shown in Figure 2 8 on the rear of the system console 2 Set up the video recording system per the manufacturer s instructions NOTES When connecting an external video recording device to your CATALYS System use o...

Страница 37: ...dditional devices to the network Disconnection of devices from the network Update and or upgrade of equipment connected to the network The internal Hardware Security Appliance HSA installed on the CATALYS System is designed to mitigate these risks to an acceptable level Access to the HSA is limited to OPTIMEDICA trained personnel only The HSA is not user accessible The HSA blocks attack attempts f...

Страница 38: ...o the networked printer by OPTIMEDICA trained personnel during system installation If the desired printer is changed or a new printer is added to your network contact OPTIMEDICA Service to have the networked printer configured for use with your CATALYS System To set up remote connectivity 1 Connect an Ethernet cable to the RJ45 Network receptacle on the rear of the system console 2 Connect the oth...

Страница 39: ...old the key in the start position for more than two seconds If the key is held in the start position for more than two seconds the system will do a hard shutdown In the event of a hard shutdown you must contact the OPTIMEDICA Service Department at 1 800 511 0911 Restarting the system will require up to a 45 minute warm up period A system self test and start up routine begins and the following scre...

Страница 40: ...uest to your CATALYS System administrator NOTE During system installation at your facility one system administrator will be set up to manage system users Contact your CATALYS System administrator to set up additional user accounts Figure 2 10 Login Screen The first time you log into the system it prompts you to enter a new password Figure 2 11 Enter New Password Window Enter and confirm your new p...

Страница 41: ... and laser are also enabled Prior to laser treatment enable the system by pressing the ENABLE SYSTEM button on the Home Screen The Enabling System window displays Figure 2 12 Enabling System Window The system runs a system wide self test and safety check and you are prompted to move the disposable lens carriage up and down through its full range of travel Save the red protective lens cover that is...

Страница 42: ...DICA part number SA 08044 for verifying system alignment Previous versions of the plastic hemispheres are obsolete and should not be used System alignment verification must be performed by a trained operator on a daily basis prior to use per the following instructions NOTE Refer to Intraoperative Instructions on page 175 for detailed instructions on the docking and undocking procedures described i...

Страница 43: ...on to go to the Verify Alignment Screen Figure 2 13 Verify Alignment Screen 2 As instructed on the screen prepare the LIQUID OPTICS Interface and a new plastic test hemisphere for docking Ensure that the suction ring handle is facing left 3 Press the CONFIRM button to continue to the Verify Alignment Docking Screen 4 As instructed in the Disposable Lens panel install the disposable lens Figure 2 1...

Страница 44: ...r by pressing the patient vacuum I on button on the docking keypad then add sterile buffered saline solution to the suction ring Figure 2 15 Vacuum Panel 6 When the system detects that the suction ring has been placed and the patient vacuum applied the Capture panel opens As instructed in the Capture panel raise the suction ring until the indicator arrow on the right is within the Capture Zone as ...

Страница 45: ...within their respective Lock Zones as shown in the following figure Figure 2 17 Lock Panel 9 When the three indicators are within their respective Lock Zones press the Lock I on button on the docking keypad 10 When the system detects that the lock has been secured the Verify Fluid panel opens As instructed in the Verify Fluid panel verify that the LIQUID OPTICS Interface is completely filled with ...

Страница 46: ...verlay press the YES button to go to the following screen Figure 2 20 Verify Scan Screen after Pressing Yes NOTE If the alignment marks are not contained within the overlay press the NO button to proceed to the Verify Alignment Results Screen Refer to step 17 on page 50 13 After verifying that the overlay matches the suction ring alignment marks press and hold the laser footswitch to initiate lase...

Страница 47: ...otswitch Lifted Before Treatment Complete 14 When laser treatment is complete the Verify Treatment Screen displays You can position the Treatment Scroll Slider to view various images that were captured during the laser treatment Position the slider near the left side and using the suppress overlay button to hide and reveal the overlay images verify that the fragmentation pattern is completely cont...

Страница 48: ...en after Treatment NOTE If the fragmentation pattern does not match the fragmentation overlay press the NO button to proceed to the Verify Alignment Results Screen Refer to step 17 on page 50 15 Position the slider to the first image that has bubbles of any size over approximately 50 of the capsulotomy circumference Press the OK button ...

Страница 49: ...Chapter 2 System Overview Part Number 0160 6411 Rev A 02 2019 Page 49 of 314 Software Release cOS 5 00 Figure 2 24 Image with Correct Amount of Bubbles Figure 2 25 Image with Too Many Bubbles ...

Страница 50: ...th Too Few Bubbles 16 If system alignment is acceptable Verify Alignment Successful displays on the Verify Alignment Results Screen Figure 2 27 Verify Alignment Successful 17 If system alignment is unacceptable Verify Alignment Failed displays on the Verify Alignment Results Screen Contact OPTIMEDICA Service for assistance ...

Страница 51: ...OME button to return to the Home Screen Disabling the System At the end of the treatment day or if the system will not be used for at least 45 60 minutes between patients disable the system by pressing the DISABLE SYSTEM button on the Home Screen The Confirm Disable System window displays Press the OK button to disable the system Figure 2 29 Confirm Disable System Window NOTE To use the system aft...

Страница 52: ...sabling System Window Shutting Down the System Except during an emergency you must shut down the system from the Login Screen To access the Login Screen from the Home Screen press the LOGOUT button in the upper right corner of the screen Figure 2 31 Location of LOGOUT Button on the Home Screen To access the Login Screen from a Treatment Planning Screen press the HOME button in the upper right corn...

Страница 53: ... the screen Press the OK button and wait for the system to shut down Figure 2 33 Location of SHUTDOWN Button on the Login Screen Turn the key switch to the off position and remove the key to prevent unauthorized use of the system NOTE If the power cable is still connected to the electrical source some internal circuits remain energized To de energize all internal circuits switch the main system ci...

Страница 54: ... the CATALYS System after an emergency shutdown rotate the emergency laser stop button to disengage it and then start the system using the key switch WARNING If the system becomes unresponsive at any time press the emergency laser stop button and turn the key to the off position NOTES The emergency laser stop button is a latching switch that will remain depressed until the button is rotated to dis...

Страница 55: ...eports Planning Screens allow users to add and edit treatment templates to add edit and initiate treatment plans to enable disable the system and to enable disable the laser Surgical Timeout Screen allows users to verify patient details and treatment parameters before proceeding to the Docking Screen Docking Screen guides users through the process of connecting the Mobile Patient Bed to the CATALY...

Страница 56: ... Screen Treatment activation status icon shows current treatment activation status black not activated green activated red LIQUID OPTICS Interface already consumed Bluetooth connection status icon shows current Mobile Patient Bed connection status gray not connected blue connected partially filled orange connected but battery power low sufficient power for one treatment partially filled red connec...

Страница 57: ...om of the screen that allows you to easily navigate between screens Refer to the following table for a description of the icons in the Quick Navigation Bar Icon Press to go to Plan a Treatment Screen Capsulotomy Basic or Details Screen Lens Fragmentation Basic or Details Screen Arcuate Incisions Basic or Details Screen Cataract Incisions Basic or Details Screen Treatment Plan Summary or Final Revi...

Страница 58: ...emplates Overview Screen and Settings Screen Verify system alignment Add new treatment plans and edit previously added treatment plans Initiate a treatment plan Icon Description The orientation icon represents the rotation of the selected eye relative to the CATALYS System The icon rotates to display axis markings for your reference The colored ring provides a visual indication of the forces exert...

Страница 59: ... Home Screen displays From the Home Screen you can Add new treatment plans and edit previously added treatment plans Initiate a treatment plan Enable disable the system and laser Go to the Login Info Screen All Treatments Reports Screen and Surgeon Templates Overview Screen Verify system alignment Return to the Login Screen Open the Software Info window Software Info Add a New Treatment Plan Edit ...

Страница 60: ...atment plans that have identical patient first and last names ID and date of birth From this page you can create a new treatment plan for this patient as shown in the following figure Go to All Treatments Reports Screen Go to Verify Alignment Screen Go to Surgeon TemplatesOverview Screen Go to Login Info Screen Enable Disable System and Laser Software Info Add a New Treatment Plan Edit Treatment P...

Страница 61: ...editing treatment plans Users Screen From the Administrator Home Screen press the USERS button to go to the Users Screen From the Users Screen the administrator can Add user accounts Assign user permission levels Admin user has administrator privileges as described in this section General user can plan and start treatments and perform system calibration and self test Disabled user has no permissio...

Страница 62: ...orted treatments View a list of treatments for each patient Search treatments by patient name ID date of birth treatment status i e pending treated aborted disabled surgeon name and or treatment date Go to the Treatment Results Screen for the selected treatment Print treatment reports to the network printer Save treatment reports as PDF files View and print surgeon statistics for the current surge...

Страница 63: ...ELECTED or SAVE SELECTED TO PDF button Refer to Printing the Treatment Report s on page 64 and Saving the Treatment Report s on page 66 for additional instructions Treatment Results Screen From the All Treatments Reports Screen select the desired patient to view a list of treatments for that patient Select the desired treatment from the list and then press the SHOW TREATMENT RESULTS button to go t...

Страница 64: ...led as described in Setting Up Network Printing and Remote Connectivity optional on page 38 2 From the All Treatments Reports Screen press the PRINT ALL or PRINT SELECTED button or from the Treatment Results Screen press the PRINT button Figure 3 7 PRINT ALL Button on All Treatments Reports Screen Figure 3 8 PRINT Button on Treatment Results Screen Scroll Through Report Save Report to PDF Go to Al...

Страница 65: ...the OK button Figure 3 9 Print Window Select Report Type 4 Select the target printer and press the PRINT button Figure 3 10 Print Window Select Printer NOTE If the target printer does not display on the screen press the REFRESH button 5 After printing press the OK button to return to the All Treatments Reports or Treatment Results Screen Figure 3 11 Print Window Print Successful Message ...

Страница 66: ...D TO PDF button or from the Treatment Results Screen press the SAVE TO PDF button 2 As instructed on the screen insert a USB storage device into one of the two USB ports on the system front panel Figure 3 14 USB Ports on System Front Panel CAUTION Do not connect anything other than a USB flash drive to the CATALYS System USB ports Figure 3 12 SAVE ALL TO PDF Button on All Treatments Reports Screen...

Страница 67: ...15 Save to PDF Window Enter File Name 4 Verify that the target USB storage device displays on the screen and press the SAVE button Figure 3 16 Save to PDF Window Select Storage Device NOTE If the target USB storage device does not display on the screen press the REFRESH button If more than one storage device is connected to the system then press the icon for the target device ...

Страница 68: ...art Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 5 After the file has been successfully saved press the OK button to return to the All Treatments Reports or Treatment Results Screen Figure 3 17 Save to PDF Window Save Successful Message ...

Страница 69: ...oftware Navigation Part Number 0160 6411 Rev A 02 2019 Page 69 of 314 Software Release cOS 5 00 Sample Report On the following pages is a sample report with graphics Figure 3 18 Sample Report with Graphics page 1 ...

Страница 70: ...Chapter 3 Software Navigation Page 70 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 19 Sample Report with Graphics page 2 ...

Страница 71: ...Chapter 3 Software Navigation Part Number 0160 6411 Rev A 02 2019 Page 71 of 314 Software Release cOS 5 00 Figure 3 20 Sample Report with Graphics page 3 ...

Страница 72: ...Chapter 3 Software Navigation Page 72 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 21 Sample Report with Graphics page 4 ...

Страница 73: ...Chapter 3 Software Navigation Part Number 0160 6411 Rev A 02 2019 Page 73 of 314 Software Release cOS 5 00 Figure 3 22 Sample Report with Graphics page 5 ...

Страница 74: ...Chapter 3 Software Navigation Page 74 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 23 Sample Report with Graphics page 6 ...

Страница 75: ...Surgeon Templates Overview Screen From the Surgeon Templates Overview Screen for administrators you can Add new surgeon template sets and edit previously added surgeon template sets Enable or disable surgeon template sets Copy surgeon template sets Figure 3 24 Surgeon Templates Overview Screen for Administrators Enable Template Set Disable Template Set Copy Template Set Edit Template Set Return to...

Страница 76: ... the EDIT button to go to the Surgeon Template Screens for that surgeon From the Surgeon Templates Overview Screen for general users select a surgeon name to go to the Surgeon Template Screens for that surgeon From the Surgeon Template Screens you can Add a new template and edit previously added templates Set default parameters Adjust overlay settings for this surgeon Adjust general preferences fo...

Страница 77: ...meters Add a Lens Fragmentation Template Go to Surgeon Template Screen for Arcuate and Cataract Incisions Return to Previous Screen Adjust Overlay Settings for this template Adjust General Preferences for this template Set Default Arcuate Incisions Parameters Add an Arcuate Incisions Template Set Default Cataract Incisions Parameters Add a Cataract Incisions Template Go to Surgeon Template Screen ...

Страница 78: ... whether and how the overlay effect appears and blinks or fades during visualization customization and laser treatment Figure 3 28 Overlay Fade Settings Screen From the Overlay Drag Settings Screen you can select whether to automatically turn on the overlay effect hide incisions during capsulotomy and adjust the touchscreen drag sensitivity Figure 3 29 Overlay Drag Settings Screen Return to Surgeo...

Страница 79: ...ting from the Customize Overlay Effect drop down menu To select the overlay effect on the Treatment Progress Screen select the desired setting from the Laser Treatment Overlay Effect drop down menu If Automatically Turn On Overlay Effect is set to Yes on the Overlay Drag Settings Screen then the selected overlay effect automatically displays on the treatment screens To turn off the overlay effect ...

Страница 80: ...en you can Automatically hide the patient name on treatment screens NOTE You can toggle the patient name on off by pressing the area to the right of the icon at the top of all treatment screens Adjust the x y direction in which the joystick control on the Mobile Patient Bed or patient chair moves the bed chair Automatically display INTEGRAL GUIDANCE System dimensions on the Surface Mapping Review ...

Страница 81: ...he displayed time zone date and time Select the user language and country for software localization1 Enable and disable graphic reports Enable and disable remote service see Setting Up Network Printing and Remote Connectivity optional on page 38 for additional information Figure 3 32 Settings Screen 1 For CATALYS System software version cOS 5 0 English and English speaking countries are the only t...

Страница 82: ... Press OK to close the window Figure 3 33 Software Info Window Help Screen The operator manual can be accessed from any screen by pressing the button which is located at the top of the screen The operator manual is not accessible during treatment or when treatment has been paused Figure 3 34 Help Screen To scroll up and down on the current page press the and buttons To go back a page press the BAC...

Страница 83: ...iled default settings are separated into laser default details such as pulse energy and geometric default details such as side cut angle and other parameters related to incision architecture Planning Screen Conventions When you touch a parameter field on a planning screen an input keypad displays on the screen The range of allowable settings is shown at the top of the keypad If you select a value ...

Страница 84: ...Chapter 3 Software Navigation Page 84 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 36 Return to default Button on the Planning Screen Return to default button ...

Страница 85: ...Treatment Plans System Defaults All basic and details parameters are user adjustable Surgeon Default Details Editable on edit templates page Copy at time of adding a surgeon Treatment Template All basic and details parameters are user adjustable Treatment Plan All basic and details parameters are user adjustable Copy basic and details parameters if template is selected Copy details only at time of...

Страница 86: ... Default Details Screens carry over to the Treatment Template and potentially to the Treatment Planning Screens see the following sections The following table summarizes user adjustable basic and details parameters DEFAULT DETAILS CAPSULOTOMY LENS FRAGMENTATION ARCUATE PRIMARY SIDEPORT Geometric Default Details Combined Combined Combined yes yes Laser Default Details yes yes TREATMENT TEMPLATES Ba...

Страница 87: ...pter 3 Software Navigation Part Number 0160 6411 Rev A 02 2019 Page 87 of 314 Software Release cOS 5 00 Figure 3 38 Capsulotomy Default Details Screen Figure 3 39 Lens Fragmentation Default Details Screen ...

Страница 88: ...are Navigation Page 88 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 40 Arcuate Incisions Default Details Screen Figure 3 41 Cataract Incisions Primary Geometric Default Details Screen ...

Страница 89: ...ation Part Number 0160 6411 Rev A 02 2019 Page 89 of 314 Software Release cOS 5 00 Figure 3 42 Cataract Incisions Sideport s Geometric Default Details Screen Figure 3 43 Cataract Incisions Primary Laser Default Details Screen ...

Страница 90: ...Chapter 3 Software Navigation Page 90 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 44 Cataract Incisions Sideport s Laser Default Details Screen ...

Страница 91: ...n to delete the template the DETAILS button to go to the Treatment Template Details Screen or the BACK button to return to the Surgeon Template Screen If you select a value other than the Default Details default value for any parameter on a Treatment Template an asterisk displays to the left of the value and a return to default button displays to the right The value of the return to default button...

Страница 92: ...pter 3 Software Navigation Page 92 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 46 Capsulotomy Template Details Screen Figure 3 47 Lens Fragmentation Basic Template Screen ...

Страница 93: ...r 3 Software Navigation Part Number 0160 6411 Rev A 02 2019 Page 93 of 314 Software Release cOS 5 00 Figure 3 48 Lens Fragmentation Template Details Screen Figure 3 49 Arcuate Incisions Basic Template Screen ...

Страница 94: ...e 94 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 50 Arcuate Incisions Template Details Screen Figure 3 51 Cataract Incisions Basic Template Screen Note that either Left or Right can be selected circled ...

Страница 95: ...on Part Number 0160 6411 Rev A 02 2019 Page 95 of 314 Software Release cOS 5 00 Figure 3 52 Cataract Incisions Primary Geometric Template Details Screen Figure 3 53 Cataract Incisions Sideport s Geometric Template Details Screen ...

Страница 96: ...gation Page 96 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 54 Cataract Incisions Primary Laser Template Details Screen Figure 3 55 Cataract Incisions Sideport s Laser Template Details Screen ...

Страница 97: ...at is pre populated with the first name last name ID and date of birth of this patient In either case the system will transition to the Plan a Treatment Screen Figure 3 56 Treatment Planning Options on the Home Screen NOTES Treatment settings may be selected prior to seating the patient However the physician should verify all treatment parameters displayed on the screen prior to proceeding with tr...

Страница 98: ...ollowing rules apply You will not be able to proceed to plan the next selected incision until the current incision is properly planned e g if the capsulotomy is not completely planned you will not be able to proceed to plan the lens fragmentation For a given incision if you have selected the Default Template and you select a value other than the Default Details default value for any details parame...

Страница 99: ...reatment Screen Press the BASIC button on the Capsulotomy Details Screen Press the BACK button on the Basic Screen for the next treatment in the sequence Select the Quick Navigation Bar Capsulotomy Icon on the Plan a Treatment Screen the Lens Fragmentation Arcuate Incisions or Cataract Incisions Basic Screen or the Treatment Plan Summary Screen Figure 3 58 Capsulotomy Basic Screen From the Capsulo...

Страница 100: ... diameter displays in the center of the eye model as shown in the preceding figure Press the DETAILS button to proceed to the Capsulotomy Details Screen the BACK button to return to the Plan a Treatment Screen or the NEXT button to proceed to the Basic Screen for the next treatment in the sequence NOTES If you selected only the capsulotomy treatment on the Plan a Treatment Screen pressing the NEXT...

Страница 101: ...e sequence NOTES If you selected only the capsulotomy treatment on the Plan a Treatment Screen pressing the NEXT button on the Capsulotomy Details Screen will take you directly to the Treatment Plan Summary Screen If you press the HOME button on the Capsulotomy Details Screen the current treatment parameters will be saved Lens Fragmentation Basic Screen The Lens Fragmentation Basic Screen can be a...

Страница 102: ...lays in the center of the eye model as shown in the preceding figure Press the DETAILS button to proceed to the Lens Fragmentation Details Screen the BACK button to return to the Capsulotomy Basic Screen or the NEXT button to proceed to the Basic Screen for the next treatment in the sequence NOTES If you selected only the lens fragmentation treatment on the Plan a Treatment Screen pressing the BAC...

Страница 103: ...softening grid pattern lines Diameter diameter for maximum allowed lens fragmentation pattern Maximized diameter is determined by the detected iris Limited diameter is determined by the smaller of either the detected iris or the limited diameter specified Segmentation Repetitions number of times the treatment of the selected segmentation lines is repeated in the lens fragmentation pattern as the t...

Страница 104: ...NEXT button will take you directly to the Treatment Plan Summary Screen If you press the HOME button on the Lens Fragmentation Details Screen the current treatment parameters will be saved Arcuate Incisions Basic Screen The Arcuate Incisions Basic Screen can be accessed in any of the following ways Press the NEXT button on the Lens Fragmentation Basic or Details Screen if you selected the lens fra...

Страница 105: ... as determined with the user selected centering method to the cornea anterior penetrating point of the arcuate incision In the case of intrastromal arcuate incisions the optical zone is twice the radius from the center of the eye to the point where the incision would intersect the cornea anterior if the incision were extended In the case of symmetric incisions the optical zone is the diameter of s...

Страница 106: ...you selected only the arcuate incisions procedure on the Plan a Treatment Screen pressing the BACK button on the Arcuate Incisions Basic Screen will take you back to the Plan a Treatment Screen and pressing the NEXT button will take you directly to the Treatment Plan Summary Screen If you press the HOME button on the Arcuate Incisions Basic Screen the current treatment parameters will be saved Arc...

Страница 107: ...arcuate incision will be at central line density Once you have chosen valid settings the side cut angle and uncut region s are displayed in the lower eye model as shown in the preceding figure Press the BASIC button to return to the Arcuate Incisions Basic Screen the BACK button to return to the Basic Screen for the previous procedure in the sequence or the NEXT button to proceed to the Basic Scre...

Страница 108: ...otomy Lens Fragmentation or Arcuate Incisions Basic Screen or the Treatment Plan Summary Screen Figure 3 64 Cataract Incisions Basic Screen From the Cataract Incisions Basic Screen you can select the following parameters Template Name Number of Primary Incisions 1 or 2 Number of Sideport Incisions 0 to 5 Axis of Primary Sideport Incision s Limbus Offset of Primary Sideport Incision s Automatic Off...

Страница 109: ... Basic Screen will take you back to the Plan a Treatment Screen If you press the HOME button on the Cataract Incisions Basic Screen the current treatment parameters will be saved Cataract Incisions Primary Geometric Details Screen To access the Cataract Incisions Primary Geometric Details Screens press the DETAILS button on the Cataract Incisions Basic Screen the Quick Navigation Bar Cataract Inci...

Страница 110: ...us procedure in the sequence or the NEXT button to proceed to the Treatment Plan Summary Screen NOTES If you selected only the cataract incisions procedure on the Plan a Treatment Screen pressing the BACK button on any of the Cataract Incisions Details Screens will take you back to the Plan a Treatment Screen If you press the HOME button on any of the Cataract Incisions Details Screens the current...

Страница 111: ... model as shown in the preceding figure Press the button to go to Cataract Incisions Primary Laser Details Screen the button to go to the Cataract Incisions Primary Geometric Details Screen the BASIC button to return to the Cataract Incisions Basic Screen the BACK button to return to the Basic Screen for the previous procedure in the sequence or the NEXT button to proceed to the Treatment Plan Sum...

Страница 112: ...d for the anterior central and posterior regions of the incision Refer to Figure 4 11 Line Density Characteristics on page 172 for a graphic representation of line density Anterior Posterior Line Distance region that line density is applied to the respective cut segment measured in microns or percentage of corneal thickness depending on Depth Unit setting used to adjust the spot spacing from the a...

Страница 113: ...ill take you back to the Plan a Treatment Screen If you press the HOME button on any of the Cataract Incisions Details Screens the current treatment parameters will be saved Cataract Incisions Sideport s Laser Details Screen To access the Cataract Incisions Sideport s Laser Details Screens press the button on the Cataract Incisions Primary Laser Details Screen Figure 3 68 Cataract Incisions Sidepo...

Страница 114: ...he anterior plane will be at central line density Horizontal Spot Spacing lateral spot to spot spacing Vertical Spot Spacing axial spot to spot spacing Pulse Energy energy delivered per pulse Press the button to go to the Cataract Incisions Primary Laser Details Screen the BASIC button to return to the Cataract Incisions Basic Screen the BACK button to return to the Basic Screen for the previous p...

Страница 115: ...ncisions Screen The Treatment Plan Summary Screen provides an overview of the current treatment plan including a graphical representation of the selected treatment parameters Figure 3 69 Treatment Plan Summary Screen After verifying the treatment plan summary press the HOME button to return to the Home Screen Editing the Treatment Plan To edit the treatment plan press the BACK button to return to ...

Страница 116: ...button to proceed to the Docking Screen If any information on the Surgical Timeout Screen is incorrect press the Home button to return to the Home Screen or the BACK TO PLANNING button to edit the Treatment Plan NOTE You must scan the circular label on the LIQUID OPTICS Interface packaging before proceeding to the Docking Screen If a circular label has not been scanned Scan to Activate displays at...

Страница 117: ... when the bed chair is in the correct range for certain steps of the docking process The line centered on top of the video and the different colored zones which change depending on the current step of the docking process indicate the lateral forces being exerted on the disposable lens The arrow on the left of the video and the different colored zones which change depending on the current step of t...

Страница 118: ...al Docking Screen for the Mobile Patient Bed displays the Connection panel is open As instructed in the panel initiate Bluetooth wireless connection between the Mobile Patient Bed and the CATALYS System NOTE Refer to Connecting the Mobile Patient Bed to the CATALYS System on page 181 for detailed instructions Figure 3 72 Docking Screen with Connection Panel Open ...

Страница 119: ... pendant illuminates blue the Bluetooth connection status icon at the top of the CATALYS System screen turns from gray to blue the Mobile Patient Bed name displays to the right of the icon and the Home panel opens As instructed in the panel return the Mobile Patient Bed to the Home position NOTE Refer to Homing the Mobile Patient Bed on page 182 for detailed instructions Figure 3 73 Docking Screen...

Страница 120: ...at the Mobile Patient Bed is in the Home position the Pivot Lock panel opens As instructed in the panel orient the Mobile Patient Bed perpendicular to the CATALYS System and place the Mobile Patient Bed into pivot lock mode NOTE Refer to Placing the Mobile Patient Bed in Pivot Lock Mode on page 182 for detailed instructions Figure 3 74 Docking Screen with Pivot Lock Panel Open ...

Страница 121: ...posable lens and install a new disposable lens NOTE Refer to Installing the Disposable Lens on page 177 for detailed instructions on installing the lens on the system TIP If using the patient chair ensure that the two arrows under the headrest neck support adjustment knob are aligned before seating the patient as described in Patient Headrest on page 292 If necessary use the headrest vertical adju...

Страница 122: ...ce on the patient s eye and then apply patient vacuum NOTE Refer to Attaching the Suction Ring on page 182 for detailed instructions on placing the suction ring and applying patient vacuum Figure 3 76 Docking Screen with Vacuum Panel Open When the system detects that the suction ring has been placed and patient vacuum applied the system emits an audible ding and a check mark displays in the Vacuum...

Страница 123: ...n ring of the LIQUID OPTICS Interface and patient vacuum Rotate the Mobile Patient Bed under the CATALYS System with the treatment eye located directly under the laser aperture Then as instructed in the panel place the Mobile Patient Bed into caster lock mode NOTE Refer to Activating Deactivating Caster Lock Mode on page 257 for detailed instructions on placing the Mobile Patient Bed into caster l...

Страница 124: ...e patient chair the Latch panel opens after the system verifies application of the suction ring of the LIQUID OPTICS Interface and patient vacuum As instructed in the panel latch the patient chair in the treatment position using the chair s foot activated chair latching lever located at the chair base Figure 3 78 Docking Screen with Latch Panel Open ...

Страница 125: ...bed chair until the indicator arrow on the right is within the Capture Zone This indicator arrow corresponds to the position of the bed chair and must be within the green Capture Zone to enable the capture The following are sample screens that show the suction ring inside and outside of the Capture Zone Figure 3 79 Docking Screen with Capture Panel Open Suction Ring Inside Capture Zone The green b...

Страница 126: ...re Zone In this example the bed chair needs to be lowered until the suction ring is in the Capture Zone and the disposable lens is engaged When the indicator arrow on the right side of the video is within the Capture Zone press the Capture I on button on the docking keypad to capture the suction ring in the disposable lens When the system detects that the suction ring has been captured the system ...

Страница 127: ...docking keypad NOTE Alternatively you can activate Guided Docking by pressing and holding the Lock I on button The system will adjust the bed chair until all three indicators are within their respective Lock Zones Release the button after the lock engages or to stop the bed chair at any point When the system detects that the lock has been secured a check mark displays in the Lock panel and the lat...

Страница 128: ...sposable lens Move the bed chair in the opposite direction of the ball at the end of the line or in the direction of the ball if the bed chair direction has been reversed on the Settings Screen to reduce the force on the disposable lens thereby moving the ball into the Lock Zone The arrow at the right indicates the vertical position of the suction ring disposable lens assembly Move the bed chair u...

Страница 129: ...ID CONFIRMED The force indicators will also change from only showing a red band to showing yellow orange and red bands indicating different severity levels of forces being exerted by the patient on the disposable lens When the disposable lens vacuum capture and lock steps have all been completed the lateral and vertical force indicators indicator to the left of the video and on top of the video wi...

Страница 130: ...ing INTEGRAL GUIDANCE System imaging press the RESCAN EYE button If the eye moves during laser treatment terminate the laser treatment by immediately releasing the laser footswitch NOTE Refer to Capturing the Suction Ring on page 186 for detailed instructions on filling the suction ring with sterile buffered saline solution TIP If your finger is wet from the docking procedure wipe it dry before us...

Страница 131: ...the parameter selections available on the treatment screens Surface Mapping Review Screen After capturing and locking the suction ring verifying that the video image of the eye is sharp and clear and pressing the FLUID CONFIRMED button on the final Docking Screen the Surface Mapping Review Screen displays and INTEGRAL GUIDANCE System imaging begins automatically The initial Surface Mapping Review ...

Страница 132: ... View Figure 3 86 Surface Mapping Review Screen All Surfaces View Cornea Anterior Cornea Posterior Lens Anterior Lens Posterior Pupil Iris Limbus Cyclorotation Go to All Surfaces View Axial View Sagittal View Display INTEGRAL GUIDANCE System Dimensions Hide Overlay Images Zoom In Out Go to Cornea Surfaces View Go to Incision Review Screen Zoom In Out on Video Image ...

Страница 133: ...factory To revert to the automatically detected ocular surface press the icon NOTES You have the option of selecting a 2 5 mm diagnostic lens thickness for the Lens Posterior surface Be aware that this may affect capsulotomy and or arcuate centration if the scanned capsule centration method is selected It is normal during the custom fit procedure for unusual fitting overlay to occur due to varying...

Страница 134: ...If the custom cyclorotation compensation method is selected the cyclorotation compensation angle may be adjusted within the range of 75 Figure 3 87 Surface Mapping Review Screen with Cornea Anterior Custom Fitting Selected Figure 3 88 Surface Mapping Review Screen with Cornea Posterior Custom Fitting Selected ...

Страница 135: ...ber 0160 6411 Rev A 02 2019 Page 135 of 314 Software Release cOS 5 00 Figure 3 89 Surface Mapping Review Screen with Lens Anterior Custom Fitting Selected Figure 3 90 Surface Mapping Review Screen with Lens Posterior Custom Fitting Selected ...

Страница 136: ...e 136 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 91 Surface Mapping Review Screen with Pupil Iris Custom Fitting Selected Figure 3 92 Surface Mapping Review Screen with Limbus Custom Fitting Selected ...

Страница 137: ...e pupil fit is properly adjusted confirm the surface fits and after the surgical timeout start treatment QUICK TIP VERIFYING AND CUSTOMIZING SURFACE FITS Take your time when confirming the surface fits This is not the time to speed up the treatment Always confirm pupil first then axial and sagittal views cornea anterior posterior and lens anterior posterior Consider saying the following out loud a...

Страница 138: ... is displayed and updated Figure 3 94 Location of INTEGRAL GUIDANCE System Dimensions The following measurements are taken along a vector orthogonal to the tilt of the lens CCT central cornea thickness distance between anterior and posterior cornea AD aqueous depth distance between posterior cornea and anterior lens ACD anterior chamber depth distance between anterior cornea and anterior lens LMP ...

Страница 139: ...incision you can press the respective icon in the Quick Navigation Bar press the grayed out incision in the eye image on the left side of the screen or press the and buttons After an incision has been reviewed a green check mark displays next to the icon in the Quick Navigation Bar If an incision is suppressed a red X displays next to the icon After all incisions have been reviewed an APPROVE butt...

Страница 140: ...apter 3 Software Navigation Page 140 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 Figure 3 96 Lens Fragmentation Incision Review Screen Figure 3 97 Arcuate Incisions Review Screen ...

Страница 141: ...Chapter 3 Software Navigation Part Number 0160 6411 Rev A 02 2019 Page 141 of 314 Software Release cOS 5 00 Figure 3 98 Cataract Incisions Review Screen ...

Страница 142: ...tomy Screens To adjust the capsulotomy parameters after performing INTEGRAL GUIDANCE System imaging press the EDIT button on the Capsulotomy Incision Review Screen to go to the Adjust Capsulotomy Basic Screen Figure 3 99 Adjust Capsulotomy Basic Screen Capsulotomy diameter can be adjusted by changing the value in the Diameter field or by pressing and dragging the capsulotomy video overlay Dragging...

Страница 143: ...lly to reflect the overlay size Figure 3 100 Red Area Represents Capsulotomy Iris Safety Zone Adjust the desired parameters on the Adjust Capsulotomy Basic Screen and then press the DETAILS button to proceed to the Adjust Capsulotomy Details Screen Alternatively you can select an icon from the Quick Navigation Bar to go to the Incision Adjustment Screens for the corresponding incision or press the...

Страница 144: ...t the desired parameters on the Adjust Capsulotomy Details Screen and then press the BASIC button to return to the Adjust Capsulotomy Basic Screen Alternatively you can select an icon from the Quick Navigation Bar to go to the Incision Adjustment Screens for the corresponding incision or press the DONE button to return to the Capsulotomy Incision Review Screen ...

Страница 145: ... Figure 3 102 Adjust Lens Fragmentation Basic Screen Adjust the desired parameters on the Adjust Lens Fragmentation Basic Screen and then press the DETAILS button to proceed to the Adjust Lens Fragmentation Details Screen Alternatively you can select an icon from the Quick Navigation Bar to go to the Incision Adjustment Screens for the corresponding incision or press the DONE button to return to t...

Страница 146: ...esired parameters on the Adjust Lens Fragmentation Details Screen and then press the BASIC button to return to the Adjust Lens Fragmentation Basic Screen Alternatively you can select an icon from the Quick Navigation Bar to go to the Incision Adjustment Screens for the corresponding incision or press the DONE button to return to the Lens Fragmentation Incision Review Screen ...

Страница 147: ...creen Figure 3 104 Adjust Arcuate Incisions Basic Screen Adjust the desired parameters on the Adjust Arcuate Incisions Basic Screen and then press the DETAILS button to proceed to the Adjust Arcuate Incisions Details Screen Alternatively you can select an icon from the Quick Navigation Bar to go to the Incision Adjustment Screens for the corresponding incision or press the DONE button to return to...

Страница 148: ... after performing INTEGRAL GUIDANCE System imaging press the EDIT button on the Cataract Incisions Review Screen to go to the Adjust Cataract Incisions Basic Screen NOTE The icons in the Quick Navigation Bar represent the primary incisions and the icons represent the sideport incisions The number of icons displayed depends on the number of primary and sideport incisions selected on the Cataract In...

Страница 149: ...s the DETAILS button to proceed to the Cataract Incisions Adjust Primary Geometric Details Screen Alternatively you can select an icon from the Quick Navigation Bar to go to the Incision Adjustment Screens for the corresponding incision or press the DONE button to return to the Cataract Incisions Review Screen Figure 3 107 Cataract Incisions Adjust Primary Geometric Details Screen Go to Cataract I...

Страница 150: ...or press the DONE button to return to the Cataract Incisions Review Screen Figure 3 108 Cataract Incisions Adjust Sideport s Geometric Details Screen Adjust the desired parameters on the Cataract Incisions Adjust Sideport s Geometric Details Screen and then press the button to go to the Cataract Incisions Adjust Primary Laser Details Screen press the button to go to the Cataract Incisions Adjust P...

Страница 151: ...rimary Laser Details Screen and then press the button to go to the Cataract Incisions Adjust Sideport s Laser Details Screen press the button to go to the Cataract Incisions Adjust Sideport s Geometric Details Screen press the BASIC button to return to the Adjust Cataract Incisions Basic Screen or press the DONE button to return to the Cataract Incisions Review Screen Figure 3 110 Cataract Incisio...

Страница 152: ...t the bottom of the Incision Review Screen to proceed to the Final Review Screen The Final Review Screen allows you to perform a final review of treatment parameters before initiating laser treatment If desired press the BACK button to return to the Incision Review Screens Otherwise press the laser footswitch to initiate laser treatment Figure 3 111 Final Review Screen WARNING Continuously monitor...

Страница 153: ...rating arcuate incisions and at the beginning and end of cataract incisions Figure 3 112 Meniscus on Video Image WARNING Continuously verify that the eye has not moved with respect to its initial presentation at the time of fluid confirmation If the eye moves during INTEGRAL GUIDANCE System imaging press the RESCAN EYE button If the eye moves during laser treatment terminate the laser treatment by...

Страница 154: ...mplete the system automatically proceeds to the Undocking Screen NOTES Laser treatment can be paused at any time by pressing the PAUSE TREATMENT button on the control panel or by releasing the laser footswitch When laser treatment is paused a Clearable Error message displays and you must press the OK button to acknowledge and clear the error To resume laser treatment release the laser footswitch a...

Страница 155: ...osable lens from the system NOTE The Mobile Patient Bed and patient chair have different undocking instructions The screens in the following sections are for the Mobile Patient Bed However differences between the undocking instructions for the Mobile Patient Bed and patient chair are identified Vacuum Panel When the initial Undocking Screen displays the Vacuum panel is open As instructed in the pa...

Страница 156: ...een released and the Mobile Patient Bed lowered the Connection panel opens Place the Mobile Patient Bed into pivot lock mode rotate the bed out from under the CATALYS System and disconnect the Mobile Patient Bed from the CATALYS System NOTE Refer to Disconnecting the Mobile Patient Bed from the CATALYS System on page 203 for detailed instructions Figure 3 115 Undocking Screen with Connection Panel...

Страница 157: ...erifies that the patient vacuum has been released and the patient chair lowered the Latch panel opens As instructed in the panel unlatch the patient chair using the chair s foot activated chair latching lever located at the chair base NOTE Systems manufactured prior to May 2013 do not have the Latch panel Figure 3 116 Undocking Screen with Latch Panel Open ...

Страница 158: ... the Mobile Patient Bed has been disconnected from the CATALYS System or the patient chair has been unlatched the Capture panel opens As instructed in the panel release and dispose of the suction ring NOTE Refer to Removing the Suction Ring and Disposable Lens on page 204 for detailed instructions Figure 3 117 Undocking Screen with Capture Panel Open ...

Страница 159: ...el After the system detects that the suction ring has been released the Disposable Lens panel opens As instructed in the panel remove and dispose of the disposable lens NOTE Refer to Removing the Suction Ring and Disposable Lens on page 204 for detailed instructions Figure 3 118 Undocking Screen with Disposable Lens Panel Open ...

Страница 160: ...fer to Instructions for Interrupted Treatments on page 200 section for guidance on how to proceed when treatment is incomplete WARNING If a laser capsulotomy is interrupted the system will not allow you to reinitiate the capsulotomy as precise co registration with the initial capsulotomy cannot be assured Instead use standard continuous curvilinear capsulorrhexis CCC surgical technique to complete...

Страница 161: ...least 1 0 mm larger than the intended capsulotomy diameter The following is a suggested iris dilation medication protocol that was used in clinical studies of the system Cyclopentolate 1 One drop every 20 minutes three times beginning 60 minutes before surgery Phenylephrine 2 5 One drop every 20 minutes three times beginning 60 minutes before surgery Ocufen flurbiprofen 0 03 One drop every 20 minu...

Страница 162: ... left and limbus bottom right shown in blue shading capsulotomy diameter top left shown by dotted line within orange shading and lens fragmentation diameter top right shown in orange shading Figure 4 2 Corneal and Iris Safety Margins Cross sectional view highlighting geometric relationships of lens shown in red and respective safety margins for iris and cornea Lens Fragmentation Diameter 3 0 10 0 ...

Страница 163: ...my Parameters Table 4 2 Capsulotomy Parameters and Safety Margins Feature Default Range Step Size Units Pattern Circle N A N A N A Depth 600 200 1000 200 µm Diameter N A 2 0 8 0 0 1 mm Horizontal Spot Spacing 5 3 10 1 µm Vertical Spot Spacing 10 5 50 5 µm Laser Pulse Energy 4 1 10 0 5 µJ Safety Margins Feature Value Units Iris 500 µm Corneal 500 µm ...

Страница 164: ... segmentation and softening laser settings and applicable safety margins are illustrated in the following figures and summarized in the following tables Patterns Description Lens Segmentation Quadrants 2 intersecting lines Lens Segmentation Sextants 3 intersecting lines Lens Segmentation Octants 4 intersecting lines Lens Softening Quadrants Lens Softening Sextants Lens Softening Octants Quadrants ...

Страница 165: ...al spacing is available for each parameter as shown Figure 4 4 Iris Safety Margins for Lens Fragmentation Axial and Sagittal Views Iris Safety Margin axial top and sagittal bottom cross sectional views depict the slope of the 500 µm iris safety margin shown in red within the crystalline lens during lens fragmentation Segmentation Softening Grid Spacing 100 2000 µm SEG SOFT Spacing 100 1500 µm SEG ...

Страница 166: ...available pupil diameter less 2 x safety margin 3 0 10 0 0 5 mm Horizontal Spot Spacing 10 5 25 2 5 µm Vertical Spot Spacing 40 10 100 10 µm Pulse Energy Anteriorb b Pulse energy to vary stepwise linear from posterior to anterior if different 8 1 10 0 5 µJ Pulse Energy Posteriorb 10 1 10 0 5 µJ Seg Soft Spacing 200 100 1500 100 µm Grid Spacing 350 100 2000 100 µm Safety Margins Feature Default Ran...

Страница 167: ...nd Cataract Incision Parameters Figure 4 6 Arcuate Incision Characteristics Frontal view of arcuate incisions Optical zone is user adjustable For asymmetric arcuate incisions the optical zone is independently adjustable for each incision Arc length is also user adjustable Axis Optical Zone Optical Zone Length Limbus Pupil ...

Страница 168: ...ide cut angle is chosen Optical Zone Center Line Pupil Limbus or Custom Centering Cornea Anterior Surface Cornea Posterior Surface Side Cut Angle Uncut Posterior Bowman s Layer Descemet s Membrane a Cross section View of Anterior Penetrating Incision Optical Zone Center Line Pupil Limbus or Custom Centering Cornea Posterior Surface Side Cut Angle Uncut Posterior Bowman s Layer Descemet s Membrane ...

Страница 169: ...e and plane depth are also user adjustable Incision length is defined in the frontal view as the distance between the projected incision intersection with the cornea anterior and the cornea posterior Axis Limbus Pupil Width Limbus Offset Length a Frontal View Posterior Plane Depth Anterior Plane Depth Anterior Side Cut Angle Cornea Posterior Surface Cornea Anterior Surface Length Bowman s Layer De...

Страница 170: ...red at the projected intersection location of the incision with the cornea anterior posterior measured at 90 to the anterior posterior cornea surface regardless of what side cut angle is chosen Uncut Anterior Cornea Thickness at anterior intersection a Cross section View of Uncut Anterior Region Cornea Posterior Surface Cornea Anterior Surface Side Cut Angle Side Cut Angle Cornea Posterior Surface...

Страница 171: ...ion none panel b bottom shown in cross section Side cut angle is user adjustable and can be independently adjusted for the anterior and posterior sections of the incision Uncut central length is user adjustable Uncut Central Length a Cross section View of Uncut Central Region Cornea Posterior Surface Cornea Anterior Surface Side Cut Angle Side Cut Angle Cornea Posterior Surface Cornea Anterior Sur...

Страница 172: ... and central regions of the incision For primary cataract and sideport cataract incisions line density can be independently adjusted for the anterior central and posterior regions of the incision Figure 4 12 Z Axis Iris Safety Margin for All Corneal Incisions Figure 4 13 Lens Safety Margin for All Corneal Incisions Line Density 1 Line Density 2 Line Density 3 Iris Z axis Iris Safety Margin 383 700...

Страница 173: ...e or Absolute N A N A N A Axisb b Independently adjustable parameters for asymmetric incisions N A 0 360 1 5 Optical Zoneb N A 2 11 0 1 0 1 mm Arc Lengthb N A 10 120 1 5 Uncut Length Anteriorc Posterior c Not applicable for anterior penetrating 20 100 µm 20 100 µm 20 50 100 250 µm 20 50 100 250 µm 1 1 µm 1 1 µm 2 10 µm 2 10 µm µm Side Cut Angle 90 30 150 1 5 Line Densityb Anterior Central 10 4 1 1...

Страница 174: ...e N A N A N A Uncut Length Anterior Posterior 20 100 µm 20 100 µm 20 50 100 250 µm 20 50 100 250 µm 1 1 µm 5 25 µm 5 25 µm µm Uncut Central Length 25 25 1000 1 25 µm Plane Depth Anterior Posterior 30 150 µm 70 350 µm 25 75 125 375 µm 25 75 125 375 µm 1 1 µm 1 1 µm 5 25 µm 50 250 µm µm Side Cut Angle Anterior Posterior 90 45 30 150 30 150 1 1 5 5 Line Density Anterior Central Posterior 10 1 4 1 10 ...

Страница 175: ...ot use after the expiration date on the packaging Keep the LIQUID OPTICS Interface disposable package sealed and unopened until immediately prior to use WARNING The OPTIMEDICA CATALYS System is designed to work with the OPTIMEDICA LIQUID OPTICS Interface The OPTIMEDICA LIQUID OPTICS Interface is the only patient interface approved for use with the CATALYS System Do not use any other patient interf...

Страница 176: ... label reader on the patient side of the system The circular label should contact and be held against the label reader until the system emits an audible ding Activated Scan Successful displays momentarily at the top of the screen and the Treatment Activation icon changes from to Figure 4 15 Treatment Activation Label Figure 4 16 Location of Treatment Activation Icon Scan to Activate Activation Suc...

Страница 177: ... the disposable lens carriage 4 With gentle upward pressure twist the disposable lens in the direction of the Mobile Patient Bed or patient chair until the disposable lens tabs line up into the disposable lens carriage The disposable lens should seat flush in the groove Figure 4 18 Installing the Disposable Lens steps 3 and 4 5 Turn the disposable lens in the opposite direction towards the touchsc...

Страница 178: ... NOTE Verify that the disposable lens is correctly installed and securely attached to the system before proceeding Installing the Fluid Reservoir 1 Remove the fluid reservoir from the packaging 2 Install the fluid reservoir into its receptacle on the system Press the fluid reservoir into the receptacle until the fluid reservoir back is fully pressed against the system indicated by a click securing...

Страница 179: ...re After the procedure is complete the operator will undock the patient using the docking control keypad reposition the patient from under the laser aperture and then provide any remaining post operative care Positioning the Patient QUICK TIP PATIENT POSITIONING Communicate with the patient throughout patient positioning to make certain the patient remains comfortable Discomfort can make the patie...

Страница 180: ...T POSITIONING Pre align the patient s treatment eye with the disposable lens on the system to minimize bed chair movement required during docking and therefore docking time QUICK TIP PATIENT POSITIONING When pre aligning do not raise the patient too close to the disposable lens because the suction ring or the patient s nose may hit the disposable lens during docking This can cause more suction rin...

Страница 181: ...tem see Positioning the Bed Next to the CATALYS System on page 258 for instructions The maximum recommended distance between the bed and the CATALYS System is 10 ft 3 m when establishing Bluetooth connection 2 Press the connect button on the Mobile Patient Bed control pendant to establish Bluetooth connection between the Mobile Patient Bed and the CATALYS System The button blinks slowly to indicat...

Страница 182: ...ivot lock mode To activate pivot lock mode press the pivot lock button on the control pendant The button illuminates and the rolling mechanism on the patient right caster at the front of the bed locks the swivel mechanism remains unlocked The rolling and swivel mechanisms on the remaining three casters also remain unlocked Attaching the Suction Ring QUICK TIP ATTACHING THE SUCTION RING Frequently ...

Страница 183: ...eye This allows you to place your entire hand against the patient s cheek with your thumb resting on their forehead The tips of your pointer finger and thumb should be slightly higher than the rim of the suction ring to provide tactile feedback in the coming steps If the patient s head is positioned properly and the patient is looking towards the ceiling the top of the suction ring should be level...

Страница 184: ... of the vacuum footswitch for systems manufactured prior to May 2013 see Chair Enable Feature on page 291 4 If using the patient chair unlatch the chair but do not move the hand holding the suction ring Maintain a slight downward pressure on the suction ring 5 Fill the suction ring with sterile buffered saline solution such as Alcon BSS Alcon P N 351 55005 1 or equivalent Consider filling the suct...

Страница 185: ...n loss and to ensure that it does not become entangled pinched and or severed 7 If using the Mobile Patient Bed press the caster lock button on the control pendant to place the bed in caster lock mode 8 If using the patient chair latch the chair using the foot activated chair latching lever located at the chair base Figure 4 25 Location of Chair Latching Lever on Patient Chair QUICK TIP LATCHING T...

Страница 186: ...re prompted to capture the suction ring as follows 1 While maintaining the suction ring as level as possible use the joystick control to navigate the bed chair up to the disposable lens As the suction ring gets closer to the disposable lens use the video image on the touchscreen as a guide Figure 4 26 Lift Patient Eye Up to Disposable Lens 2 Navigate the suction ring and bed chair with the joystic...

Страница 187: ...ion ring and disposable lens are properly mated release your hand from the suction ring QUICK TIP CAPTURING THE SUCTION RING If you do not release the suction ring at this point your finger may interfere or prevent capturing the suction ring in the disposable lens 5 Using the joystick raise the bed chair until the suction ring represented by white green arrow on screen is in the Capture Zone as sh...

Страница 188: ... to immerse the disposable lens in the fluid of the suction ring Remember to raise the bed chair and watch the video image indicators when the arrow appears at the top of the green bar on the right side of the video image Center by making sure that there is no sclera outside of red ring and no gray suction ring seal inside remember you are moving the eye not the red ring QUICK TIP CAPTURING THE SU...

Страница 189: ...the system front panel directly above the patient to capture the suction ring Figure 4 33 Turn On Capture NOTES Verify that there are no bubbles in the video image that may degrade the optical clarity If there are bubbles release capture lower the patient and then proceed to recapture the suction ring in the disposable lens You may also add sterile buffered saline solution Place your finger on the...

Страница 190: ...sing the joystick control on the Mobile Patient Bed or patient chair adjust the bed chair so that the suction ring disposable lens assembly is in the Lock Zone and the lateral and vertical forces are within the green zones as shown in the following figure QUICK TIP LOCKING THE SUCTION RING Monitor the Lateral Force Sensor and make proper adjustments with the joystick to minimize lateral forces Fig...

Страница 191: ...fter the lock engages or to stop the bed chair at any point WARNING Verify that the suction ring is correctly connected to the disposable lens component of the LIQUID OPTICS Interface during the initial patient docking procedure 3 To confirm that the suction ring and disposable lens are secured with respect to the laser gently grab the handle of the suction ring and attempt to move it slightly If ...

Страница 192: ... image as shown in the following figure Also verify that there is no fluid in the fluid reservoir and tubing slight amount is OK Figure 4 36 Confirm No Bubbles in Video Image Figure 4 37 Verify No Fluid in Fluid Reservoir and Tubing Highest level of fluid acceptable if suction has already been established If fluid level exceeds this volume do not proceed with another vacuum attempt ...

Страница 193: ...luid in the fluid reservoir especially if suction has been lost Starting and Verifying INTEGRAL GUIDANCE System Imaging WARNING Prior to INTEGRAL GUIDANCE System imaging and laser treatment the suction ring must be completely filled with sterile buffered saline solution such as Alcon BSS Alcon P N 351 55005 1 or equivalent Use the video image to verify that no air bubbles are entrapped within the ...

Страница 194: ...creen to start INTEGRAL GUIDANCE System imaging Figure 4 38 Fluid Confirmed Button Starts INTEGRAL GUIDANCE System Imaging 2 After INTEGRAL GUIDANCE System imaging is complete view the INTEGRAL GUIDANCE System data on the Surface Mapping Review Screen and inspect the surface fits and overlaid incision patterns to ensure accuracy Figure 4 39 Surface Mapping Review Screen ...

Страница 195: ...GUIDANCE System treatment customization press the APPROVE button on the Surface Mapping Review Screen all surfaces view to go to the Incision Review Screens Figure 4 40 Incision Review Screen QUICK TIP INTEGRAL GUIDANCE SYSTEM Monitor the Lateral Force Sensor and use the video to monitor the eye for movement If movement occurs rescan QUICK TIP INTEGRAL GUIDANCE SYSTEM A common message for modifica...

Страница 196: ...pil fit If you still determine that the fit does not match the underlying image adjust the pupil fit size and centration on the Surface Mapping Review Screen Once the pupil fit is properly adjusted confirm surface fits and after performing a final review of treatment parameters on the Final Review Screen start treatment QUICK TIP INTEGRAL GUIDANCE SYSTEM Take your time when confirming the surface ...

Страница 197: ... Incision Review Screens and verify that the graphical representation of all incisions is accurate and represents the selected treatment plan If desired press the EDIT button to go to the Incision Adjustment Screens to adjust treatment parameters Otherwise press the APPROVE button to proceed to the Final Review Screen Figure 4 41 Incision Review Approve ...

Страница 198: ... inspect the images created from the OCT data surface fits and overlaid pattern in both axial and sagittal views and review the treatment parameters on the Final Review Screen for accuracy QUICK TIP TREATMENT Watch the video image during the treatment Confirm that large bubbles turn into small bubbles during the capsulotomy to demonstrate breakthrough of the anterior capsule You can toggle the ove...

Страница 199: ...e aqueous humor If bubbles are seen penetrating the posterior cornea abort the treatment and release the patient Laser treatment can be paused at any time by pressing the PAUSE TREATMENT button on the control panel or by releasing the laser footswitch When laser treatment is paused a Clearable Error message displays and you must press the OK button to acknowledge and clear the error To resume lase...

Страница 200: ...Delivery A treatment that is interrupted prior to initiating laser delivery e g due to loss of Bluetooth connection between the Mobile Patient Bed and the CATALYS System loss of vacuum or pressing of the ABORT TREATMENT button on the Docking Screen may be reinitiated by re capturing the suction ring and resuming the treatment Treatments Interrupted During Laser Delivery An incision other than caps...

Страница 201: ...ge displays on the screen Figure 4 44 Loss of Vacuum Error Message A capsulotomy treatment that is interrupted during laser delivery for any reason cannot be reinitiated WARNING If a laser capsulotomy is interrupted the system will not allow you to reinitiate the capsulotomy as precise co registration with the initial capsulotomy cannot be assured Instead use standard continuous curvilinear capsul...

Страница 202: ...patient vacuum O off button on the docking keypad located on the system front panel directly above the patient or by pressing and holding the patient vacuum O off footswitch for one second The one second requirement is to prevent accidental vacuum release if the footswitch is accidentally bumped Figure 4 45 Release Vacuum NOTE Figure 4 45 shows the vacuum footswitch for systems manufactured after ...

Страница 203: ...aster lock button on the backrest by patient s right shoulder or footrest by patient s left foot or by pressing the lock foot pedal on either side of the bed 2 Press the connect button on the control pendant twice to disconnect the bed from the CATALYS System NOTE If you press the connect button only once the bed will go into safety timeout for 180 seconds During this time the connect button will ...

Страница 204: ...ent chair has been unlatched the Capture panel opens As instructed in the Capture and Disposable Lens panels of the Undocking Screen 1 Press the Capture O off button on the docking keypad located on the system front panel directly above the patient to release the suction ring Figure 4 47 Turn Off Capture 2 Remove the suction ring and the disposable lens from the system and dispose in compliance wi...

Страница 205: ...RNINGS Do not use caustic cleaners or strong detergents when cleaning the CATALYS System Allow isopropyl alcohol to dry completely before using the CATALYS System 5 2 System Maintenance The CATALYS System is a delicate medical instrument and requires regular maintenance to provide optimum performance OPTIMEDICA recommends annual system maintenance for the CATALYS System System maintenance must be ...

Страница 206: ...cluding cables specified by OPTIMEDICA Otherwise degradation of the performance of this equipment could result This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating the CATALYS System or shielding ...

Страница 207: ...rete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast tran sient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV line to ground 1 kV line to line Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV Differential mode 2 kV common mode 0 5 1...

Страница 208: ...ospital environment Surge IEC 61000 4 5 1 kV Differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Voltage Dips 30 reduc tion 25 30 periods At 0 Voltage Dips 95 reduction 0 5 period At 0 45 90 135 ...

Страница 209: ...mitter manufac turer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These ...

Страница 210: ... according to the transmitter manufac turer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency rang...

Страница 211: ... distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the tra...

Страница 212: ...ative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not rep resent actual modulation it would be worst case Parameter Freq GHz Min Typ Max Bluetooth Specification Units Sensitivity at 0 1 BER 2 402 80 86 70 dBm 2 441 80 86 dBm 2 480 80 86 dBm RF Transmit Power 2 402 0 2 4 4 dBm 2 441 0 2 4 dBm 2 480 0 2 4 dBm Initial Carrier Frequency Tolerance 2 402 5 75 75 kHz 2...

Страница 213: ...luetooth specification Security The wireless communication channel is configured to use 128 bit encryption Device System Wireless Functions Capabilities and Limitations If configured to work with the CATALYS Mobile Patient Bed MPB CATALYS Systems can wirelessly and uniquely connect to a MPB in order to enable and disable MPB control features joystick pen dant buttons etc and set MPB motor speed li...

Страница 214: ...o to the Login Screen Press the HOME button to go to the Home Screen The bed chair remains active but it can only be lowered to remove the patient from under the system all other bed chair motions are disabled If you do not take one of the preceding actions the system automatically logs you out after 300 seconds NOTE The Mobile Patient Bed or patient chair can only be lowered while the error scree...

Страница 215: ...chair If you do not take one of the preceding actions the system automatically logs you out after 30 seconds and returns to the Login Screen Figure 5 2 Sample Critical Error Bed Chair Inactive When a Critical Error Shutdown occurs the only option is to press the SHUTDOWN button to shut down the system The error screen continues to display until you press the SHUTDOWN button If the error is due to ...

Страница 216: ...ct and clear the error and proceed with treatment Figure 5 4 Sample Clearable Error No Treat Errors No Treat errors identify problems with the treatment parameters or INTEGRAL GUIDANCE System and must be corrected Modifications Required before proceeding To correct a No Treat error first review the treatment parameters and make adjustments as necessary Next reinitiate INTEGRAL GUIDANCE System imag...

Страница 217: ...r Code Table Refer to Appendix D Software Error Code Table on page 299 for a list of system error codes Column headings are defined as follows Error Type categorizes each type of error Error Number numeric error code for reference Error Message description explanation of each error code Host No Treat errors do not indicate that something is wrong with the system When necessary the algorithms of IN...

Страница 218: ...y existing manufacturer s warranty on the instrument and can result in serious personal injury 5 7 Warranty Refer to OPTIMEDICA s Terms and Conditions for important limitations regarding warranty and limitation of liability or contact OPTIMEDICA Customer Service at 1 408 273 4100 5 8 Company Information For assistance contact Customer Service at 1 408 273 4100 or your local representative 5 9 Copy...

Страница 219: ... CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES LOSS OF USE DATA OR PROFITS OR BUSINESS INTERRUPTION HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY WHETHER IN CONTRACT STRICT LIABILITY OR TORT INCLUDING NEGLIGENCE OR OTHERWISE ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE 5 10 Decontamination of R...

Страница 220: ...___________________________________ Individual Institution City State Province Country has undergone decontamination with a commercially available germicide cleared for use as a Hospital Disinfectant and is clean and free from biohazards including but not limited human or animal blood tissue or tissue fluids or components thereof The undersigned also agrees to reimburse OPTIMEDICA for any costs in...

Страница 221: ...wer lasers for this reason you must take precautions to prevent exposure of laser energy to the eye and skin from either direct or diffusely reflected laser beams except as an intentional application In addition precautions must be taken in the surgical environment to prevent the hazards of fire and electrical injury OPTIMEDICA does not recommend specific clinical practices The following precautio...

Страница 222: ...stem operation and system alignment verification Normal System Operation During normal operation of the CATALYS Precision Laser System there is no user accessible exposure to the Class 4 and Class 3 beams except for the intentional exposure of the patient for therapeutic purposes The patient is in contact with the laser aperture of the system by means of the LIQUID OPTICS Interface The interface k...

Страница 223: ...ected or scat tered radiation may exceed the applicable MPE Exposure levels beyond the boundary of the NHZ are below the appropriate MPE Nominal Ocular Hazard Distance NOHD The distance along the axis of the unobstructed beam from a laser fiber end or connector to the human eye beyond which the irradiance or radiant exposure is not expected to exceed the applicable MPE Operation The performance of...

Страница 224: ...ment beam can ignite most nonmetallic materials Use fire retardant drapes and gowns The area around the treatment site can be protected with towels or gauze sponges moistened with sterile buffered saline solution If allowed to dry protective towels and sponges can increase the potential fire hazard A UL approved fire extinguisher should be readily available Per IEC 60601 2 22 the use of flammable ...

Страница 225: ...e system interlock receptacle on the system rear panel If a remote switch is used the system can deliver laser energy only when the remote switch is closed Breaking the connection by opening the switch door or removing the plug disables laser and OCT emission and the system displays a clearable Door Interlock error message on the control panel Emergency Stop The system has an emergency laser stop ...

Страница 226: ... surgery to complete the interrupted treatment Electrical Fault Detection Circuitry If the electronic system detects a fault condition laser exposure cannot occur The safety shutter is closed and the laser is disabled Some fault conditions are user clearable Refer to System Error Codes Faults and Messages on page 214 for additional information Location and Definition of Regulatory and Other System...

Страница 227: ...Serial Number located on System Information Label on rear panel Date of Manufacture located on System Information Label on rear panel Attention Refer to Accompanying Documentation located on System Information Label on rear panel Applies to IEC 60601 1 Ed 2 Follow Instructions for Use located on System Information Label on rear panel CE Mark located on System Information Label on rear panel cETLus...

Страница 228: ...f as normal domestic refuse To prevent environmental risks or endangerments by nonprofes sional disposal the disposal of this product including any accessories must comply with valid practices as outlined in Directives 2012 19 EU and local regulations All electronic components and systems should be returned to JJSV for disposal Type B Equipment located on System Information Label on rear panel Las...

Страница 229: ...bel located next to key switch on front panel I ON O OFF Patient Vacuum Footswitch Label Laser Footswitch Label Remote Interlock Label located next to interlock port on system rear panel Dual Resettable Circuit Breaker Label located next to main power circuit breakers on system rear panel Ground Label located near system ground ...

Страница 230: ... located on docking keypad Patient Lock Label located on docking keypad Patient Chair Joystick Label located on headrest assembly at base of joystick control Laser Emission Indicator located on touchscreen control panel Laser Emission Indicator Label located on docking keypad Network Connection Label located on system rear panel Video Output Label located on system rear panel ...

Страница 231: ...Chapter 6 Safety and Regulatory Part Number 0160 6411 Rev A 02 2019 Page 231 of 314 Software Release cOS 5 00 USB Connection Port Label located on system front panel ...

Страница 232: ...Chapter 6 Safety and Regulatory Page 232 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 233: ...Part Number 0160 6411 Rev A 02 2019 Page 233 of 314 Software Release cOS 5 00 Appendix A Mobile Patient Bed Instructions ...

Страница 234: ...Appendix A Mobile Patient Bed Instructions Page 234 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 235: ...Electronics and Electrical Components 245 Software 245 Mobile Patient Bed Specifications 246 Mobile Patient Bed Installation and Setup 247 Mobile Patient Bed Operation 249 Enabling Disabling and Resetting the Mobile Patient Bed 249 Enabling the Mobile Patient Bed 249 Disabling the Mobile Patient Bed 249 Resetting the Mobile Patient Bed 249 Adjusting the Bed 250 Adjusting the Headrest Assembly 250 ...

Страница 236: ...ity 263 Bluetooth Characteristics 270 System Error Codes Faults and Messages 271 Control Pendant Faults 272 CATALYS System Error Messages 273 Emergency Stop Error Message 273 Subsystem Error Message 273 Bluetooth Communication Error Messages 274 End of Life Disposal Environmental Information 275 Warranty 275 Company Information 275 Decontamination of Returned Equipment 275 Decontamination Certific...

Страница 237: ...Part Number 0160 6411 Rev A 02 2019 Page 237 of 314 Software Release cOS 5 00 System Labels and Symbols 282 ...

Страница 238: ...Page 238 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 239: ...sly connected to the CATALYS System to position a patient for Laser Cataract Surgery When connected to the CATALYS System the Mobile Patient Bed is a fully integrated subsystem When not connected to the CATALYS System the Mobile Patient Bed can be used to transport patients to and from operating rooms The Mobile Patient Bed is equipped with an on board battery that is charged from an external AC p...

Страница 240: ...headrest and neck support position and support the patient s head and neck The headrest features a head clamp to stabilize the patient s head Various manual adjustments are available for proper head and neck positioning Refer to Adjusting the Headrest Assembly on page 250 for instructions on adjusting the headrest frame headrest and neck support Figure 1 2 Headrest Assembly Headrest assembly Contr...

Страница 241: ... each side of the Mobile Patient Bed The DIN rails can bear a load of up to 40 lb and allow for the attachment of IV poles mobile oxygen supply and other caring devices Column The column is the portion of the bed that moves vertically for bed height adjustment Refer to Adjusting the Bed Height on page 254 for instructions on adjusting the bed height Base The base houses the control electronics and...

Страница 242: ...ns monitor the battery status Refer to the Mobile Patient Bed Safety and Regulatory chapter for instructions on using the control pendant to operate the bed WARNINGS To prevent unintended movement of the bed always place the control pendant in the holster when not in use especially during surgical lens removal Do not hold the control pendant against the patient or user during surgery Metal buttons...

Страница 243: ...e bed upward in the Z axis Rotating the joystick counter clockwise moves the bed downward in the Z axis Figure 1 4 Joystick Control NOTE Once the suction ring is captured to the system the joystick is disabled The joystick is also disabled when the Mobile Patient Bed is not wirelessly connected to the CATALYS System Auxiliary Lock Buttons There are four auxiliary lock buttons two on the backrest a...

Страница 244: ... button Refer to Resetting the Mobile Patient Bed on page 249 for additional information on the reset feature Battery The Mobile Patient Bed is powered by 2 rechargeable 12V sealed lead acid SLA batteries The on board battery is designed to operate for a minimum of 2 days at 12 treatments per day and can be recharged by plugging the bed s AC power cord into a standard AC wall outlet When recharged...

Страница 245: ...Bed is equipped with an AC power cord that is used to charge the on board battery by plugging into a standard AC wall outlet The Mobile Patient Bed can operate on battery power or can be plugged into an AC power source at the installation site when used with the CATALYS System The main power receptacle and indicator are located on the base of the Mobile Patient Bed The main power indicator illumin...

Страница 246: ...ontrolled environment with temperature controlled to within 3 6 F 2 C Atmospheric pressure No atmospheric pressure dependency during the operation of the device Environmental Requirements Non operating Maximum altitude Standard commercial shipping altitude Temperature range 14 131 F 10 55 C Maximum humidity Up to 80 131 F 55 C non condensing Physical Characteristics Length bed in flat position and...

Страница 247: ...e The bed can also be permanently connected to an AC wall outlet if the bed is permanently positioned next to the CATALYS System WARNINGS To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Operate the Mobile Patient Bed using the on board battery if the integrity of the protective earth conductor is in doubt The detachable AC power cor...

Страница 248: ...Appendix A Chapter 1 Mobile Patient Bed System Description Page 248 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 249: ...ne of the auxiliary lock buttons on the backrest or footrest to wake the Mobile Patient Bed Disabling the Mobile Patient Bed If the Mobile Patient Bed becomes unresponsive during system operation press the emergency stop button on the patient left side of the Mobile Patient Bed base to disable electrical power to all motors in the bed The footrest headrest seat and column buttons on the control pe...

Страница 250: ...bed may move under some conditions on flooring surfaces such as tile or wood Use on these surfaces must be evaluated and deemed safe by the healthcare facility before using the Mobile Patient Bed When adjusting or moving the Mobile Patient Bed always ensure that the patient is properly positioned within the confines of the bed Do not allow the patient s extremities to protrude over the side of the...

Страница 251: ...backrest Headrest Adjustment The headrest has a ball joint that allows for multi directional adjustment To adjust the headrest 1 Grasp both headrest adjustment handles and rotate the handles counter clockwise to unlock the headrest 2 Adjust the headrest tilt and swivel as desired 3 Rotate the headrest adjustment handles clockwise to lock the headrest Figure 2 3 Location of Headrest Adjustment Hand...

Страница 252: ...ead clamp is adjustable by pulling apart or pushing together both sides of the head clamp The amount of force required to adjust the head clamp is also adjustable using the head clamp tension control Move the tension control to the left to loosen the tension i e reduce the amount of force required to adjust the head clamp move the tension control to the right to tighten the tension i e increase th...

Страница 253: ...the patient s body is dragged against it or the patient s clothing may get caught in the armrest locking mechanism Figure 2 6 Armrest in Raised and Lowered Positions Adjusting the Backrest Seat and Footrest The articulating backrest seat and footrest are adjustable using the control pendant The backrest can be adjusted up to 85 the seat can be adjusted up to 20 and the footrest can be adjusted up ...

Страница 254: ... when prompted by the CATALYS System To adjust the bed height using the control pendant 1 Press the column button the button illuminates 2 Press and hold the up down button to adjust the bed height 3 Release the up down button when the bed is at the desired height To adjust the bed height using the joystick rotate the joystick clockwise to raise the bed and counterclockwise to lower the bed WARNIN...

Страница 255: ...Bed casters are equipped with directional locks and wheel locks When the directional locks are applied the swivel mechanism is disabled When the wheel locks are applied the rolling mechanism is disabled The casters can be electronically locked unlocked using the control pendant the auxiliary lock buttons on the patient backrest and footrest or the foot pedals on either side of the bed The casters ...

Страница 256: ...ient right side of the footrest To activate directional lock mode for the front casters press the front caster directional lock button on the control pendant or press the button on the patient left side of the backrest When directional lock mode is activated the active directional lock buttons on the control pendant and backrest or footrest illuminate To deactivate directional lock mode press any ...

Страница 257: ...on the control pendant backrest and footrest illuminate To deactivate caster lock mode press any caster lock button on the control pendant backrest or footrest Manually Unlocking the Casters If the Mobile Patient Bed becomes unresponsive and or the emergency stop button is pressed you can manually unlock the casters by rotating the knob on the face of each caster counter clockwise 2 4 Moving the B...

Страница 258: ...or the bed to be in the upright seated or flat position LIQUID OPTICS Interface installation position The bed is rotated approximately 19 out from under the CATALYS System This position allows the physician convenient access to the treatment eye for LIQUID OPTICS Interface installation Patient treatment position The bed is rotated to the 0 position under the CATALYS System with the patient treatme...

Страница 259: ...r source immediately Solid gray Mobile Patient Bed is not connected to CATALYS System Rapidly blinking blue Mobile Patient Bed has been disconnected from CATALYS System during procedure When the Mobile Patient Bed is connected to the CATALYS System the name of the bed displays next to the Bluetooth connection status icon on the CATALYS System touchscreen 2 7 Disconnecting the Bed from the CATALYS ...

Страница 260: ...Appendix A Chapter 2 Mobile Patient Bed Operation Page 260 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 261: ...cloth and diluted isopropyl alcohol or bleach The optional drape can be cleaned with diluted isopropyl alcohol or bleach WARNINGS If liquid is spilled on and or around the Mobile Patient Bed immediately wipe up the liquid Ensure that the area is completely dry before using the bed Do not use caustic cleaners solvents or strong detergents when cleaning the Mobile Patient Bed Do not steam clean or p...

Страница 262: ...th new ones 5 Reinsert the fuse holder ensuring that the notch is at the top until the holder snaps into place WARNINGS Fuses must be replaced with the same fuse rating as described above Failure to use the proper fuses can result in damage to the Mobile Patient Bed Fuses must be replaced by a properly trained Biomedical Technician Certified Service Personnel or OPTIMEDICA Service Personnel 3 2 An...

Страница 263: ...ose provided with the Mobile Patient Bed could cause increased electromagnetic emissions or decreased electromagnetic immunity of this equipment resulting in improper operation Use of the Mobile Patient Bed adjacent to or stacked with other equipment could result in improper operation and should be avoided If such use is necessary observe and verify normal operation of the Mobile Patient Bed in th...

Страница 264: ... Patient Bed is intended for use in the electromagnetic environment specified below The customer or the user of the Mobile Patient Bed should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Mobile Patient Bed uses RF energy only for its internal func tion Therefore its RF emissions are very low and are n...

Страница 265: ... 4 4 2 kV Mains 1 kV I Os 2 kV Mains 1 kV I Os Mains power quality should be that of a typical commercial or hospital environ ment Surge IEC 61000 4 5 1 kV Differential 2 kV Common 1 kV Differential 2 kV Common Mains power quality should be that of a typical commercial or hospital environ ment Voltage Dips Drop out IEC 61000 4 11 95 Dip for 0 5 Cycle 95 Dip for 1 Cycle 30 Dip for 25 30 Cycles 95 D...

Страница 266: ...pical commercial or hospital environment Surge IEC 61000 4 5 1 kV Differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Voltage Dips 30 reduc tion 25 30 periods At 0 Voltage Dips 95 reduction 0 5 p...

Страница 267: ...the Mobile Patient Bed should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 V 0 15 MHz 80 MHz 6 V in ISM between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V in ISM between 0 15 MHz and 80 MHz 80 AM at 1 kH...

Страница 268: ...er in watts W according to the transmitter manufac turer and d is the recommended separa tion distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compli ance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher...

Страница 269: ... 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation2 18 Hz 2 0 3 28 1720 1845 1970 1700 1900 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation2 217 Hz 2 0 3 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation2 217 Hz 2 0 3 28 5240 5500 5785 5100 5800 WLAN 802 11 a n Pulse modulation2 217 Hz 0 2 0 3 9 NOTE I...

Страница 270: ... 86 70 dBm 2 441 80 86 dBm 2 480 80 86 dBm RF Transmit Power 2 402 0 2 4 4 dBm 2 441 0 2 4 dBm 2 480 0 2 4 dBm Initial Carrier Frequency Tolerance 2 402 5 75 75 kHz 2 441 5 75 kHz 2 480 5 75 kHz 20 dB bandwidth for modulated car 900 1000 1000 kHz Drift Five slots packet 15 40 kHz Drift Rate 13 20 kHz Δf1avg Max Modulation 2 402 140 165 175 140 kHz 2 441 140 165 175 kHz 2 480 140 165 175 kHz Δf1avg...

Страница 271: ...0 to 2 4835 GHz Up to 10 meters Bluetooth Specification version 2 1 Enhanced Data Rate EDR FCC CFR47 Part 15 Subpart C Intentional Radiators The MPB wireless communication has low latency high data integrity and is robust in the presence of interference as defined by the Bluetooth specification Security The MPB wireless communication channel is configured to use 128 bit encryption Device System Wi...

Страница 272: ...and column buttons are blinking Emergency stop button pressed Rotate the button clockwise to reset General error Press the reset button on the base of the bed and then calibrate the bed by pressing and holding the home button until the bed stops moving approximately 30 seconds Connect button is blinking slowly System is attempting to estab lish Bluetooth connection between Mobile Patient Bed and C...

Страница 273: ...sage displays on the CATALYS System screen Figure 3 3 Emergency Stop Error Message As instructed in the error message reset the emergency stop button fix the errors or undock the patient and then press OK to clear the message Subsystem Error Message If the Mobile Patient Bed encounters a hardware related error the following error message displays on the CATALYS System screen Figure 3 4 Subsystem E...

Страница 274: ...erify patient positioning while the system attempts to reconnect If the Mobile Patient Bed and the CATALYS System cannot automatically reconnect after a few seconds the following error message displays on the CATALYS System screen Figure 3 6 Unrecoverable Communication Error Message Press OK to clear the message NOTES Refer to Instructions for Interrupted Treatments on page 200 for guidance on how...

Страница 275: ... 4100 3 9 Decontamination of Returned Equipment To comply with United States postal and transportation law equipment shipped to OPTIMEDICA Corp for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for sale as a Hospital Disinfectant To ensure that all equipment has been properly decontaminated a signed Decontamination Certificate...

Страница 276: ...______________________________________________________ Individual Institution City State Province Country has undergone decontamination with a commercially available germicide cleared for use as a Hospital Disinfectant and is clean and free from biohazards including but not limited human or animal blood tissue or tissue fluids or components thereof The undersigned also agrees to reimburse OPTIMEDI...

Страница 277: ... 2 4th ed ETSI EN 301 489 1 V1 9 2 2011 09 ETSI EN 301 489 17 V2 2 1 2012 09 CSA STD C22 2 60601 1 The essential performance for the Mobile Patient Bed is the lack of unintended bed movement during laser surgery in any single fault condition or any combined fault conditions When essential performance degrades the operator can expect unintended bed movement WARNING If you experience unintended bed ...

Страница 278: ...erformed only by OPTIMEDICA certified personnel per the manufacturer s recommendation and institutional standards Never open the protective covers or attempt internal repairs or adjustments not specifically detailed in this operator manual Opening the covers will expose personnel to high voltage components Do not expose electrical components to liquids during routine operation or system cleaning D...

Страница 279: ...Bed casters before adjusting the bed and before patient loading and unloading Even with the casters properly locked the bed may move under some conditions on flooring surfaces such as tile or wood Use on these surfaces must be evaluated and deemed safe by the healthcare facility before using the Mobile Patient Bed When adjusting or moving the Mobile Patient Bed always ensure that the patient is pr...

Страница 280: ...nufacturer s operator manual for safe operation and compatibility with the Mobile Patient Bed Use of the Mobile Patient Bed with other equipment may lead to increased leakage current resulting in electrical shock Refer to the equipment manufacturer s operator manual for safe operation and compatibility with the Mobile Patient Bed CAUTIONS Federal law USA restricts this device to sale by or on orde...

Страница 281: ...st and two lock foot pedals that activate caster lock mode when pressed Caster lock mode simultaneously locks both the rolling and swivel mechanisms on all four casters to immobilize the bed Manual Caster Locks The Mobile Patient Bed casters have manual locks that enable you to manually unlock the casters if the Mobile Patient Bed becomes unresponsive and or the emergency stop button is pressed Co...

Страница 282: ...Equipment located on System Information Label on bed base Non ionizing Radiation located on System Information Label on bed base WEEE Symbol located on System Information Label on bed base This symbol indicates that the equipment consists of electronic assemblies and other components that may be subject to Directives 2012 19 EU of the European Parliament which advises that Electrical and Electroni...

Страница 283: ...epresentative in the European Community located on System Information Label on bed base RCM Mark located on System Information Label on bed base cETLus Mark located on System Information Label on bed base CE Mark located on System Information Label on bed base FCC Mark located on System Information Label on bed base Type BF Equipment located on bed frame Emergency Stop Label located next to emerge...

Страница 284: ...ocated on control pendant Home button located on control pendant Connect icon located on control pendant Memory button flat position located on control pendant Memory button upright seated position located on control pendant Pivot lock button located on control pendant Caster lock button located on control pendant Directional lock button back casters located on control pendant Directional lock but...

Страница 285: ...Appendix A Chapter 4 Mobile Patient Bed Safety and Regulatory Part Number 0160 6411 Rev A 02 2019 Page 285 of 314 Software Release cOS 5 00 This page was intentionally left blank ...

Страница 286: ...Appendix A Chapter 4 Mobile Patient Bed Safety and Regulatory Page 286 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 ...

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 288: ...ble for use with the CATALYS System one manufactured before May 2013 and another manufactured after May 2013 The following instructions pertain to both patient chairs except where noted Figure B 1 Patient Chair Components Headrest assembly Joystick control Joystick Cable connection to chair red dot on plug and receptacle to be in 12 o clock position Headrest Vertical Adjustment Knob Joystick opera...

Страница 289: ...air back in reclined position and patient footrest in raised position Patient treat position chair rotated under system with patient chair back in reclined position and patient footrest in raised position NOTES If the system becomes disabled for any reason during treatment lower the patient s head using the headrest vertical adjustment knob This enables removal of the LIQUID OPTICS Interface and a...

Страница 290: ...k fore or aft causes the chair to move superiorly or inferiorly in the y axis Rotating the joystick clockwise causes the chair to move upward in the z axis Rotating the joystick counter clockwise causes the chair to move downward in the z axis Figure B 3 Joystick Control from Surgeon Perspective NOTE Once the suction ring is captured to the system the patient chair joystick is disabled Moves Chair...

Страница 291: ... The patient chair joystick incorporates a chair enable button located on the top of the joystick You must continuously press the chair enable button to enable joystick control of the chair position Figure B 4 Chair Enable Button on Joystick The system has a dual function footswitch The left footswitch is a chair enable footswitch and must be continuously depressed to enable joystick control of th...

Страница 292: ... to provide patient comfort and to accommodate variation in patient head size Rotate the knob clockwise to lower the patient s head rotate the knob counter clockwise to raise the patient s head NOTE Before seating the patient align the two arrows under the headrest neck support adjustment knob Use the headrest vertical adjustment knob to adjust the vertical position of the headrest until the arrow...

Страница 293: ...ATALYS system Environmental Requirements Operating Maximum altitude 7 000 ft 2 134 m Temperature range 59 89 6 F 15 32 C Maximum humidity Up to 80 89 6 F 32 C non condensing Operating environment Temperature controlled environment with temperature controlled to within 3 6 F 2 C Atmospheric pressure No atmospheric pressure dependency during the operation of the device Environmental Requirements Non...

Страница 294: ...loading and unloading and provides clearance for the chair to be in the upright seated or flat position LIQUID OPTICS Interface installation position The chair is rotated approximately 19 out from under the CATALYS System This position allows the physician convenient access to the treatment eye for LIQUID OPTICS Interface installation Patient treatment position The chair is rotated to the 0 positi...

Страница 295: ...Part Number 0160 6411 Rev A 02 2019 Page 295 of 314 Software Release cOS 5 00 Appendix C LIQUID OPTICS Interface 12 Quick Reference Guide ...

Страница 296: ...s 1 Alignment Mark Placement Consider placing marks used to compensate for cyclorotation on the limbus or possibly more central for better visualization when applying the suction ring and aligning the fiducial marks inside of the LIQUID OPTICS Interface 12 Be careful not to place marks where a CATALYS System created incision is planned as this may prevent the incision from being created properly 2...

Страница 297: ...sualize and Customize Treat Throughout INTEGRAL GUIDANCE System imaging and treatment continue to monitor the en face video image and the force sensors for any potential patient movement or suction loss Figure C 1 Suction Ring Outside Capture Zone Figure C 2 Suction Ring Inside Capture Zone When reviewing the Axial and Sagittal OCT images in INTEGRAL GUIDANCE System imaging notice that more of the...

Страница 298: ...Appendix C LIQUID OPTICS Interface 12 Quick Reference Guide Page 298 of 314 Part Number 0160 6411 Rev A 02 2019 Software Release cOS 5 00 This page was intentionally left blank ...

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 ...

Страница 300: ...rtical force exceeds lock limit Warning 01 012 Lateral force exceeds lock limit Warning 01 013 Unlock in progress lock on ignored Warning 01 014 Simultaneous vacuum on vacuum off requests Warning 01 015 Simultaneous capture on capture off requests Warning 01 016 Simultaneous lock on lock off requests Warning 01 017 Vacuum off pressed during scan or treat Warning 01 018 Capture off pressed during s...

Страница 301: ...nt Clearable Stop 02 007 Video frame rate too low for treatment verify Liquid Optics Interface is correctly docked and patient is not moving before proceeding Clearable Machine 03 001 Capture line pressure low inspect Liquid Optics Interface and fluid catchment before attempting to dock Clearable Machine 03 002 Capture lost inspect Liquid Optics Interface and fluid catchment before attempting to r...

Страница 302: ...epancy release footswitch before proceeding Clearable Both 04 014 Vacuum chair footswitch discrepancy release footswitch before proceeding Clearable Both 04 015 Laser footswitch discrepancy release footswitch before proceeding Clearable Both 04 016 Bed disconnected from system patient automatically undocked Clearable Both 04 017 Bed emergency stop button pressed rotate button clockwise until butto...

Страница 303: ...Critical 05 022 Photodetector S delta error contact OptiMedica Service Critical 05 023 Shutter discrepancy error contact OptiMedica Service Critical 05 024 Lock discrepancy error contact OptiMedica Service Critical 05 025 Force sensor 1 saturated contact OptiMedica Service Critical 05 026 Force sensor 2 saturated contact OptiMedica Service Critical 05 027 Force sensor 3 saturated contact OptiMedic...

Страница 304: ...t OptiMedica Service Critical 05 050 FPGA execution error contact OptiMedica Service Critical 05 051 FPGA watchdog error contact OptiMedica Service Critical 05 052 FPGA FIFO timeout contact OptiMedica Service Critical 05 053 FPGA header error contact OptiMedica Service Critical 05 054 FPGA footer error contact OptiMedica Service Critical 05 055 FPGA FIFO timeout contact OptiMedica Service Critical...

Страница 305: ...ervice Critical 05 076 Thermal fuse open contact OptiMedica Service Critical 05 077 Fan error contact OptiMedica Service Critical 05 078 Vacuum solenoid error contact OptiMedica Service Critical 05 079 Capture solenoid error contact OptiMedica Service Critical 05 080 Key turned to off position Critical 05 081 Emergency stop button pressed rotate button clockwise until button is released to reset C...

Страница 306: ...e fits consider re scan Host NoTreat 07 013 OCT scan out of range re scan and verify surface fits Host NoTreat 07 014 OCT scan out of range re scan and verify surface fits Host NoTreat 07 015 Disposable lens out of spec re scan and replace disposable lens if necessary Host NoTreat 07 016 Capsulotomy intersects iris verify surface fits and adjust parameters Host NoTreat 07 017 Capsulotomy intersect...

Страница 307: ...NoTreat 07 035 Ramp pattern generation error contact OptiMedica Service Host NoTreat 07 036 Lens fragmentation pattern too large verify surface fits and adjust parameters Host NoTreat 07 037 Iris intersects limbus verify surface fits consider re scan Host NoTreat 07 038 Iris intersects suction ring verify surface fits consider re scan Host NoTreat 07 039 Disposable lens scan error verify disposabl...

Страница 308: ... fits Host NoTreat 07 057 Lens posterior fitting error verify surface fits consider re scan Host NoTreat 07 058 Lens surface fitting error verify surface fits consider re scan Host NoTreat 07 059 Lens posterior fitting error verify surface fits consider re scan Host NoTreat 07 060 Capsulotomy not computed Host NoTreat 07 061 Lens fragmentation not computed Host NoTreat 07 062 Arcuate incision 1 no...

Страница 309: ...OptiMedica Service Host NoTreat 07 088 Laser out of range contact OptiMedica Service Host NoTreat 07 089 Laser out of range contact OptiMedica Service Host NoTreat 07 090 Parallel loop error contact OptiMedica Service Host NoTreat 07 091 Limbus detection error verify surface fits consider re scan Host NoTreat 07 092 Iris detection error verify surface fits consider re scan Host NoTreat 07 093 Surf...

Страница 310: ...arameters Host NoTreat 07 111 Cataract incision computation error verify surface fits adjust parameters and consider re scan Host NoTreat 07 112 Cataract incision does not intersect cornea verify surface fits and adjust parameters consider re scan Host NoTreat 07 113 Cataract incision does not intersect cornea verify surface fits and adjust sidecut angle Host NoTreat 07 114 Cataract incision plane...

Страница 311: ...9 Cornea mapping OCT error re scan and verify surface fits Host NoTreat 07 130 Laser out of range contact OptiMedica Service Host Critical 08 001 Laser connection error contact OptiMedica Service Host Critical 08 002 Laser status error contact OptiMedica Service Host Critical 08 003 Log file error contact OptiMedica Service Host Critical 08 004 Watchdog initialization error contact OptiMedica Serv...

Страница 312: ...ica Service Host Critical 08 027 FPGA initialization error contact OptiMedica Service Host Critical 08 028 FPGA execution error contact OptiMedica Service Host Critical 08 029 Host data error contact OptiMedica Service Host Critical 08 030 Host data error contact OptiMedica Service Host Critical 08 031 Host data error contact OptiMedica Service Host Critical 08 032 Intake temperature below limits ...

Страница 313: ... Host data error contact OptiMedica Service GUI Shutdown 10 001 Host process failed shutdown GUI Shutdown 10 002 GUI communications error contact OptiMedica Service GUI Shutdown 10 003 Database error contact OptiMedica Service GUI Shutdown 10 004 Database corruption error contact OptiMedica Service GUI Shutdown 10 005 Database ID error contact OptiMedica Service GUI Shutdown 10 006 Configuration f...

Страница 314: ...GUI Shutdown 10 015 RFID reader failure contact OptiMedica Service GUI Shutdown 10 016 Remote access failure contact OptiMedica Service GUI Auto Shutdown 11 001 Touchscreen failure contact OptiMedica Service Startup Warning 12 001 Force sensors tare near limits contact OptiMedica Service Error Type Error Number Error Message ...

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