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8-16 Operator’s Manual

110017276EN Rev. B

8 Specifications

Ultrasound Mode Specifications

Parameter

Specification

Continuous Ultrasound Mode

Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Range: 0% to 100% power in 1% increments
Wave for Ultrasound: Disabled/Enabled (throughout)
Control: Linear power control via the footpedal
Nominal phaco handpiece tip stroke at 100% power setting
with DP8230 Microflow needle is 130 um at 28.5 kHz. This
results in a nominal peak tip velocity of 11.6 m/sec.

Pulsed Ultrasound Mode

Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Range: 1 to 250 pulses per second
Duty Cycle: 5 to 95% in 1% increments
Rise Time: 1 or 2

Single Burst Ultrasound Mode

Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Range: 80 to 600 msec. burst width
Control: Single burst at end of pitch or yaw travel

Fixed Pulse Ultrasound Mode

Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Duration: 2 to 600 msec
Interval: 2 to 600 msec
Control: Linear power control via the footpedal. Burst
duration and interval as selected

Multiple Burst Ultrasound Mode

Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Range: 2 to 600 msec. burst width
Maximum Duty Cycle*: 50 to 99% in 1% increments
Minimum Duty Cycle*: 1 - 50% in 1% increments.
Waveform: Enabled (Rise Time 2), Disabled (Rise Time 1)
Control: 1 burst at minimum duty cycle at start of linear
control region. Interval decreases until maximum duty cycle
is commanded at end of linear control region

*Actual Duty Cycle Range is limited by the Burst Width
Setting

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Summary of Contents for STELLARIS PC

Page 1: ...Operator s Manual ...

Page 2: ...nsent of Bausch Lomb Incorporated Rochester NY 14609 USA denote trademarks of Bausch Lomb Incorporated All other products brands are trademarks of their respective owners Bausch Lomb Incorporated Rochester NY 14609 USA Manufacturing site Bausch Lomb Incorporated 3365 Tree Court Industrial Blvd St Louis MO 63122 Bausch Lomb Incorporated 106 London Road Kingston upon Thames KT2 6TN UK 110017276EN Re...

Page 3: ...ntraindications Use of accessories not designated by Bausch Lomb for use with this equipment may result in serious permanent patient injury adverse surgical outcome or damage to the equipment which may not be covered by warranty See page 1 1 for precautions relevant to patients with implantable defibrillators and cardiac pacemakers This manual contains precautions Danger Cautions Warnings Notes et...

Page 4: ...to suit your particular needs Chapter 4 has detailed information about each function and feature how to set up the function and its associated disposables and how to interact with each function Chapter 5 provides cleaning and sterilization information These chapters are meant to serve as a reference to questions of a more technical nature Chapter 6 through Chapter 8 contain information that you ma...

Page 5: ...on which if disregarded or incorrectly performed could result in serious and or permanent injury to personnel and or patients CAUTION Calls attention to an operating procedure practice or condition which if disregarded or incorrectly performed could result in damage to the product and or equipment Note Calls attention to an operating procedure practice or condition providing essential information ...

Page 6: ... Dispose of Properly Battery Condition Indicator Serial Number Manufacturer Authorised Representative in the European Community Date of Manufacture Non Ionizing Electromagnetic Radiation Caution Consult Accompanying Documents Frequency in Hertz Type BF Applied Part Fuse Coagulation Microscope Camera High Speed Vitrectomy Ethernet Monitor Ultrasound Stellaris PC Vision Enhancement System USB Ω VA A...

Page 7: ...nation Gamma Irradiation Sterilized Viscous Fluid Control Do Not Reuse Do Not Re Sterilize 21 CFR 801 109 b Caution Federal USA law restricts this device to sale by or on the order of a physician Do Not Use If Damaged Member Green Dot Scheme Transport Symbol See page 1 30 No Latex Caution Consult Accompanying Documents ...

Page 8: ...017276EN Rev B Preface Always wear eye protection or face mask when installing or removing the lamp Warning Hot surface Electrostatic sensitive device Never touch the silica glass bulb of the lamp with bare hands Xenon Xenon Mercury ...

Page 9: ...l 1 62 2 User Interface 3 1 Posterior Combined Domain Interface Controls 2 1 3 2 Posterior and Combined Domain Surgical Information More Settings Screens 2 7 3 3 Posterior and Combined Domain Surgical Screen Layouts 2 34 3 4 CustomizingYour System Settings 2 40 3 5 Anterior Domain Basic Interface Controls 2 40 3 6 Anterior Domain Surgical More Settings Screens 2 46 3 7 Anterior Domain Surgical Scr...

Page 10: ...3 6 4 Ultrasound Handpiece andAccessories 5 6 6 5 Special Instructions for United Kingdom Users 5 11 6 6 Cleaning the MMC 5 14 6 Troubleshooting 7 1 User Troubleshooting 6 1 7 2 Power Issues 6 1 7 3 Error and Warning Messages 6 3 7 4 Troubleshooting the MMC 6 19 7 5 System Configurations Modules Accessories and Packs 6 20 7 Service and Warranty 8 1 Service Information 7 1 8 2 Environmental Protect...

Page 11: ... to determine the appropriate action WARNING Electromagnetic interaction between the phacoemulsification phaco handpiece and an implanted cardiac pacemaker is unlikely but cannot be ruled out Patients should be questioned to determine if they have such an implant and if so the manufacturer of the implant should be consulted to determine the proper course of action WARNING All external wiring must ...

Page 12: ...ge Report any damage from shipping to the carrier Before discarding packaging material assure all parts are accounted for Smaller parts may be attached to packing materials Standard components shipped with the system include System Main Console Foot Control with Battery Foot Control Wall Charger Extra Foot Control Battery Foot Control Backup cable Operator s Manual CD System Power Cord Mayo Tray F...

Page 13: ...System is pre configured at the factory to minimize setup and installation requirements The power cable Foot Control and Ethernet connections are located at the lower rear of the system Figure 1 1 Lower Rear of System 1 Fuse Holder 2 Main Power Switch disconnects system from mains voltage See IEC 60601 1 paragraph 8 6 7 3 Ethernet Port 4 Foot Control Backup Cable Port 5 Power Cord Input 6 Power Co...

Page 14: ... cable connection only applies to a Stellaris PC Vision Enhancement System with TruLink Customer Support Network enabled when you intend to upload system information to the Bausch Lomb Global Service Support server No Ethernet cable is supplied with the system If you plan to use the TruLink Customer Support Network connect an Ethernet cable from the back of the Stellaris PC Vision Enhancement Syst...

Page 15: ...25 SCFM 63 7 SLPM 1 3 System Description The Stellaris PC Vision Enhancement System has a modular design which enables it to be easily upgraded to take advantage of advances in technology The system consists of a main housing unit which contains a user interface screen and the surgical modules and a Foot Control infrared remote control for anterior application only optional accessory Handpieces pa...

Page 16: ...with the remote control The computer system includes both audio and visual capabilities which provide warning messages alarms and other audio indications as well as allowing you to view setup screens surgical settings and video from a microscope camera The volume is adjustable via the touch screen spin buttons on the A V More Screen Two USB ports on the back of the display allow you to save load a...

Page 17: ... If the pressure remains outside the set range an error message will appear on the screen 1 4 Setting Up Your System DANGER Do not use in the presence of flammable anaesthetics disinfectants aerosol sprays or in an oxygen rich atmosphere WARNING This system should only be operated by personnel who have been trained and are qualified to use this system WARNING Do not manually force the IV Pole down...

Page 18: ...the other end to the hospital network port If you have the optional MMC system this cable should be connected to the MMC and the MMC in turn connected to the hospital network port Refer to page 1 39 for detailed MMC setup instructions Turn on the switch at the bottom of the system console WARNING Ensure that the power cord is routed away from traffic areas to prevent accidental disconnection or tr...

Page 19: ...finish The front power switch is brighter when the system is off and dims when you turn the system on The Stellaris PC Vision Enhancement System performs a self check each time the power is turned on The system automatically checks its configurations for any changes since the last time it was turned on Note Whenturningthesystemonforthefirstuseoftheday paycloseattentiontoanywarningmessages that app...

Page 20: ...ery is charged then hold down any button on the Foot Control until the green ready light comes on indicating that communication has been initiated This light will turn solid green when full communications have been established When the system check is completed following system power up the Splash screen will appear See Figure 1 5 on page 1 10 Note Following system shut down wait a minimum of 15 s...

Page 21: ... A Select Surgeon Screen as shown in Figure 1 7 on page 1 12 will appear when you select any type of procedure from the Select Procedure Screen If your system is programmed to default to either the Anterior Domain Posterior Domain or the Combined Domain the Select Procedure Screen will not appear and the system will move directly to the Select Surgeon Screen as shown in Figure 1 7 below ...

Page 22: ...ghlight it Then select Confirm to load the parameters for that surgeon and advance to the Setup Screen Note If the Confirm button is not active this indicates one or more modules were not detected in the system and further operation is not allowed To set up default parameters for a new surgeon instead of using an existing surgeon s file select Create New This will allow you to setup a file for a n...

Page 23: ...rior Only and choose the case number number of operating rooms being used by the surgeon and the particular operating room to be used If desired select Select Case Anterior or Case Menu Posterior and Combined and choose the specific technique needle grade and pathology Anterior Domain or vitrectomy gauge fragmentation needle Posterior Domain for the current procedure The appearance of this screen ...

Page 24: ...1 14 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 9 Posterior Domain Case Menu Screen ...

Page 25: ...17276EN Rev B 1 Getting Started Figure 1 10 Combined Domain Case Menu Screen Advance to the open pack step by selecting Open Pack Insert Cassette Anterior Domain or Insert Cassette Posterior or Combined Domain from the clock menu ...

Page 26: ...or the entire procedure Note Ensure tube set connection is secure when connecting to the handpiece and system 1 Set up the sterile field Open the disposable pack and drop contents onto a sterile surface Note Make sure to use the proper pack for the mode you are using Packs will not work for other modes The packs are color coded Anterior packs are green and or light blue Posterior Packs and Combine...

Page 27: ...ored during the procedure Insert the fluidics cassette into the slot on the front of the system and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette The system will automatically conduct a vacuum sensor and calibration check Wait until the progress bar shows successful completion to proceed I...

Page 28: ...scous Fluid Aspiration See page 4 25 Linear Fluid Injection Linear Vacuum See page 4 27 Fragmentation See page 4 28 Anterior Domain Irrigation Aspiration See page 4 31 Phacoemulsification See page 4 37 Planned Anterior Vitrectomy See page 4 40 Unplanned Anterior Vitrectomy See page 4 41 Coagulation Fixed Coagulation See page 4 47 Linear Coagulation See page 4 48 Combined Domain See page 4 50 Note ...

Page 29: ...or lower if maximum ceiling height is set lower than 100 cm for the anterior In the posterior combined domains I V pole will raise to the maximum ceiling height programmed for the system With the air pressured infusion the pressure will raise to 73 mmHg for anterior domain and 103 mmHg for posterior combined domains Select the Prime Test Vit button to activate the vacuum on right side aspiration l...

Page 30: ...d The irrigation line and the aspiration line need to be connected to the ultrasound handpiece with the test chamber attached to the tip of the ultrasound handpiece After the line has been primed this button will change to Tune U S which will activate a shorter cycle of aspiration and tuning without the vacuum test Select the Prime Aux button to activate aspiration to fill the left aspiration line...

Page 31: ...une is initiated by any of these options a Cancel button will appear Selecting the Cancel button will immediately stop the priming and tuning process When Prime and Tune is in progress a progress bar at the lower left hand corner is displayed to indicate the status of the Prime and Tune cycle If the system does not pass the Prime and Tune test suggestions for corrective action will be displayed ...

Page 32: ...nded for priming or tuning handpieces while the handpiece is in the eye can create a hazardous situation that could result in patient injury Once the system has been successfully primed and tuned it will automatically move to the main surgical screen Manually selecting Advance to Surgery produces the same result Note If the system is not primed and tuned the aspiration vitrectomy and ultrasound fu...

Page 33: ... display the appropriate surgical screen for the current surgical mode The interface is visibly different depending on the current operational mode See Figure 1 13 for an example of a Posterior Surgical Screen see Figure 1 14 for an example of an Anterior Surgical Screen and Figure 1 15 for an example of a Combined Mode Surgical Screen When the appropriate screen appears your Stellaris PC Vision E...

Page 34: ...1 24 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 14 Anterior Surgical Screen ...

Page 35: ...tte and you will be reminded to close the clamps on the administration tube set A similar End function is accessible from the Setup Screen WARNING Make sure to close the Irrigation Clamp on the Administration Tube Set before pressing End Procedure or fluid may continue to flow from the handpiece and into the cassette The system will then advance to the End of Case Screen shown below lower the IV P...

Page 36: ...1 26 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 16 Anterior End of Case Screen ...

Page 37: ...Operator s Manual 1 27 110017276EN Rev B 1 Getting Started Figure 1 17 Posterior End of Case Screen ...

Page 38: ...diately Remove all disposables from the system Select Show Me Steps Remove Disposables to see a list of which disposables need to be removed and animations of how to remove each of them Select Next Patient to return to the Setup Screen and prepare the machine for the next procedure or select Shut Down System to power down the system ...

Page 39: ...n shut down when finished When shutting down the system make sure to recharge the Foot Control as described on page 1 51 1 9 Power Interruptions If the Stellaris PC Vision Enhancement System requires continued operation during power main interruptions the system should be powered from an uninterruptible power supply not provided In the event the power source is interrupted causing the system to sh...

Page 40: ...ng the IV pole is fully retracted 2 Remove any objects from mat on top of unit 3 Depressurize the compressed air supply that feeds your unit 4 Disconnect the pneumatic air hose from the lower left corner facing the rear end of the unit 5 Store the tray all the way in the unit s tray receptacle 6 Fully close the front drawer 7 Roll the power cord in its proper hooks at the rear end of the unit 8 Pl...

Page 41: ...s WARNING Use only handpieces cables tube sets and accessories designated by Bausch Lomb for use with this system WARNING Manufacturers of cardiac pacemakers advise against use of bipolar cautery devices on patients with such implants When conducting surgery on such a patient a battery powered thermal cautery may be used or the manufacturer of the pacemaker should be consulted to determine appropr...

Page 42: ...face Screen The User Interface Screen is the way the user communicates with the system See Chapter 2 for basic user interface controls Technical specifications can be found in Chapter 8 A typical interface setup screen is shown below Figure 1 19 Typical interface screen ...

Page 43: ...e screen 7 System Switch On Off 8 Handpiece Connectors 9 Fluidic Module 10 System Tray This is the main unit which contains the connections for all handpieces Mayo tray Ethernet connection and system housing On the rear of the main unit see Figure 1 21 on page 1 34 near the IV Pole are three buttons that move the IV Pole up down or back to the preset height for the current mode of operation The co...

Page 44: ...ooks 4 Foot Control Hook 5 Air Pressure Output connector The front of the system see Figure 1 22 on page 1 35 contains multiple ports for connecting system accessories There are five ports down the left side of the system of which only the second and third are active The second port is for ultrasound handpieces phacoemulsification and fragmentation and the third port is for coagulation see page 1 ...

Page 45: ...AFI 8 Lamp 2 9 Lamp 1 Ultrasound Functions Phacoemulsification and Fragmentation WARNING Manufacturers of implantable defibrillators recommend that these devices be temporarily disabled when using phacoemulsification or systems on patients with these implants This is especially important when using pulsed phaco modes of operation Although the implanted devices are designed to reject electromagneti...

Page 46: ...ubing Pneumatic vitrectomy supports both a Linear Cut Rate and a Fixed Cut Rate from 0 to 5000 cpm See page 4 5 for details of posterior use and page 8 17 for technical specifications Illumination Function The illumination function provides two light sources both with an adjustable attenuator More than 25 lumens output is available at maximum settings With a xenon lamp in Lamp 1 location any one o...

Page 47: ... aspiration port to the middle of the BSS drip chamber This is an equivalent pressure not Intraocular Pressure of 22 4 mmHg The IV Pole can extend to 140 cm 55 in high an equivalent pressure of 102 74 mmHg To change the programmed bottle height settings for the current surgical mode select the Fluidics More SettingsScreen page2 32 ifinPosteriorMode ortheVacuumFluidicsMoreSettingsScreen Seepage2 19...

Page 48: ...trol can be used to activate functions in the Prime and Tune window of the setup screen The remote control UP DOWN buttons are used to move the arrow and select options in the Prime and Tune window Pressing the Enter button on the remote control activates the selected function Note The batteries should be removed from the remote control if the system is to be idle for more than 30 days Note It is ...

Page 49: ...ing down and then disconnected to move or store the Stellaris PC Vision Enhancement System Upon shutdown from the End of Surgery screen the system will offer a prompt to Send data to TruLink If you agree make sure that the Ethernet cable is connected to the designated port and follow instructions After updating the system will shut down automatically Multimedia Center MMC optional The MMC if avail...

Page 50: ...e connections Note The MMC is not intended for diagnostic purposes Before installing the Multimedia Center please take note of the following Multimedia Center must be installed outside of the sterile field Do not place BSS bottles or other containers of fluid on top of the Multimedia Center The AC power source for the Multimedia Center must have a Ground Fault Interrupt 1 12 Foot Control The Foot ...

Page 51: ...seven days Refer to the battery charging options section on page 1 51 Foot Control Battery Installation Guide Note Replacing the battery when the system is powered up will disable the foot control wireless set up To re enable wireless set up see page 1 46 1 Place the Foot Control upside down on a flat dry surface 2 Open the battery door by pressing the targets on the door toward the battery compar...

Page 52: ... battery must be installed in the Foot Control at all times while operating either wired or wireless to insure proper operation The first time a Foot Control is used it must be connected via the back up cable to set the configuration Once this is set the Foot Control will only communicate wirelessly with that specific system To begin wireless operation make sure the Stellaris PC Vision Enhancement...

Page 53: ...er to the Foot Control Wireless System setup section LED Symbol for Ready on Foot Control When not in use the Foot Control can be stored on the back of the Stellaris PC Vision Enhancement System In some operating configurations the surgeon can change surgical phases using the Foot Control Figure 1 27 Back of Foot Control ...

Page 54: ...oot Control 1 Right Toe Button 2 Footpedal 3 Right Heel Button 4 Indicator Lights 5 Right LED Wireless 6 Left LED Battery 7 Left Heel Button 8 Left Toe Button Figure 1 29 Bottom of Foot Control 1 Pedal Offset Switch 2 Battery Compartment Door 3 Pedal Pitch Tension Adjustment Knob ...

Page 55: ... for system setup for right foot operation Note The pedal offset switch indicator must align with either left right or center pedal offset position Failure to align the indicator appropriately will cause the Foot Control to become inoperable Left or right offset position selections strictly follow system software programming for Left or Right foot operations For example if the system is programmed...

Page 56: ... Software upgrade will reset the Wireless System Setup to Disabled also To setup wireless operation follow steps below Step 1 Select Programming from Setup or Select Surgeon screens Step 2 Select System Setup from the programming screen as shown below Figure 1 31 Programming Screen Step 3 Select Foot Control tab from the System Setup screen Arrow in image below ...

Page 57: ...bove Note The system setup is for enabling wireless functionality it does not affect the wired functionality The wired option is always available and active when connected Note The system will disable wireless operation once it detects a loss of wireless connection at the setup and surgery screens Changing the battery at the setup and surgery screens will also disable the wireless system setup ...

Page 58: ...sabled System NOT detecting wired connection Possible cause Foot Control cable not connected Check Foot Control cable connection If Wireless System Setup is on enabled wireless connection will be activated momentarily when system detects loss of wired connection The wireless signal strength icon will be displayed indicating system is now in wireless operation Wireless System NOT detecting wireless...

Page 59: ...ted Display Type Foot Control Setup Status Action Wireless System detecting Excellent signal strength No action required Wireless System detecting Good signal strength No action required Wireless System detecting Moderate signal strength No action required ...

Page 60: ...usion will be turned ON and other functions will be disabled when the system does not detect Foot Control connectivity in surgical mode Irrigation or infusion can be turned OFF from the touch screen Battery Management This symbol on the battery indicates that the product must be disposed of separately and safely Therefore it is your responsibility to dispose of this waste equipment by handing it o...

Page 61: ... Note Use only Bausch Lomb supplied wall chargers BL4391 charging cradles BL4393 adapters BL4392US BL4392UK BL4392EU BL4392AUS BL4392ROW and batteries BL4390 with the Stellaris PC Vision Enhancement System The Foot Control Battery should be charged whenever the system is not in use Any one of three methods can be used to charge the battery With the system power cord plugged in to the electric sour...

Page 62: ... Control See Option 3 in Figure 1 34 Note When the Foot Control is connected to the wall charger it will not communicate with the system and cannot be used in surgery Note To connect the backup cable or wall charger to the Foot Control align the red dot of the connectors to the 12 o clock position Note The Foot Control is only to be used with wall charger BL4391 Figure 1 34 Foot Control Battery Ch...

Page 63: ...aneously Dual Linear control The control of linear functions is proportional to the amount of footpedal travel See page 1 57 for description of linear control In single linear mode pitch controls the linear functions selected and yaw movement provides on off control in both directions In Dual Linear mode one linear function is controlled by pitch travel and the other linear function is controlled ...

Page 64: ... below the Footpedal status icon on the bottom of the Main Surgical Screen and Setup Screen In the posterior and combined domains the Foot Control More Settings Screen is displayed by selecting the More Settings Screen button Footpedal The footpedal itself located in the center of the Foot Control provides two axes of movement and thus allows simultaneous control of two system parameters Both cont...

Page 65: ...ontrol are the linear coagulation function and fixed cut vitrectomy function Figure 1 36 Single Region Pitch Control Two Region Pitch Control There are two programmable regions two detent positions When programmed for linear control the pitch movement is a function of relative footpedal displacement in Region 2 e g 5 to 15 down corresponds to 0 to 100 output An example is I A control where Region ...

Page 66: ...ely 5 to give approximately 15 of motion to the right and approximately 5 of motion to the left See Dual Linear Yaw Control below Set and programmed for a left footed operator with the pedal home position offset to the right of center by approximately 5 to give approximately 15 of motion to the left and approximately 5 of motion to the right See Dual Linear Yaw Control below Set and programmed for...

Page 67: ...ward yaw movement provides linear control of the programmed function relative to footpedal displacement e g 0 to 15 displacement corresponds to 0 to 100 output When the footpedal is released it returns to the center position Inward yaw movement controls reflux Yaw Control of Reflux The footpedal may be programmed for use with either the right or left foot Reflux if selected is always activated by ...

Page 68: ...power is varied linearly from preset minimum to the preset limit Power begins when entering footpedal position 1 and ends at the completion of travel Note Due to compliance with IEC 60601 2 2 position 1 will not start until approximately 35 of pedal travel is attained in the linear coagulation mode ...

Page 69: ...on linear ultrasound Aspiration on yaw R1 Irrigation R2 Minimum aspiration Linear aspiration R3 Linear ultrasound Aspiration on yaw aspiration control feature on R1 Irrigation R2 Aspiration R2 minimum to fixed vacuum or vacuum limit To max aspiration R3 Min aspiration and linear ultrasound Aspiration on Pitch R1 Irrigation R2 Linear aspiration Linear ultrasound Dual Linear Ultrasound R1 Irrigation...

Page 70: ...igation R2 Linear Vitrectomy Linear Aspiration Posterior Vitrectomy Disabled Fixed cut R1 Linear Aspiration and fixed cut vitrectomy when On Cutter On Off Disabled Single cut R1 No Function Single Cut R2 Linear Aspiration Single Cut Aspiration on Pitch Dual Yaw Cut R1 No Function Linear cut R2 Linear Aspiration Linear Cut Aspiration on Yaw Dual Yaw Vac R1 No Function Linear R2 Linear Cut Linear As...

Page 71: ... periods of time due to the potential for photoretinitis and serious permanent patient injury Set the illumination level to the minimum needed to perform the surgical procedure There are two mechanisms by which harm can be induced Photoretinitis photochemical injury to the retina resulting from intense light exposure Thermal In both cases the damage is caused by the intensity of light at a given p...

Page 72: ...s PC Vision Enhancement System incorporates filters to remove ultra violet light and violet light but it is not possible to eliminate more of the phototoxic influence without significantly discoloring the light output Figure 1 42 Phototoxic sensitivity vs light wavelength 1 Phototoxic sensitivity 2 Filtered in Stellaris PC 3 Aphakic hazard weighting function 4 UV 5 Visible Note that the xenon lamp...

Page 73: ...weighted radiant exposure guideline in minutes at a working distance of 15 mm Lamp Filter Mercury Xenon None Amber Green Yellow None Amber Green Yellow Setting 100 36 120 42 54 18 120 20 26 60 61 120 70 90 30 120 34 44 50 73 120 83 108 36 120 41 53 40 Default Setting 91 120 104 120 45 120 51 66 30 120 120 120 120 60 120 68 88 20 120 120 120 120 90 120 102 120 10 120 120 120 120 120 120 120 120 Not...

Page 74: ... also contributes to the heat absorbed by the retina ISO15004 2 2007 advises limits to the thermal power density received by the retina in W per cm2 Unlike photoretinitis these limits are not time related With the high intensity output of the Stellaris PC it is possible to exceed these limits with a focal probe at 100 output level with the probe close to the retina Color filters For the lamp in po...

Page 75: ... video monitor and or a video recorder to be displayed and stored for future use The MMC is NOT intended for diagnostic purposes Installation Assure all equipment is turned off before making any connections Position the MMC on a flat surface near the video monitor and or recorder to be used WARNING The MMC is not to be placed inside the patient environment CAUTION Do not place the MMC on devices t...

Page 76: ...t Network Connector 5 Power Input 6 For Service Only 7 USB Ports For Service Only 8 Input from Stellaris PC Vision Enhancement System 9 Output to Display Monitor 10 Composite Video Figure 1 45 MMC connections 1 Internet Intranet Connection 2 AC Electrical Power Source 3 Optional Connection Without Recording Device 4 Video Camera Not Supplied 5 Optional Recorder Not Supplied ...

Page 77: ...cables Use the included RCA Jack to BNC Plug adapter if necessary The video monitor must be connected to the MMC before the MMC is powered up If the MMC is powered up with no monitor or recorder connected the video output with the overlay may not appear The MMC must be powered down and powered up again with the monitor connected Note The COMPOSITE VIDEO OUT output must be used if the input video s...

Page 78: ...1 68 Operator s Manual 110017276EN Rev B 1 Getting Started ...

Page 79: ...id control The combined domain includes all function from both domains 2 1 Posterior Combined Domain Interface Controls Push Bar This is a single button control which displays a command and initiates that action when you select it No value is associated with this control and holding it down performs no additional function Figure 2 1 Sample Push Button Option List The Option List allows you to sele...

Page 80: ... and minimum values for that parameter may be increased or decreased by selecting the up and down arrows next to each of the numbers respectively Figure 2 3 Sample Test Tube Display and Control for ranged parameters For a system parameter that has a fixed value instead of a range the value on the top of the tube will represent the current setting when that function is not active and the actual val...

Page 81: ... a command Figure 2 6 Sample Progress Bar Numeric Keypad Touching the numeric display on a test tube button brings up the numeric keypad The keypad allows you to rapidly enter numerical surgical settings or change settings Enter a number by touching the proper numeral s then selecting Enter to make the change When a surgical function is active the keypad for settings associated with that function ...

Page 82: ...lete the last character typed and selecting Clear will delete all characters Select Enter when you are done to save the entry and return to the previous screen Figure 2 8 Keyboard Character Lengths When naming functions there is a limit to the number of characters that can be used That limit is the lesser of the number of characters in the table below or the number of characters displayable in the...

Page 83: ...eft of the cassette icon shown below Figure 2 9 Eject Cassette button Foot Control Indicator The image of the Foot Control on the screen shows the status of the Foot Control Operation The yellow dots indicate that the Footpedal Yaw is activated The numeric display on the pedal indicates the Footpedal position Figure 2 10 Foot Control Indicator ...

Page 84: ...n the screen while a pop up window is on the screen The surgeon may be able to continue with the procedure once the error has been rectified Figure 2 11 Sample Pop Up Message Window For each message displayed suggested actions to resolve the condition are displayed If more than one suggested action is available pressing the Next button will cycle through all possible suggested actions Pressing the...

Page 85: ...thout Linear Coagulation Infusion Illuminators Foot Control A V Messages Figure 2 13 Vitrectomy Cut Vacuum Infusion Illuminators Foot Control A V Messages Figure 2 14 Anterior Vitrectomy Cut Vacuum Infusion Illuminators Foot Control A V Messages Figure 2 15 Phaco U S Vacuum Infusion Illuminators Foot Control A V Messages Figure 2 16 Frag U S Vacuum Infusion Illuminators Foot Control A V Messages F...

Page 86: ...2 8 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 12 Setup Screen with Linear Coagulation function active ...

Page 87: ...Operator s Manual 2 9 110017276EN Rev B 2 User Interface Figure 2 13 Setup Screen without Linear Coagulation function active ...

Page 88: ...2 10 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 14 Vitrectomy Cut More Settings Screen tab ...

Page 89: ...Operator s Manual 2 11 110017276EN Rev B 2 User Interface Figure 2 15 Anterior Vitrectomy More Settings Screen tab ...

Page 90: ...2 12 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 16 Phaco More Settings Screen tab ...

Page 91: ...Operator s Manual 2 13 110017276EN Rev B 2 User Interface Figure 2 17 Ultrasound More Settings Screen tab for Fragmentation ...

Page 92: ...2 14 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 18 Viscous Fluid Control More Settings Screen tab ...

Page 93: ...Operator s Manual 2 15 110017276EN Rev B 2 User Interface Figure 2 19 Extrude More Settings Screen tab ...

Page 94: ...2 16 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 20 I A More Settings Screen tab ...

Page 95: ...Operator s Manual 2 17 110017276EN Rev B 2 User Interface Figure 2 21 Irrigation More Settings Screen tab ...

Page 96: ...2 18 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 22 Linear Coagulation More Settings Screen tab ...

Page 97: ...Interface Vacuum More Settings Screen Tab The Vacuum More Settings Screen tab has options that control the maximum and minimum vacuum allowed venting method and mapping of these options to the Foot Control Figure 2 23 Vacuum More Settings Screen Tab ...

Page 98: ...tatus and power level Depending on which type of ultrasound you are currently using you may also see power level number of pulses per second PPS duty cycle DC burst duration BD and pulse interval PI waveform type waveform depth waveform duration and Foot Control preview You can adjust any of these settings Figure 2 24 Fragmentation More Settings Screen Tab ...

Page 99: ...Operator s Manual 2 21 110017276EN Rev B 2 User Interface Figure 2 25 Phaco More Settings Screen Tab ...

Page 100: ...ce Coagulation More Settings Screen Tab The Coagulation More Settings Screen tab shows the current minimum and maximum power levels and the Foot Control mapping mode You can adjust either power level setting Figure 2 26 Coagulation More Settings Screen tab ...

Page 101: ... current settings for the minimum and maximum CPM cuts per minute You can adjust either setting The current Foot Control preview is also shown For submodes with fixed cutting only one cut rate will be displayed For Anterior Procedures Foot Control mapping is not adjustable from this popup Figure 2 27 Cut More Settings Screen Tab ...

Page 102: ...l These functions are described in detail in the Foot Control section see page 1 40 The Settings Button shows the current status of the Foot Control switches right or left foot operation Dual Linear Control Mode Change Control Next U S Ultrasound Modulation on Yaw Reflux Type and Fixed Coag Power Selecting next to any of these options will open a list of additional selectable options Figure 2 28 F...

Page 103: ...Fixed Coagulation Next Phase Elevated Infusion On Off Reflux B Irrigation On Off anterior or Fixed Coagulation posterior combined Confirm Settings Increment bottle height anterior or Increment Infusion Pressure Posterior and Combined Decrement bottle height anterior or Decrement Infusion Pressure Posterior and Combined C Fixed Coagulation Irrigation On Off None None D Fixed Coagulation None Irriga...

Page 104: ...B 2 User Interface The Regions button shows the current settings for the footpedal pitch regions and detent options You can modify the starting depression position for each region Figure 2 29 Footpedal More Settings Screen tab Regions button ...

Page 105: ...17276EN Rev B 2 User Interface The Status button shows the current status of several footpedal options including communication status battery status and signal strength Figure 2 30 Footpedal More Settings Screen tab Status button ...

Page 106: ... of the following events Irrigation Vacuum Occlusion Ultrasound Coagulation Vitrectomy and Alert The selected tone will be played when that function is active and the frequency of the tone will change with the value of the function Figure 2 31 A V More Settings Screen tab Audio button Select the tone you want to change then use the menu and arrows on the right side of the screen to select the tone...

Page 107: ...76EN Rev B 2 User Interface The Display button control allows you to adjust the screen brightness change the display format level and select the system language as shown below Figure 2 32 A V More Settings Screen tab Display button ...

Page 108: ...video overlay If the U S combine option is set to Yes the display will appear on one line which will cycle through the three values Similarly settings are normally displayed on four lines and case information on two lines but if the combine option is set to Yes each will appear on one line that will cycle through the values Finally you can set the video overlay overscan in one degree increments fr...

Page 109: ...arameters for both injection and extraction The appearance of this screen will differ slightly depending on the current submode Injections will show minimum and maximum psi and extractions will show minimum and maximum mmHg The Foot Control preview will only appear when the fluid exchange is linearly controlled Figure 2 34 Viscous Fluid Control More Settings Screen tab ...

Page 110: ... B 2 User Interface Infusion More Settings Screen Tab The Infusion More Settings Screen tab allows control of parameters related to infusion the IV pole and pressurized air output port selection Figure 2 35 Infusion More Settings Screen tab ...

Page 111: ...2 User Interface Illuminator More Settings Screen Tab The Illuminator More Settings Screen tab allows you to control the settings for the fiber optic illuminator including range and filter usage Figure 2 36 Illuminator More Settings Screen tab ...

Page 112: ...rey Note Voice confirmation if enabled responds to Foot Control and remote operation and on screen buttons Clock Menu Figure 2 37 Clock Menu The round Clock Menu in the middle of the screen can display up to 12 phases eight normal phases and four exceptions The exceptions appear on the left side of the clock menu against a darker background These are user defined to be any mode type Irrigation onl...

Page 113: ...clock menus are shown in Figure 2 38 and Figure 2 39 Figure 2 38 Vitrectomy Surgical Screen in Posterior Domain Note When the case option is disabled in programming the surgical screen status bar will not show the case selection button When using Air Forced Infusion in the posterior and combined domains the air pump can be turned On Off in the Surgical or Setup screen When the air pump is off aspi...

Page 114: ... green light W Figure 2 39 Phaco Surgical Screen in Combined Domain If you have the optional MMC system installed the center of the Clock Menu will show the video from the microscope camera when video is available You can touch the video itself to switch between small and large video display formats ...

Page 115: ...cal Screens When the ring around the button is green the function is on When the ring is grey the function is off Note that Fluid Air Exchange and air forced infusion AFI are toggled when one function is on the other is off See Chapter 3 for details on customizing your system Figure 2 40 Large Video Combined Surgery Screen ...

Page 116: ...2 38 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 41 Small Video Combined Surgery Screen ...

Page 117: ... without using BSS A green ring around the button shows indicates that the fill system is currently on You can select the fill button to toggle to the off state The automatic Fill function is user programmable with a fill time range from 20s to 120s To program the fill time perform the following steps Select the More Screen Select the Infusion tab Change the fill time Fill sec to the desired value...

Page 118: ... option button is selected Footpedal and Coagulation The current footpedal status is displayed in the bottom center of the screen The current pitch region 1 2 or 3 is shown and the circles around the top indicate yaw position See the chart on page 1 59 for details on Foot Control setup If one of the Foot Control Buttons has been programmed to control coagulation a Coagulation control will appear j...

Page 119: ...cal function is not currently in use Figure 2 43 Sample Spin Button Push Bar This is a single button control which displays a command and initiates that action when you select it No value is associated with this control and holding it down performs no additional function Figure 2 44 Sample Push Bar Option List The Option List allows you to select an option A small next to a setting indicates that ...

Page 120: ...2 42 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 45 Sample Drop Down Option List ...

Page 121: ...nimum and maximum values are shown beside the tube The current setting may be changed by selecting and dragging the slider ring The slider ring may not be positioned below the current setting minimum value The minimum value may be changed with the surgical function More Settings Screen Figure 2 46 Sample Test Tube Display Progress Bar This graphic shows the progress of execution of a command Figur...

Page 122: ... the keypad for settings associated with that function will be removed or disabled Figure 2 48 Numeric Keypad Keyboard Sometimes you will need to enter alphabetical or numeric data into the Stellaris PC Vision Enhancement System A keyboard similar to that shown below will appear and you can touch the characters in order to enter them Selecting the back arrow will delete the last character typed an...

Page 123: ... the table below or the number of characters displayable in the corresponding area on the screen Function Maximum Characters Mode 8 Technique 20 Submode 20 Pathology 20 Surgeon 30 Display Format Selecting this button shown below steps that section of the display through multiple levels of complexity It appears on both the Status Bar Window and the Ultrasound Submode List Figure 2 50 Display Format...

Page 124: ...can be done on the screen while a pop up window is on the screen The surgeon may be able to continue with the procedure once the error has been rectified Figure 2 51 Sample Message Window For each message displayed suggested actions to resolve the condition are displayed If more than one suggested action is available pressing the Next button will cycle through all possible suggested actions Select...

Page 125: ...n Foot Control A V Messages Figure 2 54 Anterior Vitrectomy Cut Vacuum Infusion Foot Control A V Messages Figure 2 55 Phaco U S Vacuum Infusion Foot Control A V Messages Figure 2 56 I A Vacuum Infusion Foot Control A V Messages Figure 2 57 Irrigation Infusion Foot Control A V Messages Figure 2 58 Linear Coagulation Coag Infusion Foot Control A V Messages Figure 2 59 Each More Settings Screen has a...

Page 126: ...2 48 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 53 Setup with Linear Coagulation More Settings Screen Coagulation tab ...

Page 127: ...Operator s Manual 2 49 110017276EN Rev B 2 User Interface Figure 2 54 Setup without Linear Coagulation More Settings Screen Infusion tab ...

Page 128: ...2 50 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 55 Anterior Vitrectomy More Settings Screen Cut tab ...

Page 129: ...Operator s Manual 2 51 110017276EN Rev B 2 User Interface Figure 2 56 Phaco More Settings Screen Ultrasound tab ...

Page 130: ...2 52 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 57 I A More Settings Screen Infusion tab ...

Page 131: ...Operator s Manual 2 53 110017276EN Rev B 2 User Interface Figure 2 58 Irrigation More Settings Screen Infusion tab ...

Page 132: ...2 54 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 59 Linear Coagulation More Settings Screen Coagulation tab ...

Page 133: ...nual 2 55 110017276EN Rev B 2 User Interface The Aspiration Tab shows the current mode vacuum settings vacuum response setting venting method and Foot Control preview Figure 2 60 More Settings Screen Aspiration Tab ...

Page 134: ... pump on off status Figure 2 61 More Settings Screen Infusion Tab The actual IV Pole height is the current distance between the aspiration port and the mid point of the BSS drip chamber The maximum IV Pole height is the highest setting the IV Pole will be allowed to reach usually determined by the ceiling height in the room and set at the time of system installation A zero level bottle hanger BL43...

Page 135: ...ending on which type of ultrasound and programming level you are currently using you may also see number of pulses per second PPS duty cycle DC burst duration BD and pulse interval PI waveform type waveform depth and waveform duration may also be shown All of these settings are adjusted through these screens Figure 2 62 Ultrasound More Settings Screen Continuous Ultrasound ...

Page 136: ...2 58 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 63 Ultrasound More Settings Screens Pulsed Ultrasound ...

Page 137: ...User Interface Coagulation More Settings The Coagulation More Settings Screen shows the current minimum and maximum power levels and the Foot Control preview You can adjust either power level setting Figure 2 64 Coagulation More Settings Screen ...

Page 138: ...rectomy More Settings The Vitrectomy More Settings Screen shows the current settings for the minimum and maximum CPM cuts per minute Figure 2 65 Vitrectomy More Settings Screen You can adjust either setting The current Foot Control preview is shown for reference ...

Page 139: ...These functions are described in detail in the Foot Control section see page 1 40 The Settings Tab shows the current status of the Foot Control buttons right or left foot operation Dual Linear Control Mode Change Control Next U S Ultrasound Modulation on Yaw Reflux Type and Fixed Coag Power Editable functions are highlighted with a blue or gray background and marked with a Figure 2 66 Foot Control...

Page 140: ...ev B 2 User Interface The Regions Tab shows the current settings for the footpedal pitch regions and detent options You can modify the starting depression position for each region Figure 2 67 Foot Control More Settings Screen Regions tab ...

Page 141: ...10017276EN Rev B 2 User Interface The Status Tab shows the current status of several footpedal options including communication status battery status and signal strength Figure 2 68 Foot Control More Settings Screen Status Tab ...

Page 142: ...ng events Irrigation Vacuum Occlusion Ultrasound Coagulation Vitrectomy and Alert The selected tone will be played when that function is active and the frequency of the tone will change with the value of the function Figure 2 69 A V More Settings Screen Audio Tab Select the tone you want to change then use the menu and arrows on the right side of the screen to select the tone used for that conditi...

Page 143: ... Rev B 2 User Interface The Display Tab control allows you to adjust the screen brightness change the display format level select the system language and view the programming level Figure 2 70 A V More Settings Screen Screen Display Tab ...

Page 144: ...ata is shown as three separate lines on the video overlay If the U S combine option is set to Yes the display will appear on one line which will step through the three values Similarly settings are normally displayed on four lines and case information on two lines but if the combine option is set to Yes each will appear on one line that will step through the values Finally you can set the video ov...

Page 145: ...parameter to be changed and then select the new setting from the option list When you have made all the desired changes select Close and the change will take effect You can select Save Settings to have the new settings overwrite the current surgeon s preferences and be stored in the main preferences file Figure 2 72 Case More Settings Screen Note Selecting Save Settings here will save all changes ...

Page 146: ...screen buttons The Main Surgical Screen can appear in one of two formats The default format is set as a surgeon preference To switch between levels click the A V More Button located at the top of the screen select the Screen Display Tab then select the desired Display Format Level Level 1 Display At Level 1 only the basic controls are displayed Figure 2 73 Surgical Screen display level 1 ...

Page 147: ... menu against a darker background These are user defined to be any mode type Irrigation only Ultrasound Irrigation Aspiration Pneumatic Vit or Coagulation The Setup and End are the system function keys in the clock menu to change from surgical display screen to Setup and End Screens If you have the optional MMC system installed the center of the Clock Menu will show the video from the microscope c...

Page 148: ...2 70 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 74 Large Video Anterior Surgery Screen ...

Page 149: ...Operator s Manual 2 71 110017276EN Rev B 2 User Interface Figure 2 75 Small Video Anterior Surgery Screen ...

Page 150: ...et value is a pre programmed value to which you can jump quickly simply by selecting it on the screen Different surgical modes may have different preset values You can change the preset value for the current session by opening the More Settings Screen see Figure 2 61 and selecting the Infusion Tab The On Off button controls the continuous irrigation function by opening or closing the irrigation pi...

Page 151: ... overflow A green ring around the button indicates that it is currently on You can select it to toggle to the other state Air Pressure If the Pressurized Infusion function is programmed in the surgeon file the upper right corner of the screen displays the current setting of air pressure when the pump is not running When the pump is switched on the same area will display the actual output pressure ...

Page 152: ...isplay option button is selected Vacuum The upper left section of the screen shows the maximum vacuum or vacuum limit setting in a spin control button with the current actual value shown below it Footpedal and Coagulation The current footpedal status is displayed in the middle of the bottom of the screen The current pitch region 1 2 or 3 is shown The Footpedal More Button brings up a More Settings...

Page 153: ... value of each system In addition to the spin control buttons that are present in the Level 1 display the Level 2 display adds a test tube display and control see page 2 2 The current value of the function is displayed at the top of the tube and a slider ring on the tube can be used to change the setting Figure 2 78 Main Surgical Screen display level 2 ...

Page 154: ...lendar Remote Service System Setup Rooms System ID Date Time Delete Restore Backup Create Customize Surgeon Profile Technique Profile Phase Profile Phase Foot Control Phase Vacuum Phase Infusion Phase Cut Phase Visc Phase Coag Case Infusion Case Vacuum Phase U S Case List Case Cut Case U S Technique Phases Technique Exceptions Technique Foot Control Technique Fluidics Technique Illuminators Techni...

Page 155: ...perating configuration and instrument parameters Several default surgeon preference files are pre loaded on the system and you may copy and modify any of them using the Programming interface You can create modify and backup surgeon setting preference files as well as modify system parameters To program system parameters select Programming from the main clock menu on any setup screen The Main Progr...

Page 156: ... time you can select Programming to return to the Main Programming Screen or Exit Programming to return to the Select Surgeon Screen or the Setup Surgical Screen In either case the Stellaris PC Vision Enhancement System will ask if you want to save any changes you have made Select Yes to save your changes and overwrite existing files and No to discard your changes ...

Page 157: ...ttings File To change the settings for a currently existing preference file select the Customize Tab on the Main Programming Screen A list of all surgeon preference files currently loaded on your Stellaris PC Vision Enhancement System will appear Select the name of the surgeon file to be modified then select Confirm The Surgeon Programming Screen appears with the file name along the left side of t...

Page 158: ...l Customize Profile To change the surgeon s name associated with a settings file or change the default language select the Profile Tab on the Surgeon Level Programming Screen Select the surgeon s name and use the keyboard interface that appears to modify the name of that file Select Screen Voice Confirmation drop down menu and a list of all available languages will appear and you can select the on...

Page 159: ...g that technique Figure 3 4 Techniques Tab on Surgeon Level Programming Screen Surgeon Level Foot Control Fluidic A V and Video Overlay settings can also be controlled from the corresponding tab Select the right pointing arrow to show the Video Overlay tab To add a new technique to the list select Add then select any surgeon from the list that appears and the techniques defined for that surgeon wi...

Page 160: ...ted or re ordered They may also be customized as described below Foot Control Tab Foot Control Button 4 standard sets plus custom settings enable disable next ultrasound modulation on yaw reflux on yaw reflux type fixed coag power linear coag setup Fluidics Tab Vacuum response 1 Fastest to 5 Slowest venting method fluid air F AX mmHg air port front back Infusion Type IV Pole pressurized Infusion U...

Page 161: ...Status Bar Format 1 2 3 Remote Control Enable Disable For posterior techniques the A V tab is not available For combined techniques status bar format and preview are available For anterior techniques display format display format preview and status bar format are available Customizing Phases and Exceptions Both Phases and Exceptions can be reordered and customized Select a phase or exception from ...

Page 162: ...s are displayed depends on which mode you are in and whether Customize Settings by Case is disabled or enabled as detailed in the table below Mode Tabs Displayed on Phase Programming Screens Customize Setting By Case disabled Anterior Vitrectomy Posterior Vitrectomy Profile Foot Control Vacuum Infusion Cut Phaco Frag Profile Foot Control Vacuum Infusion U S Settings U S Waveform I A Profile Foot C...

Page 163: ...irm Customize Foot Control To modify the techniques and settings for the Foot Control select the Foot Control Tab on the Surgeon Level Programming Screen You can set the Foot Control for right or left foot operation The Mode Change Control allows you to set the Stellaris PC Vision Enhancement System response when the footpedal is activated and you change surgical modes Options are Allow Limit Peda...

Page 164: ...s are adjustable The anterior mode start positions are used in the anterior domain and the anterior modes of the combined domain In posterior only configuration systems the Posterior Modes Anterior Modes button will not be displayed and only the footpedal region 1 and 2 start positions will be adjustable Figure 3 7 Customize Foot Control Screen ...

Page 165: ... the Fluidics Tab from the Surgeon Level Programming Screen You can set the BSS Bottle Type Patient Eye Level relative to the aspiration port on the fluidics system Ultrasound Needle Type I A Tip Type Vit Tip Type and Frag needle by selecting the from the drop down menu that appears for each variable Figure 3 8 Customize Fluidics Screen ...

Page 166: ...this screen To change the tone or volume of a tone that is sounded for a particular condition select the function from the list at the bottom of the screen and that condition will appear in the change section in the middle of the screen Select the desired tone from the option list and use the spin control button to increase or decrease the volume Note Only tones that are not currently in use by an...

Page 167: ...ormation By default the U S data is shown as three separate lines on the video overlay If the U S combine option is set to Yes the display will appear on one line which will step through the three values Similarly settings are normally displayed on four lines and case information on two lines but if the combine option is set to Yes each will appear on one line that will step through the values You...

Page 168: ...sted on the right side of the screen Select one or more techniques by touching them Select a technique a second time to deselect it Figure 3 11 Create New Settings File Screen Once all the desired techniques are highlighted select Confirm and a keyboard will appear through which you can enter the name for the new surgeon file then select Enter The name of the new file will appear on the left side ...

Page 169: ...or on the back of the display panel Select the file or files to be backed up the location to which they should be backed up and select Confirm You must select the screen first then insert device The system will only recognize USB device after this screen is selected Note Memory devices complying with either USB 1 1 or USB 2 0 standards are supported by the Stellaris PC Vision Enhancement System Op...

Page 170: ... device into one of the two USB ports on the back of the system console behind the round sliding door Make sure the Restore Tab is active at the top of the Manage Settings Screen select the file or files to be restored and select Confirm Note You must select the Restore Settings File screen first then insert the device The system will only recognize a USB device after this screen is selected Figur...

Page 171: ...Customizing Your System Delete a Settings File To delete an existing surgeon preference file select the Delete Tab from the Manage Settings Screen select the file or files to be deleted and select Confirm Figure 3 14 Delete Settings File Screen ...

Page 172: ...mplemented immediately Set Date Time and Language To change the system language current date time or format in which the time is displayed select the Date Time Tab the top of the System Setup Screen Select from the option list menus to change the default system language month day year clock format 12 or 24 hour and current time in hours and minutes Once all changes have been made select Confirm at...

Page 173: ...sion Enhancement System select the System ID Tab at the top of the System Setup Screen You can enter or update the account name and system name that have been assigned to your Stellaris PC Vision Enhancement System You can view the system catalog number as well as its installation number but these are not editable Figure 3 16 System ID Screen ...

Page 174: ...ear and you can enter the name for that room Select Enter and the room name will be saved You can also set the Maximum IV Pole Height in centimeters as measured from the aspiration port in the fluidics system using the spin control on this screen This setting is to allow the system to be programmed to not hit the ceiling in a facility with ceilings lower than nine feet 2 75 meters Figure 3 17 Room...

Page 175: ...ot Control To change the way you Stellaris PC Vision Enhancement System connects to the Foot Control select the Foot Control Tab at the top of the System Setup Screen Select Enabled or Disabled to configure the connection mode Figure 3 18 Foot Control Connectivity Screen ...

Page 176: ...ystem select System Configuration from the Main Programming Screen Figure 3 19 System Configuration Screen 3 6 System Calendar To set up your system to default to certain surgeon preference files and room numbers at certain times of the week select System Calendar from the Main Programming Screen and the System Calendar Screen will appear with four user editable columns ...

Page 177: ...available Select a file from the list and that will be the default file when the Stellaris PC Vision Enhancement System starts up at that time In the fourth column select how many rooms that surgeon operates in and in the fifth column select in which room number this Stellaris PC Vision Enhancement System is located These settings determine how the case numbers will be incremented to avoid duplica...

Page 178: ...erves your location WARNING Do not conduct surgery or any patient procedures while TruLink Customer Support Network is activated Serious patient injury may occur This features allows Bausch Lomb technicians to remotely access your system to diagnose problems and provide updates To manage the secure point to point connection between your system and Bausch Lomb select Remote Service from the Main Pr...

Page 179: ...ected to the Stellaris PC Vision Enhancement System and to the designated hospital network port Confirm that the system is not being used for surgery and select Initiate TruLink Connection Note If you have the optional MMC system the Ethernet cable should be connected to the MMC then the MMC connected to the designated network hospital Ethernet port ...

Page 180: ...een The system will then be controlled by the remote technician When the remote technician is finished your Stellaris PC Vision Enhancement System will be shut down You may then restart the system Note Off the shelf Ethernet cables may be used with the Stellaris PC Vision Enhancement System to establish or restore connections ...

Page 181: ...0 to 100 by 5 Vit No tone Tone 1 Tone 10 0 to 100 by 5 Visc and Timer No tone Tone 1 to Tone 10 0 to 100 by 5 Key Tone 0 to 100 by 5 Coag Tone 1 to Tone 10 20 to 100 by 5 Alert and Elev Infusion 20 to 100 by 5 Surgeon Voice confirmation Enabled Disabled Volume 0 to 100 by 5 Surgeon Video overlay language English US English UK Czech Danish German Greek Spanish Estonian Finnish French Hungarian Ital...

Page 182: ...abled Enabled Phase Customize Ultrasound Settings by Needle Tip Disabled Enabled Technique Customize Ultrasound Settings by Cataract Grade Disabled Enabled Technique Customize Ultrasound Settings by Pathology Disabled Enabled Technique Pathology Name Typewriter data entry 20 characters max Technique Phase Name Typewriter data entry 8 characters max Phase Mode Type Ultrasound Irrigation Aspiration ...

Page 183: ...e Disabled Enabled Technique Reflux Continuous Single High Single Low Technique Phase Next Ultrasound Modulation on Yaw Disabled Enabled Note that for single linear footpedal modes the outward yaw motion would be used for next ultrasound modulation and for dual linear footpedal modes the inward yaw motion would be used Technique Phase Fixed Coagulation Power Level 0 to 10 by 1 10 to 30 by 2 30 to ...

Page 184: ...ettings irrigation on off reflux air on off vitrectomy cutting on off fixed coagulation increase vacuum decrease vacuum increase air pressure decrease air pressure increase bottle height decrease bottle height increase U S power decrease U S power increase U S pulse rate duration decrease U S pulse rate duration increase U S duty cycle interval decrease U S duty cycle interval increase coagulation...

Page 185: ...e F AX pressure decrease F AX pressure increase U S power decrease U S power increase U S power increase U S PPS duration decrease U S PPS duration increase U S DC interval decrease U S DC interval increase coagulation power decrease coagulation power increase vitrectomy cut rate decrease vitrectomy cut rate increase viscous fluid pressure decrease viscous fluid pressure increase lower illuminator...

Page 186: ...Phase Case Aspiration type Anterior Domain Types available depend on aspiration types enabled at the technique level the dual linear control options and the mode handpiece type selected Posterior and Combined Domain Types available depend on the sub mode selection Fixed vacuum Fixed vacuum with aspiration control feature Linear vacuum Linear vacuum with aspiration control feature Phase Case Fixed ...

Page 187: ...uto On Off Surgeon Ultrasound Parameter Options Ranges Step Sizes Ultrasound Modulation Type Continuous Pulsed Single burst Fixed pulse Multiple burst Linear Power Linear Pulse Linear Power Linear Duty Cycle Dual Linear Multiple Burst Variable Power Multiple Burst Variable Power Linear Burst Phase Case Fixed power level or linear power maximum level 0 to 10 by 1 10 to 30 by 2 30 to 100 by 5 Phase ...

Page 188: ...ol mapping for linear control front loaded linear back loaded Linear Front Loaded Back Loaded Phase Case Waveform Type Ramped not programmable Phase Case Waveform duration 250 ms to 1000 ms by 50 ms resolution of 50 ms even with calculator Phase Case Waveform Depth 25 to 100 by 5 Phase Case Pulsed mode linear pulse rate minimum 1 PPS to 20 PPS by 1 PPS 20 PPS to 50 PPS by 5 PPS 50 PPS to 250 PPS b...

Page 189: ... rate Pneumatic 30 cpm to 5000 cpm 30 cpm to 100 cpm by 10 cpm 100 cpm to 1000 cpm by 50 cpm 1000 cpm to 5000 cpm in steps of 100 cpm Phase Case Foot control mapping Linear Front Loaded Back Loaded Reverse Linear Reverse Front Loaded Reverse Back Loaded Phase Case Coagulation Parameter Options Ranges Step Sizes Coag Power level maximum level 0 to 10 by 1 10 to 30 by 2 30 to 100 by 5 Phase Power le...

Page 190: ...3 36 Operator s Manual 110017276EN Rev B 3 ...

Page 191: ...ven by compressed air which is connected to the machine by an air hose With your Stellaris PC Vision Enhancement System the irrigation line from an inverted bottle of balanced salt solution BSS is integrated into the tubing manifold at the top part of the vacuum cassette The delivery pressure of the BSS is adjusted by varying the height of the bottle in relation to the patient s eye or by air pres...

Page 192: ...ette type that is similar to the selected software domain System error messages will be displayed when wrong cassette type is inserted Emptying Cassette WARNING Improper reassembly of tubing manifold to the cassette may result in inadequate system performance The Stellaris PC Vision Enhancement System s cassette can be emptied during operation by using following instructions 1 Stop the operation a...

Page 193: ...nce 5 Detach the aspiration tubing that connects to the cassette Hold aspiration tubing very close to the connector to facilitate removal pink arrows 6 Press manifold release latch to free it from the cassette Pink arrows 7 Drain the fluid out of the cassette ...

Page 194: ...r R 9 Press the manifold to latch manifold to the cassette 10 Connect aspiration tubing to the cassette connector 11 Insert cassette to the system 12 Release irrigation clamp The clamp near the bottle and the clamp at the 2 way stopcock 13 Resume surgery once system pass vacuum check and surgical screen is displayed Note No re priming is needed ...

Page 195: ...0 cpm 10 cpm 100 to 1000 cpm 50 cpm 1000 to 5000 cpm 100 cpm Note Vitrectomy cut rate derating above 915 meters 3000 feet altitude can be compensated with increased input pressure not to exceed 6 9 bar 100 PSIG Fixed Cut Fixed cut is a single region pitch control mode and vitreous cutting is activated the moment footpedal is depressed The cut rate is fixed Vacuum is proportional to footpedal depre...

Page 196: ... If enabled an audible linear tone indicates cut rate and vacuum level the pitch of the tone increases with increased cutter speed and vacuum level Figure 4 3 Foot control pop view to illustrate Dual Yaw Cut vitrectomy programmed for Right Foot 1 Pitch Movement to control linear vacuum 2 Outward Yaw to control linear cut Dual Linear Dual Yaw Vac This is a two region pitch and a yaw control mode Pr...

Page 197: ...trectomy modes reflux if enabled is by inward yaw movement of the footpedal The foot control side button can also be programmed to activate reflux function Note Make sure the pack you are using is appropriate for the domain selected Posterior Vitrectomy Setup and Use Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instru...

Page 198: ...e pre connected tubing set Scrub Nurse e Drape the system tray and screen with drapes provided Scrub Nurse f Arrange the pre connected tubing set with cassette bottle spike air tubing filter and actuation connector toward the system front The priming cup is placed at the other end with the tubing set in the middle as shown in the figure below Scrub Nurse Figure 4 4 Pre connected Tubing set arrange...

Page 199: ...tubing to Circulating Nurse Scrub Nurse n Spike and hang the BSS bottle on the automated I V pole or the Zero Level hanger if using AFI Squeeze and release the drip chamber until it is half filled with solution For AFI setup use the spiking tool provided to puncture the rubber stopper on the bottle before inserting the metal cannula into the bottle Circulating Nurse See Figure 4 5 Figure 4 5 AFI S...

Page 200: ...activated by using the button on the GUI screen or one of the Foot Control switches assigned to this function Pressing the foot pedal into region 1 will NOT start infusion Note When the system is in Manual Infusion Mode pressing the Foot Pedal will not activate aspiration In Auto On Off Infusion Mode infusion will be activated when the foot pedal is depressed into region 1 or beyond and will be de...

Page 201: ... cup without allowing the cutter needle to touch the priming tray Illumination Function Posterior Combined Domain WARNING Care should be taken to avoid concentrating the illumination output on a small area of the retina for unnecessarily prolonged periods of time due to the potential for phototoxicity and serious permanent injury CAUTION Do not use lamps in damp locations in areas of high humidity...

Page 202: ... may be programmed to turn lamp 1 or lamp 2 on and off There are three ways to map the illuminator settings to the Foot Control 1 Using the foot control tab of the More Settings Screen 2 Programming the technique level foot control settings 3 Overriding the technique level settings on the phase level foot control settings screen in programming also Illumination Setup and Use 1 Connect the fiber op...

Page 203: ...e illumination output with the up down buttons in the display tube Click on the arrow to increase or decrease the output level or click and hold to make larger changes Note Should the light source fail during use the operator must switch the fiber optic illuminator to the other lamp port The burned out lamp should be replaced before the next surgery Illumination Filter Control The lower lamp has 3...

Page 204: ...e and the system will provide a warning when that limit is near and again once the limit has been reached Once the limit has been reached the lamp will remain on for the current surgery but once turned off will not turn on again and must be replaced The amount of lamp life remaining for each lamp is displayed in the Illumination More Screen The display represents the remaining hours of lamp life T...

Page 205: ... fitted in place If you remove a lamp you must replace it with another lamp or the system will not function 1 TURN OFF THE SYSTEM Wait 20 minutes for the system to cool before attempting lamp replacement 2 Open the lamp replacement access door on the side of the unit by placing a coin or flat head screwdriver into the slot and turning it clockwise The dot should be on the right and the door should...

Page 206: ...e domestic and international environmental laws and directives 6 If the bulb is shattered and glass fragments are found contact B L service to remove them to prevent damage to the unit Figure 4 10 Side of the unit with lamps removed with lamp location and orientation shown 7 DON T TOUCH THE LENS LAMP CONNECTORS OR OTHER PARTS INSIDE THE SYSTEM 8 Open the packaging for the replacement lamp holding ...

Page 207: ...Operator s Manual 4 17 110017276EN Rev B 4 Detailed Reference Figure 4 11 Lamp Housing Exterior ...

Page 208: ...rs on the top right and bottom left corners 10 Push the replacement lamp housing firmly into place 11 Screw the two lamp fasteners clockwise until tight thumbscrews WARNING RISK OF ARC EXPOSURE 12 Replace the door before applying power to the System Make sure the dot is pointing down indicating that the door is locked 13 Turn on the system 14 Check that the new lamp is recognized ...

Page 209: ...e Operation The Fluid Air Exchange mode is a posterior feature which provides the surgeon with the ability to instill a preset air pressure into the eye for Fluid Air Exchange It supports pressures up to 150 mmHg at flow rates up to 3 5 standard cubic feet 99 liters per hour The air pressure from the pump may be adjusted from 0 to 150 mmHg in 1 mmHg increments Fluid Air Exchange Setup and Use The ...

Page 210: ...he up down arrows to change the air pressure output Scrub nurse or Circulating nurse 4 Turn the valve of the stopcock to stop the flow of irrigating solution and start the flow of air as shown in Figure 4 14 top Scrub nurse Figure 4 14 The 2 way stopcock control of Fluid Air Exchange Top On Air flows into eye Bottom Off Fluid flows into the eye 1 Air 2 BSS ...

Page 211: ...usted by selecting the numeric pressure display or using the touchscreen Up Down arrows Air Tamponade would also be enabled whenever the Fluid Air Exchange pressure level is raised above the programmed tamponade level When the function is enabled a voice confirmation will sound and an elapsed time counter will be displayed in the surgical screen A voice confirmation for tamponade duration will be ...

Page 212: ... the Fluid Air Exchange pressure level is raised or the I V pole is adjusted above the programmed tamponade level When the function is enabled a voice confirmation will sound and an elapsed time counter will be displayed in the surgical screen A voice confirmation for tamponade duration will be provided at one minute intervals A bell will be sounded at 30 second intervals When Elev Inf is disabled...

Page 213: ... viscous fluid or balanced salt solution The Stellaris PC Vision Enhancement System s Viscous Fluid Control function generates the required injection pressures and aspiration vacuums for injecting viscous fluids to and aspirating viscous fluids from the eye during posterior segment surgery The Viscous Fluid function will deliver up to 72 5 psig 500 kPa 5 0 bar of pneumatic pressure to the disposab...

Page 214: ...yringe Refer to Figure 4 17 WARNING Ensure a black piston is in the syringe before connecting the syringe coupler to the syringe filled with silicone oil Failure to do so will cause patient injury 4 Slowly turn the syringe upward so that the tip points toward the ceiling allowing any air to move to the tip in one cohesive bubble 5 While holding the syringe in the upright position remove the syring...

Page 215: ...d injection is via the footpedal The injection pressure increases proportional to footpedal travel from the minimum programmed setting to the maximum programmed setting The minimum and maximum pressure levels are set using the touch screen Dual Yaw Vac Linear Fluid Injection Linear Vacuum Linear fluid injection is actuated by depressing the footpedal Linear aspiration through the left aspiration l...

Page 216: ...be aspirated into the system s electronic components 5 Connect the syringe coupler of the Viscous Fluid tubing to the empty syringe Twist the coupler to lock it securely to the syringe Refer to Figure 4 20 6 Connect the extraction needle to the syringe The 19 gauge steel needle is suitable for this application 7 Remove the cannula cover 8 before use 8 Select Visc Extract from the Surgical Screen c...

Page 217: ...ce Linear Extract Extraction is controlled via the center footpedal The extraction vacuum increases proportional to footpedal travel from the minimum programmed setting to the maximum programmed setting The minimum and maximum vacuum are set using the touch screen Fragmentation Posterior Only The Stellaris PC Vision Enhancement System Fragmentation function provides ultrasound emulsification and v...

Page 218: ...on footpedal pitch and linear ultrasound on outward yaw in footpedal region 1 Fragmentation Setup and Use Note Prior to setting up Fragmentation the Stellaris PC Vision Enhancement System has to be setup for Posterior Vitrectomy or Combined surgery Note Specific instructions for cleaning and sterilization included with a handpiece or accessory take precedence over these instructions WARNING A loos...

Page 219: ...urse Figure 4 21 Hold frag handpiece with tip submerged into water during priming and tuning 4 3 Anterior Functions Irrigation Irrigation is part of the fluidics system providing continuous fluid flow to compensate for fluid aspirated out of the eye Irrigation on off is controlled by the pinch valve which is opened when the footpedal is pressed and closed when the footpedal is released An Irrigati...

Page 220: ...ter 3 Viscoelastic Removal The viscoelastic removal function provides different settings for the doctor s convenience These settings may be customized to allow quick entry into a specific vacuum level as explained in Chapter 3 Venting The Vacuum Flow Fluidics system provides the surgeon with either air or fluid venting options to free an occluded tip when the footpedal is released When air venting...

Page 221: ... or as programmed a momentary increase in footpedal resistance will be noted signifying the transition from Region 1 to Region 2 and the start of aspiration Aspiration increases proportional to footpedal travel with the maximum level being set via the Max Vacuum input on the touch screen You can program Region 2 to provide either fixed or linear vacuum control The Actual Vacuum display will indica...

Page 222: ...Connect tubing to the I A handpieces Select Show Me Steps for animated setup guide if necessary 8 Ensure the irrigation clamp is open and toggle Irrigation Off to turn the flow on and allow irrigation to fill the tubing up to the handpieces 9 Fill the test chamber with irrigating solution then slide over the tip of the handpiece 10 Select Prime Only A vacuum test is part of the priming cycle 11 Af...

Page 223: ...ed from 1 to 100 using the up down spin buttons Foot Control buttons or remote and 1 increments using the keypad Pulse output control is programmable from 1 to 250 pulses per second in 1 PPS increments The pulse rate control does not adjust the ultrasound power The control adjusts the number of cycles of ultrasound power that occur during a one second time interval In Pulsed Ultrasound Mode the ul...

Page 224: ...e enabled or disabled Submodes can be toggled with the Foot Control heel switch or by footpedal outward yaw motion in Region 2 or 3 depending on how the system has been programmed The options to change submodes with the Foot Control are Either the left side button pair or the right side button pair may be grouped to change submodes to the next submode toe or previous submode heel Any of the four F...

Page 225: ...ing the transition from one Region to the next and the start of ultrasound power Ultrasound power will be initiated and controlled as a function of footpedal travel in Region 3 The next ultrasound submode may be selected if enabled by moving the footpedal in the outward yaw direction Single Linear Ultrasound Mode with Linear Aspiration Once irrigation has been initiated and the footpedal has been ...

Page 226: ...Aspiration will increase from zero to the minimum level in proportion to footpedal travel in Region 2 Linear aspiration to the maximum setting will be controlled by outward yaw footpedal travel The screen will display the actual amount of aspiration Ultrasound power is activated in Region 3 of footpedal travel Another momentary increase in footpedal resistance will be noted signifying the transiti...

Page 227: ...tion WARNING Do not touch an activated ultrasonic handpiece tip as injuries could occur WARNING A loose needle may lead to improper tuning and could cause shedding of metal fragments into the eye which can result in serious permanent patient injury WARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC...

Page 228: ...tor from the top on the left side 9 Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench 10 Slide the irrigation sleeve over the ultrasound needle so that the holes in the irrigation sleeve are placed approximately 1 mm from and perpendicular to the bevel of the ultrasound needle increase to approximately 1 5 mm for denser cataracts Figure 4 25 Irrigat...

Page 229: ...ons to set the desired aspiration level and the ultrasound maximum power Set the desired number of PPS for pulsed ultrasound Note Assure all air bubbles are cleared from lines during priming Once the system has been primed ultrasound tuning will begin automatically and ultrasound tone will sound When complete the Main Surgical Screen will appear Note As a matter of operator convenience priming is ...

Page 230: ...m 30 to 5000 cuts per minute The footpedal yaw is used to achieve dual linear function The cut rate may be adjusted from 30 to 5000 cpm with increments as shown in the table below or to any specific value using the keypad Range Step Size 30 to 100 cpm 10 cpm 100 to 1000 cpm 50 cpm 1000 to 5000 cpm 100 cpm Planned Anterior Vitrectomy Setup WARNING For optimum aspiration and reflux performance the p...

Page 231: ...inistration line 9 Ensure the irrigation clamp is opened and the tip is immersed in irrigation solution then select Cutter Test 10 After successful test select Advance to Surgery and the Main Surgical Screen will appear Planned Anterior Vitrectomy Use 1 Select Vit from the clock menu The Show Me Steps animated setup guide will appear 2 Use the spin control buttons to set the desired vacuum level a...

Page 232: ...es the cutter ON or OFF If enabled an audible tone will indicate cutter on double beep or cutter off single beep For Dual Linear Cut mode outward yaw movement provides linear control of the cut rate as a function of footpedal displacement once it is within Region 2 The actual cut rate is displayed on the screen When the footpedal is released it returns to center and the cutter is disabled If enabl...

Page 233: ...play Pressurized Infusion is an optional function of the Stellaris PC Vision Enhancement System The function could be built into the system according to the customer order or the function could be added into existing field systems with an upgrade Enable Pressurized Infusion Function If system is installed with Pressurized Infusion software the function could be enabled from surgeon file programmin...

Page 234: ...4 44 Operator s Manual 110017276EN Rev B 4 Detailed Reference Figure 4 26 More Settings Screen Infusion Tab Anterior ...

Page 235: ...sion Setup 1 Remove the filter cap A from the bottle spike venting port that comes with the system disposable pack in Figure 4 28 2 Connect the Air Tubing Line male connector to the bottle spike venting port A in Figure 4 28 3 Connect the Air Tubing Line filter to the microsurgical system air source B in Figure 4 28 4 Spike and hang the bottle on the hanger at the desired bottle height 5 Use the u...

Page 236: ... power level when changing between extraocular and intraocular cauterization WARNING Use only bipolar handpieces and cables designated by Bausch Lomb for use with this system WARNING Failure of HF surgical equipment could result in an unintended power output increase WARNING The patient leads should be positioned in such a way that contact with the patient or other leads is avoided Temporarily unu...

Page 237: ...ed as long as the button remains depressed Linear coagulation mode Provides an adjustable output between 0 and 100 Power levels are set via spin button control Linear Coagulation is selected from the clock menu on the Main Surgical Screen Linear coagulation is actuated by depressing the footpedal if it has been programmed to provide linear control as a function of angular footpedal displacement Fi...

Page 238: ...bipolar cable to the coagulation connector 3 Use the spin buttons to adjust the percentage of coagulation power desired 4 The fixed coagulation function is activated by pressing the programmed Foot Control switch When the switch is released the function will deactivate Fixed coagulation mode is accessible during the system setup 5 If programmed a tone will signify bipolar coagulation operation Lin...

Page 239: ... to compliance with IEC 60601 2 2 position 1 will not start until approximately 35 of pedal travel is attained in the linear coagulation mode Figure 4 30 Linear Coagulation Handpiece Setup 1 Adaptor CX9404 2 To system coagulation connector 3 2 pin connector style 4 Lemo connector style 1 Connect the desired bipolar forceps or pencil to its cable The use of an adapter may be necessary 2 Connect the...

Page 240: ... included with any handpiece or accessory take precedence over these instructions WARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury 1 Connect the compressed air source to t...

Page 241: ...onnected tubing set with cassette bottle spike air tubing filter and actuation connector toward the system front The priming cup is placed at the other end with the tubing set in the middle as shown in the figure below Scrub Nurse Figure 4 31 Pre connected tubing set g Remove the tape to unbind all the tubing Scrub Nurse h Straighten the tube set and secure it so it will not drop off the sterile s...

Page 242: ...cup Scrub Nurse p Place the priming cup flat on the tray as in the figure below Scrub Nurse Figure 4 32 Priming cup with infusion cannula left aspiration and vitrectomy cutter attached 9 Select the first button from the Easy Prime selection menu to initiate the auto priming and vitrectomy cutter test sequence Scrub Nurse or Circulating Nurse Note The system will not provide feedback as to whether ...

Page 243: ... over the ultrasound needle so that the holes in the irrigation sleeve are placed approximately 1 mm from and perpendicular to the bevel of the ultrasound needle increase to approximately 1 5 mm for denser cataracts 15 Toggle the Irrigation Off button to turn flow on and allow the flow to fill the irrigation tubing up to the handpieces See page 2 39 for details on the irrigation flow button activa...

Page 244: ...4 54 Operator s Manual 110017276EN Rev B 4 ...

Page 245: ...again The handpiece connector must be completely dry before it is connected it to equipment 5 1 Routine Cleaning WARNING Disconnect AC power before cleaning the system CAUTION To preserve the surface finish avoid the use of abrasive cleaners If possible clean spots before they dry Bausch Lomb tested the following products and found that they can be used on all external surfaces of the Stellaris PC...

Page 246: ...o avoid excessive quantities of cleaning solution around the ports Do not reconnect to power until the ports have completely dried 5 2 Bipolar Coagulation Accessories WARNING The coagulation accessories should not be sterilized using a cold soaking solution WARNING All bipolar accessories must be rated for an operating voltage of at least 120V CAUTION Allow 20 minutes after sterilization for the h...

Page 247: ...the electrical connector Remove all traces of the solution with a cloth dampened with clean water The surfaces should then be dried with a lint free cloth The forceps and reusable cables may be sterilized as follows Standard Gravity Steam Sterilization Wrapped for 30 minutes at 121 C 104 8 kPa 1 048 bar 250 F 15 2 psi Flash Sterilization Unwrapped but covered for 10 minutes at 132 C 186 8 kPa 1 86...

Page 248: ...e handpiece see Figure 5 2 D Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe E Repeat Steps B through D at least three times F Fill the syringe with air reattach to handpiece and push on the syringe plunger to force air through the handpiece Disconnect the syringe G...

Page 249: ...n for the handpiece and cord to cool before using them again The handpiece connector must be completely dry before it is connected it to equipment Note To maintain flexibility and prevent cable damage wind the cord only loosely if needed and do not store it coiled with a less than 6 diameter The handpiece and any reusable accessories must be autoclaved before any item is used With the exception of...

Page 250: ...Note To maintain flexibility and prevent cable damage wind the cord only loosely if needed and do not store it coiled with a less than 6 diameter Handpiece Cleaning Instructions Bausch Lomb recommends the use of the Universal Maintenance Kit CX7120 in the following instructions The irrigation sleeve needle and tubing must be removed from the handpiece before beginning A Remove the silicone irrigat...

Page 251: ... to 40 C or 85 F to 105 F distilled or deionized water to flush the handpiece Note You may use filtered compressed medical grade air medical grade nitrogen to blow out the tubing The pressure should not exceed 29 psi 200 kPa 2 bar C Flush the irrigation lumen as follows see Figure 5 5 below 1 Place the end of the syringe into a container of warm 30 C to 40 C or 85 F to 105 F distilled or deionized...

Page 252: ...7120 into the aspiration fitting 2 Push the brush bristles through the handpiece aspiration lumen then pull the brush back out Thoroughly clean the brush after each use and sterilize at the end of each day according to the maintenance kit instructions 3 Refill the syringe to the 50 cc ml mark with warm 30 C to 40 C or 85 F to 105 F distilled or deionized water 4 Connect the syringe to the center s...

Page 253: ...rements 10 Repeat Step 9 at least three times Figure 5 6 Flushing Aspiration Lumen Ultrasound Handpiece 1 Handpiece 2 Fluid Pathway 3 Stopcock 4 Syringe Figure 5 7 Flushing Aspiration Lumen Fragmentation Handpiece 1 Fragmentation Handpiece 2 Fluid Pathway 3 Stopcock 4 Syringe ...

Page 254: ... should be inspected for damage nicks crimps dents exposed wires and so on If the handpiece is damaged it should be immediately removed from service Use of damaged handpiece may result in serious permanent patient injury WARNING Do not cold sterilize the instrument The sterilizing solution may not be flushed out prior to surgery and could be flushed into the eye resulting in serious eye injury CAU...

Page 255: ...ows A Place the end of the syringe into a beaker of warm 30 C to 40 C distilled or deionized water and fill the syringe to the 50 cc ml mark B Connect the syringe to the center stopcock fitting C Rotate the stopcock lever to allow flow to the female luer fitting D Connect the stopcock female luer fitting to the handpiece aspiration fitting E Push on the syringe plunger to force fluid through the h...

Page 256: ...to allow fluid flow to the female luer fitting P Connect the stopcock female luer fitting to the handpiece aspiration fitting Q Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe R Repeat Steps M through Q at least four times S Fill the syringe with air reattach to sto...

Page 257: ...s listed below Cleaning times and conditions may be adjusted based on the degree of soiling present on the Stellaris PC Vision Enhancement System s Ultrasound handpiece The conditions indicated below were validated using a neutral pH detergent Getinge Neutrawash and a severe organic soil challenge BS 2745 Part 3 1993 The use of a neutral pH detergent solution is recommended to avoid damage to the ...

Page 258: ...d water Wipe the area to be cleaned using a soft cloth moistened with cleaning solution Avoid excessive quantities of cleaning solution around the open vents on the MMC outer chassis Remove all traces of the cleaning solution with a cloth dampened with clean water The surfaces should then be dried with a lint free cloth A periodic visual inspection of the system components should be performed to i...

Page 259: ...ate again If a known good handpiece fails calibration or if assistance is needed to determine if the original handpiece is defective contact the Global Product Support see Chapter 7 6 2 Power Issues If you flip the main power switch and no power is sent to the system i e the stand by power switch does not light up there is no faint fan noise from the lower rear of the system etc you may have a bad...

Page 260: ...ly noticeable after removal from the system by obvious discoloration within the fuse and or an obviously broken fuse wire within the fuse Note If damage is apparent to either fuse both should be replaced to ensure proper operation a Remove the power cord from the Stellaris PC Vision Enhancement System The presence of the power cord will physically prevent the removal of the fuse drawer b Using a f...

Page 261: ... display a pop up window with the message displayed The pop up window will provide the user with a choice of options for proceeding Nothing else may be done while a pop up window is displayed Messages and suggested corrective actions are shown in the following tables Message Prefix Trouble Area BPS Power Supply Module CPX Compressor Module EIV IV Pole Module LM Light Module MMC MultiMedia Center M...

Page 262: ...SG04 Call your product service representative if this problem persists Compressor Module Messages ID Type Text Message Suggested Action s CPX01 Warning The compressor module was not detected in the system Surgical mode is not available SG01 Call your product service representative CPX02 Warning The compressor module software version is not compatible with this software version Surgical mode is not...

Page 263: ... service representative if this problem persists CPX12 Warning Viscous fluid extraction vacuum is low SG92 Confirm correct viscous fluid extraction function SG04 Call your product service representative if this problem persists CPX13 Warning Viscous fluid extraction vacuum is high SG92 Confirm correct viscous fluid extraction function SG04 Call your product service representative if this problem p...

Page 264: ... Warning The IV Pole controller has failed to respond to a settings command The module settings have been re sent to the module SG04 Call your product service representative if this problem persists EIV04 Warning The IV pole controller has reset The module settings have been re sent to the module SG04 Call your product service representative if this problem persists EIV05 Warning The IV pole posit...

Page 265: ... lower illuminator bulb LM07 Warning The illuminator temperature is too high The illuminators have been turned off SG04 Call your product service representative if this problem persists LM08 Warning The illuminator temperature is too low SG97 Wait for the system to reach room temperature then try again SG04 Call your product service representative if this problem persists LM09 Warning The upper il...

Page 266: ...b is at end of life Lamp will be disabled if turned off SG94 Replace the upper illuminator bulb LM25 Warning The lower illuminator bulb is at end of life Lamp will be disabled if turned off SG95 Replace the lower illuminator bulb LM26 Warning The illuminator temperature is too high The illuminators may be turned off within 2 5 minutes SG04 Call your product service representative if this problem p...

Page 267: ... multimedia center is plugged in and powered on SG74 Check that the multimedia center data cable is plugged in to both the system and the multimedia center MMC02 Info The multimedia center software version is not compatible with this software version The video overlay function is not available SG02 Call your product service representative A compatible software version must be downloaded MMC03 Info...

Page 268: ...rol battery at your earliest convenience SG71 Check remote functions with A V pop up display SG04 Call your product service representative if this problem persists User Interface Computer UIC Module Messages ID Type Text Message Suggested Action s UIC01 Info IV pole height range is X to Y cm SG88 Go to Infusion More screen or programming function to reset max IV Pole Height UIC03 Info Phase Mode c...

Page 269: ...l your product service representative USM02 Warning The ultrasound module software version is not compatible with this software version Ultrasound and coagulation are not available SG02 Call your product service representative A compatible software version must be downloaded USM03 Warning The ultrasound module has failed to respond to a settings command The module settings have been re sent to the...

Page 270: ...coagulation handpiece in a beaker of BSS activate the function and ensure the error message does appear again If similar message appears stop using the function and call B L service support SG56 Unplug the handpiece and try another bipolar coagulation cord SG04 Call your product service representative if this problem persists USM11 Warning Coagulation circuit may have failed potential uncommanded ...

Page 271: ...is problem persists VFM05 Warning The vacuum fluidics module does not have valid factory calibration data Surgical mode is not available SG05 Call your product service representative to replace the vacuum fluidics modules SG06 Call your product service representative to replace or calibrate the vacuum fluidics module VFM07 Info The vacuum fluidics module cassette vacuum check is in progress SG13 P...

Page 272: ...the Setup icon 3 Eject the cassette 4 Empty the cassette 5 Re insert the cassette 6 Open irrigation clamp 7 Select Prime to prime cassette 8 After priming select Advance to Surgery to resume surgery Refer to operator s manual for detailed instructions to detach tubing manifold from the cassette SG29 Call your product service representative if the cassette is not full and this problem persists VFM1...

Page 273: ...geon settings are loaded If incorrect select Setup then select Select Surgeon to select the correct surgeon settings WFC04 Info The Foot Control is programmed for left footed operation but is set up for right footed operation SG36 Change the Foot Control home position switch selection SG37 Confirm that the correct surgeon settings are loaded If incorrect select Setup then select Select Surgeon to ...

Page 274: ...m WFC14 Warning The Foot Control battery is nearly discharged SG43 Disconnect the Foot Control cable reconnect the cable and try again SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system WFC16 Warning The Foot Control spring has failed the Foot Control center pedal has been disabled SG34 Replace the Foot Control with another Foot Control using the...

Page 275: ...ersion Surgical mode is not available SG02 Call your product service representative A compatible software version must be downloaded WFR03 Warning The Foot Control receiver has failed to respond to a settings command The module settings have been re sent to the module SG04 Call your product service representative if this problem persists WFR04 Warning The Foot Control receiver has reset The module...

Page 276: ... Control backup cable The Foot Control does not automatically transition to wireless operation every time the backup cable is disconnected Following the disconnection of backup cable initiate wireless Foot Control connectivity by pressing one of the Foot Control buttons The right LED light would light up within 10 seconds indicating wireless connection is ready 3 System not reading cassette fluid ...

Page 277: ...Increase air pressure setting to desired level 5 System shutdown cassette ejected and irrigation running into cassette cartridge and handpiece Power supply cut off from the source or power cable is accidentally unplug from the wall 1 Stop surgery and remove handpiece from the eye 2 Close irrigation clamp to stop fluid flow into the cassette cartridge and handpiece 3 Replace test chamber to the han...

Page 278: ...splayed Is the Stellaris PC Vision Enhancement System in a surgical mode Is the data cable connected correctly Overlayed displays not visible Check monitor adjustments Is monitor set to correct format NTSC or PAL Intermittent or flickering video Check all video cables and connections Is monitor set to correct format NTSC or PAL Rolling video Is camera powered on Video format may not be supported I...

Page 279: ...s may affect system performance The unauthorized modification or alteration of the equipment or the use of non approved accessories packs or parts with the equipment shall relieve Bausch Lomb from any warranty service obligation or other liability for damages to or failure of the equipment caused by such unauthorized acts For additional information please contact a Bausch Lomb sales representative...

Page 280: ...0 4 Tip Curved Silicone Sleeve 20 Gauge Aspirating Cannula Accessory BL3162 I A 0 4 Tip Straight Silicone Sleeve 20 Gauge Aspirating Cannula Accessory BL3163 I A 0 4 Tip Angled 45 Deg Silicone Sleeve 20 Gauge Aspirating Cannula Accessory BL3164 I A 0 4 Tip Straight Metal Outer Cannula 17 5 Gauge Accessory BL3165 I A 0 4 Tip Curve Metal Outer Cannula 17 5 Gauge Accessory BL3166 I A 0 4 Tip Angled 4...

Page 281: ...ellaneous BL4392EUR Foot Control Charger Adapter Europe Miscellaneous BL4392UK Foot Control Charger Adapter United Kingdom Miscellaneous BL4392JPN Foot Control Charger Adapter Japan Miscellaneous BL4392AUS Foot Control Charger Adapter Australia Miscellaneous BL4392ROW Foot Control Charger Adapter Rest of World Miscellaneous BL4393 Foot Control Charging Cradle Miscellaneous BL4394 Foot Control Back...

Page 282: ...ck Pack BL5275 20 Ga Fragmentation Needle 15 deg single use Pack BL5320 20 Ga Combined Procedural Pack Pack BL5323 23 Ga Combined Procedural Pack Pack BL5325 25 Ga Combined Procedural Pack Pack BL5420 20 Ga Posterior Procedural Pack with AFI Pack BL5423 23 Ga Posterior Procedural Pack with AFI Pack BL5425 25 Ga Posterior Procedural Pack with AFI Pack BL5520 20 Ga Combined Procedural Pack with AFI ...

Page 283: ...ck with AFI and Wide Field Illuminator Pack BL5525W TSV 25 Ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator Pack BL5720 20 Ga Standard Focal Light Pipe Pack BL5723 23 Ga Standard Focal Light Pipe Pack BL5725 25 Ga Standard Focal Light Pipe Pack BL5820 20 Ga Wide Field Light Pipe Pack BL5823 23 Ga Wide Field Light Pipe Pack BL5825 25 Ga Wide Field Light Pipe Software BL6230 Software ...

Page 284: ...6 26 Operator s Manual 110017276EN Rev B 6 Troubleshooting ...

Page 285: ...al Assistance Assistance for Stellaris PC Vision Enhancement System is available from Global Product Support as follows Bausch Lomb Incorporated 3365 Tree Court Industrial Blvd St Louis Missouri 63122 U S A Attention Global Product Support Department http www bausch com en_US ecp age surg_prod_support aspx For product support within the U S A call the 24 hour telephone line 1 800 338 2020 or fax 6...

Page 286: ... Vision Enhancement System located on the label on the back panel Date of purchase Description of the problem or service desired List all observable symptoms and characteristics and details of occurrence Was patient involved at time of occurrence Return authorization number assigned by our Global Product Support specialist Contact name and phone number if additional information is required Ship or...

Page 287: ...3184 Belgium Bausch Lomb Uitbreidingstraat 46 2600 Antwerpen Belgium Tel 32 3 280 82 40 Fax 32 3 280 82 59 Bermuda Bausch Lomb Ireland Bermuda HQ Office Gibbons Bldg P O Box 1154 Hamilton HM EX Bermuda Tel 441 295 1044 Fax 441 292 6140 Brazil BL Industria Otica LTDA Rua Dona Alzira 139 91110 010 Porto Alegre RS Brazil Tel 55 51 3393 2000 Fax 55 51 3393 2100 BL Industria Otica LTDA Av Eng Luiz Carl...

Page 288: ...W Shanghai 200070 P R China Tel 86 21 6317 7143 Fax 86 21 6354 7780 France Bausch Lomb France SAS 416 rue Samuel Morse Le Millenaire CS79005 34967 Montpellier Cedex 2 France Tel 33 4 67 12 30 30 Fax 33 4 67 12 30 31 General Tel 33 4 67 12 30 68 Fax 33 4 67 12 30 66 Bausch Lomb France SAS DistOps Office Tel 33 4 37 48 83 83 Reception Fax 33 4 37 48 83 84 Reception Germany Bausch Lomb GmbH Im Schuma...

Page 289: ...treet Kowloon Bay Kowloon Hong Kong Tel 85 2 2 213 3333 Fax 85 2 2567 8170 India Bausch Lomb Eyecare India Private Ltd 2nd Floor Tower A Building no 8 DLF Phase II DLF Cyber City Gurgaon 122002 Haryana India Tel 91 124 4152 100 Fax 91 124 4152 236 Indonesia Bausch Lomb Indonesia c o address in Singapore see Singapore Italy Bausch Lomb IOM S p a Via Pasubio 34 20050 Macherio Milan Italy Tel 39 039 ...

Page 290: ...B D 168 12 Samsung dong Kang namgu Seoul Korea Tel 822 558 2988 Fax 822 642 1586 Malaysia Bausch Lomb Malaysia Sdn Bhd 3rd Floor Bangunan THK Lot 2A Jalan 243 51A 46100 Petaling Jaya Selangor Darul Ehsan Malaysia Tel 60 3 7680 8828 Fax 60 3 7680 8871 Mexico Bausch Lomb Mexico S A de C V Av Santa Fe 505 Piso 6 Colonia Cruz Manca Santa Fe Delegacion Cuajimalpa Mexico D F C P 05349 Tel 52 55 30 67 46...

Page 291: ...2A Fisher Cresent Mt Wellington Auckland New Zealand Tel 64 9 259 2762 Fax 64 9 259 4067 Philippines c o address in Singapore see Singapore Portugal Bausch Lomb S A Sucursal Portugal Avenida do Forte N 3 Edificio Suecia IV Piso O Esq 2795 504 Carnaxide Lisbon Portugal Tel 351 214 24 1510 Fax 351 214 24 1519 Singapore Bausch Lomb S Pte Ltd Bausch Lomb S Pte Ltd 151 Lorong Chuan 04 03A New Tech Park...

Page 292: ... 82 820 5845 Fax 27 11 259 2650 Spain Bausch Lomb S A Avda Valdelaparra 4 28108 Alcobendas Madrid Spain Tel 34 91 657 6300 Fax 34 91 661 4266 Tel 34 902 381 010 Fax 34 902 250 310 Sweden Denmark Finland Norway and Sweden Bausch Lomb Nordic AB Söder Mälarstrand 45 P O Box 15070 S 104 65 Stockholm Sweden Tel 46 8 616 9500 Fax 46 8 669 8623 Tel 46 8 616 9585 Fax 46 8 658 2541 Switzerland Bausch Lomb ...

Page 293: ...ok 10110 Thailand Tel 66 2 259 6510 Fax 66 2 259 6511 Turkey Bausch Lomb Saglik ve Optik Urunleritic A S Degirmen Yolu sok Sasmaz Plaza No 4 Kat 12 Daire 24 Kozyatagi Istanbul Turkey Tel 90 216 373 3131 switchboard Fax 90 216 384 9489 Tel 33 4 37 488383 Fax 33 4 37 488384 United Kingdom Bausch Lomb U K Ltd 106 114 London Road Kingston upon Thames Surrey KT2 6TN England Tel 44 20 8781 2900 Fax 44 2...

Page 294: ...n Any such non conforming or defective parts which are replaced by Bausch Lomb will become the property of Bausch Lomb Any service or replacement part provided under this Warranty may be supplied by Bausch Lomb or any of its affiliates or authorized service providers in Bausch Lomb s sole discretion Any claim based on this Warranty must be submitted to Bausch Lomb in writing within the twelve 12 m...

Page 295: ...specified on your sales tender or contract If any such defect occurs within the warranty period contact Bausch Lomb to return the handpiece for replacement Bausch Lomb will as its sole obligation under this warranty and at its sole discretion replace the defective handpiece with either a new or repaired refurbished handpiece All replacement handpieces are covered for the balance of the warranty pe...

Page 296: ...iod as specified on your invoice from the date of invoice accept return of this product for a full refund less any handling and shipping charges incurred by Bausch Lomb Customer must call their local Bausch Lomb customer service representative to request a Return Good Authorization prior to expiration of the return period It is the Customer s responsibility to properly pack all items being returne...

Page 297: ...rotects human health and the environment For more information about where you can drop off your waste equipment for recycling please contact your local recycling office or electronic waste hauler Environmental Specifications Parameter Specifications Electrical Input Detachable international power cord Universal Input 100 240 VAC 50 60 Hz 1000 VA Equipotential grounding stud Fuse Set BL4352 include...

Page 298: ...et the requirements of IEC 60601 1 2005 3rd edition and all appropriate amendments collateral standards particular standards and country differences Equipment Classifications Type of Protection Against Electrical Shock Class I Degree of Protection Against Electrical Shock Type BF Degree of Protection Against Water Ingress Ordinary Mode of Operation Continuous Electromagnetic Compatibility EMC Clas...

Page 299: ...ther equipment If any physiological patient sensors are to be used in conjunction with the Stellaris PC Vision Enhancement System the phaco and bipolar circuits should be activated briefly prior to contact with the patient while the sensor operator is monitoring the output of the sensor If there is noise observed on the sensor the operator may adjust the sensor according to the instructions of the...

Page 300: ...8 4 Operator s Manual 110017276EN Rev B 8 Specifications Cable Length BL4394 Foot Control Power Cable 144 ...

Page 301: ...nce RF emissions CISPR 11 Group 2 The Stellaris PC Vision Enhancement System must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CISPR 11 Class A The Stellaris PC Vision Enhancement System is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage...

Page 302: ...al 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 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cy...

Page 303: ...romagnetic 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 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorpti...

Page 304: ...ommunications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter metres m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 1 2 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 i...

Page 305: ...xels 1280 x 1024 Physical Adjustment Tilt 15 up and 10 down Swivel 90 left and 90 right Brightness Controlled via touch screen Touch Screen Technology Resistive Analog Size Approximately 19 diagonal active area Environmental Chemical resistant to cleaning solutions Drip proof bezel Computer Assembly Motherboard Technology IBM Compatible Pentium or better Computer hardware Hard Drive or Solid State...

Page 306: ... Left On Off simulated Right On Off simulated Left Linear Right Linear Function switches Increase decrease On Off Function Center pedal Pitch Motion Pitch up down Automatic return to up position Detent 2 programmable as to position may be enabled or disabled Control Provides primary linear function or on off Center Pedal Yaw Motion Yaw Left Right Automatic return to center Detent 1 center detent N...

Page 307: ...eration up to 15 feet from display console Powered from standard AA battery batteries Low battery indicator Transmit indicator Splash proof Illuminated keys Aspiration ASP Vacuum Level Increase Decrease Air consumption Increase Decrease IV Pole Up Down Phase Next Phase Previous Phase Ultrasound Power U S Vitrectomy Coagulation Increment Decrement shared button Tab Future Use Enter Future Use Param...

Page 308: ...ameters Capacity Capable of lifting two 500 ml glass bottles of balanced salt solution Travel Range of 110 cm 43 3 in 30 cm to 140 cm 13 8 in to 55 in from aspiration port Speed 10 6 cm sec 4 in sec Control Controlled via touch screen entry remote control Foot Control or directly via buttons on the back of the system Positioning Relative from home sensed position ...

Page 309: ...Cord Modes of Operation Linear Mode Fixed Mode Operating Parameters Linear Mode Output Range 7 5 Watts Nominal 100 ohms Frequency 1 MHz nominal Maximum Peak Open Circuit Voltage 120V Range Programmable from 0 to 100 in 1 increments Control Linear control of coagulation power via the footpedal Fixed Control Output Range 7 5 Watts Nominal 100 ohms Frequency 1 MHz nominal Maximum Peak Open Circuit Vo...

Page 310: ...100 200 300 400 500 600 700 800 900 1000 5 6 Figure 8 1 1 Bipolar Power vs Load 2 Power watts 3 Load ohms 4 Power out 5 Load 6 Setting 7 Settings 8 Maximum Possible Peak Coagulation Output Voltage at all Output Control Settings and Both Modes 9 Peak Output V 10 Output Control Setting 11 Linear and Fixed Control ...

Page 311: ... System provides a probe present detection system Wave form ultrasound available Connection Type Floating BF Connection Modes of Operation Programming Levels 1 2 3 Continuous ultrasound Pulsed ultrasound Fixed pulse ultrasound Single burst ultrasound Multiple burst ultrasound Programming Level 3 only Dual Linear Ultrasound Linear Power Linear Pulse ultrasound Linear Power Linear Duty Cycle ultraso...

Page 312: ... Burst Ultrasound Mode Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Range 80 to 600 msec burst width Control Single burst at end of pitch or yaw travel Fixed Pulse Ultrasound Mode Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Duration 2 to 600 msec Interval 2 to 600 msec Control Linear power control via the footpedal Burst duration and interval as selected ...

Page 313: ... Reflux Control Gravity feed from I V bottle Modes Continuous Pulsed Activated via the Foot Control Vitrectomy Linear Cut Rate Mode Operating Parameters Range 30 to 5000 cuts per minute in 1 cut per minute increments Control Linear control of cut rate via the footpedal Fixed Cut Rate Mode Operating Parameters Range 30 to 5000 cuts per minute in 1 cut per minute increments Cut rate is derated no mo...

Page 314: ...low Rate Up to 4 8 standard cubic feet per hour 2 25 L min Safety System includes pneumatic shut off valve in case of power loss Illumination Specifications Parameter Specification Modes of Operation Independent Illumination and control of either port Lamp Type Xenon and Xenon Mercury Output Light output from a single port is minimum 25 lumens using standard 20g probe Safety Filter Both ports inco...

Page 315: ...276EN Rev B 8 Specifications 8 3 System Labels Main System Label Foot Control Label Large Remote Control Label Small Remote Control Label System Power and Fuse Label Foot Control Battery Label Foot Control Battery Compartment Label ...

Page 316: ...8 20 Operator s Manual 110017276EN Rev B 8 Specifications Xenon Lamp Label Xenon Mercury Lamp Label ...

Page 317: ... gauge needle type cataract hardness or pathology Detent Tactile feedback in Stellaris PC Vision Enhancement System foot control to alert user when foot pedal is moved from one region to another Domain System functionality and set up that provides a group of functions related to either anterior posterior or combined surgery Dual Linear Foot control feature that controls various surgical function w...

Page 318: ...cuum from the left aspiration line to be used during the procedure Fluid Air Exchange F AX A surgical procedure to replace fluid in the eye with atmospheric air The process involves injecting air with a specific pressure and an extrusion cannula to evacuate the fluid Foot Control Mapping The correspondence between foot pedal linear movement and surgical function activation Foot control mapping opt...

Page 319: ...s video overlay where real time system settings are displayed simultaneously on the surgical screen and or projected on external monitors or video recording devices The second function of the MMC is to provide streaming video from the microscope camera to the system display screen Mode Phase It is a subset of the Technique level setting It describes the surgical phase that provides a specific func...

Page 320: ... hierarchy The hierarchy is System Surgeon Technique Mode Phase Sub mode and Case levels Pulse Mode Ultrasound An intermittent ultrasound pulse modulation with fixed rate Ultrasound power is linearly controlled with the foot control Reflux Momentary reversal of fluid flow towards the handpiece Reflux pressure is generated from the irrigation bottle or mechanical plunger Rise Time Speed with which ...

Page 321: ...techniques using the default techniques as a template Tone System audio feedback specific to surgical functions and energy level TruLink Bausch Lomb technology that provides the capability to interact with Stellaris PC Vision Enhancement System installations remotely for diagnostic purposes Vacuum Response Speed with which system generates commanded vacuum level Stellaris PC Vision Enhancement Sys...

Page 322: ... to provide endoillumination It contains pure xenon gas and emits whiter light with a full spectrum Xenon Mercury lamp A type of lamp used in Stellaris PC Vision Enhancement System to provide endoillumination It contains xenon gas and small amounts of mercury metal and emits greener light Yaw Side to side movement of foot pedal ...

Page 323: ...e Ultrasound Power AVE 4 33 A V More Screen 2 28 2 63 B Backup 3 15 Batteries Remote Control 1 35 Burst U S 4 33 4 36 Button Spin 2 40 C Calibration U S 4 37 Capsule Polish Operation 4 30 Cassette Full 4 1 Cassette Nearing Full 4 1 Cleaning Handpiece Bipolar Accessories 5 2 For U K 5 11 Irrigation Aspiration 5 3 Needle Ultrasound 5 10 Clock Menu 2 34 2 68 Coag Display 2 39 2 73 Coag Spin Control 2...

Page 324: ...isplay Level 1 2 67 Display Level 2 2 74 Disposables Setup and Use Coagulation Fixed 4 47 Linear 4 48 Phacoemulsification 4 37 Dual Linear Control 1 51 Duty Cycle 2 20 2 39 2 56 2 73 4 33 E Effective Phaco Time EPT 4 33 Enterprise Server 1 27 Equipment Classifications 8 2 Error Messages 6 3 Ethernet Cable 1 7 Exceptions 2 34 2 68 F Fluidics Vacuum 4 1 Foot Control 1 3 Description 1 34 1 38 Functio...

Page 325: ...ce Cleaning 5 4 Sterilization 5 5 Irrigation Handpiece Cleaning 5 4 Sterilization 5 5 Operation 4 30 IV Pole 2 39 2 71 Description 1 34 Specifications 8 11 IV Pole Height 2 39 2 71 3 32 K Keyboard 2 4 L Language 2 30 2 65 3 4 3 13 3 18 Layout Screen 2 34 2 67 Level 1 Display 2 67 Level 2 Display 2 74 M Maximum IV Pole Height 1 35 3 32 Menu Clock 2 34 2 68 MMC MultiMedia Center 1 37 Module Computer...

Page 326: ...l Numeric Keypad 2 3 2 43 Pop Up Window 2 6 Test Tube Control 2 2 2 42 Foot Control See Also Foot Control Operation Irrigation 4 30 Phacoemulsification Burst 4 33 Linear 4 35 Turning on System 1 7 Viscoelastic Removal 4 30 Vitrectomy Cutter Modes 4 40 Yaw Aspiration 4 36 Option List 2 41 P PD Pulse Duration 4 33 Phaco Phacoemulsification 4 33 PI Pulse Interval 4 33 Pitch 1 51 PPS Pulses Per Second...

Page 327: ...ear 4 48 Phacoemulsification 4 37 Specifications Cables 8 3 Coagulation 8 12 Computer Unit 8 8 EMI 8 4 8 5 Foot Control 8 9 I A Vitrectomy 8 16 IV Pole 8 11 MMC 8 2 Physical 8 2 Remote Control 8 10 Ultrasound 8 14 Vacuum Fluidics 8 16 Spin Button 2 40 Sterilization Bipolar Accessories 5 2 I A Handpiece 5 5 Phacoemulsification Needle 5 11 Surgeon Preference File Create 3 14 T Technical Assistance 7...

Page 328: ...ions 8 14 Operation Burst 4 33 4 36 Linear 4 35 Power 4 33 Ultrasound More Settings 2 20 2 56 Unpacking 1 2 Unplanned Vitrectomy Setup Vacuum Fluidics 4 41 V Vacuum Fluidics Unplanned Vitrectomy Setup 4 41 Vacuum Limit Setting 2 73 Vacuum Response 4 31 VAFI 1 17 Vented Air Forced Infusion 1 17 Venting 4 30 Video Overlay Tab 2 30 2 65 Viscoelastic Removal Operation 4 30 Vitrectomy More 2 59 Voice C...

Page 329: ...Preface ...

Page 330: ...Table of Contents ...

Page 331: ...Getting Started ...

Page 332: ...User Interface ...

Page 333: ...Customizing Your System ...

Page 334: ...Detailed Reference ...

Page 335: ...Cleaning and Sterilization ...

Page 336: ...Troubleshooting ...

Page 337: ...Service and Warranty ...

Page 338: ...Specifications ...

Page 339: ...Glossary ...

Page 340: ...Index ...

Page 341: ...Preface ...

Page 342: ...Table of Contents ...

Page 343: ...Getting Started ...

Page 344: ...User Interface ...

Page 345: ...Customizing Your System ...

Page 346: ...Detailed Reference ...

Page 347: ...Cleaning and Sterilization ...

Page 348: ...Troubleshooting ...

Page 349: ...Service and Warranty ...

Page 350: ...Specifications ...

Page 351: ...Glossary ...

Page 352: ...Index ...

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