Iridex TxCell SSLA Operator'S Manual Download Page 1 | Manualshive

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TxCell

®

Scanning Laser
Delivery System

Operator Manual

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Summary of Contents for TxCell SSLA

Page 1: ...TxCell Scanning Laser Delivery System Operator Manual...

Page 2: ...idex logo OcuLight G Probe IQ 532 IQ 577 EndoProbe and MicroPulse are registered trademarks TxCell BriteLight CW Pulse DioPexy EasyFit EasyView FiberCheck IQ 810 LongPulse MilliPulse OtoProbe PowerSte...

Page 3: ...ENT TREATMENT AND CLINICAL INFORMATION 15 INTENDED USE INDICATIONS FOR USE 15 CONTRAINDICATIONS 16 POTENTIAL SIDE EFFECTS OR COMPLICATIONS 16 SPECIFIC WARNINGS AND PRECAUTIONS 16 PROCEDURAL RECOMMENDA...

Page 4: ...iv 70375 EN Rev B...

Page 5: ...nnections The Control Box is paired with an SSLA Cables to connect the SSLA to the Control Box and the Control Box to the laser console Iridex Corporation Contact Information Iridex Corporation 1212 T...

Page 6: ...eed rate of treatment spot delivery in either single spot repeat or multi spot pattern mode This can result in delivery of laser applications after intended release of the footswitch prior to completi...

Page 7: ...in the presence of flammables or explosives such as volatile anesthetics alcohol and surgical preparation solutions Turn off the laser before inspecting any delivery device components Always handle th...

Page 8: ...ket and installation tools depending on the slit lamp model Check the components carefully before use to ensure that no damage occurred during transit Slit Lamp Compatibility Model Spot Size m Slit La...

Page 9: ...which TxCell SSLA attaches workstation component Fiber optic cable Transmits laser light SSLA Control cable Communicates spot size filter information and scanning information to the control box Contr...

Page 10: ...er out of the way 3 For Haag Streit equivalent Install mounting bracket or spacer as necessary 4 For Haag Streit equivalent Unlatch ESF from storage position Place SLA on the post of the slit lamp mic...

Page 11: ...the slit lamp oculars per the images below as applicable 6 Install micromanipulator handle and finger rest as applicable Tighten with thumbscrews ESF Lever Slit Lamp Mounting Platform Setscrew for Se...

Page 12: ...a minimum loop diameter of 15cm in the fiber optic cable 8 Connect fiber optic cable to the laser console 9 Plug SSLA Control cable into TxCell Control Box The connector will align in a specific orie...

Page 13: ...ed within the square Both the circle and the square will appear to flash If the observed circle is outside of the square please contact your local Iridex Technical Support representative 5 If aligned...

Page 14: ...enable laser treatment 2 Move to open position to obtain a clear view unimpeded by a laser Eye Safety Filter NOTE As a safety precaution the laser is unable to enter Treat mode while the Eye Safety F...

Page 15: ...ntrol knob selects Spacing between spots Grid Triple Arc Circle only The spacing is the distance between the inner edges of a pair of spots Spacing is displayed as increments of spot size diameters an...

Page 16: ...Grid that is visualized through the slit lamp The projected Target Grid will have a spot centered within one of the cells This spot identifies the size of the associated treatment beam and the cell i...

Page 17: ...ttern scanning mode B Aiming Beam intensity during single spot mode Automated FiberCheck FiberCheck is an automated test to determine fiber integrity If the fiber needs replacement the following promp...

Page 18: ...perform single spot test exposure prior to initiating treatment If uncertain of expected clinical response always start with conservative settings and increase laser power and or duration setting in s...

Page 19: ...s and used to deliver laser energy in CW Pulse MicroPulse or LongPulse mode it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and poster...

Page 20: ...irectly or adjacent to the disc Specific to laser iridotomy or iridoplasty inadvertent corneal or lens burns opacities iritis iris atrophy bleeding visual symptoms IOP spike and rarely retinal detachm...

Page 21: ...he target grid is in sharp focus prior to laser delivery An out of focus target grid may not produce clinically satisfactory results Exposure Duration Heat Flow and Spacing Between Spots When absorbed...

Page 22: ...e posterior retina Laser treatment parameters may need to be readjusted when treating the peripheral retina Laser Settings It is the physician s responsibility to determine the appropriate treatment p...

Page 23: ...m Power mW Exposure Duration ms Retinal Photocoagulation 50 1000 50 2000 10 1000 Trabeculoplasty 50 200 500 2000 100 500 Iridotomy 50 200 200 2000 100 300 577 nm MicroPulse Treatment Treatment Spot Si...

Page 24: ...ch DC Spink CA Subthreshold Diode Micropulse Panretinal Photocoagulation for Proliferative Diabetic Retinopathy Eye Lond 2008 22 5 607 12 10 Muqit MM Marcellino GR Henson DB Young LB Patton N Charles...

Page 25: ...position If there is still no treatment beam contact your local Iridex Technical Support representative No Pattern Selection button visible on Treatment Screen Turn laser console off Turn Control Box...

Page 26: ...ue using scanner system E09010 Fan3 speed out of range Warning Chassis fan speed out of range User allowed to continue using scanner system E09011 12V power supply out of range Call Service 12V power...

Page 27: ...aser did not fire Warning IQ laser did not fire when requested and the current scan pattern has terminated prematurely User is allowed to start a new treatment E09503 Scanner needs calibration Call Se...

Page 28: ...ce When not in use cover the slit lamp with the provided cover to keep the slit lamp free of dust and store all accessories in suitable storage boxes CLEANING EXTERNAL SURFACES Remove accumulated dust...

Page 29: ...70375 EN Rev B 25 TO CHECK AND CHANGE SLIT LAMP FUSES...

Page 30: ...ority to operate the equipment Protection for the Physician Eye safety filters protect the physician from backscattered treatment laser light Integral eye safety filters are permanently installed in t...

Page 31: ...70375 EN Rev B 27 Labels NOTE The actual label may vary with laser model Serial Number and CE Label Wavelength Label ESF Wavelength Label Haag Streit ESF laser wavelength label...

Page 32: ...28 70375 EN Rev B Laser Aperture Laser Emission Labels Laser Aperture Laser Emission Labels Control Box Back Label...

Page 33: ...al with MicroPulse Laser Aperture at End of Fiber Laser Warning Illumination LOT Manufacturer Manufacture Date Off On Part Number Power Pulse Count Pulse Count Reset Non ionizing Electromagnetic Radia...

Page 34: ...Electrical 100 240 VAC 50 60 Hz Operating temperature range 10 C to 35 C 50 F to 95 F Storage temperature range 20 C to 60 C 4 F to 140 F Maximum recommended ambient air temperature for treatment 30 C...

Page 35: ...cy range The wireless footswitch has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable p...

Page 36: ...environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors shoul...

Page 37: ...in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m a Fields strengths from fixed RF transmitters as determined by an electromagnetic site sur...

Page 38: ...er of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1...

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