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IRIS Medical

®

OcuLight

®

SL/SLx

Operator Manual

PN 13099D-EN

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Содержание IRIS Medical OcuLight SL

Страница 1: ...IRIS Medical OcuLight SL SLx Operator Manual PN 13099D EN...

Страница 2: ...y effort has been made to ensure the information is accurate the information contained within is subject to change without notice IRIDEX the IRIDEX logo IRIS Medical EndoProbe and SmartKey are registe...

Страница 3: ...quired Connections 10 Front Panel Controls and Connections 11 Feature Descriptions 11 Operating Basics 13 Connecting a Delivery Device 13 Turning On the SL SLx 13 Turning Off the SL SLx 14 Emergency S...

Страница 4: ...r Safety Eyewear 32 Determining When Safety Eyewear is Required 32 Safety Features 33 Labeling 36 Back Panel 36 Manufacturing Date and Serial Number 37 Grounding Label 37 Footswitch Label 37 Guide to...

Страница 5: ...degeneration diabetic retinopathy and glaucoma IRIDEX is an FDA registered medical device manufacturer and complies with current QSR ISO 13485 and MDD regulations and guidelines Contact Information Te...

Страница 6: ...d safety standards The laser is controlled by a dedicated microprocessor that continuously monitors the safe function of all subsystems This manual contains important information on how to unpack setu...

Страница 7: ...urred during transit All standard shipments include a laser console footswitch medical grade power cord keys spare fuses remote interlock plug laser warning sign this operator manual and any other acc...

Страница 8: ...lable for reference Footswitch The footswitch activates the treatment beam when depressed AC Power Cord The power cord connects the console to an electrical outlet The plug is medical grade hospital g...

Страница 9: ...on Replacement cords may be ordered to match the IEC320 power inlet with local electrical standards Always use a three wire grounding cord set Do not alter the power inlet as it contains protective fu...

Страница 10: ...oor to the treatment room is opened To use the remote interlock attach the door switch to the screw terminals in place of the shorting wire If the remote interlock is not properly connected the messag...

Страница 11: ...he treatment laser is enabled only when Treat is selected Mode Multi function button Used to display activate confirm and clear messages and settings Key Switch The key is used to turn the system on a...

Страница 12: ...s Counter Reset Press button to clear the pulse counter Fiber Port All delivery devices are connected to the console at the fiber port Cover the end of the port with the cap between uses to protect it...

Страница 13: ...st bend or tightly coil the delivery device fiber optic Do not bend the fiber optic in loops smaller than 6 inches in diameter Loosely drape or coil excess length on a flat surface Keep the fiber opti...

Страница 14: ...Stop In the event of an emergency push the red Emergency Stop button on the front panel This will immediately disable the laser and all related electronic circuits The display will read Emergency Stop...

Страница 15: ...r a range of millisecond 10 3 values duration 10 9000 ms interval 50 1000 ms The CW Pulse waveform is shown below Power mW Duration ms Interval ms Time ms Interval ms Duration ms Selecting Treatment S...

Страница 16: ...rol to select a single pulse or repeating pulses To select a single pulse rotate the knob counterclockwise until the display is blank With this setting the SL SLx will deliver a single timed pulse eve...

Страница 17: ...mW Duration Up to 30 minutes Using LongPulse Mode Entering LongPulse Mode To access the LongPulse operating mode attach a large spot delivery device to the SL SLx Rotate the Duration control until LP...

Страница 18: ...on completion of the treatment exposure In the counter display the shows the amount of energy in Joules J delivered during the treatment Press Counter Reset to clear the display and initiate another t...

Страница 19: ...than with equivalently timed pulses in CW Pulse mode MicroPulse mode may only be used with a slit lamp adapter SLA The MicroPulse waveform is illustrated in the following diagram Power mW Pulse Durat...

Страница 20: ...hree preset duty factor settings in MicroPulse mode 5 10 and 15 After entering MicroPulse mode any of these settings can be selected by pressing the Treat Standby button to scroll through the selectio...

Страница 21: ...er Pulse Duration and Interval After selecting the desired duty factor the power pulse duration envelope and pulse interval can be selected by rotating the corresponding controls Initiating Treatment...

Страница 22: ...wise Adjusting LIO Illumination Rotate the LIO Illumination control to adjust the intensity of the while illumination lamp This adjustment is active only when an LIO is attached to the fiber port Adju...

Страница 23: ...activate the desired selection and exit the User Preferences Menu Changing the Display Language After entering the User Preferences Menu press Treat Standby to access the language preferences screen P...

Страница 24: ...operly Ensure that electrical service is on Inspect the fuses to ensure they are not blown If after checking the above items there is still no display contact IRIDEX Technical Support Poorly illuminat...

Страница 25: ...e that the remote interlock is properly connected or jumpered Ensure that door switches or other circuits are closed if applicable Calibration Required Contact IRIDEX Technical Support Emergency Stop...

Страница 26: ...fect the footswitch 1 Disconnect the footswitch from the laser console 2 Using water isopropyl alcohol or enzymatic detergents with mild pH such as ENZOL remove all traces of blood and other body flui...

Страница 27: ...Support Resetting the Circuit Breaker Next to the power inlet is a circuit breaker protecting the power supply transformer from extended overload The circuit breaker senses high internal operating tem...

Страница 28: ...the power calibration 1 Ensure that all persons in the room where the power calibration procedure will be conducted are wearing laser safety eyewear 2 Connect a properly functioning IRIDEX delivery d...

Страница 29: ...in the following table and keep with other device records Power mW Meter Reading mW Acceptable Range mW Pass Fail 200 160 240 500 400 600 1000 800 1200 2000 1600 2400 Model ________________ S N _____...

Страница 30: ...IRIDEX service personnel Product Registration Please complete and forward the product registration card to IRIDEX Prompt reply will ensure the console is tracked by customer service The registered own...

Страница 31: ...ble materials Always keep the laser in the Standby mode when not treating patients Turn the console off and remove the key between procedures to prevent unauthorized use Do not open the SL SLx enclosu...

Страница 32: ...ance NOHD The NOHD is the maximum distance from the laser at which damage to the eye can occur Any individuals within this distance from the laser must wear protective eyewear or risk unintended eye d...

Страница 33: ...33 1 Safety Features The SL SLx complies with FDA Laser Safety Requirements 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated 7 26 01 CE labeled devices comply wit...

Страница 34: ...status of the console is changed from Standby to Treat the footswitch is disabled for 3 seconds to help prevent unintentional delivery of energy Beam Attenuator The SL SLx includes an electronic atte...

Страница 35: ...improperly connected Treat cannot be selected and the Connect Footswitch message will be displayed The footswitch can be safely immersed and cleaned in compliance with IPX8 per IEC 60529 and is shrou...

Страница 36: ...Labeling Back Panel OcuLight SL SLx Operator Manual PN 13099D EN 36...

Страница 37: ...ability of the ground connection can only be assured when this device is connected to an approved mating receptacle marked for hospital use and installed in accordance with the appropriate Electrical...

Страница 38: ...nterval Footswitch Aiming Beam LIO Illumination On Treat Off Standby ETL Mark 2 x 2A H 250V Fuse CE Mark STOP Emergency Stop Remote Interlock Dispose Properly Laser Aperture at End of Fiber n Pulse Co...

Страница 39: ...0 minutes in 26 increments Repeat Interval 50 1000 ms in 11 increments and Single Pulse Aiming Beam Wavelength 650 nm nominal coaxial with treatment beam Source Solid state diode Output Power 1 mW max...

Страница 40: ...h the SL SLx Operating Mode Compatibility Delivery Device CW Pulse MicroPulse LongPulse Slit Lamp Adapter SLA Large Spot SLA LIO Large Spot LIO EndoProbe DioPexy Probe G Probe Operating Microscope Ada...

Страница 41: ...1 The SL SLx uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Cl...

Страница 42: ...ifferential mode 1 kV differential 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...

Страница 43: ...eof The undersigned also agrees to reimburse IRIDEX for any costs incurred in cleaning the enclosed equipment in the event that said item s is are received by IRIDEX in a contaminated condition ______...

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