background image

15510-EN Rev G 

Wireless Footswitch and EMC   41

EMC Safety Information

The laser system (console and accessories) needs special precautions regarding EMC and needs to 

be installed and put into service according to the EMC information provided in this section. Portable 

and mobile RF communications equipment can affect this system.
This laser system has been tested and found to comply with the limits for medical devices in 

IEC 60601-1-2 according to the tables in this section. These limits are designed to provide reasonable 

protection against harmful interference in a typical medical installation.

CAUTION:  Changes or modifications to this laser system not expressly approved by the party 

responsible for compliance could void the user’s authority to operate the equipment 

and may result in increased emissions or decreased immunity of the laser system.

The wireless footswitch transmits and receives in the frequency range of 2.41GHz to 2.46GHz with a 

limited effective radiated power as described below. The transmissions are continuous transmissions 

at discrete frequencies within the transmission frequency 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 

protection against harmful interference in a residential installation. This equipment generates, 

uses, and can radiate radio frequency energy and, if not installed and used in accordance with 

the instructions, may cause harmful interference to radio communications. However, there is no 

guarantee that interference will not occur in a particular installation. If the wireless footswitch does 

cause harmful interference to radio or television reception, which can be determined by turning the 

laser system off and on, the user is encouraged to try to correct the interference by one or more of the 

following measures:
•  Reorient or relocate the receiving device.
•  Increase the separation between the equipment.
•  Connect the laser console into an outlet on a circuit different from that to which the receiver 

is connected.

•  Consult IRIDEX Customer Service for help.
This Class B digital apparatus meets all requirements of the Canadian Interference-Causing 

Equipment Regulations.
Cet appareil numérique de la classe B respecte toutes les exigences du Réglement sur le matériel 

brouilleur du Canada. 

Summary of Contents for IQ 532

Page 1: ...IRIDEX IQ 577 IQ 532 Laser Systems Operator Manual...

Page 2: ...OcuLight EndoProbe and SmartKey are registered trademarks BriteLight CW Pulse DioPexy EasyFit EasyView FiberCheck FlexFiber G Probe IQ 532 IQ 577 IQ 810 LongPulse MicroPulse MilliPulse OtoProbe Power...

Page 3: ...Using the Laser System 17 4 Troubleshooting 24 General Problems 24 Error Messages 26 5 Maintenance 29 Inspecting and Cleaning the Laser 29 Inspecting and Cleaning the Footswitch 29 Verifying the Power...

Page 4: ...Contents iv 15510 EN Rev G...

Page 5: ...ry devices are compatible with the IQ 577 and IQ 532 laser systems TxCell Scanning Laser Delivery System EndoProbe handpiece Slit Lamp Adapters SLA Laser Indirect Ophthalmoscopes LIO ENT Delivery Devi...

Page 6: ...changes because MicroPulse laser delivery is being used instead of CW and The total laser energy of such doses is only a percentage often chosen by clinicians to be 20 70 of that energy needed to prod...

Page 7: ...inclusive and is not intended to replace surgeon training or experience The regulatory information provided is applicable only in the United States If you use the laser for indications not included he...

Page 8: ...detachment Specific to laser trabeculoplasty IOP spike and disruption of the corneal epithelium Specific Warnings and Precautions It is essential that the surgeon and attending staff be trained in al...

Page 9: ...cations for Use IQ 532 Models This section provides information on the use of the laser in clinical specialties Information is provided by specialty and includes procedural recommendations along with...

Page 10: ...tinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids including Proliferative and nonproliferative diabetic retinopathy Choro...

Page 11: ...n Ignition or perforation of endotracheal tubes by the laser beam could result in serious or fatal patient complications Use the lowest possible oxygen concentration to support the patient Use the ven...

Page 12: ...the patient s medical and wound healing history If uncertain of expected clinical response always start with a conservative setting and increase the setting in small steps 532 nm Typical Laser Treatm...

Page 13: ...1000 2500 20 100 Control of Bleeding N A 200 2500 20 100 Spot size at target is dependent on many parameters including fiber core diameter and working distance Laryngology Treatment Delivery Device Sp...

Page 14: ...ht reflective surfaces Avoid directing the treatment beam at highly reflective surfaces such as metal instruments Ensure that all personnel in the treatment room are wearing the appropriate laser safe...

Page 15: ...blems with materials or workmanship This warranty is void if service is attempted by anyone other than certified IRIDEX service personnel WARNING Use only IRIDEX delivery devices with the IRIDEX laser...

Page 16: ...IRIDEX Customer Service Representative if there are problems with your order Appearance and type of components may vary based on the system ordered Laser also Console Operator Manual not shown Power...

Page 17: ...cord included in the packaging is appropriate for your location Always use an approved three wire grounding cord set Do not alter the power inlet To ensure proper grounding follow local electrical co...

Page 18: ...PPROVAL PRINT E PN 65893 Rev E 010 8B35 3M468 MP CUT THROUGH AREAS 8X GRAPHICS WHITE BLACK TEXT WITH PMS YELLOW C FIELD BACKGROUND BLACK PMS 285C BLUE LOGO OTES CONSTRUCTION BASE MATERIAL ADHESIVE GRA...

Page 19: ...position To turn the laser off turn the key to the Off position Remove and store the key to prevent unauthorized use NOTE The key can be removed in the Off position only In an emergency press the red...

Page 20: ...llary personnel in the treatment room are wearing the appropriate laser safety eyewear 7 Select Treat mode 8 Position the aiming beam on the treatment site 9 Focus or adjust the delivery device as app...

Page 21: ...Interface A Touchscreen Interface Displays current parameter and functions and acts as the interface to select screens or parameters B Control knobs Used to adjust parameters on the screen C Laser bu...

Page 22: ...l fire when footswitch is pressed Standby Laser is disengaged Treat Laser is firing footswitch pressed H Aiming Beam and LIO adjustments I Displays pulse duration Adjust with control knob J Displays p...

Page 23: ...een MicroPulse Settings Optional A Turn MicroPulse ON or OFF B Select preset values for Duty Cycle MicroPulse duration and Interval parameters update automatically C Displays MicroPulse duration and i...

Page 24: ...the Preset Menu at the Standby screen touch PRESETS A Programmable presets B Selection button to load highlighted preset and go to Standby screen C Cancel loading preset selection and return to Stand...

Page 25: ...Pulse settings C Use control knobs to select pulse duration power and interval D Displays Preset name Press to enter Keyboard mode E Save changes and return to Treat screen F Discard changes and retur...

Page 26: ...rs 0 to 9 Do NOT use any symbols Symbols may generate a warning message Aux Device Required when a TxCell Scanning Laser Delivery System is subsequently connected to the laser console If this error oc...

Page 27: ...h laser settings C Set voice prompt Female Male OFF Use only when adjusting power with footswitch D Set Auxiliary ON in Standby or ON in Treat Operate a warning light or auditory signal outside the tr...

Page 28: ...e No treatment beam Verify that the remote interlock has not been activated Verify that the aiming beam is visible Verify that the fiber switch is in the correct position for the laser system and wave...

Page 29: ...e response threshold for consistent response Increase the laser power and or exposure duration or select a different lens Does not fit on the mounting plate OMA only Inspect and clean the mounting pla...

Page 30: ...essed Turn key off for 5 seconds then on E00701 System controller watchdog failure E01003 E01009 System needs calibration E03002 E03003 Invalid sensor reading E03010 E03020 E03040 Laser temperature in...

Page 31: ...e If installed on a room door close door to proceed E05035 Laser safety eye filter not in position System detected out of position filter while attempting to treat Verify that SmartKey is connected If...

Page 32: ...03 Missing Pulse error System unable to deliver laser pulse when it was expected Check connections and turn laser key OFF for 5 seconds then back ON W0001 Verify a 577 nm eye safety filter is in place...

Page 33: ...ay laser light to transmit WARNING Do not remove covers Removing covers and shields may result in exposure to dangerous optical radiation levels and electrical voltages Only IRIDEX trained personnel m...

Page 34: ...mage the power meter sensor 4 Set the laser Duration to 3000 ms and the Interval to Single Pulse when a CW delivery device is connected Set the Duration to 3000 ms MicroPulse Duration to 1 0 ms and Mi...

Page 35: ...del and Serial Number _______________ Calibrated by _______________ Power Measurements using a MicroPulse Delivery Device Exposure Duration ms MicroPulse Duration ms MicroPulse Interval ms Indicated P...

Page 36: ...ions not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment Protection for the Physician Eye safety filters protect the physician from...

Page 37: ...resulting in unique NOHD values for each delivery device NOTE Not all delivery devices are available for all laser models IQ 577 IQ 532 NOHD Values for Various Delivery Devices Delivery Device MPE W...

Page 38: ...Standby light provides a visible warning that laser radiation is accessible When Treat mode is selected a three second delay prevents unintentional laser exposure The console delivers laser energy onl...

Page 39: ...MALS GRAPHICS ANGLES 3M 468 010 8B35 BASE MATERIAL ADHESIVE Wireless Receiver PRINT MUST BE APPROVED AND RETURNED WITHIN 24 RS IN ORDER FOR THIS JOB TO PROCEED WITH DUCTION ACCEPTANCE OF THE BELOW ART...

Page 40: ...514 AP The Hague The Netherlands LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT CLASS 2 LASER PRODUCT IEC 60825 1 2007 2014 RAYONNEMENT LASER EXPOSIT...

Page 41: ...witch Footswitch In Footswitch Out Fuse Gauge Protective Earth Ground Illuminating Probe Decrease Increase Interval Interval with MicroPulse Laser Aperture at End of Fiber Laser Warning Illumination L...

Page 42: ...aser Firing Laser Preparing Speaker Screen System Brightness Latex Free Prescription Warning Replace with fuses as indicated Specifications Specification Description Treatment wavelength IQ 577 577 nm...

Page 43: ...al 100 240 VAC 50 60 Hz 3 A Cooling Air cooled 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 Relative humidity 20 to 80 non condensing Dimen...

Page 44: ...y linked and will not work with other IRIDEX footswitches or similar components Clearly identify each pair to prevent separation of the linked components NOTE The footswitch is designed to operate wit...

Page 45: ...ission frequency 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 provid...

Page 46: ...ronment Emissions Test Compliance RF emissions CISPR 11 Group 1 The laser system uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any i...

Page 47: ...1000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupt...

Page 48: ...eters m a Fields strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the v...

Page 49: ...mum Output Power 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 3...

Reviews: