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PASCAL
Ophthalmoscope (LIO)
(Single-Spot Version)
European Authorized Representative
Obelis
Boulevard Général Wahis 53
1030 Brussels
Belgium
Phone: +32.2.732.59.54
Fax: +32.2.732.60.03
www.obelis.net
IRIDEX LIO Operator Manual
88294-EN, Rev B
®
Laser Indirect
(532 nm or 577 nm)
Operator Manual
Iridex Corporation
1212 Terra Bella Avenue
Mountain View, CA 94043
USA
Office: +1. 650.940.4700
Fax: +1.650.962.0486
www.iridexretina.com
Page 1 of 35
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Summary of Contents for Iridex PASCAL LIO
- Page 1 Iridex Corporation Obelis 1212 Terra Bella Avenue Boulevard Général Wahis 53 Mountain View, CA 94043 1030 Brussels Belgium Office: +1. 650.940.4700 Phone: +32.2.732.59.54 Fax: +1.650.962.0486 Fax: +32.2.732.60.03 www.iridexretina.com www.obelis.net IRIDEX LIO Operator Manual Page 1 of 35 88294-EN, Rev B...
- Page 2 Iridex Corporation. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original under the law. Copying includes translation into another language.
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Page 3: Table Of Contents
Warranty Information ......................33 Warranty Shipments, Returns, and Adjustments ........... 33 Decontamination of Returned Equipment ................34 US Technical Service Information ..................34 WEEE Disposal ........................34 Decontamination Certification ..................... 35 IRIDEX PASCAL LIO Page 3 of 35 88294-EN, Rev B... -
Page 4: Introduction
CEC and NEC requirements. The warranty is void if any of these warnings are disregarded. Iridex Corporation reserves the right to make changes to the device(s) herein. Device(s), therefore, may not agree in detail with the published design or specifications. All specifications are subject to change without notice. -
Page 5: Setting Up And Using The Lio
Setting Up and Using the LIO The Iridex Corporation LIO is designed to connect to the PASCAL laser system. An optical system projects an aiming and treatment laser beam delivered from the laser via a fiber optic cable. The user can adjust the angle of projection of the laser by approximately ± 3º. -
Page 6: Adjusting The Headband
Position the binocular block as close to the eyes or spectacles as possible for maximum field of view. Slightly loosen the ophthalmoscope angle knob to allow for adjustment and tighten when in position (fig 4). IRIDEX PASCAL LIO Page 6 of 35 88294-EN, Rev B... -
Page 7: Adjusting The Interpupillary Distance
The light is positioned vertically into the upper two thirds of the field of view by rotating the mirror angle spindle located on either side of the binocular block. Turning on the Illumination Turn on the illumination by rotating the headband dimmer switch in a counter-clockwise direction. IRIDEX PASCAL LIO Page 7 of 35 88294-EN, Rev B... -
Page 8: Setting The Aperture
The mirror and optics stay in the mid position. Small The small patch is ideal for small, undilated pupils. The mirror moves back and the optics automatically converge. Aperture Lever IRIDEX PASCAL LIO Page 8 of 35 88294-EN, Rev B... -
Page 9: Selecting The Filter
Beginners may find the diffuser filter helpful, because the alignment between the headset, the condensing lens, and the pupil, in order to achieve a full lens image, is not as critical as with a conventional beam. Filter Lever IRIDEX PASCAL LIO Page 9 of 35 88294-EN, Rev B... -
Page 10: Adjusting The Illumination
Rotate the laser angle control on the front of the unit to adjust the angle of projection of the laser up or down by 3 degrees either side of the optical axis. Laser Angle Control Illumination Angle Adjustment Adjustment Control IRIDEX PASCAL LIO Page 10 of 35 88294-EN, Rev B... -
Page 11: Adapting The Power Supply
Adapting the Power Supply Replace the blanking plate with the appropriate mains plug adapter, if required, or use IEC 60320 Type 7 connector (not supplied). IEC 60320 Type 7 Connector IRIDEX PASCAL LIO Page 11 of 35 88294-EN, Rev B... -
Page 12: Laser Treatment
If you are using the 20 D aspheric lens, the diameter of the spot will be 360 µm (for an emmetropic patient eye). 7. Depress the footswitch to deliver the treatment laser beam to the tissue. IRIDEX PASCAL LIO Page 12 of 35 88294-EN, Rev B... -
Page 13: Battery Charger
1. Press the release button to release the battery pack. 2. Lift the battery pack from the cradle. 3. Place the new battery pack in the cradle until fully engaged. Battery Pack on Charger Battery Pack on Headset IRIDEX PASCAL LIO Page 13 of 35 88294-EN, Rev B... -
Page 14: Charging The Battery Pack
3. Plug the power supply into the mains outlet. 4. Place the spare battery pack or headset into the charger. Blanking Plate Power Supply Cable Mains Plug Adapter Spare battery pack Charger Power supply inlet Headset IRIDEX PASCAL LIO Page 14 of 35 88294-EN, Rev B... - Page 15 Charging Cycle The battery on the headband takes 2 hours to fully charge and will last approximately 2 hours on full power. The spare battery takes 4 hours to charge. IRIDEX PASCAL LIO Page 15 of 35 88294-EN, Rev B...
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Page 16: Mounting The Wireless Charger
Mounting the Wireless Charger Use the template document provided to mark the position of the charger and drill holes. IRIDEX PASCAL LIO Page 16 of 35 88294-EN, Rev B... -
Page 17: Replacing The Led
Ensure the cloth is not saturated with solution and excess solution does not enter the instrument. 3. Carefully hand-dry all surfaces using a clean, non-shedding cloth. 4. Safely dispose of used cleaning materials. IRIDEX PASCAL LIO Page 17 of 35 88294-EN, Rev B... -
Page 18: Specifications
Laser optical fiber Length Core diameter 100 µm Transmission < 0.005% for 577 nm or 532 Physician’s safety filter nm per LIO model Product Labels Manufacturer CE Mark Laser Emission Warning IRIDEX PASCAL LIO Page 18 of 35 88294-EN, Rev B... -
Page 19: Service
System Wavelength Compatibility When LIO is calibrated to a specific laser system. Service There are no user serviceable parts. Please refer all service requests to your local Iridex Corporation representative. IRIDEX PASCAL LIO Page 19 of 35 88294-EN, Rev B... -
Page 20: General Safety And Regulatory Information
General Safety and Regulatory Information Iridex Corporation products are precision medical instruments that have undergone extensive testing. With proper handling, they are useful and reliable clinical instruments. To protect operating personnel and patients, this entire manual and the PASCAL laser system operator manual should be read thoroughly before operation. - Page 21 LED’s can reach high temperatures in use – allow to cool before handling. Do not exceed maximum recommended exposure time. After removing the LED, do not touch the LED contacts and the patient simultaneously. IRIDEX PASCAL LIO Page 21 of 35 88294-EN, Rev B...
- Page 22 Use only Iridex Corporation-approved parts and accessories, or device safety and performance may be compromised. Use only Iridex Corporation-approved batteries, chargers and power supplies as per the accessories listed. The product has been designed to function safely when at an ambient temperature between +10°C and +35°C.
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Page 23: Safety Considerations
The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 60 minutes. IRIDEX PASCAL LIO Page 23 of 35 88294-EN, Rev B... -
Page 24: Symbols
WEEE symbol—contact your local representative for disposal information Type B applied part Mandatory action sign Follow operating instructions High voltage Trip hazard Optical radiation hazard Hot surface This way up Keep dry Fragile Material suitable for recycling IRIDEX PASCAL LIO Page 24 of 35 88294-EN, Rev B... -
Page 25: Electromagnetic Compatibility
Consult the tables below for guidance in placing the LIO. Guidance and manufacturer’s declaration – electromagnetic emissions The PASCAL LIO is intended for use in the electromagnetic environment specified below. The customer or the user of the PASCAL LIO should assure that it is used in such an environment. - Page 26 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PASCAL LIO is used exceeds the applicable RF compliance level above, the PASCAL LIO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PASCAL LIO.
- Page 27 RF communications equipment and the PASCAL LIO The PASCAL LIO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PASCAL LIO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PASCAL LIO as recommended below, according to the maximum output power of the communications equipment.
- Page 28 SIP/SOP Cable (for Footswitch) Not Used Not Used SIP/SOP Cable (for LIO) Not Used Not Used USB Cable (for HUD-1) Not Used Not Used HDMI Cable (for HUD-1) Not Used Not Used IRIDEX PASCAL LIO Page 28 of 35 88294-EN, Rev B...
- Page 29 IEC61000-3-2 connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/ flicker emissions Complies IEC61000-3-3 IRIDEX PASCAL LIO Page 29 of 35 88294-EN, Rev B...
- Page 30 30 A/m 30 A/m a typical location in a typical magnetic field commercial hospital IEC 61000-4-8 environment. NOTE U is the a.c. main voltage prior to application of the test level. IRIDEX PASCAL LIO Page 30 of 35 88294-EN, Rev B...
- Page 31 (V/m). NOTE 1 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. IRIDEX PASCAL LIO Page 31 of 35 88294-EN, Rev B...
- Page 32 DECT 217Hz LTE Band 1,3,4,25 1970 UMTS Bluetooth WLAN 802.11 b/g/n Pulse modulation 2450 2400-2570 RFID 2450 217Hz LTE Band7 5240 Pulse modulation 5500 5100-5800 WLAN 802.11 a/n 217Hz 5785 IRIDEX PASCAL LIO Page 32 of 35 88294-EN, Rev B...
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Page 33: Warranty Information
Iridex Corporation. If it becomes necessary to return a product for repair and/or adjustments, authorization from Iridex Corporation must be obtained. Instructions as to how and where products should be shipped will be provided by Iridex Corporation. Any product or component returned for examination and/or warranty repair shall be sent insured and prepaid via the means of transportation specified by Iridex Corporation. -
Page 34: Decontamination Of Returned Equipment
Decontamination of Returned Equipment To comply with United States postal and transportation law, equipment shipped to Iridex Corporation for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for sale as a Hospital Disinfectant. -
Page 35: Decontamination Certification
Hospital Disinfectant and is clean and free from biohazards, including – but not limited – human or animal blood, tissue or tissue fluids or components thereof. The undersigned also agrees to reimburse Iridex Corporation for any costs incurred in decontaminating the enclosed equipment, in the event said item is received by Iridex Corporation in a contaminated condition.
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