PASCAL and PASCAL Streamline Operator Manual Rev C April 2012

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This manual is copyrighted with all rights reserved. Under the copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Topcon Medical Laser Systems. 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. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications and schematics contained herein are subject to change without notice. Topcon Medical Laser Systems®, the Topcon Medical Laser Systems Logo™ and PASCAL® are trademarks or registered trademarks of Topcon Medical Laser Systems. PASCAL Streamline Photocoagulator and PASCAL Streamline 577 are trademarks of Topcon Medical Laser Systems. For service assistance and to order replacement parts, contact the Topcon Medical Laser Systems Service Department at the following telephone numbers: +1.888.850.1223 or +1.408.235.8221 or email [email protected].

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Table of Contents PRECAUTIONS, CAUTIONS & WARNINGS ... 8 Disclaimer... 10 Label Symbol Definitions... 10 Operator Manual Symbol Definitions ... 14 SYSTEM DESCRIPTION... 18 Introduction... 20 System Components ... 20 Slit Lamp ... 20 Slit Lamp Table ... 22 Touchscreen LCD Control Panel ... 24 Footswitch ... 25 Door Interlock Plug... 25 System Installation and Setup ... 26 Connecting the System Components ... 26 Starting the System ... 28 Setting Up the Slit Lamp ... 29 Shutting Down the System ... 31 CONTROL SCREEN DESCRIPTION ... 34 Introduction... 36 Home Screen ... 36 Select Physician and Select Favorite Dropdowns ... 37 Help Screen ... 38 Posterior Treatment Screen ... 39 Critical Controls ... 40 Information Panel ... 46 Pattern Shape and Size Controls ... 52 Pattern Density... 56 Pattern Preference Controls ... 60 Additional Controls ... 66 Posterior Pattern Descriptions ... 72 Array (20 ms default)... 73 Triple Arc ... 75 Wedge ... 77 Triple Ring ... 79 Arc ... 80 Line... 82 Octants ... 84 Array (10 ms default)... 88 Single Spot ... 89 Anterior Treatment Screen ... 91 PLT 3 Row ... 92 Array (20 ms default)... 95 Treatment Report Window ... 97

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SYSTEM SOFTWARE SETUP ... 100 Introduction... 102 System Setup Screen ... 102 Patient Information Feature ... 103 Surgical Timeout Feature ... 106 Counter Reset Feature... 108 Physician Preferences Feature ... 110 Treatment Time Feature ... 115 Additional System Features ... 117 Treatment Reports ... 118 Contact Lens Selection Screen ... 122 Editing the Custom Contact Lens ... 123 Customizing the Contact Lens List ... 124 INTRAOPERATIVE INSTRUCTIONS ... 126 Slit Lamp Treatment Procedure ... 128 LIO Treatment Procedure (532 nm only) ... 130 LIO Spot Diameter Selection ... 132 Between Patient Treatments ... 133 System Shut-down ... 134 MAINTENANCE ... 136 Scheduled Maintenance and Repair ... 138 Annual Maintenance ... 138 System Repair ... 138 User Maintenance ... 138 Cleaning the External Surfaces of the System ... 138 Cleaning the Control Panel ... 138 Replacing the Fuses ... 139 Replacing the Projector Lamp... 140 Replacing the Fixation Point LED Light Source ... 140 Electrical Requirements ... 141 System Specifications ... 142 Treatment Beam ... 142 Aim Beam ... 142 Electrical Requirements ... 143 Product Classifications per IEC 60601-1 ... 143 Classifications & Approvals ... 143 Environmental Requirements (operating) ... 144 Environmental Requirements (non-operating) ... 144 Physical Characteristics ... 145 Laser Safety Eyewear ... 145 Contact Lens Compatibility ... 146 Slit Lamp General Features ... 147 Troubleshooting Guide ... 148 Calibration Procedure ... 154 Disclaimer warning ... 154

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PASCAL Streamline Calibration Instructions ... 155 PASCAL Calibration Instructions ... 156 System Relocation Instructions ... 157 Room Preparation ... 157 SAFETY & REGULATORY COMPLIANCE... 158 Introduction... 160 Ocular Protection ... 160 Laser Safety Eyewear ... 161 Electrical Hazards ... 164 Fiber Optic Cable Assembly... 164 Fire Hazard... 164 Protecting Non-target Tissues... 165 Regulatory Compliance Safety Features ... 166 Key Lock Switch ... 166 Laser Emission Indicator ... 166 Door Interlock ... 166 Emergency Stop ... 166 Protective Housing ... 166 Safety Interlocks... 166 Safety Shutter ... 167 Location of Controls ... 167 Manual Reset ... 167 Electrical Fault Detection Circuitry ... 167 Location of Regulatory and Other System Labels ... 167 Electromagnetic Compatibility ... 174 INDICATIONS FOR USE... 180 Ophthalmic Applications of PASCAL and PASCAL Streamline... 182 Posterior Segment Laser Procedures ... 183 Indications for Use ... 183 Adverse Effects and Complications ... 184 Anterior Segment Laser Procedures ... 185 Indications for Use ... 185 Contraindications ... 185 Ophthalmology References... 187 WARRANTY & DECONTAMINATION INFORMATION ... 188 Warranty Information ... 190 Warranty Shipments, Returns, and Adjustments ... 190 Decontamination of Returned Equipment ... 191 US Technical Service Information ... 191 Decontamination Certification ... 192 End of Life Disposal – Environmental Information ... 193

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PRECAUTIONS, CAUTIONS & WARNINGS

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Disclaimer Calibration of the PASCAL® or PASCAL Streamline (532nm / 577nm) is a service procedure to be performed only by Topcon Medical Laser Systems®-certified personnel or customers who have taken and passed a Topcon Medical Laser Systems Bio-Medical Preventative Maintenance Training course on the appropriate laser system. Adjustment by anyone other than Topcon Medical Laser Systems-certified personnel or by customers who have taken and passed a Bio-Medical Preventative Maintenance Training course voids any existing manufacturer’s warranty on the instrument and can result in serious personal injury.

Label Symbol Definitions NOTE Refer to the “Safety & Regulatory Compliance” chapter for complete labeling information. System Information Label, includes: Manufacturer Part Number Serial Number Manufacture Date Follow Operating instructions

Sample System Information Label (PASCAL Streamline Shown)

Attention, refer to Accompanying documentation Type B Equipment WEEE Symbol This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment. Laser Aperture Label Laser beam may exit this area. Laser Emission Warning

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Danger Label, includes: • Laser Emission Warning • Wavelength • Power • Laser Class

Sample Danger Label (PASCAL Streamline Shown) Laser Radiation Caution Label, includes: Laser Emission Warning

Sample Laser Radiation Caution Label (PASCAL Streamline Shown) European Representative Label

Footswitch Label Ingress Protection

Warning, Hot Surface Label Warning, this surface may be extremely hot.

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General Warning Label

! Caution, Class 4 Laser Emission Laser beam may be present in this area, when opened.

Slit Lamp Bulb Label Notification to replace the slit lamp bulb only with a 6V 20W bulb.

Emergency Stop Label

“Hospital Grade” Cord Grounding Instructions

Ready

Standby

Start

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On

Off

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Micromanipulator

Power Control

Printer connection

Remote door interlock connection

Footswitch connection

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Operator Manual Symbol Definitions Please read this manual and follow its instructions carefully. The words WARNING, CAUTION, PRECAUTION and NOTE carry special meanings and should be carefully reviewed.

The personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or physician.

Disregarding this information may result in instrument failure or damage.

Possible instrument failure, instrument damage or unintended outcome may occur when disregarding this information.

An exclamation mark within a triangle is intended to alert the user to important operating and maintenance instructions in the literature accompanying the product.

NOTE

The word NOTE is used to emphasize important information to the user.

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To avoid potential injury to the user and the patient and/or damage to this device, the user must: •

Read this operating manual thoroughly and be familiar with its contents prior to using this equipment.

•

Be a qualified physician, having complete knowledge of the use of this device.

•

Test this device prior to a procedure.

•

Attempt no internal repairs or adjustments not specifically detailed in this operator manual.

•

Disconnect the laser system from the electrical outlet when inspecting the fuses.

Topcon Medical Laser Systems accepts full responsibility for safety, reliability and performance of the device only if: •

Service, readjustments, modifications and/or repairs are performed exclusively by Topcon Medical Laser Systems-certified personnel.

•

The electrical installation of the treatment room complies with the applicable IEC, CEC and NEC requirements.

The warranty is void if any of these warnings are disregarded. Topcon Medical Laser Systems 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. Please contact Topcon Medical Laser Systems or your local Topcon Medical Laser Systems representative for information on changes and new products.

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US federal law restricts this device to sale by or on order of a physician. Topcon Medical Laser Systems medical devices are solely for use by physicians trained in the operation of laser photocoagulation and associated delivery devices. When the laser system is interconnected with other medical electrical equipment, leakage currents may be additive. Ensure all systems are installed according to the requirements of IEC 60601-1. Use extreme care with the cable assembly to/from the laser system control panel and slit lamp. The cable assembly consists of wiring and fiber optic cables. Do not pull or stress any cables. Do not set items on or under the cable assembly. Damage to the fiber optic cables may cause unintended laser exposure. Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. NOTE When not in use, laser equipment should be protected against unqualified use by removing the key from the key switch.

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SYSTEM DESCRIPTION

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