This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is prohibited without the express written consent of STERIS. STERIS reserves the right to make changes in the specifications shown herein without notice or obligation. For additional information, contact STERIS.
TABLE OF CONTENTS Section Number Description Page Copyright Information........................2 A Word from STERIS ......................... 1 Introduction........................1 Indications for Use......................1 Advisory........................... 1 Addresses........................2 Summary of Warnings and Cautions....................3 Symbols .............................. 6 Specifications and Requirements ....................9 Optical Performance.......................
2.2 Indications for Use Intended Use The intended use of the LED202 Lighting System is to provide fixed pattern/variable intensity visible illumination of the surgical/clinically relevant field and the patient. The LED202 Lighting System suspension is a non-mobile flush-mounted ceiling mounted support system installed in a surgical/clinical environment.
(IEC 60601-2-41) sets minimum and maximum levels of illumination and maximum levels of radiant heat that can be emitted from a single surgical luminaire. The LED202 Lighting System has been designed to comply with this international standard and to provide a wide range of illumination levels while minimizing the potentially damaging infrared heat in the surgical field.
Eye injury may occur. The LED202 light fixture is designed to be used at a distance of more than 122 cm from the illuminated surface. Use at distances less than 122 cm may cause excessive radiant heat at the illuminated surface.
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Always follow manufacturer instructions for concentrations and use of cleaning products. Do not scratch optical coating on accessible portions of optical core when cleaning; always wear rubber gloves and use only a clean, white, lint-free cloth when wiping internal surfaces. 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
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Prevent leakage of fluids into interior of light or wall control. Ensure no excess fluids remain on light fixture or wall control during and after cleaning. The use of H₂O₂ + PAA (Hydrogen Peroxide + Peracetic Acid) is strongly discouraged for use on all STERIS products.
Voltage Rating of Unit, Alternating Current Frequency Rating of Unit Amperage Rating of Unit Symbol Indicating the Legal Manufacturer Name and Address Unique Device Identifier Symbol Indicating the Country and Date of Manufacture (YYYY-MM-DD) Medical Device 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
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Symbol Definition Line terminal Neutral terminal Ground terminal Disconnect supply before servicing Consult instructions before use General warning Warning, electricity Follow instructions for use Protective Earth (Ground) This end up Fragile Keep Dry 11042437_A LED202 In-Ceiling Lighting System Operator Manual...
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4 — Symbols Table 4-1 Definition of Symbols (Continued) Symbol Definition Temperature Specifications Humidity Specifications Atmospheric Pressure Specifications Do not stack Do not double stack 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
Single Mask w/Cavity Double Mask w/Cavity Deep Saturated Red Color Rendering Index (R9) ≥ 85 LED Life 45,000 hours Total Irradiance at D 230 W/m² Total Irradiance at D 500 W/m² Beam Angulation 56° 11042437_A LED202 In-Ceiling Lighting System Operator Manual...
Table 5-3. Transportation and Storage Conditions Light Fixture Wall Control Temperature -29 °C to 60 °C (-20 °F to 140 °F) Relative Humidity Up to 85% Barometric Pressure 500 hPa to 1060 hPa 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
• Ensure electrical service for each lighting system installation is complete (including lockout, junction box, conduit, fittings, and lighthead power cable) and capable of being locked out. These items are not furnished (except junction box) or installed by STERIS. Equipment Required...
Table 6-1. Light Components ON/OFF Switch Gimbal Mechanism Light Engine Access Panel Lid/Cover Front Window * — Shown for reference only. Internal components should not be accessed by the Customer, refer to qualified service personnel. 11042437_A LED202 In-Ceiling Lighting System Operator Manual...
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NOTE: A dual light system is shown for reference. Single light systems will only have controls for “Light 1”. Figure 6-2. Wall Control Interface Components Component Light 1 Position Controls Light 1 Intensity Controls Light 2 Position Controls Light 2 Intensity Controls 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
7 — Operating Instructions Operating Instructions WARNING EXPLOSION HAZARD Do not use in the presence of flammable anesthetics. Figure 7-1. Wall Control 11042437_A LED202 In-Ceiling Lighting System Operator Manual...
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ON, and the light engine is OFF. All green LEDs will be OFF. NOTE: For longer light life, use higher intensity levels only when needed. 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
Do not remove covers or perform service other than those described in this equipment manual. Refer servicing to qualified service personnel. Complete the following checklist to be sure the system is operating correctly. If any issues occur, contact STERIS. 1. Check intensity control.
The following basic supplies are needed to perform routine cleaning of this equipment. • Pail • Sponge • Cloth wipes • Rubber gloves • Approved disinfectant cleaner: – Quaternary Ammonium Compound (Quats) with Ethanol solvent – Quaternary Ammonium Compound (Quats) with Isopropyl Alcohol (IPA) solvent 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
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4. Clean surfaces using a soft cloth wipe and cleaning solution. Wring excess solution from cloth before wiping. 5. Rinse all surfaces with a soft cloth wipe and clear water. Wring excess water from cloth before wiping. 6. Wipe all surfaces dry with a fresh cloth. 11042437_A LED202 In-Ceiling Lighting System Operator Manual...
The light will not turn on from the wall control, but the wall control is functioning properly. General Troubleshooting Additional Information Internal components require inspection. 1. Contact STERIS. 9.4 Light Flickers Condition The light is flickering. General Troubleshooting Additional Information Internal components require inspection. 1. Contact STERIS. 11042437_A Operator Manual LED202 In-Ceiling Lighting System...
Internal components require inspection. 1. Contact STERIS. 9.7 Wall Control Does Not Function Condition Wall control does not respond to Customer input. General Troubleshooting Additional Information Internal components require inspection. 1. Contact STERIS. 11042437_A LED202 In-Ceiling Lighting System Operator Manual...
10 — Appendix Appendix 10.1 EMC Compliance Technical Data The STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 require special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in these accompanying documents.
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10 — Appendix The STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 is intended for use in the electromagnetic environment specified below. The customer or the user of the STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 should assure that it is used in such an environment.
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10 — Appendix Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 is intended for use in the electro- magnetic environment specified below. The customer or the user of the STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 should assure that it is used in such an environment.
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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 STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 is used exceeds the applicable RF compliance level above, the STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 should be observed to verify normal operation.
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10 — Appendix Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 is intended for use in the electromagnetic environment specified below. The customer or the user of the STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 should assure that it is used in such an environment.
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The STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the STERIS Corporation LED202 SYSTEM, models LED202X2 and LED202X1 can help prevent electromagnetic interference by maintaining a minimum...
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