300 Green Series Ref 771377 General Exam Light Ver B Instructions for Use Oct 2020

Medical device

Welch Allyn® Green Series™ 300 General Exam Light 901067 EXAM/PROCEDURE LIGHT

Instructions for use (English)

771377, DIR 80025946 Ver. B, Revision date: 2020-10

© 2020 Welch Allyn, Inc. All rights reserved. No one is permitted to reproduce or duplicate, in any form, this instructions for use or any part thereof without permission from Welch Allyn. Welch Allyn, Inc. (“Welch Allyn”) assumes no responsibility for any injury to anyone that may result from (i) failure to properly use the product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual, or (ii) any illegal or improper use of the product. Welch Allyn® is a trademark of Welch Allyn, Inc. Hillrom™ is a trademark of Hill-Rom Services, Inc. Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA hillrom.com Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc. and EU IMPORTER Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083

Intended use The Welch Allyn GS 300 is designed to meet the various needs of the physician’s office, hospital environment, and specialist’s office. It is not intended for rendering diagnosis or surgery.

Indications for use The devices shall be used in hospitals and health care facilities by trained healthcare professionals to provide additional illumination while performing examinations and minor procedures.

Contraindications The devices shall not be used to render diagnosis or in surgery.

Symbol descriptions For information on the origin of these symbols, see the Welch Allyn symbols glossary: welchallyn.com/symbolsglossary WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning symbols will appear with a grey background in a black and white document. CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. Product Identifier Reorder number Lot code Global Trade Item Number Consult instructions for use

Prescription only or "For Use by or on the order of a licensed medical professional" Manufacturer Authorized Representative in the European Community WARNING High intensity light Use indoors Temperature limits Atmospheric pressure limitation

Residual risks

Hillrom Technical Support

This product complies with relevant electro-magnetic interference, mechanical safety, performance, and biocompatibility standards. However, the product cannot completely eliminate potential patient or user harm from the following: • Harm or device damage associated with electro-magnetic hazards, • Harm from mechanical hazards, • Harm from device, function, or parameter unavailability, • Harm from misuse error, such as inadequate cleaning, and/or • Harm from device exposure to biological triggers that may result in a severe systemic allergic reaction.

For information about any Hillrom product, contact Hillrom Technical Support at hillrom.com/en-us/about-us/locations

Cleaning WARNING Ensure that the device is unplugged from wall socket. Luminaire 1. Clean with a cloth dampened with any of these approved cleaning agents:

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Mass in kilograms (kg)

• warm water and mild detergent • 70 percent isopropyl alcohol • 10 percent bleach solution

Fragile

2. Follow with a cloth dampened with warm water.

This way up

3. Wipe dry with a clean cloth.

Stacking limit by number

After cleaning, inspect the device for wear, fraying, or other damage. Do not use if you see signs of damage, if the instrument malfunctions, appears not to be working properly, or if you notice a change in performance. Contact Hillrom Technical Support department for assistance.

Keep dry Recyclable Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

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Warnings

CAUTION Only authorized Hillrom Service Centers can perform service on this product. CAUTION There are no user serviceable/replaceable parts.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Spot size: 14 cm @ 50 cm working distance Spot type: Soft Edge

Alternating current (AC)

Cautions

Notice to users and/or patients in EU

Performance characteristics

Table/wall mount

Power on/off

WARNING Read and understand the instructions before using this product. Failure to understand the operating requirements for this product might result in injury to yourself or the patient, and/or might damage the instrument. WARNING Illumination is intense. To minimize risk of harm to the eyes from optical radiation hazards, avoid looking at bright light sources and their reflections, do not stare at the light source in operation, and protect eyes where normal pupil sizes and aversion responses are not present. WARNING Use the examination light in its intended working range of 20 in (50 cm). Exposures at closer distances may be harmful to skin. To minimize risk of harm to the skin from optical radiation hazards, minimize illumination intensity at the tissue examination site, minimize exposure times, and take additional precautions when skin sensitivity has been altered through tissue trauma or the use of anesthesia. WARNING This is a class A product. In a hospital/physician's office environment this product might cause radio interference in which case the user should take adequate measures. WARNING This product complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other equipment. WARNING Do not modify this equipment. Any modification of this equipment can lead to patient injury. Any modification of this equipment voids the product warranty. WARNING Personal injury risk. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING Personal injury risk. The power cord is the disconnect device to isolate this equipment from supply mains. Position the equipment so that it is not difficult to reach to disconnect the cord.

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Mounting

Humidity limitation

Do not re-use, Single use device

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Troubleshooting

Green light not illuminated Possible cause Power supply fault. No power supplied to light.

3 WARNING Ensure that the mounting bracket is securely anchored to the wall or table, or that the mobile stand is securely assembled, and the exam light is securely fastened to the bracket or stand as directed. Do not hang or place objects on the equipment.

Solution Verify all cables are connected correctly.

Green light illuminated Possible cause Light is not functioning correctly.

Setup instructions

Mobile stand assembly instructions

Solution Contact Hillrom Technical Support.

Disposal Users must adhere to all federal, state, regional, and/or local laws and regulations as they pertain to the safe disposal of medical devices and accessories. If in doubt, the user of the device should first contact Hillrom Technical Support for guidance on safe disposal protocols. welchallyn.com/weee

Setup

Specifications Electrical Input: 100-240 V~ 50Hz-60Hz, 0.35A max Environment Temperature • Operating: 10 °C – 35 °C (50 °F – 95 °F) • Transport/storage: -20 °C – 49 °C (-4 °F – 120 °F) Relative humidity, non-condensing • Operating: 15 – 90 % • Transport/storage: 15 – 95% Atmospheric pressure • Operating: 700 – 1060 hPa • Transport/storage: 500 – 1060 hPa Equipment classification Safety Class 1, Continuous Operation Additional technical information welchallyn.com/gsseries

Standards and compliance The device complies with the following standards: IEC 60601-1 IEC 60601-1-2 Country-specific standards are included in the applicable Declaration of Conformity

Lot code YYWW (on product) YYDDD (on package) YY= last 2 digits of the year WW= week of the year DDD= consecutive day of the Julian year

Guidance and manufacturer’s declaration/EMC For information about electromagnetic compatibility (EMC), see the Welch Allyn website welchallyn.com/emc-examlight. A printed copy of the emissions and immunity information can be ordered from Welch Allyn for delivery within 7 calendar days.

Accessories 48955 44215 48960

Table / Wall Mount for GS Exam Light IV / GS 300 / GS 600 12” Wall Mount Extension Heavy Duty/Tall Mobile Stand

Warranty Five years.

PATENT/PATENTS

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hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications.

Hill-Rom reserves the right to make changes without notice in design, specifications and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products.