Hillrom 773428 Welch Allyn Green Series Exam Light IV Instructions

: June 6, 2024
: Hillrom

Table of Contents

Intended use
Contraindications
Symbol descriptions
Residual risks
Mounting
Setup instructions
Cleaning
Troubleshooting
Disposal
Hillrom Technical Support
Specifications
Standards and compliance
Accessories
Warranty
Documents / Resources

Hillrom 773428 Welch Allyn Green Series Exam Light IV Instructions

Intended use

The Welch Allyn GS Exam Light IV 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.
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| 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
| Medical device
| 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
| Humidity limitation
| Power on/off
| Alternating current (AC)
| Do not re-use, Single use device
| Mass in kilograms (kg)
| Fragile
| This way up
| Stacking limit by number
| Keep dry
| Recyclable
| Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.
| Warnings

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 16 in (40 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.

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

Residual risks

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.

Mounting

Table/wall mount

Mounting Instructions

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.

Setup instructions

Mobile stand assembly instructions

Setup instructions

Setup

Cleaning

WARNING Ensure that the device is unplugged from wall socket.

Focusing sleeve

CAUTION Do NOT clean with alcohol.

Clean with a cloth dampened with warm water and mild detergent.
Follow with a cloth dampened with warm water.
Dry with a clean cloth.

Control box

Clean with a cloth dampened with any of these approved cleaning agents:
- warm water and mild detergent
- 70 percent isopropyl alcohol
- 10 percent bleach solution
Follow with a cloth dampened with warm water.
Wipe dry with a clean cloth.

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.

Troubleshooting

Green light not illuminated

Possible cause
Power supply fault. No power supplied to light.
Troubleshooting Instructions
Solution
Verify all cables are connected correctly.

Green light illuminated
Possible cause
Light is not functioning correctly.
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

PATENT
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.

Hillrom Technical Support

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

Notice to users and/or patients in EU
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.

Performance characteristics
Spot size: Adjustable from 4 to 10 inches in diameter ± 10% at 16 inch working distance
Spot type: Sharp Edge

Specifications

Electrical
Input: 100-240 V~ 50Hz-60Hz, 0.30A max
Environment
- Temperature
- Operating: 50 °F – 95 °F (10 °C – 35 °C)
- Transport/storage: -4 °F – 120 °F (-20 °C – 49 °C)
- 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

48950: Mobile Stand for GS Light IV
48955: Table / Wall Mount for GS Exam Light IV / GS 300 / GS 600
44215: 12” Wall Mount Extension
52640: Disposable Sheaths for GS Exam Light IV

Warranty

Five years.
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

© 2021 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

Documents / Resources

| Hillrom 773428 Welch Allyn Green Series Exam Light IV [pdf] Instructions
773428 Welch Allyn Green Series Exam Light IV, 773428, Welch Allyn Green Series Exam Light IV
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