Welch Allyn Insight 13500 Directions For Use Manual

Welch Allyn

13500 Insight

™

Wireless LED Binocular Indirect Ophthalmoscope

Directions for use

Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication,

© 2017 the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn or its partner, Propper Manufacturing Co. No other use, reproduction, or distribution of this publication, or any part of it, is allowed without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn.

Insight is a trademark of Propper Manufacturing Co., Inc.

DIR 80022061 Ver. A

Revision date: 2017-03

Manufactured for Welch Allyn by

Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, NY 11101 USA 718-392-6650

Regulatory Affairs Representative Sean Murphy & Company – Solicitors 1 South Bank Crosses Green Cork City, Ireland

Overview .................................................................................................. 1

Symbols and definitions ......................................................................... 3

iii

Indications for use ................................................................................................ 1

General operation and schematics ....................................................................... 1

Unpacking the ophthalmoscope .......................................................................... 2

Accessories (available by order) ........................................................................... 2

Documentation symbols ...................................................................................... 3

Miscellaneous symbols ........................................................................................ 3

Warnings and cautions ........................................................................... 5

Controls, indicators, and connectors ..................................................... 7

Using the Insight BIO ............................................................................ 11

Attach the battery pack ...................................................................................... 11

Fit the instrument to your head ........................................................................ 12

Light output control ............................................................................................ 12

Light position controls ........................................................................................ 13

Filter and aperture controls ................................................................................ 13

Module position controls ................................................................................... 14

Inter-pupillary spacing controls .......................................................................... 15

Synchronized convergence and parallax controls .............................................. 15

Lens options ...................................................................................................... 16

Power-on/power-off control ............................................................................... 16

Maintenance .......................................................................................... 19

Clean and disinfect the instrument .................................................................... 19

Charge the battery ............................................................................................. 19

Specifications ........................................................................................ 21

Environmental specifications ............................................................................. 21

Rechargeable battery and charger specifications .............................................. 21

Default settings and setup ................................................................................. 22

Regulatory conformance .................................................................................... 23

Guidance and manufacturer's declarations ........................................ 25

EMC compliance ................................................................................................ 25

Emissions and immunity information ................................................................. 25

Contents Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

Appendix ................................................................................................ 29

Warranty ............................................................................................................ 29

Battery disposal/recycling .................................................................................. 30

Short-term storage ............................................................................................. 30

Long-term storage ............................................................................................. 30

Overview

Indications for use

The Welch Allyn 13500 Wireless LED Insight Binocular Indirect Ophthalmoscope (Insight BIO) is a battery-powered device containing illumination and viewing optics intended for use by medical professionals to examine the cornea, aqueous, lens, vitreous, and the retina of the eye.

General operation and schematics

For illumination, the Welch Allyn Insight BIO uses a Light-Emitting Diode (LED). The following optical schematic highlights the traditional principles that govern how the device operates.

Overview Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

Unpacking the ophthalmoscope

Open the package and verify that all components listed below are included. If any component is missing, contact Welch Allyn immediately.

Item Quantity

Insight BIO 1

Insight battery 2

Insight battery charger (USA, EU, UK plug) 1

Insight 0 diopter eyepiece lens 2

Insight directions for use 1

Insight wall mount 1

Accessories (available by order)

Part number Description

13500S Insight BIO kit complete with soft case

75360 Insight BIO rechargeable battery

13510 Insight BIO battery charger (USA, EU, UK plug)

13550 Insight BIO teaching mirror

13560 Insight BIO wall mount kit

13520 Insight BIO 2.0D eyepiece lenses (qty 2)

13530 Insight BIO 0.0D eyepiece lenses (qty 2)

13570 Insight BIO soft case

13540 Insight headband pad kit (all three pads)

13546 Insight BIO eye cups (qty 2)

Symbols and definitions

Documentation symbols

WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning statements appear with a gray background in a black and white document but have a yellow background in color hard copies.

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.

Consult directions for use (DFU).

A copy of the DFU is available on this website.

A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 days.

Miscellaneous symbols

Fragile Keep away from sunlight

This way up Keep away from rain

For indoor use only Class II equipment

Humidity limitation Atmospheric pressure limitation

Symbols and definitions Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

Temperature limit Serial Number

Product Identifier Global Trade Item Number

Reorder number

Do not dispose of in trash, for batteries only

Rechargeable battery

Manufacturer CE Mark for Class I equipment

By prescription or order of physician

Do not dispose of in trash, for devices

Authorized Representative in the European Community

Warnings and cautions

All users of the Insight BIO must read and understand all safety information presented in this manual before using the device.

WARNING The Welch Allyn 13500 Insight BIO is classified as a Group 2 instrument according to EN/ISO 15004-2:2007. The classification was performed together with a Ø54mm/20 Diopter Ophthalmoscopy loupe.

WARNING 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 10 minutes.

WARNING Because prolonged intense light exposure can damage the retina, the use of the Insight Binocular Indirect Ophthalmoscope for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device should be used with filters that eliminate UV radiation (˂400 nm) and, whenever possible, filters that eliminate UV short wavelength blue light (˂420 nm).

WARNING The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no accurate optical radiation hazards have been identified for indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. Infants and persons with aphakia or other eye disease/disorders may be at greater risk. The risk may also increase if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography.

CAUTION Charge the Insight BIO only with the provided charger. Using any other charger could damage the instrument.

CAUTION Do not autoclave, immerse, excessively wet, or use germicidal cleaners other than those identified. Doing so will damage the instrument.

CAUTION United States Federal law restricts this device to sale, distribution, or use by or on the order of a physician or licensed healthcare professional.

Warnings and cautions Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

Controls, indicators, and connectors

Instrument top, right side view

No. Feature Description

1 Headband adjustment knobs Loosen or tighten fit of the headband.

2 Binocular Provides illumination and viewing optics to examine the fundus

(shown in OFF position).

3 Battery pack Provides power to the binocular. Rechargeable with battery

charger.

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