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Summary of Contents for Welch Allyn Insight 13500
- Page 1 ® ™ Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Directions for use...
- Page 2 © 2017 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, 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.
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Page 3: Table Of Contents
Contents Overview ....................1 Indications for use ....................1 General operation and schematics ............... 1 Unpacking the ophthalmoscope ................2 Accessories (available by order) ................2 Symbols and definitions ................. 3 Documentation symbols ..................3 Miscellaneous symbols ..................3 Warnings and cautions ................5 Controls, indicators, and connectors ............. - Page 4 ® ™ iv 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...
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Page 5: Overview
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. -
Page 6: Unpacking The Ophthalmoscope
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 Insight battery Insight battery charger (USA, EU, UK plug) -
Page 7: Symbols And Definitions
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... - Page 8 ® ™ 4 Symbols and definitions Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Temperature limit Serial Number Product Identifier Global Trade Item Number By prescription or order of Reorder number physician Do not dispose of in trash, for...
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Page 9: 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. - Page 10 ® ™ 6 Warnings and cautions Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope...
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Page 11: Controls, Indicators, And Connectors
Controls, indicators, and connectors Instrument top, right side view No. Feature Description Headband adjustment knobs Loosen or tighten fit of the headband. Binocular Provides illumination and viewing optics to examine the fundus (shown in OFF position). Battery pack Provides power to the binocular. Rechargeable with battery charger. - Page 12 ® ™ 8 Controls, indicators, and connectors Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Binocular front view No. Feature Description Locking nut lever Holds binocular in place. When unlocked, enables adjusting the binocular's position. Filter selection control Enables selection of neutral (none), red-free, amber, and cobalt blue filters.
- Page 13 Directions for use Controls, indicators, and connectors 9 Binocular rear view No. Feature Description Eyepieces and lenses Provide view of the fundus. Inter-pupillary spacing adjustment controls Enable manual adjustment of the space between the eyepieces. Synchronized convergence and parallax Enables selection of wide or narrow settings to improve the view adjustment control of the fundus.
- Page 14 ® ™ 10 Controls, indicators, and connectors Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope...
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Page 15: Using The Insight Bio
Using the Insight BIO Attach the battery pack The Insight BIO operates wirelessly with a rechargeable battery pack. Follow these instructions to set up the instrument. 1. Check the charge on the battery and recharge as needed. (See Maintenance.) The charge LED on the battery charger block turns green when the battery is fully charged. -
Page 16: Fit The Instrument To Your Head
® ™ 12 Using the Insight BIO Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Fit the instrument to your head The knobs on the headband enable you to adjust the headband size. One knob is on the back of the instrument headband; the other is on the top of the headband strap. -
Page 17: Light Position Controls
Directions for use Using the Insight BIO 13 Light position controls The BIO module also has a tilt-mirror adjustment that controls the vertical position of the light beam. For convenience, the controls are located on both sides of the device so that you can adjust the light beam when the instrument is on your head. -
Page 18: Module Position Controls
® ™ 14 Using the Insight BIO Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Module position controls The Insight BIO module provides fine position adjustment controls to promote obtaining a superior view of the fundus and optimal comfort when using the instrument. The two- directional connection slots allow moving the BIO module up and down as well as closer and farther away from your face. -
Page 19: Inter-Pupillary Spacing Controls
Directions for use Using the Insight BIO 15 Inter-pupillary spacing controls Follow these instructions to manually adjust the inter-pupillary distance (spacing between the eyepieces) in the range of 49–74 mm: 1. Close the left eye and adjust the eyepiece for the right eye by manually sliding it left and right until you center the illumination spot in your field of view. -
Page 20: Lens Options
® ™ 16 Using the Insight BIO Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Lens options The Insight BIO is equipped with removable +2.00D lenses and an extra set of 0.00D lenses delivered with the product. These lens options enable you to view the fundus through lenses providing distance correction or standard lenses with no correction. - Page 21 Directions for use Using the Insight BIO 17 After completing an examination, flip up the BIO module to disengage the magnets, disconnect power, and turn off the light. The neodymium composition of the magnet guarantees a reliable electric Note contact for years.
- Page 22 ® ™ 18 Using the Insight BIO Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope...
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Page 23: Maintenance
The Insight BIO does not require regular maintenance. Change the eyepiece lenses only in a reasonably dust-free environment. If you should require service on your product, please contact Welch Allyn. Clean and disinfect the instrument CAUTION Do not autoclave, immerse, excessively wet, or use germicidal cleaners other than those identified. - Page 24 ® ™ 20 Maintenance Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope CAUTION Charge the Insight BIO battery only with the GlobTek #GTM91128LI1CEL or Cell-Con #452241-LA30 charger. Never charge the # 75360 battery with any other charger. Note The battery charger for the Insight BIO comes with interchangeable prongs to fit power outlets in different regions of the world.
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Page 25: Specifications
Specifications Environmental specifications Parameter Temperature Humidity Operation +5 °C to +40 °C 15% to 90% Storage +5 °C to +40 °C 15% to 95% Transportation –20 °C to +40 °C 15% to 90% Rechargeable battery and charger specifications Battery specifications Characteristic Specification Manufacturer... -
Page 26: Default Settings And Setup
® ™ 22 Specifications Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Battery charger electrical specifications Characteristic Specification Specification Manufacturer GlobTek Mascot Model #GTM91128LI1CEL Cell-Con #452241-LA30 Input voltage 100–240VAC 90–264VAC Input frequency 50/60Hz 47–63Hz Input current < 1.5A RMS Max 1.3A +5/–7%... -
Page 27: Regulatory Conformance
Directions for use Specifications 23 Regulatory conformance The 13500 Insight BIO conforms to the applicable requirements of the following standards: • ISO 10943 • ISO 15004-1 • ISO 15004-2 • IEC 60601-1 • IEC 60601-1-2 • IEC 62366 • EN 1041 •... - Page 28 ® ™ 24 Specifications Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope...
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Page 29: Guidance And Manufacturer's Declarations
Guidance and manufacturer's declarations EMC compliance Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment. • All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this document. •... - Page 30 ® ™ 26 Guidance and manufacturer's declarations Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Electromagnetic immunity The 13500 Insight BIO is intended for use in the electromagnetic environment specified below. The customer or the user of the 13500 Insight BIO should assure that it is used in such an environment.
- Page 31 Directions for use Guidance and manufacturer's declarations 27 Electromagnetic immunity The 13500 Insight BIO is intended for use in the electromagnetic environment specified below. The customer or the user of the 13500 Insight BIO should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
- Page 32 ® ™ 28 Guidance and manufacturer's declarations Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Recommended separation distances between portable and mobile RF communications equipment and the 13500 Insight BIO The 13500 Insight BIO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
- Page 33 Visit www.welchallyn.com/about/company/locations.htm to find the customer service phone number for your region. Welch Allyn will use your information only to contact you in case of a safety alert or recall for this product. We will not sell, rent, or share your personal information.
- Page 34 ® ™ 30 Appendix Welch Allyn 13500 Insight Wireless LED Binocular Indirect Ophthalmoscope Battery disposal/recycling Recycle the Lithium-ion battery according to local or national regulations. Short-term storage The Insight BIO can be conveniently stored on the Wall Mount or with the Soft Case accessories.
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