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

Contents

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

iv

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.

1

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.

2

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.

3

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

4

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.

5

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.

6

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

Controls, indicators, and connectors

Instrument top, right side view

7

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.

8

Controls, indicators, and connectors Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

Binocular front view

No. Feature Description

1 Locking nut lever Holds binocular in place. When unlocked, enables adjusting the

binocular's position.

2 Filter selection control Enables selection of neutral (none), red-free, amber, and cobalt

3 Aperture selection control Enables selection of small, medium, and large apertures as well

4 Light output control Enables selection of zero intensity (maximum dimming) to full

5 Tilt-mirror adjustment Controls the vertical position of the light beam.

blue filters.

as the diffuser.

intensity light output.

Directions for use Controls, indicators, and connectors 9

Binocular rear view

No. Feature Description

1 Eyepieces and lenses Provide view of the fundus.

2 Inter-pupillary spacing adjustment controls Enable manual adjustment of the space between the eyepieces.

3 Synchronized convergence and parallax

adjustment control

Enables selection of wide or narrow settings to improve the view
of the fundus.

10

Controls, indicators, and connectors Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

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.)

11

The charge LED on the battery charger block turns green when the battery is fully
charged.

2. Place the binocular in the up/OFF position.

3. Locate battery connector on the headband.

4. Attach the battery pack.

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.

1. Loosen the headband to a circumference wider than your head.

2. Place the instrument on your head and tighten the top knob until the front of the
headband is just above your eyebrow ridge.

3. Tighten the rear knob to a comfortable level.

Light output control

The LED light source constantly generates the same amount of light. The light output
adjustment is gradual between substantially full and zero intensity, and is based on the
relative position of two polarizer filters.

One of the filters is permanently affixed in the holder. You can rotate the other one with
an adjustment control located on the front panel of the BIO module directly below the
green-to-red intensity indicator graphic. By moving the control from left to right, you can
adjust the light output to the desired level. When the two polarizer filters are aligned (the
control is under the red and widest part of the graphic), the intensity level is at
maximum. When the polarizer filter is perpendicular (at 90°) to the fixed polarizer filter
(the control is under the green and narrowest part of the graphic), the intensity level is at
minimum (maximum dimming).

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.

Filter and aperture controls

The Insight BIO is equipped with built-in filter and aperture controls. The control that
selects between neutral (no filter), red-free, amber, and cobalt blue filters is located on
the right side of the control arm when the instrument is on your head.

Similarly, the control that selects between small, medium, and large apertures and the
diffuser is located on the left side of the control arm when the instrument is on your
head.

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 two­directional connection slots allow moving the BIO module up and down as well as closer
and farther away from your face. The locking nut mechanism secures the BIO module in
the desired position.

1. Place the Insight BIO module on your head.

2. Loosen the locking nut to adjust the position of the BIO module.

3. Put your hand in front of you at the approximate distance of the patient’s eye.

4. Adjust the position of the module until you center the illumination spot on the palm
of your hand.

5. Tighten the locking nut to secure the module in place

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.

2. Close the right eye and adjust the left eyepiece in the same fashion.

3. If necessary, re-adjust the position of the BIO module as described in the previous
section.

Synchronized convergence and parallax controls

Using the control in the middle of the module’s bottom panel, you can adjust for parallax
and synchronized convergence and thus improve your ability to view the fundus. On
patients with dilated pupils, use a wider distance to maximize stereopsis. On patients
with smaller pupils, use a more narrow setting.

In practice, it’s best to use the narrow setting first to obtain the fundus view. Then you
can adjust for synchronized convergence and parallax by gradually moving the control as
far as possible toward the wide setting without inducing a change in the image
brightness or stability.

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.
Select the set of lenses that most closely matches any corrective lenses you normally
wear.

To replace the +2.00D lenses, move to a reasonably dust-free environment, and follow
the steps illustrated below:

Power-on/power-off control

As shown below, the BIO module is connected directly to the headband with a pivot
bracket mechanism. Two magnets built into this mechanism secure the module in
operating position and also provide the electrical contacts which power-on/power-off the
instrument.

To perform an examination, flip down the BIO module into operating position in front of
your face. The magnets engage, connect the LED light source to the power source, and
turn on the light.

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.

Note The neodymium composition of the magnet guarantees a reliable electric

contact for years.

18

Using the Insight BIO Welch Allyn® 13500 Insight™ Wireless LED Binocular Indirect Ophthalmoscope

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

19

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

1. Remove the rechargeable battery from the Insight BIO headband.

2. Clean the Insight BIO's lens glass with a soft, lint-free cloth lightly dampened with
70% isopropyl alcohol. Do not excessively wet the lens glass.

3. Clean and disinfect the remaining surfaces of the Insight BIO with a soft cloth and
70% isopropyl alcohol or germicidal wipes labeled for healthcare equipment. Follow
wipe manufacturer's instructions for appropriate use and contact time, and heed all
warnings and cautions. Do not excessively wet the instrument or allow liquid to
penetrate the optical unit.

4. Clean dirty on/off magnet contacts with cotton swab soaked in alcohol.

Charge the battery

You can charge the battery when it is disconnected from the Insight BIO and also when
it is mounted on the Insight BIO headband.

CAUTION The battery charger for the Insight BIO is for charging the #
75360 battery. Never use it for other purposes or on other manufacturers'
batteries.

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.

1. Attach the plug prongs that correspond to your AC power outlet as shown and plug
the charger into an AC power outlet.

2. Connect the charger's output cord to the charge plug on the battery.

The LED charge status indicator on the charger block displays the following colors
during recharging:

• Solid amber or red: Pre-charge

• Solid green: Charge complete

• None: No power to battery or fault condition

3. Unplug the charger from the battery and from the AC power outlet.

4. Store charged batteries appropriately (see Appendix).

Recharge time depends on the percent of charge remaining in the battery. Full charging
takes approximately 3 hours. Charge current will terminate within 10 percent of bulk
charge current. The battery charger's internal timer terminates charging 2-3 hours after
the expected full charge time. A fully charged battery pack provides about 3 hours of
uninterrupted use.

Specifications

Environmental specifications

Parameter Temperature Humidity

Operation +5 °C to +40 °C 15% to 90%

21

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 GlobTek

Model #BL2200F603451S2PZAL

Type Lithium-ion

Output 3.7V 2200mAh (8.14Wh)

Estimated run time 3.5 hours (continuous)

Charger Use only GlobTek #GTM91128LI1CEL

or Cell-Con #452241-LA30

Protection Internal

Approvals

IEC 62133, CB Certificate # SE-74847

UN DOT 38.3

IATA 1.2m drop

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%

Charging voltage 1 cell: 4.2Vdc, +/1% Maximum 1 cell: 4.2V +.05V

Battery charging ambient
temperature

Plug prong type

LED charge status indicator

Approvals

0 °C to 35 °C –25 °C to +40 °C

USA: NEMA 1-15

EU: CEE 7/16

UK: BS 1363

Solid Amber: Pre-charge

Solid Green: Charge complete

None: No power to battery or fault
condition

EN/IEC 60601-1:2005

UL 60601-1, 1st Edition

CAN/CSA-C22.2 No. 601.1-M90, 2005

Default settings and setup

The Insight BIO is set up as follows when you first remove it from the package.

Control Setting

USA: NEMA 1-15

EU: CEE 7/16

UK: BS 1363

Solid Red: Pre-charge

Solid Green: Charge complete

None: No power to battery or fault
condition

UL 60601-1

EN 60950

EN 60601-1

EN 60335-2-29

Light output Maximum

Aperture Largest

Filter Clear

Synchronized convergence and parallax Wide

Attached lenses +2.00D

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

• EN 50581 (RoHS)

• 93/42/EEC

24

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

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.

• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.

25

The instrument complies with all applicable and required standards for electromagnetic
interference.

• It does not normally affect nearby equipment and devices.

• It is not normally affected by nearby equipment and devices.

• Avoid using the instrument in extremely close proximity to other equipment.

Emissions and immunity information

Electromagnetic emissions

The 13500 Insight BIO is intended for use in the electromagnetic environment specified below. The customer or user of
the 13500 Insight BIO should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Group 1 The 13500 Insight BIO uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.

Class B

Class A

The 13500 Insight BIO is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.

Voltage fluctuations/
flicker emissions

IEC 61000-3-3

Complies

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.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge
(ESD)

IEC 61000-4-2

Electrical fast
transient/burst

IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips, short
interruptions and
voltage variations on
power supply input
lines

IEC 61000-4-11

±6 kV contact
± 8 kV air

±2 kV for power supply
lines

±1 kV for input/output
lines

± 1 kV differential
mode

± 2 kV common mode

<5 % U

T

(>95 % dip in UT)

for 0,5 cycle

40 % U

T

(60 % dip in UT)

for 5 cycles

70 % U

T

(30 % dip in UT)

for 25 cycles

<5 % U

T

(>95 % dip in UT)

for 5 s

± 6 kV contact
± 8 kV air

±2 kV for power supply
lines

±1 kV for input/output
lines

± 1 kV differential
mode

± 2 kV common mode

<5 % U

T

(>95 % dip in UT)

for 0,5 cycle

40 % U

T

(60 % dip in UT)

for 5 cycles

70 % U

T

(30 % dip in UT)

for 25 cycles

<5 % U

T

(>95 % dip in UT)

for 5 s

Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.

Mains power quality should be that of a typical
commercial or hospital environment.

Mains power quality should be that of a typical
commercial or hospital environment.

Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the 13500 Insight BIO requires continued
operation during power mains interruptions, it
is recommended that the 13500 Insight BIO be
powered from an uninterruptible power supply
or a battery.

Power frequency (50/
60 Hz) magnetic field

IEC 61000-4-8

Note

UT is the a.c. mains voltage prior to application of the test level.

3 A/m 0,3 A/m

If image distortion occurs, it may be necessary
to position the 13500 Insight BIO further from
sources of power frequency magnetic fields or
to install magnetic shielding. The power
frequency magnetic field should be measured
in the intended installation location to assure
that it is sufficiently low.

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 Electromagnetic environment - guidance

Portable and mobile RF communications
equipment should be used no closer to any part
of the 13500 Insight BIO, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance

Conducted RF
IEC 61000-4-6

Radiated RF

3 Vrms

3 Vrms

150 kHz to 80 MHz

3 V/m 80 MHz to 1 GHz 3 V/m

d = (1,2)

d = (1,2)

80 to 800 MHz

IEC 61000-4-3

d = (2,3) 800 MHz to 2,5 GHz

whereP is the maximum output power rating of
the transmitter in watts (W) andd is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site

surveya, should be less than the compliance
level in each frequency rangeb. Interference

may occur in the vicinity of equipment marked
with the following symbol:

Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects, and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. 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 13500 Insight BIO is used exceeds the applicable
RF compliance level above, the 13500 Insight BIO should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the 13500 Insight BIO.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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. The customer or user of the 13500 Insight BIO can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the 13500 Insight
BIO as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m)

Rated max. output
power of transmitter
(W)

0.01 0.11667 0.11667 0.23333

0.1 0.36894 0.36894 0.73785

1 1.1667 1.1667 2.3333

10 3.6894 3.6894 7.3785

For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.

150 kHz to 80 MHz

d= (1.17)

80 MHz to 800 MHz

d= (1.17)

800 MHz to 2.5 GHz

d= (2.23)

Appendix

Warranty

Welch Allyn warrants that the Insight Binocular Indirect Ophthalmoscope will be free of
defects in workmanship or material for 10 years from the date of purchase. During this
period, Welch Allyn will correct any such defects by repairing or replacing the product at
its expense (excluding shipping costs). This warranty does not apply to defects caused
by normal wear and tear; damage caused by accident, abuse, misuse, neglect, fire or
other external cause, or during shipping; or damage caused by use outside of
manufacturer’s published guidelines, service performed by anyone other than Welch
Allyn or its authorized agent, or modifications to alter functionality or capability without
the express written authorization of Welch Allyn.

29

This warranty does not cover consumable parts, such as headband pads and eye cups.

Welch Allyn warrants the battery, charger, teaching mirror, and eyepiece lenses for 1
year from the date of purchase.

THIS LIMITED WARRANTY IS PROVIDED INSTEAD OF ANY OTHER IMPLIED
PRODUCT QUALITY WARRANTIES AND IT IS THE SOLE WARRANTY OF THE
PRODUCT.

Register your product

Choose one of the registration options below:

• Enter product information on the website: www.welchallyn.com/warranty

• Call the customer service phone number for your region to register your product

within 30 days of original purchase, which will validate the product warranty

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.

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

30

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. Flip up the optical unit to the “Off” position. Then place the BIO’s rear
cushion on the horizontal part of the Wall mount.

CAUTION Maintain the environmental storage conditions identified within
the specifications during storage.

CAUTION To put the Insight BIO away for storage, disconnect the battery
from the Insight BIO device and store the battery in the Soft Case away
from other metal objects. Short-term storage on the Wall Mount does not
require removing the battery pack.

Long-term storage

Follow these steps to store the Insight BIO for an extended period:

1. Disconnect battery from device and store battery in a location that meets

environmental specifications and is free from other metal objects, intense sunlight,
and moisture.
a. Charge batteries to 30–50% of capacity for long-term storage. We recommend

that batteries be charged at least once every six months to prevent over­discharge.

b. Charged batteries will remain charged for several months if left unused.

2. As with the battery, store the Insight BIO in a location that meets environmental

specifications and is free from other metal objects, intense sunlight, and moisture.