Seiler COLPOSCOPE 935 User manual

MEDICAL DIVISION
This document is property of Seiler Instrument & Mfg. Co., Inc.
No part of this manual should be reproduced or transmitted without the expressed written consent being
obtained. All the gures and images appearing in this manual are for illustration purposes only and
may vary according to the version of the device purchased. The information contained in this manual is
subject to change without notice. Please contact Seiler whenever additional information is needed.
This device is restricted to the sale and the use by authorized and trained personnel.
COLPOSCOPE 935
USER’S MANUAL
Including installation instructions for all mounting
options

-2-
Table of Contents
INTRODUCTION..................................................................................................................................4
INTENDED USE...................................................................................................................................5
PRESENTATION AND USE.................................................................................................................5
COLPOSCOPE FLOOR STAND .........................................................................................................5
THE COLPOSCOPE HEAD.................................................................................................................6
CLEANING ..........................................................................................................................................6
PREPARATION FOR USE...................................................................................................................7
COLPOSCOPE USE............................................................................................................................8
OPTICAL AND FIELD MAGNIFICATION TABLE ............................................................................... 9
TECHNICAL DATA ..............................................................................................................................9
LED LIGHT SOURCE ...................................................................................................................10-14
1.0 Intended Use ............................................................................................................................10
1.1 Precautions For Use - Contradictions ......................................................................................10
1.2 Accessories .............................................................................................................................. 10
1.3 Federal Law May Govern the Use of This Device.................................................................... 11
1.4 Qualication of Personnel ........................................................................................................ 11
1.5 Manufacturer’s Declaration ......................................................................................................12
2.0 Symbols Used in this Manual or on the Device........................................................................ 13
3.0 Hazards Associated with Improper Installation.........................................................................14
3.1 Installation Instructions/Preparing and Siting ...........................................................................15
3.2 Installation Instructions............................................................................................................. 16
4.0 Hazards Associated with Improper Use ...................................................................................16
4.1 Use Instructions........................................................................................................................17
5.0 Hazards Associated with Improper Use ...................................................................................18
5.1 Field Maintenance Instructions.................................................................................................18
6.0 Cleaning Instructions................................................................................................................ 20
7.0 Disposal Instructions ................................................................................................................20
8.0 Specications ...........................................................................................................................20
8.1 System Description ..................................................................................................................20
8.2 Front Panel............................................................................................................................... 21
8.3 Rear Panel ...............................................................................................................................21
8.4 Controls ....................................................................................................................................22
8.5 Pole Mounting ..........................................................................................................................22
8.6 Other Specications .................................................................................................................23
9.0 Limited Warranty ......................................................................................................................23
10. End of Product Life................................................................................................................... 24
RETURN POLICY ..............................................................................................................................24
OWNER’S RECORD..........................................................................................................................24
NOTES ...............................................................................................................................................24

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SYMBOLS USED IN THIS MANUAL OR DEVICE.......................................................................25-26
WARNINGS........................................................................................................................................27
WARRANTIES ..............................................................................................................................28-29
CERTIFICATE OF CONFORMITY..................................................................................................... 30
DECLARATION OF CONFORMITY ..................................................................................................31

Manufacturing Geospatial Medical Planetarium
The divisions of Seiler Instrument
Design Solutions
High tech. High touch.
Introduction
To Our Valued Professionals,
On behalf of the Seiler Medical Division, I would like to thank you for your recent purchase. We stand by
our products and are thrilled that when choosing one of the most important aspects of your practice, you
chose us.
We are proud to say that, as a company, we have over 70 years’ experience in the optical eld. We have
the expertise to provide you with modern, reliable devices that incorporate some of the most advanced
optical design tools on the market. This product’s intent is to amplify an image while providing the user
with an exceptional level of comfort, improved visual acuity, and provide awless maneuverability for any
ofce or hospital.
All of our products are manufactured according to strict medical and ISO standards. We also ensure all
optical components have undergone an anti-reective, multi-layer treatment; guaranteeing the efciency
of the system and enhancing the longevity of all of our products. Along with strict manufacturing standards
and rigorous testing, we also stand behind all of our products by offering a lifetime warranty on all optics
and mechanics for microscopes purchased in the United States, as well as a 3-year warranty on all
international purchases.
Every Seiler Medical Division team member is here to provide you with outstanding service, quality, and
knowledge. Our number one priority is, and always will be, providing 100% customer satisfaction to every
one of our customers. If you need any further information about the equipment or just have a question,
please contact us using the information below.
Thank you again for your purchase and we look forward to serving all of your optical needs for years to
come.
Sincerely,
Dane Carlson
Medical Division Manager
Seiler Medical Division
Toll Free: [phone]
Local: [phone]
Email: [email protected]

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Intended use
The Seiler Colposcope is intended to provide magnied visualization of the tissues of the vulva, vagina,
cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and
to facilitate related procedures, e.g., LEEP, conization, etc.
Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner trained in
its use.
presentation and use
The sections contained in this Manual were especially grouped to serve the owners of the COLPOSCOPE
MODEL 935 from Seiler Medical Division.
Read this Manual before setting up the equipment, in order to avoid damage from improper usage.
For safe use of the colposcope, it is necessary to be familiar with the details of its operation prior to use.
Therefore, it is advisable that personnel operating the colposcope read this manual prior to using the
equipment.
colposcope floor stand
NOMENCLATURE OF THE NUMBERED PARTS
1) Colposcope Head
2) Head securing knob
Caution: Optics will drop when knob is loosened.
3) Column height adjusting knob
4) LED Illuminator
5) Base with casters
A knob located at the stand tube (item 3) fixes the vertical move-
ment of the column.
By turning the knob (item 3) counterclockwise or clockwise, the
system can be released or fixed, and the height of the column be
adjusted to achieve the correct height for the patient examination.
1
2
3
4
5
Atlantico Systems Ltd.
34 Oldeld
Kingston, Galway
Ireland
www.atlanticosystems.com
Phone: [phone]
Seiler Instrument & Mfg. Co,
Inc.
3433 Tree Court Industrial Blvd.
St. Louis, Missouri 63122
USA
Toll Free: [phone]
Local: [phone]
Email: [email protected]
www.seilerinst.com

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Colposcope Head
optic pod components
cleaning
The Objective, at the bottom of the Colposcope body, may be exposed to blood and other bodily fluids.
Spots on the objective dim the passage of light.
Alcohol or warm water in a mild detergent, applied with a clean cotton swab can be used to remove all
smudges. Apply with soft and CIRCULAR movements. Follow your laboratory’s procedures to remove
bloodstains or other contaminants from your equipment.
If the objective is too blotched, change to another cotton swab for each circular movement to avoid
spreading the impurities again.
The Objective lens can be protected by use of the Sterilizable Protector Cap. It is fitted on the external
diameter of the objective lens and protects it against mechanical damage and against contamination.
(catalog #6132000)
Clean the metallic parts (chrome-plated or painted) with cotton, alcohol or mild detergent.
Lubrication
It is recommended to lubricate the Colposcope head after 5 years of use.
Eyepieces Binocular Head
Thumb Screw
Magnicaon Turret
Objecve Lens
Fine Focus Knob
Green Filter (Push/Pull Knob)
Handle

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PREPARATION FOR USE
INSPECT AND CLEAN
Before each use, inspect the colposcope including power cable, base, casters, lightsource and light guide.
Do not use the colposcope if any of the components are damaged, missing, or are not secure. Verify
that the light guide is properly installed in both the lightsource and the optic pod. Clean and disinfect the
colposcope before and after each use.
EYECUPS
The binocular eyecups are adjustable to allow use either with or without eyeglasses. For optimal viewing
while wearing eyeglasses, fold the eyecups down to a low profile position. While using the colposcope
without eyeglasses, ensure the eyecups are unfolded in the extended position.
INTERPUPILLARY DISTANCE ADJUSTMENT
The binocular interpupillary distance (IPD) is adjustable to match the distance between the pupils of the
user’s eyes and provides a stereoscopic view thru the colposcope. A stereoscopic view is necessary for
depth perception.
Look through the two eyepieces with both eyes open and grasp each tube of the binoculars. Using a soft
and semi-rotation movement, adjust IPD until the image of each eye superimposes and appears as only one
image.
PARAFOCALIZING PROCEDURE:
The binocular eyepieces offer a diopter adjustment to allow use of the colposcope either with or without
corrective lenses. However, the diopter adjustment can only accommodate nearsightedness (myopia) and/
or farsightedness (hyperopia). Other eye defects, such as astigmatism, cannot be corrected using the
diopter setting and require the use of corrective lenses (i.e. contacts or glasses.) The eyepiece diopters
should only be adjusted during this parafocalizing procedure. During normal colposcope use, do not adjust
the eyepiece diopters.
1) Set each eyepiece diopter setting to the zero (0) position and keep this zero position until instructed to
adjust the diopter in step 3.
2) Turn the magnification selector to the highest setting (3) and focus sharply on a target, such as a piece of
paper with an “X” drawn on it. Coarse focus by moving the entire colposcope then sharp focus by using the
objective fine focus knob.
3) Without disrupting the colposcope position or the objective fine focus, turn the magnification drum to the
lowest setting (1) then focus each eyepiece diopter by turning clockwise or counter clockwise until sharp
focus is achieved.
4) Once the image is clear in both eyes, Parfocalizing is complete. To verify, repeat steps 2 and 3 until no
diopter adjustment is needed to achieve sharp focus.

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COLPOSCOPE USE
Prepare the colposcope for use following the PREPARATION FOR USE instructions.
Turn the light source on and set the desired brightness following the instructions in the LED LIGHT
SOURCE section. Turn the lightsource off while the colposcope is not being used.
POSITION THE COLPOSCOPE
Position the colposcope for use at a distance approximately equal to the objective lens focal length which is
engraved on the external face of the objective. Example: With a 300mm objective, keep a distance of about
300mm between the objective and the specimen.
CAUTION: The colposcope column contains spring force which will release and may cause harm
when the Column height adjusting knob is loosened. Securely grasp the colposcope head before loosening
the Column height adjusting knob.
To adjust the height, firmly grasp the colposcope head while loosening the Column height adjusting knob.
Once the column is loose, lower or lift the colposcope head to the desired position then tighten the Column
height adjusting knob.
FOCUSING THE COLPOSCOPE
Coarse focus is achieved by slowly moving the entire colposcope. While looking through the eyepieces,
move the colposcope in a direction farther away then closer to the area of interest. Note the direction that
improves focus then continue moving the colposcope in that direction until focus is relatively sharp.
Fine focus is achieved by rotating the Fine Focus Knob on the objective lens. Rotate the Fine Focus Knob
unit the image is sharp. Perform coarse focus when sharp focus cannot be achieved as the focal point may
be beyond the fine focus range.
MAGNIFICATION SETTINGS
The 935 colposcope offers a magnification selector with 3 positions: 1, 2, and 3. To set the magnification,
simply rotate the magnification selector to the desired position. Setting 1 offers the lowest magnification
and widest field of view. As the selector number increases, magnification also increases but field of view
decreases. When the colposcope is configured with a 300mm objective lens and straight binocular the
magnifications are 4.25x, 7.08x, and 11.33x. The fields of view are 47.06 mm,
28.24 mm, and 17.65mm respectively. See MAGNIFICATION TABLE FOR 935 for other configurations.
COLOR FILTER
A green color filter is available to help highlight vascular patterns and offers tissue contrast viewing options.
Use the Push/Pull Knob to select either white or green light.

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eyepiece f 135 f170 f 135 f170 f 135 f170 f 135 f170 f 135 f170 f 135 f170 f 135 f170 f 135 f170 f 135 f170 f 135 f170
1 ( 0.6x ) 4.63 5.83 38.89 30.88 4.05 5.10 44.44 35.29 3.24 4.08 55.56 44.12 2.70 3.40 66.67 52.94 2.03 2.55 88.89 70.59
2 ( 1x ) 7.71 9.71 23.33 18.53 6.75 8.50 26.67 21.18 5.40 6.80 33.33 26.47 4.50 5.67 40.00 31.76 3.38 4.25 53.33 42.35
3 ( 1.6x ) 12.86 16.19 14.00 11.12 11.25 14.17 16.00 12.71 9.00 11.33 20.00 15.88 7.50 9.44 24.00 19.06 5.63 7.08 32.00 25.41
1 ( 0.6x ) 5.79 7.29 38.89 30.88 5.06 6.38 44.44 35.29 4.05 5.10 55.56 44.12 3.38 4.25 66.67 52.94 2.53 3.19 88.89 70.59
2 ( 1x ) 9.64 12.14 23.33 18.53 8.44 10.63 26.67 21.18 6.75 8.50 33.33 26.47 5.63 7.08 40.00 31.76 4.22 5.31 53.33 42.35
3 ( 1.6x ) 16.07 20.24 14.00 11.12 14.06 17.71 16.00 12.71 11.25 14.17 20.00 15.88 9.38 11.81 24.00 19.06 7.03 8.85 32.00 25.41
1 ( 0.6x ) 7.41 9.33 34.57 27.45 6.48 8.16 39.51 31.37 5.18 6.53 49.38 39.22 4.32 5.44 59.26 47.06 3.24 4.08 79.01 62.75
2 ( 1x ) 12.34 15.54 20.74 16.47 10.80 13.60 23.70 18.82 8.64 10.88 29.63 23.53 7.20 9.07 35.56 28.24 5.40 6.80 47.41 37.65
3 ( 1.6x ) 20.57 25.90 12.44 9.88 18.00 22.67 14.22 11.29 14.40 18.13 17.78 14.12 12.00 15.11 21.33 16.94 9.00 11.33 28.44 22.59
1 ( 0.6x ) 9.26 11.66 25.93 20.59 8.10 10.20 29.63 23.53 6.48 8.16 37.04 29.41 5.40 6.80 44.44 35.29 4.05 5.10 59.26 47.06
2 ( 1x ) 15.43 19.43 15.56 12.35 13.50 17.00 17.78 14.12 10.80 13.60 22.22 17.65 9.00 11.33 26.67 21.18 6.75 8.50 35.56 28.24
3 ( 1.6x ) 25.71 32.38 9.33 7.41 22.50 28.33 10.67 8.47 18.00 22.67 13.33 10.59 15.00 18.89 16.00 12.71 11.25 14.17 21.33 16.94
400
136
OBJECTIVE LENS
16x/16
20x/12
illuminated field
59
magnification
field
10x/18mm
68
85
101
200
magnification
field
12.5x/18
250
magnification
magnification
300
field
field
position
of button
magnification
field
175
technical data
A - Colposcope Head
Microscope Galilean System
Binoculars Straight, F=170mm (optional: Inclined, F=135)
Objective 300mm (optional: 200-400mm)
Eyepieces WF 12.5x (optional: 10x, 16x or 20x)
Magnification Refer to Table
Interpupillary Distance Adjustable between 42mm & 75mm
Illumination LED Illumination Sytem
(Optional: Halogen 15V/150W or Metal Halide)
Light Conductor Liquid Light Guide
Filter Green
Focusing Fine Focus: 11mm
B - Colposcope Stand
Angular Rotation 360 Degrees
Distance between the 1016mm-1193mm
floor and the objective
Base Five casters, two with brakes
Total Weight 18.14 kg
optical and field magnification table
The optical magnifications achieved with the Colposcope are determined by 3 variables: the objective focal
distance, the position of the Magnification Selector, and by the eyepiece used.
The table shows the optical magnification and the observed field diameters, in millimeters, depending on
those variables. At the bottom line of the table the illuminated field is shown, corresponding to the light disk
incident on the field, with a diameter that depends only on the focus of the work objective.
The magnification selector has 3 positions: 1, 2, and 3. The 2nd position is repeated in the selector. The
working position is the one aligned to the black dot mark.optical and eld magnication table.

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led light source
1.0 intended Use
Seiler’s LED Heliolux is a source of continuous high intensity illumination for surgical microscopy
applications.
It is intended for use providing illumination to Class I or Class II surgical microscope systems which, as
larger systems are subject to FDA regulations. It is intended to be used as a sub-component of a larger
surgical imaging system and is not intended to be used as a stand-alone medical device.
Seiler’s LED Heliolux is intended to deliver illumination only through non-electrical light cables made with
optical fibers or optical cavities (liquid light guides).
Seiler’s LED Heliolux is intended for use in a professional healthcare facility environment.
Seiler’s LED Heliolux is only to be used with light cables having the exact mating profile necessary to
ensure proper coupling of the light source to the light cable.
Illumination from this device is to be used for observation of body cavities, body surfaces, teeth, and other
surgical sites.
Portable and mobile RF communications equipment can affect medical electrical equipment.
1.1 PRECAUTIONS FOR USE - CONTRADICTIONS
• Do not operate Seiler’s LED Heliolux in an explosive atmosphere.
• Do not operate Seiler’s LED Heliolux in an MRI environment.
• Do not operate Seiler’s LED Heliolux for home health care.
• Do not modify Seiler’s LED Heliolux.
• Do not use Seiler’s LED Heliolux to illuminate eyes.
• Do not use near (12 inches or closer) equipment sensitive to electro-magnetic interference. This
device complies with International Standards (as set forth in manufacturer’s declaration following) for
electromagnetic compatibility for medical electrical equipment and/or systems. These standards
are designed to provide reasonable protection against harmful interference in a typical medical
installation. However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in healthcare and other environments, it is possible that high levels
of such interference due to close proximity or strength of a source might disrupt the performance
of this device. Medical electrical equipment needs special precautions regarding EMC, and all
equipment must be installed and put into service according to the EMC information specified in this
manual.
1.2 ACCESSORIES
Precautions to take regarding accessories:
• Accessory equipment connected to the analog and digital interfaces must be certified to the
respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1.
Any equipment connected to the signal input part or signal output part configures a medical system.
Therefore this equipment, and new configuration, must comply with the requirements of the system
standard IEC 60601-1-1.
• Failure to use approved accessories could result in excessive electromagnetic emissions and cause
harm to the essential function of other medical devices.
• Use only approved HOSPITAL GRADE mains supply cables 12 gage or better.
• Use only approved non-electrical light cables (consult factory).
• Use only approved cameras requiring 12VDC / 500 ma or less.

-11-
Approved Accessories
1.3 FEDERAL LAW MAY GOVERN THE USE OF THIS DEVICE
Federal law restricts the use of certain medical devices. Seiler’s LED Heliolux is intended to be a sub-com-
ponent of a medical device (system). Such device (system) may be regulated by Federal Law. It is the
user’s responsibility to ensure that the device is being used in a manner appropriate with Federal Law.
1.4 QUALIFICATION OF PERSONNEL
At a minimum, personnel working with the device should have the following qualifications:
• Installation – hospital engineer or similar training plus specific training by the supplier of the larger
medical system (surgical microscope for instance).
• Operation – medical or dental training in surgical procedures / dental health procedures plus specific
training by the supplier of the larger medical system (surgical microscope for instance).
Mains Cable Hospital Grade Only - Consult Factory
Light Guide Cable
(For Light Port)
Non-Electrical, Liquid or Fiber Based, Having Appropriate Ferrules for Inseron -
Consult Factory
Camera (For Camera Port) Use only cameras that operate from 12 VDC at 500 ma or lower consumpon and
having cercaons suitable for the parcular medical applicaon – for use of
HelioLux with a surgical microscope this requires that the camera be cered
to IEC 60601-1 and IEC 60601-1-2 and any addional standards relevant for the
applicaon. Consult Factory with any quesons.
Programming Port FOR FACTORY USE ONLY!

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Version Type Guidance
EN55011 2009 Emissions Pass
A1 2010 Emissions Pass
CISPR 11 2009 Emissions Group 1, Class B Pass
A1 2010 Emissions Pass
EN 61000-3-2 2014 Harmonic Current Pass
IEC 61000-3-2 2014 Harmonic Current Class A Pass
EN 61000-3-3 2013 Flicker Pass
IEC 61000-3-3 2013 Flicker Pass
EN 61000-4-2 2009 ESD Pass
IEC 61000-4-2 2008 ESD Contact 8KV, Air Discharge
2KV, 4KV, 8KV, 15KV Pass
EN 61000-4-3 2006 Radiated Immunity Pass
A1 2008 Radiated Immunity Pass
A2 2010 Radiated Immunity Pass
IEC 61000-4-3 2006 Radiated Immunity 3 V/M, 8o Mhz to 2.7 Ghz
in 1% increments
(professional use), 80%
Sinusoidal AM at 1000 Hz Pass
A1 2007 Radiated Immunity Pass
A2 2010 Radiated Immunity Pass
EN 61000-4-4 2012 EFT Pass
IEC 61000-4-4 2012 EFT 2KV Open Circuit for AC Mains
– 1KV for I/O Ports Pass
EN 61000-4-5 2014 Surge Pass
IEC 61000-4-5 2014 Surge 0.5 / 1.0 KV – Di. and Common
Mode – 2KV Common Mode Pass
EN 61000-4-6 2014 Conducted Immunity Pass
IEC 61000-4-6 2013 Conducted Immunity 3VRMS, 150Khz to 80 MHz –
1% Increments, 1s Dwell, 80%
Sinusoidal AM at 1000 Hz Pass
EN 61000-4-8 2010 Magnec Pass
IEC 61000-4-8 2009 Magnec 30 A/m RMS at 50 and
60 Hz Frequency Pass
EN 61000-4-11 2004 Voltage Dips and
Interrupts Pass
1.5 MANUFACTURER’S DECLARATION

-13-
Version Type Guidance
IEC 61000-4-11 2004 Voltage Dips and
Interrupts 0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT ; 1 cycle
70 % UT ;25/30 cycles
Single phase: at 0°
0% UT; 250/300 cycle Pass
IEC 62471 2006 Photobiological
Safety of Lamps Risk Group 2
(Moderate
Risk)
2.0 SYMBOLS USED IN THIS MANUAL OR ON THE DEVICE
The following symbols are used in these Instructions for Use and/or on the Device itself.
NOTE! This term contains important information regarding set-up and operation to facilitate ease of
use and obtain effective results.
WARNING! This term contains critical information by identifying conditions or practices that may result
in injury or loss of life if these instructions are not followed.
This term contains critical information regarding safe handling and use of this system. Device
malfunction or property damage could result if these instructions are not followed.
This symbol cautions that surfaces may be hot and could be a burn hazard.
This symbol cautions of extremely intense light hazards.
This symbol cautions of electrical shock hazard.

-14-
This device is capable of causing
a re, burns, or ignion of
ammable materials.
Do not locate or operate the unit near any ammable materials including
ammable gases and liquids.
Maintain at least 6” around the fan intakes and exhausts for adequate
venlaon to prevent overheang.
Do not operate the device unless an approved light cable is connected
between the device and the relevant system. Energy exing the light
cable is concentrated and can cause burns or res – always ensure that
the light cable is properly installed before powering the device.
This device emits some level of
electromagnec energy.
Select an appropriate locaon and power source for the unit as described
below.
Ensure there is adequate separaon distance between the unit and any
device which may be aected by the electromagnec energy coming
from the unit.
Power the unit from a circuit dierent from any circuit that contains a
device that could be aected by the electromagnec energy from the
illuminator.
Failure to read and understand
these Instrucons for Use is
hazardous.
Personnel tasked with installaon of the device should fully familiarize
themselves with the contents of these Instrucons for Use and only
aempt installaon or maintenance of the device once they have a
complete understanding of these Instrucons.
Failure to select an appropriate
installaon locaon is
hazardous
Employ only authorized and properly trained personnel to perform the
installaon.
Care must be exercised during the mounng of the unit. Fasteners of
incorrect length can damage internal circuitry and circuit boards.
3.0 HAZARDS ASSOCIATED WITH IMPROPER INSTALLATION

-15-
3.1 INSTALLATION INSTRUCTIONS/PREPARING AND SITING
READ FULLY BEFORE ATTEMPTING INSTALLATION
• Familiarize with all the instructions on all the device placards, including on the rear of the device.
If unable to read, move closer and increase illumination.
• If, at any point during or after the installation, an event of dropping, fluid ingress, or other such event
that could reasonably create damage or a hazard STOP and arrange for qualified maintenance
personnel to inspect.
• If, at any point, you suspect something is wrong then terminate installation / operation of the Seiler’s
LED Heliolux by pressing the MAINS ON/OFF (blue switch with international 0/1 designation). The
blue light should be off. Then remain the MAINS cable. Consult the factory with information as to why
the installation was halted.
• If, at any point, you determine that the ESSENTIAL PERFORMANCE of the device has been
impaired (due to electro-magnetic interference or other causes), then terminate installation / operation
and consult the factory before continuing.
• Do not use sharp instruments during installation as doing so could damage internal components and
create a hazard.
• Ensure no residual packaging materials (foam peanuts, etc.) are inside the unit.
• Use of a disposable material over the device to prevent fluids from splashing on the unit, is
discouraged. Should it be used it is the installer’s responsibility to ensure it does not block airflow
AND is not a flammable material. Failure to follow this instruction could result in a fire.
• Do not operate the device without an approved light guide installed.
• Never look directly into light port.
• Never connect any device to the factory programming port on the rear panel.
• Read the rear label at angle under 10 degrees from distance less than 0.25 meter with minimum
lighting of 1500 lux.
Site (position) the device:
• To avoid risk of electric shock this equipment must be connected to a supply mains with protective
earth. Confirm such mains power is available within range of the hospital grade power cord.
• Site the device in such a way as the MAINS ON/OFF switch and the MAINS supply cable are not
obstructed (difficult to access).
• Site the device a minimum of 24 inches from any other electrical / electronic devices to mitigate
electro-magnetic efforts between devices.
• Ensure no flammability issues with the siting.
• Ensure no electromagnetic compatibility issues with the siting.
• Ensure no ventilation issues with the siting.
• Seiler’s LED Heliolux should be positioned as far from the patient as is possible within the constraints
of the larger system and the light cable.
• Seiler’s LED Heliolux is not designed for use in STACKED Configuration. Do not stack multiple units
together.
• Do not site the device near any materials that could be impacted by high intensity light (such as light
curing adhesives, photo-sensitive materials, etc.)

-16-
3.2 INSTALLATION INSTRUCTIONS
• Inspect shipping containers for damage. In event damage is discovered STOP and arrange for
qualified maintenance personnel to inspect.
• Mount the illuminator per the system level documentation and in accordance with the hazard
mitigation instructions.
• Install the appropriate electrical and non-electrical cables
• Install an appropriate light cable per the system level documentation and in accordance with
the hazard mitigation instructions.
• Install the MAINS power cable.
• Plug an approved camera input power jack into the illumination (optional for pole mount only)
per the system level documentation and in accordance with the hazard mitigation instructions.
• Perform Functional Test for ESSENTIAL PERFORMANCE
• Turn on MAINS ON/OFF switch (blue switch with international 0/1 designation).
• Confirm LCD screen provides indication (active) and is in STANDBY mode.
• Shift to RUN mode by pushing the RUN / STANDBY mode button, “Lamp button”.
• Select dimming level by pressing UP or DOWN buttons.
• Confirm ESSENTIAL PERFORMANCE:
• Free flow of air.
• Illumination.
• Consistent noise (no scraping, clicking, etc.).
• No interference with nearby critical equipment.
• No interference from operation of nearby equipment (large unshielded motors, etc.)
• Power down – installation is complete.
4.0 HAZARDS ASSOCIATED WITH IMPROPER USE
This device is capable of causing
a re, burns, or ignion of
ammable materials.
Do not locate or operate the unit near any ammable materials including
ammable gases and liquids.
Maintain at least 6” around the fan intakes and exhausts for adequate
venlaon to prevent overheang.
Do not operate the device unless an approved light cable is connected
between the device and the relevant system. Energy exing the light
cable is concentrated and can cause burns or res – always ensure that
the light cable is properly installed before powering the device.
Failure to read and understand
these Instrucons for Use is
hazardous.
Personnel tasked with installaon of the device should fully familiarize
themselves with the contents of these Instrucons for Use and only
aempt installaon or maintenance of the device once they have a
complete understanding of these Instrucons.
Users should refrain from operang the equipment in any manner other
than is set forth in these Instrucons for Use.
WARNING!

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This device emits intense
illuminaon that can be
harmful.
Never look directly at the LED ports or reected from the LED or the ber
opc light guides.
Limit exposure of ssue or organs other than is required for the relevant
surgical procedures.
Do not illuminate paent unl ready and turn illuminaon o when the
procedure has been completed.
Do not direct the illuminaon beam at the paent’s eyes / shield the
paent’s eyes if necessary.
Do not operate the illuminator with the light guides disconnected.
BRIGHT LIGHT
hazard.
Use only with shielding
in place.
Protect eyes & skin from
exposure to intense light.
4.1 USE INSTRUCTIONS
• READ FULLY BEFORE ATTEMPTING OPERATION
• Familiarize with all the instructions on all the device placards, including on the rear of the device. If
unable to read, move closer and increase illumination.
• If, at any time after the installation, an event of dropping, fluid ingress, or other such event that could
reasonably create damage or a hazard STOP and arrange for qualified maintenance personnel to
inspect.
• If, at any point, you suspect something is wrong then terminate operation of the Seiler’s LED Heliolux
by pressing the MAINS ON/OFF (blue switch with international 0/1 designation). The blue light
should be off. Then remain the MAINS cable. Consult the factory with information as to why the
installation was halted.
• Do not use sharp instruments during use as doing so could damage internal components and create
a hazard.
• Do not operate the device without an approved light guide installed.
• Turn MAINS power OFF before removing power.
• Never look directly into light port.
• Read the rear label at angle under 10 degrees from distance less than 0.25 meter with minimum
lighting of 1500 lux.
• Confirm device has been properly installed.
• Appropriate light cable is installed at both ends (Seiler’s LED Heliolux and device requiring
illumination).
• Hospital grade power cable is properly installed.
• Device is not located near critical device that could be influenced by electro-magnetic energy levels.
• Venting on device is not blocked.
• No damage is present on device.
• Not in presence of flammable gases or fluids.
• Turn on MAINS ON/OFF switch (blue switch with international 0/1 designation).
• Confirm LCD screen provides indication (active) and is in STANDBY mode.
• Select dimming level by pressing UP or DOWN buttons.
• Ensure output of illumination does not violate any of the hazard mitigation instructions (i.e is not directed
into someone’s eyes).
• Shift to RUN mode by pushing the RUN / STANDBY mode button.

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• Adjust dimming as required.
• To remove illumination for short periods of time (less than 60 minutes) press STANDBY to extinguish the
illumination.
• To power down (when illumination is not required in the following 60 minutes) press the MAINS ON/OFF
button.
• Confirm blue back light on the MAINS ON/OFF is OFF.
5.0 HAZARDS ASSOCIATED WITH IMPROPER USE
This device contains high
voltages.
Maintenance of this device
poses addional hazards.
Do not operate with the cover removed.
Failure to read and understand
these Instrucons for Use is
hazardous.
Personnel tasked with maintenance of the device should fully familiarize
themselves with the contents of these Instrucons for Use and
only aempt maintenance of the device once they have a complete
understanding of these Instrucons.
Only qualied personnel shall inspect the unit for internal damage.
Employ only authorized and properly trained personnel to perform
maintenance funcons.
5.1 FIELD MAINTENANCE INSTRUCTIONS
• READ FULLY BEFORE ATTEMPTING FIELD MAINTENANCE
• Familiarize with all the instructions on all the device placards, including on the rear of the device. If
unable to read, move closer and increase illumination.
• If, at any time after the installation, an event of dropping, fluid ingress, or other such event that could
reasonably create damage or a hazard STOP and arrange for qualified maintenance personnel to
inspect.
• If, at any point, you suspect something is wrong then terminate operation of the Seiler’s LED Heliolux
by pressing the MAINS ON/OFF (blue switch with international 0/1 designation). The blue light
should be off.
• Then remain the MAINS cable. Consult the factory with information as to why the installation was
halted.
• Do not use sharp instruments during field maintenance as doing so could damage internal
components and create a hazard.

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• Always wait a minimum of 10 minutes after removing AC power from the unit before attempting
maintenance as this will provide adequate time for any energy storage devices to dissipate their
energy. Failure to follow this procedure could result in a hazard.
• Read the rear label at angle under 10 degrees from distance less than 0.25 meter with minimum
lighting of 1500 lux.
• Confirm device has been properly installed.
• Appropriate light cable is installed at both ends (Seiler’s LED Heliolux and device requiring
illumination).
• Hospital grade power cable is properly installed.
• Device is not located near critical device that could be influenced by electro-magnetic energy levels.
• Venting on device is not blocked.
• No damage is present on device.
• Perform Functional Test
• Turn on MAINS ON/OFF switch (blue switch with international 0/1 designation).
• Confirm LCD screen provides indication (active) and is in STANDBY mode.
• Select dimming level by pressing UP or DOWN buttons.
• Shift to RUN mode by pushing the RUN / STANDBY mode button.
• Confirm functionality:
• Free flow of air.
• Illumination.
• Consistent noise (no scraping, clicking, etc.).
• No interference with nearby critical equipment.
• No interference from operation of nearby equipment (large unshielded motors, etc.)
• Simple Troubleshooting
• Should the device appear to not power up
• Check MAINS CABLE – is it installed correctly? Is it connected to MAINS power?
• Remove MAINS Cable then remove the fuses – check for fuse integrity.
• Should no illumination be present
• Confirm unit is in RUN mode (not standby)
• Select higher dimming level.
• Confirm light cable is properly installed
• Confirm there is no fault detected / displayed on the LCD display
• System indicates TEMPERATURE FAULT
• Ensure vents are not blocked
• Ensure fans are rotating
• Should the above troubleshooting guide fail to correct a condition or any other such failure condition such
as visible damage, irregular noise, excessive heat, no illumination, fault code, etc. be present during the
above evaluation make note of the condition and contact the factory for instructions.

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6.0 CLEANING INSTRUCTIONS
Seiler’s LED Heliolux is not designed to resist spillage from any direction. Keep the device dry and free from
spillage at all times.
To clean:
• Do not use any of the following for cleaning:
• Full strength bleach.
• Steam sterilization.
• Dishwasher.
• Acetone, lacquer thinner or other solvents.
• Do not use spray cleaners as the spray could enter through vents and damage the device.
• Ensure device is turned off.
• Use a cloth dampened with any of the following solutions.
• Water with liquid detergent.
• Isopropyl alcohol.
• Household bleach and water mixed 9 parts water to 1 part bleach.
• Commercial disinfectant.
• Dry with a soft cloth.
• Allow to fully dry before next use.
7.0 DISPOSAL INSTRUCTIONS
Disposal of the device once it has been determined to be at its end of life should be done in accordance with the fol-
lowing:
• Ensure it is not connected to MAINS power.
• Clean thoroughly with anti-bacterial solution to mitigate any residual bacterial contamination.
• Disassemble (consult factory for instructions):
• Recycle (as appropriate for local regulations:
• Metals
• Electronics
• The device is in compliance with Rohs.
8.0 SPECIFICATIONS
8.1 SYSTEM DESCRIPTION
Seiler’s LED Heliolux generates illumination from a proprietary light engine which relies up a light emitting diode
and coupling reflectors designed to transfer the light from the LED into light cables at ideal beam angles and beam
diameters.
Seiler’s LED Heliolux uses a proprietary driver to power the LED. Other than power the LED this driver performs
the following functions:
• Monitors the health of the device (temperature, current, voltage, wires, etc.)
• Sends relevant data to a digital display.