EZER Horus+ Scope User manual

Horus+Scope
Digital Eye Fundus Camera
User Manual
DOC. No. 2014.01-A
Copyright@2014 MiiS Inc.
All right reserved.

Contents
Preparations
•Beforeuse 5
• Namesofcomponents 7
• Chargingthebattery 10
• Powerindicator 11
• Assembling 12
• UsingtheSetupmode 13
• EnteringthepatientID 18
Taking pictures
•Sequenceofoperations 21
• Photomode 22
• Videomode 23
• Fixationsettingandholdingposition 24
• Q&Atroubleshooting 26
Playback
•Displaymode 27
• Enlargedviewing 27
• Deletingpictures 28
Miscellaneous
•Filestransferring 29
• Viewingonacomputer/laptopscreen 29
• ViewingonaTVscreen 29
• Usagecautionsandnotes 29
• Technicaldescription 33
• Liability 34
• Disposition 34
• Symbolsandstandards 34

-4- -5-
Preparations
Preparations
Before use
Prior to installaon and start-up of the digital eye fundus camera, carefully read the user
manual. As with all technical devices, the proper funcon and safety operaon of this device
depend on the user complying with the safety recommendaons presented in these operang
instrucons. In addion, please make sure it does not appear damaged or broken. If there are
breaks on the outer casing or other visual defects, please contact the manufacturer or a cer-
ed service facility.
Camera handling
Protect the camera from excessive vibraon, force, or pressure.
Avoid using the camera under the following condions, which may damage
the lens, the monitor, or the control unit and may also cause the camera to
malfuncon or prevent recording:
•Dropping or hing the camera against a hard surface
•Exerng excessive force on the lens or the monitor
The camera is not dust resistant, splash resistant, or waterproof. Avoid using the camera in
places with excessive dust or sand, or where water can come into contact with the camera.
Avoid using the camera under the following condions, which present the risk
that sand, water, or foreign material entering the camera through the lens or
gaps around buons. Be especially careful because these condions may dam-
age the camera, and such damage may not be repairable:
•In extremely dusty or sandy places
•Exposing the camera to rain or moisture
Condensaon (when the lens or the monitor is fogged up)
Condensaon may occur when the camera is exposed to sudden changes of temperature or
humidity. Avoid these condions because they may soil the lens or the monitor, cause mold,
or damage the camera.
If condensaon does occur, turn o the camera and wait for about two hours before using it.
Once the camera adjusts to the surrounding temperature, the fogging will clear naturally.
Safe eye screening
While no acute optical radiation hazards have been identified with the camera EZ-Horus 45, it
is recommended that the intensity of light directed into the patient’s eye be limited to the
mini-mum level necessary for diagnosis. Infants, aphakes, and persons with diseased eyes are
at greater risk. The risk may also be increased if the person being examined has had any
exposure to the same instrument or any other ophthalmic instrument that uses a visible light
source within the previous 24 hours. This will apply particularly if the eye has been exposed to
retinal photography. The intended use of this device is for routine ophthalmic exams of
typically less

-6- -7-
Preparations
than 60 seconds per eye. While any medical procedure has its benet versus risk factor, more
complicated exams should not exceed three minutes of exam me within 24 hours. Signicant
use of this device beyond its intended use is not recommended as it may cause harm to the
eyes.
During the operaon of using the camera, please follow the below instrucons.
• Always use the camera or accessories in accordance with the direcons and
recommendaons contained in this user manual.
• When operang the device, please make sure that the opcal lens does not
touch the eyes or nose of the paent in order to avoid harm.
• For illumination and photography with the EZ-Horus 45, do not select an
exposure higher than required. Do not shine light on the eye beyond the
recommended me during examinaon. Otherwise, the examined eye may
experience pain or be injured.
No compensaon for missed shots
We cannot compensate for missed shots if technical problems with the camera or card pre-
vent recording.
Also refer to “Usage cauons and notes”
Please also refer to “Usage cauons and notes” (→ 29) for more instrucons of the baery,
SD card, etc.
Please note that the actual controls and components, menu items, and
other informaon of your camera may dier from those in the illustraons
provided in these instrucons.
Names of components
Scope of Delivery
Product Name Model Name Accessories
Digital eye fundus
camera
Horus+ Scope EZ-
Horus 45
1. Eyecup
2. Baery
3. Power adapter
4. USB cable
5. AV cable
6. Charging staon
7. SD card
8. Foot switch (Oponal part)
9. Slit lamp Jig (Oponal part)
Intended for use
Horus+ Scope EZ-Horus 45 is a digital hand-held eye fundus camera used to record digital
photographs and video of fundus (including retina, macula, and optic disc) of the human
eye and surrounding area.
User interface
Control Unit (Horus+ Scope EZ-Horus 45)
Top view ››
Power buon
Lens lock

-8- -9-
Preparations
From view ››
3.5” LCD touch panel
Manual focus (-20D ~ +20D)
OK buon:
• Press down halfway
for auto focus
• Completely press down
to take a photo
• Back to photo/video mode
while previewing photos
Power indicator
Brightness decrease/increase
in photo mode (0B ~ 15B)
Boom view ››
AV out / foot switch
Mini USB
Strap hook
Optical Lens of Horus+ Scope EZ-Horus 45 (Digital Eye Fundus Camera)
Lens connect ring
Contact
surface Lens assembling mark
Signal pad
Rear view ››
Lens assembling mark
Cover glass and sensor
Lens connect ring
Lens connecng pins
Baery cover
‹‹ SD slot

-10- -11-
Preparations
Charging the battery
Always charge before rst use
Prior to rst use, insert the baery into the control unit and close the baery cover referred to
the below secon. Connect USB connector to the power adapter. Let the baery be charged
for at least ve hours.
Baery replacement
Open the baery cover by digging out the gap in the boom of baery cover with a nger or
something pointed.
•Tilt the baery cover and remove the baery cover by liing it up.
•Remove the original baery and replace a new baery along the correct direcon.
•Place the baery cover and secure it in place.
Power indicator
System status Power o Power on
Light color
No light Orange light Blue light Blinking blue
light
Mixed blue
and
orange light
Informaon System o Charging Normal opera-
on
Power less
than 25%
Connect to PC
via USB cable
or enable USB
live video
Power indicator
Connect to a power adapter

-12- -13-
Preparations
Assembling
Step 1. ↘
Align the marks of the opcal lens and control unit.
Mark on the
opcal lens
Mark on the control unit
Step 2. →
Hold the opcal lens and aach it to
the control unit. Rotate and fasten the
opcal lens in a clockwise direcon.
You will hear a click when the lens locks
into the control unit.
Step 3. ←
Turn on the power (→ 13). When
opcal lens and control unit are
assembled correctly, the informaon
icons will appear on the top of LCD touch
panel. The screen will turn on, and then the blue light of the
power indicator (→ 11) will also turn on.
Step 4. →
To unlock the opcal lens,
press the lens lock and then
rotate the opcal lens in a
counterclockwise direcon.
Then the opcal lens will be
unfastened.
Using the Setup mode
Turn on the power
To turn on the system, press the power buon (→ 7) to turn on the control unit. Approxi-
mately one to two seconds later, the boot screen will appear on the LCD panel.
Once the LCD panel shows the live image, it takes about 10 seconds for the on-screen display
(OSD) to be superimposed.
→ 10 seconds →
Enter the Setup mode
Using the [Setup] menu
It is recommended that all seng items are set according to user’s requirements for
rst-me use.
Bring up the [Setup] menu
Touch the photo icon and then touch the setup icon.

-14- -15-
Preparations
Exit the [Setup] menu
Once a seng adjustment is made, the new value aects the system immediately.
Use the upper back buon or the OK buon to exit the screen.
Sengs
[Aiming Light/Capture Light]
The default setting of [Aiming Light/Capture Light] is [IR/White LED]. In the setting,
EZ-Horus 45 employs IR illumination for alignment and focusing to assure patient
comfort. With IR, the user observes fundus images monochromatically. At the
moment of press-ing the shutter button, the system will turn on the white LED
instantly. Static images and motion pictures will be captured in full color.
If the seng is [White LED/White LED], then the user observes images in full color and
capture stac images and moon pictures in full color.
Sample images of monochrome and full color.
[Picture Color Temperature]
The picture color temperature has three levels; the default seng is medium.
[Low] sets the color temperature for a warmer color tone. [High] sets the color tem-
perature for a cooler tone.
[IR brightness]
The IR brightness has three levels; the default seng is low.
[UVC]
When you connect EZ-Horus 45 to a computer via USB cable, the product works as a
USB storage device. If UVC mode is on, pictures can be shown both on the LCD panel
of the product and the screen of the computer.
To display image on the computer, please install webcam applicaon prior to enabling

-16- -17-
Preparations
UVC mode. A freeware webcam applicaon (e.g., AMCap) is a soware that can re-
ceive UVC signal on the computer. User can search for relevant informaon over the
Internet.
[Standby]
User can set standby mode to be on or o. Once the mode is on, the LCD panel will be
turned o if the system is idle for three minutes. Tap on the item to toggle the seng.
[Date Seng]
User can change the current date seng from the screen.
[Time Seng]
User can change the current me seng from the screen.
[Format SD Card]
User can format the SD card.
NOTE
All informaon will be deleted aer SD card is formaed.
[Factory Seng]
User can recover the device to its factory sengs.

-18- -19-
Preparations
Entering the patient ID
Using patient ID as partial file name is supported in EZ-Horus 45.
File naming rule
Model Name Picture Name without ID Picture Name with ID
Eye
fundus
camera
EZ-Horus 45 ELHHMMSS.jpg
ERHHMMSS.jpg
ELXXXXXXXXXXHHMMSS.jpg
ERXXXXXXXXXXHHMMSS.jpg
Meaning of each symbol:
Symbol Meaning
EL Le eye photo taken by the eye fundus camera
ER Right eye photo taken by the eye fundus camera
HH Hour
MM Minute
SS Second
XXXXXXXXXX Paent ID, up to 10 characters.
Example:
E L 1 6 1 4 3 1 .jpg E L ABCD12345 1 6 1 4 3 1 .jpg
No ID ID: ABCD12345
Eye, Le
Hour
Minute
Second
Paent IDEye, Le
Hour
Minute
Second
The image name is explained as follows:
EL: Le eye photo taken by the eye fundus camera; hour: 16; minute: 14; and sec-
ond: 31.
If the given paent number is ABCD12345, the image name would be wrien as
ELABCD12345161431.jpg.
Create a new paent ID from scratch
By gently pressing the OK buon, the user always goes back to a shoong mode, either photo
or video mode; from the top informaon icons, tap to start the process.
Create a new paent ID on an exisng one
Aer a paent ID is set, the user can quickly create a new paent ID that is based on the exist-
ing ID plus 1 e.g., ABCD12345 → ABCD12346.

-20- -21-
Takingpictures
Taking pictures
Sequence of operations
Step 1: Turn on the power
Press the power buon to turn on the control unit. Approximately one to two seconds later,
the boot screen will appear on the LCD panel. Aer about 10 seconds, the informaon icons
will appear on the top of the LCD panel. (Also refer to “turn on the power” → 13.)
Step 2: Make sure SD card is inserted
Once the SD card has been inserted, the user can start to take photographs in any shoong
mode, either photo or video mode.
Step 3: Choose a shoong mode
Tap the photo or the video mode icon to enter a shoong mode.
Step 4: Mark le/right eye
By doing so, the user can tell whether a photo/video is le eye or right eye record from its le
name. (Default value is le eye.)
Step 5: Aim and preview
Posion the camera correctly and adjust to appropriate sengs to get a clear preview (→
24). The image brightness can only be changed in photo mode, whereas the fixation lamp
can be adjusted in both photo mode and video mode. You can rely on the auto focus of EZ-
Horus 45 to improve clarity or adjust focus manually.
2014/03/17 15:52:33
Setup Mode
Display Mode
Video Mode
Photo Mode
Le eye mark
Fixaon LED
Right eye mark
Baery Indicator Remaining SD card memory
Brightness Indicator
Step 6: Press the OK buon to shoot.

-22- -23-
Takingpictures
Photo mode
The device’s default seng is “photo mode.” The user can take a picture or video in “photo
mode” or “video mode,” respecvely.
Photo mode: Press down the OK buon halfway to focus; press it all the way to take a sll
picture.
The default seng of “Aiming Light/Capture Light” is “IR/White LED”. Therefore, the le image
before pressing the OK buon is monochrome color and the right one is full color (→ 14).
When a picture is just taken, the screen shows the result image in auto review mode. To leave
auto review, gently press the OK buon.
To adjust the brightness of the image, user can press the brightness adjustment keys (“User
interface” → 8) of the control unit: to change value.
The higher value you set, the brighter image you get. Image brightness adjustment range:
Model Name Default Value Min. Value Max. Value
Eye fundus camera EZ-Horus 45 10 0 15
Reference Table:
Brightness Indicator Classicaon Note
0-5B Light Skin Blond
5-10B Light Skin Brunee 10B is default
10-15B Dark Skin
Press
fully
Press
halfway
Video mode
Video mode: Completely press the OK buon to start recording. Press again to end record-
ing. The default seng of “Aiming Light/Capture Light” is “IR/White LED.” See process below:
During the video shoong, user can press “the brightness adjustment key +” to enhance the
white LED for two seconds. It helps capture brighter moon pictures within a video.
Press
fully
Press
fully
Press
fully
Press
fully
Total length
2 seconds

-24- -25-
Takingpictures
Fixation setting and holding position
Examinaon condions
Aer the opcal lens is aached to the control unit and setup is complete, the user can start
taking images. Approaches for taking the image of human eye fundus are as follows:
• Have the examinee stay in <5 lux dark room; in such an environment, a
newspaper is nearly impossible to see. Remove the paent’s glasses or
contact lenses. Make sure that the eye’s pupil has a diameter larger than 4
mm, or be sure to suciently dilate in advance.
• Auto focus to innity by pressing the OK buon halfway down. Once the
preview image is clear, then the focus is right for eye screening.
Fixaon lamp
Choose xaon LED posion and ask the examinee to look at the xaon LED. Adjust the
brightness of xaon LEDs by using the brightness adjustment keys of the control unit.
Holding posion
Hold the control unit with one hand and use the other hand to hold the front side of the lens.
Maintain the lens at the same height of the eye being examined. To stabilize the lens, rest the
lens on the part of the hand between the thumb and index nger and put your middle and
index ngers on the examinee’s forehead, as showed in the following image.
The brightness of xaon LED
Adjust by using the brightness adjust-
ment keys:
5B is the maximum brightness level in
xaon seng.
View the examined eye keeping the lens horizontal to the examined eye. Then move forward
slowly unl you can see the opc disk in the controller screen. (For sanitary reasons, make
sure the controller lens does not touch the paent’s eyes or nose.)
Adjust focus and ne tune
•Find the opc disk then opmize the image by adjusng the focus distance by using the
focus adjustment keys of the control unit .
•Fill the screen (circle area) with the image without any shining spot. The correct working
distance is 24 mm (from the lens p to cornea).
•Completely press down the OK buon to take photographs or record videos.
•The image that was taken will be showed on the screen and is saved on the SD card. Press
the OK buon to go back to the operaon screen and take another image or record another
video.

-27-
Playback
-26-
Q&A troubleshooting
A good image should have two characteriscs:
1. Posions
The macula and the opc disc are
horizontally aligned in the middle.
2. High contrast
The macula, opc disc, and vessels are
all clear.
If the above characteriscs can’t be found in the shot, possible failures might be the following:
1. Small fundus image 2. White hot spot on the top
of the image
3. Dark shadow on the top
of the image
The lens is too far away from
the examinee's eye.
The lens is too close to the
examinee's eye.
The lens is much lower than
the visual axis.
4. Dark shadow on the bot-
tom of the image
5. Line or spot within the
view
6. Blue or white shadow on
the boom of image
The lens is much higher than
the visual axis.
Eyelashes are in the light
path.
Cornea reecon
Macula
Vessels
Opc disc
Playback
Display mode
Touch the photo icon and then the display icon to see the photos that have been taken.
Display mode:
Click the le or right arrow symbols to go to the previous or next photo, respecvely. Click
the up or down arrow symbol to backward in days or forward in days. Zoom in and out on the
photo while in display photo. The user can delete photos by touching the delete icon.
The device does not support the video le display on the control unit. Please download the
video le (.avi) to the computer to watch.
Enlarged viewing
Picture number/Total
pictures
File date
Previous photo Next photo
Delete
Zoom in 1:1
Earlier date photo
Later date photo
Paent ID
File name

-29-
Miscellaneous
-28-
Aer the image is enlarged (1:1), the arrows would work as pan funcons. Tap Zoom icon
again to return the original scale.
Deleting pictures
Tap the delete icon to delete the image. By using the “delete” funcons on your camera, this
only changes the le management informaon and does not completely delete the data from
the memory card. When disposing of or transferring your memory cards, we recommend
physically destroying them or using commercially available computer data erasing soware to
completely delete the data from the card.
Move the
enlarged secon
toward le
Move the
enlarged secon
toward right
Move the enlarged
secon downward
Move the enlarged
secon upward
Miscellaneous
Files transferring
Transfer images to an electronic device (e.g., personal computer, laptop, or mobile phone) via
the USB cable or SD card.
Viewing on a computer/laptop screen
Turn on UVC mode (→ 15) to simultaneously view images both on LCD panel and the com-
puter/laptop screen.
Viewing on a TV screen
Connect the camera and a TV through a AV cable, you can simultaneously view images on
both sides.
Usage cautions and notes
When in use
•The camera may become warm if used for long periods of me, but this is not its fault.
•Keep the camera as far away as possible from electromagnec equipment (such as micro-
wave ovens, TVs, video games, etc.).
•Do not use the camera near radio transmiers or high-voltage lines.
•Never leave the camera and the baery in a car or on a car hood in the summer. Doing so
may cause leakage of the baery electrolyte, overheang, re, or a baery explosion due
to the high temperature.
•If the opcal lens and control unit get wet, do not aempt to dry with a heater, microwave,
autoclave, or UV light.
•Do not extend the supplied cables. Do not keep the power cord near any heat source.
•When the camera is not in use, please disconnect the power plug and keep it in a safe
place.

-30- -31-
Miscellaneous
Charging the baery
•The me required for charging varies depending on the condions of baery usage. Charg-
ing takes longer at high or low temperatures and when the baery has not been used for
some me.
•The baery will get warm during charging and for some me thereaer.
•The baery will be drained completely if not used for long periods of me, even aer being
charged.
•Only use Li-ion Baery 3.7V @ 2,500mAh which shall be provided by the manufacturer or
distributors. The baery has designed the protecon circuit. To ensure the safety of the
product operaon, if the baery reaches its lifeme, please contact the manufacturer or
distributor to buy the spare baery.
Memory cards
If you purchase dierent memory capacity of micro SD card, must be preceded format to
FAT32.
To prevent damage to cards and data:
•Avoid high temperatures, direct sunlight, electromagnec elds, and stac electricity.
•Do not bend, drop, or expose to strong impacts.
•Do not touch the terminals or allow them to become dirty or wet.
When disposing of/transferring memory cards:
•If using the “format” or “delete” funcons on your camera or computer, this only changes
the le management informaon and does not completely delete the data from the
memory card. When disposing of or transferring your memory cards, we recommend
physically destroying them or using commercially available computer data erasing soware
to completely delete the data from the card. Data on memory cards should be managed
responsibly.
Accessories
About the foot switch:
•The foot switch is not waterproof.
•Avoid subjecng the foot switch to vibraon or shock.
•Avoid using the foot switch in a dusty environment.
About the slit lamp jig:
•Aach the slit lamp jig only to slit lamp equipment that has been qualied by MiiS. Make
sure the jig is completely locked by pushing it downward. The slit lamp jig is only
suitable for the EZ-Horus 25, EZ-Horus 40 and the EZ-Horus 45.
Protecon
•Do not aempt to remove the cover from the product to prevent the product from mal-
funconing.
•No modicaon of this device is allowed. The performance would be subject to any modi-
caon and may cause hazardous radiaon exposure.
EMC (electromagnec compability)
During installaon and operaon of the device, observe the following instrucons:
•Do not use the device simultaneously with other electronic equipment to avoid electromag-
nec interference with the operaon of the device.
•Do not use or stack the device near, on, or under other electronic equipment to avoid elec-
tromagnec interference with the operaon of the device.
•Do not use the device in the same room as other electronic equipment, such as life-support
equipment that has major eects on the life of the paent and results of treatment, or any
other measurement or treatment equipment that involves small electric current.
•Do not use the system with portable and mobile radio frequency communicaon systems
because that may have an adverse eect on the operaon of the device.
•Do not use cables or accessories that are not specied for the device because that may in-
crease the emission of electromagnec waves from the device and decrease the immunity
of the device to electromagnec disturbance.
•Do not touch the lens connecng the pins of the control unit or the signal pad of the lenses
without special precauons.
Cleaning and Disinfecon
The device is a precision photoelectronic instrument that shall be handled with specic care.
Please note the following cleaning instrucons:
•Turn o the device before cleaning it.
•Disinfect the control unit and charging staon with the so cloth with alcohol (70%
ethyl alcohol). Wait for the cleaning liquid to dissolve before turning the power on and
connecng the charging staon and USB cable to the control unit.
•It is recommended to clean the opcal lens with a cleaning cloth or lens cleaning s-
sue, such as THORLABS Inc. (www.thorlabs.com) lens cleaning ssue.
If a replacement for the eyecup is needed, please contact the manufacturer or retailer.
Clean the eyecup before each use:
•Disinfect the eyecup with so cloth moistened with alcohol (70% ethyl alcohol).
NOTE
The device is not intended to be sterilized. Disinfect the control unit and charging staon with
a so cloth with alcohol (70% ethyl alcohol).
Operang Environment
•Ambient temperature: 10°C to +35°C
•Relave humidity: 30% to 90%
•Atmospheric pressure: 800hPa to 1060hPa
•Shock (without packing): 10 G, duraon 6 ms
Environment for Storage
•Ambient temperature: -10°C to +55°C
•Relave humidity range: 10% to 95%
•Atmospheric pressure: 700 hPa to 1060 hPa

-32- -33-
Miscellaneous
NOTE
It is recommended to remove the baery if the device is stored over two weeks.
Environment for Transportaon
•Ambient temperature: -40°C to +70°C
•Relave humidity range: 10% to 95%
•Atmospheric pressure: 500 hPa to 1060 hPa
•Vibraon, sinusoidal: 10 Hz to 500 Hz: 0.5G
•Shock: 30 G, duraon 6 ms
•Bump: 10 G, duraon 6 ms
NOTE
It is recommended to remove the baery if the device is stored over two weeks.
Regulaons
•U.S. Federal law restricts this device, EZ-Horus 45, to be sold and distributed, and it
should be used only by or on the order of a physician.
•This device has been tested and found to comply with the limits for medical devices to the
IEC 60601-1-2: 2007. These limits are designed to provide reasonable protecon against
harmful interference in a standard medical installaon. If this device does cause harmful
interference to other devices, which can be determined by turning the system o and on,
the user is encouraged to try to correct the interference through one or more of the follow-
ing measures:
• Reorient or relocate the receiving device.
• Increase the separaon between the system and other devices.
• Connect the device to an outlet on a circuit dierent from that to which the
other device(s) are connected.
• Consult the manufacturer or eld service technician for help.
•The Internaonal Electrotechnical Commission sets the essenal requirements for electrical
and electronic equipment that may disturb or be disturbed by other equipment. The device
complies with these requirements as shown in the tables in “Symbols and standards: EMC”
(→ 34). Follow the guidance in the tables for use of the device in an electromagnec
environment.
Technical description
Horus+ Scope EZ-Horus 45, digital eye fundus camera:
• View Angle: 45 Degree (Typical)
• Diopter: -20 ~ +20D (Typical)
• Dimension: 20.9 x 9 x 20.3 cm (Typical)
• Weight: 500 Grams (Typical)
• Search Fundus Lighng: Two modes: natural white light-eming diode (LED)
or infrared LED.
Green LED for xaon.
• Camera/video ash light: Natural white LED
Focus Auto & manual focus
Camera Resoluon 2592 x 1944 pixels
Picture Resoluon 2560 x 1920 pixels
Video Resoluon 1280 x 960 pixels
LCD Monitor 3.5” Full Color TFT-LCD Touch Panel
Image Format JPEG (Photograph) and H.264 (Video)
Interface Mini USB, AV out port
File Transfer Mini USB Port to PC
Dynamic Video Output Composite AV out, or USB live video enable
from USB port
File Storage SD Card, default 8GB. Supports 2 G to 32 GB by
FAT32 Format.
Power Source Rechargeable Lithium Baery 3.7V/2500mAh
External Power Source: 100~240 VAC, 50/60 Hz
Power Adapter Spec. Input Spec.: 100~240 VAC, 50/60 Hz, 0.3 A;
Output Spec.: 5V DC, 2 A
Charging staon Input Spec. 5V DC, 1.2 A
Operang Time 3 hours at 2.5 Wa condion
Charging Time 5 hours by DSC 200
Expected service life
(dened by manufacturer)
5 years from the date of inial operaon
*Proper maintenance is necessary.

-34- -35-
Miscellaneous
Liability
Manufacturer considers itself responsible for the eects on safety, reliability, and performance
of the device only if
• Assembly operaons, extensions, readjustments, modicaons or repairs are carried
out by persons authorized.
• The electrical installaon of the relevant room complies with the requirements.
• The equipment is used in accordance with these instrucons for use.
Disposition
•Follow the local governing ordinances and recycling plans regarding disposal or recycling
of device components, especially when disposing of the lithium ion baery, circuit board,
plasc parts that contain brominated ame retardant, LCD, or power cord.
•Follow the local governing ordinances and recycling plans when disposing of the circuit
board with the lithium baery. Inappropriate disposal may contaminate the environment.
•When disposing of packing materials, sort them by material and follow local ordinances and
recycling regulaons.
•Inappropriate disposal may contaminate the environment.
•When disposing of eyecup, follow the disposal procedures for medical waste such as
needles, infusion tubes, and metal instruments for surgery as specied by your medical
facility to avoid infecon outside the facility and environmental polluon.
Symbols and standards
Symbols
Cauon must be taken. Read user manual before use.
Type BF indicates the device is classied as a device with a Type BF applied
part.
The operator is advised to read the instrucons of user manual.
Manufacturer
Date of Manufacture
CE mark
European Authorized Representave
This product has an internal rechargeable baery with a Class II power supply.
Standards
Electrical safety IEC 60601-1:2005
(EN 60601-1:2006)
EMC and regulatory compliance IEC 60601-1-2:2007
(EN 60601-1-2:2007)
Ophthalmic instruments-Fundamental requirements and
test methods Part 2: Light hazard protecon ISO 15004-2:2007
Ophthalmic instruments - Fundamen-tal requirements
and test methods - Part 1: General requirements applica-
ble to all ophthalmic instruments
ISO 15004-1:2006
•Equipment connected to the analog or digital interfaces must be cered according to
the representave appropriate naonal standards (such as EN 60601-1 and IEC 60601-
1). Furthermore, all conguraons shall comply with the system standard IEC 60601-
1. Anyone who connects addional equipment to the signal input part or signal output
part congures a medical system and is therefore responsible for the system comply-
ing with the requirements of the system standard IEC 60601-1. If in doubt, consult the
technical service department of your local representave.
EMC (Electromagnec Compability)
The device complies with the Internaonal Electrotechnical Commission standards (IEC 60601-
1 -2: 2007) for electromagnec compability as listed in the tables below. Follow the guidance
in the tables for use of the device in an electromagnec environment.
EMC (IEC 60601- 1- 2: 2007)
Guidance and manufacturer’s declaraon electromagnec emissions
The device is intended for use in the electromagnec environment specied below. The cus-
tomer or the user of the device should assure that it is used in such an environment.
Emissions test Compliance Electromagnec environment guidance
RF emissions
CISPR 11
Group 1 The device uses RF energy only for its internal funcon. There-
fore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The device is suitable for use in all establishments, including domesc es-
tablishments and those directly connected to the public low voltage power
supply network that supplies buildings used for domesc purposes.
Harmonic emissions
IEC 61000-3-2
*1
Voltage uctuaons/
Flicker emissions
IEC 61000-3-3
*2
*1 For the regions where the rated voltage is 220 V or greater, this device complies with class A.
For the regions where the rated voltage is 127 V or less, this standard is not applicable.
*2 For the regions where the rated voltage is 220 V or greater, this device complies with this stan-
dard. For the regions where the rated voltage is 127 V or less, this standard is not applicable.

-36- -37-
Miscellaneous
Guidance and manufacturer’s declaraon electromagnec immunity
The device is intended for use in the electromagnec environment specied below. The cus-
tomer or the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level Electromagnec environment guidance
Electrostac Discharge
(ESD) IEC 61000- 4- 2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood, concrete, or ceramic tile. If
oors are covered with synthec material, the rela-
ve humidity should be at least 30%.
Electrical fast transient/
burst IEC 61000- 4- 4
±2 kV
for power
supply lines
±1 kV
for input/
output lines
±2 kV
for power supply lines
±1 kV
for input/output lines
Mains power quality should be that of a typical com-
mercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV
dierenal mode
±2 kV
common mode
±1 kV
dierenal mode
±2 kV
common mode
Mains power quality should be that of a typical com-
mercial or hospital environment.
Voltage, dips, short
interrupons and
voltage variaons on
power supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 sec
<5% U
T
(> 95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 sec
Mains power quality should be that of a typical com-
mercial or hospital environment. If the user of the
device requires continued operation during power
mains interruptions, it is recommended that the
device be powered from an uninterruptible power
supply or a baery.
Power frequency (50/60
Hz) magnec eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnec elds should be at levels
characterisc of a typical locaon in a typical com-
mercial or hospital environment
NOTE: U
T
is the a.c. mains voltage prior to applicaon of the test level.
Guidance and manufacturer’s declaraon electromagnec immunity
The device is intended for use in the electromagnec environment specied below. The customer or the user of the device should assure that it is
used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level Electromagnec environment guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
(V1=3)
3 V/m
(E1=3)
Portable and mobile RF communicaons equip-
ment should be used no closer to any part of the
device, including cables, than the recommended
separaon distance calculated from the equaon
applicable to the frequency of the transmier.
Recommended separaon distance
d=1.2 150 kHz to 80 MHz
d=1.2 80 MHz to 800 MHz
d=2.3 800 MHz to 2.5 GHz
where P is the maximum output power rang
of the transmier in was (W) according to the
transmier manufacturer and d is the recom-
mended separaon distance in meters (m).
Field strengths from xed RF transmiers, as deter-
mined by an electromagnec site survey,a should be less
than the compliance level in each frequency range.b
Interference may occur in the vicin-
ity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situaons. Electromagnec propaga-
on is aected by absorpon and reecon from structures, objects and people.
a Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and land mo-
bile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theorecally with
accuracy. To assess the electromagnec environment due to xed RF transmiers, an electromagnec site survey
should be considered. If the measured eld strength in the locaon in which the device is used exceeds the ap-
plicable RF compliance level above, the device should be observed to verify normal operaon. If abnormal per-
formance is observed, addional measures may be necessary, such as reorienng or relocang the device.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separaon distances between portable and mobile RF communicaons
equipment and the device
The device is intended for use in an electromagnec environment in which radiated RF disturbances are controlled. The cus-
tomer or the user of the device can help prevent electromagnec interference by maintaining a minimum distance between
portable and mobile RF communicaons equipment (transmiers) and the device as recommended below, according to the
maximum output power of the communicaons equipment.
Rated maximum output
power of transmier
W
Separaon distance according
to frequency of transmier
m
150 kHz to 80 MHz
d=1.2
80 MHz to 800 MHz
d=1.2
800 MHz to 2.5 GHz
d=2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmiers rated at a maximum output power not listed above, the recommended separaon distance din
metres (m) can be esmated using the equaon applicable to the frequency of the transmier, where Pis the
maximum output power rang of the transmier in was (W) according to the transmier manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separaon distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situaons. Electromagnec propaga-
on is aected by absorpon and reecon from structures, objects, and people.
Please visit www.usophthalmic.com for more information.