WikiOptics nun+ WFC-01 User manual

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WikiOptics, Inc. Javitech
Room. 205, U-TOWER, 120, Sachsenhausener Str. 16,
Heungdeokjungang-ro, 65824 Schwalbach a. Ts.,
Giheung-gu, Yongin-si, Germany
Gyeonggi-do, 16950, Korea
Homepage: www.wikioptics.com
Tel.) [phone]~1
Email) [e-mail]

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SYMBOLS
Caution :
This symbol identifies a safety note. Ensure you understand the
function of this control before using it. Control function is
described in the appropriate service manual.
I
“ON” (power)
To indicate connection to the mains, at least for mains
switches, or their positions, and all those cases where safety is
involved.
○
“OFF” (power)
To indicate disconnection from the mains, at least for mains
switches or their positions, and all those cases where safety is
involved.
This symbol indicates to follow instructions for use.
Meets essential requirements of the European Medical Device
Directive 93/42/EC
This indicates the year of manufacture/production
This indicates the manufacturer.
Authorized Representative in the European Community.
Serial number
Type B applied part
Class II equipment
Battery Charging
USB
IPXØ Degree of protection provided by enclosure(IP code)
This symbol indicates to handle the fragile device with care

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This symbol indicates to keep the device away from sunlight
This symbol indicates to keep the device dry
This symbol indicates the humidity limitation for operation,
transport and storage.
Temperature limitation.
Conforms with the Waste Electrical and Electronic Equipment
Directive(2002/96/EC).
At the end of useful life, dispose of all waste according to local
requirements, or contact agent for device.
The product is designated for separate collection at an
appropriate collection point.
Do not dispose of in normal waste stream.

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INTRODUCTION
Intended use
The nun+ WFC-01 using user’s android smartphone is a portable fundus camera that records
images and videos of the patient’s retina.
Target population and diseases.
- From infants to old age
- Glaucoma, diabetic retinopathy, macular degeneration and retinal detachment
Warnings and Cautions
Warnings and Cautions can be seen on the nun+ device, the packaging, the shipping container, or
in this guidance for use. The device is safe for patients when used in accordance with the
instructions, warnings, and cautions stated in this guidance for use;
Before using the device, the user must familiarize with all the warnings and cautions, the steps to
power up the device, and the sections of this guidance for use. Specific warnings and cautions are
also found throughout this manual.
■ Failure to understand and observe any warning stated in this manual could lead to patient
injury.
■ Failure to understand and observe any caution stated in this manual could lead to damage
of the equipment or other property or loss of patient data.
CAUTIONS FOR SAFETY
This device is classified as Group 1 based on standard ISO 15004-2:2007.

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WARNING!
No acute optical radiation hazards have been identified with the device. The intended use of this
device is for routine ophthalmic examinations of typically less than 60 seconds per eye. While any
medical procedure has its benefit versus risk factor, more complicated examinations should not
exceed three minutes within 24hours.
Since long time intense light exposure can ocular damage, the use of the device for ocular
examination should not be unnecessarily prolonged, and the brightness setting should not exceed
what is enough to provide clear visualization of the target structures. Infants, persons with aphakia
or diseased eyes will be at greater risk of ocular damage. The risk may also be increased 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 past 24 hours.
CAUTIONS
Unless the instructions for operating are followed carefully, this product is possible to fail
or be broken.
SAFETY & CAUTIONS REGARDING THE USE OF THE PRODUCT
,
RECHARGEABLE BATTERY AND DC POWER SUPPLY
 It is not appropriate to use this product at a place where a flammable anesthetic mixture
exists since it is dangerous to be exploded.
 Please do not give the impact by dropping the product or put a heavy object on the
product.
 Please do not keep the product together with an object having a strong magnetism, such
as, a magnet, etc. Otherwise, it may cause a failure.
 Please do not disassemble or remodel the battery pack since it is risky of being exploded.
 Please use only the original battery pack having the protective circuit that is provided or
certified by WIKIOPTICS and a battery charger certified as a medical device.
 Please do not charge a battery pack under an environment where the temperature is not
lower than 45℃ or not higher than 0℃.

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 If the battery is fully charged, please unplug the DC power supply out of the socket.
 Please do not expose the battery pack to a temperature which is not lower than 55℃ or
not higher than -20℃.
 Please do not discharge the battery pack if the surrounding temperature is not lower than
55℃ or not higher than -20℃.

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STARTING
Thank you for purchasing our portable fundus camera, ‘nun+’.
Please read this user manual (this document) carefully before using the product.
If you have any doubts about operating this product properly, please read this user manual and
follow the instructions.
CAUTIONS
(1) It is strictly prohibited to copy all or some part of the contents of the user manual without
permission.
(2) Some contents of this document might be changed without notice.
(3) Although the contents of this document are prepared with paying full attention, if there are
any doubts, errors or omissions, etc., please contact WikiOptics, Inc.
(4) Since it is hard for this company to be responsible for any damages or a claim for business
profits, etc., for the reason of using the product regardless of the provision of the paragraph
(3), we ask your understanding beforehand.
TERMS OF USE
This portable fundus camera, ‘nun+’, is made to be used in a general office environment.
The terms of use are as follows.
■Operating temperature: 0℃~45℃
■Storage temperature (non-operating): -20℃~ 55℃
■Operating humidity: 30%~ 90%
■Storage humidity: 10%~ 95%
■ Operating & Storage Atmospheric pressure: 800hPa~ 1060hPa

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■CONTENTS
SYMBOLS--------------------------------------------------------------------------------------- 3-4
INTRODUCTION-------------------------------------------------------------------------------- 5
CAUTIONS FOR SAFETY / STARTING --------------------------------------------------------- 5-8
CHAPTER 1- HOW TO USE
PURPOSE OF USE AND USAGE OF THIS PRODUCT -------------------------- 11
COMPONENTS ----------------------------------------------------------------- 12
COMPOSITION OF BODY ------------------------------------------------------ 13
FEATURES OF PRODUCT ------------------------------------------------------- 14
STEP FOR CHARGING THE DEVICE ------------------------------------------ 15
HOW TO REPLACE BATTERY, DC POWER SUPPLY --------------------------- 16
INSTALLATION OF nun+ APP ON THE USER’S SMARTPHONE ------------ 17
EYE CUP ---------------------------------------------------------------------- 19
CLAMPING USER’S SMARTPHONE ON THE DEVICE ---------------------- 20
PRECAUSIONS FOR PROPER USE OF THE DEVICE -------------------------- 21
USE GUIDE OF MOBILE APP (Ver1.0) ------------------------------------------ 22
WASHING & REPAIRING ------------------------------------------------------- 32
PRODUCT SPECIFICATIONS ---------------------------------------------------- 33
CALIBRATION AND SERVICE --------------------------------------------------- 35

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CHAPTER 2- ELECTROMAGNETIC COMPATIBILITY
STANDARD --------------------------------------------------------------------- 36
CHAPTER 3- ELECTROMAGNETIC COMPATIBILITY
EMC ------------------------------------------------------------------------- 37-43
WARRANTY STATEMENT ------------------------------------------------------- 44
A/S SERVICE REQUEST FORM-------------------------------------------------46

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CHAPTER 1- HOW TO USE
PURPOSE OF USE AND USAGE OF PRODUCT
 This portable fundus camera nun+ is designed for use in a medical environment.
 The nun+ WFC-01 using user’s android smartphone is a portable fundus camera
that records images and videos of the patient’s retina.
 The ‘nun+’ is a medical device which can find the retinal disease by observing the
retina of the human or animal. User can focus on the retinal surface by manual
focusing knob viewing with IR light source, and get the visible image with white
LED flash. So there is no need to use any pupil dilation agent.
 Using the user’s Android OS smartphone, the user can get the view of the retinal
image and control the level of lighting, etc.

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CHAPTER 1- HOW TO USE
COMPONENTS
1. Body of the fundus camera 2. DC power supply & plug
3. Mini USB power cable 4. Eye cup
5. OTG cable 6. OTG gender
7. Cradle for battery charging 8. User manual (Download at homepage)
9. nun+ App
Any of these
components may be changed without notice for enhancing the performance or
quality of the product.

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CHAPTER 1- HOW TO USE
COMPOSITION OF BODY
No. Item Description
① Eye cup External light interception, pupil tracking function
② Diopter -20D to 20D focus adjustment
③ Shot button Retina image capture
④ Battery cover Cover to replace the battery
⑤ DC power terminal DC power terminal for lithium-ion battery charging
⑥ Smartphone holder Universal holder
⑦ Charging indicator Amber LED lighting when charging, Green LED lighting when
charging is complete
⑧ Main power on/off switch Main body power on/off switch
⑨ USB mini B type port Data interface between smartphone and medical device

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CHAPTER 1- HOW TO USE
FEATURES OF PRODUCT
NON MYDRIATIC
 Focusing with IR light source, and get the retinal image with white LED flash
WIDE FIELD OF VIEW
 >45˚(horizontal), > 40˚(Vertical)
MANUAL FOCUS ADJUSTMENT
 RANGE OF DIOPTER: -20D - +20D
Android OS SMARTPHONE
 The nun+ App for android is available so that it can conveniently manage the
patient’s retinal image and video.

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CHAPTER 1- HOW TO USE
STEP FOR CHARGING THE DEVICE
To charge the battery, connect the mini USB connector on the mini USB power cable to the fundus
camera charging cradle and connect the USB connector to a DC power adapter USB port that plugs
into a PC or wall power socket.
Place the device on the cradle and set the main power switch to OFF”○” to charge. The charging
indicator LED is amber during charging, but turns to green when charging is complete.

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CHAPTER 1- HOW TO USE
HOW TO REPLACE THE BATTERY, DC POWER SUPPLY AND MINI USB
POWER CABLE
HOW TO REPALCE BATTERY
When the rechargeable battery cannot be recharged any longer, please replace that as follows.
■ Ensure that the device is powered off when replacing the battery.
■ Open the battery cover by sliding the battery cover release knob.
■ Remove the old battery to be replaced. Insert the new 3.6V 3500mAh protection circuit 18650
battery in the correct polarity direction and press the cover firmly into place.
■ Connect the user’s smartphone to this unit turn on the power to check the operation status
through device recognition.
HOW TO REPALCE THE DC POWER SUPPLY AND MINI USB POWER
CABLE
When the DC power supply and mini USB power cable are no longer available. Please replace
them as follows.
■ Mini USB power cable can be replaced by purchasing another new mini USB power cable.
■ The DC power supply be purchased from WikiOptics or a medical power supply with integral
USB jack, compliant with 2MOPP.

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CHAPTER 1- HOW TO USE
INSTALLATION OF nun+ APP ON THE USER’S SMARTPHONE
-. The nun+ app accessory of the WFC-01
-. Smartphone environment for running nun+ app
Download and install nun+ app on the user’s smartphone from the homepage of WikiOptics, Inc.
The device can be used through the app by creating an account of the installed app.
Create account
■ The first time the user run the app, the user needs to create an account.
■ If the user already has an account, verify the account by name and password.
System Description
OS Android 5.0
CPU Quad-core 1.6GHz
RAM 2.0GB
LCD display 5.1inch display, 1080x1920

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■ If the user set up automatic login during the creation process, the account verification process
is skipped in the later execution.
■ The account requires user name and password.
■ The additional information may be used to verify the identity when the user lost the password.
■ The account is created after confirming that the name and password meet the conditions. The
conditions are as follow;
A) The name should not contain numbers or special characters.
B) The name must be at least 3 characters long.
C) There is no separate condition for the password, but the retyped password must be the
same.
If the user logs in successfully, the main screen will appear as below.

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CHAPTER 1- HOW TO USE
EYE CUP
It helps to block external light and guide the patient’s eyes properly with fixation LEDs.
Place the eye cup on the objective lens barrel of the device.

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CLAMPING USER’S SMARTPHONE ON THE DEVICE
Raise up the clamp to put the smartphone on the device.
Clamping is available maximum up to 78mm smartphone width.
Note.) Galaxy Smartphone width: Galaxy note 9 : 76.4mm, Galaxy note10+ : 77.2mm
Galaxy S20 ultra: 76mm, Galaxy S10+ : 74.1mm
Interface for user’s smartphone
The device is operated by mobile app by wired connection with the user’s smartphone using 0.3m
OTG cable.
■ One connector of the OTG cable is USB C type to be connected to the smartphone and the
other is a mini USB type to be connected to the mini USB port on the device.
■ If the device is powered on, the connected smartphone can recognize and operate it.
Permissions for user
■ External save : save video / image
■ Allow USB device access (twice) : Camera(Preview / Video or image capturing), LED light
control