FC161 User Manual
FC161 User Manual
USER MANUAL
Model: FC161
Shanghai MediWorks Precision Instruments Co., Ltd.
Contents
1 Installation ....................................................................................................................................................... 10
Troubleshooting ............................................................................................................................................... 31
Exceptions ........................................................................................................................................................ 31
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Preface
Thank you for purchasing the hand-held fundus camera made by Shanghai MediWorks Precision
Instruments Co., Ltd. Here are some basic facts and performance parameters for the hand-held
fundus camera you purchased.
Overview
This user manual is part of the hand-held fundus camera. Instructions for use and technical
descriptions are given in this manual.
The user manual includes the device manual and technical manual. The equipment
classification for the hand-held fundus camera in accordance with the requirements of IEC
60601-1 is also given in this manual.
The markings specified in the IEC 60601-1 standard have been permanently attached to
the device and been explained in the manual.
This device is suitable for observing, photographing and obtaining retinal images for the
patient's fundus without dilation.
This device has the functions of taking photos, saving photos, and viewing images in real
time.
Light weight and portable. It can meet the carrying requirements of doctors for
out-of-patient diagnosis.
Performance Parameters
Size: 28cm×13cm×15cm
Weight: 800g
Field of view: 45degrees
Minimum pupil 3mm
diameter:
Diopter adjustment -20D~+20D
range:
Focusing mode: manual / automatic
Camera pixel: 12 Mega Pixels
Fundus lighting mode: Dual mode, natural white LED or infrared LED
Flash mode: Natural white LED
LCD display: 4.3” full touch LCD
Picture format: JPEG
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Interface: USB
External storage: Micro SD card.
Power: Rechargeable battery 3.7V/3400mAh, two sections
External power supply: Power supply: 100-240V~, 0.5A, 50-60Hz
Power conversion: DC +5V , 2.0A
The color temperature of 4500K≤TC≤6700K
the camera flash
Resolution center of ≥60 lp/mm
view
Resolution at the middle ≥40 lp/mm
of the field of view
Resolution at the edge of ≥25 lp/mm
the field of view
Near-infrared spectral 800nm~880nm
range
White LED spectrum 400nm~750nm
range
Service life 4 years
Temperature +5℃~+40℃
Operating Relative humidity ≤90%
environment Atmospheric
860hPa~1060hPa
pressure
Temperature -40℃~+55℃
Storage
environment Relative humidity ≤90%
Temperature Atmospheric
860hPa~1060hPa
pressure
Temperature -40℃~+55℃
Transportation Relative humidity ≤90%
environment Atmospheric
860hPa~1060hPa
pressure
Cautions
1 Date of manufacture
2 Manufacturer information
3 Reference instructions
5 CE Mark
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6 Power switch
9 Part Number
10 Serial Number
11 TYPE B
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Product main safety features
a) Device type classification: working mode: internal power supply device; charging mode: class
II device;
b) Classification according to the degree of protection against electric shock: Type B;
c) According to the degree of protection against harmful liquid: IPX0;
d) Classification according to the degree of safety when using flammable anesthetic gas mixed
with air or flammable anesthetic gas mixed with oxygen or nitrogen oxide: not applicable, not
used in the environment;
e) Classification by operating mode: continuous operation;
f) The spectrometer of the device is as follows:
Near-infrared Spectrum
Shooting Spectrum
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EMC (Electromagnetic Compatibility)
FC161 Hand-held fundus camera (hereinafter referred to as FC161) complies with the
International Electro technical Commission standards (IEC 60601-1-2) for electromagnetic
compatibility as listed in the tables below. Follow the guidance in the tables for use of the FC161 in
an electromagnetic environment.
The FC161 is intended for use in the electromagnetic environment specified below. The customer or
the user of the FC161 should assure that it is used in such an environment.
RF emissions Group 1 The FC161 uses RF energy only for its internal
function. Therefore, the RF emissions are extremely
CISPR 11 low and not likely to cause any interference in nearby
electronic equipment.
RF emissions Class A
The FC161 is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
connected to the public low voltage power supply
Harmonic N/A network that supplies buildings used for domestic
emissions purposes.
IEC 61000-3-2
Voltage N/A
fluctuations/
Flicker emissions
IEC 61000-3-3
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the FC161 is used exceeds the applicable RF compliance level
above, the FC161 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the FC161.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
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distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
1 Installation
1.1 Product List
Before you start using it, check that all of the following items are included in the product
packaging. If there is any missing, please contact Shanghai MediWorks or its authorized
distributors.
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1.2 Product Composition
Host Device
Charging Base
Power switch
Directional key
Focusing camera
button
Charging Station
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1.3 Installation of Battery
Open the battery compartment and insert the battery. Note that the two batteries are in the same
direction. The + poles of the two batteries face the battery cover as shown in the figure below. If the
direction is reversed, it will result in an inability to turn on the device.
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1.7 Operation Procedures
Step 1: Hold the device between thumb and index finger of one hand.
Step 2: Fix the fingers on patient's forehead and keep the Lens in horizontal level as showed below.
Step 3: Carefully move the device back and forth until the whole fundus is displayed on the screen.
There might be several situations happening during the process as showed in the table below:
Infrared display image Cause Schematic
The retina image is small The lens is too far from the
and does not fill the screen eye being checked.
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There is dark shadow on The lens is below the visual
the bottom of the image axis.
Step 4: Rotate the focus dial to the left or right to observe the blood vessels near the optic disc.
After the infrared image is clear, press the camera button to obtain a clear fundus image.
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2 Operation Interface Introduction
2.1 Main Interface
Patient information
management
Brightness
adjustment
Fixation
position
1. Brightness adjustment: Click the [Light] button, and the images brightness setting scroll bar
appears on the interface as shown below:
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Click any square box to select the location of the fixation target. After clicking, the selection
box will disappear automatically.
Click on the non-selection area to discard this setting and the selection box will disappear.
3. System Settings: Click the [Settings] button to enter the system setting interface (for details,
please refer to Section 2.6 of this chapter).
4. Patient Information Management: Click the [Patient] button to enter the patient information
management interface (for details, please refer to Section 2.2 of this chapter).
5. Album management: Click the [Album] button to enter the album interface (for details, please
refer to section 2.4 of this chapter).
6. Obtain pictures: Align the lens with patient's eye, let the patient stare at the internal fixation
targets, adjust the camera's focal length to the appropriate position, and click the [Capture]
button or the device's physical camera button to take the photo.
7. Left and right eye selection: Click the [OD/OS] selection button to select the left or right eye.
8. Auto shooting: Click the [AF] switch to turn on the AF mode. After aligning the eyes, the
device will automatically focus to take best pictures.
9. Manual shooting:Click the [MF/AF] switch to turn on the MF mode. After aligning the eyes,
manually adjust the focusing button until the image is clear by observing the sharpness of the
preview image. Click the [Capture] button or the device's physical camera button to take the
photo.
Note: Both the [album] and [capture] functions need to be operated after selecting or creating
new patient information.
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Patients list Filter
z
1. Add: Click on the [Add] button or any item in the patients list to enter the patient information
editing interface for patient information addition (see section 2.3 of this chapter for specific
operations).
2. Download: This operation downloads the test records that have been created in the Mediview
software, which is convenient for users to create test records in batches.
Click the [Download] button. If the server is not successfully logged in, a login prompt box
will pop up, as shown in the figure below. Click the [OK] button in the prompt box to enter
the login interface (for details, please refer to Section 2.6.3 of this chapter). If you abandon
the download operation, click the [Cancel] button.
If you have successfully logged in to the server, click [Download] and you will
automatically download the patient information that has been created in the Mediview
software, that contains the FC161 medical record to be tested, and pop up the download
progress prompt, as shown below.
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Cancel
download
Long press any item in the patients list, the operation button area and check box will appear
on the interface, as shown below:
Upload
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Patient record sorting can be displayed in ascending or descending order according to ID, creation
date or date of birth.
2.3 Patient Information Editing Interface
Click the [Add] button in the „Patient Information Management‟ interface or any item in the
patients list to enter the „Patient Information Edit‟ interface, as shown below.
ID or name: Click the ID or name input box to pop up the „keyboard‟, as shown below. After
entering the correct information, click the [√] button to return to the „Patient Information
Editing ‟interface.
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1. Gender: Click on the gender drop-down list and select gender.
2. Birthday: Click the birthday input box to pop up the birthday selection box. After selecting the
birthday, click „OK‟ on the left to complete the selection.
Image select
1. View image details: Click any image to view the larger image (see section 2.5 of this chapter
for details).
2. Image Delete: This function is used to delete one or more images.
Click the [Image Select] button or long press on an image, the check box appears in the
interface, as shown below.
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Select all
Select one or several images (click [Select All], select all images, and click again to cancel
all selection), the [delete] button will appear at the top of the interface.
Click the [Delete] button and click OK in the confirmation prompt box that pops up to delete
the selected image.
If the user needs to cancel the selection, click the [Image select] button again.
Note: The above images are for reference only, not actual pictures.
1. Image deletion: Click the [Delete] button and click OK in the confirmation dialog box that pops
up to delete the image.
2. Return to shooting: Click the [Capture] button to enter the shooting interface.
3. Return to the album: Click the [Back] button to return to the album interface.
4. Image expansion: Double-click the image or double-finger to hold the image and zoom in and
out.
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Swipe up and down in the system time selection box to select the time to be modified.
Click the [OK] button to complete the time selection.
Click the [Cancel] button to discard this setting and return to the settings interface.
2.6.3 Server Login
Click the [Server] button in the setting interface to enter the server login interface, as shown below.
The login operation needs to be performed under the condition that the WIFI connection is
successful.
Enter the correct login information in the login information input box.
Username and password: The username and password must be the same as the username and
password created on the Mediview server.
IP: The user must know the IP address and port of the server. If the server is in the LAN, the
IP address is the IP address of the computer where the server is located. If the server is on
the Internet, you need to add the corresponding IP address.
WiFi: check the IP address of the WiFi connected to the computer.
USB : Ceck the ehernet ip address (192.168.2.XXX) on the computer, where XXX is
automatically assigned by the computer, such as (192.168.2.11).
Port: The server port defaults to 8080. If the server modifies this port, you must fill in the
modified port number.
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Auto: select auto upload mode from the drop-down list.
1. New Photo: After logging in successfully, only the new photo will be uploaded to the
server.
2. All: After successful login, all the photos not uploaded on the device will be uploaded to
the server.
Manual: Select the manual upload mode from the drop-down list. After logging in, select the
patients to be uploaded from the patient list and upload them to the server.
During uploading photo, the title bar at the top of the interface will display the upload
progress and speed of each photo.
After completing the above process, click the [OK] button to log in. After successful login,
it will automatically return to the previous interface, and the „Logged In‟ icon will appear at
the top of the interface. “Login failed” prompt is displayed after login failure.
2.6.4 ‘Sleep’ Mode Setting
Click the [Sleep] button in the setting interface to enter the standby time setting interface, as shown
in the figure below.
Slide the standby time scroll bar to select the standby time.
After completing the selection, click the [OK] button to complete the standby time setting
and return to the setting interface.
Click the [Back] button to discard this setting and return to the setting interface.
2.6.5 Network Setting
Click the [Network] button in the setting interface to enter the wireless LAN interface. The list
shows all the wireless LANs that have been searched, as shown in the figure below:
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Refresh
Prompt connected
WLAN switch
WLAN list
Click the [Refresh] button, the list will be refreshed, and the searched WLANs will be
redisplayed.
Click [WLAN Switch] to turn off or restart the WLAN function.
Click [Back] icon to return to the setting interface.
2.6.6 WLAN Connection
Click the WIFI to be connected in the WIFI list, enter the password input interface, as shown in the
figure below.
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Click the [Disconnect] button to disconnect the connected WIFI.
Select [Static] in the DHCP drop-down list and the edit box will become editable, as shown
in the figure below.
Enter the correct configuration information in the “WIFI Configuration Input Area” and
click the [OK] button to complete the configuration.
Click the [Back] button to discard this modification and return to the WIFI list.
Note: 1. If WIFI has not set a password, click the WIFI and connect directly.
2. The input information in the figure is only an example and has nothing to do with the
actual input.
2.6.8 About
Click the [About] button in the setting interface to enter the „about’ interface, as shown below.
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Click the [Back] button to return to the setting interface.
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3 Cleaning, Maintenance and Protection
Cleaning, protection and maintenance in a correct and regular way can help extend the life of
hand-held fundus camera. The maintenance period of the hand-held fundus camera is 3 months.
Maintenance should be performed every 3 months.
Hand-held fundus cameras are precise optical devices, so be sure to handle them gently.
3.1 Cleaning
1. Cleaning the outer surface of the lens: If the outer surface of the lens is exposed to the air or in
a non-clean environment for a long time, and the surface of the lens is dusty, gently wipe it
with soft cotton moistened with anhydrous alcohol, or use a special lens cleaner and cleaning
cloth to clean it.
Note: When the device is not in use, please cover the lens cap to prevent dust on the lens
surface.
2. Clean the screen: If dust sticks to the screen, gently wipe it with soft cotton moistened with
anhydrous alcohol, or use a special screen cleaner and cleaning cloth to clean it.
Note: Do not wipe with hard objects.
3. Clean plastic parts: To clean plastic parts such as the main unit, use a soft cloth dipped in
soluble detergent or water to clean the dirt, and then wipe it with medical alcohol.
Note: Do not use any abrasive cleaning agents to wipe, as it may damage the surface.
4. Clean the protection cover: The protection cover is a component that comes in frequent contact
with the patient. Cleaning and disinfection should be performed before each patient is
examined. Clean the dirt with a soft cloth dampened with a soluble cleaner or water, then wipe
with medical alcohol.
Note: Since the protection cover is made of silicone, please do not wipe it with any corrosive
cleaning agents or organic solvents, so as not to damage the protection cover.
3.2 Maintenance
The hand-held fundus camera should be used in a relatively clean environment. The main parts that
need to be cleaned are described in Chapter 3.1. In order to ensure the normal use of the hand-held
fundus camera, it is recommended to perform cleaning operations every 3 months. After cleaning,
wait until the equipment is dry before using it.
Because the surface of the lens and reflector is coated with an antireflection coating and a reflective
film, although the coating is strong enough, frequent wiping tends to cause damage to the film,
which affects the optical effect of observation. This cycle is only a suggestion. If the lens has a
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particularly large amount of dust that has affected the quality of observation, it is recommended to
clean it immediately according to the prescribed method.
3.3 Protection
1. When the hand-held fundus camera is not in use, the lens cap should be covered, and the lens cap
should be removed when in use.
2. After use, place the device in the carrying case to avoid bumps.
3.4 Battery Care
1. After the battery is fully charged, unplug the power cord to avoid overcharging or danger.
2. When the device is not used for a long time, the batteries should be removed and placed in the
corresponding position in the carrying case.
3. When the device is not used for a long time, the batteries should be charged every 3 months.
3.5 Product Life Cycle
The life cycle of the hand-held fundus camera is 4 years. Since the date of delivery, Shanghai
MediWorks Precision Instruments Co., Ltd. provides 1 year warranty on the host and the standard
SD card.
Troubleshooting
If a fault occurs, please check it according to the following table for guidance. If the fault is still not
rectified, please contact Shanghai MediWorks Precision Instruments Co., Ltd or its authorized
distributors.
It will be dark after booting The battery is exhausted Fully charge the battery before use
Exceptions
1. Shanghai MediWorks Precision Instruments Co., Ltd. is not responsible for damage caused by
fire, earthquake, third party behavior, other accidents, and carelessness of the user, misuse, or use
under abnormal conditions.
2. Shanghai MediWorks Precision Instruments Co., Ltd. is not responsible for the deficit, bankrupt,
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and any loss due to unable to use this device.
3. Shanghai MediWorks Precision Instruments Co., Ltd. is not liable for any damage to the
operation not described in the instruction.
4. Diagnosis is the responsibility of the doctors, and Shanghai MediWorks Precision Instruments
Co., Ltd. is not responsible for the results of those diagnoses.
5. The hand-held fundus camera provides about 10G of space for data storage. Please back up the
data in time. Shanghai MediWorks Precision Instruments Co., Ltd. is not responsible for the
personal data stored in the product.
6. The SD card is used as a storage medium, please back up the data in time. Shanghai MediWorks
Precision Instruments Co., Ltd. will not be responsible for the SD card data security and data
damage, as well as data loss due to SD card damage.
Version1.0 20200713
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