User Manual for MediWorks models including: FC162, FC162 Automatic Fundus Camera, Automatic Fundus Camera, Fundus Camera, Camera

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User Manual

Shanghai MediWorks Precision Instruments CO., Ltd. FC162 2BFI4FC162 2BFI4FC162 fc162


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Automatic Fundus Camera
USER MANUAL
Model: FC162
Shanghai MediWorks Precision Instruments Co., Ltd.

Automatic Fundus Camera USER MANUAL
Contents Preface ·······················································································································3
Overview ················································································································3 Product Composition ······························································································3 Intended Use ··········································································································3 Performance Parameters ·························································································4 Graphic, Symbol and Warning Signs·······································································6 Product Main safety features···················································································8 EMC (Electromagnetic Compatibility) ···································································9 Wireless Coexistence····························································································13 1 Installation·············································································································16 1.1 Product List ····································································································16 1.2 Product Composition ······················································································16 1.3 Remove the Transport Lock ············································································16 1.4 Installation of Battery ·····················································································17 1.5 How to Charge································································································18 1.6 Operation Procedures······················································································18 1.7 Shutdown Procedure ·······················································································19 2 Operation Interface································································································19 2.1 Main Interface ································································································19 2.2 Patient ············································································································20 2.3 Capture···········································································································21 2.4 Album·············································································································21 2.5 Settings···········································································································22 3 Cleaning, Maintenance and Protection···································································25 3.1 Cleaning ·········································································································25 3.2 Maintenance ···································································································25 3.3 Protection ·······································································································26
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Automatic Fundus Camera USER MANUAL
3.4 Battery Care····································································································26 3.5 Product Life Cycle··························································································26 Troubleshooting ·······································································································27 Exceptions ················································································································27
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Automatic Fundus Camera USER MANUAL
Preface
Thank you for purchasing the automatic fundus camera made by Shanghai MediWorks Precision Instruments Co., Ltd. Here are some basic facts and performance parameters for the automatic fundus camera you purchased.
Overview
 This user manual is part of the automatic 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 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 without mydriasis optometry.
 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.
Product Composition
The automatic fundus camera consists of the host machine, lianr, eye patch, lithium battery, support frame and power adapter.
Intended Use
 Intended Purpose The automatic fundus camera is intended to enable automatically capturing the images of human fundus, without dilating patient's pupils.
 Indications for Use The automatic fundus camera is intended for use in eye inspection of the fundus, for example, retina related disease examination. The captured colorful fundus images can provide the evidence to the ophthalmologist for diagnosis purpose.
 Intended Population The device can be applied to inspect the adults and the children.
 Intended Users The device is intended to use by the well trained technicians.
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Automatic Fundus Camera USER MANUAL

 Contraindication It is not clear that if the device will cause serious light radiation to the patient. But it is suggested to adjust the illumination level to the lowest level which suits the patient. The risk to infant, aphasic patient will increase. Please don't test the patient repeatedly during 24 hours with this device.

Caution The automatic fundus camera must be operated exclusively with the guidance described in this manual. Any other use of the device is considered Off Label use. Failure to observe these instructions may result in an accident, personal injury, damage to the device and accessories. Proper and intended use includes compliance with all inspection and maintenance instructions, along with the observance of all instructions in the manual.

Performance Parameters
Size: Weight: Minimum Pupil Diameter: Focusing Mode: Camera Pixel: Flash Mode: Display: Picture Format: Internal Storage: Data Connectivity: White LED Spectrum Range: Service Life:

32cm×21.5cm×12.5cm 2.7kg 3mm
Automatic 15 Mega Pixels Natural white LED 5" full touch LCD JPEG, DICOM
16G WIFI 400nm~750nm 5 years

Operating

Temperature

Environment Relative Humidity

+5~+40 90%, no condensation

4

Storage Environment
Transportation Environment

Atmospheric Pressure
Temperature Relative Humidity
Atmospheric Pressure
Temperature Relative Humidity
Atmospheric Pressure

Automatic Fundus Camera USER MANUAL
860hPa~1060hPa 40~55 90%, no condensation 860hPa~1060hPa 40~55 90%, no condensation 860hPa1060hPa

Field of View: Diopter Adjustment
Range: Power Supply:
Charger: The Color Temperature of the Camera Flash: Resolution Center of
View: Resolution at the Middle
of the Field of View: Resolution at the edge of
the field of view:

50 degrees -20D~+20D Rechargeable lithium battery DC14.4V 47.52Wh ~100-240V, 50-60Hz, 1.2A-0.5A 4500KTC6700K
60lp/mm
40lp/mm
25lp/mm

Cautions
 The device needs to be operated by trained and qualified personnel.  This is a medical device produced in accordance with the requirements of Chinese law.  Please read carefully the warnings and cautions prior to using the device.  To avoid damaging the device, please operate the device according to this user manual.  To avoid electric shock, do not insert metal objects into the holes or slots of the device. Do not disassemble and repair the device by yourself. If you have any questions, please contact Shanghai MediWorks or its authorized distributors. The authorized distributors will provide the necessary information to assist repairing.

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Automatic Fundus Camera USER MANUAL
 Please use the charger specified by Shanghai MediWorks to prevent electric shock and damage to the device.  If the device breaks down: Smoke or emit a burning smell, please cut off the power and take out the battery to avoid fire accident.  The device is not water proof. To prevent fire, electric shock, short circuit and other hazards, please don't put the device close to water. If the device is wet, don't use bake, microwave, or high pressure to dry the device.  To avoid looseness caused by vibration of the device, please place the device in the box when the device is not in use.  The device should be put in a clean environment which must be away from fire sources.  Please check if the device has been damaged prior to usage. If you notice signs of damage or defect, please contact Shanghai MediWorks or its authorized distributors.  The battery on device shall refer to the recommendation or provided by Shanghai MediWorks. The battery specification is 14.4V, 3300mAh. If the user uses other batteries, Shanghai MediWorks won't be responsible for any loss caused by this.  If the device is to be stored or remain unused for a month or longer, please remove the battery after it is fully charged.  Do not use the device while it is charging to avoid danger.  Before removing the battery, ensure the power supply is disconnected and the device is turned off. Do not remove the battery while the device is in work. Do not turn on the device without a battery installed.  The mask is an integral part of the product, and the patient should wear the mask before being tested.  The mask is a disposable consumable. Please purchase it from Shanghai MediWorks or its authorized distributors.  The device poses no residual biocompatibility risks as the materials in contact with the patient have passed biocompatibility test and verified safe.
Graphic, Symbol and Warning Signs

No.

Mark

Description

1

Date of manufacture

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Automatic Fundus Camera USER MANUAL

2

Refer to instruction manual

3

WEEE, please dispose of the waste generated by the machine in accordance with relevant laws and regulations

4

CE Mark

5

Power switch

6

TYPE B applied part

7

Class II equipment

8

Manufacturer

9

PN

Part Number

10

Catalogue number

11

Serial Number

12

Authorized representative in the European Community / European Union

13

Medical device

14

Unique Device Identifier

15

Rechargeable battery

16

Direct current

17

Class 1 laser product

18

Warning

19

This way up

20

Fragile, handle with care

21

Keep dry

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Automatic Fundus Camera USER MANUAL

22

Stacking limit by number

23

Stacking limit by mass

24

Temperature limit

25

Humidity limit

26

Atmospheric pressure limit

Product Main safety features
a) Classification of the type of protection against electric shocks: Class II b) Classification of the degree of protection against electric shocks: Type B. c) Classification of the degree of protection against 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:
1.5
1
0.5
0 250 500 750 1000 1250 1500 1750 2000 2250 2500 /nm
Shooting Spectrum

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Automatic Fundus Camera USER MANUAL

Near-infrared Spectrum

EMC (Electromagnetic Compatibility)
FC162 automatic fundus camera (hereinafter referred to as FC162) 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 FC162 in an electromagnetic environment.

Guidance and manufacturer's declaration ­ electromagnetic emissions The FC162 is intended for use in the electromagnetic environment specified below. The customer or the user of the FC162 should assure that it is used in such an environment. Emissions test Compliance level Electromagnetic environment-guidance

RF emissions Group 1

The FC162 uses RF energy only for its internal

CISPR 11

function. Therefore, the RF emissions are

extremely low and not likely to cause any

RF emissions Class A

CISPR 11

Harmonic emissions

Class A

IEC 61000-3-2

interference in nearby electronic equipment.

The FC162 is suitable for use in all

establishments,

including

domestic

establishments and those directly connected to

the public low voltage power supply network

that supplies buildings used for domestic

purposes.

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Automatic Fundus Camera USER MANUAL

Guidance and manufacturer's declaration electromagnetic immunity

The FC162 is intended for use in the electromagnetic environment specified below. The

customer or the user of the FC162 should assure that it is used in such an environment.

Immunity test IEC 60601 test Compliance level Electromagnetic

level

environment guidance

Electrostatic ±6 kV contact

Discharge

±8 kV air

(ESD) IEC

61000-4-2

±6 kV contact ±8 kV air

Electrical fast ±2 kV

±2 kV

transient/ burst for power supply for power supply

IEC 61000-4-4 lines

lines

Surge

±1 kV

IEC 61000-4-5 differential mode

±1 kV differential mode

Voltage, dips, short interruptions and voltage variationson power supply input lines
IEC
61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT)

for 5 sec

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT)
for 5 sec

Floor should be

wood,concrete,

or

ceramic tile. If floors are

covered with synthetic

material, the relative

humidity should be at

least 30%.

Mains power quality

should be that of a

typical commercial or

hospital environment.

Mains power quality

should be that of a

typical commercial or

hospital environment.

Mains power quality

should be that of a

typical commercial or

hospital environment. If

the user of the FC162

requires

continued

operation during power

mains interruptions, it is

recommended that the

FC162 be powered from

an uninterruptible power

supply or a battery.

Power

3 A/m

3 A/m

Power

frequency

frequency

magnetic fields should

(50Hz)

be

at

levels

magnetic field

characteristic of a

IEC 61000-4-8

typical location in a typical commercial or

hospital environment.

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

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Automatic Fundus Camera USER MANUAL

Guidance and manufacturer's declaration electromagnetic immunity

The FC162 is intended for use in the electromagnetic environment specified below. The

customer or the user of the FC162 should assure that it is used in such an environment.

Immunity test IEC

Compli Electromagnetic environment guidance

60601 ance

test

level

level

Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications

IEC 61000-4-6 150 kHz (V1=3) to 80

equipment should be used no closer to any part of the FC162, including cables, than the recommended separation distance calculated from

MHz

the equation applicable to the frequency of the transmitter.

Recommended separation distance

Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz (E1=3)
to 2.5 GHz

d=1.2 P 150 kHz to 80 MHz
d=1.2 P 80 MHz to 800 MHz
d=2.3 P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b. Interference may occur in the vicinity 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 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 FC162 is used exceeds the applicable RF compliance level above, the FC162 should be observed to verify normal operation. If abnormal performance is observed, additional measures may

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Automatic Fundus Camera USER MANUAL
be necessary, such as reorienting or relocating theFC162. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications

equipment and the FC162

The FC162 is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the FC162 can help prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the FC162 as recommended

below, according to the maximum output power of the communications equipment.

Rated maximum Separation distance according to frequency of transmitter/m

output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

transmitter W

d=1.2 P

d=1.2 P

d=2.3 P

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 transmitters rated at a maximum output power not listed above, the recommended separation 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.

12

Wireless Coexistence

Automatic Fundus Camera USER MANUAL

Standard
AIM 7351731 Rev 3.00
2021-06-04

Immunity Signal Type ISO 14223
ISO/IEC 14443-3 (Type A) ISO/IEC 14443-4 (Type B)
ISO/IEC 15693 (ISO/IEC 18000-3 Mode 1)
ISO/IEC 18000-7 ISO/IEC 18000-63 Type C ISO/IEC 18000-4 Mode 1

Signal Frequency 134.2 kHz 13.56 MHz 13.56 MHz
13.56 MHz
433.92 MHz 860-960 MHz
2.45 GHz

Level 65 A/m 7.5 A/m 7.5 A/m
5 A/m
3 V/m 54 V/m 54 V/m

Result Pass Pass Pass
Pass
Pass Pass Pass

Electromagnetic Compatibility (EMC) of Medical Devices:

EAS:

Standard

Immunity Signal Type

Signal Frequency

Radiated Immunity in

EAS band: 1~148.5 kHz (Refer to EN 303

CW

10 kHz~100 kHz (10 kHz/spacing)

454)

Level 65 A/m

Result Pass

WPT:

Standard

Immunity Signal Type

Signal Frequency

Level

Radiated Immunity in WPT band: 100~300 kHz and

CW

100 kHz, 200 kHz, 300 kHz

65 A/m

6.78 MHz (Refer to EN 55011 and EN 303 417)

CW

6.78 MHz

7.5 A/m

Result Pass Pass

13

5G NR: Nominal Band
5G NR Band N12
5G NR Band N26
5G NR Band N71
5G NR Band N41 5G NR Band N48 5G NR Band N77
5G NR Band N258
5G NR Band N261
5G NR Band N260
Wi-Fi 6E

Automatic Fundus Camera USER MANUAL

Frequency Range

Signal

UP-LINK DOWN-LINK Frequency

699 to 716 MHz

729 to 746 MHz

729, 737.5, 746 MHz

814 to 849 MHz

859 to 894 MHz

859, 876.5, 894 MHz

617 to 652 MHz

663 to 698 MHz

663, 680, 698 MHz

2496-2690 MHz

2496, 2593, 2690 MHz

3550-3700 MHz

3.625 GHz

3300-4200 MHz

3.75 GHz, 4.2 GHz

24.5,

24250-27500 MHz

25.875, 27.5

GHz

27.5 GHz,

27500-28350 MHz

27.925,

28.35 GHz

37000-40000 MHz

37, 38.5, 40 GHz

6.015,

5.925-7.125 GHz

6.495, 7.015

GHz

Level 23 dBm 23 dBm 23 dBm 29 dBm 23 dBm 23 dBm 35 dBm
35 dBm 35 dBm 30 dBm

Result Pass Pass Pass Pass Pass Pass Pass
Pass Pass Pass

Warning

In addition to transducers and cables sold by the manufacturer of the equipment or system as spare parts for internal components, the use of accessories, transducers and cables other than those specified can result in increased emission or reduced immunity of the equipment or system. The following type cable must be used to ensure compliance with interference radiation and immunity standards:

Cable Power Supply

Length (m) 1.5

Warning The equipment or system shall not be used in close proximity to or stacked with other

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Automatic Fundus Camera USER MANUAL
equipment. If it must be approached or stacked, observe and verify that it can work under the configuration it is using.
Warning Active medical device subject to special EMC precautions, therefore, must be installed and used in accordance with these guidelines.
Warning Portable and mobile communication RF equipment may affect the use of medical electrical equipment.
Basic property description Before, during and after the test, the equipment works normally, the imaging is clear, and there is no flicker or black screen.
Warning This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.
Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
The FCC SAR limit for extremity SAR is 4.0W/kg (10g) and head SAR is 1.6W/kg (1g). The highest SAR value reported under this this standard during product certification when properly Limb worn (0mm) on the extremity SAR is 1.03W/ kg, and close to mouth (0mm) SAR is 0.24W/kg.
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1 Installation

Automatic Fundus Camera USER MANUAL

1.1 Product List

Prior to usage, 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.

No.

Part Name

1

FC162 Fundus Camera

2

Power Adaptor

3

Shipping Locking Screw

Quantity 1 1 2

1.2 Product Composition

Flip Screen

Lens Cover Logo

Eye Patch

Status Indicator

Power Switch Battery Cover

1.3 Remove the Transport Lock
The lower part of the device is equipped with a locking screw, which is used to lock the internal mechanism during transportation, as shown in the figure below. Before using the device, remove the locking screw (open the support frame and unscrew the screw), and place the screw in the packing box to prevent loss. When the device needs to be transported, be sure to tighten the locking screw, and then put the device in the mobile carrying case. Otherwise, there may be a risk of damage to the device.

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Automatic Fundus Camera USER MANUAL
Locking screw · Support frame
1.4 Installation of Battery
Flip up the screen as presented in the figure below, open the battery cover and insert the battery. Note that the battery notch should be loaded left-side inward, as shown in the figure below. If the direction is reversed, the battery assembly cannot be inserted (the battery cannot be inserted into the slot). Excessive force may cause damage. After installing the battery, close the battery cover and lock it.
17

1.5 How to Charge

Automatic Fundus Camera USER MANUAL

Plug the power adapter into the power port at the side of the device, and plug the adapter into the power socket, and the fundus camera will automatically be charged.

Power indication
The green light is always on.
The blue light is always on. No light

Status In the charging states, the battery is at full capacity, or simply use the network power (no battery) Device is charging. The device works only with battery or it is off.

1.6 Operation Procedures

Step 1: Open the support frame and place the device on the table steadily. Step 2: Turn on the device, ask the patient to move close to the eye patch (which is an applied part) and ensure the face contact the patch. Step 3: Keep the eyes looking straight forward at the lens and then follow the device's instructions, as shown in the figure below.

Photographing diagram Note: The device comes with disposable masks. Before the test, the subject will take a mask and wear it on the eye, and then take the picture as shown in the photographing
18

Automatic Fundus Camera USER MANUAL
diagram to avoid direct contact with the machine on the face.
1.7 Shutdown Procedure
Press the power switch for 2 to 3 seconds. The screen enters the shutdown interface, as shown below:
You can tap [Shutdown] to turn off the device or [Back] to return to the previous interface.
2 Operation Interface 2.1 Main Interface
Start the device and enter the main interface, as shown in the figure below.
Battery status
Main interface includes Patient, Capture, Album, and Settings.
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Automatic Fundus Camera USER MANUAL

2.2 Patient

Click the [Patient] button on the main interface to enter the patient information

management, as shown below.

Create a patient

Search

Sort
1. Click button to create a patient. 2. Click the button to return to the main interface. 3. Click the [Sort] button to sort the patient list according to ID, creation date or birth date.
4. Enter search criteria to search for patient.  Patient details Click on any item in the patient list to view the details.
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Automatic Fundus Camera USER MANUAL

2.3 Capture
Click the [Capture] button on the main interface or any interface to start capture. Follow the vocal guidance provided by the device along with the capturing process till it is completed.
2.4 Album
Click the [Album] button on the main interface or the patient details interface to enter the album, as shown in the figure below.

Select

Capture

1. Image deletion: Click the [Selet] button, tick the image to be deleted, and click the [Delete] button to delete it. 2. Capture: Click the [Capture] button to enter the capture state. 3. Click on the picture to enter the single preview mode, as shown in the figure below:

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Automatic Fundus Camera USER MANUAL
2.5 Settings
2.5.1 Language Setting
Click the [Language] button on the setting interface to enter the language setting interface. The language includes both Chinese and English languages.
2.5.2 Date Format Setting
Click the [format] button on the setting interface to enter the date format setting interface, and slide the scroll bar to select the date format.
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Automatic Fundus Camera USER MANUAL
2.5.3 Date Time Setting
Click the [Date Time] button on the setting interface to enter the system time setting interface, slide up and down in the selection box to select the time to change.
2.5.4 Network Setting
Click the [Network] button on the setting interface to enter the network setting interface. The WIFI list displays all the WIFI servers that have been searched, as shown in the figure below.

Connected prompt

Refresh

2.5.4.1 WIFI connection Click the preferred WIFI server in the list and enter the password via input interface, as shown in the figure below.

Back OK
Click the password input box to enter the password, click for confirmation, and wait for the connection. Click to abandon this connection. 2.5.4.2 WIFI configuration It is used to present the configuration of connected WIFI. Click the connected WIFI in the WIFI list to enter the interface, as shown in the figure below.
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Automatic Fundus Camera USER MANUAL

Disconnect

Back

This interface presents the information such as the IP address of the connected WIFI. Note: The information in the figure is only an example and has nothing to do with the actual WIFI information.
2.5.5 Storage

Click the [Storage] button on the setting interface to check the storage usage of the system.
2.5.6 About

Click the [About] button in the setting interface to check the system version information.
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3 Cleaning, Maintenance and Protection

Automatic Fundus Camera USER MANUAL

Cleaning, maintenance and protection in a correct and regular way can ensure the normal operation status of device. Maintenance shall be carried out every 2 months according to the method prescribed in Section 3.2-3.4. FC162 is a sophisticated optical device, so be sure to handle it with care.
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. Note: When the device is not in use, please cover the lens cap to avoid 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. Note: Do not wipe with hard objects. 3. Clean plastic parts: To clean plastic parts such as the device surface, 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, as it may damage the surface. 4. Clean the eye patch: The eye patch 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 eye patch is made of silicone, please do not wipe it with any corrosive cleaning agents, so as not to damage it.
3.2 Maintenance
The automatic 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 fundus camera, it is recommended to perform cleaning operations every 2 months. After cleaning, wait until the device is dry before using it. Because the surface of the lens is coated with an antireflection coating and a reflective film, although the coating is strong enough, frequent wiping tends to cause damage to

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Automatic Fundus Camera USER MANUAL
the film, which affects the optical effect of observation. This cycle is only a suggestion. If the lens has a 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
After use, place the device in the mobile 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. If the device is to be stored or remain unused for a month or longer, we recommend that you remove the battery after it is fully charged and place it in the portable packing box. 3. Before removing the battery, please ensure that it is fully charged, and recharge the battery every month.
3.5 Product Life Cycle
The life cycle of the automatic fundus camera is 5 years.
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Automatic Fundus Camera USER MANUAL

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.

Fault

Possible Cause

Solution

It will be dark after booting The battery is exhausted. Fully charge the battery before use

Does not boot

Install the battery correctly Battery is placed reversely.
according to the instructions

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, 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.

Model:

FC162

Serial Number: See it on the product name plate.

Date of purchase: Please tell us the date you purchased the device.

Fault:

Please tell us as much as possible about the fault.

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Automatic Fundus Camera USER MANUAL

Production date: see label

Version 1.7

20240410
Shanghai MediWorks Precision Instruments Co., Ltd. No.7, MingPu Phase II, No.3279 SanLu Road, MinHang District, 201100,
Shanghai, China Tel: 0086-21-54260421; Fax: 0086-21-54260425
Email: international@mediworks.biz www.mediworks.biz
Company Name: CMC Medical Devices & Drugs SL Company Address: C/ Horacio Lengo N18, Málaga, 29006, Spain
Email: info@cmcmedicaldevices.com
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References

Microsoft Word for Microsoft 365