MediWorks FC162 Automatic Fundus Camera User Manual

June 1, 2024
MediWorks

MediWorks-Logo

MediWorks FC162 Automatic Fundus Camera

MediWorks-FC162-Automatic-Fundus-Camera-Product

Product Information

Specifications

  • Size: Automatic
  • Camera Pixel: 15 Mega Pixels
  • Flash Mode: Natural white LED
  • Display: 5 full-touch LCD
  • Picture Format: JPEG, DICOM
  • Internal Storage: 16G
  • Data Connectivity: WIFI
  • White LED Spectrum Range: 400nm~750nm
  • Service Life: 5 years
  • Operating Temperature: +5~+40 degrees Celsius
  • Environment Relative Humidity: 90%, no condensation

Product Usage Instructions

Overview
The automatic fundus camera is designed for observing, photographing, and obtaining retinal images without mydriasis optometry. It has functions for taking photos, saving them, and viewing images in real time. The device is lightweight and portable, making it suitable for outpatient diagnosis.

Product Composition
The automatic fundus camera includes the host machine, liner, eye patch, lithium battery, support frame, and power adapter.

Intended Use
The automatic fundus camera is intended to automatically capture images of the human fundus without dilating the patient’s pupils. It is used for fundus examination in eye inspections, especially for retina-related diseases. The captured colourful fundus images aid ophthalmologists in diagnosis. The device can be used on adults and children by well-trained technicians.

Caution
Operate the automatic fundus camera strictly according to the instructions in the manual to avoid accidents, personal injuries, or damage to the device. Any use other than described is considered off-label use. Ensure compliance with all inspection and maintenance instructions.

Frequently Asked Questions (FAQ)

Is the automatic fundus camera safe for use on infants?
While it is not clear if the device causes serious light radiation to patients, it is recommended to adjust the illumination level to the lowest suitable level for the patient. Avoid testing infants repeatedly within 24 hours with this device to minimize risks.

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 by 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 have 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.
  • Lightweight 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, liner, eye patch, lithium battery, support frame and power adapter.

Intended Use

  • Intended Purpose
    The automatic fundus camera is intended to enable the automatic capturing of the images of the human fundus, without dilating the 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 colourful fundus images can provide evidence to the ophthalmologist for diagnosis purposes.

  • Intended Population
    The device can be applied to inspect the adults and the children.

  • Intended Users
    The device is intended to be usedthe well-trained technicians.

  • Contraindication
    It is not clear if the device will cause serious light radiation to the patient. However, it is suggested to adjust the illumination level to the lowest level which suits the patient. The risk to infant, aphasic patients 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, or 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: 32cm×21.5cm×12.5cm
Weight: 2.7kg
Minimum Pupil Diameter: 3mm
Focusing Mode: Automatic
Camera Pixel: 15 Mega Pixels
Flash Mode: Natural white LED
Display: 5” full touch LCD
Picture Format: JPEG, DICOM
Internal Storage: 16G
Data Connectivity: WIFI
White LED Spectrum Range: 400nm~750nm
Service Life: 5 years
Operating Environment Temperature
--- ---
Relative Humidity ≤90%, no condensation
  Atmospheric

Pressure

| 860hPa~1060hPa
---|---|---


Storage Environment

| Temperature| -40℃~+55℃
Relative Humidity| ≤90%, no condensation
Atmospheric

Pressure

| 860hPa~1060hPa


Transportation Environment

| Temperature| -40℃~+55℃
Relative Humidity| ≤90%, no condensation
Atmospheric

Pressure

| 860hPa~1060hPa
Field of View:| 50 degrees
---|---
Diopter Adjustment

Range:

| ****

-20D~+20D

Power Supply:| Rechargeable lithium battery DC14.4V 47.52Wh
Charger:| ~100-240V, 50-60Hz, 1.2A-0.5A
The Color Temperature

of the Camera Flash:

| ****

4500K≤TC≤6700K

Resolution Center of

View:

| ****

≥60lp/mm

Resolution at the Middle

of the Field of View:

| ****

≥40lp/mm

Resolution at the edge of

the field of view:

| ****

≥25lp/mm

Cautions

  • The device needs to be operated by trained and qualified personnel.
  • This is a medical device produced by the requirements of Chinese law.
  • Please read carefully the warnings and cautions before 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 in repairing.
  • Please use the charger specified by Shanghai MediWorks to prevent electric shock and damage to the device.
  • If the device breaks down: Smoke or emits a burning smell, please cut off the power and take out the battery to avoid a fire accident.
  • The device is not waterproof. 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 the 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 before usage. If you notice signs of damage or defect, please contact Shanghai MediWorks or its authorized distributors.
  • The battery on the device shall refer to the recommendation 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 remains 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 at 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 the biocompatibility test and are verified safe.

Graphic, Symbol and Warning Signs

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(1\) MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(2\) MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(3\) MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(4\)

Product Main safety features

  • Classification of the type of protection against electric shocks: Class II
  • Classification of the degree of protection against electric shocks: Type B.
  • Classification of the degree of protection against liquid: IPX0.
  • 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.
  • Classification by operating mode: continuous operation.
  • The spectrometer of the device is as follows:MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(5\)MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(6\)

EMC (Electromagnetic Compatibility)
FC162 automatic fundus camera (hereinafter referred to as FC162) complies with the International Electrotechnical Commission standards (IEC 60601 1 2) for electromagnetic compatibility as listed in the tables below. Follow the guidance in the tables for the 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 ensure that it is used in such an environment.

Emissions test| Compliance level| Electromagnetic environment-guidance
RF emissions CISPR 11| Group 1| The FC162 uses RF energy only for its internal function. Therefore, the RF emissions are extremely low and not likely to cause any

interference in nearby electronic equipment.

RF emissions

CISPR 11

| Class A| 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.

Harmonic emissions

IEC 61000-3-2

| Class A
Guidance and manufacturer’s declaration of electromagnetic immunity

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

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

Immunity test| IEC     60601     test level| Compliance level| Electromagnetic environment guidance
Electrostatic| ±6 kV contact| ±6 kV contact| Floor         should        be
Discharge

(ESD)        IEC

| ±8 kV air| ±8 kV air| wood, concrete,            or

ceramic tile. If floors are

61000-4-2|  |  | covered with synthetic
 |  |  | material,     the    relative

humidity   should   be at

 |  |  | At least 30%.
Electrical fast transient/ burst IEC 61000-4-4| ±2 kV

for power supply lines

| ±2 kV

for power supply lines

| The main power quality should be that of a typical commercial or

hospital environment.

Surge

IEC 61000-4-5

| ±1 kV

differential mode

| ±1 kV

differential mode

| The main power quality should be that of a typical commercial or

hospital environment.

Voltage,   dips,| <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

| Mains     power     quality
short| should    be    that    of   a
interruptions| typical    commercial    or
and       voltage| hospital environment. If
variations on

power    supply

| the  user   of  the  FC162

requires            continued

input lines| operation during power
IEC

61000-4-11

| 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 before application of the test level.
Guidance and manufacturer’s declaration of electromagnetic immunity

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

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

Immunity test| IEC 60601

test

level

| Compli ance level| Electromagnetic environment guidance
Conducted RF IEC 61000-4-6| 3 Vrms

150 kHz

to       80 MHz

| 3 Vrms (V1=3)| Portable and mobile RF communications equipment should be used no closer to any part of the FC162, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=1.2 P 150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

| 3 V/m

80 MHz

| 3 V/m

(E1=3)

| d=1.2    P 80 MHz to 800 MHz
 | to      2.5|  | d=2.3    P 800 MHz to 2.5 GHz
 | 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 broadcasts and TV broadcasts 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 be necessary, such as reorienting or relocating the FC162.

b: Over the frequency range of 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 output power of the transmitter

W

| Separation distance according to frequency of transmitter/m
150 kHz to 80 MHz

| 80 MHz to 800 MHz

| 800 MHz to 2.5 GHz

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.

Wireless Coexistence

Standard| Immunity Signal Type| Signal Frequency| Level| Result
---|---|---|---|---




AIM 7351731

Rev 3.00

2021-06-04

| ISO 14223| 134.2 kHz| 65 A/m| Pass
ISO/IEC 14443-3 (Type A)| 13.56 MHz| 7.5 A/m| Pass
ISO/IEC 14443-4 (Type B)| 13.56 MHz| 7.5 A/m| Pass
ISO/IEC 15693

(ISO/IEC 18000-3 Mode 1)

| 13.56 MHz| 5 A/m| Pass
ISO/IEC 18000-7| 433.92 MHz| 3 V/m| Pass
ISO/IEC 18000-63 Type C| 860-960 MHz| 54 V/m| Pass
ISO/IEC 18000-4 Mode 1| 2.45 GHz| 54 V/m| Pass

Electromagnetic Compatibility (EMC) of Medical Devices:

EAS:

Standard| Immunity Signal

Type

| Signal Frequency| Level| Result
---|---|---|---|---
Radiated Immunity in EAS band: 1~148.5 kHz (Refer to EN 303

|

CW

|

10 kHz~100 kHz

(10 kHz/spacing)

|

65 A/m

|

Pass

WPT:

Standard| Immunity Signal

Type

| Signal Frequency| Level| Result
---|---|---|---|---
Radiated Immunity in WPT band: 100~300 kHz and

6.78 MHz (Refer to EN

55011 and EN 303 417)

| CW| 100 kHz, 200 kHz,

300 kHz

| 65 A/m| Pass
CW| 6.78 MHz| 7.5 A/m| Pass

5G NR:

Nominal Band| Frequency Range| Signal

Frequency

| Level| Result
---|---|---|---|---
UP-LINK| DOWN-LINK
5G NR Band N12| 699 to 716

MHz

| 729 to 746 MHz| 729, 737.5,

746 MHz

| 23 dBm| Pass
5G NR Band N26| 814 to 849

MHz

| 859 to 894 MHz| 859, 876.5,

894 MHz

| 23 dBm| Pass
5G NR Band N71| 617 to 652

MHz

| 663 to 698 MHz| 663, 680,

698 MHz

| 23 dBm| Pass
5G NR Band N41| 2496-2690 MHz| 2496, 2593,

2690 MHz

| 29 dBm| Pass
5G NR Band N48| 3550-3700 MHz| 3.625 GHz| 23 dBm| Pass
5G NR Band N77| 3300-4200 MHz| 3.75 GHz,

4.2 GHz

| 23 dBm| Pass
5G NR Band N258|

24250-27500 MHz

| 24.5,

25.875, 27.5

GHz

|

35 dBm

|

Pass

5G NR Band N261|

27500-28350 MHz

| 27.5 GHz, 27.925,

28.35 GHz

|

35 dBm

|

Pass

5G NR Band

N260

| 37000-40000 MHz| 37, 38.5, 40

GHz

| 35 dBm| Pass

Wi-Fi 6E

|

5.925-7.125 GHz

| 6.015,

6.495, 7.015

GHz

|

30 dBm

|

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 of cable must be used to ensure compliance with interference radiation and immunity standards:

Cable Length (m)
Power Supply 1.5

Warning
The equipment or system shall not be used near or stacked with other equipment. If it must be approached or stacked, observe and verify that it can work under the configuration it is using.

Warning
Active medical devices subject to special EMC precautions, therefore, must be installed and used under 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 pay attention that changes or modifications 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 standard during product certification when properly Limb wore (0mm) on the extremity SAR is 1.03W/kg, and close to the mouth (0mm) SAR is 0.24W/kg.

Installation

Product List
Before 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 Quantity
1 FC162 Fundus Camera 1
2 Power Adaptor 1
3 Shipping Locking Screw 2
Product Composition

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(10\)

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.MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(11\)

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.

How to Charge
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 Status
The green light is always on. In the charging states, the battery is at full

capacity, or

simply use the network power (no battery)

The blue light is always on.| The device is charging.
No light| The device works only with a battery or it is off.

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 contacts 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.

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 photograph diagram to avoid direct contact with the machine on the face.

Shutdown Procedure
Press the power switch for 2 to 3 seconds. The screen enters the shutdown interface, as shown below:

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(15\)

You can tap [Shutdown] to turn off the device or [Back] to return to the previous interface.

Operation Interface

Main Interface
Start the device and enter the main interface, as shown in the figure below.

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(16\)

The main interface includes Patient, Capture, Album, and Settings.

Patient
Click the [Patient] button on the main interface to enter the patient information management, as shown below.

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(17\)

  1. Click the 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. MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(20\)
  4. Enter search criteria to search for patients.

Patient details
Click on any item in the patient list to view the details.

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(21\)

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.

Album
Click the [Album] button on the main interface or the patient details interface to enter the album, as shown in the figure below.

  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:

Settings

Language Setting

Click the [Language] button on the setting interface to enter the language setting interface. The language includes both Chinese and English languages.

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.

Date Time Setting
Click the [Date Time] button on the setting interface to enter the system time setting interface, and slide up and down in the selection box to select the time to change.

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.

MediWorks-FC162-Automatic-Fundus-Camera-Fig- \(26\)

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

Click the password input box to enter the password, click for confirmation, and wait for the connection. Click to abandon this connection.

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.

This interface presents 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.

Storage

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

About

Click the [About] button in the settings interface to check the system version information.

Cleaning, Maintenance and Protection

Cleaning, maintenance and protection correctly and regularly can ensure the normal operation status of the 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.

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 they 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.

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. 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 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.

Protection
After use, place the device in the mobile carrying case to avoid bumps.

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 remains 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.

Product Life Cycle
The life cycle of the automatic fundus camera is 5 years.

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| The battery is placed reversely.| Install the battery correctly according to the instructions

Exceptions

  1. Shanghai MediWorks Precision Instruments Co., Ltd. is not responsible for damage caused by fire, earthquake, third-party behaviour, other accidents, carelessness of the user, misuse, or use under abnormal conditions.
  2. Shanghai MediWorks Precision Instruments Co., Ltd. is not responsible for the deficit, bankruptcy, or any loss due to the inability 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 nameplate.
    • Date of purchase: Please tell us the date you purchased the device.
    • Fault: Please tell us as much as possible about the fault.

Contact Information

  • 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.

References

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