Summary of Contents for MediWorks FC162
- Page 1 Automatic Fundus Camera USER MANUAL Model: FC162 Shanghai MediWorks Precision Instruments Co., Ltd.
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Page 2: Table Of Contents
Automatic Fundus Camera USER MANUAL Contents Preface · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · 3 Overview ·... - Page 3 Automatic Fundus Camera USER MANUAL 3.4 Battery Care· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · 26 3.5 Product Life Cycle ·...
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Page 4: Preface
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. -
Page 5: Performance Parameters
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. - Page 6 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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Page 7: Graphic, Symbol And Warning Signs
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. - Page 8 Automatic Fundus Camera USER MANUAL Refer to instruction manual WEEE, please dispose of the waste generated by the machine in accordance with relevant laws and regulations CE Mark Power switch TYPE B applied part Class II equipment Manufacturer Part Number Catalogue number Serial Number Authorized representative in the European Community /...
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Page 9: Product Main Safety Features
Automatic Fundus Camera USER MANUAL Stacking limit by number Stacking limit by mass Temperature limit Humidity limit 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. -
Page 10: Emc (Electromagnetic Compatibility)
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... - Page 11 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 60601...
- Page 12 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 Compli...
- Page 13 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...
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Page 14: Wireless Coexistence
Automatic Fundus Camera USER MANUAL Wireless Coexistence Standard Immunity Signal Type Signal Frequency Level Result 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 AIM 7351731 ISO/IEC 15693 Rev 3.00... - Page 15 Automatic Fundus Camera USER MANUAL 5G NR: Frequency Range Signal Nominal Band Level Result Frequency UP-LINK DOWN-LINK 699 to 716 729, 737.5, 5G NR Band N12 729 to 746 MHz 23 dBm Pass 746 MHz 814 to 849 859, 876.5, 5G NR Band N26 859 to 894 MHz 23 dBm...
- Page 16 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.
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Page 17: Installation
Automatic Fundus Camera USER MANUAL Installation 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. Part Name Quantity... -
Page 18: Installation Of Battery
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. -
Page 19: How To Charge
Automatic Fundus Camera USER MANUAL 1.5 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 In the charging states, the battery is at full capacity, or The green light is always on. -
Page 20: Shutdown Procedure
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. -
Page 21: Patient
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. -
Page 22: Capture
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. -
Page 23: Settings
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. -
Page 24: Date/Time Setting
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. - Page 25 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.
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Page 26: Cleaning, Maintenance And Protection
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. -
Page 27: Protection
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. -
Page 28: Troubleshooting
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. - Page 29 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...
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