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Huvitz HFC-1 User Manual

Huvitz HFC-1
36 pages
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Product Description
DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 1 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
[Summary]
Applied Standard
MDR 2017/745
2
MDD 93/42/EEC
Product Name Fundus camera
Model/Type
H
FC
-
1
(with Webviewer software)
Manufacture Name Huvitz Co.,Ltd.
Manufacture’s
Address
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si
Gyeonggi-Do, 14055, Republic of Korea
Homepage: www.huvitz.com
Trade Mark Huvitz
Comment
Prepared By
R&D Project Leader Sang Jeon,
Park
2020.06.08
Reviewed By
Q.M Manager Hyung Min, Heo
2020.06.08
Approved By
Q.M Leader Lee Chang-Soo
2020.06.08
Date of issue
2020.06.08.

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Huvitz HFC-1 Specifications

General IconGeneral
BrandHuvitz
ModelHFC-1
CategoryDigital Camera
LanguageEnglish

Summary

Summary

General Description

Indication for Use

Indicates the device's intended purpose for in-vivo viewing and color fundus imaging.

Intended Use

Describes the device's function: illuminating the fundus and photographing its state.

User Profile

Specifies who can operate the equipment, including age, occupation, training, and education.

Patient Profile

Details patient requirements for examination, including concentration and following instructions.

Contraindications

Lists conditions or patient types for which the device should not be used.

UDI Information

Provides the Unique Device Identification (UDI) number for the product.

Dimension and Weight

Photo View

External Picture

Shows the external appearance of the fundus camera from the front and rear.

External Description

Details the names and functions of external components and their corresponding numbers.

Rearview Components

Details the names and functions of rear-view components and their corresponding numbers.

Bottom View Components

Details the names and functions of bottom-view components and their corresponding numbers.

GUI Interface

Observation Screen

Details the main observation screen layout and the function of each UI element.

Confirmation Screen

Details the confirmation screen for image selection and analysis initiation.

System Configuration Settings

Configures system settings like network, sleep mode, and display.

Patient Configuration Settings

Configures patient data management, list display, and import settings.

Measurement Configuration Settings

Configures settings for auto tracking, shooting, presets, and image compression.

Analysis Configuration Settings

Adjusts image parameters like brightness, contrast, edge sharpening, and text color.

Report Configuration Settings

Configures report logo, brightness, type, pupil size, organization, and image type.

Accessories

Specifications

Device Specification

Lists detailed technical specifications of the fundus camera device.

Essential Performance

Details essential performance criteria, unacceptable risks, failure modes, and risk controls.

Functional Description

Block Diagram

Illustrates the functional connections and components of the device.

Part's Function

Details the function and part code of each component within the device.

Critical Functional Features

Explains critical functional descriptions, features, and operational sequences.

Insulation Diagram

Presents the insulation diagram with creepage and clearance distances for safety.

Operation Principle

Operator's Work Flow

Outlines the step-by-step workflow for operating the fundus camera.

Optical System

Optical System Diagram

Diagram illustrating the optical path and components of the fundus camera.

Components of Optical System

Lists and describes the individual components within the optical system.

Light Paths of the System

Details the light paths for various observation and illumination channels.

Calibration Method

Fundus Device Calibrator

Describes the software interface and categories for device calibration and testing.

System Configuration

Details system configuration parameters for device calibration and operation.

Factory Setup

Explains factory setup parameters for system LEDs, flash, auto-enhancement, and fixation.

Maintenance and Troubleshooting

Maintenance Items

Lists user maintenance tasks such as check-up, cleaning, and replacement.

Troubleshooting Guide

Provides solutions for common problems encountered with the device's operation.

Component Replacement

Instructions for replacing components like chinrest paper and fuses.

Component Cleaning

Guidance on cleaning the objective lens and illumination lens.

Exterior and Contact Part Cleaning

Instructions for cleaning the device exterior and parts contacting the patient.

Other Maintenance Procedures

Covers device storage, cleaning before service, and rubber ring handling.

Comparison with Other Devices

Life Time & Transportation

Transportation Environment

Details transportation test conditions and requirements for environmental resilience.

Drawings List