EasyManua.ls Logo

Clarity RetCam3 - User Manual

Clarity RetCam3
177 pages
Print Icon
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Loading...
QS Form QF-42-01f
COMPONENT SPECIFICATION
Issued by: QA
Date: 07/01/13 Rev. C ECO-4242
Pg. 1 of 1
THIS DOCUMENT AND THE DATA CONTAINED HEREWITH IS THE PROPRIETARY PROPERTY OF CLARITY MEDICAL SYSTEMS, INC AND IS NOT TO BE REPRODUCED,
USED, OR DISCLOSED IN WHOLE OR PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF CLARITY MEDICAL SYSTEMS, INC.
Uncontrolled Copy unless stamped “CONTROLLED COPY” in red.
Originator: P. Thompson Date: 8/15/2013
Clarity Part Number:
18-000393
Part Description:
UM, V6.3, RC3/RCS
Rev
A
Purchased off the Shelf, Without Modifications Custom Part Per Clarity Spec. (Control Drawing Req.)
Manufacturer: Clarity P/N: 18-000393 REV A
Supplier: P/N:
Supplier: P/N:
Supplier: P/N:
Alternate Manufacturer (A/M): P/N:
A/M Supplier: P/N:
A/M Supplier: P/N:
A/M Supplier: P/N:
ROHS Compliant: Yes No N/A
Approvals: CE UL _ CSA _ TUV IEC Other, specify: _
Shelf Life: Yes No If Yes, specify:
Visual Inspection: Yes No Dimensional Inspection: Yes No Functional Inspection: Yes No
Certification of Conformance: Yes No If Yes, specify type: _
Standard Unit of Measure: Each Inch Foot Millimeter Meter Ounce Other: _
Estimated cost (per standard unit of measure): $0.00
Purchase Unit of Measure: Each Inch Foot Millimeter Meter Ounce Pack Roll Box
Bottle Tube Other: _ Qty/Per: _
Special Packaging and/or Marking: Yes No If Yes, specify: _
Special Handling: Yes No If Yes, specify: _
Notes:
1. Electronic (PDF) version to be copied onto a CD per 800175.
2. Source file format is FrameMaker v8.0.
3.
See Attachments:
1. Manual text from PDF file; 176 pages including back page.
2.
3.
Rev Component Revision History Date ECO
A
Initial Release 8/22/2013
4281

Table of Contents

Question and Answer IconNeed help?

Do you have a question about the Clarity RetCam3 and is the answer not in the manual?

Summary

1 Introduction

Indications for Use

Describes the approved medical uses and applications for the RetCam system.

Contraindications

Lists conditions or situations where the RetCam system should not be used.

Warnings and Cautions

Provides critical safety information and potential hazards associated with system use.

RetCam 3 System Hardware

Details the physical components and architecture of the RetCam 3 system.

Main Hardware Components

Describes the primary functional parts of the RetCam 3 imaging system.

Electrical Safety Information

Outlines safety standards, precautions, and compliance for electrical operation.

System Hardware (RetCam Shuttle)

Details the physical components and architecture of the RetCam Shuttle system.

Important User Safety Notices for All RetCam Systems

Essential safety guidelines and precautions for operating any RetCam system.

Labels and Symbols

Explains the meaning and significance of various labels and icons on the system.

2 RetCam System Software Configuration

Configuring the RetCam System for Use with the Optional RetCam Review Software

Guides on setting up the system to work with the RCRS software.

Functions Managed by RetCam Review Software

Explains how specific software functions are controlled via the RCRS application.

Creating User Login Accounts

Step-by-step instructions for creating new user profiles and access credentials.

Assigning Patients to Domains

Process for organizing and managing patient data within the system's domain structure.

3 Synchronization with RetCam Review Software (RCRS)

Determining if RetCam is Configured for RCRS

Method to verify if the RetCam system is set up for RCRS synchronization.

Synchronization with RCRS

Procedure for transferring and synchronizing data between the RetCam system and RCRS.

Reconciling Data Mismatches

Steps to resolve data conflicts that may arise during synchronization.

Removing Videos and Images from the RetCam System

Instructions for freeing up disk space by deleting files from the system.

4 Preparing the System for Use

Preparing the RetCam 3 System for Use

Steps to set up and initialize the RetCam 3 system for operation.

Preparing the RetCam Shuttle System for Use

Steps to set up and initialize the RetCam Shuttle system for operation.

5 Using the RetCam System

Managing Patient Records

How to add, edit, search, and manage patient data within the system.

Performing Exams

Detailed instructions for capturing images and videos during patient examinations.

Using Helpful Features

Overview of useful software functionalities that enhance workflow.

Changing Image Capture Options During an Exam

How to modify imaging settings while an exam is in progress.

Adding Exam Notes

Process for documenting observations and information related to patient exams.

Turning OFF the RetCam 3 System

Procedure for safely shutting down the RetCam 3 system.

Turning OFF the RetCam Shuttle System

Procedure for safely shutting down the RetCam Shuttle system.

6 Review and Compare Images

Exam Review Screen

Interface for viewing and analyzing images acquired during an exam.

Compare Mode

Functionality allowing side-by-side comparison of multiple images.

Image Adjustment

Tools for enhancing and modifying the display of captured images.

7 Import and Export Images

Backing Up Images

Recommendations and procedures for creating data backups for long-term storage.

Exporting Images

Process for transferring patient data and images from the system to external locations.

Importing Images

Process for transferring patient data and images from external sources onto the system.

8 Printing Images

Printing Images and Reports

Instructions on how to print acquired images and generated reports.

Recommended Supplies

Lists necessary consumables and accessories for system operation.

9 User Preferences

About RetCam Software

Displays detailed information about the RetCam software version and system configuration.

Device Identification

Process for assigning a name and entering the serial number for the system device.

Domain Configuration

Manages patient and exam data organization within institutional domains.

Configuring Live Imaging

Allows adjustment of video file size and related settings for live imaging.

Configuring New Exam Defaults

Setting up default configurations for new patient exams.

Configuring Notification Options

Customizing system alerts, messages, and log file settings.

Configuring Printers

Setting default printers for imaging and report generation.

Enabling Synchronization

Configuration steps for enabling data sync with the RetCam Review Software (RCRS).

Configuring Windows Preferences

Adjusting operating system settings like date, time, and display.

10 Fluorescein Angiography (RetCam 3 System)

Theory of Operation

Explains the underlying principles and mechanism of Fluorescein Angiography imaging.

Using Fluorescein Angiography (FA) Mode

Step-by-step guide for performing imaging using the FA feature.

11 Screening for Retinopathy of Prematurity (ROP)

RetCam Physician Information

Information relevant to physicians regarding ROP screening protocols and use.

Indications for Use

Specifies the medical conditions and patient types for which ROP screening is indicated.

Contraindications

Lists conditions under which ROP screening with the RetCam is not advised.

Warnings

Safety precautions specific to performing ROP screening.

Preparation

Steps and considerations before performing ROP screening exams.

Using the RetCam

Guidelines and best practices for conducting ROP examinations.

Screening for Retinopathy of Prematurity

Details the methodology and findings of ROP screening studies.

Performance Data

Study results, including accuracy and sensitivity metrics for ROP screening.

Image Quality

Evaluation criteria and findings regarding the technical quality of captured ROP images.

Training

Information on the mandatory training programs for RetCam users.

Photo Documentation

Describes how the RetCam system captures and stores retinal images.

Adverse Events

Identifies potential risks during system use and recommended mitigation steps.

12 Maintenance and Support

Recommended General Maintenance Schedule

Outlines routine tasks for keeping the system in optimal condition.

Cleaning Procedures

Detailed instructions for cleaning various parts of the RetCam system.

Disposal of Materials

Guidance on the proper disposal of waste materials according to regulations.

Cable and Connections Inspection

Procedures for checking cables and connections for safety and integrity.

RetCam 3 Fuse Replacement

Step-by-step guide for replacing blown fuses in the RetCam 3 system.

RetCam 3 Illumination Lamp Replacement

Procedure for replacing the illumination lamp in the RetCam 3 system.

RetCam Shuttle Fuse Replacement

Step-by-step guide for replacing blown fuses in the RetCam Shuttle system.

RetCam Shuttle Illumination Lamp Replacement

Procedure for replacing the illumination lamp in the RetCam Shuttle system.

Key Validation

Process for validating system software licenses, especially after hardware or software changes.

Technical Support

Contact information and resources for obtaining assistance with the RetCam system.

13 Technical Specifications

RetCam 3 Technical Specifications

Detailed technical data for the RetCam 3 system.

RetCam 3 Hardware Requirements

Specifications for physical dimensions, weight, and electrical needs of RetCam 3.

RetCam 3 Software Requirements

Software prerequisites for operating the RetCam 3 system.

RetCam 3 Environmental Conditions

Operating, storage, and transport conditions for the RetCam 3.

RetCam Shuttle Technical Specifications

Detailed technical data for the RetCam Shuttle system.

RetCam Shuttle Hardware Requirements

Specifications for physical dimensions, weight, and electrical needs of RetCam Shuttle.

RetCam Shuttle Software Requirements

Software prerequisites for operating the RetCam Shuttle system.

RetCam Shuttle Environmental Conditions

Operating, storage, and transport conditions for the RetCam Shuttle.

14 License Agreements

Clarity Software Restricted Rights

Legal terms governing the use and distribution of Clarity's software.

RetCam Software End User License Agreement

The legal agreement for using the RetCam system's software.

Clarity RetCam3 Specifications

General IconGeneral
TypeRetinal Camera
Light SourceLED
ConnectivityUSB
Image SensorCMOS
Power Requirements100-240 VAC, 50/60 Hz
Field of View130 degrees
Image CaptureDigital
FocusAuto and Manual
Data TransferVia USB to computer
Weight0.5 kg
PowerAC Power
DisplayBuilt-in LCD
Capture ModesStill images, video
Intended UseRetinal imaging