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Hitachi OPTIGEN AP3600 User Manual

Hitachi OPTIGEN AP3600
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OPTIGEN
®
AP3600
AUTOMATED INSTRUMENT USER MANUAL

Table of Contents

Questions and Answers:

Hitachi OPTIGEN AP3600 Specifications

General IconGeneral
BrandHitachi
ModelOPTIGEN AP3600
CategoryLaboratory Equipment
LanguageEnglish

Summary

Safety Procedures

Moving Parts Hazards

Caution when working inside the instrument to avoid injury from moving parts.

Biological Hazards and PPE

Guidelines for handling biological materials and using Personal Protective Equipment.

Toxic Substances Handling

Precautions for handling sodium azide in wash buffer concentrate to prevent hazards.

Heavy Object Lifting Guidelines

Instructions for safely lifting the heavy AP3600 instrument, specifying personnel requirements.

Equipment Operation Safety Checks

Essential pre-operation verification steps for safe system use.

System Introduction and Components

OPTIGEN Assay and AP3600 System Overview

Introduction to the AP3600 system for in vitro allergy testing.

Key System Features

Highlights of the AP3600 system's automation, ease of use, and low maintenance.

AP3600 Exterior Components

Description of the external parts of the AP3600 instrument, including ports and monitor.

AP3600 Interior Components

Details of internal sections like the Sera Handling Area and Dark Box.

AP3600 Consumables List

Identifies and describes essential consumable items for the OPTIGEN assay.

Equipment Hazard Symbols

Explanation of safety symbols displayed on the AP3600 equipment.

Sample and Reagent Preparation

OPTIGEN Assay Principle

Explains the in vitro assay principle for determining allergen-specific IgE concentrations.

Sample and Supply Storage

Guidelines for proper storage of patient samples and assay components.

Specimen Collection and Preparation

Procedures for collecting and preparing patient blood samples for analysis.

Sample Vial Preparation

Instructions for preparing sample vials, including barcode label placement.

Pette Preparation and Loading

Steps for preparing Pettes and loading them into the carousel.

Reagent Preparation and Handling

Procedures for preparing reagents, including color coding and mixing.

System Setup and Initial Configuration

Starting the AP3600 System

Steps to power on the instrument and complete the initial optics check.

Navigating the Home Screen Interface

Overview of the main screen display buttons for system navigation.

User Account and Password Management

Procedures for adding users, setting passwords, and managing accounts.

Assay Setup and Execution

Instrument Preparation for Assay

Steps to prepare the AP3600 instrument, including loading consumables.

Sample Rack Loading and Barcode Scanning

Guidance on loading sample racks and scanning sample barcodes.

Assigning Test Panels to Samples

Process for assigning specific test panels to patient samples.

Pre-Run Checklist Verification

Verifying all required steps and settings before starting an assay run.

Configuring Run Settings

Setting assay completion parameters, such as drain options.

Monitoring Running Tests

Overview of the screen displaying the progress of ongoing assay tests.

Test Completion Status

Displays the status of completed tests and options for result export.

Post-Run Maintenance Steps

Procedures for instrument cleaning and reagent storage after assay completion.

Work List Management

Work List Status Display

Shows the list of scheduled assays and their current operational status.

Results Analysis and Viewing

Viewing Completed Test Results

Lists all completed test results, allowing selection for detailed viewing.

Detailed Test Result Analysis

Provides in-depth results for a selected test, including allergen data and class.

System Utilities and Tools

Instrument About Information

Displays system information useful for troubleshooting.

Manual Self-Check Procedure

Initiates an optical self-check of the AP3600 instrument.

Log File Utility Operations

Access to view and export event log files for troubleshooting purposes.

Maintenance Utility for Cycles

Configures and starts instrument rinse and drain cycles.

Printer Settings Configuration

Settings for supported printers and printer configuration.

LCD Backlight Adjustment

Adjusts the brightness of the flat panel display.

Volume Control Settings

Configures the volume for DMS software alerts.

Software Update Utility (Admin)

For qualified personnel to perform software updates on the system.

Panels Update Utility (Admin)

Allows updating assay panels using a USB drive.

Backup and Restore Utility (Admin)

Enables backup and restore of system configuration files.

User Account Administration

Manages user accounts, passwords, and access privileges.

Remove All Test Results (Admin)

Deletes all previous test results from the system.

System Settings Configuration

Language Setting Options

Selects the user interface language.

Date and Time Configuration (Admin Only)

Configures the system's date and time settings.

Laboratory Details Entry (Admin Only)

Inputs and modifies laboratory-specific information.

Change User Password

Procedure for changing the current user's login password.

Network Details Configuration (Admin Only)

Sets up network parameters like IP address and DHCP.

LIS Connectivity Settings (Admin Only)

Configures connections to the Laboratory Information System (LIS).

Panel Favorites Management

Manages a list of preferred assay panels for quick access.

Automatic Result Export Setting (Admin Only)

Enables automatic exporting of test results.

Automatic Result Printing Setting

Enables automatic printing of all test results.

Printer Setup and Connection (Admin Only)

Guides on connecting and setting up a printer for the instrument.

End of Run Procedures

Instrument Rinse and Drain Cycles

Steps for rinsing and draining the instrument's fluid lines.

Cleanup and Waste Disposal

Procedures for cleaning the instrument and disposing of waste materials.

Troubleshooting Common Issues

Troubleshooting Matrix Guide

A table listing common symptoms, causes, and remedies for operational problems.

Regulatory Compliance

Safety Certification and Emissions

Information on safety certifications and electromagnetic emissions standards.

Specifications and Ordering

Physical Specifications

Details the dimensions and weight of the AP3600 instrument.

Environmental Operating Requirements

Specifies the acceptable operating temperature, humidity, and altitude.

Power Input Requirements

Details the required input voltage, frequency, and power consumption.

Assay Processing Specifications

Information on Pettes processed per run and total processing time.

Ordering Information Contact

Contact details for ordering accessories and testing kits.

System Installation and Relocation

Installing a New AP3600 System

Procedures and site requirements for installing the instrument.

Moving the AP3600 System Safely

Steps for preparing and safely moving the instrument to a new location.

Routine System Maintenance

Cleaning and Decontamination Steps

Step-by-step guide for cleaning and decontaminating the AP3600 system.

Fuse Replacement Procedure

Instructions for safely replacing fuses in the instrument.

Glossary of Terms

Technical Term Definitions

Provides definitions for key terms and acronyms used in the manual.

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