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Advanced Instruments OsmoPRO MAX - User Manual

Advanced Instruments OsmoPRO MAX
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OsmoPRO® MAX
Automated Osmometer
User Guide
552955EN Rev 0

Table of Contents

Questions and Answers

Advanced Instruments OsmoPRO MAX Specifications

General IconGeneral
Operating Temperature15°C to 35°C
Power Requirements100-240 V AC, 50/60 Hz
Resolution1 mOsm/kg
Measurement Time2 minutes
ConnectivityEthernet, USB
Measurement Range0 to 2000 mOsm/kg H₂O

Summary

Copyright and Trademarks

Contacting Advanced Instruments

Supplies, Standards, and Controls

Quality Control

Verifying Calibration Daily

Instructions for daily verification of instrument calibration using reference solutions.

Verifying Linearity

Procedure to verify instrument linearity and reportable range.

Precision and Accuracy

Defines and explains the concepts of precision and accuracy in measurement.

Maintaining Instrument Standards

Guidance on maintaining and using Advanced Instruments osmometer standards.

Quality Control Implementation

Outlines minimum requirements and recommendations for quality control procedures.

Safe Use

Operator Training

Specifies the required training for operating the instrument and handling biological substances.

Safety Equipment

Recommendations for protective clothing and equipment when working with the device.

Guidelines and Regulations to Follow

Lists essential safety instructions, environmental specs, and regulations to adhere to.

Where is Use of the Instrument Prohibited?

Identifies environments or conditions where the instrument should not be operated.

Secure Decommissioning

Procedures for safely taking the instrument out of operation for storage or transport.

General Cautions

Provides important general cautions regarding laser safety, power, and environmental conditions.

FCC and Industry Canada Statements

Regulatory compliance statements for radio frequency emissions.

Biohazardous Material Caution

Important warnings and procedures for handling biohazardous materials and spills.

OsmoPRO MAX Overview

Product Description and Purpose

Describes the OsmoPRO MAX and its intended use in clinical laboratories.

Intended Use

Details the osmolality measurement capabilities and applications of the OsmoPRO MAX.

Principles of Freezing-Point Osmometry

Explains the scientific principles behind freezing-point osmometry used by the instrument.

Instrumentation

Describes the components and methods used by osmometers for freezing point measurement.

OsmoPRO MAX Components

Identifies and explains the main components of the OsmoPRO MAX instrument.

Touchscreen

Details the touchscreen interface for system navigation and operation.

Installation and Setup

Electrical Requirements

Specifies the electrical power and outlet requirements for instrument installation.

Select a Location for the Instrument

Provides guidance on selecting an appropriate location based on space and electrical needs.

Unpacking the Shipment

Instructions for carefully unpacking, inspecting, and registering the instrument shipment.

Lifting and Carrying the Instrument Safely

Provides detailed instructions for safely lifting and transporting the instrument.

Remove the Rear Panel

Steps to remove the rear panel to access and remove the instrument's shipping stop.

Remove the Shipping Stop

Detailed instructions for removing the shipping stop from the instrument.

Reinstall the Rear Panel

Steps to correctly reinstall the rear panel after initial setup.

Install the Turntable

Instructions for installing the turntable onto the instrument's drive spindle.

Connect Peripherals (Optional)

Guidance on connecting external devices like printers or barcode scanners to the instrument.

Setting Up the Instrument: Powering Up

Steps for connecting the power cord and turning on the instrument for the first time.

Opening Menus

Explains how to access the Main, Settings, and Diagnostics menus from the Home screen.

Logging in to the Admin User Account

Details how to log in to the default Admin account for instrument setup and configuration.

Set the Language

Instructions for changing the instrument's display language.

Set the System Date and Time

Procedure for setting the instrument's internal clock and date.

Set the Installation Date

Steps to set the installation date to enable preventative maintenance reminders.

Load the Maintenance Kit

Instructions for loading the OsmoPRO MAX Maintenance Kit, including scanning the assurance tag.

Connect the Waste Bottle

Steps for connecting the waste bottle to the instrument.

Install the Peristaltic Tubing Lines

Detailed instructions for installing the peristaltic pump tubing lines.

Connect the System Fluid Bottle

Procedure for connecting the system fluid bottle and tubing to the instrument.

Clean the Fluidics

Steps to clean the instrument's fluidic system using the Enzymatic Cleaner.

Configure Instrument Settings

Configure Operator;Testing Access

Set requirements for user IDs, sample IDs, and test replicates.

Configure Operator Permissions

Define user access levels for specific instrument functions and features.

Configure Quality Control Actions

Set system actions for results outside control limits and QC verification frequency.

Configure Timeouts

Set automatic logout and screen dimming intervals for inactivity.

Configure the Login Mode (Badge Scan)

Enable or disable badge scanning for operator login.

Set Up User Accounts: Adding a User

Procedure for adding new user accounts with specific IDs and access levels.

Editing a User

Modify existing user account passwords and access levels.

Deleting a User

Procedure for removing user accounts from the system.

Networking and LIS Configuration

Configure a LAN Connection

Set up a network connection using DHCP or a static IP address.

Configure a LIS Connection

Configure communication between the OsmoPRO MAX and a Laboratory Information System (LIS).

Configure LIS Settings

Configure server IP address, port, and send results mode for LIS communication.

Configure the Peer Group Connection

Connect to the AdvancedQC peer group program for quality control data comparison.

Configure QC Records Upload

Set up automatic or manual upload of QC records to the AdvancedQC Peer Group Program.

Change Hardware Options

Adjust system audio, screen brightness, and barcode scanner settings.

Change the Screen Brightness

Adjust the brightness level of the instrument's LCD screen.

Configure the Front Barcode Scanner

Enable/disable the front barcode scanner and adjust its brightness.

User Interface

Touchscreen

Details how to use the touchscreen for setting parameters, entering commands, and viewing data.

The Home Screen

Explains the functions and information displayed on the instrument's Home screen.

Turntable Display and Test Information Area

Describes the turntable display and the test information shown during operation.

Instrument Status

Explains the different instrument status indicators like Initializing, Ready, Scanning, etc.

Test Results

Information about viewing test results and system date/time.

Screen Capture

How to capture the current screen and save it to a USB drive.

Main Menu Button

Accessing the main menu from the Home screen.

Testing Buttons

Details the function of various buttons used for starting tests and managing samples.

Legend and Instrument Assistance

Accessing information about status icons, buttons, and system details.

Warning;Alarm Icons

Explains warning and alarm icons indicating instrument status and potential issues.

LAN;LIS Status Icon

Indicates the status of the LAN and LIS connections.

QC Icon

Shows the status of the instrument's quality control feature.

System Fluid Status Icon

Monitors the system fluid level and indicates when it needs to be reloaded.

Viewing Legend Information

Accessing explanations for status icons and testing buttons.

Testing Tab

Information on icons and buttons related to testing turntable tubes.

Indicators Tab

Details icons indicating pending tasks requiring user action.

System Fluid Tab

Provides information on system fluid status icons and fluid levels.

LAN;LIS Tab

Details LAN and LIS connection status icons.

Access Levels Tab

Shows icons indicating the access levels of different instrument users.

Viewing Instrument Assistance Information

Access instrument details, contact information, and software revisions.

System History Tab

View historical data such as total tests, installation date, and calibration dates.

The Main Menu

Overview of the main menu and its access to system functions.

Operating the OsmoPRO MAX

Explains how to perform tests, use main menu functions, and troubleshoot the instrument.

Using the Controls Log Database

Adding a Control

Steps to add a new control and its associated lot information to the system.

Deleting a Control

Procedure for removing a control from the Controls Log database.

Managing Control Lots

Add, delete, and select default lots for controls used in testing.

Adding a Control Lot

Instructions for adding a new lot for an existing control.

Deleting a Control Lot

Procedure for deleting a specific control lot from the system.

Changing the Default Control Lot

Select which control lot the system uses for testing.

Displaying and Exporting a Levey-Jennings Chart

Generate and export Levey-Jennings charts for control data analysis.

Testing Samples

Best Practices for Handling Samples

Guidelines for properly handling and preparing samples for accurate testing.

Sample Volumes and Tube Types

Details minimum sample volumes and tube specifications for testing.

Configuring Automated Testing

Set up requirements like sample ID entry and number of replicates per test.

Starting an Automated Test

Steps to initiate an automated sample testing sequence.

Testing in Progress

Describes the instrument's process during sample testing and cleaning cycles.

Checking Results of Completed Tests

How to view results for individual samples during or after an automated test.

Routine Samples

Instructions for adding more samples during or after a test sequence.

Running a STAT Test

Procedure for performing a STAT test on a single sample during automated testing.

Completing the Test

Describes how the instrument completes testing and saves results.

Viewing Test Results and System Data

Viewing Results

Access, sort, and filter stored test results records from the instrument database.

Filtering the Results List

Methods to filter the results list to display specific subsets of data.

Exporting Results

Export test results to a USB drive in CSV format for analysis.

Uploading Results to the LIS Server

Manually upload test results from the database to the LIS server.

Uploading QC Tests to the AdvancedQC Peer Group Program

Upload quality control records to the AdvancedQC program for data comparison.

Data Management and Exporting

Configuring Data Export of Results and Events

Enable or disable exporting test results and system events.

Displaying and Exporting a Levey-Jennings Chart

Generate and export Levey-Jennings charts for control data analysis.

Exporting Data to CSV Files

Steps to export results, events, users, and control logs to CSV files.

Running Instrument Calibration

When to Calibrate the Instrument

Conditions and reasons that necessitate instrument calibration.

Calibrating the Instrument

Procedure for calibrating the OsmoPRO MAX using specified calibration standards.

Preparing for Calibration

Steps to prepare the instrument and calibration standards before starting calibration.

Performing Calibration

Detailed steps for running the instrument calibration process.

Verifying Calibration Daily

Procedures for daily verification of instrument calibration using reference solutions.

Verifying Calibration with a Quality Control Test

Using Clinitrol 290 to verify calibration as part of the quality control procedure.

Testing Instrument Performance with Protinol and Renol

Testing performance with biological solutions or simulated controls.

Instrument Maintenance

Service and Maintenance Cautions

General warnings and precautions for performing service and maintenance tasks.

ESD Precautions

Guidelines for preventing electrostatic discharge damage to sensitive components.

Shutting Down the Instrument for Shipping or Long-term Storage

Steps to safely shut down the instrument for shipping or storage.

Daily;End-of-Shift Maintenance

Routine visual inspections of fluid lines and containers.

Every 500 Tests

Procedures for replacing the maintenance kit and cleaning the fluid path.

Replacing Peristaltic Pump Tube Linings

Step-by-step guide for replacing the peristaltic pump tubing.

Priming the Pipettor

Procedure to prime the pipettor and clean instrument fluidics as needed.

Logging Routine Instrument Cleaning

Record routine cleaning tasks performed on the instrument.

Logging Preventative Maintenance

Record preventative maintenance events and service engineer details.

Logging Repair Information

Record instrument repair details, including service engineer and comments.

Performing a System Update

Instructions for updating the instrument's system software and firmware.

Diagnostics

The Diagnostics Menu

Access the Diagnostics menu to check instrument component performance.

Testing the Analog-to-Digital Converter

Test the A/D converter, sample probe, block probe, and cooling assembly efficiency.

Testing the Assurance Tag Reader

Test the assurance tag reader used for loading and tracking kits.

Testing the Sample Probe

Test the sample probe's functionality at selected turntable positions.

Testing the Barcode Scanners

Verify the functionality of the front and back barcode scanners.

Viewing and Exporting Instrument Events

Review and export a log of instrument actions and events.

Exporting Events

Export displayed or selected event records to a USB drive.

Filtering the Events List

Filter the events list to display a subset of results based on criteria.

Testing the Touchscreen

Check the screen for dead pixels and adjust brightness.

Testing the Instrument Motors and Sensors

Test instrument motors and sensors to ensure correct functionality.

Troubleshooting

Who Should Perform Service?

Clarifies that only trained technicians should perform service procedures.

Issues that Require a Service Technician

Lists problems requiring service from a qualified technician.

Fuse Replacement

Detailed instructions for replacing instrument fuses, including necessary tools.

OsmoPRO MAX Warning and Alarms

Explains warning and alarm messages and their potential causes and suggested actions.

Hardware Errors: Osmometer Board

Lists common hardware errors related to the Osmometer Board and their solutions.

Hardware Errors: Motor Board

Lists common hardware errors related to the Motor Board and their solutions.

Hardware Errors: Fan and Scanner Issues

Troubleshooting for fan errors, barcode scanner issues, and liquid detection errors.

Sample Test Warnings

Details sample-specific warnings like 'Out of Range' and 'No Tube Detected'.

Performance Characteristics

Definitions

Defines accuracy and repeatability in the context of instrument performance.

Characteristics

Details reportable range, resolution, and within-run repeatability specifications.

Linearity and Sample Carryover Effect

Specifies linearity performance and the effect of sample carryover.

Product Specifications

Known Limitations

Regulatory Notices

Symbol Definitions

Explains the meaning of various symbols used on the instrument and in documentation.

OsmoPRO MAX LIS Specification

Purpose

Describes the bidirectional TCP/IP communication link for LIS integration.

Overview

Explains LIS communication protocols and capabilities of the OsmoPRO MAX.

Manual Mode

Configures operator verification of results before sending to LIS.

Low-level Protocol

Details physical and data link layer protocols for LIS communication.

Message Layer

Describes content limitations and specifications for LIS messages.

Sample Information Record

Defines fields for sample information transmitted between the instrument and LIS.

Test Order Record

Specifies fields for test orders, including specimen IDs and test details.

Result Record

Defines fields for instrument result records sent to the LIS.

Request Information Record

Specifies fields used by the instrument to request sample orders from the LIS.

Message Terminator Record

Defines the record used to signify the end of a message transmission.

User Access Quick Reference

Purpose

Describes functions available based on user access level (Supervisor/Operator).

Accessible Functions by User Access Level

Table summarizing functions accessible to Supervisors and Operators.

Product Disposal and Recycling

Warranty and Warranty Duties

Limited Warranty Conditions

Outlines the terms and conditions of the limited warranty for the instrument.

Advanced Instruments Warranties

Details what Advanced Instruments warrants regarding product quality and safety.

The User Warrants

Specifies user responsibilities for instrument operation, maintenance, and safety.

Useful Life

Defines the useful life of the instrument, referencing IRS guidelines.

Reasonable Use

Defines conditions for reasonable instrument use as per instructions.

Immediate Notification

Emphasizes the importance of immediate notification for accidents or injuries.

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