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Roche cobas h 232 User Manual

Roche cobas h 232
140 pages
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cobas h 232 System
Operator’s Manual

Table of Contents

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Roche cobas h 232 Specifications

General IconGeneral
BrandRoche
Modelcobas h 232
CategoryMeasuring Instruments
LanguageEnglish

Summary

Introduction

The cobas h 232 Meter

Instrument for quantitative evaluation of immunoassays using gold-labeling technique.

Test Principle

Detection of two lines on test strip by LED and camera sensor for quantitative evaluation.

Contents of the Pack

Lists the items included with the cobas h 232 meter and optionally available accessories.

Symbols on Packaging and Identification Plate

Explains various symbols found on the product packaging and identification plate.

Safety Information and Additional Information

Explains how safety messages and information are presented in the manual.

Safety Information

Covers operator qualification, protection against infection, and disposal of the system.

Disposal of the System

Details on treating the instrument as biohazardous waste and proper disposal.

General Care

Instructions for cleaning the meter using recommended solutions and drying.

Laser Scanner

Information about the Class 1 laser scanner and safety precautions.

Electrical Safety

Caution regarding damaged power supply or cables and contacting service.

Electromagnetic Interference

Warning against using the meter near strong electromagnetic fields.

Touchscreen Usage

Guidelines for using the touchscreen with fingers or special pens, avoiding damage.

Overview of the Meter and its Accessories

Meter Components

Details the physical parts of the cobas h 232 meter, including touchscreen, buttons, and scanner.

Test Strip Components

Explains the parts of the test strip, including the test area, application area, barcode, and code chip.

Handheld Base Unit Components

Describes the charging contacts, status indicator, data ports, and connection socket of the base unit.

Overview of the Buttons and Icons used on Screen

Button and Icon Meanings

Provides a list of common buttons and icons with their corresponding meanings for operation.

Putting the Meter into Operation

Initial Setup Steps

Outlines the steps for first-time use: connecting power, inserting battery, setting date/time.

Power Supply Options

Explains operation using handheld power supply, base unit, or battery pack.

Inserting the Handheld Battery Pack

Step-by-step guide for inserting or replacing the handheld battery pack.

Turning the Meter On and Off

Instructions for powering the meter on and off using the On/Off button.

Meter Setup

Accessing Setup Menus

Guide on navigating to the Setup menu and selecting configuration options.

Basics Setup

Configuration options for contrast, language, date/time, and sound settings.

Data Handling Setup

Configuration for connecting to computer/printer and managing result memory.

ID Setup Setting

Settings for administrator, operator, and patient identification management.

Lockout Setup

Configuration options for quality control tests and cleaning intervals.

Optional Screens Setup

Customizing display formats and test procedures for results and comments.

Performing a Test

What You Need for Testing

Lists the essential items required for performing a test with the meter.

General Test Precautions

Guidelines on operating the meter correctly, handling test strips, and avoiding errors.

Accuracy and Precision of Measured Results

Caution regarding factors that can lead to inaccurate results and potential diagnostic errors.

Preparing to Test

Steps for preparing to test, including selecting test strips and code chips.

Code Chip Function

Explains the role of the code chip in providing test and lot-specific information.

Inserting the Code Chip

Step-by-step instructions for inserting and verifying the code chip.

Switching on the Meter

Instructions for powering the meter on and off, including self-test procedure.

Test Steps Overview

Illustrates the different testing workflows based on configuration settings.

Logging In

Procedures for logging in with or without operator ID and password.

Operator Login with List

Steps for logging in when an operator list is available, including scanning.

Password Entry

Instructions for entering the operator password using the onscreen keypad.

Performing a Test (General)

Checks battery charge, date/time, and handling lockouts like QC or cleaning.

Performing Test Without Patient List

Steps for performing a test without a patient list, including optional/required patient ID entry.

Performing Test With Patient List

Steps for performing a test using a patient list, including selecting or adding patients.

Inserting a Test Strip

Instructions for removing and inserting the test strip into the meter's guide.

Code Chip Insertion and Warming Up

Procedure for inserting code chip, warming up test strip, and applying sample.

Applying Sample to Test Strip

Guidance on drawing and applying the correct sample volume to the test strip.

Processing the Sample

Describes the sample processing phase, hourglass icon, and measurement time.

Viewing Test Results

How to view the test result, navigate, and print results.

Displaying Results

Options for displaying results, including operator login if required.

Confirming or Rejecting Results

Procedure for confirming or rejecting a test result if required by the system.

Adding Comments to Results

How to add predefined or custom comments to test results.

STAT Tests

Procedure for performing STAT tests in emergency situations to bypass lockouts.

Quality Control

Methods for Quality Control

Describes the meter's independent methods for performing quality control tests.

Preparing to Run a Quality Control Test

Lists the materials needed and general preparation for running a QC test.

Performing a Quality Control Test

Step-by-step guide for executing a quality control test on the meter.

Quality Control Test Workflow

Details the workflow for QC tests, including status, inserting strips, and barcode scanning.

Selecting Quality Control Lot

Procedure for selecting the correct QC lot or inserting a new code chip.

Selecting Quality Control Level

Instructions for selecting the control material level for the measurement.

Applying QC Sample

Guidance on applying the control sample to the test strip and processing.

Viewing Quality Control Results

How to view QC test results, including target values and pass/fail indicators.

Instrument Quality Control (IQC)

Preparing IQC Test Strips

Lists the requirements for IQC tests, including IQC strips and code chips.

Instrument Quality Control Workflow

Details the workflow for IQC tests, including inserting strips and code chips.

Viewing IQC Results

How to view IQC test results, indicated as Pass or Fail.

Memory

Viewing Test Results

Steps to turn on the meter and access stored test results.

Accessing Stored Results

Navigating the memory menu to view patient history, all results, QC, IQC, and maintenance.

Patient History

How to view results for individual patients sorted by Patient ID.

All Results

How to view all stored test results sorted chronologically.

Quality Control (QC) Results

How to view stored QC tests sorted chronologically.

Instrument Quality Control (IQC) Results

How to view stored IQC tests sorted chronologically.

Maintenance History

How to view and add comments related to meter maintenance and service.

Data Downloads

Methods for archiving stored results via infrared or USB data ports.

Cleaning

Cleaning the Plastic Housing

Instructions for cleaning the meter's external housing with approved agents.

Allowed Cleaning Agents

Lists approved cleaning agents and precautions for use.

Cleaning after Contamination due to Mispipetting

Sequence of steps to follow in case of contamination from mispipetting.

Cleaning the Sampling Area

Procedure for cleaning the sample application area and cover.

Cleaning the Test Strip Guide

Instructions for cleaning the test strip guide and membrane.

Troubleshooting

Error Message Guide

Table of error messages, their descriptions, and suggested solutions.

Error 1: Date/Time Invalid

Solution for invalid date/time entry error.

Error 2: Invalid ID

Solutions for errors related to invalid or missing operator/patient IDs.

Error 3: Test Strip Issues

Solutions for errors related to test strip insertion or removal during testing.

Error 4: Meter Temperature Issues

Solutions for errors indicating meter is too warm or too cold.

Error 5: Low Battery Voltage

Solutions for errors related to low battery voltage, preventing tests.

Error 6: Battery Issues

Solution for error indicating meter cannot operate with batteries.

Error 7: Result Memory Full

Solutions when the result memory is full or near full.

Error 8: Maximum Tests Reached

Action to take when the maximum number of tests has been reached.

Error 9-11: Barcode Read Errors

Solutions for barcode reading failures on test strips or IDs.

Error 12: Code Chip Issues

Solutions for missing or unreadable code chips.

Error 13: Expired Test Strip

Solutions for errors indicating an expired test strip.

Error 14: Expired Control Material

Solutions for errors indicating expired control material.

Error 15: Sample Detection Failure

Solutions for errors where sample detection fails.

Error 16: Test Strip Faulty or Ambient Light

Solutions for faulty test strips or issues with ambient light.

Error 17: Communication Failure

Solutions for communication errors with host system or printer.

Error 18-19: Memory Test Errors (Patient/QC)

Solutions for memory corruption errors affecting patient or QC data.

Error 20-21: Memory Test Errors (Maintenance/Setup)

Solutions for memory corruption errors affecting maintenance or setup data.

General Meter Errors (22-30)

Troubleshooting for various general meter errors and system faults.

Further Information

Ordering Information

List of Roche CARDIAC products, controls, and accessories with item numbers.

Product Limitations

Information on product data and limitations, referring to test strip package inserts.

Product Specifications

Operating Conditions and Technical Data

Details temperature range, humidity, altitude, memory, interface, and battery specs.

Sample Material and Storage

Information on sample type, size, storage, transport, and disposal of the meter.

Information Service

Contact details for Roche Diagnostics customer support and service centers globally.

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