Hemochron Response User Manual

Operator’s Manual
English
TABLE OF CONTENTS
INTENDED USE.............................................................. 2
SUMMARY AND EXPLANATION.................................... 2
PRINCIPLES OF OPERATION ....................................... 2
ATTENTION LABEL ........................................................ 4
SPECIFICATIONS........................................................... 5
GETTING STARTED....................................................... 5
SETTING SUPERVISOR OPTIONS ............................. 11
SETTING OUTPUT OPTIONS ...................................... 18
SETTING PROGRAM OPTIONS .................................. 20
CUSTOMIZING THE PRINTED HEADING ................... 21
OPERATION ................................................................. 21
QUALITY CONTROL (QC)............................................ 27
OPERATING PRECAUTIONS....................................... 29
LIMITATIONS................................................................ 29
RESULTS MANAGEMENT ........................................... 30
DEFAULT SETTINGS ................................................... 32
TROUBLESHOOTING .................................................. 33
SYSTEM TESTS ........................................................... 35
MAINTENANCE ............................................................ 38
SPECIFICATIONS FOR PERIPHERALS ...................... 39
SAFETY STANDARDS ................................................. 41
INDEX ........................................................................... 42
This manual is published by International Technidyne Corporation (ITC) for use with the HEMOCHRON
Response V2.00 or above. Questions or comments regarding the contents of this manual can be directed to
the address at the back of this manual or to your ITC representative.
HEMOCHRON
®
and RxDx
®
are registered trademarks of ITC.
idms™ is a trademark of ITC.
Celite
®
is registered trademark of Celite Corporation.
©2000, 2001, 2002, 2003, 2004. This document is the copyright of ITC and must not be copied or
reproduced in any form without prior consent. ITC reserves the right to make technical improvements to
this equipment and documentation without prior notice as part of a continuous program of product
development.
Printed From ITC Intranet

Hemochron Response Specifications

General

Device Type	Coagulation Analyzer
Category	Medical Equipment
Sample Type	Whole blood
Display	LCD
Operating Temperature	15°C to 30°C
Manufacturer	Werfen
Test Types	ACT, APTT, PT/INR
Measurement Time	Varies by test
Sample Volume	Varies by test
Power Supply	AC adapter or rechargeable battery
Storage Temperature	0°C to 50°C
Connectivity	USB
Power Requirements	100-240V AC, 50-60 Hz
Intended Use	For in vitro diagnostic use in the determination of activated clotting time (ACT) and other coagulation parameters at the point of care.

Summary

INTENDED USE

SUMMARY AND EXPLANATION

PRINCIPLES OF OPERATION

Definitions and Terms

Overview of Operation

ATTENTION LABEL

SPECIFICATIONS

Dimensions and Weight

Provides the physical dimensions and weight of the HEMOCHRON Response instrument.

Operation

Details operational parameters like test wells, timing range, and incubation temperature.

AC/DC Power Module

Details the AC/DC power module's input and output specifications.

Environmental

Lists the acceptable ambient temperature range for system operation.

GETTING STARTED

Unpacking and Inspection

Provides instructions for safely unpacking and inspecting the instrument upon arrival.

Connecting External Components

Connecting a Printer

Details the process of connecting and configuring an external printer.

Charging the Battery

OPERATION

Prewarming a Well

Details the procedure for prewarming test wells to the correct temperature before sample introduction.

Automatic Shutdown

Explains the instrument's automatic shutdown features based on inactivity and power source.

Display Panel

Indicator LEDs

Explains the purpose and illumination of the various indicator LEDs on the instrument.

Menus

Guides users on navigating and interacting with the instrument's menu system.

Tests

Reagents

SETTING SUPERVISOR OPTIONS

Access to Supervisor Options

Details how to access the supervisor menu and the initial passcode settings for security.

Setting the Time

Setting the Date

Requiring Entry of PID

Requiring Entry of an OID or PIN

Specifying QC Lockouts

SETTING OUTPUT OPTIONS

Enabling Display of Remaining Battery Power

Sets whether the battery power is shown as a percentage or a graphical bar indicator.

Specifying the Device Connected to COM1 or COM2

Configures COM ports for external computers, barcode readers, or specifies no device.

SETTING PROGRAM OPTIONS

Adjusting Beep Volume

Allows adjustment of the audible beep volume for system alerts and notifications.

Setting Display Contrast

Adjusts the darkness or lightness of characters displayed on the instrument's screen.

CUSTOMIZING THE PRINTED HEADING

OPERATION

Starting the Instrument

Details the procedure for powering on the instrument and initiating its self-test sequence.

Entering OID, PIN, and PID

Specimen Collection

Starting the Test

Results Display

Printing of Results

Instrument Shutdown

QUALITY CONTROL (QC)

Self-Check

Details the automated system checks performed upon activation and test initiation for system integrity.

QC Intervals

Describes how to specify the time interval between required Quality Control (QC) tests.

QC Using Liquid Controls

OPERATING PRECAUTIONS

LIMITATIONS

RESULTS MANAGEMENT

Overview

Explains the storage capacity and types of data stored for patient and QC results.

Database Query

Explains how to query the database to check record counts, display specific records, or search criteria.

To Search a Database

DEFAULT SETTINGS

TROUBLESHOOTING

Hazard and Fault Messages

Lists common messages, their probable causes, and recommended corrective actions.

SYSTEM TESTS

Test

Lists the available system tests and their descriptions.

Description

Provides a description for each of the system tests available.

To Test the Keypad

To Test the LCDs

To Test the Internal Printer

To Test the Battery

MAINTENANCE

General Cleaning

Provides instructions for cleaning the instrument's surface and test wells.

Fan Filter Replacement

Details the procedure for accessing and replacing the instrument's fan filter.

SPECIFICATIONS FOR PERIPHERALS

Specifications for Bar Code Reader

Details the requirements and specifications for a compatible bar code reader.

SAFETY STANDARDS