ITC HEMOCHRON Signature Elite User Manual

1
HEMOCHRON
Whole Blood Microcoagulation System
Operatorʼs Manual
English
TABLE OF CONTENTS
INTENDED USE.......................................................................................... 2
SUMMARY AND EXPLANATION .............................................................. 2
PRINCIPLES OF OPERATION................................................................... 3
DESCRIPTION............................................................................................ 5
IMPORTANT LABELS AND SYMBOLS .................................................. 11
SPECIFICATIONS .................................................................................... 13
PREPARING THE INSTRUMENT ............................................................14
STARTING THE INSTRUMENT ............................................................... 26
RUNNING A TEST .................................................................................... 27
QUALITY CONTROL (QC) ....................................................................... 36
OPERATING PRECAUTIONS .................................................................. 38
LIMITATIONS ...........................................................................................39
RESULTS MANAGEMENT ...................................................................... 39
COMMUNICATION WITH A PC OR NETWORK ..................................... 46
CONFIGURATION MANAGER................................................................. 48
MASTER FILE MAINTENANCE............................................................... 69
CONFIGURATION MANAGER UTILITIES............................................... 70
TROUBLESHOOTING.............................................................................. 75
SERVICE AND MAINTENANCE .............................................................. 79
SAFETY STANDARDS............................................................................. 80
INDEX ....................................................................................................... 82
This manual is published by International Technidyne Corporation (ITC) for use with the HEMOCHRON Signature
Elite Whole Blood Microcoagulation System.
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.
ITC, HEMOCHRON and HEMOCHRON Signature Elite are registered trademarks of International Technidyne
Corporation in the United States and other jurisdictions.
ITC, ReportMaker, idms, HEMOCHRON and HEMOCHRON Signature Elite are trademarks of International
Technidyne Corporation throughout the world.
Celite
®
is registered trademark of Celite Corporation. Microsoft
®
and Windows
®
are registered trademarks of Microsoft
Corporation.
©2006. 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.
CAUTION: This manual provides safety instructions for instruments equipped with class 1 or class 2
barcode scanner lasers. Please refer to the back panel of the instrument to identify the class of laser and
follow appropriate instructions provided in this manual.

ITC HEMOCHRON Signature Elite Specifications

General

Category	Medical Equipment
Sample Type	Whole blood
Device Type	Coagulation Analyzer
Testing Method/Test Types	ACT, APTT, PT/INR
Time to Result	2-10 minutes
Display	LCD touchscreen
Connectivity	USB, Ethernet
Power Supply	AC adapter or rechargeable battery

Summary

INTENDED USE

PRINCIPLES OF OPERATION

Instrument Operation Controls

Instrument Lockouts

Explains configuration options to restrict instrument use.

IMPORTANT LABELS AND SYMBOLS

PREPARING THE INSTRUMENT

Battery and System Time Management

Setting the System Time and Date

Explains how to configure the instrument's internal clock.

Supervisor Functions and Language

Supervisor Functions

Outlines administrative tasks performable by a supervisor.

Data Entry and Scanning Procedures

Communication Protocol and Port Settings

Specifying the Communication Protocol

Selects between proprietary and CLSI POCT-1A protocols.

Specifying the Communication Port

Selects COM or Ethernet for data transfer.

Network Communication Configuration

Entering Network Communication Parameters

Configures IP address, gateway, etc., for network communication.

Connecting Peripherals

Connecting a Computer or Printer

Guides for interfacing with external devices.

Starting the Instrument

Running a Test

Designating the Sample Type

Covers setting samples as patient or control (QC Normal/Abnormal).

Entering Patient and Operator IDs

Entering an Optional Patient ID (PID) and/or an Operator ID (OID)

Details manual or scanned entry of patient and operator identifiers.

Mandatory Data Entry Procedures

Entering a Mandatory Cuvette Lot Number and Expiration Date

Explains required entry of cuvette lot and expiry information.

Mandatory Operator Identification Entry

Entering a Mandatory PID and/or OID or PIN

Details required entry of patient/operator IDs and PINs.

Mandatory QC Test Prompts

Prompts for Mandatory QC Tests

Describes prompts for required quality control testing.

Mandatory Control Information Entry

Entering a Mandatory Lot Number, Expiration Date, and Expected Range for Controls

Additional Test Data and Specimen Handling

Specimen Collection

Provides guidelines for proper blood sample collection.

Starting and Completing a Test

Starting the Test

QUALITY CONTROL (QC)

Self-Check

QC of Instrument Performance

QC Procedures

QC Using EQC

QC Using Liquid Quality Control Products

Checking QC Intervals

OPERATING PRECAUTIONS

LIMITATIONS AND RESULTS MANAGEMENT

Printing Results

COMMUNICATION WITH A PC OR NETWORK

Communicating When the POCT-1A Communication Protocol is Used

CONFIGURATION MANAGER

Installing Configuration Manager Software

Connecting an Instrument

Starting Configuration Manager

Reading or Loading Configuration Data

Setting Configuration Options

Specifying QC Lockout Parameters

Operator Table Management

Specifying Operator IDs and/or Personal Identification Numbers

Manages operator records, including IDs, PINs, and expiration dates.

Cuvette Lot Number Configuration

Entering Cuvette Lot Numbers and Expiration Dates

QC Lot Number Configuration

Entering QC Lots

Saving and Managing Configuration Data

Saving Modified Configuration Data

Writing Configuration Data to an Instrument

MASTER FILE MAINTENANCE

Manually Adding an Instrument

Automatically Adding an Instrument

Configuration Manager Utilities

Updating an Instrument Record

Updating Laboratory Information and/or PC COM Port

User Management in Configuration Manager

Adding a User

Process for creating new user accounts in CM.

Updating a User Record

Modifying existing user accounts.

Setting Instrument Date and Time via Configuration Manager

TROUBLESHOOTING

Configuration Manager Error Messages

Lists and explains errors related to the CM software.

Instrument Error Messages

Lists and explains errors displayed by the instrument.

SERVICE AND MAINTENANCE

Routine Maintenance

Service

Battery Care

SAFETY STANDARDS