HemoCue 201 DM Manual de usuario

HemoCue® 201 DM Analyzer

HemoCue®201 DM Docking Station

Reference Manual

CONTENTS

PART I

Introduction........................................................................................1

1 Introduction ........................................................................................ 2

1.1 Abbreviations/glossary ..............................................................3

1.2 Designated Terminology...........................................................6

1.3 Functional description...............................................................8

1.3.1 System Components.......................................................................8

1.3.2 Analyzer overview............................................................................9

1.3.3 Docking station – General...........................................................12

1.3.4 Docking Station overview ............................................................14

1.3.5 Functions and features .................................................................19

2 General operations..........................................................................20

2.1 How to operate the Display .................................................. 20

2.1.1 Display buttons.............................................................................. 20

2.2 Operating the Analyzer .......................................................... 24

2.2.1 Start up............................................................................................ 24

2.2.2 Login image.................................................................................... 25

2.2.3 Main Menu and Help .................................................................... 26

2.2.4 Power saver mode........................................................................ 26

2.3 Display buttons and symbols .................................................27

2.3.1 Navigation buttons ........................................................................27

2.3.2 Procedure buttons........................................................................ 28

2.3.3 Other display buttons................................................................... 29

2.3.4 Display symbols............................................................................. 32

2.3.5 Entering information with letters and digits............................ 33

2.3.6 Entering information from barcodes........................................ 35

PART II

Settings.............................................................................................36

3 Settings ............................................................................................. 37

3.1 Activating the Settings procedure.........................................37

3.2 Deﬁne Lists................................................................................ 40

3.2.1 Liquid Controls ...............................................................................41

3.2.2 Cuvette Batches ............................................................................ 47

3.2.3 Deﬁne Operators ...........................................................................51

3.2.4 Deﬁne Comments ........................................................................ 56

3.2.5 Deﬁne Log Notes .......................................................................... 58

3.3 Basic Settings............................................................................ 60

3.3.1 Date/Time........................................................................................61

3.3.2 Power Saver ................................................................................... 63

3.3.3 Audible Signals............................................................................... 64

3.3.4 Language ........................................................................................ 65

3.4 Advanced Settings ................................................................... 66

3.4.1 General Settings .............................................................................67

3.4.2 Patient Test Settings ......................................................................75

3.4.3 QC Test Settings............................................................................ 87

3.4.4 Linearity Test Settings....................................................................97

3.5 Default Settings........................................................................ 98

3.6 Infra Red .................................................................................... 99

3.6.1 The transmitting Analyzer ........................................................... 99

3.6.2 The Receiving Analyzer...............................................................101

3.7 Docking Station Settings...................................................... 102

iii

PART III

Routine use....................................................................................103

4 Patient Test procedure..................................................................104

4.1 Patient Test.............................................................................. 104

4.1.1 Patient Test Result........................................................................110

4.1.2 Verify/Duplicate sampling..........................................................112

4.1.3 Entering Comments ....................................................................115

4.1.4 Entering Comments – Veriﬁed sample...................................119

5 STAT Test procedure ......................................................................121

5.1 STAT Test ..................................................................................121

5.1.1 STAT Test Result ...........................................................................124

6 QC Test procedure ........................................................................ 125

6.1 Events necessitating QC Tests.............................................125

6.1.1 QC Reminder................................................................................125

6.1.2 QC Lockout...................................................................................127

6.1.3 Supervisory Lockout................................................................... 128

6.2 Performing a QC Test........................................................... 129

6.2.1 QC Tests at a speciﬁc concentration level .............................131

6.2.2 Linearity Test ................................................................................ 136

6.2.3 Proﬁciency Test ............................................................................145

7 Reviewing stored data................................................................... 147

7.1 Activating the Stored Data procedure................................147

7.2 Review Stored Data............................................................... 150

7.2.1 Review All Data............................................................................. 151

7.2.2 Review PAT/STAT .........................................................................152

7.2.3 Review QC Tests ......................................................................... 154

7.2.4 Review Analyzer Log .................................................................. 160

7.3 Delete Stored Data................................................................ 162

7.4 Review Latest Download ..................................................... 164

7.5 Log Input ................................................................................. 165

8 Data communications ..................................................................166

8.1 Interaction Application – Analyzer .................................... 166

8.2 Docking station setup............................................................167

8.3 Data transfer ............................................................................173

PART IV

Other actions ................................................................................176

9 Troubleshooting..............................................................................177

PART V

Miscellaneous ...............................................................................187

10 Speciﬁcations..................................................................................188

10.1 Technical Speciﬁcations ...................................................... 188

10.1.1 Analyzer......................................................................................... 188

10.1.2 Docking station ........................................................................... 189

10.2 EMC and Electrical Safety.................................................... 189

10.3 IVD Medical Device Directive.............................................. 190

10.4 Warranty .................................................................................. 190

10.5 Service and Disposal ............................................................. 190

10.6 Spare parts .............................................................................. 190

10.7 Optional items........................................................................ 190

10.8 Symbols used ..........................................................................191

Default Settings ................................................................................. i

PART I

Introduction

1 Introduction

Thank you for choosing the HemoCue 201 DM system.

The HemoCue 201 DM system is a compact, portable, yet versatile, measuring system. It

is ideally suited for health care facilities that require central lab quality values within a

few minutes, at the point of care location.

The System consists of the HemoCue 201 DM Analyzer (either HemoCue Hb 201 DM

Analyzer, HemoCue Glucose 201 DM Analyzer or HemoCue Glucose 201 DM RT

Analyzer), the HemoCue 201 DM Docking Station and the respective HemoCue

Microcuvettes.

This Reference Manual contains instructions for conﬁguration of the Analyzer and setup

of the System. For installation of the Docking Stations see Hemocue 201 DM Docking

Station Manual. For information on the HemoCue 201 DM - DMS Software, see the

separate User’s Guide on the DMS Software CD. Instructions for everyday routine use

(including sampling procedure and maintenance) have been provided in Instructions for

Use for the respective Analyzer.

This chapter gives a brief overview of the functions and features of the Analyzer and the

Docking Station.

Usage Disclaimer

The HemoCue 201 DM system has ﬂexible settings to meet dierent user needs. The setting

options are conﬁgured in the settings menu, requiring a pin code. The selected settings are

the responsibility of the local administrator. HemoCue AB does not take responsibility for

user conﬁgurations that may cause system conﬂicts, loss of data or prevent the end-user to

perform tests.

1.1 Abbreviations/glossary

AC Alternating Current

CD Compact Disc

CIC Connectivity Industry Consortium

The CIC was an open, non-proﬁt, industry-driven consortium

comprised of device manufacturers, information system vendors and

health care providers. It was chartered to address impediments to

POC device connectivity with the objective of enabling seamless

information exchange between POC devices and electronic medical

records and laboratory information systems.

DM Data Management

DMS Data Management Server

HC HemoCue

Hub A physical connecting device

A hub is a place of convergence where data arrives from one or more

directions and is forwarded in one or more other directions.

IP-address A number that identiﬁes each sender or receiver of information that is

sent in packets across the Internet.

IR Infra Red (light)

Electromagnetic radiation with wavelengths longer than those of

visible light but shorter than those of radio waves.

IrDA Infrared Data Association

LAN Local Area Network

A group of computers and associated devices that share a common

communications line and typically share the resources of a server

within a small geographic area (e.g. an oce building). The server

usually has applications and data storage that are shared in common

by multiple computer users.

LED Light Emitting Diode

A semiconductor device that emits visible light when an electric

current passes through it. In most LEDs the light is monochromatic,

i.e. occurring at a single wavelength.

LID Lab Identiﬁcation (ID) or lab number ID of a test, unique within a user

site.

CLSI Clinical and Laboratory Standards Institute (formerly NCCLS).

A globally recognized, voluntary consensus organization developing

standards, guidelines and best practices for healthcare medical

testing.

OR Observation Reviewer

The primary role of an OR, normally referred to as a middleware, is to

host one or more services to which point-of-care diagnostic devices

connect. These services facilitate the collection of test results and

quality data from, as well as the management of, these devices. In

addition, services hosted by an OR may exchange data with already

existing information systems in the hospital or laboratory, e.g.

Laboratory Information Systems (LIS).

PAT Patient Test

PC Personal Computer

PDS+Primary Docking Station

PDS Primary Docking Station (Unlabelled)

PID Patient Identiﬁcation (ID)

POC Point-of-care (The immediate surroundings of a patient)

POCT Point-of-care Testing (Testing procedures performed in the

immediate surroundings of the patient)

POCT1-A Standard for communication and messages between diagnostic

instruments, speciﬁed by CLSI, based on speciﬁcations from the

Connectivity Industry Consortium (CIC)

QC Quality Control

QC Test A measurement of control material, providing evidence of the stability

of the System

SDS+Secondary Docking Station

SDS Secondary Docking Station (Unlabelled)

STAT Short Turn Around Time

STAT Test A test mode that allows a patient test to be performed without

entering information required in the routine patient test mode. Testing

is also possible in this mode if the routine patient testing mode of the

Analyzer is locked out.

TCP/IP Transmission Control Protocol/Internet Protocol

USB Universal Serial Bus

A “plug and play” interface between a computer and peripheral

devices (e.g. keyboards, scanners, printers).

With USB, a new device can be added to the computer without having

to add an adapter card or turning the computer o.

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