HemoCue 201 DM Manuel utilisateur
HemoCue® 201 DM Analyzer
&
HemoCue®201 DM Docking Station
Reference Manual
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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
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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
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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
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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
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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 dierent 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.
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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 oce building). The server
usually has applications and data storage that are shared in common
by multiple computer users.
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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
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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.
Autres manuels pour 201 DM
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Table des matières
Autres manuels HemoCue Station d'accueil
