HemoCue Glucose 201 DM RM

HemoCue Glucose 201 DM RM
HemoCue Glucose 201 DM Analyzer
& HemoCue DM Docking Station
Reference Manual
CONTENTS
CONTENTS
PART I
Introduction . . . . . . . . . . . . . . . . . . . 1
1 Introduction . . . . . . . . . . . . . . . . . . . . 3
1.1
The HemoCue Glucose 201 DM System . . . . . 4
1.1.1
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1.2
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1.3
Materials required but not provided . . . . . . . . . . . . . . . 5
1.2
Abbreviations/glossary . . . . . . . . . . . . . . . . . . . 6
1.3
Designated Terminology . . . . . . . . . . . . . . . . . . 9
1.4
Functional description . . . . . . . . . . . . . . . . . . . 11
1.4.1
System Components . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.4.2
Analyzer overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.4.3
Docking station – General . . . . . . . . . . . . . . . . . . . . . 16
1.4.4
Docking Station overview . . . . . . . . . . . . . . . . . . . . . 18
1.4.5
Functions and features . . . . . . . . . . . . . . . . . . . . . . . 23
2 Safety . . . . . . . . . . . . . . . . . . . . . . . 25
2.1
2.1.1
2.2
2.2.1
2.3
2.3.1
HemoCue Glucose 201 DM System . . . . . . . . 25
Usage of the System . . . . . . . . . . . . . . . . . . . . . . . . . 25
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Hazard information . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Handling of the System . . . . . . . . . . . . . . . . . . 27
System Components . . . . . . . . . . . . . . . . . . . . . . . . . 27
i
CONTENTS
3 Installation/General operations . . . . . . 29
3.1
3.1.1
Power source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.1.2
Turning on the Analyzer . . . . . . . . . . . . . . . . . . . . . . 34
3.1.3
Power saver mode. . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.1.4
Turning the Analyzer off . . . . . . . . . . . . . . . . . . . . . . 36
3.1.5
Loading the Analyzer with a Cuvette . . . . . . . . . . . . . 37
3.2
Getting started – Single Docking Station. . . . . 38
3.2.1
Connect to a PC or a LAN . . . . . . . . . . . . . . . . . . . . . 38
3.2.2
Power source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.3
Getting started – Multiple Docking Stations. . . 42
3.3.1
Connecting Docking Stations . . . . . . . . . . . . . . . . . . 42
3.3.2
Connect to a PC or a LAN . . . . . . . . . . . . . . . . . . . . . 45
3.3.3
Power source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.4
Docking Station LED . . . . . . . . . . . . . . . . . . . . 47
3.5
How to operate the Display . . . . . . . . . . . . . . . 49
3.5.1
Display buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3.5.2
Using the Barcode Scanner button . . . . . . . . . . . . . . 52
3.6
ii
Getting started – Analyzer . . . . . . . . . . . . . . . . 29
Operating the Analyzer . . . . . . . . . . . . . . . . . . 54
3.6.1
Start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.6.2
Login image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3.6.3
Main Menu and On-line Help. . . . . . . . . . . . . . . . . . . 56
CONTENTS
3.7
Display buttons and symbols. . . . . . . . . . . . . . 57
3.7.1
Navigation buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.7.2
Procedure buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
3.7.3
Other display buttons. . . . . . . . . . . . . . . . . . . . . . . . . 59
3.7.4
Display symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
3.7.5
Entering information with letters and digits . . . . . . . . 65
3.7.6
Entering information from barcodes . . . . . . . . . . . . . 68
PART II
Settings . . . . . . . . . . . . . . . . . . . . . 69
4 Settings . . . . . . . . . . . . . . . . . . . . . . 71
4.1
Activating the Settings procedure . . . . . . . . . . 71
4.2
Define Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.2.1
Liquid Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.2.2
Cuvette Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4.2.3
Define Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
4.2.4
Define Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
4.2.5
Define Log Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.3
Basic Settings . . . . . . . . . . . . . . . . . . . . . . . . . 96
4.3.1
Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
4.3.2
Power Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
4.3.3
Audible Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
4.3.4
Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
iii
CONTENTS
4.4
4.4.1
Advanced Settings . . . . . . . . . . . . . . . . . . . . 102
General Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
4.4.2
Patient Test Settings . . . . . . . . . . . . . . . . . . . . . . . . 112
4.4.3
QC Test Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
4.4.4
Linearity Test Settings . . . . . . . . . . . . . . . . . . . . . . . 137
4.5
Default Settings . . . . . . . . . . . . . . . . . . . . . . . 139
4.6
Infra Red . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
4.6.1
The transmitting Analyzer . . . . . . . . . . . . . . . . . . . . 140
4.6.2
The Receiving Analyzer. . . . . . . . . . . . . . . . . . . . . . 143
4.7
Docking Station Settings . . . . . . . . . . . . . . . . 144
PART III
Routine use . . . . . . . . . . . . . . . . . 145
5 Blood specimen collection . . . . . . . . .
5.1
Capillary blood. . . . . . . . . . . . . . . . . . . . . . . . 147
5.2
Venous and Arterial Blood. . . . . . . . . . . . . . . 153
6 Patient Test procedure . . . . . . . . . . .
6.1
155
Patient Test . . . . . . . . . . . . . . . . . . . . . . . . . . 155
6.1.1
Patient Test Result . . . . . . . . . . . . . . . . . . . . . . . . . 161
6.1.2
Verify/Duplicate sampling . . . . . . . . . . . . . . . . . . . . 163
6.1.3
Entering Comments. . . . . . . . . . . . . . . . . . . . . . . . . 166
6.1.4
Entering Comments – Verified sample . . . . . . . . . . 171
7 STAT Test procedure . . . . . . . . . . . .
7.1
7.1.1
iv
147
173
STAT Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
STAT Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . 176
CONTENTS
8 QC Test procedure . . . . . . . . . . . . . .
8.1
177
Events necessitating QC Tests . . . . . . . . . . . 177
8.1.1
QC Reminder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
8.1.2
QC Lockout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
8.1.3
Supervisory Lockout . . . . . . . . . . . . . . . . . . . . . . . . 180
8.2
Performing a QC Test . . . . . . . . . . . . . . . . . . 181
8.2.1
QC Tests at a specific concentration level . . . . . . . 183
8.2.2
Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
8.2.3
Proficiency Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
9 Reviewing stored data . . . . . . . . . . .
203
9.1
Activating the Stored Data procedure . . . . . . 203
9.2
Review Stored Data. . . . . . . . . . . . . . . . . . . . 206
9.2.1
Review All Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
9.2.2
Review PAT/STAT. . . . . . . . . . . . . . . . . . . . . . . . . . 209
9.2.3
Review QC Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . 212
9.2.4
Review Analyzer Log. . . . . . . . . . . . . . . . . . . . . . . . 219
9.3
Delete Stored Data . . . . . . . . . . . . . . . . . . . . 221
9.4
Review Latest Download . . . . . . . . . . . . . . . . 224
9.5
Log Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
10 Data communications . . . . . . . . . . . .
227
10.1
Interaction Application – Analyzer . . . . . . . . . 227
10.2
Docking station setup . . . . . . . . . . . . . . . . . . 228
10.3
Data transfer . . . . . . . . . . . . . . . . . . . . . . . . . 235
v
CONTENTS
PART IV
Other actions . . . . . . . . . . . . . . . . 239
11 Maintenance . . . . . . . . . . . . . . . . . .
241
11.1
Cleaning the Cuvette holder and
the optronic unit . . . . . . . . . . . . . . . . . . . . . . . 241
11.2
Cleaning the Display . . . . . . . . . . . . . . . . . . . 243
11.3
Cleaning of the Analyzer Outer case
and the Docking Station . . . . . . . . . . . . . . . . 243
11.4
Calibrating the Display. . . . . . . . . . . . . . . . . . 244
12 Troubleshooting . . . . . . . . . . . . . . . .
12.1
247
Error messages . . . . . . . . . . . . . . . . . . . . . . . 247
PART V
Miscellaneous . . . . . . . . . . . . . . . . 257
13 Technical specifications. . . . . . . . . . .
vi
259
13.1
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
13.2
Intended purpose/ Intended Use . . . . . . . . . . 259
13.3
Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
13.4
Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
13.5
Sample material. . . . . . . . . . . . . . . . . . . . . . . 260
13.6
Storage and environmental requirements . . . 261
13.7
Quality Control. . . . . . . . . . . . . . . . . . . . . . . . 261
CONTENTS
13.8
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262
13.8.1
Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262
13.8.2
Plasma Equivalent. . . . . . . . . . . . . . . . . . . . . . . . . . 262
13.9
Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
13.10 Expected values . . . . . . . . . . . . . . . . . . . . . . 263
13.11 Technical Specifications . . . . . . . . . . . . . . . . 264
13.12 Signal input and signal output connections . . 265
13.13 Electromagnetic Compatibility . . . . . . . . . . . . 266
13.14 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
13.15 Service and Disposal. . . . . . . . . . . . . . . . . . . 272
13.16 Spare parts and accessories . . . . . . . . . . . . . 272
13.17 Symbols on System Components
and Accessories . . . . . . . . . . . . . . . . . . . . . . 273
13.18 References . . . . . . . . . . . . . . . . . . . . . . . . . . 275
APPENDICES
A Default Settings . . . . . . . . . . . . . . . . . . . i
vii
CONTENTS
viii
PART I
Introduction
Glucose 201 DM
Version 3.0
Serial no.
0711710021
Glucose 201 DM
PART I
This page intentionally left blank
2
PART I
1 Introduction
1 Introduction
Thank you for choosing the HemoCue Glucose 201 DM system.
The HemoCue Glucose 201 DM system is a compact, portable, yet versatile,
blood glucose 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 Glucose 201 DM Analyzer, the
HemoCue DM Docking Station, the HemoCue Glucose 201 Microcuvettes.
This Reference Manual contains instructions for settings, quality assessment,
patient testing, and troubleshooting of the HemoCue Glucose 201 DM Analyzer,
as well as installation of the HemoCue DM Docking Station. For information on
the HemoCue 201 DM - DMS Software, see the separate User’s Guide on the
DMS Software CD.
This chapter gives a brief overview of the functions and features of the Analyzer
and the Docking Station.
Note! Prior to starting the
HemoCue Glucose 201 DM Analyzer,
read section 2 Safety, followed by section
3 Installation/General operations.
3
1 Introduction
PART I
1.1 The HemoCue
Glucose 201 DM
System
1.1.1 Unpacking
FIGURE 1-1
Ins
truc
tion
s fo
rU
se
a) The Analyzer and the Docking Station
are supplied in two different packages,
as described below. Open up the
package and unpack the contents on a
dry and stable surface.
Analyzer:
1 HemoCue Glucose 201 DM Analyzer
2 HemoCue Glucose 201 DM Analyzer
Instructions for Use
1
2
Docking Station:
3 HemoCue DM Docking Station
3
4
PART I
1 Introduction
1.1.2 Inspection
a) Check all System Components for
damage.
Electrical shock! Use of damaged
electrical equipment poses a risk of
electrical shock or further damage to the
equipment.
b) If any visible or suspected damage is
discovered, contact the local
distributor.
1.1.3 Materials required but not
provided
1
FIGURE 1-2
HemoCue Glucose 201
Microcuvettes (1), packaged individually
or in vials
System Components:
1 HemoCue Glucose 201 Microcuvette
5
1 Introduction
PART I
1.2 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
Internet Protocol
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
(Continues)
6
PART I
1 Introduction
(Continues)
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 office
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 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
PID
Patient Identification (ID)
(Continues)
7
1 Introduction
PART I
(Continues)
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
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.
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 off.
8
PART I
1 Introduction
1.3 Designated
Terminology
The designations in the table below are
used throughout the rest of this
document.
Item
Referred to as the...
General
HemoCue Glucose 201 DM system
System
Components of the HemoCue
Glucose 201 DM system
System Components
System Components
HemoCue Glucose 201 DM Analyzer
Analyzer
HemoCue DM Docking Station
primary
Primary (Docking Station)
HemoCue DM Docking Station
secondary
Secondary (Docking Station)
HemoCue DM Docking Station
(irrespective of primary or secondary)
Docking Station
HemoCue 201 DM - DMS Software
DMS Software
HemoCue Glucose 201 Microcuvette
Cuvette
Documentation
HemoCue Glucose 201 DM Analyzer
& HemoCue DM Docking Station
Reference Manual
Reference Manual
HemoCue 201 DM - DMS Software
User’s Guide (on CD)
DMS Software Manual
9
1 Introduction
Item
PART I
Referred to as the...
Accessories
6 V 2.5 A AC Adapter
AC Adapter
HemoCue 201 DM Battery
Battery
10
PART I
1 Introduction
1.4 Functional
description
1.4.1 System Components
FIGURE 1-3
1
The System consists of a specially
designed Analyzer (1), the HemoCue
Glucose 201 DM Analyzer, specially
designed microcuvettes (2), HemoCue
Glucose 201 Microcuvettes and a
specially designed docking station (3),
the HemoCue DM Docking Station.
Analyzer
Note! The HemoCue Glucose 201 DM
Analyzer (1) is only to be used together
with the HemoCue Glucose 201
Microcuvettes (2).
2
3
The HemoCue Glucose 201 DM is a
System used for the determination of the
total amount of glucose in whole blood.
The result will either be displayed as a
whole blood or a plasma equivalent
result. This is a factory setting, and
cannot be changed by the user. The
HemoCue Glucose 201 DM Analyzer
with plasma conversion multiplies the
measured whole blood value by the factor
1.11 and displays a plasma equivalent
glucose result1. Plasma Equivalent will
be shown in the display for this version.
Note! The system is intended for in vitro
diagnostic use only.
1 Analyzer
2 Cuvette
3 Docking Station
(Continues)
11
1 Introduction
PART I
(Continues)
Docking Station
Full data management is possible when
the Analyzer is placed in the Docking
Station (3) which is connected via USB
or LAN to a PC hosting the DMS
Software. The Analyzer Battery is
recharged while in the Docking Station.
12
PART I
1 Introduction
1.4.2 Analyzer overview
Front panel
FIGURE 1-4
1
Note! Prior to performing a
measurement, read section 2 Safety, and
section 3 Installation/General operations
and perform the settings and
configuration according to section 4
Settings.
Note! Do not turn off the Analyzer in the
middle of a procedure. Data may be lost.
2
3
The Analyzer (1) is started when the
On/Off button (2) is pressed. The screen
images will be visible on the Display (3).
All navigation and information handling
is performed by pressing the appropriate
touch buttons directly on the Display (3).
4
To perform a measurement, the Cuvette
is filled with sample material and placed
in the Cuvette holder (4). The Cuvette
holder is inserted into the Analyzer (see
section 3.1.5 Loading the Analyzer with a
Cuvette).
To turn off the Analyzer (1), press the
On/Off button (2).
1
2
3
4
Analyzer
On/Off button
Display
Cuvette holder
13
1 Introduction
PART I
Back panel
FIGURE 1-5
4
The following items are found on the
back panel of the Analyzer.
• Power inlet (1) for the AC Adapter
• Power + USB signal inlet (2) for
connection to the Docking Station
• Built-in Barcode Scanner (3)
• IR Transmitter/Receiver (4) for data
transfer to/from the Docking Station
3
2
1
Data can be transmitted between the
Analyzer and the Docking Station in two
different ways:
• Via USB using the Power + USB
signal inlet (2), if the Docking Station
communicates with the DMS
Software via USB
• By means of IR-light using the IR
Transmitter/Receiver (4), if the
Docking Station communicates with
the DMS Software via LAN
1 Power inlet (for AC Adapter)
2 Power + USB signal inlet (for Docking
Station)
3 Barcode Scanner
4 IR Transmitter/Receiver
(Continues)
14
PART I
1 Introduction
(Continues)
FIGURE 1-6
4
3
Settings can be transmitted between two
Analyzers via the IR Transmitter/
Receiver (see section 4.6 Infra Red ). The
Analyzers have to be out of the Docking
Stations and positioned with the IR
Transmitter/Receivers (4) facing each
other.
2
1
The Power inlet (1) for the AC Adapter
can only be used when the Analyzer is
separated from the Docking Station.
When the Analyzer is placed in a
Docking Station, this inlet will be
blocked and the Analyzer receives power
via the Power + USB signal inlet (2).
Note! The combined Power + USB signal
inlet (2) is not a standard USB port, but a
special connector which fits the
corresponding connector on the Docking
Station.
Note! The IR Transmitter/Receiver (4) is
located inside the casing of the Analyzer.
Note! Do not cover or block the items on
the back panel; doing so may result in
malfunction.
1 Power inlet (for AC Adapter)
2 Power + USB signal inlet (for Docking
Station)
3 Barcode Scanner
4 IR Transmitter/Receiver
15
1 Introduction
PART I
1.4.3 Docking station – General
Single Docking Station
FIGURE 1-7
A Docking Station not connected to other
Docking Stations, is referred to as a
Single Docking Station.
Multiple Docking Stations
FIGURE 1-8
Up to five Docking Stations can be
connected to each other. These are
referred to as Multiple Docking Stations.
Only the Analyzer positioned furthest to
the left can be connected to an AC
Adapter. Power is supplied to the other
Analyzers through this connection.
Primary and Secondary Docking
Stations
FIGURE 1-9
Note! Primary and Secondary Docking
Stations are two physically different
products.
1 Primary or Secondary Docking Station
2 Secondary Docking Station
(Continues)
1
16
2
PART I
1 Introduction
(Continues)
FIGURE 1-10
A Primary Docking Station can be
connected to a LAN and both
receive/send data itself and pass data
from/to a Secondary Docking Station that
is connected to the Primary.
1
2
Note! When a Primary Docking Station
is connected via a USB connection, only
the IP address can be changed. No other
information can be sent to/from the
Analyzer.
A Secondary Docking Station cannot be
connected to a LAN. In order to
communicate via a LAN it must be
connected to a Primary Docking Station.
A Secondary Docking Station can
communicate directly to a PC via a USB
connection.
Both Primary and Secondary Docking
Stations can be used singularly.
A set of Multiple Docking Stations,
(maximum five), consists of either one
Primary and a number of Secondary
Docking Stations or of only Secondary
Docking Stations. If a Primary is
included, it must be positioned furthest to
the left (1) (when facing the front of the
Docking Station).
Note! Two Primary Docking Stations
must not be connected together.
1 Primary or Secondary Docking Station
2 Secondary Docking Station
17
1 Introduction
PART I
1.4.4 Docking Station overview
Front
FIGURE 1-11
3
The Docking Station consists of the
following items:
2
1
• Tracks (1) for the Analyzer
• Power + USB signal outlet (2) for the
Analyzer
• IR Transmitter/Receiver (3) for data
transmission to/from the Analyzer
• LED (4)
Note! The combined Power + USB
signal outlet (2) is not a standard USB
port, but a special connector which fits
the corresponding connector on the
Analyzer.
Note! The IR Transmitter/Receiver (3) is
located inside the casing.
4
Note! Do not cover or block the items on
the back panel; doing so may result in
malfunction.
1
2
3
4
18
Tracks
Power outlet
IR Transmitter/Receiver
LED
PART I
1 Introduction
Back panel – Primary Docking Station
FIGURE 1-12
The following items are located on the
back panel:
3
2
• Power inlet (1) for the AC Adapter
• USB port (2) for setting up the
Primary Docking Station
Note! Different from the USB port in
the Secondary Docking Station
1
• Network port (3) for data
communication via a LAN
1 Power inlet for the AC Adapter
2 USB port
3 Network port
Back panel – Secondary Docking
Station
FIGURE 1-13
The following items are located on the
back panel:
2
1
• Power inlet (1) for the AC Adapter
• USB port (2) for data communication
directly with the PC
Note! Different from the USB port in
the Primary Docking Station
1 Power inlet for the AC Adapter
2 USB port
19
1 Introduction
PART I
Data Communication Connectors
FIGURE 1-14
2
1
The male connector (1) for data
communication between Multiple
Docking Stations is positioned under the
Side Trim (2).
Important! The Side Trim (2) on the
Docking Station should always be used to
protect the Connector (1).
1 Male Connector
2 Side Trim
(Continues)
20
PART I
1 Introduction
(Continues)Single
FIGURE 1-15
4
3
The female connector (3) is positioned
under the Bottom Trim (4).
Note! There is no female connector (3)
on a Primary Docking Station .
Important! The Bottom Trim (4) on the
Docking Station should always be used to
protect the Connector (3).
3 Female Connector
4 Bottom Trim
21
1 Introduction
PART I
Placing the Analyzer in the Docking
Station
FIGURE 1-16
Important! Always slide the Analyzer
into and out of the Docking Station by
means of the Tracks (1).
1
1 Tracks
FIGURE 1-17
Important! Never try to lift the Analyzer
out of the Docking Station or press the
Analyzer downwards into the Docking
Station.
This may damage the casing and power
outlets of the Analyzer and/or the
Docking Station.
22
PART I
1 Introduction
1.4.5 Functions and features
The HemoCue Glucose 201 DM system
is a powerful data management system
for decentralized testing. It can be
customized by the user allowing the
activation or deactivation of the
following functions:
• Operator ID input, with lockout
function if the Operator ID is not
recognized
• Patient ID input
• Cuvette batch data input
• Lab number input
• Quality Control with input of lot
numbers, range and lockout functions
• Linearity and proficiency testing
• STAT tests
The Analyzer stores:
• Approximately 4000 Patient/STAT
test results (including Patient ID,
Operator ID, date, time, comments,
etc.)
• Approximately 500 QC test results
(including QC level, Operator ID,
date, time, comments, etc.)
• Approximately 500 Analyzer log
entries (Error messages, maintenance
etc.)
(Continues)
23
1 Introduction
PART I
(Continues)
The Analyzer also has the following
features:
• Easy-to-use Display
• Built-in Barcode Scanner
• Powered either by a rechargeable
lithium ion battery, AC Adapter or via
the Docking Station. The Battery is
recharged when connected to the
Docking Station.
• Communication with DMS Software
or OR via Docking Station, according
to POCT1-A standard (also known as
the CIC standard)
24
PART I
2 Safety
2 Safety
To ensure maximum safety, read this chapter carefully before using the Analyzer
or any of the System Components in the HemoCue Glucose 201 DM System.
2.1 HemoCue
Glucose 201 DM
System
2.1.1 Usage of the System
FIGURE 2-1
All System Components are designed
and manufactured to provide maximum
safety. There are three procedures related
to the System that may cause personal
injury or damage to equipment. These
procedures are found outside the core
functions of the System:
Ins
truc
tion
s fo
rU
se
• Handling of electrical components–
Always handle electrical components
with care, otherwise electrical shocks
may occur to the user.
• Handling of blood specimens –
Always handle blood specimens with
care, as they might be infectious.
• Handling of the Barcode Scanner –
Laser radiation. Do not stare into the
beam or view directly with an optical
instrument.
25
2 Safety
PART I
2.2 General
2.2.1 Hazard information
The following hazard information
describes the level of risk of injury or
damage to the user or equipment
respectively:
Hazard information
Warning!
Electrical shock!
26
Significance
Risk of serious personal injury!
Failure to observe this information can
result in personal injury and/or
serious damage to or destruction of
equipment!
Risk of electrical shock!
Failure to observe this information can
result in personal injury and/or
serious damage to or destruction of
equipment!
Caution!
Risk of minor personal injury!
Failure to observe this information can
result in minor personal injury!
Important!
Risk of damage to equipment!
Failure to observe this information can
result in damage to equipment!
Note!
Is used to emphasize important
information. The Note! is not to be
regarded as hazard information.
PART I
2 Safety
2.3 Handling of the
System
2.3.1 System Components
Carefully follow the instructions in this
document and pay special attention to the
Hazard information in section 2.2.1
Hazard information.
Battery
Warning! Lithium ion battery - Danger
of explosion - Replace the Battery with
the same type recommended by
HemoCue.
Consult local environmental authorities
for proper disposal.
Cuvette
FIGURE 2-2
Warning! Always handle blood
specimens with care, as they might be
infectious.
Always use protective gloves when
handling Cuvettes that are filled with
blood.
Although the reagents are present in the
cuvettes in extremely low quantities,
consult local environmental authorities
for proper disposal.
27
2 Safety
PART I
This page intentionally left blank
28
PART I
3 Installation/General operations
3 Installation/General
operations
This chapter describes the general operations necessary for Analyzer use.
3.1 Getting started –
Analyzer
3.1.1 Power source
The Analyzer can be powered either by
the rechargeable Battery or by a standard
electrical outlet via the AC Adapter.
Recharging the Battery
FIGURE 3-1
1
The rechargeable Battery (1) is located in
a battery compartment on the bottom of
the Analyzer.
a) Recharge the Battery (1) by
connecting the AC Adapter to the
Analyzer or by placing the Analyzer in
the Docking Station. A brand new
Battery will take longer to charge the
first 2 to 3 times.
1 Battery
(Continues)
29
3 Installation/General operations
PART I
(Continues)
A fully charged Battery will power the
Analyzer for 100 hours when in the
stand-by mode or for two days of normal
use. Normal use is defined as 60
samples/day using the Barcode Scanner.
The Battery recharges to 70% of its
capacity in less than 2 hours and to nearly
100% in less than 10 hours.
30
PART I
3 Installation/General operations
Replacing the Battery
2
FIGURE 3-2
Warning! Only the HemoCue 201 DM
Battery can be used in the Analyzer.
The Battery lasts for several years. It
should be replaced when it fails to retain
its charge for an acceptable period.
1
The Battery is available as an accessory
through HemoCue and HemoCue
distributors.
a) To remove the Battery (1), press the
Flap (2).
1 Battery
2 Flap
(Continues)
31
3 Installation/General operations
PART I
(Continues)
1
3
4
FIGURE 3-3
2
Warning! Lithium ion battery. Never try
to open the battery casing. Risk of
explosion
Consult local environmental authorities
for proper disposal.
b) Carefully loosen the Battery (1) and
lift it upwards.
c) To install the new Battery (3), place it
in the Analyzer and gently press
downwards until the Flap (4) snaps
into the locked position.
1
2
3
4
32
Old Battery
Flap
New Battery
Flap
PART I
3 Installation/General operations
Connecting the AC Adapter
FIGURE 3-4
Warning! Only use the AC Adapter that
is recommended by HemoCue. Other AC
Adapters, although physically able to be
plugged into the Analyzer, may cause
serious damage or fire.
3
1
2
a) Insert the AC Adapter’s DC plug (2)
into the Power inlet (3) on the back
panel of the Analyzer.
b) Plug the AC Adapter (1) into an
electrical outlet.
1 AC Adapter
2 DC plug
3 Power inlet
33
3 Installation/General operations
PART I
3.1.2 Turning on the Analyzer
FIGURE 3-5
a) Turn on the Analyzer by pressing the
On/Off button (1).
b) The Start Image, beginning with the
HemoCue logo, will be displayed, as
seen in FIGURE 3-6.
2
1 On/Off button
2 Display
1
Start Image
FIGURE 3-6
Glucose 201 DM
Version 3.0
1
2
The Start Image includes the following
information: Analyzer type (1), Software
version (2) and the unique Serial
number (3) of the Analyzer.
• If the Cuvette holder is in the
Measuring position (see section 3.1.5
Loading the Analyzer with a Cuvette),
the following text will be displayed:
Please Pull Out the Cuvette Holder
Serial no.
0506710001
34
3
1 Analyzer type
2 Software version
3 Serial number
(Continues)
PART I
3 Installation/General operations
(Continues)
• If the Cuvette holder is in the Loading
position (see section 3.1.5 Loading
the Analyzer with a Cuvette), the
following text will be displayed:
Please Wait Selftesting ...
No inputs can be made for
approximately 20 seconds during the
selftest.
For information on how to operate the
Display, see section 3.5 How to operate
the Display.
For instructions on how to perform tests,
see section 6 Patient Test procedure,
section 7 STAT Test procedure and
section 8 QC Test procedure.
For safety information, see section 2
Safety.
35
3 Installation/General operations
PART I
3.1.3 Power saver mode
When no procedures have been
performed within the time predefined in
the Analyzer settings (see section 4.3.2
Power Saver), the Analyzer will switch to
power save mode.
If the Analyzer is powered via the AC
adapter, the user will be logged off, the
image on the display will disappear, but
the power will remain on. Touch the
Display to reactivate it.
If the Analyzer is powered via the
Battery, the user will be logged off and
the Analyzer will be switched off. Press
the On/Off button to reactivate it.
3.1.4 Turning the Analyzer off
FIGURE 3-7
Note! Do not turn off the Analyzer in the
middle of a procedure. Data may be lost.
2
1
36
a) Turn off the Analyzer by pressing the
On/Off button (1).
b) The image on the Display (2),
disappears.
1 On/Off button
2 Display
PART I
3 Installation/General operations
3.1.5 Loading the Analyzer
with a Cuvette
The Loading position
FIGURE 3-8
FIGURE 3-8 shows the Analyzer with
the Cuvette holder (1) open, referred to as
the Loading position.
1
1 Cuvette holder
Inserting a Cuvette
Obtain a blood sample according to the
procedure described in section 5 Blood
specimen collection.
1
a) Place the Cuvette in the Cuvette
holder (1) and gently close the Cuvette
holder (1).
When closed, the Analyzer will
automatically start the measuring
procedure and the result will appear on
the Display.
1 Cuvette holder
The Measuring position
FIGURE 3-9
FIGURE 3-9 shows the Analyzer with
the Cuvette holder (1) in the closed
position, referred to as the Measuring
position.
1
1 Cuvette holder
37
3 Installation/General operations
PART I
3.2 Getting started –
Single Docking
Station
3.2.1 Connect to a PC or a LAN
Note! This procedure should be
performed by a network administrator.
Important! Always keep electrical
equipment turned off during connection
procedures.
• A Single Primary Docking Station can
be connected to a LAN or to a PC via
the USB.
Note! When a Primary Docking Station
is connected via a USB connection, only
the IP address can be changed. No other
information can be sent to/from the
Analyzer.
• A Single Secondary Docking Station
can be connected directly to a PC via
the USB, but not to a LAN.
(Continues)
38
PART I
3 Installation/General operations
(Continues)
Connect Primary Docking Station to
PC
FIGURE 3-10
To change settings on a Primary Docking
Station, see section 4.7 Docking Station
Settings. The Primary Docking Station
must be connected to a PC directly via the
USB port.
2
1
a) Insert the USB cable into the USB
port (1).
b) Insert the USB cable into the PC’s
USB port.
1 USB port
2 Network port
39
3 Installation/General operations
PART I
Connect a Primary Docking Station to
a LAN
FIGURE 3-11
A Primary Docking Station must be
connected to a LAN for data
communication. The PC hosting the
DMS Software, or an OR must also be
connected.
2
1
The speed of the network port is 10 Mb/s.
a) Insert one end of the Network cable
into the Network port on the Docking
Station (2).
b) Insert the other end of the Network
cable into a Network port on the LAN
(not directly into the PC).
1 USB port
2 Network port
Connect a Secondary Docking Station
to a PC
FIGURE 3-12
1
A Single Secondary Docking Station
must be connected via the USB to the PC
hosting the DMS Software for data
communication. No settings can be
changed in the Secondary Docking
Station.
a) Insert one end of the USB cable into
the USB port of the Docking
Station (1).
b) Insert the other end of the USB cable
into the PC’s USB port.
1 USB port
40
PART I
3 Installation/General operations
3.2.2 Power source
Connecting the AC Adapter
FIGURE 3-13
3
1
2
Warning! Only use the AC Adapter that
is recommended by HemoCue. Other AC
Adapters, although physically able to be
plugged into the Analyzer, may cause
serious damage or fire.
a) Insert the AC Adapter's DC plug (2)
into the Power inlet (3).
b) Plug the AC Adapter (1) into an
electrical outlet.
1 AC Adapter
2 DC plug
3 Power inlet
41
3 Installation/General operations
PART I
3.3 Getting started –
Multiple Docking
Stations
3.3.1 Connecting Docking
Stations
FIGURE 3-14
2
1
Important! Docking Stations should be
connected to each other before
connecting to the Power source, the PC or
the LAN.
A set of Multiple Docking Stations,
(maximum five), consists of either one
Primary and a number of Secondary
Docking Stations or a number of
Secondary Docking Stations only. If a
Primary is included, it must be positioned
furthest to the left (when facing the
Docking Station fronts).
Note! Two Primary Docking Stations
must not be connected together.
Note! Maximum four Secondary
Docking Stations should be connected to
a Primary Docking Station.
a) Remove the Side Trim (2) from the
Primary Docking Station by first
removing the screw from the bottom
side (if present), and then gently
pressing the Side Trim inwards, while
lifting it upwards. The male
connector (1) is uncovered.
1 Male Connector
2 Side Trim
(Continues)
42
PART I
3 Installation/General operations
(Continues)
FIGURE 3-15
4
3
b) Remove the Bottom Trim (4) from the
Secondary Docking Station to uncover
the female connector (3). This is done
by gently inserting a small screwdriver
into the small openings and gently
lifting the trim upwards.
3 Female Connector
4 Bottom Trim
(Continues)
43
3 Installation/General operations
PART I
(Continues)
FIGURE 3-16
c) Gently press the Secondary Docking
Station (5) downwards onto the
Primary Docking Station (6), fitting
the Female Connector and the Male
connector together.
Note! The Docking Stations must be
securely connected to each other in order
to ensure good electrical contact.
5 Secondary Docking Station
6 Primary Docking Station
5
6
FIGURE 3-17
d) If more Secondary Docking Stations
are to be added, remove the Side Trim
from the previously added Docking
Station and the bottom trim of the new
Secondary Docking Station, as shown
in FIGURE 3-14 and FIGURE 3-15 .
Repeat the procedure in FIGURE 3-16
with the new Secondary Docking
Station.
7 Previous Secondary Docking Station
8 New Secondary Docking Station
7
44
8
PART I
3 Installation/General operations
3.3.2 Connect to a PC or a LAN
Note! This procedure should be
performed by a Network administrator.
Important! Always keep electrical
equipment turned off during connection
procedures.
• A Primary Docking Station in a
multiple set can be connected to a PC
via the LAN. It can also be connected
via the USB, in this case only the IP
address of the Primary Docking
Station can be changed.
• A Secondary Docking Station in a
multiple set containing a Primary can
communicate with a LAN via the
Primary. It can also be connected
directly to a PC, via the USB, in
which case, the USB connection takes
preference.
• A Secondary Docking Station in a
multiple set consisting solely of
Secondary Docking Stations, can only
be connected to a PC directly via the
USB. Only electrical power will be
transferred between these Docking
Stations.
• A Secondary Docking Station cannot
be directly connected to a LAN.
Connect the Primary Docking Station
in a multiple set to a PC
See section FIGURE 3-10.
45
3 Installation/General operations
PART I
Connect the Primary Docking Station
in a multiple set to a LAN
See FIGURE 3-11.
Connect the Secondary Docking
Station in a multiple set to a PC
If the set consists solely of Secondary
Docking Stations, each Docking Station
must be connected via the USB to the PC
hosting the DMS Software for data
communication, see FIGURE 3-12.
If the set contains a Primary which is
connected to a LAN, the USB connection
is not necessary.
3.3.3 Power source
The Docking Station (Primary or
Secondary) furthest to the left is
connected to the Power source as
described in section 3.2.2 Power source.
The rest of the Docking Stations in a
multiple set are connected to the Power
source via this Docking Station and can
not be connected separately.
46
PART I
3 Installation/General operations
3.4 Docking Station LED
Steady green light
FIGURE 3-18
A steady green light from the LED (1)
indicates that the Docking Station (3) is
receiving power and that the Battery is
fully charged.
1 LED
2 Docked Analyzer
3 Docking Station
1
Flashing green light
FIGURE 3-19
A flashing green light from the LED (4)
indicates that the Battery in the docked
Analyzer is charging.
4 LED
i
ii i ii
ii
iiiii
2
ii
3
4
47
3 Installation/General operations
PART I
Steady red light
FIGURE 3-20
Note! Can only occur on a Primary
Docking Station
A steady red light from the LED (5)
indicates an internal communication
error within the Docking Station.
See section 12 Troubleshooting.
5 LED
5
Flashing red light
FIGURE 3-21
Note! Can only occur on a Primary
Docking Station
iiiii
i
ii i ii
ii
ii
6
A flashing red light from the LED (6)
indicates an external communication
error. The connection with the LAN is
faulty.
See section 12 Troubleshooting.
6 LED
48
PART I
3 Installation/General operations
3.5 How to operate the
Display
3.5.1 Display buttons
FIGURE 3-22
The Buttons (1) appearing on the
Display (2) activate the specific
functions symbolized by the image on the
button.
Enter
Settings Password
The Buttons (1) should only be pressed
using the fingertip.
Important! Sharp-edged objects can
damage the Display.
1 Buttons
2 Display
Activating a function
FIGURE 3-23
1
Enter
Settings Password
a) When a Button (1) is pressed, it will
appear highlighted as long as it is kept
pressed.
b) When the Button is released, the
function indicated by the button is
activated. An audible signal will sound
if the audio function has been
activated in the Settings, see section
4.3.3 Audible Signals.
1 Button, highlighted
49
3 Installation/General operations
PART I
Changing a function
FIGURE 3-24
a) Keep pressing while moving the
fingertip over to another button.
Enterr
Ente
Settings
ngs Pass
Password
word
Setti
FIGURE 3-25
Enter
Settings Password
50
b) The original button will cease to
appear highlighted and the new button
will appear highlighted.
c) When the new Button is released, the
new function will be activated.
PART I
3 Installation/General operations
Cancelling a function
FIGURE 3-26
Enter
Settings Password
a) Keep pressing while moving the
fingertip over to an area without
Buttons.
FIGURE 3-27
b) No Button will appear highlighted.
Enter
Settings Password
c) When the finger is released from the
Display, the first Button choice will be
ignored and no action will be
activated.
51
3 Installation/General operations
PART I
3.5.2 Using the Barcode
Scanner button
FIGURE 3-28
10-30
cm
4-12
inches
Warning! Laser radiation – Do not stare
into the beam or view directly with an
optical instrument.
Enter
Settings Password
See also section 3.7.6 Entering
information from barcodes.
To read barcodes, use the built-in
Barcode Scanner in the back panel of the
Analyzer.
Note! The scanning range (3) of the
Barcode Scanner, is approximately
10 - 30 cm (4 - 12 inches) from the
Barcode Scanner.
a) Press and hold the Barcode Scanner
button (1). The Barcode Scanner lights
up and scanning can be performed.
b) The decoded information from the
barcode (2) appears on the Display
when the Analyzer identifies the
barcode. The information is displayed
as long as the Barcode Scanner
button (1) remains pressed. To cancel
a reading, move the fingertip to an area
outside the Barcode Scanner Button,
before releasing.
1 Barcode Scanner button
2 Barcode
3 Scanning area
52
PART I
3 Installation/General operations
FIGURE 3-29
10-30
cm
c) When information is displayed,
remove the fingertip from the Barcode
Scanner button (1). The information
will be stored in the Analyzer, and is
no longer displayed.
4-12
inches
Enter
Settings Password
1 Barcode Scanner button
2 Barcode
3 Scanning area
53
3 Installation/General operations
PART I
3.6 Operating the
Analyzer
3.6.1 Start up
a) Turn the Analyzer on (see 3.1 Getting
started – Analyzer). The Start Image,
beginning with the HemoCue logo,
will be displayed.
b) If the Cuvette holder is in the
measuring position, the following text
will be displayed:
Please Pull Out the Cuvette Holder.
Pull the Cuvette holder out to the
loading position.
Note! When the Cuvette holder is in the
loading position the following text:
Please Wait Selftesting ...
is displayed for approximately
20 seconds while the Analyzer is
selftesting. No functions can be activated
during the selftest.
c) If the requirement for Operator ID is
set to “Not Used” (see section 4
Settings), the Main Menu will be
displayed, FIGURE 3-31, without the
Operator Name.
If Operator ID is required, the Login
Image will be displayed, FIGURE 330.
54
PART I
3 Installation/General operations
3.6.2 Login image
FIGURE 3-30
08/09/03 10:55 AM
Note! Not displayed if the requirement
for Operator ID is set to “Not Used” (see
section 4 Settings).
Enter
Operator ID
1
ABC
123
2
3
a) Enter Operator ID either directly on
the Display via the Text mode (1) and
Numeric mode (2) buttons or by the
Barcode Scanner, via the Barcode
Scanner button (3) see section 3.7.5
Entering information with letters and
digits or 3.7.6 Entering information
from barcodes.
Note! Use of the Barcode Scanner
eliminates manual input errors.
b) When a valid Operator ID is entered,
the Main Menu will be displayed, see
FIGURE 3-31.
1 Text mode button
2 Numeric mode button
3 Barcode Scanner button
55
3 Installation/General operations
PART I
3.6.3 Main Menu and On-line
Help
08/09/03 10:55 AM
JAMES SMITH
1
FIGURE 3-31
FIGURE 3-31 is referred to as the Main
Menu. It is displayed as the Startup Image
for all Tests, Setting procedures, etc.
The Help button (1) may be used to
display information about other buttons,
procedures, etc.
1 Help button
2 Operator name, Operator ID or blank,
depending on the settings
56
PART I
3 Installation/General operations
3.7 Display buttons and symbols
3.7.1 Navigation buttons
Button
ABC
ABC
123
123
Designation
Function
Erase button
Erases the last input
Previous image
button
Returns to the previous image
NOTE: Inputs/changes made in the
current image will not be saved
Text mode button
Switches to text input mode
Numeric mode
button
Switches to the numeric input mode
Barcode Scanner
button
Switches to the Barcode Scanner
mode
Scroll bar arrow
(Up)
Scrolls upwards in a list of different
options or in a text
Scroll bar arrow
(Down)
Scrolls downwards in a list of different
options or in a text
Next image
button
Continues to the next image in the
Help sequence
57
3 Installation/General operations
PART I
3.7.2 Procedure buttons
Button
58
Designation
Function
Patient test
button
Activates the Patient Test procedure
STAT test button
Activates the STAT (Short Turn
Around Time) Test procedure
QC test button
Activates the QC (Quality Control)
Test procedure
Stored data
button
Activates the Stored Data function
Settings button
Activates the Settings menu
Verify/Duplicate
sampling button
Allows for the performance of a
second test, on the same patient,
using a new Cuvette, without the need
for re-entering the Patient ID and
other information
Comment input
button
Allows a comment to be added to the
current result
Comment input
button
(dotted)
Button appearance confirms that
comments have been added to the
result
PART I
3 Installation/General operations
3.7.3 Other display buttons
Button
DEF
GHI
JKL
MNO
PQR
STU
VWX
YZ
[
ABC
123
Designation
Function
Help button
Displays on-line help regarding other
buttons, procedures, etc.
Confirm button
Saves text or numbers and/or
displays the next screen image
NOTE: All inputs/changes will be
saved
Log Out button
Logs out the operator
NOTE: The Log Out button is only
displayed if the Operator ID is
required.
Special
Character button
Enters a special character
(see explanations below)
NOTE: Other special characters can
only be loaded into the Analyzer by
means of the Barcode Scanner.
.-
123
See above
Space – press once
See above
Period – press twice
See above
Hyphen – press three times
View button
Provides a more detailed description
of the highlighted item
59
3 Installation/General operations
Button
Designation
Function
Letter buttons
Allows input of a text
Example:
To enter a “G” – press once
To enter an “H” – press twice
To enter an “I”– press three times
GHI
DEF
GHI
JKL
MNO
PQR
STU
VWX
YZ
[
ABC
123
PART I
.-
123
NOTE: Only capital letters will be
entered. Lower-case letters can be
entered into the Analyzer by means of
the Barcode Scanner.
Digit buttons
Allows input of a digit
Dilution button
Allows measurement of a diluted
sample.
NOTE: The Dilution button is only
displayed if activated in the Settings
menu
NOTE: The Dilution function is not
available in all markets.
Add button
Allows addition of a comment to a
result, an item to a list, etc.
Delete button
Allows deletion of a comment from a
result, an item from a list, etc.
3
1
2
3
4
5
6
7
8
9
0
123
ABC
Add
Delete
60
PART I
3 Installation/General operations
Button
Designation
Function
Accept button
Accepts a measurement
Reject button
Rejects a result
A rejected result will be saved and
flagged as rejected.
Save button
Stores the entered information
No button
The entered information will not be
stored.
Continue button
Continues the current operation
Statistics button
Displays statitics on the chosen
subject
Date format
button
Switches between the following date
formats:
• YYMMDD
• DD.MM.YY
• MM/DD/YY
Time format
button
Switches between the following time
formats:
• 12 hours
• 24 hours
Accept
Reject
Save
No
Continue
61
3 Installation/General operations
Button
AM/PM
62
PART I
Designation
Function
AM/PM button
Enables adding “AM/PM”
(only 12-hour format)
PART I
3 Installation/General operations
3.7.4 Display symbols
Symbol
03/03/04
Designation
Function
Battery
Indicates the voltage status of the
Battery in four levels. The furthest to
the left is fully charged, the one to the
right is almost empty.
Date
Indicates the Date format chosen
(from three possibilities) in the
Settings Menu
Big Hourglass
The big hourglass is displayed when
the Analyzer is in the measuring or
selftesting state
(rotating)
NOTE: The big hourglass is rotating
when displayed
Small hourglass
When the small hourglass is
displayed, the instrument is in a
measuring or blanking state
NOTE: When displayed in the Main
Menu, only Settings and Stored Data
functions are available. It is also
possible to log out
Waste bin
Indicates that a result has been
rejected. The result is stored in the
Analyzer.
63
3 Installation/General operations
Symbol
64
PART I
Designation
Function
QC Reminder
Reminder that a QC Test will be
required within stated time or number
of measurements
QC Lockout
QC Lockout, i.e. no more Patient Test
measurements can be made
The required QC Test has not been
performed.
Lockout
Supervisory Lockout
The Analyzer has been locked by the
Supervisor. A text that indicates this
will be displayed.
PART I
3 Installation/General operations
3.7.5 Entering information with
letters and digits
FIGURE 3-32
08/09/03 10:55 AM
Inputs to the Analyzer such as Operator
ID, Patient ID, etc. can be made via the
display or via the Barcode Scanner (see
section 3.7.6 Entering information from
barcodes)
Enter
Operator ID
1
ABC
123
2
The display can be set to two different
modes, text mode for entering letters
(including a few special characters) and
numeric mode for entering digits.
a) Press the Text mode button (1) or the
Numeric mode button (2) depending
on if the first character that is to be
entered is a letter or a digit.
b) Depending on the mode chosen,
follow the description for FIGURE 333 or FIGURE 3-34 .
1 Text mode button
2 Numeric mode button
65
3 Installation/General operations
PART I
Text mode
FIGURE 3-33
Operator ID
1
DEF
GHI
JKL
MNO
PQR
STU
VWX
YZ
[
ABC
.-
123
2
3
4
5
Note! Only capital letters and a few
special characters can be used in the text
mode. Lower-case letters can only be
entered into the Analyzer by means of the
Barcode Scanner.
a) In the text mode, inputs are made
using the Letter buttons (1) and the
Special Character button (2).
b) The Erase button (3) erases the last
input.
c) If a digit is to be entered, switch to the
numeric input mode by pressing the
Numeric mode button (4). FIGURE 334 will be displayed.
d) When all information has been
entered, press the Confirm button (5).
1
2
3
4
5
66
Letter button
Special Character button
Erase button
Numeric mode button
Confirm button
PART I
3 Installation/General operations
Numeric mode
FIGURE 3-34
Operator ID
a) In the numeric mode, inputs are made
using the Digit buttons (1).
b) The Erase button (2) erases the last
input.
1
2
3
4
5
6
7
8
9
0
1
c) If a letter or a special character is to be
entered, switch to the text input mode
by pressing the Text mode button (3).
FIGURE 3-33 will be displayed.
2
d) When all information has been
entered, press the Confirm button (4).
3
4
ABC
1
2
3
4
Digit button
Erase button
Text mode button
Confirm button
67
3 Installation/General operations
PART I
3.7.6 Entering information
from barcodes
FIGURE 3-35
08/09/03 10:55 AM
Also see 3.5.2 Using the Barcode
Scanner button.
Enter
Operator ID
ABC
Inputs to the Analyzer such as Operator
ID, Patient ID, etc. can be made via the
Barcode Scanner or via the display (see
3.7.5 Entering information with letters
and digits). Use of the Barcode Scanner
eliminates manual input errors.
123
1
Note! Special characters can be entered
into the Analyzer by means of the
Barcode Scanner.
a) Press and hold the Barcode Scanner
button (1). The Barcode Scanner lights
up and scanning can be performed.
b) When the barcode has been read, the
information will appear on the
Display.
c) The Barcode Scanner will be switched
off.
d) As long as the Barcode Scanner
button (1) is kept pressed, the scanned
information will be displayed.
e) Release the button. The scanned
information is stored and the next
image will be displayed.
1 Barcode scanner button
68
PART II
Settings
Enter
Settings Password
Glucose 201 DM
PART II
This page intentionally left blank
70
PART II
4 Settings
4 Settings
This chapter guides you through the process of setting and configuring the
Analyzer and the Docking Station.
4.1 Activating the
Settings procedure
FIGURE 4-1
08/09/03 10:55 AM
JAMES SMITH
Note! Access to the Settings function is
dependent on the setting for Operator ID
entry and on the operator’s user level.
The Analyzer is delivered with the
Operator ID set to “Not Used”.
a) In the Main Menu, press the Settings
button (1).
1
b) If the requirement for Operator ID
entry is set to “Not Used” (see 4.4.1
General Settings) FIGURE 4-2 will be
displayed, as this is a password
protected function.
Two other screens may be displayed,
dependent on the setting for entry of
the Operator ID:
If the operator’s user level does not
permit access to Settings, FIGURE 43 will be displayed.
If the operator’s user level permits
access to Settings, FIGURE 4-4 will
be displayed.
1 Settings button
(Continues)
71
4 Settings
PART II
(Continues)
FIGURE 4-2
Enter
Settings Password
Note! Only displayed if the Operator ID
requirement at startup is set to “Not used”
(see 4.4.1 General Settings)
2
3
ABC
123
4
c) Enter the Settings Password (default
value is “0000”), either directly on the
Display via the Text mode (2) and
Numeric mode (3) buttons, or with the
Barcode Scanner via the Barcode
Scanner button (4).
d) If the wrong password is entered,
FIGURE 4-3 will be displayed.
If the correct password is entered
FIGURE 4-4 will be displayed.
2 Text mode button
3 Numeric mode button
4 Barcode Scanner button
FIGURE 4-3
e) Pressing the Previous image button (5)
will result in a return to, either the
Main Menu (if the operator’s user
level does not permit access to the
Settings), or FIGURE 4-2 (if the
Operator ID is set to “Not Used”).
Pressing the Confirm button (6)
allows the Settings to be viewed only.
FIGURE 4-4 will be displayed.
Settings
Incorrect
Password or User
Level
No Changes to the
Settings will be
Saved
5
6
Note! In this “view only” mode, the
pressing of any button will highlight the
option but no change will be effected.
5 Previous image button
6 Confirm button
(Continues)
72
PART II
4 Settings
(Continues)
FIGURE 4-4
Settings
The Settings menu with the following
Setting categories (7) is displayed:
Define Lists
• Define Lists (see 4.2 Define Lists)
• Basic Settings (see 4.3 Basic Settings)
• Advanced Settings (see 4.4 Advanced
Settings)
• Default Settings (see 4.5 Default
Settings)
• Infra Red (see 4.6 Infra Red)
7
Basic Settings
Advanced Settings
Default Settings
8
f) Press the Scroll bar arrow (8) to view
categories (7) not initially visible on
the Display .
g) Select a Settings category (7) by
pressing it.
7 Settings categories
8 Scroll bar arrow
73
4 Settings
PART II
4.2 Define Lists
FIGURE 4-5
Define
Lists
Liquid Controls
1
Cuvette Batches
Define Operators
Define Comments
2
When the Define Lists button is pressed
in the Settings menu (see FIGURE 4-4),
the following Define Lists categories (1)
are displayed:
• Liquid Controls (see 4.2.1 Liquid
Controls)
• Cuvette Batches (see 4.2.2 Cuvette
Batches)
• Define Operators (see 4.2.3 Define
Operators)
• Define Comments (see 4.2.4 Define
Comments)
• Define Log (see 4.2.5 Define Log
Notes)
Note! Define Operators may only be
activated if the operator is designated as
Supervisor, or if the correct password has
been entered.
a) View Define Lists categories (1) not
initially visible by pressing the Scroll
bar arrow (2).
b) Select a Define Lists function (1) by
pressing it.
1 Define Lists categories
2 Scroll bar arrow
74
PART II
4 Settings
4.2.1 Liquid Controls
A Liquid Control is a liquid with a known
concentration, intended for checking the
accuracy of the system.
Liquid Controls
1
L2 123456789
L3 123456789
L4 123456789
Delete
Results from Liquid Controls can only be
stored as QC measurements if the Liquid
Control specifications have been entered.
FIGURE 4-6
When the Liquid Controls button is
pressed in the Define Lists menu (see
FIGURE 4-5), the Liquid Controls list (1)
is displayed (see FIGURE 4-6). The
Liquid Controls list can hold up to twelve
different Liquid Control specifications.
Add
2
When pressing the Add button (2) to add
a new Liquid Control specification, the
following Liquid Controls options (1) are
displayed:
• Level 1
•
•
•
•
Liquid Controls
Level 1
Level 2
Level 3
Level 4
1
Level 2
Level 3
Level 4
Level 5
FIGURE 4-7
Note! Level 1, Level 2, Level 3, Level 4
and Level 5 refer to the different
concentration levels of Liquid Controls.
The settings procedure is the same for all
concentration levels. For this reason, only
the Level 1 is described.
c) Select a Liquid Control option (1) by
pressing it, in this example Level 1.
1 Liquid Controls option
(Continues)
75
4 Settings
PART II
(Continues)
Control Name
(Level 1)
2
GlucoTrol NG
4
ABC
3
FIGURE 4-8
The control level (2) and the currently
used name (3) of the Liquid Control are
displayed.
5
Note! If no information had been entered
previously, the Liquid Control name (3)
will not appear.
6
Note! If the Confirm button is repeatedly
pressed through FIGURE 4-8 to FIGURE
4-11, no changes will be effected.
123
7
d) Enter Liquid Control name (3) either
directly on the Display via the Text
mode (4) and Numeric mode (5)
buttons, or with the Barcode Scanner
via the Barcode Scanner button (6).
e) Press the Confirm button (7).
2
3
4
5
6
7
Liquid Control concentration level
Liquid Control name
Text mode button
Numeric mode button
Barcode Scanner button
Confirm button
(Continues)
76
PART II
4 Settings
(Continues)
FIGURE 4-9
Control Lot
(Level 1)
f) Enter the Lot No. for the Liquid
Control either directly on the Display
via the Text mode and Numeric mode
buttons, or by the Barcode Scanner via
the Barcode Scanner button.
123456789
g) Press the Confirm button (8).
ABC
8 Confirm button
123
8
FIGURE 4-10
QC Level 1
h) The Expiration Date of the specific
control Lot can be entered or changed
using the numeric buttons, if desired.
Lot: 123456789
Expiration Date
08/10/03
i) Press the Confirm button (9).
1
2
3
4
5
6
7
8
9
0
9 Confirm button
(Continues)
9
77
4 Settings
PART II
(Continues)
FIGURE 4-11
QC Level 1
Unit:mg/dL
Warning Min (0)
Warning Max (400)
10
30
60
1
2
3
4
5
6
7
8
9
11
The warning limits define the range of
results for QC testing that must be
obtained to prevent a warning from being
displayed.
j) Enter min. value (10) and max.
value (11) for the warning interval.
k) Press the Confirm button (12).
0
12
A similar image for the lockout limits
will be displayed. The lockout limits
define the range for QC testing that must
be obtained to prevent the Analyzer from
performing a lockout.
l) In the image for the lockout limits,
enter min. value (10) and max.
value (11) for the lockout interval.
m)Press the Confirm button (12).
10 Min. value
11 Max. value
12 Confirm button
(Continues)
78
PART II
4 Settings
(Continues)
FIGURE 4-12
QC Level 1
13
14
GlucoTrol NG
Lot: 12345678
Exp.: 08/10/03
20
30
15
60
70
(mg/dL)
19
17
Save?
16
No
All settings for the Control are shown in
a summary display.
n) Press Save to store the setting
information or press No to cancel.
13
14
15
16
17
18
19
Control Liquid name
Control Liquid Lot No.
Control Liquid expiration date
Warning interval min. value
Warning interval max. value
Lockout interval min. value
Lockout interval max. value
18
Save
Delete a Liquid Control specification
FIGURE 4-13
Liquid Controls
3
b) A confirm dialogue is displayed. Press
Delete to delete the Liquid Control or
press No to cancel.
1
L2 123456789
L2 123456789
L3 123456789
L1 123456789
Delete
2
a) To choose the Liquid Control
specification that is to be deleted,
highlight the Liquid Control
specification (1) by pressing the Scroll
Bar Arrows (2). Press the Delete
button (3).
Add
c) The updated Liquid Control list will be
displayed. Press the Confirm button in
this display to return to the Define List
menu (see FIGURE 4-5).
1 Liquid Control specification (to be deleted)
2 Scroll bar arrows
3 Delete button
79
4 Settings
PART II
View/Change Liquid Control
specification
FIGURE 4-14
Liquid Controls
L2 123456789
L2 123456789
L3 123456789
L1 123456789
Delete
1
Add
2
3
a) To choose the Liquid Control
specification that is to be viewed/
changed, highlight the Liquid Control
specification by pressing the Scroll bar
arrows (1). Press the View button (2).
By pressing repeatedly on the confirm
button, FIGURE 4-8 to FIGURE 4-12
will be displayed. Press the Save
button to store any changes made and
return to the Liquid Controls List.
b) Press the Confirm button (3) to return
to the Define Lists menu (see FIGURE
4-5).
1 Scroll bar arrows
2 View button
3 Confirm button
80
PART II
4 Settings
4.2.2 Cuvette Batches
Note! A Cuvette Batch is a set of cuvettes
manufactured in one series under the
same conditions. Information entered for
a specific batch will apply to all cuvettes
within that batch. Five distinct Cuvette
Batches with corresponding information
can be stored in the Analyzer.
Add Cuvette Batch Information
FIGURE 4-15
Cuvette
Batches
1
123456789
234567891
345678912
456789123
Delete
When the Cuvette Batches button is
pressed in the Define Lists menu (see
FIGURE 4-5), the Cuvette Batch list (1)
will be displayed.
Note! In the initial settings, the Cuvette
Batch list (1) will be empty.
Add
2
Note! When trying to enter more than
five Batches, the following text will be
displayed:
Maximum Five Batches are Allowed.
a) To add a Cuvette Batch to the list,
press the Add button (2).
1 Cuvette Batches list
2 Add button
(Continues)
81
4 Settings
PART II
(Continues)
FIGURE 4-16
Add Cuvette Batch
ABC
b) Enter the Cuvette Batch No., either
directly on the Display via the Text
mode and Numeric mode buttons, or
with the Barcode Scanner via the
Barcode Scanner button.
c) If the Batch No. was entered via the
Barcode Scanner from the barcode on
the Cuvette vial, FIGURE 4-18 will be
displayed, otherwise FIGURE 4-17
will be displayed.
123
FIGURE 4-17
Cuvette Batch
Note! This screen will not be displayed if
the Cuvette Batch No. was entered via the
Barcode Scanner from the barcode on the
Cuvette vial.
Batch: 123456789
Expiration Date
08/09/03
1
2
3
d) Enter the Expiration Date for the
Cuvette Batch.
4
5
6
e) Press the Confirm button (3).
7
8
9
f) A summary is displayed, (see
FIGURE 4-18).
0
3
3 Confirm button
ABC
(Continues)
82
PART II
4 Settings
(Continues)
FIGURE 4-18
New
Cuvette Batch
g) Press Save to store the information or
press No to cancel.
h) The updated Cuvette Batch list will be
displayed. Press the Confirm button in
this display to return to the Define List
menu (see FIGURE 4-5).
Cuvette batch:
123456789
Expiration Date:
08/09/03
Save?
No
Save
Delete Cuvette Batch Information
FIGURE 4-19
Cuvette
Batches
1
123456789
234567891
345678912
456789123
567891234
2
Delete
3
Add
a) To choose the Cuvette Batch
information that is to be deleted,
highlight the Cuvette Batch No. (1) by
pressing the Scroll Bar Arrows (2).
Press the Delete button (3).
b) A confirm dialogue is displayed. Press
Delete to delete the Cuvette Batch or
press No to cancel.
c) The updated Cuvette Batch list will be
displayed. Press the Confirm button in
this display to return to the Define List
menu (see FIGURE 4-5).
1 Cuvette Batch (to be deleted)
2 Scroll bar arrows
3 Delete button
83
4 Settings
PART II
View Cuvette Batch Information
FIGURE 4-20
Cuvette
Batches
123456789
234567891
345678912
456789123
567891234
Delete
1
Add
2
3
a) To choose the Cuvette Batch
information that is to be viewed,
highlight the Cuvette Batch No. by
pressing the Scroll bar arrows (1).
Press the View button (2). A summary
of the stored information will be
displayed. Press the Confirm
button (3). The Cuvette Batch List will
be displayed.
b) Press the Confirm button (3) in the
new display to return to the Define
Lists menu (see FIGURE 4-5).
1 Scroll bar arrows
2 View button
3 Confirm button
84
PART II
4 Settings
4.2.3 Define Operators
A list of Operators that can log in and use
the System can be stored in the Analyzer.
Add Operator
FIGURE 4-21
Define
Operators
When the Define Operators button is
pressed in the Define Lists menu (see
FIGURE 4-5), the Define Operators
list (1) will be displayed.
HBJ2926
FJO1819
KSV1315
MSV5566
Delete
1
Add
a) To add an Operator to the list, press the
Add button (2).
2
3
123
1 Define Operators list
2 Add button
FIGURE 4-22
Add Operator ID
ABC
Note! In the initial settings, the Define
Operators list (1) will only contain the
default name “SUPERVISOR”.
4
5
b) Enter the Operator ID either directly
on the Display via the Text mode (3)
and Numeric mode (4) buttons, or
with the Barcode Scanner via the
Barcode Scanner button (5).
c) A similar image for Operator name
will be displayed. Enter the Operator
name according to instructions b)
above.
3 Text mode button
4 Numeric mode button
5 Barcode Scanner button
(Continues)
85
4 Settings
PART II
(Continues)
FIGURE 4-23
Activate
d) Enter the date from which the
Operator will have access to the
Analyzer.
Operator: JDO1943
Date
08/09/03
1
2
3
4
5
6
7
8
9
e) Press the Confirm button (6). FIGURE
4-24 will be displayed.
6 Confirm button
0
6
FIGURE 4-24
Deactivate
f) Enter the date after which the Operator
will be denied access to the Analyzer.
Operator: JDO1943
Date
g) Press the Confirm button (7). FIGURE
4-26 will be displayed.
08/09/04
1
2
3
4
5
6
7
8
9
0
86
7 Confirm button
(Continues)
7
PART II
4 Settings
(Continues)
FIGURE 4-25
Access Level
h) The following Access Level
options (8) are available:
Supervisor
8
Key Operator
Trusted User
User
9
•
•
•
•
•
Supervisor
Key Operator
Trusted User
User
Training
i) Press the Scroll bar arrow (9) to view
options not initially visible on the
screen.
Each operator belongs to only one Access
Level.
The different Access Levels give the
Operator the following authority:
8 Access Level options
9 Scroll bar arrow
Operator category
Authority description
Supervisor
Full Access to system
Key Operator
Same as Supervisor
Trusted User
Patient and QC function access only
User
Same as Trusted User
Training
Patient and QC function access only. No results are
stored.
(Continues)
87
4 Settings
PART II
(Continues)
FIGURE 4-26
Access Level
j) Select an Access Level option (8) by
pressing it.
8
k) A summary of the entered information
is displayed. Press Save to store the
information or press No to cancel.
9
l) The updated Define Operators list will
be displayed. Press the Confirm button
in this display to return to the Define
List menu (see FIGURE 4-5).
Supervisor
Key Operator
Trusted User
User
8 Access Level options
9 Scroll bar arrow
Delete Operator
FIGURE 4-27
Define
Operators
1
HBJ2926
FJO1819
KSV1315
MSV5566
2
3
Delete
Add
4
a) To choose the Operator information
that is to be deleted, highlight the
Operator ID (1) by pressing the Scroll
bar arrows (2). Press the delete
button (3).
b) A confirm dialogue is displayed. Press
Delete to delete the Operator
information or press No to cancel.
c) The updated Define Operators list will
be displayed. Press the Confirm
button (4) to return to the Define List
menu (see FIGURE 4-5).
1
2
3
4
88
Operator (to be deleted)
Scroll bar arrows
Delete button
Confirm button
PART II
4 Settings
View Operator
FIGURE 4-28
Define
Operators
HBJ2926
FJO1819
KSV1315
MSV5566
Delete
1
Add
2
3
a) To choose the Operator information
that is to be viewed, highlight the
Operator ID by pressing the Scroll bar
arrows (1). Press the View button (2).
A summary of the stored information
will be displayed. Press the Confirm
button (3). The Define Operator List
will be displayed.
b) Press the Confirm button in the new
display to return to the Define Lists
menu (see FIGURE 4-5).
1 Scroll bar arrows
2 View button
3 Confirm button
89
4 Settings
PART II
4.2.4 Define Comments
A comment is a short piece of text that
can be added to a result.
Add Comment
FIGURE 4-29
Define
Comments
1
Wrong Patient
Wrong QC Level
Old Cuvette
Old Liquid Control
Delete
When the Define Comments button is
pressed in the Define Lists menu (see
FIGURE 4-5), the Define Comments
list (1) will be displayed.
Note! In the initial settings, the Define
Comments list (1) will be empty.
Add
2
Note! When trying to enter more than 30
Comments, the following text will be
displayed:
Maximum 30 Comments are Allowed in
the List.
a) To add a Comment to the list, press the
Add button (2).
1 Define Comments list
2 Add button
(Continues)
90
PART II
4 Settings
(Continues)
FIGURE 4-30
Add Comment
3
4
ABC
123
5
b) Enter the Comment either directly on
the Display via the Text mode (3) and
Numeric mode (4) buttons, or with the
Barcode Scanner via the Barcode
Scanner button (5).
c) The updated Define Comments list
will be displayed. Press the Confirm
button in that display to return to the
Define List menu, (see FIGURE 4-5).
3 Text mode button
4 Numeric mode button
5 Barcode Scanner button
Delete Comment
FIGURE 4-31
Define
Comments
Wrong Patient
Wrong QC Level
Old Cuvette
Old Liquid Control
Delete
1
a) To choose the Comment that is to be
deleted, highlight the Comment (1) by
pressing the Scroll Bar Arrows (2).
Press the Delete button(3).
2
b) A confirm dialogue is displayed. Press
Delete to delete the Comment or press
No to cancel.
3
c) The updated Define Comments list
will be displayed. Press the Confirm
button (4) to return to the Define List
menu, (see FIGURE 4-5).
Add
4
1
2
3
4
Comment (to be deleted)
Scroll bar arrows
Delete button
Confirm button
91
4 Settings
PART II
View Comment
FIGURE 4-32
Define
Comments
A Comment that requires more space
than is available in the current display can
be viewed by pressing the View button.
Wrong Patient
Wrong QC Level
Old Cuvette
Old Liquid Control
Delete
1
Add
2
3
a) To choose the comment that is to be
viewed, highlight the Comment by
pressing the Scroll bar arrows (1).
Press the View button (2). The
complete comment will be
displayed.Press the Confirm
button (3). The Define Comment List
will be displayed.
b) Press the Confirm button in the new
display to return to the Define Lists
menu (see FIGURE 4-5).
1 Scroll bar arrows
2 View button
3 Confirm button
92
PART II
4 Settings
4.2.5 Define Log Notes
A log note is a short text, used to define
specific actions performed on the
Analyzer.
Add Log
FIGURE 4-33
Define
Log
Cleaned Touch pad
Calibrated LCD
When the Define Log button is pressed in
the Define Lists menu (see FIGURE 4-5),
the Define Log list (1) will be displayed.
1
Note! In the initial settings, the Define
Log list (1) will be empty.
Note! When trying to enter more than 30
Log notes, the following text will be
displayed:
Delete
Add
2
Maximum 30 Log Notes are Allowed in
the List.
a) To add a Log note to the list, press the
Add button (2).
1 Define Log list
2 Add button
(Continues)
93
4 Settings
PART II
(Continues)
FIGURE 4-34
Add Log
3
4
ABC
123
5
b) Enter the Log note either directly on
the Display via the Text mode (3) and
Numeric mode (4) buttons, or with the
Barcode Scanner via the Barcode
Scanner button (5).
c) The updated Define Log list will be
displayed. Press the Confirm button in
the new display to return to the Define
List menu, (see FIGURE 4-5).
3 Text mode button
4 Numeric mode button
5 Barcode Scanner button
Delete Log Notes
FIGURE 4-35
Define
Log
1
a) To choose the Log note that is to be
deleted, highlight the Log note (1) by
pressing the Scroll bar arrows (2).
Press the delete button (3).
2
b) A confirm dialogue is displayed. Press
Delete to delete the Log or press No to
cancel.
3
c) The updated Define Log list will be
displayed. Press the Confirm button in
the new display to return to the Define
List menu, (see FIGURE 4-5).
Cleaned Touch pad
Calibrated LCD
Delete
Add
1 Log (to be deleted)
2 Scroll bar arrows
3 Delete button
94
PART II
4 Settings
View Log
FIGURE 4-36
Define
Log
A Log note that requires more space than
is available in the current display can be
viewed by pressing the View button.
Cleaned Touch pad
Calibrated LCD
1
Delete
Add
2
3
a) To choose the Log note that is to be
viewed, highlight the Log note by
pressing the Scroll bar arrows (1).
Press the view button (2). The
complete Log note will be displayed.
Press the Confirm button (3). The
Define Log List will be displayed.
b) Press the Confirm button in the new
display to return to the Define Lists
menu (see FIGURE 4-5).
1 Scroll bar arrows
2 View button
3 Confirm button
95
4 Settings
PART II
4.3 Basic Settings
FIGURE 4-37
Basic
Settings
When the Basic Settings button is pressed
in the Settings menu (see FIGURE 4-4),
the following Basic Settings
categories (1) are displayed:
Date/Time
Power Saver
Audible Signals
Language
1
• Date/Time (see 4.3.1 Date/Time)
• Power Saver (see 4.3.2 Power Saver)
• Audible Signals (see 4.3.3 Audible
Signals)
• Language (see 4.3.4 Language)
a) Select a Basic Settings category (1) by
pressing it.
1 Basic Settings categories
96
PART II
4 Settings
4.3.1 Date/Time
FIGURE 4-38
Adjust Date
1
Format: MM/DD/YY
02/02/02
1
2
3
4
5
6
7
8
9
0
2
3
4
When the Date/Time button is pressed in
the Basic Settings menu (see FIGURE 437), the date setting function is displayed
first.
a) Select the Date format (1) with the
Date format button (3). The formats
available are:
• MM/DD/YY (default format)
• DD.MM.YY (press once)
• YY-MM-DD (press twice)
MM symbolizes the month as two digits.
DD symbolizes the day of the month as
two digits.
YY symbolizes the year as two digits.
b) Enter the current date with the Digit
buttons (2)
c) Press the Confirm button (4). FIGURE
4-39 will be displayed
1
2
3
4
Date format
Digit button
Date format button
Confirm button
(Continues)
97
4 Settings
PART II
(Continues)
FIGURE 4-39
Adjust Time
5
Format: 12h
10:55 AM
1
2
3
4
5
6
7
8
9
AM/PM
0
The time setting function is now
displayed.
a) Select the Time format (5) with the
Time format button (6). The following
formats are available:
• 24hours
• 12hours
6
5 Time format
6 Time format button
FIGURE 4-40
Adjust Time
b) If the 12h-format is selected, select
AM or PM by means of the AM/PM
button (7).
Format: 12h
10:55 AM
8
1
2
3
4
5
6
7
8
9
AM/PM
0
7
9
Note! The AM/PM button (7) will only
be displayed if the 12h-format is selected.
c) Enter the current time with the Digit
buttons (8).
d) Press the Confirm button (9). The
Basic Settings menu will be displayed
(see FIGURE 4-37).
7 AM/PM button
8 Digit button
9 Confirm button
98
PART II
4 Settings
4.3.2 Power Saver
A detailed description of the Power Saver
mode is described in 3.1.3 Power saver
mode
FIGURE 4-41
Power Saver
1
2
When the Power Saver button is pressed
in the Basic Settings menu (see FIGURE
4-37), the Power Saver settings function
is displayed.
a) To change the Power Saver time (1)
press the Scroll bar arrows (2).
Minutes
30
15
Note! The Power Saver time is set in five
minute intervals from 5 - 30 minutes.
b) Press the Confirm button (3).
3
c) The Basic Settings menu will be
displayed (see FIGURE 4-37).
1 Power Saver time
2 Scroll bar arrows
3 Confirm button
99
4 Settings
PART II
4.3.3 Audible Signals
FIGURE 4-42
Audible
Signals
Button Click
When the Audible Signals button is
pressed in the Basic Settings menu (see
FIGURE 4-37), the following Audible
Signal setting choices are displayed:
1
Test Ready
Error
• Button Click
• Test Ready
• Error
a) To adjust the volume of an audible
signal, press one of the Audible Signal
buttons (1).
In this example the Button Click button is
pressed.
1 Audible Signal buttons
FIGURE 4-43
Button Click
2
3
b) Set the Volume (2) from 0 - 4 by
means of the Scroll bar arrows (3).
Note! To turn an Audible Signal off, set
the Volume (2) to value 0.
Volume
c) Press the Confirm button (4).
24
d) The Audible Signal settings will be
displayed (see FIGURE 4-42).
4
100
2 Volume
3 Scroll bar arrows
4 Confirm button
PART II
4 Settings
4.3.4 Language
An Analyzer is delivered with two
predefined language options.
Language
FIGURE 4-44
2
When the Language button is pressed in
the Basic Settings menu (see FIGURE 437), the Language settings function is
displayed.
1
The two language options are displayed
as Language buttons (1). The language
currently in use is indicated by the
selected Radio button (2).
English
Deutsch
3
a) To change the language, press the
desired Language button (1).
b) Press the Confirm button (3).
c) The Basic Settings menu will be
displayed (see FIGURE 4-37).
1 Language buttons
2 Radio button
3 Confirm button
101
4 Settings
PART II
4.4 Advanced Settings
FIGURE 4-45
Advanced
Settings
When the Advanced Settings button is
pressed in the Settings categories menu
(see FIGURE 4-4), the following
Advanced Settings categories (1) are
displayed:
General Settings
Patient test
QC test
Test
Linearity test
1
• General Settings (see 4.4.1 General
Settings)
• Patient test (see 4.4.2 Patient Test
Settings)
• QC test (see 4.4.3 QC Test Settings)
• Linearity test (see 4.4.4 Linearity Test
Settings)
a) Select one of the Advanced Settings
categories (1) by pressing the button.
The Advanced Settings categories are
explained on the following pages.
1 Advanced Settings categories
102
PART II
4 Settings
4.4.1 General Settings
FIGURE 4-46
General
Settings
When the General Settings button is
pressed in the Advanced Settings menu
(see FIGURE 4-45), the following
General Settings categories are
displayed:
Operator ID
Units
Operator ID
Password
Cuvette Batch
Password
CuvetteList
Patient
Batch
1
2
•
•
•
•
•
Operator ID (See FIGURE 4-47 )
Password (See FIGURE 4-49 )
Cuvette Batch (See FIGURE 4-51 )
Patient List (See FIGURE 4-52)
Memory (See FIGURE 4-53 )
a) Press the Scroll bar arrow (2) to view
categories not initially visible on the
display.
b) Select a General Settings function (1)
by pressing it.
1 General Settings categories
2 Scroll bar arrow
103
4 Settings
PART II
Operator ID requirement
Operator ID
FIGURE 4-47
2
Not Used
Entry Required
1
Approved Only
3
When the Operator ID button is pressed
in the General Settings menu (see
FIGURE 4-46), the settings for Operator
ID requirement are displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Not Used : The Operator ID cannot be
entered at startup. An Operator may
perform all functions except the
password protected functions (see
FIGURE 4-49).
Entry required : An Operator ID must be
entered at startup. Any operator not
verified against the Operator List will be
considered as belonging to the “user”
category (see FIGURE 4-22).
Approved Only : An Operator ID must be
entered at startup. Any operator not
verified against the operator list will be
denied access to the Analyzer.
Note! The Approved Only function will
provide optimal operator traceability.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3).
1 Options for Operator ID requirement
2 Selected option
3 Confirm button
(Continues)
104
PART II
4 Settings
(Continues)
If Entry Required or Approved Only was
selected, FIGURE 4-48 will be displayed
for setting the Operator ID specifications.
If Not Used was selected, the General
Settings menu, FIGURE 4-46, will be
displayed.
FIGURE 4-48
Operator ID
4
Min Character (1) 3
Max Character (15) 1 2
5
1
2
3
4
5
6
7
8
9
6
0
7
The settings for the min. and the max.
number of characters for the Operator ID
are displayed.
Note! Numbers in brackets show the
lowest and the highest allowable number
of characters. To allow only an exact
number of characters, enter the same
value in the Min. and Max. settings.
c) Enter the min. No. of characters (4) for
the Operator ID via the Digit (6)
buttons. Press the Confirm button (7).
d) Enter the max. No. of characters (5)
for the Operator ID via the Digit
buttons (6). Press the Confirm
button (7). FIGURE 4-46 will be
displayed.
4
5
6
7
Operator ID, min. number of characters
Operator ID, max. number of characters
Digit button
Confirm button
105
4 Settings
PART II
Password for protected functions
Some Analyzer functions are password
protected. The password protection
function is only activated when the
Operator ID requirement is set to “Not
Used”.
FIGURE 4-49
Password
Old Password (1 - 10)
1
2
3
4
5
6
7
8
9
1
0
2
ABC
3
When the Password button is pressed in
the General Settings menu (see FIGURE
4-46), the settings for Password are
displayed.
Note! Numbers in brackets show the
lowest and the highest allowable number
of characters.
a) To change the password, enter the Old
Password using the Digit buttons (1)
and the Letter buttons that are
displayed when the Text Mode
button (2) is pressed. (The default
password is 0000).
b) Press the Confirm button (3).
1 Digit button
2 Text mode button
3 Confirm button
(Continues)
106
PART II
4 Settings
(Continues)
FIGURE 4-50
Password
c) Enter the New Password.
d) Press the Confirm button (4).
New Password (1 - 10)
1
2
3
4
5
6
7
8
9
0
ABC
e) FIGURE 4-50 will be displayed again.
Verify the New Password by reentering it.
f) Press the Confirm button to return to
the General Settings menu (see
FIGURE 4-46).
4
Note! If the re-entered password is
incorrect, a display with the text
Invalid Entry
will be displayed. Press the back arrow to
return to the previous display.
4 Confirm button
107
4 Settings
PART II
Cuvette Batch requirement
FIGURE 4-51
Cuvette Batch
2
Not Used
Entry Required
1
Approved only
3
When the Cuvette Batch button is pressed
in the General Settings menu (see
FIGURE 4-46), the settings for Cuvette
Batch requirements are displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Not Used : The Cuvette Batch No. cannot
be entered.
Entry required : The Cuvette Batch No.
must be entered. The Cuvette Batch No.
entered is not verified against the
predefined list.
Approved Only : The Cuvette Batch No.
must be entered and verified against the
predefined Cuvette Batch list in the
Analyzer for the result to be displayed.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3) to return
to the General Settings menu,
FIGURE 4-46.
1 Options for Cuvette Batch No. requirement
2 Selected option
3 Confirm button
108
PART II
4 Settings
Patient List setting
A Patient List is a list containing Patient
ID’s and corresponding Patient names. If
an OR supports the sending of Patient
Lists to the HemoCue Glucose 201 DM
Analyzer, the Analyzer can display the
name of a patient after the patient ID has
been entered, allowing for positive
patient identification.
Patient List
FIGURE 4-52
2
Not Used
Entry Required
Used
1
3
When the Patient List button is pressed in
the General Settings menu (see FIGURE
4-46), the Patient List settings are
displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Not Used : The Patient List feature is not
used.
Used : The Patient List feature is used
when running a Patient test. See chapter 6
Patient Test procedure for more
information.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3) to return
to the General Settings menu,
FIGURE 4-46.
1 Options for Patient List
2 Selected option
3 Confirm button
109
4 Settings
PART II
Full Memory Options
FIGURE 4-53
Patient
Memory Full
Lockout
Overwrite
2
1
3
Up to 4000 Patient/STAT tests can be
stored in the Analyzer. When the
Memory button is pressed in the General
Settings menu (see FIGURE 4-46), the
options for when the patient memory is
full are displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Lockout : The Analyzer is locked out
when the patient memory is full. No
patient tests can be performed until the
stored results have been deleted from the
Patient Memory function.
Overwrite : When the patient memory is
full, the Analyzer stores the new patient
test result by overwriting the oldest
result.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3).
FIGURE 4-54 will be displayed.
1 Full Memory options
2 Selected option
3 Confirm button
(Continues)
110
PART II
4 Settings
(Continues)
FIGURE 4-54
QC
Memory Full
5
The options for QC Memory full will be
displayed. The option currently in use is
indicated by the selected Radio
button (5).
4
c) To change the setting, press the button
for the desired option (4).
Lockout
Overwrite
d) Press the Confirm button (6) to return
to the General Settings menu,
FIGURE 4-46.
6
Note! The option selected for QC
Memory Full will automatically be
selected for Log Memory Full.
4 Memory Full option buttons
5 Selected option
6 Confirm button
111
4 Settings
PART II
4.4.2 Patient Test Settings
FIGURE 4-55
Patient Test
Settings
Critical Limits
Patient ID
Lab Number (LID)
STAT
2
1
When the Patient test button is pressed in
the Advanced Settings menu (see
FIGURE 4-45), the following Patient
Test Settings categories are displayed:
• Critical Limits (See FIGURE 4-56 )
• Patient ID (See )
• Lab Number (LID) (See FIGURE 460 )
• STAT (See FIGURE 4-62 )
• Duplicate Sampling (See FIGURE 464 )
• Dilution (See FIGURE 4-66 )
Note! The Dilution function is not
available in all markets.
a) Press the Scroll bar arrow (1) to view
categories not initially visible on the
display.
b) Select a Patient Test Settings
category (2) by pressing it.
1 Scroll bar arrow
2 Patient Test Settings categories
112
PART II
4 Settings
Critical Limits
The Critical Limits define the range of
values outside of which the patient test
results will be listed as critical.
FIGURE 4-56
Critical Limits
Min (0)
Max (400)
80 mg/dL
110 mg/dL
1
2
3
4
5
6
7
8
9
1
2
3
When the Critical Limits button is
pressed in the Patient Test Settings menu
(see FIGURE 4-55), the settings for
Critical Limits are displayed.
Note! The numbers in brackets show the
lowest and the highest values for the
critical limits.
a) Enter the min. value (1) via the Digit
buttons (3). Press the Confirm
button (4).
0
4
b) Enter the max. value (2) via the Digit
buttons (3). Press the Confirm
button (4).
The Patient Test Settings menu,
FIGURE 4-55, will be displayed.
1
2
3
4
Min. value
Max. value
Digit button
Confirm button
113
4 Settings
PART II
Patient ID
FIGURE 4-57
Patient ID
2
When the Patient ID button is pressed in
the Patient Test Settings menu (see
FIGURE 4-55), the settings for the
Patient ID requirements are displayed.
1
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Not Used
Optional
Required
Not Used : The Patient ID cannot be
entered.
3
Optional : The Patient ID can be entered
or left blank.
Required : The Patient ID must be
entered.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3).
1 Options for Patient ID requirement
2 Selected option
3 Confirm button
(Continues)
114
PART II
4 Settings
(Continues)
If Optional or Required was selected,
FIGURE 4-58 will be displayed for
setting the Patient ID specifications.
If Not Used was selected, the General
Settings menu, FIGURE 4-55, will be
displayed.
FIGURE 4-58
Patient ID
4
Min Character (1) 3
Max Character (25) 1 2
5
1
2
3
4
5
6
7
8
9
6
0
7
Note! Numbers in brackets show the
lowest and the highest allowable number
of characters. To allow only an exact
number of characters, enter the same
value in the Min. and Max. options.
c) Enter the min. No. of characters (4) via
the Digit buttons (6). Press the
Confirm button (7).
d) Enter the max. No. of characters (5)
via the Digit buttons (6). Press the
Confirm button (7).
FIGURE 4-59, will be displayed.
4
5
6
7
Min. number of characters
Max. number of characters
Digit button
Confirm button
(Continues)
115
4 Settings
PART II
(Continues)
FIGURE 4-59
Clear
Patient ID
Used
The setting for clearing the Patient ID is
displayed.
9
8
The options available are displayed as
buttons (8). The option currently in use is
indicated by the selected Radio
button (9).
Used : The previous Patient ID will be
cleared when a new test is initiated.
Not Used
10
Not Used : The previous Patient ID will
be displayed until a new Patient ID is
entered.
e) To change the setting, press the button
for the desired option (8).
f) Press the Confirm button (10) to return
to the Patient Test Settings menu (see
FIGURE 4-55).
8 Clear Patient ID options
9 Selected option
10 Confirm button
116
PART II
4 Settings
Lab Number (LID) requirement
Lab Number
(LID)
FIGURE 4-60
2
Not Used
Optional
1
When the Lab Number (LID) button is
pressed in the Patient Test Settings menu
(see FIGURE 4-55), the settings for Lab
ID requirement are displayed (1).
The option currently in use is indicated
by the selected Radio button (2).
Not Used : The Lab No. cannot be
entered.
Required
3
Optional : The Lab No. can be entered or
left blank.
Required : The Lab No. must be entered.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3).
1 Options for Lab Number requirement
2 Selected option
3 Confirm button
(Continues)
117
4 Settings
PART II
(Continues)
Lab Number
(LID)
4
Min Character (1)
3
Max Character (25) 1 2
5
If Optional was selected, FIGURE 4-61
will be displayed for setting the Lab
Number specifications.
If Not Used was selected, the Patient Test
Settings menu, FIGURE 4-55, will be
displayed.
1
2
3
4
5
6
The settings for the min. and the max.
length of the Lab Number are displayed.
7
8
9
FIGURE 4-61
6
0
7
Note! Numbers in brackets show the
lowest and the highest allowable number
of characters.
c) Enter the min. No. of characters (4) via
the Digit buttons (6). Press the
Confirm button (7).
d) Enter the max. No. of characters (5)
via the Digit buttons (6). Press the
Confirm button (7).
The Patient Test Settings menu,
FIGURE 4-55, will be displayed.
4
5
6
7
118
Min. number of characters
Max. number of characters
Digit button
Confirm button
PART II
4 Settings
STAT Test usage
FIGURE 4-62
STAT Test
2
Used
1
Not Used
3
When the STAT button is pressed in the
Patient Test Settings menu (see FIGURE
4-55), the settings for STAT Tests are
displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Used : STAT tests are permitted even
when the Analyzer has performed a
QC lockout.
Not Used : STAT tests are not permitted.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3).
1 Options for STAT test usage
2 Selected option
3 Confirm button
(Continues)
119
4 Settings
PART II
(Continues)
STAT Test
Tests allowed (1 - 100)
10
4
1
2
3
4
5
6
7
8
9
5
If Used was selected, FIGURE 4-63 will
be displayed for setting the STAT Test
specifications.
If Not Used was selected, the General
Settings menu, FIGURE 4-55, will be
displayed.
FIGURE 4-63
Note! The numbers in brackets show the
lowest and the highest number of tests
that can be set.
0
6
c) Enter the max. No. of STAT tests that
will be allowed after the Analyzer has
performed a QC lockout, via the Digit
buttons (5). Press the Confirm
button (6).
The Patient Test Settings menu,
FIGURE 4-55, will be displayed.
4 Max. number of STAT tests
5 Digit button
6 Confirm button
120
PART II
4 Settings
Duplicate sampling
In order to minimize errors due to
preanalytical factors, local
recommendations might involve
measurements in duplicates when
capillary blood is used. The Duplicate
sampling function is used to
facilitate these recommendations.
FIGURE 4-64
Duplicate sampling
Max. Difference
2
Not Used
1
Used
Optional
When Duplicate sampling is pressed in
the Patient Test Settings menu (see
FIGURE 4-55), the setting to enable the
use of the duplicate sampling function is
displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
3
Not Used : The duplicate sampling
function is not activated on the Analyzer.
Used : The duplicate sampling function is
activated on the Analyzer.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3).
1 Options for duplicate sampling function
2 Selected option
3 Confirm button
(Continues)
121
4 Settings
PART II
(Continues)
Duplicate sampling
Max. Difference
1
mmol/L
0.2
If Used was selected, FIGURE 4-65 will
be displayed for setting the Duplicate
Sampling specifications.
If Not Used was selected, the General
Settings menu, FIGURE 4-55, will be
displayed.
FIGURE 4-65
2
3
c) To change the maximum difference
allowed between two samples (1),
press the arrows (2) for the desired
value.
d) Press the Confirm button (3) to return
to the Patient Test Settings menu,
FIGURE 4-55.
1 Max. allowed difference between samples
2 Arrows for increasing/decreasing the
Difference
3 Confirm button
122
PART II
4 Settings
Dilution possibilities
Note! The Dilution function is not
available in all markets.
Whole Blood: Results above 400 mg/dL
(22.2 mmol/L) will be displayed as
overrange. The measuring range may be
extended to 800 mg/dL (44.4 mmol/L) by
dilution with saline, 1+1.
Plasma equivalent: Results above
444 mg/dL (24.6 mmol/L) will be
displayed as overrange. The measuring
range may be extended to 888 mg/dL
(49.2 mmol/L) by dilution with saline,
1+1.
Samples must be mixed thoroughly
before dilution and measurement.
Note! By using the dilution function in
the Analyzer, the stored and displayed
result will automatically be multiplied by
a factor of 2.
Note! Dilution of the sample may reduce
the accuracy of the result.
For specific performance characteristics,
see the “HemoCue Glucose 201
Microcuvettes instructions for use”.
(Continues)
123
4 Settings
PART II
(Continues)
FIGURE 4-66
Dilution
2
Not Used
1
Optional
(Dilution with NaCl 1+1)
3
4
When the Dilution button is pressed in
the Patient Test Settings menu (see
FIGURE 4-55), the setting to enable the
use of diluted samples is displayed.
The options available are displayed as
buttons (1). The option currently in use is
indicated by the selected Radio
button (2).
Not Used : The dilution function cannot
be activated on the Analyzer.
Optional : The dilution function can be
activated on the Analyzer.
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (4) to return
to the Patient Test Settings menu,
FIGURE 4-55.
1
2
3
4
124
Options for dilution function
Selected option
Explanation of the type of dilution possible
Confirm button
PART II
4 Settings
4.4.3 QC Test Settings
FIGURE 4-67
QC Test
Settings
When the QC test button is pressed in the
Advanced Settings menu (see FIGURE
4-45), the following QC Test Settings
options are displayed:
Level 1
Low
Level 2
Normal
Level 3
High
Other 4
Level
Level
1
2
•
•
•
•
•
•
•
Level 1 (See FIGURE 4-68 )
Level 2
Level 3
Level 4
Level 5
Reminder Time (See FIGURE 4-76 )
QC Result Options (See FIGURE 478 )
• Failed QC Comment (See FIGURE 479)
Level 1, Level 2, Level 3, Level 4 and
Level 5, refer to the different
concentration levels of Liquid Controls
used in QC tests. The settings procedure
is the same for all concentration levels.
For this reason, only one of these is
described.
a) Press the Scroll bar arrow (2) to view
options (1) not initially visible on the
display.
b) Select a QC Test Settings option (1)
by pressing it.
1 QC Test Settings options
2 Scroll bar arrow
125
4 Settings
PART II
QC Test settings for distinct
concentration levels
An Analyzer can be set to perform a
lockout if the required QC test is not
performed within a pre-defined time or
after a pre-defined number of
measurements. The Analyzer will be
unlocked when an approved QC test at
the required concentration level has been
performed. The lockout configuration
must be set for each concentration level
of Liquid Control.
QC Level 1
Lockout
FIGURE 4-68
2
Not Used
Time
1
Measurements
When the Level 1 button is pressed in the
QC Test Settings menu (see FIGURE 467), the settings for QC lockout at this
level are displayed.
The options available are displayed as
buttons. The option currently in use is
indicated by the selected radio button.
Not Used : No QC lockout will be
performed.
3
Time : The QC lockout will be activated
if the required QC test has not been
performed within the defined time
interval.
1 Options for QC lockout criteria
2 Selected option
3 Confirm button
(Continues)
126
PART II
4 Settings
(Continues)
Measurements : The QC lockout will
occur if the required QC test has not been
performed within the predefined number
of measurements.
FIGURE 4-69
QC Level 1
Lockout
2
Not Used
Time
1
Measurements
3
a)To change the setting, press the button
for the desired option (1).
b)Press the Confirm button (3).
If “Not Used” is selected, the QC Test
Settings Menu, FIGURE 4-67, is
displayed.
If “Time” is selected, FIGURE 4-70, is
displayed.
If “Measurements” is selected, FIGURE
4-74, is displayed.
1 Options for QC lockout criteria
2 Selected option
3 Confirm button
127
4 Settings
PART II
QC lockout determined by time
FIGURE 4-70
Start of First
Workshift
1
Format: 12h
10:55 AM
1
2
3
4
5
6
7
8
9
AM/PM
0
2
a)Enter the start time (1) for the
beginning of the interval using the
Digit button (2). Press the Confirm
button (3).
1 Start time
2 Digit button
3 Confirm button
(Continues)
3
128
If Time was selected in the QC lockout
menu, the setting for the QC lockout
based on time is displayed.
PART II
4 Settings
(Continues)
Lockout
Interval
FIGURE 4-71
5
The QC lockout interval may be set in
either Hours or Days (4).
4
The options are displayed as buttons. The
option currently in use is indicated by the
selected Radio button (5).
7
The number of Hours or Days is also
displayed (6).
Hours
Days
8
a) To change the setting, press the button
for the desired option (4).
6
8
b) To change the length of the time
interval, use the Scroll bar arrows (7).
c) Press the Confirm button (8).
If the reminder time needs to be
adjusted, FIGURE 4-72 will be
displayed.
Otherwise FIGURE 4-73 will be
displayed.
4
5
6
7
8
Time interval options
Selected option
Selected time interval
Scroll bar arrows
Confirm button
(Continues)
129
4 Settings
PART II
(Continues)
FIGURE 4-72
Lockout
Interval
d) To adjust the reminder time to fit the
new QC lockout time, press Adjust.
After adjusting to an acceptable
reminder time (See FIGURE 4-76),
FIGURE 4-73 will be displayed.
To return to FIGURE 4-71, press No.
The selected time interval until the
next QC lockout will then need to be
adjusted.
Note!
New Lockout Time
Requires Adjusted
Reminder Time
Adjust?
No
Adjust
QC Level 1
Lockout
FIGURE 4-73
9
e) Press the Confirm button (12) to return
to the QC Test Settings menu,
FIGURE 4-67.
Next lockout
09/12/03
04:00 PM
10
11
12
130
The date and time of the next QC lockout
for the chosen QC level will be displayed.
9
10
11
12
Concentration level of QC test
Date for next QC lockout
Time point for next QC lockout
Confirm button
PART II
4 Settings
QC lockout determined by number of
measurements
FIGURE 4-74
Lockout
Interval
Measurements (2 - 200)
100
1
2
3
4
5
6
7
8
9
1
2
If Measurements was selected in the QC
lockout menu (see FIGURE 4-68), the
setting for the QC lockout based on the
number of patient or STAT test
measurements performed is displayed.
Note! The numbers in brackets show the
lowest and the highest number of tests
that can be set.
0
3
a) Enter the number of measurements
after which QC lockout will occur (1)
via the Digit buttons (2). Press the
Confirm button (3).
b) If the reminder value needs to be
adjusted, FIGURE 4-75 will be
displayed.
Otherwise there will be a return to
FIGURE 4-67.
1 No. of measurements after which
QC lockout occurs
2 Digit button
3 Confirm button
(Continues)
131
4 Settings
PART II
(Continues)
FIGURE 4-75
Lockout
Interval
Note!
New Lockout Value
Requires Adjusted
Reminder Value
Adjust?
No
132
Adjust
c) To adjust the number of measurements
for the reminder so that it corresponds
with the new value for the number of
measurements before QC lockout,
press Adjust.
After adjusting to an acceptable value
(See FIGURE 4-77), there will be a
return to the QC Test Settings menu,
FIGURE 4-67.
Otherwise, to return to FIGURE 4-74,
press No. The selected time/Number
of measurements until the next QC
lockout will then need to be adjusted,
in order to correspond with the defined
reminder.
PART II
4 Settings
QC Test Reminder settings
FIGURE 4-76
QC
Reminder
3
When the Reminder Time button is
pressed in the QC Test menu (see
FIGURE 4-67), the settings for the QC
reminder based on time is displayed. A
reminder message will be shown at this
set time, prior to QC lockout.
2
The Reminder time can be set to no more
than half the shortest of the QC lockout
times, irrespective as to which level this
refers.
1
Hours
0.5
4
The current value of the reminder
time (2) expressed in the given unit (1) is
displayed.
a) Set the reminder time using the Scroll
bar arrows (3).
Note! To turn the Reminder Time
function off, set the value (2) to “0”.
b) Press the Confirm button (4). FIGURE
4-78 will be displayed.
1
2
3
4
Unit for reminder time
Reminder time value
Scroll bar arrows
Confirm button
(Continues)
133
4 Settings
PART II
(Continues)
FIGURE 4-77
QC
Reminder
Measurements (1 - 50)
X)
10
5
1
2
3
4
5
6
7
8
9
6
The settings for the QC reminder based
on the number of Patient or Stat tests
performed is displayed. A reminder
message will be shown when this number
of tests are remaining, prior to QC
lockout.
The number of measurements for this
reminder can be set to no more than half
the lowest number of measurements,
irrespective as to which level this refers.
0
7
Note! The numbers in brackets show the
lowest and the highest number of tests
that can be set.
a) Enter the number of measurements for
the reminder (5) via the Digit
buttons (6).
b) Press the Confirm button (7).
FIGURE 4-67 will be dispalyed.
5 No. of measurements for reminder
6 Digit button
7 Confirm button
134
PART II
4 Settings
QC Result Presentation Options
QC Result
Options
FIGURE 4-78
2
Numeric
1
Passed/Failed
3
When the QC Result Option button is
pressed in the QC Test menu (see
FIGURE 4-67), two options are
displayed.
QC Test results can be presented either as
quantitative (numerical) or qualitative
(“Passed”/”Failed”) values.
The options are displayed as buttons (1).
The option currently in use is indicated
by the selected Radio button (2).
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3) to return
to the QC Test Settings menu,
FIGURE 4-67.
1 Options for presentation of test results
2 Selected option
3 Confirm button
135
4 Settings
PART II
Failed QC Comment
Failed QC
Comment
FIGURE 4-79
2
When the Failed QC Comment button is
pressed in the QC Test menu, two options
are displayed.
1
When Failed QC Comment is set to Entry
Required it forces the operator to enter at
least one comment to a QC Test that has
failed.
Not Used
Numeric
Entry Required
Passed/Failed
3
The options are displayed as buttons (1).
The option currently in use is indicated
by the selected Radio button (2).
a) To change the setting, press the button
for the desired option (1).
b) Press the Confirm button (3) to return
to the QC Test Settings menu,
FIGURE 4-67.
1 Options for Failed QC Comment
2 Selected option
3 Confirm button
136
PART II
4 Settings
4.4.4 Linearity Test Settings
For a description of linearity tests, see
8.2.2 Linearity Test.
FIGURE 4-80
Linearity
When the Linearity test button is pressed
in the Advanced Settings menu (see
FIGURE 4-45), options for the number of
concentration levels for the linearity test
are displayed.
3 Levels
4 Levels
1
5 Levels
The options are displayed as buttons (1).
The option currently in use is indicated
by the selected Radio button (2).
2
a) To change the setting, press the button
for the desired option (1).
3
b) Press the Confirm button (3).
FIGURE 4-81 will be displayed.
1 Options for number of levels
2 Selected option
3 Confirm button
(Continues)
137
4 Settings
PART II
(Continues)
FIGURE 4-81
Linearity
Cuvettes / Level (1-20)
3
1
2
3
4
5
6
7
8
9
4
Note! The numbers in brackets show the
lowest and the highest number of tests
that can be set.
5
c) Enter the number of cuvettes (4) for
each level, via the Digit buttons (5)
d) Press the Confirm button (6).
FIGURE 4-45 will be displayed.
4 Number of cuvettes per level
5 Digit button
6 Confirm button
0
6
138
PART II
4 Settings
4.5 Default Settings
FIGURE 4-82
Default
Settings
Are You Sure You
Want to Change to
Default Settings?
All current settings
will be changed
No
Continue
When the Default Settings button is
pressed in the Settings menu (see
FIGURE 4-4), confirmation or
cancellation of the requested change to
the Analyzer default setting is required. A
question will be displayed.
Note! Default settings affect only the
Analyzer configuration (including
password). Measurement results or lists
(Liquid Controls, Cuvette Batches,
Operators, Comments or Logs) will not
be affected. For a list of default values see
Appendix A – Default Settings.
a) If all the settings in the Analyzer are to
be changed to Default settings, press
Continue.
Otherwise, press No.FIGURE 4-4 will
be displayed.
Note! If the choice was to change all
settings to default, the following text will
be displayed for a few seconds:
Settings have Now Changed to Default
Settings.
b) The Settings menu, FIGURE 4-4, will
be displayed again.
139
4 Settings
PART II
4.6 Infra Red
Settings (but not measurements) can be
transmitted between two Analyzers when
the IR-ports are facing each other.
4.6.1 The transmitting Analyzer
FIGURE 4-83
Infra Red
When the Infra Red button is pressed in
the Settings menu (see FIGURE 4-4), the
categories (1) that can be transferred are
displayed
All Settings
Analyser Config.
Cuvette batches
Batches
Liquid Controls
1
2
• All Settings (include all the categories
in the rest of the options)
• Analyzer Configuration (see 4.3 Basic
Settings and 4.4 Advanced Settings)
• Cuvette Batches (see 4.2.2 Cuvette
Batches)
• Liquid Controls (see 4.2.1 Liquid
Controls)
• Operator List (see 4.2.3 Define
Operators)
• Comment List (see 4.2.4 Define
Comments)
• Log List (see 4.2.5 Define Log Notes)
1 Settings options
2 Scroll bar arrow
(Continues)
140
PART II
4 Settings
(Continues)
All options are transfered by the
Analyzer in the same manner, therefore,
only one of these, "All Settings" is
described.
a) Press the Scroll bar arrow (2) to view
options not visible on the display.
b) Select the settings category (1) to be
transfered by pressing the
corresponding button.
Infra Red
All Settings
Are You Sure You
Want to Send the
Settings?
No
Continue
FIGURE 4-84
3
Confirmation or cancellation of the
transfer of the desired setting (3) is
required.
c) To initiate data transfer of the category
indicated (3) to the receiving
Analyzer, press Continue.
To cancel, press No.
d) If the process was initiated, the
connection will be established and the
following text will be displayed:
Transmitting via IR port ...
3 Settings to transfer
(Continues)
141
4 Settings
PART II
(Continues)
e) If a connection was established
successfully and the transfer was
accepted by the receiving Analyzer
(see FIGURE 4-85), the same text will
continue to be displayed during data
transfer. When the transfer is
completed, the following text will be
displayed for a few seconds:
Transmission OK
and a beep will be heard if the audible
signal is enabled.
FIGURE 4-83 will be displayed.
f) If no connection was established or
transfer was rejected by the receiving
Analyzer, the following text will be
displayed:
No Connection With Compatible IR
Device
An error beep will be heard if the
audible signal is enabled. See
Troubleshooting on page 247.
Press the Confirm button.
FIGURE 4-83 will be displayed.
142
PART II
4 Settings
4.6.2 The Receiving Analyzer
FIGURE 4-85
Infra Red
Transmission
Update
All Settings?
All current
settings will be
changed
No
Continue
Confirmation or cancellation of the
transmitted setting information (1) is
required on the receiving Analyzer.
1
a) To accept data transfer of the category
indicated (1) from the sending
Analyzer, press Continue.
To cancel, press No.
b) If the transfer is accepted, while data
is being received, the following text
will be displayed:
Receiving via IR port ...
with slight variations depending on the
category of settings information.
c) When the transfer is completed, the
following text will be displayed for a
few seconds:
Transmission OK
1 Settings to receive
143
4 Settings
PART II
4.7 Docking Station
Settings
The settings of a Docking Station consist
of network parameters necessary to
enable communication with a LAN, such
as the IP address of the Docking Station.
Settings can only be made on Primary
Docking Stations, not on Secondary, see
Primary and Secondary Docking
Stations.
The setting of a Docking Station is made
from the DMS Software application. In
order to perform the settings, the Docking
Station must be connected to the PC
hosting the DMS Software, see section
10.2 Docking station setup.
144
PART III
Routine use
Patient Test
Please Fill
and
Insert a Cuvette
Glucose 201 DM
PART III
This page intentionally left blank
146
PART III
5 Blood specimen collection
5 Blood specimen
collection
This chapter describes the procedure for obtaining a blood sample to be used for
glucose analysis.
5.1 Capillary blood
Note! In cases of severe hypotension or
peripheral circulatory failure, glucose
measurements from capillary samples
may be misleading. In such
circumstances it is recommended that
you use venous or arterial whole blood1.
Before obtaining a blood sample, the
Analyzer should be in the “Ready” mode.
To perform a Patient test, see section 6
Patient Test procedure. To perform a
STAT test, see section 7 STAT Test
procedure.
FIGURE 5-1
a) Make sure the patient's hand is warm
and relaxed. Use only the middle or
ring finger for sampling. Avoid fingers
with rings on.
(Continues)
147
5 Blood specimen collection
PART III
(Continues)
FIGURE 5-2
b) Clean with disinfectant and allow to
dry or wipe off with a dry, lint-free
tissue.
FIGURE 5-3
c) Using your thumb, lightly press the
finger from the top of the knuckle
towards the tip. This stimulates the
blood flow towards the sampling
point.
FIGURE 5-4
d) For best blood flow and least pain,
sample at the side of the fingertip, not
the center.
(Continues)
148
PART III
5 Blood specimen collection
(Continues)
Warning! Always handle blood
specimens with care, as they might be
infectious.
FIGURE 5-5
e) While applying light pressure toward
the fingertip, puncture the finger using
the lancet.
FIGURE 5-6
f) Wipe away the first 2 or 3 drops of
blood with a lint free wipe.
Note! Do not use cotton balls.
149
5 Blood specimen collection
PART III
FIGURE 5-7
g) Re-apply light pressure towards the
fingertip until another drop of blood
appears.
FIGURE 5-8
h) When the blood drop is large enough,
fill the Cuvette in one continuous
process.
Note! Do not refill!
FIGURE 5-9
i) Wipe off excess blood from the outer
surface of the Cuvette with lint-free
tissue, being careful not to touch the
open end of the Cuvette.
Note! Make sure that no blood is drawn
out of the Cuvette during this procedure.
(Continues)
150
PART III
5 Blood specimen collection
(Continues)
FIGURE 5-10
j) Look for air bubbles in the filled
Cuvette. If any air bubbles are present,
fill a new Cuvette. Small bubbles
around the edge can be ignored.
Note! If a second sample is to be taken
from the same finger stick, it is important
that this is done after the first sample has
been measured. Wipe away the remains
of the initial sample and fill a second
Cuvette from a new drop of blood.
FIGURE 5-11
k) Place the filled Cuvette in the Cuvette
holder, see FIGURE 5-11.
151
5 Blood specimen collection
PART III
(Continues)
FIGURE 5-12
To perform a Patient test, see in section
6 Patient Test procedure. To perform a
STAT test, see section 7 STAT Test
procedure.
l) Enter the required information.
m)Push the Cuvette holder to the
Measuring position.
Note! This should be performed within
40 seconds after filling the Cuvette!
After 40 seconds to 4 minutes, the result
will be displayed. See an example of the
display appearance in 6.1.1 Patient Test
Result.
The result will remain on the display until
the Confirm button has been pressed, see
FIGURE 6-10 in 6.1.1 Patient Test
Result.
Note! Do not re-measure the Cuvette!
FIGURE 5-13
Note! Although the reagents are present
in the Cuvette in extremely low
quantities, consult local environmental
authorities for proper disposal.
152
PART III
5 Blood specimen collection
5.2 Venous and Arterial
Blood
FIGURE 5-14
a) The blood should be well mixed prior
to performing the measurement.
FIGURE 5-15
b) Place a drop of blood onto a
hydrophobic surface, e.g. a plastic
film, using a pipette.
FIGURE 5-16
It is also possible to use a suitable blood
transfer device.
153
5 Blood specimen collection
PART III
FIGURE 5-17
c) Fill the Cuvette in one continuous
process.
Note! Do not refill!
Note! Wipe off excess blood from the
outer surface of the Cuvette with lint-free
tissue, being careful not to touch the open
end of the Cuvette (see FIGURE 5-9 ).
FIGURE 5-18
d) Look for air bubbles in the filled
Cuvette. If any air bubbles are present,
fill a new Cuvette. Small bubbles
around the edge can be ignored.
e) Perform the measurement as described
in FIGURE 5-11, FIGURE 5-12 and
FIGURE 5-13 in section 5.1 Capillary
blood.
154
PART III
6 Patient Test procedure
6 Patient Test procedure
This chapter guides you through the process of performing a Patient Test.
6.1 Patient Test
The Patient Test procedure may vary,
depending on which information
requirements have been activated in the
Settings, see section 4.4.2 Patient Test
Settings. The following information may
be required:
• Cuvette Batch No.
• Patient ID
• Lab ID
08/09/03 10:55 AM
JAMES SMITH
2
3
1
FIGURE 6-1
Note! A Patient Test procedure may be
initiated in two different ways. The first
way is described below. The other way is
by filling and inserting a Microcuvette,
then closing the cuvette holder, allowing
required information to be entered while
the sample is being analyzed.
a) In the Main Menu, press the Patient
Test button (1).
2
Note! If the small hourglass is displayed
only the buttons (2) can be used.
b) FIGURE 6-2 will be displayed.
1 Patient Test button
2 See Note! above.
3 Operator name, Operator ID or blank,
depending on the settings
(Continues)
155
6 Patient Test procedure
PART III
(Continues)
Enter
Cuvette Batch
ABC
4
123
FIGURE 6-2
Note! FIGURE 6-2 will not be displayed
if the Cuvette Batch No. requirement is
set to “Not Used” in the Settings (see
4.4.1 General Settings).
c) Enter Cuvette Batch No. either
directly on the Display via the Text
mode and Numeric mode buttons, or
with the Barcode Scanner via the
Barcode Scanner button.
Note! If Cuvette Batch No. requirement
is set to Entry required (see 4.4.1 General
Settings), and a Cuvette Batch No. that
has not previously been stored in the
Analyzer (see 4.2.2 Cuvette Batches) is
entered, or the Cuvette Batch is expired,
the following text will be displayed:
Invalid Cuvette Batch.
If the Previous image button (6) is
pressed, the Main Menu will be displayed
(see 3.6.3 Main Menu and On-line Help).
d) If Cuvette Batch No. requirement is
set to Entry required (see 4.4.1
General Settings), and the Cuvette
Batch No. is entered via the Barcode
Scanner using the barcode from the
Cuvette vial, the expiration date is
automatically entered, and FIGURE 64 will be displayed. Otherwise
FIGURE 6-3 will be displayed.
4 Previous image button
(Continues)
156
PART III
6 Patient Test procedure
(Continues)
FIGURE 6-3
Cuvette Batch
Note! Will only be displayed if the
Cuvette Batch No. requirement when
inserting a cuvette is set to “Entry
required” (see 4.4.1 General Settings),
and Cuvette Batch No. was not entered
via the Barcode Scanner using the
barcode from Cuvette vial
Batch: 123456789
Expiration Date
09/12/03
1
2
3
4
5
6
7
8
9
e) Enter the Expiration Date for the
Cuvette Batch via the Numeric mode
buttons.
0
5
f) Press the Confirm button (7).
5 Confirm button
Enter
Patient ID (PID)
FIGURE 6-4
Note! Will not be displayed if the Patient
ID requirement is set to “Not Used” (see
4.4.2 Patient Test Settings).
g) Enter the Patient ID (PID) via the Text
mode and Numeric mode buttons, or
with the Barcode Scanner via the
Barcode Scanner button.
ABC
123
Note! It is recommended to use the
possibility to limit the number of
characters for Operator ID, Patient ID
and Lab ID in order to prevent possible
mix-up of identification.
(Continues)
157
6 Patient Test procedure
PART III
(Continues)
Patient ID (PID)
123456789
(James Smith)
FIGURE 6-5
Note! Will not be displayed if the Patient
List setting is set to “Not Used” (see 4.4.1
General Settings), or the Patient ID
requirement is set to “Not Used”.
If the Patient List setting is set to “Used”
and there is a Patient List on the Analyzer
that contains the Patient ID and
corresponding Patient Name, this display
will show the Patient ID and
corresponding Patient Name as a means
of positive patient identification. If the
Patient List doesn’t contain a Patient
Name corresponding to the entered
Patient ID, then the text (Unknown
Patient Name) will be displayed.
h) Press OK to continue or the back
arrow to go back and re-enter the
Patient ID.
Enter
Lab Number (LID)
ABC
158
123
FIGURE 6-6
Note! Will not be displayed if the Lab ID
requirement is set to “Not Used” (see
4.4.2 Patient Test Settings).
i) Enter the Lab Number (LID) either
directly on the Display via the Text
mode and Numeric mode buttons, or
with the Barcode Scanner via the
Barcode Scanner button.
(Continues)
PART III
6 Patient Test procedure
(Continues)
Verify
Cuvette Batch: 6789
PID: 123456789
(James Smith)
LID: 123456789
FIGURE 6-7
j) A display will be shown where it is
possible to verify all entered
information. If some of the entered
information is wrong, press the back
arrow to go back and re-enter the
information, otherwise press OK to
continue.
(Continues)
159
6 Patient Test procedure
PART III
(Continues)
Patient Test
7
Please Fill
and
Insert a Cuvette
FIGURE 6-8
k) The Dilution button (4) and the Help
button (5) will only be displayed if the
dilution option has been chosen (see
section 4 Settings).
l) If the sample is diluted, press the
Dilution button (4). FIGURE 6-9 will
be displayed.
Note! The Dilution function is not
available in all markets.
6
FIGURE 6-9
Dilution
m)Confirm with Yes or No. FIGURE 6-8
will then be displayed again.
Sample Diluted
with NaCl 1+1?
No
160
6 Dilution button
7 Help button
Yes
n) Obtain a blood sample according to
the procedure described in section
5 Blood specimen collection.
o) Place the Cuvette in the Cuvette holder
and gently insert it into the measuring
position.
When the measurement is ready
FIGURE 6-10 will be displayed.
PART III
6 Patient Test procedure
6.1.1 Patient Test Result
FIGURE 6-10
Patient Test
Result
1
PID: 123456789
LID: 123456789
2
714 mg/dL
4
Critical, Diluted
5
3
6
7
8
9
Position numbers (1) to (3) are explained
in the position list below.
The Result (4) is presented in bold print.
The Note (5) Critical will be displayed if
the result is outside the critical limits that
are defined in the Settings (see 4.4.2
Patient Test Settings).
The Comment (6) Diluted will
automatically be displayed and added to
the results Comment list (see 6.1.3
Entering Comments) if the sample was
diluted and the result was calculated.
1
2
3
4
5
6
7
8
9
Type of test
Patient ID
Lab Number ID
Result
Critical Note
Diluted Comment
Comment input button
Verify/Duplicate sampling button
Confirm button
(Continues)
161
6 Patient Test procedure
PART III
(Continues)
FIGURE 6-11
Patient Test
Result
1
PID: 123456789
LID: 123456789
2
714 mg/dL
4
Critical, Diluted
5
3
6
To add comments to the result press, the
Comment input button (7). See 6.1.3
Entering Comments.
The Verify/Duplicate sampling
button (8) allows the verification of the
result by measuring a new sample from
the patient (see 6.1.2 Verify/Duplicate
sampling).
Note! Do not press the Confirm
button (9) in this screen if the result is to
be verified.
Note! Never re-measure a Cuvette!
7
8
9
a) Press the Confirm button (9) to store
the information.
The Main Menu, FIGURE 6-1 will be
displayed.
Note! The result will remain on the
display even if the Cuvette holder is
pulled out, allowing for examination of
the Cuvette before comments are made.
1
2
3
4
5
6
7
8
9
162
Type of test
Patient ID
Lab Number ID
Result
Critical Note
Diluted Comment
Comment input button
Verify/Duplicate sampling button
Confirm button
PART III
6 Patient Test procedure
6.1.2 Verify/Duplicate sampling
FIGURE 6-12
Patient Test
Results may be verified by obtaining a
second sample from the same patient and
performing a new measurement.
Depending on whether the Duplicate
sampling function (see Duplicate
sampling) has been activated or not the
outcome of this procedure may vary.
Result
PID: 750629-3694
LID: 12345
Note! Never re-measure a Cuvette!
63 mg/dL
a) When the first result is displayed,
press the Verify/Duplicate Sampling
button (1). FIGURE 6-13 will be
displayed.
1 Verify/Duplicate sampling button
1
FIGURE 6-13
Patient Test
b) Accept the information for the new
measurement by pressing the Confirm
button (2).
Verify
PID: 750629-3694
LID: 12345
Cuv.123456
c) The following text will be displayed:
Please Fill and Insert a Cuvette.
d) When the new Cuvette is inserted and
the measurement is in progress, the
following text will be displayed:
Press "OK"
to Accept
Please Wait Measuring ...
e) Upon completion of the measurement,
the result is displayed, see FIGURE 614.
2
2 Confirm button
163
6 Patient Test procedure
PART III
Result Verification
FIGURE 6-14
Patient Test
1) indicates the result from the first
measurement (1).
Result Verify
PID: 750629 - 3694
LID: 12345
3
= 12.2 g/dL
1) 12.1 g/dL
2) 12.3 g/dL
4
1
2
5
2) indicates the result from the second
measurement (2).
X indicates the Mean value (3) for these
two measurements.
Note! If the Duplicate sampling function
is used and the two results differ more
than the maximum difference set in the
settings (see FIGURE 4-65 ), the results
will automatically be rejected and instead
of the mean value the following text will
be displayed “Difference too large”.
When the confirm button is pressed
FIGURE 6-15 is displayed. When
pressing the confirm button (1) in
FIGURE 6-15 the Main Menu will be
displayed.
FIGURE 6-15
Duplicate sampling
Warning
Note! When the Duplicate sampling
function is used, predefined comments
will automatically be added to the two
results, pairing them together. This will
enable OR’s to see that the two results
belong together and make it possible to
calculate a mean value.
Difference too large.
Please perform
another
measurement.
To add comments, press the Comment
input button (4), see 6.1.4 Entering
Comments – Verified sample.
(Continues)
1
164
PART III
6 Patient Test procedure
(Continues)
a) Press the Confirm button (5) to store
the information.
The Main Menu, FIGURE 6-1 will be
displayed.
Note! The result will remain on the
display even if the Cuvette holder is
pulled out, allowing for examination of
the Cuvette before comments are made.
1
2
3
4
5
FIGURE 6-16
Patient Test
The Comment input button (4) indicates
that there are no comments added to the
result.
Result Verify
PID: 750629 - 3694
LID: 12345
3
To add comments, press the Comment
input button (4), see 6.1.4 Entering
Comments – Verified sample.
1
b) Press the Confirm button (5) to store
the information.
The Main Menu, FIGURE 6-1 will be
displayed.
= 12.2 g/dL
1) 12.1 g/dL
2) 12.3 g/dL
4
Result from first measurement
Result from second measurement
Mean value
Comment input button
Confirm button
2
5
165
6 Patient Test procedure
PART III
6.1.3 Entering Comments
FIGURE 6-17
Patient Test
Comments may be entered prior to saving
the result.
Result
a) When the result is displayed, press the
Comment input button (1).
FIGURE 6-18 will be displayed.
PID: 750629-3694
LID: 12345
1 Comment input button
63 mg/dL
1
FIGURE 6-18
Comments
The Comment list (2) is empty prior to
the addition of any comments.
2
Delete
Add
3
Note! The only exception is the auto
generated comment Diluted, displayed in
the results Comment list (2) if the
Dilution button has been pressed earlier
(see FIGURE 6-8).
b) To add a comment, press the Add
button (3).
FIGURE 6-19 will be displayed.
2 Result Comment list
3 Add button
(Continues)
166
PART III
6 Patient Test procedure
(Continues)
FIGURE 6-19
Add Comment
Free Text
Expired cuvette
Air bubble
Comment:4
Comment:5
Comment:6
7
5
4
Note! This list will be empty if no
comments have been pre-defined in the
Settings menu, see 4.2.4 Define
Comments.
c) Press the Scroll bar arrows (4) to
select a Comment (5). In this example:
EXPIRED CUVETTE.
d) Press the Add button (6). FIGURE 620 will be displayed.
Add
6
Note! If information is to be added as text
and numbers or via the Barcode Scanner,
press the Free text button (7).
4
5
6
7
FIGURE 6-20
Comments
The added comment is displayed in the
Comment list (8).
Expired cuvette
Delete
Scroll bar arrows
Selected comment
Add button
Free text button
8
Add
9
10
e) If more comments are to be added,
press the Add button (9) again and
repeat the procedure according to
FIGURE 6-19 .
f) If comments are to be deleted, press
the Delete button (10).
FIGURE 6-21 will be displayed.
8 Result Comment list
9 Add button
10 Delete button
(Continues)
167
6 Patient Test procedure
PART III
(Continues)
FIGURE 6-21
Comments
All added comments are displayed. In
this example, Air bubble and Expired
Cuvette are displayed.
Air bubble
Expired Cuvette
11
g) Press the Scroll bar arrows (11) to
select a Comment, in this example
Expired Cuvette.
h) Press the Delete button (12)
Delete
Add
12
168
11 Scroll bar arrows
12 Delete button
(Continues)
PART III
6 Patient Test procedure
(Continues)
FIGURE 6-22
Comments
13
Expired cuvette
i) When all comments that are to be
added are displayed in the Comment
list (13), press the Confirm
button (14).
Note! If the Previous image button (15) is
pressed, this text will be displayed:
Delete
If you continue no comment changes
will be saved. Continue?
Add
14
15
If Continue is pressed again all changes
entered in the Comment list (13) will be
lost.
Note! If an attempt is made to add more
than four comments to the result, the
following text will be displayed:
Maximum four Comments are allowed.
j) FIGURE 6-23 will be displayed.
13 Result Comment list
14 Confirm button
15 Previous image button
(Continues)
169
6 Patient Test procedure
PART III
(Continues)
FIGURE 6-23
k) The result may now be accepted or
rejected, by means of the Accept
button (16) or Reject button (17)
respectively.
Acceptance
Accept or Reject
the Current
Measurement
Note! Both accepted and rejected results
will be stored.
17
16
Reject
Accept
l) If the Reject button (17) is pressed
without any comments being added,
this text will be displayed:
To Reject a Sample, Enter at least
one Comment.
16 Accept button
17 Reject button
FIGURE 6-24
Patient Test
Result
The dotted Comment input button (18)
indicates that there are comments added
to the result.
PID: 750629-3694
LID: 12345
The Waste bin (19) indicates that the
result has been rejected (see FIGURE 623).
63 mg/dL
m)Press the Confirm button (20).
The Main menu, FIGURE 6-1 will be
displayed.
19
18 Comment input button
19 Indicator for rejected test result
20 Confirm button
18
170
20
PART III
6 Patient Test procedure
6.1.4 Entering Comments –
Verified sample
FIGURE 6-25
Patient Test
Result Verify
Comments may be added to the results of
verified samples before saving.
PID: 750629-3694
LID: 12345
a) When the results are presented, press
the Comment input button (1).
= 64 mg/dL
1) 63 mg/dL
2) 65 mg/dL
1
b) This text will be displayed:
Comment Cuvette Number 1.
c) To add comments to the result from
the first cuvette, follow the same
procedure as in 6.1.3 Entering
Comments, FIGURE 6-18 to FIGURE
6-22.
d) When the comments for the first
Cuvette are made, this text will be
displayed:
Comment Cuvette Number 2.
e) To add comments to the result from
the second cuvette follow the same
procedure as in 6.1.3 Entering
Comments, FIGURE 6-18 to FIGURE
6-22.
f) FIGURE 6-26 will be displayed.
1 Comment input button
(Continues)
171
6 Patient Test procedure
PART III
(Continues)
FIGURE 6-26
Patient Test
The dotted Comment input button (2)
indicates that comments have been
added.
Result Verify
PID: 750629-3694
LID: 12345
= 64 mg/dL
1) 63 mg/dL
2) 65 mg/dL
In this example the Waste bin (3)
indicates that the result for the first
Cuvette has been rejected.
3
4
2
172
g) Press the Confirm button (4).
The Main menu, FIGURE 6-1, will be
displayed.
2 Comment input button
3 Indicator for rejected test result
4 Confirm button
PART III
7 STAT Test procedure
7 STAT Test procedure
This chapter guides you through the process of performing a STAT Test. The
STAT Test fulfils the same function as a Patient Test but a predefined number of
STAT tests can be performed by overriding the requirement of performing any
type of QC Test. When performing a STAT Test, it is optional whether or not to
enter Cuvette Batch, Patient ID or Lab Number in order to make the measuring
procedure quicker.
7.1 STAT Test
Note! STAT tests are only available if
enabled during the configuration of the
Analyzer settings (see 4.4.2 Patient Test
Settings).
FIGURE 7-1
08/09/03 10:55 AM
JAMES SMITH
1
a) In the Main Menu, press the STAT
Test button (1) to enter the STAT Test
procedure.
(Continues)
173
7 STAT Test procedure
PART III
(Continues)
b) Enter the information for the 3
following images:
Enter Cuvette Batch
Enter Patient ID (PID)
Enter Lab Number (LID)
(see section 6 Patient Test procedure)
or just press the Confirm button if no
data is to be added.
Note! The three images above will not be
displayed if the Cuvette Batch No.
requirement (see 4.4.1 General Settings),
the Patient ID requirement (see 4.4.2
Patient Test Settings) and the Lab ID
requirement (see 4.4.2 Patient Test
Settings) are set to “Not Used”.
1 STAT Test button
(Continues)
174
PART III
7 STAT Test procedure
(Continues)
3
STAT Test
FIGURE 7-2
Note! The Dilution function is not
available in all markets.
Note! The Dilution button (2) and Help
button (3) will only be displayed if the
dilution option was chosen during the
configuration of the Analyzer settings
(see 4 Settings).
Please Fill
and
Insert a Cuvette
2
c) If the sample is diluted, press the
Dilution button (2).
FIGURE 7-3 will be displayed.
2 Dilution button
3 Help button
FIGURE 7-3
Dilution
d) Confirm with Yes or No. FIGURE 7-2
will then be displayed once again.
Sample Diluted
with NaCl 1+1?
e) Obtain a blood sample according to
the procedure described in section
5 Blood specimen collection, and
dilute it with NaCl (Saline), one part
blood and one part NaCl.
f) Fill a Cuvette and place it in the
Cuvette holder and gently insert it into
the measuring position.
No
Yes
175
7 STAT Test procedure
PART III
7.1.1 STAT Test Result
FIGURE 7-4
The result (4) is presented in bold print.
STAT Test
Result
1
PID: 750629-3694
LID: 12345
2
3
52 mg/dL
4
To add a comment to the result, press the
Comment input button (5). The
procedure is the same as for a Patient
Test, see 6.1.3 Entering Comments.
The Verify/Duplicate sampling
button (6) allows the verification of the
result by measuring a new sample from
the same patient. The procedure is the
same as for a Patient Test, see 6.1.2
Verify/Duplicate sampling.
Note! Never re-measure a Cuvette!
a) Press the Confirm button (7) to store
the information.
5
6
7
Note! The result will remain on the
display even if the Cuvette holder is
pulled out, allowing for the examination
of the Cuvette before comments are
made.
1
2
3
4
5
6
7
176
Type of test
Patient ID
Lab Number ID
Result
Comment input button
Verify/Duplicate sampling button
Confirm button
PART III
8 QC Test procedure
8 QC Test procedure
This chapter describes the process of performing QC Tests, Linearity Tests and
Proficiency Tests
8.1 Events necessitating
QC Tests
8.1.1 QC Reminder
Based on the settings made for the QC
Test Reminder, the Reminder icon (1)
will be displayed to warn of an
impending QC lockout.
1
2
FIGURE 8-1
3
The QC Reminder (1) indicates Time (2)
or Number of measurements (3)
remaining before the QC Lockout.
08/09/03 10:55 AM
JAMES SMITH
2h 47min (QC1)
100 cuv (QC2)
4
Note! The number of measurements
remaining refer only to Patient Tests and
STAT tests.
The text inside the brackets indicates the
types of QC Tests (4) that must be
performed in order to avoid a QC lockout.
QC1 = QC Test Level 1
QC2 = QC Test Level 2
QC3 = QC Test Level 3
QC4 = QC Test Level 4
QC5 = QC Test Level 5
1 QC Reminder
2 Time remaining before QC Lockout
3 Number of measurements remaining
before QC Lockout
4 Type of QC Test required
(Continues)
177
8 QC Test procedure
PART III
(Continues)
FIGURE 8-2
08/09/03 10:55 AM
If the required QC Test is performed after
the reminder is displayed, but before the
QC lockout, the time/measurement
counter is reset to the max. time/number
of measurements until the next QC
lockout.
JAMES SMITH
2h 47min (QC1)
100 cuv (QC2)
a) To enter the QC Test procedure, press
the QC Test button (5).
FIGURE 8-6 will be displayed.
5 QC Test button
5
178
PART III
8 QC Test procedure
8.1.2 QC Lockout
If the required QC Test is not performed
within the time or number of
measurements indicated by the
QC Reminder, FIGURE 8-1, the
Analyzer will perform a QC lockout.
FIGURE 8-3 will be displayed.
1
FIGURE 8-3
2
The QC Lockout (1) indicates that the
Analyzer has performed a QC lockout.
08/09/03 10:55 AM
Note! Patient Tests are not allowed when
the Analyzer has performed a
QC lockout.
JAMES SMITH
Run QC 1, QC 2
Note! Linearity and Proficiency Tests are
not allowed when the Analyzer has
performed a QC lockout.
3
Note! STAT Tests are not allowed when
the Analyzer has performed a QC lockout
if usage of STAT Tests is set to “Not
Used” (see 4.4.2 Patient Test Settings) or
if the number of STAT Tests performed
has reached the max. limit allowed.
The Information text (2) indicates the
types of QC Tests required to unlock the
QC Lockout.
a) To enter the QC Test procedure, press
the QC Test button (3).
FIGURE 8-6 will be displayed.
1 QC Lockout
2 Information text
3 QC Test button
179
8 QC Test procedure
PART III
8.1.3 Supervisory Lockout
FIGURE 8-4
1
08/09/03 10:55 AM
JAMES SMITH
Supervisory
Lockout
2
The Analyzer has been locked out by the
Supervisor. This can only be performed
via the DMS Software or an Observation
Reviewer (OR). The Analyzer can only
be unlocked by the Supervisor via the
DMS Software or an OR.
1 QC Lockout
2 Supervisory Lockout Text
180
PART III
8 QC Test procedure
8.2 Performing a QC Test
FIGURE 8-5
08/09/03 10:55 AM
a) In the Main Menu, press the QC Test
button (1).
FIGURE 8-6 will be displayed.
JAMES SMITH
1 QC Test button
1
181
8 QC Test procedure
PART III
FIGURE 8-6
QC Test
Level 1
Low
There are 7 QC Test options (1):
1
Level 2
Normal
Level 3
High
Other 4Level
Level
2
• Level 1 (See 8.2.1 QC Tests at a
specific concentration level)
• Level 2
• Level 3
• Level 4
• Level 5
• Linearity (See 8.2.2 Linearity Test)
• Proficiency (See 8.2.3 Proficiency
Test)
a) View options (1) not initially visible
by pressing the Scroll bar arrow (2).
b) Select a QC Test option by pressing it.
Note! Level 1, Level 2, Level 3, Level 4
and Level 5, refer to the different
concentration levels of Liquid Controls
used in QC tests. The procedure for
performing a QC test is the same for all
the concentration levels. Therefore only
one, Level 1, is described.
1 QC Test options
2 Scroll bar arrow
182
PART III
8 QC Test procedure
8.2.1 QC Tests at a specific
concentration level
QC Level 1
Please Fill
and
Insert a Cuvette
FIGURE 8-7
1
Note! The QC Tests procedure for Level
1, Level 2, Level 3, Level 4 and Level 5
are identical, and therefore only one,
Level 1, is described.
The concentration level of the QC
Test (1) is displayed.
a) Fill a Cuvette with the appropriate
level of Liquid Control (1).
b) Place the Cuvette in the Cuvette holder
and gently insert it into the measuring
position.
FIGURE 8-8 will be displayed.
1 Concentration level of QC Test
(Continues)
183
8 QC Test procedure
PART III
(Continues)
Enter
Cuvette Batch
ABC
123
Enter
Control Lot
ABC
123
FIGURE 8-8
c) Enter the Cuvette Batch No. either
directly on the Display via the Text
mode and Numeric mode buttons, or
with the Barcode Scanner via the
Barcode Scanner button.
FIGURE 8-9 will be displayed.
Note! If the Cuvette Batch No.
requirement is set to Approved only (see
4.4.1 General Settings), and a Cuvette
Batch No. that was not previously stored
in the Analyzer (see 4.2.2 Cuvette
Batches) is entered, or the Cuvette Batch
has expired, the following text will be
displayed:
Invalid Cuvette Batch.
FIGURE 8-9
d) Enter the Lot No. for the Liquid
Control used, either directly on the
Display via the Text mode and
Numeric mode buttons, or with the
Barcode Scanner via the Barcode
Scanner button.
FIGURE 8-10 will be displayed.
Note! If a Liquid Control Lot has not
previously been stored in the Analyzer
(see 4.2.1 Liquid Controls) and/or has
expired, the following text will be
displayed:
Invalid Control Lot.
(Continues)
184
PART III
8 QC Test procedure
(Continues)
FIGURE 8-10
QC Level 1
2
Result
3
Lot No: 234567
4
43
47
53
57
50 mg/dL
Pass
5
6
7
8
The Numeric Test Result (5) and the
Qualitative Test Result (6) are displayed
in bold text.
For a result within the Approved area (2)
(the blank area), the Qualitative Test
Result (6) will indicate “Pass”.
For a result within the Warning area (3)
(the dotted area), the Qualitative Test
Result (6) will indicate “Pass, Warning”.
For a result within the Fail area (4) (the
solid area), or for two consecutive results
within the Warning area (3), the
Qualitative Test Result will (6) indicate
“Fail”.
To avoid or unlock a QC lockout, the
Qualitative Test Result must indicate
“Pass”.
e) To view a graphic presentation of the
most recent QC Tests, press the
Statistics button (7).
FIGURE 8-12 will be displayed.
f) Press the Confirm button (8). FIGURE
8-6 will be displayed.
2
3
4
5
6
7
8
Approved area
Warning area
Fail area
Numeric Test Result
Qualitative Test Result
Statistics button
Confirm button
(Continues)
185
8 QC Test procedure
PART III
(Continues)
QC Level 1
Result
Enter at Least
one Comment for
a Failed QC
FIGURE 8-11
g) If the Failed QC Comment setting is
set to “Entry Required” (see 4.4.3 QC
Test Settings) and the QC Test has
failed, then FIGURE 8-11 will be
displayed when the Confirm button
shown in FIGURE 8-10 is pressed.
Use the Previous Image button (9) to
go back and add at least one comment.
9 Previous Image button
(Continues)
9
186
PART III
8 QC Test procedure
(Continues)
FIGURE 8-12
QC Level 1
The diagram shows the trend for the most
recent QC measurements performed on
the control lot.
Recent Trend
h) To continue to the statistics image,
FIGURE 8-13, press the Confirm
button (9).
10 Confirm button
9
FIGURE 8-13
QC Level 1
All Statistics
10
Lot No: 234567
09/10/03 - 09/11/03
N= 30
= 52 mg/dL
SD= 0.76 mg/dL
CV= 1.5 %
11
12
13
14
15
16
The All Statistics report shows statistical
data for all QC Tests for the level of
control and Lot No. displayed.
i) Press the Confirm button (16).
FIGURE 8-10 will be displayed.
11 Lot No. of Liquid Control used in QC tests
12 Date interval of test results
13 No. of test results on which statistics are
based
14 Mean value
15 Standard Deviation
16 Coefficient of Variation
17 Confirm button
187
8 QC Test procedure
PART III
8.2.2 Linearity Test
A linearity test consists of replicate
testing of different concentrations of the
desired analyte within the measuring
range of the Analyzer. The purpose of the
test is to make sure that the relationship
between the analyte concentration and
the system output is linear.
Enter
Cuvette Batch
ABC
123
FIGURE 8-14
a) To perform a Linearity Test, press the
linearity button in the QC test options
display, see FIGURE 8-6 .
b) Enter the Cuvette Batch No. of the
cuvettes to be used, either directly on
the Display via the Text mode and
Numeric mode buttons, or with the
Barcode Scanner via the Barcode
Scanner button.
Note! If the Cuvette Batch No.
requirement is set to Approved only (see
4.4.1 General Settings), and a Cuvette
Batch No. that was not previously stored
in the Analyzer (see 4.2.2 Cuvette
Batches) is entered, or the Cuvette Batch
has expired, the following text will be
displayed:
Invalid Cuvette Batch.
c) If the linearity test is interrupted and
then resumed within 10 hours by the
same operator, using the same Cuvette
Batch No. FIGURE 8-15 will be
displayed.
Otherwise FIGURE 8-16 will be
displayed.
(Continues)
188
PART III
8 QC Test procedure
(Continues)
FIGURE 8-15
Linearity
d) To resume a previously interrupted
linearity test, press Yes.
FIGURE 8-17 will be displayed
Otherwise press No.
FIGURE 8-14 will be displayed.
Resume
Interrupted
Linearity Test?
1 Yes button
2 No button
2
1
No
Yes
FIGURE 8-16
Kit Name
GlucoLin
ABC
3
If a kit name was entered previously, it
will be displayed (3).
e) If desired, change the kit name (3)
either directly on the Display via the
Text mode and Numeric mode
buttons, or with the Barcode Scanner
via the Barcode Scanner button.
123
f) Press the Confirm button (4).
FIGURE 8-17 will be displayed.
4
3 Kit name
4 Confirm button
(Continues)
189
8 QC Test procedure
PART III
(Continues)
FIGURE 8-17
Linearity
Level 1
Level 2
If there are any already completed levels
within the linearity test, the buttons for
these will have bold text (5).
5
Continue testing until all levels have been
completed.
6
g) The levels not visible initially are
available by pressing the Scroll bar
arrow (7).
Level 3
Level 4
7
h) Select a level by pressing the button
for it (6).
i) If testing for the selected level has
been completed (5) the following will
be displayed:
Chosen Level has been completed. Do
You Wish to Retest this Level?
Press No to return to the current image
or press Yes to continue to image
FIGURE 8-18.
If testing for the selected level (6) is
not complete, FIGURE 8-18 is
displayed.
5 Buttons for already completed levels
6 Buttons for non-completed levels
7 Scroll bar arrow
(Continues)
190
PART III
8 QC Test procedure
(Continues)
FIGURE 8-18
Kit Lot
(Level 1)
ABC
The Kit Lot is the Lot No. of the material
used at the designated concentration
level.
j) Enter the Lot No. either directly on the
Display via the Text mode and
Numeric mode buttons, or with the
Barcode Scanner via the Barcode
Scanner button.
When finished, FIGURE 8-19 will be
displayed.
123
FIGURE 8-19
Level 1
Lot: 56489754
Expiration Date
08/09/03
1
2
3
4
5
6
7
8
9
8
The Lot No. (8) is displayed.
9
k) Enter the Expiration Date (9) for the
current Lot via the Digit buttons (10).
10
l) Press the Confirm button.
FIGURE 8-20 will be displayed.
8
9
10
11
0
11
Lot No.
Expiration Date
Digit button
Confirm button
(Continues)
191
8 QC Test procedure
PART III
(Continues)
Level 1
12
Unit:mg/dL
Range Min (0 - 400)
Range Max (0 - 400)
70
80
13
14
FIGURE 8-20
The level of the linearity material and it’s
concentration unit are displayed.
If levels with known concentration
ranges are used, the ranges should be
entered.
1
2
3
4
5
6
Note! Numbers in brackets show the
lowest and the highest allowable value.
7
8
9
.
0
If a range is not entered for the first level,
only numerical values for each level
tested will be displayed and no range can
be entered for the remaining levels. If a
range is entered for the first level, ranges
must be entered for the remaining levels.
15
m)Enter the min. value for the
concentration range (13) via the Digit
buttons. Press the Confirm
button (15).
n) Enter the max. value for the
concentration range (14) via the Digit
buttons. Press the Confirm
button (15).
FIGURE 8-21 will be displayed.
12
13
14
15
Unit for concentration
Concentration range, min. value
Concentration range, max. value
Confirm button
(Continues)
192
PART III
8 QC Test procedure
(Continues)
FIGURE 8-21
Level 1
16
GlucoLin
Lot: 56489754
Exp.: 08/09/03
17
70
18
80
Save?
19
20
No
Save
Level 1
Please Fill
and
Insert a Cuvette
The previously entered values for the
linearity material at the designated level
are displayed for confirmation.
o) To confirm the displayed values and to
save them for future comparisons to
the measured value, press Save.
FIGURE 8-22 will be displayed.
Otherwise press No. FIGURE 8-17
will be displayed.
16
17
18
19
20
Kit name
Lot No.
Expiration Date
Concentration range, max. value
Concentration range, min. value
FIGURE 8-22
21
The level of linearity material to be
tested (21) is shown on the display.
p) Fill a Cuvette from the previously
designated batch with the appropriate
level of linearity material.
q) Place the Cuvette in the Cuvette holder
and gently insert it into the measuring
position.
FIGURE 8-23 will be displayed.
21 Concentration level of Linearity material
(Continues)
193
8 QC Test procedure
PART III
(Continues)
FIGURE 8-23
22 23
The result will be displayed.
Level 1
24
Result
25
Cuvette 1 (3)
70
80
75 mg/dL
Please Fill
and
Insert Next Cuvette
26
Continue testing the designated level
until the number of required
measurements have been completed.
Note! If the result is beyond the upper
measuring range of the Analyzer, the
display will read:
Overrange
and a Confirm button will be shown.
If other errors occur, an error message
and a Confirm button will be displayed.
When Confirm is pressed the following
message will be displayed:
Error.
All Cuvettes for this Level will be
Rejected.
When Confirm is pressed all
measurements for the designated level
are rejected but still kept in memory, and
FIGURE 8-17 is displayed.
22
23
24
25
26
Measurement No.
Total No. of measurements required
Concentration range, min. value
Concentration range, max. value
Numeric test result
(Continues)
194
PART III
8 QC Test procedure
(Continues)
r) If the result is within range and the
Previous image button is pressed, the
following message will be displayed:
Do You wish to Reject all Cuvettes
Measured for this Level?
To reject all measurements at the
current level press Yes. FIGURE 8-17
will be displayed.
Press No to continue the Linearity test.
If FIGURE 8-23 is displayed and the test
is to be continued:
s) Fill a Cuvette from the previously
designated batch with the appropriate
level of linearity material.
t) Place the Cuvette in the Cuvette holder
and gently insert it into the measuring
position.
If additional tests are required
FIGURE 8-23 will be displayed again.
If no additional tests are required,
FIGURE 8-24 will be displayed.
(Continues)
195
8 QC Test procedure
PART III
(Continues)
FIGURE 8-24
Level 1
Result
Cuvette 3 (3)
70
75 mg/dL
196
80
u) Press the Confirm button.
If other levels of the linearity material
need to be measured FIGURE 8-17
will be displayed.
If testing for all levels is completed,
FIGURE 8-25 will be displayed.
(Continues)
PART III
8 QC Test procedure
(Continues)
Linearity
FIGURE 8-25
Result
27
N = 15
mg/dL
1 = 75
(70 - 80)
2 = 143 (140 - 150)
3 = 209 (210 - 220)
4 = 278 (280 - 290)
5 = 354 (350 - 360)
Out of Range
28
29
30
31
32
When all levels have been completed, an
image containing all results is displayed.
If the mean result (29) for each level is
within the concentration range (30) for
the level, the Qualitative test result (31)
will indicate “Within range”.
If the mean result (29) for any level is
beyond the concentration range for the
level (30), the result and the range limits
will appear in bold, and the Qualitative
test result (31) will indicate “Out of
range”.
v) Press the Confirm button (32).
FIGURE 8-26 will be displayed.
27 Total No. of cuvettes used in the linearity
test
28 Unit for analyte concentration
29 Mean result at the level
30 Concentration min. and max. value at the
level
31 Qualitative Test Result
32 Confirm button
(Continues)
197
8 QC Test procedure
PART III
(Continues)
FIGURE 8-26
Linearity
Result
33
N = 15
mg/dL
1 = 75
2 = 143
3 = 209
4 = 278
5 = 354
34
35
a) Press the Confirm button (35).
FIGURE 8-17 will be displayed.
36
198
If no ranges are specified for the
concentration levels (see FIGURE 8-20),
only the mean results at each level (34)
are listed and no range limits will be
displayed. No Qualitative test result is
given.
33 Total No. of cuvettes used in the linearity
test
34 Unit for analyte concentration
35 Mean result at the level
36 Confirm button
PART III
8 QC Test procedure
8.2.3 Proficiency Test
Proficiency testing is performed on
samples from external sources. The
expected value is unknown to the site
performing the test. The purpose of the
test is to ensure that the systems enrolled
in the proficiency testing all have the
same level of calibration.
FIGURE 8-27
Proficiency
Please Fill
and
Insert a Cuvette
a) To perform a Proficiency Test, press
the Proficiency button in the QC test
options display, see FIGURE 8-6 .
b) Fill a Cuvette with the proficiency
sample.
c) Place the Cuvette in the Cuvette holder
and gently insert it into the measuring
position.
FIGURE 8-28 will be displayed.
(Continues)
199
8 QC Test procedure
PART III
(Continues)
Enter
Cuvette Batch
ABC
123
Enter
Specimen ID
ABC
123
FIGURE 8-28
d) Enter the Cuvette Batch No. of the
cuvette used, either directly on the
Display via the Text mode and
Numeric mode buttons, or with the
Barcode Scanner via the Barcode
Scanner button.
FIGURE 8-29 will be displayed.
Note! If the Cuvette Batch No.
requirement is set to Approved only (see
4.4.1 General Settings), and a Cuvette
Batch No. that was not previously stored
in the Analyzer (see 4.2.2 Cuvette
Batches) is entered, or the Cuvette Batch
has expired, the following text will be
displayed:
Invalid Cuvette Batch.
FIGURE 8-29
The Specimen ID is the ID of the
proficiency sample.
e) Enter the Specimen ID either directly
on the Display via the Text mode and
Numeric mode buttons, or with the
Barcode Scanner via the Barcode
Scanner button.
When finished, FIGURE 8-30 will be
displayed.
(Continues)
200
PART III
8 QC Test procedure
(Continues)
FIGURE 8-30
Proficiency
f) Press the Confirm button (3) to return
to FIGURE 8-27.
Result
Spec ID: 234567
138 mg/dL
1
1 Specimen ID
2 Test Result
3 Confirm button
2
3
201
8 QC Test procedure
This page intentionally left blank
202
PART III
PART III
9 Reviewing stored data
9 Reviewing stored data
This chapter describes the process of reviewing stored data.
9.1 Activating the Stored
Data procedure
FIGURE 9-1
08/09/03 10:55 AM
Note! Access to the Stored Data
functions is dependent on the operator’s
user level and on the existing requirement
for an Operator ID. Only a Supervisor can
delete data, change an accepted or
rejected result or add comments.
JAMES SMITH
a) In the Main Menu, press the Stored
Data button (1).
1
b) If the entry requirement for an
Operator ID is set to “Not Used” (see
4 Settings) FIGURE 9-2 will be
displayed, as this is a password
protected function.
Otherwise the Analyzer can respond in
two different ways:
If the operator’s user level does not
permit access to the Stored Data (see
Figure 4-22), FIGURE 9-3 will be
displayed.
If the operator’s user level permits
access to the Stored Data, FIGURE 94 will be displayed.
1 Stored Data button
(Continues)
203
9 Reviewing stored data
PART III
(Continues)
FIGURE 9-2
Enter Stored
Data Password
Note! Only displayed if the Operator ID
requirement is set to “Not used” (see
4.4.1 General Settings).
2
3
ABC
123
4
c) Enter the Password (default value is
“0000”) for protected functions, either
directly on the Display via the Text
mode (2) and Numeric mode (3)
buttons, or with the Barcode Scanner
via the Barcode Scanner button (4).
d) If the incorrect password is entered,
FIGURE 9-3 will be displayed.
If the correct password is entered
FIGURE 9-4 will be displayed.
2 Text mode button
3 Numeric mode button
4 Barcode Scanner button
(Continues)
204
PART III
9 Reviewing stored data
(Continues)
FIGURE 9-3
e) Pressing the Previous image button
returns the user to FIGURE 9-2 and
allows entry of the correct password.
By pressing the Confirm button Stored
Data can be viewed, but not changed.
FIGURE 9-4 will be displayed.
Stored Data
Incorrect
Password or User
Level
No Changes to the
Stored Data will be
Saved
5
Note! If the password is not correct, and
the Confirm button is pressed, the user
can make changes, but the changes will
not be saved in the Analyzer.
6
5 Previous image button
6 Confirm button
FIGURE 9-4
Stored Data
The following options are displayed:
Liquid Controls
Review
Cuvette Batches
Delete
7
Define Operators
Lastest
Download
Define
Log
Input
Comments
• Review (see 9.2 Review Stored Data)
• Delete (see 9.3 Delete Stored Data)
• Latest Download (see 9.4 Review
Latest Download)
• Log Input (see 9.5 Log Input)
The Stored Data options (7) are
explained in the pages that follow.
8
f) Select an option by pressing it.
g) To return to the previous image, press
the Previous image button (8).
7 Stored Data options
8 Previous image button
205
9 Reviewing stored data
PART III
9.2 Review Stored Data
FIGURE 9-5
Review
When the Review button is pressed in the
Stored Data menu (see FIGURE 9-4), the
following options are displayed:
Liquid
All
Data
Controls
Cuvette Batches
PAT/STAT
Define
QC
Test
Operators
Define Comments
Analyzer
Log
1
• All Data (see 9.2.1 Review All Data)
• PAT/STAT (see 9.2.2 Review PAT/
STAT)
• QC Test (see 9.2.3 Review QC Tests)
• Analyzer Log (see 9.2.4 Review
Analyzer Log)
a) Select an option by pressing it.
1 Review option buttons
206
PART III
9 Reviewing stored data
9.2.1 Review All Data
FIGURE 9-6
All Data
1
From 07/10/03
To 02/01/04
2
1
2
3
4
5
6
7
8
9
3
0
4
Press the All Data button in the Review
menu, FIGURE 9-5.
The From date (1) and To date (2)
displayed represent the earliest and latest
stored records. It is possible to change the
date interval. If no change is required,
press the Confirm button (4). All stored
data (Patient tests, STAT tests, QC tests
and Analyzer Logs) will be available for
review.
a) If required, change the From date (1)
via the Digit buttons (3). Press
Confirm (4).
b) Repeat the instruction “a)” to change
the To date (2).
1
2
3
4
From date
To date
Digit button
Confirm button
(Continues)
207
9 Reviewing stored data
PART III
(Continues)
c) All stored data (Patient tests, STAT
tests, QC tests and Analyzer Logs)
within the date interval will be
available for review. The latest record
is displayed first. The different images
possible are described in FIGURE 9-8,
FIGURE 9-12, FIGURE 9-15,
FIGURE 9-17, FIGURE 9-19.
If no data within the date interval is
found, the following message will be
displayed:
No Records Found
Press the Previous image button to
return to the All Data image, FIGURE
9-6.
208
PART III
9 Reviewing stored data
9.2.2 Review PAT/STAT
FIGURE 9-7
PAT/STAT
1
From: 07/10/03
To:
02/01/04
Press the PAT/STAT button in the
Review menu, FIGURE 9-5.
2
The From date (1) and To date (2)
displayed represent the earliest and latest
stored Patient Tests and STAT tests. It is
possible to change the date interval. If no
change is required, press the Confirm
button (4). FIGURE 9-8 will then be
displayed.
1
2
3
4
5
6
7
8
9
3
0
4
a) If required, change the From date (1)
via the Digit buttons (3). Press the
Confirm button (4).
b) Repeat instruction “a)” to change the
To date (2).
c) In the next display a Patient ID No. can
be entered to view specific patient
data. Otherwise press the Confirm
button (4) to view all Patient and
STAT data.
1
2
3
4
From date
To date
Digit button
Confirm button
(Continues)
209
9 Reviewing stored data
PART III
(Continues)
d) All Patient Tests and STAT tests
within the defined date interval will be
available for review. Initially, the
latest record is displayed. For Patient
tests and STAT tests see FIGURE 9-8.
e) If no data within the date interval is
found, the following message will be
displayed:
No Records Found
The Previous image button must be
pressed to return to the PAT/STAT
image, FIGURE 9-7.
210
PART III
9 Reviewing stored data
Patient/STAT test
Patient Test
1
07/10/03 10:24 AM
2
5
6
c) Press the Confirm button (9). FIGURE
9-5 will be displayed.
4
198 mg/dL
7
8
9
a) To browse through the available
records, use the scroll bar arrows (4).
b) Depending on the operator’s user
level, comments can either be added,
deleted or changed or just viewed, by
pressing the Comment input
button (8). See 6.1.3 Entering
Comments.
3
OP: Chris
PID: 670317- 4987
LID: 124-4456
Diluted, Critical
FIGURE 9-8
1
2
3
4
5
6
7
8
9
Date and time of test
Operator ID
Patient ID
Scroll bar arrows
Lab Number
Indicator for rejected test result
Result
Comment input button
Confirm button
211
9 Reviewing stored data
PART III
9.2.3 Review QC Tests
FIGURE 9-9
QC Test
From 07/10/03
To
02/01/04
1
2
3
4
5
6
7
8
9
1
Press the QC Test button in the Review
menu, FIGURE 9-5.
2
The From date (1) and To date (2)
displayed represent the earliest and latest
stored QC tests. It is possible to change
the date interval. If no change is required,
press the Confirm button (4). FIGURE 910 will then be displayed.
3
0
4
a) If required, change the From date (1)
via the Digit buttons (3). When
finished, press the Confirm button (4).
b) Repeat instruction “a)” to change the
To date (2).
c) FIGURE 9-10 will be displayed.
1
2
3
4
From date
To date
Digit button
Confirm button
(Continues)
212
PART III
9 Reviewing stored data
(Continues)
QC Test
All QC Data
Level 1
Low
Level 2
Normal
Level 3
High
FIGURE 9-10
There are different categories of QC Test
data. The following options are available:
•
•
•
•
•
•
•
•
All QC Data
Level 1
Level 2
Level 3
Level 4
Level 5
Linearity
Proficiency
(Continues)
213
9 Reviewing stored data
PART III
(Continues)
FIGURE 9-11
QC Test
All QC Data
Level 1
Low
5
Level 2
Normal
Level 3
High
6
7
The categories Level 1, Level 2, Level 3,
Level 4 and Level 5, refer to the different
concentration levels of Liquid Controls
used in a QC test. Linearity and
Proficiency define other types of tests.
The procedure for reviewing QC Tests is
the same for all the concentration levels.
Therefore only one, Level 1, is described.
d) To view categories not initially
visible, press the Scroll bar arrow (6).
e) Select a category by pressing it.
f) All QC tests within the selected
category and the defined date interval
will be available for review. The latest
test is displayed first. For Level 1,
Level 2, Level 3, Level 4 and Level 5
see FIGURE 9-12. For Linearity see
FIGURE 9-15. For Proficiency see
FIGURE 9-17.
If no data within the date interval is
found, the following message will be
displayed:
No Records Found
The Previous image button (7) must be
pressed to return to the QC Test
categories image, FIGURE 9-10.
5 QC categories
6 Scroll bar arrow
7 Previous image button
214
PART III
9 Reviewing stored data
All QC Data
All categories of QC data within the
defined date interval will be available.
The different images possible are
described in FIGURE 9-12, FIGURE 915 and FIGURE 9-17.
QC tests at a specific concentration
level
FIGURE 9-12
1
QC Level 1
2
08/11/03 10:24 AM
3
OP: Kalle
Lot: 1413-1245
57
4
44 mg/dL
Pass, Warning
5
43
47
53
6
7
8
9
10
a) To browse through the available
records, use the scroll bar arrows (4).
b) Depending on the operator’s user
level, comments can either be added,
deleted or changed or just viewed, by
pressing the Comment input
button (8). See 6.1.3 Entering
Comments.
c) To view a graphic presentation of the
the most recent QC tests at the defined
concentration level, press the Statistics
button (9).
FIGURE 9-13 will be displayed.
d) To return to the QC Test categories
image, FIGURE 9-10, press the
Confirm button (10).
1
2
3
4
5
6
7
8
9
10
Date and time of test
Operator ID
Lot No. of Liquid Control
Scroll bar arrows
Indicator for rejected test result
Result
Qualitative test result
Comment input button
Statistics button
Confirm button
(Continues)
215
9 Reviewing stored data
PART III
(Continues)
FIGURE 9-13
QC Level 1
11
Recent Trend
Lot No:1413-1245
12
13
The diagram shows the trend for the most
recent QC measurements at the defined
concentration level. No consideration is
given to the defined date interval.
14
e) Press the Confirm button (15).
FIGURE 9-14 will be displayed.
15
11
12
13
14
15
Lot No. of Liquid Control
Fail area
Warning area
Pass area
Confirm button
FIGURE 9-14
QC Level 1
All Statistics
16
Lot No:234567
09/10/03 - 09/11/03
N= 30
= 52 mg/dL
SD= 0.76 mg/dL
CV= 1.5 %
17
18
19
20
21
22
216
The image shows statistical data for all
stored QC tests with the current Lot No.
f) Press the Confirm button (22).
FIGURE 9-12 will be displayed.
16 Lot No. of Liquid Control
17 Date interval of test results
18 Number of test results on which statistics
are based
19 Mean value
20 Standard Deviation
21 Coefficient of Variation
22 Confirm button
PART III
9 Reviewing stored data
Linearity tests
For a description, see 8.2.2 Linearity Test
1
Linearity [L5]
08/11/03 10:24 AM
OP: Chris
Lot: 142387
350
2
3
4
360
FIGURE 9-15
a) To browse through the available
records, use the scroll bar arrows (4).
b) To view statistics for the linearity test,
press the Statistics button (7).
FIGURE 9-16 will be displayed.
c) Press the Confirm button (8).
FIGURE 9-10 will be displayed.
354 mg/dL
5
6
7
8
1
2
3
4
5
6
7
8
Date and time of test
Operator ID
Lot No. of Linearity material
Scroll bar arrows
Indicator for rejected test result
Result
Statistics button
Confirm button
FIGURE 9-16
Linearity
9
Result
N = 15
mg/dL
1 = 75 (70 - 80)
2 = 143 (140 - 150)
3 = 209 (210 - 220)
4 = 278 (280 - 290)
5 = 354 (354 - 360)
Out of Range
10
11
12
13
The image shows statistical data. For
more information on the image, see
FIGURE 8-25.
d) Press the Confirm button. FIGURE 910 will be displayed.
9 Total No. of cuvettes used in the linearity
test
10 Unit for analyte concentration
11 Mean result for the level
12 Concentration min. and max. value for the
level
13 Confirm button
217
9 Reviewing stored data
PART III
Proficiency tests
For a description, see 8.2.3 Proficiency
Test
Proficiency
01/05/03 11:43 AM
1
2
3
OP: Emma
Spec: 1435-3425
4
248 mg/dL
5
6
218
FIGURE 9-17
a) To browse through the available
records, use the scroll bar arrows (4).
b) Press the Confirm button (6). FIGURE
9-10 will be displayed.
1
2
3
4
5
6
Date and time of test
Operator performing the test
Specimen ID
Scroll bar arrows
Result
Confirm button
PART III
9 Reviewing stored data
9.2.4 Review Analyzer Log
Press the Analyzer Log button in the
Review menu, FIGURE 9-5.
An individual Analyzer Log can be either
an error message or a log note.
Analyzer Log
1
From 09/23/03
To
11/05/03
2
1
2
3
4
5
6
7
8
9
3
FIGURE 9-18
The From date (1) and To date (2)
displayed represent the earliest and latest
stored Logs. It is possible to change the
date interval. If no change is required
press Confirm (4). FIGURE 9-19 will
then be displayed.
a) If required, change the From date (1)
via the Digit buttons (3). Press
Confirm (4).
0
4
b) Repeat the instruction “a)” for the To
date (2).
c) FIGURE 9-19 will be displayed.
1
2
3
4
From date
To date
Digit button
Confirm button
(Continues)
219
9 Reviewing stored data
PART III
(Continues)
Analyzer Log
09/23/03 09:47 AM
5
6
OP: Tom
Warning
7
The individual Analyzer Logs can have
different degrees of severity.
• Critical (error messages)
• Warning (error messages)
• Note (log notes)
d) To browse through the available
records use the scroll bar arrows (7).
QC Buffer Full
8
9
10
220
FIGURE 9-19
e) Press the Confirm button (10).
FIGURE 9-5 will be displayed.
5
6
7
8
9
10
Date and time of test
Operator ID
Scroll bar arrows
Degree of severity of the Analyzer Log
Log note
Confirm button
PART III
9 Reviewing stored data
9.3 Delete Stored Data
FIGURE 9-20
Delete
When the Delete button is pressed in the
Stored Data menu (see FIGURE 9-4), the
following options for deleting data are
displayed:
All Data
PAT/STAT
QC Test
Analyser Log
Analyzer
1
•
•
•
•
All Data
PAT/STAT
QC Test
Analyzer Log
a) Select an option by pressing it.
FIGURE 9-21 will be displayed
1 Delete options
(Continues)
221
9 Reviewing stored data
PART III
(Continues)
FIGURE 9-21
Delete
2
From 01/09/03
To
01/11/03
3
1
2
3
4
5
6
7
8
9
4
0
5
The From date (2) and To date (3)
displayed represent the earliest and latest
stored records of the selected type. It is
possible to alter the To date but not the
From date. If no change is required, press
Confirm (5). FIGURE 9-22 will be
displayed.
b) If required, enter a new To date (3) via
the Digit buttons (4). When finished
press Confirm (5). FIGURE 9-22 will
be displayed.
2
3
4
5
From date
To date
Digit button
Confirm button
(Continues)
222
PART III
9 Reviewing stored data
(Continues)
FIGURE 9-22
Delete
6
All Data
From: 01/09/03
To: 01/11/03
Data Will Be
Permanently Lost.
Are You Sure?
7
c) To cancel the request to delete the
data, press No (7).
To confirm the request to delete the
data, press Yes (8)
The Delete menu, FIGURE 9-20, will
be displayed.
6 The type of data requested for deletion
7 No button
8 Yes button
8
No
Yes
223
9 Reviewing stored data
PART III
9.4 Review Latest
Download
FIGURE 9-23
Latest
Download
1
09/11/03 02:45 PM
Patient Data:
53
QC Data:
13
Analyzer Log:
Resend Data
2
a) To transfer the Data again, press the
Resend Data button (3)
3
b) Press the Confirm button (4). FIGURE
9-4 will be displayed.
5
4
224
When the Latest Download button is
pressed in the Stored Data menu,
FIGURE 9-4, data regarding the latest
information exchange with an OR is
displayed.
1
2
3
4
Date and time of transfer
No. of transferred records
Resend Data button
Confirm button
PART III
9 Reviewing stored data
9.5 Log Input
FIGURE 9-24
Log Input
2
When the Log Input button is pressed in
the Stored Data Menu, FIGURE 9-4, data
for reviewing or adding logs to the
Analyzer log list is displayed.
3
It is possible to enter free text or to chose
log notes from a predefined list.
1
Free Text
Cleaned Cuv. Holder
Cleaned Opt. Unit
a) Press the Scroll bar arrows (3) to
select either a log note (2), or the Free
Text option (1).
Add
4
b) Press the Add button (4)
c) If a log note was selected, it will be
added to the Analyzer Log and
FIGURE 9-4 will be displayed.
If the Free Text option (1) was
selected FIGURE 9-25 will be
displayed.
1
2
3
4
Free text option
Selected Log Note
Scroll bar arrows
Add button
225
9 Reviewing stored data
PART III
FIGURE 9-25
Log Input
Cleaned Display
5
6
ABC
123
7
8
226
d) Enter a free text notation either
directly on the Display via the Text
mode (5) and Numeric mode (6)
buttons, or with the Barcode Scanner
via the Barcode Scanner button (7).
e) Press the Confirm button (8). FIGURE
9-4 will be displayed.
5
6
7
8
Text mode button
Numeric mode button
Barcode Scanner button
Confirm button
PART III
10 Data communications
10 Data communications
This chapter briefly describes the data communication between the Analyzers and
the DMS Software.
10.1 Interaction
Application –
Analyzer
Specially developed DMS Software is
necessary to provide full data
management for the Analyzers.
Results of measurement are transferred to
the DMS Software for storage and
evaluation. Settings in an Analyzer can
be updated from the DMS Software.
The Analyzer must be placed in a
Docking Station that is connencted to a
PC or to an Observation Reviewer (OR)
to facilitate communication with the
DMS Software or OR.
Depending on the settings, one or several
Analyzers can be connected and
administered by the same PC via the
Docking Stations (see 10.2 Docking
station setup).
227
10 Data communications
PART III
10.2 Docking station setup
Single Primary Docking
FIGURE 10-1
A Single Primary Docking Station must
be connected to a LAN (1) to which the
PC hosting the DMS Software (2), or an
OR, is also connected.
3
4
2
The communication Analyzer - DMS
Software is two-way:
1
• Analyzer Data is transmitted from the
Analyzer to the PC (2) for Data
Management, see Arrow (3).
• Analyzer Settings are transmitted
from the PC (2) to the Analyzer, see
Arrow (4).
To make settings on a Primary Docking
Station, e.g. IP-address, it must be
connected to a PC via a USB (the same
type of connection a Secondary Docking
Station uses for data communication, see
FIGURE 10-2 ).
Note! When a Primary Docking Station
is connected via a USB connection, only
the IP address can be changed. No other
information can be sent to/from the
Analyzer.
1
2
3
4
228
LAN
PC hosting the DMS Software or OR
Analyzer Data to DMS Software or OR
Analyzer Settings from DMS Software or
OR
PART III
10 Data communications
Single Secondary Docking Station
FIGURE 10-2
2
3
4
1
A Single Secondary Docking Station
must be connected via a USB (1) to the
PC hosting the DMS Software (2). A
Secondary is only connected to a PC for
data communication. No settings can be
made on the Secondary Docking Station.
The communication between the
Analyzer and the DMS Software is twoway:
• Analyzer Data is transmitted from the
Analyzer to the PC (2) for Data
Management, see Arrow (3).
• Analyzer Settings are transmitted
from the PC (2) to the Analyzer, see
Arrow (4).
1
2
3
4
USB connection
PC hosting the DMS Software
Analyzer Data to DMS Software
Analyzer Settings from DMS Software
229
10 Data communications
PART III
Set of Multiple Docking Stations
containing a Primary
FIGURE 10-3
4
3
In a set of Multiple Docking Stations
containing a Primary (1), the Primary is
connected to a LAN (3) to which the PC
hosting the DMS Software (4), or the
OR, is also connected.
The communication between the
Analyzer and the DMS Software is twoway.
For the Analyzer in the Primary Docking
Station (1) the following applies:
• Analyzer Data is transmitted from the
Analyzer in the Primary Docking
Station (1) to the PC (4) for Data
Management, see Arrow (5).
• Analyzer Settings are transmitted
from the PC (4) to the Analyzer in the
Primary Docking Station (1), see
Arrow (6).
5
6
1
2
1
2
3
4
5
6
Primary Docking Station
Secondary Docking Station
LAN
PC hosting the DMS Software or OR
Analyzer Data to PC
Analyzer Settings from PC
(Continues)
230
PART III
10 Data communications
(Continues)
FIGURE 10-4
For an Analyzer in a Secondary Docking
Station (2), the following applies:
4
3
7
5
8
6
• Analyzer Data is transmitted via the
Secondary Docking Stations to the
Primary Docking Station (1), see
Arrow (7). The Primary Docking
Station (1) transmits the Data to the
PC (4), see Arrows (5).
• Analyzer Settings are transmitted
from the PC (4) via the Primary (1)
and Secondary Docking Stations, to
the Analyzers in the Secondary
Docking Station (2), see Arrow (6)
and (8).
A Secondary Docking Station in such a
set, can at the same time, be connected
separately to a PC via a USB, in which
case the USB connection overrides the
LAN connection. Normally there is no
reason for this type of configuration.
1
2
1
2
3
4
5
6
7
8
Primary Docking Station
Secondary Docking Station
LAN
PC hosting the DMS Software or OR
Analyzer Data to PC
Analyzer Settings from PC
Analyzer Data from Secondary via Primary
Analyzer Settings to Secondary via Primary
(Continues)
231
10 Data communications
PART III
(Continues)
To make settings on the Primary Docking
Station in such a set, e.g. the IP-address,
it must be directly connected to a PC via
a USB (the same type of connection a
Secondary Docking Station uses for data
communication, see FIGURE 10-2).
232
PART III
10 Data communications
Multiple set consisting solely of
Secondary Docking Stations
FIGURE 10-5
5
3
4
In a multiple set consisting solely of
Secondary Docking Stations, each
Docking Station (1) must, for data
communication, be connected separately
to a USB port (4) on the PC hosting the
DMS Software (5). If the PC doesn’t
have enough USB ports, a USB hub can
be used.
Only electrical power can be transferred
between Docking Stations in this
configuration.
2
Analyzers in a multiple set consisting
solely of Secondary Docking Stations
communicate with the DMS Software
according to FIGURE 10-6.
1
2
3
4
5
Secondary Docking Station
USB connection Docking Station - hub
USB connection hub to PC
USB hub
PC hosting the DMS Software
(Continues)
1
233
10 Data communications
PART III
(Continues)
FIGURE 10-6
5
3
7
8
4
6
2
9
1
234
• Analyzer Data is transmitted directly
from the Analyzers in the Secondary
Docking Station (1) via a USB cable
(2) and (3) through the USB hub (4)
on to the PC (5) according to Arrows
(6) and (7).
• Analyzer Settings are transmitted
directly from the PC (5) via a USB (3)
and (2) through the USB hub (4) on to
the Analyzer in the Secondary
Docking Station (1) according to
Arrows (8) and (9).
1
2
3
4
5
6
7
8
9
Secondary Docking Stations
USB connection Docking Station to hub
USB connection hub to PC
USB hub
PC hosting the DMS Software
Analyzer Data to PC via hub
Analyzer Data to PC via hub
Analyzer Settings from PC via hub
Analyzer Settings from PC via hub
PART III
10 Data communications
10.3 Data transfer
Analyzers can be administered by the
DMS Software from a central PC. The
central PC can communicate with several
Analyzers at the same time. The
communication between the DMS
Software and the Analyzer is two-way,
using the POCT1-A standard (also
known as the CIC standard).
Data transfer from the PC to an Analyzer
is activated manually from the DMS
Software.
Data transfer from an Analyzer to the PC
is activated automatically when a data
communications connection is
established, either by connecting a
docking station containing an Analyzer to
the PC, or by placing an Analyzer in a
docking station already connected to the
PC. If the Analyzer is busy with a
measurement when the connection is
established, data transfer will start as
soon as the measurement is completed.
Data transfer from an Analyzer to the PC
will always contain measurement results
not already transferred.
During the activation and data exchange
process a number of images can/will
appear on the Analyzer Display.
235
10 Data communications
PART III
FIGURE 10-7
Connecting to
Server ...
When the data transfer process is being
activated, FIGURE 10-7 will be
displayed for as long as it takes to
establish the connection. This may
happen instantly, in which case this
image will not appear at all.
FIGURE 10-8
During data transfer, FIGURE 10-8 will
be displayed until the process is
completed or interrupted.
Data Exchange ...
236
PART III
10 Data communications
FIGURE 10-9
When an Analyzer is removed from the
docking station, FIGURE 10-9 will be
displayed.
Note! After removing the Analyzer from
the docking station it can take up to 20
seconds before FIGURE 10-9 is
displayed.
Data Exchanged
with server OK
FIGURE 10-10
When the data transfer process is being
activated, but the connection is not
established successfully, FIGURE 10-10
will be displayed.
No Connection to
Server
One of the following errors has occured:
- The Docking Station is not properly
connected to the network.
- The network server is not available.
- There is a fault in the Docking Station.
1
a) Press the Confirm button (2) to return
to the Main Menu, FIGURE 3-31
1 Confirm button
237
10 Data communications
PART III
FIGURE 10-11
If, during data transfer, an error or
malfunction between the Analyzer and
the recieving computer is detected,
FIGURE 10-11 will be displayed. Refer
to the section 10 Data communications.
Communication
Error
a) Press the Confirm button (2) to return
to the Main Menu, FIGURE 3-31
1 Confirm button
E31
238
2
PART IV
Other actions
?
QC Memory Full.
No more QC data
can be saved
E27
OK
Glucose 201 DM
PART IV
This page intentionally left blank
240
PART IV
11 Maintenance
11 Maintenance
This chapter describes the maintenance procedure for the Analyzer.
11.1 Cleaning the Cuvette
holder and the
optronic unit
The Cuvette holder should be cleaned
after each day of use. A dirty optronic
unit may cause the Analyzer to display an
error code. To clean the optronic unit,
proceed as follows:
a) Check that the Analyzer is turned off.
The display should be blank.
FIGURE 11-1
b) Pull the Cuvette holder out to the
Loading position.
c) Carefully press the small catch (1)
positioned in the upper right corner of
the Cuvette holder.
1 Catch
1
241
11 Maintenance
PART IV
FIGURE 11-2
d) While pressing the catch, carefully
rotate the Cuvette holder sideways as
far as possible to the left.
e) Remove the Cuvette holder from the
Analyzer.
f) Clean the Cuvette holder with alcohol
or mild detergent.
2
3
g) To clean the optronic unit, push the
HemoCue Cleaner into the opening of
the optronic unit.
h) Move the HemoCue Cleaner from the
right to the left 5-10 times, and then
pull it out.
i) If the HemoCue Cleaner is stained,
repeat with a new HemoCue Cleaner.
Note! A cotton tip swab moistened with
70% alcohol (without additive) or water
may also be used for cleaning.
2 Cuvette holder
3 Opening of the optronic unit
FIGURE 11-3
j) Wait 15 minutes before putting the
Cuvette holder back into the Analyzer.
It is important that the Cuvette holder
be completely dry before reinserting it
into the Analyzer.
242
PART IV
11 Maintenance
11.2 Cleaning the Display
The display can be cleaned with alcohol,
without additives.
11.3 Cleaning of the
Analyzer Outer case
and the Docking
Station
FIGURE 11-4
a) Make sure that the Analyzer is turned
off. The display should be blank.
b) The outer case on the Analyzer and the
Docking Station may be cleaned with
alcohol or a mild soap solution.
c) The Scanner glass should be cleaned
gently with alcohol.
243
11 Maintenance
PART IV
11.4 Calibrating the
Display
If the function on the display is not
activated when pressed, the display may
need to be recalibrated.
FIGURE 11-5
2
6
1
4
5
a) Make sure that the Analyzer is turned
off. The display should be blank.
3
b) To recalibrate the display, press the
On/Off button (1) for at least 10
seconds. A plus sign (2) will appear in
the upper left corner of the display.
c) Gently press the center of the plus sign
(2) with a blunt object. Using the
fingertip may not be precise enough.
Note! This is the only occasion when
anything other than the fingertips should
be used to touch the display. Sharp edged
objects can damage the Display.
d) The first plus sign will disappear and
two additional plus signs (3 and 4) will
appear in sequence.
Repeat according to instruction c).
e) Two more plus signs (5 and 6) will
appear to verify the calibration of the
display.
Repeat according to instruction c).
(Continues)
244
PART IV
11 Maintenance
(Continues)
f) If the verification of the calibration is
successful, the Analyzer will continue
with the normal startup. If the
verification of the calibration fails,
then the display calibration procedure
will start over again. If the procedure
fails more than five times the normal
startup procedure will continue, but
the Analyzer probably needs service
1
2
3
4
5
6
On/Off button
Plus sign
Plus sign
Plus sign
Plus sign
Plus sign
245
11 Maintenance
PART IV
This page intentionally left blank
246
PART IV
12 Troubleshooting
12 Troubleshooting
This chapter describes the Error Codes that may be displayed while using the
Analyzer. If you are unable to resolve the problem by following this
troubleshooting guide, please contact your local HemoCue distributor or
HemoCue AB. Customers in the US should contact HemoCue Inc., Technical
Support. There are no serviceable parts inside the Analyzer.
12.1 Error messages
Symptom
Explanation
Action
The Analyzer
shows an error
code
May be an occasional
fault
Turn off the Analyzer and turn it on
again after 30 seconds.
Take a new Cuvette and repeat the
measurement.
If the problem continues, see the
specific error codes below.
E00
No stable endpoint
found within the time
range.
1) The Cuvette is
faulty.
2) The circuit board is
out of order.
1a) Check the expiration date for the
Cuvettes.
1b) Take a new Cuvette and repeat
the measurement.
2) The Analyzer needs service.
Contact your distributor.
E01-E05
Fault in the optics or
electronics
a) Turn off the Analyzer and clean
the optronic unit as described in
the maintance section.
b) The Analyzer needs service.
Contact your distributor
247
12 Troubleshooting
PART IV
Symptom
Explanation
Action
E06
Unstable blank value.
The Analyzer might be
cold
Turn off the Analyzer and allow it to
reach room temperature.
If the problem continues, the Analyzer
needs service. Contact your
distributor
E08
The absorbance is too
high.
Light blocking item in
the Cuvette holder
a) Check that the Analyzer and
Cuvettes are used according to
the Instructions for Use.
b) The Analyzer needs service.
Contact your distributor
E11
Hardware Error
The Analyzer needs service. Contact
your distributor
E17
Internal Error
The Analyzer needs service. Contact
your distributor
E23
Data Error Real Time
Clock
Real Time Clock
backup battery has
been drained
The backup battery needs to be
replaced. Contact your distributor
E25
Analyzer not calibrated
The Analyzer needs service. Contact
your distributor
E26
The Patient test
memory is full. No
more patient data can
be saved.
Save test results by placing the
Analyzer in a Docking Station
connected to DMS Software or OR.
For the following, supervisory
authority is needed.
a) Delete all or part of the Patient
Tests stored in the Analyzer (see
9.3 Delete Stored Data)
b) Change Analyzer settings
regarding full internal memory for
Patient tests to ”Overwrite” (see
4.4.1 General Settings).
248
PART IV
12 Troubleshooting
Symptom
Explanation
Action
E27
The QC memory is full.
No more QC data can
be saved.
Save test results by placing the
Analyzer in a Docking Station
connected to DMS Software or OR.
For the following, supervisory
authority is needed.
a) Delete all or part of the QC Tests
stored in the Analyzer (see 9.3
Delete Stored Data)
b) Change Analyzer settings
regarding full internal memory for
QC tests to ”Overwrite” (see 4.4.1
General Settings).
E28
The Analyzer log
memory is full. No
more Error Codes and
Log Notes can be
saved.
Save test results by placing the
Analyzer in a Docking Station
connected to DMS Software or an OR.
For the following, supervisory
authority is needed.
a) Delete all or part of the Analyzer
logs stored in the Analyzer (see
9.3 Delete Stored Data)
b) As the Analyzer settings regarding
full memory for Analyzer logs is
the same as the setting for full
memory of QC tests, change
Analyzer behaviour for QC tests to
”Overwrite” (see 4.4.1 General
Settings).
249
12 Troubleshooting
PART IV
Symptom
Explanation
Action
E29
The electronic selftest
failed.
The communication
selftest failed. The
Analyzer may not work
properly when
connected to a docking
station.This is stored as
a failed Electronic QC
Test (EQC) in the
Analyzer Log book.
The Analyzer needs service. Contact
your distributor.
E30
The electronic selftest
failed.
The optical selftest
failed. The Analyzer
may not work properly
when measuring.This
is stored as a failed
Electronic QC Test
(EQC) in the Analyzer
Log book.
a) Turn off the Analyzer and clean the
optronic unit as described in the
maintance section.
b) The Analyzer needs service.
Contact your distributor.
250
PART IV
12 Troubleshooting
Symptom
Explanation
Action
E31
Communication Error
a) Check the network parameters.
b) Check that the LED on the Primary
Docking Station does not show a
red light (stable or flashing).
c) More than 5 Docking Stations are
docked together.
d) Check that a USB connection is
not used for communication in a
Primary Docking Station.
e) Check that two Primary Stations
are not docked together.
f) Check the electrical connections.
The LED on the docking station
should give either a stable green
light or a flashing green light.
If problems remain contact your
distributor.
E70/E71
Erroneous Kinetics
The cuvette is faulty or the sample
might be grossly lipemic. Check that
the system is used according to the
instructions for use.
Fill a NEW cuvette and place it
immediately in the analyzer.
If the error code appears again, use a
suitable laboratory reference method
to analyze the specimen.
251
12 Troubleshooting
PART IV
Symptom
Explanation
Action
Overrange
Whole blood: The
measured value
exceeds 400 mg/dL
(22.2 mmol/L).
Whole blood:
The measuring range may be
extended to 800 mg/dL (44.4 mmol/L)
by using the dilution function
(see4.4.2 Patient Test Settings ).
Plasma Equivalent: The measuring
range may be extended to 888 mg/dL
(49.2 mmol/L) by using the dilution
function (see 4.4.2 Patient Test
Settings).
Note: The Dilution function is not
available in all markets.
Plasma Equivalent:
The measured value
exceeds 444 mg/dL
(24.6 mmol/L).
No characters
on the display
1) The Analyzer is not
receiving power.
2) If on battery power,
the Battery need to
be recharged.
3) The display is out of
order.
1a) Check that the AC adapter is
connected to the power supply.
1b) Check that the AC adapter is
securely connected to the
Analyzer or Docking Station.
1c) If the Analyzer is docked, check
that the green LED on the Docking
Station gives a flashing green light.
1d) Check that the adapter is not
damaged.
2) Recharge the Battery via an AC
adapter or a Docking Station.
3) The Analyzer needs service.
Contact your distributor.
The display
gives erroneous
characters.
1) The display is out of
order.
2) The microprocessor
is out of order.
1) The Analyzer needs service.
Contact your distributor.
2) The Analyzer needs service.
Contact your distributor.
252
PART IV
12 Troubleshooting
Symptom
Explanation
Action
The Scanner is
malfunctioning
1) The incorrect
barcode is being
scanned.
2) The product has
expired.
3) The Analyzer is too
close or too far from
the barcode.
4)The barcode is
indinstinct.
5)The Scanner glass is
dirty.
6) The barcode is not
compatible with the
Scanner.
7) The Scanner is
broken.
1) Check that you are reading the
barcode from the correct product.
2) Check the expiration date of the
product.
3) Hold the Analyzer within 10 -30 cm
(4 - 12 inches) from the barcode.
4) Enter the information manually.
5) Clean the Scanner glass according
to section 11.3 Cleaning of the
Analyzer Outer case and the
Docking Station
6) The standards that can be scanned
are listed in section 13.11
Technical Specifications.
7) The Analyzer needs service.
Contact your distributor.
253
12 Troubleshooting
PART IV
Symptom
Explanation
Action
No transfer of
data
1) No network
communication with
OR
2) No network
communication with
PC
3) Communication
error
4) No communication
5) No communication
between the first
and second
Docking Station
6) No communication
between the
Secondary Docking
Stations
7) No communication
with any Docking
Station
1a) Check the network parameters.
1b) Check that the LED on the
Primary Docking Station does not
show a red light (stable or
flashing).
2a) Check the network parameters.
2b) Check that the LED on the
Primary Docking Station does not
show a red light (stable or
flashing).
3) More than 5 Docking Stations are
docked together.
4) Check that a USB connection is
not used for communication in a
Primary Docking Station.
5) Check that two Primary Stations
are not docked together.
6) Check the electrical connections.
The LED on the docking station
should give either a stable green
light or a flashing green light.
7) Check the electrical connection.
The LED on the docking station
should give either a stable green
light or a flashing green light.
If problems remain contact your
distributor.
254
PART IV
12 Troubleshooting
Symptom
Explanation
Action
No transfer of
data via USB
No USBcommunication
a) Check that the Analyzer is
properly docked.
b) Check the cable connections in
both the Docking Station and the
PC.
c) Check that the Docking Station is
not a Primary Docking station.
d) Check that all Docking Stations
that should communicate are
connected with a USB cable to the
PC.
e) Check that the DMS Software is
properly installed.
Analyzer not
charged
No charging of the
Battery
a) Check that the Analyzer is
properly docked.
b) Check that the green LED on the
Docking Station gives a flashing
green light when docking the
Analyzer.
c) Replace the Battery.
Unintentional
downloading
Data is sent
unintentionally
Using a Primary Docking Station
(Single or within a set), the Analyzer
downloads via IrDA. This means that
the Analyzer will start downloading as
soon as it is close enough to the
Docking Station (even if not properly
docked).
Note! To prevent data from being
unintentionally transmitted, keep the
Analyzer away from the Docking
Station.
Empty Cuvette
The cuvette inserted is
empty
Insert a cuvette filled according to
correct sampling procedure
255
12 Troubleshooting
PART IV
This page intentionally left blank
256
PART V
Miscellaneous
Glucose 201 DM
PART V
This page intentionally left blank
258
PART V
13 Technical specifications
13 Technical
specifications
This chapter contains the technical specifications for the System Components in
the HemoCue Glucose 201 DM System.
13.1 General
The HemoCue Glucose 201 DM is a System used for the determination of the total
amount of glucose in whole blood. The System consists of a specially designed
Analyzer with specially designed Cuvettes containing dried reagents. The Cuvette
serves as pipette, reaction vessel and as a measuring Cuvette. No dilution is required.
The glucose measurement takes place in the Analyzer, which follows the progress of
the reaction and displays the result only when the end point of the reaction has been
reached. The System is factory calibrated according to a wet chemistry glucose
dehydrogenase method using hemolysis and deproteinization.
The HemoCue Glucose 201 DM Analyzer either displays the result as a whole blood
result or converted to a plasma equivalent result. This is a factory setting, and cannot
be changed by the user.
13.2 Intended purpose/ Intended Use
Quantitative determination of glucose in whole blood using a specially designed
Analyzer, the HemoCue Glucose 201 DM Analyzer and specially designed
Microcuvettes, the HemoCue Glucose 201 Microcuvettes.
The quantitative determination of the instant blood glucose concentration in
circulation supplements the clinical evidence in the diagnosis and treatment of
patients with diabetes as well as in the monitoring of neonatal blood glucose levels.
To establish HemoCue Glucose reference values and an intervention level, neonatal
blood samples should be evaluated against a suitable laboratory method, taking into
consideration the difference between whole blood and plasma reference values. The
HemoCue Glucose 201 DM with plasma conversion multiplies the measured whole
blood value by the factor 1.11 and displays a plasma equivalent glucose result1.
259
13 Technical specifications
PART V
The HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only.
The HemoCue Glucose 201 DM Analyzer is only to be used with HemoCue Glucose
201 Microcuvettes.
13.3 Theory
The chemistry method utilized by the HemoCue Glucose 201 Microcuvette is a
modified glucose dehydrogenase method described by Banauch et al.3 A chromogen
compound is added to the reagents according to the principle outlined by
Bergmeyer4 with saponin used for hemolyzing the erythrocytes. The absorbance is
measured at two wavelengths (660 and 840 nm) to compensate for turbidity.
13.4 Reagents
Saponin, NAD, MTT and NaF.
Enzyme mix: Glucose Dehydrogenase, Diaphorase and Mutarotase.
13.5 Sample material
Capillary, venous or arterial blood may be used. Appropriate anticoagulants in solid
form (e.g. EDTA and Heparin) and glycolysis inhibitors (e.g. Sodium Oxalate,
Sodium Fluoride and Potassium Oxalate) may be used. Glycolysis is a major concern
in all glucose measurements. To minimize the effect of glycolysis, measure the blood
sample as soon as possible after it has been obtained.
Samples of blood collected in containers with recommended anticoagulants should
be analyzed within 30 minutes. If the blood has been kept in a refrigerator, it must be
allowed to reach room temperature 18 - 30 °C (64 - 86 °F) before analysis. Mix all
samples thoroughly on a mechanical mixer for at least two minutes or invert the tube
at least 10 times before measurement.
(Continues)
260
PART V
13 Technical specifications
(Continues)
13.6 Storage and environmental requirements
HemoCue Glucose 201 Microcuvettes
Use the HemoCue Glucose 201 Microcuvettes prior to their expiration date. The
expiration date is printed on each package.
Store HemoCue Glucose 201 Microcuvettes in a refrigerator at 2 - 8 °C (35 - 46 °F)
or in a freezer at < –18 °C (< –1 °F). Note that if the container is taken directly from
the freezer, the Cuvette must be allowed to reach room temperature (approximately
30 minutes) before analysis. Cuvettes kept in an opened container are stable for 30
days when stored in a refrigerator at 2 - 8 °C (35 - 46 °F).
After breaking the seal of the container, the container can be stored at room
temperature for up to 3 days.
The individually packaged cuvettes can be stored at room temperature, 18 - 30 °C
(64 - 86 °F), for up to 3 days.
HemoCue Glucose 201 DM Analyzer and HemoCue DM Docking Station.
The Analyzer and Docking Station can be stored at 0 - 50 °C (32 - 122 °F). Operating
temperature is 18 - 30 °C (64 - 86 °F). Allow the Analyzer and Docking Station to
reach ambient temperature before use. The Analyzer and the Docking Staion should
not be operated at high (i.e. > 90 % non-condensing) humidity.
13.7 Quality Control
The HemoCue Glucose 201 DM Analyzer has an internal quality control, the
"Selftest". Every time the Analyzer is turned on, it will automatically verify the
performance of the optronic unit of the Analyzer. This test is performed every eighth
hour if the Analyzer is left turned on. The result of the selftest is stored as an EQC
(Electronic Quality Control).
Quality control checks may be required for regulatory reasons. Quality control
checks should be performed using Liquid Controls recommended by HemoCue.
Please refer to the HemoCue Glucose 201 Microcuvette package insert for
information.
261
13 Technical specifications
PART V
13.8 Results
13.8.1 Whole Blood
The Measuring range is 0 - 400 mg/dL (0 - 22.2 mmol/L).
Any results with HemoCue Glucose Systems suggesting clinical intervention in the
hyperglycemic range on pre-term neonates (<37 weeks), should be verified against
a suitable laboratory method. Results above 400 mg/dL (22.2 mmol/L ) will be
displayed as overrange. The measuring range may be extended to 800 mg/dL (44.4
mmol/L) by dilution with saline 1+1. Mix the sample thoroughly before dilution and
measurement. By using the dilution function in the Analyzer, the stored and
displayed result will automatically be multiplied by a factor of 2.
Note! The Dilution function is not available in all markets. Dilution may reduce
accuracy. For specific performance characteristics, see the HemoCue Glucose 201
Microcuvettes instructions for use.
13.8.2 Plasma Equivalent
The Measuring range is 0 - 444 mg/dL (0 - 24.6 mmol/L).
Any results with HemoCue Glucose Systems suggesting clinical intervention in the
hyperglycemic range on pre-term neonates (<37 weeks), should be verified against
a suitable laboratory method. Results above 444 mg/dL (24.6 mmol/L ) will be
displayed as overrange. The measuring range may be extended to 888 mg/dL (49.2
mmol/L) by dilution with saline 1+1. Mix the sample thoroughly before dilution and
measurement. By using the dilution function in the Analyzer, the stored and
displayed result will automatically be multiplied by a factor of 2.
Note! The Dilution function is not available in all markets. Dilution may reduce
accuracy. For specific performance characteristics, see the HemoCue Glucose 201
Microcuvettes instructions for use.
262
PART V
13 Technical specifications
13.9 Limitations
HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only. The
HemoCue Glucose 201 Analyzer is only to be used together with HemoCue Glucose
201 Microcuvettes. For further limitations of the procedure, see the HemoCue
Glucose 201 Microcuvettes instructions for use.
The HemoCue Glucose 201 DM with plasma conversion multiplies the obtained
whole blood value by a factor and displays a plasma equivalent glucose result. Please
note that this factor is based on the relationship between plasma and whole blood at
normal hematocrit. When comparing Glucose 201 DM results from samples with
extreme hematocrits to a method that measures plasma directly, the results may not
correlate as expected. This difference is however minimal.
13.10 Expected values
Fasting Values
Whole blood, adults 65 - 95 mg/dL (3.5 - 5.3 mmol/L)5.
Plasma, adults 74 - 106 mg/dL (4.5 - 5.9 mmol/L)5.
For diagnosis of diabetes mellitus, follow local recommendations or use the
following value according to WHO:
Whole blood glucose >110 mg/dL (> 6.1 mmol/L)6.
Plasma blood glucose > 126 mg/dL (> 7.0 mmol/L)6.
263
13 Technical specifications
PART V
13.11Technical Specifications
Analyzer
Dimensions: 170 x 93 x 50 mm (6.70 x 3.66 x 1.97 inches)
Weight: 350 g (0.77 pounds)
AC adapter: Egston
Mod. No.: N2UFMW3 (US)
Mod. No.: N2EFMW3 (EU)
Mod. No.: N2GFMW3 (GB)
Input: 100 - 240 VAC, 50 - 60 Hz
Output: 6VDC, 2.5 A
Or,
HCA02
Input: 100V~ - 240V~/50-60 Hz/< 600mA
Only use adapters recommended by HemoCue.
Barcodes that can be scanned:
UPC/EAN (UPC-A; UPC/E; EAN-8; EAN-13)
Code 128 (USS-128; UCC/EAN-128; ISBT 128)
Code 39
Interleaved 2 of 5
Codabar
Pollution degree: 2
Overvoltage category: II
Atmospheric pressure: 700 hPa to 1060 hPa
Equipment not suitable for use in the presence of flammable mixtures
The instrument is tested according to EN 61010-1/IEC 61010-1 and amendments 1
and 2, EN 60601-1-2 and complies with the IVD Medical Device Directive 98/79/
EC. The instrument is CE marked.
This product is covered by one or more of U.S. patents, 4,758,717; 5,130,520;
5,262,628; 5,396,055; and 5,532,469.
264
PART V
13 Technical specifications
Docking Station
Dimensions: 206x135x61 mm (8.10 x 5.30 x 2.40 inches)
Weight: 566 g (1.24 pounds)
AC adapter: Egston
Mod. No.: N2UFMW3 (US)
Mod. No.: N2EFMW3 (EU)
Mod. No.: N2GFMW3 (GB)
Input: 100 - 240 VAC, 50 - 60 Hz
Output: 6VDC, 2.5 A
Or,
HCA02
Input: 100V~ - 240V~/50-60 Hz/< 600mA
Only use adapters recommended by HemoCue.
Pollution degree: 2
Over voltage category: II
Atmospheric pressure: 700 hPa to 1060 hPa
Equipment not suitable for use in the presence of flammable mixtures
The instrument is tested according to EN 61010-1/IEC 61010-1 and amendments 1
and 2, EN 60601-1-2 and complies with the IVD Medical Device Directive 98/79/
EC. The instrument is CE marked.
13.12 Signal input and signal output connections
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective UL standards (i.e. UL 60950-1 for data processing
equipment and IEC 60601-1 for medical equipment). Furthermore all configurations
must comply with the system standard, IEC 60601-1-1. Connections of additional
equipment to the signal input or signal output connections is deemed to be
“configuring a medical system”, and therefore assumes responsiblity for the systems
compliance within the requirements of IEC 60601-1-1. If in doubt, consult the
technical service department or your local representative.
265
13 Technical specifications
PART V
13.13Electromagnetic Compatibility
Use only cables with the following specifications:
USB Shielded maximum 2 m
Guidance and manufacturer´s declaration – electromagnetic emissions
The HemoCue Glucose 201 DM is intended for use in the electromagnetic
enviroment specified below. Users of the HemoCue Glucose 201 DM should assure
that it is used in such an enviroment.
Table 1: Electromagnetic emissions
Electromagnetic environment
guidance
RF Emissions
Compliance
RF emissions
Group 1
The HemoCue Glucose 201 DM uses
RF energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference with nearby electronic
equipment.
RF emissions
Class B
Harmonic emissions IEC
61000-3-2
Class A
The HemoCue Glucose 201 DM is suitable for use in all establishments other
than domestic and those directly connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
266
PART V
13 Technical specifications
Guidance and manufacturer’s declaration – Electromagnetic immunity
The HemoCue Glucose 201 DM systems are intended for use in the electromagnetic
environment specified below. The customer or user of the HemoCue systems should
assure that it is used in such an environment.
Table 2: Electromagnetic Immunity
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment
guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
+ 6 kV contact
+ 8 kV air
+ 6 kV contact
+ 8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%
Electrical fast
transient/burst
IEC 61000-44
+ 2 kV for
power supply
lines
+ 1 kV for
input/output
lines
2kV for power
supply lines
Mains power quality
should be that of a typical commercial or hospital enviroment.
Surge IEC
61000-4-5
+ 1 kV differential mode
+ 1 kV differential mode
±1kV for input/
output lines
Mains power quality
should be that of a typical commercial or hospital enviroment.
267
13 Technical specifications
PART V
Guidance and manufacturer’s declaration – Electromagnetic immunity
The HemoCue Glucose 201 DM systems are intended for use in the electromagnetic
environment specified below. The customer or user of the HemoCue systems should
assure that it is used in such an environment.
Table 2: Electromagnetic Immunity
Immunity
test
IEC 60601
test level
Compliance
level
Voltage dips,
short interruptions and voltage variations
on power supply input
lines.
IEC 61000-411
<5%U (>95%
dip in U) for a
0.5 cycle
40%U (60%
dip in U) for 5
cycles
70%U (30%
dip in U) for
25 cycles
<5%U (>95%
dip in U) for 5
seconds.
For explanation of U see
NOTE below
table
<5%U (>95%
dip in U) for a
0.5 cycle
40%U (60% dip
in U) for 5
cycles
70%U (30% dip
in U) for 25
cycles
<5%U (>95%
dip in U) for 5
seconds
268
Electromagnetic
environment
guidance
Mains power quality
should be that of a typical commercial or hospital enviroment. If the
user of the HemoCue
Glucose 201 DM
requires continued operation during power
mains interruptions, it is
recommended that the
HemoCue Glucose 201
DM be powered from an
uninterruptible power
supply or Battery.
PART V
13 Technical specifications
Guidance and manufacturer’s declaration – Electromagnetic immunity
The HemoCue Glucose 201 DM systems are intended for use in the electromagnetic
environment specified below. The customer or user of the HemoCue systems should
assure that it is used in such an environment.
Table 2: Electromagnetic Immunity
Immunity
test
Power frequency (50/60
Hz)
Magnetic field
IEC 61000-48
IEC 60601
test level
3A/m
Compliance
level
3A/m
Electromagnetic
environment
guidance
If image distortion
occurs, it may be necessary to position the
HemoCue Glucose 201
DM systems image
intensifier further from
sources of power frequency magnetic fields
or to install magnetic
shielding. The power frequency magnetic field
should be measured in
the intended installation
location to assure that it
is sufficiently low.
269
13 Technical specifications
PART V
Guidance and manufacturer’s declaration – Electromagnetic immunity
The HemoCue Glucose 201 DM systems are intended for use in the electromagnetic
environment specified below. The customer or user of the HemoCue systems should
assure that it is used in such an environment.
Table 2: Electromagnetic Immunity
Immunity
test
IEC 60601
test level
Compliance
level
Conducted RF
IEC 61000-46
3 Vrms 150
kHz to 80
MHz
3 Vrms
Radiated RF
IEC 61000-43
3 V/m 80
MHz to 2.5
GHz
3 V/m
Electromagnetic
environment
guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the
HemoCue Glucose 201 DM systems, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter
Recommended separation
distance
d=1.2√P
d=1.2√P 80MHz to 800MHz
d=2.3√P 800MHz to 2.5GHz
Were (P) is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter manufacturer and (d) is the recommended separation distance in
meters (m). Field strengths from
fixed RF transmitters, as deter-
mined by an electromagnetic
site survey (a), should be less
than the compliance level in
each frequency range (b).
Interference may occur in the
vicinity of equipment marked
with the following symbol.
270
PART V
13 Technical specifications
Recommended separation distances between Portable and mobile RF
communications equipment and HemoCue Glucose 201 DM systems.
The HemoCue Glucose 201 DM systems are intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the
user of HemoCue Glucose 201 DM systems can help prevent electromagnetic
interference by maintaining a minimum distance between portable and RF
communications equipment (transmitters) and HemoCue Glucose 201 DM systems
as recommended below, according to the maximum output power of the
communications equipment.
Table 3: Recommended separation distances
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of
transmitter (m)
150kHz to
80MHz
d=1.2√P
80MHZ to
800MHz
d=1.2√P
800MHz to
2.5GHz
d=2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at maximum output power not listed above, the recommended
separation distances (d) in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where (P) is the maximum output power rating of
the transmitter in watts (W) according to transmitter manufacturer.
Note! At 80MHz and 800MHz, the separation distance for the higher
frequencyrange applies.
Note! These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
271
13 Technical specifications
PART V
13.14 Warranty
The Analyzer carries a 24-month warranty from the day of receipt. After the
warranty period, service/repair is carried out at fixed prices.
13.15 Service and Disposal
The Analyzer should be cleaned as recommended under Maintenance prior to service
or disposal. Consult your local environmental authorities for proper disposal.
13.16 Spare parts and accessories
The following spare parts and accessories are available:
•
•
•
•
•
•
•
•
AC adapter
HemoCue 201 DM Battery
Cuvette holder
HemoCue 201 DM DMS Software
USB cable
Liquid controls
HemoCue Cleaner
HemoCue Lancet
272
PART V
13 Technical specifications
13.17 Symbols on System Components and
Accessories
Symbol
Meaning
Laser radiation – Do not stare into the beam or view directly with
optical instruments.
Caution
!
CE mark
This product complies with the IVD Medical Device Directive
98/79/EC.
Refers to Type BF Applied Part, Per EN 60601-1.
Class II equipment, per EN 60601-1
Direct current.
Alternating current.
Input
273
13 Technical specifications
PART V
Output
Caution! Laser light. Do not stare
into beam. 630nm-680nm Laser, 1.0 mW
max output. Class 2 Laser Product. This
product meets the requirements of
IEC 60825-1:A2:2001.
Caution: Laser light. Do not stare into beam. 630nm-680nm Laser,
1.0 mW max output. Class 2 Laser Product. This product meets the
requirements of IEC 60825-1:A2:2001.
Only valid within the European Community. Indicates separate
collection for waste of electrical and electronic equipment.
WARNING!
Lithium ion battery.
Danger of explosion. Replace the battery
with the same type recommended by the
equipment manufacturer.
WARNING! Lithium ion Battery. Danger of explosion. Replace the
battery with the same type recommended by the equipment
manufacturer.
Temperature limitation
Efficiency Level
Consult instructions for use.
To maintain safety use only adapter HCA02.
274
PART V
13 Technical specifications
13.18 References
1 Fogh-Andersen N et al, Approved IFCC Recommendation on Reporting Results
for Blood Glucose (Abbreviated) Clinical Chemistry 2005;51:9,1573-1576.
2 Atkin et al, Annals of Internal Medicine, 1991, 114;12, 1020-1024.
3 Banauch et al, Z. Klin. Chem. u. Klin. Biochem, 1975;13:101-107.
4 Bergmeyer, Methods of Enzymatic Analysis 1, 1974; Chemie Publishers,
Weinheim.
5 Tietz, Fundamentals of Clinical Chemistry: Carbohydrates, 3. Fifth Edition,
Editor, W.B. Saunders Company, 2001, 427-461.
6 Definition, Diagnosis and Classification of Diabetes Mellitus and its
Complications. Report of a WHO Consultation. Geneva: WHO, 1999.
WHO/NCD/NCS/99.2.
275
13 Technical specifications
This page intentionally left blank
276
PART V
APPENDICES
PART V
This page intentionally left blank
278
APPENDICES
Appendix A – Default
Settings
Analyzer Serial Number :
Date :
Section Identifier
Available options Default value
Customer
Settings
Basic Settings
Date format
MM/DD/YY
DD.MM.YY
YY-MM-DD
MM/DD/YY
Time format
12 AM/PM
24 H
12 AM/PM
Power saver time
5-30 min.
15 min.
Audible signals
(volume)
Button Click
0-4
4
Audible signals
(volume)
Test Ready
0-4
4
Audible signals
(volume) Error
0-4
4
Language
Language 1
Language 2
Language 1
Not Used
Entry Required
Approved Only
Not Used
Advanced
Settings
General Settings
Operator ID
i
APPENDICES
Section Identifier
Available options Default value
Min/Max characters
in Operator ID
1/15
3/12
Password for
protected functions
Free choice (1-10
characters)
0000
Cuvette Batch
Not Used
Entry Required
Approved Only
Not Used
Patient List
Not Used
Used
Not Used
Patient Memory Full Lockout
Overwrite
Overwrite
QC Memory Full
Lockout
Overwrite
Overwrite
Critical Limits
(Whole Blood)
0-400 mg/dL
0.0-22.2 mmol/L
0-400 mg/dL
Critical Limits
(Plasma Equiv.)
0-444 mg/dL
0.0-24.6 mmol/L
0-444 mg/dL
Patient ID
Not Used
Optional
Required
Not Used
Min/Max characters
in Patient ID
1/25
3/12
Clear Patient ID
Used
Not Used
Used
Lab Number (LID)
Not Used
Optional
Not Used
Min/Max characters
in Lab Number
1/25
3/12
Patient Test
settings
ii
Customer
Settings
APPENDICES
Section Identifier
Available options Default value
STAT Test
Used
Not Used
Customer
Settings
Used
STAT Tests Allowed 1-100
10
Duplicate sampling
Not Used
Used
Not Used
Duplicate sampling
Max. Difference
0-40 mg/dL
0-2.2 mmol/L
0 mg/dL
Dilution
Not Used
Optional
Not Used
QC Test Settings
QC Level 1 Lockout Not Used
Time
Measurement
Not Used
Start of First
Workshift
Free choice of
time
12:00 AM
Lockout Interval,
time
1, 2, 3, 4, 6, 8, 12, 8 hours
24 hours, 2-7 days
Lockout Interval,
measurement
2-200
100
QC Level 2 Lockout Not Used
Time
Measurement
Not Used
Start of First
Workshift
Free choice of
time
12:00 AM
Lockout Interval,
time
1, 2, 3, 4, 6, 8, 12, 8 hours
24 hours, 2-7 days
Lockout Interval,
measurement
2-200
100
iii
APPENDICES
Section Identifier
Available options Default value
QC Level 3 Lockout Not Used
Time
Measurement
Not Used
Start of First
Workshift
Free choice of
time
12:00 AM
Lockout Interval,
time
1, 2, 3, 4, 6, 8, 12, 8 hours
24 hours, 2-7 days
Lockout Interval,
measurement
2-200
100
QC Level 4 Lockout Not Used
Time
Measurement
Not Used
Start of First
Workshift
Free choice of
time
12:00 AM
Lockout Interval
time
1, 2, 3, 4, 6, 8, 12, 8 hours
24 hours, 2-7 days
Lockout Interval,
measurement
2-200
100
QC Level 5 Lockout Not Used
Time
Measurement
Not Used
Start of First
Workshift
Free choice of
time
12:00 AM
Lockout Interval
time
1, 2, 3, 4, 6, 8, 12, 8 hours
24 hours, 2-7 days
Lockout Interval,
measurement
2-200
100
QC Reminder, time
0,30 min, 1, 2, 3, 4
hours
1 hour
iv
Customer
Settings
APPENDICES
Section Identifier
Available options Default value
QC Reminder,
measurements
1-50
20
QC Result Options
Numeric
Passed/Failed
Numeric
Failed QC
Comment
Not Used
Entry Required
Not Used
Linearity
3, 4, 5 Levels
5 Levels
Linearity, Cuvettes/
level
1-20
3
Customer
Settings
Linearity Settings
v
APPENDICES
This page intentionally left blank
vi
Manufacturer
HemoCue AB
Box 1204
SE - 262 23 Ängelholm
Sweden
Phone: + 46 77 570 02 10
Fax: + 46 77 570 02 12
E-mail: info@hemocue.se
www.hemocue.com
HemoCue Distributor USA
HemoCue Inc.
40 Empire Drive
Lake Forest, CA 92630
Phone 800-881-1611
Order 800-323-1674
Technical support 800-426-7256
Fax 800-333-7043
901411 091124
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertising