HemoCue Hb 201 DM Manuale utente
HemoCue®Hb 201 DM Analyzer
Instructions for Use
CONTENTS
1 Introduction......................................................................................................1
1.1 Unpacking ...........................................................................................................2
1.2 Functional description........................................................................................2
1.2.1 System Components...............................................................................................2
1.2.2 Analyzer overview ....................................................................................................3
2 General operations .........................................................................................6
2.1 Getting started – Analyzer...............................................................................6
2.1.1 Power source........................................................................................................... 6
2.1.2 Turning on the Analyzer ........................................................................................ 9
2.1.3 Power saver mode ................................................................................................ 10
2.1.4 Turning the Analyzer o....................................................................................... 10
2.1.5 Loading the Analyzer with a Cuvette.................................................................11
2.2 Docking Station LED .......................................................................................12
2.3 How to operate the Display...........................................................................13
2.3.1 Display buttons.......................................................................................................13
2.3.2 Using the Barcode Scanner button....................................................................16
2.3.3 Main Menu and Help .............................................................................................17
2.4 Display buttons and symbols ........................................................................18
2.4.1 Navigation buttons.................................................................................................18
2.4.2 Procedure buttons.................................................................................................19
2.4.3 Other display buttons...........................................................................................20
2.4.4 Display symbols..................................................................................................... 22
2.4.5 Entering information with letters and digits.................................................... 24
3 Sampling and Measuring .............................................................................27
3.1 Capillary blood .................................................................................................27
3.2 Control Material, Venous or Arterial Blood ............................................... 30
4 Routine Use....................................................................................................31
4.1 Patient Test Procedure....................................................................................31
4.2 STAT Test Procedure ...................................................................................... 33
4.3 QC Test Procedure......................................................................................... 34
4.4 Stored data....................................................................................................... 36
4.4.1 Reviewing Stored Data......................................................................................... 36
4.4.2 Deleting Stored Data ............................................................................................ 37
4.4.3 Review Latest Download ..................................................................................... 37
4.4.4 Log Input................................................................................................................. 37
5 Maintenance.................................................................................................. 38
5.1 Cleaning the Cuvette holder and the optronic unit................................ 38
5.2 Cleaning the Display ......................................................................................40
5.3 Cleaning of the Analyzer Outer case and the Docking Station ............ 40
5.4 Calibrating the Display....................................................................................41
6 Troubleshooting ........................................................................................... 42
7 Specifications................................................................................................ 47
7.1 Intended purpose/ Intended use................................................................. 47
7.2 Principles of the method and procedure .................................................. 47
7.3 Storage and handling..................................................................................... 47
7.4 Quality Control................................................................................................ 48
7.5 Limitations........................................................................................................ 48
7.6 Expected values .............................................................................................. 48
7.7 EMC and Electrical Safety ............................................................................. 49
7.8 Warranty............................................................................................................ 49
7.9 Service and Disposal ...................................................................................... 49
7.10 Materials required but not provided ........................................................... 50
7.11 Spare parts ....................................................................................................... 50
7.12 Optional items................................................................................................. 50
7.13 Symbols used ...................................................................................................51
7.14 References........................................................................................................ 52
Technical Specifications .................................................................................... 53
1
1 Introduction
Thank you for choosing the HemoCue Hb 201 DM system.
The HemoCue Hb 201 DM system is a compact, portable, yet versatile, hemoglobin
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 Hb 201 DM Analyzer, the HemoCue 201 DM
Docking Station and the HemoCue Hb 201 Microcuvettes.
This Manual contains step-by-step instructions for the routine use of the HemoCue Hb
201 DM Analyzer. For configuration of the Analyzer and set-up of the System, consult
the HemoCue 201 DM Reference Manual. Installation of HemoCue DM Docking Station
has been described in HemoCue 201 DM Docking Station Manual.
The HemoCue Hb 201 DM system complies with the IVD Medical Device Directive 98/79/
EC and carries the CE mark.
Read and follow this operating manual and the HemoCue Hb 201 Microcuvettes
package insert to attain optimum performance and safety. Any other use of the system than
recommended by the manufacturer may impair the safety.
Usage Disclaimer
The HemoCue Hb 201 DM system has flexible settings to meet dierent user needs. The
setting options are configured in the settings menu, requiring a pin code. The selected
settings are the responsibility of the local administrator. HemoCue AB does not take
responsibility for user configurations that may cause system conflicts, loss of data or
prevent the end-user to perform tests.
2
1.1 Unpacking
FIGURE 1-1
a) Open up the package and unpack the
contents on a dry and stable surface.
b) Check all Components for damage. If any
visible or suspected damage is
discovered, contact HemoCue AB or the
local distributor.
1 HemoCue Hb 201 DM Analyzer
2 HemoCue Hb 201 DM Analyzer Instructions for
Use
1.2 Functional description
1.2.1 System Components
FIGURE 1-2
The System consists of a specially designed
Analyzer(1), the HemoCue Hb 201 DM
Analyzer, specially designed Cuvettes(2), the
HemoCue Hb 201 Microcuvettes and a
specially designed Docking Station(3), the
HemoCue 201 DM Docking Station.
Analyzer
The HemoCue Hb 201 DM Analyzer(1) is
only to be used together with the HemoCue
Hb 201 Microcuvettes(2).
The System is intended for In Vitro
diagnostic use only.
1 Analyzer
2 Cuvette
3 Docking Station
Instructions for Use
r
U
se
1
2
3
1
23
3
1.2.2 Analyzer overview
Front panel
FIGURE 1-3
The Analyzer(1) is started when the On/O
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).
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.
To turn o the Analyzer(1), press the On/O
button(2).
1 Analyzer
2 On/O button
3 Display
4 Cuvette holder
1
4
3
2
4
Back panel
FIGURE 1-4
The following items are found on the back
panel of the Analyzer.
• Power inlet(1) for the Power 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
The Power inlet(1) for the Power Adapter
can only be used when the Analyzer is out of
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).
1 Power inlet (for Power Adapter)
2 Power + USB signal inlet (for Docking Station)
3 Barcode Scanner
4 IR Transmitter/Receiver
3
4
1
2
5
Placing the Analyzer in the Docking
Station
FIGURE 1-5
Always slide the Analyzer into and out of the
Docking Station by means of the Tracks(1).
Make sure the Analyzer is fully inserted.
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.
Remove the Analyzer if there is no
communication between the Analyzer and
the Docking Station and then re-dock the
Analyzer in the Docking Station.
1 Tracks
1
6
2 General operations
This chapter describes the general operations necessary for Analyzer use.
2.1 Getting started –
Analyzer
Always follow the operating and storage
conditions listed under section Technical
Specifications. Allow the Analyzer to reach
operating temperature before use.
2.1.1 Power source
The Analyzer can be powered either by the
rechargeable Battery or by a standard
electrical outlet via the Power Adapter.
Recharging the Battery
FIGURE 2-1
The rechargeable Battery(1) is located in a
battery compartment on the bottom of the
Analyzer.
a) Recharge the Battery(1) by connecting
the Power Adapter to the Analyzer or by
placing the Analyzer in the Docking
Station that is connected to the Power
Adapter. New Battery will take longer to
charge the first 2 to 3 times.
1 Battery
1
7
Replacing the Battery
FIGURE 2-2
Only the HemoCue 201 DM Battery
can be used in the Analyzer.
Lithium-ion battery. Never try to open
the battery casing. Risk of explosion.
The Battery lasts for several years. It should
be replaced when it fails to retain its charge
for an acceptable period. Replace it when
the capacity to hold a charge starts to
deteriorate quickly.
a) To remove the Battery(1), press the
Flap(2). Carefully loosen the Battery(1)
and lift it upwards.
b) To install the new Battery(3), place it in
the Analyzer and gently press downwards
until the Flap(4) snaps into the locked
position.
Consult local environmental authorities for
proper disposal.
1 Old Battery
2 Flap
3 New Battery
4 Flap
1
2
3
4
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