Duo Photometer DP 200 Operating Manual

1
Duo Photometer
DP 200
Operating Manual
Version 5.4 / 5.7 SI
2
Dear customer,
Thank you for selecting Diaglobal’s Duo Photometer and for the confidence you have
placed in us.
The Duo Photometer belongs to a new generation of small mobile instruments which are
being developed by Diaglobal GmbH and are specially designed for on-site analysis.
An automatic operational device check has been additionally integrated with the actual
software version V5.4. The Duo Photometer therewith complies with the requirements of
the regulations of the German Medical Association which came into effect on 15.02.2008
and will be binding from 01.04.2010.
The Duo Photometer can be used to determine 3 clinical-chemical parameters.
The device can be delivered on request, with SI-units (see chapter 9. Technical data,
table measuring ranges)
The kits and accessories which are required to carry out the tests and measurements
are also available from Diaglobal GmbH.
All the best for your work with the new Duo Photometer !
Yours
Diaglobal GmbH
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Table of contents
Page
1.
General information regarding the Photometer
4
2.
Installation
5
3.
3.1
3.1.1
3.1.2
3.2
Description of the instrument
Power supply
Mains power operation
Network-independent operation
Measuring system
5
6
6
6
6
4.
4.1
4.2
4.3
4.4
Service
Calibration
Maintenance
Disturbances
Disposal
7
7
7
7
7
5.
5.1
5.2
5.3
Required reagents and laboratory accessories
Reagents / parameter list
Control materials
Laboratory aids
7
7
7
8
6.
Internal quality control
8
7.
Measuring process
8
8.
8.1
8.2
8.3
8.4
8.5
Measurement
Switching the instrument on
Self-testing when switching on
Test selection
Switching the instrument off
Integrated operational device checks
9
9
9
9
9
9
9.
Technical data
11
10.
General guidelines and notes
12
11.
Appendix: “Step-by-step measurement”
12ff.
4
1.
General information regarding the Photometer
Device name:
Duo Photometer
Model:
DP 200
Features:
In-vitro diagnostics, measuring instrument for the
determination of selected clinical-chemical
parameters in blood
The Duo Photometer fulfils the basic requirements of Appendix I of Directive
98/79/EC regarding in-vitro diagnostics.
The conformity of the instrument with Directive 98/79/EC is confirmed by the use
of the CE marking.
Manufacturer:
Diaglobal GmbH
Innovationspark Wuhlheide
Köpenicker Str. 325
12555 Berlin
Tel:
+49 - 30 - 65 76 25 97
Fax:
+49 - 30 - 65 76 25 17
E-Mail: info@diaglobal.de
http://www.diaglobal.de
5
2.
Installation
Please observe the following instructions for use:
Insert the rechargeable battery if the instrument is to be used networkindependent or connect the photometer to the power supply unit.
Press the key <ON/ENTER> (Fig. 1) to activate the internal instrument check
which is automatically carried out by the instrument.
Following this, the instrument is immediately ready for measuring.
3.
Description of the instrument
Cuvette shaft
Display
Function keys
Fig. 1
6
3.1.
Power supply
The Duo Photometer can be operated as desired using a power supply, a (9V
block) battery or (model 6F22 or PP3) rechargeable battery.
3.1.1 Mains power operation
The power supply connector plug is connected to the instrument’s socket.
The Duo Photometer is provided with a power supply unit (6-9V=) for operation
at 230 V/50 Hz.
3.1.2 Network-independent operation
Insertion of the rechargeable battery or the normal battery:
Unscrew the knurled screws on the bottom side and remove the cap. Connect
the rechargeable battery or the normal battery using the push-button contact and
insert it. Place the cap back on top and fasten the knurled screws.
The rechargeable battery cannot be charged whilst it is installed. A separate
battery charger is required for this purpose.
Please note:
The Duo Photometer can be operated using a power supply and it is not
necessary to remove the rechargeable battery or the normal battery for this
purpose.
3.2
Measuring system
The optical section is shown in Fig. 2.
Focus
Cuvette
Fig. 2
The light emitted by an LED is first selected by an interference filter IF (HBW ~ 5
nm) in its spectral ranges (546 nm) and then guided concentrated to the cuvette
in the shaft. After it has passed through the cuvette, a broadband photo sensor
converts the light falling onto its sensor surface to current, proportional to its
intensity.
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4.
Service
4.1
Calibration
The instrument is works calibrated when supplied - it is not necessary for the
customer to calibrate it.
4.2
Maintenance
After the expiration of warranty we recommend regular yearly maintenance of
the instrument.
4.3
Disturbances
If any disturbances or problems occur, simply call us. We can answer most
questions on the telephone. Faulty instruments must be sent to our Berlin
address. We can lend our customers an instrument whilst theirs is being repaired.
4.4
Disposal
We take back instruments free of charge which are no longer needed or cannot
be repaired and dispose of them.
5.
Required reagents and laboratory accessories
5.1
Reagents / parameter list
The following tests can be measured by the Duo Photometer:
Sample material
Parameter
5.2
Tests/pack Art. No.
Blood
Capillary blood
Haemoglobin
+
+
40
HB 142
Haemoglobin (SLS-Method)
+
+
40
HB 342
Erythrocytes
+
+
40
ERY 142
Haematocrit
+
+
40
HCT 142
Control materials
Art. No.
Description
HEM QS
Reference for monitoring accuracy and precision of the haemoglobin
measurement for normal range
ERY QS
Reference for monitoring accuracy and precision of the haematocrit and
erythrocytes meas. for normal range
Contents
Haemoglobin control
5 x 1 mL
Erythrocytes- und Haematocrit control
5 x 1 mL
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5.3
Laboratory aids
Art. No.
Description
Contents
LH 001
Blood lancets
500
LH 004
Capillaries 10 µL, with ringmark
250
LH 006
Cuvette rack
1
LH 007
Micropipettor (pipetting aid)
1
LH 009
Cellulose swabs
LH 010
Cellulose swab box
LH 011
Alkohol pads, non-steril
100
LH 012
Latex gloves, size 6-7 small or 7-8 medium
100
1000
1
All reagent kits, control materials and other materials are supplied by Diaglobal
GmbH and can be stored and transported together with the Duo Photometer in a
practical case.
6.
Internal quality control
We recommend using the blood control HEM QS and ERY QS with target value in
the normal concentration area for checking the accuracy of measurements of
haemoglobin, haematocrit and erythrocyte counts.
7.
Measuring process
End point measurement
The absorbency after reaching the end point is measured.
It is measured against the reagent’s blank count.
Parameters: Haemoglobin (HB), Haemoglobin-SLS (HB SLS), Erythrocytes (ERY),
Haematocrit (HCT)
Calculation
Concentration = Absorbance x Factor
The erythrocyte and haematocrit counts are determined using stored reference
curves.
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8.
Measurement
8.1
Switching the instrument on
Press the <ON / ENTER> key
8.2
Self-testing when switching on
A self-testing of the digital and analogue circuit occurs when switching on the
instrument. The operational device check proceeds automatically after the
switching-on. It lasts ca. 5 seconds, after this the device is ready for measuring.
Note:
In case during the testing it should emerge that one of the device functions does
not satisfy the required settings, the following display appears: <SERVICE>
In this case please switch off the instrument.
Please call the Service of Diaglobal GmbH (tel. 0049 / 30 / 6576 2597) or contact
your speciality retailer.
8.3
Test selection
Press the <ON / ENTER> key
Select the desired method using from the menu using the right or left arrow key:
HB - HB-SLS - ERY - HCT - ABS546
Press the right arrow key to mark the respective next test and the left arrow key
to return to the previous test. The test currently selected is shown in the upper
right-hand corner of the display.
Confirm test selection by pressing the <ON / ENTER> key
8.4
Switching the instrument off
To switch the instrument off, press the keys together.
8.5
Integrated operational device checks
Self-testing when switching on
The testing of the device’s digital and analogue circuit occurs automatically
already when switching on the instrument.
Please see chapter 8, point 8.2.
Differential measurements
All measurements are based on differential measurements, i.e. after having
chosen the desired test the instrument requests a reference measurement
with a blank value cuvette. Thus, a reference basis to the measured value is
established so that minor deviations may be compensated.
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Measurement range controls
The measurement ranges of all measurement results indicated in the
display become verified by an integrated measurement range control. An
error display appears when exceeding the measurement range.
All measurement ranges, which are separately defined for each parameter,
are documented in the respective package inserts as well as in the
operating manual, chapter 9, technical data.
Plausibility controls
When performing multiple point measurements the extinction, which was
measured first, represents the reference basis. The programme tests the
individual measured values for plausibility. In case particular requirements
(e.g. A2 > A1 for rising reactions) are not met, an error message is
displayed.
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9.
Technical Data
Storage temperature:
- 20°C...70°C
Operating temperature:
0°C...40°C
Dimensions:
200 x 100 x 50 mm
Weight:
450 g
Measuring principle:
Absorption metering with a single-beam (Fig. 2),
choppered operation
Projection:
LED
Spectroscopic apparatus:
Interference filter
Measuring wavelengths:
520 nm / 546 nm
Spectral half-width value:
~ 5 nm
Extraneous light influence:
Negligible
Interface:
V24 (9600, 8, n, 2)
Power supply:
9V battery or rechargeable battery block 6F22
or PP3 optional plug-in power pack
Warm-up time:
0 min
Interference suppression:
According to DIN VDE 0871 and DIN VDE 0875
Measuring ranges:
DP 200
DP 200 SI
Haemoglobin
0.0 - 50 g/dL
0.0 - 31 mmol/L
Haemoglobin (SLS-method)
0.0 - 50 g/dL
0.0 - 31 mmol/L
Erythrocytes
1.0 - 10 Mio/µL
1.0 - 10 Mio/µL
Haematocrit
5 - 90 %
5 - 90 %
ABS 546nm
E = 2.500
E = 2.500
Inaccuracy:
< 0.5 % at E = 1.000
Relative photometric
short-time standard deviation:
< 0.1 %
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10.
General Guidelines and Notes
EC Directives
1. Directive 98/79/EC on in vitro diagnostic devices
EN / ISO standards
2. EN ISO 9001:1994, Quality Management Systems, Model for quality
assurance in design, development, production, installation and
servicing
3. EN ISO 13485, Medical devices, Requirements for regulatory purposes
4. EN ISO 14971, Medical devices - Application of risk management to
medical devices
5. EN 61010 –1, Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 1: General
requirements
6. EN 61010 -2-101, Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment
7. EN 61326 –1, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 1: General requirements
8. EN 61326-2-6, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 2-6: Particular requirements
- In vitro diagnostic (IVD) medical equipment
9. EN 592, Instructions for use for in vitro diagnostic instruments for
professional use
National directives and recommendations (Germany)
10. Guidelines for Quality Assurance of Laboratory Examinations of the
German Medical Association of 24.08.2001
Note on electromagnetical compatibility
a) This photometer meets the requirements of the IEC 61326 series of
standards regarding electromagnetic radiation and interference
immunity.
b) Do not use this unit near to sources of intense electromagnetic
radiation as these may disturb its correct functioning. During the
measurement, a distance of at least 1 m should be kept between an
operative (turned on) mobile telephone and this photometer.
Note on the unit's internal quality control
This unit checks its functionality when it is turned on.
Moreover, it performs electronically controlled individual tests during the
measurement causing an error message when defined conditions are not
met.
11.
Appendix:
“Step-by-step measurement”
Please refer to the illustrations in the how-to manual “Step by Step”
Step by step instructions
Device manual
1. Switch on:
2. Select test:
Press ON/ENTER
Press arrow key until required test
appears
Wait for device check and confirm with
ON/ENTER
3. Confirm required test:
4. Switch on:
Press ON/ENTER
Press both arrow keys at the same time
Note:
If SERVICE appears after the device
check, the device has a fault.
In this case, please contact our customer
service at +49 (0) 30-6576-2597.
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
HB 142 / HB 342 / ERY 142 / HCT 142
1. Insert capillary with blood
sample into cuvette
2. Wash out blood with
micropipetter
3. Screw on cap
Turn cuvette upside down
several times
Wait 3 minutes
HB 342: wait 30 seconds
HB-SLS
Zero
HB-SLS
0
Insert
blank
ON
ON
ENTER
4. Switch on photometer with
ON/ENTER
Wait for device check,
confirm with ON/ENTER
Select the required test,
confirm with ON/ENTER
HB-SLS
Sample 01
insert
ON
ENTER
5. Blank adjustment:
Insert non-treated cuvette
from package into
photometer
ENTER
6. Remove cuvette after
signal tone
Blank is stored in memory
HB-SLS
Sample 01
12.6 g/dL
ON
ENTER
7. Insert cuvette with blood
sample (fig. 3) into photometer
In regard to serial
measurement
Read result
After blank setting any number of
additional samples can be
measured
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
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