Diaglobal Duo Photometer plus DP 210 User manual

1
2021-01
Duo Photometer plus
DP 210
Operating Manual
Version 5.12 / 5.12 SI
Edition 2021-01

2
2021-01
Dear customer,
We are pleased that you have chosen the Duo Photometer plus from Diaglobal GmbH and
thank you for the confidence you have placed in us.
The Duo Photometer plus belongs to a new generation of small mobile devices developed
by Diaglobal GmbH and specially designed for on-site analysis.
With the software version V5.3 and higher, an automatic test of the device function has
also been integrated. Therefore, the Duo Photometer plus complies with the
requirements of the guidelines of the German Medical Association.
With the Duo Photometer plus, 9 clinical-chemical parameters can be determined.
The device can be supplied with SI units of measurement on request (see chapter 9,
Technical Data, table Measuring Ranges).
The kits and accessories required for the test are also available from Diaglobal GmbH.
All the best for your work with the new Duo Photometer plus!
Yours
Diaglobal GmbH

3
2021-01
Table of contents
Page
1. General information regarding the Photometer 4
2. Installation 5
3. Description of the device 5
3.1 Power supply 6
3.1.1 Mains power operation 6
3.1.2 Mains-independent operation 6
3.2 Measuring system 6
4. Service 7
4.1 Adjustment and Calibration 7
4.2 Maintenance 7
4.3 Cleaning Instructions 7
4.4 Malfunctions 7
4.5 Disposal 7
5. Required reagents and laboratory accessories 8
5.1 Expiration date of consumables 8
5.2 Reagents / parameter list 8
5.3 Control materials 8
5.4 Laboratory aids and accessories 9
6. Quality control according to the Guideline of the German Medical
Association 10
7. Measuring procedure 11
7.1 End-point measurement 11
7.2 End-point measurement, taking the sample’s blank value and
pre-programmed measuring time into account 11
8. Measurement 12
8.1 Switching the device on 12
8.2 Self-test when switching on 12
8.3 Test selection 12
8.4 Switching the device off 12
8.5 Integrated operational device checks 12
8.6 Notes on taking samples and carrying out measurements 13
9. Technical data 15
10. General guidelines and notes 16
11. Appendix: “Step-by-step measurement” 16ff.

4
2021-01
1. General information on the Photometer
Device name: Duo Photometer plus
Model: DP 210
Features: In-vitro diagnostics, measuring device for the
determination of selected clinical-chemical
parameters in blood and serum/plasma
The Duo Photometer plus fulfils the basic requirements of Appendix I of Directive
98/79/EC regarding in-vitro diagnostics.
The conformity of the device with Directive 98/79/EC is confirmed by the use of
the CE marking.
Manufacturer: Diaglobal GmbH
Innovationspark Wuhlheide
Köpenicker Str. 325 / Haus 41
12555 Berlin
Tel: [phone]
Fax: [phone]
E-Mail: [e-mail]
http://www.diaglobal.de

5
2021-01
2. Installation
For trouble-free operation of the device, the following environmental conditions
must be met:
• Ambient temperature: 0 °C ... 40 °C
• No direct exposure to sunlight or similar sources of radiant heat
• Free from excessive dust
• Free from vibrations
• Free from interference by electromagnetic waves
• Operation on a horizontal surface
Please observe the following instructions for use:
Insert a rechargeable battery or normal battery if the device is to be operated
independently of a power supply or connect the photometer to a power supply
unit.
Press the <ON/ENTER> key (Fig. 1) to activate the internal device check which
is automatically carried out by the device.
The device is then immediately ready for measurement.
3. Description of the device
Cuvette shaft
Display
Function keys
Fig. 1

6
2021-01
3.1 Power supply
The Duo Photometer plus 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 Photometer is supplied with a power supply unit for operation on a mains
voltage in the range of 100 V ... 240 V AC. The mains plug is marked with a
Diaglobal logo (sticker).
The connector plug of the power supply unit is connected to the power supply
socket on the back of the device.
3.1.2 Network-independent operation
To insert the rechargeable battery or the normal battery:
Unscrew the knurled screws on the bottom of the unit and remove the battery
compartment cover. Connect the battery to the push-button contact and insert it
into the device. Replace the battery compartment cover and screw in the knurled
screws.
Please note:
The Duo Photometer plus can be operated using a power supply without the need
to remove the rechargeable battery or the normal battery.
The rechargeable battery cannot be charged while it is installed. A separate
battery charger is required for this purpose.
3.2 Measuring system
The optical section is shown in Fig. 2.
Fig. 2
The light emitted by an LED is first selected into its wavelength range (546 nm)
by an interference filter IF (HBW ~ 5 nm) and then bundled and directed onto the
cuvette in the shaft. After passing through the cuvette, a broadband photosensor
converts the light falling on its sensor surface into a current, proportional to the
intensity.

7
2021-01
4. Service
4.1 Adjustment and Calibration
The instrument is adjusted and calibrated at the factory on delivery, adjustment
by the customer is not necessary.
Adjustment is carried out via the interface socket on the rear panel. It can only be
carried out at the factory, adjustments by the customer are not possible.
Information on calibrating the device can be found in chapter 6. Quality control
according to the Guideline of the German Medical Association.
4.2 Maintenance
The device is maintenance-free. Maintenance after the warranty period is
recommended, but not mandatory.
Due to the integrated test of the unit functions (chapter 8.5) and regular tests
with control material, maintenance is only recommended if one of these two test
functions indicates an error message.
4.3 Cleaning Instructions
Commercially available decontaminating solutions commonly used in clinical
chemistry laboratories, such as Mikrozid® AF Liquid, Bacillol® plus, 3 %
Kohrsolin® or similar, are recommended for cleaning the device and the surface.
Before cleaning the unit with a soft cloth and the decontaminating solution, it
must be switched off and the electrical power supply must be disconnected.
Make sure that no liquids get into the device. There is no protection against
penetrating liquids (Code IP X0).
The cuvette shaft must not be cleaned by the user of the device, as this may
damage the device. If cleaning is necessary, especially because of leaking liquids
or broken glass, please contact Diaglobal GmbH.
4.4 Malfunctions
If any malfunctions or problems occur, simply call us. Most questions can be
answered on the phone. Non-functional units should be sent to our Berlin address.
We will provide a loan device for the duration of the repair.
4.5 Disposal
Diaglobal GmbH will take back and dispose of units that are no longer needed or
cannot be repaired, free of charge.

8
2021-01
5. Required reagents and laboratory accessories
5.1 Expiration date of consumables
It is important to ensure that all consumables may only be used within the
expiration date.
5.2 Reagents / parameter list
The following tests can be measured with the Duo Photometer plus:
Parameter
Sample material
Tests/pack Art. no.
Blood Serum Plasma
Bilirubin - + + 40 BIL 142
Neonatale Bilirubin1) 2) + - -
Haemoglobin (SLS-method) + - - 40 HB 342
Haemoglobin (HiCN-method) + - - 40 HB 142
Erythrocytes + - - 40 ERY 142
Haematocrit + - - 40 HCT 142
1) Mini centrifuge required (Art. no. DZ 002)
2) From blood, with subsequent sample preparation (centrifugation with mini centrifuge)
5.3 Control materials
Art. no. Description Contents
HEM QS Haemoglobin control
Haemolysate for correctness and precision control of haemoglobin
determination in blood in the normal range
5 x 1 mL
ERY QS Erythrocytes- and Haematocrit control
Control blood for accuracy and precision control of haematocrit and
erythrocytes determination in blood in the normal range
5 x 1 mL
BIL QS Bilirubin control
Lyophilisate for accuracy and precision control of bilirubin determination 20 caps

9
2021-01
5.4 Laboratory aids and accessories
Art. no. Description Contents
LH 001 Blood lancets 500
LH 004 Capillaries 10 µL, with ring mark 250
LH 006 Cuvette rack 1
LH 007 Micropipettor (pipetting aid) 1
LH 009 Cellulose swabs 500
LH 010 Cellulose swab box 1
LH 011 Alcohol pads, non-sterile 100
LH 012 Powder-free nitrile gloves size M 200
LH 023 Capillaries 100 µL, with ring mark 250
LH 024 Capillaries 20 µL, with ring mark 250
LH 031 Microvettes CB 300 100
LH 034 Safety Lancets Neonatal, pink 1.2 mm 200
LH 035 Safety lancets extra, orange 1.8 mm 200
DZ 002 Mini centrifuge 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 plus in a
practical case.

10
2021-01
6. Quality control according to the Guideline of the
German Medical Association1)
The Duo Photometer plus has been specially developed for near-patient immediate
diagnostics with unit-use reagents (German Medical Association, part B, chapter
2.1.5). According to the guideline of the German Medical Association, there is
therefore no obligation to participate in surveys (German Medical Association,
part B, chapter 2.2, paragraph (3) a). The user only has to carry out internal
quality checks.
Internal quality assurance is carried out in the form of a weekly accuracy check
(calibration) with subsequent documentation of the measured value. The
corresponding protocol forms are available from Diaglobal free of charge.
We recommend using the Diaglobal control caps BIL QS to check the accuracy of
bilirubin determinations.
We recommend using the blood control HEM QS and ERY QS with target values in
the normal concentration area for checking the accuracy of determinations of
haemoglobin, haematocrit and erythrocyte counts.
In agreement with the requirements of the German Medical Association, a test of
the device function (see operating instructions, chapter 8.5) is integrated in the
Duo Photometer plus, therefor a daily test by means of a standard manual test
(German Medical Association, part B, chapter 2.1.5, paragraph (2) is not
necessary.
1) Guideline of the German Medical Association for the quality assurance of laboratory medical examinations
Deutsches Ärzteblatt | Jg. 116 | Heft 51-52 | 23. Dezember 2019

11
2021-01
7. Measuring process
7.1 Endpoint measurement
The absorbance is measured after reaching the endpoint.
It is measured against the reagent’s blank count.
Parameters: Haemoglobin SLS (HB SLS), Erythrocytes (ERY), Haematocrit (HCT),
Haemoglobin (HiCN)
Calculation: Concentration = Absorbance x Factor
The erythrocyte and haematocrit counts are determined using stored reference
curves.
7.2 Endpoint measurement with consideration of the sample blank value and
pre-programmed measuring time
After measuring the sample blank value, the colour reaction in the cuvette is
started and the endpoint absorbance is measured after a specified time has
elapsed.
Parameters: Bilirubin (BIL), Neonatal bilirubin (BIL N)
Calculation: Concentration = Absorbance x Factor
Measurement time: 2 Minutes
The samples are measured in succession:
Sample 01: Measurement 1 (sample blank value)
Sample 01: Measurement 2 (result)
Sample 02: Measurement 1 (sample blank value)
Sample 02: Measurement 2 (result)
etc.

12
2021-01
8. Measurement
8.1 Switching the device on
Press the <ON/ENTER> key
8.2 Self-test when switching on
When the device is switched on, a self-test of the digital and analogue circuitry is
conducted. The operational device check proceeds automatically after it is
switched on. It takes approx. 5 seconds, after which the unit is ready for
measuring.
Note:
If it becomes obvious during the test that one of the device functions does not
correspond to the required settings, <SERVICE> will appear in the display.
In this case, switch the device off.
Please call Diaglobal GmbH service (Tel. [phone]) or contact your
specialist retailer.
8.3 Test selection
Press the <ON/ENTER> key.
The desired test is selected from the menu with the right or left arrow key:
HB - HB-SLS - ERY - HCT - BIL - BIL N - ABS546
Pressing the right arrow key activates the next test while pressing the left arrow
key returns to the previous test. The selected test is shown in the upper right
corner of the display.
Confirm test selection with the <ON/ENTER> key.
8.4 Switching the device off
To switch the device off, press both arrow keys simultaneously.
8.5 Integrated operational device checks
Self-test when switching on
Testing of the digital and analogue circuits of the device is automatically
performed by the device when it is switched on.
Please see chapter 8, point 8.2.
Differential measurements
All measurements are based on differential measurements. I. e. after selecting the
desired test, the device requests a zero measurement with a blank value cuvette.
This creates a reference base to the measured value so that minor deviations can be
compensated.

13
2021-01
Measurement range controls
The measurement ranges of all measurement results shown in the display are
verified by an integrated measurement range control. If the measurement range
is exceeded, an error is displayed.
The measurement ranges that are separately defined for each parameter are
documented on the respective package inserts as well as in this operating manual,
chapter 9, Technical Data.
Plausibility controls
For multi-point measurements, the absorbance measured first forms the reference
basis. The programme verifies the plausibility of the individual measured values. If
specific requirements (e.g. E2 > E1 for ascending reactions) are not met, an error
message is displayed.
8.6 Notes on taking samples and carrying out measurements
Errors in taking samples will always lead to incorrect measurement results.
This chapter addresses the most common errors that can occur during taking
samples and measuring samples.
1. Before measuring, cuvettes stored in a refrigerator must be brought to room
temperature. If the cuvettes are too cold, they will become misty with water
on the outer wall due to the humidity, which will lead to incorrect
measurement results.
2. Never touch the lower part of the cuvette (where the liquid is) with bare
hands. If this should happen accidentally, clean the vials with a fluff-free cloth
before use. Cleaning with a fluff-free cloth is recommended in any case. Even
if the package is still new and unopened. Fingerprints on the cuvette lead to
incorrect measurement results.
3. If the blood is taken from the heel using the microvette (neonatal bilirubin),
make sure that there is enough blood (approx. 60 µL) in the microvette, as
20 µL serum/plasma is needed for the measurement. Close the microvette well
after taking the blood sample and return it to the small sample tube for
centrifugation.
4. After centrifugation of the microvette, please make sure that the
centrifugate has separated completely and that the supernatant is clear and
free of any solid particles. If not, repeat the centrifugation. If the supernatant
is not free of suspended matter or if particles of the centrifugate accidentally
enter the capillary, the measurement result will be incorrect.
5. If blood is taken from the fingertip or earlobe, note that the first drop that
forms spontaneously must be wiped away with a cellulose swab. It contains a
high proportion of tissue fluid, which will corrupt the measurement result.
6. The second drop that forms is for blood sampling. To support blood collection,
it may be pressed carefully (!). The emphasis on carefully, otherwise too much
tissue fluid will get into the blood sample again.
7. Make sure that the blood drop that forms is large enough to fill the capillary
with the required sample volume in one go. Repeated filling of the capillary
leads to air bubbles that cannot be removed from the capillary. If air bubbles
form, discard the capillary and start sampling again.

14
2021-01
8. The capillary must be filled exactly up to the black ring mark.
Please note: A deviation of only 1 mm from the ring mark is sufficient to
obtain a completely incorrect measurement result!
If the sample is above the black ring mark, this will lead to incorrect positive
measurement results. A cellulose swab can be used to carefully soak up too
much blood.
If the sample is below the black ring mark, this will lead to incorrect negative
measurement results. In this case, correction is hardly possible due to the air
bubble that will form when trying to collect more blood.
9. Before the capillary is placed in the cuvette, the lower area must be carefully
wiped on the outside with a cellulose swab to remove sample particles
attached to the capillary. Otherwise, this would lead to incorrect positive
measurement results.
10. With the help of the micropipetter, the sample is completely transferred into
the cuvette. The complete transfer of the sample is done by ejecting it several
times with the help of the push button on the micropipetter.
Please note: The micropipetter is only used when the capillary is filled with the
sample. It is not needed for filling the capillary. The capillary is filled by the
capillary action alone.
11. When changing the cap with the starter cap, make sure that the substance in
the starter cap has completely dissolved. Failure to do so will result in a non-
linear kinetic reaction process, which will lead to an error message in the
display or unreliable measurement results.

15
2021-01
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 measurement with single beam
photometer (Fig. 2), chopped operation
Projector: LED
Spectral apparatus: Interference filter
Measuring wavelengths: 546 nm
Spectral half-width value: ~ 5 nm
External light influence: Negligible
Interface: V24 (9600, 8, n, 2)
Power supply: 6 V ... 12 V DC
Current consumption: max. 250 mA
Warm-up time: 0 min
Interference suppression: According to DIN VDE 0871 and DIN VDE 0875
Inaccuracy: < 0.5 % at A = 1.000
Relative photometric
short-time standard deviation: < 0.1 %
Measuring ranges: DP 210 DP 210 SI
Haemoglobin (HiCN-method) 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 %
Bilirubin 0.50 - 25 mg/dL 8.50 - 428 µmol/L
Neonatal Bilirubin 2.30 - 50 mg/dL 39.0 - 850 µmol/L
ABS 546 nm A = 2.500 A = 2.500

16
2021-01
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 customer
service
3. EN ISO 13485, Medical devices, Requirements for regulatory purposes
(application of EN ISO 9001)
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 23.12.2019
Note on electromagnetic compatibility
a) The photometer meets the requirements for electromagnetic radiation
and interference immunity as described in the IEC 61326 series of
standards.
b) Do not use this device near sources of intense electromagnetic radiation
because they may interfere with correct functioning. A distance of at
least 1 m should be maintained between an operational (switched on)
mobile phone and the photometer during measurement.
Note on the unit's internal quality control
The functionality of the device is checked when it is switched on. In addition,
electronically controlled checks are carried out for individual tests during the
measurement, which leads to an error message if specified requirements are
not met.
11. Appendix: “Step-by-step measurement”
Please refer to the illustrations in the "Step by step" instruction manual.

Step by step instructions
Device manual
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · [phone] · [e-mail] · www.diaglobal.de 2021-01
1. Switch on:
Press ON/ENTER key
Wait for device check and confirm with
ON/ENTER
2. Select test:
Press arrow key until required test
appears
3. Confirm required test:
Press ON/ENTER
4. Switch off:
Press both arrow keys at the same time
Note:
If SERVICE appears in the display after
the device check, the device has a defect.
In this case, please contact our customer
service at [phone].

Step by step instructions
BIL / BIL N (BIL 142)
Additionally required: Mini centrifuge
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · [phone] · [e-mail] · www.diaglobal.de 2021-01
1. Insert capillary with sample
(serum/plasma) into cuvette
BIL: 100 µL (adults)
BIL N: 20 µL (newborns)
Sampling of BIL N see next
page
2. Eject sample several times
with micropipetter into
cuvette
3. Screw cap on
Turn cuvette upside down
several times
5. Zero point adjustment:
Insert cuvette with sample
(Fig. 3) into photometer, zero
point is stored in memory
Remove cuvette after signal
tone
4. Switch photometer on with
ON/ENTER key
Wait for device check, confirm
with ON/ENTER
Select the required test,
confirm with ON/ENTER
6. Replace screw cap with
starter cap
ON
ENTER
ON
ENTER
BIL
Sample 01
insert
9. Time is displayed, wait for
measured value
7. Turn cuvette upside down
several times
8. First press ON/ENTER
Then insert cuvette into
photometer
ON
ENTER
BIL
Sample 01 00:30
Measuring
BIL
Sample 01
ENTER

Step by step instructions
BIL / BIL N (BIL 142)
Sampling of BIL N
Additionally required: Mini centrifuge, Microvette
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · [phone] · [e-mail] · www.diaglobal.de 2021-01
1. After pricking with the lancet,
take about 60 µL of blood
(approx. 1 drop) from the heel
with the microvette
Note: Close the microvette
carefully before placing it into
the mini centrifuge
2. Insert microvette into mini
centrifuge
Centrifugate for 3-5 minutes
Note: Ensure an even loading
inside the mini centrifuge
3. Take 20 µL plasma from
the microvette
Continue with Fig. 1 on the
previous page
Mini centrifuge
Art. No. DZ 002
Microvette
Art. No. LH 031
(100 pieces per package)

Step by step instructions
HB 142 / HB 342 / ERY 142 / HCT 142
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · [phone] · [e-mail] · www.diaglobal.de 2021-01
1. Insert capillary with 10 µL
blood sample into cuvette
2. Eject blood several times
with micropipetter into
cuvette
3. Screw cap on
Turn cuvette upside down
several times
Wait 3 minutes
HB 342: wait 30 seconds
5. Zero point adjustment:
Insert an unprocessed
cuvette from package into
photometer
Zero point is stored in
memory
4. Switch photometer on with
ON/ENTER key
Wait for device check,
confirm with ON/ENTER
Select the required test,
confirm with ON/ENTER
In regard to series
measurement:
After zero point setting any
number of additional samples
can be measured
ON
ENTER
ON
ENTER
HB-SLS
Insert
blank
Zero HB-SLS
0
7. Insert cuvette with blood
sample (Fig. 3) into photometer
Read measured value
ON
ENTER
HB-SLS
Sample 01
12.6 g/dL
6. Remove cuvette after
signal tone
ON
ENTER
HB-SLS
Sample 01
insert