Post on 20-Apr-2020
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Dear customer,
We are pleased that you have chosen the Vario Photometer from Diaglobal GmbH and thank
you for the confidence you have placed in us.
The Vario Photometer belongs to a new generation of small mobile instruments developed
by Diaglobal GmbH and specially designed for on-site analysis.
With the new software version from V5.3, an automatic test of the instrument function has
also been integrated. The Vario Photometer thus meets the requirements of the guidelines
of the German Medical Association that came into force on 15.02.2008 and are binding from
01.04.2010.
With the Vario Photometer, 12 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 Vario Photometer!
Yours
Diaglobal GmbH
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Table of contents
Page
1. General information regarding the Photometer 4
2. Installation 5
3. Description of the instrument 5
3.1 Power supply 6
3.1.1 Mains power operation 6
3.1.2 Network-independent operation 6
3.2 Measuring system 6
4. Service 7
4.1 Adjustment and Calibration 7
4.2 Maintenance 7
4.3 Cleaning 7
4.4 Disturbances 7
4.5 Disposal 7
5. Required reagents and laboratory accessories 8
5.1 Durability of consumables 8
5.2 Reagents / parameter list 8
5.3 Control materials 9
5.4 Laboratory aids 9
6. Internal quality control 10
7. Measuring process 10
7.1 End point measurement 10
7.2 End point measurement, taking the sample’s blank count
and pre-programmed measuring time into account 10
7.3 Multipoint measurement, taking the sample’s blank point
and recognition of the end point into account 11
7.4 Multipoint measurement, taking the sample’s blank point
and calculation of the end point into account 11
8. Measurement 12
8.1 Switching the instrument on 12
8.2 Self-testing when switching on 12
8.3 Test selection 12
8.4 Switching the instrument off 12
8.5 Integrated operational device checks 13
9. Technical data 14
10. General guidelines and notes 15
11. Appendix: “Step-by-step measurement” 15ff.
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1. General information regarding the Photometer
Device name: Vario Photometer
Model: DP 300
Features: In-vitro diagnostics, measuring instrument for the
determination of selected clinical-chemical
parameters in blood, serum / plasma and liquor.
The Vario 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 / Haus 41
12555 Berlin
Tel: +49 (0) 30 6576 2597
Fax: +49 (0) 30 6576 2517
E-Mail: info@diaglobal.de
http://www.diaglobal.de
5
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 heat radiation sources
• Free from excessive dust
• Free from shocks
• Free from interference from electromagnetic waves
• Operation on a horizontal surface
Please observe the following instructions for use:
Insert the rechargeable battery if the instrument is to be used network-independent
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 Vario 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 connection plug of the power supply unit has to connect to the rear power
supply socket of the device.
The Vario Photometer is offered with a power supply (9 V DC) for operation at a
mains voltage in the range 100 V ... 240 V AC.
3.1.2 Network-independent operation
Insertion of the rechargeable battery or the normal battery:
Unscrew the knurled screws on the bottom side of the device and remove the battery
compartment cap. Connect the rechargeable battery or the normal battery using the
push-button contact and insert into the device. Place the battery compartment cap
back on top and fasten the knurled screws.
The rechargeable battery cannot be charged while it is installed. A separate battery
charger is required for this purpose.
Please note:
The Vario Photometer plus 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.
Fig. 2
The light emitted by an LED is first selected by an interference filter IF
(HBW ~ 5 nm) in its spectral ranges (520 nm and 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 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, settings by the customer are not possible.
Information about the calibration of the instrument can be found in Chapter 6,
Quality Assurance according to RiliBÄK.
4.2 Maintenance
After the expiration of warranty, we recommend regular yearly maintenance of the
instrument.
4.3 Cleaning
To clean the surface of the device, commercially available decontaminating solutions
commonly used in clinical chemistry laboratories such as Mikrozid® AF Liquid,
Bacillol® plus, 3% Kohrsolin® or similar are recommended. Before cleaning the
device with a soft cloth and the decontaminating solution, it must be switched off
and unplugged.
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. Should it be necessary to clean it, in particular in cases of leaking liquids
or glass breakage, please contact us.
4.4 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.
4.5 Disposal
We take back instruments free of charge which are no longer needed or cannot
be repaired and dispose of them.
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5. Required reagents and laboratory accessories
5.1 Durability of consumables
It is important to ensure that all consumables may only use within the expiration
date.
5.2 Reagents / parameter list
The following tests can be measured by the Vario Photometer:
Parameter Sample material
Tests/pack Art.-No. Blood Serum Plasma
Lactate + - + 40 LAC 142
Lactate-rapid + - + 40 LAC 342
Glucose + + + 40 GLU 142
Cholesterol + + + 40 CHO 142
HDL-Cholesterol1) 3) + + + 20 HDL 321
Triglycerides + + + 40 TRI 142
Haemoglobin (HiCN-Method) + - - 40 HB 142
Haemoglobin (SLS-Method) + - - 40 HB 342
Erythrocytes + - - 40 ERY 142
Haematocrit + - - 40 HCT 142
Urea1) 3) + + + 20 HST 321
Uric acid - + + 40 HSR 342
Creatinine2) - + + 20 KRE 121
Bilirubin - + + 40 BIL 142
Bilirubin for newborn1) 3) + + + 40 BIL 142
1) Minicentrifuge required (Art.-No. DZ 002) 2) Dry block heater required (Art.-No. DZ 003) 3) From blood and with subsequent sample preparation (centrifugation with Minicentrifuge)
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5.3 Control materials
Art.-No.
Description
Contents
HEM QS Haemoglobin control Reference for monitoring accuracy and precision of the haemoglobin measurement for normal range
5 x 1 mL
ERY QS Erythrocytes- und Haematocrit control Reference for monitoring accuracy and precision of the haematocrit and erythrocytes measurement for normal range
5 x 1 mL
GLU QS Glucose control 100 mg/dL 3 x 4 mL
LAC QS Lactate control set 2 mmol/L ; 4 mmol/L ; 10 mmol/L 3 x 4 mL
BIL QS Bilirubin control caps Lyophilizates for accuracy and precision control of the bilirubin meas.
20 caps
DIA QS System-Check Lyophilizates for accuracy and precision control of the system photometer and reagent
20 caps
5.4 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 500
LH 010 Cellulose swab box 1
LH 011 Alkohol pads, non-steril 100
LH 012 Powder-free nitrile gloves size M 200
LH 020 Capillaries 20 µL, heparinized, end-to-end 100
LH 024 Capillaries 20 µL, with ringmark 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
LH 050 Reaction tubes to isolate the plasma 500
LH 055 Pipette tips, 50-1000µL blue 500
LH 060 Capillaries 60µL, heparinized, end-to-end 5 x 20
LH 500 Pipette fix 500µL 1
DZ 002 Minicentrifuge 1
DZ 003 Dry block heater 1
All reagent kits, control materials and other materials are supplied by Diaglobal
GmbH and can be stored and transported together with the Vario Photometer in a
practical case.
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6. Internal quality control
We recommend using the Diaglobal control solutions LAC QS and GLU QS to check
the accuracy of measurements of lactate and glucose.
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.
We recommend using the Diaglobal control caps BIL QS to check the accuracy of
measurements of bilirubin.
We recommend using the Diaglobal control caps DIA QS to check the accuracy and
precision of the system photometer and reagent.
For all other parameters we recommend using the universal control sera from
company Roche, www.roche.de: PreciControl ClinChem Multi 1 Order-No.: 05 947 626 190 (4 x 5 mL) for normal range PreciControl ClinChem Multi 2 Order-No.: 05 947 774 190 (4 x 5 mL) for pathological range
7. Measuring process
7.1 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), Uric Acid (UA), HDL Cholesterol (HDL/CHO)
Calculation: Concentration = Absorbance x Factor
The erythrocyte and haematocrit counts are determined using stored reference
curves.
7.2 End point measurement, taking the sample’s blank count and pre-
programmed measuring time into account
After measurement of the sample blank count, the colour reaction is started in the
cuvette and the end point absorbency is measured after a preset period has lapsed.
Parameters: Bilirubin (BIL), Bilirubin for newborn (BIL N), and Creatinine (CRE)
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.
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Parameter: UREA (UREA)
Calculation: Concentration = Absorbance x Factor
Measurement time: 10 Minutes
Blanks of the samples are measured in succession:
Sample 01: Measurement 1 (sample blank value)
Sample 02: Measurement 1 (sample blank value)
Sample 03: Measurement 1 (sample blank value)
etc.
Results are measured one after another:
Sample 01: Measurement 2 (result)
Sample 02: Measurement 2 (result)
Sample 03: Measurement 2 (result)
etc.
7.3 Multipoint measurement, taking the sample’s blank point and recognition of
the end point into account
After measurement of the sample blank value (= measurement 1), the colour
reaction is started in the cuvette. The reaction process is monitored by the
instrument (= measurement 2). The measuring procedure is stopped as soon as the
end point is reached.
The time needed to reach the end point is temperature-dependent. It is normally
2 - 6 minutes for the lactate test. If temperatures are close to freezing point,
measuring times of up to 20 minutes may result, dependent on the parameters.
Both single measurements and series measurements can be selected.
If single measurements are made, the samples are measured one after another. For
series measurements, all E1 values are measured first.
Parameters: Lactate (LAC), Cholesterol (CHO), Triglycerides (TRI)
Calculation: concentration in plasma = Absorbance Difference x Factor
7.4 Multipoint measurement, taking the sample’s blank point and calculation of
the end point into account
After measurement of the sample blank value (= measurement 1), the colour
reaction is started in the cuvette. The reaction process is monitored by the
instrument. The end point is calculated using several absorbency values recorded at
different times.
Parameters: Glucose (GLU), Lactat-rapid (LAC-rapid)
Measuring times: Glucose 2 minutes
Lactat-rapid 1 minute
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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. +49 (0) 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:
LAC - LAC-rapid - GLU - CHO - HDL/CHO - TRI - HB - HB-SLS - ERY - HCT -
UREA - UA - CRE - BIL - BIL N - ABS520 - 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 both arrow keys together.
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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.
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 and 546 nm
Spectral half-width value: ~ 5 nm
Extraneous light influence: Negligible
Interface: V24 (9600, 8, n, 2)
Power supply: 6 V ... 10 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 E = 1.000
Relative photometric
short-time standard deviation: < 0.1 %
Measuring ranges: DP 300 DP 300 SI
Lactate 0.2 - 30 mmol/L 0.2 - 30 mmol/L
Lactate-rapid 0.2 - 20 mmol/L 0.2 - 20 mmol/L
Glucose 20 - 630 mg/dL 1.1 - 35 mmol/L
Cholesterol 20 - 1300 mg/dL 0.5 - 35 mmol/L
HDL-Cholesterol 10 - 200 mg/dL 0.2 - 5 mmol/L
Triglycerides 20 - 2000 mg/dL 0.2 - 23 mmol/L
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 %
Urea 5 - 200 mg/dL 0.8 - 35 mmol/L
Uric acid 0.0 - 25 mg/dL 0.0 - 1500 µmol/L
Creatinine 0.0 - 5 mg/dL 0.0 - 440 µmol/L
Bilirubin 0.50 - 25 mg/dL 8.50 - 428 µmol/L
Bilirubin for newborn 2.30 - 50 mg/dL 39.0 - 850 µmol/L
ABS 520nm E = 2.500 E = 2.500
ABS 546nm E = 2.500 E = 2.500
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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 19.09.2014
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
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Switch on:
Press ON/ENTER
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 after the device check, the device has a fault.
In this case, please contact our customer service at +49 (0) 30-6576-2597.
Step by step instructions
LAC 142 / LAC 342 / GLU 142 / CHO 142 / TRI 142
Single measurement
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Insert capillary with
sample into cuvette
2. Wash out sample with
micropipetter
3. Screw on cap
Turn cuvette upside down several times
5. Blank adjustment:
Insert cuvette with sample (fig. 3) into photometer, blank is stored in memory
Remove after signal tone
4. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select the required test, confirm with ON/ENTER
6. Replace screw cap against starter cap
ON
ENTER
ON
ENTER
M1 LAC
Sample 01
insert
9. Timing appears
Wait for result
7. Turn cuvette upside down several times
8. First press ON/ENTER
Thereafter insert cuvette in photometer
ON
ENTER
M2 LAC
Sample 01 00:30
Measuring
M1 LAC
Sample 02
insert or
ENTER
Step by step instructions
LAC 142 / CHO 142 / TRI 142
Serial measurement
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Wash out samples from capillaries into cuvettes with micropipetter
4. Blank adjustment:
Insert cuvette with samples (fig. 2) into photometer, blank is stored in memory
Ensure correct order of samples !
3. Switch on photometer with
ON/ENTER
Wait for device check, confirm
with ON/ENTER
Select the required test,
confirm with ON/ENTER
5. After blank adjustment of the last cuvette replace all screw caps against starter caps
ON
ENTER
ON
ENTER
M1 LAC
Sample 01
insert
8. Read the measured value of cuvette 1, remove cuvette
Insert cuvette 2, read the measuring value, remove cuvette
etc.
6. Turn cuvettes upside down several times at the same time
7. First press ON/ENTER
Thereafter insert cuvette 1 in photometer
Timing appears
Wait for result
ON
ENTER
M2 LAC
Sample 01 00:30
Measuring
M1 LAC
Sample 19
insert or
ENTER
2. Screw on cap
Turn cuvette upside down several times
9. Repeat the process until the measured value of the last cuvette is displayed
Pay attention to correct assign-ment and sequence of samples!
ON
ENTER
M2 LAC
Sample 19
5.28 mmol/L
Step by step instructions
HDL 321
Additionally required: Cholesterol-test (CHO 142) page 1
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. HDL 321
Insert 60 µL of sample (e-t-e capillary) into the reaction tube "R" and mix well
Leave 5 minutes
3. CHO 142
Insert capillary with 10 µL sample in cuvette
4. CHO 142
Wash out sample with micropipetter
Screw on cap
Turn cuvette upside down several times
6. CHO 142
Blank adjustment:
Insert cuvette with sample (fig. 4) into photometer, blank is stored in memory
Remove after signal tone
5. CHO 142
Switch on photometer with ON/ENTER, wait for device check, confirm with ON / ENTER
Select the HDL/CHO, confirm with ON/ENTER
Start with CHO measurement
7. CHO 142
Replace screw cap against CHO 142 starter cap
ON
ENTER
ON
ENTER
M1 CHO
Sample 01
insert
9. CHO 142
First press ON/ENTER
Thereafter insert cuvette in photometer
Timing appears
Wait for result
ON
ENTER
M2 CHO
Sample 01 00:30
Measuring
M1 CHO
Sample 02
insert or
ENTER
8. CHO 142
Turn cuvette upside down several times
2. HDL 321
Insert reaction tube „R“ with capillary into centrifuge
Centrifugate 5 minute
Continue with CHO 142
Step by step instructions
HDL 321
Additionally required: Cholesterol-test (CHO 142) page 2
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
11. HDL 321
Remove 500 µL supernatant from the centrifuged reaction tube "R" (fig. 2) and transfer it into a cuvette
12. HDL 321
Screw on HDL 321 starter cap
15. HDL 321
Blank adjustment:
Insert non-treated HDL 321 cuvette from package into photometer, blank is stored in memory
Remove after signal tone
14. HDL 321
After 5 minutes waiting time remove CHO 142 cuvette from photometer
HDL measurement is prompted
16. HDL 321
Insert cuvette with sample (fig. 13) in photometer
Read result
ON
ENTER
ON
ENTER
HDL
Insert
blank
HDL
Sample 01
insert
13. HDL 321
Turn cuvette upside down several times
Wait 5 minutes
10. CHO 142
Cholesterol value is stored in memory
CHO cuvette remains in Photometer
Continue with HDL 321
In regard to serial measurement
Up to 20 samples can be measured in series.
First the measurement of all CHO 142 - samples must be performed as usual. Thereafter the measurement of the corresponding HDL 321 - samples is carried out.
Pay attention to correct assignment and sequence of samples!
Step by step instructions
HB 142 / HB 342 / ERY 142 / HCT 142
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
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
5. Blank adjustment:
Insert non-treated cuvette from package into photometer
Blank is stored in memory
4. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select the required test, confirm with ON/ENTER
In regard to serial measurement
After blank 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 result
ON
ENTER
HB-SLS
Sample 01
12.6 g/dL
6. Remove cuvette after signal tone
ON
ENTER
HB-SLS
Sample 01
insert
Step by step instructions
HST 321
Additionally required: minicentrifuge
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Insert 20 µL sample (e-t-e capillary) into the reaction tube "R" and mix well
3. Remove 500 µL supernatant from the reaction tube "R" and transfer it into a cuvette
4. Screw on cap and turn cuvette upside down several times
6. Blank adjustment:
Insert cuvette with sample (fig. 4) into photometer, blank is stored in memory
Remove after signal tone
5. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select UREA confirm with ON/ENTER
7. Replace screw cap against starter cap
Turn cuvette upside down several times
ON
ENTER
ON
ENTER
M1 UREA
Sample 01
insert
ON
ENTER
M2 UREA
Sample 01 00:30
Measuring
M1 UREA
Sample 02
insert or
ENTER
8. First press ON/ENTER
Thereafter insert cuvette in photometer
Time (10 minutes) is displayed
2. Insert reaction tube „R“ with capillary into centrifuge
Centrifugate 1 minute
Hint: Pay attention to an even load of the centrifuge!
9. Wait for result
Hint
Serial measurement up to 20 samples: procedure is similar to serial measurement of LAC 142
Step by step instructions
HSR 342
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Insert 100 µL serum/plasma into cuvette
4. Leave at room temperature for 10 minutes
5. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select UA 342 confirm with ON/ENTER
7. After 10 minutes of waiting time insert cuvette (Fig. 3) into the device
Read the measured value
6. Blank adjustment:
Insert non-treated cuvette from package into photometer, blank is stored in memory
Remove after signal tone
In regard to serial measurement
After blank setting any number of additional samples can be measured
ON
ENTER
ON
ENTER
UA 342
Sample 01
insert
ON
ENTER
UA 342
Insert
blank
UA 342
Sample 01
4.52 mg/dL
2. Screw on starter cap from plastic bottle
3. Turn cuvette upside down several times
Step by step instructions
KRE 121
Example: 6 samples
Additionally required: Thermostat (30 min. preheated)
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Pipette 1 mL buffer solution in each cuvette
Close cuvettes
2. Incubate cuvettes 7 minutes in the preheated thermostat
Note: Work on each cuvette individually, one after the other
3. Insert 500 µL sample in the cuvette and return it immediately in the thermostat to avoid cooling
5. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select CRE, confirm with ON/ENTER
ON
ENTER
7. Wait for result
6. Insert cuvette into photometer
Time (2 minutes) is displayed
ON
ENTER
CRE
Sample 01 00:15
Measuring
CRE
Sample 01
insert
ON
ENTER
CRE
Sample 01
0.95 mg/dL
4. Incubate cuvette exactly for 1 minute, meanwhile switch on photometer
8. Read the measured value, remove cuvette and repeat the process in the same way with all other cuvettes, starting from pt 3.
Step by step instructions
BIL 142 / BIL 142 N
Additionally required: minicentrifuge
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Insert capillary with sample into cuvette
BIL 142: 100 µL
BIL 142 N: 20 µL
Sample collection for BIL 142 N see next page
2. Wash out sample with micropipetter
3. Screw on cap
Turn cuvette upside down several times
5. Blank adjustment:
Insert cuvette with sample (fig. 3) into photometer, blank is stored in memory
Remove after signal tone
4. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select BIL or BIL N, confirm with ON/ENTER
6. Exchange screw cap against starter cap
ON
ENTER
ON
ENTER
BIL
Sample 01
insert
9. Timing appears
Wait for result
7. Turn cuvette upside down several times
8. First press ON/ENTER
Thereafter insert cuvette in photometer
ON
ENTER
BIL
Sample 01 00:30
Measuring
BIL
Sample 01
ENTER
Step by step instructions
BIL 142 / BIL 142 N
Sample collection: BIL 142 N
Additionally required: minicentrifuge , microvette
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. Withdraw about 60 µL blood with microvette from heel
Close microvette
2. Insert microvette in centrifuge
Zentrifugate 3-5 minutes
Hint: Pay attention to an
even load of the centrifuge!
3. Remove 20 µL plasma from microvette
Continue on the previous page fig. 2
Minicentrifuge
Order-No.: DZ 002
Microvette
Order-No.: LH 031
(100 pc. per pack.)
Step by step instructions
DIA QS / BIL QS
Quality assurance
Photometer testing with control caps
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
1. 20 control caps with lyophilized control serum
DIA QS: glucose, lactate, triglycerides, cholesterol, HDL-cholesterol, uric acid, bilirubin
BIL QS: bilirubin, bilirubin for newborn
2. Screw on control cap on the cuvette that is to be tested
Mix well
3. Leave cuvette for 1 minute
The cuvette now contains a sample of known concentration
4. Switch on photometer with ON/ENTER
Wait for device check, confirm with ON/ENTER
Select the required test, confirm with ON/ENTER
6. Replace control cap against starter cap
ON
ENTER
GLU
8. Measurement:
First press ON/ENTER, thereafter insert cuvette into photometer
Wait for result and compare it with the target value specified in the package insert
7. Turn cuvette upside down several times
5. Blank adjustment:
Insert cuvette with sample (fig. 3) into photometer, blank is stored in memory
Remove after signal tone
Step by step instructions
Parameter Overview
Sample material / Sample number of serial measurement
Pos. Article No. Parameter Method Sample material
Serial measurement Blood Serum Plasma Liquor
1 BIL 142 Bilirubin
DPD - + + -
not possible Neonat. Bilirubin + + + -
2 CHO 142 Cholesterol CHOD-PAP + + + - up to 20 samples
3 HDL 321 HDL-Cholesterol CHOD-PAP + + + - up to 20 samples
4 CK 321 CK-NAC / blood UV-test, IFCC mod. + + + - up to 6 samples
5 CK 121 CK-NAC / serum UV-test, IFCC mod. - + + - up to 6 samples
6 CRP 321 C-reactive Protein Immunoturbidimetry - + + - up to 20 samples
7 ERY 142 Erythrocytes Turbidimetric test + - - - unlimited
8 GLU 142 Glucose GOD-PAP + + + - not possible
9 GOT 442 GOT / ASAT UV-test, IFCC 37°C - + + - up to 6 samples
10 GPT 442 GPT / ALAT UV-test, IFCC 37°C - + + - up to 6 samples
11 HB 142 Haemoglobin Cyanmethaemoglobin + - - - unlimited
12 HB 342 Haemoglobin-SLS SLS-method + - - - unlimited
13 HCT 142 Haematocrit Turbidimetric test + - - - unlimited
14 HSR 342 Uric acid / serum Uricase-PAP - + + - unlimited
15 HST 321 Urea Berthelot, mod. + + + - up to 20 samples
16 KRE 121 Creatinine Jaffé, kinetic - + + - not possible
17 LAC 142 Lactate LOD-PAP + - + + up to 20 samples
18 LAC 342 Lactate-Rapid LOD-PAP + - + + not possible
19 TRI 142 Triglycerides GPO-PAP + + + - up to 20 samples
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de