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1 Vario Photometer DP 300 Operating Manual Version 5.12 / 5.12 SI Edition 2020/1

Vario Photometer DP 300 Operating Manual 300_en.pdfVario Photometer DP 300 Operating Manual Version 5.12 / 5.12 SI Edition 2020/1 2 Dear customer, We are pleased that you have chosen

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1

Vario Photometer

DP 300

Operating Manual

Version 5.12 / 5.12 SI

Edition 2020/1

2

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

3

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.

4

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: [email protected]

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.

7

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.

8

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)

9

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.

10

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.

11

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

12

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.

13

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.

14

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

15

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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · 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 · [email protected] · www.diaglobal.de