Vario Photometer DP 300 Operating Manual. Version 5.11 / 5.11 SI

1 Vario Photometer DP 300 Operating Manual Version 5.11 / 5.11 SI

2 Dear customer, Thank you for selecting Diaglobal s Vario Photometer and for the confidence you have placed in us. The Vario 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 Vario 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 Vario Photometer can be used to determine 12 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 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 Calibration 7 4.2 Maintenance 7 4.3 Disturbances 7 4.4 Disposal 7 5. Required reagents and laboratory accessories 7 5.1 Reagents / parameter list 7 5.2 Control materials 8 5.3 Laboratory aids 8 6. Internal quality control 9 7. Measuring process 9 7.1 End point measurement 9 7.2 End point measurement, taking the sample s blank count and pre-programmed measuring time into account 9 7.3 Multipoint measurement, taking the sample s blank point and recognition of the end point into account 10 7.4 Multipoint measurement, taking the sample s blank point and calculation of the end point into account 10 8. Measurement 11 8.1 Switching the instrument on 11 8.2 Self-testing when switching on 11 8.3 Test selection 11 8.4 Switching the instrument off 11 8.5 Integrated operational device checks 11 9. Technical data 13 10. General guidelines and notes 14 11. Appendix: Step-by-step measurement 14ff.

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 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 </> (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 power supply connector plug is connected to the instrument s socket. The Vario 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 Vario 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 (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 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 Vario Photometer: Parameter Sample material Blood Serum Plasma Tests/pack Art. No. Lactate + - + 40 LAC 142 Lactate-rapid + - + 40 LAC 342 Glucose + + + 40 GLU 142 Cholesterol + + + 40 CHO 142 HDL-Cholesterol* + + + 20 HDL 321 Triglycerides + + + 40 TRI 142 Haemoglobin + - - 40 HB 142 Haemoglobin (SLS-Method) + - - 40 HB 342 Erythrocytes + - - 40 ERY 142 Haematocrit + - - 40 HCT 142 Urea - + + 40 HST 321 Uric acid - + + 40 HSR 342 Creatinine** - + + 40 KRE 142 Bilirubin - + + 40 BIL 142 Bilirubin for newborn* + + + 40 BIL 142 * Minicentrifuge (Art.-No. DZ 002) required ** Dry block heater (Art.-No. DZ 003) required

8 5.2 Control materials Art. No. Description Contents HEM QS ERY QS Haemoglobin control Reference for monitoring accuracy and precision of the haemoglobin measurement for normal range Erythrocytes- und Haematocrit control Reference for monitoring accuracy and precision of the haematocrit and erythrocytes meas. for normal range 5 x 1 ml 5 x 1 ml GLU QS Glucose control 100mg/dL 3 x 4 ml LAC QS Lactate control set 2mmol/L ; 4mmol/L ; 10mmol/L 3 x 4 ml BIL QS DIA QS Bilirubin control caps Lyophilizates for accuracy and precision control of the bilirubin meas. System-Check Lyophilizates for accuracy and precision control of the system photometer and reagent 20 caps 20 caps 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 500 LH 010 Cellulose swab box 1 LH 011 Alkohol pads, non-steril 100 LH 012 Latex gloves, size 6-7 small or 7-8 medium 100 LH 020 Capillaries 20µL, heparinized, end-to-end 100 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.

9 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: Precinorm U Order-No.: 10 171 735 122 (4 x 5 ml) for normal range Precipath U Order-No.: 10 171 760 122 (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 preprogrammed 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 the 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.

10 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 of 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

11 8. Measurement 8.1 Switching the instrument on Press the < / > 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 < / > 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 < / > 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.

12 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.

13 9. Technical Data Storage temperature: Operating temperature: Dimensions: Weight: - 20 C...70 C 0 C...40 C 200 x 100 x 50 mm 450 g Measuring principle: Absorption metering with a single-beam (Fig. 2), choppered operation Projection: Spectroscopic apparatus: Measuring wavelengths: Spectral half-width value: Extraneous light influence: LED Interference filter 520 nm / 546 nm ~ 5 nm Negligible Interface: V24 (9600, 8, n, 2) Power supply: Warm-up time: 9V battery or rechargeable battery block 6F22 or PP3 optional plug-in power pack 0 min Interference suppression: According to DIN VDE 0871 and DIN VDE 0875 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 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 0.0-50 mg/dl 0.0-850 µmol/l Bilirubin f. newborn 0.0-50 mg/dl 0.0-850 µmol/l ABS 520nm E = 2.500 E = 2.500 ABS 546nm E = 2.500 E = 2.500 Inaccuracy: < 0.5 % at E = 1.000 Relative photometric short-time standard deviation: < 0.1 %

14 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 / Press arrow key until required test appears Wait for device check and confirm with / 3. Confirm required test: 4. Switch on: Press / 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 LAC 142 / LAC 342 / GLU 142 / CHO 142 / TRI 142 Single measurement 1. Insert capillary with sample into cuvette 2. Wash out sample with micropipetter 3. Screw on cap Turn cuvette upside down several times M1 LAC M1 LAC Sample 01 insert Sample 02 insert or 4. Switch on photometer with / Wait for device check, confirm with / Select the required test, confirm with / 5. Blank adjustment: Insert cuvette with sample (fig. 3) into photometer, blank is stored in memory Remove after signal tone 6. Replace screw cap against starter cap M2 LAC Sample 01 00:30 Measuring 7. Turn cuvette upside down several times 8. First press / Thereafter insert cuvette in photometer 9. Timing appears Wait for result Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions LAC 142 / CHO 142 / TRI 142 Serial measurement M1 Sample 01 insert LAC 1. Wash out samples from capillaries into cuvettes with micropipetter 2. Screw on cap Turn cuvette upside down several times 3. Switch on photometer with / Wait for device check, confirm with / Select the required test, confirm with / M1 Sample 19 insert or LAC 4. Blank adjustment: Insert cuvette with samples (fig. 2) into photometer, blank is stored in memory Ensure correct order of samples! 5. After blank adjustment of the last cuvette replace all screw caps against starter caps 6. Turn cuvettes upside down several times at the same time M2 LAC Sample 01 00:30 Measuring M2 LAC Sample 19 5.28 mmol/l 7. First press / Thereafter insert cuvette 1 in photometer Timing appears Wait for result 8. Read the measured value of cuvette 1, remove cuvette Insert cuvette 2, read the measuring value, remove cuvette etc. 9. Repeat the process until the measured value of the last cuvette is displayed Pay attention to correct assignment and sequence of samples! Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions HDL 321 Additionally required: Cholesterol-test (CHO 142) page 1 1. HDL 321 Insert 60 µl of sample (e-t-e capillary) into the reaction tube "R" and mix well Leave 5 minutes 2. HDL 321 Insert reaction tube R with capillary into centrifuge Centrifugate 5 minute Continue with CHO 142 3. CHO 142 Insert capillary with 10 µl sample in cuvette M1 CHO M1 CHO Sample 01 insert Sample 02 insert or 4. CHO 142 Wash out sample with micropipetter Screw on cap Turn cuvette upside down several times 5. CHO 142 Switch on photometer with /, wait for device check, confirm with / Select the HDL/CHO, confirm with / Start with CHO measurement 6. CHO 142 Blank adjustment: Insert cuvette with sample (fig. 4) into photometer, blank is stored in memory Remove after signal tone M2 CHO Sample 01 00:30 Measuring 7. CHO 142 Replace screw cap against CHO 142 starter cap 8. CHO 142 Turn cuvette upside down several times 9. CHO 142 First press / Thereafter insert cuvette in photometer Timing appears Wait for result Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions HDL 321 Additionally required: Cholesterol-test (CHO 142) page 2 10. CHO 142 Cholesterol value is stored in memory CHO cuvette remains in Photometer Continue with HDL 321 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 Insert blank HDL Sample 01 insert HDL 13. HDL 321 Turn cuvette upside down several times Wait 5 minutes 14. HDL 321 After 5 minutes waiting time remove CHO 142 cuvette from photometer HDL measurement is prompted 15. HDL 321 Blank adjustment: Insert non-treated HDL 321 cuvette from package into photometer, blank is stored in memory Remove after signal tone 16. HDL 321 Insert cuvette with sample (fig. 13) in photometer Read result 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! 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 HB-SLS Insert 0 Sample 01 insert blank 4. Switch on photometer with / Wait for device check, confirm with / Select the required test, confirm with / 5. Blank adjustment: Insert non-treated cuvette from package into photometer Blank is stored in memory 6. Remove cuvette after signal tone HB-SLS Sample 01 12.6 g/dl 7. Insert cuvette with blood sample (fig. 3) into photometer Read result In regard to serial measurement 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

Step by step instructions HST 321 Additionally required: minicentrifuge 1. Insert 20 µl sample (e-t-e capillary) into the reaction tube "R" and mix well 2. Insert reaction tube R with capillary into centrifuge Centrifugate 1 minute Hint: Pay attention to an even load of the centrifuge! 3. Remove 500 µl supernatant from the reaction tube "R" and transfer it into a cuvette M1 UREA M1 UREA Sample 01 insert Sample 02 insert or 4. Screw on cap and turn cuvette upside down several times 5. Switch on photometer with / Wait for device check, confirm with / Select UREA confirm with / 6. Blank adjustment: Insert cuvette with sample (fig. 4) into photometer, blank is stored in memory Remove after signal tone M2 UREA Sample 01 00:30 Measuring 7. Replace screw cap against starter cap Turn cuvette upside down several times 8. First press / Thereafter insert cuvette in photometer Time (10 minutes) is displayed 9. Wait for result Hint Serial measurement up to 20 samples: procedure is similar to serial measurement of LAC 142 Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions HSR 342 1. Insert 100 µl serum/ plasma into cuvette 2. Screw on starter cap from plastic bottle 3. Turn cuvette upside down several times Insert blank UA 342 Sample 01 insert UA 342 4. Leave at room temperature for 10 minutes 5. Switch on photometer with / Wait for device check, confirm with / Select UA 342 confirm with / 6. Blank adjustment: Insert non-treated cuvette from package into photometer, blank is stored in memory Remove after signal tone UA 342 Sample 01 4.52 mg/dl 7. After 10 minutes of waiting time insert cuvette (Fig. 3) into the device Read the measured value In regard to serial measurement 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

Step by step instructions KRE 121 Example: 6 samples Additionally required: Thermostat (30 min. preheated) 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 Sample 01 insert CRE CRE Sample 01 00:15 Measuring 4. Incubate cuvette exactly for 1 minute, meanwhile switch on photometer 5. Switch on photometer with / Wait for device check, confirm with / Select CRE, confirm with / 6. Insert cuvette into photometer Time (2 minutes) is displayed Sample 01 0.95 mg/dl CRE 7. Wait for result 8. Read the measured value, remove cuvette and repeat the process in the same way with all other cuvettes, starting from pt 3. Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions BIL 142 / BIL 142 N Additionally required: minicentrifuge 1. Insert capillary with sample into cuvette BIL 142: 100 µl BIL 142 N: 10 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 Sample 01 insert BIL Sample 01 BIL 4. Switch on photometer with / Wait for device check, confirm with / Select BIL or BIL N, confirm with / 5. Blank adjustment: Insert cuvette with sample (fig. 3) into photometer, blank is stored in memory Remove after signal tone 6. Exchange screw cap against starter cap BIL Sample 01 00:30 Measuring 7. Turn cuvette upside down several times 8. First press / Thereafter insert cuvette in photometer 9. Timing appears Wait for result Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions BIL 142 / BIL 142 N Sample collection: BIL 142 N Additionally required: minicentrifuge, microvette 1. Withdraw about 50 µl blood with microvette from heel Close microvette 2. Insert microvette in centrifuge Zentrifugate 1 minute Hint: Pay attention to an even load of the centrifuge! 3. Remove 10 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.) Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions DIA QS / BIL QS Quality assurance Photometer testing with control caps 1. 20 control caps with lyophilized control serum DIA QS: glucose, lactate, triglycerides, cholesterol, HDLcholesterol, 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 GLU 4. Switch on photometer with / Wait for device check, confirm with / Select the required test, confirm with / 5. Blank adjustment: Insert cuvette with sample (fig. 3) into photometer, blank is stored in memory Remove after signal tone 6. Replace control cap against starter cap 7. Turn cuvette upside down several times 8. Measurement: First press /, thereafter insert cuvette into photometer Wait for result and compare it with the target value specified in the package insert Diaglobal GmbH Köpenicker Straße 325 12555 Berlin +49 (0)30 6576 2597 info@diaglobal.de www.diaglobal.de

Step by step instructions Parameter Overview Sample material / Sample number of serial measurement Pos. Article No. Parameter Method Blood Sample material Serum Plasma Liquor Serial measurement 1 BIL 142 Bilirubin - + + - DPD Neonat. Bilirubin + + + - not possible 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