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Summary of Contents for Diaglobal Vario Photometer II
- Page 1 Vario Photometer II DP 310 Operating Manual Version 5.13 / 5.13 SI Edition 2021-01 2021-01...
- Page 2 Dear customer, We are pleased that you have chosen the Vario Photometer II from Diaglobal GmbH and thank you for the confidence you have placed in us. The Vario Photometer II belongs to a new generation of small mobile devices developed by Diaglobal GmbH and specially designed for on-site analysis.
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Page 3: Table Of Contents
Table of contents Page General information regarding the Photometer Installation Description of the device Power supply 3.1.1 Mains power operation 3.1.2 Mains-independent operation Measuring system Service Adjustment and Calibration Maintenance Cleaning Instructions Malfunctions Disposal Required reagents and laboratory accessories Expiration date of consumables Reagents / parameter list Control materials Laboratory aids and accessories... -
Page 4: General Information Regarding The Photometer
General information on the Photometer Device name: Vario Photometer II Model: DP 310 Features: In-vitro diagnostics, measuring device for the determination of selected clinical-chemical parameters in blood, serum/plasma and cerebrospinal fluid The Vario Photometer fulfils the basic requirements of Appendix I of Directive 98/79/EC regarding in-vitro diagnostics. -
Page 5: Installation
Installation For trouble-free operation of the device, the following environmental conditions must be met: • Ambient temperature: 0 °C ... 40 °C • No direct exposure to sunlight or similar sources of radiant heat • Free from excessive dust • Free from vibrations •... -
Page 6: Power Supply
Power supply The Vario Photometer II can be operated as desired using a power supply, a (9V block) battery or (model 6F22 or PP3) rechargeable battery. 3.1.1 Mains power operation The Photometer is supplied with a power supply unit for operation on a mains voltage in the range of 100 V ... -
Page 7: Service
Non-functional units should be sent to our Berlin address. We will provide a loan device for the duration of the repair. Disposal Diaglobal GmbH will take back and dispose of units that are no longer needed or cannot be repaired, free of charge. 2021-01... -
Page 8: Required Reagents And Laboratory Accessories
Expiration date of consumables It is important to ensure that all consumables may only be used within the expiration date. Reagents / parameter list The following tests can be measured with the Vario Photometer II: Sample material Parameter Tests/pack Art. no. -
Page 9: Control Materials
Pipette fix 500 µL DZ 002 Mini centrifuge DZ 003 Dry Block Thermostat All reagent kits, control materials and other materials are supplied by Diaglobal GmbH and can be stored and transported together with the Vario Photometer II in a practical case. 2021-01... -
Page 10: Quality Control According To The Guideline Of The German Medical Association
In agreement with the requirements of the German Medical Association, a test of the device function (see operating instructions, chapter 8.5) is integrated in the Vario Photometer II, therefor a daily test by means of a standard manual test (German Medical Association, part B, chapter 2.1.5, paragraph (2) is not necessary. -
Page 11: Measuring Procedure
Measuring process Endpoint measurement The absorbance is measured after reaching the endpoint. It is measured against the reagent’s blank count. Parameters: Haemoglobin SLS (HB SLS), Erythrocytes (ERY), Haematocrit (HCT), HDL Cholesterol (HDL/CHO) Calculation: Concentration = Absorbance x Factor The erythrocyte and haematocrit counts are determined using stored reference curves. -
Page 12: 7.5.1 Creatine Kinase From Blood
Multi-point measurement with consideration of the sample blank value and recognition of the endpoint After measuring the sample blank value (=measurement 1) the colour reaction in the cuvette is started. The reaction process is monitored by the device (=measurement 2). The measuring process is terminated as soon as the endpoint is reached. -
Page 13: 7.5.2 Creatine Kinase From Serum/Plasma
Individual haematocrit values can be considered, they will be requested before calculation. The default setting is an HCT value of 40%. Please note: If the sample material is serum/plasma, the HCT value must always be set to 0%. 7.5.2 Creatine Kinase from serum/plasma <CK 121> The reaction in the cuvette is started by adding the sample. -
Page 14: Measurement
If it becomes obvious during the test that one of the device functions does not correspond to the required settings, <SERVICE> will appear in the display. In this case, switch the device off. Please call Diaglobal GmbH service (Tel. +49 (0) 30 6576 2597) or contact your specialist retailer. Test selection Press the <ON/ENTER>... -
Page 15: Notes On Taking Samples And Carrying Out Measurements
Measurement range controls The measurement ranges of all measurement results shown in the display are verified by an integrated measurement range control. If the measurement range is exceeded, an error is displayed. The measurement ranges that are separately defined for each parameter are documented on the respective package inserts as well as in this operating manual, chapter 9, Technical Data. - Page 16 If the sample is below the black ring mark, this will lead to incorrect negative measurement results. In this case, correction is hardly possible due to the air bubble that will form when trying to collect more blood. 7. Before the capillary is placed in the cuvette, the lower area must be carefully wiped on the outside with a cellulose swab to remove sample particles attached to the capillary.
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Page 17: Technical Data
Technical data Storage temperature: -20 °C ... 70 °C Operating temperature: 0 °C ... 40 °C Dimensions: 200 x 100 x 50 mm Weight: 450 g Measuring principle: Absorption measurement with single beam photometer (Fig. 2), chopped operation Projector: Spectral apparatus: Interference filter Measuring wavelengths: 365 nm and 520 nm... -
Page 18: General Guidelines And Notes
General Guidelines and Notes EC Directives 1. Directive 98/79/EC on in-vitro diagnostic devices EN / ISO standards 2. EN ISO 9001:1994, Quality Management Systems, Model for quality assurance in design, development, production, installation and customer service 3. EN ISO 13485, Medical devices, Requirements for regulatory purposes (application of EN ISO 9001) 4. - Page 19 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 2021-01...
- Page 20 After entering the last HCT value, read all measured values one after the other by Fig. 7 Then press ON/ENTER pressing the right arrow key Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 21 30 seconds! For the M2 measurement follow the display in the same way as discribed in Fig. 6 Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 22 For the M2 measurement follow the cuvettes in the correct order display in the same way as discribed in Fig. 7 Then press ON/ENTER Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 23 9. Time is displayed, wait for 7. Turn cuvette upside down 8. First press ON/ENTER several times measured value Then insert cuvette into photometer Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 24 Note: Ensure the correct or- Time is displayed, wait for measured value, remove der of the samples! measured value cuvette, and so on Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 25 First press ON/ENTER starter cap of CHO 142 several times Then insert cuvette into photometer Time is displayed, wait for measured value Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 26 Important: P ay attention to the Insert cuvette with sample correct order and assignment of (Fig. 13) in photometer the samples! Read measured value Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 27 Urea up to 20 samples is Time is displayed the same procedure as the serial measurement of LAC Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 28 8. Read the measured value, remove the cuvette and (2 minutes) repeat the same process with all other cuvettes, starting from Fig. 3 Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 29 In regard to series sample (Fig. 3) into photometer measurement: Read measured value After zero point setting any number additional samples can be measured Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
- Page 30 Wait for measured value Compare the measured value with the target value on the package insert Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de 2021-01...
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