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Summary of Contents for Diaglobal DP 220
- Page 1 Gyn Photometer DP 220 Operating Manual Version 5.9 / 5.9 SI Edition 2021-01 2021-01...
- Page 2 Dear customer, We are pleased that you have chosen the Gyn Photometer from Diaglobal GmbH and thank you for the confidence you have placed in us. The Gyn Photometer 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... -
Page 4: General Information Regarding The Photometer
General information on the Photometer Device name: Gyn Photometer Model: DP 220 Features: In-vitro diagnostics, measuring device for the determination of selected clinical-chemical parameters in blood and serum/plasma The Gyn 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
The Photometer is supplied with a power supply unit for operation on a mains voltage in the range of 100 V ... 240 V AC. The mains plug is marked with a Diaglobal logo (sticker). The connector plug of the power supply unit is connected to the power supply socket on the back of the device. -
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. Required reagents and laboratory accessories... -
Page 8: Reagents / Parameter List
Powder-free nitrile gloves size M LH 035 Safety Lancets Extra, orange 1.8 mm All reagent kits, control materials and other materials are supplied by Diaglobal GmbH and can be stored and transported together with the Gyn Photometer in a practical case. -
Page 9: Quality Control According To The Guideline Of The German Medical Association
(calibration) with subsequent documentation of the measured value. The corresponding protocol forms are available from Diaglobal free of charge. We recommend using the Diaglobal control solution GLU QS to check the accuracy of glucose determinations We recommend using the blood control HEM QS and ERY QS with target values in the normal concentration area for checking the accuracy of determinations of haemoglobin, haematocrit and erythrocyte counts. -
Page 10: 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 11: Integrated Operational Device Checks
Integrated operational device checks Self-test when switching on Testing of the digital and analogue circuits of the device is automatically performed by the device when it is switched on. Please see chapter 8, point 8.2. Differential measurements All measurements are based on differential measurements. I. e. after selecting the desired test, the device requests a zero measurement with a blank value cuvette. - Page 12 4. After centrifugation microvette, please make sure that centrifugate has separated completely and that the supernatant is clear and free of any solid particles. If not, repeat the centrifugation. If the supernatant is not free of suspended matter or if particles of the centrifugate accidentally enter the capillary, the measurement result will be incorrect.
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Page 13: Technical Data
< 0.5 % at A = 1.000 Relative photometric short-time standard deviation: < 0.1 % Measuring ranges: DP 220 DP 220 SI Glucose 20 - 630 mg/dL 1.1 - 35 mmol/L Haemoglobin 0.0 - 50 g/dL 0.0 - 31 mmol/L... -
Page 14: 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 15 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 16 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 17 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...
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