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Table of Contents
Related Manuals for R-Biopharm RIDA CUBE SCAN
Summary of Contents for R-Biopharm RIDA CUBE SCAN
- Page 1 2014-09-30 Page 1 of 34 R-Biopharm AG...
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Page 2: Symbols & Abbreviations
Relative humidity limitations Manufacturer Production date Sterile Warnings and precautions, see accompanying documents Operator's action Refer to the user’s manual and follow the instructions Do not dispose with household waste ERS TC ERS Testing Cartridge 2014-09-30 Page 2 of 34 R-Biopharm AG... - Page 3 Light Emitting Diode Personal Computer Identification HIS / LIS Hospital Information System / Laboratory Information System Alternating Current Direct Current RFID Radio Frequency Identification Table 1: Product Labelling and User Manual Symbols 2014-09-30 Page 3 of 34 R-Biopharm AG...
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Page 4: Table Of Contents
The automatic start-up and warm-up processes ........................14 Configuring the RIDA®CUBE SCAN ............................15 Setting normal values and limits ..................Fehler! Textmarke nicht definiert. Setting units ..................................... 15 Configuring inputs (Sex, Sampletype, Hematocrit, Operator) ....................16 Configuring interfaces ................................17 2014-09-30 Page 4 of 34 R-Biopharm AG... - Page 5 Service information .................................. 30 Technical specifications ............................... 31 RIDA®CUBE SCAN Instrument ..............................31 Power supply ................................... 31 Options ..................................... 31 Declaration of conformity ..............................32 Shut down and waste management ............................. 33 Manufacturer information ..............................34 2014-09-30 Page 5 of 34 R-Biopharm AG...
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Page 6: Introduction
The RIDA CUBE SCAN Instrument is highly compact and is designed as a point of care measuring Instrument for R-Biopharm. It is easy to use and provides quick, reliable and accurate results. About this user manual This user manual will guide you through the installation, operation and maintenance of your ®... -
Page 7: Cube Packaging
CUBE SCAN Tablet PC is delivered in a separate package and must be returned in this if necessary. WARNING: Wrong packing and/or the use of inappropriate packaging can cause severe damage to the Instrument! These damages won’t be covered under warranty. 2014-09-30 Page 7 of 34 R-Biopharm AG... -
Page 8: System Description
PC (for data transfer) • Do not use liquid cleaners on the Instrument or Tablet PC! Use a lint-free, slightly damp cloth only! • Do not attempt to open the door manually 2014-09-30 Page 8 of 34 R-Biopharm AG... -
Page 9: Indicator Lights
The door prevents ambient light, dust, dirt and humidity from entering the Instrument during the testing process and when the Instrument is not in use. Please make sure the door is closed whenever the Instrument is not in use. 2014-09-30 Page 9 of 34 R-Biopharm AG... -
Page 10: How The Rida Cube Scan Laboratory Photometer Works
CUBE SCAN Instrument is manufactured according to the highest quality standards in order to yield safe and accurate testing results. Every Instrument is inspected and calibrated during the manufacturing process, using the EU-stipulated reference methods. 2014-09-30 Page 10 of 34 R-Biopharm AG... -
Page 11: Pictogramms / Button Symbols
Displays the next page Page backward Displays the previous page Recycle bin Opens the delete dialogue Synchronize Synchronises result(s) and Instrument status with the servers for technical support Table 2: CUBE Tablet PC symbols 2014-09-30 Page 11 of 34 R-Biopharm AG... -
Page 12: Getting Started
Always connect to the proper supply voltage. The power supply voltage must comply with the regulations cited in the technical specifications on page 31. Ensure a properly installed electrical grounding. The Instrument is to be operated only using the power supply unit provided. 2014-09-30 Page 12 of 34 R-Biopharm AG... -
Page 13: The Tablet Pc
Tapping Settings opens the Android settings menu Note: If the standard Android Desktop appears instead, switch the Tablet PC off, back on, select ® “RIDA CUBE SCAN Launcher” and confirm by tapping “Always”. 2014-09-30 Page 13 of 34 R-Biopharm AG... -
Page 14: Changing The Language Of The Rida®Cube Scan Application
The Instrument is warmed up to its proper working temperature in approximately 10 - 15 minutes. As soon as the initialization of the optical unit is completed, the button turns from b/w to color and reacts to tapping. The Instrument is now operational. 2014-09-30 Page 14 of 34 R-Biopharm AG... -
Page 15: Configuring The Rida®Cube Scan
RFID card has been placed on the Instrument and read. Setting units 1. Configuration menu 2. Unit selection menu Tap Units to open the Unit and select a unit in the selection menu. appearing drop-down menu. Confirm the change(s) with 2014-09-30 Page 15 of 34 R-Biopharm AG... -
Page 16: Configuring Inputs (Sex, Sampletype, Hematocrit, Operator)
Confirm with To delete an operator, tap and select a name in the drop Press to cancel. down menu, then tap 2014-09-30 Page 16 of 34 R-Biopharm AG... -
Page 17: Configuring Interfaces
If you do not know the Service Note: the screenshot above is Password please contact your for demonstration purposes only. dealer. By default all boxes are unchecked. 2014-09-30 Page 17 of 34 R-Biopharm AG... -
Page 18: Optional Equipment
PC (for data transfer) Tablet PC-Lock eyelet Bluetooth on/off switch (left: Bluetooth OFF) USB Port for connecting a Tablet PC RS 232 socket for connecting a printer, a barcode reader or a PC (for data transfer) 2014-09-30 Page 18 of 34 R-Biopharm AG... -
Page 19: Using A Barcode Scanner To Scan Patient Id And/Or Operator Information
Lock Switch will re-illuminate the display to its customary level of brightness. It is not necessary to switch the Instrument off every day. Switching the Instrument off completely can only be done by disconnecting it from the power supply. 2014-09-30 Page 19 of 34 R-Biopharm AG... -
Page 20: Test Procedures
Be sure to follow the detailed instructions for the analysis processes that are provided in the following sections and to comply with the information provided on the package insert enclosed with each testing kit. 2014-09-30 Page 20 of 34 R-Biopharm AG... -
Page 21: Operating Safety Precautions
CUBE SCAN Instrument and follow all instructions regarding: o The proper temperature a cartridge must have before a test is performed o The exact amount of the sample volume o The regulations for the proper storage of the test cartridges 2014-09-30 Page 21 of 34 R-Biopharm AG... -
Page 22: Analysing A Patient Sample
(see 3.4 on p. 16 for details). This screen only appears if the operator input as enabled (see 3.4 on page 16)! 2014-09-30 Page 22 of 34 R-Biopharm AG... - Page 23 Be sure the test cartridge is fully inserted into the proper opening in the Instrument • Use ONLY manufacturer-approved test cartridges! Otherwise serious damage to ® the RIDA CUBE SCAN photometer and/or inaccurate test results may occur • Do not attempt to open the door manually! 2014-09-30 Page 23 of 34 R-Biopharm AG...
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Page 24: Viewing And Processing Test Results
Instrument is working properly and providing reliable results. Data integrity can only be assured when controls and GCLP practices are used routinely. The frequency of performing QC differs from laboratory to laboratory; please comply with your national quality control regulations. 2014-09-30 Page 24 of 34 R-Biopharm AG... -
Page 25: Choosing Quality Control (Qc) Materials
Perform a test using a control from a new lot. If all instructions have been followed but control results are still not within range please contact your local R-Biopharm supplier for assistance before proceeding on testing any new samples. 2014-09-30... -
Page 26: Frequency Of Qc Testing
• when new personnel is being trained to use the equipment . • if local regulations require more frequent control testing than described above, then the number of control tests performed must comply with these regulations. 2014-09-30 Page 26 of 34 R-Biopharm AG... -
Page 27: Cleaning Instructions
Do not clean the surface of the Tablet PC with isopropyl alcohol! ® The surface of the RIDA CUBE SCAN Instrument should be cleaned with a clean, lint-free cloth only moistened with isopropyl alcohol. Wipe down the exposed surfaces. 2014-09-30 Page 27 of 34 R-Biopharm AG... -
Page 28: External Interface Description
Time: 14:44 Date: dd-mm-yyyy Date: 08-02-2007 Operat: Text Operat:Max Muster Optional Lot No: Value Lot No:4111 Optional Ser No: Value Ser No:Ca10001 Optional USB Interface The USB interface emulates the serial interface. 2014-09-30 Page 28 of 34 R-Biopharm AG... -
Page 29: Error Information And Troubleshooting
(e.g. pipetting error). with correct sample volume. Cartridge temperature error The cartridges’ temperature is too Repeat the test and refer to the low for a proper test. package inserts for proper cartridge use. 2014-09-30 Page 29 of 34 R-Biopharm AG... -
Page 30: Service Information
• the test lot number • the control lot number • the control results obtained so far • a description of the problem, including any of the RIDA ® CUBE SCAN error messages 2014-09-30 Page 30 of 34 R-Biopharm AG... -
Page 31: Technical Specifications
Max. 30 VA Options Thermo printer Seiko DPU-414 Interface Serial Mains adapter 100-240 VAC Barcode reader (scanner) Datalogic Touch65 Reading area 63 mm Max. resolution 0.10 mm (4 mils) Mains adapter 100-240 VAC 2014-09-30 Page 31 of 34 R-Biopharm AG... -
Page 32: Declaration Of Conformity
- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment“, and the standards referenced below were taken in consideration: EN 55011:2009 Class B; EN 61000-4-2:2009; EN 61000-4-3:2009; EN 61000-4-4:2009; EN 61000-4-5:2009; EN 61000-4-6:2009; EN 61000-4-11:2009; EN 61326-1:2006-05-01; ISO 14971:2007-10-01. 2014-09-30 Page 32 of 34 R-Biopharm AG... -
Page 33: Shut Down And Waste Management
(see page 7). For proper waste management according to the directive 2002/96/EG please contact your local dealer. Used cartridges need to be disposed with laboratory waste and according to the corresponding regulations. 2014-09-30 Page 33 of 34 R-Biopharm AG... -
Page 34: Manufacturer Information
Manufacturer information R-Biopharm AG An der neuen Bergstrasse 17 64297 Darmstadt, Germany Tel: +49 (0) 61 51 - 8102-0 Fax: +49 (0) 61 51 - 8102-0 info@r-biopharm.de www.r-biopharm.com 2014-09-30 Page 34 of 34 R-Biopharm AG...