Rigel Medical FloTest User Manual
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Rigel Medical FloTest User Manual

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USER MANUAL
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Summary of Contents for Rigel Medical FloTest

  • Page 1 FloTest USER MANUAL rigelmedical.com...

  • Page 2: Table Of Contents

    RIGEL MEDICAL FloTest MANUAL Table of contents Introduction 2 Intended use Safety instructions Representation of hazards, cautions and notes Personnel Responsibility and guarantee Service life Specifications Measurement parameters Principle of flow measurement Special functions Communication interfaces Physical data Calibration by user...

  • Page 3: Introduction

    Introduction Validity This documentation is valid for the product: Rigel FloTest You will find the name FloTest on the label at the back of your device. Software and firmware version This documentation applies to the following versions: FloTest firmware – Version 1.2.000 In the case of older or newer versions there may be minor discrepancies in relation to this User Manual.

  • Page 4: Intended Use

    FloTest is intended for use in an indoor test laboratory environment. It may only be used outside the nursing sector. It must not be used directly on patients or devices that are connected to patients. The FloTest is intended for over-the-counter sale.

  • Page 5: Safety Instructions

    Information and/or instructions and prohibitions to prevent damage of any kind. Personnel Work on and with FloTest may only be performed by persons who have undergone appropriate general technical training and have the necessary experience. Responsibility and...

  • Page 6: Service Life

    RIGEL MEDICAL FloTest MANUAL Although the device meets high quality and safety standards and has been constructed and tested according to the current state of the art, it is not possible to rule out the risk of injuries with serious consequences if the device is not used in compliance with the intended use (improperly) or is misused.

  • Page 7: Specifications

    RIGEL MEDICAL FloTest MANUAL Specifications Measurement parameters Parameter Value Flow Range ±300 L/min Accuracy FloTest: .13 Feature Set) ±1.9 % or ±0.05 L/min Volume Range Accuracy 0 L – 500 000 L ±4 % or ± 1 mL Absolute pressure in the Range Accuracy 0.5 –...

  • Page 8: Principle Of Flow Measurement

    RIGEL MEDICAL FloTest MANUAL 4.2 Principle of flow Flow in the flow channel is determined by differential pressure measurement. To build up measurement differential pressure Δp, a measuring disc is used to provide flow resistance. For flow rates > 50 L/min the differential pressure Δp2 is used.

  • Page 9: Calibration By User

    6.5.8 Zero offset calibration user Degree of protection, against water and dust, according to IEC 60529: IP 20 Operating data The FloTest has 3 different modes: • Battery operated • Mains supplied / battery charging • Switched off / storage Please note the different ambient condition for the different modes.

  • Page 10: Gas Standards For Flow And Volume Measurement

    Atmospheric pressure 54 kPa – 110 kPa * Non-condensing FloTest converts the flow and volume readings measured in the device to match the conditions of Gas standards for flow the standard selected. The following gas standards are supported by FloTest:...

  • Page 11: Battery Operation

    The device is not intended for use outside a building. Simplified EU Declaration of Conformity Hereby, IMT Analytics AG declares that the radio equipment type FloTest is compliant with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://www.rigelmedical.com/gb/support/download/197/...

  • Page 12: Device Labels And Symbols

    RIGEL MEDICAL FloTest MANUAL 4.12 Device labels and symbols The following labels and symbols can be found on FloTest, packaging or accessories: Symbol Description Warning notice Power button Alternating current Class II equipment For indoor use only Direct current Power input...

  • Page 13: Feature Set

    Keep dry Protect from sunlight Temperature for transport and storage Humidity range for transport and storage Atmospheric pressure for transport and storage 4.13 Feature Set The FloTest available features. FloTest Top cover Grey ±300 L/min Flow measurement ±1.9 % or ±0.05 L/min...

  • Page 14: Start-Up

    RIGEL MEDICAL FloTest MANUAL Start-up Individual parts in the packaging TESTED, TRUSTED…WORLDWIDE.

  • Page 15: Power Supply

    RIGEL MEDICAL FloTest MANUAL Power supply The power supply socket is located at the rear of FloTest. The device can be disconnected from the mains by disconnecting the power supply. The power supply should therefore be easily accessible. 5.2.1 Supply voltage The mains voltage of the power supply is 100 –...
  • Page 16 RIGEL MEDICAL FloTest MANUAL 5.3.2 Flow channel The flow channel can be used to perform gas flow measurements from -300 L/min to 300 L/min. The channel includes pressure and temperature sensors. Measuring range & accuracy details: see chapter ( 4.1 Measurement...

  • Page 17: Electrical Interfaces

    Actuation of the RS-232 port takes place via a special RS-232 cable. If the device shall be actuated via the RS-232 interface, your dealer will be pleased to provide you with a detailed protocol. FloTest pin assignment (RJ-10 connector): Pin 1 NC Pin 2 RxD (Input of FloTest)
  • Page 18 RIGEL MEDICAL FloTest MANUAL 5.4.3 USB-A The USB-A host connector can be used to connect a USB flash drive for data recording and software update. Rating: 5 V, 0.5 A The USB flash drive must comply with the following requirements.

  • Page 19: Operation

    FloTest MANUAL 6 Operation Switching the FloTest The FloTest is switched on and off using the power button on the rear of the device on and off 6.2 Acoustic feedback The FloTest provides a beep as acoustic feedback as follows:...
  • Page 20 RIGEL MEDICAL FloTest MANUAL If the FloTest is switched on, the Measurement screen appears. TESTED, TRUSTED…WORLDWIDE.

  • Page 21: Screens

    RIGEL MEDICAL FloTest MANUAL 6.4 Screens 6.4.1 Measurement screen The measurement screen is the starting point to operate the FloTest. The software version described in this User Manual displays the menu items listed below: Description Action Value tiles Three different tiles can be configured...
  • Page 22 RIGEL MEDICAL FloTest MANUAL Description Action Battery level Indicates the battery level: Empty battery: No bar • Full battery: Full bar • Charging: A bolt symbol next to the • battery Chart tile The Chart tile offers a Numerical view and...
  • Page 23 RIGEL MEDICAL FloTest MANUAL 6.4.2 Configuration of the Measurement screen The Measurement screen offers 1 chart tile and 3 value tiles which can be configured individually. Long press the tile for 1 sec. to open the Edit parameter screen. Here you can select between all available values and units.
  • Page 24 RIGEL MEDICAL FloTest MANUAL 6.4.3 Configuration of the Statistic screen For each row, long press for 1 sec. to select any measurement value. Long press on a row for 1 sec. to open the Edit parameter screen. Use the swipe up / down gesture to scroll through the lists of parameters.

  • Page 25: Menu

    RIGEL MEDICAL FloTest MANUAL Menu By tapping the Menu button, the sub menus are displayed: Description Action Zero Opens the sub menu zero calibration Tap: The sub menu opens Calibration 6.5.8 Zero offset calibration Start Opens the sub menu with the recording...
  • Page 26 RIGEL MEDICAL FloTest MANUAL Settings 6.5.1 In the Settings menu, all device settings can be made: Description Action Back Go back to the main Menu Measurement Opens the sub menu for the Tap: The sub menu opens measurement settings: Gas Standard •...
  • Page 27 RIGEL MEDICAL FloTest MANUAL 6.5.2 Measurement settings The Measurement menu contains all measurement related settings: Description Action Back Go back to Settings menu Gas Standard Opens the gas standards settings with the Tap: Selection of all gas following available choices: standards opens •...
  • Page 28 RIGEL MEDICAL FloTest MANUAL 6.5.3 Filter types Numeric values for the graph are displayed when the screen is refreshed every 50 ms, but measurement takes place every 1 ms. The sampling interval for measurement parameters is 1 ms. To reduce fluctuation of the reading and to make measurements easier to read, a filter can be applied.
  • Page 29 RIGEL MEDICAL FloTest MANUAL 6.5.4 Trigger settings The Trigger menu contains all settings to configure the trigger Description Action Back Go back to Settings menu Start Signal Opens the start signal setting with the following Tap: Selection of start signal...
  • Page 30 RIGEL MEDICAL FloTest MANUAL 6.5.5 Device settings The Device menu contains all settings to configure the device: Description Action Back Go back to Settings menu Screen Opens a slider to adjust the brightness of Tap: Slider to adjust the Brightness...
  • Page 31 Google Play store or App store on your mobile device. Be sure, that Bluetooth is enabled. In Settings menu on your FloTest select the sub menu Bluetooth to enable it. Pare your mobile device with your FloTest by entering the pairing code provided by the FloTest.
  • Page 32 RIGEL MEDICAL FloTest MANUAL In the FloTest App, a long press on a tile for 1 sec. opens the edit parameter screen. Use the drop- down menu to select parameters and units. 6.5.7 Software update The software update file can be downloaded from the IMT Analytics website. A USB flash drive with FAT32 formatting is required to install new software.
  • Page 33 Once the update is completed, the measurement screen is displayed 9. Disconnect the USB flash drive from the FloTest The device is ready for use If the verification of a valid software update file was unsuccessful, one of the following error messages is shown on the screen: TESTED, TRUSTED…WORLDWIDE.
  • Page 34 RIGEL MEDICAL FloTest MANUAL Error message displayed Troubleshooting 1. Tap Retry! to try it again 2. Ensure that a USB flash drive is connected to the USB-A host port (5.4 Electrical interfaces) 3. Ensure the battery charge is > 50% 4.
  • Page 35 RIGEL MEDICAL FloTest MANUAL Error message displayed Troubleshooting 1. Tap Retry! to try it again 2. Ensure the USB flash drive is connected to the device while the software update is in progress 3. Format the USB flash drive using the file system...
  • Page 36 Zero offset calibration Follow the procedure described below to achieve the most accurate readings: • Perform the zero offset calibration when the FloTest has warmed up. Warm up takes approximately 30 minutes. • To perform zero offset calibration, you must remove all connected tubes and protection caps from the device •...
  • Page 37 In case the measurement values seam implausible, check the measurement setup and measurement equipment. When in doubt about the performance of the FloTest, send it back to the manufacturer for calibration and do not change any settings on the medical device.

  • Page 38: Measuring Volume

    7 Measuring volume 7.1 General principle The FloTest measures volumes by integrating the flow between the start and stop trigger events. Flow, Absolute Pressure (in Flow) and Differential Pressure can be used as trigger source. If you set a trigger for the first time, it is important to know the characteristic of the signal that will be used for the trigger (flow or pressure).

  • Page 39: Servicing And Care

    RIGEL MEDICAL FloTest MANUAL TESTED, TRUSTED…WORLDWIDE.

  • Page 40: Cleaning

    (9.2 Parts Note: If the flow channel was observed to be clean in the past, contamination can easily be recognized. Every 12 months Factory calibration ensures reliable measurement. To calibrate the FloTest by the manufacturer, visit the website www.easy-cal.com Only use the spare parts recommended by the manufacturer (...
  • Page 41 Flow channel dirty • Visually inspect the flow channel • values of the Calibration due • Contact IMT Analytics soon for • FloTest not match • Error in setup measurement calibration: www.easy-cal.com the device under test Check measurement setup • (DUT)

  • Page 42: Contact

    RIGEL MEDICAL FloTest MANUAL Contact If you have any questions or problems, please contact one of the departments listed below Contact details 8.6.1 Rigel Medical 15-18 Bracken Hill South West Industrial Estate Peterlee Co. Durham SR8 2SW United Kingdom Tel: +44 (0) 191587 8730 Email: sales@rigelmedical.com...
  • Page 43 RIGEL MEDICAL FloTest MANUAL 9 Accessories and spare parts Ordering address Rigel Medical 15-18 Bracken Hill South West Industrial Estate Peterlee Co. Durham SR8 2SW United Kingdom Tel: +44 (0) 191587 8730 Email: sales@rigelmedical.com Parts Picture Name Article Number Power Supply including 700.421.000...
  • Page 44 RIGEL MEDICAL FloTest MANUAL Picture Name Article Number Carrying Bag FloTest 700.422.000 Flow Channel Protection Cap 302.780.000 TESTED, TRUSTED…WORLDWIDE.
  • Page 45 RIGEL MEDICAL FloTest MANUAL Disposal Disposal of the device is the operator's responsibility. Keep in mind the FloTest contains a Li-Ion battery and must be disposed of accordingly. The device can: • be delivered, carriage free and duty paid to the manufacturer for disposal.
  • Page 46 RIGEL MEDICAL FloTest MANUAL Measurement parameters and units 11.1 Measurement 11.1.1 Pressure readings parameters and units Measurement parameter Designation Units of measurement Absolute pressure in flow PAbs mbar, inH O, cmH O, PSI, channel mmHg, hPa, kPa, Pa 11.1.2 Flow and Volume readings...
  • Page 47 RIGEL MEDICAL FloTest MANUAL Wireless communication FloTest contains a generation 5.1 Bluetooth module for wireless communication. The module complies with all requirements from EN 300 328 V2.2.2. FCC ID: QOQGM210P IC ID: 5123A-GM210P The module is restricted to the following channels and output power.
  • Page 48 [the ITU] Radio Regulations. * The mechanical design of the FloTest ensures the distance to the transmitter is always equal or above 5.3 mm TESTED, TRUSTED…WORLDWIDE.
  • Page 49 RIGEL MEDICAL FloTest MANUAL Appendix Abbreviations and glossary 13.1 Ampere 1 bar = 14.50 psi ° C Degrees Celsius Conversion from Celsius (C) to Fahrenheit (F): F = 9×C/5 + 32 Centimeters cmH 2 O Centimeters of water column Decibel-milliwatts °...
  • Page 50 RIGEL MEDICAL FloTest MANUAL TESTED, TRUSTED…WORLDWIDE. Pascal Pounds per square inch (1 bar = 14.50 psi) Relative Humidity RS-232 Serial interface Connector for serial interface (telephone connector according to RJ-10 FCC FCC registration, U.S. Federal Communications Commission; RJ = ‘Registered Jack’) sec.
  • Page 51 RIGEL MEDICAL FloTest MANUAL TESTED, TRUSTED…WORLDWIDE. 13.2 Index Abbreviations and glossary Gas standards Accessories General principle Acoustic feedback Gestures Appendix Glossary Approvals Guarantee Battery operation Intended use Bluetooth settings Introduction Calibration by user Measurement Changing parts Measurement parameters Cleaning Measurement parameters and units...
  • Page 52 RIGEL MEDICAL FloTest MANUAL Safety instructions 6, Screens Service life Servicing Servicing and care Servicing routines Settings 28, Software updates 34, Spare parts Special functions Specifications Start-up Supply voltage Switching the device on and off Symbols Trigger settings 29, Trouble shooting...

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