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GM INSTRUMENTS Naris User Manual

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Naris
Naris
User Manual
V14
Naris User's Manual V14
14/02/20
Page 1 of 52

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Summary of Contents for GM INSTRUMENTS Naris

  • Page 1 Naris Naris User Manual Naris User’s Manual V14 14/02/20 Page 1 of 52...

  • Page 2: Table Of Contents

    COMMON PROBLEMS AND TROUBLESHOOTING PAGE 24 ACOUSTIC MEASUREMENTS PAGE 25 MAKING MEASUREMENTS PAGE 27 FACTORS WHICH AFFECT ACCURACY PAGE 28 ENVIRONMENTAL FACTORS PAGE 29 MAINTENANCE MICROPHONE AND TRANSDUCER DIAGNOSTICS PAGE 30 Naris User’s Manual V14 14/02/20 Page 2 of 52...
  • Page 3 ENVIRONMENT IN WHICH TO OPERATE THE INSTRUMENT APPENDIX 2: TECHNCIAL INFORMATION (relative to EN 60601-1:2006) PAGE 48 APPENDIX 3: CARE OF FLOWHEADS PAGE 50 APPENDIX 4: DEFINITIONS FOR CLEANING/DISINFECTING/STERILIZING PAGE 52 Naris User’s Manual V14 14/02/20 Page 3 of 52...

  • Page 4: Naris Safety Information

    Federal (USA) law restricts this device to sale by or on the order of a physician. The use of an NR6 Rhinomanometer near to sources of electromagnetic radiation, such as mobile phones, radio transmitters, x-ray equipment etc, may prevent it from functioning Naris User’s Manual V14 14/02/20 Page 4 of 52...
  • Page 5 Any incident, which results in actual or potential injury or death to a subject while using an NR6, should be immediately communicated to GM Instruments at the address on page 7. NR6 should only be connected to other mains-powered devices such as computers and printers, which comply with EN 60950-1 and we also advise the use of a separating transformer.

  • Page 6: Nr6 Rhinomanometer Technical Specifications

    Transportation and Storage Temperature -40 °C to +60 °C Relative 20% to 80% RH non-condensing Humidity Pressure 50 to 106 kPa Mechanical Performance Size 27 x 8 x 30 cm Weight 2 Kg Naris User’s Manual V14 14/02/20 Page 6 of 52...

  • Page 7: Nr6 Rhinomanometer Table Of Symbols Used

    Symbols used on labelling and packaging, as for A1, but with the following additions: Symbol Meaning Location Do not re-use Consumables IEC7000-1051 Packaging- Filter, Nasal Inserts Non- sterile Applied parts packaging- Flowhead ISO7000-2609 Assembly Naris User’s Manual V14 14/02/20 Page 7 of 52...

  • Page 8: A1 Acoustic Rhinometer Safety Information

    Federal (USA) law restricts this device to sale by or on the order of a physician. The use of an A1 Acoustic Rhinometer near to sources of electromagnetic radiation, such as mobile phones, radio transmitters, x-ray equipment etc., may prevent it from functioning correctly. Naris User’s Manual V14 14/02/20 Page 8 of 52...
  • Page 9 Any incident, which results in actual or potential injury or death to a subject while using an A1 should be immediately communicated to GM Instruments at the address on page 6. An A1 should only be connected to other mains-powered devices such as computers and printers, which comply with EN 60950-1 and we also advise the use of a separating transformer.

  • Page 10: A1 Acoustic Rhinometer Technical Specifications

    -40 °C to +60 °C Relative 20% to 80% RH non-condensing Humidity Pressure 50 kPa to 106 kPa Mechanical Performance Size 27 cm x 8 cm x 30 cm Weight 2 Kg Naris User’s Manual V14 14/02/20 Page 10 of 52...

  • Page 11: A1 Acoustic Rhinometer Table Of Symbols

    IEC 60601-1 and IEC 60601-1-2. Symbols used on labelling and packaging: SYMBOL MEANING LOCATION Manufacturer Instrument Label ISO7000-3082 Date of Manufacture Instrument Label Where ZZZZ: Date of Manufacture ISO7000-2497 Serial Number Instrument Label ISO7000-2498 Naris User’s Manual V14 14/02/20 Page 11 of 52...
  • Page 12 ISO 7010- M001 ADDRESS AND CONTACT DETAILS: MANUFACTURED BY: G M INSTRUMENTS LTD, GREIG HOUSE ANNICKBANK INNOVATION CAMPUS, ANNICK ROAD, IRVINE, KA11 4LF, TEL: +44 (0)1294 55466 EMAIL: enquiries@gm-instruments.com WEBSITE: www.gm-instruments.com Naris User’s Manual V14 14/02/20 Page 12 of 52...

  • Page 13: Installation

    Naris INSTALLATION SOFTWARE Installation of the NR6 Software is described fully in the accompanying manual titled “NARIS Software Manual” INSTALLING THE NARIS HARDWARE NR6 HARDWARE CONNECTIONS Please see the pictures below for the NR6 hardware connections: NR6 front view - flowhead and...
  • Page 14 A1 back panel view showing USB socket, which connects to the PC, a link socket, which connects to an NR6 link socket, the sound tube socket, the power socket, and the relevant manufacturing labels. Naris User’s Manual V14 14/02/20 Page 14 of 52...

  • Page 15: Introduction To Measurement Techniques

    The calculation techniques, which are used to present relevant numerical information from the flow and pressure signals, are described in the rhinomanometry standardisation paper. Naris User’s Manual V14 14/02/20 Page 15 of 52...

  • Page 16: How To Make And Record Measurements

    Naris HOW TO MAKE AND RECORD MEASUREMENTS Two methods of acquiring data are provided within the Naris software: rhinomanometric acquisition, and acoustic acquisition. These are described separately in the sections below. RHINOMANOMETER OVERVIEW The measure of rhinomanometry or nasal airway resistance (R) depends on measuring nasal air...
  • Page 17 In addition to resistance values, Rohrer coefficients are also calculated for K1 and K2: K0 should be zero as the curve goes through the origin K1 represents the laminar flow part of the curve K2 represents the turbulent part of the curve Naris User’s Manual V14 14/02/20 Page 17 of 52...

  • Page 18: Performing A Measurement

    The process to be followed is therefore: • connect and test patient • disconnect patient • reconnect and retest patient. Continue this process until the CV figure drops to an acceptable level. Naris User’s Manual V14 14/02/20 Page 18 of 52...

  • Page 19: Performing A Test

    (or foam into FOAM INSERT the nose), position the tube against (alternative to tape/Tip) the cheek where it will be during the test, and check for leakage by blocking the Naris User’s Manual V14 14/02/20 Page 19 of 52...
  • Page 20 In the event of this occurring, the patient should be given time to become familiar with the mask and then asked to breathe more slowly Mask assembly for anterior testing Naris User’s Manual V14 14/02/20 Page 20 of 52...
  • Page 21 ANTERIOR COMPONENTS Hole Punch Anterior Tape Anterior tip connector Single Use Mask Anterior mask with Tape/Tip connections Anterior mask with Foam connections Naris User’s Manual V14 14/02/20 Page 21 of 52...
  • Page 22 (it will pass through the origin) and within a short time the patient will associate a successful test with a certain posture, meaning tests can now be made Naris User’s Manual V14 14/02/20 Page 22 of 52...
  • Page 23 POSTERIOR MEASUREMENT Mask showing Posterior tube connections and above, with a posterior mouth tube included A posterior test being made Naris User’s Manual V14 14/02/20 Page 23 of 52...

  • Page 24: Common Problems And Troubleshooting

    One solution is to remove the USB connection at the PC or instrument side then re-connect. That may be sufficient, but if not, save any results, and close down the instrument software and restart it. Naris User’s Manual V14 14/02/20 Page 24 of 52...

  • Page 25: Acoustic Measurements

    Acoustic icon on the main toolbar, and then on the Calibrate button as show below. A1 Acoustic Rhinometer [USB-201] calibrated will show when completed A1 sound tube with calibration plug fitted, ready for calibration. The system is now ready for use. Naris User’s Manual V14 14/02/20 Page 25 of 52...
  • Page 26 N.B. the caution statement on page 4 at the front of this manual Naris User’s Manual V14 14/02/20 Page 26 of 52...

  • Page 27: Making Measurements

    Print on full page. 7) The results can be saved by clicking on Save, confirming the file name to save to, and then clicking on OK. Naris User’s Manual V14 14/02/20 Page 27 of 52...

  • Page 28: Factors Which Affect Accuracy

    2 or 3 times, testing each time and compare results. The Acoustic Standardisation Committee have now reported on the measurement and this is referred to on page 4 of this manual. Naris User’s Manual V14 14/02/20 Page 28 of 52...

  • Page 29: Environmental Factors

    The effect of altitude is significant on the density of a gas and therefore on the speed of sound, for example, at an altitude of 1km, distance is overestimated by 7%. Naris User’s Manual V14 14/02/20 Page 29 of 52...

  • Page 30: Maintenance

    NR6 circuit board (VR1) can be adjusted in real time to correct this. NR6 (Pressure) Run InstaCal as described above and select your A/D board by highlighting USB-201. Click on Test>Analog>Scan Test>Scan Options Set the following options: Naris User’s Manual V14 14/02/20 Page 30 of 52...
  • Page 31 If it lies significantly lower or higher than zero units the Pressure Offset potentiometer on the NR6 circuit board (VR4) can be adjusted in real time to correct this. Naris User’s Manual V14 14/02/20 Page 31 of 52...

  • Page 32: A1 Troubleshooting

    ▪ You have clicked on save without specifying a file name Export to "%s" has failed! ▪ The data export you have set up has failed. Perhaps the folder name is wrong? Naris User’s Manual V14 14/02/20 Page 32 of 52...
  • Page 33 A1 Acoustic User Software Guide. If issues arise when trying to use the system, the following can be used to check that the system has been correctly set up, and to diagnose any problems: Naris User’s Manual V14 14/02/20 Page 33 of 52...
  • Page 34 The line you see should lie on zero Volts and should move when talking into the open end of the sound tube – if this is ok then the microphone and connections between A1, the A/D card and the PC are ok. Naris User’s Manual V14 14/02/20 Page 34 of 52...
  • Page 35 0 and one as board 1. Provided you go into the software of one of them (File -> Settings -> Device) and change it to board 1 then you can easily switch between each system without having to run InstaCal. Naris User’s Manual V14 14/02/20 Page 35 of 52...
  • Page 36 The second peak shows the reflected signal from the calibration plug returning back down the tube and reaching the microphone again. Each pair of pulses that follow show the event repeating, as the sound travels up and down the closed tube. Naris User’s Manual V14 14/02/20 Page 36 of 52...
  • Page 37 Selection of what constitutes incident and reflected waves is controlled by settings within the A1 program for: incident wave window, reflected wave start point and reflected wavelength. These are set for a particular length of sound tube and should not be altered. Naris User’s Manual V14 14/02/20 Page 37 of 52...

  • Page 38: A1 Spare Parts And Accessories

    USB Cable If you have any questions about your Acoustic Rhinomanometer or require spare parts or consumables (part numbers listed above) then please contact your supplier or GM Instruments directly. We will be able to advise you and give you help with any problem you may encounter.

  • Page 39: Cleaning And Decontamination

    N.B. the white insert screw should mate up with an indentation found on the side wall of the nosepiece holder, via a small grey plastic disc. Naris User’s Manual V14 14/02/20 Page 39 of 52...

  • Page 40: A1 Acoustic Rhinometer Calibration

    N.B. take care to not over tighten the fixing plastic screws when re-fitting the tube as this may cause damage to it Naris User’s Manual V14 14/02/20 Page 40 of 52...

  • Page 41: Nr6 Rhinomanometer Calibration

    Variable former Transformer to NR6 The procedure to be employed is as follows: Naris User’s Manual V14 14/02/20 Page 41 of 52...

  • Page 42: Nr6 Rhinomanometer Maintenance

    Should the enclosure require cleaning for any reason, unplug it from the PC and wipe it with a damp cloth, or a cloth soaked in a mild alcohol based solution or cleaning wipes. Do not allow liquid to run into the enclosure. Naris User’s Manual V14 14/02/20 Page 42 of 52...
  • Page 43 1. Pressure Channel - the gain of the pressure transducer is adjusted by means of calibration potentiometer, VR 2. Flow Channel - the gain of the flow transducers is adjusted by means of calibration potentiometer, VR Naris User’s Manual V14 14/02/20 Page 43 of 52...

  • Page 44: Nr6 Spare Parts And Accessories

    If you have any questions about your Rhinomanometer or require spare parts or consumables (part numbers listed above) then please contact your supplier or GM Instruments directly. We will be able to advise you and give you help with any problem you may encounter.
  • Page 45 Naris User’s Manual V14 14/02/20 Page 45 of 52...

  • Page 46: Appendix 1: Guidance On The Elecetromagnetic

    ± 2 kV line(s) to earth ± 2 kV line(s) to earth for input / output lines Conducted RF 3 V - 150 kHz to 80 MHz 3 Vrms Naris User’s Manual V14 14/02/20 Page 46 of 52...
  • Page 47 <5% U 0% U (>95 % dip in U ) For 5 s (100 % dip in U For 250/300 cycles Power frequency (50/60Hz) 30 A/m 30 A/m Magnetic field IEC61000-4-8 Naris User’s Manual V14 14/02/20 Page 47 of 52...

  • Page 48: Appendix 2: Techncial Information (Relative To En 60601-1:2006)

    7.2.5 NR6 cannot be powered directly from the mains supply 7.2.6 The NR6 USB connection provides DC voltages of 5 volts dc. 7.2.11 The NR6 Rhinomanometer is rated for continuous use. Naris User’s Manual V14 14/02/20 Page 48 of 52...
  • Page 49 7.9.2.15 The applied parts should be disposed of after use in line with your hospital or clinics policy on disposal of potentially contaminated plastic parts. The NR6 Rhinomanometer can be returned to GM Instruments for dismantling and disposal, while your PC/Printer should be returned to your supplier for dismantling and disposal.

  • Page 50: Appendix 3: Care Of Flowheads

    The MF100L has linearity of 3% or better in the normal range. It is essential for accuracy to ensure that the gauze assembly is kept clean from contaminants and that the head itself is kept free of infectious agents. Naris User’s Manual V14 14/02/20 Page 50 of 52...
  • Page 51 GMI for a replacement. Note definitions of Definitions for Cleaning/Disinfecting/Sterilising are show in Appendix 4 Naris User’s Manual V14 14/02/20 Page 51 of 52...

  • Page 52: Appendix 4: Definitions For Cleaning/Disinfecting/Sterilizing

    Decontamination is a general term for the destruction or removal of microbial contamination to render an item safe. This will include methods of cleaning, disinfection and sterilisation. Naris User’s Manual V14 14/02/20 Page 52 of 52...

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