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Naris

Naris

User’s

Manual V14 14/02/20 Page 48 of 52

APPENDIX 2: TECHNCIAL INFORMATION (relative to EN 60601-1:2006)

No modification to this equipment is allowed

.

6.2

When the NR6 Rhinomanometer is powered by a PC, power can be removed by

unplugging the PC mains plug, by switching power off at the mains plug, or by removing the
USB cable from either socket.

It complies with the specification for Class I ME equipment, and can only be used along with
a PC and printer, normally supplied by the customer. NB the warning made earlier about the
PC and printer being compliant with EN 60950 and placing these items out of the reach of a
subject.

The Applied Parts comprise, mask, anti-viral filter or posterior or anterior tubing, tip
connector, microfoam tape, foam inserts, flowhead and silicone rubber tubes which are
classified as type B applied part.

6.3

The enclosure does not provide protection against the ingress of liquids and is therefore

classified as IPX0.

6.4

There are no parts which are supplied sterile or are required to be sterile.

6.5

The NR6 Rhinomanometer is

NOT

suitable for use in an oxygen rich environment.

6.6

The NR6 Rhinomanometer rated for continuous use.

7.2.2

The NR6 serial number can be found on the label on the back panel, and the software

version number can be viewed on the start-up screen and by clicking on Help, found on the
top bar of the NR6 software

7.2.3

Information is given in the Warning and Caution section of this manual, which the user

must read prior to operating this instrument. Appropriate labels are fixed to the back panel

7.2.4

Single use parts are identified by packaging labels detailing single use only

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.

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Содержание Naris

Страница 1: ...Naris Naris User s Manual V14 14 02 20 Page 1 of 52 Naris User Manual V14 ...

Страница 2: ...ETER TECHNICAL SPECIFICATIONS PAGE 10 A1 ACOUSTIC RHINOMETER TABLE OF SYMBOLS PAGE 11 INSTALLATION PAGE 13 INTRODUCTION TO MEASUREMENT TECHNIQUES PAGE 15 HOW TO MAKE AND RECORD MEASUREMENTS RHINOMANOMETER OVERVIEW PAGE 16 PERFORMING A MEASUREMENT PAGE 18 PERFORMING A TEST PAGE 19 COMMON PROBLEMS AND TROUBLESHOOTING PAGE 24 ACOUSTIC MEASUREMENTS PAGE 25 MAKING MEASUREMENTS PAGE 27 FACTORS WHICH AFF...

Страница 3: ...R ROUTINE MAINTENANCE PAGE 40 NR6 RHINOMANOMETER CALIBRATION PAGE 41 NR6 RHINOMANOMETER MAINTENANCE PAGE 42 NR6 SPARE PARTS AND ACCESSORIES PAGE 44 APPENDIX 1 GUIDANCE ON THE ELECETROMAGNETIC PAGE 46 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 DISINFECTIN...

Страница 4: ...and the NR6 If your PC or printer does not have a power supply approved for a patient environment then an isolation transformer which complies with BS EN 60601 1 should be used to power the PC Printer You must use the transformer or run the PC by battery to ensure that the NR6 is in compliance with BS EN 60601 1 Applied Parts The applied parts consist of single use foam inserts microfoam tape tip ...

Страница 5: ...ge 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 Unless computers and printers built to EN 60950 are used patient safety might be compromised Non medical equipment such as computers and printers should be kept out of reach of subjects being tested as such equipment doe...

Страница 6: ...be made available to competent persons on request Medical CE Mark The CE mark indicates that the device meets the requirement of Annex V VII of the Medical Device Directive 94 42 EEC Standards Safety BE EN 60601 1 2006 EMC BS EN 60601 1 2007 Performance Flow Range 800 cc sec Pressure Range 800 Pa Accuracy 2 Operation Environment Temperature 15 o C to 35 C Relative Humidity 20 to 80 RH non condensi...

Страница 7: ...rument Front Panel Flow head Assembly Protective Earth IEC 60417 5019 _ Instrument Back panel Internal _ For connected parts marked only connect the accessories supplied with the instrument These parts have been tested for use with the instrument for compliance to standards IEC 60601 1 and IEC 60601 1 2 Symbols used on labelling and packaging as for A1 but with the following additions Symbol Meani...

Страница 8: ...connected product it is advisable to not touch the patient while using the equipment The equipment should be positioned in such a way that it can be easily disconnected from the mains supply The operation of the system can be safely terminated by switching off the device or removing the mains plug The applied part is the nosepiece which is marked for single use It should not be re used as no metho...

Страница 9: ...omputers and printers which comply with EN 60950 1 and we also advise the use of a separating transformer Unless computers and printers built to EN 60950 are used patient safety might be compromised Non medical equipment such as computers and printers should be kept out of reach of subjects being tested as such equipment does not comply with medical safety standards Refer to clause 16 of EN 60601 ...

Страница 10: ...al CE Mark The CE mark indicates that the device meets the requirement of Annex V VII of the Medical Device Directive 94 42 EEC Standards Safety BE EN 60601 1 2006 EMC BS EN 60601 1 2007 Performance using standard nose Repeatability Better than 2 Volume Accuracy 0cm to 5cm Better than 2 Minimum Area Accuracy within 0cm to 5cm Better than 5 Area Range max 20 default 10 0 1 cm2 to 10 cm2 Distance Ra...

Страница 11: ... Compliant 5 Pin Socket Instrument Front Panel Sound Tube Protective Earth IEC 60417 5019 _ Instrument Back panel Internal _ Direct Current IEC 60417 5931 _ Mains Adaptor AC DC _ For connected parts marked only connect the accessories supplied with the instrument These parts have been tested for use with the instrument for compliance to standards IEC 60601 1 and IEC 60601 1 2 Symbols used on label...

Страница 12: ...O7000 2609 Applied parts packaging Nosepieces Temperature Limit ISO7000 0632 Instrument Shipper Packaging HumidityLimitation ISO7000 2620 Instrument Shipper Packaging Mandatory Action Sign ISO 7010 M001 Operating Manual ADDRESS AND CONTACT DETAILS MANUFACTURED BY G M INSTRUMENTS LTD GREIG HOUSE ANNICKBANK INNOVATION CAMPUS ANNICK ROAD IRVINE KA11 4LF UK TEL 44 0 1294 55466 EMAIL enquiries gm instr...

Страница 13: ...e Red is the positive flow input Green is the negative flow input Connect each tube onto the input nozzle with the corresponding coloured marker i e black black red red etc Connect the free ends of the tubes to their corresponding coloured markers green and red tubes onto the green and red nozzles on the flowhead and the tube marked blue onto the mask port marked blue If you are going to be making...

Страница 14: ...nual V14 14 02 20 Page 14 of 52 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 ...

Страница 15: ...as been developed for use in the tracheo bronchial system by Jackson et al 1977 and for use in the nose by Hilberg et al 1989 For further information the reader should consult these publications 1 A C JACKSON J P BUTLER E J MILLET F G HOPPIN JR AND S V DAWSON Airway geometry by analysis of acoustic pulse response measurements J Appl Physiol 43 3 523 536 1977 2 J A WARE AND K AKI Continuous and dis...

Страница 16: ...rameter to measure and this is done using one of two standard techniques ANTERIOR TEST detailed on P12 In the anterior test the black pressure tube is connected to one side of the nose while airflow is measured through the other side allowing for resistance to be calculated on that side The pressure tube is then moved to the second side flow is recorded and resistance is calculated again The two r...

Страница 17: ... of the tube with the black ring marker on it which is connected to the black nozzle on the outside of the mask The reference pressure tube blue is also connected to the outside of the mask Patient co operation is required to use this technique in which a measure of total nasal resistance is obtained from one test PRINCIPAL POINTS TO NOTE 1 Prepare the patient by having them wait in relaxed quiet ...

Страница 18: ...d prior to testing They should also be advised to breathe at a normal level and rate b POOR PATIENT CONNECTION The pressure tube and mask must not leak and must be placed on the face correctly to avoid distorting the nose Errors arising from a can be avoided by careful processing of patients prior to testing and those arising from b can be checked by using the batch test facility Clinical Research...

Страница 19: ...thod flow is measured on the open nostril The mouth should be closed during the test and once the resistance figure for one side has been obtained the role of the nostrils is reversed by moving the tape assembly or foam insert to the other nostril It is a fundamental requirement of this technique that an airtight connection of the instrument pressure tube onto one side of the nose be made with as ...

Страница 20: ...t to maintain pressure on the mask to achieve an airtight seal while closing their lips and breathing through their nose Ensure that the patient s fingers do not obstruct the output from the flowhead There are two principal hazards associated with this technique a The patient could press so hard that the anterior tube collapses and is obstructed completely this will result in the display showing a...

Страница 21: ...f the cheek Test for leakage Place the mask on the face to secure the tube Ask the subject to quietly breath through their nose with their mouth closed If the traces reach the default sample point click on the red button to record data If not ask them to increase the depth of their breathing After four cycles have been recorded default move the foam or tape to the other nostril and repeat the proc...

Страница 22: ...que does not interfere in any way with the nasal passages but it does have the disadvantage that it depends on the mouth area having an uninterrupted connection to the respiratory tract It is therefore essential that a the subject does not bite the mouth tube b the end of the tube is not blocked by the tongue cheek or saliva c the soft palate is relaxed and the back of the tongue is held down in t...

Страница 23: ...th the mask in position If the cheeks can move in and out the soft palate tongue etc must be correctly positioned and posterior measurements can be made 3 Keeping the head erect and the jaw forward during measurements can also help keep the back of the mouth in direct contact with the nasal driving pressure signal POSTERIOR MEASUREMENT Mask showing Posterior tube connections and above with a poste...

Страница 24: ... applied or moves in a very erratic way This suggests that the A D card has not been installed properly has it been set to Board 0 or there is no connection between the NR6 and the PC Is the green light on the front of NR6 illuminated e There is no response on the screen to flow or pressure input but the connections are intact and the light on the front of the instrument is lit 1 Check that the US...

Страница 25: ...orrect operation To perform a calibration switch on the A1 put the calibration plug in the sound tube click on the 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 ...

Страница 26: ...ith the least distortion The conical nosepieces are suitable for use with a nose which has a small round opening while the anatomical nosepieces are designed to sit on the outside of a nose with a long narrow opening and are shaped to make it easy in most circumstances to get a good seal In addition they have a flange which a soluble gel can be put onto to reduce any remaining gap CHILD NOSEPIECES...

Страница 27: ...dle click on the mouse with the cursor inside the capture window to sample the data This process can be repeated until at least 3 consecutive results show little variation If the patient can co operate the measurements may be made in rapid succession with 600mS or so between samples during a single breath hold manoeuvre N B a footswitch optional extra is available as an alternative to clicking on ...

Страница 28: ...5 dB Angle of probe relative to the head Aim for floor of nose Rigidity of probe Doesn t move Effect of probe on the nose Avoid distortion Patient co operation Hold breath during measurements Nosepiece nose seal Use gel and careful positioning to ensure a good seal Check for leaks Distortion Repeat test at least twice if not 3 times and check for variation i e apply remove probe 2 or 3 times testi...

Страница 29: ...its density and therefore the rate at which the pulse travels through the gas The overall effect is in the range of 3 20 oC Distance is therefore slightly overestimated if there is an increase in temperature ALTITUDE EFFECT 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 ...

Страница 30: ...ube end you will see the response on the trace in the window NR6 Flow 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 Scan channels CH1 through CH1 A D range 10 Volts Scan rate 1000 Mode Continuous Data format Volts Click on OK Start If you now create a flow through the flowhead or gently press ...

Страница 31: ...tart If you now create a pressure on the NR6 pressure tube or gently press on the pressure nozzle the trace will show this The trace should lie at close to zero units and travel up and down from there 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 ...

Страница 32: ...dows font folder License key is missing or invalid Either no license key is present or it does not match the program License key does not match product The key file in the program folder does not match the program The requested file cannot be loaded in this application The record file you tried to load is not matched to this program File saving attempt failed The record file has not been saved is ...

Страница 33: ...09 Signal below trigger level Either there is no click it is weak or the microphone or cable is faulty Use A1Test exe to measure signal strength If appropriate VR2 may be increased if the signal is only a little below the trigger level or the trigger level setting can be reduced to below the measured signal level in the Acquisition adv tab Details on how to use A1test exe can be found below Error ...

Страница 34: ...folder The opening dialog will show which boards are installed The board you installed should be numbered 0 or the corresponding number in the A1 software if for some reason you have multiple devices installed Select Test from the top bar and Analog from the drop down menu then CH0 signal source External and A D range 10V for 201 USB interface The line you see should lie on zero Volts and should m...

Страница 35: ...one already recorded is no longer present by comparing serial numbers and offer to remove it When you answer yes InstaCal will offer to record the new USB interface and when you click OK it will edit the ini file to include the new board type and serial number If board 0 is free it will automatically allocate it to board 0 otherwise it will allocate it to the lowest available board number It is fo...

Страница 36: ...lay when the calibration plug is fitted to the sound tube and sample is selected The peak pulse size is also documented in the table on the left hand side as Maximum It should peak at a level greater than that set within the A1 program for Trigger and using VR2 is normally set to between 3200 and 3500 If the peak height is smaller than this the level can be increased by using the gain control resi...

Страница 37: ... and you will be able to hear the click when Sample is selected 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 ...

Страница 38: ...l Nose and Straight Tube A1 test ONE SPARE PARTS AND ACCESSORIES NOSEPIECES A1 PRM Medium anatomically conformed nosepiece A1 PRL Large anatomically conformed nosepiece A1 PR8 Conical nosepiece MISCELLANEOUS A1 PLUG Replacement calibration plug A1 MIC Replacement microphone and inner sound tube A1 CABLE USB Cable If you have any questions about your Acoustic Rhinomanometer or require spare parts o...

Страница 39: ...t we recommend using a flat head screwdriver c Loosen the inner sound tube securing white insert screw from the sound generator box and withdraw the tube The tube can now be cleaned with a non alcoholic antiseptic wipe push the wipe down the sound tube with a suitably long thin object and if desired gas sterilised Do not allow liquids to run into the tube as the microphone could be damaged d Assem...

Страница 40: ...emoved from the sound box cleaned by one of the methods described below and then thoroughly dried prior to reconnecting it to the sound box N B Take care not to over tighten the fixing screws when re fitting the tube as this could damage the tube ROUTINE MAINTENANCE Nosepieces are supplied for single use only Care should be taken in use to prevent the passage of nasal secretions down the nosepiece...

Страница 41: ...g static individual calibration units such as a liquid column for pressure and a rotameter for flow CALIBRATION EQUIPMENT to NR6 Pressure Port Black A Pressure Gauge a liquid column covering the range 0 500 Pa 51mm H20 It is an added convenience if this is connected in the manner shown because adjustment to the desired pressure level is more easily achieved Hand Pump Reservoir Liquid Column B Flow...

Страница 42: ...urther adjustment of the pressure calibration potentiometer MAINTENANCE The routine maintenance which is required is as follows a Regularly check the condition of the pneumotachograph which is mounted on the mask and the condition of the plastic tubes which connect the mask to the instrument The pneumotachograph should be kept clean as dust build up on the gauze will result in incorrect results Th...

Страница 43: ...STMENTS 1 Switch on the NR6 and allow 5 minutes to warm up 2 Measure the voltage between test point 5 and test point 4 using a sensitive DC voltmeter Adjust pressure offset potentiometer VR4 to give a reading of 0 volts 3 Measure the voltage between test point 5 and test point 6 using a sensitive DC voltmeter Adjust flow offset potentiometer VR1 to give a reading of 0 volts TRANSDUCER CALIBRATION ...

Страница 44: ...NE Anterior Tubing NR ANTUB 1 metre length Tip Connectors NR TIP CON Pkt 5 Tape for Tip Connectors NR TAPE ONE Foam Inserts Large NR Large Inserts Pkt 4 Foam Inserts Standard NR Std Insert Pkt 4 Foam Inserts Small NR Small InsertPkt 4 Hole Punch for tape NR HP ONE POSTERIOR PARTS Posterior Mouth Tubes NR POSTUB 1 metre length Spare Parts and Consumables If you have any questions about your Rhinoma...

Страница 45: ...at your right to copy any part of them is limited by copyright law Making copies or derivative works except in certain limited instances and except for making copies for archival purposes or as an essential step in the utilisation of the computer program in conjunction with an instrument without prior authorisation is prohibited by copyright law and constitutes a punishable violation of such law ...

Страница 46: ...act 2 4 8 15 kV air 8 kV contact 2 4 8 15 kV air Radiated RF EM Fields IEC61000 4 3 3 V m 80 MHz to 2 7 GHz 3 V m 80 MHz to 2 7 GHz Proximity fields from RF wireless communications IEC61000 4 3 385MHz 27 V m 450MHz 28 V m 710 745 780MHz 9 V m 810 870 930MHz 28V m 1 72 1 845 1 97GHz 28 V m 2 45 GHz 28 V m 5 24 5 5 5 875GHz 9 V m 385MHz 27 V m 450MHz 28 V m 710 745 780MHz 9 V m 810 870 930MHz 28V m ...

Страница 47: ...oltage variations on power supply input lines IEC61000 4 11 0 UT 100 dip in UT For 0 5 cycle 0 UT 100 dip in UT For 1 cycle 70 UT 30 dip in UT for 25 30 cycles 0 UT 100 dip in UT For 250 300 cycles 5 UT 95 dip in UT For 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT For 5 s Power frequency 50 60Hz Magnetic field IEC61000 4 8 30 A m 30 A m ...

Страница 48: ...fied as type B applied part 6 3 The enclosure does not provide protection against the ingress of liquids and is therefore classified as IPX0 6 4 There are no parts which are supplied sterile or are required to be sterile 6 5 The NR6 Rhinomanometer is NOT suitable for use in an oxygen rich environment 6 6 The NR6 Rhinomanometer rated for continuous use 7 2 2 The NR6 serial number can be found on th...

Страница 49: ...keeping the equipment clean and cables free of twisting 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 These parts a...

Страница 50: ...nute 4 The passage of flow through the head must be laminar It would be particularly misleading if for example a syringe with a small outlet diameter was used to put a known volume of air through a flowhead to check the calibration of NV2 The air from the syringe would simply pass through the gauze at one spot instead of covering the whole area and the flow and therefore volume indicated would be ...

Страница 51: ...steps above if required 8 Check the flowhead for damage Special care should be taken to ensure that the annular rings which connect to the pressure ports within the flowhead are also thoroughly dry before re using the head Washing does not affect the pressure drop produced at a given flow and therefore does not alter the instrument calibration provided all detergent etc is removed before the heads...

Страница 52: ...normal and intact skin eg stethoscopes washing bowls cleaning and drying usually adequate To define the terms within the definitions above Sterilisation is a process used to reduce an object free from all living organisms Disinfection is a process used to reduce the number of microorganisms but not usually of bacterial spores the process does not necessarily kill or remove all microorganisms but r...

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