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Rhinomanometer NR6

NR6 User

’s

Manual V 16 14/02/2020 P30 of 34

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

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 in accordance with MDD
93/42/EEC and can only be used along with a PC and printer, normally supplied by the
customer. The patient environment and conditions for usage are defined earlier.

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.

7.2.17

Environmental conditions for transport and storage with no additional special

measures
Temperature:

-40 °C to +60 °C

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Содержание NR6

Страница 1: ...Rhinomanometer NR6 NR6 User s Manual V 16 14 02 2020 P1 of 34 Rhinomanometer NR6 User Manual and Installation Notes V16 ...

Страница 2: ... TEST PROCESS PAGE 15 POSTERIOR METHOD PAGE 16 POSTERIOR MEASUREMENT PAGE 17 COMMON PROBLEMS AND TROUBLESHOOTING PAGE 18 ERROR MESSAGES Page 19 CLEANING OF PATIENT CONTACT PARTS PAGE 21 SUPPLIED PARTS PAGE 23 SPARE PARTS AND CONSUMABLES PAGE 23 MAINTENANCE MANUAL PAGE 24 CALIBRATION PAGE 24 MAINTENANCE PAGE 25 SERVICING PAGE 26 APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY PAGE 28 APPENDIX 2 TECHNICAL ...

Страница 3: ...acturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the ME SYSTEM including cables specified by the manufacturer Otherwi...

Страница 4: ...60950 1 Option 2 Patient Environment for Medically approved PC Printer Figure 2 Patient Environment for Medically approved PC Printer If the PC and or printer is compliant to BS EN 60601 1 and medically approved then the Printer and PC can be positioned within the patient environment as shown in Figure 2 In circumstances where the PC and or printer are not medically approved but are to be used wit...

Страница 5: ...n the event of a single fault condition arising leakage current will be limited to less than 0 5 mA 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 8 Non medical equipment such as computers and printers should be kept out of reach of subjects being tested as such equipment ...

Страница 6: ... 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 A1 2013 EMC BS EN 60601 1 2 2015 Performance Flow Range 800cc sec Pressure Range 800Pa Accuracy 2 Operation Environment Temperature 15 o C to 35 C Relative Humidity 20 to 80 RH non condensing Pressure 50 to 106 Kpa Duty Cycle Continuous Warm...

Страница 7: ... Tubing 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 SYMBOL MEANING LOCATION Manufacturer ISO7000 3082 Instrument Label Date of Manufactur...

Страница 8: ...re Limit ISO7000 0632 Instrument Shipper Packaging Humidity Limitation ISO7000 2620 Instrument Shipper Packaging Atmospheric Pressure limitation ISO7000 2621 Instrument Shipper Packaging Mandatory Action Sign ISO 7010 M001 Operating Manual ADDRESS AND CONTACT DETAILS MANUFACTURED BY GM Instruments Ltd Greig House Annickbank Innovation Campus Annick Road Irvine KA11 4LF UK TEL 44 0 1294 554664 EMAI...

Страница 9: ...SB cable from the PC into the NR6 NR6 REAR VIEW AND CONNECTIONS NOTE LINK SOCKET ONLY USED WHEN CONNECTRED WITH A1 IN NARIS CONFIGURATION NR6 FRONT VIEW AND CONNECTIONS The NR6 box has four nozzles on it which are colour coded Black is the pressure input Blue is the pressure reference Red is the positive flow input Green is the negative flow input Connect each tube onto the input nozzle with the c...

Страница 10: ...then put into the formula below to calculate total resistance The pressure connection to the nose is made by either a tip connector pushed through a small hole punched in microfoam tape or a foam insert linked to the black pressure tube using anterior tubing and an anterior connector The reference pressure tube blue is connected to the mask It is essential that the pressure connection is airtight ...

Страница 11: ...tance is obtained from one test PRINCIPAL POINTS TO NOTE 1 Prepare the patient by having them wait in relaxed quiet conditions for 15 to 20 minutes prior to measurements being taken and decongest them 2 Check for leakage of the pressure tube and for good mask fit 3 Ask the patient to breathe in a quiet relaxed way avoid excited rapid manoeuvres Posterior and Anterior tests can be performed using a...

Страница 12: ... patient with automatic comparison of one of the measured parameters and production of mean standard deviation and coefficient of variation figures for the test runs repeated for that patient 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 Determination of satisfa...

Страница 13: ...this method 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 w...

Страница 14: ...atient 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 show...

Страница 15: ...oft part of 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 4 default cycles have been recorded move the foam or tape to the other nostril and repeat t...

Страница 16: ...e 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 the mouth Difficulty may be experienced in...

Страница 17: ...n 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 posterior mouth tube included A posterior tes...

Страница 18: ...tion 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 USB cable is in place linking the NR6 and PC 2 Run the program Instacal to ensure that the NR6 USB module has been recognised by the PC see software manua...

Страница 19: ... 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 the folder valid and is set with permissions to save to Target file already exists You are attempting to overwrite an existing file with this name Directory s does not exist The directory folder you are trying to save...

Страница 20: ...y and then right click in the folder containing the software and select Paste Explanation of how the InstaCal program works Each time InstaCal is opened it looks to see what Measurement Computing Company interfaces it can find The first one found is designated board 0 and the next board 1 etc It records the board type and serial number and automatically edits a ini file to include this information...

Страница 21: ...TACT PARTS In the case of the Rhinomanometer direct patient contact can be made by SINGLE USE ITEMS These should be disposed of after use Single use mask Anti viral filter Posterior tubing Anterior tubing Tip connector Microfoam tape Foam inserts REUSABLE ITEMS These can be reused if decontamination process is followed as per the instructions of the mask manufacturer supplied with the masks Re usa...

Страница 22: ...intended for use by one patient only and over a period not exceeding 24 hours Its use must be restricted to situations approved by Intersurgical Westmed No filter is 100 efficient so you may consider it prudent if dealing with a patient who has a known or probable infection problem to decontaminate the flowhead after use even when a filter has been used Further details for this can be found in App...

Страница 23: ...or NR AT CON ONE 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 abou...

Страница 24: ...essure They can be set using 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 Res...

Страница 25: ...e and if necessary make a further 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 res...

Страница 26: ...converter Full circuit diagrams are available on request and service adjustments are noted below TRANSDUCER SETUP ADJUSTMENTS 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 us...

Страница 27: ... Copyright G M Instruments Ltd 2017 All rights reserved Copyright Protection Software and manuals are copyrighted which means that 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 wi...

Страница 28: ...tatic discharge ESD IEC61000 4 2 8 kV contact 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 ...

Страница 29: ...en 150 kHz to 80 MHz N A Voltage dips short interruptions and voltage 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 N A Power frequency 50 60Hz Magnetic field IEC61000 4 8 30 A m 30 A m ...

Страница 30: ...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...

Страница 31: ...ing 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 are subject to the WEEE directive and should not be d...

Страница 32: ...es minute 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 woul...

Страница 33: ...peat 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 ...

Страница 34: ...with 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 ...

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