Rhinomanometer NR6 - G M Instruments Ltd.
Contents
1. The mask assembly comprises a pneumotachograph to measure flow and a mouth tube onto which can be added disposable mouthpieces to measure pressure The subject is asked to put the disposable tube in his mouth and close his lips round it while breathing through the nose Under ideal conditions the pressure developed in the mouth will equal that behind the nasal passages and by dividing this pressure by the flow passing a measure of resistance is obtained Resistance Pressure Flow This technique does not interfere in any way with the nasal passages but is 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 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 training some subjects to perform satisfactorily success figures of around 80 for adults and 50 70 for children may be typical Two techniques have been found useful in training subjects 1 Allow the subject to obtain visual feedback by watching the screen The clinician by looking at the trace can tell the patient when a valid test has been obtained and within a short time the patient will associate a successful test with a certain posture and measurement can be made Filter r Flowhead2. Anterior parts Anterior Tube Connector Anterior Tubing Tip Connectors Tape for Tip Connectors Hole Punch for tape Foam Inserts Large Foam Inserts Standard Foam Inserts Small Posterior parts Posterior Mouth Tubes Available to order NR FL NR RA NR RC NR Filter NR Cap NR AT CON NR ANTUB NR TIP CON NR TAPE NR HP NR Large Inserts NR Std Insert NR Small Insert NR POSTUB All of the parts listed above Adult Masks single use Child Masks single use Rhinocal supplied with the Clinical Research NR6 but also available separately MANUFACTURED BY NR6 Users Manual V 10 NR SA NR SC NR CAL GM INSTRUMENTS LTD Standard Unit ONE ONE ONE ONE 10 pkt ONE 1 metre lengths ten box 12 box ONE 24 pkt 50 pkt 50 pkt 1 metre lengths ONE ONE ONE UNIT 6 ASHGROVE WORKSHOPS ASHGROVE ROAD KILWINNING KA13 6PU UK TEL 01294 554664 FAX 01294 551154 EMAIL gminstruments aol com enquiries m instruments com WEB www gm instruments com 11 09 2012 P24 of 23
3. ONE USB Cable NR USB ONE Flowhead NR FL ONE 4 tube set NR 4T ONE Software Manual NR SM ONE User Manual NR UM ONE NR6 Software CD NR Disk ONE Measurement Computing CD MCC ONE Rhinocal Exec versions only NR CAL ONE Consumables Starter Pack Common parts Adult Mask Re useable NR RA ONE Child Mask Re useable NR RC ONE Filter single use NR Filter ONE Anterior parts Anterior Tube Connector 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 Hole Punch for tape NR HP ONE Foam Inserts Large NR Large Inserts Pkt 4 Foam Inserts Standard NR Std Insert Pkt 4 Foam Inserts Small NR Small Insert Pkt 4 Posterior parts Posterior Mouth Tubes NR POSTUB 1 metre length NR6 Users Manual V 10 11 09 2012 P9 of 23 Rhinomanometer NR6 ENVIRONMENTAL REQUIREMENTS TEMPERATURE The normal operating temperature range is from 15 C to 35 C The transducers are temperature compensated between those limits but the flowhead calibration will be affected at the rate of 5 20 C change The calibration is initially set at 18 C HUMIDITY The operating relative humidity range is from 20 to 80 non condensing COMPUTERS SUPPORTED The software and hardware can be provided in a format suitable for IBM or compatible PC s with a free USB port Computers built to BS EN 60950 1 are recommended PRINTERS SUPPORTED As this version of the Rhinomanometer operates in a Windows envir
4. H U Red Green Flow 2 Ask the subject to breathe through his nose deeply with his mouth shut and adopt a position that allows his cheeks to puff out with each expiration Try it first of all without the mask and then with the mask in position If the cheeks can move in and out the soft NR6 Users Manual V 10 11 09 2012 P16 of 23 Rhinomanometer NR6 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 COMMON PROBLEMS amp TROUBLESHOOTING The NR6 is almost perfect it s the patients which cause the problems The principal problems are as follows 1 There is leakage in the pressure tube circuit The trace is almost vertical and its only when using the Broms technique that you can calculate results because the trace will not reach the 75 Pa or 150 Pa sample point threshold line used in the standard technique Check the pressure tube connections to the patient and to the NR6 box black ringed tube 2 There is leakage in the flow circuit The trace is almost horizontal indicating a very high resistance or little or no flow component 3 Check the mask fit and the tube runs between the flowhead and the NR6 box red amp green Check that the black mask port is capped when doing an anterior test 4 The spot do
5. Rhinomanometer NR6 instruments Ltd Rhinomanometer NR6 User Manual and Installation Notes V10 C 0473 NR6 Users Manual V 10 11 09 2012 P1 of 23 Rhinomanometer NR6 TABLE OF CONTENTS INTRODUCTION P5 SAFETY WARNING CAUTION STATEMENTS P6 RISK ASSESSMENT FOR PATIENT CONTACT COMPONENTS P7 PRODUCT SUPPORT P9 PACKAGE amp CONTENTS P9 ENVIRONMENTAL REQUIREMENTS P10 COMPUTER SUPPORTED P10 PRINTERS SUPPORTED P10 PRODUCT FEATURES and SPECIFICATION P10 RHINOMANOMETRY OVERVIEW P11 PERFORMING A MEASUREMENT P13 COMMON PROBLEMS TROUBLESHOOTING P17 MAINTENANCE MANUAL P20 CONSUMABLES amp ACCESSORIES P23 CONTACT DETAILS P23 NR6 Users Manual V 10 11 09 2012 P2 of 23 Rhinomanometer NR6 TRADEMARKS IBM personal system 2 and PS 2 are trademarks of International Business Machines Corporation Microfoam is a trademark of the 3M Company WINDOWS is a trademark of Microsoft Company COPYRIGHT NOTICE Copyright GM Instruments Ltd 2011 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 with an NR6 Rhinomanometer card without prior authorisation is prohibited by copyright law and constitutes a punishable vi
6. ctured by GMI refer to the sterilisation procedures in that product s operating manual where appropriate DO NOT STERILISE THE INSTRUMENT To sterilise patient applied parts follow these directions 1 Place each part in a suitable vented sterilisation pouch e g Tyvak side or port Include a sterility indicator designed for use with Ethylene Oxide and heat seal the package with a device specifically designed for this purpose 2 Place the sealed packages in a sterilisation chamber designed for 100 ethylene oxide gas After loading the packages according to the sterilisation chamber manufacturer s directions close and secure the chamber door 3 Evacuate the sterilisation chamber to a pressure of 0 01 atmospheres 7 6 mm Hg 4 Fill the sterilisation chamber with 100 ethylene oxide gas until the chamber pressure reaches 0 2 atmospheres 152 mm Hg 5 Increase the sterilisation chamber temperature to 48 C 6 Maintain the sterilisation chamber temperature at 48 C for 210 minutes 3 5 hours 7 Reduce the sterilisation chamber temperature to room temperature Purge ethylene oxide from the sterilisation chamber according to manufacturer s directions and local environmental regulations 8 After sterilisation place the sealed packages in a quarantined ventilated area away from human contact for at least 2 days to allow any residual ethylene oxide gas to disperse Follow local environmental regulations selecting the area and posting n
7. ecessary cautionary statements 9 Examine each sealed package s sterility indicator Discard or re sterilise any part if its sterility indicator is negative or the package is broken or opened Store the sterilised packages in a cool dry place Sterilisation chamber conditions may be affected by age lack of periodic re calibration metering errors or other problems The effectiveness of the sterilisation procedure with your specific equipment should be validated by an independent accredited testing laboratory to certify sterility and package integrity after sterilisation Check with a local accredited laboratory for further guidance Never make the assumption that re sterilised patient applied parts are sterile until sterility certification has been established NR6 Users Manual V 10 11 09 2012 P19 of 23 Rhinomanometer NR6 GMI assumes no responsibility that this sterilisation procedure for patient applied parts will be effective with your specific sterilisation equipment Independent sterility certification by an accredited testing laboratory is the only validation method that can establish this level of confidence NR6 Users Manual V 10 11 09 2012 P20 of 23 Rhinomanometer NR6 Maintenance Manual NR6 Calibration A calibration check should be made and if required the instrument adjusted in the following circumstances If the pressure or flow transducers are changed If the flowhead is contaminated with dust or other particl
8. epeated for that patient The process to be followed is therefore connect and test patient disconnect patient reconnect and retest patient Continue the process until the CV figure drops to an acceptable level NR6 Users Manual V 10 11 09 2012 P13 of 23 Rhinomanometer NR6 TO PERFORM A TEST The patient should be connected to the instrument only when the screen shows the flow and pressure axis and after checking that the dot lies on the origin of the graph If the system is not correctly zeroed press Z for zero or click on the zero button a ANTERIOR METHOD The anterior test requires no patient co operation and can therefore be performed an any subject The technique requires that one side of the nose is used as an extension to the pressure tube to monitor the pressure component relative to the mask pressure and this connection is achieved using either 1 Microfoam tape a tip connector anterior tubing and an anterior connector or 2 a foam insert anterior tubing and an anterior connector If resistance of the total nose including the nasal valve area is required the tape method should be used but if the nasal valve area is not of interest the foam inserts may be used The black mask connector should be sealed for anterior use as it is not required 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
9. ers Manual V 10 11 09 2012 P12 of 23 Rhinomanometer NR6 PERFORMING A MEASUREMENT The program has adopted many standard windows conventions and can be controlled by using the mouse function keys or hot letter keys Most are self explanatory but some features may not be immediately obvious e g how to compare one test against another to get change figures or how to mark a group of files for printout A software guide has been supplied separately to aid quick referral BATCH TEST FACILITY Executive version only Measurements can be made in full on a one at a time basis or alternatively the batch test facility can be used Most errors in Rhinomanometer can be attributed to a Poor patient preparation They should be in a stable environment for 15 20 minutes and blow their nose or be decongested prior to testing They should also be advised to breathe at a normal rate and level or b Poor patient connection The pressure tube and mask must not leak and must be placed correctly on the face 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 by using the batch test facility Clinical Research version only Essentially the batch test facility allows rapid retesting of a 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 r
10. es not move when a pressure or flow is 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 and 4 channel differential or there is no connection between the NR6 and the PC Is the green light on the front of NR6 illuminated 5 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 If the PC has been allowed to go in to sleep mode the USB interface is powered down When brought out of sleep mode the PC does not re initialise the USB interface and therefore it is effectively not present A 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 then close down the instrument software and restart it NR6 Users Manual V 10 11 09 2012 P17 of 23 Rhinomanometer NR6 NR6 Users Manual V 10 11 09 2012 P18 of 23 Rhinomanometer NR6 HOW TO STERILISE REUSABLE PARTS Never reuse or re sterilise any patient applied part whose original package was labelled with FOR ONE TIME USE SINGLE USE DISPOSE AFTER USE or equivalent wording When in doubt about whether a patient applied part can be re sterilised always consider it for one time use The following sterilisation procedure is intended for removable reusable patient applied parts manufactured by GMI For a product that is sold by GMI but not manufa
11. es or has been washed or disinfected If some time has elapsed since the last calibration Ideally a check should be made before each testing session If there is any uncertainty about the results achieved Two transducers are employed One for the flow measurement and one for the pressure They may be set using static individual calibration units such as liquid column for pressure and a float gauge for flow Calibration Equipment to NR6 Pressure Port 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 used in this way adjustment to the desired pressure level is more easily achieved Hand Pump Reservoir Liquid Column B Flow Gauge such as a rotameter covering the range 0 500cm3 sec 0 30 l min and an adjustable Rotameter source of flow with a variable Vacuum voltage supply Such a motor is Motor Flowhead available from manufacturers of vacuum cleaners and the speed at which it runs and therefore the flow it produces can be controlled by powering it from a variable trans Variable Transformer former NR6 Users Manual V 10 11 09 2012 P21 of 23 Rhinomanometer NR6 The procedure to be employed is as follows Switch on the instrument and allow 5 minutes warm up time Select calibration from the setup menu bar item Zero the output Apply a flow of 300cm3 sec 18 litres min to the flowhead and if the value s
12. his is done using one of two standard techniques POSTERIOR TEST detailed on P16 In the posterior test a tube is placed in the mouth just long enough to sit on the tongue and the lips closed round the tube Provided the soft palate is relaxed the pressure measured by this tube will be the same as the pressure driving airflow through the nose This pressure signal is taken to the NR6 by means of the tube with the black marker on it The reference pressure tube blue is connected to the mask Patient co operation is required to use this technique A measure of total nasal resistance is obtained from one test ANTERIOR TEST detailed on P14 In the anterior test the black pressure tube is connected to one side of the nose while airflow is measured through the other side Resistance is calculated The pressure tube is then moved to the second side flow is recorded and resistance is calculated again The two resistance values are then put into the formula 1 1 1 RTOTAL RLEFT RRIGHT to calculate total resistance Pressure connection to the nose is made by means of a tip connector pushed through a small hole punched in microfoam tape or a foam insert if the nasal valve performance is not of interest and 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 and this should be checked by as
13. hown on the screen is not correct adjust the flow calibration potentiometer marked VR2 inside the NR6 until the reading is correct Remove the flow and check that the value returns to zero If it does not reset the zero position apply the flow and if necessary re adjust the flow calibration potentiometer VR2 Apply a pressure of 300 Pa 31mm H20 to the black input nozzle and if the value on the screen does not read 300 adjust the potentiometer VR5 inside the NR6 until it does read correctly Remove the pressure and check that the value returns to zero If it does not reset the zero position re apply the pressure and if necessary make a further adjustment of the pressure calibration potentiometer NR6 Users Manual V 10 11 09 2012 P22 of 23 Rhinomanometer NR6 Maintenance The routine maintenance which is required is as follows a Check regularly 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 The gauze mask tip connectors and tubes can be washed subjected to sterilising solution and can be gas sterilised but must be thoroughly dried out prior to making measurements They cannot be autoclaved The tubing should not be used if it kinks or if it becomes slack on the pneumotachograph or instrument connector tubes It sho
14. king the patient to obstruct the free side of the nose with one thumb and the free end of the tube connected to the tip connector or foam insert with their other thumb If the patient then tries to gently breathe in and out through their nose they will be able to tell you whether or not they feel any air leakage at the tape or foam Posterior and Anterior tests can be performed using a fixed reference level selectable from 75 to 300 Pa or cc sec or alternatively under the Broms technique with a radius of 200 units In either case resistance is calculated when the trace crosses the fix line or arc of the circle NR6 Users Manual V 10 11 09 2012 P11 of 23 Rhinomanometer NR6 The recommended reference points are as follows Standard posterior 75 Pa Standard anterior 150Pa Broms 200 units Resistance values averaged over at least 4 breaths is recommended and offered by default In addition to resistance values Rohrer coefficients are also calculated for K1 and K2 KO 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 PRINCIPAL POINTS TO NOTE 1 Prepare the patient by having them in a relaxed quiet condition for 15 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 breath in a quiet relaxed way avoid excited rapid manoeuvres NR6 Us
15. olation of such law CAUTIONS If the NR6 Rhinomanometer is to be used in conjunction with a PC or printer whose power supply is not approved for use in a patient environment then an isolation transformer which is in compliance with BS EN 60601 1 should be used to power the system You must use the transformer to ensure that the NR6 is in compliance with BS EN 60601 1 The use of NR6 near to sources of electromagnetic radiation such as mobile phones radio transmitters x ray equipment etc may prevent it from functioning correctly Federal USA law restricts this device to sale by or on the order of a physician The NR6 Rhinomanometer is a medical instrument which is classified as a Type B device A Type B device categorisation is used to describe an instrument which Applied parts offer protection to the subject against electrical shock and in the event of a single fault condition arising leakage current will be limited to less than 0 5mA Any incident which results in actual or potential injury or death to a subject while using NR6 should be immediately communicated to GM Instruments at the address below NR6 should only be connected to other devices such as computers and printers which comply with EN 60950 1 Unless computers and printers built to EN 60950 1 are used patient safety might be compromised NR6 Users Manual V 10 11 09 2012 P3 of 23 Rhinomanometer NR6 Non medical equipment such as computers and printers sho
16. onment print capability depends on you having installed a printer under Windows Virtually any printer which works under the version of Windows you have will be suitable PRODUCT FEATURES Your NR6 Rhinomanometer is capable of giving a well defined assessment of the function of the nose and of recording changes within it due to surgical intervention allergic response or other factors To achieve this please ensure that you read carefully the sections dealing with using the instrument in pages 11 to 17 of this manual SPECIFICATION Size 27x8x30 cm Weight 2 Kgm Flow Range 800cc sec Pressure Range 800Pa Accuracy 2 Supply taken from PC Standards Electrical Safety and EMC BS EN 60601 1 series Warm up time Operating Temperature Operating Humidity Duty Cycle NR6 Users Manual V 10 5 minutes 15 to 35 C 20 to 80 RH non condensing Continuous 11 09 2012 P10 of 23 Rhinomanometer NR6 RHINOMANOMETRY OVERVIEW The measure of Rhinomanometer or nasal airway resistance depends on measuring nasal air flow and the pressure producing that airflow R P F Nasal airflow is collected by a mask which must form an airtight seal round the face and is then passed out through a pneumotachograph head in which the flow is converted to a pressure differential This differential is transmitted to the NR6 by means of the tubes marked with red and green bands Nasal pressure is the more difficult parameter to measure and t
17. protects them Cleaning is an always useful sometimes essential prerequisite to disinfection and sterilisation 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 In the case of the Rhinomanometer direct patient contact is made by a mask posterior tubing anterior tubing TIP connector and microfoam tape or foam inserts There is no need to decontaminate these components as they are all single use items NB a range of re usable masks is now available There is however concern about the possibility of contamination being deposited onto the flowhead beyond the single use mask and then being available to subsequent users NR6 Users Manual V 10 11 09 2012 P7 of 23 Rhinomanometer NR6 There are 2 ways of dealing with this 1 A washer disinfector could be used to achieve thermal disinfection This process should be restricted a maximum temperature of 85 C and all solutions routinely used to reprocess anaesthetic equipment tubing should be suitable This processing should be considered between each patient and the calibration of the NR6 checked after such processing Provided the NR6 can be calibrated the flowhead can be used again 2 Alternatively an antiviral filter could be placed between the mask and flowhead obviating the need to disinfect the flowhead We recommend use of the Intersurgical Fil
18. residue which could be harmful NR6 Users Manual V 10 11 09 2012 P6 of 23 Rhinomanometer NR6 RISK ASSESSMENT FOR THE NR6 PATIENT CONTACT COMPONENTS The accepted ground rules for the risks that medical equipment poses to patients are High Risk Items in close contact with a break in the skin or mucous membrane or introduced into a normally sterile body area eg surgical instruments syringes amp needles intrauterine devices and associated equipment dressings urinary and other catheters sterilisation is required Medium Risk Items in contact with intact mucous membranes eg respiratory equipment gastroscopes or other items contaminated with particularly virulent or readily transmissible organisms or if the item is to be used on highly susceptible patients disinfections required Low Risk Items in contact 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 micro organisms but not usually of bacterial spores the process does not necessarily kill or remove all micro organisms but reduces them to a level which is not harmful to health Cleaning is a process which removes contaminants including dust soil large numbers of micro organisms and the organic matter eg faeces blood which
19. 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 little distortion as possible Satisfying this criteria results in the best possible accuracy If foam inserts are to be used substitute the foam insert for the TIP connector and TAPE shown below ANTERIOR TEST PREPARATION a make a hole in the tape using TIP CONNECTOR the smallest die on the punch supplied b fit a tip connector and 15cms a of anterior tubing to the tape TAPE as shown or 15 cm of anterior tubing onto a foam insert De grease the nose with an appropriate agent such as SILICONE surgical spirit ANTERIOR TUBING lt lt c fix the tape onto the nose 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 tube with your finger ask the subject to block NR6 Users Manual V 10 11 09 2012 P14 of 23 Rhinomanometer NR6 their open nose with their thumb and gently breathe in and out through their nose Any leakage will be felt by them d if airtight secure the tube in this position by bringing the mask up to the face taking care to position it on the bridge of the nose Ask the patient to hold the LAER KE Mask mask assembly there gt e connect the ante
20. rior tubing Tee Filter Flowhead free end to the pressure tube X ji marked black using Ha ALKAA Hj the anterior tube connector J GE J F d fi ZY Red 7 Wa j A A RS Ure Green f ask the patient to maintain A K ats A l Fow pressure on the mask to E7 capped achieve an airtight seal AY gio while closing his lips and 2 J Anterior Tubing breathing through his nose ee oe Ensure that the patients KA fingers do not obstruct the Black Pressure Tube 4 an output from the flowhead Anterior Connections ae There are two principal hazards associated with this technique a The patient will press so hard that the anterior tube collapses and obstructs completely this will result in the display showing an almost vertical line and can be corrected by asking the patient to apply a little less pressure b If the respiratory rate is too high there will be a tendency to create an open loop on the display 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 Hole Punch Anterior Tape Anterior TIP Con Anterior Tubing Anterior Tube Connector Foam Inserts Anti Viral Filter Single use Mask NR6 Users Manual V 10 11 09 2012 P15 of 23 Rhinomanometer NR6 b POSTERIOR METHOD The posterior method allows direct measurement of total nasal resistance from a single manoeuvre without any direct contact with the nose and as such is perhaps the preferred technique
21. ses noted below TECHNICAL NOTE This guide assumes you are familiar with your computers hardware and basic WINDOWS commands If you are not familiar with these items you may wish to keep a Microsoft manual and your computers users guide close at hand while you are installing your Rhinomanometer CONTACT INFORMATION GM INSTRUMENTS LTD UNIT 6 ASHGROVE WORKSHOPS ASHGROVE ROAD KILWINNING KA13 6PU UK TEI 01294 554664 FAX 01294 551154 EMAIL qminstruments aol com or enquiries gm instruments com www gm instruments com NR6 Users Manual V 10 11 09 2012 P5 of 23 Rhinomanometer NR6 SAFETY STATEMENTS PRODUCT NAME amp MODEL No RHINOMANOMETER NR6 NAME OF MANUFACTURER G M INSTRUMENTS LTD UNIT 6 ASHGROVE WORKSHOPS ASHGROVE ROAD KILWINNING KA13 6PU MANUFACTURED IN UK RHINOMANOMETER LABELS amp MEANING DANGER DO NOT USE IN THE PRESENCE OF INFLAMMABLE ANAESTHETIC GAS CLASS I EQUIPMENT e TYPE B EQUIPMENT ATTENTION CONSULT A N DOCUMENTS BEFORE CONNECTING READ INSTRUCTIONS DANGEROUS VOLTAGE WARNING CAUTION STATEMENTS Note the comments on page 2 of this manual relating to Computer power supply patient environment specification BS EN 60601 1 requirements Problems created by electromagnetic radiation and interference Federal USA restrictions Parts marked for single use should not be re used as no method of sterilisation can be guaranteed disinfection materials may not be effective and may leave a
22. ter guard filter code 1944 This is specified by Intersurgical to be 99 999 efficient for bacterial viral filtration and has ports which fit our NR6 mask on one side and our flowhead on the other This filter is 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 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 ac priors shes ih Jin RAAS Adult mask 1 use set for Anterior test As before but with filter added Note blanking plug on black mask port Note blanking plug on black mask port NR6 Users Manual V 10 11 09 2012 P8 of 23 Rhinomanometer NR6 PRODUCT SUPPORT If you have any questions about your Rhinomanometer call your supplier or ourselves We will be able to advise you and give you help with any problem you may encounter When you call for product support please have the following information available This User Manual and a note of your interface PCI or USB The operating system of your computer Windows XP Vista 7 etc It may also be helpful if you are in front of your computer when you call This information will help our personnel to quickly and accurately answer your questions PACKAGE CONTENTS Instrument and Associated Parts NR6 Rhinomanometer NR6
23. uld be kept out of reach of subjects being tested as such equipment does not comply with medical safety standards Servicing can only be carried out by GMI approved and authorised personnel No modification of this equipment is allowed Patient connection components may cause an irritation reaction in some patients Use of such components should be discontinued in patients who exhibit such a reaction Certain components are marked single use items Single use items should not be reused as they could carry infections between subjects STORAGE The NR6 Rhinomanometer and its accessories should be stored within the following temperature and humidity range Temperature 40 C to 60 C Humidity 20 to 80 RH non condensing NR6 Users Manual V 10 11 09 2012 P4 of 23 Rhinomanometer NR6 INTRODUCTION This manual is organised into a number of sections which deal with the installation features and use of the NR6 Rhinomanometer In includes statutory information as required for a medical instrument which is CE marked along with background information on Rhinomanometer A list of current scientific papers can be downloaded from our web site which is noted below It concludes with a section on maintenance and calibration If you have any comments on this manual its associated software manual or need additional help please do not hesitate to contact the supplier of this instrument or the manufacturer GM Instruments on the email addres
24. uld be replaced by a new length b Conditions of various instrument to PC interconnecting cables should be checked regularly to look for damage to insulation c 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 Servicing The NR6 contains two transducers with associated instrumentation amplifiers balance and gain controls along with an isolated 5 volt to 12V DC converter Full circuit diagrams are available on request and service adjustments are noted below Transducer set up adjustments 1 Switch on the NR6 and allow 5 minutes warm up 2 Measure the voltage between test point 5 and test point 4 using a sensitive DC voltmeter Adjust pressure offset pot 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 pot VR1 to give a reading of 0 volts Transducer calibration adjustments 1 Pressure Channel The gain of the pressure transducer is adjusted by means of VR5 2 Flow Channel The gain of the flow transducers is adjusted by means of VR2 NR6 Users Manual V 10 11 09 2012 P23 of 23 Rhinomanometer NR6 Consumable amp Accessories List Description Code Supplied with each NR6 Flowhead Adult Masks Re use Child Masks Re use Filter Mask tube caps
Download Pdf Manuals
Related Search