THE EU PEAK FLOW METER 01

THE EU PEAK FLOW METER01PRODUCT LISTINGSEU StandardEN13826• Designed specifically tomeet EN13826 scale standard• Movable asthma managementcolour zones that won’t wash off• In-built internal check valve, avoidingcross-infection concerns• Available with either European or ATS scaleMicro Medical LtdPO Box 6, Rochester,Kent ME1 2AZ, United KingdomTel +44 (0) 1634 893500Fax +44 (0) 1634 893600MicroPeak Peak Flow MeterMicro DiaryCard SpirometerThe new standard in Peak FlowmeasurementA new powerful and flexible replacementfor paper diaries and mechanical PEFmeters Designed specifically for Europeanstandard (EN13826) High visibility EU scale ATS scale version also available Wash-proof Colour-Zone asthmamanagement system Built-in check valve Fully customisable for promotionalpurposes Easily cleaned Measures and stores PEF,FEV 1 and FVC, Flow/Volumecurves and symptomresponses All data electronically dateand time stamped Easily configured for clinicaltrial protocols Simple to use forpatients at home Secure audit path forregulatory clinical trialswww.micromedical.co.ukPhone: +44 (0) 1634 893500www.micromedical.co.ukPhone:+44 (0) 1634 893500THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS 7

THE EU PEAK FLOW METER01Table 1. A list of manufacturers, their devices with characteristics and estimated cost.Manufacturer / Supplier Website Device Transduction PEF only Price € LoggingClement Clarke www.clementclarke.com mini Wright variable orifice yes 15 noInternational airzone variable orifice yes 15 noEdinburgh Way mini Wright digital fixed orifice no 35 yesHarlow one flow tester fixed orifice no 535 yesEssexCM20 2TT, UKMicro Medical www.micromedical.co.uk MicroPeak variable orifice yes 10 noPO BOX 6 PulmoLife stator/rotor no 165 noRochester Micro Spirometers stator/rotor no 335 yesKent. ME1 2AZUnited Kingdom(part of VIASysHealthcare Inc.)nSpire Health www.nspirehealth.com Pocket Peak variable orifice yes 25 noLouisville, Colorado, PiKo-1 fixed orifice no 25 yesUSA KoKo fixed orifice no 25 yes(formerly FerrarisRespiratory)ndd Medizintechnik www.ndd.ch Easyone ultrasonic no 1875Technoparkstrasse 1CH-8005 Zürich,SwitzerlandRespironics peakflowfamily.respironics.com Assess variable orifice yes 15 no1010 Murry Ridge Lane AsthmaCheck/Mentor variable orifice yes 15 noMurrysville, Personal best variable orifice yes 15 noPA 15668-8525, USAVitalograph www.vitalograph.co.uk mechanical PEF meters variable orifice yes 10 noMaids Moreton, Asma-1 stator/rotor no 28 yesBuckingham Vitalograph Micro pneumotacho- no 500 yesMK18 1SW, UKgraphTable 2.. Clinical settings for recording PEF and instrument requirementsSettingAccident and emergency, outpatient dept, wardHome, workplaceLung function laboratory, primary careRequirements to considerLow cost, robust, multi-patient use, fixed calibrationLow cost, robust, fixed calibration, data loggingAbsolute accuracy, multi-patient useFlowFigure 6. The ultrasonic flow meter.UltrasonicFigure 6 shows the design fordevices where an ultrasonic beamis passed diagonally across a flowof gas and the transit of the beamis affected by the gas flowaccording to the Doppler effect. Bysending beams in both directions,various corrections can be made torender this an extremely accurateand low-resistance device. Thecalibration is stable and the outputis affected by properties thatdetermine the speed of sound,such as gas density. The crosssectionalarea of the beam needs tobe adequately matched to thediameter of the tube throughwhich the gas flow profile ispassing. For example, measuringthe Doppler effect on a verynarrow beam passing across theflow in a much wider-bore tubewould not give a signalrepresentative of the whole of theflow profile. These devices aretechnically sophisticated and offerpromise for many applications.Their calibration is stable, whichhas advantages for non-laboratoryapplications.AccuracyAll PEF meters in the EU must meetthe CE standard PrEN13826 [8],which means the accuracy ofreadings from handheld PEF meterswill now agree with the standardsmet by larger laboratory-basedequipment. In addition, the metershave to meet a drop testrequirement to show they aresuitably robust for patient selfadministereduse. PEF meters in usein the USA do not have to meetTHE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS 9

01THE EU PEAK FLOW METERPRODUCT LISTINGSPiKo MonitorsMini-Wright DigitalnSpire Health introduces PiKo Lung Health Monitors, theworld’s smallest electronic PEF, FEV1, and FEV6 meters.All PiKo monitors provide automatic test quality alerts,electronic data storage of 96 patient tests, single buttonreview, and offer optional PiKoNET software for extendedtracking and trending. PiKo monitors are downloadable toa personal computer. Revolutionary in their design, theseminiaturized devices exceed all published accuracystandards, and remarkably, is priced at a similar cost tomechanical peak flow meters. For more information call+44 (0) 1992 526300 or visit www.nspirehealth.com.THE NAME SPEAKS VOLUMESIt’s Intelligent. It’s Simple. It’s Accurate.It’s Compact. It’s Easy to Clean. It’s a Mini-Wright.Not only the name speaks volumes, so does the product.Accurate PEF and FEV1 measurements for treating bothasthma and COPD patients at the touch of a button.Easily customised, intelligent patient monitoring in thepalm of your hand. A water tight seal for simplesterilisation required under industry standards. And aname synonymous with accuracy, reliability andperformance.Visit www.clement-clarke.com to find out more about thedigital peak flow meter that speaks volumes or for thedistributor nearest you.Phone: +44 (0) 1992 526300www.nspirehealth.comPhone: +44 1279 414 969www.clement-clarke.comTelehealthcareSIBEL – DATOSPIR PEAK-10A modern medicine techniquewith definitive solutions Remote Patient Monitoring (RPM) Effective monitoring of chronic disease Effective therapy control Cost efficient Remote diagnostic possibilities Selective emergency managementThe DATOSPIR PEAK-10 peak flow meter provides anobjective measurement of your Peak expiratory Flow (PEF)and is valuable information of your lung functions. It includes acolour zone asthma management. The correct use of thisinstrument will help you and your doctor to follow yourcondition closely and will enable him/her to provide the mostbeneficial treatment for you. It is important to keep a record ofyour peak flow. Readings should be taken twice a day; firstthing in the morning and at bed time, or as directed by yourphysician. You should also measure and note your peak flow ifyou suddenly become wheezy or breathless at any time of theday or night. The peak flow meter DATOSPIR PEAK-10 hasbeen designed and manufactured according to the MedicalDevice Directive 93/42/CEE. This device meets new EN 13826scale standard. This device has been verified and calibrated atSIBEL, S.A., according to the verification and adjustmentprocedure.www.viasysclinical.comPhone: +49 (0) 931 4972 900Phone: +34 93 436 00 07www.sibelmed.com10 THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS

THE EU PEAK FLOW METER01this standard but are tested againsta less demanding standard from theAmerican Thoracic Society [7]. Thereadings from old devices based onthe original Wright meter scale[1, 2] can be clinically misleading[6], depending on where acrosstheir range the reading is beingmade [4, 5]. The CE standard hasaddressed these accuracy issues andalso addressed the frequencycharacteristics of these devices forthe first time. It had been noted bypaediatric clinicians that astutechildren could generate falsely highPEF readings by “tongueing” thedelivery of the blow – a bit likespitting into the meter – which inunder-damped meters would give ahigh flow. This new aspect of PEFmeter testing found that somemeters available in the USA wereseverely under-damped [12], that isthey over-read with flow profilesthat have a rapid rise up to and falloff from the peak. These meters donot meet the new EC standard,which is the only standard to testthis aspect of performance.CalibrationMost hand held PEF meters do notneed day-to-day calibration. This isideal for unsupervised patient useof the meter. The moresophisticated flow measuringdevices common in lung functionlaboratories do need frequentcalibration, since their transductionsystems for converting flow into ameasurement signal are usually notso stable and are influenced byambient conditions. Althoughdevices are marketed as notrequiring calibration, it is possiblewith misuse or accident that thedevice no longer reads correctly.Most manufacturers state that if adevice gives surprising readingsthen a calibration check procedureis required [13].For handheld devices that are onlygiving a flow output, such asvariable orifice meters, acalibration check is beyond thecapability of all but the mostsophisticated laboratories, since apump system is needed that candeliver calibrated flows [14].Human calibration can be usedwhere, for instance, lung functionlaboratory staff who are free oflung disease regularly check theirown PEF on a meter. This can soondetect an unexpected trend in theoutput of the device. If the devicerecords volume as well as flow,then discharging a 3-L syringeseveral times through the deviceusing a range of flows can give anindication if there is a significanterror in the device.Resistance to flowPEF meters offer a compleximpedance to flow, which will bereferred to here as a resistance.When compared with variableorificemeters, some devices, such aspneumotachographs or ultrasonicdevices, offer very little resistance.This can be easily appreciated whenblowing through one such deviceand then through a variable-orificemeter. Standards for PEF metersstate what is the acceptable limit forresistance [8, 13]. Turbine devicesoffer greater resistance at higherflows, while for variable orificemeters it is the reverse [15]. A highresistancemeter has been found toreduce the achieved PEF by anaverage of 8% compared with PEFmeasured with a low-resistancedevice, but the PEF readings werealso less variable [16], which may bean advantage in some settings.ReliabilityThe variable-orifice meters such asthe original mini-Wright meter haveworking parts that have been foundto work correctly for up to 15 yearsof continuous patient use withoutloss of accuracy [17]. However, if aPEF meter is mistreated then it canfail to work properly even whennew. Thus instruction to the userabout how to use and care for themeter is a key part of the clinician’srole in suggesting the patient usesTHE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS 11

01THE EU PEAK FLOW METERa PEF meter to help manage theirasthma. This is equally true forhealthcare professionals in accidentand emergency depts or in primarycare who use PEF meters. Cleaningof PEF devices can cause moreharm than benefit and so themanufacturer’s instructions must befollowed. Disassembling a devicecan lead to damage to importantkey components, such as the springin the mini-Wright meter and othervariable-orifice meters, which thenrender all subsequent readingsinvalid. Many devices are affectedby excess heat and so leaving adevice close to a heater may distortits component parts, rendering ituseless.Environmental conditionsMost PEF meters are used at home,at work or in a hospital setting. Theambient conditions in these settingsdo not usually present a problem. Ifaccurate PEF recordings are neededat altitude, then turbine devices orpneumotachographs would be thebest choice, as their readings are notaffected by the changes in gasdensity at altitude [14].Clinical settingsAccident and emergency depts andoutpatient deptsIn this setting, the instrument needsto be readily available and suitablefor multi-patient use. Devicesthrough which the patient cannotinhale can be used for differentpatients without the necessity forensuring cleaning of the insides ofthe instrument itself. One-waymouthpieces can also be used tofacilitate the use of one instrumentfor difference patients. Ideally thisenvironment also requires rugged,robust and calibration-freeinstruments.In-patient wardsWard patients with asthma will berecording their PEF for several dayswhile they recover and canindividually use a single instrumentfor this time. A number of patientswill take this instrument home ondischarge to facilitate themonitoring of their condition. Theenvironment is otherwise asdemanding as the accident andemergency dept. Cleaning of suchmeters should be undertaken,especially for high-risk patientssuch as those with cystic fibrosisand tuberculosis. Suggestions havebeen made about how this can bedone for simple mechanical variableorifice meters [18]. Themanufacturer’s instructions must befollowed to ensure the PEF readingsremain accurate after cleaning.Home, school, workThese settings require the PEFmeter to be used by the patientwithout supervision. Thus theinstrument has to be reliable, robustand calibration free. Most devicesfor patient use fulfil theserequirements. However, the resultsfrom unsupervised recordings canbe less than accurately registeredfor a number of reasons [19, 20].Electronic data logging meters maythen be necessary to obtain faithfulresults. Another consideration isthat if the readings are to be takenin open social environments, theinstruments should not be awkwardto use. For children the device mayneed to “look cool” to be acceptableand so increase the likelihood it willbe used appropriately.Primary careIncreasingly, it is hoped thatsatisfactory lung functionmeasurements will be made in theprimary care setting rather than in ahospital laboratory. There aretensions between the technicalrequirements for using instrumentsfor diagnosis, which require thattheir calibration and results areaccurate, and the simplicity ofcheaper calibration-free instruments.In primary care other lung functionindices, such as forced expiratoryvolume in one second (FEV1) may12 THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS