SIGMA: English - Masimo

“Nothing isimpossible.If there’s a willthere’s a way.“Our customers have come to expect from us not only technicalinnovation and leadership in the multigas monitoring field, butalso to be treated as part of our company. We would never haveit any other way.We have been working in the fields of anesthesia and intensivecare for almost 30 years. Our goal was to create the smallest,best performing plug-in multigas analyzer in the world. Withthe experience of bringing three generations of infrared gasmeasurement technology to life we embarked on what mayhave appeared to be an impossible challenge. With the besttechnical team in place and firm determination, we ultimatelysucceeded, and the result was the IRMA family of multigassensors. Weighing only 30 grams, it was born in 2003, and wasfollowed by new products every year since then.We also know that technology for its own sake is not a meansto an end, and we believe that our ultimate achievement willbe measured by the success of our customers. For that reason,PHASEIN’s commitment to our customers is as strong as it is to ourtechnology. We are committed to assisting our customers withthe integration of PHASEIN technology into their products.Working together with your engineering team, engineeringcosts and time to market can be minimized. PHASEIN’s staff isalways ready to support our customers with their marketing,clinical education, training, and regulatory activities. Once ourcustomers’ products are on the market, PHASEIN will alwaysbe there for them. Whenever the need arises, we are ready toprovide responsive support, because we expect our customers toconsider us as part of their team.In the meantime, our work continues to address the nexttechnical challenges before us. We believe that nothing isimpossible, and if there’s a will – there’s a way.Robert ZyzanskiAnders EckerbomCEODirector of TechnologyDevelopmentIRMA OR/AX Multigas ProbeThe world’s first multigas probemeasuring CO 2 , N 2 O, O 2 andanesthetic agents.EMMA Emergency CapnometerThe world’s first and smallestportable emergency capnometer.IRMA AX+ ProbeThe world’s first mainstreammultigas probe with automaticagent ID.ISA CO2, ISA AX+NomolineThe world’s smallest sidestreamanalyzers. The world’s firstsampling line with water removalproperties.2005200620072008

A new heart for the ultimate multigas performanceIf you are considering adding gas monitoring to your system then there are many considerations you should take into account. Some are ofobvious importance while others are subtle, yet critical for your ultimate satisfaction and success. When it comes to SIGMA technology, eachdetail and function is engineered to facilitate a successful design into your product.The SIGMA spectrometerAt the heart of any ISA multigas analyzer liesPHASEIN’s sophisticated SIGMA spectrometer. Thisstate-of-the-art spectrometer detects the slightestchanges in infrared radiation at nine differentwavelengths in the LWIR spectrum to preciselydetermine gas concentrations in a mixture. TheSIGMA spectrometer has a true single-beamdesign, thus eliminating frequent zeroing commonfor older designs using dual beam sensors or beamsplitters.Crisp waveformsin any clinical situationEvery single detail in an ISA analyzer has beenengineered to precisely depict the clinicalsituation, even for young patients with very highbreathing rates. To be able to measure under suchextreme conditions, the measuring chamber ofthe SIGMA spectrometer has been compressed to50 μl (microliters)! ISA is the world’s first multigassidestream analyzer with a 50 ml/min samplingflow for all patients, from adults to neonates.High efficiency LWIR light sourcePHASEIN’s has engineered its own infrared sourceto provide excellent power efficiency and stability.A specially designed parabolic reflector focuses theinfrared beam so that no energy is lost. That meansthe ISA analyzers can deliver high fidelity gas datawhile maintaining micropower operation.SIGMA can be tailored to a variety of applicationsranging from single gas capnography in the ICU (ISACO2) to state-of-the-art multigas measurementsof carbon dioxide (CO 2 ), nitrous oxide (N 2 O), andmixture of binary anesthetic agents, with agentidentification, in the OR (ISA AX+). Irrespective ofthe application, the SIGMA spectrometer deliveriesstate-of-the-art performance in a packageweighing less than 5g!No cross interferenceor broadening effectsThe SIGMA spectrometer uses the 4 to 10 μmLWIR wavelength band to precisely measure theinfrared absorption caused by molecules in the gassample. The LWIR wavelength band contains strongabsorption peaks for CO 2 , N 2 O and the anestheticagents, with negligible interference from alcohol,acetone, and other gases and vapors that couldpotentially degrade measurement accuracy. Inthe multigas version, seven carefully selectednarrow band optical filters are used to trace thegas sample composition, while two filters are usedfor temperature compensation. The precisely tunedoptical filter set provides for high signal-to-noiseratio gas measurements, as well as automaticcompensation for cross interference and broadeningeffects caused by oxygen, nitrous oxide, anestheticagents and for pressure broadening effects.Patented gas measurement algorithmsThe SIGMA spectrometer, the flow controller andthe micro pump are controlled by a 32-bit RISCmicroprocessor. Analog pressure, temperature andflow signals combined with data from the SIGMAspectrometer are processed using complex, matrixcalculations. The latest advances in digital signalprocessing provide unparalleled gas measurementaccuracy and reliable agent gas identification inany clinical situation.Temperature stabilized gas analysisThe ISA analyzers are designed without the need forheaters or coolers. Instead, three temperature sensorsand two optical filters in the SIGMA spectrometerare used to compensate for temperature variationsand gradients. The result is not only an impressivelow power consumption, but also ”instant on”performance. Accurate data is available within 10seconds, and full accuracy for anesthetic agentswithin 20 seconds from power on.System OK Anesthetic agent present Alarm warning

NomolineThe no moisture sampling line for all clinical applicationsSidestream systems sample respiratory gases through a sampling line for analysis within the patient monitor. The sampled gas is usually warm andhumid and cools down in contact with the wall of a sampling line and condenses in form of water droplets. These droplets could potentially occludethe sampling line and interfere with the gas measurements. To protect the monitors from occlusion, special water vapor permeable solutions andwater traps are frequently being used.Eliminates both water and water vaporThe Nomoline fluid protection technology incorporatesa standard sampling tube, a unique water separationsection, the nomo section, made of a special polymerand a hydrophobic bacterial filter. Unlike traditionalsolutions, that remove water vapor or collect water ina plastic container, the Nomoline removes water vaporand aspired or condensed water. Water and watervapor passes through the membrane-like surface ofthe Nomoline and evaporates into the surrounding air,while leaving oxygen, carbon dioxide and anestheticgases unaffected.No cross contaminationThe Nomoline contains a bacterial filter (BFE ≥ 99.9980%) to protect the ISA analyzers and modules fromwater intrusion and cross contamination.Specially designed for low-flowapplicationsThe Nomoline is specially designed for low flowapplications. It has excellent response time making CO 2 ,N 2 O, and anesthetic agents measurement possible evenat high respiratory rates. The Nomoline can be used forall type of patients from adults to neonates.Key features• Removes water and water vapor from sample line• Hydrophobic bacterial filter reduces potential forwater intrusion and cross contamination• Luer connector options• Works in any orientation• Works in any clinical application• Latex free11234Sample lineHydrophilic absorberNomo (no moisture) polymerHydrophobic bacterial filter234Nomoline with Luer Lock connectorBox of 25CAT.NO. 108210Nomoline – one sampling line for all your clinical applications

Technical SpecificationsDescriptionUltra-compact, low flow sidestream gas analyzers withintegrated pump, zeroing valve and flow controller.Dimensions (W×D×H) ISA CO2/AX+: 33x78x49 mm (1.3”x3.1”x1.9”)ISA OR+:49x90x100 mm (3.3”x5.6”x1.6”)ISA CO2/AX+ Module: 23x64x39 mm (0.9”x2.5”x1.5”)Weight ISA CO2/AX+: 130 g excluding cableISA OR+:400 g excluding cableISA CO2/AX+ Module: 70 gOperating temperature ISA CO2/AX+:ISA OR+:Storage temperatureOperating humidity-40 to 70 °C (-40 to 158 °F)< 4 kPa H 2 O (non-condensing)95% RH at 30 °COperating atmospheric 52,5 to 120 kPapressure(corresponding to a max altitudeof 4572 m / 15 000 feet)Ambient CO 2Mechanical robustnessPower supplyInterfaceWater handlingSampling lineSampling flow rate≤ 800 ppm0 to 50 °C (32 to 122 °F)5 to 50 °C (41 to 122 °F)ISA CO2: Meets the shock and vibration requirementsfor transport of SS-EN ISO 21647:2004 clause 21.102and SS-EN 1789:2007 clause 6.3.4.2.ISA OR+ / AX+: Meets the shock and vibrationrequirements for transport of SS-EN ISO 21647:2004clause 21.101.4.5-5.5 VDC,ISA CO2: < 1.4 W (normal op.), < 1.8 W (peak @ 5 VDC)ISA AX+: < 1.6 W (normal op.), < 2.0 W (peak @ 5 VDC)ISA OR+: < 2.0 W (normal op.), < 2.4 W (peak @ 5 VDC)USB or RS232 serial interface. Software upgradepossible using the RS232 serial interface.Sampling line with proprietary water removal tubing.2 ± 0.1 m50 ± 10 ml/minData outputBreath detection Adaptive threshold, minimum 1 vol% change in CO 2concentration.Respiration rate0-150 breaths/minFi and ET ISA CO2: CO 2ISA OR+/AX+: CO 2 , N 2 O, O 2 , primary andsecondary agents(HAL, ISO, ENF, SEV, DES)Automatic agentidentificationWaveformsDiagnostic parametersFlagsISA OR+/AX+: Primary and secondary agent.Up to five simultaneous gas concentration waveforms.Atmospheric pressure, Serial number, Software andHardware revisions.Breath detected, No breath detected, Replace O 2 sensor,Check sampling line, Unspecified accuracy and Sensorerror.Gas analyzerSensor head2–9 channel NDIR type gas analyzermeasuring at 4–10 µm.Compensations Pressure, temperature and broadening effects on CO 2 .CalibrationWarm-up timeNo span calibration required. An automatic zeroreference calibration is performed once every startupand then once every 24 hours .ISA CO2: < 10 seconds (Concentrations reported and fullaccuracy)ISA OR+/AX+: < 20 seconds (Concentrations reported,automatic agent identification enabled and fullaccuracy)Typical rise time CO 2 ≤ 200 ms (≤ 250 ms for ISA OR+/AX+)at 50 ml/min N 2 O ≤ 350 mssample flow Agents ≤ 350 msO 2 ≤ 450 ms 1)Primary agent 0.15 vol%. When an agent is identified, concentrationsthresholdwill be reported even below 0.15 vol%.(ISA OR+/AX+)Secondary agent 0.2 vol% + 10% of total agent concentrationthreshold(ISA OR+/AX+)Agent identification < 20 seconds (typically < 10 seconds)time(ISA OR+/AX+)Total system < 3 seconds (with 2 m sampling line)response timeNote 1: For a 5 vol % O 2 step.Accuracy, standard conditions 1)Gas Range 2) AccuracyCO 2 0-15 vol% ±(0.2 vol% + 2% of reading)15-25 vol% UnspecifiedN 2 O 0-100 vol% ±(2 vol% + 2% of reading)HAL, ISO, ENF 0-8 vol% ±(0.15 vol% + 5% of reading)8-25 vol% UnspecifiedSEV 0-10 vol% ±(0.15 vol% + 5% of reading)10-25 vol% UnspecifiedDES 0-22 vol% ±(0.15 vol% + 5% of reading)22-25 vol% UnspecifiedO 2 0-100 vol% ±(1 vol% + 2% of reading)Note 1: Dry single gases at 22 ± 5°C and 1013 ± 40 hPa.Note 2: All gas concentrations are reported in units of volume percent and maybe translated into mmHg or kPa using the reported atmospheric pressure.ComplianceCE marked according 93/42/EEC Medical Device DirectiveEN 60601-1:2006, EN ISO 21647:2004, EN 864:1996, EN ISO 5356:2004,ISO 594-1:1986, EN 1789:2007, IEC 60529:2001 (IPX4)Data subject to change without noticePHASEIN’s world class product sourcing is a balancedsystem based on global suppliers and company’s own stateof-the-artmanufacturing plant. Our flexible sourcingsystem is optimized to meet our customers’ requirementsfor competitive manufacturing cost, high quality andvolume agility.ERP system based on Microsoft’s latest .net platform, ABBrobot and computerized production test systems are justfew examples of our modern production tools. Manufacturing and material handling areas with complete ESD protection and temperature stabilization together with local laminar flow workplacessecure high class production environment.PHASEIN AB, Svärdvägen 15, SE-182 33 Danderyd, Sweden - phone: +46 8 544 98 150, fax: +46 8 544 98 169 - info@phasein.com - www.phasein.com0000-6957/01