EXHALYZER® D

Pulmonary Function Testing from infant to adult patients

The EXHALYZER^® D offers various lung function tests for infants (>3 kg), children and adult patients. The modular system is easily upgradable and fully compliant with the ATS / ERS recommendations for infant and pediatric pulmonary function testing.

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Unmatched accuracy
The EXHALYZER D offers the “gold standard” in accuracy for clinical application.

Flexible and upgradable
The EXHALYZER D can be extended with several optional modules. The nitrogen washout bypass system allows the performance of multiple washout tests, while the optional NO measurement module allows the non-invasive detection of lung inflammation (fractional exhaled nitric oxide, FeNO), for example. The instrument works independently of the temperature, humidity or viscosity of the gas.

Wide application range
One system for pulmonary function testing for all patients: From infants to school age children to adults, all age groups can be tested on the EXHALYZER D. In particular, the EXHALYZER D is ideally suited for infants (>3 kg). The low airflow restriction prevents interference with the infant’s spontaneous breathing. Furthermore, infant sedation is not required for standard tests. Respiratory conditions can be easily followed up from infants to adults.

ATS / ERS compliance
The instrument and software are fully compliant to the recent ATS / ERS recommendations for pulmonary function testing and exhaled nitric oxide measurements.

Easy operation
All tests are easily started, executed, recorded and evaluated by the SPIROWARE^® software. Display options include numerical and graphical data analysis. Respiratory conditions can be monitored over time, from newborn to adult age.

® EXHALYZER and SPIROWARE are registered trademarks of ECO MEDICS.

Flow and pressure measurement	Flow range: ± 0.5 l/s (DSR small), ± 1.5 l/s (DSR medium), ± 8 l/s (DSR large) Volume resolution: 0.6 / 1 ml Accuracy: ± 2% Dead space: 1.9 ml (DSR small), 7.2 ml (DSR medium), 20 ml (DSR large) Resistance: <0.15 kPa / 0.5 l/min Sampling frequency: 200 Hz
FRC / LCI infant measurement (option)	Principle: SF₆ washin / washout Application: spont. breathing Cont. flow: adjust. up to 250 ml/s
Nitrogen washout FRC module (option)	Principle: N₂ washout by 100% O₂ Maneuvers: Single and multiple breath tests Application: spont. breathing Cont. flow: up to 1250 ml/s
NO measurement (option)	Measurement range: 01. To 5000 ppb Detection limit: 0.06 ppb* Rise time (T90): <100 ms Sampling rate: 10 Hz Sample flow rate: select. 100 or 300 ml/min*
CO₂ measurement (option)	Principle: Mainstream, self calibrating Measurement range: 0 to 14 % 0 to 14 kPa Accuracy: 2 mm Hg (0 to 40 mm Hg), 5% of read. (> 40 mm Hg), 10% of read. (> 77 mm Hg) Detection limit: 0.06 ppb* Rise time (T90): <100 ms
Oxygen measurement (option)	Principle: Side stream, laser diode Measurement range: 2 to 100% Resolution: 0.01% Accuracy: 0.3% Rise time (T90): 100 ms Sampling frequency: 100 Hz Sample flow: 200 ml/min
Airway occlusion module (option)	Modes of operation: Automatic (flow triggered), manual Response time : <10 ms Closing time: select. 50 to 1500 ms Pressure range: -120 to 120 mbar
General	Temperature range: 10-40 °C Humidity tolerance: 5-95% rel. humidity (non-condensing) Supply voltage : 100 – 240 V, 50 – 60 Hz Power required: 230 VA max. Data interface: USB Mini Data acquisition: SPIROWARE 3.x Weight (basic module): 5 kg (w/o PC and printer) Dimensions (h x w x d) : 100 x 550 x 400 mm (4 x 21.7 x 15.8 inch)
System requirements	Intel Core i5 type processor or higher, compliant to the Council Directive 93/42 EEC concerning medical devic-es and the European Safety Standard EN 60601-1 (e.g. ViewMedic Clinico 222C3, Rein Medical GmbH, 47877 Willich, Germany), Microsoft Windows WIN 7, .NET Framework 4.0 or higher, 16 Mbyte RAM, 10 GB free space on hard disk, XGA Graphics or better, USB 2.0 or higher

(*) depending on sample flow
(Note: PC, Printer, calibration gases and zero-air supply are not part of delivery.)

ECO MEDICS reserves the right to change these specifications without notice.

Product Overview Brochure – English
EXHALYZER^® D Brochure – English
SPIROWARE^® Software Brochure – English

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Applications

Tidal Breathing Analysis
FRC and ventilation inhomogeneity measurements
Small airway monitoring: Lung Clearance Index (LCI) and Slope 3 analysis (SnIII)
Multiple and single breath nitrogen washout measurements (N2MBW, N2SBW)
SF6 multiple breath washout
Single occlusion lung mechanics analysis
Capnography and Oximetry
Optional multiple and single breath FENO analysis

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Your Advantage

Integrated system for pulmonary function testing suitable for infants (>3 kg) to school age and adult patients
No sedation required for standard tests
Noninvasive detection of lung inflammation (fractional exhaled NO, FeNO test)
Fully upgradeable
CE MDD 93/42 approved for clinical use
Compliance with all ATS/ERS recommendations for pulmonary function testing and exhaled Nitric Oxide measurements

Application Videos

N2-MBW with the EXHALYZER D

This video demonstrates how to perform a nitrogen multiple breath washout test and how to assess the quality of the measurement.

TBFVL

Tidal breathing flow volume analysis for non-cooperative infants (> 3kg)

FRC/LCI INFANT

Functional residual capacity and ventilation inhomogeneity measurements (LCI) during normal tidal breathing by innert gas multiple breath washin /-out technique, no sedation and patient cooperation required

FRC/LCI PRE-SCHOOL TO ADULT

Functional residual capacity (FRC) and ventilation inhomogeneity measurements (LCI) during normal tidal breathing by Multiple Breath Nitrogen Washout Principle using 100% oxygen.

SOT

Single occlusion technique for Resistance (Rint, Rrs) and Compliance (Crs) measurements, manual or automatic, fully patient synchronized by adjustable flow trigger and occlusion time.

FeNO

FeNO measurements to detect airway inflammation by multiple and single breath technique in accordance with ATS / ERS recommendations.
CLD 88 EXHALYZER – the reference method for chemiluminescence nitric oxide measurement

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References

Anagnostopoulou, P. et al. Normative data for multiple breath washout outcomes in school-aged Caucasian children. European Respiratory Journal 55, (2020).
Arianto, L. et al. Sensitivity of multiple breath washout to detect mild-to-moderate asthma in adolescence. J Allergy Clin Immunol Pract 7, 2052-2054.e5 (2019).
Bates, J. H., Schmalisch, G., Filbrun, D. & Stocks, J. Tidal breath analysis for infant pulmonary function testing. ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/American Thoracic Society. European Respiratory Journal 16, 1180–1192 (2000).
Gustafsson, P. M., Robinson, P. D., Lindblad, A. & Oberli, D. Novel methodology to perform sulfur hexafluoride (SF6)-based multiple-breath wash-in and washout in infants using current commercially available equipment. J. Appl. Physiol. 121, 1087–1097 (2016).
Hasler, D. et al. A multi-scale model of gas transport in the lung to study heterogeneous lung ventilation during the multiple-breath washout test. PLoS Comput. Biol. 15, e1007079 (2019).
Kentgens, A.-C., Oppelaar, M. & Merkus, P. A new breeze from an inspiring past: normality with multiple breath washout in school-aged children. European Respiratory Journal 55, (2020).
Kjellberg, S., Houltz, B. K., Zetterström, O., Robinson, P. D. & Gustafsson, P. M. Clinical characteristics of adult asthma associated with small airway dysfunction. Respir Med 117, 92–102 (2016).
Manco, A. et al. Small airway dysfunction predicts excess ventilation and dynamic hyperinflation during exercise in patients with COPD. Respiratory Medicine: X 2, 100020 (2020).
Ratjen, F. et al. Inhaled hypertonic saline in preschool children with cystic fibrosis (SHIP): a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet Respiratory Medicine 7, 802–809 (2019).
Robinson, P. D. et al. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. European Respiratory Journal 41, 507–522 (2013).
Robinson, P. D. et al. Preschool Multiple-Breath Washout Testing. An Official American Thoracic Society Technical Statement. Am J Respir Crit Care Med 197, e1–e19 (2018).
Robinson, P. D., Goldman, M. D. & Gustafsson, P. M. Inert gas washout: theoretical background and clinical utility in respiratory disease. Respiration 78, 339–355 (2009).
Robinson, P. D., Kadar, L., Lindblad, A. & Gustafsson, P. M. Effect of change of body position in spontaneous sleeping healthy infants on SF6-based multiple breath washout. European Respiratory Journal 54, (2019).
Schmidt, M. N. et al. What it takes to implement regular longitudinal multiple breath washout tests in infants with cystic fibrosis. Journal of Cystic Fibrosis 0, (2020).
Singer, F., Houltz, B., Latzin, P., Robinson, P. & Gustafsson, P. A realistic validation study of a new nitrogen multiple-breath washout system. PLoS ONE 7, e36083 (2012).
Skov, L. et al. Lung compartment analysis assessed from N2 multiple-breath washout in children with cystic fibrosis. Pediatric Pulmonology 55, 1671–1680 (2020).
Stahl, M. et al. Multiple Breath Washout Is Feasible in the Clinical Setting and Detects Abnormal Lung Function in Infants and Young Children with Cystic Fibrosis. RES 87, 357–363 (2014).