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.

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 newborns and infants (>3 kg). The low airflow restriction prevents interference with the infant’s spontaneous breathing. Furthermore, newborns sedation is not required for standard tests. Respiratory conditions can be easily followed up from newborns 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 is a registered trademark 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.

 

 

Applications

  • Tidal Breathing Analysis
  • FRC and ventilation inhomogeneity measurements
  • Small airway monitoring: Lung Clearance Index (LCI) and Slope 3 analysis (SnIII)
  • Nitrogen Washout FRC measurements
  • Single occlusion lung mechanics analysis
  • Capnography and Oximetry
  • Optional multiple and single breath FENO analysis

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
TBFVL

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

FRC/LCI INFANT

Functional residual capacity and ventilation inhomogeneity measurements 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 measurments (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

  1. Tidal breath analysis for infant pulmonary function testing, J.H.T. Bates, G. Schmalisch, D. Filbrun, J. Stocks, on behalf of the ERS/ATS Task Force on Standards for Infant Respiratory Function Testing; Eur Respir J 2000; 16: 1180-1192
  2. The bias flow nitrogen washout technique for measuring the functional residual capacity in infants M.G. Morris, P. Gustafsson, R. Tepper, M. Gappa, J. Stocks, on behalf of the ERS/ATS Task Force on Standards for Infant Respiratory Function Testing; Eur Respir J 2001; 17: 529–536
  3. Passive respiratory mechanics: the occlusion technique, M. Gappa, A. Colin, J. Stocks; Eur Respir J 2001; 17: 141–148
  4. Tidal forced expirations, P.D. Sly, R. Tepper, M. Henschen, M. Gappa, J. Stocks, on behalf of the ERS/ATS Task Force on Standards for Infant Respiratory Function Testing; Eur Respir J 2000; 16: 741 – 748
  5. Standardization of Spirometry 1994 Update, ATS Board of Directors, November 11, 1994, Am J Respir Crit Care Med Vol 152. pp 1107 – 1136, 1995
  6. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005; ATS Board of Directors, December 2004, and by the ERS Executive Committee, June 2004
  7. ERS / ATS Statement „Measurement of exhaled nitric oxide in children, 2001“, Eur. Respir. J 2002;20: 223 – 237
  8. Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide in Adults and Children—1999, Am J Respir Crit Care Med Vol 160. pp 2104–2117, 1999
  9. Measurement of lung volume and ventilation distribution with an ultrasonic flow meter in healthy infants, A. Schibler et al; Eur Respir J 2002; 20: 912–918
  10. The Effect of Montelukast on Exhaled Nitric Oxide and Lung Function in Asthmatic Children 2 to 5 Years Old, G. Hall et al; J Appl Physiol 92: 59–66, 2002.
  11. Nasal nitric oxide is low early in life: case study of two infants with primary ciliary dyskinesia, E. Baraldi et al; Eur Respir J 2004; 24: 881–883
  12. Tidal exhaled nitric oxide in healthy, unsedated newborn infants with prenatal tobacco exposure, G. Hall et al; J Appl Physiol 92: 59–66, 2002
  13. Evaluation of the interrupter technique in healthy unsedated infants, G.L. Hall, J.H. Wildhaber, M. Cernelc, U. Frey; Eur Respir J 2001; 18: 982–988
  14. Inert Gas Washout: Theoretical Background and Clinical Utility in Respiratory Disease; Robinson et al: Respiration 2009;78:339-355
  15. A Realistic Validation Study of a New Nitrogen Multiple-Breath Washout System. Singer F, Houltz B, Latzin P, Robinson P, Gustafsson P (2012) PLoSONE 7(4)
  16. An Official American Thoracic Society/European Respiratory Society Statement: Pulmonary Function Testing in Preschool Children: Am J Respir Crit Care Med Vol 175. pp 1304–1345, 2007

FeNO Testing

Exhaled nitric oxide analysis for asthma management and PCD screening in cooperative and non-cooperative patients

Analyzer CLD 88 sp – FeNO analysis by single and multiple breath testing; bronchial, alveolar and nasal FeNO

Pulmonary Function Testing

Detection and monitoring of ventilation inhomogeneity and small airway diseases such as asthma, cystic fibrosis and COPD

EXHALYZER D – Nitrogen washout by single breath or multiple breath (SBW or MBW), breathing pattern (TBFVL), FRC, LCI, moment ratios and slope analysis

Infant Pulmonary Function Testing

Suitable for cooperative and non-cooperative patients from infants >3kg body weight to adults

EXHALYZER D – Breathing pattern (TBFVL), FRC, LCI and SOT analysis for patients > 3 kg body weight

Liquid NO analysis

Nitric oxide analyzer for liquid samples from biomedical or pharmaceutical applications

ANALYZER CLD 88 – Liquid NO detection in combination with liquid purge vessel and chromatographic software