LCI PFT system EXHALYZER® D

FEV1FVCforced vital capacity

Overview
The EXHALYZER® D provides a comprehensive range of pulmonary function tests for infants (>3 kg), children and adults. The modular design allows upgrades with optional measurement modules. The device performs consistently regardless of temperature, humidity or gas viscosity. All measurements are recorded and analysed with SPIROWARE® software for numerical and graphical longitudinal monitoring.

Key features

• Reference accuracy: Measurement accuracy suitable for clinical use.
• Modular and upgradable: Optional modules include nitrogen washout, SF6 washin/washout and NO measurement; modular upgrades are available.
• Broad patient range: Applicable from infants (>3 kg) to adults; low airflow resistance designed for infant testing; standard infant tests do not require sedation.
• Standards compliance: Instrument and software comply with ATS/ERS recommendations for pulmonary function testing and exhaled nitric oxide.
• Intuitive operation: Tests are started, recorded and evaluated using SPIROWARE® with numerical and graphical displays.

Applications

• Tidal Breathing Analysis (TBFVL)
• FRC and ventilation inhomogeneity measurements
• Small airway monitoring: Lung Clearance Index (LCI) and Slope 3 analysis (SnIII)
• Multiple and single breath nitrogen washout measurements (N2-MBW, N2-SBW)
• SF6 multiple breath washout
• Volumetric capnography and oximetry
• Optional multiple and single breath FeNO analysis

Clinical capabilities / Test types

• TBFVL: Tidal breathing flow–volume analysis for non-cooperative infants (>3 kg).
• FRC/LCI infant: Functional residual capacity and ventilation inhomogeneity by inert gas multiple breath washin/washout during spontaneous breathing; no sedation or active cooperation required.
• FRC/LCI pre-school to adult: Multiple Breath Nitrogen Washout using 100% O2 during normal tidal breathing.
• Spirometry: Standard spirometry suitable for children and adults (where applicable < 4 years).
• FeNO: Fractional exhaled nitric oxide measurement (single and multiple breath) in accordance with ATS/ERS guidelines.

Detailed specifications (from product specifications table)
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: spontaneous breathing
Continuous flow: adjustable up to 250 ml/s

Nitrogen washout FRC module (option):
Principle: N2 washout by 100% O2
Maneuvers: Single and multiple breath tests
Application: spontaneous breathing
Continuous flow: up to 1250 ml/s

NO measurement (option):
Measurement range: 0.1 to 5000 ppb
Detection limit: 0.06 ppb*
Rise time (T90): <100 ms
Sampling rate: 10 Hz
Sample flow rate: selectable 100 or 300 ml/min*

CO2 measurement (option):
Principle: Mainstream, self-calibrating
Measurement range: 0 to 14 % and 0 to 14 kPa
Accuracy: 2 mm Hg (0 to 40 mm Hg), 5% of reading (> 40 mm Hg), 10% of reading (> 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

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 (without 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:
Modern multi-core processor (e.g., Intel Core or AMD Ryzen, dual-core minimum), compliant with EU MDR 2017/745 and EN 60601-1, Microsoft Windows 11, .NET Framework 4.8 and Microsoft Visual C++ 2015-2019 Redistributable, 4 GB RAM (8 GB recommended), 10 GB free disk space, DirectX 11 capable graphics and HD display (1280×720) or higher, and USB 2.0 port.

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

Technical specifications

• Model: EXHALYZER® D (modular system for infant to adult pulmonary function testing)
• Flow measurement ranges: ±0.5 / ±1.5 / ±8 l/s depending on DSR transducer
• Volume resolution: 0.6 / 1 ml; Accuracy: ±2%
• Optional modules: SF6 washin/washout, N2 washout FRC module, NO measurement, CO2 measurement, O2 measurement
• Sampling frequencies: flow 200 Hz; NO sampling 10 Hz; O2 sampling 100 Hz
• Weight (basic): 5 kg; Dimensions: 100 x 550 x 400 mm
• Data acquisition via SPIROWARE 3.x; USB Mini interface
• Medical device classification: Class IIa, CE certified