Our Technology
Beyond Spirometry: Seeing the Full Picture
Spiroluft is a portable, handheld device that measures exhaled carbon monoxide (CO) and lung function (FEV1, FVC, FEV1/FVC) in adults. Measurement results are sent wirelessly to a companion application, where healthcare professionals can view results and follow changes in exhaled CO between test sessions.
Spiroluft is intended to support biochemical verification of smoking status and the assessment of smoking-related respiratory function, primarily within structured smoking cessation programs. It is an adjunct to clinical assessment: all results are interpreted by a qualified healthcare professional and do not provide a standalone diagnosis.
Spiroluft technology
Exhaled carbon monoxide and spirometry in one handheld device
Regulatory status: Spiroluft is under development and is not CE-marked. It is not available for sale or clinical use. Conformity assessment under Regulation (EU) 2017/745 on medical devices is in progress. The information on this page describes the device as currently designed and may change.
What Spiroluft is
Spiroluft is a portable, battery-operated respiratory assessment device for trained healthcare professionals. It combines two established, non-invasive measurement methods in one instrument: measurement of fractional exhaled carbon monoxide (FECO) and spirometry. The Spiroluft system consists of the handheld device, a detachable flow tube and the Spiroluft application for Android tablets. A new single-use bacterial/viral filter, available separately, serves as the mouthpiece for each patient.
Intended purpose
Spiroluft is a handheld, non-invasive, active medical device intended for use by healthcare professionals for feedback, monitoring and counselling in adults undergoing structured smoking-cessation treatment for tobacco dependence. The device measures the patient’s fractional exhaled carbon monoxide (FECO) concentration directly during a supervised breath manoeuvre and presents the result, via the Spiroluft application, as objective information on the patient’s recent smoke inhalation, for use by the healthcare professional in giving feedback to the patient, monitoring progress and counselling during treatment.
Spiroluft additionally measures spirometric pulmonary function parameters (FVC, FEV1, FEV1/FVC and PEF) during a supervised forced expiratory manoeuvre, to support the assessment and monitoring of pulmonary function in adults in whom spirometry is clinically indicated.
Spiroluft is intended for use in clinical and outpatient settings. It does not provide a standalone diagnosis; results are interpreted by the healthcare professional in conjunction with other available clinical information.
How the measurements work
Before each test, the healthcare professional selects the test mode, FECO or spirometry, in the Spiroluft application. Both tests use the same mouthpiece and flow tube but are measured and processed separately.
Exhaled carbon monoxide (FECO). Guided by the application, the patient breathes out steadily through the mouthpiece for about ten seconds. During this supervised manoeuvre, the device measures the carbon monoxide concentration directly in the final part of the exhalation with an electrochemical sensor and reports the result in parts per million (ppm). Carbon monoxide in exhaled breath mainly reflects recent exposure to inhaled carbon monoxide, for example from tobacco smoke. During smoking-cessation treatment, the result gives the healthcare professional objective information on the patient’s recent smoke inhalation, for use in feedback to the patient, monitoring of progress and counselling.
Spirometry. The patient performs a forced exhalation through the flow tube. A differential-pressure flow sensor measures the expiratory flow. From this, the application calculates forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the FEV1/FVC ratio and peak expiratory flow (PEF). It applies acceptability and repeatability criteria based on the ATS/ERS 2019 technical standard for spirometry.
Data handling
Results are transmitted from the device to the Spiroluft application via Bluetooth Low Energy. The application stores and displays the results for review by the healthcare professional. FECO and spirometry results are shown in separate views, and FECO values can be compared between visits.
Important information for users
- Spiroluft is intended to be operated only by trained healthcare professionals, such as physicians, nurses and respiratory technicians. It is not intended for use by patients or lay persons.
- Spiroluft is intended for adults (18 years and older) undergoing structured smoking-cessation treatment and/or in whom spirometry is clinically indicated.
- Results support, but do not replace, clinical assessment. Spiroluft does not provide a diagnosis.
- Exhaled CO can also be raised by sources other than active smoking, such as second-hand smoke or environmental carbon monoxide. Electrochemical CO sensors can respond to some other substances in breath, for example hydrogen or alcohol. Results should be interpreted with this in mind.
- Spirometry results depend on correct technique and patient effort. Tests should be performed and supervised by trained staff.
- Use a new single-use bacterial/viral filter for each patient.
Development and standards
Spiroluft is being developed by GattyInstruments AB, Uppsala, Sweden, under a quality management system based on EN ISO 13485:2016. The design takes into account the ATS/ERS 2019 spirometry standard, ISO 26782 (spirometers), IEC 60601-1 (electrical safety), IEC 62304 (medical device software), ISO 14971 (risk management) and IEC 62366-1 (usability engineering). Conformity with the applicable requirements will be demonstrated through the conformity assessment process.
Verified technical specifications will be published on this page once design verification is complete.
By improving the accuracy and accessibility of respiratory healthcare, the company contributes to the global effort to ensure well-being for all, in line with UN SDG 3.
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