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The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546. The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. Its primary functions are: 1. Interaction will be via the touch Screen interface. 2. Running the Spirotrac software, as cleared in K141546, The model 6600 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function 3. Record subject demographic data. 4. Produce printed reports to external printers.

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes. Its primary functions are; 1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions, Display a single subject's demographic data entered by the user. 2. Produce reports In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Spirotrac shall provide a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: 1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and it's subdivisions, The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift). 2. Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database. 3. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis on a windows based PC.

The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis of the cough sounds on a windows based PC. The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by: a) The contact sensor channel, which records the data for later analysis. b) An air microphone channel. This is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above. This can be achieved by listening, or otherwise determining, signals such as speech and other noises that will be ignored when examining channel (a) data. These two individual analogue signals are electronically conditioned and then digitally sampled. The sampled information data is then stored to a suitable internal memory module. The data will be transferred to the PC by removing the memory card from the VitaloJAK.

The device is a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer.

The Vitalograph Model 2120 is intended to be used, as its predecessor, as a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer. The Model 2120 series has been available to the marketplace for over 15 years {ref K946075}. This device is a hand held electronic Spirometer, used in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. Spirometry. This revised design is an upgrade to the existing product in terms of modernising its look and feel {i.e. changes to ergonomics and user interface}. The intended uses and operating principles in relation to its measurement of respiratory function remain unchanged. Its primary functions are: 1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including FVC, VC, MVV) and it's subdivisions, 2. Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac {see K912412}. 3. The flowhead will be a Fleisch Pneumotachograph type flowhead, the operating principle of which has been well established in the existing Model 2120 {K946075} and various other spirometers. {e.g. Vitalograph Compact Ref K854526. Vitalograph Alpha ref K873562, Vitalograph Escort K925085} All variants of the Model 2120 {e.g. including In2itive, e-Diary} will use very same operating principle, LCD, Buttons, optional Touchscreen, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. Navigation is allowed via the use of five buttons {Up, Down, Enter/Select, Cancel /Esc and power On/Off} or an optional touch screen.

To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.

The Vitalograph Model 4000 series {asma-1 and copd-6} are battery powered handheld electronic spirometers used to measure expired Peak Flow and forced expired volume after one second {FEV1} .. The results can aid in the diagnosis of Asthma and COPD in patients. All variants {asma-1 and copd-6} within the range use the very same operating principle, LCD, Buttons, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. I.e. Asma-1 displays FEV 1 and PEF, whilst the copd-6 displays FEV 1 and FEV6 only. A uni-directional rotating vane with flow sensor to measure lung function is used. The measurements are taken via expiration into the unit flowhead, which is In-turn displayed onto an LCD. Navigation is allowed via the use of four buttons {Up, Down, Enter/Select and power On/Off}