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The SpiroSphere is a compact device inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital. With the option ECG, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use. A qualified physician has to reassess all ECG measurements. An interpretation by SpiroSphere ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the SpiroSphere ECG represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The SpiroSphere ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The minimum age for ECG application is 4 years. It can be used by physicians in the office or hospital. With the CardioSphere, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use. A qualified physician has to reasurements. An interpretation by CardioSphere is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CardioSphere represent partial qualitative and quantitative information on the patient's cardition and no therapy or drugs can be administered based solely on the interpretation statements. The CardioSphere is not intended for use in an EMS environment (Emergency Medical Services Environment). The minimum age for ECG application is 4 years. It can be used by physicians in the office or hospital.

SpiroSphere is a compact spirometry device. Its Sensor Unit is batterypowered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time. SpiroSphere ECG is a compact spirometry device. Its Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time. With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded. The Main Unit can be powered by battery or power supply. The Main Unit is wirelessly connected to an ECG amplifier via Bluetooth. With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded. A printer can be connected and data (e.g. reports, screenshots) can be printed. Moreover, it is possible to transfer data by USB. Wifi. 3G. and Ethernet connections. Pulmonary function assessments - Slow Spirometry . - Forced Spirometry . - Flow-Volume loop and Volume-Time tracing, pre/post tests ● - Trending capabilities ● Cardiovascular assessments - 12 Lead Electrocardiogram ●

MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope/MasterScope ECG represent partial quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements. It can be used by physicians in the office or hospital. The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.

The MasterScope is a portable device, which can collect spirometry and ECG data. With the option Spirometry, inspiratory and expiratory lung function measurements can be performed with a wired sensor (Digital Handle USB) or wireless spirometry sensor unit (WSSU Bluetooth). Both spirometry sensors work with a pneumotach (Lilly Type Pneumotachograph). The Wireless Spirometry Sensor Unit is battery-powered and can be charged with a dedicated charging station. With the option ECG, a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use. The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm. The MasterScope software allows protocol-driven workflows and can be customized for use in clinical trials (e.g. individual access rights). MasterScope provides automated and secure data transmission to a centralized data base. The measured data is saved into the MasterScope software and can be read out at any time. A printer can be connected with the notebook and all needed data can be printed. Moreover it is possible to transfer data by USB, Wifi, and Ethernet. The MasterScope WSSU is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

The Asthma Monitor AM3 G+ is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV 1. The AM3 is used to monitor the respiratory status of human beings (adults and children 5 years and older) in the areas of asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for the selected parameters (e.g. PEF, FEV ). Furthermore, a visual control unit, displayed in the form of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. In addition, (symptom and medications) questionnaire functionality can be called up by the use of a software (AMOS) to record e.g. the "Quality of Life"status. When enabled, the AM3 can be programmed with a couple of questions, where the patient can then select from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation using the software AMOS. The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. The asthma monitor AM3 is intended to be used in health care, clinical and home use environments.

The Asthma Monitor AM3 G+ is a medical device (peak flow meter with symptom diary) providing following design and performance characteristics: - Handheld device - Battery operation - Storing capacity of 1200 measurements - Storing capacity of 400 sets of questionnaires (max. 20 questions each) - Measurement Parameters: PEF and FEV1 - Accuracy Flow: ± 5% or ± 20 I/min - . Accuracy Volume: ± 3% or ± 0.05 litre - Wireless communication with computer/mobile device/database via Bluetooth and mobile communication (3G, TCP/IP) by using accessory software AMOS - . Rotary Flow Sensor (single patient use) The Asthma Monitor AM3 G+ is an instrument that combines a peak flow meter with a symptom and medication diary. This device displays questions concerning symptoms and medication to be answered twice a day and measures and evaluates the Peak Flow (PEF = Peak Expiratory Flow [l/min]) and FEV1 (Forced Expiratory Volume in 1 second [1]). The AM3 G+ keeps a diary of patient measurements by automatically recording all answers and PEF measurements with the date and time in its memory. Data can be collected for approximately 100 days. Every time the patient visits the centre, the data will be downloaded by using AMOS software. Additionally the data can be exchanged to a predefined database using the 3G mobile communication module (SMS, TCP/IP). Scheduled sessions, including questionnaire and PEF measurements, can be configured wirelessly using AMOS software, performed and stored with the AM3 G+. Following the study protocol, the patient has to carry out scheduled sessions twice a day. In the morning and the evening session, there is a set of questions to be answered before a scheduled PEF measurement can be performed. As soon as the patient switches on the AM3 G+ for the first time during one of the time windows, the first question of the appropriate questionnaire will be displayed. AMOS is a stand-alone software for the professional user (physician/clinical staff) for configuration, parameter processing and data display. It does not provide a diagnosis or treatment suggestions. Diagnosis and appropriate therapeutic treatments are only made by the physician. The AMOS software allows to set and adjust individual thresholds which are based on international and national standards such as ATS and ERS. They are based on the patient's individual best value which is determined by the doctor.

The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital.

The SpiroSphere is a compact spirometry device. It's Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved into the device and can be read out at any time. A printer can be connected with the SpiroSphere and all needed data (e.g. reports, Screenshots) can be printed. Moreover it is possible to transfer data by USB, Wifi, 3G, and Ethernet. Pulmonary functions - Slow Spirometry - Forced Spirometry - Flow-Volume loop and Volume-Time tracing, pre/post tests - Trending capabilities