PiKo® Monitors Complete Home Monitoring Solutions for Clincial Trials Ideal for clinical trials, PiKo® Lung Health Monitors deliver lung function measurements not traditionally available through home monitoring. PiKo efficiently and effectively obtains diagnostic quality volume and flow measurements of FEV1 and Peak Flow through a portable, easy to use, hand-held device. The Right Choice – For Clinical Trials PiKo. Features and Benefits • Meets volume/time waveform standards of the ATS/ERS for FEV1 and Peak Flow • Captures Peak Flow and FEV1; definitive measures for asthma studies • Small size, mobility, and singlesingle button operation enhance patient compliance • Built-in test quality alerts improve consistency in patient effort and optimize acceptable test results • Automated test storage and computer download eliminate transcription errors • Seamlessly integrates to both PiKoLogic electronic diary and eSP clinical trial software Inspiring Respiratory Health PiKo’s patented design ensures the highest level of accuracy and reproducibility in a home-based respiratory monitoring device. Its sub-compact design and ease of use increase subject compliance, improving the overall quality of subject reported data and reducing overall study costs. PiKo allows investigator sites to download subject data directly to nSpire Health’s eSP™ clinical trial software during subject site visits, eliminating data errors associated with manual entry and improving principle investigator site productivity. The Right Choice – For Subject Compliance PiKo’s intuitive design and portability increase compliance for a broad range of subject populations. Critically following your clinical trial, every PiKo is uniquely linked to a trial subject. All measurements are time and date stamped, providing study teams the ability to manage subject compliance and prevent unnecessary de-enrollment.

The Right Choice – For Cleaner Data Faster Technical Specifications Confidence in PiKo home-based spirometry is guaranteed through production in an ISO certified facility with exacting quality assurance standards and through independent laboratory validation. With over one million units produced, PiKo establishes the benchmark in home-based lung function monitoring by achieving comparable FEV1 and Peak Flow measurement performance to full office based spirometry devices without the need for operators and at a fraction of the cost. FEV1: Range: 0.15 - 9.99 liter (0.01 liter resolution) Accuracy:...