KoKo DigiDoser
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KoKo® DigiDoser a Clinical Research Challenge Testing Solution Designed for both centralized bronchial challenge and centralized spirometry, the KoKo® DigiDoser spirometer automates timing of challenge stages and dosing intervals, decreasing opportunity for user error, while providing the most advanced, controlled, and reproducible aerosol dosing available. Redefining accuracy in every step of the testing process, nSpire Health’s KoKo DigiDoser delivers the most accurate test results possible. The Right Choice – For your Clinical Trial KoKo DigiDoser. Features and Benefits. • Automated bronchoprovocation greatly simplifies the complex sequence of challenge testing • True dosing automation and userfriendly workflow enhance patient compliance • Remote configuration with eSP software speeds study start-up • Industry proven unique brass pneumotachometer guarantees the highest possible accuracy, precision, and performance • FDA 21 CFR Part 11 compliance ensures consistent, reliable data and transparent audit trails Repeatability and reproducibility of spirometry measurements are essential to obtaining reliable safety and efficacy data. KoKo DigiDoser incorporates the original research grade KoKo spirometer, dramatically exceeding all published standardization criteria, maximizing data quality and minimizing time to data lock. Through over a decade of customer inputs and successful clinical trial experience KoKo spirometry continues establishing new benchmarks in centralized spirometry performance. With many years of clinical trial experience, the KoKo DigiDoser’s rugged design has proven to withstand the most rigorous of trial designs. The Right Choice – For Subject Compliance Protocol driven workflow through eSP™ software controls and guides the testing process. Real-time continuous monitoring of protocol compliance improves data inclusion rates and eliminates unnecessary patient efforts. Automated dosimetry incorporates the use of a characterized nebulizer greatly reducing inter-device variability. Inspiring Respiratory Health

The Right Choice – For Data Confidence Technical Specifications Confidence in KoKo DigiDoser’s performance is guaranteed through production within an ISO certified facility with exacting quality assurance standards and controls and through independent laboratory validation. For over ten years KoKo has been the clinically proven choice for centralized spirometry. Tests Performed: FVC Screening, FVC Pre-Post, SVC Screening, SVC Pre-Post, Methacholine Challenge, User-defined Challenge Parameters Measured: FVC (L), FEV1 (L), FEV1/FVC , FEF25-75% (L/s), PEF (L/M), PEF (L/s), Exp Time (s), PEFT...