In2itive™ e-Diary is an approved medical device, designed for clinic or home use. With a large, high-performance touch screen, the device can host any ePRO, eCOA or sponsor questionnaire using text, VAS, images, tick box, radio button, etc., and offers a range of pre-validated ePRO questionnaires. It utilizes Vitalograph’s proven, accurate Fleisch flowhead to achieve the highest-quality respiratory data.
The In2itive e-Diary meets or exceeds ISO 23747 & ISO 26782 performance standards with spirometry endpoints compliant with ATS/ERS 2019 recommendations.
Pre-integrated and validated ePRO questionnaires:
Respiratory – asthma
Respiratory – COPD
The In2itive is used in studies in conjunction with the COMPACT workstation running Spirotrac software, or on its own via Vitalograph Web Portal in studies featuring ePRO and spirometry endpoints.
It is a fully validated, CE marked and FDA-cleared Class II (USA)/ IIa (EU) medical device that meets or exceeds all relevant technical requirements for cyber-security and data protection.
|Vitalograph 2120 In2itive e-Diary|
|Dimensions:||186 mm x 81 mm x 48 mm net|
|Weight:||0.3 kg net|
|Communications:||Minimum USB 2.0, Integrated Cellular/Mobile (optional)|
|Power Supply:||Internal rechargeable battery
Universal Input 100 -240V, 50-60 Hz or USB Power 5V/500mA (as supplied)
|Flow Detection Principal:||Fleisch type Pneumotachograph capable of giving linear signals throughout the entire physiological range.|
|Volume Accuracy:||±2.5% or ±0.05L of the reading|
|Flow Measurement Range:||Max. flow rate ±14 L/s
Min. flow rate ±0.02 L/s
|PEF Accuracy:||±10% or ±10L/min of the reading|
|Performance Standards: (device meets or exceeds)||ATS/ERS 2019, ISO 23747:2015 &
|QA/GMP Standards:||ISO 13485, FDA 21 CFR 820, SOR/98-282 & JPAL, MDSAP|
|Medical Device Classification:||II (US)/IIa (EU)|
Please get in touch. We would welcome the opportunity to hear about your study needs and to explain how our services can support you.
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