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
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.