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In2itive e-Diary
Innovative eCOA platform combining respiratory endpoints and ePRO data gathering in a robust medical device.
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
ACQ
AQLQ(S)12+
AQ20
ACT
Respiratory - COPD
EXACT
EXACT E-RS
CAT
Health status
EQ5D-3L
EQ5D-5L
Large touch screen with intuitive workflows for ease of use.
ePRO only or combined Spirometry endpoint options.
Configurable to meet protocol requirements:
Symptom scores
Medication use
ePRO questionnaires
Adaptable workflows
Custom alerts, alarms and reminders
Fleisch pneumotachograph flowhead for accurate spirometry endpoints.
Live spirometry blow quality feedback – promoting high-quality, reliable data.
Integrated animated help file options supporting training and compliance.
Date/time stamps ensure data integrity.
Transmitted data is instantly viewable, for remote insight into site and subject performance.
Updates implemented directly to In2itive e-Diary devices.
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 & ISO 26782:2009 |
QA/GMP Standards: | ISO 13485, FDA 21 CFR 820, SOR/98-282 & JPAL, MDSAP |
Medical Device Classification: | II (US)/IIa (EU) |
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Weiterbildung in Atemwegsdiagnostik und Krankheitsmanagement
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