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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
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.
Integrated wireless 3G/4G cellular/mobile communications option.
Integrated WiFi option.
Automatic end-to-end secure encrypted data transmission.
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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