The Micro DiaryCard is a compact, hand-held electronic data capture Spirometer, specially designed for patient PEF and spirometry monitoring at home. Featuring the Micro Medical digital volume transducer, with its proven accuracy and reproducibility, each unit is individually calibrated to the ATS/ERS 2005 Standard on a waveform generator and routine calibration is not required. The tactile universal keypad and easy to read backlit graphics display, ensures ease of use by all subjects.
The unit is supplied complete with easy to use, comprehensive PC based Windows software for clinical researchers and data managers to configure to a trial specific protocol and is activated by the subject according to the investigators’ protocol, allowing any sequence of pre-determined commands to be executed at specified times.
‘Blow ’commands with incentive settings and quality check messages can be displayed on screen to encourage good, reproducible patient technique. Full symptom questions can also be viewed on a scrolling screen display and responses may be obtained using numeric, visual analogue or yes/no scoring systems.The Micro DiaryCard incorporates optional patient reminder alarm and low readings warning features.
To comply with FDA requirement 21 CFR Part 11 ensuring secure data entry, the Micro DiaryCard can be PIN number protected for regulatory clinical trial requirements. Data can be retrieved via the Micro DiaryCard serial port either directly to a PC, or remotely using a modem and results can be printed directly at the investigator’s site or exported into a central database.
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