LactoFAN2
Intended Purpose
The LactoFAN2 is a portable analytical device intended for display of the hydrogen (H₂) concentration in exhaled breath.
The device is limited to the presentation of analysed values in ppm and does not provide medical diagnoses or clinical interpretations. The interpretation of the results displayed is the sole responsibility of the user.
Notice on Possible User Applications
In medical practice and scientific research, the measurement of hydrogen concentration in exhaled breath may be used for:
- investigations related to carbohydrate absorption
- functional gastroenterological assessments
- scientific evaluation of gastrointestinal transit phenomena
Specific test protocols are not part of the intended purpose of the LactoFAN2.
FAN does not conduct clinical performance studies or clinical
validations for diagnostic test procedures based on such applications and does not guarantee their diagnostic or clinical validity.
The selection, implementation, and evaluation of any test protocols, including their medical or scientific interpretation, are the sole responsibility of the user or the respective test or protocol provider.
Product Description
The LactoFAN2 is a compact, handheld analyzer designed for the reliable analysis and display of hydrogen concentration in exhaled breath.
After a slow exhalation through the device, the H₂ value is immediately shown in ppm on a clear, easy-to-read display. The device is designed for straightforward operation and supports the user in performing structured analytical procedures, without evaluating or interpreting the results.
Key Features
- intuitive operation via a glove-capable touchscreen
- graphical user guidance with supportive visual elements
- no warm-up time required
- management of multiple patient-related result tables
- integrated quality control routines for technical device function checks
- continuously stored data history for traceability of previous analysis
- auto-reset function and automatic detection of sensor deviations
- semi-automatic calibration procedure to support the user
- powered by 4× standard AA batteries
- free Windows® PC software for data export via the supplied USB cable
- delivery including a starter kit in a robust carrying case
Optional Software
Using the FANh2 Windows® software via the supplied interface cable you can transfer result data from the LatoFAN2 into test reports.
Both pre-designed and completely customized reports can be used.
Via standard data interfaces like GDT, HL7 or ASTM the software can be connected to local EDP–systems easily.
