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For personal monitoring of expiratory-breath function at home under direction of a physician. It measures, logs, and reports events related to respiration and the spirometric values of peak expiratory flow (P.EF), zone and percent of PEF compared to a reference value, timed forced expiratory volumes over 1 second (FEV1) and 6 seconds (FEV6), and the ration of FEV1/FEV6.

KP+ LFM is a model variation of the KoKo Peak KP and KP+ peak flow meters. The KoKo Peak KP+, complete with data-communication accessory and dedicated PC display software, was cleared for over-the-counter sale in 510(k) notification K010009. The LFM is identical to its predicate device-the KP+-physically, technologically, and logically. This new variation extends some KP+ features-namely, an additional timed flow measurement and extended electronic features. These variations make the LFM a prescription device, rather than an over-the-counter one, like its predicate. All KP flow meters are personal, electronic, flow meters for measuring the rate at which a person blows through them. Approximately 5x2x1 inches in size, the devices are batterypowered, hand-held, single-user instruments with a mouthpiece removable for cleaning. The meter has a custom liquid-crystal display, one-button operation, and an infrared data port for communicating to a serial port of a PC through an optional data-communication link. Selecting between the models is done during manufacture by simply setting appropriate flags in the device's memory. This selection can be done during initial calibration at the factory, only. The model is then designated by packaging and labeling. LFM features include - Performing all KoKo Peak KP+ features and functions - Measuring six-second forced expiratory volume (FEV6) by continuing to integrate the breath flow measurement over a 6-s period and displaying the value after a test session - Displaying the FEV1/FEV6 ratio on meter's front panel after a test session - Enabling diary logs to be expanded to up to 16 entries from the 5 entries preprogrammed into the KP+ - Enabling options for uploading diary ranges, zone ranges, reference PEF, data-clear command, and alarm-clock settings directly to meter's memory from a PC