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510(k) Data Aggregation
K Number
K103631Device Name
SLEEPMINDER BREATHING FREQUENCY INDICATOR
Manufacturer
BIANCAMED LIMITED
Date Cleared
2011-07-21
(220 days)
Product Code
BZQ
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
BIANCAMED LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea monitor.
The device is indicated for use as suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.
Device Description
The SleepMinder Breathing Frequency Indicator BM07 consists of
- A small sensor unit that can stand on a desk top or shelf. The sensor . unit emits a very low power radio signal that is aimed at the patient. The sensor utilizes the reflected radio signal to measure the chest movement of the patient, and thus discern the respiration rate. The sensor has no part that is in contact with the patient.
- The sensor data is transmitted to a PC running a proprietary display . program. The validated transmission method to the PC is a BlueTooth wireless link.
- . The PC display program runs a proprietary algorithm to extract the respiration rate from the sensor movement data. The program displays
- The respiration rate, and o
- Indicates whether there is a valid target, whether the o target is moving too much for a breathing signal to be indentified or the signal is clear enough for a breathing rate to be calculated.
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