QuinTron Class A Software Description.docx

Class A software descriptionChina SFDA needs following information for the Class A software:1）Product IDSoftware name：BTSC; BTDP; BTH2+; BTH2; BTSCGC; BTDPGCModel No. and version No.：QT02900, Rev 16A; QT02800, Rev 14A; QT02700, Rev 14A; QT02600, Rev 14A; QT02776, Rev 1; QT02777, Rev 1Manufacturer name：QuinTron Instrument Company, Inc.Manufacturer address :2208 South 38th Street, Milwaukee, WI 53215 USAProduction address：2208 South 38th Street, Milwaukee, WI 53215 USA2）Product Safety levelThe level of security: Level A.Elaborate the reason to confirm its security level：No risk of injury or damage to health is possible. There is no contact between the patient and the instrument. The instrument software does not make a diagnosis; it only reports H2, CH4 and/or CO2 measurements.3）Structure and functionA. the structure and relationship of the software modules：Please give the architecture diagram (refer to the diagram as a sample）, which could describe the relationship of the software modules, relationship between external interface and modules, alsostate user interface content and their relationships：Not applicable; the instrument software is not intended to interact with external interfaces or modules.B．Please see the table below for software module and module function：Not applicableSoftware Module name（And if it has optional module ,please mark out）Module version No.（if have，please mark out）Module function4）Relationship with the hardwarePlease give the topological graph, which should describe the connections relationship among software, general purpose computer and medical equipment hardware. Below is the BreathTracker insulation diagram. The software is installed inside the instrument. There is no connection between the software installed into the instrument and a patient or a computer or any other type of instrumentation.If it is the lonesoft, please state the general purpose computer’s type and function. And if it is used with medical equipment hardware, please