Futrex HealthGuard-15, Руководство пользователя

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Appendix 2
Essential Performance Report
The HealthGuard-15 Essential Performance includes listing all functions that the device
performs. The following functional listing is in chronological order. Next to each
function is whether it is performed by the device’s hardware or device’s software.
•
Power Up (hardware)
•
Warm Up (hardware)
•
Acquire Subject Height, Sex, and Age; Prevent Invalid Entries (software)
•
Acquire Subject Weight; Prevent Invalid Entry (hardware/software)
•
Initiate Reading (software)
•
Measure Percent Body Fat (hardware)
•
Measure Blood Pressure; Prevent Cuff Over-inflation (hardware)
•
Transmit Results (hardware)
•
Save Results (software)
•
Display Results (software)
•
Print Results (software)
•
E-Mail Results(software)
Functions of Essential Performance
Referring to the Risk Management File given in Section 17-2 and Appendix B, the only
function that contains unacceptable risk is:
Measure Blood Pressure; Prevent Cuff Over-inflation
In terms of essential performance, the term “over-inflation” is defined as any cuff
pressure that could cause bruising or other harm to the user’s arm. The risk is mitigated in
three ways:
1) There is an on-screen “ABORT” button. When pressed, the Abort command is
sent to the firmware running within the HG-15. This sends a signal to the Blood
Pressure module forcing it to instantly end the reading and immediately open the
pressure relief valve to allow the cuff to rapidly deflate.
2)
In addition to the above, there is an “EMERGENCY STOP” pushbutton built on
the HealthGuard-15’s Cuff Housing. This pushbutton is easily accessible by the
user’s right hand. When this button is pressed, it grounds the lines connected to
the Non Maskable Interrupt pin on the HealthGuard-15’s microprocessor. This
immediately forces a system reset, which forces the blood pressure module to
reset, thereby, opening the pressure relief valve which rapidly deflates the cuff.