软件风险分析报告(最后)

更新时间:2023-07-03 14:45:38 阅读：评论：0

Software Risk Management File In MC0188F

1. Risk Management Summary

1.1 Software Faults

Hazard	Risk reduction (Before action			Risk reduction action	Risk reduction (after action )			Acceptable Level of Risk
The device may not carry our auto power off process after operation for a long time (more than 25 mins). 使用过程中，有可能会出现码率25分钟后不自动关机现象	S4	P4	R	The IC is equipped with dual automatic timing function. If there are any errors in one of the timing functions, the remaining timing function will work properly for auto power off process. 蜻蜓的简笔画 IC内部设有双重自动计时功能，如果其中一个计时功能出错，另一个计时功能还在正常工作，可正确计时关机	S1	P1	A	ACC
During u, operation faults may cau buttons out of order or in error. 在使用过程中，因操作失误有可能会出现按键无功能或出错现象	S3	P4	R	The IC is equipped with automatic error correction function and every button with operation delay function. If operation fault is caud by continuous/ multiple pressing buttons, the system will justify as invalid input for operation fault during delay time. IC内部设有自动纠错程序，每一个按键设有操作延时功能，如操作失误连续按或多次按时，在延时时间内错误操作无效	S1	P1	A	ACC
When the device encounters power failure during u, it may not work properly after start again. 在使用过程中，如遇供电异常，可能会造成再次开机无法工作	S4	P5	R	The hardware circuit is quipped with large capacity voltage storage device, which can let IC stop working until delayed to safe time. Plea refer to EMC test report (Ref. GZ10071005-1). 在硬件电路上设有大容量电压贮存器，可让IC延迟到安全时间内停止工作，可见EMC测试报告。编号：	S1	P1	A	ACC海外留学申请
When changing program, the output intensity may not returned to zero level. 在使用过程中，模式转换时，有可能会出现输出强度不归零情况	S2	P2	R	The IC has the ret process on intensity level during program changed and synchronous processor to program change. When the program is changed, the intensity level will return to zero. In the ca for the intensity is not returned to 00, the total output voltage will not cau any injury to patient at highest intensity and the value of square root of maximum output is not exceeded 10V. IC内部设有模式转换输出强度检测归零处理，且设有与模式转换同步处理器，当模式发生转换时的同时，输出强度就归零，另就是输出不归零，共输出电压在最高档对人体不会造成伤害。最强档输出的平方根值未超过10V。	S1	P1	A	ACC
When holding down the intensity increa or decrea button, the intensity level may be adjusted disorderly. 在使用过程中，按强度“+”或“-”键时，强度出现降低或增加，可能出现强度加减功能错乱	S2	P2	R	The IC is equipped with verification function on button signal and the intensity interval for each level is 1V only, which will not cau patient injury. Plea refer to EMC test report (Ref. GZ10071005-1). IC内部设有按键信号检测纠错功能，另本产品强度“+“或”-“每档仅间隔1V，对人体不会造成伤害。可见EMC测试报告。编号：	S1	P1	A	ACC
During u, there may be no EMS output or feeling to patient but normal operation showed on LCD display. 在使用过程中，LCD显示功能正常，但是输出端使用者有可能感觉无EMS输出	S3	P3	R	The IC has the synchronous detection processor between LCD display and EMS output signal which can minimize this hazard. However, there is another possible cau: the patient skin is too dry causing high resistance for EMS transition. This cau is mentioned in ur manual and cannot be solved by dampen the skin of treatment area in order to reduce skin resistance. IC内部设有LCD显示与EMS信号输出同步检测处理器，出现LCD 有输出显示，但是无输出，IC出错的机会是无，另有可能是使用者的皮肤太干燥，电阻值过大造成，此况有在说明书中指出，在使用前，须在接触位皮肤喷少量水份或导电液。	S1	P1	A	ACC
When simultaneous u for all 4 electrodes to body & soles, the intensity of EMS output may be reduced due to high workload. 在使用时，身体与脚底四个导电片同时使用时，输出强度因负载被拖弱鲁滨逊漂流记的读书笔记	S3	P3	R	The bands for sole massager and body massager are completely independent channels. Also, the hardware applied is high-power components which will not reduce the EMS output during simultaneous u for all 4 electrodes. 本产品身体与脚底是两个完全独立的通道，且硬件使用的为大功率元器件，使用时产品不会出现因为四个导电片同时用时而拖弱输出强度，有可能是使用者的皮肤太干燥，两极间的电阻值过大造成，此况有在说明书中指出，在使用前，须在接触位皮肤喷少量水份或导电液。	S1	P1	A	ACC
		屈原郭沫若

1.2 Environmental Conditions

Hazard	Risk reduction (Before action )			Risk reduction action	Risk reduction (after action )				Acceptable Level of Risk
Strong external EM wave interference may cau failure or error for button function. 因为外界强电磁波信号干扰，按键功能有可能出现失灵或出错，	S3	P4	R	The IC is equipped with anti-interference process and the external hardware with anti-interference circuit, which can block or reduce signal interference. Plea refer to EMC test report (REF. NO. GZ10071005-1) IC内部设有抗干扰处理程序，且外部硬件另有增加抗干扰电路，可屏蔽或减少干扰信号，见EMC测试报告。	S1	P1	A	ACC
External interference to IC may disable the auto power off function after 25 minute operation. 使用过程中，因为外界干扰IC，25分钟后有可能不会自动关机	S4	P4	R	The IC is equipped with dual automatic timing function. If there are any errors in one of the timing functions, the remaining timing function will work properly for auto power off process. IC内部设有双重自动计时功能，如果其中一个计时功能出错，另一个计时功能还在正常工作，可正确计时关机	S1	P1	A	ACC
Extreme environment temperature and humidity may cau instable functioning or other conditions 使用过程中，因为环境的影响造成功能不稳定或其它情况	S4	P4	R	The high & low environment temperature/ humidity tests are conducted during product design and after production. The operating temperature and humidity is 0°C ~ 50°C, ≤80% RH listed in ur manual. Plea find further detail in ur manual. 产品设计时与生产后有做高低温测试，另说明书中有规定使用环境温度为0-50度，相对湿度：≤80%；详见说明书。	S1	P1	A 潮州景点	ACC

1.3 Classification of Hazard Severity

Level	Code	Definition
Disastrous	S4	Potential risk for multiple deaths or rious injuries
Fatal	S3	Potential risk for death or rious injury
Moderate	S2	Moderate injury
Mild	S1	Mild injury or no injury

1.4 Classification of Hazard Possibility

Level	Code	Probability (Number of Events/ Year/ Unit of Product)
Often	P6	10-1 ~ 10-2
Sometimes	P5	10-2 ~ 10-3
Occasional	P4	10-3 ~ 10-4
Seldom	西红柿鸡蛋炸酱面 P3	10-4 ~ 10-5
Impossible	P2	10-5 ~ 10-6
Incredible	P1	< 10-6

Note: Probability is number of events or predictable events per year per unit of product.

1.5 Guideline for Risk Evaluation

防火征文

Probability	Severity
Probability	S4: Disastrous	S3: Fatal	S2: Moderate	S1: Mild
P6: Often	U	U	U	U
P5: Sometimes	U	U	U	R
P4: Occasional	U个人简历下载	U	R	R
P3: Seldom	U	R	R	A
P2: Impossible	U	R	A	A
P1: Incredible	A	A	A	A

Key: A – Acceptable Risk; R – “As Low As Reasonably Practicable” Risk; U – Unacceptable Risk even before Risk/ Profit analysis

2: Risk Management Plan风险管理计划

2.1:Deisgn Input设计输入;

2.1.1 ;Product No.产品代码:MC0188F

2.1.2 Reason for designing/developing the product:

Electronic Nerve Stimulation is a non-invasive, safe nerve stimulation intended to reduce pain. The Electrical Stimulator us proven neuromuscular electrical stimulation therapy to nd micro current puls through the soles of ur’s feet. This type of electrical stimulation is clinically proven to be safe and effective and can be carried out in the comfort of ur’s own home. The Electrical Stimulator improves muscle functions by stimulating nerves increasing the flow of blood helping to reduce pain, swelling, tired and aching legs.

2.1.3:Expected U 预期用途:

This Electrical Stimulator is intended to be ud as a muscle stimulator to relieve (muscle) pain, increa blood circulation, relax stiff muscles, reduce swollen feet, ankles and relieve fatigue. The massaging effect is achieved by electronic stimulation of the nerves through electrode pads placed on the skin or through the foot plates. Various massage regions and treatment programs can be lected.

2.1.4 Required function of the product

●Massage function to foot and body脚底和身体按摩功能.

●With 7 control buttons 有7个控制按键.

●Operation data is displayed on LCD. LCD上面显示工作信息.

●4: Operation time is displayed on LCD. LCD上面显示工作时间.

●5: Output intensity to body and foot is displayed on LCD. LCD上面显示身体或脚底输出强度.

●6: The massage program is displayed on LCD. LCD上面显示工作模式.

2.1.5 Safety requirements:

●Operated by C size batteries or DC 4.5V adaptor and large LCD display can show operation data clearly and easily. 使用C型电池供电,或使用DC4.5V火牛供电.LCD显示面积大,易于看清楚工作信息.

●The button will be effective only after prolonged pressing for 3 conds. 长按住”开机”键约3秒,按键才有效.

●Anti-slipping design of plastic ca. 胶壳有防滑措施.

2.1.6 Applicable law and rule requirement:

●EN 980: Graphical symbols for u in the labeling of medical devices

●EN 1041:Information supplied by the manufacturer with medical devices

本文发布于:2023-07-03 14:45:38，感谢您对本站的认可！

本文链接：https://www.wtabcd.cn/fanwen/fan/89/1066118.html

上一篇：新编实用英语综合教程1课后答案

下一篇：选修七Unit A LETTER HOME一封家信