医疗器械产品技术要求编号：
Technical requirements No. of medical instrument product:
HeadaTerm-wet偏头痛治疗仪
HeadaTerm-wet HeadaTerm-wet device for preventing and treating primary headache
图片转自网络
1. 产品型号/规格及其划分说明
1. Product model/specification and division description
1.1 产品型号规格划分
1.1 Product model specification division
类别代号 Type code
产品代号 Product code
公司代号 Company code
2. 性能指标
2. Performance index
2.1 产品尺寸
2.1 Product size
2.2 产品外观
2.2 Product appearance
表面应光洁平整，无明显的凹痕、划伤、裂纹等现象，背面导电膏干净、无拉丝或溢出，丝印字符和图案清晰。
The surface should be bright, clean and smooth, without obvious dent, scratch, crack, and etc, the conductive paste on the back should be clean, no wiredrawing or overflowing, and the silk-screen characters and pattern should be clear.
2.3 脉冲重复频率
2.3 Pulse repetition rate
以27KΩ电阻和47nF电容并联作为负载，脉冲重复频率为50Hz（±1Hz）。
With 27KΩ resistance and 47nF capacitance connected in parallel as the load, the pulse repetition frequency is 50 Hz (±1Hz).
负载波动±10%范围内，脉冲重复频率偏差不超过±2%。
When the load fluctuation is within ±10%, the pulse repetition frequency deviation is not more than ±2%.
内部电源电压输出在3.4-2.8v范围内（电压波动在3.1V±10%范围内），脉冲重复频率偏差不大于±2%。
When the internal power supply voltage output is within the scope of 3.4-2.8 v (voltage fluctuation is within the range of 3.1V ±10%), the pulse repetition frequency deviation is not more than ±2%.
2.4 脉冲宽度
2.4 Pulse width
以27KΩ电阻和47nF电容并联作为负载，脉冲宽度为125us（±10us）
With 27KΩ resistance and 47nF capacitance connected in parallel as the load, the pulse width is 125us（±10us）.
负载波动±10%范围内，脉冲宽度偏差不超过±30%。
When the load fluctuation is within ±10%, the pulse width deviation is not greater than ±30%.
电源电压波动±10%范围内，脉冲宽度偏差不大于±10%。
When the mains voltage fluctuation is within the scope of ±10%, the pulse width deviation is not greater than ±10%.
2.5 脉冲幅度值
2.5 Impulse amplitude value
以27KΩ电阻和47nF电容并联作为负载，脉冲幅度值为60V（±3V）。
With 27KΩ resistance and 47nF capacitance connected in parallel as the load, the impulse amplitude is 60V (±3V).
负载波动±10%范围内，脉冲幅度值偏差不超过±30%。
When the load fluctuation is within ±10%, the impulse amplitude deviation is not greater than ±30%.
电源电压波动±10%范围内，脉冲幅度值偏差不大于±10%。
When the mains voltage fluctuation is within the scope of ±10%, the impulse amplitude deviation is not greater than ±10%.
2.6 脉冲能量
2.6 Pulse energy
新出产品，以27KΩ电阻和47nF电容并联作为负载，脉冲能量为18.4uJ（±10%）。
For the new product, with 27 kΩ resistance and 47 nF capacitance connected in parallel as a load, the pulse energy is 18.4 uJ (±10%).
2.7 强度调节
2.7 Intensity adjustment
此产品开机后，电极输出电压呈线性持续上升，5分钟后升到最高电压，之后稳定在最高电压不再变化。在升压的5分钟内 ，可按主机按键锁定当前电压。
After the product starts up, the electrode output voltage shows a linear rise, and it reaches the peak after 5 minutes, and then it maintains stable at the highest voltage. Within the 5 minutes of voltage rise, you can press the host key to lock the current voltage.
2.8 连续工作时间
2.8 Continuous working hours
此产品单次工作最长时长为20分钟（±5秒），累计使用时长不小于7小时。使用过程中，工作时长不足20分钟情况下，因人为原因造成产品关机，此工作时间计入总时长！
The longest working time of this product once is about 20 minutes (±5s), and the cumulative hours used is not less than 7 hours. In the use process, if the work time is less than 20 minutes, and the product is shutdown due to man-made reason, such working time will be included in the total duration!
2.9 失效提醒
2.9 Failure warning
此产品自带一次性电池，保证工作时长不少于7小时。产品累计使用总时长满7小时后，电池接近耗尽，随时可能停止工作。表示产品失效，不能够再使用！This product comes with disposable batteries, so it can guarantee the working time not less than 7 hours. After the product is used for 7 hours, the battery will be close to be used up, and the product could stop working at any time. It shows the product loses lose efficacy, and can't be used any more!
3.5脉冲幅度值
3.5 Impulse amplitude value
新出产品，电池电压最高状态下，在两电极中间串联一个27KΩ的电阻，同时并联一个47nF电容，产品开机后不按主机按键），工作五分钟后，产品输出电压脉冲达到最大值。用示波器的参考点和测试点分别接触两个电极，测得脉冲幅度值符合2.5的要求。
For a newly produced product, under the highest battery voltage, connect a 27KΩ resistance between the two electrodes in series, and connect a 47nF capacitance in parallel at the same time (don't push the host key after product startup), after it works for five minutes, the product output voltage pulse will reach the peak. Use the reference point and test point of oscilloscope to contact the two electrodes respectively, and the measured pulse amplitude value conforms to the requirements in Section 2.5.
3.7强度调节
3.7 Intensity adjustment
长按偏头痛治疗仪按键，蜂鸣器连续响两声，指示灯亮起并开始间隔双闪，表示机器开机。电极输出电压自动由低向高随时间线性上升，指示灯间歇式双闪，直到5分钟后电极输出电压达到最大，指示灯变成间歇单闪；在强度上升过程中，可短按键（蜂鸣器响一声），锁定当前电压。锁定当前电压后，指示灯变成间歇单闪。
Long press the key on the device for preventing and treating primary headache long, the buzzer ring two consecutive times, and the indicator lights up and begins double flash alternately, showing the machine starts. The electrode output voltage linearly increases from low to high over time automatically, and the indicator makes intermittent double flash; the electrode output voltage will reach the peak 5 minutes later, and the indicator light makes intermittent single flash; In the process of intensity increase, you can press the key for a shorter time (buzzer rings once) to lock the current voltage. After locking the current voltage, the indicator will turn into intermittent flash.
3.8 连续工作时间
3.8 Continuous working hours
在两电极中间串联一个27KΩ的电阻，同时并联一个47nF电容，产品开机后，电极输出电压自动由低向高随时间线性上升，同时开始用计时器计时，20分钟后产品自动关机。。
Connect a 27kΩ resistance between the two electrodes in series, and a 47 nF capacitance in parallel at the same time; after product startup, the electrode output voltage will linearly increase from low to high over time automatically, you can use the timer for timing at the same time, and the product will automatic shut down 20 minutes later.
此产品允许在工作过程中，直接把负载去掉，产品会自动关机；或者手动长按主机按键1.5S，可以直接把产品关机。因外因导致中途关机，此工作时间计算在总工作时长内。
The load is allowed to be removed directly when the product is working, and the product will automatically shut down; or you can press the host key manually for 1.5S, so as to directly power off the product. If midway shutdown occurs due to external causes, the working hours should be included in the total working hours.
按上面测试方案，一个产品从开始使用到电池能量用尽，工作时长符合2.8要求。
According to the test plan above, from the startup of the product to the battery energy being used up, the working hours comply with the requirement in Section 2.8.
3.9 失效提醒
3.9 Failure warning
在两电极中间串联一个27KΩ的电阻，电阻同时并联一个47nF电容，产品开机后，电极输出电压自动由低向高随时间线性上升，同时开始用计时器计时；产品单次工作时长为20分钟（±5s），20分钟后自动关机。
Connect a 27kΩ resistance between the two electrodes in series, and a 47 nF capacitance in parallel at the same time; after product startup, the electrode output voltage will linearly increase from low to high over time automatically, and you can use the timer for timing at the same time; the working duration of the product once is 20 minutes (±5s), and it will power off 20 minutes later.
按上述方法，当产品累计使用总时长满7小时后，电池能量接近耗尽。当产品单次工作时处在工作总时长7-9小时之间时某个时间点时，产品工作会出现下面情况:产品工作不满20分钟自动关机，再次开机后，指示灯连续闪亮5次后，自动关机。表示产品电池已经耗尽，产品不再能够在使用。
According to the above-mentioned method, when the product has been used for 7 hours in total, the battery energy is close to be used up. At a certain time point in the period when the product is used for 7 to 9 hours, the following situations may occur while the product is working: the product automatically powers off before working for 20 minutes, after it starts again, and the indicator flashes 5 times in a row, it will automatically power off. It shows that the battery energy has been used up, and the product can not be used any more.