Risk assessment
An assistive technology hardware device designed to help visually impaired access a standard keyboard.
Medical Device
According to the MHRA definition of a medical device, this does not constitute a medical device. However, as we are aware that the device will be used by visually impaired users, we have taken steps to ensure that the device is safe and secure and meets the necessary standards.
Hardware Components
echolocation relies on off-the-shelf hardware components. They are purchased from PiHut and manufactured by M5Stack.
M5Stack CoreS3
The CoreS3 is the main processor for the device as well as the touch screen display.
It has the following certifications:
- CE Mark
- SAR Certification
Base M5GO Bottom3
The Base M5GO is the battery expansion for the CoreS3 device. It contains a 500mAh lithium battery.
It has a CE Mark.
USB Module with MAX3421E v1.2
This is the device that adds USB compatibility to the device.
M5Stack Audio Module (STM32G030)
This is the device that adds an audio output jack to the device.
Data Privacy
echolocation collects no data on the user and does not log any data they input.
Although echolocation is designed to be used with another device (like an iPad), you will need to consult that device or software to find out how they use keyboard input data.
Risks
Below is a list of risks associated with this product. Outlined are the decisions made at design and manufacturing stages to mitigate them. There are also recommended mitigations that the user should take to further reduce risk.
| Risk | Design Mitigation | Recommended User Mitigation |
|---|---|---|
| Device being damaged | The device is held together using 4 tightly screwed M3 bolts. The screen is also made of plastic, reducing the risk of sharp glass causing injury | As soon as there is any damage to the device stop using it immediately. |
| Charging cables can be a hazard | The device requires a cable, but for use it supports Bluetooth connections for input and output, reducing the need for a cable | Safely store the device while charging and use wireless capabilities when you can |
| Device stops working, so user can't communicate | The device has been extensively tested, and in the event of a code failure the device will restart. | The communication partner should be aware of the device and monitor its output. The user should always have low-tech alternatives available. |
| Disclosure of sensitive data | The device stores no data or shares it beyond the device | Ensure the user understands that if they are typing sensitive information, anyone nearby can hear it. |
Other risks
The device is designed to be used with other devices such as an iPad and a keyboard. When using the device with other devices, you should be aware of the risks associated with those devices as well.
Insurance
AACTools holds professional indemnity insurance and public liability insurance. If you have any questions about this, please contact us.