USER
MANUAL
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51335-006
EEG System
Quality of Service and Associated Risks
1. The risk of corrupt data due to interference is very small due to error detection, error correction and resend data
packet mechanisms. In addition to this error detection and correction, the application provides time-stamped
data packages, which enables the detection of corrupt, delayed or missing data.
2. The risk of missing data due to interference is also very small, but at the extreme, the data rate decreases as
more and more data packets have to be dropped and resent. Ultimately, in the presence of extreme interference,
the data rate will decrease to zero and the wireless link will be dropped. This situation is also adequately
handled with the provision of time-coded data packets, which enables the detection of corrupt, delayed or
missing data. In the extreme case whereby the interference causes the wireless link to be dropped all together,
the application automatically reconnects when the interference is removed. This situation is very similar to
being out-of-range and the same mechanisms apply and, again, the application will automatically reconnect
when the device comes back into range.
In the presence of extreme and persistent interference, the cabled USB connection is, of course, available.
3. The risk of unauthorised users is very small due to the authentication requirements of the wireless link and the
fact that the R40 Interface Protocol is proprietary.
4. The medical system uses mature, industry-standard hardware and protocols: Bluetooth and WiFi. This ensures
that the system utilises all the benefits associated with these mature standards, concerning the authentication,
data integrity and interference performance as discussed in this document.
5. The radio modules are tested according to their own EMC emissions and immunity standards: EN 300 328, EN
301 489-1, EN 301 489-17 and IEC 60601-1-2 (Bluetooth).
6. The radio modules are pre-certified and Type Approved.
Considering the medical system function, its indication for use and very low risk associated with a low level
of concern, the analysis, evaluation and preventative measures undertaken reveal the low risk associated with
wireless communication. In the presence of extreme interference, the rate of delivery of data packets will decrease
until ultimately, the wireless link is dropped. Wireless communication problems are identified, prevented and
mitigated, as described. The application identifies these wireless problems and automatically reinstates the
wireless link if dropped in the presence of extreme interference. Alternatively, the cabled USB connection is
available.
Pre-compliant Wireless Modules
The use of pre-compliant, certified and Type-approved optionally-fitted internal Bluetooth and WiFi wireless
modules which comply with applicable national radio regulations ensures best performance, interoperability,
coexistence and quality of service is achieved.
Appendix 4
Содержание neuro R40
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