9
NOTE 3
The device cannot be used to verify whether the alerted body movement was caused by a
tonic-clonic seizure. The occurrence of a tonic-clonic epileptic seizure can be verified,
among other things, against electroencephalogram (EEG) data interpreted by a healthcare
professional. The product cannot replace an EEG recording system.
NOTE 4
Always ensure the suitability of the device - particularly for small children - by conducting a
test run. There are no weight or age restrictions for the use of the device.
3.3 Intended user and operator
The intended user of the product is the monitored person.
The intended operator is the caregiver of the user. The operator needs to be adult who
fully understands instructions and limitations of use mentioned in these instructions for
use. Otherwise no special skills or knowledge is needed for the operator.
3.4 Liability of the manufacturer
Abilia is liable to ensure the safety, reliability and performance of the device, provided that:
• the device is installed, used and cleaned in accordance with the instructions in these
instructions for use
• any changes to the product, maintenance and repairs are conducted by a person
trained by Abilia or its representative
• any spare parts or accessories used have been approved by Abilia.
3.5 About these instructions for use
Read all warnings and reminders in these instructions for use with care to avoid any
hazardous situations and damage.
