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9. Important information
Before you use the product, read and understand the contents of this user manual.
9.1. Safety definitions
WARNING: Risk of injury or death if the instructions are not followed.
CAUTION: Risk of damage to the product if the instructions are not followed.
NOTE: Information that is necessary in a given situation.
TIP: Additional information that can improve the use of the product.
9.2. Safety instructions before using Emfit Epilepsy Alarm
WARNING: Read the following warning instructions before you use the product.
If an external force breaks the AC adapter and parts remain in the socket, it can result in
•
electric shock.
9.3. Serious incidents
If a serious incident related to the product occurs, report this to the manufacturer and the
competent authority of your country. A serious incident directly or indirectly led, might have
led or might lead to the death of a patient, user or other person; the temporary or permanent
serious deterioration of a patient's, user's or other person's state of health; or a serious
public health threat.
9.4. Conformance with requirements for medical devices
Emfit Epilepsy Alarm is marketed as a technical aid for people with disabilities. It complies with
all necessary requirements, regulations and directives for medical devices.
9.5. Product liability
The product is developed and risk-assessed according to ISO 14971. The manual and the
technical specifications are made according to the safety assessments in the risk analysis. Always
consider the safety when using the product. Abilia AB does not take responsibility for any
consequences following incorrect use or installation of the product. Any form of damage or
tampering with the product invalidates the warranty and disclaims the manufacturer's liability. The
estimated lifetime of the product applies when used in accordance with its intended use and
maintenance instructions.
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