Important Information; Safety Definitions; Safety Instructions Before Using Ir-1Sp Micro; Serious Incidents - Abilia IR-1SP Micro Manuel

Important information

Before you use the product, read and understand the contents of this user manual.

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.

Safety instructions before using IR-1SP Micro

WARNING: Read the following warning instructions before you use the product.
The string lock is a safety feature to prevent strangling. Make sure that the ends of the neck
•
strap can be pulled out eg. if the transmitter gets caught on something. Never make knots in
the neck strap.

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.

Conformance with requirements for medical devices

IR-1SP Micro is marketed as a technical aid for people with disabilities. It complies with all
necessary requirements, regulations and directives for medical devices.

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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