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Abilia IR-1S - Safety, Storage, and Compliance; Storage and Disposal; Safety Instructions and Definitions; Incident Reporting and Product Liability

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13
Storage and disposal
Storage
Keep the product indoors at room temperature and away from moist.
Recycling Waste Electrical and Electronic Equipment
The IR-1S Wrist transmitter contains electronics components that must be recycled.
When the product is no longer of use, hand it in to a recycling centre for waste electrical
and electronic equipment.
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-1S Wrist transmitter
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-1S Wrist transmitter 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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