14
Interference
Although the
TheraKair Visio
Therapy Unit conforms to the intent of IEC 60601-1-2 in relation to
electromagnetic compatibility, all electrical equipment may produce interference. If interference
is suspected, move equipment from sensitive devices or contact the manufacturer. (IEC 60601-
1-2. Medical Electrical Equipment – Part 1: General Requirements for Safety, Amendment
No. 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests). See the
Electromagnetic Emissions Information
section for detailed testing data.
General Protocols
Follow all applicable safety rules and institution protocols concerning patient and caregiver safety.
If a serious incident occurs in relation to this medical device, affecting the user, or the patient
then the user or patient should report the serious incident to the medical device manufacturer
or the distributor. In the European Union, the user should also report the serious incident to the
Competent Authority in the member state where they are located.
End of Life Disposal
•
Fabric material used on the mattresses or any other textiles, polymers or plastic materials
etc. should be sorted as combustible waste.
•
Mattresses at the end of life should be disposed of as waste according to the national or
ORFDOUHTXLUHPHQWVZKLFKPD\EHODQG¿OORUFRPEXVWLRQ
•
Pump units have electrical and electronic components should be disassembled and
recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with
local or national regulation.
Customer Contact Information
For questions regarding this product, supplies, maintenance, or additional information about Arjo
products and service, please contact Arjo or an Arjo authorized representative or see www.Arjo.
com.
