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Does the SitnStand have CE approval?
Yes, the SitnStand is a class a of medical device and it is approved for marketing, sales and use in the UK and Europe.
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EC/EN 60601-1: 2012, 3.1 Ed., Medical electrical equipment, part 1: General requirements for Basic Safety and Essential Performance.
IEC/EN 60601-1-2:2014, Medical Electrical Equipment- Part 1-2: General requirements for safety –Collateral standard: Electromagnetic compatibility –Requirements and tests.
IEC/EN 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance – Collateral Standard: Usability
IEC 62366:2008 Medical devices -- Part 1: Application of usability engineering to medicaldevices
IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid
electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
BS EN 12182 Assistive products for persons with disability – General requirements and test methods
EN 1021-1 and EN 1021-2, - Furniture – Assessment of the ignitability of upholstered furniture – Part 1: Ignition source smouldering cigarette.
- Furniture – Assessment of the ignitability of upholstered furniture – Part 2: Ignition source match flame equivalent.
IEC 62304:2006/AC:2008, Medical Device Software – Software Lifecycle Processes.
IEEE 1028-1997, IEEE Standard for Software Reviews.
EN ISO 14971:2012, Implementation of Risk Management for Medical Devices.
ISO 15223-1:2016, Labeling and Marking Symbols for Medical Devices
EN 1041:2008: Information supplied by the manufacturer of medical devices Flammability and ignitability:
BS 5852:2006, Methods of test for assessment of the ignitability of upholstered seating by smoldering and flaming ignition sources
Does the SitnStand have FDA approval?
What is the Max weight allowed for use with the SitnStand?
Is there a Minimum weight allowed?
There is no minimum weight for the SitnStand.
I’m 6 feet tall, can I use the SitnStand?
I'm under 5 feet tall, can I use the SitnStand?
Is there any danger of an electric shock?
No. The SitnStand operates with a low voltage rechargeable battery.
How often do you need to re-charge the battery?
You need to charge it approximately every 4 to 6 days, obviously depending on how frequently you are using it.
Does it come with an electrical charger for the rechargeable battery?
How heavy is it?
How many inches high will it inflate?
It will Inflate 7.9 inches.
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