FAQ

Ask us anything you want to know, if you didn't find an answer to your question, please feel free to contact us.

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. Legal Manufacturer: - Life Assistant Ltd
- 8 Harod St. Afula, 1871208, Israel EU Authorised Representative (EC REP): - Advena Limited - Address - Tower Business Centre, 2nd Flr, Tower Street, Swatar, BKR 4013 Malta. The SitnStand meet all the standards below: Applicable standards
Electrical Safety:

  • 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
  • Assistive devices
  • 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.
Software:
  • IEC 62304:2006/AC:2008, Medical Device Software – Software Lifecycle Processes.
  • IEEE 1028-1997, IEEE Standard for Software Reviews.
Risk Management:
  • EN ISO 14971:2012, Implementation of Risk Management for Medical Devices.
Labeling:
  • 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?


Yes, the SitnStand is a class A medical device, it is FDA registered and it is approved for marketing, sales and use in the US. The SitnStand FDA registration information is: FDA Listing Number: D413831 Owner Operator Number: 10076737 Product Code: IKX Device Name: Aid, Transfer United States Agent Information: Emergo Global Representation LLC Initial Importer: Techlink International Consulting.




What is the Max weight allowed for use with the SitnStand?


The Max weight allowed for the current model is 265 lbs.(120 kg)




Is there a Minimum weight allowed?


There is no minimum weight for the SitnStand. The only requirement to use the SitnStand is to make sure that both your legs are on the floor before you start using it.




I’m 6 feet tall, can I use the SitnStand?


Yes, you can. The only requirement to use the SitnStand is to make sure that both your legs are on the floor before you start using it.




I'm under 5 feet tall, can I use the SitnStand?


Yes, you can. The only requirement to use the SitnStand is to make sure that both your legs are on the floor before you start using it.




Is there any danger of an  electric shock?


No. The SitnStand operates with a low voltage rechargeable battery. There is no danger to get an electric shock, and the battery conforms to the most severe standards for medical devices. IEC 60601-1-11:2015 and IEC 62133-2:2017




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?


Yes, it does. The SitnStand comes with an electrical charger that can operate in the US and in Europe.




How heavy is it?


The total weight of the SitnStand is about 6.6 lbs (3 kg)




How many inches high will it inflate?


It will Inflate 7.9 inches. We ran many tests in order to find the optimal height. We searched for the right combination of stability and the effective height that will help to get up. Many users who without the SitnStand could not get up at all, with the SitnStand help they manage to get up on their own without the risk of falling.





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