Heartway Medical Products S11E User Manual page 26

The FDA has written to the manufacturers of power scooters asking them to test new
products to be sure they provide a reasonable degree of immunity against EMI. The FDA
requires that a powered scooter should have an immunity level at least 20 V/m, which
provides a reasonable degree of protection against more common sources of EMI. The
higher the immunity level the greater the protection. Your powered scooter has an immunity
level of 20 V/m which should protect
against common sources of EMI.
WARNING
• The scooter itself can disturb the performance of the electromagnetic fields such as emitted
by alarm systems of shops.
• The driving performance of the scooter can be influenced by electro magnetic fields.
S11E seat is tested according to EN 1021 regarding resistance to ignition, but it is
recommended to avoid the use of flame near the power scooter and of smoking during
sitting on the power scooter.
Remarks:
The stability tests were performed in the least stable positions of the seat (height and
front/rear position).
The distance will be reduced if the wheelchair is used frequently on slopes, rough round or
to climb the kerbs.
WARNING
The stopping distance on the slope can be significantly greater than on the level
ground.
Indication/ Intended Purpose:
Considerable to pronounced limitation of mobility/walking abilities/structural and/or
functional damages the lower extremities (including amputation, consequences of
injuries, musculoskeletal.
Severe impairment of strength and grasping capabilities
 Sufficient orientation and coordination capabilities
 Ensuring mobility indoors as well as outdoors (access to neighborhood and
handling of routine errands)
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