Prescription Statement; Intended Use; Indication For Use; Regulations - Invacare TDXSP2V User Manual

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Invacare® TDX® SP2 Series
Symbols in the Manual
Battery Recycling Symbol — Lead Acid
Recycle this product. Refer to Disposal and
Recycling sections.
Manufacturer
Symbols on the Product
Read Manual
Tie-Down Point
Compliant with RESNA WC-4:2017, Section 19.

1.3 Prescription Statement

Per 21 CFR 801.109(b)(1) the device is labeled for
prescription use only.
CAUTION!
Federal Law (USA) restricts this device to sale by
or on the order of a licensed physician.

1.4 Intended Use

The intended use of the device is to provide mobility and
positioning to persons limited to a sitting position.
6

1.5 Indication for Use

The indication for use of the Invacare® TDX® SP2 Power
Wheelchair is to provide mobility and positioning to persons
limited to a sitting position.

1.6 Regulations

The vehicle was successfully tested according to international
standards as to its safety. It satisfies the requirements
according to RoHS 2011/65/EU, CAL117, RESNA.
It was also tested successfully according to EN 60529 IPX4
as to its resistance to spray water.

1.7 Service Life

The expected service life is five years, presuming that
the product is used daily and in accordance with safety
instructions, maintenance instructions and intended use,
stated in this manual.
60101877-B

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