Invacare TDXSP2V Owners Manual - Page 6
Prescription Statement, Intended Use, Indication for Use, Regulations, Service Life
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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