2097937-002 Rev G T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 3
11 March 2019
Contents
1 Introduction ............................................................................................................ 9
Intended User ......................................................................................................... 9
Indications for Use ................................................................................................ 9
Prescription Device Statement ........................................................................... 9
Regulatory and Safety Information ................................................................... 9
Safety Conventions ................................................................................... 10
Safety Hazards........................................................................................... 10
Classification of Medical Device ............................................................. 13
Regulatory and Safety Conformance .................................................... 13
Table 1: Guidance and Manufacturer’s Declaration - Emissions ..... 14
Table 2: Guidance and Manufacturer’s Declaration – Immunity All
ME Equipment and ME Systems ............................................................. 15
Table 3: Guidance and Manufacturer’s Declaration – Immunity ME
Equipment and ME Systems that is NOT Life-supporting ................. 16
Table 4: Recommended Separation Distances between portable and
mobile RF Communications equipment and the T2100-ST Series ME
Equipment and ME Systems that is NOT Life-supporting ................. 17
Responsibility of the Manufacturer ....................................................... 17
Responsibility of the Customer .............................................................. 18
Product and Package Information ......................................................... 20
Symbols ....................................................................................................... 20
Equipment Identification ................................................................................... 23
Product Label ............................................................................................. 23
Service Information ............................................................................................ 24
Service Requirements ............................................................................... 24
Warranty Information .............................................................................. 24
Additional Assistance ............................................................................... 24
Manual Information ............................................................................................ 25
Manual Purpose ......................................................................................... 25
Document Conventions............................................................................ 25
Related Documents .................................................................................. 26
2 Product Overview ................................................................................................ 29
Safety Systems .................................................................................................... 30
Treadmill ............................................................................................................... 30
Drive System ........................................................................................................ 30
Speed Range ......................................................................................................... 30
Incline Range ........................................................................................................ 30
Running Surface .................................................................................................. 30
Communication Ports ......................................................................................... 31