content
file: n:\article\cos14310m5-v1_06hpc-en\20120215_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_running_machine.doc
© 2012 h/p/cosmos sports & medical gmbh author: fh [email protected] created 15.02.2012 printed 15.02.2012 page: 6 of 213
[2.]
Content
[1.] Introduction ........................................................................................................................................................................ 4
[2.] Content ............................................................................................................................................................................... 6
[3.] Introduction ...................................................................................................................................................................... 12
[3.A]
Description of the device and its intended application ................................................................................................... 12
[3.B]
Position on the treadmill ................................................................................................................................................. 12
[3.C]
Treadmill-Patient-Interface ............................................................................................................................................. 12
[3.D]
Materials used ................................................................................................................................................................ 13
[3.E]
Device components, including software and accessories .............................................................................................. 13
[3.F]
Mechanical characteristics ............................................................................................................................................. 14
[3.G]
Performance claims & performance data ....................................................................................................................... 14
[3.H]
Describe how the device achieves its intended purpose ................................................................................................ 14
[3.I]
Specific safety or performance claims made for the device: .......................................................................................... 15
[3.J]
Emergency buttons: ....................................................................................................................................................... 15
[3.K]
Pictures of safety devices ............................................................................................................................................... 16
[4.] Safety, warnings, precautions, prohibitions ................................................................................................................. 17
[4.A]
Safety precautions, safety regulations, prohibitions and warnings ................................................................................. 17
[4.B]
Exit the device in emergency case; emergency dismount.............................................................................................. 18
[4.C]
Emergency Off, Emergency Stop and Safety Stop Devices and functions .................................................................... 18
[4.D]
General Instructions / Safety .......................................................................................................................................... 21
[4.E]
Instructions for safety and operation .............................................................................................................................. 22
[4.E1]
Electric safety / safety classes / degree of protection ........................................................................................ 22
[4.E2]
Patient security according to VDE 0750 (IEC 60601-1) type B
R
applied part ............................................... 22
[4.E3]
Potential equalization ......................................................................................................................................... 22
[4.E4]
Connection of units installed outside medically utilized locations ...................................................................... 23
[4.E5]
Medical electrical systems ................................................................................................................................. 23
[4.E6]
Subject's surroundings ....................................................................................................................................... 23
[4.E7]
Protection against the danger of electrical shocks ............................................................................................. 24
[4.E8]
Environmental requirements .............................................................................................................................. 24
[4.F]
Medical device software ................................................................................................................................................. 25
[4.G]
Connection of external host and/or auxiliary devices via interface ................................................................................. 26
[4.H]
Programmable, electrical medical systems (PEMS)....................................................................................................... 27
[4.H1]
In-house production according to § 12 MPG ..................................................................................................... 27
[4.I]
Economic life-time .......................................................................................................................................................... 33
[4.J]
Symbols used ................................................................................................................................................................. 33
[4.K]
Safety standards, norms ................................................................................................................................................ 33
[4.K1]
VDE / IEC EN norm ........................................................................................................................................... 34
[4.K2]
The
c
mark for sports devices ........................................................................................................................ 34
[4.K3]
The
n
mark for medical devices ........................................................................................................... 34
[4.K4]
EMC Electromagnetic Compatibility ................................................................................................................... 34
[4.K5]
General advice ................................................................................................................................................... 34
[4.L]
h/p/cosmos medical running machines - MDD medical device directive. Safety standards ........................................... 35