Inspection of Electromedical Devices according to DIN EN 62353 (VDE 0751-1):
2015-10
Manufacturer: Stiegelmeyer
GmbH & Co.
User-specific parts:Mattress
base, headboard and foot-
board, safety sides
Testing equipment used
(type/inventory no.):
1.
2.
Medical Devices Regulation
classification:Class I
I. Visual inspection OK Not
ok
Description
of Defect
What? How?
Visual Inspection of the Electrical Components (if Installed)
Control unit/
power pack:
Type plate: Present, legible
Housing: Securely fixed, No cracks/damage
All plugs inserted and locked in securely?
Motors: Housing and lifting tubes: No cracks/
damage/deformation?
Handset/foot
pedal
Housing + keyboard + display: No damage?
Internal cabling:
Motor cable,
handset cable,
mains cable, ad-
ditional compo-
nent cables
No damage, securely fixed, safe routing of
cable without risk of it being crushed when
bed is moved, mains cable holder available
I. Visual inspection OK Not
ok
Description
of Defect
What? How?
Visual Inspection of the Mechanical Components (if Installed)
Type plate +
warning labels
on bed
Available on bed frame, legible
Appendix
Instruction Manual 150