Medical Device Directive (MDD)
English
This device is not medical equipment according to EN 60 601-1 and must therefore not enter
the Patient Environment as defined in EN 60 601-1-1. The following requirements have to
be met:
1.
Distance from device to Patient Contact Equipment (see illustration). Horizontal = 1,83
metres; Vertical = 2,5 metres above the floor under the patient.
2.
Contact of patient and device simultaneously by caregiver not allowed.
3.
NO direct electrical connection between device and Patient Contact Equipment is
allowed.
AUTHORISED AGENT:
Manager, Product Safety; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, GERMANY.
1,83m
1,83m
1,83m
2,5m
