Medical Equipment Classification - Carestream DRX-1 User Manual

Safety and Regulatory Information

Medical Equipment Classification

Table 1: CARESTREAM DRX-1 System Detector Medical Equipment Classification
Specification
Type of protection against electrical shock:
Degree of protection against electrical shock:
Degree of protection against ingress of
water:
Mode of operation:
Flammable anesthetics:
a. Only internally powered unless the tether is connected. When the tether connected, the Class depends on the
tether used:
Tether Model DRX-1 System Tether Interface = Class I, Tether Model DRX-TPC1 = Class II
Table 2: CARESTREAM DRX 2530 Detector Model DRX-2530-01 Medical Equipment
Specification
Type of protection against electrical shock:
Degree of protection against electrical shock:
Degree of protection against ingress of
water:
Mode of operation:
Flammable anesthetics:
a. Only internally powered unless the tether is connected. When the tether connected, the Class depends on the
tether used:
Tether Model DRX-1 System Tether Interface = Class I, Tether Model DRX-TPC1 = Class II
1–2
Classification
Description
Internally powered equipment Class I or Class
a
II Equipment
Type B Applied Part
Ordinary protection
Continuous operation
Not suitable for use in the presence of flam-
mable anesthetics or a mixture of flammable
anesthetics with air or oxygen or nitrous
oxide.
Description
Internally powered equipment Class I or
a
Class II Equipment
Type B Applied Part
Ordinary protection
Continuous operation
Not suitable for use in the presence of flam-
mable anesthetics or a mixture of flammable
anesthetics with air or oxygen or nitrous
oxide.
AA5348 | 2012-12-20