DHHS — STATEMENTS and INFORMATION according to 21 CFR
Sub Chapter J
HELIODENT
70 single-tank dental x-ray generator
1020.30 (h) (1) (i)
Instructions for the use of the HELIODENT
70 and precautionary statements are part
of the OPERATING
INSTRUCTIONS:
1020.30 (h) (1) (ii)
After a period of 12 months the X-ray control must be serviced to keep it in compliance
with the DHHS Performance Standard.
Note:
Failure of the user to do so relieves the manufacturer or his agents, from all responsibility in
this matter.
1020.30 (h) (2) (i)
Rated maximum peak tube potential
70 kV
leakage technique factors
70 kV/0,12 DCmA
(0,12 mA is the equivalent maximum
rated continuous tube current for
7 mA with a duty cycle 1 : 60)
Minimum filtration in useful beam
2,7 mm Al at 70 kV
1020.30 (h) (2) (ii)
1020.30 (h) (2) (iii)
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