Ralco R 221 ACS DHHS Series, Инструкция по эксплуатации

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MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
C
OMPLIANCE
V
ERIFICATION
95
Model R 221 ACS - R 221 ACS DHHS
MT
R
2
21
ACS
-
MTR
2
21
AC
S DHH
S - Compli
ance V
erification
COMPLIANCE VERIFICATION
M
INIMUM
F
ILTRATION
R
EQUIREMENT
To indicate compliance with 21 CFR, sub-chapter J, part 1020 of Performance Standard it is
necessary for the assembler to perform a series of tests.
Description of test methods are illustrated in this chapter but factors, such as experience,
availability of equipment and tolerance on compliance are referred directly to the Safety
Standards covering Electro-medical equipment.
The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in
the primary beam is not less than that shown in the following table:
1
Dental X-ray Systems designed for use with intraoral image receptors and manufactured after
December 1, 1980.
2
Dental X-ray Systems designed for use with intraoral image receptors and manufactured before
or on December 1, 1980, and all other X-ray systems subjected to this section and manufac-
tured before June 10, 2006.
W
ARNINGS
T
HE
F
OLLOWING
P
ROCEDURES
R
EQUIRE
T
HAT
X-
RADIATION
B
E
P
RODUCED
. T
AKE
A
DEQUATE
P
RECAUTIONS
T
HAT
N
O
P
ART
O
F
H
UMAN
B
EING
I
S
E
XPOSED
T
O
X-
RADIATION
, D
IRECT
O
R
I
NDIRECT
.
Minimum Filtration Requirement - Beam Quality (HVL)
X-Ray Tube Voltage
(kilovolt peak)
Minimum HVL
(mm of aluminum)
Designed
Operating Range
(kVp) Measured
Operating Potential
(kVp)
Specified Dental
System
1
I-Other X-Ray
Systems
2
II-Other X-Ray
Systems
3
Below 51
30
40
50
1.5
1.5
1.5
0.3
0.4
0.5
0.3
0.4
0.5
From 51 a70
51
60
70
1.5
1.5
1.5
1.2
1.3
1.5
1.3
1.5
1.8
Above 70
71
80
90
100
110
120
130
140
150
2.1
2.3
2.5
2.7
3.0
3.2
3.5
3.8
4.1
2.1
2.3
2.5
2.7
3.0
3.2
3.5
3.8
4.1
2.5
2.9
3.2
3.6
3.9
4.3
4.7
5.0
5.4