Canon OMNERA 400T Operator's Manual page 11

Table 1-1 . Identification Labels
1
0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
Model:
2
SN
Power rating:
Intermittent operation: 20% 1min ON / 4min OFF
3
4
0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
Model:
5
SN
Al equivalency: 0.6 mm AL
Model:
6
SN
7
0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
8
0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
Operator´s Manual
2020-09-18
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0175
0175
XXXX
MM/YYYY
230VAC, 50/60 Hz, 6A
100-230VAC, 50/60Hz, 1A
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0058
0058
XXXX
MM/YYYY
0170CS
XXXX
MM/YYYY
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0170CS
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0058
0180-095-418-EN Rev. 6.1
Model:
9
SN
MM/YYYY
Al equivalency: 0.25 mm AL
ARCOMA AB
10
Annavägen 1, 352 43 Växjö, SWEDEN
0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
Type:
11
Model:
SN
Power rating:
Long-time (positioning) 2A, 50/60Hz
Momentary (exposure) 150A, 50/60 Hz
Intermittent operation: 20% 1min ON / 4min OFF
Associated equipment:
0181, 0175, 0170CS, 0058, 0180 SC
IEC60601-2-54:2009
Model:
12
SN
ARCOMA AB
13
Annavägen 1, 352 43 Växjö, SWEDEN
0413 0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
14
Model:
SN
Power rating: 2x115 VAC
Aluminium equivalence <= 0.9 mm AL
Max patient weight: 295 kg
Intermittent operation: 20% 1min ON / 4min OFF
Associated equipment 0181, 0058
IEC60601-2-54:2009
ARCOMA AB
15
Annavägen 1, 352 46 Växjö, SWEDEN.
0413
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH &SAFETY ACT OF 1968.
Model:
16
SN
Power rating: 100-240VAC 50/60Hz, 16A
Aluminium equivalence <= 0.9 mm
Max patient weight: 300 kg
Intermittent operation: 20% 1min ON / 4min OFF
Page 3
Introduction
Identification Labels
0058
XXXX
0180
X-ray System
0180
XXXX
MM/YYYY
400 3~VAC
400 3~N VAC
480 3~VAC
0180 SC
XXXX
MM/YYYY
0181
0181
XXXX
MM/YYYY
0055
0055
XXXX
MM/YYYY
OMNERA®