Canon OMNERA 400T, Operator'S Manual

Page: 11 / 166

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