Canon OMNERA 400T, Operator'S Manual

Page: 10 / 166

OMNERA® 0180-095-418-EN Rev. 6.1
Operator´s Manual
Page 2 2020-09-18
1.2 Identification Labels
The figure shows the location of the identification labels on the equipment.
400 3~VAC
400 3~N VAC
480 3~VAC
Model: 0180 SC
SN XXXX
MM/YYYY
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
Model: 0180
SN XXXX
Power rating:
Intermittent operation: 20% 1min ON / 4min OFF
MM/YYYY
Type: X-ray System
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
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.
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0413
Model: 0170CS
SN XXXX
MM/YYYY
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
0181
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
Aluminium equivalence <= 0.9 mm AL
Max patient weight: 295 kg
Model: 0181
SN XXXX
MM/YYYY
Intermittent operation: 20% 1min ON / 4min OFF
0413
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.
Model: 0058
SN XXXX
MM/YYYY
Al equivalency: 0.6 mm AL
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
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
0413
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
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
Power rating: 2x115 VAC
Long-time (positioning) 2A, 50/60Hz
Momentary (exposure) 150A, 50/60 Hz
Associated equipment:
0181, 0175, 0170CS, 0058, 0180 SC
IEC60601-2-54:2009
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.
Model: 0058
SN XXXX
MM/YYYY
Al equivalency: 0.25 mm AL
Associated equipment 0181, 0058
IEC60601-2-54:2009
0413
0413
13
14
3
12
3
11
10
7
6
3
1
2
3
4
5
8
9
Fig. 1-1
3484
-01
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.
ETL Classified
CONFORMS TO
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
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
15
16
3
Fig. 1-2
Introduction
Identification Labels