Identification Labels - Canon OMNERA 400T Operator's Manual

Introduction

Identification Labels

1.2 Identification Labels
The figure shows the location of the identification labels on the equipment.
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
1
0175
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: 0175
SN XXXX
MM/YYYY
2
Power rating:
230VAC, 50/60 Hz, 6A
100-230VAC, 50/60Hz, 1A
Intermittent operation: 20% 1min ON / 4min OFF
ETL Classified
CONFORMS TO
3
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
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: 0058
SN XXXX
5
MM/YYYY
Al equivalency: 0.6 mm AL
OMNERA®
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0058
8
0413
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
9
MM/YYYY
Al equivalency: 0.25 mm AL
0180-095-418-EN Rev. 6.1
Model: 0170CS
SN XXXX
6
MM/YYYY
3
3097698
CAN / CSA STD C 22.2 NO 601.1
10
11
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
0181
13
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.
Model: 0181
SN XXXX
MM/YYYY
Power rating: 2x115 VAC
14
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
Fig. 1-1
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:
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
3097698
CAN / CSA STD C 22.2 NO 601.1
Fig. 1-2
Page 2
ARCOMA AB
Annavägen 1, 352 43 Växjö, SWEDEN
7
0170CS
0413
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
CERTIFIED TO
ARCOMA AB
ETL Classified
Annavägen 1, 352 43 Växjö, SWEDEN
CONFORMS TO
UL STD 60601
0180
0413 3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS
UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL
FOR HEALTH & SAFETY ACT OF 1968.
Type: X-ray System
Model: 0180
SN XXXX
MM/YYYY
Power rating:
400 3~VAC
400 3~N VAC
480 3~VAC
Long-time (positioning) 2A, 50/60Hz
Momentary (exposure) 150A, 50/60 Hz
Intermittent operation: 20% 1min ON / 4min OFF
Model: 0180 SC
Associated equipment: SN XXXX
0181, 0175, 0170CS, 0058, 0180 SC
MM/YYYY
IEC60601-2-54:2009
ETL Classified
CONFORMS TO
3
UL STD 60601
3097698 CERTIFIED TO
CAN / CSA STD C 22.2 NO 601.1
ARCOMA AB
Annavägen 1, 352 46 Växjö, SWEDEN.
15
0055
0055
XXXX
MM/YYYY
16
ETL Classified
CONFORMS TO
UL STD 60601
3
CERTIFIED TO
Operator´s Manual
2020-09-18
3
12