
X
TRA
Operator’s Manual
20077/021 US
B-1
Appendix B: Approvals and Test Certificate
The X
TRA
and X
VAC
equipment have been tested and comply with the following:
EMC Standards
Appendix A: Safety Standards EN 60601-1-2
)
EMC Emission
• IEC 60601-1-2
: 2007 and : 2014
EMC Immunity
• IEC 60601-1-2
: 2007 and : 2014
Electrical and Mechanical Safety Standards
• IEC 60601-1
Edition 3.1
Certification
• C-US NRTL Certification
• CB Certification
The LivaNova quality assurance system complies with the following standards:
• UNI - EN - ISO - 13485
Содержание 75220
Страница 1: ...Operator s Manual SOFTWARE VERSION 2 00 20077 021 US FOR US MARKET ONLY...
Страница 70: ...System Description 3 32 20077 021 US XTRA Operator s Manual...
Страница 148: ...Special Cycles 6 10 20077 021 US XTRA Operator s Manual...
Страница 156: ...Automated Functions 7 8 20077 021 US XTRA Operator s Manual...
Страница 178: ...Programmability Option 9 10 20077 021 US XTRA Operator s Manual...
Страница 206: ...Preoperative Sequestration PPP and PRP 10 28 20077 021 US XTRA Operator s Manual...
Страница 232: ...Vacuum Module 13 10 20077 021 US XTRA Operator s Manual...
Страница 260: ...Troubleshooting 14 28 20077 021 US XTRA Operator s Manual...
Страница 270: ...Maintenance 15 10 20077 021 US XTRA Operator s Manual...
Страница 282: ...A 6 20077 021 US XTRA Operator s Manual...
Страница 284: ...B 2 20077 021 US XTRA Operator s Manual...
Страница 286: ...C 2 20077 021 US XTRA Operator s Manual...
Страница 298: ...D 2 20077 021 US XTRA Operator s Manual...
Страница 302: ...E 4 20077 021 US XTRA Operator s Manual...
Страница 304: ...LivaNova Deutschland GmbH Lindberghstrasse 25 D 80939 M nchen Germany Tel 49 0 89 32301 0 Fax 49 0 89 32301 555...