8-5
17 368 02 0320
Technical data, conformity and labelling
8.2
Type plate DUOLITH
®
SD1
8.3
Conformity with directives
This medical product bears the CE mark in accordance with the
Medical Device Directive (MDD) 93/42/EEC.
8.4
Conformity with standards
This device complies with the applicable standards EN 60601-1, CAN / CSA-C22.2
No. 601.1, UL Std. No. 60601-1.
Acc. to EN 60601-1
- Type of protection against electric shocks:
Protection class 1
- Application unit of type B
Equipment safety (“essential performance“) according to IEC 60601-1:2005 +
A1:2012 / EN 60601-1:2006 + A1:2013, 3rd edition:
1 The device shall be free from excessive pressure pulse energy
2 The device shall be free from incorrect display of energy levels
3 The device shall be free from unintentional shockwave release
are fulfilled.
The essential performance characteristics of the device cannot be affected by electro-
magnetic interference (EMI).
Summary of Contents for DUOLITH SD1 R-SW
Page 2: ...II 17 360 02 0320 Preface...
Page 12: ...XII 17 360 02 0320 Preface...
Page 13: ...1 General Safety Information...
Page 19: ...2 Principles...
Page 24: ...2 6 17 362 02 0320 Principles empty page...
Page 25: ...3 System Description...
Page 49: ...4 Operation...
Page 100: ...4 52 17 364 02 0320 Operation...
Page 101: ...5 Status Displays and Trouble shooting...
Page 106: ...5 6 17 365 02 0918 Status messages and trouble shooting empty page...
Page 107: ...6 Cleaning Maintenance Overhaul...
Page 119: ...7 Accessories...
Page 122: ...7 4 17 367 02 0320 Accessories...
Page 123: ...8 Technical data conformity and labelling...
Page 137: ...9 Warranty and service...
Page 139: ...10 Ultrasound optional...