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2000966-386D
Dash™ 3000/4000/5000
CE-1
CE Marking Information
Compliance
The patient monitor bears CE mark CE-0459 indicating its conformity with the
provisions of the Council Directive 93/42/EEC concerning medical devices and
fulfills the essential requirements of Annex I of this directive. The product is in radio-
interference protection class A in accordance with EN 55011.
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility - Medical Electrical Equipment”.
The system meets the requirements of EN 60601-1-2 (2001) Medical Electrical
Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard:
Electromagnetic compatibility — Requirements and tests.
Exceptions
Users should be aware of known RF sources, such as radio or TV stations and hand-
held or mobile two-way radios, and consider them when installing a medical device
or system.
Be aware that adding accessories or components, or modifying the medical device or
system may degrade the EMI performance. Consult with qualified personnel
regarding changes to the system configuration.
Radio and Telecommunication Terminal Equipment
Directive
The monitor contains a transmitter. The transmitter bears a CE mark indicating
conformity with the essential requirements specified in Article 3 of the Council
Directive 1999/5/EC of 9 March 1999 concerning Radio Equipment and
Telecommunications Terminal Equipment (R&TTE).
The essential requirements are as follows:
Article 3.1 (a) Health Safety; the product complies with the particular medical device
safety standards specified in the Medical Device Directive 93/42/EEC: EN 60601-1/
1990 + A1: 1993 + A2: 1995: Medical electrical equipment. General requirements for
safety.
Article 3.1 (b) EMC; the product complies with:
EN 60601-1-2 (2001) Medical electrical equipment: Part 1: General requirements
for safety - 2. Collateral standard: Electromagnetic compatibility - requirements
and test.
ETS 300 826 (1997): “Electromagnetic compatibility and Radio spectrum
Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for 2.4 GHz
Summary of Contents for Dash 3000
Page 11: ...2000966 386D Dash 3000 4000 5000 ix Symbols F 8 ...
Page 12: ...x Dash 3000 4000 5000 2000966 386D ...
Page 15: ...2000966 386D Dash 3000 4000 5000 1 1 1 Introduction ...
Page 33: ...2000966 386D Dash 3000 4000 5000 2 1 2 Equipment Overview ...
Page 48: ...2 16 Dash 3000 4000 5000 2000966 386D Equipment Overview ...
Page 49: ...2000966 386D Dash 3000 4000 5000 3 1 3 Monitor Setup ...
Page 61: ...2000966 386D Dash 3000 4000 5000 4 1 4 Alarms ...
Page 69: ...2000966 386D Dash 3000 4000 5000 5 1 5 Managing Patients ...
Page 81: ...2000966 386D Dash 3000 4000 5000 6 1 6 Patient Data ...
Page 92: ...6 12 Dash 3000 4000 5000 2000966 386D Patient Data ...
Page 93: ...2000966 386D Dash 3000 4000 5000 7 1 7 Printing ...
Page 97: ...2000966 386D Dash 3000 4000 5000 8 1 8 Monitoring ECG ...
Page 116: ...8 20 Dash 3000 4000 5000 2000966 386D Monitoring ECG ...
Page 117: ...2000966 386D Dash 3000 4000 5000 9 1 9 Monitoring Invasive Pressures ...
Page 125: ...2000966 386D Dash 3000 4000 5000 10 1 10 Monitoring NBP ...
Page 135: ...2000966 386D Dash 3000 4000 5000 11 1 11 Monitoring SpO2 ...
Page 149: ...2000966 386D Dash 3000 4000 5000 12 1 12 Measuring Cardiac Output ...
Page 155: ...2000966 386D Dash 3000 4000 5000 13 1 13 Monitoring Respiration ...
Page 159: ...2000966 386D Dash 3000 4000 5000 14 1 14 Monitoring Temperature ...
Page 162: ...14 4 Dash 3000 4000 5000 2000966 386D Monitoring Temperature ...
Page 163: ...2000966 386D Dash 3000 4000 5000 15 1 15 Monitoring End Tidal CO2 ...
Page 170: ...15 8 Dash 3000 4000 5000 2000966 386D Monitoring End Tidal CO2 ...
Page 171: ...2000966 386D Dash 3000 4000 5000 16 1 16 Monitoring Anesthesia Gases ...
Page 179: ...2000966 386D Dash 3000 4000 5000 17 1 17 Monitoring Impedance Cardiography ICG ...
Page 185: ...2000966 386D Dash 3000 4000 5000 18 1 18 Monitoring Bispectral Index BIS ...
Page 193: ...2000966 386D Dash 3000 4000 5000 A 1 A Maintenance ...
Page 210: ...A 18 Dash 3000 4000 5000 2000966 386D Maintenance ...
Page 211: ...2000966 386D Dash 3000 4000 5000 B 1 B Software Packages ...
Page 214: ...B 4 Dash 3000 4000 5000 2000966 386D Software Packages ...
Page 215: ...2000966 386D Dash 3000 4000 5000 C 1 C Factory Defaults ...
Page 227: ...2000966 386D Dash 3000 4000 5000 D 1 D Custom Defaults ...
Page 236: ...D 10 Dash 3000 4000 5000 2000966 386D Custom Defaults ...
Page 237: ...2000966 386D Dash 3000 4000 5000 E 1 E Interfacing with Non GE Devices ...
Page 255: ...2000966 386D Dash 3000 4000 5000 F 1 F Abbreviations and Symbols ...
Page 268: ...Index 6 Dash 3000 4000 5000 2000966 386D ...
Page 269: ......