Navigator 2.0 User Manual & Service Guide
N2-5000-07-001 Rev 7
-
6-
Revised 10/16/2018
www.Dilon.com
Trademarks
The following are trademarks of Dilon Technologies: Navigator 2.0
™, Wireless Pilot Probe™, Dilon
Navigator GPS
™, Dilon Navigator™, Dilon Technologies Navigator GPS™, Dilon Technologies
Navigator
™, Dilon Technologies Navigator 2.0™, Daniel Lung Probe™, and Navigator™ when used
in context with the above.
Navigator GPS
®
is a registered trademark of Dilon Technologies.
Regulatory and Safety Requirements
The Dilon Navigator GPS
™ System including Probes and accessories complies with the
following standards:
EC Directives
EMC Directive 89/336/EEC
Group l, Class B
EN 55011
EMC Directive 89/336/EEC
IEC 60601-1-2: 3
rd
Edition
Reciprocal Interference
This product has been tested and verified to ensure that there are no issues or concerns
regarding reciprocal interference. This includes EMI, EMC and RF. This product has been
certified and tested by 3rd party testing facilities. List of standards is as follows:
• Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral
Standard: Safety Requirements For Medical Electrical Systems
– IEC 60601-1-1: 3
rd
Ed.
• Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral
Standard: Electromagnetic Compatibility - Requirements and Tests
– IEC 60601-1-2: 3
rd
Ed.
Safety
• Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral
Standard: Safety Requirements For Medical Electrical Systems
– IEC 60601-1: 2
nd
& 3
rd
Ed.
• Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral
Standard: Electromagnetic Compatibility - Requirements and Tests
– IEC 60601-1-2: 3
rd
Ed.
• Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral
Standard: Usability - IEC 60601-1-6: 3
rd
Ed.
• Information supplied by the manufacturer of medical devices- EN 1041:2008
• Symbols for use in the labeling of medical devices - EN 980 :2008
• CAN/CSA C22.2 No. 60601-1, "Medical Electrical Equipment, Part 1: General Requirements
for Safety & Essential Performance; issued 2008-02-01 Ed. 2
• AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand
CAUTION: Federal (USA) law restricts this device to sale and use by, or on the
order of, a physician.
Summary of Contents for Navigator 2.0
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