ECO 2 Ultrasound Diagnostic System
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I
spta,α
at z
pii,α
or
z
sii,α
Operating
Control
Conditons
NOTE 1 Only one operating condition per index.
NOTE 2 Data should be entered for “at surface” and “below surface” both in the columns related to
TIS or TIB.
NOTE 3 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not
intended for transcranial or neonatal cephalic uses.
NOTE 4 If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the
columns related to TIS, TIB or TIC.
NOTE 5 If the requirements of 201.12.4.2b) are met, it is not required to enter any data in the column
related to MI.
NOTE 6 The depths z
pii
and z
pii,α
apply to NON-SCANNING MODES, while the depths z
sii
and z
sii,α
apply to SCANNING MODES.
Appendix C: Guidance and Manufacturer’s Declaration
1. Guidance and manufacturer’s declaration – electromagnetic emissions
The ECO 2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ECO 2 should assure that it is used in such an environment.
Electromagnetic environment –
guidance
The ECO 2 uses RF energy only
for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference in nearby
electronic equipment.
The ECO 2 is suitable for use in
medical establishments
including domestic