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Chapter 3. Special Construction Requirements
3.1 Radiation Protection
Because x–ray equipment produces radiation, special precautions may be needed or special site
modifications may be required. The General Electric Company does not make recommendations
regarding radiation protection. It is the purchasers' responsibility to consult a radiation physicist for
advise on radiation protection in x–ray rooms.
3.2 EMI Consideration
IEC60601-1-2 Electromagnetic Standard Compliance & Documentation
The information contained in this section is also found in the Innova system Operator Manual.
General Scope
This equipment complies with IEC-60601-1-2: Edition 2.1, Edition 3 and Edition 4 EMC standard for
medical devices.
The Innova system is intended to be used:
• in a PROFESSIONAL HEALTHCARE facility environment and
• in a SPECIAL ENVIRONMENT for systems OR configurations (vicinity of active HF SURGICAL EQUIPMENT
– refer to Installations Requirements & Environment Control).
The Innova system is suitable to be used in the electromagnetic environment, as per the limits &
recommendations described in the tables here after:
• Emission Compliance level & limits
• Immunity Compliance level & recommendations to maintain equipment clinical utility (see
on page
121,
Table 3-3 on page 122
NOTE
The Innova system complies with above–mentioned EMC standard when used with
supplied cables up to maximum lengths referenced in the MIS MAPS or system cables
interconnect diagrams.
Electromagnetic Emission
The Innova system is intended for use in the electromagnetic environment specified below.
The purchaser or user of the Innova system should assure that it is used in such an environment.
5750182-1EN 3
(Table 3-1 on page
and
Table 3-6 on page
TM
Innova
IGS 6
120).
125).
Special Construction Requirements
Table 3-2
119
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