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BLUETOOTH WIRELESS TECHNOLOGY
The Bluetooth
technology used in the AortaScan AMI 9700 is compliant with:
®
• Bluetooth Specification as defined and approved by The Bluetooth Special Interests Group.
• Logo certification with Bluetooth wireless technology as defined by The Bluetooth Special Interest
Group.
ELECTROMAGNETIC COMPATIBILITY
The AortaScan AMI 9700 system is designed to be in compliance with IEC 60601‑1‑2:2007, which contains
electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions
and immunity specified in this standard are designed to provide reasonable protection against harmful
interference in a typical medical installation.
The AortaScan AMI 9700 system complies with the applicable essential performance requirements specified
in IEC 60601‑1 and IEC 60601‑2‑37. Results of immunity testing show that the essential performance of
the system is not affected under the test conditions described in the following tables. For more information
about the essential performance of the AortaScan AMI 9700 system, see
page 2.
ELECTROMAGNETIC EMISSIONS
Table 26.
Guidance and Manufacturer's Declaration—Electromagnetic Emissions
The AortaScan AMI 9700 system is intended for use in the electromagnetic environment specified below.
The customer or the user of the AortaScan AMI 9700 system should assure that it is used in such an
environment.
EMISSIONS TEST
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000‑3‑2
Voltage fluctuations/
flicker emissions
IEC 61000‑3‑3
72
COMPLIANCE
The AortaScan AMI 9700 system uses RF energy only for its
Group 1
internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.
Class A
The AortaScan AMI 9700 system is suitable for use in all
Class A
establishments other than domestic and those directly connected
to the public low‑voltage power supply network that supplies
buildings used for domestic purposes.
Complies
Essential Performance
ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
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