Safety
Vivid S5/Vivid S6 User Manual 19
R2424458-100 Rev. 2
Regulatory information
Directives
The GE Healthcare Ultrasound product families are tested to
meet all applicable requirements in relevant EU Directives and
European/International standards.
• Council Directive 93/42/EEC concerning MDD (Medical
Devices Directive): the CE label affixed to the product
testifies compliance to this Directive.
The location of the CE marking is specified in "Device
labels" on page 22.
Product Classifications
The Vivid S5/Vivid S6 ultrasound unit confirms to the following
classifications, in accordance with the IEC/EN 60601-1:6.8.1:
• According to 93/42/EEC Medical Device Directive, this is
Class IIa Medical Device.
• According to IEC/EN 60601-1, Equipment is Class I, Type
B with BF or CF Applied Parts.
• According to CISPR 11, this is Group 1, Class B ISM
Equipment.
• According to IEC 60529, the footswitch rate IPx8 is suitable
for use in surgical rooms.
• Classification according to the degree of protection against
ingress of water as detailed in the current edition of IEC 529
(section 6.1.1): Ordinary for Main Unit (PC), IPX1, IPX7,
IPX8 for ultrasound probes (transducers).
Conformity to Standards
To fulfill the requirements of relevant EC directives and/or
European Harmonized/International standards, the following
documents/standards have been used:
• International Electrotechnical Commission (IEC).
CAUTION
Any changes to accessories, peripheral units or any other part of
the system must be approved by the manufacturer. Ignoring this
advice may compromise the regulatory approvals obtained for
the product.
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