Zeiss opmi lumera 700, Инструкция по эксплуатации

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Instructions for Use 11 Technical specifications
OPMI LUMERA 700 11.1 Essential performance features
G-30-1673-en - 14.0 - 2018-07-12 201 / 236
11 Technical specifications
11.1 Essential performance features
The device does not have any essential performance features as
defined in IEC 60601-1.
11.2 Compliance
Guidelines with which the device complies
• OPMI LUMERA 700 complies with Medical Device Directive
93/42/EEC: Class I
It is labeled with
• This device satisfies the US American and Canadian safety
regulations for medical electrical devices/systems.
It is labeled with
• The device complies with Directive 2011/65/EU on the
restriction of the use of certain hazardous substances in
electrical and electronic equipment.
Classification of the device according to IEC 60601-1
The device is classified as follows:
• Degree of protection against electric shock: Class I
• Degree of protection against entry of water: IP 20
• Electromagnetic compatibility (EMV): Fulfills IEC 60601-1-2,
Class B (as per CISPR 11)
• Operating mode: continuous operation
Classification of the 14-function foot control panel
• See also document G-30-2021 (Radio Approval Information).
The radio frequency approvals apply only to the wireless version
of the 14-function foot control panel.