1-2 Starling Monitor - User Guide
Prescription Notice
Prescription Notice
Equipment Classification
In the European Union, the Starling system is classified as Class IIa, continuously operated,
ordinary equipment with applied part and with signal input output parts.
The device is not intended for use in the presence of flammable mixtures.
Compliance with International Standards
The Starling system is designed to comply with international safety standards for medical
electrical equipment that include the following:
Federal (USA) law restricts this device to sale by or on the order of a physician. In addition, the
user should be properly trained in use of the system.
Table 1-1 Compliance with International Standards
Standard Description
IEC 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
IEC 60601-1-2
Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests.
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