Safety Information

    This topic provides the safety information for the system.

    General Safety Information

    CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
    CAUTION: Customer-Supplied Hardware—Hardware supplied by the customer must meet the minimum specifications listed in the Centricity Perinatal Customer-Supplied Equipment Reference Manual.
    The following table defines symbols used throughout this document and/or the product software:
    SymbolDefinition

    This symbol indicates the MANUFACTURER of the product.

    This symbol indicates the DATE OF MANUFACTURE of the product.

    This symbol indicates that the operator should CONSULT INSTRUCTIONS FOR USE for further information.

    This symbol indicates the manufacturers BATCH CODE, or lot number of the product.

    Rx Only

    For products distributed in the US, the symbol for "Rx Only" indicates:

    Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

    This symbol indicates that instructions for use are supplied in electronic form.

    Surveillance and Monitoring Concerns

    CAUTION: Physiological Monitor Synchronization—Users and members of the Biomedical Engineering staff should be aware that the time on the monitor should be synchronized with the time on the systems' servers.

    Erroneous Data Entry and Calculations

    Note: Data Entry—Be sure that the specified patient is selected before performing data entry. Failure to make the selected patient the focal point of data operations could result in the data being placed into another patient file.
    Note: Typographical Errors—Although the systems' modules may be configured to ensure that numeric data (for example, pulse, BP, or temperature) is within a specified range of acceptability, users may make typographical errors when entering data. Failure to verify your manually entered data could result in the storage of incorrect data.

    System Security Considerations

    Note: System Security—The GE HealthCare Centricity Perinatal products provide the capability to define the degree of user access to workstations through the use of IDs and passwords. It also allows the assignment of READ/WRITE privileges via security objects to determine who may access or record patient data. Failure to properly configure the security feature could result in unauthorized personnel gaining entry into Centricity and ultimately viewing or recording patient data.