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510(k) Data Aggregation

    K Number
    K062388
    Device Name
    ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
    Manufacturer
    DOCUSYS
    Date Cleared
    2007-02-22

    (191 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCUSYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs. The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSys' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes. The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature. Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.
    Device Description
    The DocuSys System is substantially equivalent to the Philips CompuRecord Peri-Operative Anesthesiology Information System. (K030939) and the SAFERsleep System (K050883) marketed by Safer Sleep, LLC. All three systems are software application programs that run on Windows-based computer systems. The Phillips, Safer Sleep and DocuSys systems are intended for use by anesthesiologists for the tracking and record keeping of anesthesia procedures including the administration of drugs. All three systems can connect electronically to patient monitors that are used during the anesthesia procedure to provide a detailed record of the anesthesia process for record retention and billing purposes.
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