Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152124
    Device Name
    Tempus IC2
    Manufacturer
    REMOTE DIAGNOSTICS TECHNOLOGIES LTD
    Date Cleared
    2015-10-28

    (89 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMOTE DIAGNOSTICS TECHNOLOGIES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tempus IC2 is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. The Tempus IC2 is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident. The Tempus IC2 is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required. Tempus IC2 measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETC02, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module). The Tempus IC2 is suitable for use on adults or children (over 10 years old and over 20kg in weight).
    Device Description
    The Tempus IC2 device is a portable vital signs monitor that can measure 12 Lead ECG, non-invasive blood pressure. SpO2 and pulse rate. ETCO2 and respiration rate, temperature (via an unmodified thirdparty Bluetooth enabled tympanic thermometer) and blood glucose (via an unmodified third-party Bluetooth enabled glucometer). It also provides an integral camera, built-in third-party Bluetooth headset, touchscreen and membrane button controls, user removable lithium-ion battery and Ethernet, Wi-Fi and cellular phone communications. These are all the same features as provided by the Tempus IC. The Tempus IC2 is intended primarily to be used as a telemedicine device for trained, non-healthcare practitioners in remote locations e.q. cabin crew on aircraft. It is designed to be and to transmit all data displayed to a healthcare practitioner in a different location. The healthcare professional receives the data on a PC installed with a programme called i2i. The device also transmits still or lowrate moving images (from the device to the i2i software) and also transmits voice communications through the use of an off-the-shelf Bluetooth headset which is connected to the Tempus IC2. These descriptions are all the same as the Tempus IC. The Tempus IC2 is provided in a bag which stores the device and the accessories and consumables needed to operate the device. This is the same as the Tempus IC which is also provided with a bag.
    Ask a Question

    Page 1 of 1