FDA EUA AUTHORIZED
(Contact US for Pricing and Updates)
Multi-use Stainless Steel Base & Removable Stainless Steel Rails (shown without disposable isolette)
Multi-use Base/Rails, Single-use Isolette Sleeve with Four Integrated Gloves and Multi-port Airway Management Gateway
Single-use Device: Includes Foldable Frame and Isolette Sleeve with Four Integrated Gloves and Multi-port Airway Management Gateway (shown without isolette)
A NEEDED LAYER OF EXTRA PROTECTION
FOR MEDICAL PROFESSIONALS.
(DOES NOT REPLACE PPEs)
ISOCUBE™ was developed by Prep Tech’s medical team as an additional level of protection for medical workers in the OR, ER and ICU. ISOCUBE™ devices supplement current PPE supplies by providing an additional layer protection from pathogen exposure.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for ISOCUBE™ SS and ISOCUBE™ ONE, for use by healthcare providers (HCP) as an additional layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing temporary isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, or when performing airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic.
Authorized non-transport use of ISOCUBE™ ONE is only for definitive airway management (e.g., intubation, extubation and suctioning airways), or when performing any airway-related medical procedures (e.g., high flow nasal cannula oxygen treatments, nebulizer treatments, manipulation of oxygen mask or continuous positive airway pressure/bi-level positive airway pressure [CPAP/BiPAP] mask use, airway suctioning, percussion and postural drainage), or during certain patient transport. Authorized use of ISOCUBE ONE during patient transport is only within a hospital setting for temporary transfer with direct admission within the hospital in the presence of a registered nurse or physician. The patient must have constant monitoring of vital signs, electrocardiogram (EKG), oxygen saturation (SpO2%), end-tidal carbon dioxide (EtCO2) if available throughout transport. For all authorized uses, the patient must always have supplemental oxygen during use of ISOCUBE™ ONE. If end-tidal CO2 monitoring is not available, limit the duration of transport to 30 minutes with inline blower fan on and under direct observation.
ISOCUBE™ has not been FDA-approved or cleared for this use; ISOCUBE™ has been authorized for emergency use by FDA under an EUA. ISOCUBE™ has been authorized only for the duration of the COVID-19 public health emergency declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
ISOCUBE’S two innovative flagship products each utilize patent-pending frames, drapes, and clear disposable isolette bags with integrated gloves – specifically designed to reduce medical team exposure to potential contaminants.
• ISOCUBE™ SS – Stainless Steel Base and Rails with Disposable Custom Isolette/Drape
• ISOCUBE™ ONE – Lightweight, Single-use Isolette with Metal Frame and Custom Isolette/Drape
The four integrated gloves allow patient access on three sides of the device, adding an extra barrier of protection to medical personnel by reducing the chance of exposure to airborne pathogens. ISOCUBE™ provides for unidirectional airflow with air flowing from around the patient’s upper body, toward the head, past the airway, and out through a vacuum port located in the lower right corner of the device. This pathogen containing air is removed by the existing hospital evacuation system or a portable vacuum system with HEPA filtration.
Slight negative pressure is generated within ISOCUBE™ by connecting an external vacuum source through the holes in the foam section of ISOCUBE™. There are many ways to connect a vacuum source to ISOCUBE™. Consult your Anesthesia or Respiratory therapy departments for available connectors/HEPA filters.
• Designed for most all airway management cases (intubation, extubation, suctioning, BiPAP, etc.)
• Does not impede patient care or standard medical procedures
• Reduces healthcare worker exposure to pathogenic airborne particulates
• Easily assembled
• Custom bags (and complete ISOCUBE™ ONE unit) are discarded between patients
• Cost effective protection for patients, doctors, nurses, visitors
• Helps reduce spread of pathogens throughout the hospital
• ISOCUBE™ SS is reusable with standard hospital disinfection
• Hospital in-patient and out-patient procedures
• In-the-field and emergency medical transport
• Industrial and military first aid supplement