Frequently Asked Questions
What is ISOCUBE™?
1. Is ISOCUBE™FDA Approved?
In May 2020, the FDA authorized a “generic” Emergency Use Authorization (EUA) for devices such as ISOCUBE™. Prep Tech is now in the process of requesting our own EUA from the FDA.
2. How is ISOCUBE™ used?
Protective Barrier Enclosures are used as a physical barrier between the patient and Healthcare Professionals (HCPs). According to the FDA’s previous EUA, devices can be used by HCP’s in situations including, but not limited to, airway management (e.g., intubation, extubation, and suctioning of airways) and any aerosol generating procedures (e.g., nebulizer treatments, manipulation of oxygen mask or Bilevel Positive Airway Pressure (BiPAP) mask).
3. Does ISOCUBE™ replace PPE?
No. ISOCUBE™ is planned to provide an additional layer of barrier protection to supplement Personal Protective Equipment (PPE) against airborne particles or droplets from a patient’s airway. Devices like ISOCUBE™ are NOT intended to replace PPE.
4. Does ISOCUBE™ use Negative Pressure?
Yes. 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.
5. How are pathogens removed with ISOCUBE™?
Uni-directional airflow travels past the patient’s upper body, past the airway and head, and is vacuumed out though tubing attached through one or more of the ISOCUBE™ foam vacuum ports. Continuous drawn air is intended to remove aerosolized droplets and particles that may contain harmful viruses or bacteria.
6. Does ISOCUBE™ completely seal around the patient?
Not completely. The included drape is intended to allow air intake through naturally occurring gaps between the patient and the ISOCUBE™ isolette/drape.
7. How do the integrated gloves work?
Prep Tech’s patent pending designs uniquely allow PPE gloved hands to be inserted into the four glove sleeves integrated into the ISOCUBE™ disposable isolette. This reduces PPE exposure to pathogens and minimizes spread from contaminated PPE’s to other areas.
8. How large is the included drape and how does it work?
The clear, rectangular drape included with each isolette is 30” x 84”. The ISOCUBE™ drape is attached via double-stick tape to the ISOCUBE™ isolette. It is then tucked under the patient’s body to make a loose seal.
9. What is the difference between ISOCUBE™SS and ISOCUBE™ONE?
ISOCUBE™ SS is a robust, reusable, stainless steel base system that can be cleaned between surgeries and minimize hospital waste. The system base is easily cleaned through standard hospital procedures and reused with new disposable isolettes for each surgery.
ISOCUBE™ ONE is a collapsible frame/isolette system used once and then discarded. The device includes a disposable metal frame that folds upward to hold open the Prep Tech custom disposable isolette and drape. ISOCUBE ONE is designed for use where portability is paramount (e.g. ER, patient transportation, emergency tents, etc.) and device decontamination is not easily available.
10. How many surgeries can ISOCUBE™ be used?
ISOCUBE™ SS can be used indefinitely by cleaning of the base unit between uses and donning a new isolette bag/drape between patients.
ISOCUBE™ ONE is designed for single-use-only applications.
11. What are shipping options and product lead times?
We currently use Fed Ex and UPS for shipping. Expedited shipping options are available subject to product availability. We anticipate a high demand for these devices and are working diligently with our manufacturers to ramp up production during the COVID-19 pandemic.
Prep Tech will notify the purchaser with an estimated delivery date if longer than 4-6 weeks. If express shipment is requested at the time of purchase, units will still be sent with those requested options once devices are in stock. Please note however that items may NOT be received next day or two-days from the time of ordering.
12. Is ISOCUBE™ Patented?
Prep Tech has 7 patents pending and more being added for a variety of engineered designs and functions.
13. Is ISOCUBE™ available outside the US?
Please contact Prep Tech for details and options.
14. How can we become a reseller for Prep Tech devices?
Please contact us if you have direct connections in the medical community and can help us protect healthcare professionals.