Instructions for Use

For Healthcare Facilities and Providers

    FDA EUA APPROVED COVID-19 MEDICAL DEVICE  

Intended Uses

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the SCONE, 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 isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, when performing airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic.

Authorized non-transport use of SCONE is only for definitive airway management (e.g., intubation, extubation and suctioning airways), 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 SCONE 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 should have constant monitoring of vital signs, electrocardiogram (ECG/EKG), SpO2% (oxygen saturation), End-tidal carbon dioxide (EtCO2) if available throughout transport. For all authorized uses, the patient should always have supplemental oxygen during use of SCONE. SCONE can be used longer than 30 minutes only if constant monitoring of vital signs is maintained and only for as long as required to complete the indicated procedures. If EtCO2monitoring is not possible, then use of the SCONE is limited to a maximum of 30 minutes with negative pressure suction on and under direct observation, while ECG/EKG and SpO2% must be monitored at all times. 

The SCONE has not been FDA-approved or cleared for this use; The SCONE 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 authorization is terminated or revoked sooner.

HCP should follow these instructions, as well as procedures at their healthcare facility to use the SCONE.

 


exclamation-triangle-solidThe instructions below are to assist in using the SCONE. The SCONE is an adjunctive protective barrier designed to mitigate risk to HCP. The SCONE is not meant to be a stand-alone unit of PPE. The SCONE should always be used with appropriate PPE and pursuant to the guidance of your institution.


 

All connections should be tightly secured and checked frequently. Any time anyone is within the SCONE, direct observation is required. Inspect SCONE prior to use. Any wear/tear of the chamber or other signs of degradation on the SCONE must promptly be reported to SCONE Medical Solutions Inc. The healthcare facility must not use on patients and must dispose of such a SCONE. Rx Only.

Warnings

  • Flammability of the SCONE has not been tested. No interventions that could create a spark or be a flammable source should be used within the SCONE.
  • Remove the SCONE and use standard of care if there is difficulty visualizing or identifying anatomic landmarks or inability to intubate after the first try.
  • Prolonged use of the SCONE may induce hypercarbia in a spontaneously breathing patient. The SCONE should be used with medical air flow and suction both on and working, under direct observation, and with end-tidal CO2 monitoring if available. If end-tidal CO2 monitoring is not available, then the use of the SCONE should be limited to no more than a short duration of time with medical air flow and suction both on and under direct observation.
  • Patient transport must only occur within a hospital setting for temporary transfer with direct admission within the hospital in the presence of a registered nurse or physician. Maintenance of negative pressure with adequate air flow must be assured. All patients should be on supplemental oxygen. Patients must have continuous monitoring of pulse oxygen saturation (Sp-O2), vital signs, EKG, and End-tidal CO2 if available during transport.
  • Use caution prior to use on non-sedated or lightly sedated patients with severe claustrophobia and/or confined space anxiety.
  • When using the SCONE patients should always be receiving supplemental oxygen.
  • Patients with diminished hearing may have difficulty understanding the provider while inside the SCONE.
  • SCONE is a single-use device and should be disposed of following the disposal instructions after use.

Contraindications

The SCONE is not authorized:

  • For emergent endotracheal intubation with severe hypoxemia
  • On patients with anticipated or known history of difficult airway
  • On patients with other anatomical abnormalities that might interfere with clinical care including decreased neck mobility from arthritis or other causes
  • On individuals with communication disorders that might interfere with clinical care
  • On children under 45 lbs.

SCONE Instructions for Use

Device Description:

The SCONE is a single-use, clear, negative pressure chamber that attaches to a standard hospital or surgical bed and extends around the patient’s head, neck, and shoulders. Access holes, sealed by vinyl access covers, are built into the chamber to allow for isolated patient access. The negative pressure environment is generated via wall-mounted hospital vacuum lines or negative pressure pumps equipped with in-line HEPA filters. The SCONE unit acts as an added layer of physical barrier in addition to personal protective equipment (PPE) to prevent healthcare practitioners (HCP) exposure to pathogenic biological airborne particulates during triage, transportation, and treatment, including aerosol generating procedures (AGPs), and end-of-life care. SCONE will be available to healthcare providers and healthcare facilities.

Items You Will Need:

  • SCONE Device
  • 2 (or 1) Facility Wall-Mounted Pressure Regulators (capable of maintaining continuous high suction at 200mmHg to produce 30 LPM per line) OR Portable Vacuum Pump (capable of maintaining continuous high suction at 200mmHg to produce 30 LPM per line) w/ Inline HEPA Filter (single use only; recommend 0.1 μm or better filtration)
  • 1 Facility Wall-Mounted Oxygen Delivery Regulator
  • 2 (or 1) Healthcare Facility Standard Suction Hose Lines (minimum 1/4"ID) (Single Use Only)
  • 1 Healthcare Facility Standard Oxygen Line (usually 3/16"ID) (Single Use Only)
  • 1 Blanket for Patient

 Device Components:

ONE TWO
THREE FOUR

 

Setting up the SCONE device

Setup Instructions:

  1. PPE IS REQUIRED AT ALL TIMES WHEN OPERATING SCONE DEVICE.
  2. Remove the SCONE from packaging. If desired, keep the shipping box for safer disposable. 
    Step01
  3. Unfold the SCONE chamber by fully extending the frame and locking the hinges on each side. Verify that the 4 arm access hole covers are properly sealed.
    Step02aStep02b
  4. Place the SCONE at the head of the bed over the patient's upper torso (head, neck and shoulders) and tuck the slide flaps underneath the bottom front part of the frame. Drape a blanket across the patient over the front edge of the SCONE overlay to create a proper seal.
    Screen Shot 2020-10-01 at 4.09.44 PMStep4b
  5. Attach the SCONE to the bed using the Velcro straps located at the back of the device. These may be attached and reattached as needed depending whether the patient is laying supine or elevated.
    Screen Shot 2020-10-01 at 5.48.10 PMStep5b
  6. Locate the suction and oxygen port adapters sealed by caps on either side of the device. The side with 2 port adapters is for suction tubing and the side with 1 port adapter is for oxygen tubing. The port adapter caps will hang off and remain attached to the adapter when in use. If an adapter port is not in use, the cap should always be sealed.
    Step6aStep6b
  7. Connect 2 (or 1) standard healthcare facility wall suction hoses (minimum 1/4"ID) to the wall-mounted pressure gauge or portable vacuum pump(s) w/ inline HEPA filter(s) and set to continuous high suction (200mmHg) to achieve a minimum of 50-70 LPM of airflow (30 LPM per line) for a minimum clearance time of 5 minutes. When using a portable pump, each line should be connected to a single portable pump. Note, the tubing and HEPA filter(s) should be single use only. If only one line is available, set the pressure to continuous high suction (200mmHg) but allow a minimum of 10 minutes of clearance time to ensure full evacuation of airborne particulates. 
    Screen Shot 2020-10-01 at 4.25.02 PMScreen Shot 2020-10-01 at 4.32.16 PM
  8. Connect 1 standard healthcare facility oxygen line to the SCONE port adapter, which is a single port located on the opposite side of the 2 port adapters (suction adapters) on the outside of the SCONE device. Connect the other end of the oxygen line to wall regulator mount and set to 10 LPM. Note, if a nasal cannula will be in use for the patient, skip this step and do not connect an oxygen line to the SCONE device. Instead, run the nasal cannula through the draping to the patient. Ensure the single port adapter cap is over the port.
    Step8a
  9. Monitor patient vitals during use. (EKG, SpO2, EtCO2, etc.)
  10. SCONE is intended for use during airway management and aerosol generating procedures with continuous suction or for transport of patients in healthcare facilities for a maximum duration of 30 minutes. Patient vitals should be continuously monitored during use. SCONE may be used longer than 30 minutes only if constant monitoring of vital signs is maintained and only for as long as required to complete the indicated procedures. If End-Tidal CO2 monitoring is not possible, then use of the SCONE is limited to a maximum of 30 minutes with negative pressure suction on and under direct observation, while ECG/EKG and SpO2% must be monitored at all times. 

Performing a Procedure while using SCONE

  1. PPE IS REQUIRED AT ALL TIMES WHEN OPERATING SCONE DEVICE.
  2. Instruments (e.g. EKG, SpO2, EtCO2, etc.) for monitoring may fed up under the front draping next to the patient’s torso, making sure to keep an appropriate seal around the instrumentation. Procedural instrumentation may be passed through arm access holes or also fed up under the front draping.
    Screen Shot 2020-10-01 at 4.50.02 PM
  3. Open arm access flaps as needed to access patient during procedure. Keep them sealed when not in use.
    Screen Shot 2020-10-01 at 4.50.59 PM
  4. After the procedure, wait for the SCONE to clear all particulates before removing.
    Screen Shot 2020-10-01 at 4.55.00 PM

Emergency Removal Instructions

  1. PPE IS REQUIRED AT ALL TIMES WHEN OPERATING SCONE DEVICE.
  2. Detach the Velcro bed straps from the bed and pull SCONE off the patient. Set aside.
    Screen Shot 2020-10-01 at 5.48.10 PMScreen Shot 2020-10-01 at 5.36.29 PM

 Disposal Instructions

  1. PPE IS REQUIRED AT ALL TIMES WHEN DISPOSING OF THE SCONE DEVICE.
  2. Once the patient has been removed from the SCONE device, wait for the device to clear the particulates in the environment (between 5-10 minutes depending on configuration).
    Screen Shot 2020-10-01 at 4.55.00 PM
  3. Unlock hinges and fold the SCONE back down into collapse position, careful to not expose the underneath part of the overlay. Place SCONE back into shipping box (if available).
    Screen Shot 2020-10-01 at 4.58.37 PMDisposal_Step3b
  4. Follow the facility’s policy and protocol for disposal of biohazardous waste.
    Disposal_Step4
  5. The SCONE is a single-patient-use item and is not to be reused under any circumstances.

Cleaning Instructions

*** DO NOT AUTOCLAVE ***

*** DO NOT USE UV LIGHTS***

  1. Put on clean gloves and appropriate PPE before beginning the cleaning and disinfection procedure.
  2. Remove patient and O2/suction hoses from the device.
  3. To move device for cleaning
    1. Collapse SCONE by tapping on the hinges in an upward motion
    2. Fold the excess TPU facedown and around the sides so that you are able to pick up the device holding only the TPU that was facing outward away from the patient
    3. With caution careful not to drop, strike, or place heavy objects on the SCONE continue with the cleaning procedure
  4. Move the SCONE to a designated clean room with a flat disinfected surface
  5. There is no disassembly required for the cleaning
  6. Dispense a towelette of hospital approved EPA-registered quaternary ammonium compound/isopropyl alcohol-based hospital disinfectant wipe, and wipe clean the inner and outer surfaces of the SCONE, carful to include the oxygen and suction ports, aluminum scaffolding, and TPU material in-between the scaffolding
  7. If visible debris remains, repeat the procedure. Let the SCONE sit visibly wet for at least 2 minutes. Allow then to air dry.
  8. For disinfection, spray the inner surface of the SCONE with a hospital approved EPA-registered isopropyl alcohol-based disinfectant. Let the SCONE sit visibly wet for at least the contact time indicated in the labeling before allowing all parts to air dry. Remove and discard gloves.
  9. Disinfectants for Use Against SARS-CoV-2 https://cfpub.epa.gov/giwiz/disinfectants/index.cfm
  10. Do not use harsh chemicals, UV lights, or abrasives to clean. Do not apply heat. Do not use high concentrations of ammonium in excess of 20% as this may degrade components.
  11. Store the SCONE at room temperature in the original box, if possible, to avoid dust or build up on the device.

*** The SCONE is a single patient use device, and should be cleaned:

  1. When you have completed the continuous use period and it is going back into storage (the original box it was shipped in) AND/OR
  2. If there is buildup, or physical debris visibly present.

 


exclamation-triangle-solid

The SCONE is a one-time use device. The device after use is a biohazard and requires proper disposal per facility standard procedures. Please instruct all personnel involved in breakdown and disposal of the SCONE to be dressed in full PPE.


 

Use Case Scenarios

Intubation

Type of Patient:

  • Respiratory Distress
  • Critical arterial blood gas
  • Altered Mental Status/Lethargy

Instructions for Use:

  1. With intubation team standing by and patient on gurney, place SCONE device above patient’s head with, preferably, bed lying nearly flat during set up.
  2. Unfold the device, ensure hinges are locked.
  3. Attach suction ports x 2 (or one if only one available)
  4. Patient likely to already have oxygen support, so continue oxygen mask therapy. Hook up to wall oxygen if there is a separate wall port available
  5. Place BVM and video laryngoscopy equipment and vent tubing into the device via the caudal end.
  6. Smooth out excess PVC material over the patient’s abdomen (head/shoulders now are within the device itself) and tuck it under the patients back.
  7. RT/Nursing open up side arm slot for suction/BVM use
  8. Physician uses dual arm slots at patients head to achieve intubation.
  9. RT connect vent tubing
  10. Reseal arm slots and wait 5-7 minutes for viral clearance.
  11. Remove device, clean, fold and place in box
Intubation

Extubation

Type of Patient:

  • COVID + intubated patient (or any other droplet/aerosol infectious agent)
  • Ready for extubation vs terminal extubation/end of life care

Instructions for Use: 

  1. Read the patient for extubation: supplemental oxygen, suction, etc by patients head
  2. Place bed at position of comfort with aforementioned tools at patient’s head of bed
  3. Unfold SCONE device around patient with supplemental oxygen and extra suction wand within the SCONE.
  4. Attach one suction to suction port (2nd if there are a total of 3 available)
  5. With provider at the head of the bed and respiratory therapist or nurse using the side arm slots, remove endotracheal tube. Provide supplemental oxygen and suction the airway as needed.
  6. If a “terminal wean,” begin palliative care treatments and see “Family Visits” section.
  7. When patient has adequately recovered, remove SCONE device and save for further use, should patient require AGPs or reintubation.

Nebulized Treatments

Type of Patient:

  • Admitted to inpatient, obs or surgery
  • Requiring transport to another facility
  • Requiring Interventional radiology or other department

Instructions for Use: 

  1. With Patient in bed/gurney, place bed at a comfortable angle.
  2. Remove device from box, use straps to fasten it to the bed frame.
  3. Unfold SCONE device and lock hinges in place.
  4. Attach suction, turn on.
  5. If patient does not require supplemental oxygen, attach oxygen tubing to the oxygen port via portable cylinder.
  6. After 5 minutes, remove suction ports and reseal. Ensure arm slots are all sealed.
  7. Patient is set for transport.

BiPAP/CPAP

Type of Patient:

  • Respiratory illness requiring more advanced oxygen support than nasal cannula or mask therapy.
  • Hi Flow 02 or BiPAP/CPAP systems that are “open” systems.

Instructions for Use: 

  1. Assess patient, if requiring emergency intervention, place BiPAP/CPAP on patient first. Then begin SCONE device set up.
  2. If less emergent, unfold SCONE device and using Velcro straps attach to the bed and place patient in angle of comfort.
  3. Place BiPAP/CPAP mask on bed next to the patient, with hosing exiting the caudal end of where the device will sit.
  4. Unfold the device around the patient and lock the hinges.
  5. Attach suction tubing.
  6. Through any of the arm slots, remove the patients already established supplemental oxygen and place them on the BiPAP/CPAP.
  7. Seal arm slots.
  8. Remain in device until a negative pressure room is available.

Endoscopy/Bronchoscopy

Type of Patient:

  • Either COVID + or COVID status unknown, or any other droplet/aerosol infectious agent that requires either procedure.

Instructions for Use: 

  1. Ensure all sedation tools are present (supplemental oxygen, suction, sedation meds and monitoring)
  2. Begin sedation then lie patient flat in the bed.
  3. Unfold SCONE device over the patient, attach oxygen and 1 or 2 suction hoses (depending if there are 2 or 3 available).
  4. Place patient in lateral decubitus position.
  5. Using hand slots on the side and at the head of the bed, position the patients head and insert the endoscopy/bronchoscopy within the device and into patients oropharynx.
  6. Perform procedure to completion.
  7. Remove device and reseal arm slots.
  8. Wait 5-7 minutes and remove the SCONE device.

Family Visitation / End-of-Life Care

Type of Patient:

  • COVID + (or any other negative pressure requiring infectious agent)
  • Prolonged hospitalization or palliative care

Instructions for Use: 

  1. While in patient’s room, place position in hospital bed in position of comfort.
  2. Unfold SCONE device and attach to bed via straps.
  3. Secure around the patient and fold excess PVC around the patient’s trunk.
  4. Attach suction and oxygen (if not requiring supplemental oxygen).
  5. After five minutes remove from suction, ensure that all arm hole slots are sealed and attach to transportable oxygen cannister.
  6. Move patient to a “clean” room and reattach to suction.
  7. Allow family members with negative COVID testing to visit patient.
SCONE™ Stories

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We know times are hard. At SCONE™, we are working every day to try and ease the burden for healthcare workers like you that are caring for so many high-risk patients. We would love to hear from you. Would you share your story with us?