Technical Information

Cobra Introducer™

Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner 

INTENDED USE

To assist in:

  • Routine oral intubations
  • Difficult oral intubations
  • Where the laryngeal opening is not fully visible
  • As determined by a physician or other licensed practitioner

WARNING!

Injury to a patient may occur under the following conditions, including but not limited to:

  • Blind intubation
  • Advancement of any part of the device beyond the carina
  • Do not apply excessive force for placement or removal of device. If excessive force is required, remove Cobra and endotracheal tube as a unit”.

THE DEVICE IS FOR SINGLE USE ONLY. DO NOT ATTEMPT TO RE-CLEAN, RE-STERILIZE, AND / OR USE THE DEVICE ON ANOTHER PATIENT

The device is non-sterile if packaging is open or damaged in any way

PRECAUTIONS

The device should only be used by clinicians trained in its use. Although difficult intubations are often recognized by experienced clinicians, unanticipated difficult intubations pose a higher risk. Experience and practice under simulated and real conditions will best prepare the clinician for such scenarios

Not recommended for:

  • Nasal intubation
  • Use without a laryngoscope
  • Use with endotracheal tubes smaller than 7.0-millimeters in diameter
  • Exchange of endotracheal tubes

Excessive bending, especially in areas of the device that are open to the internal extension wire, may cause device malfunction. This includes, but is not limited to:

  • Deterioration or damage of device components
  • Inability to
    • Shape the device to facilitate oral intubation
    • Properly advance the internal extension wire

Avoid exposing device to solutions of:

  • Bleach products (sodium hypochlorite) that contain greater than 10% lye (sodium hydroxide)
  • Hydrogen peroxide
    • Greater than 10%
    • Greater than 1-3% for extended periods

During storage, avoid exposing device to:

  • Extreme temperatures
  • UV light
  • Radiation sources

INSTRUCTIONS FOR USE

  1. Inspect device prior to use for oral intubation procedure
    1. Inspect packaging – discard the device and package immediately if open or damaged in any way
    2. Open package and remove the device
    3. Inspect the appearance of device – discard the device and package immediately if any damage is discovered
    4. Verify operation of the device – discard the device and package immediately if device does not perform as intended
  2. Shape the device as needed to facilitate oral intubation
  3. Verify location with laryngoscope if applicable
  4. Ensure the internal extension wire is fully retracted on the end of the device that will be inserted into the trachea – the atraumatic tip of the internal extension wire should be in contact with the end of the device body
  5. Perform laryngoscopy using currently accepted medical techniques.
  6. Insert the device into the oral cavity and advance it towards the tracheal opening.
  7. FOR ROUTINE ORAL INTUBATION:
    1. Continue advancing the distal end of the device into the trachea to the desired depth using the incremental depth markings on the device as a guide
    2. Place the endotracheal (ET) tube over the device. Advance the ET tube into the trachea using a rotating motion (clockwise or counterclockwise). Do not advance the ET tube if more than slight resistance is encountered, as this may cause tissue trauma resulting in patient injury and / or death
    3. Correct placement of the ET tube should be confirmed by currently accepted medical techniques, including CO2 detection whenever possible
  8. FOR DIFFICULT ORAL INTUBATION (as determined by a licensed practitioner):
    1. Advance the distal end of the device until resistance is encountered or as indicated
    2. Use a finger or thumb to advance the internal extension wire into the area of the tracheal opening
    3. Continue to advance the internal extension wire to the desired depth in the trachea – rotating the device may help direct the internal extension wire along the desired path
    4. Place the endotracheal (ET) tube over the device. Advance the ET tube into the trachea using a rotating motion (clockwise or counterclockwise). Do not advance the ET tube if more than slight resistance is encountered, as this may cause tissue trauma resulting in patient injury and / or death
    5. Retract the internal extension wire back into the body of device and remove the device from the endotracheal tube
    6. Correct placement of the ET tube should be confirmed by currently accepted medical techniques, including CO2 detection whenever possible

Cobralet Introducer™

Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner 

INTENDED USE

To assist in:

  • Routine oral intubations
  • Difficult oral intubations
    • Where the laryngeal opening is not fully visible
    • As determined by a physician or other licensed practitioner

WARNING!

Injury to a patient may occur under the following conditions, including but not limited to:

  • Blind intubation
  • Advancement of any part of the device beyond the carina
  • Do not apply excessive force for placement or removal of device. If excessive force is required, remove Cobra and endotracheal tube as a unit”.

THE DEVICE IS FOR SINGLE USE ONLY. DO NOT ATTEMPT TO RE-CLEAN, RE-STERILIZE, AND / OR USE THE DEVICE ON ANOTHER PATIENT

The device is non-sterile if packaging is open or damaged in any way

PRECAUTIONS

The device should only be used by clinicians trained in its use. Although difficult intubations are often recognized by experienced clinicians, unanticipated difficult intubations pose a higher risk. Experience and practice under simulated and real conditions will best prepare the clinician for such scenarios

Not recommended for:

  • Nasal intubation
  • Use without a laryngoscope
  • Use with endotracheal tubes smaller than 7.0-millimeters in diameter
  • Exchange of endotracheal tubes

Excessive bending, may cause device malfunction. This includes, but is not limited to:

  • Deterioration or damage of device components
  • Inability to shape the device to facilitate oral intubation

Avoid exposing device to solutions of:

  • Bleach products (sodium hypochlorite) that contain greater than 10% lye (sodium hydroxide)
  • Hydrogen peroxide
    • Greater than 10%
    • Greater than 1-3% for extended periods

During storage, avoid exposing device to:

  • Extreme temperatures
  • UV light
  • Radiation sources

INSTRUCTIONS FOR USE

  1. Inspect device prior to use for oral intubation procedure
    1. Inspect packaging – discard the device and package immediately if open or damaged in any way
    2. Open package and remove the device
    3. Inspect the appearance of device – discard the device and package immediately if any damage is discovered
    4. Verify operation of the device – discard the device and package immediately if device does not perform as intended
  2. Shape the device as needed to facilitate oral intubation
  3. Verify location with laryngoscope if applicable
  4. Perform laryngoscopy using currently accepted medical techniques.
  5. Insert the device into the oral cavity and advance it towards the tracheal opening.
  6. FOR ROUTINE ORAL INTUBATION:
    1. Continue advancing the distal end of the device into the trachea to the desired depth using the incremental depth markings on the device as a guide
    2. Place the endotracheal (ET) tube over the device. Advance the ET tube into the trachea using a rotating motion (clockwise or counterclockwise). Do not advance the ET tube if more than slight resistance is encountered, as this may cause tissue trauma resulting in patient injury and / or death
    3. Correct placement of the ET tube should be confirmed by currently accepted medical techniques, including CO2 detection whenever possible
  7. FOR DIFFICULT ORAL INTUBATION (as determined by a licensed practitioner):
    1. Using a video laryngoscope to visualize and identify the trachea, the introducer is advanced into the trachea.
    2. Continue advancing the distal end of the device into the trachea to the desired depth using the incremental depth markings on the device as a guide
    3. Place the endotracheal (ET) tube over the device. Advance the ET tube into the trachea using a rotating motion (clockwise or counterclockwise). Do not advance the ET tube if more than slight resistance is encountered, as this may cause tissue trauma resulting in patient injury and / or death
    4. Correct placement of the ET tube should be confirmed by currently accepted medical techniques, including CO2 detection