Cobralet Introducer
The new Cobralet introducer offers significant advantages in routine and difficult intubations. Like the Cobra Introducer, without the telescopic extension, Cobralet’s unique shape holding design helps with intubations, yet it is soft and flexible to reduce potential for trauma. Paired with a video laryngoscope the easy to use Cobralet introducer allows you to reach the trachea fast and successfully.
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Technical Information
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
- Inspect device prior to use for oral intubation procedure
- Inspect packaging – discard the device and package immediately if open or damaged in any way
- Open package and remove the device
- Inspect the appearance of device – discard the device and package immediately if any damage is discovered
- Verify operation of the device – discard the device and package immediately if device does not perform as intended
- Shape the device as needed to facilitate oral intubation
- Verify location with laryngoscope if applicable
- Perform laryngoscopy using currently accepted medical techniques.
- Insert the device into the oral cavity and advance it towards the tracheal opening.
- FOR ROUTINE ORAL INTUBATION:
- 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
- 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
- Correct placement of the ET tube should be confirmed by currently accepted medical techniques, including CO2 detection whenever possible
- FOR DIFFICULT ORAL INTUBATION (as determined by a licensed practitioner):
- Using a video laryngoscope to visualize and identify the trachea, the introducer is advanced into the trachea.
- 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
- 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
- Correct placement of the ET tube should be confirmed by currently accepted medical techniques, including CO2 detection
Cobralet Features:
- Unique shape holding design helps with intubation, yet it is soft and flexible to reduce potential for trauma
- ??Hollow Channel
- Coude/Angled tip to assist with tube placement during intubation
- Familiar shape, for familiar use with no learning curve
- Depth Markings on the body
- Sterile Single use disposable device
- Cobralet is available in 15FR, and works with endotracheal tubes from 6-11mm
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