Cook Medical G26907 - SET, BLOCKER, C-AEBS-7.0-65-SPH, EACH
Arndt Endobronchial Blocker Set
The Arndt Endobronchial Blocker Set is designed for use during one-lung ventilation. The endobronchial blocker uses a guide loop assembly that fits through the lumen of the endobronchial blocker and exits from the endobronchial blockers distal end to form a small, adjustable guide loop. This assembly may be advanced or retracted at the endobronchial blockers proximal end to enlarge or decrease the size of the guide loop.
A small diameter bronchoscope is advanced through the guide loop to couple the bronchoscope and the endobronchial blocker together. This allows the endobronchial blocker to follow the bronchoscope. After the area to be blocked is entered, advance the blocker until the loop disengages from the bronchoscope. The lung may then be blocked by inflating the balloon.The guide loop may be removed. The guide loop can be re-inserted into the blocker for repositioning, if necessary, in the 9Fr size only.A suction adapter is provided for an alternative method of lung deflation, if desired. The multi-port adapter is designed for connection to a ventilation device and allows introduction of the blocker and bronchoscope.
- Bronchial Blocker
- Arndt Multiport Adapter
- CPAP Adapter
- Suction Adapter"
|Order Number||Reference Part Number||Smallest Recommended ETT* (mm)||Catheter Fr||Catheter Length (cm)|
Features and Benefits
- The adjustable guide loop is coupled with an appropriately sized bronchoscope to enable precise placement.
- The low-pressure, high-volume balloon creates excellent surface area contact with the inner bronchial wall while minimizing potential trauma to the bronchus.
- The distance markings indicate how far the blocker has been advanced.
- The suction adapter included with the set offers an additional method of lung deflation.
The Arndt Endobronchial Blocker Set is intended to differentially intubate a patients bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5.0 French Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older. All other sizes are for adult use only.
- Airway diameter insufficient to allow passage of the Arndt Endobronchial Blocker
- Bronchoscopy equipment unavailable
- This product is intended for use by clinicians trained and experienced in the use of bronchoscopes and airway anatomy. Standard techniques for use of bronchoscopes and endobronchial blockers should be employed.
- The use of pulse oximetry is recommended when using this device.
- Caution is recommended when working near the hilum. The balloon position should be verified to prevent inadvertent balloon damage.
- During the use of this device for one-lung ventilation, an increased FIO2 for the ventilated lung is often needed to help maintain adequate arterial oxygen saturation. However, in some circumstances, an increased FIO2 for the ventilated lung may not be sufficient to maintain adequate arterial oxygen saturation, and other techniques may also be necessary.
- Inflate balloon initially under direct vision to ensure correct position and placement.
NOTE:Placement in the right mainstem bronchus may result in herniation of the balloon into the right upper lobe bronchus and thereby occlude it.
- Care should be taken to ensure the balloon remains fully inflated during longer procedures.
- During one-lung ventilation, the patient should be paralyzed to help prevent dislodgement of the balloon.
- The endobronchial blocker should be placed with the patient in a supine position.
- To avoid damage to the small diameter bronchoscope, the guide loop size should be adjusted with care.
- The position of the balloon should be reconfirmed after positioning the patient for the procedure.
- Assure the endotracheal tube is securely taped in place during use of the endobronchial blocker.
- The capnograph waveform may become distorted during use of the endobronchial blocker.
- The Arndt Endobronchial Blocker Set can be placed through a standard endotracheal tube. For optimal performance, the largest endotracheal tube appropriate for the patients anatomy is recommended.
- The smallest recommended size endotracheal tube for use with the Arndt Endobronchial Blocker size 9.0 French is 7.5 mm; 7.0 French is 6.0 mm; and 5.0 French is 4.5 mm.
- The 5.0 French Arndt Pediatric Endobronchial Blocker, when placed in an endotracheal tube with a diameter smaller than 6.0 mm, will cause slightly higher Peak Airway Pressures when attempting to achieve constant tidal volume.
- The 7.0 French Arndt Endobronchial Blocker, when placed in an endotracheal tube with a diameter smaller than 7.0 mm, will cause slightly higher Peak Airway Pressures when attempting to achieve constant tidal volume.
- Following insertion of the blocker balloon through the multiport adapter, the balloon should be test inflated.
- If using supplied suction adapter during lung deflation procedure, ensure that you do not inadvertently attach it to the pilot balloon assembly. Suction adapter should only be attached to Luer lock connector.
Potential Adverse Events
The adverse events associated with this device are those of lung isolation and one-lung ventilation, including:
- Tracheal and/or bronchial irritation or injury
Instructions for Use
- Fully deflate the balloon on the endobronchial blocker.
- Generously lubricate the bronchoscope, endobronchial blocker and inside of the endotracheal tube.
- Place the endobronchial blocker through the blocker port of the Arndt Multiport Airway Adapter, advancing the endobronchial blocker until the guide loop is visualized outside of the airway adapter.(Fig. 1)
NOTE:Air leakage can be controlled by screwing down the cap on the blocker port.
- Place the bronchoscope through the diaphragm of the bronchoscopy port of the Arndt Multiport Airway Adapter, advancing the bronchoscope until it is outside of the airway adapter.(Fig. 2)
- Advance the bronchoscope into and through the guide loop, coupling the endobronchial blocker to the bronchoscope.(Fig. 2)
NOTE:This may also be performed within the multiport adapter, the endotracheal tube or the trachea proper. The guide loop should be adjusted to loosely approximate the diameter of the bronchoscope.
- Advance the bronchoscope into the section of the lung to be blocked.(Fig. 3)
NOTE:The blocker guide loop may be cinched onto the bronchoscope by unscrewing the guide loop port and pulling back on the snare. The snare may be affixed in place by inserting syringe or CPAP adapter into the guide loop port.
- Keeping the bronchoscope position stable (loosen guide loop if snare is cinched onto bronchoscope), advance the endobronchial blocker until the guide loop disengages from the bronchoscope.(Fig. 4)
- Retract the bronchoscope. The endobronchial blocker may be either advanced or retracted to place the balloon within either the right or left mainstem bronchus.(Fig. 5)
- Place patient in final position. Under bronchoscopic vision, inflate the balloon with air using the pilot balloon assembly. The balloon should fill the entire endobronchial lumen to be blocked and not herniate into the mainstem trachea. Do not overinflate balloon.(Fig. 6)
WARNING:The lungs should be carefully auscultated following initial endobronchial blocker placement and balloon inflation to ensure proper functioning of the endobronchial blocker. If ventilation should be acutely difficult during endobronchial blockade, the balloon should be immediately deflated.
- Following correct balloon placement, the balloon may be deflated until one-lung ventilation is required.
- To achieve one-lung ventilation, the balloon is inflated with the same volume of air that was used during initial placement.
WARNING:To prevent airway damage, the balloon should never be overinflated.
- Once the blocker is in final position, tighten the blocker port on the multiport adapter. This contains a Tuohy-Borst valve that will prevent the blocker from moving and will prevent a gas leak.
- . After the balloon is properly inflated, remove the guide loop assembly from the endobronchial blocker and inspect the position of the endobronchial blocker using the bronchoscope. Reconfirm the position of the balloon if the patient is repositioned.
NOTE:When removing the guide loop assembly from the endobronchial blocker, excessive force should not be used as this may dislodge the endobronchial blocker.
- The guide loop assembly may be re-inserted if repositioning of the blocker is necessary (9.0 French size only).
- Upon completion of one-lung ventilation, deflate the balloon and remove the catheter from bronchus.
NOTE:Assure complete deflation of the balloon before attempted removal of the endobronchial blocker. The Arndt Multiport Airway Adapter should be detached upon removal of the endobronchial blocker.
|What MRI safety information does the labeling contain?||Labeling does not contain MRI Safety Information|
|Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):||No|
|Device labeled as "Not made with natural rubber latex":||No|
|Prescription Use (Rx):||Yes|
|Over the Counter (OTC):||No|
|Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):||No|
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.
CAUTION:U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed practitioner).