Teleflex RÜSCH EZ-BLOCKER KIT Gebrauchsanweisung Seite 4

940659 Ez-Blocker 13spr:Layout 1
• This device is intended for single use only. Do not reuse, re-sterilise or autoclave. Reuse of single use
devices creates a potential risk of patient or user infections. Contamination of the device may lead to
injury, illness or death of the patient. Cleaning, disinfection and sterilization may compromise essential
material and design characteristics leading to device failure. The manufacturer will not be responsible
for any direct, incidental or consequential damages resulting from resterilisation or reuse.
• No lidocaine or lubricant containing lidocaine should be used on product balloons.
Precautions:
• It is recommended to use pulse oxymetry when using the device.
• During procedures near the hilum caution is recommended. The position of the cuff should be verified
by a surgeon to prevent inadvertent cuff damage.
• During the use of this device for one-lung ventilation, an increased FIO2 for the ventilated lung is often
needed in order to maintain adequate arterial oxygen saturation. In some circumstances however,
an increased FIO2 may not be sufficient to maintain adequate arterial oxygen saturation and other
techniques, e.g. CPAP through the central lumen of the EZ-Blocker, may be necessary.
• Care should be taken to ensure the cuff remains fully inflated during longer procedures.
• The patient should be paralyzed during one-lung ventilation.
• The initial placement of the EZ-Blocker should be with the patient in a supine position.
• The position of the inflated cuff should be reconfirmed after positioning and after repositioning the
patient for the procedure, especially after turning the patients head.
• The position of the endotracheal tube should be secured with tape before and during the use of the
EZ-Blocker.
• During use of the EZ-Blocker the capnograph waveform may become distorted.
• The EZ-Blocker can be introduced through a standard endotracheal tube. The largest size possible
fitting the patient is recommended for optimal performance.
• A tube size 7 (inner diameter in mm) is the smallest recommended endotracheal tube size when
using the EZ-Blocker.
• The outer diameter of the bronchoscope should be 3,2 to 4,2 mm.
These recommendations are only designed to serve as a general guideline. They are not intended to
supersede institutional protocols or professional clinical judgments concerning patient care.
Instructions for Use:
• Take the EZ-Blocker™ and remove EZ-Blocker from cardboard
ATTENTION:
Prior to use remove the protection tube as follows:
• Hold bifurcation in one hand and remove protection tube by pulling on warning label, check EZ-
Blocker for damage.
• Check both cuffs for leakage and asymmetric inflation by injecting air into the cuffs with a clean
syringe. Place the caps to seal off both proximal endings (luer lock fitting) of the lumina in the EZ-
Blocker (Fig. 2).
• Warning: to prevent airway damage, the balloon and cuff should never be overinflated.
• Care must be taken to avoid damage of the product and its accessories.
• After intubation of the patient with a proper sized endotracheal tube, the EZ-Multiport™ Adapter
(Fig. 1) should be placed on the endotracheal tube (port D, Fig. 4) and the patient should be ventilated
(port A, Fig. 4).
• Deflate both cuffs of the EZ-Blocker completely.
• Lubricate the distal part of the EZ-Blocker and the bronchoscope according to standard practice
procedures.
• No lidocaine or lubricant containing lidocaine should be used on product balloons.
• During introduction of the blocking device, the endotracheal tube should be positioned 4 cm
above the carina to ensure proper functioning of the EZ-Blocker (Fig. 3).
• Introduce the EZ-Blocker through port (B), after removal of the closing plug of port (B), of the EZ-
Multiport Adapter and advance into the endotracheal tube (Fig. 5).
• Introduce the fiberoptic or video bronchoscope through the other port (C) of the EZ-Multiport Adapter
after removing the plug of the closing cap in order to visualize the airway and the EZ-Blocker (Fig. 6).
• Advance the EZ-Blocker under direct visual control until both extensions are just outside the
endotracheal tube (Fig. 7).
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