INSTRUCTIONS FOR USE

BLEScath^® is intended for the administration of bovine lipid extract surfactant suspension using minimally invasive surfactant therapy (MIST) / less invasive surfactant administration (LISA) technique for rescue treatment of infants with Neonatal Respiratory Distress Syndrome (NRDS/Hyaline Membrane Disease).

BLEScath^®, with its integrated stainless steel (SS) stylet, is uniquely designed to be compatible with low viscosity surfactants like bovine lipid extract surfactant suspension. BLEScath^® is a 5 Fr radiopaque polyvinyl chloride (PVC) tube with a length of 205 mm and an inner diameter of 0.91mm with a slip tip connector at the proximal end and a soft rounded tip at the distal end. The integrated SS stylet is rigid but flexible for ease of insertion. Markings on the outside of the catheter aid in determining insertion depth.

Each package contains one 5 Fr radiopaque PVC tube with stainless steel stylet.

1. Neonates should be kept on nasal continuous positiveairway pressure (nCPAP) or non-invasive positive pressureventilation (NIPPV) for the entireprocedure.
2. Prepare a syringe according to the bovine lipid extract surfactant suspension dosing procedures. When using BLEScath^® it is recommended to draw up 0.5 – 1.0 mL of air in the syringe followed by the prescribed surfactant dose to ensure the entire dose is expelled at the end of the procedure.
3. Open the BLEScath^® package and carefully remove the catheter.
4. There are three unlabelled black line markings near the distal tip (at 2.0, 2.5 and 3.5 cm from the end), which serve as a visual aid for controlling the insertion depth at the level of the vocal cords. Additionally, there are five line markings of 7 to 11 cm (labelled 7, 8, 9, 10 and 11) on the catheter to indicate the distance from the distal tip to the patient’s lip (tip to lip distance). The depth of insertion is 6 cm plus birthweight in kilograms. For example: The depth of insertion for a 1 kg baby is 6 cm + 1 = 7 cm. Insert BLEScath^® to line marker “7”.
5. Bend the catheter into the preferred shape. Use the laryngoscope to visualize the vocal cords and insert the catheter from the side and through the cords into the trachea. The unlabelled black line markings near the distal end of the catheter should be at or just below the vocal cords. Remove the laryngoscope. Adjust the insertion depth and tip to lip distance by checking the labelled line markings.
6. Hold the catheter and press the baby’s lips together.
7. Attach the syringe with surfactant to the catheter.
8. Instill surfactant in micro-boluses synchronizing with the neonate’s inspiration. Micro-bolusing every 2-3 breaths is also acceptable if the infant is tachypneic. It can take 1 to 3 minutes to administer the full dose.
9. When the instillation is complete, inject air through the catheter to empty the syringe and remove the catheter immediately.
10. If unable to deliver the dose successfully using MIST/LISA after three attempts, administer the dose via the INSURE method.
11. After surfactant instillation, monitor the patient’s oxygen requirements according to the bovine lipid extract surfactant suspension product insert.

Storage

Store sterile BLEScath^® package at room temperature.

Disposal

Follow hospital biomedical waste disposal policy.

Use of BLEScath^® and bovine lipid extract surfactant suspension are contraindicated in infants with active pulmonary haemorrhage.

• Use of BLEScath^® and bovine lipid extract surfactant suspension should be restricted to a highly supervised clinical setting with immediate availability of experienced neonatologists and other clinicians experienced with general care of premature infants. Transient episodes of bradycardia and decreased oxygen saturation may occur during dosing. For more details, see the bovine lipid extract surfactant suspension product insert.
• Do NOT use BLEScath^® to administer any surfactant other than bovine lipid extract surfactant suspension.
• BLEScath^® is intended for intratracheal use only. Do NOT introduce BLEScath^® into other body openings.
• BLEScath^® is intended for single use. Do NOT reuse the catheter.
• Do not use BLEScath^® if the packaging is open or if packaging or its contents are damaged.