BSmart Instructions for Use
BSmart™: A disposable manometer for measuring nerve block injection pressures
Indications for Use: A disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
Contraindications: There are no known contraindications.
The disposable manometer is sterile in undamaged package. For single use only. Do not reuse, clean, reprocess or resterilize. Store at Controlled Room Temperature.
Directions:
- Use aseptic technique.
- Open package and remove the BSmart™ manometer.
- Attach the female end of the BSmart™ manometer to the syringe and the luer lock to the tubing of the block needle.
- Prime System (Syringe, BSmart™ and Needle). The BSmart™ piston must move upwards during priming in order for the device to be ready for use.
- After a nerve is located using a typical technique, begin the injection after confirming that the needle is not placed into a blood vessel.
- Throughout the injection, the piston indicator will continuously provide information on the pressure during injection.
- The pressure ranges specified on the piston indicator are:<15 psi (white), 15-20 psi (yellow); >20 psi (orange).
Technical Characteristics: Priming volume 1ml max.
Caution: In an animal model, injection of 2% lidocaine at a flow rate of 4ml/min via a 12.7 mm long 25 gauge needle (0.225 mm internal diameter) resulted in an average pressure of 29.69 +/- 7.38 psi when the injection was intraneural in a large nerve and 7.48 +/- 2.86 psi when injected adjacent to the nerve. Pressure during injection into other tissue or combinations of tissues was not evaluated.
Precautions:
The BSmart™ has no user serviceable parts. Do not attempt to repair or alter the device.
The device is disposable and must be discarded after use in accordance with hospital, administrative and/or local government policy.
Do not use the device if the package is open or damaged. Do not use if sterile barrier is damaged.
Caution: THE DEVICE MUST BE USED EXCLUSIVELY BY SPECIALIZED MEDICAL PERSONNEL. FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
