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:

1. Use aseptic technique.
2. Open package and remove the BSmart ™ manometer.
3. Attach the female end of the BSmart ™ manometer to the syringe and the luer lock to the tubing of the block needle.
4. Prime System (Syringe, BSmart ™ and Needle). The BSmart ™ piston must move upwards during priming in order for the device to be ready for use.
5. After a nerve is located using a typical technique, begin the injection after confirming that the needle is not placed into a blood vessel.
6. Throughout the injection, the piston indicator will continuously provide information on the pressure during injection.
7. 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:

1. The BSmart ™ has no user serviceable parts. Do not attempt to repair or alter the device.
2. The device is disposable and must be discarded after use in accordance with hospital, administrative and/or local government policy.
3. 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