Return Of Used Products - SORIN GROUP MT Serie Instrucciones De Uso

INSTRUCTIONS FOR USE
1. Remove the Mister from the packaging using aseptic technique.
WARNING: Inspect the product thoroughly for damage prior to use. Damage to the
product (i.e., kinks, crimps, distortion or cuts) may result in obstruction or disruption
of flow during use and product performance may be affected. Do not use damaged
product.
2. Ensure that the regulated source of USP Medical Air is shut off. Also make certain the gas
line clamp on the Mister is closed. Connect the administration set's slip connector to the
regulated source of USP Medical Air.
3. Initially adjust the flow control to 5 liters per minute (L/min.)
DO NOT EXCEED 8 L/MIN.
WARNING: Do not flow at a rate of greater than 8 liters per minute (L/min.)
WARNING: Do not use oxygen with this device.
4. Close the fluid administration inlet line clamp. Aseptically connect the spike to a new bag
of sterile saline and place in a pressure cuff. Inflate the cuff to approximately 150 mm Hg.
Open the clamp and adjust sterile saline flow to 1-5 milliliters per minute using the roller
clamp on the fluid administration line.
5. Disengage the gas line clamp on the Mister. Adjust the irrigation mist as needed by
making adjustments to either the roller clamp on the fluid administration line or to the
regulated source of USP Medical Air.
6. Bend the malleable shaft to the desired shape to easily access the surgical site.
WARNING: Do not bend malleable shaft excessively or at abrupt angles as kinking or
failure in shaft may occur.
7. Hold the tip 5 cm – 15 cm from the surgical site to be visualized. Adjust this distance as
needed to clear the site. Use caution when moving the tip closer than 3 cm to the surgical
site. Do not allow tip to contact tissue.
WARNING: Use caution when moving the tip of the Mister closer than 3 cm to the
surgical site.
WARNING: Do not allow tip to contact tissue.
8. Upon completion of the procedure, remove the Mister from the compressed air line and
from the saline solution and discard it properly.
WARNING: Do not use this device in an MRI environment.
DISPOSAL
Handle with care after use as the product may be contaminated with blood and/or body
fluids. Dispose of in accordance with applicable regulations in the country of use.

RETURN OF USED PRODUCTS

For Customers Outside the United States
If for any reason this product must be returned, please contact your sales representative for
specific instructions.
If the product has been in contact with blood or body fluids, it must be thoroughly cleaned
and disinfected before packing. It should be shipped in either the original carton, or an
equivalent carton, to prevent damage during shipment.
CAUTION
It is the responsibility of the health care institution to adequately prepare and identify the
product for return shipment. Do not return products that have been exposed to blood
borne infectious diseases.
Sorin Group USA, Inc.
435085219 Rev A English 5