Instructions For Use (English) - SORIN GROUP MT Serie Instrucciones De Uso

Single Use only.
Do not reuse. Do not resterilize.
Do not use if package is damaged or open.
Ethylene oxide sterilized. Non-pyrogenic.
Store in a cool, dry place.
WARNING: Read directions carefully before using this device.
DESCRIPTION
The Mister with Administration Set is available with or without a plastic handle and with a
malleable plastic or metal wand provided for ease in positioning near the surgical site. Each
configuration has a soft distal tip that contains a plastic tube which carries saline solution
to the distal tip of the device. Each configuration's proximal end includes a "Y" adapter
with a fluid inlet line, which terminates in a locking female luer connection where the
administration set's fluid line is connected with a locking male connector. The gas line is
connected to the straight leg of the "Y" adapter. The gas line has an in-line 0.2-micron filter
and terminates in a slip connector for connection to a gas source. The fluid administration
set features PVC tubing co-joined to the gas line to facilitate tubing management. The fluid
administration set has both a roller and a tubing clamp, which provide a means to adjust
fluid flow. The gas line has a tubing clamp to control the gas flow. The administration set is
approximately 8' (244 cm) in length.
INDICATIONS
The Mister is intended for use during procedures when a wound or surgical site must be
cleared by non-contact means for improved visibility at the site.
CONTRAINDICATIONS
The Mister is not designed, sold or intended for use other than indicated. Do not use when
the effects of an air stream or irrigation mist are contraindicated.
WARNINGS
• This device is only intended to be used by professionally trained personnel. Proper
surgical procedures and techniques are necessarily the responsibility of the medical
professional. These instructions are furnished for informational purposes only. Each
surgeon must evaluate the appropriate use of this device, case by case, based on medical
training, experience, and the type of surgical procedure employed.
• For single use and for single-patient use only. During use, the device is in contact with
human blood, body fluids, liquids or gases and due to its specific design, it cannot
be fully cleaned and disinfected at the end of use. Therefore, reuse on other patients
might cause cross-contamination, infection and sepsis. In addition, reuse increases the
probability of product failure (integrity, functionality and clinical effectiveness).
• If used on children, pregnant or nursing women, be aware that this device contains di(2-
ethylhexyl) phthalate (DEHP) and/or di-n-hexyl phthalate (DnHP) which are presently
classified in the European Union as toxic to reproduction. The amount of phthalate which
might be released from the device does not raise specific concerns about the residual
risks.
• Do not use this device if package is damaged or opened as sterility of the device may
have been compromised.
• Never use a device if it is beyond its expiration date.
• Do not use this device if it shows signs of damage, e.g., crimps, kinks, or crushed areas.
• This device is for short term use only (<6 hours).
• Removal should always be done under visualization.
• 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.
• DO NOT REUSE. DO NOT RESTERILIZE.
• CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
4 English
INSTRUCTIONS FOR USE
Sorin Group USA, Inc.
435085219 Rev A