Directions For Use - SORIN GROUP SU-10101 Mode D'emploi

RIGID TIP SUCTION WANDS (SU-10101 & SU-12202)
FLEX-TIP SUCTION WANDS (SU-14101 & SU-18202)
FLEXIBLE SUCTION WANDS (SU-12402)
MALLEABLE SUCTION WANDS (SU-12502)
LOW PROFILE SUCTION WAND (SU-2X702)
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
Rigid, Flex-Tip, Malleable and Flexible Suction Wands
The Rigid and Flex-Tip Suction Wands are designed for hand-held use, whereas the Flexible and Malleable Suction
Wands are designed for stationary use. Both types of Suction Wands are used for removal of excess fluid from a
surgical field. The Rigid and Flex-Tip Suction Wands are available in both standard and small sizes. Both sizes consist
of an angled stainless steel suction wand bonded either to a rigid, fluted style suction tip made of ABS or a flexible
suction tip made of soft PVC at the distal end and a 1/4" barbed connector at the proximal end, both of which are
made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material. The
standard Flex-Tip Suction Wand has a vent hole for finger tip suction control located on the handle, whereas the
small Flex-Tip Suction Wand has two side holes at the flexible distal tip to prevent the direct application of suction
to the tissue. The Flexible Suction Wand is made of a flexible PVC tubing consisting of one large lumen for drainage
and a second small lumen intended to minimize tube kinking. The tubing is bonded to a flexible fluted style suction
tip at the distal end and a 1/4" straight tapered connector at the proximal end. The Malleable Suction Wand is
made of the same components as with the Flexible Suction Wand with the exception, that a permanently placed
malleable stainless steel wire is placed in the small lumen of the flexible PVC tubing. The malleable stainless steel
wire provides support during placement to the surgical field and enables pre-shaping of the Suction Wand before
or after placement to the surgical field.
Low Profile Suction Wands
The Low Profile Suction Wands are designed for hand held use in the removal of excess fluid from a surgical field.
The Low Profile Suction Wands are available in both Soft and Frazier tips. Each configuration has a plastic handle
and a stainless steel wand provided for ease in positioning near the surgical site. The Suction Wands have a vent
hole located on the handle for fingertip suction control to prevent the direct application of suction to the tissue.
The PVC tubing connected to the handle terminates in a proximal connector and is provided with a clamp, which
provides a means to adjust fluid flow.
INDICATIONS FOR USE
The Suction Wands are indicated for use to remove excess fluid from the surgical field.
CONTRAINDICATIONS
The Suction Wands are not designed, sold or intended for use other than indicated. The Suction Wands are
contraindicated to return blood to the extracorporeal circuit.
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) that is 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 residual risks. Further information is
available on request.
• 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.
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DIRECTIONS FOR USE

Sorin Group USA, Inc.
435085209 Rev A