Indications For Use; Instructions For Use - SORIN GROUP sprinklers Manual Del Usuario

ATRA Sump (SU‑29602)
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 ATRA Sump consists of a flexible polyvinyl chloride tubing that terminates in a
weighted distal tip. The weight of the distal tip is provided for by the stainless steel spring
which is encapsulated in a polyvinyl chloride encasing. The encasing is comprised of round
apertures running longitudinally in four rows each offset by ninety degrees. A 1/4" straight
tapered polyvinyl chloride connector is located proximally and interference mated to the
flexible tubing.

INDICATIONS FOR USE

The ATRA Sump is indicated for use to remove excess fluid from the surgical field.
CONTRAINDICATIONS
The ATRA Sump is not designed, sold or intended for use other than indicated. The ATRA
Sump is 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.
• This device contains stainless steel. Do not use this device in a MRI environment.
• CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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INSTRUCTIONS FOR USE

Sorin Group USA, Inc.
435085224 Rev A