Product Description - Merit Medical Aspira Instrucciones De Uso

Universal Tubing Adapter
INSTRUCTIONS FOR USE

PRODUCT DESCRIPTION

The Universal Tubing Adapter is designed for use with the Aspira® Valve
Assembly. It connects to the valve and enables connection of the drainage
catheter to a drainage system.
INDICATIONS FOR USE
The Universal Tubing Adapter is intended to provide access to the Aspira
Valve Assembly. It is used to drain fluid using standard wall suction, water
seal drainage system, glass vacuum bottle, syringe or other appropriate
method.
CONTRAINDICATIONS
None known when used with the Aspira Valve Assembly.
WARNINGS
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural integrity of
the device and/or lead to device failure which, in turn, may result in patient
injury, illness or death. Reuse, reprocessing or resterilization may also create
a risk of contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may
lead to injury, illness or death of the patient.
• Attach the Universal Tubing Adapter to the drainage line prior to
attaching it to the catheter.
• Do not use excessive force on the valve or catheter. Excessive force or
incorrect usage may damage the device, or cause accidental catheter
dislodgement.
• Do not access the catheter valve with anything other than Aspira Drainage
System approved devices.
• Accessing the catheter valve with anything other than Aspira Drainage
System approved devices may damage the valve.
• Dispose of used product in accordance with accepted medical practice and
applicable local, state and federal regulations. Used product may present a
potential biohazard.
PRECAUTIONS
• Caution - Federal Law (USA) restricts this device to sale by or on the
order of a physician.
• Use this device only if you are a qualified health professional.
• Use only the Universal Tubing Adapter to access the catheter with a wall
suction unit, water seal drainage system, glass vacuum bottle, syringe or
other appropriate device.
POTENTIAL COMPLICATIONS
Pleural and Peritoneal fluid drainage may result in any of the following
complications:
• Accidental catheter dislodgement,
breakage or removal
• Exposure to bodily fluids
• Hypotension subsequent to
drainage
• Infection
• Leakage
• Low flow rate/prolonged drainage
• Occlusion
• Pain during fluid removal
• Skin irritation or infection
USE INSTRUCTIONS
NOTE: Before beginning this procedure, read the "Contraindications",
"Warnings", "Precautions" and "Potential Complications" sections of these
instructions for use.
DRAINAGE PROCEDURE
USING A WALL SUCTION UNIT:
1. Connect the Universal Tubing Adapter to the wall suction line and
activate the pinch clamp.
2. Push the Universal Tubing Adapter and suction line onto the catheter
until you hear or feel a click. Tug gently to ensure the connection is
secure. Open the pinch clamp.
3. Initiate drainage.
4. When ready to disconnect wall suction, pinch the wings on the Luer
Adapter or the Universal Tubing Adapter until it easily comes away from
the catheter valve.
NOTE: Continuous or intermittent wall suction is acceptable.
5. Wipe the end of the catheter valve with a new alcohol pad. Place the new
valve protective cap over the catheter valve.
English
PLEURAL COMPLICATIONS
• Re-expansion pulmonary edema
PERITONEAL COMPLICATIONS
• Electrolyte imbalance
• Loculation of peritoneal cavity
• Peritonitis
• Protein depletion
WARNING: Attach the Universal Tubing Adapter to the wall suction line
prior to attaching it to the catheter.
CAUTION: Use only the Universal Tubing Adapter to access the catheter
with a wall suction unit, water seal drainage system, glass vacuum bottle, or
other appropriate method.
SYMBOL
Use By: YYYY-MM-DD
Lot Number
Catalog Number
Do Not Re-sterilize
Do Not Use If Package is Damaged and Consult Instruction
for Use
Single Use
Caution
Sterilized Using Ethylene Oxide
Caution: Federal (USA) law restricts this device to sale by or
on the order of a physician
Medical Device
Unique Device Identifier
Single Sterile Barrier
Consult Instructions for Use
For electronic copy scan QR code, or go to www.merit.
com/ifu and enter IFU ID. For printed copy, call U.S.A. or EU
Customer Service
Authorized Representative in European Community
Manufacturer
DESIGNATION