Product Description - Merit Medical Aspira Instrucciones De Uso

Dressing Kit
INSTRUCTIONS FOR USE

PRODUCT DESCRIPTION

The Aspira® Dressing Kit provides the supplies necessary to dress the Aspira
Drainage Catheter.
INDICATIONS FOR USE
The Aspira Dressing Kit is indicated for dressing a catheter and exit site.
CONTRAINDICATIONS
None known when used with the Aspira Drainage 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.
• Be careful when placing or removing dressing not to dislodge the catheter.
PRECAUTIONS
• Caution - Federal Law (USA) restricts this device to sale by or on the
order of a physician.
• Follow a clean procedure when dressing the catheter.
• Inspect kit to ensure all components are included.
• The patient should be instructed to contact their physician if:
- Patient develops fever (body temperature above 100.5º F [38º C]), notice
redness, swelling, oozing or have pain at the exit site. These may be signs
of infection that may require treatment.
POTENTIAL COMPLICATIONS
• Accidental catheter dislodgement, breakage or removal
• Infection
• Skin irritation or infection
DRESSING INSTRUCTIONS
NOTE: Before beginning this procedure, read the "Contraindications",
"Warnings", "Precautions"and "Potential Complications" sections of these
instructions for use.
DRESSING OPTION 1
If the patient's doctor has recommended this dressing option, you will
need to change the dressing around the catheter at least once per week.
You should also change the dressing if the area under the clear dressing
becomes moist.
1. Carefully remove the clear dressing, gauze and split catheter pad from
your catheter.
2. Look at the exit site and skin around it. If you notice any redness, swelling
or oozing at the exit site, finish the dressing procedure and call the
patient's doctor.
3. Prepare a clean work space.
4. Wash and dry your hands thoroughly.
5. Place the gloves on your clean hands holding them at the cuffed end.
6. Open the CSR wrap and lay it flat on the cleaned work space.
7. Clean the skin around the catheter exit site with an alcohol pad.
NOTE: Make sure the exit site and skin around it are dry before
completing the dressing.
8. Place the split gauze or foam pad on the skin around the catheter.
9. Lay the catheter straight down toward the patients waist.
10. Place the gauze over the top of the catheter.
11. Hold gauze, catheter and split gauze or foam pad in place with one hand.
12. Place clear dressing over the catheter and gauze. Make sure the clear
dressing sticks to the skin around the gauze. Smooth down the dressing
edges.
13. Optional: Tape the catheter to the skin where it is most comfortable for
the patient.
DRESSING OPTION 2
If the patient's doctor has recommended this dressing option, you will need
to change the dressing around the catheter every time you drain fluid
from the catheter. You should also change the dressing if the area beneath
the clear dressing becomes moist.
1. Carefully remove the clear dressing, gauze and split catheter pad from
your catheter.
2. Look at the exit site and skin around it. If you notice any redness, swelling
or oozing at the exit site, finish the dressing procedure and call the
patient's doctor.
3. Prepare a clean work space.
4. Wash and dry your hands thoroughly.
English 5. Place the gloves on your clean hands holding them at the cuffed end.
6. Open the CSR wrap and lay it flat on the cleaned work space.
7. Clean the skin around the catheter exit site with an alcohol pad.
NOTE: Make sure the exit site and skin around it are dry before
completing the dressing.
8. Place the split gauze or foam pad on the skin around the catheter.
9. Coil the catheter on top of the pad. Place gauze on top of the coiled
catheter.
10. Hold gauze, catheter and split gauze or foam pad in place with one hand.
11. Place clear dressing over the catheter and gauze. Make sure the clear
dressing sticks to the skin around the gauze. Smooth down the dressing
edges.
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
This product can expose you to chemicals including
Diisononyl phthalate, (DINP), which is known to the State
of California to cause cancer and birth defects or other
reproductive harm. For more information go to www.
P65Warnings.ca.gov."
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