Argon Medical Devices SKATER Single Step Drainage Set Manual Del Usuario

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 800-927-4669
Tel: +1 903-675-9321
www.argonmedical.com
EMERGO EUROPE
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2514 AP The Hague
The Netherlands
+31 70 345 8570
Argon Medical Devices UK Ltd
Eastgate Business Centre
Eastern Avenue
Burton-on-Trent
Staffordshire
DE13 0AT
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en - English
SKATER™ Single Step Drainage Set Locking and Non-Locking
Intended Use/Purpose
The SKATER™ Single Step Drainage Set is used for percutaneous drainage
procedures.
Device Description
The SKATER™ Single Step Drainage Set are designed to promote maximum
drainage flow. They are formulated for patient comfort, kink resistance, and
easy insertion.
Indication for use
Non-Locking Pitail - the product is for single step drainage of cysts, abscesses,
heamatomaes, pleural exudates, ascites, gall bladders and nephrostomies.
Locking Pigtail - The product is for single step drainage of cysts, gall bladders
and nephrostomies.
Duration
Up to 12 weeks
Warnings
This device was designed, tested and manufactured for single use only.
•
Reuse or reprocessing has not been evaluated and may lead to its failure
and subsequent patient illness, infection or other injury. Do not reuse,
reprocess or re-sterilize this device.
Inspect the package integrity before use.
•
• Do not use if package appear open or if the expiry date has been
IFU9009/0221A
exceeded.
• During insertion avoid contact with bone, cartilage and scar tissue which
can damage the catheter tip.
Caution (Locking Pigtail)
If the catheter is to be removed in another department, we recommend that
these guidance notes accompany the patient's case notes to ensure that the
relevant personnel are aware of the presence of a locking catheter. It is also
advisable to inform the patient.
Precaution
The product must only be used by licensed, knowledgeable physician and
•
qualified personnel who are familiar with the technique and who can
ensure that patients will be monitored and appropriately treated for
expected complications.
Ensure the drain is secured and the system is intact to prevent
•
dislodgement. Secure with a catheter fixation device, suture, or tape.
Assess drain insertion site for signs of leakage, redness, or oozing. These
•
signs may indicate an infection or irritation of the surrounding skin.
Monitor changes in character or volume of fluid or bleeding.
•
It is recommended affixing the catheter in a straight line and that any
•
curvature be applied to the connecting tube.
• The drain also provides a pathway for bacteria to get into the wound. The
risk of infection can be due to ascending bacterial invasion, foreign body
reaction, decreased local tissue resistance, bacterial hiding places, poor
placement due to kinked drain, and poor postoperative management.
• It is recommended that the physician follow the hospital's standard of
care procedures for drainage catheters.
• As with any draining procedure, there is risk of infection, pain, discomfort,
inadvertent tissue damage, and fluid loss. When used as intended by a
physician, the benefits of using the SKATER™ Single Step Drainage
Catheter outweigh the risks associated with the use of the device.
Preparation
Advance the straightener carefully over the curvature of the catheter,
•
while straightening the curvature with your fingers.
Locking Pigtail - Gently pull the thread to avoid unintentional looping of
•
the thread.
Introduce the metal stiffener fully with the trocar needle slightly drawn
•
back to avoid damaging the catheter wall.
Fasten the stiffener onto the catheter and introduce the trocar needle.
•
Support the tip of the catheter advancing the needle. Snap the Choice
Lock™ onto the stiffener hub.
• Remove the straightener and the catheter is now ready for use.
• Activate the coating by saline.
Procedure
Single-step catheterisation through a skin incision.
• Perform the skin incision under local anaesthesia.
• Introduce the catheter set to the cavity using ultrasound guidance, CT or
fluoroscopy.
• Verify correct position by releasing the Choice Lock™ with one hand and
remove the stylet. Check that fluid is escaping or aspirate with a 10 ml
syringe. The stylet must always be correctly positioned if you want to
change the placement. When correctly positioned advance the catheter
over the needle, holding the needle steady.
Ensure that the complete length of the pigtail is in the cavity.
•
Non-Locking Pigtail
•
1.
Locking Pigtail
•
1.
The pigtail "curls" in the cavity. Remove the needle and connect the
catheter to a drainage bag with suitable connecting tube.
Gently pull the thread to ensure correct position and to complete
curvature of the pigtail.