Argon Medical Devices SKATER Allzweck- und Nephrostomie-Drainageset Gebrauchsanweisung

SKATER™ All-Purpose and Nephrostomy Drainage Set
(Locking and Non-Locking Pigtail)
ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1(903) 675-9321
Tel: +1(800) 927-4669
www.argonmedical.com
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31 70 345 8570
Https://www.argonmedical.com/resources/product-information
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EN-English
Intended Use/Purpose
The SKATER™ All-Purpose and Nephrostomy Drainage Set is used for fluid
drainage procedures.
Indication for use
The product is for percutaneous drainage in a variety of drainage applications
(e.g., nephrostomy and abscess).
Device Description
The SKATER™ All-Purpose and Nephrostostomy Drainage Set Catheters are
designed to promote maximum drainage flow. They are formulated for patient
comfort, kink resistance, and easy insertion.
Duration
Up to 12 weeks.
Warnings
• This device was designed, tested and supplied sterile and is intended for
• Do not reuse or reprocess this device. Reuse or reprocessing has not been
IFU7000CE/1020A
• Inspect the package integrity before use.
• Do not use if package is open or damaged, or if the expiration date has
• During insertion, avoid contact with bone, cartilage, and scar tissue which
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.
Precautions
• The product must only be used by licensed, knowledgeable physician and
• Ensure the drain is secured and the system is intact to prevent
• Assess drain insertion site for signs of leakage, redness, or oozing. These
• Monitor changes in character or volume of fluid or bleeding.
• It is recommended affixing the catheter in a straight line and that any
• The drain also provides a pathway for bacteria to get into the wound. The
• It is recommended that the physician follow the hospital's standard of care
• As with any draining procedure, there is risk of infection, pain, discomfort,
Preparation
• Advance the straightener carefully over the curvature of the catheter while
• Locking Pigtail - Gently pull the thread to lock the pigtail in order to avoid
• For Single-Step:
• For Over the Wire:
• Remove the straightener and the catheter is now ready for use.
• Activate the catheter coating by saline.
Procedure
• For Single-Step:
1
SKATER™ All-Purpose and Nephrostomy Drainage Set
(Locking and Non-Locking Pigtail)
single use only. Do not re-sterilize.
evaluated and may lead to its failure and subsequent patient illness,
infection or other injury.
been exceeded.
can damage the catheter tip.
qualified personnel who are familiar with the technique and who can ensure
that patients will be monitored and appropriately treated for expected
complications.
dislodgement. Secure with a catheter fixation device, suture, or tape.
signs may indicate an infection or irritation of the surrounding skin.
curvature be applied to the connecting tube.
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.
procedures for drainage catheters.
inadvertent tissue damage, and fluid loss. When used as intended by a
physician, the benefits of using
Nephrostomy Drainage Set outweigh the risks associated with the use of
the device.
straightening the curvature with your fingers.
unintentional looping of the thread.
1. Introduce the metal stiffener fully with the trocar needle slightly drawn
back to avoid damaging the catheter wall.
2. 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.
NOTE: 35, 45, and 60cm devices are not provided with a trocar needle
and must be placed over the wire. Guidewire not included.
1. Introduce the chosen stiffener and fasten the stiffener onto the catheter
(Luer Lock).
NOTE: The flexible stiffener included with 45 and 60cm devices is coated.
Activate the coating with saline prior to use.
1. Perform the skin incision under local anaesthesia.
the SKATER™ All-Purpose and