ARGON Skater FIX Catheter Fixation Device Instruction Manual
- June 6, 2024
- ARGON
Table of Contents
Skater FIX Catheter Fixation Device
Instruction Manual
https://www.argonmedical.com/resources/product-information
The symbols glossary is located electronically at www.argonmedical.com/symbols
Intended Use/Purpose
SKATER™ FIX is a catheter fixation device designed to secure drainage
catheters.
Device Description
Skater™ FIX is a latex-free device, consist of a central thin carrier that has
hydrocolloid adhesive and a covered with non-woven adhesive medical grade. The
soft foam support block and velcro prevent the catheter from kinking. The
velcro cover can be opened for puncture site allowing for inspection for
infection or leakage.
Indication for use
The Skater™ FIX is indicated for the fixation of drainage catheters.
Contraindications for Use
There are no contraindications with the use of this product. However, the
assessment of the patient’s overall physical state by the physician is
required prior to the procedure.
Possible complications/Risks:
There are no known complications for this device.
Warnings
- Contents are supplied sterile and are intended for single use only. Do not re-sterilize.
- Reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection, or another injury.
- Do not use if the package is open or damaged and if the expiration date has passed.
Precautions
- The product must only be used by a licensed physicians.
- Mechanical forces are minimal and under the control of the user. Risk acceptable if used as intended by licensed physician.
Disposal
After use, handle, and dispose of in accordance with hospitals policies and
procedures concerning biohazard materials and waste.
Storage: Store at controlled room temperature.
NOTE: In the event, a serious incident related to this device occurs, the
event should be reported to Argon Medical at
quality.regulatory@argonmedical.com
as well as to the competent health authority where the user/patient resides.
ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 800-927-4669;
Tel: +1 903-675-9321
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