ARGON Contrast Management System Instruction Manual

CONTRAST MANAGER
INSTRUCTIONS FOR USE

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 (903) 675 9321
Tel: +1 (800) 927 4669|
EMERGO EUROPE
Prinsessegracht 20
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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https://www.argonmedical.com/resources/product-information

20-2046-01A/0221A
The symbols glossary is located electronically at www.argonmedical.com/symbols

INTENDED USE/PURPOSE:
This product is used in angiographic or radiologic procedures in controlling fluids/waste and the injection of contrast media into the patients.

INDICATION FOR USE: This product is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

CONTRAINDICATIONS:
None known.

DEVICE DESCRIPTION: The system consists of two (2) parts described below.

Spike Assembly: The set consists of a spike, pinch clamp and means of delivering fluid to the disposable portion of the system. The spike assembly is intended to be used on only one bottle of contrast media. Do not spike a second bottle with the spike currently in use. Spike using hospital protocol and aseptic technique. To maintain sterility of this assembly, a sterile port dead ender (small separate package) is provided within the package.
Disposable Flex Chamber: This set consists of a one-way check-valve, a flexible fluid chamber, blue ball, stopcock and tubing set. This disposable flex chamber portion is intended for use on one (1) patient only and is to be replaced prior to the next patient procedure.

WARNING

1. Contents are supplied sterile and are intended for single use only. Do not re-sterilize.
2. Reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection or other injury.
3. Inspect the package integrity before use.
4. Do not use if package is open or damaged and if the expiry date has been exceeded.
5. Inspect the device prior to use to verify that no damage has occurred during shipping.
6. Do not continue to use if any of the component are damaged during the procedure.
7. Do not over-tighten connections; all connections should be finger-tight. Over-tightened connections may result in cracks or leaks. Wet connections promote over-tightening by lubricating the ports. 8
8. Use proper aseptic technique when handling this device.
9. Spike contrast container only one (1) time. Dispose of Spike Assembly when the contrast container is depleted. Do not use the Spike Assembly on more than one bottle of contrast media.
10. Do not leave the Contrast Manager System intact for longer than six (6) hours.
11. Do not use the Disposable Flex Chamber on more than one patient. Do not replace the Disposable Flex Chamber more than two (2) times after initial set-up (for a total of three procedures).
12. Do not use this Products with parenteral nutritional solutions containing lipids or nitroglycerin. These substances are known to degrade some medical plastics resulting in cracks and/or leaks. Other drugs or solutions may have similar effects. Before using drugs or solutions with which you are unfamiliar, please consult the drug manufacturer’s IFU for plastics compatibility information.
13. This device is intended for use by trained, qualified license physician or other healthcare practitioner.

INSTRUCTIONS FOR USE:

1. Close the pinch clamp of the Spike Assembly. Attached the Spike Assembly to the bottle/bag.

2. Attach the Disposable Flex Chamber to the Spike Assembly.

3. Attach the fixed male luer at the end of the tubing set on the Disposable Flex Chamber to the manifold port.

4. Open the pinch clamp on the Spike Assembly and the vent on the Disposable Flex Chamber to begin priming the system. (If necessary, float the blue ball by gently squeezing the base of the Disposable Flex Chamber).

5. After priming, fill the Disposable Flex Chamber to the “10cc Fill Level” line. Stop the contrast flow by closing the vent on the Disposable Flex Chamber cap.
   (NOTE: The contrast in the Disposable Flex Chamber will refill to approximately the same level until the contrast bottle/bag is depleted).
   (NOTE: Do not fill the Disposable Flex Chamber above the maximum fill line or 30 ml.)

6. To maximize contrast savings, close the pinch clamp on the Spike Assembly at a desired point prior to the last injection to prevent the Disposable Flex Chamber from continuing to refill. When the Disposable Flex Chamber is emptied, the blue ball will seat shutting off the Disposable Flex Chamber from the line.

7. Open the 3-way stopcock below the Disposable Flex Chamber to atmosphere so that the remaining contrast in the line may be utilized.
   CAUTION: When venting the line, ensure that air entering the line is not pulled into the manifold.

8. Remove the Disposable Flex Chamber from the Spike Assembly and discard at the end of the case. Attach the port protector to the distal end of the Reusable Spike Assembly.

Possible Complications:
None Known

Disposal: After use the product may be potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable laws and regulations.

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.

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