REUSABLE PVC MANOMETRIC CATHETER - ANORECTAL EXPULSION CATHETER (AIR ONLY)
Usage: 5 years or 50 uses; whichever comes first
INTENDED PURPOSE
The Anorectal Expulsion Catheter is a specific Reusable PVC Manometric Catheter model which isolates the anorectal balloon function of an anorectal manometric catheter. The Anorectal Expulsion Catheter is used to evaluate the muscular contractions of the rectum.
INDICATIONS FOR USE
Use of the Anorectal Expulsion Catheter is indicated when there is a need or suspicion of an anorectal disorder.
CONTRAINDICATIONS
The presence of any stenosis, structural deformity or disease within the rectum, that results in an unacceptably increased risk of distention, perforation, or any other adverse consequence arising from use of this device.
WARNINGS
Read through entire IFU to reduce any possible risks from misuse.
This catheter is supplied non-sterile.
Inspect catheter and packaging for any evidence of mechanical damage or imperfections. Do not use if damaged.
This catheter must not be altered or modified in any way. Mui Scientific is not liable for personal injury and damage to property if original Mui Scientific parts are not being used.
Proper aseptic technique and universal barrier precautions (UBP) must apply.
Post-procedure manometric catheters are contaminated with body fluid. Immediately clean and disinfect according to the procedure stipulated in the accompanying Instructions For Use.
This catheter must only be used under medical supervision by personnel who have been adequately trained.
The detailed instructions contained within this IFU is sufficient for guidance of the usage of this equipment; no further training from the manufacturer is required.
Do not use devices beyond their prescribed lifetime or validated number of uses; injuries may result.
This catheter is to be used in the anatomy and for the age group for which is intended, as dictated by the device name/description on the label.
Inflate balloon with air only; risk of balloon detachment or rupture if balloon filled with water. (Use catheter SR2B if you wish to inflate balloon with water).
TARGET POPULATION
There are no specific intended patient populations.
The use for specific patients is at the discretion of the medical personnel who have received professional training in gastrointestinal manometry.
CLINICAL BENEFIT
The Anorectal Expulsion Catheter is to be inserted anorectally, for pressure measurements of the rectum. The balloon is to be filled with air to stimulate the rectum.
BALLOON EXPULSION FUNCTION- INSTRUCTIONS FOR USE
1. Water-based lubricants may be used to assist in insertion of catheter. Do not use silicone-based lubricants on balloons.
2. Insert the catheter through the anus to a depth of 8-10cm.
3. Attach a 3-way stopcock to the catheter and fill the balloon with 30-60ml of air (do not fill with water; balloon detachment would occur).
4. Close off the balloon port, and remove syringe.
5. Have the patient go to the toilet / commode and attempt to expel the catheter.
6. Expulsion of the catheter within 2-5 minutes indicates normal function.
7. Post-procedure catheters are contaminated with body fluid, and must be immediately dispose of the catheter to avoid re-use.
BIO-FEEDBACK FUNCTION – INSTRUCTIONS FOR USE
For handheld bio-feedback devices:
1. With a 3-way stopcock, attach the catheter to the male luer end of the stopcock, a syringe to one female luer end and an extension tube (with a male and female luer end) to the other female luer end of the stopcock.
2. Water-based lubricants may be used to assist in insertion of catheter. Do not use silicone-based lubricants on balloons.
3. Insert the catheter through the anus to a depth of 8-10cm.
4. Attach the other end of the extension tube to the handheld device and fill the balloon with air accordingly (30-60ml). Close off the syringe port, and remove syringe.
5. Any squeeze pressure by the patient will be displayed on the handheld device.
6. Post-procedure catheters are contaminated with body fluid, and must be immediately dispose of the catheter to avoid re-use.
CHEMICAL CLEANING / DISINFECTING INSTRUCTIONS
The following reprocessing procedures have been validated by the manufacturer for the user to follow within their own facilities.
1. Cleaning
• Attach the stopcock to the luer and close it to ensure no liquid enters into the balloon.
• Wash catheter in warm water with enzymatic detergent.
• Rinse catheter with clean fresh water to remove detergent. Repeat as needed.
• Wipe external surface.
2. Chemical Disinfection (high-level disinfection)
• Attach the stopcock to the luer and close it to ensure no liquid enters into the balloon.
• Ensure the entire catheter is submerged in disinfectant.
• Soak catheter in disinfectant solution according to solution manufacturer’s instructions.
Caution:
• The catheter contains Polyvinyl Chloride (PVC), Polycarbonate, Polyisoprene or Polyolefin and Silk Sutures.
• Check with disinfectant manufacturer to ensure their disinfectant can be used safely on the materials listed above.
• Sporox (Sultan Chemists Inc.), Korsolex Extra (Bode Chemie GmbH & Co.), OPTIM CS (SciCan Ltd.) and Adaspor Plus Ready to Use (IMS Group) are compatible with the catheter and should be used according to the solution’s manufacturer’s instructions.
• DO NOT USE CIDEX PRODUCTS.
• Do not soak the catheter in alcohol.
• Do not steam autoclave the catheter.
3. Final Rinsing and Blow Drying
• Rinse catheter with sterile water to remove disinfectant. Repeat as needed.
• Wipe all water from external surface.
• The following reprocessing procedures have been validated by the manufacturer for the user to follow within their own facilities.
STORAGE
Store catheter in a dry and clean location.
Temperature limit:
15°C - 30°C (60.8°F – 80.6°F)
Humidity limit:
10% - 75%
Lifetime of product – 5 years or 50 uses whichever occurs first.
Time period for each use - 30 min inside the gastrointestinal system.
It is the responsibility of the user to manually track the age and number of uses of the device.
Manufacturer’s Warranty – 6 months from Manufactured Date for any manufacturer’s defects.
The user and/or patient should report any serious incident that has occurred in relation to this device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Dispose of the device safely, in accordance with the local policies where this device shall be used.
Complete Healthcare Supplies Inc or its suppliers are not liable for any damage to the catheter, or harm to patients or personnel, caused by improper use of a disinfectant or procedure.
