STANDARD SINGLE USE RECTAL - PVC SINGLE USE CATHETER
INSTRUCTIONS FOR USE
Avoid inserting/ using Single Use catheter into any patient more than once
INTENDED PURPOSE
The anorectal balloon expulsion catheter is a specific Single-Use PVC Manometric Catheter model which isolates the anorectal balloon function of an anorectal manometric catheter. The anorectal balloon expulsion catheter is used to evaluate the muscular contractions of the rectum.
This catheter is designed for single-use, and is to be used only under the supervision of a physician who has received adequate training in gastro-intestinal manometry.
INDICATIONS FOR USE
Use of the Anorectal Balloon 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 assembly.
WARNINGS
Read through entire IFU to reduce any possible risks from misuse.
This device is supplied non-sterile.
The catheter contains low amounts of phthalates. Use with caution for pregnant and pediatric cases.
Anorectal Balloon Expulsion 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.
This balloon expulsion catheter is designed for single-use only.
Attempts to reprocess, re-sterilize, and/or re-use may lead to failure of the device and/or transmission of disease. Immediately dispose of the balloon expulsion catheter after use to avoid re-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.
Catheter is to be used in the anatomy for which is intended, as dictated by the device name/description on the label.
Catheter is to be used for the age group for which it is intended, as dictated by the device name/description on the label.
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
Standard Single Use Rectal PVC Catheters are to be inserted anorectally, for pressure measurements of the rectum (and possibly the colon). They may contain balloon, to be inserted with air, to simulate the rectum.
BALLOON EXPULSION FUNCTION- INSTRUCTIONS FOR USE
Inspect catheter and packaging for any evidence of mechanical damage or imperfections. DO NOT USE IF DAMAGED.
1. Remove the anorectal probe after the HRM study is complete.
2. Insert the balloon expulsion catheter through the anus to a depth of 8-10cm.
3. Attach a 3-way stopcock to the balloon expulsion catheter and fill the balloon with 30-60ml of air
4. Close off the balloon port, and remove syringe.
5. Have the patient go to the toilet / commode and attempt to expel the balloon expulsion catheter.
6. Expulsion of the balloon expulsion catheter within 2-5 minutes.
7. Indicates normal function.
8. Post-procedure balloon expulsion catheters are contaminated with body fluid. Immediately dispose of the balloon expulsion catheter to avoid re-use.
BIO-FEEDBACK FUNCTION – INSTRUCTIONS FOR USE
For handheld bio-feedback devices:
1. With a 3-way stopcock, attach the balloon expulsion 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. Insert the balloon expulsion catheter through the anus to a depth of 8-10cm.
3. 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.
4. Any squeeze pressure by the patient will be displayed on the handheld device.
For use with a water-perfused manometry system:
1. Disconnect the capillary tubing from the bottom of the transducer and allow all the water to drain out of the transducer (for it to be used with air only).
2. Close off the stopcock at the bottom of the transducer (to create a closed system and prevent any water from entering into the transducer).
3. With a 3-way stopcock, attach the balloon expulsion 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.
4. Insert the balloon expulsion catheter through the anus to a depth of 8-10cm.
5. Connect the extension tube to the top of the transducer.
6. Inflate the balloon with air accordingly (30-60ml). Close off the syringe port, and remove syringe.
7. Any squeeze pressure by the patient will be displayed on the computer monitor.
