TensCare X-PR13 FR Anal Probe User Guide

: June 3, 2024
: TensCare

Table of Contents

TensCare X-PR13 FR Anal Probe
INDICATIONS FOR USE
CONTRAINDICATIONS
PROBE CAUTIONS
INSTRUCTIONS FOR USE
CLEANING
TECHNICAL SPECIFICATIONS
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

TensCare X-PR13 FR Anal Probe

INDICATIONS FOR USE

The Liberty Fit probe is specifically designed to suit your body. The small dimensions, smooth outer casing and curved edges mean it is easy to insert and comfortable to use.
The probe has a curved tip for easy insertion and an adjustable flange for personalized depth.

For use as an intra-anal probe. For use only with Muscle Stimulation equipment approved to EN 60601-1, EN60601-2-10, and EMG Biofeedback equipment approved to EN60601-1 in the treatment of ‘Stress’, ‘Urge’, and ‘Mixed’ and/or fecal incontinence as well as pelvic pain. Pelvic floor muscle training is recommended for recovery from some causes of Erectile Dysfunction. However, it is not intended to treat any medical issues and your first step in deciding on appropriate therapy should be to consult your professional medical advisor. The Liberty Fit probe is a medical device designed to be used in the home healthcare environment and is suitable for use by all who can control the device and understand the instructions.

CONTRAINDICATIONS

Follow the Contraindications and Warnings supplied with your stimulator or biofeedback device.
Do not use with electrical stimulation in patients with a history of carcinoma at the site of stimulation.

PROBE CAUTIONS

Caution : This probe is intended for single-patient use only. Do not share your probe with anyone else. Improper treatment or cross-infection may occur.
Caution : This probe is intended for single-orifice use only. Do not move between anus and vagina. Cross-infection may occur.
Caution : It is important that the probe is cleaned before and after each use. Ineffective cleaning may lead to irritation or infection.
Caution : Electrode surface area is 3.77cm2. At high output settings on some devices, this could result in a current density greater than 2mA RMS/cm2. High current density may be associated with localized tissue damage or minor non-thermal burns. Increase intensity carefully and reduce if you experience sharp pain during use or discharge or bleeding after use.
Caution : Never insert or remove the probe unless the control unit is powered OFF as insertion or removal when stimulation is active may cause discomfort or tissue irritation.
Caution : If tissue irritation occurs, discontinue treatment immediately. Ask your healthcare professional for advice before continuing further treatment to prevent injury.
Caution : Do not use a silicone-based lubricant on the metal plates of the probe as it may decrease the effectiveness of the electrical stimulation.
Warning: Do not use if the pack is opened or damaged.

INSTRUCTIONS FOR USE

Clean the probe with an alcohol-free anti-bacterial wipe or with warm soapy water.
Rinse under running water and dry thoroughly.
Connect the lead from the base of the unit to the lead in the probe. Push the pin ends firmly into the pigtail ends of the probe lead.
Before using the probe, you will need to visit the toilet.
Lubricate the metal electrode surfaces and probe tip with a water-based lubricant, such as TensCare Go Gel or water.
Caution: Do not use a silicone-based lubricant on the stimulation contacts as it may decrease the effectiveness of the muscle stimulation.
Choose a comfortable position, such as lying down on your bed on your side with your knees raised.
Warning: Ensure the unit is switched OFF before inserting the probe.
Anal insertion: After wires are securely connected, insert the probe into the anus whilst ‘bearing down (as in the action of passing stool) to a comfortable limit until the base of the flange on the probe touches the anus. The metal parts conduct the electrical pulse and should be in contact with the main part of the muscle at all times. The tissues close to the entrance are more sensitive, so you should avoid stimulating them. It is recommended that the probe is inserted past the sphincter muscles of the anus unless directed otherwise by a healthcare professional. For Faecal incontinence, the aim is to stimulate the external sphincter and/or puborectalis muscle, so circular electrodes should be placed so that the external ring is just inside the sphincter.
For Urinary Stress incontinence, the aim is to stimulate the levator muscles and the probe should be inserted deeper.
Note: Sometimes the wearing of tight-fitting undergarments or a tight pair of jeans will help to keep the probe in place and maintain correct contact during the program.
After your training session, switch the control unit off, then remove the probe by holding the positioning end rim and gently pulling it outwards.

CLEANING

It is important that the probe is cleaned before and after each use. Clean with either an alcohol-free antibacterial wipe or by wiping with a cloth dampened with warm soapy water. Rinse under running water, dry thoroughly and return the unit to the storage pouch.

Warnings:
Do not immerse the probe in a liquid. Keep the device away from lint and dust, as long-term exposure to lint or dust may affect the socket. Keep the device away from sunlight, as long-term exposure to sunlight may affect the rubber causing it to become less elastic and crack. Keep away from children under 5 years of age. Long cable – risk of strangulation in infants.

DISPOSAL
Clean thoroughly and dispose of it according to local regulations.

TECHNICAL SPECIFICATIONS

Material: Electrode body: Plastic ABS PA-757
Electrodes: Stainless steel #304
Cables: PVC over copper tinsel conductor
The surface area of electrodes: 3.77 cm2
“In Use” product lifetime: 6 months

ENVIRONMENTAL CONDITIONS:

Storage: -25 to+700C, RH up to 93%.
Operation: +5 to +400C, RH 15 to 93%, 700 to 1060 hPa
Water ingress protection: IP22

The first number 2:
Protected against access to hazardous parts with a finger, and the jointed test finger of 12 mm ø, 80 mm length

The second number 2:
Protected against vertically falling water drops when the enclosure is tilted up to 15˚.

This symbol on the device means “Follow operating instructions” To report unexpected operations or events contact Tenscare Ltd at the address below. TensCare-X-PR13-FR-Anal-Probe-fig-2