TensCare X-VPL Liberty Loop Vaginal Probe User Manual
- June 15, 2024
- TensCare
Table of Contents
TensCare X-VPL Liberty Loop Vaginal Probe
Specifications
- Material:
- Electrode body: Plastic ABS PA-757
- Electrodes: Stainless steel #304
- Cables: PVC over copper tinsel conductor
- Use product lifetime: 6 months
- Environmental Conditions:
- Storage: +5 to +40°C, RH up to 93%
- Operation: +5 to +40°C, RH 15 to 93%, 700 to 1060 hPa
- Water ingress protection: IP22
Product Usage Instructions
Before Use
Read the contraindications and warnings supplied with your stimulator or
biofeedback device. Do not use electrical stimulation in patients with a
history of carcinoma at the site of stimulation. Do not use if the pack is
opened or damaged.
INDICATIONS FOR USE
The Liberty Loop 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 a flange at the base for
easy removal.
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 faecal incontinence as well as pelvic pain.
For Women: The Liberty loop probe is an effective way to target the pelvic floor muscles which helps to treat symptoms of urinary incontinence, it may also help to relieve symptoms of chronic pelvic pain. Additionally, it may help improve sexual intimacy by toning the pelvic floor muscles.
CONTRAINDICATIONS
- Follow the Contraindications and Warnings supplied with your stimulator or biofeedback device.
- Do not use electrical stimulation in patients with a history of carcinoma at the site of stimulation.
PROBE CAUTIONS
- This probe is intended for single-patient use only. Do not share your probe with anyone else. Improper treatment or cross-infection may occur.
- The probe must be cleaned before and after each use. Ineffective cleaning may lead to irritation or infection.
- 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.
- 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.The electrode surface area is 4.24cm2. 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.
Warning: Do not use if the pack is opened or damaged.
INSTRUCTIONS FOR USE
-
Connect the lead from the base of the unit to the lead in the probe. Pushthe 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. -
Vaginal insertion: After the wire is securely connected, insert the probe into your vagina, in the same way as you would a tampon until only the plastic ring at the base of the probe is visible. 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. This probe should always be inserted with the metal parts facing hip-to-hip.
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The Liberty Loop probe has a pointer attachment which enables you to visually monitor the successfulness of your pelvic floor contractions (the probe can be used without the pointer). The pointer demonstrates the strength and duration of each contraction, whether caused by stimulation or performed voluntarily. For example, weak contractions are defined by little or no movement in the pointer. Assemble the pointer and attach to the probe as follows:
- When performed correctly, the pointer will move downwards.
- When performed incorrectly, the pointer will move upwards
-
After your training session, switch the control unit off, then remove the probe by holding the positioning end rim and gently pulling outwards.
DIMENSION
CLEANING
The probe must be cleaned before and after each use. Clean with either an
alcohol-free antibacterial wipe such as TensCare Wipes (see X-WIPES) or by
wiping with warm soapy water. Rinse under running water and 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 – the 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
- “In Use” product lifetime: 6 months
ENVIRONMENTAL CONDITIONS
- Storage: +5 to +400C, 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. Please find
our details on the final page of this insert.
TensCare Ltd,
- ADDRESS: 9 Blenheim Road. Epsom, Surrey, KT19 9BE, UK
- Tel: +44(0) 1372 723434
- Web : www.tenscare.co.uk
Advena Ltd.
Tower Business Centre, 2nd FIr, Tower Street, Swatar, BKR 4013, Malta
TensCare Europe BV
Juliana van Stolbergstraat 52 1723LD Noord-Scharwoude Netherlands
- Pub No.: I-VPL-ML Rev 3.2 08/22