FEI 12-1672

FEI Baseline Tactile Monofilament User Manual

Model: 12-1672

For ADA/LEAP/LOPS Tactile Sensation Testing

1. Product Overview

The FEI Baseline Tactile Monofilament is a specialized diagnostic tool used for evaluating tactile sensation. Each monofilament is designed to deliver a precise force of 10 grams (5.07 level) when applied correctly, adhering to ADA, LEAP, and LOPS program testing protocols. This product is supplied in a pack of 20 disposable monofilaments.

2. Intended Use

These monofilaments are intended for healthcare professionals to assess peripheral neuropathy, particularly in patients at risk for foot ulceration due to diabetes or other conditions affecting nerve function. They are used to detect loss of protective sensation.

3. Important Safety Information

  • For single patient use only. Do not reuse. Reuse may lead to inaccurate results or cross-contamination.
  • Store in a clean, dry environment away from direct sunlight and extreme temperatures.
  • Inspect each monofilament before use. Do not use if bent, damaged, or if the filament is missing.
  • Keep out of reach of children.
  • This device is for professional use only.

4. Components

Each package contains:

  • 20 x FEI Baseline Tactile Monofilaments (10 gram / 5.07 level)
FEI Baseline Tactile Monofilament packaging showing 20 disposable monofilaments.

This image displays the clear plastic packaging containing 20 individual FEI Baseline Tactile Monofilaments. Each monofilament is a thin, black filament attached to a small white base, labeled with 'BASELINE EVALUATION INSTRUMENTS', 'LEAP / LOPS / ADA test sites', 'tactile monofilament evaluator', '10 gram 5.07 level', and '12-1672'.

5. Setup and Preparation

  1. Ensure the patient is in a comfortable, relaxed position, typically supine or seated with feet supported.
  2. Explain the procedure to the patient, instructing them to say "yes" or "touch" each time they feel the monofilament.
  3. Select a clean, undamaged monofilament from the package.
  4. Practice applying the monofilament on the patient's hand or arm first, so they understand the sensation.

6. Operating Instructions: Tactile Sensation Testing Protocol

Follow these steps for accurate tactile sensation testing:

  1. Application Technique: Hold the monofilament perpendicular to the skin surface. Apply enough pressure to cause the monofilament to bend into a C-shape. This ensures the correct 10-gram force is applied.
  2. Test Sites: Apply the monofilament to specific test sites on the foot, avoiding calluses, scars, or open wounds. Common sites include the plantar surface of the great toe, the first, third, and fifth metatarsal heads, and the heel.
  3. Duration: Apply the monofilament for approximately 1-2 seconds at each site.
  4. Randomization: Vary the timing and location of applications to prevent the patient from anticipating the touch. Do not allow the patient to see where the monofilament is being applied.
  5. Response: Record whether the patient correctly identifies the sensation at each site.
  6. Interpretation: Loss of protective sensation is indicated if the patient fails to perceive the monofilament at four or more of the ten standard test sites.
Close-up of FEI Baseline Tactile Monofilament packaging.

This image provides a closer view of the FEI Baseline Tactile Monofilament packaging, highlighting the individual monofilaments and the product labeling. It shows the thin black filaments ready for use.

7. Care and Storage

As these monofilaments are disposable, extensive maintenance is not required.

  • Store unused monofilaments in their original packaging in a cool, dry place.
  • Protect from physical damage that could bend or break the filament.

8. Troubleshooting

  • Monofilament does not bend into a C-shape: Ensure you are applying sufficient, but not excessive, pressure. If the filament is damaged, discard and use a new one.
  • Patient reports no sensation: Re-verify the application technique. If sensation is still not perceived, this may indicate a loss of protective sensation, which is the purpose of the test.
  • Filament breaks: Discard the broken monofilament and use a new one.

9. Product Specifications

  • Model: 12-1672
  • Pressure Level: 10 grams (5.07 level)
  • Quantity: 20 disposable monofilaments per pack
  • Intended Use: Tactile sensation evaluation (ADA/LEAP/LOPS protocols)
  • Item Weight: 8 ounces
  • Product Dimensions: 6 x 3.5 x 1 inches (packaging)

10. Disposal

Dispose of used monofilaments according to local regulations for medical waste. As they are single-use, they should be discarded after each patient to prevent cross-contamination and ensure accuracy.

11. Warranty and Support

For product inquiries, technical support, or warranty information, please contact FEI customer service. Specific warranty details are typically provided with the product purchase documentation.

Contact Information: Refer to your purchase invoice or the manufacturer's official website for current contact details.