How does the monofilament test work?
Using the monofilament, you may screen your own feet or ask a relative, friend, or neighbor to do it for you.
To use the monofilament you:
1. Hold the monofilament by the paper handle.
2. Use a smooth motion to touch the filament to the skin on your foot. Touch the filament along the side of, not directly on, an ulcer, callus, or scar. Touch the filament to your skin for 1-2 seconds. Push hard enough to make the filament bend.
3. Touch the filament to both of your feet in the sites circled in the figures on the instruction card that came with the monofilament. Place a (+) in the circle if you can feel the filament at that site and a (-) if you cannot feel the filament at that site.
4. If another person is performing a monofilament test on you, it is advised that you have your eyes closed during the test and simply say βyesβ every time you feel the 10-gram force from the monofilament on your foot.
How long do monofilaments last? Do they have an expiration date?
Our monofilaments have an expiration date of 2 years. All monofilaments are designed to be used within 24 months after fabrication, in accordance with FDA standards. All of our products are shipped with at least 22 months before expiration.
Are monofilaments reusable?
No. In accordance with FDA guidelines, our monofilaments are guaranteed to deliver a 10-gram force range for use in a single test. This means performing a screening for LOPS on one individual and then discarding the monofilament.
Is the monofilament latex-free?
Yes.
Are your monofilaments FDA approved?
Yes, all of our monofilaments have FDA clearance. More specifically Medical Monofilament Manufacturing has attained the 510(k) clearance for medical devices by the FDA.
How should monofilaments be stored?
Monofilaments can be adversely affected by time, extreme temperature, and high humidity, and should therefore be stored appropriately at room temperature in a dry environment.
What does a calibrated monofilament mean?
A calibrated monofilament means that the device has been tested and precisely provides the 10-gram force range as recommended. We calibrate our products daily using a gram scale, and our machinery later tests and records gram force range readings with precision inline sensors. Our manufacturing process also utilizes a high-tech visual inspection system that ensures we deliver the highest quality monofilaments available.
What does a 5.07 monofilament mean?
5.07 refers to the diameter of the monofilament fiber. The 5.07 monofilament has been accepted as the medical standard for screening for loss of protective sensation in the foot. At this diameter and at a precise length, the monofilament delivers 10 grams of force at flexion.
What is the monofilament made of?
Our monofilaments are made of a proprietary fiber that delivers 10 grams of force when bent to the point of flexion.