The number of uses depends entirely on the proper application, storage and care by the user. The durability of the electrodes depends on the adhesiveness of the gel and its adhesiveness depends on keeping the gel clean, hydrated, and free from foreign debris.
Application: Before each electrode application, skin must be cleaned with water and soap to remove any lotions, skin oils, make-up, and dead skin. Any debris on the skin will be transferred to the gel of the electrode thereby compromising the integrity of the gel's adhesiveness. A clean surface is the most important factor in the number of applications for an electrode.
Storage: After every use the electrode must be returned to the "ON" side of the Mylar liner and placed in the original, re-sealable package to prevent loss of moisture. Electrodes should be stored at a temperature between 41.0°-80.6°F.
DO NOT: store in freezer/refrigerator, leave in extreme heat, submerge in water, or leave outside of the package.
Care: After usage, if the electrode picks up small amounts of debris you may use a drop of water on your finger to gently rub the debris off the electrode. Most important to the care of the electrode is applying it to a clean surface with each use.
DO NOT: use soap, alcohol, submerge in water, or scrub with abrasive material.
Yes. When electrodes show wear and tear, or are no longer comfortable for the patient, simply replace them with a new set.
For proper hygiene, the FDA requires them to be labeled for single patient use. Our electrodes are intended for single patient use only. By sharing electrodes, you are subjected to cross contamination. All electrodes are disposable and should be discarded if compromised, and a fresh set used.
We design our products for reuse provided there is proper care of the skin and the electrodes. However, with reuse, the risk of contamination increases with each application. Each time an electrode is removed, it lifts off dirt and skin debris, which in turn becomes absorbed into the gel. To maintain optimal hygiene you would want to change electrodes when they become contaminated in this fashion. The pH of our gel is controlled at a level to prevent the spontaneous growth of molds. However, during use in a spore rich environment, it is possible to overwhelm this mold growth control feature of the gel.
PALS® Clinical electrodes are made with DermaFlow® hydrogel, specially formulated with a composition less likely to cause allergic reactions or skin sensitivity. While DermaFlow is designed to be our most gentle to skin hydrogel yet, there is still a slight chance of a patient developing skin sensitivity as different people have different reactions. All Axelgaard hydrogels have passed ISO 10993 testing for skin irritation, sensitization and cytotoxicity.
Axelgaard's MultiStick® hydrogel's proprietary formula has always exhibited antimicrobial properties since it was first patented in 1999. Testing by the independent EMSL Analytic Laboratory has demonstrated the gel's ability to kill MRSA with an observed > 99.99999% reduction. For proper hygiene, the FDA requires electrodes to be labeled for single patient use only.
All products manufactured by Axelgaard Manufacturing are latex free. We do not use latex of any kind in the electrodes we manufacture or in the packaging.
Always lift electrodes from the edge - not the leadwire.
Use of hot or cold packs for long periods of time can cause adhesive separation.
Our products are made only in the USA.
All our gels may be sterilized using the proper electron beam or gamma irradiation dose.
The “process by” shelf life is for roll goods prior to conversion. Refer to each hydrogel’s Technical Data Sheet for the master roll shelf life, as this may vary by part number. The shelf life for slit rolls is 6 months. Establishing the shelf life for finished goods is the responsibility of the converter.
All AmGel hydrogels are manufactured in Fallbrook, California USA.
No. All of our gels are latex free.
Yes, we can slit master rolls to almost any necessary width.
Most standard hydrogels have an MOQ of only 1 roll.
For standard hydrogels the lead time varies based on our production schedule and the quantity ordered.
For easy release, plasma/non-stick coated dies should be used to convert hydrogel. Deep cavity dies should be considered for hydrogels thicker than 35 mil.
Hydrogel should remain in its shipping plastic bag and kept in a temperature controlled environment. Short term temperature recommendation is 32° - 104°F (0° - 40°C). Long term and optimal temperature recommendation is 41° - 81°F (5° - 27°C).
The proper storage and packaging of products using AmGel Hydrogel are dependent on several factors, including the hydrogel type, product type and packaging type. It is the converter’s responsibility to determine the storage conditions of finished goods.
Some converters find that cooling the hydrogel makes for easier converting. A hydrogel is a viscoelastic material which is dependent on temperature. The lower the temperature will exhibit more elastic behavior and the higher the temperature will exhibit more viscous behavior. It will be firmer at the colder temperature and softer/more adhesive at the higher temperature. Cold does not have a negative impact on converting.
A high moisture barrier foil package is recommended for sensing hydrogels (small surface area), however it is the converter’s responsibility to determine finished product packaging requirements. Hydrogels can lose and gain water depending on environmental conditions, which can affect its performance. It’s recommended to keep the hydrogel on the protective liner. Also, if planning to reuse the product, a re-sealable package is recommended.
The re-stick capabilities depends on the hydrogel series. For most gels, the number of times the hydrogel can be applied to skin depends on the proper preparation of the skin prior to application. Skin should be cleaned with water and soap to remove any lotions, skin oils, make-up and dead skin. Any debris on the skin will be transferred to the gel thereby compromising the integrity of the gel’s adhesiveness. When the skin is properly prepared, the hydrogel will perform well for repeated application or wear.
The converter is responsible for aging parameters. A hydrogel is a viscoelastic material which is dependent on temperature. The lower the temperature will exhibit more elastic behavior and the higher the temperature will exhibit more viscous behavior. It will be firmer at the colder temperature and softer/more adhesive at the higher temperature. The conductivity of a hydrogel is dependent on the temperature. The hydrogel should be conditioned prior to testing to have accurate and reproducible data.
Our Engineering/R&D team will work with you regarding volumes, specifications, cost, and prototypes.
The converter is responsible for determining the compatibility of any materials used in conjunction with the hydrogel. We can supply a stimulating gel already laminated with a conductive film. We also offer quality liners for purchase.
Yes, our hydrogels have passed all the ISO 10993-1 biocompatibility tests for intact skin contact. Samples were tested by NAMSA.
AmGel hydrogels are a component, not a finished device. The gel by itself does not require a 510(k) pre-market approval.
Water activity basically describes the amount of water available for hydration. It represents the ratio of the water vapor pressure of a substance (i.e. hydrogel) to the water vapor pressure of pure water. The scale is from 0 to 1.0 (pure water).
Axelgaard's testing is modeled after the American Society for Testing and Materials (ASTM) Standard D3330/D3330M "Standard Test Method for Peel Adhesion of Pressure-Sensitive Tape", Test Method A. Our adhesive and release tester operates on gel level based on the distance traveled to collect adhesion force data needed to obtain the average value. Our Stainless Steel (Skin Side) Adhesion specification is based on 180° peel, with the unit of measure being grams per inch of width.