Flexcon
omni-wave™
OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8
Bio-Signal Sensing, Hydrogel-Free Technology for Electrodes and Wearable Devices
No Hydrogel-Associated Skin Reactions
- A revolutionary dry biomedical electrode technology developed with patient comfort in mind
- Utilizes a skin-friendly, medical grade conductive adhesive that requires no hydrogel or Ag/AgCl to get a signal, offering a hydrogel-free patient experience.
Approved component in customer 510(k) and CE marked finished good medical devices and meets internationally-accepted standards for quality
- Passes AAMI and ISO 10993-10 for sensitization and irritation
- Approved by the FDA for use in electrodes and wearables
- REACH and RoHS compliant
Features and Benefits
- H-502 hydrogel-free skin contact adhesive (transfer tape) engineered for short-term wear (3 days) for medical device attachment (electrodes or sensors) demonstrates minimal skin irritation as compared to hydrogel electrodes
- Conductive adhesive layer allows electronics to send and receive waveform signals between the surfaces it connects to
- Product performance is not affected by humidity
- 1.5 mil ultra-smooth polyester release liner provides ultimate smoothness and flow-out of adhesive, and is ideal for roll-form converting
- 44 lb. polycoated natural Kraft release liner ideal for roll-form converting
- Patented FLEXcon® OMNI-WAVE™ technology
- Association for Advancement of Medical Instrumentation (AAMI) compliant
- Passes ISO 10993-10 (biological evaluation of medical devices) for sensitization and irritation
technical data
Values
|
Thickness (Mils[microns])
|
---|---|
44 PP-8 Liner
|
3.0 (76) +/- 10%
|
Adhesive
|
2.0-2.2 (51-56) +/- 0.1 (3)
|
150 Poly H-9 Liner
|
1.4 (36) +/- 5%
|
ADHESION properties
Ultimate Peel From
|
Average Oz/In
|
(N/m)
|
---|---|---|
Stainless Steel
|
13
|
(143)
|
Electrical properties
Property
|
Value
|
Test Method
|
---|---|---|
Expected Shear
|
Room Temp (hours): 2
|
ASTM D 3654 Method A, a. 1 hr. dwell, b. 1 sq. in. surface, c. 4 lb. load
|
Tack (gm/sq cm)
|
340
|
ASTM D 2979
|
Electrical Properties
|
Z-Direction Resistance: Less than 20 Ohms/in²
|
|
Electrical Properties
|
Surface Resistivity: Less than 200 Ohms/square
|
|
Storage Stability
|
Two years stored at 70°F (21°C) and 50% RH in the original packaging; two year out-of-package shelf life
|
Product ID # FLX068983
Adhesion Properties – Ultimate Peel from test method: ASTM D 903 (15 min. dwell) a. 180° degree peel DISCLAIMER: FLEXcon MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, COURSE OF PERFORMANCE, OR TRADE USAGE. This product is a device component intended solely for further processing, manufacturing, incorporation into a finished device, and is further intended only for use as a device component on intact skin (i.e., not intended for use in the presence of open sores or wounds nor for applications inside the body). Customer is solely responsible for determining whether this component product is fit for Customer’s intended use, including, without limitation, incorporation into Customer’s finished device(s), and for performing any additional testing that may be necessary to support Customer’s intended use. Customer is solely responsible for ensuring that its use of the component product is in compliance with the applicable laws and for obtaining any necessary clearances or approvals from its use of the component product and any finished device that incorporates the component product. Full biocompatibility results are available upon request.