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A
Revolutionary Coating for Medical Devices |
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MEDCOAT
2000™ - Overview |
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MEDCOAT 2000™ was developed by The Electrolizing Corporation
of Ohio specifically to meet the needs of the medical device industry.
This process has been tested by the North American Science Associates
(NAMSA), and shown to greatly improve the performance and service
life of medical devices.
Our medical device coating can be successfully
applied to most ferrous and some nonferrous metals such as copper
and aluminum.
MEDCOAT 2000™, an electroplate process, increases
wear resistance, reduces friction, prevents galling and seizing
and
minimizes corrosion.
Unless otherwise specified, MEDCOAT 2000™ is applied directly
to the base metal without an intermediate coating. It
is applied following completion of all base metal processing, which
includes
a proprietary surface preparation procedure as part of the MEDCOAT
2000™ process. |
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The
Unique Chemistry of MEDCOAT 2000™ Makes it the Perfect
Finish
- Positive ion bond to metal creates excellent adhesion
- no chipping, flaking or peeling.
- Density of MEDCOAT 2000™ makes
it more lubricious.
- Reduces friction: does not rub away or generate heat.
- Reduces galling and seizing.
- Cleaning instruments is quick and easy.
- Non-magnetic: will not affect any sensitive electronic
operating room equipment.
- Wear resistance is 14 times greater than uncoated stainless
steel.
- Electrical conductivity of MEDCOAT 2000™ is
greater than that of stainless steel.
- Hardness of Rc 72-74: near ceramic hardness.
- Provides a barrier to nickel exposure.
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USP
Class VI Certified |
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Acute System Toxicity - No systemic
toxicity
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Intracutaneous Toxicity - No
localized tissue reaction
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Implant Toxicity - No irritation
to human tissue
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ISO/Tripartite
Tested |
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Hemolytic - non-hemolytic
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Mutagenicity - not mutagenic
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Pyrogenicty - non-pyrogenic
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Cytotoxicity - non-toxic to living cells
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Toxicity - non-toxic
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Sensitization - non-sensitizing
Testing to the subchronic level has already been
completed. MEDCOAT 2000™ is an extensively GLP tested USP
class approved coating that exceeds many Tripartite Guidelines and meets
many ISP 9000 biocompatibility standards pertaining to subchronic
use classifications. Our medical device coating has tested favorably to some of the ISO 10993 biocompatibility standard for medical. |
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Proven
Applications of MEDCOAT 2000™
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All types of surgical and dental instruments
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Bone saw guides & blades
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Bone screw taps
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Broaches & acetabular reamers
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Cannulas
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Endoscopic and laprascopic instruments
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Oscillating orthopedic saw blades
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Single-pieces curettes, elevators, chisels
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Tibial stylus assemblies
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Bone drills
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Reamers
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Dental drills
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Aluminum handles
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MEDCOAT
2000™ -
Application
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MEDCOAT 2000™ can be applied with great precision and
consistency. Each part drawing should specify the coating thickness
dimension and tolerance. Consult one of our sales engineers
to establish the proper coating thickness and tolerance. The
practical coating range for MEDCOAT 2000™ is 0.00005" to
0.0006" (1.2µ to 15.38µ). Depending upon the
thickness specified and the part's quality requirements, the
following thickness tolerance can typically be maintained: ±.0001".
Coating thickness is measured and can be certified, using fluorescence
X-Ray technology. For thicker applications and special conditions,
please consult one of our sales engineers.
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MEDCOAT 2000™'s maximum operating temperature during processing
will not exceed 400°F. MEDCOAT 2000™ can withstand
approximately 1600° F (710° C). Oxidation begins at
approximately 1100° F (430° C). Diffusion occurs at
1650° F (740° C). Time-at-temperature
parameters should be reviewed with The Electrolizing Corporation
of Ohio technical staff prior to specifying or testing MEDCOAT
2000™.
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- Abrasion and Wear Resistance
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Taber Abrasion Wear Resistance testing was conducted
on MEDCOAT 2000™. Two types of stainless steel were used
in these tests: AMS 5511 (low C, 18% Cr, 8% Ni steel: Sheet;
AMS for SAE 30304) and AMS 5504 (.15% C, 12.5% Cr steel; Sheet;
AMS for SAE 51410). One of each material type was coated with
MEDCOAT 2000™ one was coated with conventional hard chrome,
the other was uncoated. Testing was performed in compliance with
Specification FED-STD-141, Method 6192.1. CS-10 Calibrase Wheels
were used. One thousand grams of pressure was used against the
test panels. The panels were cleaned with acetone prior to weighing.
Results of the testing show a great improvement in wear resistance
of the MEDCOAT 2000™ specimens versus the conventional
hard-chrome plated specimen and the uncoated specimen.
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Application of MEDCOAT 2000™ results in a smooth, fine-grained deposit that is uniform in thickness and appearance. The surface is free of blisters, pits, nodules and porosity. There is minimal edge buildup. It can be applied in a dull non-reflective finish, satin or bright finish.
Samples of our medical device coating show
no evidence of discoloration, cracking, flaking, rust or other
change following
repeated autoclave exposures. Two samples, placed in a heat-resistant
dish, were subjected to over 1000 autoclave cycles. Steam exposure
was conducted in production type gravity displacement steam
sterilization vessels at 250° F (121° C). After every
fifth cycle, visual and microscopic inspections were made for
discoloration and degradation of the samples. Tests were discontinued
because repeated autoclave exposures had no effect of the outer
surfaces of the samples.
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Ordering Information |
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When submitting parts for processing, clearly specify the basis
metal designation, required MEDCOAT 2000™ thickness and
tolerance, and accompanying part print that delineates coverage:
critical
surfaces to be covered by MEDCOAT 2000™, areas not to be
covered, and optional areas. To achieve optimum performance and
cost-effectiveness,
all coating requirements should be reviewed with the Electrolizing
Corporation of Ohio prior to processing.
For maximum protection against damage and corrosion, before and
after processing, all parts must be properly wrapped, preserved
and shipped in suitable containers. Parts need to be free of scale,
rust and corrosion prior to processing. The Electrolizing
Corporation of Ohio will remove oil, grease and other preservative
materials. We can provide custom packaging to customer specification,
so that the product is shipped ready for sterilization and use.
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