PI-72-04 Datasheet, PDF (10/11 Pages) Cymbet Corporation – EnerChip Standards Compliance and Use Procedures

PI-72-04 EnerChip Standards Compliance
Bare die:
• CBC050 weighs approximately 16 mg.
15 mg of Silicon and Silicon Dioxide which is 93.75% of the mass
500 micrograms of Lithium Cobalt Oxide which is 3.1%
500 micrograms of LiPON which is 3.1%
The remainder is less than .1% of Aluminum, nickel, titanium and a polyimide
• CBC012 weighs approximately 5 mg.
4.7 mg of Silicon and Silicon Dioxide which is 93.75% of the mass
150 micrograms of Lithium Cobalt Oxide which is 3.1%
150 micrograms of LiPON which is 3.1%
The remainder is less than .1% of Aluminum, nickel, titanium and a polyimide
Packaged Enerchip:
• CBC050 weighs approximately 160 mg.
A majority of the mass is the molding compound. This is Sumitomo Bakelite EME-G770H.
The remainder is the bare die, gold wire. A lead frame made of nickel, palladium and gold with copper
plating and an epoxy coating which is Ablestik 84-1LMI. All materials are ROHS compliant.
• CBC012 weighs approximately 69 mg.
Contains the same materials as the CBC050.
• CBC3150 weighs approximately 220 mg
The only difference from the CBC050 is the CBC3150 contains an ASIC control chip. This is a the
CBC910 ASIC device. The remaining components are the same as in the CBC050.
• CBC3112 weighs approximately 130 mg and contains the same materials as the CBC3150.
Section XIV - In vitro Biocompatibility Test Standards for Cytotoxicity
There are many medical applications where EnerChip solid state batteries might be used in vitro or in vivo. The
biocompatibility of the EnerChip was evaluated using the following battery of in vitro test methods:
• Cytotoxicity: Medium Eluate Method (MEM) - 1x CMEM Cell Growth Medium Extract
• Cytotoxicity: Agar Diffusion - Solid Sample
Passing results in these procedures has a strong correlation to acceptable results in the remaining aspects
of biocompatibility as suggested by both the EN ISO 10993-1:2009 Biological Evaluation of Medical Devices
- Part 1: Evaluation and testing within a risk management process and the U.S. Food and Drug Administration
(FDA) Blue Book Memorandum No. G95-1 (1995) guidelines. The test conclusions for the EnerChip test article
were:
The gamma sterilized Cymbet CBC005-BDC-ES 5μA-hr EnerChipTM was found to be non-cytotoxic
(0% cell lysis) using both the Medium Eluate Method Eluation Test and Agar Diffusion Test feasibility
screening procedures. The lack of any adverse biological responses in these very sensitive in vitro
cell culture assays is indicative (although not a guarantee) of biocompatible test results in the other
in vitro and in vivo aspects of biocompatibility as suggested by the ISO 10993-1 and FDA G95-1
guidelines.
©2012 Cymbet Corporation • Tel: [phone] • www.cymbet.com
Doc PI-72-04 Rev A


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