GAMMASAFE™ PORTABLE MEMORY--Supports Gamma & E-Beam Sterilization
 For years, medical OEMs have used Datakey Electronics' rugged portable memory with their disposable attachments. Our SlimLine™ memory tokens have been proven to survive both EtO and autoclave sterilization procedures. Gamma and electronic beam (e-beam) sterilization however, has long posed a challenge for electronics, as high-energy radiation damages traditional electronics, such as solid state memory devices and the data they hold. This meant that traditional portable memory products could not be used in medical devices that used gamma or e-beam sterilization...
...Until Now!
Datakey Electronics' GammaSafe™ portable memory token has been tested and proven to survive medical device sterilization doses of both gamma and e-beam radiation, up to 45 kGy, with no data loss. The SGT4Kb GammaSafe™ memory token contains 4Kbits of non-volatile, reprogrammable memory. The memory is accessed using a standard SPI bus and is functionally similar to an SPI EEPROM.
Features:
SGT4Kb GammaSafe™ Memory Token Features: |
Memory |
4Kbits (4096 bits) 512 x 8 |
Voltage |
2.7V to 3.6V |
Serial Interface |
SPI |
Gamma/E-Beam Radiation |
Up to 45kGy (4.5Mrad) Cumulative |
Panel-Mount Receptacles |
GR4310 and GR4410 Receptacles |
PCB-Mount Receptacles |
GR4220PCB and GR4220SMT |
Reader/Writer |
GammaLink™ III Reader/Writer |
Sterilization Indicator
(Optional) |
Located in window opposite side from contacts. 10kGy turns indicator red. |
Integrated Tether
(Optional) |
5-inch (12.7cm) pre-looped cable-tie |
Optional Features:
Sterilization Indicator
  Mechanically, the GammaSafe™ token is similar to the popular SlimLine™ token form-factor, except that it only has contacts on one side of the token. On the side opposite of the token contacts is a recessed window that is used for an optional sterilization indicator. This optional feature indicates whether the token (and the medical device it is used with) has been exposed to gamma or e-beam radiation. Unexposed, or at low doses (significantly under 10kGy), the indicator is a yellow/orange color (see token on the left). After being exposed to a 10kGy (or greater) dosage of radiation, the indicator changes to a vivid red color (see token on the right). This optional feature enables medical personnel to confirm at-a-glance that the sealed medical device they are about to open up has indeed been sterilized.
Integrated Tether
 The GammaSafe™ memory token is an ideal solution for disposable medical devices that attach to a base unit that is controlled by a microprocessor/microcontroller. Often times, these disposable attachments (e.g. catheters, tubing, etc.) won't have any active electronics, especially if gamma or e-beam sterilization is being used. Adding a portable memory device allows OEMs to incorporate anti-counterfeit and usage tracking features to the disposable. How can OEMs attach a GammaSafe™ memory token to their disposable attachment? There are three common solutions:
- Some OEMs choose not to attach the memory token to the disposable at all. Instead, they simply include it with the disposable in the sealed packaging.
-
 Some OEMs choose to tether the token to their disposable using their own tether design (see example right). Both GammaSafe™ and SlimLine™ tokens have a hole in the head of the token that can be used for attaching the token to a device.
- Some OEMs choose to take advantage of Datakey Electronics' optional integrated tether. The optional tether consists of a 5-inch (12.7 cm) cable-tie that has been "pre-looped" and integrated into the head of the token (see picture above-left). This allows OEMs an easy way to attach the memory token to their disposable medical device right out of the box.
GammaSafe™ Receptacles:
 Because GammaSafe™ memory tokens only have contacts on one side, they cannot be used with Datakey Electronics standard SlimLine™ receptacles (SR4000 series receptacles). Instead, they have their own line of mating receptacles, which integrate all of the field-proven aspects of the SlimLine™ receptacles. The GammaSafe™ receptacles (the GR4000 series) are designed to be used with GammaSafe™ tokens, but they also accept SlimLine™ tokens. This allows OEMs to use low-capacity GammaSafe™ memory tokens for applications like product authentication and limit-use, while also accepting larger-capacity SlimLine™ tokens for applications like firmware updates or the transfer of logged data—all through the same receptacle! Since the SlimLine™ tokens have contacts on both sides, they can be inserted into the GammaSafe™ receptacles in either orientation (face-up or face-down). The GammaSafe™ memory tokens employ a keying feature that ensures that they are inserted into the GammaSafe™ receptacles in the proper orientation (contacts-down, window-up).
There are three lines of GammaSafe™ receptacles—two are panel-mount and one is a board-mount design.
GR4220
 The GR4220 receptacles are board-mount receptacles. They are available in both through-hole (GR4220PCB) and surface-mount (GR4220SMT) versions. These right-angle, edge-mount receptacles are designed to minimize the amount of PCB real estate used, while still providing excellent retention of the memory token. The GR4220PCB has a PCB footprint that is 37.5% smaller than that of an SD card receptacle, and utilizes two retention nubs to help keep the token firmly in place. These retention features also give users tactile feedback when the memory token is fully seated.
GR4310
 The GR4310 receptacles are panel-mount receptacles that provide enhanced water protection. The GR4310 is available in three versions:
- a splash-proof (IP65-rated) version, the GR4310SP;
- an immersion-rated (IP67) version, the GR4310IM; and,
- an immersion-rated (IP67) version with a conductive outer shell that reduces electromagnetic emissions, the GR4310EI.
All GR4310 receptacles come standard with a 10-pin header on the back of the receptacle for connecting to the OEM's PCB using a common ribbon cable. Other connectors are available by request.
GR4410
 The GR4410 receptacles are similar in design to the GR4310 receptacles, but are designed to mount from behind the panel, whereas the GR4310 mounts on the outside of the panel. The GR4410 is available in the same three versions:
- GR4410SP (IP65-rated),
- GR4410IM (IP67-rated), and
- GR4410EI (IP67-rated with EMI reduction).
Reader/Writers and Development Kits:
It is often necessary/desirable to communicate with a memory token using a personal computer. The GammaLink™ III reader/writer connects to a PC's USB port and includes a sample application that provides a simple interface for reading data off a GammaSafe™ token or writing data to it. A GammaSafe™ development kit is also available. It includes GammaSafe™ token and receptacle samples and a GammaLink™ III reader/writer. The kit includes the sample application and its source code, along with documentation explaining each of the functions included in the DLL.
Call 1-800-328-8828 (1-952-746-4066) or email us for more information.
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