In December of 1993, the U.S. Food and Drug Administration issued a product safety
alert concerning lead wires with 2mm (unprotected) pin connectors. During the early part
of 1994, Nicolet Biomedical made a decision to change each of our neurodiagnostic systems
so that they would accept a new, protected, electrode connection. The design specification
chosen by Nicolet is called the DIN 42 802 design. This design is also being used by many
other neurodiagnostic instrument manufacturers - though the terms used to describe the
design connection vary. Currently, all new systems manufactured by Nicolet Biomedical
accept protected electrodes.
In addition, Nicolet has available DIN 42 802 style electrodes. A complete listing of
these new electrodes is available in our 1995 Supplies Catalog. The catalog also offers
options for changing your existing Nicolet system to accept the DIN 42 802 style
electrodes. Finally, if your facility continues to use the 2mm style electrodes, Nicolet
does offer labels for those items as recommended by the FDA.
Although we recognize this conversion may be difficult for your organization, Nicolet
Biomedical has and will continue to strive to make the transition as smooth as possible.
Should you have any questions regarding this issue, please contact your Nicolet
representative or our customer Service department.
Thank you for your continued support of Nicolet Biomedical, Inc.
Disposable hypodermic EMG needle electrodes for Botulinum Toxin Type A drug therapy are
available in the following sizes:
| Sizes |
2mm pin style |
DIN 42 802 style |
| 25mm, 27 gauge |
019-407200 |
019-407500 |
| 37mm, 26 gauge |
019-407300 |
019-407600 |
| 50mm, 25 gauge |
019-407400 |
019-407700 |
|
