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Networked Environments
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Connect the system on secured networks only. Using the system on a wide-open network, including wi-fi, Bluetooth,
etc. based networks is not recommended.
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Keep the network software updated with latest patches.
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Use encrypted data communication over “less safe” network segments (ipsec, VPN).
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Enforce that all resources within the network (shares, printers, other equipment) can be accessed by authenticated
users only.
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All resources within the network can only be accessed by authenticated users.
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Avoid acquisition systems having contact with patient to act as network servers for different functionality.
Secure Access to Windows Systems
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Users should require an account with suitable privileges to use the system (note no special elevated rights are
required to use the EMG application).
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Policies should ensure passwords are complex, non-repeated and regularly changed.
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Enable auditing of system use including windows logins in the operating system.
Data Confidentiality
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The user should lock the system manually if they leave it unattended.
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Short inactivity timeouts are always active and lock the system when the timeout expires.
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The EMG application supports the use of windows screen saver, manual lock screen and automatic switch to the
home page after a timeout on review stations to prevent showing confidential information on unattended systems.
Data Protection
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Do not install any 3rd party software which is not intended for use with the application. An unknown software can
possess a potential security risk.
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Encrypt system drives which contain local databases and temporarily store data files/reports.
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Disable unnecessary windows services designed for not work-related features.
Protective and Equipment Classifications
This system is intended for continuous operation and has an IEC 60601-1 protective classification of Class I, Type BF
applied parts, ordinary equipment, not suitable for use in the presence of flammable anesthetics.
Ancillary Accessories
To facilitate the acquisition of electrophysiological information using this system, there are ancillary accessories that must
be used. These accessories include surface electrodes and needle electrodes that are not included with the system. To
ensure proper use of the system; descriptions, recommendations and or specifications are provided for these ancillary
accessories that are deemed compatible with the UltraPro S100 system.
It is recommended that the surface electrodes selected are those that have been cleared or approved for nerve conduction
and or evoked potential studies. Either disposable or reusable surface electrodes may be used. The size of the electrode
should be appropriately selected for the test being conducted. Reusable surface electrodes are made of metal and are
typically fabricated from platinum, gold or silver. Metallic reusable electrodes must be cleaned and or conditioned for reuse
according to instructions provided by the manufacturer of those electrodes. All surface electrodes used should have a
protective pin connector that complies with DIN 42 802 standard. This nonproprietary pin connector is an industry standard
for EMG systems.
Disposable and reusable needle electrodes may be used. Needle electrodes are fabricated from a variety of materials. It is
