Patient Population And Target Group; Residual Risks And Side Effects; General And Network Security Measures; General Security Policies - natus Dantec Keypoint G4 User's And Service Manual

Patient Population and Target Group

The Keypoint G4 assists the physician in the diagnosis of patients with neuromuscular diseases for pediatric and adult patients.

Residual Risks and Side Effects

There are no known residual risks or side effects for procedures performed with the Keypoint G4. Please note the Warnings and Cautions
before applying power to and using the system. Security Measures
Utilize best practice security measures in your clinical environment including the following:

General and Network Security Measures

General Security Policies

Prevent physical access to the system from unauthorized persons.
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Make frequent backup of the system. Store the backup on a safely stored device.
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Protect the system with updated antivirus.
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Use the Microsoft Windows firewall at all times.
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Store all DCDs and flash drives provided with your system in a safe location.
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Networked Environments

• 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.
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.

Windows Systems Secure Access

• Users should require an account with suitable privileges to use the system (note no special elevated rights are required to use the
EMG application).
• Policies should ensure passwords are complex, non-repeated and regularly changed.
• Enable auditing of system use including windows logins in the operating system.

Data Confidentiality

• The user should lock the system manually if they leave it unattended.
• Short inactivity timeouts are always active and lock the system when the timeout expires.
• 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

Do not install any 3rd party software which is not intended for use with the application. An unknown software can possess a
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potential security risk.
• Encrypt system drives which contain local databases and temporarily store data files/reports.
• Disable unnecessary windows services designed for not work-related features.

Protective and Equipment Classification

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.

Accuracy of Controls

Stimulator values are determined by the operator based on the electrophysiological responses and the subjective reaction of the patient to the
stimulus, therefore an accuracy of ±30% pro vides acceptable levels for safe use of this equipment in the intended applications.
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