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Connecting the Device into a Medical System
Incorporating the device into a medical system requires the integrator to identify, analyze, and
evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical system
after device integration could introduce new risks and will require additional analysis. Changes to the
medical system that must be evaluated include:
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Changing the system configuration
•
Adding devices to or disconnecting devices from the system
•
Updating or upgrading equipment connected to the system
Issues resulting from user-initiated system changes may include corruption or loss of data.
NOTES:
•
Use of a multiple-socket outlet with multiple devices results in a Medical Electrical System.
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When using the USB port to connect the device to other equipment, follow each device's
cleaning instructions.
•
Verify all equipment connected to the device is suitable for the patient's environment.
CAUTION: Failure of a network data coupling (USB cable/connectors) will result in
!
loss of data transfer.
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Data Output and Software
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