
Q9 Digital Color Doppler Ultrasound System
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electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections require
verification of compatibility and conformity to IEC/EN 60601-1-1 by the installer. Equipment modifications
,
possible resulting malfunctions and electromagnetic interference are the responsibilities of the owner.
General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking.
There must be adequate mechanical mounting of the device and stability of the combination.
Risk and leakage current of the combination must comply with IEC/EN 60601-1.
Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2.
Peripheral used in the non-patient environment
The system has been verified for compatibility, and compliance for connection to a local area network (LAN) via a wire
LAN. The provided LAN components are IEC/EN 60950 compliant.
General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking.
The added device(s) must be used for their intended purpose having a compatible interface.
CAUTION:
Make sure using ONLY the dedicated USB disk or removable media to save or back up data. Before
connecting to the ultrasound system, make sure using the latest antivirus software on the USB disk or removable
media to clean any virus. It is user’s responsibility to ensure the USB disk or removable media is virus-free.
Improper use of USB disk or removable media may cause the virus infections of system and eventually malfunction
may occur. Such malfunction may impact the stability, effectiveness and safety of the system and probes, and users
should immediately stop using the system and probes until CHISON authorized engineer has checked the system
and confirm the effectiveness and safety of the system and probes.
CAUTION:
Use only secure Local Area Network connection. Don’t connect the ultrasound system to Internet.
Make sure your hospital’s firewall software is configured correctly, thus blocking incoming connection requests
from Internet. Improper use of network connection may cause the virus infections of system and eventually
malfunction may occur.
2.5
Biological Safety
This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be used
both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As Reasonably
Achievable) to produce diagnostically acceptable images. The AIUM offers the following guidelines:
Clinical Safety Quoted from AIUM
Содержание Q9
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