U60 Diagnostic Ultrasound System User Manual Safety Guidance
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WARNING
42. If a sterile probe cover becomes compromised during an intraoperative application
involving a patient with transmissible spongiform encephalopathy, such as
Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Disease Control Center
and this document from the World Health Organization: WHO/CDS/APH/2000/3,
WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies.
The probes for your system cannot be decontaminated using a heat process.
43. When the device works with the mobile trolley, DO NOT place the device on slopes.
It may suddenly slide, resulting in injury and/or equipment damage.
44. To ensure safety, two people are required to move the device across slopes when
the device works with the mobile trolley.
45. All repairs on products must be performed or approved by EDAN. Unauthorized
repairs will void the warranty. In addition, whether or not covered under warranty, any
product repair shall be exclusively be performed by EDAN certified service
personnel.
46. To ensure optimal imaging, begin the scan session by selecting the correct probe
and application for each examination.
47. The medical electrical equipment needs to be installed and put into service according
to Appendix IV EMC Information.
48. Portable and mobile RF communications equipment can affect medical electrical
equipment. Refer to the recommended separation distances provided in Appendix IV
EMC Information.
49. The use of cables, transducers and accessories not supplied by the manufacturer
may result in increased emissions or decreased immunity of the equipment.
50. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix IV EMC Information.
51. The system and its accessories shall not be serviced or maintained while in use with
a patient.
52. The mains plug is used to isolate the system from the main power. Position the
system so that it is easy to disconnect the device.
53. Assembly of the system and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
54. This system can not be used together with high-frequency surgical equipment.
55. DO NOT perform any unauthorized modification of the equipment.
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