Points To Note; Disposal - GE Healthcare B30 User's Reference Manual

discharge one's body to earth or to the frame of the equipment or bond oneself by
means of a wrist strap to the equipment or the earth prior to making a connection.

Points to note

•
Medical electrical equipment needs special precautions regarding electromagnetic
compatibility, EMC, and needs to be installed and put into service according to the EMC
information provided in the "Technical Reference Manual" by qualified personnel.
•
Portable and mobile RF communications equipment can affect the medical electrical
equipment.
•
The equipment is suitable for use in the presence of electrosurgery. Please notice the
possible limitations in the parameter sections and in
•
Service and repairs are allowed for authorized service personnel only.

Disposal

•
Dispose of the whole device, parts of it, its packing material and manuals in accordance
with local environmental and waste disposal regulations.
Product Compliance
The B30 Patient Monitor is classified in the following categories for compliance:
•
This equipment is suitable for connection to public mains as defined in CISPR 11.
•
This Monitor conforms to general safety standard for medical devices to IEC 60601-1.
•
This Monitor conforms to EMC safety standard to IEC 60601-1-2.
•
This Monitor conforms to usability safety standard for medical devices to IEC 60601-1-6.
•
Software is developed in accordance with IEC 60601-1-4.
•
The application of risk management analysis to medical device conforms to ISO 14971.
•
The SpO2 Parameter conforms to ISO 9919.
•
The TEMP parameter conforms to EN 12470-4.
•
The CO2 parameter conforms to ISO 21647.
•
This Monitor conforms to particular safety standard for multifunction patient monitoring
equipment to IEC 60601-2-49 with the exception of Sub- clause 51.103; 51.103.1 and
51.102.4.
NOTE:
−
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WARNING The latching alarms function is convenient for the user to analyze and track
the old state of the patient. This is a advanced function, which protected by
the password in the monitor. This function should be operated by a
qualified medical personnel only. The latched technical alarms do not affect
safety and effectiveness of monitor.
This Monitor conforms to particular safety standard for multifunction patient
monitoring equipment to IEC 60601-2-49 with the exception of Sub- clause 51.103:
Both non-latched and latched alarms are selectable for technical alarms.
If the Latching Alarms selection is active, both technical alarm and physiological
alarm messages stay on the screen even if the initial alarm condition goes away.
Safety precautions
"Performance" on page 2-30.
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