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Fukuda VaSera VS-2000 Series - General Safety and Design Specifications; Compliance with Medical Electrical Standards; Preventive Maintenance Requirements

Fukuda VaSera VS-2000 Series
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3
Safety
Design Specifications
This device complies with ANSI/AAMI ES 60601-1: "Medical Electrical Equipment - Part1: General Requirements for
Basic Safety and Essential Performance" and is classified as follows:
1. Protection against electrical shock
Class I, Internally Powered Device.
2. Degree of protection against electrical shock
Type CF applied part.
3. Degree of protection against ingress of water
No special protection against ingress of water. (IPX0)
4. Degree of safety when using in air, flammable anesthetic gas, or in areas where oxygen, nitrous oxide
or flammable anesthetic gas are used
To be used in environments without flammable anesthetic gas or other flammable substances.
5. Operation Mode
Can be used continuously.
Preventive Maintenance
Preventive maintenance should be performed to ensure that the device can be used safely at all times and prevent various
problems from occurring in future.
This maintenance needs to be performed at least once every 12 months.
Inspect the mainframe and all connectors and cables for any external damage.
If any of the following events occurs, perform maintenance immediately.
The device receives a strong impact due to dropping, etc.
Liquid is spilled on or into the device
The device does not function normally
The enclosure of the device is cracked, broken or damaged
Cables such as the power cable and lead wires have deteriorated in performance
Check all cables, devices and accessories for damage, leakage current and accuracy.

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