Important Safeguards And Notices; Serious Adverse Events - IC Medical CRYSTAL VISION 450D Operating And Installation Manual

IMPORTANT SAFEGUARDS AND NOTICES

The following pages provide important guidelines for operators and service personnel. Specific warnings and cautions
appear throughout the manual where they apply. Please read and follow this important information, especially those
instructions related to risk of electric shock or injury to patient or staff members.
Any instructions in this manual that require opening the equipment cover or enclosure are for use by I.C.
Medical, Inc. qualified service personnel only. To reduce the risk of electric shock, do not perform any other
service than that contained in the operating instructions unless you are determined by I.C. Medical, Inc. to
be qualified to do so.
Symbol Description:
"ON" (power)
"OFF" (power)
Caution
The device is Class 1,
Type BF applied part
Fuse
Earth (ground)

SERIOUS ADVERSE EVENTS

Any serious adverse event or incident that occurs in relation to the device or accessory should be reported
to the manufacturer, I.C. Medical, Inc., at
European customers should also report to the Authorized Representative at the address listed on the label
or IFU and to the competent authority in the member state.
complaints@icmedical.com
iv
and to the FDA. In addition,