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8000-INS-UMENG Rev. 4
0120
4
Warnings and Cautions
4.1 Meaning of Signal Words
In this manual, the signal words “Warning” and “Caution” are used to highlight
important safety and usage instructions. All users of the DGH 8000 must understand the
meanings of these signal words.
Signal Word
Meaning
! WARNING
Indicates a potentially hazardous situation which if not avoided
could cause injury or harm to the equipment or erroneous
results.
! CAUTION
Indicates a potentially hazardous situation which if not avoided
may result in minor injury or harm to the equipment.
4.2 Description of Symbols
This symbol indicates the degree of protection against electric shock. The
DGH 8000 Scanmate-B
is classified as type BF equipment.
This symbol instructs the operator to read the operating manual.
This mark indicates that Notified Body 0120 (SGS United Kingdom Ltd) has
certified the management system of DGH Technology, Inc. meets the
requirements applicable requirements of 21 CFR 1010 (Performance
Standards for Electronic Products: General) and 21 CFR 1050 (Performance
Standards for Sonic, Infrasonic, and Ultrasonic Radiation-Emitting
Products). The device also conforms to the following International
Standards:
▪
EN 60601-1: Medical electrical equipment – Part 1: General
requirements for safety – IEC 60601-1
▪
EN 60601-1-2: Medical electrical equipment – Part 1: General
requirements for safety. Collateral standard: Electromagnetic
compatibility requirements and tests. IEC 60601-1-2
▪
NEMA Standard Publication UD-2: Acoustic Output Measurement
Standard for Diagnostic Ultrasound Equipment
▪
NEMA Standard Publication UD-3: Standard for Real-Time Display
of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment
