
General Information bk3000 – bk3500 – bk5000
1-2 SM34584-10
1.1 Safety Aspects
The System complies with:
•EN/IEC 60601-1 (2006)
•EN 60601–2–37 (2007)
•ANSI/AAMI ES60601-1 (2005)
•CAN/CSA C22.2 No.601.1 (2008)
It fulfils the requirements for dust protection (IP20) for ordinary equipment specified in EN 60529.
The System is classified as follows:
Electrical safety class (IEC/EN 60601-1):
Transducer Input Module: Type B (Body)
ECG Input Module: Type BF (Body Floating)
1.1.1 Terms and Symbols
Throughout this manual the following terms are used to indicate a situation that requires
safety precautions:
Describes precautions necessary to prevent (patient or user) injury or loss of life.
Describes precautions necessary to protect the scanner and other associated
equipment from harm.
Symbol
Name Description
ATTENTION
Consult accompanying User Guide when this sign is encountered on the
instrument, to avoid reducing its safety
Potential
Equalisation
Terminal connected to the chassis. Should be connected to corresponding
terminals on other equipment to eliminate potential differences.
Protective
Earth
Additional protective ground (earth).
Type CF
CF: Isolated from earth. Maximum Patient Leakage Current under:
•Normal Conditions: ≤10µA
•Single Fault Conditions: ≤50µA.
Type BF
BF: Isolated from ground.
Maximum Patient Leakage Current under:
•Normal Conditions: ≤100µA
•Single Fault Conditions: ≤500µA.
Type BF
BF: Defibrillator proof.
Type B
B: Maximum Patient Leakage Current under:
•Normal Conditions: ≤100µA
•Single Fault Conditions: ≤500µA.
IP20
SEALING
Dust and immersion protected according to IEC Publication 529.
Stand-by
Push button to switch scanner from stand-by to active. (The power supply cord
is the means of separation from the main power supply.)
Off
Main power supply off.
On
Main power supply on.
Non-ionizing
radiation
Ultrasound scanner emits acoustic radiation.
STERILE
Device is in sterile condition.