bk ultrasound Flex Focus 1202, User Manual

Page: 13 / 66

Flex Focus 1202 User Guide (BB1756-Q) Safety Information 13
CE Marks on Electrical Devices
The European Union has introduced directives requiring
b
marks on devices.
Non-medical devices marked with
b
comply with relevant directives, for example
EEC Directive 2004/108/EC concerning Electromagnetic Compatibility.
BK Ultrasound devices marked with
b
or
c
comply with EEC Council Directive
93/42/EEC of 14 June 1993 concerning Medical Devices.
b
applies to Class I medical
devices.
c
applies to Classes Im, IIa, IIb and III. BK Ultrasound defines classes
assuming imaging duration for individual patients does not exceed 60 minutes.
General Safety Precautions
The ultrasound system is designed and tested in accordance with EN/IEC 60601-1
[2]
(Part 1: General requirements for safety) and EN 60601–2–37 [3] (Particular
requirements for the safety of ultrasonic medical diagnostic and monitoring
equipment)
. The ultrasound system and the optional battery charger station
(UA1247) comply with requirements for Class 1 (protective earth) and – for systems
that include the mobile battery keyboard dock – internally powered devices of
EN/IEC 60601-1. They also comply with UL 60601-1 [4]
and CSA C22.2 No.
601.1–M90 [5]. They fulfill the requirements for dust protection (IP20) for ordinary
equipment specified in EN 60529 [1].
Internally Powered (On the battery pack.) The text “Internally powered or
100V~, 60Hz / 100V-230V~, 50 Hz” indicates that the
system can also use batteries as a power source.
Symbol Name Description
Table 2-1. Symbols and information on the equipment. (continued)
Physicians
only
Caution Rx-c1
United States law restricts this device to sale to, or on the order of, a physician.
Proper
Training
WARNING GS-w1
To ensure safe and proper use of the equipment, before you attempt to use BK equipment,
you should be trained in ultrasonography or be under the supervision of someone who is
trained in ultrasonography. You should also be thoroughly familiar with the safe operation
of your ultrasound system: read all the user documentation that accompanies it.
In addition, if your system interacts with other equipment directly or indirectly, you need
to make sure the interactions are both safe and secure.
No further training is required, but BK Ultrasound offers training in how to use the system.
Consult your BK representative for information.