General and Safety Information 21
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 Council Directive 89/336/EEC of 3 May 1989 concerning Electromagnetic
Compatibility.
B-K Medical 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. B-K Medical defines
classes assuming scanning duration for individual patients does not exceed 60
minutes.
General Safety Precautions
The ultrasound scanner is designed and tested in accordance with EN/IEC 60601-1
[2] and EN 60601–2–37 [3]. It complies with requirements for Class 1 (protective
earth) devices of EN/IEC 60601-1 [2]. It also complies with UL 2601-1 [4] and CSA
C22.2 No. 601.1–M90 [5]. It fulfills the requirements for dust protection (IP20) for
ordinary equipment specified in EN 60529 [1].
Equipment
failure
Isolating the
scanner
Condensation
Caution: Large variations in temperature or humidity may cause water to condense
inside the scanner. If this happens, the scanner may fail to operate properly. Always let
the scanner come to room temperature before you plug it in.
•
Wait at least 2 hours after the scanner has been subjected to major changes in
temperature or humidity.
•
If there is visible evidence of condensation, wait at least 8 hours.
Before you use the scanner, make sure that all the safety requirements described in
this chapter have been satisfied.
WARNING Federal law in North America restricts this device to sale to, or on the order
of, a physician.
WARNING If at any time the scanner malfunctions, or the image is severely distorted
or degraded, or you suspect in any way that the scanner is not functioning correctly:
•
Remove all transducers from contact with the patient.
•
Turn off the scanner. Unplug the scanner from the wall and make sure it cannot be
used until it has been checked.
•
Do not remove the scanner cover.
•
Contact your B-K Medical representative or hospital technician.
WARNING The power supply cord connects the scanner to the line voltage. To isolate
the scanner, you must unplug the power supply cord from the wall outlet. Do this before
you try to make any repairs to the system.
Содержание Pro Focus 2202
Страница 1: ...English BB1279 A June 2005 Pro Focus 2202 Extended User Guide ...
Страница 14: ...14 ...
Страница 15: ...Part 1 Basics ...
Страница 16: ......
Страница 32: ...32 Chapter 1 ...
Страница 48: ...48 Chapter 2 ...
Страница 49: ...Part 2 Working with the Image ...
Страница 50: ......
Страница 98: ...98 Chapter 5 ...
Страница 117: ...Part 3 Imaging Modes ...
Страница 118: ......
Страница 136: ...136 Chapter 8 ...
Страница 152: ...152 Chapter 10 ...
Страница 164: ...164 Chapter 12 ...
Страница 165: ...Part 4 Setting up and Maintaining Your System ...
Страница 166: ......
Страница 200: ...200 Chapter 13 ...
Страница 208: ...208 Chapter 14 ...
Страница 209: ...Part 5 Pro Packages ...
Страница 210: ......
Страница 288: ...288 Chapter 19 ...
Страница 313: ...Part 6 Appendixes ...
Страница 314: ......
Страница 344: ...344 Appendix C ...