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CHAPTER 6 REFERENCES
Compliance Statement
ASUSproducts comply with international and national standards and laws. Users are
responsible for ensuring that the chosen smart device and scanner are compliant with the
law in the jurisdiction where the product is used. ASUSmeets all regulatory standards
listed in this chapter.
Authorized Representative
European Authorized Representative (AR)
Name: MedNet GmbH
Address: Borkstrasse 10 • 48163 Muenster • Germany
Phone +49 25132266-61 • Fax +49 251 32266-22
Product Classification
•
The device with transducers: Class IIa/internally powered ME equipment.
•
Transducers: Type BF applied parts, IPX1
•
Ordinary Equipment/Continuous Operation
•
Non-AP/APG
Electromechanical Safety Standards Met
The transducers and software comply with the requirements of IEC 60601-1 Medical
Electrical Equipment, General Requirements for Safety, including all applicable collateral and
particular standards, as well as all applicable deviations. System users are responsible for
ensuring that the chosen device is compliant with the law in the jurisdiction in which the
product is used.
Product Serial Number
ASUShas assigned a unique serial number on each ultrasound device. This serial number,
displayed in the format X –YY –M-XXXXXX, is used to track quality control.
X
ASUSserial product model name.
X
Model
Name
YY
2-digit year of manufacture.
M
A
B
LU700C
LU700L
P58
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