Huntleigh sonicaidONE Guide De L'utilisateur page 5

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The SonicaidOne has been designed and manufactured by Huntleigh Healthcare,
an international company with an enviable reputation for innovation and quality
of its products.
The SonicaidOne has been independently tested and successfully approved to
the following medical safety standards:
EN 60601-1/
IEC 60601-1
EN 60601-1-2/
IEC 60601-1-2
UL 2601-1
CAN/CSA-C22.2
No. 601.1
JIS T 0601-1
EN61157/IEC 1157
Caution: in the USA federal law restricts this device to sale by, or on the
order of, a physician
The SonicaidOne is CE marked in accordance with the
European Council Directive 93/42/EEC concerning
medical devices.
Huntleigh Healthcare has been certified by Lloyd's
Register Quality Assurance (LRQA) as an approved
medical devices manufacturer as meeting the require-
ments of BS EN ISO 9001, BS EN 46001 and the Medical
Devices Directive (93/42/EEC).
Medical Electrical Equipment Part 1:
General Requirements for Safety
Standard for electromagnetic compatibility
requirements for medical electrical equipment
American standard for safety for medical
electrical equipment
Canadian standard for safety for medical electrical
equipment
Japanese standard for safety for medical electrical
equipment
Requirements for the declaration of the acoustic
output of medical diagnostic ultrasonic equipment
SonicaidOne User Guide