Safety
348 Vivid i User’s Manual
2378958-100 Rev. 02
Regulatory information
The GE Vingmed Ultrasound product families are tested to
meet all applicable requirements in relevant EU Directives and
European/International standards. (See “Standards used”
below.) Any changes to accessories, peripheral units or any
other part of the system must be approved by the
manufacturer: GE Vingmed Ultrasound. Ignoring this advice
may compromise the regulatory approvals obtained for the
product.
Please consult your local GE Vingmed Ultrasound
representative for further details.
Standards used
The Vivid i ultrasound unit is a Class I device, type BF,
according to Sub-clause 14 of IEC 60601-1 (1988). To fulfill the
requirements of relevant EC directives and/or European
Harmonized/International standards, the following
documents/standards have been used:
Standard/Directive Scope
93/42/EEC Medical Devices Directive (MDD)
EN 55011/CISPR 11/ 3.1991 Emitted noise according to Class B requirements +
Electromagnetic Susceptibility
IEC 60601-1 (1988)
EN 60601-1 (1990)
UL 2601-1/ 8 (1994)
Medical Electrical Equipment, Part 1; General
Requirements for Safety
“CLASSIFIED BY UNDERWRITERS LABORATARIES
INC WITH RESPECT TO ELECTRICAL SHOCK, FIRE
AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL2601-1 AND CAN/CSA C22.2
NO.601.1”
IEC 1157/ EN 61157/ (1994) Requirements for the declaration of the acoustic output
of medical diagnostic ultrasonic equipment.
EN 60601-1-2 (2001) Medical Electrical Equipment - part 2. Collateral
standard: Electromagnetic compatibility - Requirements
and tests.
EN 60601-1-2-37 (2001) Medical Electrical Equipment - part 2: "Particular
requirements for the safety of ultrasound medical
diagnostics and monitoring equipment", (2001).
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