Vorschriften - GE Medical Systems Vivid 3 Pro Benutzerhandbuch

Vorschriften

Die Vivid 3-Systeme erfüllen die Anforderungen der europäischen Richtlinie 93/42/EEC für medizinische Geräte.
Die Überprüfung der Konformität wurde von KEMA entsprechend Anhang II durchgeführt.
Alle Änderungen an Zubehörteilen, Peripheriegeräten oder Teilen des Systems bedürfen der Genehmigung durch den Hersteller, GE Medical Systems.
Das Ignorieren dieses Hinweises kann zum Verlust der für das Produkt erwirkten behördlichen Zulassung führen.
Die Anforderungen der geltenden lokalen Gesetzgebung/Gesetze/Verordnungen sind vom Benutzer/Installateur einzuhalten. [Beispiel: Das deutsche
Medizinproduktegesetz und die deutsche Medizinprodukte-Betreiberverordnung.]
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GE ULTRASOUND ISRAEL PRODUCTS:
GE ULTRASOUND ISRAEL products 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 part of the system must be
approved by the manufacturer, GE Ultrasound Israel. Ignoring this advice may
compromise the regulatory approvals obtained for the product.
Please consult your local GE ULTRASOUND ISRAEL representative for further details.
GE ULTRASOUND EUROPE, Regulatory Affairs Dept. Beethoven Str. 239,Solingen
Germany, tel +49-(0)212-2802-243, has been empowered to enter into commitments
on our behalf in any matter concerning the provisions of the 93/42/EEC directive.
Standards used:
To fulfill the requirements of relevant EC directives and/or European Harmonized/
International standards the following documents/standards have been used:
MEDICAL ELECTRICAL EQUIPMENT
CLASSIFIED BY UNDERWRITERS LABORATORIES INC.
WITH RESPECT TO ELECTRIC SHOCK, FIRE , MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH UL 2601-1 AND
CAN/CSA C22.2 NO. 601
E178816
Standard/Directive Scope
89/336/EEC EMC Directive
93/42/EEC Medical Device Directive
IEC 801-2 Electrostatic Discharge
IEC 801-3 Radiated Electromagnetic Field
IEC 801-4 Electrical Fast Transient/Burst
IEC 805-1 Surge
EN 55011/CISPR 11 Electromagnetic Susceptibility
EN 60601-1/IEC 601-1/UL 2601-1 Medical Electrical Equipment; General
Requirements for Safety
EN 61157/ IEC 61157 Requirements for the declaration of the acoustic
output of medical diagnostic ultrasonic equipment
IEC 60601-2-27 Medical electrical equipment - Part 2: Particular
requirements for the safety of electrocardiographic
monitoring equipment.
IEC 60601-1-4 Medical electrical equipment: Part 1-4: General
requirements for collateral standard: Programmable
electrical medical systems
ISO 10993-1 Biological evaluation of medical devices
ISO 13485 Quality management standards for medical devices
GE Medical System: Telex 3797371
P. O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
(Asia, Pacific, Latin America, North America)
GE Ultraschall TEL: 0130 81 6370 toll free
Deutschland GmbH & Co. KG TEL: (49)(0) 212.28.02.208
Beethovenstraße 239, Postfach 11 05 60, D-42655 Solingen
GERMANY
GE Medical Systems