Valleylab EC Certificates and Declarations of Conformity

For Worldwide Released Product

Valleylab markets advanced electrosurgical, ultrasonic surgical, and radiofrequency ablation and lesioning systems worldwide. Doing business on a worldwide basis requires medical device manufacturers to conform to international quality system standards. The International Organization for Standardization (ISO) 9000 series Quality System standards have evolved to include derivatives, which have been customized to different types of industries. ISO 13485:2003 is the derivative stand alone Quality Management Standard, which is applicable to the medical device industry throughout the world. Valleylab has been registered to ISO 13485 since April 2000 and received an upgraded registration to ISO 13485:2003 in December 2004. This certificate, FM 71825, which also meets the Canadian Medical Devices Conformity Assessment System (CMDCAS) requirements was issued by the British Standards Institution.

As of 14 June 1998, all medical devices sold within the member states of the European Union are required to bear the CE mark. Affixing the CE mark to higher risk devices requires an audit of the company’s quality system by a Notified Body. This is to ensure the company meets the requirements of the European communities’ Medical Device Directive (93/42/EEC) and EN/ISO 13485. BSI issued EC certificates CE 00500 and CE 01948 to Valleylab.

In addition to affixing the CE mark to product, each manufacturer must also issue a Declaration of Conformity, which attests that the product meets all of the applicable requirements. Valleylab has issued Declarations of Conformity for the following product families (Click on the product family to view the applicable Declaration of Conformity):

• Valleylab Accessories (Declaration Number 101A)
• Argon (GSU) Handsets and Electrodes (Declaration Number 102A)
• Valleylab Cables and Cords (Declaration Number 103A)
• Active Electrodes (Declaration Number 106A)
• Electrosurgical Generators (Declaration Number 107A)
• Electrosurgical Pencils (Declaration Number 109A)
• Suction Coagulators (Declaration Number 110A)
• Force Argon (GSU) (Declaration Number 111A)
• Electrosurgical Forceps (Declaration Number 112A)
• Laparoscopic Handpieces and Electrodes (Declaration Number 113A)
• Return Electrodes (Declaration Number 114A)
• Smoke Evacuation Devices (Declaration Number 115A)
• Electrosurgical Vessel Sealing Devices (Declaration Number 116A)
• Footswitches and Cords (Declaration Number 117A)
• RF Ablation System (Declaration Number 119A)
• Pain Management Accessories (Declaration Number 121A)
• Pain Management Cables, Returns (Declaration Number 122A)
• Microwave Ablation System Accessories (Declaration Number 123A)
• Microwave Ablation System (Declaration Number 124A)

Distributed Product Declarations of Conformity

Quantum Reusable Cables
(QI2301, QI2401, QI2407, QS2101, QS2103, QW2201)

Questions concerning Valleylab regulatory certifications should be directed to:

Regulatory Department
Valleylab
a division of Tyco Healthcare Group LP
Boulder, CO 80301-3299 USA
303-530-2300