Electrosurgical Unit Minicutter
6
Revision 08
1
Product Liability and Warranty
1.1
General Information
We thank you for buying a KLS Martin product. This product carries the CE mark, which means that it
satisfies the essential requirements laid down in the EC Directive concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
P.O. Box 60 · D-78501 Tuttlingen · Germany
Phone +49 7461 706-0 · Fax +49 7461 706-193
[email protected] · www.klsmartin.com
1.2
Scope of Delivery
HF generator
•
Electrosurgical Unit Minicutter
•
Mains cable
•
Instructions for Use
1.3
Intended Use
The unit is used for electrosurgical cutting or coagulation of live human tissue.
The operator may operate the device only if an on-site functional test has previously been performed by
Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a responsible person designated
by the operator must have been instructed in the proper handling, application and operation of the unit, as
well as in its permissible combination with other medical devices, objects and accessories. This duly
instructed officer shall subsequently be responsible for familiarizing the operator’s staff with the unit as the
need arises. We recommend documenting all user instructions in a medical device logbook. A copy of the
logbook is available from Gebrüder Martin.
The operational safety of the unit must be verified at regular intervals, see section 7 Safety Check (SC), page 32.
If the device is not functionally reliable and/or safe to operate, it must be marked as “out of order” and
withdrawn from service. A technical check is required in any such case.
1.4
Warranty
Our Standard Terms and Conditions of Sale as most recently amended shall apply. Any agreements
diverging from these Standard Terms and Conditions shall not limit the statutory rights of the buyer.
Any warranty exceeding the above provisions shall require a contractual form and shall exclude
component-related vandalism, software updates and consumables.
Under this warranty, we will remedy free of charge any defects due to faulty workmanship or the use of
faulty materials, either through our Customer Service or directly at the factory. The warranty for the unit is
not extended by this.
