Creo Medical CROMA Instrucciones De Uso página 49

Serious incidents
In the event of a serious incident involving the product, please inform the manufacturer or its
authorized representative and the competent authority of the country in which the user and/or patient
is established.
Specifications
Product servicing
The electrosurgical generator and Footswitch require periodic preventive maintenance every 12 months
from the date of purchase. Servicing must only be performed by Creo personnel or their designated
representative.
The AC power supply cord may be replaced with one that meets the requirements stated in the
Specification section of these Instructions for Use.
In the event of product failure please contact Creo Medical Ltd to arrange servicing or repair. Please do
not send the product to Creo Medical Ltd (or its authorized agent) without first obtaining a Returned
Merchandise Authorization (RMA) number.
Disposal at end of service life
This product must be disposed of in accordance with local electrical and
electronic waste regulations. Please contact Creo Medical Ltd or your local
distributor if you have any questions concerning disposal.
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Proprietary & Confidential - Page 49 of 391 - Uncontrolled if Printed
MEDICAL - APPLIED CURRENT/ENERGY EQUIPMENT,
MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2010 +
A1:2012, IEC 60601-1-6:2010 + A1:2013, ANSI/AAMI/IEC 60601-2-2:2017,
IEC 60601-2-6:2012 + A1:2016, CAN/CSA-C22.2 No. 60601-1:2014, CAN/
CSA-C22.2 No. 60601-1-6:2011 + A1:2015, CAN/CSA C22.2 NO. 60601-2-
2:2019, CAN/CSA-C22.2 No. 60601-2-6:2014 + A1:2018
CE marking
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