General; Manufacturer; Hotline; Adverse Incident Reporting Requirement - KLS Martin group MedLED Instrucciones De Uso

MedLED® face shield
Instructions for Use

1 General

1.1

Manufacturer

Thank you for choosing a KLS Martin product.
This product has the CE mark, which means that it is compliant with the essential safety and performance
requirements for medical devices pursuant to applicable European regulations.
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
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com
1.2

Hotline

If you have questions about how to use this product, questions about clinical applications or questions
about maintenance contracts and other services, please contact the product management team:
Tel: +49 7461 706-352
Fax: +49 7461 706-312
1.3

Adverse incident reporting requirement

All serious adverse incidents related to this product must be reported to the manufacturer and to the
competent authorities immediately.
1.4

Safety warnings used in this document

Possible danger to life of or serious injury to the patient, user or a third party if these instructions are
not followed
Read and observe the Instructions for Use completely. In particular, heed all warnings.
This text refers to male, female and non-binary individuals equally, but not all pronouns have been used,
solely for reasons of readability.
• Keep these instructions for use accessible to users at all times
• The electronic version of these instructions for use can be downloaded from www.klsmartin.com or can
be requested there.
Revision 01 23