Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations - AMATECH F-93000 Instrucciones De Uso

INSTRUCTIONS FOR USE

1.5.2 Intended User and Patient Population:

Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare
professionals involved in the device intended procedure. Not intended for Lay
persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight in the
safe working load field specified in the product specification section 4.2

1.5.3 Compliance with medical device regulations:

This product is a non-invasive, Class I Medical Device. This system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device
Regulations (REGULATION (EU) 2017/745)

EMC considerations:

This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
Document Number: 80028279
Version: B
Indicates the device do not contain
natural rubber or dry natural rubber
latex
Indicates the authorized representative
in the European Community
Indicates the Medical Device complies
to REGULATION (EU) 2017/745
Indicates a Warning
Intended to show when the IFU
should be referenced for use
Page 9
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E