AMATECH I-ABSLFH, Instructions For Use Manual, Page: 9 / 334

INSTRUCTIONS FOR USE
Document Number: 80028239
Page 9
Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Indicates the device do not contain
natural rubber or dry natural rubber
latex
EN ISO 15223-1
Indicates the authorized representative
in the European Community
EN ISO 15223-1
Indicates the Medical Device complies
to REGULATION (EU) 2017/745
MDR 2017/745
Indicates a Warning IEC 60601-1
Intended to show when the IFU
should be referenced for use
EN ISO 15223-1
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 the
safe working load specified in 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