Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations - Hillrom A-80200 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)

1.6 EMC considerations:

This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
Document Number: D-720442
Version: C
Indicates the need for the user to consult
the instructions for use for important
cautionary information such as warnings
and precautions.
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
Indicates the need for the user to consult
the instruction for use
Page 9
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 16 MAR 2020
Ref Blank Template: 80025117 Ver. F