Intended User And Patient Population; Compliance With Medical Device Regulations - Hillrom O-ABMT Instrucciones De Uso

INSTRUCTIONS FOR USE
Indicates the manufacturer's catalogue
number
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
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)
Document Number: 80028132
Version: B
Page 9
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 13 MAR 2020
Ref Blank Template: 80025117 Ver. F