Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations - Hillrom Allen Yellofins Apex Instrucciones De Uso

INSTRUCTIONS FOR USE
Symbol used
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: 80028475
Version: A
Description
Indicates the manufacturer's serial
number. The device serial number is
encoded as 1YYWWSSSSSSS.
YY indicates the year of manufacture.
i.e. 118WWSSSSSSS where 18 represents
the year 2018.
WW indicates the number of the
manufacturing week per a standard
shop calendar. (Leading zeros
included.)
SSSSSSS is a sequential unique number.
Indicates the authorized representative
in the European Community
Indicates the Medical Device complies
to REGULATION (EU) 2017/745
Indicates a Warning
Page 9
English
Reference
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
Issue Date: 26 November 2020
Ref Blank Template: 80025117 Ver. F