Hillrom O-LPS, Instructions For Use Manual, Page: 9 / 197

INSTRUCTIONS FOR USE
Document Number: 80028139
Page 9
Issue Date: 25 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions.
EN ISO 15223-1
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
Indicates the need for the user to consult the
instruction 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 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)