Intended Use; Introduction; Safety Information - Hillrom ICU Prone Head Positioner Mode D'emploi

INTENDED USE

The ICU Prone Head Positioner is intended for use in a variety of surgical or ICU procedures. The ICU
prone head positioner is capable of being used with a broad patient population as determined
appropriate by the caregiver or institution. The intended users of this product are healthcare employees
who have been trained to use the product; surgeons, nurses, doctors, physicians, and/or healthcare
professionals involved in the device intended procedure. Not intented for Lay persons. This device is
intended to be used with patients that do not exceed the weight in the safe working load field specified
in the Specifications section.

INTRODUCTION

The ICU Prone Head Positioner is a head positioning system that is used as an attachment to hospital
beds to support the patient's head in a variety of surgical or ICU procedures.
This manual contains information necessary for the normal operation of the ICU Prone Head Positioner.
Before you operate the positioner, make sure that you read and understand in detail the contents of this
manual. It is important that you read and strictly obey the aspects of safety contained in this manual.

SAFETY INFORMATION

The techniques detailed in this manual are only manufacturer's suggestions. The final responsibility for
patient care with respect to this device remains with the attending physician. Keep this manual
available for future reference. Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority listed in this document. Do not use the
product if the sterile package is damaged or unintentionally opened before use. 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). This is not an electromechanical device. Therefore,
EMC Declarations are not applicable.
WARNING:
Obey all warnings throughout the manual. Failure to do so could cause injury and/or equipment
damage:
Warning—Before using this or any other type of medical apparatus with a patient, it is
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recommended that you read the Instructions for Use and familiarize yourself with the product.
Warning—The ICU prone head positioner is to be used as a support surface only, not intended
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for rigid fixation.
Warning—Make sure to lock the ball joint securely.
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Warning—Make sure to remove the handle after tightening the ball joint to avoid unintended
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release.
Warning—Do not use if the product shows visible damage.
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Warning—Do not exceed the 500 lb patient weight limit of the ICU prone head positioner.
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Warning—Make sure the ICU prone head positioner is latched correctly and locked before use
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with a patient.
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