Residual Risk; Important Notices - Hillrom ICU Prone Head Positioner Mode D'emploi

Important Notices

WARNING:
(Warnings continued) Obey all warnings throughout the manual. Failure to do so could cause injury
and/or equipment damage:
Warning—Make sure the patient's head is adequately supported during any bed movement.
•
Warning—All modifications, upgrades, or repairs must be performed by an authorized person.
•
Warning—Make sure to replace the disposable face cushion if it becomes soiled or damaged.
•
Warning—Incorrect placement of the face cushion could result in patient injury.
•
Warning—Do not perform CPR when the ICU prone head positioner is in use.
•
Warning—Stay clear of pinch points while adjusting the ICU prone head positioner and the
•
mirror.
R R
ESIDUAL ISK
This product complies with relevant performance, safety standards. However, patient harm from
misuse, device or function hazards cannot be completely excluded.
IMPORTANT NOTICES
Prior to using this or any other type of medical apparatus with a patient, it is
recommended that you read the Instructions for Use and familiarize yourself with the
product.
• Read and understand all warnings in this manual and on the device itself prior to use with a
patient.
• This symbol is intended to alert the user to important procedures or safety instructions
regarding the use of this device.
• This symbol on the labels is intended to show when the IFU should be referenced for use.
• 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.
• Device function should be checked prior to each usage.
• This device should only be operated by trained personnel.
• All modifications, upgrades, or repairs must be performed by an authorized specialist.
• 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.
ICU Prone Head Positioner Instructions for Use (773439 REV 2 DIR: 80028583 REV A) Page 8 of 106