Integra MAYFIELD A2011 Gebrauchsanleitung Seite 5

EN –ENGLISH
Indications for Use/Intended Purpose
The MAYFIELD® Pediatric Radiolucent Horseshoe Headrest is intended to be used to support a patient's head in both the prone and supine
positions during diagnostic examination or surgical procedures where support and stabilization of the head is desired but complete
fixation of the head is not required.
WARNING:
Failure to read and follow instructions furnished in this product insert may result in serious patient injury.
WARNING:
Device must not be used if it appears to be damaged or functioning incorrectly. Doing so may result in serious patient injury.
WARNING:
Ensure the mating starburst teeth of the Swivel Adaptor and the Stationary Horseshoe Faceplate are the same size and have
properly engaged (meshed) when fully tightened. Failure to do so may damage teeth, compromise stability, and result in serious
patient injury.
WARNING:
Do not position the Slide Horseshoe Faceplate past the end of the Stationary Horseshoe Faceplate slide bar (Figure 11). Doing so
may result in serious patient injury.
WARNING:
Horseshoe Faceplates should be adjusted prior to patient positioning. Make certain to always support the patient's head when
adjusting the Horseshoe Faceplates or unlocking any connection of this device. Failure to do so may result in serious patient injury.
WARNING:
Failure to properly position the patient and to fully secure all adjustment portions of this or any support device may result
in serious patient injury.
WARNING:
Device must not be used if it has been dropped or mishandled. Doing so may result in serious patient injury.
WARNING:
Do not steam sterilize any component of this device. Doing so may damage device and result in serious patient injury.
WARNING:
Do not use MAYFIELD products and accessories in conjunction with other manufacturers' stabilization equipment.
Intended Population
MAYFIELD Skull Clamp fixation devices are not recommended for use on children under five (5) years of age. Extreme caution should be
exercised in pediatric cases because of the thin skull.
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