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This device is not made with natural rubber latex.
Intended Use:
®
The single use Boost
head positioner is intended to stabilize a patient's head position during endoscopy procedures and cradle the
head in a position for endoscopic access to the mouth.
Warnings and Precautions:
•
Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic
techniques.
•
Consult the medical literature relative to complications, hazards and techniques prior to the performance of any endoscopic
procedure.
•
Patient positioning should be performed by persons having adequate knowledge in applying the principles of proper patient
positioning to mitigate patient injury.
•
It is not recommended to place a cover, (sheet, Chux, towel), on the Boost
absorb fluids.
•
It is not recommended to modify the Boost
•
User is responsible for the application and use of appropriate and accepted positioning techniques with the device.
•
Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. STERIS Endoscopy did not design this
device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on
this disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination,
infection).
Directions for Use:
1.
Prior to clinical use, familiarize yourself with the device.
Read the "Warnings and Precautions" and the "Directions for Use".
2.
Inspect the package for shipping or handling damage. If damage is evident, do not use this product and contact your
local Product Specialist.
3.
Open the pouch by:
•
Holding the pouch with the label facing you, and read the label.
•
Grasp the left upper corner of the pouch with one hand.
•
Look for the slit in the pouch below the upper left corner.
•
Grasp below the slit with the other hand and tear the pouch open in a left to right direction.
4.
Carefully place the Boost
5.
Periodically assess the patient during the procedure.
00731460 Rev.L
®
head positioner. Modifications will affect the devices safety and efficacy.
®
head positioner under the patient's head prior to the insertion of the endoscope (See Fig. 1).
Fig. 1
®
head positioner. It will minimize its ability to
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