Indication For Use - Integra MAYFIELD Infinity XR2 Manual De Instrucciones

Indication For Use

The MAYFIELD Infinity XR2 Skull Clamp is placed on the patient's skull to hold their head and neck
securely in a particular position when rigid fixation is desired. The Skull Clamp is indicated for use
in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In
addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative
CT imaging, C-Arm X-Ray, digital subtraction techniques, and MR imaging.
Failure to read and follow the instructions furnished in this product insert may result
in serious patient injury.
The Skull Clamp must be applied along the center line of the patient's head with
pins entering the skull perpendicularly (See Table 1). Failure to properly position
the Skull Clamp on the patient's head could result in patient injury such as scalp
laceration due to skull pin slippage. Failure to properly position patient and to fully
secure all adjustment positions of the Skull Clamp or any support device may result
in patient injury.
It is cautioned that only MAYFIELD products have been validatd for use with other
MAYFIELD products. Integra cannot advise whether other suppliers' products
would function properly with the MAYFIELD line of products. Integra does not offer
warrantly protection when a non-MAYFIELD brand product is used with a MAYFIELD
branded product
Do not alter the design of the device in part or whole as serious patient injury could
result.
WARNING!
Page 3