SPINAL elements

oI-Flex Distal Handle Instructions for Use

4 Pages

Instructions for Use Distal Handle DEVICE DESCRIPTION: The iO-Flex® Distal Handle is an accessory device for the iO-Flex System, designed to securely terminate and clamp the distal portion of the iO-Flex® Wire.  HOW SUPPLIED: The iO-Flex® Distal Handle is supplied sterile for single-patient use:  Order Number  Description  iO-DH  iO-Flex Distal Handle  INTENDED / INDICATION FOR USE: The iO-Flex® Distal Handle can be used with iO-Flex® Wires, neural localization, cutting and biting devices during spinal surgery.  CONTRAINDICATIONS: None known.  WARNINGS: •  Decompressing L1/L2 with the iO-Flex system is not advised due to the theoretical risk of damage to the conus medullaris and the low incidence of stenosis at this level.  PRECAUTIONS: • • • •  Read all instructions prior to use. Failure to properly follow instructions may result in improper functioning of the device and may lead to patient injury. This device should only be used by personnel trained in the use of this device. Do not use the product after the “Use By” date.  •  Do not use the product if packaging integrity appears compromised, open, or damaged.  •  Do not attempt use if any component of the system appears damaged, bent or is missing.  •  For single patient use only. Do not reuse or resterilize.  •  Reuse or attempted resterilization of the device may lead to device failure and subsequent patient injury. Attempted resterilization of the device may create the risk of contamination and patient infection.  LBL1159 Rev. R (DCR 19-0013, Effective Date: 2019-07-25)  1 of 4
File Type: PDF
File Size: 167 KB
File Name: SPINAL elements - LBL-1159 - oI-Flex Distal Handle Instructions for Use - 2019-07 - Rev R.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions