The ARAS Retractor Instrumentation is intended to provide
surgical access to the thoracic and lumbar spine from a posterior and
posterior lateral approach.
Misuse of the instrument may inhibit or prevent proper functioning
and may cause injury to the patient or operator.
- Do not use the instrument for any purpose for which it is not
- Ensure that the instrument is clean and sterile
prior to use.
- If damaged do not reuse; replace.
- Instruments designated for single use only must not be reused
and must be properly disposed of.
It is strongly recommended that the patient be informed of the risks
associated with surgical procedures and components.
- Carefully read all instructions and be familiar with the
surgical technique prior to use.
- Inspect all instruments
prior to each use for wear, corrosion, loosening, ageing or
fracture. The spacer cutter blade should be periodically replaced to
maintain optimal cutting performance.
- If instruments are
subjected to excessive loading, are damaged or are handled
improperly, they may fracture, corrode, oxidize and show excessive
wear or their functionality may be impaired.
- Neutral pH
enzymatic and cleaning agents are recommended. Cleaning or
disinfecting agents containing aldehyde, mercury, active chlorine,
chloride, bromine, bromide, iodine, iodide, and potassium or sodium
hydroxide can accelerate the degradation of these instruments and
should not be used.
- Never tighten Universal joints or Rail
Clamps without Frame Components or Retractors in the holes. Joints
may collapse and be rendered unusable.
- All implants and
some instruments are intended for single use only; refer to the
product label to determine if the instrument is intended for single
use only. Single use devices should not be re-used. Possible risks
associated with re-use of single use devices include:
- Mechanical malfunction
- Transmission of infectious
Possible adverse effects associated with the use of orthopedic
instruments are similar to those associated with any spine surgery, including:
- Nerve damage