1
Devices
Indications for Use
T
hese instructions for use are intended for reusable surgical
instruments labeled with the CareFusion, V. Mueller
N
euro/Spine name comprising fixed assemblies (no moving
parts), simple hinged, and self-locking surgical instruments,
i
ncluding those containing aluminum.
How Supplied
D
evices are packaged as non-sterile. Cleaning and sterilization
of devices must occur prior to use.
Limitations on Reprocessing
Repeated processing has minimal effect on these devices. End
o
f life is normally determined by wear and damage due to use.
Warnings
D
evices shall be used in accordance with these Instructions for
Use. Read all sections of this IFU prior to use. Improper use of
t
hese devices may cause serious injury. In addition, improper
care and maintenance of the devices may render the devices
n
on-sterile prior to patient use and may cause serious injury to
the health care provider or the patient.
C
olor-anodized aluminum instruments may lose their color if
automatic cleaning and sterilization methods are used.
Cautions
I
f there are any variations between these Instructions for Use
and either your facility’s policies and/or your cleaning/sterilizing
e
quipment manufacturer’s instructions, those variations should
be brought to the attention of the appropriate responsible
hospital personnel for resolution before proceeding with
c
leaning and sterilizing your devices.
Use of a device for a task other than what it is intended for will
usually result in a damaged or broken device.
Prior to use, inspect devices to ensure proper function and
condition. Do not use devices if they do not satisfactorily
perform their intended function or if they have physical
damage.
Avoid mechanical shock or overstressing the devices. Close
distal ends prior to insertion or removal through cannulas.
Always use caution when inserting or removing devices through
the cannula. Lateral pressure on the device during removal can
damage the working tip, and/or shaft of the device. Be sure the
tips are closed and the device is pulled straight out until
completely clear of the cannula to avoid catching the valve
assemblies in cannulas or dislodging the cannula.
Fading of anodized aluminum devices may be accelerated if
cleaning and sterilization instructions are not followed.
Only the cleaning and sterilization processes which are defined
within these Instructions for Use have been validated.
Use only neutral pH (6-8) detergent solutions.
Pre-processing Instructions
Initiate cleaning of device within 2 hours of use.
Transport devices via the institutions established transport
procedure.
Remove excess gross soil as soon as possible after use by
rinsing or wiping the device.
All devices must be processed in the completely open position
(i.e. flushports, jaws, etc.) to allow solution contact of all
surfaces.
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
36-3430I
en
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