Instructions for Use

Proper Stripping Tool Selection (SureFlex™ and ProFlex™ Laser Fibers):

1)    STRIPPING THE BUFFER

HOLD THE TOOL IN ONE HAND, THE FIBER IN THE OTHER.  WITH HANDLES FULLY EXPANDED INSERT THE FIBER IN THE GUIDE UNTIL THE FIBER END ALIGNS APPROXIMATELY WITH THE TOOLS 5cm (2”) RULE MARKING. SQUEEZE THE HANDLES AND MAINTAIN THE CLOSED POSITION WHILE SIMULTANEOUSLY WITHDRAWING THE FIBER FROM THE TOOL AS STRAIGHTLY AS POSSIBLE (KEEPING THE FIBER AXIS ORTHOGONAL TO THE PLANE OF THE BLADES IS NECESSARY FOR MAINTENANCE OF A ROUND BLADE APERTURE).  IF FIBER CANNOT BE INSERTED INTO THE FIBER GUIDE THE BUFFER MAY BE MELTED OR DAMAGED: CUT APPROXIMATELY 2.5cm (1”) OF FIBER OFF THE DISTAL TIP AND TRY AGAIN. CONTINUED INSERTION PROBLEMS INDICATE USE OF THE WRONG SIZE TOOL.

 2)    TESTING THE STRIPPED SECTION FOR DAMAGE

STRIPPING BLADES CAN BECOME MISALIGNED OR WORN, DAMAGING THE FIBER 2° CLADDING IN THE ACT OF STRIPPING. MORE COMMONLY, FIBERS PULLED FROM THE TOOL AT ANGLES SIGNIFICANTLY OFF NORMAL TO THE BLADE PLANE MAY BE DAMAGED. IT IS GOOD PRACTICE TO TEST THE STRIPPED SECTION OF FIBER FOR ANY DAMAGE PRIOR TO PROCEEDING. FIRST INSURE THERE ARE NO PROJECTING GLASS FRAGMENTS AT THE FIBER TIP, THEN WHILE HOLDING THE FIBER NEAR THE END, BUT ON THE BLUE BUFFER, PLACE A FINGER ON THE FIBER TIP AND BEND THE TIP TO ABOUT 30 TO 45 DEGREES OFF THE FIBER AXIS. WHILE MAINTAINING THIS BEND STRESS ON THE FIBER TIP, ROTATE THE TIP 360 DEGREES A FEW TIMES (SEE ILLUSTRATION, BELOW). IF THE FIBER CLADDING WAS NICKED BY THE STRIPPING BLADES, THIS APPLICATION OF BENDING STRESS WILL REVEAL THAT FACT BY CAUSING THE FIBER TO BREAK AT THE BUFFER. IF A BREAK OCCURS, REPAIR OR REPLACE THE STRIPPER.

3)     CLEAVING THE FIBER

A.     WITH THE SCORING WAFER, GENTLY SCORE THE EXPOSED FIBER WITH A STRAIGHT LINE PERPENDICULAR TO THE FIBER AXIS, ONE TIME, APPROXIMATELY 3mm TO 5mm FROM THE TIP. IQ’s RULED SCORING WAFER PERMITS REPRODUCIBLE TIP LENGTHS TO BE GENERATED (P/N: 3-8012S). DO NOT ATTEMPT TO CUT THROUGH THE FIBER WITH THE SCORING WAFER. UNDER AIMING BEAM ILLUMINATION, A PROPER SCORE WILL BARELY CAUSE A LIGHT LEAK AT THE SCORE LINE.

B.    HOLD THE BUFFERED FIBER IN ONE HAND AND THE STRIPPED PORTION BETWEEN THE THUMB AND INDEX FINGER OF THE OTHER HAND. PULL THE STRIPPED PORTION AWAY FROM THE BUFFERED SECTION ALONG THE FIBER AXIS TO REMOVE THE CLEAVED TIP FROM THE FIBER. DO NOT BEND THE DISTAL TIP WHILE CLEAVING OR BREAK THE FIBER WITH A SIDEWAYS MOTION. BENDING WILL OFTEN RESULT IN A POOR CLEAVE.

C.    INSPECT THE QUALITY OF THE CLEAVE.

4)    INSPECTING THE QUALITY OF THE CLEAVED FIBER

A.    USING A MAGNIFYING EYEPIECE (loupe), MICROSCOPE OR ENDOSCOPE WITH OPERATING ROOM VIDEO SYSTEM (MINIMUM MAGNIFICATION 20X, 30X to 40X IS PREFERRED – IQ P/N: 3-5030A IS OUR 30X LOUPE), INSPECT THE FIBER FACE AT THE DISTAL END OF THE FIBER TO VERIFY A SMOOTH AND CLEAN CLEAVE. GLASS PROTRUDING FROM THE NEW FIBER TIP WILL LIKELY SCORE YOUR WORKING CHANNEL LINER.

B.    CONNECT THE FIBER TO THE LASER AND TURN ON THE LASER AIMING BEAM.

C.    HOLD THE FIBER TIP APPROXIMATELY 5cm FROM A LIGHT SURFACE TO EXAMINE THE PATTERN OF THE AIMING BEAM.

D.    A WELL DEFINED CIRCULAR PATTERN INDICATES A GOOD CLEAVE. A SLIGHTLY OVAL OR DISTENDED PATTERN THAT REMAINS WELL DEFINED IS AN ACCEPTABLE CLEAVE. A POORLY DEFINED PATTERN WITH ONE OR MORE “RAYS” EXTENDING FROM THE CENTRAL CORE OF THE PATTERN INDICATE AN UNACCEPTABLE CLEAVE.UNACCEPTABLE CLEAVES CAN RESULT FROM TO MUCH PRESSURE WHEN SCORING THE FIBER (SCORING TO THE CORE), SIDEWAYS MOTION WHEN INITIATING THE FRACTURE (BENDING RATHER THAN PULLING) OR SCORING THE TIP AT AN ANGLE OTHER THAN PERPENDICULAR (90⁰) TO THE FIBER AXIS.

E.    IF THE CLEAVE IS UNACCEPTABLE, REPEAT THE CLEAVING PROCEDURE.

Fiber Stripper and Scoring Wafer (aka "cleaving tile") Sterilization:

Scoring wafers typically need no preparation for sterilization; just insure the wafer is clean and dry prior to adding it to a load. With very low surface area and no porosity, clean alumina wafers (polycrystalline sapphire) present virtually no bio-burden or other challenge to any sterilization method. Alumina wafers, including laser marked wafers, are impervious to ethylene oxide, hydrogen peroxide, carbon monoxide, gamma rays, high temperature steam, and dry heat up to 1000 degrees centigrade (above which prolonged exposure will fade the printing on the wafers).

Prepare the stripper

Thoroughly clean the stripper and remove the blade set (if the existing blades have been sterilized before, they should be replaced after cleaning). Use a neutral pH detergent or enzymatic cleaner to remove debris from all parts of the stripper. Rinse well.

 The fiber stripper (Micro-Strip® Green Handle) body is made of GE’s Ultem® and can withstand autoclave temperatures up to 270°F (132°C) without losing function, repeatedly. The high carbon steel blades, however, begin oxidizing on exposure to the autoclave environment. Blades should be replaced after one autoclave exposure.

 The white plastic spring will take on a heat-set in the autoclave and may lose its functionality if autoclaved under tension. Prior to sterilizing the stripper, remove the fiber support (green center guide see to the side of the stripper in the photo) and release one side of the white spring from its dowel pin within the handle (see photo). Sterilized in this relaxed, the spring will retain function.

 After sterilization, using aseptic technique, re-attach the spring to its dowel and re-insert the fiber support and install new blades and the fiber guide.

 Sterilizing the stripper and scoring wafer

The operational parameters listed below are offered for reference only as other validated sterilization methods and cycles may be used if approved under your facility’s policies and procedures. Bio-burden in sterilization must be minimized so the fiber must be cleaned prior to sterilization (see “Preparing the Stripper” section, above.) Sterility must be validated by individual users or reprocessed products before use.

EtO Sterilization:

Precondition the load at 80% (minimum) humidity for one (1) hour at 130°F (55°C).

Sterilize in a 100% ethylene oxide chamber with the following parameters:

1. EtO concentration: 600mg/l
2. Cycle time: 105 minutes
3. Temperature: 130°F (55°C)
4. Humidity: 80% minimum
5. Aeration: 12 hours at 130°F (55°C)

Gravity Displacement Steam Sterilization:

 Sterilize under the following parameters:

1. Temperature: 270°F (132°C)
2. Exposure: 10 minutes
3. Drying cycle: 10 minutes

                   ---- OR ----

 Sterilize under the following parameters:

1.  Temperature: 250°F (121°C)

2.  Exposure: 30 minutes

3.  Drying cycle: 10 minutes

Pre-Vac Steam Sterilization:

 Sterilize in a forced air removal (pre-vac) steam sterilizer with the following parameters:

 Temperature: 250°F (121°C)

1. Exposure time: 4 minutes
2. Drying cycle: 10 minutes.