Instructions for Use

ProFlex™ Laser Lithotripsy Fiber

For use with Ho:YAG, Tm:YAG, Nd:YAG/KTP, Alexandrite, Argon & all 500nm to 2200nm cleared lasers equipped with SMA ports. Some models are equipped with Trimedyne connectors and may be used with Trimedyne Ho:YAG Lasers. For fibers smaller than 550, only those designated "DEKA" are compatible with DEKA Smart 2100 lasers. "NSL" models are designed particularly for New Star Lasers but may be used on other SMA port equipped lasers as well. "S-" prefix models are designed for single use, only, and may be severely damaged by reprocessing and sterilization: injury to surgical staff may result. Only "R-" prefix devices are validated for reprocessing and reuse and may be reused up to 5 times (5 sterilization cycles, maximum). "SPY" suffix models are longer than standard models for accessing gallstones. 

 STERILE ProFlex™ Laser Fiber

 Products of InnovaQuartz LLC

Indications

READ ALL INSTRUCTIONS THOROUGHLY BEFORE USE

 Instructions for Use:

 Prepare the Fiber

 It is important to review the laser’s Operator's Manual for instructions on proper set-up and operation of the laser system prior to activation of the laser.

• Aseptic technique must be employed to insure sterility when removing the product from the sterile pouch. Unwind the fiber from the distal (working) tip. This ProFlex™ fiber is provided sterile. Sterility is not assured if there is visible damage to the pouch or the pouch has been previously. Permanent and severe damage may result from autoclaving single use models.
• Insure that the laser is “OFF” or in “STANDBY” mode before attaching the fiber at the laser aperture (e.g. SMA port). Remove the protective cap from the connector. Contamination on the laser fiber input (the lens-equipped quartz ferrule face within the connector) may reduce performance. Inspect the input using a loupe or under digital magnification and, if contaminated, wipe it clean with a sterile tissue. Attach the Pulsar™ fiber connector to the laser port and finger-tighten the connector nut until a secure connection is achieved (generally indicated by release of interlock mechanisms). Standard ProFlex LLF models will not release New Star laser interlocks; use "NSL" models, only.
• While ProFlex fibers are generally robust, the optical conduit is made of glass and may be damaged if the fiber is bent sharply, struck or pinched. The output tip is unprotected by buffer and is the most delicate and easily damaged portion of the fiber. If the output tip is damaged, it may be reprocessed using a sterile scoring wafer and sterile fiber stripper (supplied separately) using the instructions found herein. For detailed, best practice instructions on producing efficient output faces on fibers, see "How to Properly Cut Fiber" in IQ University.

Inspect the Fiber 

• Inspect the entire length of the fiber for breaks by first activating the laser aiming beam: breaks will appear as bright. Do not attempt to use a broken fiber. The working beam is coincident with the aiming beam.
• Inspect the working tip using the aiming beam output. With the tip about 5 cm from a light surface, the fiber is ready to use if the spot appears uniform and round with fuzzy edges. “Comet tails” are indicative of a broken tip requiring repair or an improperly reprocessed tip.

 Using the Fiber 

• In “STANDBY”, hold the fiber about 5 cm from the output or, if using an endoscopic device, carefully insert the fiber tip into the working channel and steadily pass it through until the fiber tip is visible in the field of view and extends about 1 cm from the scope.
• Adjust the laser output to the a level appropriate for the intended use and where the fiber maximum approved power is not exceeded (J X PPS = Watts, e.g. 0.8J @ 10pps = 8W). The maximum power for ProFlex laser fibers is: 10W for ProFlex 150, 30W for ProFlex 200, 50W for ProFlex 273 and 120W for ProFlex 365, ProFlex 550, ProFlex 800 and ProFlex 910/940.
• Exceeding the maximum power rating may lead to failure of the device, injury to the patient, operator or associated equipment.
• Using laser fibers in direct contact with target tissue greatly accelerates tip degradation. Techniques where fiber tips stand off target tissue, e.g. “dusting”, preserve the fiber tip. If the tip becomes degraded performance will diminish. Producing a freshly cut output will restore most of the fiber’s original performance but the tip will not pass working channels as easily as a fresh and original Smooth Passage™ tip. Sterile tools and proper technique (see instructions on the following page) are required for intraoperative production of a safe and effective fiber tip .
• If the tip accumulates debris, turn the laser to “STANDBY” and carefully wipe the tip with a sterile pad. Do not scrape the fiber with instruments or the tip will be damaged and may detach when passing channels and in use.

 GUIDE TO PRODUCING A SAFE AND EFFECTIVE FIBER TIP

FIRST, INSPECT THE FIBER TIP

• Before unnecessarily discarding a functional fiber tip it is advisable to inspect it for damage and debris. With a minimum magnification of 15X for a magnifying eyepiece (loupe), microscope or video system, inspect the output tip for adhered tissue or other debris and if present, wipe the tip clean with a sterile gauze pad.
• Degradation of the working tip is normal and will occur with prolonged use. While inspecting the fiber, slightly tilt the fiber face and view it at a variety of angles and with light reflecting from the fiber face. It is also advisable to inspect the hard polymer coating near the blue buffer for damage. Missing or scratched hard polymer coating predisposes the tip to detaching in use. The fiber should be reprocessed if coating damage is detected or if the fiber has pits, cracks, chips or if intractable debris is present.

REPROCESSING THE FIBER TIP

The recommended tools for stripping fibers may be ordered from your authorized ProFlex distributor or directly from IQ. Check with an IQ sales representative for additional information. The following tools are recommended for stripping and cleaving ProFlex™ laser fibers.

 IMPORTANT NOTE 

Verify the stripping tool is appropriate for the fiber size. Tools from other manufacturers and other manufacturers’ fibers may appear quite similar and labeled fiber sizes are often misleading, e.g. many “200 micron” laser fibers are actually 273 micron core and most “400 micron” laser fibers are actually 365 micron core. Even similar sizes of ProFlex™ fibers are difficult to differentiate without reference to laser inscribed model number on the fiber connector, e.g. ProFlex 200 and ProFlex 273 have very similar total diameters (blue Tefzel®) but require different size stripper blades (see table below).  Refer to the table and use blade colors as a guide.  Insure tools are sterile and maintained within the sterile field for intraoperative fiber repair. Refer to Stripper IFU for proper use and sterilization guidance.

Autoclavable Stripping Tools (and useful fiber data)

Autoclavable Stripping and Cutting Tools 

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 AT LEFT). IF THE FIBER CLADDING WAS NICKED BY THE STRIPPING BLADES, THIS APPLICATION OF BENDING STRESS WILL REVEAL DAMAGE BY CAUSING THE FIBER TO BREAK. REPLACE THE STRIPPER BLADES IF BREAKS OCCUR REPEATEDLY.

 CLEAVING THE FIBER

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 BLUE BUFFER.  THE IQ RULED SCORING WAFER PERMITS REPRODUCIBLE TIP LENGTHS TO BE GENERATED. 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.

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 SCRAP TIP FROM THE FIBER.  DO NOT BEND THE DISTAL TIP WHILE BREAKING THE FIBER — NO SIDEWAYS MOTION. BENDING WILL GENERALLY RESULT IN A POOR CLEAVE.

 INSPECTING THE NEW TIP

USING A MAGNIFYING EYEPIECE (loupe), MICROSCOPE OR ENDOSCOPE WITH OPERATING ROOM VIDEO SYSTEM (MINIMUM MAGNIFICATION 15X, 30X 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 OR HANG UP IN PASSAGE.

CONNECT THE FIBER TO THE LASER AND TURN ON THE LASER AIMING BEAM. HOLD THE FIBER TIP APPROXIMATELY 5cm FROM A LIGHT SURFACE TO EXAMINE THE PATTERN OF THE AIMING BEAM.

A  FUZZY EDGED BUT 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 “COMMET TAILS” EXTENDING FROM THE CENTER OF THE PATTERN INDICATES AN UNACCEPTABLE CLEAVE.

UNACCEPTABLE CLEAVES CAN RESULT FROM TO MUCH PRESSURE WHEN SCORING THE FIBER (CUTTING TO THE FIBER CORE), SIDEWAYS MOTION WHEN INITIATING THE FRACTURE (BENDING RATHER THAN PULLING) OR SCORING AT AN ANGLE OTHER THAN ORTHOGONAL (90⁰) TO THE FIBER AXIS.

IF THE CLEAVE IS UNACCEPTABLE, READ "HOW TO PROPERLY CUT FIBER" IN IQ UNIVERSITY AND REPEAT THE CLEAVING PROCEDURE.

InnovaQuartz Single Use fibers (designated by the "S" prefix in the model number and clearly labeled as such) are disposable products that are not intended for intraoperative reprocessing or reuse. Do not reuse single use fibers. Reprocessing and re-sterilization may compromise structural integrity and lead to malfunction or failure, which may result in patient or user injury. Serious infection may occur due to improper reprocessing, sterilization and reuse of single use fibers.

CLEANING THE FIBER

1. Soak the fiber for ten (10) minutes (minimum) in an enzymatic detergent suitable for surgical instruments.
2. Use a clean, soft gauze pad or sponge soaked in the detergent solution to wipe the fiber from end to end: remove all residue and debris.
3. Thoroughly rinse the fiber in warm water to remove the cleaning solution and any loose residues
4. Dry the fiber with a soft cloth or laboratory wipe and visually inspect for any remaining debris.

STERILIZING THE FIBER

The fiber may be sterilized by EtO or steam.  The parameters shown below are offered as a reference only.  The fiber MUST be cleaned prior to sterilization.  Optical fibers are glass and should be handled with care.  The individual user must verify the actual sterility of reprocessed product prior to use.

EtO Sterilization:

1. 1. Accelerated fiber aging in sterilization is directly proportional to the fiber coil diameter so LOOSELY COIL THE FIBER and place it in the largest available ethylene oxide compatible and permeable pouch and seal the pouch.
2. Precondition the load at 80% (minimum) humidity for one (1) hour at 130°F (55°C).
3. Sterilize in a 100% ethylene oxide chamber with the following parameters:

EtO concentration: 700mg/l

Cycle time: 1 hour

Temperature: 130°F (55°C)

Humidity: 80% minimum

Aeration: 12 hours at 130°F (55°C)

Gravity Displacement Steam Sterilization:

1.     Accelerated fiber aging in sterilization is directly proportional to the fiber coil diameter so LOOSELY COIL THE FIBER and place it in the largest available steam compatible and permeable pouch and seal the pouch.

2.      Sterilize under the following parameters:

Temperature: 270°F (132°C)

Exposure: 15 minutes

Drying cycle: 15 minutes

Pre-Vac Steam Sterilization: 

1.      The accelerated aging of fibers in sterilization is directly proportional to the fiber coil diameter so LOOSELY COIL THE FIBER and place it in the largest available steam sterilization compatible and permeable pouch and seal the pouch.

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

Number of vacuum pulses: 3

Exposure time: 8 minutes

Drying cycle: 25 minutes.

IMPORTANT NOTE:    

Optical fibers age when tiny glass flaws grow to larger flaws: a 1µm flaw can initiate a fracture. These flaws grow faster under stress and faster still in high humidity and at elevated temperature, conditions precisely describing those of a sterilization chamber. Once a sterilization method has been selected and validated, humidity and temperature are fixed, but the level of stress the fiber is subjected to under these most adverse conditions can be controlled. Stress is directly proportional to the coil diameter so a fiber coiled to 4” ages twice as much as a fiber coiled to 8”. Maximize safety: use LOOSE coiling and large pouches.

Caution:  Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Potential Complications: 

Complications could include local and/or systemic infection, thermal damage to surrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or after energy application.  In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps.  Irrigate the area thoroughly to remove any traces of the tip. 

Cautions: 

• If tissue appears to be stuck to the lasing tip, carefully remove the tip from the tissue. Use a soft, sterile cloth to clean the debris from the glass tip, taking care to avoid side pressure that may damage the tip.
• Increased laser exposure time will result in a deeper and wider zone of necrosis.
• Do not bend fiber at sharp angles. If visible (aiming beam) light can be seen leaking from the fiber, fiber failure is likely to result when therapeutic energy is applied.
• Care should be exercised with the glass tip to avoid severe impacts or side stresses that may fracture the tip.
• The time and energy required for treating a specific target area may be different when using the InnovaQuartz ProFlex™ laser fiber compared to using other fibers. A different beam divergence, transmission efficiency and a laser spot size may alter treatment times.
• During each lasing interval, it is helpful to move the distal tip up and back 1 to 2mm to prevent the tip from sticking to tissue.
• Immediately discontinue use if breaks or fractures appear in laser fiber. These breaks or fractures may allow undirected emission of laser energy, rendering the distal tip useless and potentially causing harm to surrounding tissues.
• Always wear appropriate protective eyewear during the delivery of laser energy.
• Do not use the InnovaQuartz ProFlex™ laser fiber in the presence of flammable anesthetics or any combustible materials. 
• NEVER attempt to sterilize ProFlex fibers that are marked as single use devices: improperly sterilized products present an explosive hazard when fired.
• Reuse of single use fibers, or reuse of reusable fibers beyond the validated five cycles following initial use, may compromise the structural integrity of the device and may lead to malfunction or failure which may, in turn, result in patient or operator injury. Serious infection may result from improper sterilization and reuse of single use and limited reuse fibers.

How Supplied and Stored: 

• This InnovaQuartz ProFlex™ laser fiber is supplied sterile as single use, disposable product, not intended for reprocessing and reuse and designated by an "S" prefix in the product model number, or as a limited reuse product, validated for five cycles of reprocessing, sterilization and reuse. Initial sterility is guaranteed only if the package is not opened or damaged. 
• Store in a cool, dry place.
• As supplied, sterile shelf life is two years from the date of sterilization: sterility expiration is marked on the product label.

ProFlex LLF products are protected by US Patents 9,122,009, 9,223,089 & pending