ROCAMED Single Use Sterile Surgical Laser Fiber User Manual

: June 9, 2024
: ROCAMED

Table of Contents

ROCAMED Single Use Sterile Surgical Laser Fiber
Fiber Specification
Single-use Sterile Surgical Laser Fiber
Indications for Use
Tip Refurbishing
Glossary
Manufactured by
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ROCAMED Single Use Sterile Surgical Laser Fiber

ROCAMED-Single-Use-Sterile-Surgical-Laser-Fiber-PRODACT-
IMG

Fiber Specification

ROCAMED-Single-Use-Sterile-Surgical-Laser-Fiber-FIG-1

Single-use Sterile Surgical Laser Fiber

Scope of validity
These instructions detail the care and the use of the Rocamed Single-Use Sterile Surgical Laser Fiber. They are not recommendations for the medical or the surgical application of this device. Any physician using this device should be thoroughly familiar with the surgical procedures performed before the use of the device.

WARNING: This product shall be used by trained and qualified users only.
CAUTION: Federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

In order to ensure safe handling of the laser probe, you must first fully read and understand this User Manual. Refer to the laser system User Manual for specific instructions concerning warnings, cautions, contraindications and clinical use of the laser.

Product description and specification
The Sterle Surgical Loser Fiber are a sterile packed instrument for short- time, invasive and non-invasive use. To avoid risks due to infection and injury the tiber should be used only it the sterile packaging has not been damaged and not expired. IThe Sterile Surgical Loser fibers are sterilized with Ethylene Oxide. Refer to the Fiber Specification Table 1.

Indications for Use

Rocamed Surgical Laser Fibers are:

intended to be used in conjunction with any cleared surgical loser equipped with SMA 905 or SMA 906 or a compatible Connector.
indicated for use in general surgical applications tor. incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in contact or noncontact mode (with a compatible laser marketed for use in the desired application).
indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery,
plastic surgery, ENT/ otolaryngology, endovenous Occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser-assisted lipolysis with an approved compatible laser marketed for use in the desired application.
also indicated for use in open or closed endoSCopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation moy be indicated with an
approved compatible laser marketed for use in the desired application.
also intended as an aid tor otologic procedures, tor use in the incision, excision, coagulation and vaporization of soft and fibrous fisue including osseous fisue with an
approved compatible lser marketed for use in the desired application.
also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
indicated tor use with loser devices emitting radiation trom 532 nm to 2100 nm, with puised and continuous wave (CW) emission mode.
indicated, but not imited, for use with Diode laser, Argon, KTP/532, Ho:YA6, Nd:YAG, Im:YAG pulsed and continuous wave CW lser devices.
Rocamed Surgical Loser Fibers moy be used in surgical specialty or procedures tor which compatible losers have received regulatory clearance: for complete information obouf applications, contraindications, precautions and warnings when using fiber opticit is necessary to refer to the applicable laser device User Manual.

Application and Safety Notes

Refer to the specific laser User Manual for the maximum input power values as well for warnings, cautions, contraindications and clinical use of the fiber in conjunction with the laser itself. Please do not hesitate to contact Rocamed for technical assistance. In order to ensure safe handling of the laser probe, you must first fully read and understand this User Manual. Please take care to read and understand the following Safety Notes:
To ensure the proper and sote handling of the Sterile Surgical Laser Fiber should be used only by physicians familiar with the use of medical laser devices.
The general guidelines and instructions for working with loser radiation apply. The precautionary measures are indicated on the labels and in the User Manual of the loser device.
WARNING: AlIl people present must wear safety goggles while the loser cable is in use. Ihe requirements tor the protective equipment depending on the particular application. Refer to the User Manual of the loser device used.
WARNING: the Sterile Surgical Laser Fiber may be used only under surgical-room procedures. The steril packaging must be checked for only detects. Fibers from opened or damaged packaging are not-sterile and must not be used. Please checks the expiration date.
Perform a visual inspection after the fiber hos been removed trom the packaging. Ensure that the distal end is intact and that the SMA plug is clean. Do not use tiber with a damaged distal end or SMA plug.
The minimum bending radius of the laser fiber must be maintained at all times throughout the entire time of Use.
The smallest permissible short-time bending radius corresponds to 100 times the radius of the fiber cladding. For the use of the fiber with flexible endoscopes, recommended considering the short-term minimum bending radius as given in label.
Before and after removing the laser fiber trom its packaging, check the fiber for visible signs of damage, in particular, breakage. if any damage is found, do not use the product!
WARNING: Do not use a defective laser tiber, nor should you use the laser fiber in an incorrect manner because this Could cause severe eye or tissue injury, unintended exposure to patients or operating stott to loser radiation or tire in the treatment area. Observe the detailed safety intormation in the User Manual of the respective laser device and the instructions for protection against laser radiation.
Always prevent the distal end of the laser fiber trom from coming into contact with the reflecting surfaces of other instruments or products used in order to prevent any uncontrolled leakage radiation or damage to the tiber or tissue.
The loser moy be activated only oter precise targeting and inspection ot the tssue to be treated and with a correctly positioned fiber tip.
Remnants of blood and tissues or defects can lead to overheating and changes in the fiber tip, thus directly influencing the power density of the laser radiation and the resulting therapeutic fisue detects. Ihis can lead to a significant risk for the patient and the treating physician. If such an ettect is observed the distal end must be cleaned with the loser in a Standby state. It the full power of the laser cannot be restored, the tiber must be replaced.
During the treatment, the laser tiber can be cleaned with a sterile pad soaked with hydrogen peroxide or sterilized water.
WARNING: during dealing, the laser must be in a Standby state and the distal end of the fiber has been cooled down. In contact surgery treatments the distal end of the laser tiber should be moved over or placed on the fissue surtace without pressure. Avoid any loteral pressure.

Operating instruction

Reter fo the lser system User Manual for specific instructions concerning warnings, cautions, contraindications and clinical Use of the loser.
Check fist the expiration date. The sterile packaging must be checked for any defects. Fibers from opened or damaged packaging are not-sterile and must not be used.
Pertorm a visual inspection after the tiber has been removed trom the packaging. Ensure thot the distal end is intact ond thot the SMA plug is dean. Do not use fibers with a damaged dstol end or SMA plug.
Check the taces of the connector and of the distal tiber end tor soiling or foreign matter. Damaged or soiled faces can damage or destroy the product and/or the loser system used.

NOTE: only the Use of a suitable microscope objective (or magnifying glasS of a minimum 40x or 20x mognitricafions) con ossure on accurate inspection ot the connector’s force. Insert carefully the fiber connector in straight line into the fiber coupler of the laser device and tighten that by hand until you teel a resistance in doing that. Do not use tools. Please note that the tider coupler of the laser system moy be damaged, fi the fiber connector is handled improperly or tightened with too much torce. Switch on the loser device as shown in the User Manual and activate the aiming beam. Check the loser fiber once agoin for buckling, breakage and other detects. Pay special attention to the radiation leakage ot the aiming beam outside the distal end surtace. Direct the distal end at a non-reflecting surtace: the target beam should generate a sharply defined, non-trayed, circular light spot (Fig. A2). Any iregular output profile may result in lower emission quality (Fig. A1). ROCAMED-Single-Use-Sterile-Surgical-Laser-Fiber-
FIG-2

WARNING: If any damage is found, do not use the laser fiber! lt used in conjunction with a surgical instrument, make sure that the tiber tip extents out of the instrument.
WARNING: Please, consider that the tip of Balip fibers is typically degraded by use in a short time during laser treatment. I necessary, the tip can be refurbished (intraoperative dealing: see the Tip Returbishing Section) and the fiber con be used asa standard, frontal-emission, iber.

Tip Refurbishing

Please reter to the following instructions to refurbish the tiber tip during the treatment, when the degraded fiber tip results in a bad qulity of loser emission (intraoperative cleaving)

Use a pair of scissors, or a comic cutter, in order to cut off around 30 mm.
Use a pair of stripping pliers suitable tor the tiber diameter in order to strip the timber jacket by around 40 mm.
Manually remove the coating material (silicone).
Use a ceramic or equivalent fool in order to score a crak around 5 mm distant from the outer plastic jocket.
Pull the tiber tip oft in the direction of the longitudinal tiber axis, do not applya twisting or bending action (fig.B).
Check the beam pattern.

Properly dispose of separated quartz tip, then inspect the cleaved fip to assess cleove quality. Ifa better cleave is required or the obtained one is not satisfactory, repeat the cleavage procedure trom the beginning tll a sofistoctory cleave quality is achieved. A good cleave quality consists in the homogeneous and circular profile of the aiming beam (Fig. A2), whereas a bad quality one is characterized by a blurred protile with irregular regions (Fig. Al).
WARNING: When performing intraoperative timing, only sterile or sterilized devices can be used. If properly utilized, the same device can be used intraoperatively more than once exclusively tor trim the same fiber. Dispose and wasting
WARNING: Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or restabilization may compromise the structural integrity of the device ond/or led to a device failure which, in tum, may result in patient injury, illness or death. Reuse, reprocessing or sterilization moy also reate a nisk of contamination ot fhe device and/or couse potient infection or cross-infection, including but not limited to, the transmission of intectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness and death of the paient.
WARNING: Dipose of the lser fiber os a hospital waste folowing local lws.

Possible risks and/or complication
In order to ensure sate handling of the laser probe, you must first tully read ond understand this User Manual. Reter to the laser system User Manual for specic instructions concerning warnings, cautions, contraindications and dinical use of the laser. Complications that could occur during laser treatments include local ond/or systemic intection, thermal changes to the SUrrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or ater (laser) energy application. In the unlikely event of a detached tip, it may be visually located through an appropriote scope and removed using forceps. Irigate the area thoroughly to remove ony traces of the tip.