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UM-20061740EN - C Moses Family of Fibers DFU - English
UM-20061740EN - C Moses Family of Fibers DFU - English
Instruction Guide
Indications for Use To avoid damage to the fiber
Lumenis Moses fibers are intended for use with the • Do not pull on the fiber when it is connected to the laser.
compatible laser systems in surgical procedures involving • Avoid clamping or clipping any devices such as a hemostat
open, laparoscopic, and endoscopic ablation, vaporization, on to the fiber.
excision, incision, coagulation of soft tissue and for • Avoid any contact of metallic instruments with the fiber
lithotripsy. For the safe use of the fibers, read and tip.
comprehend these instructions and the appropriate laser • Ensure that the scope port is open prior to inserting the
system operator’s manual1 before use. fiber into the scope.
• Ensure laser calibration maintenance was performed
Compatible Systems according to Lumenis’ recommendations, and that it
The Lumenis Moses family of fibers is compatible with the supports all types of Moses fibers. An uncalibrated
Lumenis Pulse™ 120H laser system. system may lead to fiber damage.
UM-20061740EN, Revision C 1
5. Inspect the fiber for kinks, punctures, fractures, or other fiber or return it to the supplier for replacement. In the first
damage. If the fiber appears damaged, do not use the use of the Moses 200 D/F/L fiber, the spot may be a bit dif-
fiber; return it to the supplier for replacement. For the ferent due to the ball shape of the tip.
Moses 200 D/F/L fiber, verify that the ball tip is complete
and not damaged. Circulating nurse:
WARNING - A damaged fiber may cause accidental 12. Set the laser treatment parameters, as instructed in the
! laser exposure or injury to the treatment room laser operator’s manual.
personnel or patient, and/or fire in the treatment room.
WARNING - Ensure the fiber is properly handled so that At any energy setting, the repetition rate should be
it is not damaged by being stepped on, pulled, left lying ! adjusted so as not to exceed the power specification
listed in the specifications table. The maximum allowed
in a vulnerable position, kinked or tightly coiled.
energy for the Moses 200 D/F/L fiber is 2J.
WARNING - Do not clamp the fiber with a hemostat or
other instruments.
WARNING - If sterile tape is used to secure the fiber, Intra-Operative Instructions
always remove the tape before lifting the fiber.
1. Position the aiming beam on the target tissue or
6. Hand the laser connector to the circulating nurse. calculi.
7. Secure the distal portion of the fiber in the sterile field 2. Ensure that the fiber tip is visible through the operating
scope. Verify that the fiber tip was not damaged during
until ready for use.
the insertion of the fiber through the scope.
Circulating nurse: 3. Place the laser in ready mode.
8. Hold the laser connector and remove the protective cap. 4. Press the footswitch to deliver the treatment beam.
Do not hold the rubber strain relief or the fiber.
NOTE - With the Moses 200 D/F/L fiber, the ball tip will fall
after initial emission of the laser.
Protective
Cap
WARNING - Improper use of the fiber or use of a
! damaged fiber may result in severe eye or tissue
damage, fire in the treatment room, or accidental laser
exposure to the treatment room personnel or patient.
Refer to the appropriate laser operator manual for
detailed safety information.
CAUTION - Do not touch the tip of the fiber
! connector.
Fiber tip renewal during operation
WARNING - When removing the protective cap hold the
! laser connector, not the strain relief or fiber-optic cable. For the Moses 200 D/F/L fiber, only the cleaving
Pulling on the strain relief or fiber-optic cable may instructions in this section are relevant.
damage the fiber and result in unintended laser
exposure.
WARNING - Do not remove the protective cap from the Strip the fiber using the stripper
laser connector in the sterile field. Removing the
protective cap in the sterile field may compromise 1. Insert the fiber into the stripper so that the tip extends
sterility. two centimeters past the blades.
9. Insert the laser connector into the fiber receptacle on the 2. Squeeze the stripper handles with one hand while
front of the laser console, and finger-tighten. gripping the fiber with the other hand.
3. Rotate the stripper 90°, and quickly pull the fiber
10. Turn on the laser, and set the aiming beam to high
from the strippers.
intensity, as instructed in the laser operator’s manual.
Cut the fiber using scissors
Scrub nurse:
1. Position the fiber tip between the scissor blades so that
11. Hold the fiber tip to a nonreflective surface, and ensure
the tip is perpendicular to and extending
that a circular green spot appears. If the spot is not circular, approximately one centimeter past the blades.
re-cleave the fiber (see “Fiber tip renewal during operation”
for details). If the spot is weak or not visible, discard the 2. Quickly cut the fiber.
2 UM-20061740EN, Revision C
OR: Storage and Usage Conditions
Cleave the fiber tip Store at room temperature under dry and clean conditions.
Do not expose to organic solvents, ionizing radiation or
1. Position the fiber tip between the thumb and forefinger. ultraviolet light. Rotate inventory so that fibers are used
2. Gently score the fiber once, one centimeter from the prior to the expiration date on the package label.
stripped fiber tip.
Laser Safety Eyewear
3. Pull the tip straight away from the fiber. Do not break
with a sideways motion. The Laser Safety Officer at your facility should determine
the need for safety eyewear based on the optical parameters
outlined in the appropriate laser operator’s manual. For
Inspect the quality of the renewed optical fiber
detailed laser safety eyewear information, carefully read the
After stripping and cleaving the optical fiber, inspect the laser system operator’s manual before use.
quality of the cleave by directing the aiming beam onto a
piece of non-reflective material, such as a tongue depressor. Decontamination of Returned Equipment
Hold the tip of the fiber perpendicular to and approximately In order to comply with postal and transportation laws,
1.0 centimeter from the surface, and examine the output equipment shipped to the supplier’s offices for return or
pattern of the laser spot. A well-defined circular pattern repair must first be decontaminated. To communicate that
indicates an ideal cleave. An ill-defined pattern indicates an the returned equipment has been properly decontaminated,
unacceptable cleave. a signed Decontamination Certificate (obtained from
Customer Service) must be enclosed in the shipping
Ideal Acceptable Unacceptable
package. Failure to enclose the Decontamination Certificate
will cause the supplier to assume the product is
contaminated. The supplier will assess the customer with
cleaning costs. Any decontamination inquiries should be
directed to Customer Service.
Poor cleaves are often the result of too much pressure Warranty Information
applied when scoring ("nicking") the fiber; bearing the fiber
Lumenis warrants this fiber to be free from defects in
with a sideways - instead of longitudinal - pull; or cutting
materials and workmanship, and to perform in the manner
the tip at an angle other than 90°.
and under the conditions specified in this instruction guide.
Post-Operative Instructions The customer is entitled to a replacement or credit for a
fiber that is defective upon initial inspection of the sterile
The fiber must be disposed of according to local regulations
packaging or upon first use when properly connected to the
applying to hazardous biological substances due to danger of
laser. The defective fiber must be returned to the company
contamination through contagious germs. from which it was purchased.
WARNING - The fiber must not be reprocessed and/or
! re-used. Invisible debris may remain on the fiber that
can heat up during use, causing possible destruction of
the fiber or injury to the patient.
WARNING - Resterilization and use of the fiber more
than once can lead to degradation of the fiber’s
performance envelope, creating a possible injury hazard
to the patient.
UM-20061740EN, Revision C 3
Regulatory Symbols Specifications
As required by national and international regulatory
Moses Family of Delivery Fibers Holmium
agencies, appropriate warning labels are located on the outer
Specifications Air Water
packaging.
Compatible Wavelengths
Symbol Glossary Moses 200 D/F/L fiber: 2.0 J
Maximum Input
Moses 365 D/F/L fiber:
Energy 6.0 J
Symbol Description Moses 550 D/F/L fiber:
Manufactured for Moses 200 D/F/L fiber: 60 W
Manufactured for Lumenis, Energy to Maximum Input
Moses 365 D/F/L fiber:
Healthcare Power 120 W
Moses 550 D/F/L fiber:
Legal Manufacturer
NOTE - The actual maximum specifications are subject to
the laser system’s limitations. The specifications above
detail the maximum allowed energy and power.
CE compliance
0483
Fiber Specifications 200 365 550
2
STERILIZE
Do not re-sterilize
Do not re-sterilize
2 Do not re-use
Do not re-use
4 UM-20061740EN, Revision C
0483
Lumenis Ltd.
Yokneam Industrial Park
Hakidma Street 6
P.O.Box # 240
Yokneam 2069204, Israel
Tel: + 972.4.959.9000
Authorized Representative in the European Community:
Lumenis (Germany) GmbH
Heinrich-Hertz-Strasse 3
D-63303 Dreieich-Dreieichenhain
Germany
Tel: + 49.6103.8335.0
Copyright ©2017, Lumenis Ltd.
UM-20061740EN, Revision C
July 2017
This instruction guide is copyrighted with all rights reserved.
Under the copyright laws, this manual may not be copied in whole
or in part or reproduced in any other media without the express
written permission of Lumenis. Permitted copies must carry the
same proprietary and copyright notices as were affixed to the
original. Under the law, copying includes translation into another
language.
Please note that while every effort has been made to ensure that
the data given in this document is accurate, the information,
figures, illustrations, tables, specifications and schematics
contained herein are subject to change without notice.
Lumenis, the Lumenis logo, VersaPulse, PowerSuite and Moses are
trademarks or registered trademarks of Lumenis.
UM-20061740EN, Revision C 5