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Lumenis

®

 Pulse

TM

 50H / 100H Laser Systems 

Indications for Use

UM-20006520DE, Rev. A

Page 24

Indications for Use

The Lumenis Pulse 50H and 100H system with delivery devices and 
accessories are intended for use in surgical procedures involving open, 
laparoscopic and endoscopic ablation, vaporization, excision, incision, 
and coagulation of soft tissue in medical specialties including: urology; 
urinary lithotripsy; arthroscopy; discectomy; endo-nasal surgery; 
gynecological surgery; pulmonary surgery; gastroenterology surgery; 
dermatology and general surgery.

Contraindications

The use of a laser instrument for an application is at the physician’s 
discretion except in cases where the indication has been contraindicated.

• Inability to receive endoscopic or laparoscopic treatment.

• Intolerance to anesthesia.

• Resection or excision of large, highly vascularized organs.

Specific Contraindications in Urology

• Carcinoma of the prostate

Specific Contraindications in Gynecology

• Septic peritonitis

• Intestinal obstruction

• Septic shock

• Resection or excision of large, highly vascularized organs.

NOTE:

Lumenis has no clinical information concerning the safety of laser 
treatment on pregnant or nursing women.

Warnings and Precautions

This section contains warnings and precautions that are applicable to 
surgical procedures specifically related to the use of this system.

• Holmium lasers are intended solely for use by physicians trained in the 

use of the Ho:YAG (2.1 µm) wavelength.

• Incorrect treatment settings can cause serious tissue damage. Therefore, 

it is recommended that you use the lowest acceptable treatment settings 

Содержание PULSE 100H

Страница 1: ...Holmium Surgical Lasers Operator s Manual Lumenis PULSE 50H 100H TM...

Страница 2: ...art Number UM 20006520DE July 2015 Revision A Manufactured by Lumenis Germany GmbH Heinrich Hertz Strasse 3 D 63303 Dreieich Dreieichenhain Germany Tel 49 0 6103 8335 0 Directive 2012 19 EU on Waste E...

Страница 3: ...otswitch 10 Optical Fibers 11 Component Checklist 11 Chapter 2 Theory of Operation 12 Laser Power Parameters 12 Chapter 3 Safety 14 Introduction 14 Optical Hazards 14 Laser Safety Eyewear 14 Additiona...

Страница 4: ...Surgery 32 Chapter 5 Preparing the System for Use 33 Moving the Laser System Console 34 Connecting the Footswitch 35 Connecting the External Door Interlock Connector 36 Plugging in the Main Power Cabl...

Страница 5: ...Panel 53 System Overheats 54 Message Appears Attach an Authorized Fiber 54 Message Appears Attach fiber 54 Message Appears Attach footswitch 54 Message Appears Check footswitch 55 Message Appears Che...

Страница 6: ...e With International Standards 68 Emergency Stop Button 68 Keyswitch 68 Laser Emission Indicators 68 External Door Interlock 68 Protective Housing 68 Safety Shutter 68 Manual Reset 69 Electronic Fault...

Страница 7: ...ncluding all Safety and Regulatory sections should be carefully read and comprehended before operation Lumenis medical lasers and laser optical fibers are intended solely for physicians trained in the...

Страница 8: ...ual refers specifically to the Pulse 50H system or to the Pulse 100H system Manual Conventions NOTE A Note is a statement that alerts the operator to particularly important information CAUTION A Cauti...

Страница 9: ...Features The Lumenis Pulse 50H or Pulse 100H laser system comprises the following main components and features Laser system console Rotatable control panel with touch screen technology Dual pedal foo...

Страница 10: ...vered to the treatment site Touch Screen Control Panel The control panel is an LCD monitor with touch screen technology that allows the operator to select treatment settings outside of the sterile fie...

Страница 11: ...0H and Lumenis Pulse 100H laser systems Lumenis fibers incorporate Security Identification System SIS technology Refer to the appropriate optical fiber s instruction guide for specific operating instr...

Страница 12: ...a sufficient amount of water that absorbs the laser energy leading to lithotripsy When working in liquid environment the holmium laser energy provides additional safety since laser energy will be abso...

Страница 13: ...the appropriate energy and frequency settings is dependent on the procedure and specific target tissue Each pulse is delivered at a specific time frame leading to fast heating rise in temperature of t...

Страница 14: ...mance of procedures other than those specified herein may result in hazardous laser radiation exposure Optical Hazards Laser Safety Eyewear The following specifications were calculated for this system...

Страница 15: ...y result in an inadvertent secondary laser beam Severe eye or tissue damage could occur Never substitute prescription eyewear for the appropriate laser safety eyewear as severe eye damage could occur...

Страница 16: ...Fire Hazards WARNING Do not use this device in the presence of flammables or explosives such as volatile anesthetics alcohol certain surgical preparation solutions and similar substances An explosion...

Страница 17: ...laser exposure to the treatment room personnel or patient and or fire in the treatment room Except during actual treatment the laser system must always be in Standby mode Maintaining the laser system...

Страница 18: ...or the left and right pedals When lasing a lasing emission indicator appears on the screen Warning Certification and Identification Labels As required by national and international regulatory agencies...

Страница 19: ...1040 11 LB 20001720_A except for deviations pursuant to Notice 50 dated June 24 2007 LASER CLASS 4 IV Holmium YAG 2 1 m 3 5 J max 600 s pulse max LASER CLASS 3R Illa DSPP Laser 532 nm 5 mW max CW VISI...

Страница 20: ...isible Laser Radiation Avoid eye or Skin Exposure to Direct or Scattered Radiation Class 4 laser product per IEC 60825 1 2007 CLASS IV LASER PRODUCT per 21 CFR 1040 10 1040 11 except for deviations pu...

Страница 21: ...y Laser Stop Fiber Connection Port Aperture External Interlock Connection Footswitch Connection Rx ONLY Caution U S federal law restricts this device to sale by or on the order of a physician CSA Comp...

Страница 22: ...ter 1940 nm The absorption of the laser energy by water produces an energy density that heats the tissue to greater than 100 C thus vaporizing or ablating the tissue without deep coagulation allowing...

Страница 23: ...orption in water is advantageous when working in a water filled environment as it enables safe delivery of energy without harming non targeted tissue Any water that interfaces between the laser and th...

Страница 24: ...indicated Inability to receive endoscopic or laparoscopic treatment Intolerance to anesthesia Resection or excision of large highly vascularized organs Specific Contraindications in Urology Carcinoma...

Страница 25: ...tical fiber is within the scope can result in penetration of holmium laser energy through the scope and destruction of the scope Use of the laser system on anatomical structures in proximity to known...

Страница 26: ...reatment Remnants of destructed tissue may become necrotic or infected If a question of infection exists appropriate treatment should be carried out Patients may experience bleeding at the site of las...

Страница 27: ...lmium laser resection of the prostate HoLRP hemostasis vaporization and excision for treatment of benign prostatic hypertrophy BPH Open and endoscopic urological surgery ablation vaporization incision...

Страница 28: ...tomy Plica removal Ligament and tendon release Contouring and sculpting of articular surfaces Debridement of inflamed synovial tissue synovectomy Loose body debridement Chondromalacia and tears Latera...

Страница 29: ...iopsy pylorostenotomy and removal of polyps of the sigmoid colon Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs tumors and les...

Страница 30: ...ocystorhinostomy DCR Functional endoscopic sinus surgery FESS Endonasal surgery ablation vaporization incision excision and coagulation of soft tissue including Lesions or tumors of the oral nasal glo...

Страница 31: ...calculi Benign and malignant neoplasm Polyps Colitis Ulcers Angiodysplasia Hemorrhoids Varices Esophagitis Esophageal ulcer Mallory Weiss tear Gastric ulcer Duodenal ulcer Non bleeding ulcer Gastric...

Страница 32: ...tion of soft mucosal fatty and cartilaginous tissues in therapeutic plastic dennatologic and aesthetic surgical procedures including Scars Vascular lesions Port wine stains Hemangioma Telangiectasia o...

Страница 33: ...rgery including inspecting and cleaning the laser and optical fibers connecting disconnecting and sterilizing the delivery systems and verifying the aiming beam integrity These procedures are detailed...

Страница 34: ...As with any heavy equipment use caution when tilting the laser console or moving it up or down an incline For optimum safety use a second person when moving up or down a steep incline NOTE Do not mov...

Страница 35: ...tswitch receptacle on the rear of the laser system console Align the red dot on the footswitch connector on top then press it in Figure 4 Connecting the Dual Pedal Footswitch NOTE If the footswitch is...

Страница 36: ...1 Align the pins of the external door interlock connector with the socket of the external interlock receptacle 2 Insert the external interlock connector into the external interlock receptacle 3 Turn t...

Страница 37: ...main power circuit breaker is in the off down position 3 Insert the laser system s main power plug into the wall socket If the laser system has a locking plug and socket connect the plug collar to the...

Страница 38: ...tical fiber sterile packaging to ensure that it has not been torn or punctured If there is any damage to the sterile packaging do not use the optical fiber When using an optical fiber always inspect t...

Страница 39: ...cal fiber packaging do not use a optical fiber whose expiration date has passed NOTE SIS Secure Identification System enabled Lumenis Pulse 50H and Lumenis Pulse 100H laser systems will only operate w...

Страница 40: ...tor to the laser system by screwing the connector into the optical fiber receptacle on the front of the laser system If the laser connector is not properly seated and securely screwed into the optical...

Страница 41: ...ical fiber and result in unintended laser exposure CAUTION Do not remove the protective cap from the laser connector in the sterile field Removing the protective cap in the sterile field may compromis...

Страница 42: ...diately disable emission of the laser energy Refer to figure 8 NOTE When the main power cable is connected to the electrical source some internal circuits remain energized To de energize all internal...

Страница 43: ...e the spring loaded key rotates to the on position A laser self test and warm up begin The self test and warm up take approximately one minute As internal tests are performed self test pass fail messa...

Страница 44: ...the Energy Frequency and Pulse width settings for lasing when the corresponding pedal is pressed Press the or selectors to reach the desire settings the derived power will be displayed 4 Pulse Width t...

Страница 45: ...he display automatically resets to zero the first time you press Ready after turning on the laser system to allow reading of the total Energy of last treatment To manually reset the display press the...

Страница 46: ...arameter areas are highlighted by a yellow margin surrounding the applicable pedal on the screen see figure 10 when the appropriate pedal is pressed to alert the operator that laser energy is being em...

Страница 47: ...am is set to high intensity and is still weak or not visible the optical fiber may be damaged A damaged optical fiber may cause accidental laser exposure or injury to the treatment room personnel or p...

Страница 48: ...tment beam As the laser delivers the treatment beam the highlighted yellow margin appears around the appropriate footswitch settings area on the control screen and an audible signal sounds to alert yo...

Страница 49: ...opriate optical fiber instruction guide 4 Set the laser system s main power circuit breaker to the Off down position 5 Turn off the mains circuit breaker 6 Remove the main power plug from the wall rec...

Страница 50: ...nt and rear handles move the laser system to the desired site CAUTION As with any heavy equipment use caution when tilting the laser console or moving it up or down an incline For optimum safety use a...

Страница 51: ...task as detailed in the message If the error is resolved the message will fade and normal operation may be resumed 3 Several types of errors will not fade in a case like this press the Standby button...

Страница 52: ...oes not illuminate 1 Plug in the laser system 2 Set the laser system s main circuit breaker to the On up position 3 Turn on the main electrical circuit breaker 4 Use another power outlet or have the o...

Страница 53: ...recognized Fiber 1 Replace the optical fiber with a Lumenis compatible one and resume normal operation 2 If problem persists contact Lumenis Service A Notification or Error Message Appears on the Cont...

Страница 54: ...al operation Message Appears Attach an Authorized Fiber SIS enabled Lumenis Pulse 50H and Lumenis Pulse 100H laser systems will only operate with Lumenis qualified SIS Secure Identification System opt...

Страница 55: ...o lasers The system is experiencing a laser malfunction Contact Lumenis Customer Service Message Appears Energy high The energy delivered is more than 50 higher than the selected level Press the Stand...

Страница 56: ...nd resume normal operation If the condition continues turn off the laser system for five seconds then turn it back on If the condition persists contact your Lumenis Customer Service Message Appears Ra...

Страница 57: ...tal Clinic Staff If damage is found call Lumenis Customer Service Check remote interlock connection and emergency stop button Weekly Hospital Clinic Staff If interlock and or button do not perform as...

Страница 58: ...opyl alcohol or a hospital grade disinfectant solution CAUTION Do not spray or pour cleaning agents directly on the laser console or control screen You may damage the console screen and laser system e...

Страница 59: ...ch 3 Press the Ready button on the LCD or footswitch to enable lasing If this is not the situation discontinue use and contact Lumenis Service Inspect the Debris Shield The debris shield protects the...

Страница 60: ...d Inspect the Optic Inspect the debris shield optic to verify that it is free of any burn marks scratches dust or fingerprints If the optic is damaged or dirty replace it as instructed in Change the D...

Страница 61: ...rt the Debris Shield 1 Holding the debris shield handle position the shield so that the pin is aligned with the pin groove 2 Insert the debris shield into the debris shield receptacle 3 Replace the pa...

Страница 62: ...surface of the debris shield optic with your fingers 4 Carefully turn over the vial and allow the optic to drop onto a lens cleaning tissue 5 Lay the debris shield over the new debris shield optic 6 H...

Страница 63: ...ineer or technician qualified to work with laser equipment Questions regarding this procedure should be referred to Lumenis Customer Service DISCLAIMER Calibration is a service procedure to be done on...

Страница 64: ...of the optical fiber 3 Turn on the laser system as instructed earlier in this manual 4 Set the laser system to deliver 5 Watts of laser energy 5 Target the aiming beam at the detector disc of the exte...

Страница 65: ...the laser system Thereafter you or the nursing staff at your facility will perform the daily maintenance routines associated with the laser system and any delivery systems used during surgery If your...

Страница 66: ...ion supply the electrical power from a dedicated 200 208 or 230 VAC single phase 50 60 Hz supply mains in accordance with local codes The socket and wall plug connection must be rated for 30A 60 Hz or...

Страница 67: ...is removed while the laser system is in Ready mode The interlock can be set up with a remote switch or an external switch can be wired to the interlock plug Plug wiring shall only be performed by a q...

Страница 68: ...r patient to poten tial electrical energy and laser radiation hazards Laser Emission Indicators A laser emission indicator appears on the control screen to alert you that laser energy is being emitted...

Страница 69: ...has a safety interlock on the optical fiber laser connector Precision of Displayed Values The precision of the energy and rate values displayed on the control screen are factory preset to within 5 of...

Страница 70: ...r Type Green DPSS continuous wave Laser wavelength 532 nm Laser Classifications FDA classification Class IIIa laser EN 60825 classification Class 3R laser Power 5 mW maximum Input power recommended se...

Страница 71: ...Numbers Compatible Optical Fibers The laser system is intended for use only with Lumenis qualified optical fibers Contact Lumenis Customer Service for a list of available products Pressure 77 106 kPa...

Страница 72: ...stomer with cleaning costs Any decontamination inquiries should be directed to Lumenis Customer Service Customer Service and Warranty For specific and detailed warranty information for this instrument...

Страница 73: ...Pulse 50H 100H systems use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CIS...

Страница 74: ...typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment 2 kV co...

Страница 75: ...e in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the...

Страница 76: ...imum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d...

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