VersaPulse PowerSuite Operator Manual Rev B Oct 2018

2

This manual is copyrighted with all rights reserved. Under 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, and VersaPulse are registered trademarks of Lumenis. PowerSuite, Select, VersaCut, CaseSaver, InfraTome, and SlimLine are trademarks of Lumenis (Germany) GmbH. Caution - In the USA: Federal law restricts this device to sale by or on the order of a physician

Copyright © Lumenis (Germany) GmbH Catalog Part Number: 0637-117-01DE-L October 2018 Revision B

Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich-Dreieichenhain GERMANY Tel: +49 (0) 6103.8335.0

Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) In accordance with Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE), any item which is marked with the crossed-out wheelie bin symbol must not be disposed of as unsorted municipal waste, but segregated from other waste types for eventual treatment and recovery at an approved recycling facility. By returning waste electrical and electronic equipment via the correct segregated disposal channel, users can ensure the environmentally sound treatment and disposal of the waste equipment, thereby reducing the potential for any environmental or health risks that could arise as a result of incorrect disposal. Lumenis provides web-based collection, recycling and reporting arrangements to the business end-user for equipment marked with the crossed-out wheelie bin. Please visit www.Lumenis.com/Service-Support/Recycle to understand what arrangements Lumenis has made in each EU Member State.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

3

Table of Contents Safety and Regulatory

11

Introduction ... 11 Laser Safety Eyewear ... 12 Additional Ocular Protection ... 14 Additional Safety Considerations ... 15 Protecting Non-Target Tissues ... 15 Electrical Hazards ... 18 Fire Hazards ... 18

Compliance with International Standards ... 19 Emergency Off Push Button ... 19 Key Lock Switch ... 19 Laser Emission Indicators ... 19 External Door Interlock ... 19 Protective Housing... 19 Location of Controls ... 20 Safety Shutter ... 20 Manual Reset... 20 Electronic Fault Detection Circuitry ... 20 Safety Interlocks ... 20 Precision of Displayed Values ... 20 Warning, Certification and Identification Labels ... 21 Description of System Labels ... 23

Operation

26

Introduction ... 26 Characteristics of the Holmium and Nd:YAG Laser Wavelengths ... 27

Laser Preparation ... 27 VersaPulse PowerSuite Components ... 28 Laser Console... 30 External Door Interlock Plug ... 30 Single-Pedal Footswitch ... 30 Dual-Pedal Footswitch ... 30 Remote Control (Optional) ... 30 Delivery Systems ... 30

Laser Component Inspection ... 31 Delivery System Inspection ... 31 Connection Instructions... 32 Connecting the Optional Remote Control ... 32 Connecting the Footswitch ... 33 Inserting the External Door Interlock Plug ... 34

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

4

Plugging in the Main Power Cable (for removable wall plug configurations only) ... 35 Connecting the Delivery System ... 37

Laser Basics ... 39 Turning on the Laser ... 39 Restarting the Laser ... 40 Turning off the Laser ... 41 Emergency off... 41 Disconnecting the Laser and Delivery System ... 43 Moving the Laser Console ... 45

Aiming Beam Verification ... 46 General Laser Functions ... 47 System Beeps ... 47 Aiming Beam ... 48 Laser Status: Ready and Standby Modes ... 49

CaseSaver™ Mode ... 50 Setting Treatment Values ... 52 VersaPulse PowerSuite Dual-wavelength Laser ... 52 Selecting the Treatment Screen ... 54 VersaPulse PowerSuite Holmium Laser ... 55 Setting Holmium Treatment Values (for Dual-wavelength and Holmium Lasers) ... 56 Energy ... 56 Energy Bar Graph ... 57 Pulse Rate ... 59 Rate Bar Graph ... 60 Power ... 61 Total Energy ... 62 Setting Nd:YAG Treatment Values (for Dual-Wavelength laser only) ... 63 Timed or Continuous Exposure ... 63 Repeat Exposure ... 65 Power ... 67 Total Energy ... 68

Treatment Beam Delivery ... 69 VersaPulse PowerSuite Holmium Laser ... 69 VersaPulse PowerSuite Dual-Wavelength Laser ... 69 Dual-Pedal Footswitch Operation ... 69 Single-Pedal Footswitch Operation ... 69

Control Screen Messages ... 71 Advisory Messages ... 71 Laser Emission Message ... 71 Treatment Message ... 71 Footswitch Message (Dual-Wavelength Laser Only) ... 71

Optional Remote Control... 73

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

5

VersaPulse PowerSuite Dual-Wavelength Remote Control ... 73 VersaPulse PowerSuite Holmium Remote Control ... 74

Pre-Operative Instructions ... 75 Intra-Operative Instructions ... 76 Post-Operative Instructions ... 77 Holmium Average Power Tables ... 78

Maintenance

85

Troubleshooting Guide ... 85 User Maintenance ... 91 Annual Laser Maintenance ... 91 Laser Repair ... 91 Clean the External Surfaces of the Laser Console ... 91 Clean the Laser Control Screen ... 91 Inspect the Debris Shield Optic ... 92 Remove the Debris Shield ... 92 Inspect the Optic ... 93 Reinsert the Debris Shield ... 94 Change the Debris Shield Optic ... 95

Electrical Utilities ... 97 Systems Designed for Use Outside of Europe ... 97 Systems Designed for Use in European Communities Under the MDD ... 97 Hard-Wired Configurations ... 98 Removable or Lockable Wall Socket and Plug Configurations ... 98 Systems Designed for Use Outside of Europe ... 98 Systems Designed for Use in European Communities Under MDD ... 98

System Specifications ... 99 VersaPulse PowerSuite Dual-Wavelength Laser ... 99 Laser Medium ... 99 Treatment Beam Wavelengths ... 99 VersaPulse PowerSuite Holmium Laser ... 100 Laser Medium ... 100 Treatment Beam Wavelength ... 100 VersaPulse PowerSuite Dual-Wavelength and Holmium Lasers ... 100 Laser Classifications ... 100 Aiming Beam ... 100 Input Power ... 100 System Electrical Classifications ... 101 Cooling ... 101 Cooling air Requirements... 101 Physical Characteristics ... 101 Power Cable Length... 101 Footswitch Cable Length... 101

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

6

Environmental Requirements (Operating) ... 101 Environmental Requirements (Non-Operating) ... 101 Laser Safety Eyewear ... 101 Compatible Delivery Systems ... 102 Replacement Parts ... 102

External Door Interlock Pin Assignments ... 102 Professional Maintenance ... 103 Energy Detectors Calibration ... 103

Customer Service Information ... 105 Warranty ... 105 Decontamination of Returned Equipment ... 105 Returning the System to Lumenis ... 105

Clinical Guide

107

General Warnings, Precautions, and Complications to Consider When Using the Holmium and Nd:YAG Wavelengths ... 107 General Laser Warnings ... 108 General Laser Precautions ... 109 General Laser Complications ... 110

Indications for Use Specific to the Ho:YAG Wavelength ... 111 Arthroscopy Indications ... 111 Urology Indications ... 112 Urology Contraindications ... 112 Urology Warnings ... 113 Urology Precautions ... 113 Urology Complications ... 114 Urology Clinical Parameters ... 114 Urinary Lithotripsy Indications ... 115 Urinary Lithotripsy Contraindications ... 115 Urinary Lithotripsy Warnings ... 115 Urinary Lithotripsy Precautions ... 116 Urinary Lithotripsy Complications ... 117 Urinary Lithotripsy Clinical Parameters ... 118 E.N.T. Surgery Indications ... 119 E.N.T. Surgery Contraindications ... 119 E.N.T. Surgery Warnings ... 119 E.N.T. Surgery Precautions ... 121 E.N.T. Surgery Complications ... 121 E.N.T. Surgery Clinical Parameters ... 121 Gynecology Indications ... 122 Gynecology Contraindications ... 122 Gynecology Relative Contraindications ... 122 Gynecology Warnings ... 122

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

7

Gynecology Precautions ... 123 Gynecology Complications ... 123 Gynecology Clinical Parameters ... 123 General Surgery Indications ... 125 General Surgery Contraindications ... 126 General Surgery Relative Contraindications ... 126 General Surgery Warnings ... 126 General Surgery Precautions ... 126 General Surgery Complications ... 127 General Surgery Clinical Parameters ... 127 Gastroenterology Surgery Indications ... 129 Gastroenterology Surgery Contraindications ... 129 Gastroenterology Surgery Relative Contraindications ... 130 Gastroenterology Surgery Warnings ... 130 Gastroenterology Surgery Precautions ... 130 Gastroenterology Surgery Complications ... 130 Gastroenterology Surgery Clinical Parameters ... 131

Indications for Use Specific to the Nd:YAG Wavelength ... 133 Urology Indications ... 134 Urology Contraindications ... 134 Urology Warnings ... 134 Urology Precautions ... 135 Urology Complications ... 135 Urology Clinical Parameters ... 135 General Surgery Indications ... 136 General Surgery Contraindications ... 136 General Surgery Warnings ... 137 General Surgery Precautions ... 137 General Surgery Complications ... 137 General Surgery Clinical Parameters ... 137 Gynecology Indications ... 138 Gynecology Contraindications ... 138 Gynecology Warnings ... 139 Gynecology Precautions ... 139 Gynecology Complications ... 140 Gynecology Clinical Parameters ... 140 Dermatology and Plastic Surgery Indications ... 141 Dermatology and Plastic Surgery Contraindications ... 141 Dermatology and Plastic Surgery Warnings ... 141 Dermatology and Plastic Surgery Precautions ... 141 Dermatology and Plastic Surgery Complications ... 142 Dermatology and Plastic Surgery Clinical Parameters ... 142 E.N.T. Surgery Indications ... 143

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

8

E.N.T. Surgery Contraindications ... 143 E.N.T. Surgery Warnings ... 143 E.N.T. Surgery Precautions ... 143 E.N.T. Surgery Complications ... 143 E.N.T. Surgery Clinical Parameters ... 143 Podiatry Indications ... 144 Podiatry Contraindications ... 144 Podiatry Warnings ... 144 Podiatry Precautions ... 144 Podiatry Complications ... 144 Podiatry Surgery Clinical Parameters ... 145 Gastroenterology Surgery Indications ... 146 Gastroenterology Surgery Warnings ... 147 Gastroenterology Surgery Precautions ... 147 Gastroenterology Surgery Complications ... 147 Gastroenterology Surgery Clinical Parameters ... 147 Thoracic and pulmonary surgery indications ... 148 Thoracic and pulmonary surgery contraindications ... 148 Thoracic and pulmonary surgery warnings ... 148 Thoracic and pulmonary surgery precautions ... 148 Thoracic and pulmonary surgery complications ... 148 Thoracic and Pulmonary Surgery Clinical Parameters ... 149

EMC Guidance and Manufacturer’s Declarations

150

Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 150 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 151 Recommended separation distances between portable and mobile RF communications equipment and the VersaPulse PowerSuite ... 153

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

9

List of Illustrations Figure 1: Warning, Certification and Identification Labels: Front & Side Views ... 21 Figure 2: Warning, Certification and Identification Labels: Rear View ... 22 Figure 3: PowerSuite Laser Console ... 28 Figure 4: VersaPulse PowerSuite Components... 29 Figure 5: Connecting the Optional Remote Control ... 32 Figure 6: Connecting the Footswitch (single-pedal footswitch shown) ... 33 Figure 7: Inserting the External Door Interlock ... 34 Figure 8: Main Power Circuit Breaker and Main Power Plug ... 36 Figure 9: Connecting the Delivery System (InfraTome™ shown) ... 39 Figure 10: Controls for Turning on and Restarting the Laser ... 40 Figure 11: Controls for Turning off the Laser ... 42 Figure 12: Laser console cable wrap and footswitch storage mounts ... 44 Figure 13: Aiming Beam Intensity... 48 Figure 14: Laser Status ... 50 Figure 15: CaseSaver Mode Screen ... 51 Figure 16: Holmium Treatment Screen (Nd:YAG inset screen) ... 53 Figure 17: Nd:YAG Treatment Screen (Holmium inset screen) ... 53 Figure 18: Selecting the Treatment Screen ... 54 Figure 19: VersaPulse PowerSuite Holmium Control Screen ... 55 Figure 20: Holmium Energy per Pulse ... 57 Figure 21: Energy Bar Graph ... 58 Figure 22: Holmium Pulse Rate ... 59 Figure 23: Rate Bar Graph ... 60 Figure 24: Holmium Power ... 61 Figure 25: Holmium Total Energy ... 62 Figure 26: Nd:YAG Timed or Continuous Exposure ... 64 Figure 27; Nd:YAG Repeat Exposure ... 66 Figure 28: Nd:YAG Power ... 67 Figure 29: Nd:YAG Total Energy ... 68 Figure 30: Select the Nd:YAG Treatment Screen ... 70 Figure 31: Location of Control Screen Messages (Dual-wavelength Control Screen Shown) ... 72 Figure 32: VersaPulse PowerSuite Dual-wavelength Remote Control (Ho:YAG Screen Shown) ... 73 Figure 33: VersaPulse PowerSuite Holmium Remote Control ... 74 Figure 34: Holmium Average Power Table - 20 Watt Systems (maximum rate, 20 pulses/second) .. 78 Figure 35: Holmium Average Power Table - 30 Watt Systems (maximum rate, 25 pulses/second).. 79 Figure 36: Holmium Average Power Table - 45 Watt Systems (maximum rate, 40 pulses/second) .. 80 Figure 37: Holmium Average Power Table - 60 Watt Systems (maximum rate, 40 pulses/second) .. 81

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

10 Figure 38: Holmium Average Power Table - 80 Watt Systems (maximum rate, 40 pulses/second).. 82 Figure 39: Holmium Average Power Table - 100 Watt Systems (maximum rate, 40 pulses/second) ... 83 Figure 40: Average Power Table for VersaPulse PowerSuite 100 Watt Holmium systems operating in countries with an electrical supply of 220 VAC / 50 Hz. ... 84 Figure 41: Locate the debris shield ... 92 Figure 42: Remove the debris shield ... 93 Figure 43: Inspect the Debris Shield Optic ... 93 Figure 44: Reinsert the Debris Shield ... 94 Figure 45: Change the Debris Shield Optic ... 96 Figure 46: External Door Interlock Pin Assignments (solder side of plug shown) ... 102 Figure 47: Urology-Recommended Treatment Parameters, for Holmium Only... 114 Figure 48: Urinary Lithotripsy-Recommended Treatment Parameters, for Holmium Only ... 118 Figure 49: E.N.T. surgery-Recommended Holmium Treatment Parameters When Using the SlimLine Family of Fiber Optic Delivery Devices ... 121 Figure 50: Gynecology-Recommended Treatment Parameters, Holmium Only ... 124 Figure 51: General Surgery-Recommended Treatment Parameters, Holmium Only ... 128 Figure 52: Gastroenterology Surgery-Recommended Treatment Parameters, Holmium Only ... 132

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

11

Safety and Regulatory Introduction Users must take precautions to prevent exposure of laser energy to the eyes and skin from either direct or diffusely reflected laser beams, except as a therapeutic application. Additional precautions must be taken to prevent fire, electrical injury, and explosion. Lumenis does not make recommendations regarding the practice of medicine. Laser treatment parameters are provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints.

WARNING Unauthorized servicing or modification of this system, not described in this manual, may expose the surgeon/patient to potential electrical hazards.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

12

Laser Safety Eyewear The following specifications were calculated for this system: System

Wavelength Used

Maximum Permissible Exposure

Nominal Ocular Hazard Distance

VersaPulse PowerSuite

2.1 µm

20 J/m2

2M

VersaPulse PowerSuite Dual-Wavelength

2.1 µm

25 J/m2

1.7 M

VersaPulse PowerSuite Dual-Wavelength

1064 nm

1.28 J/m2

5.2 M

All personnel who are within the Nominal Ocular Hazard Distance (NOHD) are considered to be within the controlled area and must wear eye protection according to the following specifications: System

Wavelength Used

Minimum Optical Density

Protection Level

VersaPulse PowerSuite

2.1 µm

3.0

DI LB3

VersaPulse PowerSuite Dual-Wavelength

2.1 µm

2.0

DI LB3

VersaPulse PowerSuite Dual-Wavelength

1064 nm

4.0

D LB5 I LB7

WARNING Select the appropriate laser safety eyewear, for the specific laser in use, by verifying that the above specifications are indicated on the laser safety eyewear that is at your disposal. WARNING Always provide eye protection for the patient. Wet thick cloths or wet gauze 4 x 4s can be use together with the patient protective eyewear to reduce patient inconvenience. Never use them to replace protective goggles.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

13

WARNING For periorbital treatment, always protect the patient with dulled, metal eye shields, as severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam. Laser safety eyewear must meet all additional requirements as per ANSI Z136.1 and EN 207. In addition to providing the required laser safety eyewear, take the following steps to secure the treatment room, or the controlled area: 1. To alert personnel before they enter the controlled area, place a warning sign on the outside of the treatment room door when the laser is in use. 2. Close the treatment room door during operation of the laser. 3. External door interlocks that automatically disable the laser when the treatment room door is opened may be installed. NOTE A blocking barrier, screen, or curtain capable of blocking or filtering the laser beam could be placed to create a controlled area inside a large operating room. The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time, relative to the configuration of the controlled area and the treatment parameters for the specific medical application.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

14

Additional Ocular Protection WARNING Always verify that the delivery device is properly connected to the laser. An improper connection may result in an inadvertent secondary laser beam. Severe eye or tissue damage could occur. WARNING Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe eye damage could occur. Prescription eyewear can concentrate the laser light to the eye and/or can be shattered by a high power density beam, possibly causing severe eye damage. WARNING Use caution when performing procedures around the eyes. Severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam. The predominant ocular structures at risk are dependent on the laser wavelength in use. In general, visible and near-infrared wavelengths are most damaging to the retina, while ultraviolet or infrared wavelengths are most damaging to the cornea and sclera. Severity of injury depends on how concentrated or diffused the treatment beam is and the length of exposure. A thorough understanding of the specific ocular risks and safety precautions for each laser wavelength is necessary to ensure the safety of the patient and operating personnel. WARNING Never look directly into any optical lens, optical fiber, handpiece, probe, laser articulated arm, or laser system aperture while the laser is energized. Severe eye damage could occur. Turn off the laser before inspecting any delivery system or laser components.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

15

Additional Safety Considerations CAUTION US federal law restricts this device to sale by or on the order of a physician. CAUTION Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments.

CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. CAUTION Smoke evacuation may be required if using the laser in open-air procedures.

Protecting Non-Target Tissues WARNING When using a fiber optic delivery device, always inspect the fiber optic cable to ensure that it has not been kinked, punctured, fractured, or otherwise damaged. The fiber optic cable may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not clamp the cable with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting the cable. A damaged fiber optic cable may cause accidental laser exposure or injury to

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

16

the treatment room personnel or patient, and/or fire in the treatment room.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

17

WARNING Never deliver the treatment beam to the target tissue if the aiming beam is not visible; the fiber optic cable may be damaged. A damaged cable may cause accidental laser exposure to the treatment room personnel or patient, and/or fire in the treatment room. WARNING Except during actual treatment, the laser must always be in standby mode. Maintaining the laser in standby mode prevents accidental laser exposure if the footswitch is inadvertently depressed. CAUTION To prevent accidental laser discharge, always turn off the laser before connecting the delivery system. CAUTION Never place hands or other objects in the path of the laser beam. Severe burns could occur. CAUTION Only the person directing the aim of the laser beam should have access to the laser footswitch. Use caution depressing the laser footswitch when it is in proximity to footswitches for other equipment. Make sure the footswitch depressed is the correct one to avoid accidental laser exposure. CAUTION Never discharge the laser without a target to absorb it and without consideration given to what lies behind the target. Place energy-absorbing material behind the target tissue when aiming the laser at an oblique target.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

18

Electrical Hazards WARNING Never open the laser console protective covers. Opening the covers will expose the user to high voltage components, the laser resonator, and possible laser radiation. Only Lumenis-certified service technicians shall work inside the console. WARNING The area around the laser and footswitch should be kept dry. Do not operate the laser if any of the cords are faulty or frayed. The laser should undergo routine inspection and maintenance per Lumenis manufacturer’s recommendations and institutional standards.

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 and/or fire could occur. WARNING The treatment beam can ignite most non-metallic materials. Use fire retardant drapes and gowns. The area around the treatment site can be protected with towels or gauze sponges moistened with sterile saline solution or sterile water. If allowed to dry, protective towels and sponges can increase the potential fire hazard. A ULapproved fire extinguisher and water should be readily available. WARNING When performing procedures in the perianal area, the flammability of methane gas must be considered. Moistened sponges should be inserted into the rectum.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

19

Compliance with International Standards In accordance with regulations a recommended routine inspection and maintenance schedule is provided in the System Requirements and General Information section of this manual. In compliance with these standards, the system is equipped with the following:

Emergency Off Push Button The laser has an emergency off push button that, when pushed, immediately turns off the laser in emergency situations.

Key Lock Switch The laser can only be turned on with the master key. The key can only be removed in the off position, and the laser only operates with the key in place. When the key switch is turned to the start position, power is available to the laser. When treatment is complete, always remove and secure the key to prevent unauthorized use of the laser.

Laser Emission Indicators “Laser emission” appears on the control screen at all times to alert the user that laser energy is available. Before treatment beam delivery, the laser emits a high-pitched double beep to indicate Holmium laser emission or a low-pitched single beep to indicate Nd:YAG laser emission. During treatment beam delivery, “Treat Ho” or “Treat Nd” appears on the Dual-wavelength laser control screen, and “Treatment Ho” or “Treatment Nd” appears on the remote control. “Treatment” appears on the Holmium laser control screen and remote control.

External Door Interlock An external door interlock outlet and plug are provided to disable the laser if the treatment room doors are opened while the laser is in ready mode.

Protective Housing The laser has a protective housing that prevents unintended human access to laser radiation. No sections of the protective housing can be

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B

20

easily opened without special tools. This housing is to be opened only by a Lumenis-certified technician.

Location of Controls The controls are located on the control screen and the remote control so the user need not be exposed to the treatment beam.

Safety Shutter The laser features a safety shutter that prevents the treatment beam from exiting the laser. The safety shutter opens only when the laser is in ready mode and the footswitch is depressed.

Manual Reset If laser emission is interrupted during treatment (e.g., main electrical power loss), the laser automatically turns off. To resume treatment, you must manually restart the laser with the key switch. (See “Restarting the laser” in the Operation section of this manual.)

Electronic Fault Detection Circuitry If any of the electronic system monitors detect a fault condition, laser exposure cannot occur. The high voltage power supply disables, the safety shutter closes, and the footswitch disables.

Safety Interlocks The laser has a safety interlock on the fiber optic laser connector in accordance with Section 1040 of 21 CFR.

Precision of Displayed Values The precision of the energy and rate values displayed on the control screen are factory preset to within ±5% of a calibrated standard. The energy of every pulse is monitored by two internal detectors to ensure no safety hazard is caused by failure of a single component. If the delivered system energy deviates from the commanded parameters by more than 20%, the user is notified but allowed to continue. If the deviation is greater than 50%, the treatment is stopped, the user is notified of the fault, and allowed to continue.

VersaPulse ® PowerSuite ™ Holmium and Dual-Wavelength Surgical Lasers 0637-117-01DE-L, Rev. B