Lightlas 532 Service Manual Rev 05

Service Manual for the LightLas 532 Medical Frequency Doubled YAG Laser Only authorized Service personnel should attempt to perform the procedures contained within this Service Manual. The manufacturer can organise detailed Service Training for authorized agents. The manufacturer will under no account accept any responsibility for any conditions arising as a result of unauthorized maintenance or adjustments to the LightLas 532 Medical Frequency Doubled YAG Laser. This Service Manual should be fully studied and understood before proceeding to operate or service the equipment. For further details relating to the operation of the LightLas 532 Medical Frequency Doubled YAG Laser the Service Manual should be referred to. CAUTIONS - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Any modification to the LightLas 532 Medical Laser will result in the necessity for it to be reclassified. CAUTIONS - US Law restricts this device to sale by or on the order of a physician. This Service Manual contains confidential and proprietary information of the manufacturer. Manufactured by:

LightMed Corporation, No.1-1, Ln. 1, Pao-An St.

Sec. 3,Shulin Dist., New Taipei City 23861, Taiwan USA Address: 1030 Calle Cordillera, Suite 101, San Clemente, CA 92673 Tel No.: 949-218-9555 Fax No.: 949-218-9556 Copyright © LightMed Corporation EU Representative: Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover, Germany Document Title: Service Manual for the LightLas 532 Medical Frequency Doubled YAG Laser. Document Number: DC2000-532 Document Revision History:  October 2001 - Draft prepared  March 2002 - Second version updated information  May 2002 - Third version with new Installation section, new drawings, CE Mark information, Change to Revision 01  March 2003 - Rev.02 Modify drawings  February 2004 - Rev. 03 Safety Glasses description change; Delete Warranty Statement  January 2005 - Rev. 04 Change EU Representative to ALF in ITALY 2



November 2010 -

Rev. 05 Update the current modification, service procedure.

3

Contents of Manual SECTION

PAGE

1. INTRODUCTION

9

1.1 General

9

1.2 How to Use the Manual

10

2. SAFETY

11

2.1 Product Classifications

11

2.2 Warnings and Precautions

13

2.3 Optical Hazards

14

2.3.1 Nominal Ocular Hazard Distance (NOHD)

14

2.3.2 Avoid Exposure to Laser beams

15

2.4 Electrical Hazards

15

2.5 Safety Controls and Features

17

2.6 Product Labeling

20

3. PRODUCT SPECIFICATIONS

26

3.1 LightLas 532 System Specifications

26

3.2 CSO SL980, SL990 Slitlamp Specifications

29

3.3 Module Specifications

29

3.3.1 System Block Diagram

29

3.3.2 Optical Elements Diagram

32

3.3.3 Laser Cavity Block Diagram and description

33

3.3.4 Remote Control description

34

3.3.5 Laser Diode source

34

3.3.6 Slitlamp Delivery Unit (Integrated model)

35

3.3.7 Laser Indirect Ophthalmoscope (LIO) Delivery Unit

37

3.3.8 Slitlamp Attachment LDU

38

3.3.9 Doctors Operating Microscope Safety Filter

38

3.3.10 Endoprobes

39

3.3.11 Laser Console Internal Modules

39

3.4 Optional Accessories

49

4

4. PRINCIPLES OF OPERATION

52

4.1 General Description

52

4.2 LightLas 532 Laser Controls and Displays

55

4.2.1 Laser Console

55

4.2.2 Slitlamp Integrated Delivery Unit

60

4.2.3 LIO

63

4.3 CSO SL980, SL990 Slitlamp Controls

65

4.4 Detailed Description

69

5. INSTALLATION

72

5.1 Introduction and Requirements

72

5.2 Unpacking and Receiving Inspection

73

5.3 Tools and Equipment

75

5.4 Setting Up and Checking the Laser System

76

5.4.1 Preparation

76

5.4.2 Table and Slitlamp

77

5.4.3 Integrated Slitlamp Delivery Unit

78

5.4.4 Attachment Slitlamp Delivery Unit

80

5.4.5 Laser Console

86

5.4.6 Pre-Laser operation checks

87

5.4.7 Alignment Checks

89

5.4.8 Laser Indirect Ophthalmoscope

97

5.4.9 Endoprobe

101

5.5 Installation Record Sheet

102

6. MAINTENANCE

104

6.1 Operator / User Routine Maintenance

104

6.1.1 General Routine Maintenance Procedures

105

6.1.2 Laser Console Routine Maintenance

105

6.1.3 Slitlamp Delivery Routine Maintenance

106

6.1.4 LIO Delivery Routine Maintenance

106

6.1.5 Endoprobe Routine Maintenance

107

6.1.6 Operating Microscope Routine Safety Filter Maintenance

107

6.2 Calibration and Alignment Procedures for Console

107

6.2.1 Fiber link alignment

108

6.2.2 Aiming Alignment adjustment

110

5

6.2.3 Console Power Calibration checks

111

6.2.4 Earth / Ground resistance checking

113

6.2.5 Aiming Power adjustment

113

6.2.6 Remote Door Interlock connections

113

6.2.7 LightLas 532 Laser Power Calibration Procedure

115

6.2.8 Power Detector Calibration Procedure

122

6.2.9

127

Process for upgrading LightLas 532 software

6.3 Checking Delivery Units Laser beam alignment

138

6.4 Trouble shooting guide

139

6.4.1 Operator Trouble Shooting

139

6.4.2 Service Trouble Shooting

140

6.5 Error and Interlock Warning messages

142

7. WARRANTY STATEMENT

148

8. GETTING HELP AND PARTS

149

8.1 Contacting the factory

149

8.2 Service Report Form

151

8.3 Returning Parts

152

9. GLOSSARY OF TERMS

153

10. MAINTENANCE HISTORY RECORD

159

11. EUROPEAN COMMUNITY ISSUES

163

12. EMC Test Tables

165

LIST OF DRAWINGS / FIGURES Figure

Description

Page

2.1 2.2 2.3 2.4(a) 2.4(b) 2.5 2.6 2.7

Safety Controls Laser Console Safety and Controls Labels Laser Console Labels Integrated Slitlamp LDU with Labels (RH side) Integrated Slitlamp LDU with Labels (LH side) LIO LDU with Labels Attachment LDU with Labels Microscope Doctor Safety Filter with Labels

17 20 21 22 23 24 25 25

6

Figure 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11

Description System Wiring Drawing System Block diagram Optical Elements Block Diagram Laser Cavity Block Diagram Integrated Slitlamp LDU Beam Diagram LIO Optics Beam Paths Attachment Slitlamp LDU Beam Diagram Endoprobes diagram Laser Console Internal Modules (Old Version) Laser Console Internal Modules (New Version CE Mark Version) New Laser Console Internal Modules (New Version CE Mark Version)

Page 30 31 32 33 35 37 38 39 39 43 44

4.1 4.2 4.3 4.4(a)

55 56 60 60

4.5 4.6 4.7 4.8 4.9

Laser Console Controls and Displays Remote Control and Displays Integrated Slitlamp LDU Controls Attachment Slitlamp LDU Controls(Old One with Micromanipulator) Attachment Slitlamp LDU Controls (New One without Micromanipulator-Truspot) LIO Controls SL980 Slitlamp Parts List SL980 Slitlamp Controls SL990 Slitlamp Parts List SL990 Slitlamp Controls

5.1 5.2

Packing Carton for Integrated LDU and Slitlamp Portable Carry Cases for Console and LDU’s

73 74

4.4(b)

Installation 1 Laser System Parts 2 Slitlamp mounted onto Table Top ready for Integrated LDU 3 Slitlamp arm ready for Delivery housing 4 Fit Delivery unit housing to the Slitlamp 5 Lock housing to Slitlamp when it is pushed against Chrome Stop screw 6 Align the keyways then fit the Zoom unit to the Delivery housing 7 Rotate the Zoom housing to the end stop 8(a) Haag Streit style Slitlamp with Tonometer mount ready for Attachment LDU Attaching Tonometer mount and Attachment LDU Mounting Arm to Zeiss 8(b) 30SL 9(a) Lock the Haag Streit Attachment LDU Mounting Arm to the Tonometer mount The Zeiss Style Slitlamp with Attachment LDU Mounting Arm ready for 9(b) LDU

7

61 63 65 66 67 68

76 77 78 78 79 79 80 81 81 82 82

10 11 Figure 12(a)

Moving Safety Filter between Binoculars and Microscope Housing Safety Filter for Haag Streit style

83 83

26(a) 26(b) 27 28 29 30 31

Description Page Attachment LDU fitted to Haag Streit style Slitlamp with 84 Micromanipulator Attachment LDU fitted to Zeiss 30SL Slitlamp with Micromanipulator 84 Original Illumination Tower 85 New modified Illumination Tower fitted 85 Attach the cables and connectors to the back panel of Laser Console 86 Attach the Delivery Fiber and Delivery Key to Laser Console 86 Initial Power on displays and outputs 87 Safety filter checks 88 Attach the Delivery fiber to the Zoom unit 88 Set the eyepieces and slitlamp ready to do alignment checks 90 Check Slitlamp focus on Target Rod and Laser focus of aiming beam 91 Checking Laser focus and manipulator operation on black material target 91 Check Slitlamp focus on Target Rod and Laser focus of aiming beam 92 Adjust the Attachment LDU Spot Size Focus using the Knob on the 93 Mounting Arm Adjusting Micromanipulator Arm to verify Laser Spot is in Aperture 94 Center Release the lock screw for the sideways movement adjustment 95 Adjusting sideways movement of Attachment LDU during alignment 95 Typical Laser settings for demonstration of the Laser System 97 Fiber and Delivery Key fitted to Console Front Panel 98 Fiber and Illumination Cable attached to LIO 98 Locking Set Screws and Rotation of Optics Tube during alignment 99 LIO of Keeler All Pupil Ⅱ 100

6.6(a) 6.6(b) 6.7 6.8 6.9

Measure the laser output power connect a brand new fiber into the laser output aperture and set up Aiming Alignment adjustment Aiming Module Remote Interlock Connections

12(b) 13 14 15 16 17 18 19 20 21 22 23 24 25

108 108 110 110 114

LIST OF RECORD SHEETS / FORMS

PAGE

Record Sheet 1

Installation Record Sheet

102

Record Sheet 2

Fiber Focus Checking Record Sheet

106

Record Sheet 3

Power Calibration Checking Record Sheet

112

Record Sheet 4

Service Report form

151

Record Sheet 5

Maintenance History Record

160

8

Section 1

INTRODUCTION

Contents 1.1 1.2

1.1

General How to use this Manual

General

This manual is intended for the use of authorized service agents of the manufacturer. The aim of this manual is to present an overview of the Operation and Safety requirements for the LightLas 532 Medical Photocoagulator Laser along with sufficient details and procedures to troubleshoot and maintain the Laser System throughout its normal useful life. This manual will not provide any details on actual treatment procedures and it is expected that users of the Laser will have undertaken training prior to using the equipment. Authorized service agents should not attempt to provide guidance to doctors and physicians on actual treatment procedures. The manufacturer and authorized sales agents assume no liability through the use of this Laser System. The manufacturer also assumes no responsibility for the actions of the authorized agents although all efforts will be made to support and train the agents. All care has been taken in the preparation and checking of this manual however there is no guarantee provided that all the information is correct. The information provided in this manual is subject to change without notice. Only accessories that are designed and approved for use with the LightLas 532 may be used. The Manufacturer and Distribution organization shall not be held liable or responsible for damages or injury caused as a result of using untested and non-approved accessories. This includes all Optical Fiber systems, Laser Delivery Units, Safety Filters, Safety Glasses and Table units. All maintenance and service work must be carried out by authorized service agents and only the following procedures are allowed. Any service work carried out by non-authorized persons or not to the procedures contained herein will void all warranties. Before carrying out any of the procedures that follow in this manual pay particular attention to the sections and warnings contained within on Safety and Precautions to be taken. Many of the procedures detailed in this manual can result in exposure to hazardous Laser radiation so ALWAYS observe eye safety precautions.

9

1.2

How to use this Manual

This manual is intended to provide you, the Service person, with sufficient technical details so that you can maintain and repair the LightLas 532 Green Laser. Section 2 of this Manual MUST be read before attempting any service work on the Laser System so that you are aware of the precautions that must be observed. Sections 3 and 4 provide details on how the LightLas 532 operates, all of the controls and displays and the specifications for both the System and its various assemblies. You can read these sections to gain a better understanding of the LightLas 532. Section 5 should be read prior to Installation of the LightLas 532. Follow this section to ensure that you follow all the correct steps when installing the Laser. At the end of the Section is the Checklist and Report that must be completed and a copy sent to the manufacturer to show that the unit is functioning correctly. You can use the Checklist at future Service visits to verify the general operation of the Laser System. Section 6 contains all the procedures that you should require to perform Maintenance, Calibration and Alignment of the LightLas 532. It is recommended that you suggest to the customer that their Laser have a Routine Maintenance performed every 6 months to ensure correct reliable operation. If the customer does not agree to this then at the very least the Power Meter must be calibrated every 12 months and the Earth connection checked. These procedures are in Section 6.1 and 6.2. Section 6 should also be used, if you have a problem with the LightLas 532, to help identify which module or assembly to replace. Section 7 details how to get help from the factory and has a copy of the Service report form to use when you need help or wish to return faulty parts. Use the Maintenance History Record in Section 9 to record all Service work carried out on any LightLas 532 Lasers that you maintain.

10

Section 2

SAFETY

Contents 2.1 Product Classifications 2.2 Warnings and Precautions 2.3 Optical Hazards 2.4 Electrical Hazards 2.5 Safety Controls and Features 2.6 Product Labeling This Laser has been designed and tested to function safely and correctly when used as indicated in this manual. Do not use this laser before reading and understanding completely this Service Manual. It is important to remember that this laser emits high levels of visible laser radiation which can cause permanent and irreparable eye and tissue damage. Always observe precautions for laser safety including using warning signs, safety glasses and only operating the laser in a treatment room that provides protection to casual observers.

2.1

Product Classifications The LightLas 532 Medical Laser is a Class IV (4) laser product as specified in the standard IEC60825-1 (2001) and the USA 21 CFR’s 1040.10, 1040.11. The LightLas 532 MEDICAL Laser is classified as Class I Type B Electromedical equipment as specified in the EN60601-1 standard. The LightLas 532 MEDICAL Laser is classified as a Class II device according to the FDA CFR21 regulations. The LightLas 532 MEDICAL Laser is classified as a Class IIB Medical Device according to the MDD 93/42/EEC (as amended by2007/47/EC). The LightLas 532 has been designed to comply with the following standards. Laser standards IEC60825-1 (2007) Safety of Laser Products Part 1 : Equipment classification, requirements and user’s guides USA 21 CFR 1040.10, 1040.11 (1997) 886.4390 etc IEC60601-2-22 (1995) Medical Electrical Equipment Part 2 : Particular requirements for the safety of diagnostic and therapeutic laser equipment Electrical standards IEC60601-1 (1988) + Amendments A1 and A2 Medical Electrical Equipment Part1 : General requirements IEC60601-1-2 (2007) USA UL 2601-1 (1999) Medical Electrical Equipment Part1 : General requirements JIS T1001 (1992) and T1002 (1992) Others MDD 93/42/EEC Annex II (as amended by 2007/47/EC) 11

IEC60601-1-4 (1996) + A1(1999) ISO14971 (2007) VBG-93 FDA 21 CFR 1010, 886

12

2.2

Warnings and Precautions

The following warnings apply to the LightLas 532 Laser and should be observed by all users. DO NOT look directly into or at the Laser beam or at specular laser reflections. Direct and reflected laser light can cause permanent eye injury. DO NOT operate the laser unless observers are using the correct protective eyewear. Protection is afforded by using protective eyewear having an optical density of OD4 (or higher) at 532 nanometers wavelength. This information must be present on the eyewear. DO NOT use objects, that can readily reflect light, in the vicinity of the Laser beam to avoid reflecting the beam in a hazardous manner. 

DO NOT use the Laser in the presence of flammable agents as the focused laser beam may cause ignition. There is no AP/ APG protection.

Visible laser radiation is emitted from the Laser aperture during operation of the equipment. DO NOT try to service or repair the laser other than what is included in this manual. Service should only be performed by an authorized agent of the manufacturer. DO NOT use the Laser on a patient without first checking the operation of the Laser and verifying the optical alignment of the treatment Laser beam. 

ALWAYS use the lowest Power settings possible when treating a patient with the laser and start the treatment at minimum Power.



ALWAYS set the correct spot size and/or use the most appropriate for the power setting and type of procedure that is to be performed.



DO NOT put the Laser into TREAT mode until ready to operate on the patient.



DO NOT inhale any Laser Plume generated by the Laser during surgery. Personnel should take suitable precautions such as wearing surgical masks or use Plume evacuation systems.



ALWAYS take particular care of the optical fibers that connect the Laser Delivery Units to the Console to make sure they do not get damaged. Additional Clinical Warnings may be found in Section 6.1.4 of the Operator Manual.



DO NOT place Multiple Portable Socket Outlets that are used for connecting the Mains Power cables for each part of a System on the floor as fluid spillage may enter the Outlet and create a Hazard. Also do not use more than one Outlet for a System and no extensions cords.



DO NOT exceed the Maximum power rating for any Multiple Portable Socket Outlets used and do not connect other devices that are not part of the System to the Outlet. Connecting other equipment to the Outlet may overload the Outlet and may introduce an unknown hazard condition due to EMC (electrical noise)



DO NOT use the Laser Console if the ambient temperature is outside the range of 15 to 35°C. This temperature range is the rated operating temperature limits where the Laser system can be guaranteed to operate without any interruptions to normal use. Outside this

13

range of temperature it is possible for the Laser to go to an error condition where the word “hold” is displayed and the system goes to Standby until the internal temperature returns to within normal limits then the Laser can be used again but the error condition may reoccur unless the rated temperature comes within limits.

2.3

Optical Hazards

Guidance for the Safe use of Lasers and Laser systems is found in the standard IEC60825-1, the USA 21CFR 1040.10, 1040.11 and ANSI Z136.1 - 1986. During normal operation of the LightLas 532 the operator is protected from Laser hazards by built in optical absorption Safety Filters. All other personnel in the area should wear protective eyewear to eliminate the risk of eye injury occurring. The Optical density (OD) must be 4 or high than 4 and 532nm must be included in the wavelength range on safety glasses. The Optical density (OD) and wavelength are marked on safety glasses. For example in the following form: OD4+ @ 375 - 532nm Otherwise, the safety glasses are NOT suitable for eye protection. Safety Glasses are required to have the CE Mark applied if used in the EU. The LightLas 532 uses a Class II Laser Diode Aiming beam. The wavelength is 635 to 650 nanometers (nm), and the maximum power output is set at the factory to be less than 1mW delivered to the Patients Cornea (eye) however it is always recommended to always use the lowest practical aiming beam intensity during treatments. The LightLas 532 Photocoagulator Laser has been classified a Class 4 Laser product according to the standards quoted above. This classification is based on the Accessible Emission Limits (AEL) as calculated according to the standards.

2.3.1 Nominal Ocular Hazard Distance (NOHD) The Nominal Ocular Hazard Distance (NOHD) is the distance between the equipment and a persons eye for which the optical power, from the equipment, entering the dilated pupil of the person will be less than or equal to the Maximum Permissible Exposure (MPE) as specified in the standards (i.e. less than a Class 1 Laser Output). The calculated NOHD for the LightLas 532 with different Laser Delivery Units is: 

5 meters at maximum power settings for the Endoprobes.



18 meters at maximum power settings and 1000m spot size for Slitlamp Delivery Units



20 meters at maximum power settings for LIO

Therefore when the Laser is in operation all persons that are closer than these distances to the equipment should be wearing eye protection. These NOHD are calculated assuming that the person would not be using any eye protection. If some eye protection is being used then the distances would require to be recalculated. Patients, where possible, should have the eye that is not been treated covered or protected in some way from reflections. 14

2.3.2 Avoid Exposure to Laser beams Assembly and Maintenance of the Laser System should only be performed by authorized and trained personnel. The external housing of the Laser System should never be removed otherwise you could be exposing yourself to dangerous levels of optical laser radiation and potentially lethal electrical voltages. Eye Safety Filters, designed to protect physician’s eyes from back scattered Laser beams must always be used. They are integrated into the Slitlamp and LIO Delivery Units and when using the endoprobes a separate filter that attaches to the operating microscope must be used. For other personnel that may be exposed to reflections or backscatter they must wear Laser Safety glasses or goggles. In any case NEVER look directly at the Treatment Laser beam as severe eye injury is likely. This means avoid looking into the Aperture of any of the Laser Delivery Units or the Console. If the Laser System requirement maintenance or checking work to be performed inside either the Laser Console or one of the Delivery Units then it is very important that personnel wear approved Safety Glasses to ensure that they protect their eyes from unintended Laser beams. It is important to remember that outside the Console you can only be exposed to the 532nm wavelength but when the cover is removed from the Console there is the possibility of being exposed to 808nm Laser light from the Laser Diode source as well. The output from the Laser Diode source is directly connected to the Green Laser Cavity with a short Fiber link and when the Laser is operating Invisible Laser Radiation is being transmitted through this Fiber Link. Any damage to the Fiber could result in exposure to 808nm Laser Radiation. Therefore the Safety Glasses used should provide protection for both the 532nm and 808nm wavelengths. This is the Collateral Radiation for the LightLas 532. It should be made clear that it is not possible to be exposed to any Collateral Radiation so long as the Covers are not removed from the Laser Console. Inside the Green Laser Cavity the 808nm Laser Diode output is converted into 1064nm wavelength Laser Light and if the Cavity was opened then additional protection to this wavelength is essential. The Manufacturer does not permit opening of the Laser Cavity as it is a factory sealed unit. Look in Section 3 under the Accessories part for details relating to the Safety Glasses available from the manufacturer.

2.4

Electrical Hazards

The LightLas 532 Photocoagulator Laser has been designed to comply with International Standards for Medical Electrical equipment. The Laser System is designed to operate with a 3 terminal mains AC voltage supply with the third pin being the Earth or Ground connection. WARNING: It is not safe to operate the LightLas 532 Photocoagulator Laser without an Earth or Ground connection. Risk of electrical shock is possible.

15

The earth connection provides protection against electrical shock as it provides a path away from the operator or Service person for any fault condition. When servicing the LightLas 532 Photocoagulator Laser take particular care when servicing or testing the mains AC wiring and also any internal power supply voltages. The current supplied to the Laser Diode source can exceed 30 Amps. Also of particular importance is that ESD precautions always be observed when servicing the LightLas 532 Console because the Laser Diode source is particularly sensitive to ESD and very small levels (around 50 volts) can cause severe and permanent damage to this high cost device. It is recommended that where possible always have the mains power disconnected when servicing the LightLas 532 Photocoagulator Laser. If power must be connected to effect service or testing then observe the strictest care to avoid electrical shock.

16

2.5

Safety Controls and Features

For the LightLas 532 to comply to the various requirements of the standards referred to previously there are a number of Controls and Features that are provided. A description of these Safety items is provided following the Figure 2.1.

STOP

POWER

EMERGENCY

Delivery Key

LIO

LIO

! LASER STOP

INPUT: 100-230V ~ (Fuse:T3.15AH250V) 50/60Hz, 400VA

DANGER!

DANGER!

Do not remove covers. Shock hazard and accessible laser radiation. Refer servicing to qualified service personnel. Risk of explosion if used in the presence of flammable anesthetics.

Ne pas ouvrir L'appareil risque de chocs electriques exposition dangereuse au rayonnement Laser direct ou diffuse reparations par service technique qualifie. Risques d'explosion si utilise en presence d'anesthesiques inflammables

ACHTUNG!

AC MAINS INPUT

GEHAUSETEILE NICHT ENTFERNEN Gefahr eines elektrischen Schlages Laserstrahlung zuganglich. Wartungsarbeiten nur durch qualifizierten Kundendienst. EXPLOSIONSGEFAHR Dieses Gerat ist nicht fur den Betrieb in explosiongefahrdeten bereichen bestimmt

Danger/Caution Visible and Invisible laser radiation when open

AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION

For grounding reliability connect only to with a "Hospital Grade receptacle". Complies to the requirements of 21CFR, Chapter 1, Subchapter J

FOOTSWITCH WARNING Risk of fire Replace only with fuse as marked above

Figure 2.1 Safety Controls

17

DOOR INTERLOCK

1.

Emergency Stop Switch This switch is provided to enable a fast response shutdown of the Laser System in the event of some serious problem occurring. It is a RED push switch that locks down when pushed and in this position all power to the internal parts is removed. The switch actuator ( the red part ) must be rotated to reset to the ON position.

2.

Key Switch The Key switch is the main power ON/OFF switch. The power can only be turned on by inserting the key and rotating clockwise to the ON position. In the ON position the key cannot be removed. The key should be stored in a safe, controlled place.

3.

Shutter Attenuator Internal to the Laser System and in the Laser beam path there is a mechanical shutter unit that completely blocks the beam path at all times except when the Laser System is in the TREAT mode. There are electronic sensors that check the position of the shutter at all times for the microprocessor.

4.

Mode Set Switch This press switch toggles the Laser System between the STANDBY and TREAT modes. In the Standby mode the Footswitch cannot fire the Laser, Aiming beam disables, and the Shutter is always closed. The Treat mode is only used when the operator wants to deliver a pulse of laser power and aiming beam to the patient and in this mode the footswitch is enabled and the shutter can be opened.

5.

Standby Indicator When this indicator is illuminated the Laser System is in the Standby mode and the Laser power CANNOT be delivered to the patient. This indicator is Yellow in color.

6.

Treat Indicator When this indicator is illuminated the Laser System is in the Treat mode and the Laser power CAN be delivered to the patient. The System will only stay in the Treat Mode for a maximum of 10 minutes if the unit is not used or some controls operated. The System will go back into the STANDBY mode after this time. This also is used to provide a Ready indicator prior to emissions of the Treatment Laser. This indicator is Green in color.

7.

Remote Door Interlock On the back of the Laser Box there is a connector from which 2 wires can be connected to a switch on the door(s) of the treatment room and wired so that the switch(s) go open circuit if the door is opened. When the Laser is turned on and the door is opened a warning tone is made and the Laser cannot be fired. The system will go to the Standby mode if it was in the Treat mode before the door was opened. This is a user installed feature and the manufacturer supplies a connector with the two pins shorted together so that the Laser will function if this feature is not used by the operator.

18

8.

Footswitch checks The microprocessor monitors the signal from the footswitch in order to be certain that the switch contact is good. It is not possible to go to the TREAT mode or change any set up condition if the footswitch is ON.

9.

Self Checks When the Laser system of the LightLas 532 is first turned on it operates the Laser and during this time the microprocessor performs various checks to ensure the Laser is functioning correctly. If the test passes then the unit goes to the Standby mode.

10. Others In addition to these particular safety controls there are a number of features that have been designed into the LightLas 532. 

All the controls are located so as to prevent the operator inadvertently firing the laser.



The Laser System has protective housings on the Laser and optical system to prevent exposure to laser emissions. Special tools are required to remove the housings and only authorized agents are permitted to remove the housings.



There are optical safety filters built into the Laser System to protect the operators eyes from being exposed to the Laser beam when using the equipment.



The Laser system has been designed to comply to the Electrical Safety standards for Earth connections and Earth leakages.



If the Laser System is not used or no controls are operated for 10 minutes the System will go back to the STANDBY Mode if it was set into the TREAT Mode.



The Console gives an audible warning whenever the Laser is firing.

With all these controls and features the LightLas 532 is a very safe instrument when used correctly and as indicated in this manual and the Operator manual.

19

2.6

Product Labeling

All the labels on the LightLas 532 comply with the requirements of the various regulatory standards referred to previously. A full facsimile of all the safety and control labels is shown in the figures 2.2 and 2.3.

POWER

EMERGENCY STOP

POWER

EMERGENCY

Delivery Key

LIO

LIO

! LASER STOP

INPUT: 100-230V ~ (Fuse:T3.15AH250V) 50/60Hz, 400VA

DANGER!

DANGER!

Do not remove covers. Shock hazard and accessible laser radiation. Refer servicing to qualified service personnel. Risk of explosion if used in the presence of flammable anesthetics.

Ne pas ouvrir L'appareil risque de chocs electriques exposition dangereuse au rayonnement Laser direct ou diffuse reparations par service technique qualifie. Risques d'explosion si utilise en presence d'anesthesiques inflammables

ACHTUNG!

AC MAINS INPUT

GEHAUSETEILE NICHT ENTFERNEN Gefahr eines elektrischen Schlages Laserstrahlung zuganglich. Wartungsarbeiten nur durch qualifizierten Kundendienst. EXPLOSIONSGEFAHR Dieses Gerat ist nicht fur den Betrieb in explosiongefahrdeten bereichen bestimmt

Danger/Caution Visible and Invisible laser radiation when open

AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION

For grounding reliability connect only to with a "Hospital Grade receptacle". Complies to the requirements of 21CFR, Chapter 1, Subchapter J

FOOTSWITCH

DOOR INTERLOCK

WARNING Risk of fire Replace only with fuse as marked above

Figure 2.2 Laser Console Safety and Control Labels

20

LASER STOP