SeLecTor II Operators Manual Rev 03 Oct 2014

Operator’s Manual for the Ophthalmic YAG Laser SeLecTor II (YAG Mode: Ophthalmic YAG Laser 1064nm and SLT Mode: Frequency Doubled YAG Laser 532nm)

Directive: 93/42/EEC as amended by 2007/47/EC Doc. No.: YL0416 Rev. No.: 03

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Operator’s Manual for the Ophthalmic YAG Laser, SeLecTor II.

Clinicians and Doctors should ensure that they are adequately trained in the procedures that the SeLecTor II will be used for prior to operating the equipment. This Operators Manual should be studied and understood before proceeding to operate the equipment on patients.

CAUTION

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

CAUTION

Any unauthorized modification to the Ophthalmic YAG Laser, SeLecTor II will result in the necessity for it to be reclassified

CAUTION

U.S. law restricts this device to sale by or on the order of a physician.

This Operators Manual contains confidential and proprietary information of the Manufacturer. Manufactured by: LightMed Corporation, No.1-1, Ln. 1, Pao-An Street Sec.3, Shulin Dist., New Taipei City, 23861, Taiwan WEB Address: www.lightmed.com Copyright © LightMed Corporation EU Representative: Medical Device Safety Service GmbH Schiffgraben 41,30175 Hannover,Germany Document Title:

Operators Manual for the Ophthalmic YAG Laser, SeLecTor II

Document Number:

YL0416

Document Revision History: DRAFT

January,2009

Draft prepared.

01

October,2009

Rev 01 released

02

June ,2010

Change CE0197 to CE0434 , All labels add the graphic symbol, 93/42/EEC as amended by 2007/47/EC, update standards, update address of manufacture, update labelling to comply with IEC standard 60825-1 and the USA 21 CFR 1040.10, 1040.11.

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03

October, 2014

Change section 2.2 Conformance to Standards. Update the revision standards. (60601-1, 60601-2-22, EN ISO 14971, 60601-1-6) Delete 60601-1-4. Change section3.2 CSO 950 specifications for Magnification Ratio: 8X, 14X, 25X (5X, 38X for option) Change 3.3 Optional Accessories 600022 to 600018 Change section 3.1 SeLecTor II System Specification for adding aiming laser to SLT mode

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Contents of Manual SECTION 1.

INTRODUCTION ... 8

SECTION 2.

SAFETY ... 9

2.1

Product Classifications ... 9

2.2

Conformance to Standards ... 9

2.3

Warnings and Precautions ... 10

2.4

Optical Hazards ... 11

2.5

Electrical Hazards... 12

2.6

Safety Controls and Features ... 12

2.7

Product Labeling ... 16

SECTION 3.

PRODUCT SPECIFICATIONS ... 19

3.1

SeLecTor II System Specification... 19

3.2

CSO 950 Slitlamp Specifications ... 20

3.3

Optional Accessories ... 21

SECTION 4.

PRINCIPLES OF OPERATION ... 23

4.1

General Description ... 23

4.2

Ophthalmic YAG Laser Controls and Displays ... 27

4.3

CSO 950 Slitlamp Controls ... 32

4.4

Start up and operation of the Laser System ... 34

SECTION 5.

INSTALLATION ... 38

5.1

Introduction and Requirements ... 38

5.2

Unpacking and Receiving Inspection ... 39

5.3

Tools and Equipment ... 41

5.4

Unpacking and Setting Up the System ... 42

5.5

Installation Checklist and Report ... 46

SECTION 6.

CLINICAL USE... 48

6.1

Use of the SeLecTor II as a Slitlamp Microscope... 48

6.2

Use as a SeLecTor II Ophthalmic YAG Laser... 49

6.3 Indications for Use ... 53 6.3.1 Posterior Capsulotomy and Pupillary Membranectomy... 53 6.3.2 Iridotomy (hole in the Iris) ... 59 6.3.3 Selective Laser Trabeculoplasty ... 63 6.3.3.1 Clinical Applications of SLT ... 63 6.3.3.2 The SLT treatment... 64 5

6.3.3.3 6.4

Candidates for SLT ... 64

Ophthalmology References ... 65

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LIST OF DRAWINGS / FIGURES FIGURE 2.1 SAFETY CONTROLS ... 13 FIGURE 2.2 SAFETY AND CONTROL LABELS ... 17 FIGURE 2.3 SAFETY LABELS ... 18 FIGURE 3.1 USE THESE DRAWINGS TO HELP IDENTIFY THE CORRECT LAMP FOR YOUR SLITLAMP 22 FIGURE 4.1 YAG LASER FOCUSING FOR TREATMENT ... 24 FIGURE 4.2 SELECTOR ILASER CONTROLS AND DISPLAYS ... 28 FIGURE 4.3 CSO 950 SLITLAMP CONTROLS... 32 FIGURE 5.1 PACKAGING CARTON ... 39 FIGURE 5.2 STEPS TO FOLLOW WHEN REMOVING THE LASER SYSTEM FROM ITS CKINGCARTON39 FIGURE 5.3 ASSEMBLY OF YAG LASER SYSTEM ... 43 FIGURE 5.4 ASSEMBLY OF YAG LASER SYSTEM ... 44 FIGURE 5.5 POSITIONING THE SLITLAMP CABLES ... 44 FIGURE 5.6 EXPLODED VIEW OF SYL9000 FOR INSTALLATION ... 45

Record Sheet RECORD SHEET 1 INSTALLATION RECORD SHEET... 47

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Section 1. INTRODUCTION This manual is intended to provide the operator with an overview of the operation and safety requirements for the Selector II. This manual is not intended to provide instructions on actual treatment procedures and it is expected that users will have undertaken training prior to using the equipment. The Manufacturer and Distribution organization assume no liability through the use of this Laser system. All care has been taken in the preparation and checking of this manual however there is no guarantee provided that all information is correct. The information provided in this manual is subject to change without notice. Only accessories that are approved for the SeLecTor II 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 non approved accessories. All maintenance and service must be carried out by authorized service agents and only those procedures outline in the Operator and Service manuals are allowed. Any service work carried out by non authorized persons will void all warranties. No Circuit Diagrams or component part lists are supplied with the SeLecTor II. If you require technical documentation that is not provided in this manual then please contact the Manufacturer or your local Distributor in writing with your reasons for wanting them and then a copy of the service manual may be provided. Before using the SeLecTor II system the operator should read this manual carefully and pay particular attention to the sections on Safety, Operation and Maintenance.

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Section 2. SAFETY Contents 2.1 2.2 2.3 2.4 2.5 2.6 2.7

Product Classifications Conformance to Standards Warnings and Precautions Optical Hazards Electrical Hazards Safety Controls and Features 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 the Operators Manual. It is important to remember that this laser emits high levels of either invisible or 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 safe environment that provides protection to casual observers. When servicing the SeLecTor II always observe Safety precautions and warnings as indicated in this manual. When not viewing through the binoculars and in particular when the cover is removed from the Laser Arm wear safety glasses of OD4 or greater @ 1064nm/532nm to protect your eyes.

2.1 Product Classifications 

The SeLecTor II is a Class IIIB laser product as specified in the IEC standard 60825-1 (2007) and the USA 21 CFR 1040.10, 1040.11.



The SeLecTor II is classified as Class I Type B Electromedical equipment as specified in the IEC Standard 60601.1.



The SeLecTor II is classified as a Class II device according to the FDA 21 CFR regulations.



The SeLecTor II is classified as a Class IIB Medical Device according to the MDD 93/42/EEC (as amended by 2007/47/EC).



The SeLecTor II has been EMC tested and approved according to the requirements of the international standard IEC60601.1.2.

2.2 Conformance to Standards The SeLecTor II device has been designed and built to comply with the requirements of the following standards: 

Laser standards EN 60825-1:2007 USA 21 CFR 1040.10, 1040.11 (1997) 9

EN 60601-2-22:2013 

IEC 60601-2-22:2007+A1:2012 Electrical standards EN 60601-1 :2006+A11:2011 IEC 60601-1:2005 EN 60601-1-2:2007 IEC 60601-1-2:2007 USA UL2601



JIS T1001 (1992) and T1002 (1992) Others MDD

93/42/EEC (as amended by 2007/47/EC)

EN 60601-1-6 :2010 IEC 60601-1-6:2010 EN 62366:2008 IEC 62366:2007 EN 980:2008 EN ISO 14971:2012

2.3 Warnings and Precautions The following warnings apply to the SeLecTor II and should be observed by all users  DO NOT look directly into or at the Laser beam or at specula 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 at 1064/532 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.  DO NOT operate the Laser unit without all the cables connected as there is a risk of electric shock from the back panel connectors.  Invisible and 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 SeLecTor II to the Aiming beams.  ALWAYS use the lowest energy settings possible when treating a patient with the laser and start the treatment at minimum energy.  ALWAYS note the “Preset Energy” display when adjusting the Energy and confirm the actual test fire energy is close to the Preset value.  DO NOT put the Laser into TREAT mode until ready to operate on the patient. 10

2.4 Optical Hazards Guidance for the Safe use of Lasers and Systems is found in the IEC standard 60825-1, the USA 21CFR 1040.10, 1040.11 and ANSI Z136.1 - 1986. During normal operation of the SeLecTor II the operator is protected from Laser hazards by built in optical absorption filters in the viewing optical path. All other personnel in the area should wear protective eyewear to eliminate the risk of eye injury occurring. When servicing the Laser, it is recommended to wear safety glasses of OD4 or greater @ 1064nm/532nm to protect your eyes. Viewing through any optical attachments to the Slitlamp is safe for the operator’s eye because of the built in safety filters. An optical density of at least 4 (four) and 1064nm/532nm in wavelength range must be used by any other personnel that are not directly looking through an accessory. The Optical density (OD) and wavelength are marked on safety glasses for example in the following form: OD4 at 1064nm and OD4 at 532nm Otherwise the safety glasses are NOT suitable for eye protection. The SeLecTor II uses a Class I Laser Diode Aiming beam. The wavelength is 635 nanometers, and the maximum power output is set at the factory to be less than 200 microWatts (W). The maximum safe power that can be visualized by the retina is 390 micro Watts so the delivered beam to the patient is less than this however it is recommended to always use the lowest practical aiming beam intensity during treatments. The SeLecTor II has been classified a Class 3B Laser product according to the standards quoted above. This classification is based on the Accessible Emission Limits (AEL) as calculated according to the standards assuming the laser beam energy is delivered through a dilated pupil of diameter 7mm to the posterior capsule surface in the eye. In single pulse operation the maximum energy allowed is 30mJ for a Class 3B Laser. In double pulse operation the maximum cumulative energy allowed is 40mJ. In triple pulse operation the maximum cumulative energy allowed is 45mJ. These limits are calculated according to the CFR 21 regulations as their AEL’s are lower than the IEC 60825. The product then complies to both requirements. The Nominal Ocular Hazard Distance (NOHD) is the distance between the equipment and a persons eye for which the optical energy, 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. The calculated NOHD for the SeLecTor II at single pulse (nominal) and at triple pulse (maximum) is: Single Pulse Energy = 11 meters Triple Pulse Energy = 20 meters

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Therefore when the Laser is in single pulse mode all persons that are closer than 11 meters to the equipment should be wearing eye protection and in triple pulse mode all persons that are closer than 20 meters should wear 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.

2.5 Electrical Hazards The SeLecTor II has been designed to comply with International Standards for Medial 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 SeLecTor II without an Earth or Ground connection. Risk of electrical shock is possible.

The earth connection provides protection against electrical shock as it provides a path away from the operator or Service person for any fault condition.

2.6 Safety Controls and Features The SeLecTor II has been designed to meet the safety features as required by the various standards identified in section 2.2. But in addition, the SeLecTor II also includes a number of additional safety features to enhance the safety of the Laser System.

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YAG

SLT

Mode TREAT

STANDBY

Mode

SET

PULSES

TOTAL

ENERGY

mJ

FIGURE 2.1 SAFETY CONTROLS

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The following identifies the various safety features included in the SeLecTor II: 1. Emergency Stop Switch Should an emergency condition arise, pressing the Emergency Stop button will switch both laser and slit lamp power supplies off. Only when safe, to release the button rotate it in either direction and the button will automatically pop up. 2. Key Switch The Key switch is the main power ON/OFF switch. Rotate the key in a clockwise direction to turn the device ON. When the key is on the ON position the key cannot be removed. The key should be stored in a safe, controlled place when the device is not in use. 3. Power ON Indicator The green lamp located next to the key switch indicates when illuminated, that the power is being applied to the system. 4. Laser Power ON/OFF Switch. With the key switch in the ON position, pressing this button for at least 0.5seconds, the Laser Power ON indicate will illuminate and after approximately 7seconds delay, laser emissions will be possible. Power is immediately removed when the switch is pushed to turn OFF. By default, whenever power is applied to the system, this switch will be in the OFF state. 5. Laser Power ON Indicator The yellow lamp located next to the Laser ON/OFF switch, when illuminated, indicates that the power is being applied to the Laser electronics. 6. Shutter Attenuator The Laser System is fitted with a mechanical shutter that kept in the closed position by a spring under tension. The shutter blocks the treatment laser beam path unless the system is on TREAT mode and the fire switch is pressed. At this point, the shutter momentarily opens (less than 100ms) to allow the treatment laser pulse through and then shutter closes. At all times, the shutter position is detected by two sensors which are continuously by the microprocessor. 7. Mode Set Switch This press switch toggles the Laser System between the STANDBY and TREAT modes. In the Standby mode the Laser cannot be fired by the Joystick fire-switch and the Shutter is always closed. The Treat mode is only the only mode that will allow external laser emissions. 8. Standby Indicator When this indicator is illuminated, the Laser System is set to STANDBY mode. In the mode, no external emission will be delivered. 9. Treat Indicator When this indicator is illuminated, the Laser System is in the TREAT mode and the Laser energy CAN be delivered to the patient. If none of the Laser System is operated for period of 5mins, the laser System will automatically toggle back to STANDBY mode.

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10. Remote Door Interlock On the rear of the Control 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(es) go open circuit if the door is opened. When the connection is broken, by opening the door, a warning tone is sounded and the Laser System will toggle to standby Mode to prevent laser from firing. This is a user installable feature and the manufacturer supplies a connector with the two pins shorted together so that the Laser will function normally if this feature is not utilized. 11. Test Fire Switch Pressing this switch in either STANDBY or TREAT modes, will fire the laser but keeping the shutter closed. The purpose is that it provides the operator a safe way to check the laser’s output energy. The updated energy is displayed on the Display panel. 12. Test Fire Operation Whenever the Energy control is adjusted or the number of pulses is changed the Laser system does an automatic test fire to verify the new Energy level. The Energy is displayed on the Display panel. 13. Joystick Fire switch checks The microprocessor monitors the signal from the fire switch in order to be certain that the switch contact is good. If the fire switch is held down when in TREAT mode for too long the System will go to the Standby mode. Also it is not possible to go to the TREAT mode if the Fire switch is ON. 14. Self Checks On power up, the Laser system of the SeLecTor II performs a series of internal checks, displays the software version number as well as firing a several test fires. If the test passes then the Energy of the last shot is displayed and the unit enters Standby mode. If the microcontroller detects that Laser System requires a Voltages Calibrated then it will automatically start this test. If this situation occurs, the Display Panel will show “CAL”. This test takes approximately 10 minutes to perform and should only occur once or twice a year. If during the test, problems are detected, the Laser System will display the appropriate Error message. 15. Others In addition to these particular safety controls there are a number other features that have been designed into the SeLecTor II System:  There are optical safety filters built inside the Laser System, which will particularly eliminate both of 1064nm and 532nm laser beams, to protect the operator’s eyes from being exposed to the Laser beam when using the equipment.  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. The protective housings on the entire system are designed to prevent exposure to high voltage shock. Special tools are required to remove the housings and only authorized agents are permitted to remove the housings.

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   

The Laser system has been designed to comply with the Electrical Safety standards for Earth connections and Earth leakages. If the Laser System is not used or no controls are operated for 5 minutes the System will go back to the STANDBY Mode if it was set into the TREAT Mode. If the Operator or User of the Laser holds the Joystick Fire Switch down for longer than 1 second then if the unit was in the TREAT Mode it will jump back into the STANDBY Mode. When the Laser Power Supply is being charged, following a Laser Fire, the TREAT Indicator will momentarily go OFF and the STANDBY Indicator will momentarily go ON to show that the charging function is occurring. The Laser cannot be fired while the Laser Power Supply is being charged.

With all these controls and features the SeLecTor II is a very safe instrument when used correctly and as indicated in the Operators Manual.

2.7 Product Labeling All the labels on the SeLecTor II comply with the requirements of the various regulatory standards referred to previously. An illustration of all the safety and control labels is shown in the figures 2.2 and 2.3.

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SLT

YAG

Mode TREAT

STANDBY

Mode

SET

PULSES

TOTAL

ENERGY

mJ

FIGURE 2.2 SAFETY AND CONTROL LABELS

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Lightmed Corporation MODEL NO: SERIAL NO:

Lightmed Corporation MODEL NO: SERIAL NO:

T Se Lec

or AIMING BEAM INTENSITY

SLT ENERGY ENERGY ADJUST ADJUST

YAG ENERGY ADJUST

EC REP

EU Authorized Representative

(MDD 93/42/EEC) Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover, Germany

MANUFACTURED:

FIGURE 2.3 SAFETY LABELS

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Section 3. PRODUCT SPECIFICATIONS Contents 3.1 3.2 3.3

SeLecTor II System Specifications CSO 950 Slitlamp Specifications Optional accessories

3.1 SeLecTor II System Specification The following are the System Specifications for the Ophthalmic YAG Laser, SelecTor II. Specification Laser Type

YAG Mode Neodymium Yttrium Aluminum Garnet (Nd:YAG)

SLT Mode Frequency Doubled Nd:YAG

Wavelength

1064nm

532 nm

Mode Structure

Fundamental

Fundamental

Mode of Operation

Q-switched (CQ-Crystal)

Q-switched (CQ-Crystal)

Energy Output

Maximum of 45 mJ in Triple pulse mode. Nominally 10 mJ maximum in Single pulse mode Continuously variable across full energy range

Maximum of 2.0 mJ in Single pulse mode

Energy Adjustment

Continuously variable across full energy range

Burst Mode

1, 2 or 3 pulses each burst with the separation between pulses of 20 µs (nominal).

Single pulse only

YAG Laser Offset

Continuously variable from Anterior (-)500µm to Posterior (+)500µm. Detent steps @ 0, +/150, 250, 500µm

Not applicable

Pulse Width

4 ns+2ns

3 ns

Repetition Rate

2.5Hz for single pulse

2.5Hz

Air Breakdown

Better than 4 mJ

Not applicable

Spot Size

8µm ( FWHM )

400µm ( FWHM )

Cone Angle

16°

< 3°

Focus Length

107mm

107mm

Ocular Safety Filter

OD4 at 1064 nm

OD4 at 532 nm

Safety Class

Class 3B

Class 3B

Better than +/-20% of actual

Better than +/-20% of actual

Laser Type

Laser diode twin beam

Laser diode one beam

Wavelength

635 nm (Red)

635 nm (Red)

Energy accuracy

Display

Aiming Laser

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Mode of operation

Continuous Wave

Continuous Wave

Output power

Maximum of 200µW

Maximum of 400µW

Power adjustment

Continuously variable

Continuously variable

Safety Class

Class 1

Class 1

General Electrical Input

100-230V AC 50/60Hz Single phase

Power

200VA

Fuse rating:

T3.15 AH250V @ 100-120V AC (Time-Lag) T2.5 AH250V @ 200-230V AC (Time-Lag)

Temperature Range:

Transport:-10 to 70°C Operating: 20 to 40°C Storage: -10 to 55°C

Relative Humidity

Operating: 30% -85% non-condensing

Range

Storage and Transport: up to 95% non-condensing

Atmospheric pressure

Operating:800~1060mbar Transport:500~1060mbar Storage:500~1060 mbar

Cooling System

Air convection

Dimensions (Total)

520mm(H) x 320mm(W) x 450mm(D)

Weight

21 Kg (System) 28 Kg (Packed)

Slitlamp Type : Specially altered CSO 950 to include Laser system in the binocular arm.

3.2 CSO 950 Slitlamp Specifications The following are the Slitlamp Specifications for the CSO 950 Slitlamp that is used in the SeLecTor II. Slit-lamp Slit-lamp

CSO SL950

Microscope

Galilean

Magnification Set

3 Step Drum Rotation, (5 Step Drum Rotation for option)

Magnification Ratio

8X, 14X, 25X, (5X, 38X for option)

Eyepiece

12.5X

PD Range

55-75mm

Diopter Adjustment

+8D

Real Fields of View

5.2-40mm

Slit Illumination

6V 20W Halogen Lamp

Slit Width

0-14mm

Slit Length

1-14mm

Slit Aperture

0.3,6,10,13mm and continuous

Slit Angles

0° - 180° 20

Filters

Red Free(Green) /Heat Absorbing /Cobalt Blue

Illumination Intensity

0-60,000 Lux

Movement Ranges Longitudinal (In/Out)

90mm

Lateral (Left/Right)

105mm

Vertical (Up/Down)

30mm

Chin Rest Range

75mm

3.3 Optional Accessories Non-Eurpoean Customers The following accessories can be purchased from the Distributor to use with the SeLecTor II Product. The accessories are only available for customers outside the EU Countries due to the requirements for CE Marking and the manufacturer not having control over the use of the attachments that are available and their indications for use. Item Abraham Capsultomy Lens Abraham Iridectomy Lens Bearing Plate for Tonometer mounting (Type T900) Beam Splitter for YAG Laser Observation Microscope for Assistant (use with Beam Splitter) 870Z Tonometer mount Adapter for video camera (Requires P/N 600018) Motorized Table with central drive column (Includes Top) Motorized Table with side drive column (for wheelchair access) Safety glasses OD7 @ 1064nm Safety glasses OD6 @ 532nm Safety glasses OD5 @ 1064nm and 532nm Ocular Latina SLT lens

Part Number 600036 600035 600027 600018 600023 600163 600025 600015 600016 620032 620003 620021 600403

The following are spare part accessories: Item Slitlamp Bulb, 6 Volt 20 Watt, type HLX64251 Fixation Lamp Bulb for Chinrest Chinrest Papers Model Eye Kit Model Eye Membranes (bag of 25)

Part Number 240012 240014 600026 YL0508 540010

European Customers The following accessories are available for use within the EU Countries however the

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physician must ensure that the indications for use of the attachments that fit to these adapters are satisfactory. The manufacturer assumes no responsibility for use of the SeLecTor II when used with any attachments. The user should ensure that any attachments used have the CE Mark applied and are approved for use within the EU Countries.

Item Bearing Plate for Tonometer mounting (Type T900) Beam Splitter for YAG Laser Observation Microscope for Assistant (use with Beam Splitter) 870Z Tonometer mount Adapter for video camera (Requires P/N 600018)

Part Number 600027 600018 600023 600163 600025

P/N: 240012 Type HLX64251 FIGURE 3.1 USE THESE DRAWINGS TO HELP IDENTIFY THE CORRECT LAMP FOR YOUR SLITLAMP

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Section 4. PRINCIPLES OF OPERATION Contents 4.1 4.2 4.3 4.4

General Description Ophthalmic YAG Laser Controls and Displays CSO 950 Slitlamp Controls Start Up and Operation of the Laser System

4.1 General Description YAG Mode: Ophthalmic YAG Laser 1064nm YAG Mode of SeLecTor is a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue( posterior capsulotomy, pupillary mambranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.2-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodistruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slitlamp center of rotation) and along the slitlamp objective lens axis. A twin aiming beam is also focused by the slitlamp objective to a converging 20μm spot located at the focal point of the lens. The focal point of photodisruption is adjustable 0-500μm in the posterior direction by the physician relative to this convergence of the twin aiming beams. YAG Mode of SeLecTor is an Ophthalmic YAG Laser that has been designed for performing Posterior Capsulotomy, Pupillary Membranectomy and Iridotomy procedures. YAG Mode of SeLecTor has a wavelength of 1064 nanometers (nm) which is in the near infrared spectrum and is invisible to the human eye. The word LASER is an acronym for “Light Amplification by Stimulated Emission of Radiation”. The light from a Laser has particular characteristics which make it a valuable tool for medical applications. 

The beam from a laser is Collimated which means that the beam does not diverge and can maintain a constant diameter over a long distance. This means that the Laser beam can be focused to a very small spot with high energy and power densities.



The beam is Monochromatic which means that it is a single wavelength beam and therefore the effects of the beam on tissue are very predictable and reproducible.



The light waves are coherent which means they are in phase with each other and do not interfere and generate losses in energy.

Because the treatment Laser beam in YAG Mode is invisible, the SeLecTor II uses a twin beam Red aiming laser system to provide a means of focusing the YAG beam on the tissue. 23

The Laser systems are housed in a specially designed Slitlamp which has been adapted for use as a Laser delivery system. All the normal functions of a Slitlamp are available to the operator. When the system is being used as YAG laser to perform a capsulotomy or membranectomy procedure, the physician will normally uses a contact lens in order to direct the Laser energy to the part of the eye being treated. The contact lens also helps to hold the eye still and open during the procedure. The physician will normally turn the Laser System ON and check its operation before positioning the patient in the Chinrest and adjusting to the correct height. After selecting a low energy setting the physician can view the patients eye and after confirming that the indications and contraindications permit the procedure then the Laser can be put in the TREAT mode and by viewing the Aiming beams on the posterior surface of the capsule the laser can be focused correctly and then using the joystick fire switch the laser can be fired in order to put a hole in the capsule. Several laser shots will normally be required in order to produce a large enough hole in the posterior capsule to give clear vision to the patient. All of the controls and displays on the Laser System are used by the physician in order to prepare the laser for the procedure and ensure that normal operating conditions are occurring. For full details on Clinical Use see Section 6 of this manual. _________________________________________________________________________ The following paragraphs give a general description of the operation of the Laser System. The YAG Mode of SeLecTor generates a focused light beam of the wavelength 1064 nanometers (nm) at the same focal plane as the Slitlamp. This Laser beam has a spot size of approximately 8 microns and its energy is adjustable and selected by the Operator. The focused Laser energy will create a small plasma effect ( or spark ) in the eye media which in turn causes an acoustic wave that can disrupt or create a hole in the adjacent tissue. This is commonly called the Opto-acoustic effect.

FIGURE 4.1 YAG LASER FOCUSING FOR TREATMENT

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The size of the plasma effect is directly proportional to the amount of energy in the focused Laser beam. Therefore as the energy is increased the plasma will also increase and this then generates a stronger, more powerful acoustic wave which can make larger holes in the tissue. This stronger acoustic wave can also damage the Intra-ocular lens (IOL) if the plasma effect is focused too close to the IOL. Therefore to prevent this happening it is important to focus the Laser beam more posterior or further away from the tissue that is to be disrupted when increasing the Laser energy. This avoids damaging the IOL and also gives the best and most effective disruption effect on the tissue. When the Laser energy is reduced then the effect is the reverse of the above so the focus needs to be brought closer to the tissue. In the YAG Mode of SeLecTor, Treatment Laser beam focus is adjustable by a Control that is located on the left hand side of the Laser Arm. The focus can be set by the Doctor to the most appropriate offset according to the Energy set and the procedure that is being carried out. The (+) or Posterior offset sets the Laser treatment beam posterior or behind the Aiming beams (Slitlamp focal plane) by the setting as indicated on the control. The Control is calibrated in micrometers µm (microns). The (-) or Anterior offset sets the Laser treatment beam anterior or in front of the Aiming beams (Slitlamp focal plane) by the setting as indicated on the control. As a guide, for Posterior Capsulotomy procedures this offset should be set to around 150µm for Energies of 1.0 to 1.5 milli-joules (mJ). As the Energy is increased the offset is increased accordingly. The Doctor should always start with a lower energy setting and larger offset to ensure that no damage is caused to the IOL. Remember that a larger offset will mean that there is less effect on the capsule surface so it is important not to have too much offset such that a higher energy is used than necessary. The 1064nm Treatment Laser beam is invisible to our eyes so a visible red Aiming beam system is used to allow precise positioning of the Treatment Laser beam. The Aiming system originates from a Red laser diode which is split into two collimated beams that are then focused such that they are parfocal to the Slitlamp and coaxial with the Treatment Laser beam. This means that the Aiming beams focus together exactly at the focal plane for the Slitlamp and the centre point for the Aiming beams and Treatment Laser beams are the same at the focal plane of the Slitlamp. The intensity of the Aiming beams is set by the small knob on the right hand side of the Slitlamp Arm near the display. Note: It is recommended that the lowest effective treatment Laser energy be used to perform Opto-acoustic procedures as a means of minimizing unwanted side effects such as IOL damage or retinal damage. Always start the procedure at the minimum energy. Also, where a larger Laser offset focus may reduce the likelihood of IOL damage, this needs to be considered carefully such that an unnecessarily high energy is not used to overcome the larger offset. (Refer to Indications for use Section 6.3 of this manual for further warnings.)

SLT Mode: Frequency doubled YAG Laser 532nm SeLecTor II SLT Mode is a Nd:YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 3nsec, 0.2-2.6mJ, adjustable single pulse of energy. The aiming and treatment 25

beams are coaxial with each other and focused by the slitlamp objective to a 400μm spot at the focal point of the lens. SeLecTor II is an ophthalmic laser system specifically designed to treat open-angle glaucoma through Selective Laser Trabeculoplasty (SLT). - A lightweight, portable Q-Switched frequency-doubled solid-state 532nm laser - 3 nanosecond pulse duration confines thermally medicated damage to selectively targeted pigmented cells, without creating collateral damage to surrounding tissue - Fixed 400-micron spot size facilitates effortless delivery of energy to the trabecular meshwork - Plugs into standard 110V or 220V electrical outlets - Nearly 5 years of clinically proven performance ensures high quality and reliability Selective Laser Trabeculoplasty (SLT) A proven solution for managing open-angle glaucoma - Reduces IOP by improving aqueous outflow - No adverse systemic side effects commonly associated with medications - Effective as primary, adjunct and repeat therapy - Assures patient compliance - Proven Long-term efficacy - Lowers the need for cost-prohibitive drug therapy The SeLecTor II System consists of two main parts; 1.

The base is called the Control Box and in here are the power supplies and mains power switches. Also the Slitlamp Illumination controls are on the front panel of the Control Box. The Chinrest is fixed to the rear of the Control Box.

2.

The Slitlamp is mounted on top of the Control Box and in the Arm of the Slitlamp are all of the optical modules including the Laser beams, Energy adjuster and the control and Display circuits. On the front panel of the Arm are 5 switches which are used to set the operating modes of the Laser System.

Mains power must be connected to the Laser System then when the key-switch is turned ON (with the Emergency switch in the out or ON position) the Slitlamp Illumination is turned on. The power on indicator should be illuminated and in this mode of operation the Slitlamp can be used as a standard diagnostic instrument. The CSO 950 has all the functions of a standard Slitlamp and a full range of accessories are available for use with it if required. All the electronics and laser functions will not operate in this mode. To turn ON the electronics in order to set and use the Laser functions the Laser ON/OFF switch must be pressed. When this switch is turned on there is an indicator lamp which comes on and then the displays on the front panel of the Slitlamp Arm will turn on. The System controller performs some internal checks and some Laser test shots are fired to verify the correct operation of the Laser. All the operating conditions are shown on the display and the switches can be used to change operating modes or perform functions. The display shows the Energy selected, number of Pulses set, accumulated number of pulses and energy and two types of operation MODE. One 26

operation Mode is for the treatment laser type (YAG/SLT), while another one is for the treatment laser status. Especially, this operation Mode for treatment laser status is an important display. When the Laser ON/OFF switch is turned ON then the mode, “STANDBY” is automatically selected. This prevents any accidental firing of the Treatment Laser by disabling the fire switch and keeping the internal mechanical shutter that is in the beam path, closed. By pressing the Mode Switch the system is set into the “TREAT” mode of operation. The fire switch and shutter are now enabled and if the fire switch is pressed then the shutter opens momentarily to allow the Treatment beam to be delivered from the front of the Slitlamp Arm through the objective (or focusing) lens. The “STANDBY” mode can be selected by pressing the Mode Switch again. It is recommended that prior to going into the Treat Mode, all operating conditions, such as patient positioning, energy selection, number of pulses and Slitlamp Illumination are set correctly. This prevents the likelihood of accidental firing of the treatment laser during the set up steps. On either side of the Slitlamp Arm are two sets of large knobs which are used to control the energy level of the delivered Treatment Laser beam respectively. Whenever these knobs are rotated, the Energy display changes to indicate the Preset new energy setting. When the adjustment has been made then a test fire is initiated and this energy is then displayed. When a test fire is made the energy is not delivered through the system because the mechanical shutter is closed preventing any energy from being delivered. On the shutter there are sensors which the controller uses to ensure the shutter is in its correct position at all times otherwise an error condition will occur. Whenever the Treatment Laser is fired the energy of the shot is measured and displayed. An audible beep is sounded to indicate to the Operator that a Laser shot has been fired. If the delivered Laser Energy has changed by more than 20% from the previous treatment shot then a short burst of 3 beeps will sound to warn the Operator to check the Laser Energy. If the System is in the TREAT mode then the accumulated pulses and energy displays are incremented and the laser can be fired again in around 1 second. In the case of an emergency the Red Emergency Switch can be pushed to turn off all power. Normally power can be turned off using the key-switch. The key should not be left in the key-switch when the Laser System is unattended.

4.2 Ophthalmic YAG Laser Controls and Displays All the Controls and Displays for the SeLecTor II are located either on the Control Box front panel or the Laser head arm / display panel. The following figure 4.2 shows all of these controls and displays and then there is a description following.

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YAG

T Se Lec

SLT

Mode TREAT

STANDBY

Mode

or AIMING BEAM INTENSITY

SET

PULSES

SLT

TOTAL

ENERGY ADJUST

RESET YAG

ENERGY

ENERGY ENERGY ADJUST ADJUST

TEST

mJ

SeLecTor

POWER

POWER LASER

BOOST

EMERGENCY

ILLUMINATION INTENSITY

SeLecTor

LASER STOP

FIGURE 4.2 SELECTOR LASER CONTROLS AND DISPLAYS

Item 1

Feature Emergency Stop Switch

2

Key Switch

3

Power ON

Description 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 must be rotated to reset to the ON position. 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. Indicator A green lamp indicates that the power is turned on to the system.

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Item 4

5 6

7

8

9

10

11

Feature Laser Power ON/OFF Switch

Description This press switch applies power to the internal electronics so that the Laser system including the Aiming Laser turns on. There is a built in delay to operate this switch ON. This means that the user has to push the switch for at least 0.5 seconds to make the electronics turn on. Power is removed immediately when the switch is pushed to turn OFF. The system will always start in the YAG Mode when this switch is pressed on. Whenever the power is turned ON to the system this switch is in the OFF condition. Laser power ON A yellow lamp located next to the Laser ON/OFF switch Indicator indicates that the power is turned on to the Laser electronics Mode Set Switch This press switch toggles the Laser System between the STANDBY and TREAT modes. In the Standby mode the Laser cannot be fired by the Joystick fire switch and the Shutter is always closed. The Treat mode is only used when the operator wants to deliver a pulse of laser energy to the patient and in this mode the Joystick switch is enabled and the shutter will open. In the SLT mode, there will be 3 automatic internal shots right after this switch is pressed, while there will be no additional internal shots in the YAG mode Standby Indicator When this indicator is illuminated the Laser System is in the Standby mode and the Laser energy CANNOT be delivered to the patient. Treat Indicator When this indicator is illuminated the Laser System is in the Treat mode and the Laser energy CAN be delivered to the patient. Test Fire Switch This press switch can be used in either the Standby or Treat modes to fire the laser. The Shutter is always closed during the test fire and this features allows checking of operation and Energy levels. The Energy is displayed on the Display panel Pulses Set In YAG Mode: Switch This switch when pressed advances the number of pulses that the Laser will deliver in burst mode. When the Laser is first turned ON only 1 (single) Pulse mode is selected. Pressing the switch once will advance to 2 (double) Pulse mode and pressing again will advance to 3 (triple) Pulse mode. Pressing again will return back to 1 (single) Pulse mode. Whenever the Pulse mode is changed the laser does a test fire to measure and display the new Energy level. The number of Pulses selected is displayed on the Pulses display. In SLT Mode This switch is no function. Only Single Pulse. Pulses Display This LED indicates the number of pulses that will be delivered whenever the Laser is fired. This display will change whenever the Pulses Set Switch is pressed 29

Item 12

Feature Energy Display

13

Totals Displays

14

Totals Reset Switch

15

Joystick fire switch

16

Slitlamp Illumination intensity adjuster Slitlamp Illumination Boost Switch Aiming Beam Intensity Control

17

18

19

YAG Energy Adjustment Control

20

SLT Energy Adjustment Control

Description This 7-segment display shows the measured Energy level of the YAG Laser. This display is also used to indicate the approximation of the selected energy whenever the Energy adjustment control is changed. Whenever the Laser System is in TREAT mode and the Laser is fired with the Joystick switch these Displays increment to record / display the Total number of pulses delivered and the Total energy delivered. The displays are always reset to zero when the Laser System is switched ON. This switch can be used to reset both the Totals displays to zero. This reset would be done between patients and also would be done after doing performance and operating checks before using the Laser on patients. When this switch is pressed and the Laser System is in the TREAT mode a pulse or burst of pulses will be delivered from the Laser unit. The fire switch must not be held down in the ON position otherwise the microprocessor will detect this and put the Laser System back into the Standby Mode. Also if the Fire Switch is pressed in Standby Mode it is impossible to go into the TREAT Mode. This provides control over the brightness of the Illumination lamp in the Slitlamp. This switch can be used by the physician to momentarily provide maximum illumination to the patients’ eye. This control is not intended to be used for long periods of time. Located on the Right hand side of the Laser head arm this control provides continuous adjustment over the intensity of the Aiming beam spots. At minimum intensity there is still some illumination of the Aiming beams. Located on either side of the Laser head arm are the two knobs which provide the means to adjust the energy level of the YAG Laser. When this control is adjusted the microprocessor displays an approximation of the selected energy on the ENERGY display located on the Front Panel display. When the adjustment has been made then the Laser performs a test shot to measure the actual energy and then this is also displayed. Located on either side of the Laser head arm are the two knobs which provide the means to adjust the energy level of the SLT Laser. When this control is adjusted the microprocessor displays an approximation of the selected energy on the ENERGY display located on the Front Panel display. When the adjustment has been made then the Laser performs a test shot to measure the actual energy and then this is also displayed. 30

Item 21

Feature YAG Laser Focus Offset Control

22

YAG/SLT Mode Set Switch

23

YAG Mode Indicator SLT Mode Indicator

24

Description Located on the left hand side of the Laser Arm is a control that allows the YAG treatment laser beam focus point to be adjusted posterior (+) or anterior (-) to the Aiming beams focus. This control needs to be set by the doctor to the most appropriate offset for the procedure being carried out. In general Posterior Capsulotomy and Membranectomy procedures will use the Posterior offset and Iridotomy procedures will use Anterior offset. Zero offset means that the YAG Laser beam is set to the same focus plane as the Aiming beams and Slitlamp illumination. This press switch toggles the Laser System between the YAG and SLT modes. When this switch is pressed form the YAG mode to SLT mode, the system will automatically fire 5 internal shots to warm up the SLT laser. However, there will be no automatic internal shot form SLT mode to YAG mode When this indicator is illuminated the Laser System is in the YAG mode. When this indicator is illuminated the Laser System is in the SLT mode.

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4.3 CSO 950 Slitlamp Controls

T Se Lec

or AIMING BEAM INTENSITY

SLT ENERGY ADJUST

YAG ENERGY ADJUST

FIGURE 4.3 CSO 950 SLITLAMP CONTROLS

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