Operators Manual
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Operator’s Manual for the Ophthalmic YAG Laser SeLecTor II (YAG Mode: Ophthalmic YAG Laser 1064nm and SLT Mode: Frequency Doubled YAG Laser 532nm)
Litechnica Ltd, Kirby House, 122 Heston Road, Heston, Middlesex, TW5 0QU, UK T: 020 8577 2450 E: [email protected] W: www.litechnica.co.uk
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