AURA PT / II Operator Manual Rev 1

Contents of Manual SECTION 1. INTRODUCTION... 6 SECTION 2. SAFETY ... 8 2.1 Product Classifications ... 8 2.2 Conformance to Standards... 8 2.3 Warnings and Precautions ... 9 2.4 Optical Hazards... 9 2.5 Electrical Hazards... 11 2.6 Safety Controls and Features... 11 2.7 Product Labeling... 15 SECTION 3. PRODUCT SPECIFICATIONS ... 18 3.1 AURA PT / II System Specification... 18 3.2 CSO 950 Slitlamp Specifications ... 19 3.3 Optional Accessories ... 20 SECTION 4. PRINCIPLES OF OPERATION ... 22 4.1 General Description ... 22 4.2 Ophthalmic YAG Laser Controls and Displays ... 26 4.3 CSO 950 Slitlamp Controls ... 30 4.4 Start up and operation of the Laser System ... 32 SECTION 5. INSTALLATION ... 36 5.1 Introduction and Requirements... 36 5.2 Unpacking and Receiving Inspection ... 37 5.3 Tools and Equipment... 39 5.4 Unpacking and Setting Up the System ... 40 5.5 Installation Checklist and Report... 44 SECTION 6. CLINICAL USE ... 46 6.1 Use of the AURA PT / II System as a Slitlamp Microscope ... 46 6.2 Use as an Ophthalmic YAG Laser... 47 6.3 Indications for Use ... 49 6.3.1 Posterior Capsulotomy and Pupillary Membranectomy... 50 6.3.2 Posterior Capsulotomy and Pupillary Membranectomy... 56 SECTION 7. MAINTENANCE ... 62 7.1 Operator / User Maintenance ... 62 7.2 Routine Maintenance Procedures... 62 7.3 Calibration Procedures... 66 7.4 Trouble Shooting Guide ... 70 7.5 Error and Warning Messages ... 71

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LIST OF DRAWINGS / FIGURES

PAGE

Figure 2.1

Safety Controls

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Figure 2.2

Safety and Controls Labels

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Figure 2.3

Safety Labels

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Figure 3.1

Lamp Drawings

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Figure 4.1

YAG Laser Focusing for Treatment

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Figure 4.2

YAG Laser Controls and Displays

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Figure 4.3

CSO 950 Slitlamp Controls

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Figure 5.1

Packing Carton

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Figure 5.2

Unpacking AURA PT / II

Figure 5.4 (a)

Assembly of YAG Laser System

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Figure 5.4 (b)

Assembly of YAG Laser System

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Figure 5.4 (c)

Positioning the Slitlamp Cables

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Figure 5.4 (d)

Exploded View of AURA PT / II for Installation

Figure 7.1

Laser Beams Alignment Checks

68

Figure 7.2

YAG Laser Beams Offset Focus Checks

68

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5

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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 AURA PT / II Ophthalmic YAG Laser. 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 AURA PT / 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 AURA PT / 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 AURA PT / II YAG Laser 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

Classifications Warnings Optical 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 invisible 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 AURA PT / II YAG Laser 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 OD5 or greater @ 1064nm to protect your eyes.

2.1 Product Classifications •

The AURA PT / II YAG Laser is a Class IIIB laser product as specified in the IEC standard 60825.1 (2001) and the USA 21 CFR’s 1040.10, 1040.11.

•

The AURA PT / II YAG Laser is classified as Class I Type B Electromedical equipment as specified in the IEC Standard 60601.1.

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The AURA PT / II YAG Laser is classified as a Class II device according to the FDA CFR21 regulations.

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The AURA PT / II YAG Laser is classified as a Class IIB Medical Device according to the MDD (93/42/EEC).

•

The AURA PT / II YAG Laser has been EMC tested and approved according to the requirements of the international standard IEC60601.1.2.

2.2 Conformance to Standards The AURA PT / II device has been designed and built to comply with the requirements of the following standards: •

Laser standards EN 60825-1:1998+A1:2002+A2:2001 USA 21 CFR 1040.10, 1040.11 (1997) EN 60601-1-2-22:1996 8

•

Electrical standards IEC 60601-1:1988+A1:1991+A2:1995 EN 60601-1:1990+A1:1993+A2:1995+A13:1996 EN 60601-1-2 (2001) USA UL2601

•

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

93/42/EEC

IEC60601-1-4 (1996) + Amendment A1(1999) EN ISO 14971 (2000) + A1 (2003)

2.3 Warnings and Precautions The following warnings apply to the AURA PT / II Laser 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 OD5 at 1064 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 YAG Laser 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.

2.4 Optical Hazards Guidance for the Safe use of Lasers and Systems is found in the IEC standard 825.1, the USA 21CFR 1040.10, 1040.11 and ANSI Z136.1 - 1986.

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During normal operation of the AURA PT / II YAG Laser 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 OD5 or greater @ 1064nm to protect your eyes. Viewing through any optical attachments to the Slitlamp is safe for the operators eye because of the built in safety filters. An optical density of at least 5 (five) and 1064nm 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: OD5 at 1064nm Otherwise the safety glasses are NOT suitable for eye protection. The AURA PT / II YAG Laser 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 (µW). 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 AURA PT / II YAG Laser 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 825.1. 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 AURA PT / II YAG Laser at single pulse (nominal) and at triple pulse (maximum) is: Single Pulse Energy = 11 meters Triple Pulse Energy = 20 meters 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. 10

2.5 Electrical Hazards The AURA PT / II YAG Laser 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. It is not safe to operate the AURA PT / II YAG Laser

WARNING 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 AURA PT / II YAG Laser has been designed to meet the safety features as required by the various standards identified in section 2.2. But in addition, the AURA PT / II also includes a number of additional safety features to enhance the safety of the Laser System.

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Figure 2.1 Safety Controls

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The following identifies the various safety features included in the AURA PT / 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 are operated for period of 5mins, the laser System will automatically toggle back to STANDBY mode. 13

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(s) 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 AURA PT / 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. Other In addition to these particular safety controls there are a number other features that have been designed into the AURA PT / II YAG Laser System: • 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. • 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. 14

• • •

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 AURA PT / II YAG Laser is a very safe instrument when used correctly and as indicated in the Operators Manual.

2.7 Product Labeling All the labels on the AURA PT / II YAG Laser 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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Figure 2.2 Safety and Control Labels

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Lightmed Corporation MODEL NO: SERIAL NO:

EU Authorized Representative MANUFACTURED:

Safety Labels Figure 2.3

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Section 3. PRODUCT SPECIFICATIONS Contents 3.1 3.2 3.3

AURA PT / II System Specifications CSO 950 Slitlamp Specifications Optional accessories

3.1 AURA PT / II System Specification The following are the System Specifications for the AURA PT / II Ophthalmic YAG Laser. Treatment Laser Laser Type: Wavelength: Mode Structure: Mode of Operation: Energy Output: Energy Adjustment: Burst Mode: YAG Offset Focus: Pulse Width: Repetition Rate: Air Breakdown: Spot Size: Cone Angle: Focal Length: Ocular Safety Filter: Safety Class: Energy Display accuracy: Aiming Laser Laser Type: Wavelength: Mode of operation: Output power: Power adjustment: Safety Class:

Neodymium Yttrium Aluminum Garnet ( Nd:YAG ) 1064 nm Fundamental Q-switched (CQ-Crystal) Maximum of 45 mJ in Triple pulse mode Nominally 10 mJ maximum in Single pulse mode Continuously variable across full energy range 1, 2 or 3 pulses each burst with the separation between pulses of 20 µs (nominal). Continuously variable from Anterior (-)500µm to Posterior (+)500µm. Detent steps @ 0, +/-150, 250, 500µm 4 ns +/- 2ns 2.5Hz for single pulse Better than 4 mJ 8µm ( FWHM ) 16° 107 mm OD5 at 1064 nm Class 3B Better than +/-20% of actual

Laser diode twin beam 635 nm (Red) Continuous Wave (CW) Maximum of 200µW Continuously variable Class 1

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General Electrical Input: Power: Fuse rating: Temperature Range:

Relative Humidity Range: Atmospheric pressure: Cooling System Dimensions (Total) Weight

100-230V AC 50/60Hz Single phase 200VA T3.15 AH250V @ 100-120V AC (Time-Lag) T2.5 AH250V @ 200-230V AC (Time-Lag) Transport: -10 to 70°C Operating: 20 to 40°C Storage: -10 to 55°C Operating: 30% -85% non-condensing Storage and Transport: up to 95% non-condensing Operating: 800-1060 mbar Storage and Transport: 500-1060 mbar Air convection 520mm(H) x 320mm(W) x 450mm(D) 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 AURA PT / II YAG Laser System. Microscope: Magnification Set: Eyepiece: Magnification Ratio: PD Range: Diopter Adjustment: Real Fields of View: Slit Illumination: Slit Width: Slit Length: Slit Apertures: Slit Angles: Filters:

Illumination Intensity:

Galilean 5 Step Drum Rotation 12.5X 6X, 10X, 16X, 25X, 40X 55 - 75mm +/-8D 5.2 - 40mm 6V 20W Halogen Lamp 0 - 13mm 2 – 12.5mm 0.3, 6, 10, 13mm and continuous 0° - 180° Red Free (Green) Heat Absorbing Cobalt Blue 0 - 600,000 Lux

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Movement Ranges Longitudinal (In/Out): Lateral (Left/Right): Vertical (Up/Down): Chin Rest Range

3.3

90mm 105mm 30mm 80mm

Optional Accessories

Non-Eurpoean Customers The following accessories can be purchased from the Distributor to use with the AURA PT / II YAG Laser 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 600022) Adapter for camera (Requires P/N 600022) Motorized Table with central drive column (Includes Top) Motorized Table with side drive column (for wheelchair access) Safety glasses OD5 @ 1064nm

Part Number 600036 600035 600027 600022 600023 600163 600025 600024 600015 600016 620001

The following are spare part accessories: Item Slitlamp Bulb, 6 Volt 20 Watt, type HLX64250 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 240013 240012 240014 600026 YL0508 540010

European Customers The following accessories are available for use within the EU Countries however the 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 AURA PT / 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. 20

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 600022) Adapter for camera (Requires P/N 600022)

P/N: 240013 Type HLX64250

Part Number 600027 600022 600023 600163 600025 600024

P/N: 240012 Type HLX64251

Use these drawings to help identify the correct lamp for your Slitlamp Figure 3.1

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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 The AURA PT / II is an Ophthalmic YAG Laser that has been designed for performing Posterior Capsulotomy, Pupillary Membranectomy and Iridotomy procedures. The YAG Laser 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. z

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.

z

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.

z

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 YAG Laser beam is invisible the AURA PT / II YAG Laser uses a twin beam Red aiming laser system to provide a means of focusing the YAG beam on the tissue. 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 an Ophthalmic YAG Laser to perform a capsulotomy or membranectomy procedure the physician will normally use 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 22

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 Laser System 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.

YAG Laser Focusing for Treatment Figure 4.1

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