Lumenis AURA PT Operator Manual Rev D

This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Lumenis, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Aura PT, Lumenis, and the Lumenis logo are registered trademarks of Lumenis, Inc. Lumenis, Inc. 1870 S Milestone Dr Salt Lake City, UT, 84104, USA 1-877-Lumenis

Manufactured by LightMed Corporation No. 1-1, Lane 1, Pao-An St., Sec. 3 Shulin City, Taipei Hsien, Taiwan EU Representative: Medical Devices Safety Service GmbH Schiffgraben 41 30175 Hannover, Germany Exclusive Distribution: Lumenis Inc. 1870 S Milestone Dr, Salt Lake City, UT, 84104 WEB Address: www.lumenis.com © Lumenis, Inc. Published in USA

Document Title:

Operator Manual for the AURA PT Ophthalmic YAG Laser

Document Number:

UM-0035610

Document Revision History: DRAFT

August 2006

Draft prepared.

Revision A

November 2006

Initial release in ECO 9287.

Revision B

January 2007

ECO 9440 to update power supply changes

Revision C

May 2011

ECO 12056 to update labeling

Revision D

January 2015

ECO-0004275 Update referenced Standards Section 2.2, Magnification Ratio Section 3.2, Magnification Ratio Figure 2.3, 4.3, 5.4(b). Update Lumenis address and logo. Add EN 207 information.

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Operator Manual for the AURA™ PT Ophthalmic YAG Laser Clinicians and physicians should ensure that they are adequately trained in the procedures that the AURA PT YAG Laser will be used for prior to operating the equipment. This Operator 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 AURA PT Ophthalmic YAG Laser 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 Operator Manual contains confidential and proprietary information of the Manufacturer.

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Contents of Manual SECTION 1.

INTRODUCTION ... 8

SECTION 2.

SAFETY ... 10

2.1

Product Classifications ... 10

2.2

Conformance to Standards ... 10

2.3

Warnings and Precautions... 11

2.4

Optical Hazards ... 11

2.5

Electrical Hazards ... 12

2.6

Safety Controls and Features ... 13

2.7

Product Labeling ... 17

SECTION 3.

PRODUCT SPECIFICATIONS ... 20

3.1

AURA PT System Specification ... 20

3.2

CSO 950 Slitlamp Specifications ... 21

3.3

Optional Accessories ... 22

SECTION 4.

PRINCIPLES OF OPERATION ... 24

4.1

General Description ... 24

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 ... 33

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 ... 39

5.5

Installation Checklist and Report ... 44

SECTION 6.

CLINICAL USE ... 48

6.1

Use of the AURA PT System as a Slitlamp Microscope ... 48

6.2

Use as an Ophthalmic YAG Laser ... 49

6.3

Indications for Use... 51

6.3.1 Posterior Capsulotomy and Pupillary Membranectomy ... 52 6.3.2 Posterior Capsulotomy and Pupillary Membranectomy ... 57 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

SECTION 8.

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CUSTOMER SUPPORT, SALES, AND SERVICE ... 74

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LIST OF DRAWINGS / FIGURES

PAGE

Figure 2.1

Safety Controls

14

Figure 2.2

Safety and Controls Labels

17

Figure 2.3

Safety Labels

18

Figure 4.1

YAG Laser Focusing for Treatment

25

Figure 4.2

YAG Laser Controls and Displays

28

Figure 4.3

CSO 950 Slitlamp Controls

32

Figure 5.1

Packing Carton

37

Figure 5.2

Unpacking AURA PT

38

Figure 5.4 (a)

Assembly of YAG Laser System

41

Figure 5.4 (b)

Assembly of YAG Laser System

42

Figure 5.4 (c)

Positioning the Slitlamp Cables

42

Figure 5.4 (d)

Exploded View of AURA PT for Installation

43

Figure 7.1

Laser Beams Alignment Checks

65

Figure 7.2

YAG Laser Beams Offset Focus Checks

65

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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 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 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. 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 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

Classifications

2.2

Warnings

2.3

Optical Hazards

2.4

Safety Controls and Features

2.5

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 Operator 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 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. See the American National Standard (ANSI) publications Z136.3, ANSI Z136.1, and EN 207 for recommendations on the safe use of lasers in health care facilities.

2.1 Product Classifications 

The AURA PT YAG Laser is a Class 3B laser product as specified in the IEC standard 60825.1 (2007) and Class IIIb per USA 21 CFR1040.



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



The AURA PT YAG Laser is classified as a Class II device according to the FDA 21 CFR regulations.



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



The AURA PT 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 device has been designed and built to comply with the requirements of the following standards: 

Laser standards IEC 60825-1 USA 21 CFR Part 1040 & 1040.11 IEC 60601-2-22

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

Electrical standards IEC 60601-1 EN 60601-1 EN 60601-1-2 USA UL2601 JIS T1001 and T1002



Others MDD

93/42/EEC

EN ISO 14971

2.3 Warnings and Precautions The following warnings apply to the AURA PT 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 60825.1, the USA 21 CFR Part 1040 and ANSI Z136.1. During normal operation of the AURA PT YAG Laser the operator is protected from Laser hazards by built in optical absorption filters in the viewing optical path. All other personnel in

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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. For users who must comply with EN 207, the safety eyewear must have a protection class of L5 @ 1064nm. 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 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 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 (W). The maximum safe power that can be visualized by the retina is 390 microWatts 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 YAG Laser has been classified a Class 3B/IIIb 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/IIIb 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 60825.1. The product then complies with 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 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.

2.5 Electrical Hazards The AURA PT YAG Laser has been designed to comply with International Standards for Medical Electrical equipment. The Laser System is designed to operate with a 3 terminal mains AC voltage supply with the third pin being the Earth or Ground connection.

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is not safe to operate the AURA PT YAG Laser WARNING Itwithout 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 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 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: 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 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 a 7second delay, laser emissions will be possible. Power is immediately removed when the switch is pus hed 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 is 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 the shutter closes. At all times, the shutter position is detected by two sensors which are continuously monitored 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 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 th is 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 Systems are operated for a period of 5mins, the laser System will automatically toggle back to STANDBY mode. 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

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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 the 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 while keeping the shutter closed. This 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 performs a series of internal checks, displays the software version number as well as firing 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 the Laser System requires a Voltage Calibration 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 YAG Laser System: 

All of the controls are located so as to prevent the operator from 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 operator’s eyes from being exposed to the Laser beam when using the equipment.



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 and no controls are operated for 5 minutes the System will go back to the STANDBY Mode if it was set inTREAT Mode.

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

If the Operator or User of the Laser holds the Joystick Fire Switch down for longer than 1 second in the TREAT Mode, the unit will revertto 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.

2.7 Product Labeling All labels on the AURA PT YAG Laser comply with the requirements of the regulatory standards referred to previously in this Manual. An illustration of all safety and control labels is shown in the figures 2.2 and 2.3.

MODE

SET

TREAT

STANDBY

SET PULSES RESET

TOTALS

TEST

ENERGY

mJ AURA PT TM

POWER

LASER POWER

BOOST

ILLUMINATION INTENSITY

EMERGENCY

LASER STOP

Figure 2.2 Safety and Control Labels

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Lumenis Inc. MODEL NO: SERIAL NO:

Lumenis Inc. MODEL NO: SERIAL NO:

AIMING BEAM INTENSITY

ENERGY ADJUST

Distributed for Lumenis Inc, www.lumenis.com, 1870 S Milestone Dr, Salt Lake City, UT 84104, 1-877-LUMENIS. Manufactured by LightMed Corporation No1-1, Lane 1, Pao-An Street, Section 3 Shulin dist, New Taipei 23861, TAIWAN

EC REP

EU Authorized Representative

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

MANUFACTURED:

Safety Labels Figure 2.3

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Section 3. PRODUCT SPECIFICATIONS Contents 3.1 3.2 3.3

AURA PT System Specifications CSO 950 Slitlamp Specifications Optional accessories

3.1 AURA PT System Specification Following are the System Specifications for the AURA PT Ophthalmic YAG Laser. Treatment Laser Laser Type:

Neodymium Yttrium Aluminum Garnet ( Nd:YAG )

Wavelength:

1064 nm

Mode Structure:

Fundamental

Mode of Operation:

Q-switched (CQ-Crystal)

Energy Output:

Maximum of 45 mJ in Triple pulse mode Nominally 10 mJ maximum 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).

YAG Offset Focus:

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

Pulse Width:

4 ns +/- 2ns

Repetition Rate:

2.5Hz for single pulse

Air Breakdown:

Better than 4 mJ

Spot Size:

8µm ( FWHM )

Cone Angle:

16°

Focal Length:

107 mm

Ocular Safety Filter:

OD5 at 1064 nm

Safety Class:

Class 3B

Energy Display accuracy:

Better than +/-20% of actual

Aiming Laser Laser Type:

Laser diode twin beam

Wavelength:

635 nm (Red)

Mode of operation:

Continuous Wave (CW)

Output power:

Maximum of 200µW

Power adjustment:

Continuously variable

Safety Class:

Class 1

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