OPTIMIS FUSION User Manual sw ver 1.06 May 2015

This QUANTEL MEDICAL equipment is proprietary products of QUANTEL MEDICAL under international copyright law and all rights are reserved. This manual may only be reproduced in whole or in part with written permission of QUANTEL MEDICAL. This manual is furnished for informational use only and QUANTEL MEDICAL reserves the right to modify the equipment characteristics and manual without previous notice. Photos and diagrams are not contractual. QUANTEL MEDICAL cannot be held responsible for any damage or injury which results from a failure to follow, or incorrect use of, the instructions contained in this manual. The guarantee of the equipment will be void if the equipment is opened (even partially), modified or repaired in any way by persons who are not authorized by QUANTEL MEDICAL.

Any question regarding the installation or the use of the OPTIMIS FUSION system should be directed to QUANTEL MEDICAL Service Department or to a local distributor:

International

U.S.A.

QUANTEL MEDICAL 11, rue du bois joli, CS 40015 63808 Cournon d’Auvergne Cedex FRANCE Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700 E-mail : [email protected] Web site: www.quantel-medical.com

QUANTEL USA MEDICAL UNIT 601, Haggerty Lane BOZEMAN MT 59715 U.S.A.

© 2015 QUANTEL MEDICAL All rights reserved OPTIMIS FUSION User Manual Software version 1.06 International version (Ref: XL_FUSION_ME_AN) MAY 05th, 2015

Tel : +1 888 660 6726 Fax : +1 (406) 586 2924 E-mail : [email protected] Web site www.quantel-medical.com

User manual Introduction

11, rue du bois joli - CS 40015 63808 Cournon d’Auvergne Cedex FRANCE Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700 E-mail : [email protected] Web site: www.quantel-medical.com

MAY 2015

CONTENTS 1 2 3

4

Rev. 05/05/2015 USER MANUAL DESCRIPTION ... ... ... ... ... ... ... 1 USER MANUAL TERMS AND SAFETY SYMBOLS ... ... ... ... ... 1 UNPACKING THE INSTRUMENT ... ... ... ... ... ... ... 2 3.1 TRANSPORTATION INFORMATION ... ... ... ... ... 2 3.2 UNPACKING THE INSTRUMENT ... ... ... ... ... 3 3.3 PACKING LIST ... ... ... ... ... ... ... 5 3.3.1 BASIC CONFIGURATION ... ... ... ... ... 5 3.3.2 ACCESSORIES ... ... ... ... ... ... ... 5 OPTIMIS FUSION LASER DESCRIPTION ... ... ... ... ... 6 4.1 GENERAL DESCRIPTION... ... ... ... ... ... ... 6 4.2 CONTROL MODULE LCD SCREEN ... ... ... ... ... 6

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User manual Introduction

1

USER MANUAL DESCRIPTION DESCRIPT ION The OPTIMIS FUSION user manual is organized into the following chapters: Introduction I Regulatory & safety information II Technical information III Using the laser system IV Maintenance V Clinical information

2

USER MANUAL TERMS AND AND SAFETY SYMBOLS WARNING Potential hazards which, if not avoided, could result in serious injury or death CAUTION Potential hazards which, if not avoided, could result in minor or moderate injury and/or product damage NOTE Significant additional information or explanation

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User manual Introduction

3

UNPACKING THE INSTRUMENT 3.1

TRANSPORTATION INFORMATION INFORMATION

To minimize transportation risks, this instrument has been packed with special care. However, before unpacking the laser, check the packaging for any sign of damage or improper handling.

Handling label

 Delivery label

NOTE In case of any problem, immediately contact the shipping company. Do only open the box in the presence of a company representative. Draw up a list of all damaged parts and ask for it to be signed by the company representative.

CAUTION If the instrument is at a temperature below 16°C 16°C (60.8°F), switching on the instrument may cause serious damages. Unpack the instrument and leave it at normal temperature for at least half a day to ensure that the internal components warm up gradually.

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User manual Introduction

3.2

UNPACKING THE INSTRUMENT INSTRUMENT 1/ Normal position position :

2/ Turn upside down :

3/ Open the box :

4 / Turn it back to the normal position :

5 / Pull up the box :

6 / Pull up the main foam with caution :

7 / Turn the binocular with caution to remove it from main frame :

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3

User manual Introduction 8 / Remove the flat foam located on the table and binocular foam :

9 / Remove the OPTIMIS FUSION from the bottom foam :

To mount the laser, refer to the: OPTIMIS FUSION User Manual: II – Technical information Section 4.2: Mounting the laser NOTE To repack the OPTIMIS FUSION laser: use the above procedure in reverse order.

CAUTION The chinrest must be placed on “high” position.

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User manual Introduction

3.3

PACKING LIST 3.3.1

BASIC CONFIGURATION

Before beginning the installation, check the contents of the package against the following list: Basic configuration LASER OPTI OPT I MIS FUSION Nd:YAG Power cord Keys (2) Remote User Manual Gear cover (2) Focusing bar 3.3.2

Codes XLFUSION

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ACCESSORIES

Please contact QUANTEL MEDICAL to ask for any of the following accessories: Accessories

Codes

For ancillary personnel XL 532 PROT Laser safety goggles OD 5 for 532nm XL 1064 PROT Laser safety goggle OD 6 for 1064nm Slit Lamp Adaptor XL FUS 1 Fusion Link adaptor Base Multi-voltage base XL LAF PIED3 Footswitch XLAAAPEDALE5 Footswitch

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User manual Introduction

4

OPTIMIS FUSION LASER DESCRIPTION 4.1

GENERAL DESCRIPTION

Bionocular head Headrest Slit lamp Magnification button Fixation LED Chinrest Slit width control button Energy button Generator blocking knob Slit lamp blocking knob

Controle module LCD screen Aiming beam button

X, Y, Z Joystick & Fire switch

Blocking knob Slit lamp illumination intensity button

Green LED ON when the main switch is activated Emergency stop button Keyswitch

Slit lamp illumination button

4.2

CONTROL MODULE LCD SCREEN SCREEN

LCD screen display

BURST MODE button STANDBY / READY button

6

FOCUS OFFSET button. RESET COUNTER button

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User manual I – Regulatory and safety information

11, rue du bois joli - CS 40015 63808 Cournon d’Auvergne Cedex FRANCE Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700 E-mail : [email protected] Web site: www.quantel-medical.com

MAY 2015

CONTENTS

Rev. 05/05/2015 1 INTENDED USE AND CONTRAINDICATIONS ... ... ... ... ... 1 CLASSIFICATIONS... 2 ... ... ... ... ... ... 1 3 SAFETY INFORMATION AND PRECAUTIONS ... ... ... ... ... 1 3.1 GENERAL WARNINGS AND SAFETY INFORMATION... ... ... 1 3.2 IMPORTANT RECOMMENDATIONS ... ... ... ... ... 3 3.3 SAFETY FEATURES ... ... ... ... ... ... ... 4 3.4 ADDITIONAL SAFETY FEATURES ... ... ... ... ... 5 3.5 LASER SAFETY AND NOHD ... ... ... ... ... ... ... 6 3.5.1 SAFETY EYEWEAR ... ... ... ... ... ... ... 6 3.5.2 SAFETY EYEWEAR ... ... ... ... ... ... 7 3.5.2.1 OPTIMIS FUSION WITH 1064NM LASER SELECTION ... ... ... 7 3.5.2.2 OPTIMIS FUSION WITH 532NM LASER SELECTION ... ... ... 8

3.6

PRECAUTION TO TAKE CONCERNING WASTES AND ELIMINATION OF DEVICE AND ACCESSORIES9 ACCESSORIES9

User manual I – Regulatory and safety information

1

INTENDED USE AND CONTRAINDICATIONS CONTRAINDICATIONS The OPTIMIS FUSION incorporates two treatment modes and is intented for: YAG photodisruption mode - to carry out:

posterior capsulotomy

iridotomy

posterior membranectomy

selective Laser Trabeculoplasty (SLT)

SLT mode - to carry out:

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CLASSIFICATIONS The system is intended for continuous operation and has the following classifications: Protective class Type

3

I (Main insulation) B (Protection against electrical shocks through the limiting of leakage current and the provision of a protective earth connection)

Protection degree

IP20 (Protection from solid substances: Ø>12,5mm)

Operation

Continuous with short-time loading

SAFETY INFORMATION AND A ND PRECAUTIONS If any incident occurs, QUANTEL MEDICAL shall not be liable if the following safety information and precautions are not followed.

3.1

GENERAL WARNINGS AND SAFETY INFORMATION

WARNING:

This user manual is designed to acquaint the user with the normal operation and maintenance of the OPTIMIS FUSION ophthalmologic laser. The manual scope is limited to the operation, maintenance and controls of the system. It is not intended to be a guide to laser eye treatment. Laser safety begins with the understanding that the purpose of this device is to perform controlled destruction of living tissues. Misuse of this system could result in patient, physician or attendees injuries. QUANTEL MEDICAL consequently strongly recommends the user to read and understand this entire manual before using the product, especially this section concerning safety.

WARNING:

The American National Standards for the Safe Use of Laser in Health Care Facilities (ANSI ANSI Z 136.3136.3- 1996 and ANSI Z 136.1136.1-1993) 1993 provide guidance to safely use lasers and laser systems in the diagnostic and therapeutic areas. Those two standards are related to eye and skin hazards and recommend the use of protective eye wear, clothing, barriers and screens.

WARNING:

Any use of controls or performance adjustments for procedures other than those specified herein may result in hazardous radiation and/or electrical exposure.

CAUTION:

USA Federal Law restricts this device to sale by, or on the order of, a physician.

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User manual I – regulatory and safety information

2

WARNING:

This user manual is intended to solely be used by trained ophthalmologists for diagnosis and treatment of ocular pathology.

CAUTION:

QUANTEL MEDICAL cannot be held responsible for any damage or injury that results from a failure to follow or incorrect use the instructions contained in this manual.

WARNING:

This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

WARNING:

To comply with medical electrical equipment safety standard requirements, the laser power plug must be connected on to a wall grounded single phase power socket on its own. The use of an adaptor (for multiple connections) or a power bar is prohibited.

WARNING:

Do not connect the laser power plug (3 pin adaptor) on an ungrounded power socket (2pin).

WARNING:

Before cleaning the unit, unplug the power cord from the wall mains plug. Please refer to the: OPTIMIS FUSION user manual: IV – Maintenance Section 2: Care and maintenance of the OPTIMIS FUSION laser system

WARNING:

The instrument calibration must be performed every year by a technician authorized by QUANTEL MEDICAL.

WARNING:

In case the laser efficacy is altered and the laser system needs servicing: you must contact QUANTEL MEDICAL Service Department or your local distributor.

WARNING:

Unit servicing must only be performed by QUANTEL MEDICAL technicians or otherwise technicians authorized by QUANTEL MEDICAL (local distributors).

WARNING:

Transport the OPTIMIS FUSION equipment only under the conditions described in the: OPTIMIS FUSION user manual: II – Technical information Section 4.3: Moving the OPTIMIS FUSION equipment

CAUTION:

To preserve the appearance of the device, do not use abrasive cleaning products, or solvents. If possible, clean off stains immediately

CAUTION:

The device's guarantee will be void if the equipment is opened (even partially), modified or repaired in any way by persons who have not been authorized to do so by QUANTEL MEDICAL.

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User manual I – Regulatory and safety information

3.2

IMPORTANT RECOMMENDATIONS RECOMMENDATIONS

WARNING:

To prevent injury to personnel or damage to the instrument, all operators must fully versed in the instructions and procedures detailed herein and in the ANSI Standard Z136.3. 1.

Never directly look into a laser light source and avoid exposure to reflected or scattered laser light. This device is classified as Class IIIb (3b) laser product: direct, reflected or scattered light from this laser may cause injury.

2.

The treatment beam emitted from this instrument has the potential to ignite anesthetics or flammable materials or explosives. Do not use this system in proximity to these materials.

3.

Safety goggles or masks are required for anyone who is present during a treatment session, except for the physician and the patient. During some procedures it may be advisable to shield untreated eyes (Please refer to Section 3.5.1: Safety eyewear).

4.

Never leave the system on when it is unattended or within the reach of unauthorized persons. Before leaving the vicinity, turn off the system and keep the key with you.

5.

When the laser is on, always keep the system in “STANDBY” mode unless it is used to perform treatment.

6.

Contact lens wearers should use anti-reflection lenses treated for 532nm and 1064nm wavelengths. Contact lenses, particularly those with plano surfaces, can generate dangerous reflections.

7.

Never open the laser enclosure as hazardous levels of visible and invisible optical radiations are present inside. Refer any servicing problem to qualified personnel authorized by QUANTEL MEDICAL.

8.

Observe all DANGER, DANGER WARNING or CAUTION labels placed on the device: An overview of the location and contents of these labels can be found in the: OPTIMIS FUSION User manual: II - Technical information Section 1: Labels

9.

Circuitry is provided for the connection of a remote interlock. When attached to the laser door room or other actuator, the interlock will prevent the laser from firing if someone enters in the room while the system is in use. Installation instructions are provided in: OPTIMIS FUSION User Manual: II - Technical information Section 4.5: Door switch & External red lamp installation

10.

Regular maintenance, which can be performed by the user, is described in: OPTIMIS FUSION User Manual: IV – Maintenance Performing regular maintenance, which includes checking the power calibration, will help ensuring trouble-free operation.

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User manual I – regulatory and safety information

3.3

SAFETY FEATURES FEATURE

Lockable key switch

Emergency Laser Stop switch

Laser Selection Button

Laser READY / STANDBY indicator

Safety remote interlock

Safety shutter

Energy deviation warning

Protective housings

Location of controls

Ocular filters

FDA and IEC compliance labels

Electrical leakage protection

4

DESCRIPTION The lasers can only be turned on with the correct key that corresponds to the laser key switch. The key cannot be removed while the laser is operating, so the laser cannot function without the key in place. During normal operation the red push button (mushroom shaped) is in the “out” position (not down). When pressed in, it immediately switches off all power and eliminates any risk of laser irradiation. The button must be released by turning clockwise to the ON position to restart the system and return to “STANDBY” status. Once the Emergency Laser Stop switch is in the ON position, the main switch located behind the unit is switched on, and the interlock is closed (where applicable): the treatment mode can be selected by turning the keyswitch to the YAG or SLT position. Once the keyswitch is turned on the YAG or SLT position: the OPTIMIS FUSION laser system interface displays (after a start up automatic procedure) the welcome screen that corresponds to the selected mode (YAG or SLT). Once the treatment mode has been selected by turning the keyswitch to the YAG or SLT position: the system performs an autotests sequence and an initialisation procedure. Once completed, : the YAG or SLT treatment screen is displayed with the laser in STANDBY mode by default (GREEN LED is turned ON). The READY mode can now be selected by pressing the READY/STANDBY button (located on the LCD control module). Pressing on the READY/STANDBY button allows the user to switch the laser from STANDBY to READY. The green LED (STANDBY) turns off and the yellow LED (READY) switches ON. The system must thus be manually switched to READY status before the treatment laser can fire. This Th is is a useruser-installed feature that is highly recommended. The doorswitch is a magnetically or mechanically triggered switch which closes the electrical circuit when the door is closed (the laser can fire) or which opens the electrical circuit when the door opens (to prevent the laser from firing). The user should provide the doorswitch. The unit is supplied with a bypass plug which allows the user to short-circuit the doorswitch security and thus use the laser without this security.. Each laser and optical system module is equipped with a spring loaded safety shutter that keeps the treatment laser optical path blocked unless the system is manually switched to READY status: in this case, the safety shutter opens up ans stays open to allows the laser to fire. The system warns the operator if delivered energy deviates more than ±20% from the set value. Protective housings on the laser and optical system, as well as the control and display systems, prevent the operator from being inadvertently exposed to laser emission or high voltage shock. The protective housings cannot be removed without tools and must only be opened by QUANTEL MEDICAL personnel or QUANTEL MEDICAL authorized personnel (local distributors).. All the operator controls are located so that there is no risk to the operator of inadvertent laser exposure. The operator viewing port on the laser and optical system module contains a safety filter to limit the exposure level to the operator's eyes to below class 1 limits. Any standard slit lamp viewing accessory can be used with the OPTIMIS FUSION slit lamp without hazard. Locations and illustrations of the safety compliance labels are contained in the: OPTIMIS FUSION User Manual: II - Technical information Section 1: Labels A medical grade power supply is built into the power supply console. This ensures that the complete instrument including the slit lamp power supply meets the requirements of IEC 601-1 for earth leakage protection.

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User manual I – Regulatory and safety information

3.4

ADDITIONAL SAFETY FEATURES FE ATURES FEATURE Memory test

Laser powerpower-up test

Treatment mode

STANDBY status

DESCRIPTION When the OPTIMIS FUSION is first switched on, the system automatically checks the microprocessor memory. If a malfunction is detected an error code is displayed and the laser cannot be switched into READY status. Refer to: OPTIMIS FUSION User Manual: IV - Maintenance Section 10: Appendix – Error codes After the memory test the system automatically performs a self-test program where it confirms the safe and correct operation of the modules. During this procedure the microprocessor fires a serie of test shots with the shutter closed. If this test routine is satisfied, the control module LCD screen displays the normal chosen treatment screen (YAG or SLT). The energy of the last test shot is displayed. If a malfunction is detected, an error code is displayed and the laser cannot fire. Refer to: OPTIMIS FUSION User Manual: IV - Maintenance Section 10: Appendix – Error codes At the end of the self-test routine and initialization process the control module automatically displays the selected treatment screen (YAG or SLT). At the end of the self-test routine and initialization process the control module automatically enters STANDBY status. In this state the aiming beam is activated and all the controls function allowing the user to adjust treatment parameters can be selected, however the treatment laser is disabled and the laser fire switch will not function. STANDBY status eliminates the risk of accidental treatment beam activation during patient set up. To enable the treatment laser to function, it is necessary to select READY so that the laser can fire.

Note: There is a delay of two seconds after READY is selected before the

Shutter monitor

Automatic test fire

Reset after power failure

Fault conditions

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laser can be fired. A dual sensor shutter monitor checks the correct opening and closing of the shutter. In the event of a shutter malfunction, the laser fire switch is disabled and an error code is displayed in the LCD screen on the control module. Refer to: OPTIMIS FUSION User Manual: IV - Maintenance Section 10: Appendix – Error codes Every time an energy setting is changed, either the energy selection or the number of pulses, an automatic test fire occurs. During this test fire, the shutter remains closed so there is no risk of exposing the patient or operator to laser radiation. After a test fire, the resultant energy is shown in the LCD screen on the control module. When power is restored after a power failure, the system will restart and will be in STANDBY status. If the system detects a fault during operation, an error code is displayed on the control module LCD. Warnings may be cleared by the operator, while errors result in automatic system shut down. Refer to: OPTIMIS FUSION User Manual: IV - Maintenance Section 10: Appendix – Error codes

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User manual I – regulatory and safety information

3.5

LASER SAFETY AND NOHD NOHD 3.5.1

SAFETY EYEWEAR Safety glasses or filters must protect the eyes from the emitted wavelength (spectral response) and should therefore have a high optical density at the emitted wavelength:

6



Safety goggles or masks are required for anyone present at a treatment session.



All terminals (including slit lamp accessories such as camera adaptors and co-observation tubes) must be equipped with filters that guarantee eye protection to the operator. Protection at an appropriate Optical Density (OD) must also be provided for the eye that is not directly viewing through the accessory.

WARNING:

Appropriate safety glasses should be available before accessing the treatment room. Any treatment room window or opening should be protected.

WARNING:

QUANTEL MEDICAL recommends the use of safety interlocks and warning lamps adapted to the treatment area.

WARNING:

Any reflective instrument should be avoided. All room surfaces should be matt finished to prevent any potential laser light reflection.

WARNING:

Avoid staring into the aiming beam unless under controlled conditions. However, damage to the retina from the aiming beam is most improbable.

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User manual I – Regulatory and safety information 3.5.2

SAFETY EYEWEAR 3.5.2.1

OPTIMIS FUSION WITH 1064NM LASER SELECTION

The safety eyewear requirement is based on the Maximum Permissible Exposure (MPE MPE), MPE the Nominal Ocular Hazard Distance (NOHD NOHD) OD). NOHD and the Optical Density (OD OD For additional information, please refer to the standard: ANSI Z136.1Z136.1- 1993, 1993, ANSI Z136.3Z136.3-1996, 1996 or European Standard EN 60825: 1992, 1992, Appendix A. The following formula has been used to calculate the NOHD for the worst case scenario for the 1064nm laser part of the OPTIMIS FUSION unit.

Pf . (4 . Po / (3,14 . EEMP)) - Ø DNRO = a Where:

Ø: beam waist diameter; z: distance between the laser system and the beam waist; a:

full angle beam divergence;

Po:

maximum laser power available;

Pf:

profile correction factor;

E MPE: Maximum Permissible Exposure, in power density units (power per unit area). NOHD: Nominal Ocular Hazard Distance (measured from laser aperture) the distance required to reduce the power density to the MPE. Parameters:

Ø Po Pf a

= = = =

0.01 mm 2.5 106 W 1 0.279 rad

EMPE = 6.678 105 W/m² NOHD = 7.82 m

Safety Eyewear: All personnel who are within the NOHD are considered to be within the controlled area and should wear eye protection with a minimum optical density (OD) of: OD = - LOG (EMPE / Fluence) = 3.16 Where Fluence = 1162.82 J/m² (taking into account the pupil diameter of 7 mm) WARNING:

For a maximum of security, the safety eyewear must have a protection class of:

L4 @ 1064nm (EN 207 Standard).

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User manual I – regulatory and safety information 3.5.2.2

OPTIMIS FUSION WITH 532NM LASER LASER SELECTION

The safety eyewear requirement is based on the Maximum Permissible Exposure (MPE MPE), MPE the Nominal Ocular Hazard Distance (NOHD NOHD) and the Optical Density (OD OD). NOHD OD For additional information, please refer to the standard: ANSI Z136.1Z136.1- 1993, 1993, ANSI Z136.3Z136.3-1996, 1996 or European Standard EN 60825: 1992, 1992, Appendix A. The following formula has been used to calculate the NOHD for the worst case scenario for the 532nm laser part of the OPTIMIS FUSION unit.

Pf . (4 . Po / (3,14 . EEMP)) - Ø DNRO = a Where:

Ø: beam waist diameter; z: distance between the laser system and the beam waist; a:

full angle beam divergence;

Po:

maximum laser power available;

Pf:

profile correction factor;

E MPE: Maximum Permissible Exposure, in power density units (power per unit area). NOHD: Nominal Ocular Hazard Distance (measured from laser aperture) the distance required to reduce the power density to the MPE. Parameters:

Ø Po Pf a

= = = =

0.4 mm 5 105 W 1 0.0104 rad

EMPE = 1.56 106 W/m² NOHD = 193 m

Safety Eyewear: All personnel who are within the NOHD are considered to be within the controlled area and should wear eye protection with a minimum optical density (OD) of: OD = - LOG (EMPE / Fluence) = 4.92 Where Fluence = 1299.88 J/m² (taking into account the pupil diameter of 7 mm) WARNING:

For a maximum of security, the safety eyewear must have a protection class of:

L5 @ 532nm (EN 207 Standard).

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