vitra 689 User Manual sw ver 1.0 and over

TABLE OF CONTENTS Rev.04/05/2021

INTRODUCTION ... 6

x

REGULATORY INFORMATION AND SAFETY ... 14

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II. TECHNICAL INFORMATION... 30

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I.

III. USE ... 48

IV. MAINTENANCE ... 65

V. CLINICAL INFORMATION... 76

TABLE OF CONTENTS Rev. 04/05/2021

1.

USER MANUAL DESCRIPTION... 6

2.

TERMS AND SYMBOLS ... 6

3.

UNPACKING THE INSTRUMENT ... 7 3.1. TRANSPORTATION INFORMATION & LABELS ... 7 3.2. PACKING LIST... 9 3.3. ACCESSORIES... 10

4.

GENERAL DESCRIPTION ... 11 4.1. LASER... 11 4.1.1.

FRONT PANEL ... 11

4.1.2.

REAR PANEL... 11

4.1.3.

PDT ADAPTOR ... 12

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USER MANUAL

INTRODUCTION

1. USER MANUAL DESCRIPTION This user manual is organized into the following chapters: -

Introduction

-

I – Regulatory information and safety

-

II – Technical information

-

III - Use

-

IV - Maintenance

-

V – Clinical information

This manual is provided with the device under electronic format (PDF) with the documentation package of the USB stick. A player software (Sumatra) for this file format is also furnished on the USB stick.

The user is able to ask Quantel Medical for a paper version of this user manual.

2. TERMS AND SYMBOLS This manual uses symbols and terms that draw the attention of the reader to additional security information. Their signification is described below:

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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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INTRODUCTION

3. UNPACKING THE INSTRUMENT 3.1. TRANSPORTATION INFORMATION & LABELS Before being shipped, the unit has been packed with special care in order to reduce the risk of damage during transportation. However, before unpacking the laser, it is imperative to check and identify any possible sign of package deterioration. 2 3 1

1

1

Shipping label – Handle with care

2

Environmental conditions eligible for transportation and storage.

Package positioning direction.

Pressure limit.

Fragile. Handle with care.

Relative humidity limit.

Keep dry.

Temperature limit.

Fragile. Keep dry.

Keep away from sunlight. Consult the user manual.

Keep dry.

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INTRODUCTION 3

Goods receipt 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 15°C (59°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. PACKING LIST When receiving the shipment, check the contents of the package in the following list:

-

Laser VITRA 689

-

Power cord

-

Red bypass connector doorswitch

-

Blue bypass connector

-

Keys (2)

-

Footswitch

-

Elbow rest

-

User manual on electronic format (USB)

-

Quick start guide

-

689 nm PDT adaptor

-

With Slit Lamp kit: -

Mirror with black mask for Slit lamp

-

7,5 mm Rising ring for Slit Lamp Haag Streit 900BQ 3 mm additional rising ring

NOTE:

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The device could be delivered with one or several accessories from the following table.

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INTRODUCTION

3.3. ACCESSORIES To order the following elements, contact QUANTEL MEDICAL or your local distributor. Accessories for the laser VITRA 689 FOR ANCILLARY PERSONNEL Laser safety goggles for 689 nm wavelength FOR CALIBRATION PURPOSE Laser power measurement system CARRYING CASE Carrying case

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USER MANUAL

INTRODUCTION

4. GENERAL DESCRIPTION 4.1. LASER 4.1.1. FRONT PANEL Laser status light

Control screen

Spot size adjustment knob Fiber connector

Emergency stop button

Power supply LED

Key switch

4.1.2. REAR PANEL

Main switch Fuse trapdoor Power supply socket

Doorswitch connector Spot size setting potentiometer connector

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Footswitch connector Adaptor connector

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4.1.3. PDT ADAPTOR

Fiber guide

Fiber

Zoom

Output lens

Doctor filter

Dichroic

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TABLE OF CONTENTS Rev. 04/05/2021

1.

INTENDED USE AND CONTRAINDICATIONS ... ERREUR ! SIGNET NON DÉFINI.

2.

SYMBOLS ... 18

3.

CLASSIFICATIONS ... 20

4.

5.

6.

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3.1

CLASSIFICATION OF THE DEVICE... 20

3.2

ELECTRICAL CLASSIFICATION OF THE DEVICE ... 20

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3.3

ELECTRICAL CLASSIFICATION OF TERMINALS ... 20

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3.4

CLASSIFICATION OFTHE TREATMENT BEAM ... 20

3.5

CLASSIFICATION OF THE AIMING BEAM ... 20

WARNINGS AND PRECAUTIONS ...21 4.1.

GENERAL WARNINGS AND SAFETY INFORMATION... 21

4.2.

IMPORTANT RECOMMENDATIONS ... 23

4.3.

SAFETY FEATURES ... 24

LASER SAFETY EYEWEAR & NOHD ... 26 5.1.

SAFETY EYEWEAR ... 26

5.2.

NOHD ... 27

ELIMINATION OF WASTES ... 28

USER MANUAL

I REGULATORY INFORMATION AND SAFETY

1.

INTENDED USE AND CONTRAINDICATIONS The VITRA 689 ophthalmic laser photoactivator and the HS BM/BQTM slit lamp adaptors are intended to be a light source for photo-activation of the light activated drug VISUDYNE® (verteporfin for injection) in photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis. This user manual is intended to solely be used by trained ophthalmologists for diagnosis and treatment of ocular pathology. The VITRA 689 laser output wavelength is: 689 nm.

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2. SYMBOLS Symbols situated on the laser system, its packaging and accessories, are described in the following charts. SYMBOL PUBLICATION DESCRIPTION IEC 60417 - 5007

ON POSITION (Power: mains connection)

IEC 60417 - 5008

OFF POSITION (Power: mains disconnection)

IEC 60417 - 5265

"OFF" Switching off for a part of the equipment.

IEC 60417 - 5266

Stand-by or preparatory state for a part of the equipment.

IEC 60417 - 5264

"ON" Switching on for a part of the equipment.

IEC 60417 - 5016

Fuses

IEC 60417 - 5032

Alternating current

IEC 60417 - 5114

Footswitch

IEC 60417 - 5152

Radiation of laser products

IEC 60417 - 5333

BF type equipment

(Protection against electrical shocks)

ISO 7010-W001 General

GENERAL WARNING SIGN

ISO 7000-3082 ISO 15223-1 :2017 n°5.1.1

“MANUFACTURER” of the device

ISO 7000-2497 ISO 15223-1:2017 n° 5.1.3

“DATE OF MANUFACTURE” of the medical device

ISO 7000-2493 ISO 15223-1:2017 n° 5.1.6

“CATALOGUE NUMBER” of the medical device

ISO 7000-2498 ISO 15223-1:2017 n° 5.1.7

“SERIAL NUMBER” of the medical device

ISO 7010-M002

“REFER TO INSTRUCTION MANUAL” RoHs sign: Restriction of the use of hazardous substances

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IEC 60417-5957

For indoor use only

EN50419

Electrical and electronic equipment in accordance with Directive 2012/19/EU (WEEE) Do not dispose in domestic waste.

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PUBLICATION

DESCRIPTION Package positioning way

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ISO 7000-0621 ISO 15223-1:2017 n° 5.3.1

Fragile HANDLE WITH CARE.

ISO 7000-0626 ISO 15223-1:2017 n° 5.3.4

“KEEP DRY”

ISO 7000-2621 ISO 15223-1:2017 n° 5.3.9

Upper and lower limits of atmospheric pressure for transport and storage.

ISO 7000-2620 ISO 15223-1:2017 n° 5.3.8

Upper and lower limits of relative humidity for transport and storage.

ISO 7000-0632 ISO 15223-1:2017 n° 5.3.7

“TEMPERATURE LIMIT”

ISO 7000-0624 ISO 15223-1:2017 n° 5.3.2

“KEEP AWAY FROM SUNLIGHT”

ISO 7000-1641 ISO 15223-1:2017 n° 5.4.3

Consult operating instructions

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3. CLASSIFICATIONS The conception of the system is classified into the following way:

3.1

3.2

CLASSIFICATION OF THE DEVICE European 93/42/EEC, Appendix IX

IIb

Laser Safety Classification US FDA

Class Laser II

ELECTRICAL CLASSIFICATION OF THE DEVICE Protective class Type Protection degree Operation

3.3

I BF IP20 Continuous

(main insulation) (Protection against electrical shocks) (Protection from solid substances: Ø>12.5 mm. IEC 60529) with short time loading.

ELECTRICAL CLASSIFICATION OF TERMINALS Conception of terminals class them in the following way: Terminal Slit lamp adaptor

Type Protection against electrical shocks: Applied parts of BF type

3.4

CLASSIFICATION OFTHE TREATMENT BEAM Laser classification US FDA CDRH European laser classification IEC 60825-1 Type Output power Wavelength Divergence angle Exposure time

3.5

Class IIIb Class 3B Lasers can produce accidental injuries to the eye from viewing the direct beam or a specularly reflected beam

Laser diode 6 – 400 milliWatts (adaptor output) 689 nm Ø = 0,026 rad 83 s

CLASSIFICATION OF THE AIMING BEAM Laser classification US FDA CDRH

Class II Class 2

European laser classification IEC 60825-1

Type Output power Wavelength Divergence angle

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These sources are harmless for the eye because of the action reflex. This reaction to visible light ensures a sufficient protection in standard conditions of use, even if the user needs optical instruments to look at the beam.

Laser diode < 1 milliWatt (Delivery system output) 635 nm Ø = 0,026 rad XL_VIT689_ME_AN_210504

USER MANUAL

I REGULATORY INFORMATION AND SAFETY

4. WARNINGS AND PRECAUTIONS If any incident occurs, Quantel Medical shall not be liable if the following safety information and precautions are not followed.

4.1. GENERAL WARNINGS AND SAFETY INFORMATION WARNING:

This user manual is designed to acquaint the user with the normal operation and maintenance of the laser system. 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 Z 136.3-2011 and ANSI Z 136.1-2014) provides 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.

WARNING:

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

WARNING:

Quantel Medical cannot be held responsible for any damage or injury that results from a failure to follow the instructions or incorrect use outlined 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:

Do not use an electric cable extension.

WARNING:

To comply with medical electrical equipment safety standard requirements, the laser power plug must be connected 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 (2-pin).

WARNING:

Before cleaning the unit, unplug the power cord from the wall mains plug. Refer to the user manual:

Chapter 4 – Maintenance

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Section 2.4 - Cleaning the laser system

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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:

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.

WARNING:

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

WARNING:

Adhesive solvents and flammable solutions used to clean and disinfect the laser system should be allowed to evaporate before use.

WARNING:

The use of the laser system in the presence of endogenous gases may present a risk of ignition of these gases.

WARNING:

The expected lifespan of the system laser is 7 years.

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4.2. IMPORTANT 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 use of LASER EMISSION in the presence of flammable materials, solutions or gases, or in an oxygen-rich environment, presents a risk of fire and / or explosion. 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: Chapter I – Regulatory information & safety Section 5 - Laser safety glasses and NOHD

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) Always keep the system in STANDBY mode When the laser is on, unless it is used to perform treatment. 6) 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. 7)

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

8) 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 the user manual: Chapter II – Technical information Section 5.5 - Doorswitch & warning red lamp

9) Regular maintenance, which can be performed by the user, is described in the user manual: Chapter IV – Maintenance

Performing regular maintenance, which includes checking the power calibration, will help ensuring trouble-free operation.

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4.3. SAFETY FEATURES CHARACTERISTIC

DESCRIPTION

Key switch

The laser system can only be turned on with the 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.

Emergency laser stop switch

In normal position, the red push button is in the « UP » position (not pressed). Once pressed, all power is immediately cut off and the risk of laser radiation is thus eliminated. This button can be released by turning it clockwise to the ON position (while pressing on it) to the operating position to restart the system and return to the “STANDBY” status.

Treatment screen selection

To display the treatment screen, the user has to:  Make sure that the emergency stop button is released (operating position);  Switch on the laser system main switch (located under the unit table);  Make sure that the door interlock system is closed (if applicable);  Turn the laser system ignition key (located on the front of the system) to the “ON” position;  Select the treatment screen: And at this stage only, the user can access the treatment screen and thus activate the laser system by pressing on the “STANDY” / “READY” button.

The “STANDBY” / “READY” laser status can be selected by pressing on the “STANDBY” / “READY” icon.

“STANDBY”/ “READY” status

Selecting the “STANDY” / “READY” icon while the laser is in “STANDBY” status, switches it to “READY” status. The “READY” status allows the user to shoot by pressing on the footswitch. Selecting the “STANDBY” / “READY” icon while the laser is in “READY” status, switches it to “STANDBY” status. In “STANDBY” status, the user cannot shoot, even when pressing on the footswitch. The laser must be manually switched to “READY” status to enable the laser treatment shot.

The « door safety remote interlock » feature is highly recommended (to be installed by the user). Door safety remote interlock

The « door switch » connector is available under the unit table; it is indicated by the label: Connecting the door safety remote interlock prevents the laser from firing when the door is open. The unit is supplied with a bypass connector.

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Safety shutter

The laser optical module is equipped with a safety shutter that blocks the laser treatment optical path. To “unblock” it, it is necessary to: select the laser treatment, manually switch the system to “READY” status, and press on the footswitch.

Energy deviation warning

The system warns the operator if the delivered energy deviates more than ±20% from the set value.

Protective housing

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).

Controls location

All user controls are located so that there is no risk of accidental laser exposure.

FDA and CEI regulatory labels

The regulatory safety labels are positioned as indicated in the user manual:

Electrical leakage protection

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DESCRIPTION

Chapter II – Technical information Section 1 - Labels

A medical grade power supply is built in the power supply console. This ensure that the whole instrument, including the slit lamp power supply meets the IEC 60601-1 related to the earth leakage protection.

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