PUREPOINT Laser Operators Manual Rev E May 2010

OPERATOR'S MANUAL

Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A.

EU Authorized Representative: Alcon Laboratories (U.K.) Ltd. Boundary Way, Hemel Hempstead Hertfordshire, HP2 7UD United Kingdom

Produced By: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A. Telephone: FAX:

949/753-1393 800/832-7827 949/753-6614

8065751131 Rev. E, CATALOG NUMBER 905‑5620‑001 Rev. E, TEXT ONLY

©

2008-2010 Alcon, Inc.

PurePoint® Operator's Manual 8065751131 MANUAL REVISION RECORD DATE

REVISION

ECN NUMBER AND DESCRIPTION

02/2008

A

ECN 20080465 - Initial Release of manual

03/2008

B

ECN 20080841 - Update manual to support product release.

09/2008 C

ECN 20082494 - Update "Indications for Use" statement. Pages affected: title, ii, 1.14.

12/2008

D

ECN 20083006 - Updated manual for software release 1.02. Pages affected: i-v, 1.2,1.5, 1.8,1.17,1.20, 2.6, 2.8-2.11, 2.13-2.22 (pages repaginated), 3.7, 3.8, 3.10, 4.3-4.12, 5.3, 5.4, 6.1, 6.19, 7.1, 7.2. Trademark changes: updated all PurePoint® (all pages) and ENGAUGE® (1.7, 3.11) trademarks from ™ to ®.

05/2010

E

ECN 20100587 - Updated specifications table, environmental considerations statement, hazardous substances table, cable routing warning, and reuse warning. Pages affected: i, ii, v, 1.3, 1.4, 1.9, 1.20, 3.1-3.3, 3.5, 6.1, and 6.5.

CSO is a registered trademark of Costruzione Strumenti Oftalmici S.R.L. Nikon is a registered trademark of Nikon Inc. Corporation. Topcon is a registered trademark of Kabushiki Kaisha Topcon Corporation. Meditec is a registered trademark of Meditec Reinhardt Thysel GMBH. Ellex is a registered trademark of Taracan Pty. Ltd. Zeiss is a registered trademark of Carl-Zeiss-Stiflung. Haag-Streit is a registered trademark of Haag-Streit AG Corporation. Heine is a registered trademark of Hein Optotechnik GmbH. * Registered U.S. Patent & Trademark Office ii

8065751131

TOPIC

TABLE OF CONTENTS

PAGE #

Manual Revision Record... ii Foreword... vi Important Notice... vii SECTION ONE - GENERAL INFORMATION Introduction... 1.1 Technical Specifications... 1.2 Laser Characteristics... 1.2 Environmental Considerations... 1.3 Universal Precautions... 1.4 EMC Statement... 1.4 FCC and IC Compliance Statement... 1.7 Labeling... 1.8 Carrying Case... 1.9 Preparing For Installation... 1.9 PurePoint® Laser Safety Features... 1.13 Professional Operator’s Information... 1.14 Product Service... 1.19 Limited Warranty... 1.20 SECTION TWO - DESCRIPTION Introduction... 2.1 Front Panel Description... 2.1 Rear Panel Description... 2.7 Footswitch... 2.8 System Modes... 2.9 Treatment Modes... 2.9 Screen Descriptions... 2.10 SECTION THREE - OPERATING INSTRUCTIONS Introduction... 3.1 1 Initial Setup... 3.1 2 System Connections... 3.1 3 System Power Up and Set Up... 3.4 4 Normal Operating Procedure... 3.7 5 Turn Off Sequence... 3.9 6 Changing The System Settings... 3.10 7 Identifying Unrecognized Probes... 3.11 SECTION FOUR - CARE AND MAINTENANCE Introduction... 4.1 Care And Cleaning... 4.1 Fuse Replacement Procedure... 4.2 Calibration Verification... 4.3 System Calibration... 4.9 SECTION FIVE - TROUBLESHOOTING System Messages... 5.1

8065751131

iii

TOPIC

TABLE OF CONTENTS

PAGE #

SECTION SIX - ACCESSORIES AND PARTS... 6.1 Slit Lamps with Doctor Protection Filters and Adaptations... 6.2 Positioning the Doctor Protection Filter... 6.4 The PurePoint® Passive Doctor Filter... 6.5 Alcon® SL 1000 and Zeiss* 30SL Adaptation... 6.6 Alcon PurePoint® Laser Indirect Ophthalmoscope (LIO)... 6.11 Laser Station... 6.22 SECTION SEVEN - INDEX... 7.1

FIGURE # Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4 Figure 1-5 Figure 1-6 Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8 Figure 2-9 Figure 2-10 Figure 2-11 Figure 2-12 Figure 2-13 Figure 2-14 Figure 2-15 Figure 2-16 Figure 2-17 Figure 2-18 Figure 2-19 Figure 2-20 Figure 2-21 Figure 2-22 Figure 2-23 Figure 2-24 Figure 2-25 Figure 2-26 Figure 2-27 Figure 2-28 Figure 3-1 Figure 3-2 Figure 3-3 iv

TITLE

LIST OF ILLUSTRATIONS

PAGE #

The Alcon PurePoint® Laser... 1.1 Labels and Icons used on the PurePoint® Laser Console... 1.8 The PurePoint® Carrying Case... 1.9 Recommended Laser Room Layout... 1.10 Remote Connector/Door Lamp Circuit Diagram... 1.11 Dr. Filter Message... 1.17 The PurePoint Laser Front Panel... 2.1 Typical PurePoint® Screen... 2.2 Unidentifiable Probe Selection Screen... 2.3 The PurePoint® Laser Rear Panel... 2.7 The PurePoint® Laser Footswitch... 2.8 Screens Displayed on the PurePoint® LCD... 2.10 Initialization Screen... 2.11 Footswitch Side Switch Configuration Screen... 2.11 Dr. Filter Confirmation Screen... 2.11 Operating Display-Standby Screen... 2.12 Ready Screen... 2.13 Laser On Screen... 2.13 Main Menu... 2.13 Settings Menu... 2.15 Aiming Beam Settings... 2.15 Audio Settings... 2.15 Contrast Settings... 2.16 Fiber Custom Pre-Sets Screen... 2.16 Footswitch Settings... 2.17 Language Settings... 2.18 Revert to Standby Settings... 2.18 Treatment Totals Settings... 2.19 System Information Menu... 2.20 About PurePoint® Screen... 2.20 Version Numbers... 2.20 System Messages... 2.21 System Totals... 2.21 Reset to Factory Defaults Display... 2.21 Slit Lamp Connections... 3.3 Display During Initialization... 3.4 Transition from Standby to Ready Mode... 3.8 8065751131

FIGURE # Figure 3-4 Figure 3-5 Figure 3-6 Figure 3-7 Figure 3-8 Figure 4-1 Figure 4-2 Figure 4-3 Figure 5-1 Figure 6-1 Figure 6-2 Figure 6-3 Figure 6-4 Figure 6-5 Figure 6-6 Figure 6-7 Figure 6-8 Figure 6-9 Figure 6-10 Figure 6-11 Figure 6-12 Figure 6-13 Figure 6-14 Figure 6-15 Figure 6-16

TABLE # Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 1-5 Table 1-6 Table 2-1 Table 4-1 Table 5-1 Table 5-2 Table 6-1 Table 6-2 Table 6-3

8065751131

TITLE

LIST OF ILLUSTRATIONS

PAGE #

Transition from Ready State to Laser On... 3.8 Transition from Laser On to Standby because of a Warning Condition... 3.9 Main Menu... 3.10 Settings Menu... 3.10 Unidentifiable Probe Display... 3.11 Fuse Location... 4.2 Exposure Time Test Configuration... 4.4 Power Test Configuration... 4.5 Error Message... 5.2 Alcon® SL1000 Slit Lamp... 6.2 Zeiss* 30SL... 6.2 Haag-Streit* 900 BM... 6.3 Doctor Protection Filter Mounted Between Binoculars and Slit Lamp Assembly... 6.4 Label Location Diagram on Adaptation - Alcon® SL 1000 shown... 6.7 To avoid injury, the beam splitter/accessories must be placed between the binoculars and Doctor Protection Filter (Alcon® SL 1000 shown)... 6.7 Controls on Alcon® SL 1000 Slit Lamp with Doctor Protection Filter and Adaptation Installed... 6.8 Laser Spot Focus... 6.10 PurePoint® LIO... 6.11 PurePoint® LIO Labeling... 6.13 Adjusting the PurePoint® LIO Overband... 6.15 PurePoint® LIO Controls and Adjustments... 6.16 Eyecup Retainers and Ocular Lens on the PurePoint® LIO... 6.17 PurePoint® LIO Bulb Replacement... 6.21 Laser Station... 6.22 Assembling the Laser Station... 6.23

TITLE

LIST OF TABLES

PAGE #

Technical Specifications... 1.2 Laser Characteristics... 1.2 Information on the Location of Hazardous Substances in the PurePoint® Laser... 1.4 Guidance and Manufacturer's Declaration - Electromagnetic Emissions... 1.4 Guidance and Manufacturer's Declaration - Electromagnetic Immunity... 1.5 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the PurePoint® Laser... 1.6 532 Green Laser Power Values (in milliwatts)... 2.6 Energy Matrix... 4.7 Advisory Messages... 5.3 Warning Messages... 5.4 PurePoint® Laser Accessories... 6.1 Adaptation Troubleshooting... 6.10 PurePoint® LIO Technical Specifications... 6.13

v

FOREWORD This Operator's Manual is designed to acquaint the operator and operating room personnel with the PurePoint® Laser System. The manual presents an organized summary of the operating principles, main components, safety features, and instructions for care and use of the instrument. The information in this manual should be supplemented with reference works on laser theory and the interaction of laser energy with biologic tissues. No attempt is made in this manual to answer all the questions that arise during the use of the instrument in medical procedures. Questions concerning technique, safety and effectiveness should be referred to pertinent publications or recognized medical experts in laser surgery. Physicians should not attempt to treat patients with this instrument if not thoroughly familiar with its operation, or if in doubt as to its safe operation. All personnel authorized to use this instrument should be required to be thoroughly familiar with this manual. Please contact Alcon for complete technical support and service if you have questions concerning any aspect of this instrument's operation or if it fails to perform satisfactorily. To order supplies in U.S.A.: 800-862-5266 FAX: 800-241-0677 Outside U.S.A.: Contact your local Alcon representative for supplies.

vi

8065751131

IMPORTANT NOTICE Equipment improvement is an on-going process and, as such, changes may be made to the equipment after this manual is printed. Pay close attention to warnings and cautions in this manual. Warnings are written to protect individuals from bodily harm. Cautions are written to protect the instrument from damage. Illustrations contained in this manual are for reference only. It is recommended that maintenance be performed by a qualified Alcon Field Engineer. Alcon Surgical shall not be liable for any damage resulting from failure to comply with the enclosed instructions. Alcon reserves the right to change specifications without further notice. Operator Profile The PurePoint® Laser System is designed to be operated by two basic groups; surgeons and nurses/scrub technicians. The nurses/scrub technicians are primarily constrained to the front panel controls, while the surgeon primarily uses the footswitch. The design of the footswitch allows the surgeon to map several basic functions. The front panel design incorporates color coding on all connectors to facilitate easy identification of the ports. CAUTION U.S. Federal Law restricts this device to sale by or on the order of a physician only.

WARNINGS!

Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. A qualified technician must perform a visual inspection of the following components every twelve months. In case of a deficiency, do not use the system; call Alcon Technical Services. - Warning Labels - Power Cord - Fuses A qualified technician must check ground continuity and both polarities for leakage current every twelve months to ensure they are within the applicable standard (for example: EN 60601-1/IEC 601-1). Values must be recorded, and if they are above the applicable standard, or 50% above your first measurement, do not use the system; call Alcon Technical Services. Use of accessories and cables other than those provided may result in increased emissions or decreased immunity of the system. Portable and mobile RF communications equipment can affect this medical electrical equipment.

8065751131

vii

Comments or corrections concerning this manual should be addressed to: Alcon Technical Services Group PO BOX 19587 Irvine, CA, USA 92623 All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval system, in any form or by any means; photocopying, electronic, mechanical, recording, or otherwise; without prior written permission from Alcon Laboratories, Inc.

viii

LAST PAGE OF THIS SECTION

8065751131

SECTION ONE GENERAL INFORMATION INTRODUCTION The Alcon PurePoint® Laser provides an exceptional combination of performance, solid-state reliability, versatility, and portability all in one system. It is a diodepumped solid-state type laser designed for ophthalmic use. This laser delivers a visible 532 nm green treatment beam, and a visible 635 nm Diode Laser aiming beam (635 nm is an approximate value between 630-640 nm). The system is also supported by a wide range of high quality laser probes, a laser indirect ophthalmoscope (LIO), and is compatible with a wide variety of slit lamps.

Figure 1-1

8065751131

The Alcon PurePoint® Laser

1.1

Table 1-1 Technical Specifications CATEGORY Approximate Dimensions Approximate Weight

Electrical Characteristics

Environmental Limitations

Miscellaneous

SPECIFICATION Width: 0.28 m (11.00 inches) Depth: 0.39 m (15.5 inches) Height: 0.19 m (7.5 inches) 10.4 kg (23 lbs) Voltage: 100-120 VAC @ 5 A (max current) 220-240 VAC @ 2.5 A (max current) Frequency: 50/60 Hz Fuse rating: 250 V,Single Phase, T5 Amps Insulation class: Class I, type BF Illumination Power Port Output: 7.5 V maximum at 2.25 A Operating: • Temperature: 10°C ≤ T°≤ 35°C • Relative Humidity: 10% to 90% with no condensation • Atmospheric Pressure Requirements: 126.4 m (415 ft) below sea level to 2438.4 m (8000 ft) above sea level Storage: • Temperature: -40°C ≤ T°≤ 70°C • Relative Humidity: 10% to 95% with no condensation • Atmospheric Pressure Requirements: 126.4 m (415 ft) below sea level to 12,192 m (40,000 ft) above sea level

PurePoint ® Laser complies with CE MDD requirements. Not suitable for use in the presence of flammable anesthetic, oxygen or nitrous oxide. System not protected against the ingress of water. Leakage current per IEC 60601-1 is below 500 micro amps at 264 VAC. Leakage current per IEC 60601-1 is below 300 micro amps at 132 VAC. Ground continuity per IEC 60601-1 is below 0.1 ohm.

Table 1-2 Laser Characteristics CATEGORY

TREATMENT LASER BEAM

AIMING LASER BEAM

Laser Class

IV

II

Laser Power

• 30 mW to 200 mW in 10 mW steps

Less than 1 mW; adjustable by operator

• 200 mW to 500 mW in 20 mW steps with additional steps at: 250, 350, 450 • 500 mW to 950 mW in 50 mW steps • 1000 mW to 2000 mW in 100 mW steps Laser Wavelength 1.2

532 nm

635 nm +/- 5 nm 8065751131

WARNINGS! There are potential hazards when inserting, steeply bending, or improperly securing the fiber optic. Not following the recommendations of the manufacturer may lead to damage to the fiber or delivery system and/or harm to the patient or user. Since the aiming beam passes down the same delivery system as the treatment beam, it provides a good method of checking the integrity of the delivery system. If the aiming beam spot is not present at the distal end of the delivery system, or its intensity is reduced or it looks diffused, this a possible indication of a damaged or not properly working delivery system. If there is any doubt, contact Alcon Technical Services. The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided. Some materials - for example cotton wool when saturated with oxygen - may be ignited by the high temperatures produced in normal use of the laser equipment. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. There is also danger of ignition of endogenous gases. Route the footswitch cable, power cord and any other cables connected to the PurePoint® Laser to avoid tripping.

NOTE: To eliminate power consumed when the key switch is off, turn off the main power switch on the rear panel. Environmental Considerations The equipment that you have purchased requires the use of natural resources for its production and operation. This equipment may also contain hazardous substances which could have potential effect on the environment and human health if disposed of improperly. In order to avoid the entry of any such substances into our environment, and to promote natural resource conservation, please install, maintain, and operate the equipment in accordance with the instructions. Information on the location of hazardous substances, resource consumption and emissions of the equipment can be found throughout this Operator's Manual. Please use the appropriate take-back systems. Such take-back systems reuse or recycle many of the materials in your end-of-life equipment in a beneficial way. Please contact your local Alcon office for assistance in take-back options through Alcon or other providers. The crossed-bin symbol located on this equipment reminds you to use take-back systems, while also emphasizing the requirement to collect waste equipment separately, and not dispose of it as unsorted municipal waste.The Pb notation, if present, indicates that the labeled device contains greater than 0.004% lead. If you need more information on the collection, reuse, or recycle systems available to you, please contact your local or regional waste administration, or contact your local Alcon office for more information.

8065751131

1.3

Table 1-3

Information on the Location of Hazardous Substances in the PurePoint® Laser - The PurePoint® Laser contains hazardous substances which could have potential effect on the environment and human health if disposed of improperly. Material Location

Hazardous Substances Contained

Printed Circuit Board Assembly

Lead, Polybrominated Biphenyls (PBB)

Other Electrical / Electronic Device

Lead, Polybrominated Biphenyls (PBB)

Cable Assembly

Lead

Power Supply

Lead, Polybrominated Biphenyls (PBB)

For information on the disassembly of the product, please contact your local Alcon office. Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA guidelines. EMC Statement It is important to install and use the equipment in accordance with the instructions in order to prevent harmful interference with other devices in the vicinity. If this equipment causes harmful interference to other devices (determined by turning the equipment off and on), the user is encouraged to try to correct the interference by one or more of the following measures: • • • •

Reorient or relocate the other device(s). Increase the distance between the equipment. Connect this equipment into an outlet on a circuit different from that to which the other device(s) is connected. Consult the manufacturer or your Alcon field service engineer for help.

Table 1-4 Guidance and Manufacturer's Declaration - Electromagnetic Emissions - The PurePoint® Laser is intended for use in the electromagnetic environment specified below. The customer or the user of the PurePoint® Laser should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment-Guidance

RF emissions CISPR 11

Group 1

The PurePoint® Laser uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Based on extensive field experience the PurePoint® Laser is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Complies

1.4

The EMC Statement provides guidance on steps to take in case of electromagnetic interference.

8065751131

Table 1-5 Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The PurePoint® Laser is intended for use in the electromagnetic environment specified below. The customer or the user of the PurePoint® Laser should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

• ±6 kV contact • ±8 kV air

• ±6 kV contact • ±8 kV air

Floors should be wood, concrete, or ceramic tile. Do not use around floors that are covered with synthetic material to avoid laser stoppage due to ESD.

Electrical fast transient/burst IEC 61000-4-4

• ±2 kV for power supply lines • ±1 kV for input/output lines

• ±2 kV for power supply lines • ±1 kV for input/ output lines

Mains power quality should be that of a typical commercial or hospital environment. To avoid laser stoppage due to fast transients avoid powering the PurePoint® Laser on the same branch circuit with sources that can generate fast transients (inductive switching; e.g., high current motors).

Surge IEC 61000-4-5

• ±1 kV differential mode • ±2 kV common mode

• ±1 kV differential mode • ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment. To avoid laser stoppage due to power-line surges consider powering the PurePoint® Laser through branch circuit that has surge suppressor for protection against lightning surges (e.g., at power panel to surgical/office suite).

Voltage dips, short • <5% UT (>95% dip in interruptions, and UT) for 0.5 cycle voltage variations • 40% UT (60% dip in on power supply UT) for 5 cycles input lines • 70% (30% dip in UT) IEC 61000-4-11 for 25 cycles • <5% (>95% dip in UT) for 5 sec

• <5% UT (>95% dip in UT) for 0.5 cycle • 40% UT (60% dip in UT) for 5 cycles • 70% (30% dip in UT) for 25 cycles • <5% (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the uses of the PurePoint® Laser require continued operation during power mains interruptions, it is recommended that the PurePoint® Laser be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Portable and mobile RF communications equipment should be used no closer to any part of the PurePoint® Laser, including cables, than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter.

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3V/m

Electromagnetic Environment-Guidance

Recommended separation distance: d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz where P is the maximum output power rating to the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strength from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with following symbol.

Note: Note 1: Note 2: a

b

UT is the a.c. mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PurePoint® Laser is used exceeds the applicable RF compliance level above, the PurePoint® Laser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PurePoint® Laser. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

8065751131

1.5

Table 1-6 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the PurePoint® Laser - The PurePoint® Laser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PurePoint® Laser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PurePoint® Laser as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W)

150 kHz to 80 MHz d = 1.2√P

80 MHz to 800 MHz d = 1.2√P

800 MHz to 2.5 GHz d = 2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rates at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 - At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

1.6

8065751131

FCC and IC Compliance Statement Equipment contains Alcon's ENGAUGE® Radio Frequency Identification (RFID) device. Operating Frequency: 13.56 MHz Type of modulation: Amplitude Shift Keying (ASK) Output power (e.i.r.p): 703 nW This device complies with Part 15 of the FCC Rules and with Industry Canada Radio Standards Specification RS-210. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CAUTIONS Change or modifications made to this equipment not expressly approved by Alcon may void the FCC authorization to operate this equipment. To ensure that the RFID transmitter complies with current FCC regulations limiting both maximum output RF power and human exposure to radio frequency radiation, a separate distance of at least 20 cm must be maintained between the unit’s antenna and the body of the user and any nearby persons at all times and in all applications and uses.

This device complies with the RF exposure limits for humans as called out in RSS-102. Europe - R&TTE Directive 99/5/EC This device complies with the requirements of the Council Directive 99/5/EC (R&TTE). Australia and New Zealand This device complies with the Australian/New Zealand Standard AS/NZS 4268: 2003 Radio Equipment and Systems – Short Range Devices – Limits and methods measurement. Canada

8065751131

This ISM device complies with Canadian ICES-001. (Cet appareil ISM est conforme a la norme NMB-001 du Canada.)

1.7

LABELING Figure 1-2 shows the labeling found on the PurePoint® Laser.

Non-ionizing Radiation OFF Alternating Current Aiming Beam CSA Mark in accordance to CSA C22.2 No. 601.1 and UL60601-1 (LR103168), IEC 60601-1-2 and IEC 60601-2-22

ON

!

Ready

Dangerous Voltage Footswitch

Consult Operator's Manual, or System Error or Advisory

Standby State

SYSTEM FAULT

System Fault

Fuse size and rating System Information

Illumination

Type BF Equipment Keyswitch USB Connector Laser Connection Laser Emergency Stop Switch 1

Remote Door Lamp Laser Status

Laser Port Date of Manufacture

Figure 1-2 1.8

Use appropriate take-back system (see Environmental Considerations in this manual).

Remote Interlock

Labels and Icons on PurePoint® Laser Console 8065751131

Carrying Case The carrying case shown in Figure 1-3 is included with the system and intended to be used as an aid to carrying the system. CAUTION The carrying case should not be used for shipping the system.

Figure 1-3

The PurePoint® Laser Carrying Case

PREPARING FOR INSTALLATION The PurePoint® Laser system was thoroughly inspected and carefully packaged for shipping. If the container is damaged, leave system in original container with packaging and request inspection by the carrier within 3 days of delivery. Included as part of the packaging is the carry box for the PurePoint® Laser. This container is intended to protect the system when moving it from one location to another. Use the carry box whenever the system must be moved. Initial installation must be performed by an Alcon representative. Prepare the facility for installation of the PurePoint® Laser as follows: General Laser Room Layout The PurePoint® Laser must be installed in a dust free room, and positioned so the laser beam cannot be directed toward a door, window, mirror, or reflective area. To reduce dust, avoid installing the instrument in a carpeted room. An example of a typical laser room layout is shown in Figure 1-4.

8065751131

1.9

Figure 1-4

Recommended Laser Room Layout (Overhead View)

Securing the System to a Cart or Table The system can be secured to a cart or table using the threaded mounting hole located on the underside of the system. Use a screw with a M4 x 0.7 thread and the appropriate length to extend through the surface of the table or cart. NOTE: The accessory equipment connected to or used with this equipment must be certified according to the respective IEC standard; e.g., IEC 950 for data processing equipment (data processing equipment must not be used during patient treatment) and IEC 601-1 for medical equipment. Additionally, all configurations shall comply with the system standard IEC 601-1-1. Anyone connecting additional equipment, or otherwise causing a different system configuration than provided by Alcon, is responsible for continued compliance to the requirements of the System Standard IEC 601-1-1. If in doubt, consult the Technical Services department or your local Alcon representative. WARNING! It is recommended not to use a power strip (multiple portable socket outlets) to plug in accessory equipment. Each accessory should be plugged into a wall unit.

1.10

8065751131

General Safety Precautions (Refer to IEC 825-1 or ANSI Z136.1) • A laser safety officer should be appointed to supervise the installation and use of the system. • Install an indicator light outside the laser room warning of instrument operation. • Position the instrument so that the laser beam is never directed toward a door, window, or reflective surface. • Use non-reflective matte finish wall paint. • Avoid covering laser room floor and walls with carpet or any other dust generating material. This will minimize the possibility of excess grime and dust on the instrument optics, and interference with equipment cooling. • The instrument requires a minimum of 0.5 meter of open space on all sides for proper cooling ventilation; therefore, the system should be set flat, resting on the legs provided on the bottom of the console. • Unauthorized use of this laser should be prevented by removing the On/Off key. • Entrances to areas or protective enclosures containing Class IV lasers should be posted with appropriate warning signs. • Appropriate eye protection must be used in all hazard areas. Use eye protection with OD 4 or above at 532 nm. Nominal Ocular Hazard Distance (NOHD) Accessory Beam Divergence (NOHD) LIO 0.024 radians (20 meters) Slit Lamp 0.011 radians (40 meters) Endoprobe 0.23 radians (3 meters) • • •

A qualified technician must verify that the power plug used is properly grounded. The remote interlock connector should be connected to an emergency master disconnect interlock or to room/door/fixture interlocks. Please refer to figure 1-5. The footswitch, endoprobe, LIO, and slit lamp adaptation/slit lamp should be placed within 2 meters of the PurePoint® Laser console.

REMOTE CONNECT

1

CUSTOMER SUPPLIED DOOR SWITCH (OPTIONAL)

6

9-PIN D-CONNECTOR

1

COM NC

9

NO

TO DRIVE DOOR LAMP (OPTIONAL)

3

Figure 1-5

8065751131

Remote Connector/Door Lamp Circuit Diagram

1.11