GreenLight HPS Laser Operators Manual Rev A

Copyright © 2006 Laserscope. All right reserved. Notice No part of this manual may be reproduced or transmitted in any form or by any means without the written consent of Laserscope. The information in this manual is subject to change without notice. Disclaimer Laserscope provides this document in its commitment to help facilitate consistent, positive clinical outcomes, and to reduce patient risk and injury. These guidelines are not, however, intended to in any way replace or substitute a physician’s duty of care, professional responsibility, or professional judgment, nor are they intended to provide any warranty, promise, guarantee, assumption of risk or duty, release, or indemnity. Physicians shall at all times maintain responsibility for patient treatment and outcomes, and Laserscope further assumes no liability for patient treatment or outcome or for physician’s negligence, breach of duty of care, or malpractice. In no way does this or any of Laserscope’s policies, procedures, training materials, guidelines, or instructions create an obligation for Laserscope to perform any services. Products and services may be purchased from Laserscope. Trademarks GreenLight HPS is a Laserscope trademark Laserscope is a registered trademark of Laserscope. Laserscope Corporate Headquarters 3070 Orchard Drive San Jose, CA 95134-2011 U.S.A. Tel: 800 356-7600 (Customer Service) Tel: 408 943-0636 Fax: (+1) 408 943-1051 www.laserscope.com

Laserscope France, S.A. Parc Technologique 18 rue du Bois Chaland 91090 Lisses, France Tel: 33/1 60 86 20 49 Fax: 33/1 60 86 14 88

Laserscope (UK) Ltd. Berwyn, The Pavilions Llantarnam Park Cwmbran, South Wales, NP44 3UW United Kingdom Tel: 44/1633-838081 Fax: 44/1633-838161

Part No. 0010-0009 Rev. A

TABLE OF CONTENTS Preface ... v About This Manual... v Conventions ... vi Who Should Read This Manual ... vi Obtaining Help... vi Safety ... vii Eye Injury...vii Burns ... xiii Reflection of the Beam from Instruments ... xiii Ignition of Flammable Materials ... xiv Vapor/Smoke Plume ... xiv Electrical... xiv Operating Room Environment ...xv Reference Sources ... xvii Safety Features of the GreenLight HPS™ ... xviii Safety Classifications ... xix Labeling ... xxi Section 1: Introduction ... 1 1.1 System Overview ... 1 1.2 GreenLight HPS Fiber Optic... 6 1.3 General Instructions for Use ... 7 1.4 Sterilization ... 8 Section 2: System Installation ... 9 2.1 Responsibility ... 9 2.2 Space and Power Requirements ... 10 Section 3: Operating the System... 11 3.1 The Touch Screen and Footswitch ... 11 3.2 Turning the System On... 12 3.3 Operating Procedure ... 16 3.4 Turning the System Off ... 20 Section 4: Physician Information ... 21 4.1 Training Requirements ... 21 4.2 Indications ... 21 4.3 Contraindications………………….… ... 21 4.4 Potential Complications and Risks ... 22 4.5 Precautions ... 22 Section 5: Maintenance ... 25 5.1 Care of the Console... 25 5.2 Coolant Refill Instructions ... 25 5.3 Preventive Maintenance Schedule ... 26

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Section 6: Troubleshooting ... 27 6.1 System Prompts ... 27 6.2 Service Prompts... 28 Specifications... 29 Warranty... 30 Warranty Policy ... 30 Product Returns ... 34 Support Materials... 36 Clinical Competency Validation Checklist ... 37 Supplies Needed ... 39 Laser Log... 40 Operative Record Template ... 41 Pre-Procedural Patient Instructions ... 42 General Post-Procedural Instructions ... 43

List of Figures Figure S-1

GreenLight HPS™ Laser Warning Sign ...xv

Figure S-2

Labeling of Front Panel of Laser ... xxi

Figure S-3

Labeling of Rear Panel of Laser ... xxii

Figure 1-1

Front View of Laser ... 2

Figure 1-2

Rear View of Laser ... 4

List of Tables Table W-1

Warranty Codes ... 32

Table W-2

Product Warranties ... 33

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Preface About This Manual This manual contains the safety, installation, operation, and maintenance instructions for the GreenLight HPS™ laser system. It also provides information on the use and care of the system components, proper eye protection, troubleshooting, and warranty for the GreenLight HPS™ laser system. •

Safety provides recommendations to avoid bodily injury, especially the use of protective eyewear. Read this section before attempting to operate the equipment when treating a patient.

•

Section 1: Introduction describes the basic components of the system and describes the interface features.

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Section 2: System Installation provides the physical and environmental requirements necessary to operate the GreenLight HPS™ laser system, as well as information on how to move the instrument should you need to.

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Section 3: Operating the System gives you step-by-step instructions on how to start up the system, select treatment parameters, operating procedures, and how to turn the system off.

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Section 4: Physician Information contains information regarding indications, contraindications, possible complications, precautions, and post-treatment care.

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Section 5: Maintenance provides instructions on cleaning the system.

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Section 6: Troubleshooting presents a list of error messages and codes, and gives suggestions on how to solve the problem.

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Specifications lists the product specifications. This section also includes the labels found on the GreenLight HPS™ laser system console and provides the meaning of each symbol found on the system and the labels.

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Warranty contains warranty information and specific instructions for returning the GreenLight HPS™ laser system and GreenLight HPS™ fiber optic for repair.

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Support Materials contains documents to help you organize the operation and management related to the GreenLight HPS™ laser system.

Preface

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Conventions NOTE: Points out additional information that may be helpful.

S CAUTION: Alerts you to situations that could result in instrument damage, failure in a procedure, or incorrect results.

¡ WARNING: Alerts you to situations that could result in bodily harm or irreparable damage to the equipment.

Who Should Read This Manual? All users of the GreenLight HPS™ system should read this manual thoroughly before attempting any surgical procedure. Pay particular attention to all warnings, contraindications, and precautions noted in this manual and other related materials. Failure to do so may result in harm to a patient or the user of the system.

Obtaining Help 1. Read through the section of the guide specific to the operation you are performing. Refer to the table of contents to locate information. 2. See Section 6: Troubleshooting for a list of problems and suggested solutions. 3. For additional information covering installation, medical applications, or any other questions, contact Laserscope Customer Response Center at: •

(800) 356-7600 from inside the US, or

•

Outside the US, contact your local distributor. Laserscope France, S.A. Parc Technologique 18 rue du Bois Chaland 91090 Lisses, France Tel: 33/1 60 86 20 49 Fax: 33/1 60 86 14 88

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Laserscope (UK) Ltd. Berwyn, The Pavilions Llantarnam Park Cwmbran, South Wales, NP44 3UW United Kingdom Tel: 44/1633-838081 Fax: 44/1633-838161

Operator’s Manual

Safety ¡ WARNING: Laser light presents a severe eye hazard and a potential for

burns or fire. The system’s aiming beam may be viewed by an unprotected eye. Never activate the system treatment beam without eye protection. It presents a severe eye hazard if viewed directly or by reflection. Avoid exposure to the laser beam. Take all necessary protective measures in areas where the laser is being used.

Introduction This section describes specific laser hazards and appropriate precautionary measures. Guidance for the safe use of lasers is given in IEC 825-1. It is also given in two equivalent American National Standards. The first is ANSI Z136.1-2000, The Safe Use of Lasers, and covers general use of lasers. The second standard is ANSI Z136.3-1996, The Safe Use of Lasers in Health Care Facilities, and covers specific use of lasers in medical applications. Refer to the general ANSI Z136.1-2000 standard for the actual calculations for eye protection. This device complies with part 15 of the FCC Rules. 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.

S CAUTION: Changes or modifications not expressly approved by Laserscope could void the user's authority to operate this equipment.

EYE INJURY RECOMMENDED PRACTICE V: ALL PEOPLE IN THE NOMINAL HAZARD ZONE SHOULD WEAR APPROPRIATE EYEWEAR APPROVED BY THE LASER SAFETY OFFICER. 1 Visible light and near-infrared laser energy passes through the transparent components of the eye (cornea, lens, aqueous and vitreous humor), and is focused on the retina. This light can cause an accidental retinal burn. The degree of injury to the eye will depend upon the power of the beam, how focused the beam is, and how long the eye is exposed to the beam.

1

2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in Practice Settings. AORN. Denver 2006: pg 565-570

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Precautions against eye injury should include wave-length specific laser protective eyewear for the operating room staff. Patient’s eyes and eyelids should be protected from the laser beam in a method deemed appropriate by the laser safety officer. 2 See the Eye Protection Information Guide in this section for more information regarding eye protection. Laser eyewear is not interchangeable for a variety of lasers.

Eye Protection Information Guide It is the responsibility of the hospital or medical institution where the laser surgery is performed to establish a written policy on eye protection. Several articles have been published stating the strong OSHA and JCAHO (Joint Commission on Accreditation of Hospital Organizations) position to adhere to ANSI Standards. Refer to ANSI Z136.1-2000 and ANSI Z136.31996, in conjunction with the recommendations of your Laser Safety Officer (LSO) to develop your facility’s laser policy. This guide will address some common questions raised on the issue of laser eye protection. The information contained in this guide is designed to assist you in tailoring a policy to fit the needs of your institution, particularly in relation to the use of the GreenLight HPS™ laser system.

Laser Protective Eyewear There are several products available for use with the GreenLight HPS™ laser system to protect both eyes and video equipment. This section describes the laser protective eyewear and the video camera filters that have been designed to meet ANSI Z136.3-1996, ANSI Z136.1-2000 and DIN standards for safe viewing in a medical facility. All the filters have optical densities greater than 5.0 at 532 nm. The OD of the filters indicates how much the light is attenuated and is defined as:

Optical Density = OD = –Log10 (Filter Transmission) A filter with an OD of 2 has a transmission of 1/100 or 10-2 while a filter with an OD of 5 has a transmission of 1/100,000 or 10-5. NOTE: It is required for everyone in the room to wear protective eyewear.

2

American National Standards Institute, Laser Institute of America, American National Standard for Safe Use of Lasers in Health Care Facilities. (Orlando, FL: The Laser Institute of America. 1996)

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Two different types of eyewear have been designed to protect operating room personnel from the GreenLight HPS™ laser energy. These include:

•

The Surgeon Glasses (catalog number 10-1350 and 10-0008). They have a min. optical density (OD) of 5.0 at both 532. The essentially clear lens material has very high visible light transmission and minimal color distortion.

•

The 532nm Surgeon Protective Goggles (catalog number 10-7030). Have a min. optical density (OD) of 5.0 at 532 nm. Although they have good visible light transmission, the orange color of the plastic lens causes some color distortion.

Eye Protection Product Reorder Information • • •

532nm Surgeon Protective Glasses, Large Frame (catalog number 10-0008) 532 Surgeon Protective Glasses, Small Frame (catalog number 10-1350) 532nm Surgeon Protective Goggles, Standard Frame (catalog number 10-7030)

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COMMON QUESTIONS ABOUT EYE PROTECTION 1. “O.D.” is marked on the laser eyewear. What does it mean? O.D. stands for optical density. It is specific to the spectral wavelength marked on the eyewear and represents the capability of the eyewear to block out laser light. The higher the O.D., the greater the amount of light blocked out. The O.D. marked on the eyewear is sufficient to provide protection for the use described in the associated product insert. Eyewear is not interchangeable for different wavelengths. Eyewear designated for use at 532 nm should only be used when viewing the 532 nm wavelength. For more information about the O.D. of Laserscope’s eyewear, consult the product insert shipped with the specific eyewear. 2. Why is the eyewear for the GreenLight HPS™ laser system 532 nm laser tinted? The human eye is very sensitive to light in the green portion of the spectrum. Since the GreenLight HPS™ 532 nm laser system operates in the visible green light wavelength, protective eyewear for 532 nm must block a portion of this green light to provide adequate eye protection. 3. Does my eyewear protect me if I can see green light during lasing? Laserscope eyewear is designed to block out a specific portion of the light spectrum in green, and allow other parts of the spectrum to pass through. There is nothing dangerous about viewing green light at low intensity or the red aiming beam. The eyewear is designed to protect against the high intensity of the green laser light used to perform surgery. 4. Why do goggles fog and what can be done to prevent this from happening? The fogging of goggles is a common problem experienced by many laser users. The warmth of the wearer, stress of the case, and coolness of the procedure room are ideal conditions for condensation to form on all eyewear, despite manufacturing design. The use of anti-fogging agents after cleaning and before each case should reduce the fogging problem. 5. What is the potential for a fiber to break during a procedure and cause eye injury? During normal use, a fiber may incur stress when it is inserted into the cystoscope. Stress is a concern when fibers are being used because small nicks in the nylon jacket of the fiber can result in increased fragility. x

Operator’s Manual

The probability that a person without eyewear will directly view a fiber breaking is low, but can occur. The probability of the fiber breaking while actually aimed at someone's eye is low. The following factors must all occur simultaneously in order to result in hazardous exposure: • • •

Alignment of the laser beam with the eye Close proximity of the eye to the source of the laser light Exposure time in excess of damage threshold

With proper use of the laser equipment, the chance of these events occurring simultaneously is remote, but may occur. Laserscope supports the ANSI recommendation that all personnel in the operating room wear appropriate eyewear when the laser is being used for open or endoscopic procedures. 6. Do I need laser eyewear with endoscopic cases? Yes, protective eyewear is routinely required for most laser cases. In an editorial article published by Rockwell Laser Industries, the use of eye protection during endoscopic laser surgery was addressed. According to Rockwell’s interpretation of ANSI Z136.1 (Section 4.3.6.2), Class 1 conditions shall be considered as fulfilled for those limited open beam path lasers or laser systems where measurements and analysis confirm that the accessible levels during operation are at or below applicable maximum permissible exposure (MPE) levels. By this definition, endoscopic laser surgery (ruling out the possibility of a broken fiber) could be considered a Class 1 condition. Laserscope supports the ANSI and AORN recommendations that protective eyewear be available and worn during all laser procedures by all personnel present. 7. What are some appropriate ways to protect the patient’s eyes during laser surgery? The patient should always be educated on the laser procedure and eye protection requirements prior to the start of the procedure. In addition, the following protective measures should be taken: • Use moist towels where appropriate. • If the patient is awake, use suitable protective eyewear, and instruct the patient not to remove the eyewear. • If the patient is anesthetized, lubricate and tape the patient’s eyelids shut. • Use a combination of moist towels, gauze eye pads, eyeshields, and drapes to protect the eyes when the surgical site is on or near the face. Safety

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8. Where can I find additional information about eye safety and protection? Current literature on laser applications is available in medical libraries. Additional information on terms, definitions and reference materials may be obtained by reviewing ANSI Z136.1-1986 and ANSI Z136.1-2000 and ANSI Z136.3-1996, or by contacting: •

Laser Institute of America 12424 Research Parkway, Suite 130 Orlando, FL 32826 Phone: (800) 34-LASER or www.laserinstitute.org

•

Rockwell Laser Industries P.O. Box 43010 Cincinnati, OH 45243 Phone: (800) 94-LASER or www.rli.com

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BURNS RECOMMENDED PRACTICE VIII: ALL PERSONNEL IN THE LASER TREATMENT AREA SHOULD BE PROTECTED FROM FLAMMABILITY HAZARDS ASSOCIATED WITH LASER USE. 3 Personnel using lasers should be knowledgeable of the fire hazards associated with laser use. Accidental irradiation of tissue other than the target tissue may result in a burn or vaporization, regardless of the wavelength. Surrounding the target area with moist drapes or saline-soaked sponges will keep it moist and greatly reduce this hazard. Flammable or combustible items in the laser environment may include: flammable liquids or combustible ointments, gases, plastics, paper or gauze materials, adhesive or plastic tapes, and endotracheal tubes. Laser appropriate fire extinguishers and water should be available where lasers are utilized. Care and precision in aiming and applying laser energy is of paramount importance.

¡ WARNING: Never use a clamp to secure the laser fiber optic to a

drape. The use of a clamp to secure a fiber may cause the fiber to bend at sharp angles and damage the fiber. To do so can result in an unsafe condition. The fiber can break and release laser energy causing a burn in the protective jacket. If undetected, this condition will result in a burn or ignition of flammable materials.

When using the fiber with the laser, the fiber device connector should never be allowed to touch the floor or any wet surface. If the fiber connector does contact a surface other than the laser device port, dispose of the fiber in accordance with hospital safety regulations.

REFLECTION OF THE BEAM FROM INSTRUMENTS RECOMMENDED PRACTICE V: ALL PEOPLE IN THE LASER TREATMENT AREA SHOLD BE PROTECTED FROM UNINTENTIONAL LASER BEAM EXPOSURE. ibid Care should be taken when aiming the laser beam to prevent reflection of the beam off metallic surgical instruments. Mirror-finish instruments are especially dangerous as they have highly reflective surfaces. The laser light reflected from such instruments is intense and potentially very harmful. Matte, dull, satin-finished, or ebonized instruments have less glare and those with curved surfaces do not reflect light as intensely. While these instruments usually produce a more diffused reflection that is less harmful, 3

2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in Practice Settings. AORN. Denver 2006: pg 565-570

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this reflection can still be damaging. Protective eyewear should be worn at all times to prevent eye damage.

¡ WARNING: When using anodized, black chrome finished, or

ebonized instruments during a surgical procedure, additional care should be taken to prevent burns. These instruments will become extremely hot when they come in contact with a laser beam and are not able to quickly dissipate heat. When any tissue is touched under these conditions, a burn may result.

IGNITION OF FLAMMABLE MATERIALS The laser can ignite many materials used during a surgical procedure. Use of non-flammable materials is strongly recommended. See Operating Room Environment in this section for more information regarding flammable materials.

VAPOR/SMOKE PLUME RECOMMENDED PRACTICE VI: PERSONNEL WORKING IN THE LASER ENVIRONMENT SHOULD AVOID EXPOSURE TO SMOKE PLUME GENERATED DURING LASER SURGERY. ibid There is considerable concern about the biological plume created by electrocautery units, bone saws and lasers. Current medical literature recommends that a smoke evacuator and in-line filter be used to capture this plume. The plume should be regarded as a source of active biological material and a possible carcinogen.

ELECTRICAL RECOMMENDED PRACTICE VII: ALL PEOPLE WORKING IN THE LASER TREATMENT AREA SHOULD BE PROTECTED FROM ELECTRICAL HAZARDS ASSOCIATED WITH LASER USE. ibid Electrical hazards with the laser are the same as with any electrical device. Care should be taken when plugging the unit into the wall outlet. The area must be free of water and your hands must be dry. Always disconnect the laser by grasping the plug and not the power cord. Examine the electrical cord routinely; if signs of wear are noted, contact the Laserscope Customer Response Center at (800) 356-7600 to have it repaired or replaced. When performing a surgical procedure that requires large amounts of irrigation, protect the foot pedal in a plastic bag.

ibid ibid

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OPERATING ROOM ENVIRONMENT This section describes specific safety measures for the operating room to aid in the safe operation of the laser system.

Laser Warning Signs RECOMMENDED PRACTICE III: ALL PEOPLE SHOULD KNOW WHERE LASERS ARE BEING USED AND ACCESS TO THESE AREAS SHOULD BE CONTROLLED. 4 The area where the laser is operated should be clearly labeled. Warning signs that specify the laser wavelength being used should be posted at all operating room and access-door entrances. Figure S-1 is an example of a sign suitable for use with the GreenLight HPS™ laser system.

¡ WARNING: Warning signs are not interchangeable. Select a sign that is appropriate for the wavelengths in use.

Figure S-1

GreenLight HPS™ laser system Warning Sign

4

2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in Practice Settings. AORN. Denver 2006: pg 565-570

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Remote Door Interlock Always limit personnel in the operating room to those essential to the procedure. To protect intruding personnel from exposure to the laser beam, an optional remote door interlock can be connected from the laser system to the operating room entrance door. This interlock will automatically put the laser in STANDBY if the door is opened during a procedure. The laser will remain in STANDBY until the door is closed and the interlock is reconnected. Once reconnection is made, the operator can place the system back in READY and reactivate the surgical beam. The laser cannot be placed in READY unless the interlock is reconnected. If the use of the remote door interlock is desired, the biomedical personnel at the user’s facility can connect it. Access to the laser unit’s interlock is made via a socket located on the back panel of the laser (see Section 1.1. System Overview).

Safety Recommendations The following are general safety recommendations for the operating room and are not specific to the GreenLight HPS System:

„

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Keep drapes and towels moist to prevent their ignition and burning.

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Use non-flammable prepping solutions.

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Prevent combustion of methane gas by packing the rectum during perineal procedures.

NOTE: All lasers operate with a keyswitch. Keep the laser key in a designated place and allow only trained personnel access to the key.

¡ WARNING: Do not fire the laser unless the aim beam is clearly visible and directed at the targeted tissue.

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REFERENCE SOURCES Reference material and additional information regarding laser safety may be obtained from the following sources: ANSI Z136.3 The Safe Use of Lasers in Health Care Facilities American National Standards Institute, (ANSI), 1988. AORN: Standards, Recommended Practices and Guidelines. 2006 edition: Recommended Practices for Laser Safety in the Practice

Settings. Pg 565-570 Safety Considerations for the Use of Medical Lasers The Nursing Spectrum of Lasers Pfister, Kneedler, Purcell, Education Design, 1988, Pg. 70-72. Lasers: The Perioperative Challenge Ball, Kay A.. 3rd edition, Denver, AORN, Inc. 2004 Diffuse Reflections Endoscopic Surgery: Is Laser Safety Eyewear Really Needed? Radiant Resources Newsletter, Winter 1992, Rockwell Laser Industries.

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SAFETY FEATURES OF THE GreenLight HPS™ LASER SYSTEM Safety Regulations The United States Code of Federal Regulations, CFR Title 21, Ch. 1, Sections 1040.10, and 1040.11, requires that lasers have certain safety features. It further requires that labels be affixed to each laser unit identifying the manufacturer, the class or classes of radiation produced, and the location of the laser aperture(s) on the unit. The safety features of Laserscope’s GreenLight HPS™ laser system are described in the following sections. All required labeling information is also provided in these sections.

System Safety Features Laserscope’s GreenLight HPS™ laser system incorporates the following safety features: •

The laser will stop firing when the pressure is removed from either footswitch.

•

An automatic circuit breaker shuts the system completely off in the event of an electrical overload.

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The laser provides an operating room door interlock connection, which must be set up by the hospital personnel.

•

The key can only be removed when the keyswitch is in the OFF position.

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An on-board microprocessor continuously monitors the status of the system, and displays messages on the video screen along with appropriate operator prompts.

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Laser energy cannot be emitted from the system unless a fiber optic has been connected.

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Laser will go into ready when the READY button is touched, or when the button on top of the footswitch is pressed.

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A fiber support pole elevates and positions the fiber in a safe and unobtrusive position.

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A continuous audible tone is heard when the surgical beam is activated (i.e., foot pedal is pressed). A higher frequency tone is heard for vaporization and a lower tone for coagulation.

•

A 2-second delay occurs before laser energy is emitted after the laser is placed in READY status.

•

An Emergency Laser Stop switch is available to disable the system immediately, in the case of an emergency situation

When switching between READY and STANDBY, a voice will announce the current mode. xviii Operator’s Manual •

IMPORTANT NOTE: Do not attempt to remove any panel from the laser console. All panels are fitted with tamper-proof fastenings. Any attempt to remove the panels, unless instructed by authorized Laserscope personnel, can damage the laser and will void the manufacturer’s warranty.

¡ WARNING: Unauthorized use of internal controls, adjustments to the equipment, or performance of procedures other than those specified herein, may result in hazardous radiation exposure.

SAFETY CLASSIFICATIONS In accordance with UL 2601-1/IEC 60601-1, the product is classified as Class I equipment at continuous operation with intermittent loading, which is not protected against ingress of liquids. The product is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Performance & Safety Standards: The GreenLight HPS™ laser system and accessories comply with U.S. Federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. In addition, the information below identifies Standards (European Norms and other Regulatory Guidelines) deemed as relevant for addressing particular aspects of the Quality System, the requirements for Medical Lasers, the Requirements for Medical Devices, and the Essential requirements of the EU Medical Device Directive (Annex I). ANSI Z136.1;200 ANSI Z136.3:2005 21 CFR Part 820 21 CFR Part 1040.10-11 MDD 93/42/EEC WEEE 2002/96/EEC EN60601-2-22:1996

EN 60601-1-4:1997 EN29001 ISO 11135 ANSI/AAMI ST81:2004 AAMI TIR 12:2004 AAMI TIR 30:2003 ISO 8600-1:1997

ISO 8600-3:1997 ISO 8600-4:1997 ISO 60601-2-18 CB Scheme ISO 13485:2003 CMDCAS

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This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1994. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be 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:

• • • •

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Reorient or relocate the receiving device. Increase the separation between the equipment. Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. Consult the manufacturer or field service technician for help.

Operator’s Manual