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Novus Spectra
0642-543-01, Rev A, 12/02

84   Indications for Use

Posterior Segment Laser Procedures

CAUTION - 

Users should be aware of general laser warnings, precautions, 

and adverse effects listed in “General Information” in this chapter.

CAUTION - 

Please see 

“Ophthalmology References” in this chapter

 for 

literature regarding the use of the laser in retinal laser procedures.

Indications

The laser is indicated for posterior chamber procedures involving the retina.

The Conditions of the retina for which the laser is useful include diabetic 
retinopathy, retinal detachments, and senile macular degeneration, among 
others.

Contraindications

Contraindications for using the laser include opacities in the cornea or lens, or 
blood in the vitreous humor that may interfere with the delivery of laser 
energy to the desired structure.

The following are additional contraindications for panretinal 
photocoagulation

1

:

•

Grade IV or greater glial proliferation exists throughout the 
posterior pole of the eye.

•

Grade IV or greater vitreoretinal traction exists.

•

Excessive areas of capillary closure are present by fluorescein 
angiography. When more than 60% of the macular and 
paramacular areas have been occluded by microinfarction and 
macroinfarction, photocoagulation has not been beneficial and has 
exacerbated some cases of macular edema, resulting in immediate 
visual loss in the treated eye.

•

Florid surface neovascularization extends over most of the posterior 
pole in a vine-like arborization. In these cases, pituitary ablation 
has proved to be the method of choice for the control of these 
drastically afflicted eyes.

•

The posterior polar regions have been replaced by surface glial 
proliferation, and a network of cord-like vitreous membranes exists 
between the various vascular components that cannot be 
satisfactorily attacked by any vitrectomy, vitreo-retinal, or 
membranectomy procedure. In these cases, photocoagulation can 
shrink the closely adherent vitreous strands, causing an increase in 
the vitreo-retinal tractional and possibly a detachment of the 
retina. However, laser endophotocoagulation at the time of 

1. Reference 7, “Ophthalmology References”

Содержание Novus Spectra

Страница 1: ...Novus Spectra Solid State 532 nm Green Laser Operator Manual...

Страница 2: ...ery effort has been made to ensure that the data given in this document is accurate the information figures illustrations tables specifications and schematics contained herein are subject to change wi...

Страница 3: ...13 Connecting the footswitch 14 Using the external door interlock 15 Plugging in the main power cable 16 Connecting the remote control 17 Connecting the delivery device s 18 Connecting eye safety filt...

Страница 4: ...oting Guide 43 User Maintenance 47 Annual laser maintenance 47 Laser repair 47 Clean the external surfaces of the laser console 47 Clean the laser control screen 47 Water utilities 47 Electrical Requi...

Страница 5: ...es 78 General references 78 Ophthalmic Applications of the Laser 79 Adverse effects and complications 80 Precautions 81 Guidelines for use 81 Anterior Segment Laser Procedures 84 Indications 84 Uses 8...

Страница 6: ...6 Contents Novus Spectra 0642 543 01 Rev A 12 02...

Страница 7: ...ovus Spectra Laser 9 Laser Preparation 10 Novus Spectra Components 11 Connection Instructions 13 Laser Console Basics 22 Laser Console and Remote Control Basics 26 Setting Treatment Parameters 30 Preo...

Страница 8: ...Novus Spectra 0642 543 01 Rev A 12 02 8 General Operation...

Страница 9: ...rgone extensive testing and with proper handling are useful and reliable clinical instruments If you have questions regarding your laser or delivery system contact your local Lumenis representative WA...

Страница 10: ...to ensure that your surgical staff is experienced with the operation and safety considerations of the laser Thereafter you or the nursing staff at your facility will perform the daily maintenance rou...

Страница 11: ...display an optional remote control a footswitch all electrical cables necessary for proper connection Delivery devices including integrated slit lamps and slit lamp tables if ordered may also be ship...

Страница 12: ...ed to an external switch to disable the laser if the treatment room doors are opened during treatment Footswitch The footswitch activates the laser treatment beam when you depress it while the laser i...

Страница 13: ...nents cables and electrical connections for dirt debris or damage Ensure that the electrical cables are not frayed or split Inspect all delivery devices as instructed in the appropriate delivery devic...

Страница 14: ...otswitch Insert the footswitch plug into the footswitch receptacle on the rear of the laser console If the footswitch is not properly connected when the laser is turned on E200 displays on the laser c...

Страница 15: ...ug is inserted into the receptacle For your convience the Novus Spectra comes from the factory with an interlock plug pre installed An external door interlock rated at 12 VDC is required for this syst...

Страница 16: ...hat the keyswitch is in the off position 2 Insert the mains power plug into the mains receptacle on the rear of the laser console 3 Insert the other end of the main power plug into the wall socket and...

Страница 17: ...12 02 Connecting the remote control If desired connect the remote control at any time by inserting the remote control plug into the remote control receptacle on the rear of the laser console Remote co...

Страница 18: ...nsure that it has not been torn or punctured If there is any damage to the sterile packaging do not use the delivery system WARNING If an emulation plug is used the operator shall assume all responsib...

Страница 19: ...erly connected to the laser an E400 error code will display on the laser console If the eye safety filter is not compatible an E401 error code will display Refer to the appropriate delivery device ope...

Страница 20: ...ety filter plug into the eye safety filter extension cable as instructed in the appropriate delivery device operator manual 2 Insert the extension cable plug into the ACC receptacle on the front of th...

Страница 21: ...onnection Instructions 21 Novus Spectra 0642 543 01 Rev A 12 02 To fiber port To slit lamp power supply Fiber Example of delivery device and eye safety filter connections slit lamp and LaserLink shown...

Страница 22: ...y screen will show Stdby to indicate that the laser is in standby mode Depressing the footswitch during warmup will disable the footswitch If any fault conditions are encountered during the laser self...

Страница 23: ...e electrical source some internal circuits remain energized To de energize all internal circuits unplug the main power plug from the wall socket or turn off the main electrical service wall circuit br...

Страница 24: ...vice s as instructed in the appropriate delivery device operator manual s 5 Remove the footswitch from the laser 6 Disconnect the automatic eye safety filter s if used and remove the eye safety filter...

Страница 25: ...o the laser as described in the Connection Instructions section of this manual 2 Turn on the laser 3 Verify that E300 fiber not connected or E301 fiber not compatible IS NOT displayed on the laser con...

Страница 26: ...are identified by English labels and icons Aiming beam intensity selectors Illumination intensity selectors For future product enhancement Pulse count reset selector Pulse duration display Pulse dura...

Страница 27: ...tons icons and displays 800 05 mW s 05 0 s n 0 Treatment power display Aiming beam intensity selectors Pulse repeat interval display Pulse duration display Pulse duration selectors Pulse count display...

Страница 28: ...control the icon is illuminated In standby mode the aiming beam is present but the footswitch is disabled and the treatment laser cannot be activated Pressing the Mode selector will switch the laser t...

Страница 29: ...1 Rev A 12 02 Standby ready mode selector and Standby icon on laser console Standby ready mode selector and icons on remote control Standby ready mode selector Standby icon 800 05 mW s 05 0 s n 0 Stan...

Страница 30: ...tes on the console display or remote control indicates a LaserLink or slit lamp is connected indicates a probe is connected indicates an LIO is connected WARNING Always ensure that a compatible eye sa...

Страница 31: ...Setting Treatment Parameters 31 Novus Spectra 0642 543 01 Rev A 12 02 800 05 mW s 05 0 s n 0 Aiming beam intensity selector Aiming beam intensity selector Adjusting the aiming beam...

Страница 32: ...the laser power by pressing the switches on the inside left decrease power and right increase power of the footswitch housing WARNING Always inspect the optics and delivery device as describedin Conn...

Страница 33: ...Setting Treatment Parameters 33 Novus Spectra 0642 543 01 Rev A 12 02 800 05 mW s 05 0 s n 0 Pulse duration selectors Setting the pulse duration...

Страница 34: ...settings If you attempt to select an interval that is unavailable at the existing power and exposure time settings the laser changes to meet the duty cycle requirements for that power setting You must...

Страница 35: ...Setting Treatment Parameters 35 Novus Spectra 0642 543 01 Rev A 12 02 800 05 mW s 05 0 s n 0 Pulse interval display and selectors Setting the treatment interval...

Страница 36: ...The range on the Novus Spectra display is 0 9999 pulses It can be reset to zero by pressing the Count Reset selector located above the display on the laser console or by pressing the count reset sele...

Страница 37: ...ay and Remote Con trol Basics in this chapter 7 Perform the aiming beam integrity check as instructed in Laser beam integ rity check in this chapter WARNING Lasers generate a highly concentrated beam...

Страница 38: ...the biological interaction between the laser energy and tissue 1 Set the treatment values as instructed in this manual and verify that the desired settings are displayed on the control panel 2 Ensure...

Страница 39: ...he footswitch and coil the cable to prevent damaging it 5 If desired disconnect the delivery device disconnect and store the laser and delivery device components as instructed in Laser Console Basics...

Страница 40: ...Novus Spectra 0642 543 01 Rev A 12 02 40 General Operation...

Страница 41: ...12 02 41 Maintenance Overview Troubleshooting Guide 43 User Maintenance 47 Electrical Requirements 48 Replacing the Fuses 49 Specifications 50 Calibration Procedure 52 Warranty Information 54 Decontam...

Страница 42: ...Novus Spectra 0642 543 01 Rev A 12 02 42 Maintenance...

Страница 43: ...ng table that follows Error codes appear on the laser console display or on the remote control display screen Laser console electrical Verify that the laser is on and properly connected to an electric...

Страница 44: ...h the laser in ready mode verify that the laser emission icon appears remote control or that a tone laser console occurs when the footswitch is depressed If either the tone or the icon does not appear...

Страница 45: ...The fiber is not properly connected Ensure that the fiber is properly connected E301 The fiber is not compatible Connect a compatible fiber E400 The delivery device is not properly connected Ensure t...

Страница 46: ...ted a lower level of energy than the level selected by the user Turn off the system for five seconds then restart If the condition persists contact your local Lumenis representative E502 The laser det...

Страница 47: ...ernal surfaces of the laser console Use a cloth dampened with a noncaustic cleaning solution such as soap and water isopropyl alcohol or a hospital grade disinfectant to wipe the external surfaces of...

Страница 48: ...1 2 60601 1 4 60601 2 22 and 60825 1 and CSA 22 2 No 601 requirements The laser is available in one electrical configuration with a universal 100 240 V 5 0 A power input The supplied hospital grade p...

Страница 49: ...cket and the main power receptacle on the rear of the laser console 3 Locate the fuse holder directly below the main power receptacle 4 Unlock and pull out the fuse holder by inserting a small insulat...

Страница 50: ...1 00 s and single pulse Pulse counter Counts pulses delivered range 0 9999 Laser beam spot size Controlled by delivery system Illumination The accessory port provides from 0 20W of electrical power to...

Страница 51: ...10 in 35 6 cm 14 in 8 kg 17 lb Power cable length 4 1 m 13 5 ft U S 2 4 m 8 ft International Footswitch cable length 4 6 m 15 ft Latex This product is latex free Laser safety eyewear Refer to Laser Sa...

Страница 52: ...alibration is a service procedure to be done only by Lumenis certified Service Engineers or customers who have taken and passed a Lumenis Service Certification Training course Adjustment by anyone oth...

Страница 53: ...radiation Only Lumenis certified service technicians shall work inside the console 3 On the CPU board bottom PCB slide switches 1 and 2 of SW2 to the open position 4 Turn the keyswitch to the on posit...

Страница 54: ...uipment shipped to Lumenis U S offices for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for use as a Hospital Disinfectant To e...

Страница 55: ...vus Spectra 0642 543 01 Rev A 12 02 55 Safety and Regulatory Overview Introduction 57 Laser Safety Eyewear 58 Additional Ocular Protection 61 Additional Safety Considerations 62 Regulatory Compliance...

Страница 56: ...Novus Spectra 0642 543 01 Rev A 12 02 56 Safety and Regulatory...

Страница 57: ...ser beams except as a therapeutic application Additional precautions must be taken to prevent fire electrical injury and explosion Lumenis does not make recommendations regarding the practice of medic...

Страница 58: ...following formula was used to calculate the worst case NOHD for Lumenis Novus Spectra lasers and compatible delivery systems where Z the distance of the beam waist from the laser system a the beam wai...

Страница 59: ...results in a worst case NOHD of a Z NOHD 1 4 MPE Pf a2 Z Laser system rad W MPE W cm2 Pf a cm Z cm LaserLink HS LaserLink Z LIO Acculite 0 050 0 041 0 022 0 140 2 5 2 5 2 5 2 5 0 00255 0 00255 0 00255...

Страница 60: ...tion to providing the required laser safety eyewear take the following steps to secure the treatment room or the controlled area 1 To alert personnel before they enter the controlled area place a warn...

Страница 61: ...indirect exposure to the treatment beam The predominant ocular structures at risk are dependent on the laser wavelength in use In general visible and near infrared wavelengths are most damaging to the...

Страница 62: ...mage can occur due to incorrect energy repetition rate exposure duration or power application The lowest energy repetition rate exposure duration and power settings that are effective for the intended...

Страница 63: ...ion or sterile water If allowed to dry protective towels and sponges can increase the potential fire hazard A UL approved fire extinguisher and water should be readily available Electrical hazards WAR...

Страница 64: ...e Directive MDD 93 42 EEC CAUTION US law restricts this device to sale by or on the order of a physician CAUTION Lumenis medical lasers and laser delivery systems are intended solely for physicians tr...

Страница 65: ...on the laser power up sequence is initiated Location of controls Operation and adjustment controls are located so that the user need not be exposed to laser radiation during laser operation or adjustm...

Страница 66: ...red by the operator Refer to the Troubleshooting Guide in this manual for additional information Safety shutter The laser includes an electronic safety shutter that prevents unintentional laser emissi...

Страница 67: ...abels As required by national and international regulatory agencies appropriate labels have been mounted in specified locations 800 05 mW s 05 0 s n 0 Laser console front panel Laser console top Laser...

Страница 68: ...3 s 3 s 1064 nm 10 mW LASER CLASS LASER CLASS Laser 630 nm mW Max VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT per IEC 60825...

Страница 69: ...h plug Fuse rating label replace fuse as marked Ingress protection Attention read manual Read and comprehend the operator manual before use Remote interlock Footswitch Laser aperture label Laser apert...

Страница 70: ...543 01 Rev A 12 02 70 Safety and Regulatory Laser emission indicator Slit lamp icon Probe icon Ready Aiming beam Standby Pulse interval Count reset Pulse Duration Treat Power Illumination LIO n 0 Rem...

Страница 71: ...r Use Overview General Information 73 Ophthalmic Applications of the Laser 83 Posterior Segment Laser Procedures 84 Anterior Segment Laser Procedures 90 Ophthalmology References 93 Otologic Applicatio...

Страница 72: ...Novus Spectra 0642 543 01 Rev A 12 02 72 Indications for Use...

Страница 73: ...and incidence angle of the laser beam onto the target tissue Laser light is preferentially absorbed by pigments within tissue and causes an increase in tissue temperature Laser light is also absorbed...

Страница 74: ...ion coefficient scatter coefficient attenuation coefficient and depth of penetration for some representative tissue types Tissue Absorption Coefficient cm 1 Scatter Coefficient cm 1 Attenuation Coeffi...

Страница 75: ...n This list is not intended to be all inclusive A cookbook approach to surgery and tissue effects is not recommended General guidelines can however be suggested The guidelines suggested are intended t...

Страница 76: ...es so that opposed edge tissues may be fused by reforming covalent bonds Below 45 C there is little cell damage Above 45 C enzymes degrade These changes may or may not be reversible A faint whitening...

Страница 77: ...o that the laser light is not transmitted through such tissue or fluids with attendant thermal damage to more highly pigmented tissue in underlying or surrounding regions The wavelength will be transm...

Страница 78: ...er emissions travel in a straight line until obstructed or reflected and care should be taken concerning what materials are present beyond or behind the target tissue This is necessary to protect surg...

Страница 79: ...n CAUTION Although it is highly unlikely that viable tumor cells occur in the laser plume it has been reported that intact viral DNA is liberated into the air with the vapor of CO2 laser treated verru...

Страница 80: ...of pain following laser therapy is usually minimal but is dependent upon the surgical procedure Sepsis The possibility of infection must be considered and treated accordingly in any surgical procedure...

Страница 81: ...a description of the physics of laser light interaction Tissue effect may be controlled by altering the distance between hand held fiber optic delivery devices and the target tissue Once the treatmen...

Страница 82: ...edical Laser Develop ments Lasers in Medical Sciences Vol 8 pp 47 66 1986 2 American National Standards Institute Safe Use of Lasers in Health Care Facilities ANSI Standard Z 136 3 New York ANSI 1430...

Страница 83: ...stem to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp It usually includes some kind of mechanism to manipulate the position of the laser beam...

Страница 84: ...or pole of the eye Grade IV or greater vitreoretinal traction exists Excessive areas of capillary closure are present by fluorescein angiography When more than 60 of the macular and paramacular areas...

Страница 85: ...e eye is afflicted with severe renal retinopathy with edema intraretinal yellowish serum accumulations attenuation and tortuosity of the vascular elements and general deterioration of the retina In th...

Страница 86: ...ld be observed closely so that pars plana vitrectomy can be used if necessary to alleviate excessive vitreoretinal traction caused by the panretinal photocoagulation process An increase in lenticular...

Страница 87: ...rapeutic result The normal procedure is to start with a low power density that produces no visible reaction on the retina The power density is then increased until a blanching occurs in the area being...

Страница 88: ...ng untreated retinal tissues can be supplied with sufficient nutrients by the existing blood supply so the new blood vessels stop growing The laser can also be used to coagulate a blood vessel that is...

Страница 89: ...exiting the probe has a fixed angle of divergence the farther the probe is from the target the larger the spot on the retina will be Also because no lens system is needed to focus the beam on the tar...

Страница 90: ...trabeculoplasty Aphakic eye with vitreous in the anterior chamber Neovascular glaucoma Glaucoma caused by congenital abnormalities of the angle Less than 90 of open angle or extensive low lying periph...

Страница 91: ...e permanent depending on the severity of the accidental damage WARNING Angle closure glaucoma has been reported following laser trabeculoplasty when miotics were discontinued Medical therapy should be...

Страница 92: ...own to a 25 m spot on the iris and so the power density is raised by a factor of four At this spot size a laser power setting of 1 W gives a power density of about 200 000 W cm2 This is enough power t...

Страница 93: ...6 o clock position the 12 o clock portion of the meshwork is viewed The inferior half of the meshwork is usually treated first so the lens is placed with the mirror in the 12 o clock position 2 The la...

Страница 94: ...ne 1980 5 Schwartz AL et al Krypton Laser Trabecular Surgery in Uncontrolled Phakic Open Angle Glaucoma Ophthalmology Vol 88 No 3 March 1981 6 Ophthalmic Laser Therapy Posterior Segment Laser Section...

Страница 95: ...welding 3 Uses The laser is indicated in both micro and macro otologic procedures The selective absorption of the laser wavelength by color permits the surgeon to work on closely approximated soft ti...

Страница 96: ...ning hemostasis in cortical bone CAUTION Blood should not be allowed to contaminate or color the perilymph surface A bloodless field will help prevent absorption of the laser energy by the clear peril...

Страница 97: ...94 Suppl 385 1 31 1982 9 Vollrath M Schreiner C Effect of Argon Laser Stapedotomy on Cochlear Potentials Acta Otolaryngol 95 47 53 1983 10 Vollrath M Schreiner C Influence of Argon Laser Stapedotomy o...

Страница 98: ...ertson JH Gardner G Selective Absorption and Control of Thermal Effects A Comparison of the Laser Systems Used in Otology and Neurotology Otolaryngol Head Neck Surg 92 l 73 79 1984 21 Gillis TM Strong...

Страница 99: ...al surgery including panretinal photocoagulation retinopexy and treatment of neovascularization Spot sizes delivered through the Acculite endoprobes vary depending on the distance of the Acculite endo...

Страница 100: ...Indications for Use Ensure that the probe tip does not come into direct contact with tissue when treating if it does the optical efficiency of the fiber will be compromised Use a suction tip in the t...

Страница 101: ...Equation 4 Equation 5 Equation 6 where Table 4 lists resulting spot sizes using approximate irradiance and fluence for 1 W of delivered power durations of 0 5 s and 1 0 s and a fiber diameter of 300 o...

Страница 102: ...ot size as a function of distance from the end of the fiber optic and Figure 2 illustrates the relationship between irradiance and the distance from the fiber tip Figure 1 Spot size as a function of d...

Страница 103: ...nsideration the irradiance which is effective for each procedure the user can determine the different laser power settings Table 5 Spot Size and Irradiance at 1 W Delivered Fiber Optic Distance from t...

Страница 104: ...pacities diabetic retinopathy pan retinal photocoagulation segmental peripheral photocoagulation segmental photocoagulation cloudy vitreous cavities pediatric retinal repairs under general anesthesia...

Страница 105: ...r and should have an anti reflective coating Although condensing lenses are available with yellow tints to reduce the amount of short wavelength light which reaches the retina these tinted lenses shou...

Страница 106: ...etina is in this position the retina can be attached using the laser and may be less likely to detach again If the patient can be positioned so that the retina can be treated without the laser beam ha...

Страница 107: ...ge plane can be varied by moving the point of focus of the laser beam out of the laser beam s object plane retinal image plane Figure 2 shows how altering working distance affects retinal spot size No...

Страница 108: ...corporates an internal protective physician s filter Indications Slit lamp delivery systems and LaserLinks are indicated for the delivery of laser energy to the eye They can be used in conjunction wit...

Страница 109: ...y Individual Institution City State Country has undergone decontamination with a commercially available germicide cleared for use as a Hospital Disinfectant and is clean and free from biohazards inclu...

Страница 110: ...Novus Spectra 0642 543 01 Rev A 12 02 110 Indications for Use...

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