Users Manual
28 Pages
Preview
Page 1
Auriga™ XL 4007 Laser System User’s Manual
Auriga XL ™
Auri ™ ga X
L
Black (K) ΔE ≤5.0
TABLE OF CONTENTS 1 INTRODUCTION...5 1.1 Product Description and Operating Principles ...5 1.2 Intended Use and Indication ...5 1.3 Contraindications ...5 1.4 Adverse Events...5 1.5 Safe Use Requires Reading The User's Manual ...5 2 SAFETY ...5 2.1 General User Notes ...5 2.2 Safety Notes ...6 2.3 Eye Protection ...7 2.4 Limitations of Application ...7 2.5 Product Label...7 3 TECHNICAL PREREQUISITES AND COMMISSIONING ...8 3.1 Technical and Spatial Prerequisites ...8 3.2 Commissioning ...9 3.3 Laser Area Signs ...9 4 DEVICE DESCRIPTION ...9 4.1 Basic Laser Console ...9 4.2 Switching Elements and Interfaces ...10 4.3 Display ...11 5 OPERATION AND APPLICATION ...11 5.1 Installation of the Laser fiber ...11 5.2 Disassembly of the Laser fiber ...11 5.3 Switching on the console ...12 5.4 Main Menu ...12 5.5 Application Menu...13 5.6 LITT ...14 5.7 Triggering Laser Impulses ...15 5.8 Submenus...16 5.8.1 Memory Submenu...16 5.8.2 Pilot Laser Submenu ...17 5.8.3 Configuration Menu (Setup) ...17 5.8.4 Language Settings ...18 5.8.5 Treatment Log ...18 5.8.6 Setting date and time ...19 5.8.7 Screen Settings ...19 5.8.8 Volume Settings ...19 5.8.9 View Device Information ...20 5.8.10 Reset to factory settings ...20 5.8.11 Call Error History ...20 5.8.12 Access to the service level (authorized service personnel only) ...20 5.9 Switching off the console ...21 5.10 Cleaning and Maintenance ...21 5.11 Transport, Storage and Operating conditions ...21 6 ACCESSORIES/TOOLS ...22 6.1 Accessory/Tool Information ...22 6.2 Cleaning ...22
User’s Manual
3
Black (K) ΔE ≤5.0
7 TECHNICAL DATA ...22 7.1 Device Data...22 7.2 Laser Parameters...23 7.3 Electromagnetic Compatibility ...23 7.4 Electromagnetic Emissions ...23 7.5 Electromagnetic Interference Resistance ...23 7.6 Recommended Protective Distances ...25 8 TROUBLESHOOTING AND MAINTENANCE ...25 8.1 Isolating the laser console from the mains power supply ...25 8.2 Troubleshooting...25 8.3 Error Messages ...25 8.4 Device Data...26 8.5 Maintenance...27 8.6 Disposal of the product, accessories/tools, and packaging materials ...27 9 LIMITED WARRANTY ...28 10 OBTAINING WARRANTY SERVICE FROM BOSTON SCIENTIFIC CORPORATION ...28
4
Black (K) ΔE ≤5.0
User’s Manual
ONLY Federal Law (USA) restricts this device to sale by or on the order of a physician. 1 INTRODUCTION 1.1 Product Description and Operating Principles The Auriga™ XL Laser Console is a flash lamp pumped holmium laser and emits laser light at a wavelength of approximately 2.1 μm. The Auriga XL Laser Console generates laser impulses of 200 mJ to 4200 mJ and 5 to 25 Hz at a maximum average output of 50 W. The Auriga XL Laser Console emits laser radiation in the area of the maximum absorption of light in tissue at 2.1 μm. An essential absorber for laser radiation of the Auriga XL Laser Console is the water that is contained in different tissue types at different percentages (soft tissues approx. 70 % - 80 %, bone approx. 8 - 10 %). Due to the high absorption coefficient of water, this suffices to achieve the desired effects, such as lithotripsy (fragmentation of calculus), as well as cutting, ablation and coagulation of soft tissues or solid tissues. Cutting (dissection) or ablation of tissue leads to a thermal coagulation zone that enables low bleeding during work. The laser irradiation is transferred to the target tissue through laser fibers by the laser console device. These laser fibers can be guided by suitable instruments like endoscopes, robots or applicators (e.g. hand pieces). 1.2 Intended Use and Indication The Auriga XL holmium Laser is designed for interdisciplinary use for all invasive and non-invasive surgical applications (e.g. Urology, ENT, Orthopaedics, Gynecology or Gastroenterology). Due to its application adapted parameters, the AURIGA XL Laser Console is qualified for t -JUIPUSJQTZ t "CMBUJPO EJTTFDUJPO BCMBUJPO PGIBSEBOETPGUUJTTVF t $PBHVMBUJPOPGIBSEBOETPGUUJTTVF
t 7BQPSJ[BUJPOPGMJRVJE
1.3 Contraindications Laser-specific contraindications are not known at this time. However, indication for treatment of children and pregnant women should be accordingly strict. 1.4 Adverse Events Refer to the applicable Fiber Directions for Use for adverse events. 1.5 Safe Use Requires Reading The User's Manual Prior to using the Auriga XL Laser System, all operating personnel should familiarize themselves with the contents of this manual to become familiar with Auriga XL Laser System's features and controls. Failure to thoroughly understand and follow all instructions, cautions and warnings provided in this User's Manual may result in injury to the patient and/or user, and/or may result in damage to, or malfunction of, this equipment. Additionally, damage to other equipment or property may result. Follow all instructions, cautions, and warnings provided with all products and equipment to be used in conjunction with the Auriga XL Laser Console to avoid any possible hazards due to device incompatibility. The holmium laser Auriga XL Laser System is manufactured at Boston Scientific Corporation, 150 Baytech Drive, San Jose, CA 95134, USA. 2 SAFETY 2.1 General User Notes The Auriga XL Laser Console is a medical-technical treatment device that must only be used according to its intended use.
Use of mobile phones or similar devices is not permitted during laser operation. WARNING t %VFUPQPTTJCMFEBOHFSGSPNFMFDUSPNBHOFUJDSBEJBUJPO JUJTSFDPNNFOEFEUIBUQFSTPOTXJUIQBDFNBLFSTPSXIPBSFQSFHOBOUTIPVME not be present within the range of the laser. t "SJTLPGGJSFBOEPSFYQMPTJPOFYJTUTXIFOUIF-"4&3065165JTVTFEJOUIFQSFTFODFPGGMBNNBCMFNBUFSJBMT TPMVUJPOTPSHBTFT PSJO an oxygen enriched environment. The respective protective measures are to be taken. t 8FBSUIFQSFTDSJCFEMBTFSHMBTTFTJOUIFMBTFSBSFBEVSJOHMBTFSFNJTTJPO t /PVOBVUIPSJ[FENPEJGJDBUJPOPGUIJTFRVJQNFOUJTBMMPXFE%POPUBUUFNQUUPSFQBJSPSBMUFSBOZDPNQPOFOUTQBSUTPG"VSJHB9--BTFS4ZTUFN Auriga XL Laser System contains no operator serviceable components. All repairs and servicing are to be performed only by authorized Boston Scientific personnel.
User’s Manual
5
Black (K) ΔE ≤5.0
Caution: t -JLFBOZNFEJDBMEFWJDF BMBTFSSFRVJSFTTQFDJBMFYQFSUJTFBOEDBSFJOIBOEMJOHBOEVTF5IFMBTFSNVTUPOMZCFVTFECZQFSTPOT who are instructed in proper handling of the device under consideration of the operating instructions and who are familiar with its therapeutic effect and possible danger and adverse events. t 6TFPGUIFMBTFS PQFSBUJOHEFWJDFPSTFUUJOHPQUJPOTJOBOZPUIFSNBOOFSUIBOEFTDSJCFEIFSFNBZMFBEUPTFSJPVTJOKVSZ t Laser fumes and/or fume extraction may contain viable tissue particulates. Use suitable extraction and filter systems and take appropriate measures for protection. t /FWFSVTFBOZEBNBHFEPSVOTUFSJMJ[FEMBTFSGJCFST t Wrong or improper operation of the laser console may lead to irreversible damage. Therefore, the laser console must only be operated accordingly by trained and experienced staff. 2.2 Safety Notes Intended User t 0OMZQFSTPOTUSBJOFEJOUIFVTFPGUIFMBTFSBOEXIPIBWFTVGGJDJFOUNFEJDBMLOPXMFEHFTIPVMEVTFUIF"VSJHB9--BTFS$POTPMF There are no specialized skills assumed for use of the console. Only that the user understands the console’s operation and the risk associated with improper use. t 5IJTNBZJODMVEFCVUJTOPUMJNJUFEUPQBSUTPGUIFCPEZBQQMJDBCMFUPTVSHJDBMQSPDFEVSFTJOWPMWJOHFOEPTDPQJD MBQBSPTDPQJDBOEPQFO surgical procedures involving vaporization, ablation, fragmentation of calculi (urinary and biliary), coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissues. t 8JUIJNQSPQFSVTFFWFSZMBTFSDBOMFBEUPTFSJPVTJOKVSZ"VSJHB9--BTFS$POTPMFJTB$MBTTMBTFSQSPEVDUBDDPSEJOHUP&/ t 3FDPNNFOEFEEJTUBODFCFUXFFOQIZTJDJBOPQFSBUPSBOEUIF"VSJHB9--BTFS$POTPMFJToNFUFST t 5IFPQFSBUPSNVTUFOTVSFUIBUQBUJFOUIBTOPDPOUBDUXJUIMBTFSDPOTPMFEVSJOHUIFQSPDFEVSF t 8IFOJOTUBMMJOHUIF"VSJHB9--BTFS$POTPMF FOTVSFUIBUUIFGMPPSJTFWFOUPQSFWFOUUIFDPOTPMFGSPNUJQQJOHPWFS Intended Use Environment t 5IFDPOTPMFJTJOUFOEFEUPCFVTFEJOBTUBOEBSETVSHJDBMSPPNXJUITUBOEBSEMJHIUJOH t *UJTSFDPNNFOEFEUPVTFUIF"VSJHB9--BTFS$POTPMFPOMZJOSPPNTXJUIBUFNQFSBUVSFPG¡$¡$ IVNJEJUZPG non-condensing and with pressure ranges of 795 - 1060 hPa. General Safety Notes t 8IFOVTJOHPQUJDBMEFWJDFTGPSPCTFSWJOHPSTFUUJOH ZPVNBZIBWFUPVTFTVJUBCMFQSPUFDUJWFGJMUFSTJOUIFDPSSFDUQSPEVDUJPOMFWFM t 1MFBTFPCTFSWFUIBUSFGMFDUJWFNBUFSJBMTPSJOTUSVNFOUTNBZEFGMFDUUIFMBTFSCFBNJOBOVODPOUSPMMFEGBTIJPO5BLFTQFDJBMDBSFXJUIHMBTT surfaces, but high-gloss metal surfaces also may cause dangerous laser beam dispersion even at a distance of several meters. t 3FHJPOBMSFRVJSFNFOUTGPSTFUVQBOEPQFSBUJPOPGNFEJDBMMBTFSTNVTUCFDPNQMJFEXJUI5IJTNBZSFRVJSFOPUJGJDBUJPOPGUIFMBTFSUPBOZ national authorities and which provisions must be observed. t %VSJOHPQFSBUJPO UIFMBTFSBSFBNVTUCFMPDLFEPGGBOENBSLFEBDDPSEJOHUPTBGFUZTUBOEBSE&/*&$ t 8IFOVTJOHBOZBDDFTTPSJFTUPPMT EJTQPTBCMFTPSNBUFSJBMTUIBUXFSFJODPOUBDUXJUIUIFQBUJFOU UBLFQSPUFDUJWFNFBTVSFTUPQSFWFOU cross contamination. t 0OMZVTFMBTFSGJCFSTJOQFSGFDUDPOEJUJPOBOETUFSJMJ[FEBDDPSEJOHUPUIFSFTQFDUJWFPQFSBUJOHJOTUSVDUJPOT'PSSFVTBCMFMBTFSGJCFSTUIF cleaning and sterilization cycles indicated in the respective operating instructions must be complied with. Never use any damaged or contaminated laser fibers. t 0OMZVTF“single use” or “reusable” laser fibers approved by Boston Scientific with the Auriga XL Laser Console. The laser fibers may be subject to region-specific limitations and are therefore not approved and available everywhere. t 5IFPQFSBUPSNVTUFOTVSFUIBUQSPUFDUJWFNFBTVSFTBHBJOTUGJSFBOEFYQMPTJPOBSFUBLFOJODBTFPGNFEJDBMBQQMJDBUJPOPGMBTFS radiation in the area of organs, body cavities and tubes that may contain flammable gases or vapors. t %POPUVTFUIFMBTFSDPOTPMFJGUIFEJTQMBZJTOPUGVODUJPOBM EBSLPSPUIFSXJTFVODMFBS$IFDLJGUIFCSJHIUOFTTJOUIFEJTQMBZJTBEKVTUFE as desired. t %JTBTTFNCMFBMMBDDFTTPSJFT MBTFSQPXFSDBCMF GPPUQFEBM FUD CFGPSFUSBOTQPSUJOHUIF"VSJHB9--BTFS$POTPMF t 1VMMPSQVTIUIFDPOTPMFDBSFGVMMZVTJOHUIFJOUFOEFEIBOEMFEVSJOHUSBOTQPSUBUJPO t 5IFTFSWJDFBCMFMJGFPG"VSJHB9--BTFS$POTPMFJTMJNJUFEUPZFBST t )PMEUIFGJCFSUJQUPBOPOSFGMFDUJWFTVSGBDF BOEFOTVSFUIBUBDJSDVMBSHSFFOTQPUBQQFBST*GUIFTQPUJTXFBLPSOPUWJTJCMF EPOPUVTF and return the fiber to Boston Scientific for replacement. t 5IFTBGFUZEJTUBODF /0)% PGUIFXPSLJOHCFBNGPSUIFMBTFSGBDJMJUZEVSJOHVTFJOUIFOPSNBMTUBUF *&$ JTN t 5IFNJOJNVNCFBNEJWFSHFODFJTNSBE5IFNBYJNVNEFWJBUJPOPGUIFMBTFSQFSGPSNBODFJT5IFJNQVMTFEVSBUJPOTBSF between about 100 μs and 800 μs, depending on energy and application. t 5IFPQFSBUPSTIPVMEGPMMPXBMMTDSFFOQSPNQUTSFHBSEJOHTFSWJDJOHPGQBSUT4FF4FDUJPOGPSBMJTUPG&SSPSDPEFTUIBUJODMVEFUIF need for service.
6
Black (K) ΔE ≤5.0
User’s Manual
2.3 Eye Protection Wear the prescribed laser glasses in the laser area when using the console. Even a low power/weak laser beam can cause eye injury. o1SPUFDUFRVJQNFOU QBUJFOUBOEVTFSXJUIJOSBOHFPGUIFMBTFSGSPNEJSFDUPSJOEJSFDUSBEJBUJPOFYQPTVSF Within the operational area, every person must wear laser glasses or suitable eye protection to prevent eye injury. Prior to use, always check that the laser glasses are in perfect condition, i.e. they must not have any mechanical damage. The type stipulated in the following must be used. The laser glasses for the Auriga™ XL Laser Console must comply with at leastUIFGPMMPXJOHDPOEJUJPOT I 2100 nm L2 (pursuant to EN 207) Laser operating types I = Pulsed Laser
Wavelength at which the laser glasses have a protective function
Protective level
Laser glasses must be marked accordingly. Laser glasses with higher protection level (e.g. L2, L3,...) or laser glasses with a broadband filter with protection level L4 or more including the wavelength of 2100 nm may also be used. Never look right into the laser beam even while wearing laser glasses. If the patient is unable to wear laser glasses during the treatment because the treatment is performed in the area of the eye, other adequate protective measures must be taken, e.g. by using eye bowls. 2.4 Limitations of Application Please observe: The Auriga XL Laser System is tested pursuant to EN/IEC 60601-1-2 (EMC). For more, see chapter 7.3 Electromagnetic Compatibility. The Auriga XL Laser Console must only be used with accessories/tools approved by Boston Scientific. Every accessory is inspected and approved for use with the laser console by the manufacturer pursuant to EC directive 93/42/EEC. The Auriga XL Laser Console has IP20 protection against solid objects over 12.5mm (e.g. hand, large tools). The foot pedal has IPX8 protection again harmful ingress of water or particulate matter. WARNING: t 5PBWPJESJTLPGFMFDUSJDTIPDL FOTVSFUIBUUIFMBTFSQPXFSDBCMFJTGJSNMZJOTUBMMFEJOBTPDLFUXJUIBQSPUFDUJWFHSPVOE FYDMVTJWFMZ secured with at least 16 A). Do not use any multiple outlets. For connection requirements, see Chapter 3.1 Technical and Spatial Prerequisites. t 5IFSFJTBOJODSFBTFESJTLPGGJSFBOEPSFYQMPTJPOXIFOVTJOHMBTFSSBEJBUJPOJOBOPYZHFOFOSJDIFEPSGMBNNBCMFHBTFOWJSPONFOU The respective protective measures are to be taken. t 5IF"VSJHB9--BTFS4ZTUFNNVTUPOMZCFVTFEJOBMPDBUJPOXIJDINFFUTMPDBMSFRVJSFNFOUTGPSTBGFUZ t 5IFMBTFSTZTUFNXBTUFTUFEGPSFMFDUSPNBHOFUJDJOUFSGFSFODFTVQQSFTTJPO &MFDUSPNFDIBOJDBM%JTUVSCBODF&.4 BOE corresponds to all applicable EMS requirements. Nevertheless, interferences cannot be excluded completely. t t t
*UJTSFDPNNFOEFEUPVTFUIF"VSJHB9--BTFS4ZTUFNPOMZJOSPPNTXJUIBUFNQFSBUVSFPG¡$¡$ IVNJEJUZPG non-condensing and with pressure ranges of 795 - 1060 hPa. 5IF"VSJHB9--BTFS$POTPMFNVTUOPUCFPQFSBUFEBUBIJHIFSBMUJUVEFUIBONBCPWFTFBMFWFM 5IF"VSJHB9--BTFS$POTPMFXBTEFTJHOFEGPSJOUFSNJUUFOUPQFSBUJPO %VUZ$ZDMF BUMBTFSBOECSFBLUJNFGPSNJOVUFT At permanent operation, the maximum laser time without interruption should not exceed approx. 5 minutes. Operation beyond this may lead to an error message for overheating.
2.5 Product Label All laser console and products are labelled. NOTE: Observe the following: 1. All labeling must be clear and legible. 2. The signs must be clearly visible during operation and servicing. 3. Laser warning signs must be black on yellow.
User’s Manual
7
Black (K) ΔE ≤5.0
Console Type Label The manufacturer’s type sign is located on the back of the laser console. The warning icon on the type label indicates that the operating instructions must be observed when using the console
Foot pedal DANGER: VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT ACCORDING TO EN 60825-1:2007
DANGER: RAYONNEMENT LASER VISIBLE ET INVISIBLE EXPOSITION DANGEREUSE DE L’ŒIL OU DE LA PEAU AU RAYONNEMENT DIRECT OU DIFFUS APPAREIL À LASER DE CLASSE 4 SELON EN 60825-1:2007
LASER LASER CLASS 4
LASER LASER DE CLASSE 4
PILOT LASER CLASS 2
Fig. 1: IEC 60601-1 Symbol “Follow Instructions for Use”
Service interface and door contact plug notice sign on the rear The notice sign shows the connections for the door contact plug and the service interface (SISOP).
Laser warning sign on the rear of the Laser console The laser warning sign on the rear of the laser console supplies information on laser class, wavelength and laser radiation output to take the respective protective measures. Operational Instructions
65 W P2 < PP < 25 kW t = 100 - 800 μs F < 30 Hz O = 2,1 μm P2 < O =
1 mW 0,5 μm
PILOTE LASER DE CLASSE 2
65 W P2 < PP < 25 kW t = 100 – 800 μs F < 30 Hz O = 2,1 μm P2 < O =
Fig. 2: Warning and notice signs on the laser console
Door contact connection
1 mW 0,5 μm
Fig. 3: Notice sign foot pedal and door contact connection
The signs of Fig. 2 and 3 are placed on the back side of the laser unit, see 4.1. Laser exit aperture sign When connecting the laser fiber, the laser beam exits at the end of the laser fiber. Figure 4 is placed on the side near the laser fiber connecting point, see 4.1 Fig. 4: Laser exit aperture sign Avoid exposure - laser radiation is emitted from this aperture.
Laser emergency stop button sign In an emergency, press the Emergency Stop Button in order to immediately turn off the laser. Figure 5 is placed on the front of the unit on the emergency stop button. Fig. 5: Laser emergency stop button sign
The symbols of Fig. 4 are located on the side near the laser fiber connecting point, see 4.1.
Auriga XL ™
Auriga
™
XL
DANGER: VISIBLE AND INVISIBLE LASER RADIATION TO AVOID EYE OR SKIN EXPOSURE DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT ACCORDING TO EN 60825-1:2007
LASER LASER CLASS 4
PILOT LASER CLASS 2
65 W P2 < 25 kW PP < t = 100 - 800 μs 30 Hz F < 2,1 μm O = P2 < O =
1 mW 0,5 μm
LASER DANGER: RAYONNEMENT VISIBLE ET INVISIBLE EXPOSITION DE LA DANGEREUSE DE L’ŒIL OU DIRECT OU PEAU AU RAYONNEMENT DE DIFFUS APPAREIL À LASER CLASSE 4 SELON EN 60825-1:2007
LASER LASER DE CLASSE 4
PILOTE LASER DE CLASSE 2
65 W P2 < 25 kW PP < t = 100 – 800 μs 30 Hz F < 2,1 μm O = P2 < O =
1 mW 0,5 μm
Auriga™ XL/4007 REF
Catalog No.
GTIN Date of
M006830G0
08714729894247 YYYY-MM-DD
Manufacture
SN
Serial Number
12345678
3 kW) Hz max. 16 A (max 220 V - 240 V ~ 50 (max 3 kW) 60 Hz max. 16 A 220 V ~ 1 - Schutzklasse Class 1 equipment
GS1 (01)08714729894247(11)YYMMDD(21)12345678 Consult CAUTION. Attention: ACCOMPANYING DOCUMENTS. Consult CAUTION. Attention: ACCOMPANYING DOCUMENTS. Attention : Lire les
AVERTISSEMENT. documents joints.
Follow Instructions For Use
more patents. Patent protected by one or This product may be obtained at http://www.bostonscientific.com/patents information can be
Legal Manufacturer
SAFE WORKING
Corporation Boston Scientific Way 300 Boston Scientific 01752 Marlborough, MA USA 888-272-1001 USA Customer Service
150 Baytech Dr. San Jose, CA 95134
EC
REP
Boston Scientific Limited Park Ballybrit Business Galway IRELAND
Fig. 6: labelling on front side of Auriga™ XL Laser Console
LOAD = 90 kg
IP20
Type BF Applied Part
EU Authorized Representative
0086 9116xxxxx-01
Fig. 7: labelling on back side of Auriga XL Laser Console
3 TECHNICAL PREREQUISITES AND COMMISSIONING 3.1 Technical and Spatial Prerequisites The electrical installation of the room in which the Auriga XL Laser Console is operated must correspond to the regional requirements and specifications. The required sockets must be installed firmly and wired correctly. The Auriga XL Laser Console must be separately secured so the unit does not inadvertently roll. Electrical fuses used must have a line circuit breaker type C16 A or higher.
8
Black (K) ΔE ≤5.0
User’s Manual
To warrant sufficient cooling, the air supply should be as unhindered as possible to the front and side, and the same applies to the exhaust to the rear. At least 15 cm clearance is required for air supply or removal at the side. Observe sufficient ventilation of the treatment room. Due to the laser’s heat output, ventilation of at least 200 m³/h is recommended. 3.2 Commissioning The user also must verify that the laser console is functionally safe and in proper working order and condition before using it. t $IFDLMBTFSDPOTPMF BDDFTTPSJFTBOEDPOOFDUJPOMJOFTGPSWJTJCMFEFGFDUT t 5IFMBTFSDBOOPUCFPQFSBUFEXJUIPVUBOZDPOOFDUFEMBTFSGJCFST t 3FMFBTFUIFMBTFSFNFSHFODZTUPQTXJUDIJGJUXBTQSFTTFECZUVSOJOHUIFSFECVUUPODMPDLXJTF t $PNQMZXJUIUIFSFHJPOBMTBGFUZQSPWJTJPOTUIBUBQQMZGPSZPVSSFTQFDUJWFMPDBUJPODPVOUSZ5IJTJOTUSVNFOUTIPVMECFJOTUBMMFE BOEPQFSBUFEBDDPSEJOHUP$"/$4";-BTFSTBGFUZJOIFBMUIDBSFGBDJMJUJFT Connect the foot pedal to the socket at the lower right of the back of the console (refer to fig 10). Connect the door contact plug to the socket at the lower right of the rear of the console (refer to fig 10). Install the required laser fiber to the laser console. See Chapter 5.1 Installation of the Laser fiber and the operating instructions for the laser fiber. WARNING: t &OTVSFMBTFSQPXFSDBCMF GPPUBOEEPPSDPOUBDUTXJUDI BTXFMMBTUIFMBTFSGJCFSTBSFTFDVSFTPUIFSFJTOP danger of tripping or other accidental injury to any persons in the room or damage to the equipment. 3.3 Laser Area Signs According to EN/IEC 60825, the current warning signs must be attached to all access doors in the laser treatment room at eye level. Additionally to the warning signs, warning lamps must be installed according to the respective applicable statutory provisions. Fig. 8: Laser area sign 4 DEVICE DESCRIPTION 4.1 Basic Laser Console
Auriga XL ™
Laser emergency Stop switch
Connection for laser fiber Auriga
™
XL
Key switch Warning signs laser exit aperture
Fig. 9: Laser Console
User’s Manual
9
Black (K) ΔE ≤5.0
Type label
Service interface
Auriga™ XL/4007 REF
Catalog No.
GTIN SN
Console mains switch
M006830G0
08714729894247
Date of Manufacture
YYYY-MM-DD
Serial Number
12345678
220 V - 240 V ~ 50 Hz max. 16 A (max 3 kW) 220 V ~ 60 Hz max. 16 A (max 3 kW) Class 1 equipment - Schutzklasse 1
(01)08714729894247(11)YYMMDD(21)12345678
GS1
CAUTION. Attention: Consult ACCOMPANYING DOCUMENTS. CAUTION. Attention: Consult ACCOMPANYING DOCUMENTS. AVERTISSEMENT. Attention : Lire les documents joints.
Follow Instructions For Use
Foot pedal connection
This product may be protected by one or more patents. Patent information can be obtained at http://www.bostonscientific.com/patents
Laser power cable connection
Legal Manufacturer
SAFE WORKING LOAD = 90 kg
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA USA Customer Service 888-272-1001
150 Baytech Dr. San Jose, CA 95134
EC
REP
IP20
Door contact connection
Type BF Applied Part
EU Authorized Representative
Boston Scientific Limited Ballybrit Business Park Galway IRELAND
0086 9116xxxxx-01
Figure 10. Rear of Auriga™ XL Laser Basic Device Caution: t 5IFTFSWJDFJOUFSGBDFNVTUPOMZCFVTFECZBVUIPSJ[FEUFDIOJDJBOTPG#PTUPO4DJFOUJGJD5IFTFSWJDFNBOVBMJTEPDVNFOUFEQFS 4.2 Switching Elements and Interfaces Laser emergency stop switch The laser emergency stop switch is used for immediate switching off the laser emission. The switch is triggered by pressing the red button on the front of the device. When the switch is triggered, it must be released before the console can be switched back on. To release the switch turn it clockwise. When the switch is depressed, the console cannot be switched on. When the laser emergency stop switch is pressed, power supply to the console is not interrupted. This is only achieved by operating the console’s main switch on the rear of the console.
Key switch 5IFLFZTXJUDIJTVTFEGPSTXJUDIJOHUIFMBTFSDPOTPMFPOBOEPGG5IFLFZTXJUDIIBTUISFFQPTJUJPOT 0'' 0/ 45"35 Secure the console against unauthorized use by taking out the key. Foot pedal connection Socket for connecting the foot pedal. Foot pedal The foot pedal is used to trigger laser emission. Connection of the laser fiber The laser fiber is connected via a SMA 905 connection. The Auriga XL Laser Console must only be operated with laser fibers that were specified by Boston Scientific. The laser fibers must be recognized by the console. Electronic verification ensures that only the parameters permissible for this laser fiber type can be set and that the laser fibers cannot be used exceeding their specification. Unsupported laser fibers will not be accepted by laser console. Console mains switch The console mains switch (on the rear of the Laser console) is used for powering on and off the laser. After switching on the console mains switch, the power supply is ready for operation and the console can be started by using the key switch. The symbols on the switch indicate if the switch is on or off. The console is only powered down when the console mains switch is switched off. Door contact connection The door contact connection of the console can be connected to a door contact. It will interrupt laser emission when the door is open. When there is no door contact to be connected, connect the door contact plug to bypass safety interlock. Laser power cable connection Connect the included laser power cable to the mains adapter. It must only be used with the laser power cable specified in Chapter 7.3 Electromagnetic Compatibility.
WARNING: t 5PBWPJEUIFSJTLPGFMFDUSJDTIPDL UIJTFRVJQNFOUNVTUPOMZCFDPOOFDUFEUPBTVQQMZNBJOTXJUIQSPUFDUJWFFBSUI
10
Black (K) ΔE ≤5.0
User’s Manual
4.3 Display
The display unit is a touch screen unit that offers information output as well as input. The round operating buttons are used for input.
Fig. 11: Display NOTE: Do not touch the surface of the touch screen with any sharp or unclean objects. This leads to poor image quality or damage to the surface. 5 OPERATION AND APPLICATION 5.1 Installation of the Laser fiber For the specified and approved laser fibers, see Chapter 6.1. Accessories/Tools. Caution: t 5PQSFWFOUEBNBHFEVSJOHVTF SFGFSUPUIFBQQMJDBCMFGJCFS%'6GPSNJOJNVNCFOEJOHSBEJVT/PUGPMMPXJOHUIJTSFDPNNFOEBUJPONBZ lead to damage to the fiber including exposure to laser radiation. t %POPUPQFSBUFMBTFSDPOTPMFXJUIEBNBHFEMBTFSGJCFS t 6TFPGDPOUSPMTPSBEKVTUNFOUTPSQFSGPSNBODFPGQSPDFEVSFTPUIFSUIBOUIPTFTQFDJGJFEIFSFJONBZSFTVMUJOIB[BSEPVTSBEJBUJPOFYQPTVSF t 0CTFSWFUIFJOTUBMMBUJPOBOEXPSLJOTUSVDUJPOTQSFTFOUFEJOUIFPQFSBUJOHJOTUSVDUJPOTGPSUIFSFTQFDUJWFMBTFSGJCFST *OHFOFSBM UIFQSPDFTTJTBTGPMMPXT 1. Verify sterile package integrity. 2. Remove the sterilized laser fiber from the packaging shortly before use and place it on a sterile surface. NOTE: The fiber is fragile and must be carefully manipulated prior to and during use. 3. Remove the protective cap from the laser fiber and keep it safe. 4. Before use, inspect the laser fiber to confirm it has no breaks or sharp edges or bends. Insertion of sharply bended or improperly secured laser fiber may lead to damage to the laser fiber or the laser console and/or harm the patient and/or the laser operator. Prior to installation, remove the fiber connector cap on the front of the console. 5. Install the laser fiber at the laser console and switch on the console. Be sure to fully engage the fiber connector into the console connector receptacle to ensure proper operation of the laser system. 6. The diameter of the laser fiber used is set by automatic fiber identification in the display. Please verify that the indicated diameter of the laser fiber corresponds to the plugged-in laser fiber. 7. Laser fibers that are only approved for one-time use are automatically locked in case of reuse. 8. Verify that the pilot beam is visible, nearly circular and homogenous by pointing the laser fiber on a level, light surface (e.g. white paper). 5.2 Disassembly of the Laser fiber 1. Switch off the laser console with the console mains switch. 2. Remove the laser fiber from the laser console. 3. Put a protective cap on the laser fiber. Dispose of single use laser fibers in their packaging. Clean, disinfect, package and sterilize reusable laser fibers (not approved and available everywhere) according to provisions. 4. Replace the fiber connector cap on the front of the console. NOTE: Management of single-use laser fibers Single-use laser fibers are one time use only and deactivated once the foot pedal is depressed. 4JOHMFVTFMBTFSGJCFSTDBOOPMPOHFSCFVTFEJG t -BTFSGJCFSJTUIFOSFNPWFE FWFOBDDJEFOUBMMZ t -BTFSDPOTPMFTXJUDIFEPGG t 5IFMBTFSFNFSHFODZPGGCVUUPOJTQSFTTFE
User’s Manual
11
Black (K) ΔE ≤5.0
5.3 Switching on the console Switch on the laser console with the console mains switch. Plug the key in the key switch and turn it clockwise to the stop position. Keep the key in this position until the start-up screen with the company logo appears on the device display. During start-up, the laser console performs a system test. After passing through the test routines, the console automatically switches to the main menu. When the console is switched on and the console test is then performed, no changes must be made to the system (do not press foot pedal, do not touch the touch screen, do not press any switch, do not connect or disconnect laser fibers). NOTE: The laser emergency stop switch must not be pressed. Release the laser emergency stop switch by turning the red knob clockwise. At first switching on of the console (commissioning) and when restarting after resetting the console to “factory settings”, the language must be selected. The language settings are made on the configuration level. 5.4 Main Menu
After the console is switched on, the following message appears during the start-up system tests.
Fig. 12: Message during self-tests
After this, the BSC logo is displayed during the system test.
Fig. 13: Company logo during self-test When the reusable laser fiber is connected, a message is displayed indicating how often the laser fiber has already been used. The number of usage cycles for the laser fiber is incremented by one the first time the foot pedal is activated. For the maximum number of usage cycles, please consult the operating instructions.
Please confirm this message by touching the “OK” icon . Then the main menu appears.
Fig. 14: Number of usage cycles for the connected applicator
12
Black (K) ΔE ≤5.0
User’s Manual
, you can access By pressing the configuration button the configuration menu (setup), where the basic console settings can be changed. If a valid laser fiber is connected, press the application button
Fig. 15: Main menu
on the screen to call the application menu (fig. 16). 5IFSF ZPVDBOTFUBOEBDUJWBUFUIFUSFBUNFOUNPEFTMJUIPUSJQTZ ablation or coagulation. The selection field for LITT mode is displayed greyed out because special laser fibers are required for it. If the application menu cannot be called, check the laser fiber and replace it if required Now the screen displays the selections in the application menu.
Tap the desired treatment mode to get to the application menu
Fig. 16: Application selection menu
This pictogram symbolizes the lithotripsy function. Please tap this button in order to perform lithotripsy treatments.
This pictogram symbolizes the ablation (cutting) function. Please tap this button in order to perform ablation treatments
This pictogram symbolizes the coagulation function. Please tap this button in order to perform coagulation treatments.
This pictogram symbolizes the LITT (Laser Induced Thermo Therapy) function. Please tap this button in order to perform LITT treatments. The LITT function requires an especially designed laser fiber. Unless such a fiber is connected to the laser unit, the LITT button is not selectable. The LITT fiber is not available in all countries (for example USA).
5.5 Application Menu
In the application menu, you can select all relevant parameters for the laser application and any required submenus. The device can also be switched from “STANDBY” to “READY”.
Fig. 17: Application menu in STANDBY mode
User’s Manual
13
Black (K) ΔE ≤5.0
Overview: -FGUBQQMJDBUJPONFOVTJEF - On the left, there are the navigation icons to select the menu levels. $FOUFSBOESJHIUPGUIFBQQMJDBUJPONFOVTJEF - At the upper right, the laser can be switched from STANDBY to READY and back. - Below it (blue display), the pulse sequence frequency is set. - At the center you can see information on the size of the fiber used and the selected treatment mode. - The bottom one (green display) sets the pulse energy (depending on the frequency set). Use the arrows right/left to change the laser settings. The selected settings appear as numbers and graphical display between the arrow icons. Operating buttons: Use the button “Home”
to go back to the main menu and the button “back“
Use the button “Pilot laser”
to move up one menu level.
to call the submenu for setting the pilot laser.
Use the setting buttons “left” and “right” to set the laser output. Press the respective button to change the pulse energy or pulse frequency upwards or downwards by one level. The currently set laser output is indicated numerically as an exact value and graphically between the setting buttons. Parameters or menus can only be changed during STANDBY mode. Use the laser button
to switch from STANDBY to READY mode or to return the device from READY to STANDBY mode.
The current setting can be stored or a stored setting called by tapping the
memory button.
Only in READY mode can the foot pedal be used to activate laser emission. While the foot pedal is pressed, the Auriga™ XL Laser Console emits laser radiation at the indicated parameters. In READY mode (laser not activated by the foot pedal), any touch of the screen will return the device to STANDBY mode. While the laser emission is triggered by the foot pedal, no entry can be made on the screen.
Fig. 18: Application menu in READY mode
5.6 LITT
Fig. 19: Application menu in READY mode
14
Black (K) ΔE ≤5.0
In the LITT application menu (LITT = laser-induced-thermotherapy), you can select all relevant parameters for the laser application and any other submenus where applicable. The device can also be switched from “STANDBY” to “READY”. In the application menu, you can select all relevant parameters for the laser application and any other submenus where applicable. The device can also be switched from “STANDBY” to “READY”. The LITT application menu can only be used when a LightTrail side-fire LITT laser fiber is connected to the Auriga XL Laser Console. LITT is used to coagulate tissue internally. In order to do so, the LITT is inserted and positioned in the tissue. Depending on the program and application duration, the necrosis zone is circular around the tip of the LightTrail side-fire LITT laser fiber. Depending on regulations, The LightTrail side-fire LITT is not available in all countries.
User’s Manual
Overview: -FGUTJEFPGUIFBQQMJDBUJPONFOV - The navigation icons to select other menu levels appear on the left side. $FOUFSBOESJHIUTJEFPGUIFBQQMJDBUJPOTDSFFO - At the upper right, the laser can be switched from STANDBY to READY and back. - Below that (blue display), the 3 LITT programs can be selected. t N+ )[ t N+ )[ t N+ )[ - Information about the chosen treatment mode and the parameters of the program selected in the line above that (blue) is displayed in the center. - The number of pulse applications (10 to 1000) is entered in the line at the bottom (green display). The ∞ setting permits the application of any number of pulses. When the number of pulses is specified, the laser applies the number of pulses entered when it is activated and then switches off automatically. Use the arrows right/left to change the laser settings. The selected settings appear as numbers and graphical display between the arrow icons. Operating Icons: Use the “Home” icon
to go directly back to the main menu and the “Back“
Use the “Aiming beam” icon
to move up one menu level.
to call the submenu for setting the aiming beam.
NOTE: As the AIMING BEAM passes down the same delivery system as the WORKING BEAM it provides a good means of checking the integrity of the delivery system. If the AIMING BEAM is not present at the distal end of the delivery system, its intensity is reduced or it looks diffused, this is a possible indication of a damaged or malfunctioning delivery system. and “Right” Use the “Left” setting icons to select the program in the upper (blue) line. In addition to any number (∞) of pulses, a specific number of pulses (10 to 1000) can also be specified in the line at the bottom. Touch the respective icon to move upwards or downwards by one level. 5.7 Triggering Laser Impulses
In the READY state, the laser can be activated by pressing UIFGPPUQFEBMMBTFSSBEJBUJPOJTFNJUUFEBDDPSEJOHUPUIF parameters set. The display shows the laser warning icons and the word "LASER". When the laser is active (foot pedal pressed), no changes can be made at the screen. When the device is activated by the foot pedal and laser radiation is emitted, the laser warning signs and the word "LASER" appear in the display.
Fig. 20: Application menu while laser pulses are emitted Caution: t *OUIF3&"%:TUBUF UIFMBTFSDBOCFUSJHHFSFECZBDDJEFOUBMMZQSFTTJOHUIFGPPUQFEBM'PSSFBTPOTPGTBGFUZ UIFMBTFSDPOTPMFTIPVME be switched from READY to STANDBY in treatment breaks. t *GUIFMBTFSJTOPUBDUJWBUFEJO3&"%:NPEFGPSBCPVUNJOVUFT UIFMBTFSBVUPNBUJDBMMZTXJUDIFTCBDLUP45"/%#:NPEFGPS safety reasons. t #ZQSFTTJOHUIF-"4&3CVUUPOBHBJO UIFMBTFSJTUBLFOCBDLJOUP3&"%:NPEF NOTE: READY mode cannot be activated if any error messages are present on the screen. NOTE: Ensure laser fiber is directed to the treatment location prior to triggering the laser emission. If using the fiber with an endoscope, be sure to pass the fiber tip beyond the opening of the working channel until you see it clearly in your visual field to prevent damage to the endoscope.
User’s Manual
15
Black (K) ΔE ≤5.0
5.8 Submenus 5.8.1 Memory Submenu
Fig. 21: Memory Page - Parameter input
memory button to save and call The user can tap the icon treatment parameters The device has four memory slots for each treatment mode and for every fiber size that can be assigned to treatment parameters by the user. If no parameters were stored, the screen appears as displayed in fig.21. The combination of pulse energy and pulse frequency currently set in the application menu can now be stored. If all memory slots are assigned already, the selected memory slot is overwritten. For this, the desired memory slot must be selected by tapping one of the numbered buttons. In fig.22, memory slot no. 1 was selected as an example.
Tap the "save" button (fig. 22) parameter.
to store the treatment
A button that displays a keyboard when tapped appears next to the memory slot (fig.23). It can be used to assign a comment to the stored measured value (fig.24).
Fig. 22: Memory Page - Memory slot selection
Fig. 23: Memory Page - Comment input
Touch the “Keyboard Change” icon numeric keyboard, ref. Fig. 25..
to display the
Fig. 24: Memory Page - Comment input
16
Black (K) ΔE ≤5.0
User’s Manual
Touch the “Keyboard Change” icon alphabetic keyboard, ref. Fig. 24.
to display the
to accept the entered comment. Press the "OK" button The keyboard disappears and the display is as indicated in fig.26. Press the "OK" button parameter.
Fig. 25: Memory screen - entering comments (numeric keyboard)
again to save the treatment
in the application menu to call Tap the memory button treatment parameters that were already stored. Now the desired treatment parameter can be selected by tapping the numbered button. The button is framed in color (fig.26).
Tap the load button to load the selected treatment parameter and return the display to the application menu. After selection of a memory slot, the comment can be changed subsequently as well. Proceed as if assigning a comment.
Fig. 26: Memory Page - Selection of stored treatment parameters 5.8.2 Pilot Laser Submenu Press the pilot laser button (see fig. 17).
in the application menu
In the pilot laser submenu, you can set the pilot laser brightness. Press the setting buttons "left“ or "right", to adjust pilot laser brightness from 0 to 100%. Press the "OK" button to "Back“ button Fig. 27: Pilot Laser Submenu
TUPSFUIFWBMVFTFU QSFTTUIF
to return to the application menu without
TUPSJOHUIFOFXMZTFUWBMVF VTFUIF)PNFCVUUPO return to the main menu.
to
5.8.3 Configuration Menu (Setup)
Press the configuration button in the main menu (see fig. 15) to call the configuration menu (setup).
Fig. 28: Configuration menu
User’s Manual
17
Black (K) ΔE ≤5.0
)FSFZPVDBODBMMUIFGPMMPXJOHCBTJDJOGPSNBUJPOPSTFUUJOHT
Call treatment log
Adjust screen settings
Reset to factory settings
Set language
Set volume
Call error list
Set date and time
View device information
Access to the service level (only for authorized service personnel)
5.8.4 Language Settings
Use the navigation arrows to select the respective language Use the
button to activate the selected language.
Fig. 29: Set language 5.8.5 Treatment Log
This menu item can be used to recall the last 15 treatment logs. The logs are drawn up automatically.
Fig. 30: Treatment log
5IFGPMMPXJOHJTEJTQMBZFE - Treatment Log Number,
- Total energy,-
- Date,
- Max. Energy,
- Starting time (first activation of laser by foot pedal),
- Fiber Counter (The number of fiber usages from the beginning of the operation),
- Fiber used,
- Fiber ID,
- Treatment duration (activation by foot pedal to fiber change or switching off of the Auriga™ XL Laser),
- Number of pulses.
- Laser-on-time (time duration for which the Laser was active and emitted laser radiation),
18
Black (K) ΔE ≤5.0
User’s Manual
5.8.6 Setting date and time
This menu item is used to adjust date and time. Touch the hours display to activate it and give it a grey background. Use the arrow buttons to change the hour display. The same procedure can be used to set the minutes, year, month and day. The newly set values are confirmed and accepted with the button. Fig. 31: Date and time 5.8.7 Screen Settings
This menu item adjusts screen brightness. Changes must be confirmed by the
button.
Fig. 32: Screen settings 5.8.8 Volume Settings
The volume of the acoustic warning signal can be adjusted from 0% to 100% within the permissible range. Loudspeaker volume should be adjusted depending of ambient noises. Acoustic warning signal should be recognizable during the whole procedure. Changes must be confirmed by the
button.
Fig. 33: Volume settings
User’s Manual
19
Black (K) ΔE ≤5.0
5.8.9 View Device Information
5IJTQBHFEJTQMBZTEBUBBOEJOGPSNBUJPO4FSJBM/P 481BDLBHF Version, Min. Terminal version, Mainboard Revision and Flash lamp usage
Fig. 34: Device Info 5.8.10 Reset to factory settings
In this menu item, the user can reset the device to the factory settings. button. It sets all the Changes must be confirmed by the WBMVFTUPGBDUPSZEFGBVMUWBMVFTBTQFSGPMMPXJOH - Audio to 40%, - Display brightness to 80%. - Local date to the system date. - Selected language to “English”. Fig. 35: Reset to factory settings
- Deletion of all memory entries for all laser fibers and applications.
5.8.11 Call Error History
On this page, error codes and error-relevant data can be viewed.
Fig. 36: Error History 5.8.12 Access to the service level (authorized service personnel only)
Only available to authorized service personnel
Fig. 37: Service Access
20
Black (K) ΔE ≤5.0
User’s Manual
5.9 Switching off the console 5IFMBTFSDPOTPMFJTTXJUDIFEPGGCZUVSOJOHUIFLFZTXJUDIDPVOUFSDMPDLXJTF UIFEJTQMBZHPFTPVU8FSFDPNNFOEUIBUUIFEFWJDF then be disconnected from the mains by the console mains switch. Caution: t /FWFSMFBWFUIFEFWJDFTXJUDIFEPOXJUIPVUTVQFSWJTJPO4FDVSFUIFEFWJDFBHBJOTUVOBVUIPSJ[FEVTFCZSFNPWJOHUIFLFZGSPN the key switch. Caution: Laser emergency stop switch t 5IFMBTFSFNFSHFODZTUPQTXJUDIJTPOMZJOUFOEFEGPSFNFSHFODJFTEVSJOHOPSNBMPQFSBUJPO t 1SFTTUIFMBTFSFNFSHFODZTUPQTXJUDIUPTXJUDIPGGMBTFSFNJTTJPOJNNFEJBUFMZ t *GUIFMBTFSFNFSHFODZTXJUDIXBTPQFSBUFE FOTVSFCFGPSFSFTUBSUUIBUUIFMBTFSFNFSHFODZTUPQTXJUDIXBTSFMFBTFECZUVSOJOHUIF red knob clockwise. 5.10 Cleaning and Maintenance Cleaning the Console Caution: t "MXBZTDMFBOBOEEJTJOGFDUXJUIUIFMBTFSQPXFSDBCMFSFNPWFE t 5PBWPJEUIFQPUFOUJBMGPSFMFDUSJDTIPDL EJTDPOOFDUUIFMBTFSQPXFSDBCMFGSPNUIFFMFDUSJDBMPVUMFUCFGPSFDMFBOJOHUIFDPOTPMF t 5IFDPOTPMFBOEBMMBDDFTTPSJFTUPPMTNBZCFDMFBOFEXJUINJME OPOBCSBTJWFDMFBOJOHTPMVUJPOTDPNNPOMZVTFEJOUIFIPTQJUBM FOWJSPONFOU5IFDPOTPMFJTDPNQBUJCMFXJUIUIFGPMMPXJOHDMFBOJOHTPMVUJPOT t *TPQSPQZMBMDPIPM t "NNPOJVN$IMPSJEF t 4PEJVN)ZQPDIMPSJUF t %POPUTQSBZUIFEJTQMBZTDSFFOXJUIDMFBOJOHTPMVUJPO"QQMZUIFDMFBOJOHTPMVUJPOUPBDMFBOJOHDMPUIBOEXJQFBMMFYUFSOBMTVSGBDFT t 5PBWPJEDPOTPMFEBNBHF EPOPUBMMPXGMVJETUPFOUFSUIFDPOTPMF QPXFSDBCMFDPOOFDUJPOT DPOOFDUPSDBCMFSFDFQUBDMF PSPUIFS component/accessory connections. t 6TJOHDMFBOFSTBOEEJTJOGFDUBOUTPMVUJPOTUIBUDPOUBJOMPOHMJGFTVSGBDUBOUTDBOMFBWFDPOEVDUJWFSFTJEVFTPOUIFDPOUBDUTJOUIF console. To prevent electrical malfunctions due to conductive residue buildup on the contacts, do not use cleaners and disinfectant solutions that contain long-life surfactants. t 5IFTPMWFOUTPGBEIFTJWFTBOEPSGMBNNBCMFTPMVUJPOTVTFEGPSDMFBOJOHBOEEJTJOGFDUJPOTIPVMECFBMMPXFEUPFWBQPSBUFCFGPSFUIFMBTFS equipment is used. Attention should be drawn to the danger of ignition of endogenous gases. t "HHSFTTJWFDMFBOJOHBHFOUT TVDIBTBCSBTJWFTBOE BDFUPOFPSBDJEJDDMFBOJOHBHFOUTNBZDBVTFEBNBHFUPUIFEFWJDFTVSGBDFT display and labels and must not be used. t 8IFODMFBOJOHUIFEFWJDF FOTVSFUIBUOPMJRVJEXJMMHFUJOUPUIFJOTJEFPGUIFEFWJDF5IJTNBZMFBEUPJOUFSGFSFODF 5.11 Transport, Storage and Operating conditions 5IF"VSJHB9--BTFS$POTPMFDBOCFTUPSFEBOEUSBOTQPSUFEBUUFNQFSBUVSFTPG ¡$ ¡$ SFMIVNJEJUZPG OPODPOEFOTJOH and an air pressure of 700 hPa to 1060 hPa. 5IF"VSJHB9--BTFS$POTPMFDBOCFPQFSBUFEBUUFNQFSBUVSFTPG¡$¡$ SFMIVNJEJUZPG OPODPOEFOTJOH BOEBOBJS pressure of 795 hPa to 1060 hPa. Caution: t $POEFOTBUJPOBUUIFMBTFSEVSJOHPQFSBUJPONBZDBVTFEBNBHFUPUIFDPOTPMF"MXBZTBMMPXFYDFTTJWFMZDPMEEFWJDFTUPBEKVTUUPUIF required environmental conditions in the treatment room for several hours before treatment. t #FGPSFUSBOTQPSUPSQBDLBHJOHPGUIF"VSJHB9--BTFS$POTPMFT SFNPWFBMMBDDFTTPSJFTUPPMT 'JCFS4USJQQFS %JBNPOE'JCFS$VUUFS Laser Glasses, Foot Pedal, Laser Power Cable) from the console. The device must only be packaged in the packaging approved by Boston Scientific Corporation.
User’s Manual
21
Black (K) ΔE ≤5.0