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Support Materials

To help you and your staff organize the operation and management related

to the GreenLight HPS™ laser system, Laserscope has developed a package
of practice assistance documents

Listed below are the forms that are

included in this chapter. For printing and customizing purposes, the forms
are also included on the CD supplied with this manual.

•

Clinical Competency Check List

•

Equipment Check List (OR equipment needed for the procedure)

•

Laser Log (Check list and log for operation of the GreenLight
HPS™ Laser System)

•

Operative Record Template. (The document is a template and
must be customized for each individual patient treatment. The
document must not be used as a preprinted operative record.)

•

Pre-Procedural Patient Instructions

•

General Post-Procedural Instructions for Patients

Warr

Support Materials 36

Содержание GreenLight HPS

Страница 1: ...Laser Operator s Manual Manufactured by 3070 Orchard Drive San Jose CA 95134 800 356 7600 1 408 943 0636...

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Страница 3: ...lity 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...

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Страница 5: ...m 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...

Страница 6: ...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...

Страница 7: ...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 Section 4 Physician Information...

Страница 8: ...e 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...

Страница 9: ...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...

Страница 10: ...tions 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...

Страница 11: ...ht 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 transmissi...

Страница 12: ...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 porti...

Страница 13: ...on 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 accessib...

Страница 14: ...l 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 Res...

Страница 15: ...afe 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...

Страница 16: ...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 an...

Страница 17: ...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 us...

Страница 18: ...e 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 l...

Страница 19: ...d 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 Pf...

Страница 20: ...er 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 An on board microprocessor...

Страница 21: ...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 regulation...

Страница 22: ...nce 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 whic...

Страница 23: ...l labels on the laser unit The actual labels used in these locations are also shown LASER APERTURE AT END OF DELIVERY DEVICE Attention Consult Accompanying Documentation International Figure S 2 Label...

Страница 24: ...LOCK SAFETY AND COOLING SYSTEM PROTECTION FILL COOLING SYSTEM WITH 100 D I WATER ONLY F I L L CAUTION CAUTION SAFETY AND COOLING SYSTEM PROTECTION FILL COOLING SYSTEM WITH 100 D I OR DISTILLED WATER O...

Страница 25: ...ser system features a Plug and Play capability that self adjusts to the facility s individual voltage requirements eliminating the need for electrical modifications The laser system also consists of a...

Страница 26: ...r s Manual 1 Display Touch screen 2 Card reader 3 Data Port 4 Storage Compartment 5 Fiber Shield 6 Fiber pole 7 Fiber Optic Port 8 Emergency Laser Stop Button 9 ON OFF Key Switch Figure 1 1 Front View...

Страница 27: ...l Joule meter displays total number of Joules delivered Exposure time displays total time light is emitted Button to arm and disarm the laser Error codes and screen prompts 2 Card Reader Reads fiber c...

Страница 28: ...ook 4 Footswitch 12 Remote Interlock Socket Storage Hook 5 Lower Footswitch Cord Storage Hook 6 Upper Power Cord Storage Hook 7 Coolant Reservoir Fill 13 Electrical Connection 8 Coolant Drain 14 Circu...

Страница 29: ...lant Refill Instructions 8 Coolant Drain for draining the internal cooling liquid see section 5 2 Coolant Refill Instructions 9 Lower Power Cord Storage Hook 2 lower hooks for coiling power cord 10 Re...

Страница 30: ...y GreenLight HPS Fiber Optic Specifications Fiber size 600 microns Fiber length 12 feet 3 66m Laser beam Side fire Sterilization Single use Fiber Optic Handling Guidelines If the tip of the fiber accu...

Страница 31: ...eatment site The tip of the GreenLight HPS fiber should be in clear view and extended approximately 1 to 2 cm beyond the distal end of the endoscope The output beam of the fiber is aligned with the ra...

Страница 32: ...The GreenLight HPS fiber should be stored under ambient conditions WARRANTY The warranty for the GreenLight fiber optic covers only defects in the material and workmanship Should you need to return t...

Страница 33: ...tion site the representative will perform the following 1 Verify appropriate power 2 Uncrate the system and inspect for damage 3 Perform all optical electronic and system checks necessary to bring the...

Страница 34: ...ht 43 25 109 9 POWER REQUIREMENTS The power source for the GreenLight HPS laser system must be 200 208 220 230 or 240 VAC 30 Amp 50 60 Hz The laser will automatically adjust to the voltage and frequen...

Страница 35: ...e system is changed from STANDBY to READY and the surgical beam is activated by pressing the foot pedal Press the yellow pedal for VAPOR and the blue pedal for COAG Power is set by touching the or but...

Страница 36: ...following procedure is recommended for system start up 1 Confirm the system circuit breaker is in the OFF position to prevent a power surge to the system 2 Connect the power cord to the wall outlet 3...

Страница 37: ...s of self tests When the tests are completed the following screen will be displayed 6 Located inside of each fiber box attached to the sterile fiber pouch is a fiber card Insert the card into the card...

Страница 38: ...lowing screen will appear 8 To select the treatment parameters adjust the power by touching or under the VAPOR and COAG indicators 9 The laser system has both an automatic joule counter and a lasing t...

Страница 39: ...ill re appear 12 To change the system s settings touch press for Set Up at the bottom of the main screen The following screen will appear 13 Adjust the desired setting by touching the or indicators Pr...

Страница 40: ...rd during an emission The system will return to STANDBY mode after two minutes without any exposures To go back to STANDBY press STANDBY or step on the Ready Standby footswitch 16 Treatment power may...

Страница 41: ...rted The GreenLight HPS fiber can be used up to the energy limit printed on the seal of the fiber package The user is alerted by an audible tone and a screen message when less then 50 000 joules remai...

Страница 42: ...e tone will alert the user when 50 000 joules of usage remain on the fiber The remaining energy will be displayed on the screen 2 The following message will appear on the screen when the user lifts th...

Страница 43: ...s and lasing time remaining will be displayed 4 To get the laser into Ready Mode press the Ready Standby button 5 The following message will appear when the energy limit has been reached 6 To continue...

Страница 44: ...was used 4 Turn the Keyswitch to the OFF position and remove the key Store the key in a safe place 5 Coil the footswitch cable around the designated hooks and hang foot switch onto the rear panel of t...

Страница 45: ...atment of benign prostatic hypertrophy hyperplasia BPH The device is not intended to treat prostate cancer The laser system has also been cleared for use on various other soft tissue applications incl...

Страница 46: ...ists a culture should be taken and other appropriate evaluations made Perforation Perforation can occur as a result of excessive exposure to laser radiation Perforation can also occur from tumor erosi...

Страница 47: ...e potential for re treatment and shortness of breath Use of lower power levels and shorter exposure times are required in order to prevent thermal damage to underlying structures for example to thin w...

Страница 48: ...ficulty with previous endoscopic cystoscopic procedures Extra precaution should be taken when radiation therapy and laser therapy are to be used concurrently including more stringent post operative mo...

Страница 49: ...cleaning the console never do the following NEVER use harsh or abrasive cleansers especially on the LCD display screen panel Damage to the finish will result NEVER pour water or any other liquid over...

Страница 50: ...at the filler reservoir is still about half full Add water if necessary 6 Replace cap 7 Continue with laser start up If a water low message is still present call Laserscope Customer Service at 800 356...

Страница 51: ...Message Corrective Action Emergency Stop Touch the Press Here to Continue prompt Not In Ready Press the Ready Standby button Attach a Fiber Attach a valid device Invalid Fiber Type Device attached is...

Страница 52: ...56 7600 or call your local Laserscope distributor NOTE System Prompts Correct the problem as indicated in the System Prompt table above and continue the procedure Service Prompts The system can be res...

Страница 53: ...red 635 nm 5mW adjustable Output Beam Divergence 0 05 0 15 radians full angle at half minimum Electrical Requirements 200 240 VAC 60 Hz or 50 Hz 30 A Operating Temperature 55 F 13 C 85 F 30 C Storage...

Страница 54: ......

Страница 55: ...nts shipped under this agreement or used as replacements under this warranty may be refurbished or new equipment or components at Laserscope s option Warranty service is performed either on site or at...

Страница 56: ...for their first cases and beyond 2 Every mobile provider must have qualified as certified by Laserscope technicians on staff to transport setup and operate the GreenLight HPS during all cases Annual...

Страница 57: ...RT OR OTHER LEGAL THEORY Warranty Codes Table W 1 summarizes the warranty codes assigned to Laserscope products and lists the warranty period for each code Warranty Code Warranty Commencement Period D...

Страница 58: ...15 months from shipment Replacement parts will be warranted for the remaining amount of the 90 day warranty or 30 days whichever is the longest Adapter Plates Rings 3 Eye Protection Filters Parts Lab...

Страница 59: ...this section Please refer to this insert for answers to questions on return and repair policies and procedures for end users of Laserscope accessories All returns are handled by the Laserscope Custom...

Страница 60: ...35 Operator s Manual...

Страница 61: ...also included on the CD supplied with this manual Clinical Competency Check List Equipment Check List OR equipment needed for the procedure Laser Log Check list and log for operation of the GreenLight...

Страница 62: ...Warr...

Страница 63: ...steps 3 Knows location of laser serial number Inspects power cord for damage prior to connection to wall outlet Demonstrates connection of foot pedal to laser Turns on circuit breaker at rear of laser...

Страница 64: ...r degradation status by requesting that aiming beam be examined at appropriate times during procedure 6 Laser Shut down Records Joules power settings and duration of laser time used during procedure o...

Страница 65: ...Foley catheter 16 20Fr 5cc 2 way Urinary drainage bag 10 cc syringe NON STERILE SUPPLIES GreenLight HPS Surgical Laser System GreenLight HPS fiber card supplied in fiber package Laserscope video came...

Страница 66: ......

Страница 67: ...note joules expended per fiber under comments section Scrub Nurse Total of fibers used Laser On AM PM Laser Operator Laser Off AM PM Lasing Time min sec LASER SAFETY PROCEDURES Power Settings Used wa...

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Страница 70: ...e prostatic urethra The median lobe was vaporized from the bladder neck to the verumontanum The left and right lateral lobes were vaporized from the bladder neck to the verumontanum Vaporization was c...

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Страница 72: ...your procedure before noon do not take anything by mouth after 12 00 midnight the night before 7 Wear comfortable loose fitting clothing to the hospital or ambulatory surgery center on the day of your...

Страница 73: ......

Страница 74: ...de a Antibiotic prevents infection b Non steroidal anti inflammatory drug reduces inflammation c A drug to reduce bladder spasms d Mild over the counter pain reliever as needed 6 Do not engage in sexu...

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