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DVC-2010 User`s Manual

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1. eene 45 After EtO Gas Sterilization nisin cine arrestin ewe 45 STERRAD and STERIS St rilizati nis ste ioca etos evt oce aet sain abated 46 Care and Storage aoi du ise is esskk nde E Un Ee eaa Rp sk naa OE Pa USE RR ER EUR a CE 47 eireprz a mE E EE RT D RD aces NT EUM 47 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Table of Contents b crece Q 48 8 Troubleshooting icceu itis iced eae dca ciu xu ead i acre dni 49 9 Warranty and Service eeeeseee eene enne nnne nnne nnn nnn 55 Miartanty IDforfiatlOLl coossesceviceei deve bier dk v e cx xci ic E na a KY DE 55 Vision Sciences Service Information eene nennen 56 Shipping to Visiori Sclerices If C isieuesiadexeceexexies redux died ry ava dx aede v apad eiae 56 Appendix iiiiucicccu ei narisane cape duds ces 2os ax EREEERER RUP EuREETe TREE US ARAA SERERE SR REM REEREREREDS 59 Specifications CST 5000 CST 5000i 11 ee eseeeee eren nennen nnn 59 Infection Control Information soo esae ste e a Peg rea aar el de 60 Electromagnetic Compatibility Declarations eeeeeeeeeeeeeeee 61 Index of Figures Figure 2 1 Incorrect and Correct Sheath Alignment ceeeeeeeeeeeeeeeeeeeeeeeeaaeeees 6 Figure 3 1 CST 5000 5000i Flexible Video Cystoscope Hysteroscope 13 Figure 3 2 CST
2. Radiated maximum Separation distance according to frequency of transmitter output power of transmitter m w 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz D 3 5 M VP D 3 5 A VP D 7 amp VP 0 01 D 0 12 D 0 12 D 0 23 0 1 D 0 37 D 0 37 D 0 74 1 D 1 17 D 1 17 D 2 33 10 D 3 69 D 3 69 D 7 38 100 D 11 67 D 11 67 D 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidances may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table A 5 Recommended Separation Distances 64 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual VISION sciences Vision Sciences Inc 40 Ramland Road South Orangeburg NY 10962 USA Phone 845 359 0276 or 800 874 9975 International 1 845 359 0276 Fax 845 365 0620 E Mail info visionsciences com www visionsciences com For additional product information or questions pertaining to sales and service please contact the local distrib
3. Figure 6 1 Leak Tester Connection Leak Tester Components 1 Connector 2 Vent Valve 3 Alignment Pin align with slot in Connector Pressurize the Endoscope The Videoscope Cable s Sealing Cap must be attached to the plug CAUTION end of the Videoscope Cable Connector prior to leak testing or immersion of the endoscope in water or disinfecting solution 1 Make sure that the Leak Tester s Pressure Relief Valve is closed by moving the button to the out position 2 Pump the hand bulb of the Leak Tester until the pressure gauge s needle reaches the green zone Due to the size of the internal space of the endoscope 2 3 pumps of the hand bulb may be required to pressurize the entire chamber After the first pump the needle may drop out of the green zone and reach a stable position in the white zone Continue with additional pumps until the needle no longer falls back into the white zone CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 39 Reprocessing E AUTION Do not over pressurize the interior of the endoscope do not allow the needle to go above the green area on the gauge Over pressurizing the interior of the endoscope can damage the light transmission and or optical system components 3 Maintain the pressure for ten 10 seconds observing the position of the needle on the pressure gauge If the pressure decreases the Sealing Cap of the Videoscope Cable may not be secured onto the
4. If the endoscope has a leak or tear or fails the leak test or for some other reason cannot be disinfected properly as described in Chapter 6 Reprocessing wipe the endoscope down with 70 ethyl or isopropyl alcohol to remove debris Indicate on the outer package that the contents are contaminated Ship the endoscope in its carrying case Place the carrying case inside a corrugated box containing protective shipping material to prevent damage during shipment 56 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Warranty and Service Regardless of warranty status all shipping charges to and from an authorized Vision Sciences Inc facility are the responsibility of the customer NoTE The customer will be contacted and advised of the estimated Ld repair costs Repairs will not begin on any equipment until authorization or a purchase order has been issued indicating approval of the charges CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 57 Appendix Specifications CST 5000 CST 5000i CV 2 1 Sheath 5 6 mm 16 8 Fr with sheath Insertion Tube Diameter 08 5101 Nominal CV 1 5 Sheath 5 2 mm 15 6 Fr with sheath 08 5102 Overall Endoscope Length Distal Tip to 650 mm Top of Control Body Insertion Tube Working Length w Sheath 370 mm Field of View in Air Water 110 air 76 water Direction of View Forward Depth of Field 3 50 mm Env
5. A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and prevent damage to the device and other medical instruments Ensure that insulation or grounding is not compromised Do not immerse electrosurgical instruments in liquids unless the instruments are specifically designed and labeled to function in liquids Set the high frequency peak voltage level of the electrosurgical unit no higher than the voltages given below for the respective operating modes e CUT 560 V e COAG 775 Vp e SPRAY 1 700 Vp Always utilize the lowest output setting necessary on the Electrosurgical Unit This reduces the potential for patient injury or equipment damage When the recommended voltages shown in the instructions for electrosurgical accessories differ from normally acceptable limits always use the lowest recommended voltage Always confirm that the electrode section of the electrosurgical accessory is an appropriate distance from the Distal Tip of the endoscope and that the electrode is clearly in view If the electrode is in close proximity to the Distal Tip or still within the Slide On EndoSheath Technology during use the endoscope and or Slide On EndoSheath Technology may be damaged and patient injury may occur Do not supply oxygen or use in presence of combustible gases during electrosurgery There is the
6. All Slide On EndoSheath Technology undergoes a rigorous Quality Assurance process to ensure the utmost in product quality and efficacy Please contact Vision Sciences Customer Service for a detailed information packet regarding Infection Control and the Slide On EndoSheath Technology viral challenge testing performed with bacteriophage 27 nanometers in size per FDA guidance Per FDA Clearance requirements barriers must be tested by the guidelines set within the FDA Guidance for Manufacturers Seeking Marketing Clearance of Endoscope Sheaths Used as Protective Barriers 60 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Appendix Electromagnetic Compatibility Declarations Use of accessories not specified in this manual or sold by Vision Sciences Inc may result in increased electromagnetic emissions or decreased immunity of the equipment or system Guidance and manufacturer s declaration electromagnetic emissions The CST 5000 5000 Flexible Video Cystoscope Hysteroscope with DPU 5000 7000 Series Digital Video Processor the System is intended for use in the electromagnetic environments specified below The customer or the user of the System should ensure that it is always used in such environments Emissions Test Compliance Electromagnetic environment guidance RF emissions Group 1 The System uses RF energy only for its internal CISPR 11 function Therefo
7. Wipe all external surfaces of the endoscope with a soft lint free cloth or gauze 4x4 until it is completely dry 4 Confirm that the Lens at the endoscope s Distal Tip is free of disinfectant residue 44 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Reprocessing Ethylene Oxide EtO Gas Sterilization The CST 5000 5000 Flexible Video Cystoscope Hysteroscope may be sterilized using a validated ethylene oxide EtO gas sterilization protocol following the processing parameters given below L AUTION If the Vent Valve is not opened during gas sterilization the increased heat and pressure from the sterilization process will cause pressure to build up inside the endoscope and could rupture the watertight seals and or softer materials of the endoscope C AUTION The Videoscope Cable s Sealing Cap must be removed from the Videoscope Cable Connector prior to EtO Sterilization EtO Gas Sterilization Parameters Temperature 125 5 F 52 C 3 C Relative Humidity 50 10 EtO Concentration 600 mg liter Exposure Time 3 hours 1 0 hour Post Sterilization Aeration 12 hours at 130 F 55 C or 72 hours at 75 F 24 C L Note EtO Gas Sterilization at the above parameters has been validated by Vision Sciences Inc and will sterilize the device to a sterility assurance level SAL of 10 5 Prior to EtO Gas Sterilization the endoscope must be leak tested pre cleaned and dried as descr
8. 37 Reprocessing Reprocessing Steps The endoscope reprocessing procedure is made up of a series of discrete steps each of which is essential to successful reprocessing The steps are listed below in their proper order and the complete instructions for each step are given in greater detail in this chapter e Leak Testing The reprocessing procedure requires exposing the endoscope s surface to and immersing the endoscope itself in fluids If there is a leak in any part of the endoscope the internal components of the endoscope are vulnerable and will likely be damaged by fluid ingress Before cleaning disinfecting and or sterilizing the endoscope it is essential to perform a leak test to ensure the interior of the endoscope is resistant to fluid invasion e Cleaning Visible debris is removed from the surface of the endoscope in this procedure which uses water and an instrument grade detergent When the Slide On EndoSheath Technology is used and inspection after the procedure confirms that the Sheath was not compromised surface cleaning and intermediate level disinfection of the endoscope should be sufficient to prepare it for the next procedure e Intermediate Level Disinfection After use with an EndoSheath Technology and proper cleaning the endoscope should undergo intermediate level disinfection For the complete routine see Cleaning After Slide On EndoSheath Technology Use on page 41 e High Level Disinfect
9. 5000 5000i Flexible Video Cystoscope Hysteroscope Control Body 14 Figure 3 3 CV 2 1 Slide On EndoSheath Technology eennne 16 Figure 3 4 CV 1 5 Slide On EndoSheath Technology eene 18 Figure 3 5 DPU 5000 7000 Series Digital Video Processor e 19 Figure 3 6 Installation Stand uoces sex trux ernst cease oes DipA EFE Dp E PEDIR IE ti EP EE EU 20 Figure 4 1 Incorrect and Correct Sheath Alignment eeeeeeeeeeeeeeese 25 Figure 6 1 Leak Tester ConrnectiOno ooi cii re perma ra roches enr ke ge S xr aea Rex ERE RR E RS 39 Figure 6 2 Opening the Vent Valve nre rer rn radere 41 Index of Tables Table 3 1 CST 5000 5000i Flexible Video Cystoscope Hysteroscope Components 12 Table 6 1 STERRAD and STERIS Validated Systems Cycles 46 Table 8 1 TroublesoOLlng scies cci od us dene anara anaeandika aeania 50 Table A 1 SSDecITICabIORS s temi estrrep ute prdprenhes pa eere edesatus dusendu dsdus v denuo mu 59 Table A 2 Electromagnetic Emissions Declaration eeeseeeeeeseeess 61 Table A 3 Electromagnetic Immunity Declaration esseeeeeeeeeeeeeees 62 Table A 4 Electromagnetic Immunity Declaration eese 63 Table A 5 Recommended Separation Distances eeeeeeeeeeneeeennnee 64 CST 5000 5000 Flexible Vi
10. Bending Section and attempt to insert the accessory again If resistance is still felt confirm again that the accessory s diameter is compatible with the size of the Working Channel Refer to Chapter 8 Troubleshooting for additional suggestions Electrosurgical Devices Accessories The CST 5000 5000 Flexible Video Cystoscope Hysteroscope and Slide On EndoSheath Technology may be used with high frequency HF electrosurgical devices Operators utilizing HF devices and accessories should follow all manufacturer and facility guidelines for proper and safe use Refer to the user manuals of all HF devices being used in the procedure and closely follow all indications instructions and safety precautions CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Before using any electrosurgical devices for high frequency cauterization users should be thoroughly familiar with all guidelines safety precautions and proper use of the equipment Follow all manufacturer instructions on proper equipment preparation and use Accessories should be inspected for damage before and after each procedure Before electrosurgery inspect the endoscope for any physical damage to surfaces and components If damage is discovered discontinue use and contact Vision Sciences Inc for repair Continued use of damaged equipment during electrosurgery may lead to equipment damage and or patient injury 33 Preparation Inspection and Operation
11. Series Digital Video Processor eeesee 19 Tristallation Stand aiena ache dedi enschitde i cizaashr lbi va iv ui DR DER 20 PCCESSORISS MAMMA mm 21 Video Processor uocis tens Scb ev Narn S Dao Qui E ON Du Gb ehe 21 Light SOUF COS sis iceaieveduta que duca d uada AVR a RU EU UD VMMadiN NN Nad aaa 21 Leak TOSUNG e 21 REDEOCSSSING BD P LP V 21 Therapeutic ACCeSSOFIGS n iixrecs pne Eee a atq reed dA Fe edafunss a drida 21 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual iii Table of Contents 4 iv Installing and Removing the Slide On EndoSheath Technology 23 Install the Slide On EndoSheath Technology eene 23 Insert the Endoscope Into the Sheath eene 24 Connect Irrigation Tubing Complete Sheath Attachment 26 Observe the Endoscopic IMAGE s us secas oce ruri aieo rr etit rotor Pocrr bo rEE 26 Remove the Slide On EndoSheath Technology eese 27 Preparation Inspection and Operation esee 29 Preparation and Inspection 15 cop ore deo xix cons a xg x x RD c adu a 29 Select an Installation Site v ocveesvi eene ya rcv YE I voci drama e vica vua Ve va 29 Endoscope OP Sr ablON ety uere vaveluvisvavewenebavevivevaremuccvawsvivevaxe ato a de Nava o Ve NA 31 ASpirating Fl ldS cease avente orator eo
12. Video Cystoscope Hysteroscope may only be leak tested with a Vision Sciences V1 Endoscope Leak Tester Reprocessing The CST 5000 5000 Flexible Video Cystoscope Hysteroscope may be reprocessed by a variety of methods Refer to Chapter 6 Reprocessing for the accessories that will be used when reprocessing the endoscope Contact Vision Sciences Customer Service for advice on compatibility issues Therapeutic Accessories The CV 2 1 Slide On EndoSheath Technology features a 2 1mm Working Channel for the passage of therapeutic tools Cystoscopy Hysteroscopy tools and accessories that are compatible with a 2 1mm channel should be compatible with this system Br AUTION The CV 1 5 Slide On EndoSheath Technology does not support accessory tool passage Attempting to insert an accessory or tool could damage this Sheath For further information regarding tools and accessories please contact your local distributor or Vision Sciences Customer Service Department CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 21 4 Installing and Removing the Slide On EndoSheath Technology CAUTION Installation and removal of the Slide On EndoSheath Technology onto and from the Cystoscope Hysteroscope should always be performed with the Installation Stand Failure to utilize the installation stand for setup and preparation may lead to difficulty in installation and ultimately equipment damage Ensure that the endo
13. a typical 1 kV for lines commercial or hospital environment IEC 61000 4 4 input output SEI lines input output lines Surge 1 kV 1 kV Mains power quality should be the differential mode differential equivalent of that in a typical IEC 61000 4 5 2 kV mode commercial or hospital environment common mode 2 kV common mode Voltage dips short gt 95 dip Ur Compliant with Mains power quality should be the interruptions and for 0 5 cycle all levels of equivalent of that in a typical voltage variations 60 dip U for 5 Voltage dips commercial or hospital environment on power supply cycles for If the user of the System requires input lines U 100 VAC continued operation during power rn ui and mains interrupts it is recommended IEC 61000 4 11 e es Ur 240 VAC that the System be powered from an s 95 dip Ur for 5 uninterruptible power supply or a sec battery Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz magnetic field IEC 61000 4 8 should be at levels characteristic of a typical location in a standard commercial or hospital environment Table A 3 Electromagnetic Immunity Declaration 62 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Appendix Guidance and manufacturer s declaration electromagnetic immunity The CST 5000 5000 Flexible Video Cystoscope Hysteroscope with the DPU 5000 7000 Series Video Processor the System is intend
14. equipment damage is signified by the Warning and Caution symbols shown in this section Warnings Cautions and Notes will appear throughout this manual carefully read and follow all statements WARNING Alerts the user to situations which if not avoided could result in death or serious injury 4 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Important Information E AUTION Alerts the user to situations which if not avoided could result in moderate or minor injury to the user or patient It is also used to alert the user to conditions and actions that could cause equipment damage L NorE Indicates additional helpful information Important Warnings and Safety Precautions The following precautions should always be exercised when using the endoscope and all medical equipment to ensure safety for all involved parties user s patient s etc They are summarized here in the order of the stages of the endoscope s use Preparation Inspection and Assembly The CST 5000 5000 endoscope and the Slide On Endo Sheath Technology are designed to operate as an integrated system Neither component can be used independently of the other The Slide On EndoSheath Technology is designed for a single patient use only Do not reuse or attempt to re sterilize the Sheath For installing the Sheath in a sterile environment users should wear two pairs of sterile gloves Refer to Chapter 4 Installing and Rem
15. for the Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope The Sheath isolates the endoscope from contact with patient fluid and material during the procedure and supports irrigation but does not support accessory instrument passage 18 771 AN ry 2 b y A n Figure 3 4 CV 1 5 Slide On EndoSheath Technology Control Body Cover Covers and protects the endoscope s Control Body from contaminants during the procedure Slot for Locking Knob Slides past the Locking Knob to secure the Sheath to the endoscope Irrigation Port Luer Lock syringe attachment allows for fluid irrigation and withdrawal EndoSheath Connector Secures the Sheath to the endoscope Channel A tube that runs the length of the Sheath and allows for fluid irrigation and evacuation Insertion Tube Barrier A flexible elastomeric sleeve that creates a barrier covering for the endoscope s Insertion Tube CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Endoscope and Accessories 7 Sheath Window A patented optically clear window that covers the Distal Tip of the endoscope 8 Control Body Cover Clips 2 Secures the Control Body Cover to the Video Cable 9 Drape Bag Covers the Installation Stand to prevent contamination The Drape Bag can also be used to conveniently dispose of the Sheath DPU 5000 7000 Series Digital Video Processor CAUTION The CST 5000 5000 Flexible Video Cysto
16. gap is observed between the Distal Tip and the Sheath s window or if glare is observed in the endoscopic image move the Angulation Lever up and down several times to articulate the Distal Bending Section This process should properly seat the Sheath In some cases it may be necessary to hold the edge of the optical window while wearing gloves and move it to fully seat the Sheath 26 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Installing and Removing the Slide On EndoSheath Technology Remove the Slide On EndoSheath Technology When the endoscopic procedure is complete the Slide On EndoSheath Technology must be removed and disposed of properly to eliminate the possibility of infection control risks CAUTION Wear appropriate personal protective equipment when removing the Sheath from the endoscope to prevent the possibility of infection from contact with patient material Vision Sciences Inc strongly recommends that a double set of gloves be worn for this procedure Always use the Installation Stand to remove the endoscope from the Sheath Attempting to remove the endoscope without using the Installation Stand could cause damage to the endoscope 1 Put on two pairs of sterile gloves 2 Ensure that the Drape Bag is completely covering the installation stand 3 Slide the sheathed endoscope into the draped Installation Stand The sheathed Insertion Tube must be contained within the Drape B
17. or Vision Sciences Customer Service Monday through Friday from 8 00 AM to 5 00 PM EST USA customers call 1 800 874 9975 International customers call 1 845 359 0276 for Vision Sciences Customer Service or call your regional distributor Provide a detailed description of the problem If troubleshooting cannot solve the problem a Returned Goods Authorization RGA number will be issued Complete an Incident Report Form and send it to Vision Sciences Inc along with the returned goods Returned merchandise will only be accepted with an RGA number Shipping to Vision Sciences Inc or Distributor If the CST 5000 5000 Flexible Video Cystoscope Hystero WARNING scope has been used in a clinical setting disinfect all system components before shipping as described in Chapter 6 Reprocessing Shipping contaminated equipment could present an acute infection control risk for those handling the endoscope both during shipping and at Vision Sciences Inc or authorized repair facility If the CST 5000 5000 Flexible Video Cystoscope Hystero scope has been used in a clinical setting but cannot be disinfected before shipping place a red biohazard label on the shipping container to indicate that the contents are contaminated in accordance with OSHA standards 29 CFR 1910 1030 Observe the following precautions before shipping the endoscope 1 2 Attach the Vent Cap to the endoscope s Vent Valve in preparation for shipping
18. potential for combustion during cauterization Vision Sciences Inc recommends the use of isolated electrosurgical accessories Use of non isolated accessories may result in operator injury To best determine the necessary minimum output operators should conduct basic tests before electrosurgery according to the User s Manual of the Electrosurgical Unit 34 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Preparation Inspection and Operation Laser Devices Accessories Before using any laser devices users should be thoroughly familiar with all guidelines safety precautions and proper use of the equipment This includes but is not limited to proper eye and skin safety guidelines Do not use a damaged laser fiber accessory Utilizing a probe with a damaged cover or distal end may result in patient injury and or equipment damage Always confirm that the distal tip of the laser fiber accessory is an appropriate distance from the Distal Tip of the endoscope and that the laser fiber tip is clearly in view If the distal tip of the accessory is in close proximity to the endoscope s Distal Tip or still within the Slide On EndoSheath Technology during use the endoscope and or Slide On EndoSheath Technology may be damaged and patient injury may occur Do not supply oxygen when performing laser surgery do not perform laser surgery in the presence of combustible gases There is the potential for combu
19. to enable instillation and close the Valve to stop it CAUTION Make sure that the syringe is seated properly and straight in the Sheath s Accessory Port Otherwise the seal may be compromised and fluid may not flow smoothly into the Working Channel 32 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Preparation Inspection and Operation Inserting Accessories CAUTION Accessories may only be inserted when using the CV 2 1 Slide On EndoSheath Technology The CV 1 5 Slide On EndoSheath Technology does not support accessory instrument passage Before inserting an accessory into the Sheath confirm that it is compatible with a 2 1 mm diameter Working Channel If the accessory is too large it will damage the Sheath and may compromise the integrity of the barrier Do not continue advancing an accessory if excessive resistance is encountered and do not use excessive force to try and advance it The use of excessive force may result in damage to the Sheath and or the endoscope 1 Before inserting an accessory straighten the endoscope s Distal Bending Section 2 Insert the tip of the accessory through the Sheath s Accessory Port Using straight steady strokes pass the accessory through the Working Channel until the tip of the accessory is visible on the video monitor 3 If resistance is encountered while inserting the accessory withdraw the accessory straighten the endoscope s Distal
20. 000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 7 Important Information A thorough understanding of the principles and techniques involved in laser electrosurgical and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and to avoid damage to the device and other medical instruments Ensure that insulation or grounding is not compromised During Use Hysteroscopy 8 Prior to performing a hysteroscopic procedure it is extremely important that the user review the following information which may be critical to ensuring patient safety Continuous CO Flow Hysteroscopy If CO gas is used as a distention medium operative hysteroscopy is contraindicated due to the risk of gas embolization with the exception of non electrosurgical polypectomy or directed biopsy CO gas may be used for diagnostic procedures It is extremely important that a hysteroscopic insufflator is used Death has been reported when laparoscope CO insufflators were used during hysteroscopy The CO flow rate should be limited to less than 100 ml min and the patient s intrauterine pressure should not exceed 100 mm Hg Potential complications of continuous flow hysteroscopy with CO include e CO embolization e Circulatory collapse e Death Continuous Fluid Flow Hysteroscopy If a liquid distention medium is used strict fluid intake and output surveillance should be maintained to ensure th
21. E REED ENS 3 TOMES d e E H H 3 Contraindications for HySteroScopy i2 ta votar aeui kann E aaa nna cU cu a Ra 3 User QualifiGatiOns adunco ibra uie uda Cavo cir ea bue ccv cii CV cda Via da 3 REPrOCESSINO eR Me D Ke D EE E E aaa 4 Maintenance and ReBalis cenis Evo circ ea bc ce oe CUR aci an Ve ha 4 ence 4 Important Warnings and Safety Precautions eeeeeeeeeeeneeennnee 5 Preparation Inspection and Assembly eeeeeeeeeenneeenne 5 During fot ak C ol Pee een on ean ii diet Daten esten zl uc e onu 7 During Use Hysteroscopy sevivevavsevavevavevadevanevavewavewevewiee cr ence ics 8 REDIOCESSING sivccharuksrasie van vvsedcssnsbencbausbancueiabunanceatctnusisianesncbaiwsauciuncsanies 9 Endoscope and Accessories s ssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnn 11 Inspect the Standard Set a iia enden niae ew an a UE 12 CST 5000 5000 Cystoscope Hysteroscope Standard Set 12 E duipment DiegbelTiS seams nione detta qae dt tetra a dua cu Dau d 13 CST 5000 5000 Flexible Video Cystoscope Hysteroscope 13 CST 5000 5000 Flexible Video Cystoscope Hysteroscope 14 Instrument COMPONENUS suus vasi e erre rrr aen n e n nr xxt n Ya n nio Na Ye Nau Y a 14 CV 2 1 Slide On EndoSheath Technology enne 16 CV 1 5 Slide On EndoSheath Technology eene 18 DPU 5000 7000
22. Hysteroscope User s Manual 51 Troubleshooting Cannot insert endoscope into the sheath Cannot remove the endoscope from the sheath The Sheath s channel is misaligned The endoscope s Locking Knob is not aligned with the slot The endoscope s Insertion Tube has been damaged and its diameter has increased The Angulation Lever has been actuated The Sheath s Window is not aligned with the Insertion Tube The D shaped opening of the EndoSheath Connector is not aligned with the Insertion Tube The Sheath is torn or punctured Locking Knob not rotated The Sheath is torn or punctured The Sheath has been attached to the endoscope for an extended period of time causing it to adhere to the Insertion Tube The flat portion of the Insertion Tube is not properly aligned with the Biopsy Port The Distal Head of the Insertion Tube is lodged in the Sheath Straighten the channel before continuing scope insertion Make sure the Locking Knob is positioned vertically Align Locking Knob with slot and fully seat the endoscope in the sheath Rotate the Locking Knob clockwise until it is horizontal Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Place the Angulation Lever in the neutral position so the Distal Bending Section of the endoscope is straight Articulate the Insertion Tube back and forth several times to fully seat the Sheath Gen
23. On EndoSheath Technology C AUTION If you experience difficulty removing the endoscope from the Sheath do not use excessive force in trying to remove it Refer to Chapter 8 11 12 13 14 28 Troubleshooting for further instructions Place the endoscope in a non contaminated area Power off the video processor Inspect the Insertion Tube and Distal Tip and confirm that these areas are dry If moisture is observed there may have been a leak into the Sheath during the procedure provided that the endoscope was dry when the Sheath was attached In this case the endoscope must be high level disinfected or sterilized following the instructions given in Chapter 6 Reprocessing Fold the top end of the contaminated Drape Bag over the EndoSheath Connector and remove it from the Installation Stand Carefully discard the contaminated Sheath per hospital policy The endoscope should then undergo the recommended cleaning procedure detailed in Chapter 6 Reprocessing CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 5 Preparation Inspection and Operation If an abnormality is detected during endoscope preparation do not use the equipment refer to the tables in Chapter 8 Troubleshooting If the problem cannot be solved using the information in that chapter contact your regional distributor or Vision Sciences Customer Service When using the Slide On EndoSheath Technology with the endoscope refe
24. Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Clean the Objective Lens with an alcohol prep pad to remove material or stain Excess staining may not be correctable and the lens may require replacement Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Adjust the settings on the Video Processor or Display Perform a White Balance procedure on the Video Processor Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Check power cord connection and fuses or connect the Video Processor to a different mains outlet Check the cable connection between the endoscope and the Video Processor Check the video output cable connections when using an external monitor Replace the cable if necessary If the problem cannot be corrected send the endoscope and Video Processor to Vision Sciences Inc for repair Table 8 1 Troubleshooting 50 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Troubleshooting PROBLEM PROBABLE CAUSE ACTION Loss of Patient material or Clean the Distal Tip with an alcohol prep pad illumination other substance on the to remove material or stain Excess staining Light Guides may not be correctable and the lens may require replaceme
25. TSC CST 5000 Flexible Video Cystoscope Hysteroscope PAL Vision Sciences CST 5000 5000 Carrying Case Vent Cap CST 5000 5000 User s Manual this document VIDEO PROCESSORS NOT SHIPPED WITH ENDOSCOPE 07 5050 07 5051 07 7001 DPU 5050 Video Processor with LCD Display DPU 5050A Video Processor with LCD Display DPU 7000A Video Processor with LCD Display OPTIONAL ITEMS AND ACCESSORIES NOT SHIPPED WITH ENDOSCOPE 07 6160 07 6161 07 6162 07 6010 08 5101 08 5102 Installation Stand Floor Model Installation Stand Clamp Model Installation Stand Wall Mount Videoscope Leak Tester ENDOSHEATH TECHNOLOGY CV 2 1 Slide On EndoSheath Technology with 2 1mm 6 3 Fr Working Channel for the CST 5000 5000 Flexible Video Cystoscope Hysteroscope CV 1 5 Slide On EndoSheath Technology with 1 5mm 4 5 Fr Irrigation Channel for the CST 5000 5000 Flexible Video Cystoscope Hysteroscope Table 3 1 CST 5000 5000i Flexible Video Cystoscope Hysteroscope Components 12 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Endoscope and Accessories Equipment Diagrams CST 5000 5000 Flexible Video Cystoscope Hysteroscope P VAN CR eet itj uu s SS i V J i AN A Ne pd AN Lue DS 91 he ROS Figure 3 1 CST 5000 5000i Flexible Video Cystoscope Hysteroscope A Control Body B Insertion Tube CST 5000 5000 Flexible Video Cystoscope Hysterosco
26. VISION sciences USER S MANUAL VISION SCIENCES Flexible Video Cystoscope Hysteroscope CST 5000 50001 and Slide On EndoSheath Technology www visionsciences com 2009 2010 2012 2013 2014 Vision Sciences Inc All rights reserved Printed in the United States of America The information contained herein is the exclusive and confidential property of Vision Sciences Inc No part of this manual may be disclosed or reproduced in whole or in part without permission from Vision Sciences Inc How to Use This Manual This User s Manual contains the recommended procedures for preparing and using the Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope and the Slide On EndoSheath Technology It is intended for physicians and other medical personnel who will come in contact with the equipment before during and after any patient procedures performed with them The manual also contains pertinent information on the proper care and handling of the equipment Please read and become familiar with this entire manual before using the equipment This manual contains the following information e Description of the endoscope and Slide On EndoSheath Technology e The endoscope s intended use e Components and features of the endoscopes and peripheral equipment used in conjunction with the endoscope e Complete instructions on endoscope preparation inspection operation reprocessing and storage e Warnin
27. a do seta cae evade vn Mt 32 Instllirig FII sco udezev di edu aaa a la El a E V recs 32 Inserting ACCOSSOFIBS eoo taii vade A 33 Electrosurgical Devices Accessories 1eceeeeeeeee eere nennen nnn 33 Laser Devices Accessories ccccceccececuccuecuueeeeuesuecueeuuseuseueeuueeueeuesauseueeaueeas 35 i e ilr 37 Reprocessing SUES Pee x 38 Leak TSUN er Ecc 38 Attach the Leak Tester to the Endoscope eeeeeeenneeeeneenn 39 Pressurize the Endoscope uidere deinde eeia s orte Ra E Da 39 Cleaning Disinfection Sterilization eeeeeeee eene nennen 41 Use of the Vent Calc m dedecori oi oaa sd ce ida andi Sb 41 Cleaning After Slide On EndoSheath Technology Use 41 High Level Disinfection and Sterilization eeeeeeeeeeeeeeeeeeee 42 Recommended Disinfection and Sterilization Procedures 42 Acceptable Reprocessing Materials 1 ec eene nennen 43 Incompatible MethodS didi dep dn Rattek dux dd ahead Coma R ata ec ad Ca 43 FliglisEevebDisinecti hiPEOUD CO eek pius PER Edu t SeR aie eg Pup Red 44 musa cci gem E cc cea aan cna scat 44 EVISU ECCI OM misrin ana wut eNa f aaa ww Co unde va DU ERN N 44 Hu 44 Ethylene Oxide EtO Gas Sterilization eeeeeeeee eee 45 EtO Gas Sterilization Parameters
28. ag to capture and contain any patient material and or fluids The Accessory Port must be facing toward you 4 Disconnect Irrigation tubing from source 5 Remove the Control Body Cover Clips and discard them in the Drape Bag Keeping your hands on the outside of the contaminated Control Body Cover pull the Cover forward and down off of the endoscope 6 Remove the outer set of gloves Do not handle the endoscope s Control Body with contaminated gloves 7 Disconnect the Irrigation Tubing from the Flow Control Valve by pressing the Open Flow button and then stretch the tubing while pulling it away from the base of the slot towards the open slot of the valve Continue pulling on the tubing until it is clear of the valve 8 Rotate the Locking Knob into the vertical position so that it is aligned with the slot on the EndoSheath Connector 9 Using the Angulation Lever articulate the Distal Bending Section of the endoscope into the straight neutral position 10 Hold the endoscope s Control Body in one hand Using the bottom outside portion of the Drape Bag as a barrier between your fingers and the Sheath gently grasp the Sheath s Window and then gently and slowly withdraw the endoscope from the Sheath IM YE REI f Do not twist the endoscope when removing it from the Sheath Doing so can damage the Insertion Tube CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 27 Installing and Removing the Slide
29. at fluid deficit is known at all times Depending on whether a non electrolytic or an electrolytic solution is being used when excessive fluid deficit occurs consideration should be given to stopping further infusion and concluding the procedure When using a fluid distention medium closely monitor fluid intake output Excessive intake of distention fluid can lead to fluid overload and complications Potential complications of continuous flow hysteroscopy with fluid distention media include e Hyponatremia e Hypothermia e Uterine perforation resulting in possible injury to bowel bladder major blood vessels and ureter e Pulmonary edema e Cerebral edema e Death CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Important Information If pregnancy is suspected perform a pregnancy test prior to performing hysteroscopy DO NOT perform hysteroscopy if the patient is pregnant If performing Endometrial Ablation or Hysteroscopic Myomectomy verify that the patient does not have procedural contraindications CAUTION Vaginal ultrasonography before hysteroscopy may identify clinical conditions that will alter patient management Gravity fed intrauterine fluid distention can usually be accomplished with pressures in the range of 35 75 mm Hg Hanging the fluid distention medium 42 inches above the patient can generate intrauterine pressure of approximately 80 mm Hg Unless the systemic blood pressure is excessiv
30. deo Cystoscope Hysteroscope User s Manual v 1 Symbols and Terms Symbols The symbols listed below can be found on the CST 5000 5000 Flexible Video Cystoscope Hysteroscope and on other components of the endoscopic system v NDE ZAR SS gt fe un ERE Type BF applied part Safety degree specified by IEC 60601 1 Alerts the user to the presence of important operating maintenance and service instructions Refer to the user s manuals for warnings and safety precautions associated with equipment used in the procedure Equipment bearing this mark has been designed tested and certified as essentially compliant with all applicable European Union EU regulations and recommendations Serial number of the endoscope Up position for the Angulation Lever Down position for the Angulation Lever STERIS and STERRAD Reprocessing Compatibility Refer to Chapter 6 Reprocessing Endoscope must feature the S symbol for STERRAD STERIS compatibility Products do not contain natural rubber latex Consult Instructions for Use Terms The following terms are used throughout this User s Manual Cystoscope Hysteroscope Videoscope and Endoscope refer to the Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 1 Symbols and Terms Slide On EndoSheath Technology or Sheath refers to the disposable CV 2 1 o
31. e it is seldom necessary to use pressures greater than 75 80 mm Hg A Note Hysteroscopes are used as tools to access the uterine cavity and are not in and of themselves a method of surgery Diagnostic hysteroscopy can be used to evaluate numerous conditions including the following e Abnormal uterine bleeding e Infertility e Evaluation of abnormal hysterosalpingogram or sonohysterogram e Intrauterine foreign body e Amenorrhea e Pelvic pain Operative hysteroscopy is used to perform numerous procedures including the following e Directed endometrial biopsy e Polypectomy e Submucous Myomectomy e Transection of Intrauterine Adhesions e Transection of Intrauterine Septa e Endometrial Ablation Reprocessing The endoscope must be properly reprocessed by cleaning disinfecting and or sterilizing before its first use and after each subsequent use Using an endoscope in a procedure that has not been properly reprocessed presents an acute infection control risk to both the patient and medical personnel performing or assisting in the procedure CAUTION Always wear appropriate personal protective equipment when reprocessing the endoscope and or sheath such as a gown gloves and face and eye shields CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 9 Important Information 10 Use extreme care when reprocessing the endoscope Do not forcefully pull push or drag wipes towels or cloths along
32. e Control Body Cover to expose the top opening of the EndoSheath Connector Insert the Endoscope Into the Sheath 10 Take the endoscope in hand and verify that the articulation section Distal Bending Section of the endoscope is straight 11 Hold the endoscope vertically above the Sheath Align the endoscope s D shaped Insertion Tube with the D shaped opening of the EndoSheath Connector the flat portion of the Insertion Tube should face toward the Sheath s Accessory Port toward you 12 Gently slide the endoscope s Insertion Tube into the Sheath Keep the Insertion 24 Tube as straight as possible Do not rotate the Insertion Tube during insertion this will cause resistance CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Installing and Removing the Slide On EndoSheath Technology When inserting the endoscope into the Sheath avoid excessive bending of the Insertion Tube as it could damage the Sheath and or the endoscope Do not apply excessive force to install the Sheath onto the endoscope if insertion is found to be difficult If you experience difficulty installing the Sheath refer to Chapter 8 Trouble shooting If the recommended actions given there do not ease endoscope insertion call your local distributor or Vision Sciences Customer Service at 800 874 9975 or 1 845 359 0276 for further instruction Note It is extremely important to maintain the alignment between the
33. e actions to take towards resolving minor problems Chapter 9 Warranty and Service This chapter contains the terms of the Vision Sciences Inc warranty on the endoscope any restrictions that apply and user actions that may void the warranty if taken This chapter also includes shipping instructions in case the endoscope must be returned to Vision Sciences Inc for repair The Appendix contains the technical specifications for the CST 5000 5000 Flexible Video Cystoscope Hysteroscope and infection control information Additional Information The information in this User s Manual is subject to change without notice If you have any questions regarding any of the material contained in this manual or wish to confirm that this is the most comprehensive information available for this product please contact your local distributor or Vision Sciences Customer Service Department at 800 874 9975 or 1 845 359 0276 International ii CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Table of Contents How to Use This Manali netus o3 caiscadateaestciuseenecaewaucenswedemsdwensenssaeancveuse i Organization of this Manual iiid oe aaa aeui eae eade aes i Additional Informat Oa a a aaa A Aa A AANA ii Symbols and Terms s ssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn mnnn nnn 1 SAA 91010 KAA A A OOSA A E A AE 1 NITE 1 Important InfOrmoatlOn 3 oou epnEud quani unus Qa Cu dEE TEES yRCNNEEAA Gu nala
34. e should be stored in a dry well ventilated environment avoid high humidity direct sunlight and temperatures below 10 C or above 60 C e Do not store the endoscope in its carrying case This case is only intended for endoscope transport it is not properly ventilated for storage e Avoid storing the endoscope in heavily trafficked areas where there is a chance that it may sustain physical damage CAUTION The endoscope should NEVER be stored in areas where it could be exposed to liquids or environmental conditions such as high temperature humidity direct sunlight dust salt etc which could adversely affect its operation The endoscope should NEVER be stored in the presence of flammable or explosive gases or chemicals CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 47 Care and Storage Disposal The equipment should be returned to Vision Sciences Inc for disposal Contact your local Vision Sciences representative or service facility for further information 48 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 8 Troubleshooting The information in this chapter is intended to help users diagnose problems that may occur during operation of the endoscope The tables include some of the problems that could arise during operation possible causes for those problems and suggested corrective action IM ERIN E If the problem persists even after the corrective action has b
35. ect the Irrigation Tubing to endoscope s Flow Control Valve by pressing the Open Flow button and stretching the tubing into the slot of the valve This allows the Flow Control Valve to secure the tubing in place Do not pull the tubing too tightly Ensure that the tubing is placed into slot completely before pressing the Close Flow button 19 When using the CV 2 1 Slide On EndoSheath Technology Remove the Sterile Cap from the Irrigation Tubing 20 Connect a fluid management accessory such as saline line to the Sheath s Irrigation Tube Luer fitting 21 Connect the Irrigation Luer Lock to the Irrigation source A NOTE The Flow Control Valve may be bypassed and a stopcock used for on off fluid management 22 Remove outer pair of gloves 23 Pull the Sheath s Control Body Cover up over the endoscope s Control Body and the Videoscope Cable to completely cover them 24 Secure the Control Body Cover and Irrigation Tubing to the Videoscope Cable using the Control Body Cover Clips A Norte Fluid withdrawal and irrigation may also be accomplished by connecting to the standard luer fitting on the Sheath s Accessory Port 25 Turn the Flow Control Valve on and off and confirm that it operates properly Observe the Endoscopic Image The Sheath s window should now be in direct contact with the Insertion Tube s Distal Tip To confirm this view an endoscopic image with illumination on there should be no glare If a
36. ed and or enlarged The stopcock is closed The Irrigation Tubing is kinked crushed or open to the atmosphere Irrigation Tubing is tightly positioned in the endoscope s Flow Control Valve The Flow Control Valve is closed e The Working Channel is clogged e The Syringe is not fully seated into or aligned with the Accessory Port Troubleshooting Move the Distal Bending Section back and forth several times to fully seat the Sheath Gently manipulate the edges of the Sheath s window to properly seat the endoscope Remove the endoscope from the Sheath Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Open the stopcock Straighten out or relieve any tension on the tubing Relieve tension on the tubing by repositioning it to provide more slack ahead of the Flow Control Valve Open the Flow Control Valve Remove the endoscope from the patient and inject 10cc of saline through the channel If the channel remains blocked remove the Sheath from the endoscope and install a new Sheath Insert the syringe tip fully and straight into the Accessory port Table 8 1 Troubleshooting cont d CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 53 Troubleshooting The Accessory will not pass through the Sheath s Working Channel e Accessory is too large e The Channel is occluded by patient debris e The endoscope s Distal Be
37. ed for use in the electromagnetic environment specified below The customer or the user of the System should assure that it is always used in such environments Immunity Test IEC 60601 test Compliance Electromagnetic environment level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the System including cables than the recommend separation distance calculated from the equation applicable to the frequency of the transmitter Recommend separation distance d 1 17 P Conducted RF 3 Vrms 3V IEC 61000 4 6 150 kHz to 80 d 1 17 P 80MHz to 800MHz MHz d 2 33VP 800MHz to 2 5GHz Radiated RF 2m 3 V m where Pis the maximum output power IEC 61000 4 3 80 MHz to 2 5 rating of the transmitter in watts W GHz according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stat
38. edure which could cause serious patient injury and or further damage to the equipment Always wear appropriate personal protective equipment when using the endoscope and or sheath such as a gown gloves and face and eye shields Avoid excessive bending or twisting of the endoscope s Insertion Tube and Videoscope Cable Although they are designed to bend excessive bending can damage the fiber bundles and internal components Do not apply excessive pressure to the endoscope s Angulation Lever as it could damage the endoscope and lead to patient injury Do not look directly at the intense light emitted from the endoscope tip to avoid the possibility of eye injury If resistance is encountered when inserting an instrument into the Sheath do not force it as it could damage the instrument the endoscope and or the CV 2 1 Slide On EndoSheath Technology The Irrigation Working Channel of the CV 2 1 Slide On EndoSheath Technology accommodates instrumentation indicated by the accessory manufacturer to be compatible with a 2 1 mm or smaller working channel All instrumentation must be tested for compatibility with the channel prior to clinical use If assistance is needed to determine compatibility contact your local distributor or Vision Sciences Customer Service Department Do not attempt to advance an exposed needle or other sharp instruments through the working channel Doing so could damage the sheath s channel CST 5
39. een taken or a problem occurs that is not covered in the tables do not use the endoscope Contact Vision Sciences Inc for service or repairs using the information given in Chapter 9 Warranty and Service The CST 5000 5000 Flexible Video Cystoscope Hysteroscope requires a video processor to process and display images In order to identify issues related to image problems you may also have to refer to the Troubleshooting chapter in the DPU 5000 7000 Series Video Processor User s Manual CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 49 Troubleshooting PROBLEM PROBABLE CAUSE ACTION Angulation feels stiff Angulation alignment is no longer up down Loss of angulation Cloudy or foggy images or poor image quality when the endoscope is unsheathed No image Damaged Distal Bending Section causing impaired angulation Insertion Tube has become twisted Angulation wires have been stretched or broken during use Patient debris or other material on the Objective Lens Fluid incursion into the videoscope s optical system Improper settings on the Video Processor or Display Damaged optics sensor or electronics in the endoscope Video Processor is not powered on Connection between the endoscope and the Video Processor is lost No video output signal to a monitor Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service
40. endoscope was dry when the sheath was attached In this case the endoscope must be high level disinfected or sterilized following the instructions given in this chapter 2 For Cleaning Gently wash all external surfaces of the endoscope with an appropriate instrument grade detergent An ample size basin must be used for cleaning the endoscope If the basin is too small the endoscope may inadvertently be kinked or damaged during cleaning 3 After washing thoroughly rinse the outside of the endoscope with clean lukewarm water and place it on a clean dry surface 4 For Intermediate Level Disinfection Wipe down the entire endoscope with a soft lint free cloth gauze soaked in 70 ethyl or isopropyl alcohol 5 Ensure that all external surfaces of the endoscope are thoroughly dried prior to attaching another Sheath or storing the endoscope High Level Disinfection and Sterilization In the event that the endoscope is contaminated it should be high level disinfected or sterilized after cleaning Use caution when cleaning and then high level disinfecting or sterilizing the endoscope Recommended Disinfection and Sterilization Procedures The following procedures have been determined by Vision Sciences Inc to be compatible with the CST 5000 5000 Flexible Video Cystoscope Hysteroscope e High Level Disinfection in Glutaraldehyde All Vision Sciences endoscopes are validated for high level disinfection in 2 4 glutaraldehyde
41. erly reprocessed presents an acute infection control risk to both the patient and medical personnel performing or assisting in the procedure C AUTION Some methods of disinfection and sterilization may be harmful to the endoscope and exposure to them could result in extensive equipment damage Please contact Vision Sciences Inc Customer Service to verify the compatibility of a cleaning method not listed in this manual and or a complete list of functionally compatible agents Clean the endoscope immediately after use in a procedure Failure to do so may allow patient debris to harden on the endoscope s external surfaces which can become difficult to remove and could inhibit subsequent disinfection sterilization processes Do not use an endoscope that has been determined to have a leak and do not immerse such an endoscope in any fluids Fluid entry into the endoscope can cause equipment damage and render the endoscope unfit for patient use Always wear appropriate personal protective equipment when reprocessing the endoscope or any of its components Appropriate protective equipment includes items such as a gown gloves and face and eye shields Complete and thorough reprocessing of the endoscope is the only way to ensure that a patient ready endoscope is used in all patient procedures Closely adhere to the reprocessing instructions given in this chapter CST 5000 5000i Flexible Video Cystoscope Hysteroscope User s Manual
42. essor to perform designated image control functions These functions include a Image Freeze a Image Capture a Image Enhancement a Remote Activation Copy Print a Gain Control Refer to the DPU 5000 7000 Series Video Processor User s Manual for further information on available control functions and instructions on programming the Control Buttons 7 When the procedure is completed withdraw the endoscope under direct visualization without holding the Angulation Lever This will allow the Distal Bending Section to move freely during withdrawal Aspirating Fluids 1 Attach a syringe to the Sheath s Accessory Port When using the CV 2 1 Slide On EndoSheath Technology first remove the Accessory Port Seal 2 Aspirate fluids by withdrawing the syringe s plunger 3 To aspirate fluids via the CV 2 1 Sheath s irrigation tubing confirm that the Accessory Port Seal is in place and then open the endoscope s Flow Control Valve Press the Close Flow button to stop aspiration Instilling Fluids To inject anesthetic saline or other fluids attach a syringe to the Sheath s Accessory Port When using the CV 2 1 Slide On EndoSheath Technology the tip of the syringe may be inserted directly into the Accessory Port Seal s opening If necessary remove the Accessory Port Seal before withdrawing fluid back into the syringe The irrigation tubing may also be used to instill fluids Open the Flow Control Valve
43. etails on instructions for use IM YER ELE Failure to properly clean the videoscope may inhibit the STERRAD or STERIS sterilization process The Vent Cap must be attached for the STERRAD IM YE REIR E sterilization process The Vent Cap must be removed for the STERIS sterilization process CAUTION STERRAD or STERIS compatibility applies only to endoscopes which feature the S symbol located on the Control Body s Identification Ring 46 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 7 Care and Storage Follow the instructions in this chapter if you anticipate that the endoscope will not be used for a prolonged period of time Do not leave the endoscope exposed to the elements in such circumstances Storage Follow the instructions below when storing the CST 5000 5000 Flexible Video Cystoscope Hysteroscope DO NOT store the endoscope with a Slide On EndoSheath Technology installed on the Insertion Tube Over time the Sheath material may adhere to the Insertion Tube and become difficult to remove e When storing the endoscope be sure to keep the Insertion Tube as straight as possible The Videoscope Cable may be stored either straight or neatly coiled to prevent kinking or bending e The equipment should be completely clean and dry before storing e This endoscope should be maintained in a clean condition during storage so that it is ready for subsequent use e The endoscop
44. flat portion of the Insertion Tube and the Biopsy Port on the EndoSheath Connector during installation and removal If there is resistance in loading the endoscope into the Sheath check this alignment and straighten the channel before continuing endoscope insertion Fi Hl f rr LUA MISALIGNED ALIGNED Figure 4 1 Incorrect and Correct Sheath Alignment 13 Make sure the Locking Knob on the endoscope is in a vertical position 14 Align the endoscope s Locking Knob with the vertical slot on the EndoSheath Connector and continue sliding the endoscope into the Sheath until the Locking Knob is fully seated at the base of the slot 15 Rotate the Locking Knob to the horizontal position locked position This will ensure a secure fit between the EndoSheath Connector and the endoscope 16 Using the angulation lever articulate the Bending Section in both directions to ensure proper sheath fit CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 25 Installing and Removing the Slide On EndoSheath Technology 17 Visually inspect the Sheath and confirm that the endoscope s Distal Tip is flush with the Sheath s window If the Distal Tip is not flush with the Sheath s window articulate the Distal Bending Section until the window is seated properly Connect Irrigation Tubing Complete Sheath Attachment 18 When using the CV 2 1 Slide On EndoSheath Technology Conn
45. g and Caution statements that must be observed by endoscope users to ensure patient and user safety If you are a first time endoscope user Vision Sciences Inc strongly recommends that you read this manual from beginning to end and become intimately familiar with the endoscope and its use If you are an experienced endoscope user select specific chapters and or sections that pertain to features and procedures that you are using Organization of this Manual Following is a list of the chapters included in this User s Manual Each chapter s title is listed at the top of all pages after the title page so that you can quickly access the information you need Chapter 1 Symbols and Terms This chapter defines the symbols on the endoscope and peripheral equipment There is also a brief list of the terms that are commonly used in the manual Chapter 2 Important Information The information in this chapter is a summary of critical Warning and Caution statements in the manual This information is essential to the safe operation and reprocessing of the endoscope Vision Sciences Inc strongly recommends that this chapter be read thoroughly and completely understood by all users before working with the endoscope Chapter 3 Endoscope and Accessories Introduces the CST 5000 5000 Flexible Video Cystoscope Hysteroscope and compatible peripheral equipment This chapter includes instrument diagrams identifies components and defines thei
46. hen using the Angulation Lever Doing so can damage the angulation mechanism 5 Clean the Lens on the Distal Tip with an alcohol prep pad CAUTION Do not use abrasive materials to clean the Lens Doing so could damage the Lens and impair the endoscope s imaging capability 6 Insert the endoscope s Videoscope Cable Connector into the connector on the front panel of the DPU 5000 7000 Series Video Processor and power on the Video Processor when ready for the procedure CAUTION Turn off the Video Processor s power switch before connecting or disconnecting the Videoscope Cable Connecting or disconnecting the cable with the power on could damage both the endoscope and the Video Processor 7 Connect an irrigation source to the Sheath s Irrigation Tube 30 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Preparation Inspection and Operation L Note When using the CV 2 1 Sheath with irrigation tubing connecting the irrigation source to the Sheath s Irrigation Tube will allow for irrigation while an accessory device is either inserted into or attached to the Accessory Port Fluid withdrawal and irrigation may be accomplished by connecting to the standard luer lock fitting on the Accessory Port by removing the Accessory Port Seal when no accessory device is used L Note The Flow Control Valve may be bypassed and a stopcock used on the Accessory Port for on off fluid management Endoscope Operati
47. hment for fluid withdrawal EndoSheath Connector Secures the Sheath to the endoscope Working Channel A solid impermeable tubing that runs the length of the Sheath allowing for maximum fluid irrigation volume and evacuation while also allowing the passage of accessory devices CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Endoscope and Accessories 6 Insertion Tube Barrier A flexible elastomeric sleeve that creates a barrier covering for the endoscope s Insertion Tube 7 Sheath Window A patented optically clear window that covers the Distal Tip of the endoscope 8 Control Body Cover Clips 2 Secures the Control Body Cover to the Video Cable and Irrigation Tube 9 Irrigation Tube Provides access for irrigation or evacuation suction to the distal tip during a procedure 10 Irrigation Tube Connector A standard Luer Lock fitting to allow for coupling to the Irrigation Suction tube 11 Luer Cap A standard Luer Lock fitting cap to prevent internal contamination of the Irrigation tube before making a connection 12 Drape Bag Covers the Installation Stand to prevent contamination The Drape Bag should also be used to conveniently dispose of the Sheath CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 17 Endoscope and Accessories CV 1 5 Slide On EndoSheath Technology The CV 1 5 Slide On EndoSheath Technology shown in Figure 3 4 is a sterile disposable barrier
48. hysteroscopy if any one of the following conditions exists Do not perform hysteroscopy using this equipment if The patient is pregnant or suspected to be pregnant The patient s cervix cannot be properly dilated The patient s uterus cannot be distended The patient has acute pelvic inflammatory disease PID The patient has invasive carcinoma of the cervix The patient has had a recent uterine perforation User Qualifications This equipment should only be used in a medical facility by or under the supervision of a physician trained in cystoscopy hysteroscopy Use of the system does not require any deviation from standard cystoscopy or hysteroscopy technique However the operator should have complete familiarity with the operation of the entire system prior to clinical use CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 3 Important Information Only practitioners with adequate training in hysteroscopy should perform hystero scopic procedures Vision Sciences Inc strongly recommends a thorough review of all relevant medical literature relative to techniques complications and hazards prior to undertaking any hysteroscopic procedure For preparation of the endoscope before use and disassembly and proper cleaning after use users should be thoroughly trained in the proper procedures Failure to completely understand these details such as but not limited to EndoSheath Technology installation and authorized dis
49. ibed for the High Level Disinfection Protocol C AUTION Failure to properly pre clean the endoscope may inhibit the EtO gas sterilization process Prior to Gas Sterilization the Vent Valve must be opened as shown in Figure 6 2 page 41 to accommodate the heat and pressure changes of the Gas Sterilization process To open the Valve press the red Vent Cap onto the Vent Valve and rotate it clockwise until it is seated and locked After EtO Gas Sterilization Effective aeration must be completed after EtO gas sterilization Vision Sciences Inc recommends following the instructions for use supplied by the manufacturer of the gas sterilizer and that a biological indicator be used to confirm sterilization efficacy CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 45 Reprocessing STERRAD and STERIS Sterilization Prior to STERRAD and STERIS Sterilization the endoscope must be leak tested cleaned and dried as described in this chapter The CST 5000 5000 Flexible Video Cystoscope Hysteroscope has been validated for material and functional compatibility with the following sterilization systems cycles STERRAD STERRAD STERRAD STERIS 100S NX 100NX System 1E i d Y Y Short and Long Short and Long Flex Cycle Cycles Cycles Only Table 6 1 STERRAD and STERIS Validated Systems Cycles Refer to the STERRAD or STERIS Sterilization System User s Manual for complete d
50. infection protocols may pose an infection control risk and or cause equipment damage Only use the endoscope and peripheral equipment according to the instructions and under the operating conditions given in this User s Manual Failure to do so could result in compromised safety equipment malfunction and or instrument damage If training assistance is desired from either the manufacturer or local distributor please contact Vision Sciences Customer Service at 800 874 9975 or 1 845 359 0276 Reprocessing The endoscope must be thoroughly cleaned disinfected and or sterilized before its first use and after each subsequent use This is the only way to ensure that a patient ready endoscope is used in every procedure See Chapter 6 Reprocessing for information on all reprocessing equipment and procedures Maintenance and Repair The endoscope contains no user serviceable parts never attempt to modify or repair it Doing so may cause further equipment damage and or compromise patient safety if the endoscope is subsequently used in a procedure The endoscope may only be serviced repaired at an authorized Vision Sciences Inc facility In addition to thoroughly inspecting the endoscope before each procedure it should be periodically inspected to determine if there is damage or wear that requires attention Signal Words Information included in this manual to warn users of the possibility of patient injury and or
51. ion If the user suspects the endoscope has been contaminated it will be necessary to immerse the endoscope in a high level disinfectant e Sterilization In addition to high level disinfection the endoscope may be sterilized using ethylene oxide EtO gas It must then be thoroughly aerated to ensure that all residues have been removed The endoscope may also be sterilized using a validated STERRAD or STERIS system Refer to the STERRAD STERIS section in this chapter Leak Testing The CST 5000 5000 Flexible Video Cystoscope Hysteroscope must be evaluated for possible leaks in the Control Body and or the Insertion Tube before immersion in any fluids The Leak Tester accessory should be used for this test Vision Sciences Leak Tester is required Follow the steps given below It is essential that gloves be worn when performing the leak test procedure in case the endoscope s Insertion Tube has been contaminated and requires further disinfection or sterilization An endoscope in this condition can present an infection control risk to the person s reprocessing the endoscope 38 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Reprocessing Attach the Leak Tester to the Endoscope Connect the Leak Tester to the endoscope s Vent Valve see Figure 6 1 Align the slot on the Leak Tester s connector with the pin on the Vent Valve then push down and rotate the connector clockwise until it locks
52. ions for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above the System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the System Over the frequency range 150 KHz to 80 MHz field strengths should be less than 3 v m Table A 4 Electromagnetic Immunity Declaration CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 63 Appendix Recommended separation distances betweenportable and mobile RF communications equipment and the System The CST 5000 5000 Flexible Video Cystoscope Hysteroscope with the DPU 5000 7000 Series Video Processor the System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the System as recommended below according to the maximum output power of the communications equipment
53. ironmental Effects on Optical Performance None Angulation 215 Up 140 Down CV 2 1 Sheath 08 5101 Working Channel Diameter 2 1 mm 6 3 Fr CV 1 5 Sheath 08 5102 Channel Diameter 1 5 mm 4 5 Fr Operating Environment Temperature Relative Humidity Air Pressure 50 to 104 F 10 to 40 C 30 to 85 700 to 1060 hPa Storage Environment Temperature Relative Humidity Air Pressure 14 to 140 F 10 to 60 C 0 to 95 700 to 1060 hPa Mode of Operation Continuous Electrical Safety IEC 60601 1 amp IEC 60601 2 18 Thermal Safety IEC 60601 1 amp IEC 60601 2 18 Electromagnetic Compatibility IEC 60601 1 2 Degree of Protection Against Electrical Shock Type BF Degree of Protection Against Invasion of Liquids Fully Immersible as per Reprocessing Instructions Table A 1 Specifications CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 59 Appendix Infection Control Information The Slide On EndoSheath Technology for the CST 5000 5000 Flexible Video Cystoscope Hysteroscope is designed to offer practitioners the ability to perform safe efficient endoscopy The Slide On EndoSheath Technology has been proven to be an effective barrier to microorganisms as small as 27 nanometers Efficacy testing for barrier qualities has been performed by an independent laboratory per FDA required guidelines
54. l or other cleaning agents prior to use CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 23 Installing and Removing the Slide On EndoSheath Technology L Nork Refer to Instructions For Use for CV 2 1 and CV 1 5 Sheaths CAUTION Do not use this equipment in the presence of a flammable anesthetic mixture containing air oxygen or nitrous oxide There is a possibility of fire or explosion Prepare the Endoscope and Sheath 1 Before installing the Sheath clean the endoscope s lens on the Distal Tip with an alcohol prep pad Do not use abrasive materials to clean any part of the endoscope particularly the lens at the Distal Tip Doing so could damage the lens and impair the endoscope s imaging capability Connect the CST 5000 5000 video cable to the DPU 5000 7000 Series video processor and turn the processor on Check the EndoSheath disposable packaging for defects or damage Open the Sheath s package carefully put on two pairs of sterile gloves Remove the Drape Bag from the tray open remove the adhesive strip backing and press the adhesive area to the back of the Installation Stand Secure the Drape Bag with a plastic clip if necessary Carefully remove the Sheath from the package Place the Sheath into the Installation Stand with the Accessory Port facing outward toward you NOTE The Sheath fits in the Stand in only one direction Discard the disposable packaging Fold back th
55. moved toward the Insertion Tube the Distal Bending Section will articulate in the visual down direction Flow Control Valve Secures the EndoSheath Irrigation Tubing for button actuated irrigation during use with Open Flow and Close Flow buttons Videoscope Cable The connector at the end of the cable connects to the DPU 5000 7000 Series Video Processor Control Buttons Four programmable function buttons which allow the user to activate different functions of the video system Consult the DPU 5000 7000 Series Video Processor User s Manual for instructions regarding the control functions and how to program the buttons Locking Knob Mates with the EndoSheath Rigid Connector to secure the Slide On EndoSheath Technology to the endoscope EndoSheath Interface Secures the disposable EndoSheath cover to endoscope body Identification Ring Includes the Serial Number which is a unique number identifying the endoscope and the S symbol which indicates the endoscope can be sterilized using a validated STERRAD STERIS system The endoscope must feature this symbol on the Identification Ring in order for STERRAD STERIS compatibility to apply Vent Valve When the Vent Cap is connected this valve allows access to the interior of the endoscope for EtO and STERRAD gas sterilization and should be connected during transport The Vent Cap must be attached to the valve prior to EtO and STERRAD gas sterilization a
56. n e Shipping The Vent Cap is to be removed from the endoscope prior to e Patient Procedures e Immersion in Fluids Figure 6 2 Opening the Vent Valve Cleaning After Slide On EndoSheath Technology Use The Slide On EndoSheath Technology is intended for a single use only do not reuse it When the procedure is complete remove the Sheath from the endoscope and dispose of it as described in Chapter 4 Installing and Removing the Slide On Endo Sheath Technology Reusing the Sheath can present an acute infection control risk to the user and the next patient on whom the endoscope is used CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 41 Reprocessing After a procedure in which the Slide On EndoSheath Technology was attached over the endoscope s Insertion Tube Vision Sciences Inc recommends performing the following prophylactic cleaning and intermediate disinfection routine between endoscopic procedures C AUTION Because of the possibility that a Sheath could be torn or that the endoscope or Sheath could come in contact with contaminated surfaces the user should develop and follow a prophylactic routine when handling the endoscope sheathed or unsheathed 1 After removing the Sheath inspect the Insertion Tube and Distal Bending Section and confirm that these areas are dry If moisture is observed there may have been a leak into the Sheath during the procedure providing the
57. nd prior to shipping The valve is also used as a Leak Tester Connector for Leak Testing Distal Bending Section Deflects up and down when the Angulation Lever is actuated Distal Tip The terminating point of the video camera module and the light guide fiber bundles Light Guides Sealing Cap Seals the plug prior to soaking for leak testing or disinfection Control Body This component provides physician control over endoscopic functions Insertion Tube This segment along with the Distal Tip is the part of the endoscope that is inserted into the patient CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 15 Endoscope and Accessories CV 2 1 Slide On EndoSheath Technology The CV 2 1 Slide On EndoSheath Technology shown in Figure 3 3 is a sterile disposable barrier for the Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope The Sheath isolates the endoscope from contact with patient fluid and material during the procedure 16 Figure 3 3 CV 2 1 Slide On EndoSheath Technology Control Body Cover Covers and protects the endoscope s Control Body from contaminants during the procedure Slot for Locking Knob Slides past the Locking Knob to secure the Sheath to the endoscope Accessory Port with Removable Seal Allows rapid fluid injection and passage of accessory instruments during procedures A removable Accessory Port Valve Seal allows for secure Luer Lock syringe attac
58. nding Section is angulated Verify that the CV 2 1 Slide On Endo Sheath is being used Check the diameter of the accessory Make sure that the Accessory is compatible with a 2 1 mm Working Channel Remove the endoscope from the patient and inject 10cc of saline through the Channel If after repeated attempts the channel remains blocked remove the Sheath from the endoscope and install a new one Do not force the Accessory through the working Channel as this may damage the Channel and compromise the integrity of the barrier Maneuver the endoscope s Distal Tip to an area of the anatomy in which it can be safely straightened out Insert the Accessory until its tip can be seen on the endoscopic image Now angulate the endoscope s Distal Bending Section and proceed to the desired area Table 8 1 Troubleshooting cont d 54 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 9 Warranty and Service Warranty Information L NorE Alterations or repairs done by persons not authorized by Vision Sciences Inc will void this warranty Vision Sciences Inc is not liable for any damages to the CST 5000 5000 Flexible Video Cystoscope Hysteroscope resulting from misuse negligence or improper cleaning or storage The warranty defined herein shall apply only to the original buyer In no event shall Vision Sciences Inc be liable for anticipated profits consequential damages or loss of time incurred by the buye
59. nt Light Intensity is set too low Adjust Light Intensity setting Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 9 Warranty and Service Damaged light guide fiber bundles Internal light source is Return the endoscope to Vision Sciences deteriorating Inc for repair Refer to Chapter 9 Warranty and Service Wrinkles These may be a result Return the endoscope to Vision Sciences and or folds in of excessive force Inc for repair Refer to Chapter 9 Warranty the Insertion applied to the Insertion and Service Tube Tube during cleaning or Sheath removal or the long term effects of repeated immersion in chemical disinfecting solutions which could stretch and weaken the outer coverings Insertion tube Dents can be caused by Return the endoscope to Vision Sciences is dented physical trauma to the Inc for repair Refer to Chapter 9 Warranty endoscope e g and Service closing the case on the Insertion Tube Loss of The Leak Tester is not Re connect the Leak Tester and perform the pressure during connected properly to test again leak test the Vent Valve The Leak Tester s Close the Pressure Relief Valve Pressure Relief Valve is open A hole or crack has Return the endoscope to Vision Sciences broken the endoscope s Inc for repair Refer to Chapter 9 Warranty watertight seal and Service Table 8 1 Troubleshooting cont d CST 5000 5000 Flexible Video Cystoscope
60. on EtO Gas Sterilization STERRAD 100S NX 100NX STERIS System 1E Endoscope must feature the S symbol for STERIS STERRAD compatibility Incompatible Methods The high level disinfection and sterilization chemicals and methods shown below are not compatible with the CST 5000 5000 Flexible Video Cystoscope Hysteroscope DO NOT USE THEM as they could cause extensive damage to the endoscope If you have any questions regarding the compatibility of a given disinfection or sterilization method please contact your local distributor or the Vision Sciences Customer Service Center Incompatible High Level Disinfection and Sterilization Methods Chemicals High Level Disinfection DO NOT USE Chemicals e Chlorines e Formaldehyde e Iodophors Sterilization Methods DO NOTUSE Autoclave e Ultrasonic CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 43 Reprocessing High Level Disinfection Protocol If the endoscope was determined to be free of leaks it may be immersed in a glutaraldehyde solution for the amount of time recommended by the disinfectant manufacturer to achieve high level disinfection E AUTION It is imperative that the endoscope be leak tested and cleaned prior to immersion in high level disinfectant Failure to do so may not detect leaks that could allow fluid ingress and damage the endoscope Failure to clean the endoscope may allow gross debris to remain on external surface
61. on L AUTION Avoid excessive bending or twisting of the endoscope s Insertion Tube particularly at the distal end While the tube is designed to bend excessive pressure can damage the fiber bundles and internal components Excessive angulation or excessive pressure placed on the Angulation Lever may cause equipment damage Do not exert force to move the lever beyond its natural limits 1 Hold the endoscope so that the Control Body fits comfortably in your hand allowing easy manipulation of the Angulation Lever The other hand is free to manipulate the Insertion Tube 2 The DPU 5000 7000 Series Video Processor should be on adjust the settings to the desired level using the Processor s controls 3 Perform the White Balance function 4 Prepare the patient using normally acceptable clinical practice prior to endoscope insertion 5 Lubricate the outside of the Sheath before inserting the endoscope into the patient Vision Sciences Inc recommends that the Sheath be lubricated with water or a water based lubricant just prior to insertion 6 Introduce the sheathed endoscope into the patient using normally acceptable clinical practice Operate the Angulation Lever as necessary for advancement and observation CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 31 Preparation Inspection and Operation NorE The four 4 programmable buttons on the endoscope s Control L Body may be programmed on the Video Proc
62. oving the Slide On EndoSheath Technology for complete details Carefully inspect all equipment before using it in a procedure and do not use any equipment that is damaged or excessively worn Doing so could lead to patient injury and or further damage to the equipment If inspection reveals difficulty in articulation of the endoscope s Distal Bending Section the endoscope may be damaged Do not use the endoscope if damage occurs doing so could cause patient injury and may result in further damage to the endoscope All devices that are connected to the CST 5000 5000 Flexible Video Cystoscope Hysteroscope and DPU 5000 7000 Series Video Processor must be Classified Medical Equipment Before using any additional equipment confirm that it complies with the appropriate end product safety standard such as IEC 60950 1 and the Standards for Medical Electrical Equipment UL 60601 1 or IEC 60601 1 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 5 Important Information Never drop the equipment or subject it to severe impact as it could compromise the functionality and or safety of the equipment or system Should the equipment be mishandled or dropped do not use it Immediately return it to an authorized Vision Sciences service facility for inspection and repair While the Sheath is being installed the endoscope should move freely without the application of force Should any resistance be encountered verify that
63. pe User s Manual 13 Endoscope and Accessories CST 5000 5000 Flexible Video Cystoscope Hysteroscope CST 5000 CST 50004 Figure 3 2 CST 5000 5000i Flexible Video Cystoscope Hysteroscope Control Body Instrument Components 1 14 Angulation Lever Located on the Control Body this component Controls Distal Bending Section deflection There is only one difference between the CST 5000 and 5000 Models the Up and Down conventions are reversed in the Angulation Lever and its effect on articulation deflection in the Distal Bending Section CST 5000 Model The Angulation Lever on the CST 5000 provides control of the bending section in the traditional directions This indicates that when the Angulation Lever is moved toward the top of the Control Body the Distal Bending Section will articulate in the visual down direction When the Angulation Lever is moved toward the Insertion Tube the Distal Bending Section will articulate toward the visual up direction CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 10 11 A B Endoscope and Accessories CST 5000 Model The Angulation Lever on the CST 5000 provides control of the bending section in the intuitive directions This indicates that when the Angulation Lever is moved toward the top of the Control Body the Distal Bending Section will articulate in the visual up direction When the Angulation Lever is
64. plug or the Leak Tester to endoscope connection may be loose Check the Pressure Relief Valve on the Leak Tester it may still be open and should be closed Make sure the Sealing Cap is securely placed over the plug remove and reattach the Leak Tester to the endoscope and repeat Steps 1 3 e Ifthe pressure decreases after the connections are restored the endoscope has a damaged seal Do not continue to use the endoscope or immerse it in fluids in this condition Contact your regional distributor or the Vision Sciences Customer Service Center to arrange for evaluation and or repair When returning the endoscope follow the instructions given in Chapter 9 Warranty and Service 4 If the needle s position remains steady on the Leak Tester immerse the entire endoscope in water and observe it for thirty 30 seconds Angulate the Distal Bending Section up and down while the endoscope is immersed as holes in the soft covering of the Distal Bending Section may not be evident while it is in a relaxed position 5 A steady stream of air bubbles at a given location indicates a small leak in the endoscope that was not detected by the pressure gauge If a leak is detected the air pressure in the endoscope will prevent water from entering through the leak However immediately remove the endoscope from the water and do not immerse it in any more fluids C AUTION Do not continue to use an endoscope if leaks are detected Contact your local distribu
65. r functions CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual i How to Use This Manual Chapter 4 Installing and Removing the Slide On EndoSheath Technology The Slide On EndoSheath Technology is a sterile single use barrier placed over the endoscope s Insertion Tube before the procedure and removed and discarded after the procedure is completed This chapter includes the procedures for installing the sheath prior to the procedure and removing it when the procedure is over Chapter 5 Preparation Inspection and Operation This chapter describes how to prepare the endoscope and peripheral equipment for use and how to assemble the equipment into a system The chapter also leads you through a detailed inspection procedure to confirm that the equipment is undamaged and working properly before it is used in a procedure Chapter 6 Reprocessing This chapter contains important instructions on the proper cleaning disinfection and sterilization of the endoscope before its first use and after each subsequent use Strict adherence to the instructions in this chapter will render the endoscope patient ready for each procedure Chapter 7 Care and Storage If the endoscope will not be used for a prolonged period refer to this chapter for instructions on safe secure storage Chapter 8 Troubleshooting Describes possible problems that may be encountered with the endoscopic system and suggests correctiv
66. r CV 1 5 Slide On EndoSheath Technology for the CST 5000 5000 Flexible Video Cystoscope Hysteroscope Processor refers to the DPU 5000 7000 Series Video Processors 2 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 2 Important Information The information in this chapter is essential for the correct and safe operation of the CST 5000 5000 Flexible Video Cystoscope Hysteroscope Please read and understand this information before preparing or using the endoscope or any peripheral equipment with which it will be used Intended Use Cystoscopy The Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope with Slide On EndoSheath Technology is intended to be used for endoscopic access to and examination of the lower urinary tract including the bladder When combined with accessory instruments the endoscopic system allows the user to perform various diagnostic and therapeutic procedures Hysteroscopy The Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope and Slide On EndoSheath Technology is also intended to be used for direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures Do not use the equipment for any purpose other than these intended uses Contraindications for Hysteroscopy The CST 5000 5000 endoscope and Slide On EndoSheath Technology should not be used to perform
67. r to the instructions for use that are shipped with the system These instructions will provide complete details on preparing installing and removing the disposable sheath During the procedure the temperature at the distal end of the endoscope may exceed 41 C 106 F due to the intense endoscope illumination Surface temperatures over 41 C 106 F may cause mucosal burns Always use the minimum level of illumination necessary for adequate viewing Whenever possible avoid close stationary viewing and do not leave the distal end of the endoscope in close proximity to mucous membranes for a long time The Slide On EndoSheath Technology is shipped sterile and intended for a single use only do not reuse it When the procedure is complete remove the Sheath from the endoscope and dispose of it Reusing the Sheath can damage it and in turn cause endoscope damage In addition a reused Sheath presents a marked infection control risk to the next patient A complete review and understanding of the DPU 5000 7000 Series User s Manual is recommended before using the CST 5000 5000 Flexible Video Cystoscope Hysteroscope Preparation and Inspection Follow the inspection steps listed below before connecting any equipment or using the system Do not use the equipment if abnormalities are detected Select an Installation Site It is important to select an appropriate location in which to install the Video Processor e Place the Video P
68. r with the purchase or use of this equipment L NoTE Vision Sciences Inc sells many of its products through regional distributors Before sending equipment to Vision Sciences Inc contact your regional distributor for repair return procedures Vision Sciences Inc warrants that the CST 5000 5000 Flexible Video Cystoscope Hysteroscope and its accessories will be free from defects in materials and workmanship for a period of one year from the date of the invoice Replacement parts are warranted for a period of ninety 90 days from the date of the invoice All non warranty repairs will be warranted to be free from defects in materials and workmanship for a period of ninety 90 days from the date of the invoice Upon receipt of a CST 5000 5000 Flexible Video Cystoscope Hysteroscope for repair Vision Sciences Inc will evaluate the instrument and make the final decision as to the warranty status The above warranties are in lieu of all other warranties either expressed or implied including warranties of fitness or merchantability CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 55 Warranty and Service Vision Sciences Service Information CST 5000 5000 Flexible Video Cystoscopes Hysteroscopes are serviced at authorized Vision Sciences repair facilities only Use the following procedure to expedite returned goods for repair or replacement 1 Telephone your Regional Distributor Territory Manager
69. re its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The System is suitable for use in all CISPR 11 establishments non domestic excepting those directly connected to a public low voltage power Harmonic emissions Class A supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage Complies fluctuations flicker emissions IEC 61000 3 3 Table A 2 Electromagnetic Emissions Declaration CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 61 Appendix Guidance and manufacturer s declaration electromagnetic immunity The CST 5000 5000 Flexible Video Cystoscope Hysteroscope with DPU 5000 7000 Series Digital Video Processor the System is intended for use in the electromagnetic environments specified below The customer or the user of the System should ensure that it is always used in such environments Immunity Test IEC 60601 test Compliance Electromagnetic environment level level guidance Electrostatic 6kV contact 6kV contact Floors should be wood concrete or ceramic tile If floors are covered with discharge ESD 8KV air 8KV air synthetic material the relative idi 0 IEC 61000 4 2 humidity should be at least 3096 Electrical fast 2kV for power 2kV for Mains power quality should be the transient burst supply lines power supply equivalent of that in
70. rocessor on a stable rigid surface such as a cart counter top or solid stand e The location must not contain explosive or flammable gases CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 29 Preparation Inspection and Operation e Place the CST 5000 5000 Videoscope and Video Processor away from radios televisions cell phones or any other devices that emit electromagnetic energy These can interfere with proper operation Avoid stacking the Videoscope or the Video Processor on other equipment to avoid possible electromagnetic interference e Place the Video Processor in a dry place and avoid contact with liquids e Do not allow the Video Processor s vents to be obstructed full ventilation is necessary for proper operation Vents are located on the bottom and back of the unit 1 Check the Insertion Tube for holes superficial cuts or abrasions 2 Lightly run your fingertips over the entire length of the Insertion Tube to confirm that it is smooth and does not exhibit looseness or bagging B AUTION Do not apply excessive pressure to the endoscope s Insertion Tube Doing so can damage the internal components of the insertion tube 3 Check the Distal end of the Sheath s working channel for any sharp edges being careful to minimize contact with the clear window 4 Check for full Distal Tip deflection by actuating the Angulation Lever up and down DL AUTION Avoid applying excessive pressure w
71. s which could impair proper disinfection In the event that the endoscope fails the leak test do not immerse the endoscope in liquids and do not use it in a procedure Return the endoscope to the manufacturer for repairs Make sure that the sealing cap is securely attached to the Videoscope Cable prior to immersion Failure to do so will lead to fluid invasion and severe equipment damage Pre Cleaning 1 Gently wipe down the Insertion Tube and Distal Bending Section with a soft lint free cloth or gauze 4x4 to remove visible debris Perform the Leak Test procedure Gently wash down all external surfaces with an enzymatic cleaning solution and soak the endoscope in the enzymatic cleaning solution for the time recommended by the enzymatic solution s manufacturer 4 Remove the endoscope from the cleaning solution and rinse it thoroughly with clean lukewarm water 5 Dry all external surfaces of the endoscope Disinfection 1 Immerse the endoscope in the disinfectant solution at the temperature recommended by the disinfectant manufacturer 2 Allow the endoscope to remain immersed in the disinfectant solution for the period of time recommended by the disinfectant manufacturer 3 Following disinfection remove the endoscope from the solution Rinsing 1 Immerse the endoscope in a container of clean lukewarm water 2 Thoroughly rinse the outside of the endoscope with clean lukewarm water and place it on a clean dry surface 3
72. scope Hysteroscope is not compatible with any other manufacturers video processors Attempting to connect the endoscope to or use it in conjunction with another manufacturer s video processor could cause damage to the endoscope and or the video processor The CST 5000 5000 Flexible Video Cystoscope Hysteroscope must be used in conjunction with a DPU 5000 7000 Series Video Processor shown in Figure 3 5 below Refer to the DPU 5000 7000 Series User s Manual for complete instructions on the operation of the unit Figure 3 5 DPU 5000 7000 Series Digital Video Processor CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 19 Endoscope and Accessories Installation Stand CAUTION Installation and removal of the Slide On EndoSheath Technology onto and from the Cystoscope Hysteroscope should always be performed using the Installation Stand Failure to do so may cause difficulty in installation and or equipment damage Refer to Figure 3 6 below and to the Installation Stand s Instructions For Use for information on the correct preparation and use of the stand Figure 3 6 Installation Stand 1 EndoSheath Slot Holder The slot that securely holds the EndoSheath Connector which is designed to fit with its Accessory Port facing out 2 Endoscope Storage Slots Post procedure slots for hanging endoscopes Not intended for long term storage unless the Installation Stand is wall mo
73. scope is clean and dry prior to installing the Slide On EndoSheath Technology Any moisture on the endoscope prior to installation may result in difficulty removing the endoscope from the Slide On EndoSheath Technology after the procedure Wear appropriate protective gear when using the Slide On EndoSheath Technology and Cystoscope Hysteroscope including gown gloves and face and eye shields To maintain a sterile field during installation it is recommended that users wear two 2 pairs of sterile gloves The Endoscope and Sheath do not have any user serviceable parts Do not attempt any repairs If malfunction occurs refer to the Troubleshooting section of this manual or call Vision Sciences Inc for assistance Install the Slide On EndoSheath Technology Before installing the Sheath carefully inspect the endoscope s Insertion Tube for any damage or defects If any irregularities are found do not use the endoscope Using a damaged or defective endoscope could damage the Sheath cause further damage to the endoscope itself and or cause patient or user injury The Slide On EndoSheath Technology is supplied sterile and is intended for a single use only Do not reuse or attempt to re sterilize the Sheath as it could become damaged which could in turn cause damage to the endoscope and or present an infection control risk to the patient and or user Do not expose the interior or exterior of the Sheath to alcoho
74. solutions Perform the High Level Disinfection Protocol described in this chapter e Sterilization by Ethylene Oxide EtO Gas The endoscope may be sterilized using a validated EtO protocol The acceptable processing parameters and procedure are given in the Ethylene Oxide EtO Gas Sterilization section beginning on page 45 42 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Reprocessing e Sterilization by STERRAD The endoscope may be sterilized using a validated STERRAD protocol Refer to Table 6 1 on page 46 for the approved systems cycles suitable for use with this endoscope e Sterilization by STERIS The endoscope may be sterilized using a validated STERIS protocol Refer to Table 6 1 on page 46 for the approved system suitable for use with this endoscope WNE gpI Disinfection and sterilization methods not listed here may be harmful to the endoscope and could cause extensive equipment damage Please contact Vision Sciences Customer Service to determine the compatibility of a disinfection or sterilization method not listed in this manual and or a complete list of functionally compatible agents Acceptable Reprocessing Materials Cleaning e e Intermediate Level e Disinfection e High Level Disinfection E Sterilization e Soft Material Lint Free Gauze 4x4 Enzymatic Cleaner Instrument Grade Detergent 70 Isopropyl Alcohol or 70 Ethyl Alcohol 2 4 Glutaraldehyde based soluti
75. stion during cauterization Follow all manufacturer instructions on proper equipment preparation and use Accessories should be inspected for damage before and after each procedure Before inserting or removing the laser fiber accessory ensure that the endoscope s Distal Bending Section is in the neutral position and straight If the Distal Bending Section is articulated there is a risk of damaging the Instrument Channel of the Slide On EndoSheath Technology CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 35 6 Reprocessing The CST 5000 5000 Flexible Video Cystoscope Hysteroscope utilizes the Slide On Endo Sheath Technology The Slide On EndoSheath Technology is a sterile disposable protective covering which limits the need for elaborate chemical disinfection or sterilization procedures after every endoscopy procedure The complete system enables the user to implement a fast and effective method of reprocessing the endoscope and benefits both user and patient by providing an Insertion Tube covered with a sterile Sheath for every procedure For cleaning disinfection procedures when using the EndoSheath Technology see Cleaning After Slide On EndoSheath Technology Use on page 41 The endoscope must be properly reprocessed by cleaning disinfection or sterilization before its first use and after each subsequent use according to protocols in this section Using an endoscope in a procedure that has not been prop
76. the Insertion Tube The use of excessive force could damage the endoscope Do NoT immerse the endoscope in disinfectant solution for long periods of time gt 1 hour Prolonged immersions may damage the outer coverings of the endoscope and allow fluid infiltration Do Nor place the endoscope in or near contaminated areas after it has been reprocessed Doing so can re contaminate the endoscope and require reprocessing to be repeated Do Nor place the endoscope in awkward or confining areas between procedures as this could result in equipment damage CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 3 Endoscope and Accessories The Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope and Slide On EndoSheath Technology are designed to perform safe sterile and efficient cystoscopic hysteroscopic procedures The two major components of the endoscopic system are e The CST 5000 5000 Flexible Video Cystoscope Hysteroscope which is shown in Figure 3 1 and Figure 3 2 on pages 13 and 14 The endoscope s Insertion Tube has no working channel it contains the video camera module and illumination bundles e The disposable Slide On EndoSheath Technology The sterile disposable Sheaths are installed over the endoscope s Insertion Tube acting as a protective barrier to protect patients and users from the spread of potentially pathogenic materials The Sheaths also contain working channels thro
77. the Sheath s channel is properly aligned If the channel of the Sheath is misaligned straighten out the channel before continuing scope insertion as shown in Figure 2 1 below Also refer to Chapter 8 Troubleshooting for further information If the suggestions given in that chapter do not solve the alignment or insertion problems contact your local distributor or Vision Sciences Customer Service Department NoTE The Vision Sciences CST 5000 5000 Flexible Video Cystoscope Hysteroscope and Slide On EndoSheath Technology are not made with natural rubber latex MISALIGNED ALIGNED Figure 2 1 Incorrect and Correct Sheath Alignment 6 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Important Information During Use General CAUTION Do not use this equipment in the presence of a flammable anesthetic mixture containing air oxygen or nitrous oxide There is a possibility of fire or explosion If any component of the endoscopic system malfunctions during the procedure or if the endoscopic image is lost or compromised immediately move the endoscope s Distal Bending Section to the neutral position and slowly withdraw the endoscope from the patient Using an endoscope that is not functioning properly could cause patient injury and or further damage to the equipment Do not use any accessory instrumentation that is damaged Doing sO may result in instrumentation malfunction during the proc
78. tly manipulate the edges of the Sheath s Window to fully seat it Align the opening of the EndoSheath Connector with the Insertion Tube Replace the Sheath Rotate Locking Knob to the vertical position Contact your regional distributor or Vision Sciences Inc for removal instructions Disinfect sterilize the endoscope Use a syringe without a needle to introduce small amounts of 70 alcohol into the opening at the proximal end of the EndoSheath Connector When the liquid reaches the Distal Tip of the endoscope sheath carefully attempt to remove the endoscope from the Sheath If necessary contact your Regional Distributor or Territory Manager for removal instructions Disinfect sterilize the endoscope Align the flat portion of the Insertion Tube with the Biopsy Port and then remove the endoscope from the Sheath Gently grasp the Sheath s Optical Window using the hanging drape bag as a barrier between your fingers and the Sheath Then slowly and gently withdraw the endoscope from the Sheath Table 8 1 Troubleshooting cont d 52 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Glare evident when viewing through the sheath Insufficient or no irrigation during procedure Cannot inject fluid through the Accessory Port The Sheath s window is not in contact with the Distal Tip of the endoscope due to Incomplete insertion into the Sheath OR The endoscope s tip is damag
79. tor or the Vision Sciences Customer Service Center to arrange for evaluation and or repair When returning the endoscope follow the instructions given in Chapter 9 Warranty and Service L Norte Do not mistake the release of trapped air from the crevices on the endoscope s outer surface for a leak Trapped air can be released by tapping the endoscope gently after immersing it in water 6 The absence of air bubbles confirms that the endoscope is watertight Remove it from the water and open the Leak Tester s Valve 7 Make sure that the needle on the pressure gauge falls to zero 0 and disconnect the Leak Tester from the endoscope The endoscope can now be safely immersed in cleaning solutions CAUTION Failure to discharge depressurize the endoscope after leak testing may place stress on the soft covering of the Insertion Tube potentially producing a rolling over of the covering 40 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Reprocessing Cleaning Disinfection Sterilization Use of the Vent Cap IM YER E Failure to follow the instructions given in this section regarding the use of the Vent Cap may result in damage to the endoscope Any such damage will void the product warranty The Vent Cap is to be attached to the endoscope prior to all of the following procedures in order to prevent damage to the endoscope caused by changes in pressure and temperature e Gas Sterilization e Aeratio
80. ugh which irrigation can be performed and or accessory equipment can be used There are two types of Sheaths available for use with the CST 5000 5000 a The CV 2 1 Slide On EndoSheath Technology Figure 3 3 on page 16 This Sheath contains a 2 1mm 6 3Fr channel through which irrigation fluids can be instilled into the patient or accessory instruments can be inserted a The CV 1 5 Slide On EndoSheath Technology Figure 3 4 on page 18 has a 1 5mm 4 5Fr channel that supports irrigation but cannot accommodate the insertion of accessory devices CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual 11 Endoscope and Accessories Inspect the Standard Set Do not use any equipment that is observed to be damaged or excessively worn Doing so could lead to patient injury and or further damage to the equipment When the endoscope is received from Vision Sciences Inc immediately confirm that all of the applicable items listed in Table 3 1 have been shipped and inspect them for damage If any item is missing or damaged do not use the endoscope Contact Vision Sciences Inc to obtain a replacement part CST 5000 5000 Cystoscope Hysteroscope Standard Set VISION SCIENCES CATALOG NO 08 5201 08 5202 08 5203 08 5204 07 6180 07 6015 DESCRIPTION CST 5000 Flexible Video Cystoscope Hysteroscope NTSC CST 5000 Flexible Video Cystoscope Hysteroscope PAL CST 5000 Flexible Video Cystoscope Hysteroscope N
81. unted 3 Cable Storage Slots For securing the Videoscope Cable when the endoscope is not in use or being stored 4 Wall Mounting Bracket Holes For mounting on a wall or inside a cabinet for storage purposes 20 CST 5000 5000 Flexible Video Cystoscope Hysteroscope User s Manual Endoscope and Accessories Accessories Do not use any accessories that are not in compliance with the equivalent safety requirements of this equipment Doing so may reduce the operational safety of the system and could cause patient and or user injury For all accessories confirm that safety certifications have been performed in accordance with the appropriate standard IEC 60601 1 and or IEC 60601 1 1 The use of accessories not specified in this manual or sold by Vision Sciences Inc may result in increased electromagnetic emissions or decreased immunity of the equipment or system Video Processor The CST 5000 5000 Flexible Video Cystoscope Hysteroscope is designed to work with the Vision Sciences DPU 5000 7000 Series Video Processors The endoscope is not compatible with any other manufacturers video processors Light Sources The CST 5000 5000 Flexible Video Cystoscope Hysteroscope has an integrated solid state light source which is controlled by the DPU 5000 7000 Series Video Processors No external light source is required for the CST 5000 5000 Flexible Video Cystoscope Hysteroscope Leak Testing The CST 5000 5000 Flexible
82. utor or the manufacturer MedPass International Ltd Windsor House Bretforton Evesham Worcestershire WR11 7JJ United Kingdom C 0843 2009 2010 2012 2013 2014 Vision Sciences Inc Vision Sciences EndoSheath and Slide On are registered trademarks of Vision Sciences Inc Covered by one or more of the following U S Patents 6 350 231 6 530 881 6 733 440 Other U S and international patents pending 03 14 09645 EN Rev F 02014

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