User`s Manual - PolyDiagnost
Contents
1. POLYDIAGNOST Operating Manual MICROPERC Optic 10 000 pixels semi rigid PD PN 0080 C Eoss PD_IFU_MicroPerc optic E_A 1 PD PN 0080 Rev A Date 19 03 2015 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 3 1 3 2 4 1 4 2 4 3 4 4 4 5 4 6 5 1 9 1 4 5 1 2 5 1 3 5 1 4 Du 5 2 1 5 2 2 5 2 3 5 2 4 9 2 0 5 2 6 27 5 3 Table of Contents Page Safety NSS ss a men 4 Intended m 4 VP idunoIN6VUCi0liS ss a S I eee 4 After Receiving the Optic cscccsscsecessesccecnenecusnenecusnenecusnensceseenscuseenseuseenteuseenteuseentantas 4 Surroundings Operation esessseeeeeenenenne nenne nenne nene nnne nennen nenas sena na sena ne nenas 4 ReDIOCeSSIDO and SO I N K K E MIO UE 5 Products in sterile DOCS TE susce N K N N 5 Compatibility and accessories eeseeeeeeenene nennen nennen nenne nennen nnne nenas 5 Een 5 Repair fepl c l ft www SKEEREFFEKERNTFESEFHVEKEEXMESKIETERSFEFETIGESE FE E VE RE EET EFE VER V 5 MICROPERC Optic Specifications 6 Product DSC DU OR gente S S S ON I O N NN ERIS 7 MICROPERE OPIC a si UE 7 MICROPERC Set aaa 8 MICROPERC operating mode eeeeeeeeeneeeeeme enne nnne eene enn nnn 10 Assembly T N 10 Connection to the endoscopy video system aja 11 Check the2. Problem Possible causes Remedy Problem Possible causes Remedy No picture no or insufficient connection to the light guide cable endoscope or the light source incorrect light guide cable adapter no or insufficient connection between the endoscope and the ocular defective optic light source and or camera and or monitor defective configuration of the monitor camera is not correct mains power not connected or failed check the connections to the light guide cable and ocular check the light guide cable check the light source camera and monitor check the monitor camera configuration check the mains power send in the optic Cloudy image stripes streaks etc the optical components of the endoscope are dirty defective optic carefully clean with a swab dunked in alcohol 70 ethanol or appropriate cloths send in the optic Severe noise due to insufficient amount of light the optical components of the endoscope are dirty insufficient connection to the light guide cable endoscope or the light source insufficient connection between the endoscope and the ocular defective light guide cable or defective light guide to the optic careful cleaning with a O tip dunked in alcohol or suitable cloths check the connections to the light guide cable and ocular check the light guide cable send in the optic If the trouble cannot be solved using simple measures
3. Reusable optic room temperature 15 C to 35 C Operating conditions rel humidity 30 9o to 60 air pressure 760 to 1060 mbar temperature 10 C to 45 C rel humidity 10 to 85 air pressure 760 to 1060 mbar Conditions for storage and transport PD IFU MicroPerc optic E A 6 PD PN 0080 Rev A Date 19 03 2015 3 Product Description 3 1 MicroPerc Optic 1 Optic oJnmmm 2 Optic objective 2 3 Body with connection to fibre optic and for ocular 4 Protective optic tube 5 Ocular 6 Shifter Figure 1 Figure 2 Shifter 26 mm PD DS 1210 Figure 3 Fixed focus ocular PD FS 4001 autoclavable reusable PD_IFU_MicroPerc optic E_A 7 PD PN 0080 Rev A Date 19 03 2015 3 2 MicROPERC Set 1234 10 Go aku A TB gl eo Figure 4 Figure 5 Puncture needle Outer diameter 1 65 mm Sterile disposable Figure 7 4 8F shaft for puncture needle and laser fibre lt 400u Sterile disposable Figure 9 Dilator for 8F shaft Sterile disposable PD IFU MicroPerc optic E A PD PN 0080 MICROPERC Set PD PN 1008 consisting of 1 Introducer needle 2 8F shaft 3 4 8F shaft 4 Dilator for 8F shaft 5 3 port adapter for 4 8F and 8F shaft 6 Cap 7 Tuohy Borst adapter 8 3 way stop cock 9 Perfusion tube 10 Lunderquist guide wire Figure 6 T piece to the stiletto of the introducer needle Figure 8 8F shaft for laser fibr
4. please contact your service techni cian or your POLYDIAGNOST customer representative Rev A Date 19 03 2015 PD_IFU_MicroPerc optic E_A 25 PD PN 0080 7 Repair warranty disposal 1 Sending for repairs Maintenance of defective eguipment may only be performed by persons authorized by the manu facturer and only with the use of original spare parts Do not make any unauthorized modification to the product and do not attempt a repair This could result in eguipment damage and thus a danger to patients staff Unauthorized changes or repairs release the manufacturer from any liability for the functionality and reliability of the device Arbitrarily performed repairs performed during the warranty period void any warranty Important Ask for a repair number from PoLyDIAGNosT before sending the device You can send the unit for repair with this repair number Provide a description of the fault and the phone number of the contact with the shipment Equipment must be thoroughly cleaned and disinfected before being sent for repair Place a written confirmation of this with the device Insufficiently reprocessed devices represent an infection risk for anyone who comes into contact with it Contaminated instruments are not accepted by POLYDIAGNOST 7 2 Warranty The warranty period is 12 months from date of invoice 7 3 Disposal The device must be disposed at the end of its useful life in accordance with local requirements PD IF
5. 5 1 2 Important information All personnel responsible for reprocessing must be thoroughly incorporated into the relevant reprocessing procedure the work protection regulations the national and local hospital policy the operating instructions the functions of the endoscopic equipment labelling of disinfectants 5 1 3 Definition of terms Microorganisms Bacteria yeasts fungi and viruses Microorganisms should not be found on surgical instruments and endoscopes risk of infection Cleaning Physical chemical removal of impurities including organic matter Disinfection Reducing the number of microorganisms with the goal of minimising the number of viable micro organisms low germ product Sterilization Reducing the number of microorganisms with the objective that no viable microorganisms survive sterile product Sterile Absence of viable microorganisms very high safety and only less than one micro organism per million may survive PD_IFU_MicroPerc optic E_A 14 PD PN 0080 Rev A Date 19 03 2015 5 1 4 Causes of improper reprocessing e Shortening or interruption of the reprocessing process e Non compliance with mandatory concentration and residence time e Use of improper chemicals e Incompatible cleaning and disinfecting solution e Misunderstanding of the consequences that might arise from improper implementation of re processing e Insufficiently reprocessed and prepared equipment and or cleaning and d
6. be treated and removed with a swab which has been dunked in alcohol 70 ethanol or with a neutral detergent Thorough suitability of POLYDIAGNOST endoscopy devices for effective manual cleaning and disin fection was tested by an independent testing laboratory using the cleaning agent CIDEZYME concentration used 1 6 96 penetration time 5 min and the disinfectant CIDEX undiluted acti vated solution penetration time 30 min The procedure described above was considered in this process Johnson amp Johnson Medical GmbH Norderstedt 5 2 5 Mechanical cleaning and disinfection disinfector Important Note that the device has proven efficacy The device via appropriate connections for the work and has flushing channels Ensure that the cleaning and disinfectant products are compatible The materials used by the manufacturer are approved for cleaning and disinfection of endoscopes Ensure that an appropriate program is selected for thermolabile products Do not use too high flushing pressure for the working and flushing channels see 5 2 2 precau tions pressure not greater than 50 kPa The program contains sufficient rinse cycles If a thermal disinfector is used it should be noted that due to the drying temperatures of about 100 C which can be reached only endoscopes units marked as autoclavable may be so treated For thermolabile endoscopes cleaning programs must be selected which do not exceed a tempera ture of 6
7. dilator and guide wire from the shaft PD IFU MicroPerc optic E A 12 PD PN 0080 Rev A Date 19 03 2015 v Figure 37 Insert the optic through the side port then insert into the 8F shaft and affix 4 6 Optional Instruments Figure 38 10F shaft with obturator PD PN 1020 3 port adapter PD PN 1030 autoclavable NOTE when used with lasers The optic must be protected from penetration of the laser In order to avoid burns and or undesirable low effects in surrounding tissue or damage to the optic the laser power may only be activated when the tip of the laser fibre can be seen through the endoscope When using laser devices wear suitable protective glasses to avoid potential damage to the eyes PD_IFU_MicroPerc optic E_A 13 PD PN 0080 Rev A Date 19 03 2015 5 Reprocessing 5 1 General Instructions 5 1 1 RKI guidelines The Robert Koch Institute RKI has issued guidelines for the treatment of applied medical prod ucts First one must review the necessary preparation steps e Proper preparation collect possibly disassembling pre treatment and pre cleaning of medical devices used and their safe enclosure and bringing the protected goods to the processing ar ea e Cleaning disinfection rinsing and drying e Testing for cleanliness and integrity of the surfaces e Care and maintenance e Checking the technical and functional safety e Labelling e Packaging and sterilization e Storage
8. must take place immediately following the examination This will prevent drying of blood protein and other or other substances loosen remove all instruments valves caps and accessories from the optic dispose of all disposable products loosen the shifter from the optic clean all exterior surfaces with a disinfectant with a dunked soft cloth flush the internal channels of the accessories with disinfectant carefully clean the objective distal end of the optic with light friction with a damp cloth put the optic protection tube on the optic then flush with disinfectant solution see Figure 39 Figure 39 Note The disinfectant used must be approved by the manufacturer for the disinfection of endoscopes Use cleaning friendly instrument panel for endoscopes Avoid shocks and contact with other in struments Finally it must be sufficiently rinsed with tap water or sterile water Cleaning and disinfection must be carried out immediately after use This can be done soaking in cleaning and disinfectant in mechanized process disinfector or the manual method 5 2 4 Manual cleaning and disinfection Important Note that cleaning and disinfection agents have a proven efficacy Ensure that the cleaning and disinfectant products are compatible The materials used by the manufacturer are approved for cleaning and disinfection of endoscopes The concentrations and exposure times specified by the manufacturer of
9. selecting the cleaning agents and disinfectant that these do not contain the following listed chemicals potassium hydroxide solution ethanol potassium bifluoride mineral lubricants aniline hydrochloride bromine gt 1 perchloric acid chlorosulphonic acid sulphuric acid 10 and conc chloroform styrene chromic acid turpentine ferric chloride trichloroethane acetic acid 10 and conc trichlorethylene hydrofluoric acid hydrogen peroxide 30 hydrofluoric acid xylene formalin 30 cinnammonium hexachloride glycol and glycolic acid citric acid PD IFU MicroPerc optic E A 23 PD PN 0080 Rev A Date 19 03 2015 5 3 Storage of optic and accessories The storage area must be germ free low dust dry and well ventilated Avoid temperature var lation Do not store the optic in the carrying case Store the optics and accessories in the supplied protective tube in an appropriate sterilization tray or a suitable storage tray This reduces the risk of damage Thoroughly dry all optic parts and accessories before storage Store the accessories separately from the optic Storage in direct sunlight high temperature or under the influence of X rays can damage the optic and accessories or pose a risk of infection PD IFU MicroPerc optic E A 24 PD PN 0080 Rev A Date 19 03 2015 6 Troubleshooting 6 1 Occurrence of a problem Problem Possible causes Remedy
10. 0 C The concentrations and exposure times specified by the manufacturer of the cleaning or disinfect ing agent must be strictly adhered to Use only sterile water for rinsing after disinfection One may only use freshly prepared cleaning disinfecting and rinsing solutions they may not be used more than once PD IFU MicroPerc optic E A 19 PD PN 0080 Rev A Date 19 03 2015 Note The endoscope and endoscopic accessories must be manually pre cleaned when using mechanical cleaning and disinfection as per RKI guidelines Therefore follow steps 1 to 10 of the Cleaning set in Chapter 5 2 5 Manual cleaning and disin fection Only then proceed as follows 1 Put the disassembled endoscopy system into the disinfector using sterilization tablets Ensure that the equipment is not damaged in this step Sort instruments and accessories properly on machine suitable instrument trays 2 Close the working and flushing channels to the hoses connected to the disinfection basket 3 Choose the appropriate and manufacturer s recommended endoscope cleaning program in ac cordance with the loading Start the program 4 Remove the endoscopy system after the program ends Let the endoscopy dry if necessary Remaining contamination on optical surfaces can be removed with a cloth which has been dunked in alcohol 70 ethanol or with a neutral detergent and disposed of The thorough suitability of POLYDIAGNOST endoscopy devices for effectiv
11. D_IFU_MicroPerc optic E_A 21 PD PN 0080 Rev A Date 19 03 2015 5 2 7 Material tolerability One cannot guarantee that this list is complete due to constant technical development We rec ommend the tested and approved disinfectants type 1 and detergent type 2 shown below Manual cleaning and disinfection sterilization Product name Manufacturers Type CIDEZYME Advanced Sterilization Products c o Johnson amp Johnson Medical GmbH Cidex OPA Advanced Sterilization Products c o Johnson amp Johnson Medical GmbH Aseptisol Bode Chemie GmbH Korsolex AF Bode Chemie GmbH Korsolex Plus Bode Chemie GmbH Sekusept Extra N Ecolab GmbH Sekusept Forte Ecolab GmbH Sekusept Plus Ecolab GmbH Instru Plus Laboratory of Dr Deppe PhD Instru Star Laboratory of Dr Deppe PhD Instru Zym Laboratory of Dr Deppe PhD gigasept Sch lke amp Mayr GmbH e je N fe je je je je je je je e N N N N gigasept FF Sch lke amp Mayr GmbH Mechanical cleaning and disinfection sterilization Product name Manufacturer Wype neodisher Septo DA Dr Weigert GmbH amp Co KG Sekumatic FD Ecolab GmbH Endomat Plus Laboratory of Dr Deppe PhD 3E Zyme Medisafe UK Ltd thermosept ED Sch lke amp Mayr GmbH thermosept ER Sch lke amp Mayr GmbH thermosept RKN zym Sch lke amp Mayr GmbH PD IFU MicroPerc optic E A PD PN 0080 Rev A Date 19 03 2015 22 Please ensure when
12. ENdOSCOPIClM fd sa 11 Changing instruments after puncture sseseeeeeeee nennen nenne nennen nnn nnne nnne nenas 11 Larger U I es ae S TM NIC n dPrieII 12 Saisie Mazim RID TTE ETT TET na 13 Msjelrees neem cc i sv S S ee 14 General INSIrUCUONS 14 RISE Glld lii6 sass aaa wooden ii 14 IMportant iffOfifi lOlss asas 14 Definition of terms 14 Causes of improper reprocessing eseeseeeenee nnne nennen nennen nnn nnne nnne nenne nens 15 Cleaning disinfection and sterilisation ceeeeeeeennnnn mmm 15 PISCE ICH ONG lt D O 15 Prec UONG N rere rer rr ere rt rte 16 PS NUNN a V D eee NNI 17 Manual cleaning and disinfectioN aaa aaa 17 Mechanical cleaning and disinfection disinfector 1 11i aaa 19 eiue d dj p s es 20 Material tolerapillty Ber 22 Storage of optic and accessories aaa 24 Troubleshooting 1 oen ener nenne nnn nenne nnn ner nune nnne nnn nenne 25 PD IFU MicroPerc optic E A 2 PD PN 0080 Rev A Date 19 03 2015 Occurrence of a problem Repair warranty disposal Sending for repairs Warranty Disposal Transport of the optic Classification PD_IFU_MicroPerc optic E_A 3 PD PN 0080 Rev A Date 19 03 2015 1 Safety instructions 1 1 Intended Use MICROPERC optic for percutaneous micro endoscopic diagnosis and therapy of kidney stones is designed exclusively for use with the MICROP
13. ERC Set PD PN 1008 from PMT GmbH 1 2 Operating Instructions Before using optic thoroughly read the manual as well as manuals for other necessary equipment which are used in examination Follow the instructions All safety instructions must be observed Keep the manual in a safe easily accessible place The different endoscopic procedures and the medical aspects of endoscopy are not covered by this manual A prerequisite for the safety of the patient is that the physician and medical staff properly handle the endoscope The user must be instructed on the unit 1 3 After Receiving the Optic Check the optic for damage and operability Do not use the optic if damage can be seen and or the functionality is not assured If you have any abnormalities or irregularities contact your customer service representative Transport damage must be reported to the parcel service carrier immediately WARNING Optic are neither sterilised nor disinfected before delivery They must be cleaned and disinfected sterilised before each use as described in the corresponding chapter of the manual 1 4 Surroundings Operation Note the operating conditions of the endoscope and the conditions for storage and transport The endoscope could be damaged or fail to operate if it is outside specified tolerances The optic and related accessories must be checked before each use for possible optical and mechanical damage to eliminate the risk of in
14. U MicroPerc optic E A 26 PD PN 0080 Rev A Date 19 03 2015 8 Transport of the optic Optic may only be transported and disposed if they are in a disinfected state In order to reduce the risk of damage transport the optic and accessories using a sterilisation tray or appropriate storage tray Or transport the optic using the carrying case Ensure that the optic are carefully placed in the places provided for them in the case and that it is not closed as long the cables stick out of the case NOTE The carrying case cannot be cleaned or disinfected Clean and disinfect or sterilize the optic before you put it in the carrying case Important Observe the following instructions if there is transport damage as not complying with the formal requirements of the transport insurer may lead to non payment of claims If there is transport damage it is in your interest to ensure payment of damage claims and those claims must be made to agents of the parcel services transport companies as per the relevant provisions in time for determination of the damages This means loss or damage of the goods which can be recognised from the outside must be notified by the receiver to the freight forwarder in the case of loss or damage at latest at the delivery of the goods If transported by rail in addition one must request a statement of facts For parcel shipments before acceptance damaged packages must be indicated to the parcel delivery se
15. ate 19 03 2015 Only the following presented sterilization methods are to be used for sterilisation other sterilisa tion procedures are not allowed MICROPERC Optics Shifter PD DS 1210 with the obtu with protection tube in rator shaft 10F PD PN 1020 3 port the sterilization tray adapter PD PN 1030 ETO gas sterilization 55 C to max 60 C Low temperature plasma sterilization STERRAD 100S Steam sterilization autoclaving 121 C 20 minutes max 124 C Steam sterilization autoclaving 132 134 C 5 minutes max 137 C X allowed Ensure that only appropriate equipment and product specific validated methods for cleaning disin fection and sterilization are used and that the validated parameters are maintained at each cycle In addition observe the regulations of the hospital and the manufacturer of the sterilisers and the applicable laws in your country Proof in principle of suitability of endoscopes for effective ETO gas sterilization was performed by an independent testing laboratory using the Sterivit process from DMB Apparatus GmbH Wiesba den The procedure described above was considered in this process Note It is the user s responsibility to perform the treatment process to achieve the desired sterilization The use of various sterilization processes in alternating sequence can lead to premature ageing of endoscopes If possible use only one of the approved methods P
16. e gt 400u Sterile disposable 8 Rev A Date 19 03 2015 Figure 10 3 port adapter for introducer needle 4 8F and 8F shaft Sterile disposable ur Figure 12 Tuohy Borst Adapter for fibre laser Sterile disposable Figure 14 Perfusion tube Sterile disposable PD_IFU_MicroPerc optic E_A PD PN 0080 Figure 11 Cap Sterile disposable e Figure 13 3 way stop cock Sterile disposable Figure 15 Lunderquist guide wire Sterile disposable 9 Rev A Date 19 03 2015 4 J MicROPERC operating mode Figure 16 4 1 Assembly Figure 17 4 8F shaft puncture needle lt Figure 19 Get optic and shifter ready J Figure 21 Introduce into the puncture needle PD_IFU_MicroPerc optic E_A PD PN 0080 Figure 18 Join together and affix to one another Figure 20 Shift the shifter with Open screw onto the optic Figure 22 Place optic in stylus and attach the shifter screw 10 Rev A Date 19 03 2015 Figure 23 Connect the perfusion tube Figure 24 Connect ocular with optic and connect it to the camera Flush the system before puncture 4 2 Connection to the endoscopy video system Connect the endoscope through the ocular with the endoscopy video system Connect the fibre optic cable to the endoscope 4 3 Check the endoscopic image After switching on the endoscopy video system turn the light source on the highest intensity Hold the distal end of the semi rigid optic ab
17. e mechanical cleaning and disinfection was conducted by an independent testing laboratory using the Hamo LS 20001 disin fector program No 89 50 C Korsolex Endo Cleaner cleaning agent concentration 150 ml 30 penetration time 5 min and Korsolex Endo Disinfectant concentration 300 ml 30 I pene tration time 10 minutes The procedure described above was considered in this process 1 Hamo AG Switzerland Bode Chemie GmbH Hamburg After cleaning disinfection rinsing and drying e inspect for cleanliness and integrity of the surfaces e g corrosion material properties free of sharp edges and dents and patency of the internal channels if applicable identification to de ciding whether to restart the reprocessing or disposal e care e check the technical and functional safety 5 2 6 Sterilisation Only previously cleaned disinfected and completely dried endoscopes and accessories may be sterilised The products must be inserted in the sterilization tray prior to sterilization One must ensure that the products are not kinked or damaged The sterilization tray is then placed in a suitable steriliza tion pack disposable sterilization packaging for the sterilization method according to DIN EN 868 2 and DIN EN ISO 11607 1 Holding clamps are installed in the original sterilization trays of the POLYDIAGNOST which prevent mechanical damage of unattached devices PD IFU MicroPerc optic E A 20 PD PN 0080 Rev A D
18. isinfectant solutions note storage times 5 2 Cleaning disinfection and sterilisation 5 2 1 Instructions Effective pre cleaning cleaning and disinfection are an essential prerequisite for effective steriliza tion of optic and accessories Ensure that there is complete wetting of all surfaces with the solution including any working channels or cavities Note concentration and immersion time manufacturers specifications for cleaning and disinfect ants Pay attention to the mutual compatibility of the solutions used and follow the manufacturer s in structions e g in relation to concentration and exposure times Ensure that only appropriate equipment and product specific validated methods for cleaning disin fection and sterilization are used and that the validated parameters are maintained at each cycle It is the user s responsibility to perform the treatment process to achieve the desired disinfection cleaning and sterilization In addition observe the regulations of the hospital and the manufacturer of the cleaning and disin fectant the disinfectors and sterilizers and the applicable laws in your country PD_IFU_MicroPerc optic E_A 15 PD PN 0080 Rev A Date 19 03 2015 5 2 2 Precautions NOTE If the devices and related accessories are not properly cleaned and disinfected steri lized this may jeopardize the safety of the patient staff If the cleaning is not done this may jeopardize the effectivenes
19. jury Endoscopes with damaged or defective items must not be used Follow with the use of laser electrosurgery pneumatic or electro hydraulic lithotripters the instruc tions for use and safety of the devices and accessories used Ensure that BF conditions insulated ungrounded application parts are maintained with joint op eration of the endoscope with electrical medical devices The failure of a jointly used light source may cause hazards Make sure you have a ready replace ment light source PD_IFU_MicroPerc optic E_A 4 PD PN 0080 Rev A Date 19 03 2015 1 5 Reprocessing and storage Prepare the optic after use and store them in accordance with general guidelines Inadequate reprocessing may pose a risk of infection and cause equipment damage NOTE The optic are not autoclavable Autoclaving may destroy the optic 1 6 Products in sterile packaging Check in sterile packed products that the sterile packaging is undamaged The products may not be used if the packaging is damaged 1 7 Compatibility and accessories Combination with devices other than those recommended can lead to a deterioration of security and performance Use only the specified accessories for optic The use of incompatible accessories may lead to func tional disruptions and or damage to the user patient and third parties 1 8 _ Tolerability Our products may contain nickel and or latex One must note applicable allergies In such cases the u
20. optic thoroughly with cleaning solution at least five times by disposable syringe see Figure 40 Also rinse the accessories at least five times thoroughly with the cleaning solution Remove the optic and the accessories at the earliest after the time recommended by the man ufacturer for exposure to the cleaning agent 9 Then rinse all at least five times with sterile water disposable syringe Duration per cycle at least 1 minute 10 Then dry all internal passages by blowing with medical grade compressed air PD_IFU_MicroPerc optic E_A 18 PD PN 0080 Rev A Date 19 03 2015 Disinfection 1 Filla basin with fresh disinfectant solution 2 Put the optic with an attached protection tube or the accessories into the disinfectant solution the optic accessories must be completely immersed Disinfect the outside surfaces with a soft cloth or sponge 4 Rinse the optic thoroughly with disinfectant solution at least five times by disposable syringe see Figure 40 Also rinse the accessories at least five times thoroughly with the disinfectant solution 6 Remove the optic and the accessories at the earliest after the time recommended by the manufacturer for exposure to the cleaning agent 7 Then rinse all at least five times with sterile disposable syringe Duration per cycle at least 1 minute 8 Then dry all internal passages by blowing with medical grade compressed air Remaining contamination on optical surfaces can
21. out 1 cm above a white surface and set the white balance using the appropriate switch Then hold the distal end of the optic at the same distance above a colourful graphic and adjust the image sharpness by turning the adjustment ring on the TV adapter Also check the colour fi delity Note Image guality also depends upon optimal light output Always keep the light interfaces of the en doscope and the fibre optics clean in order to ensure that light output remains optimal 4 4 Changing instruments after puncture Figure 25 Loosen the puncture needle including Figure 26 Attach the 3 port adapter optic from the working shaft and pull it out to the working shaft Figure 27 Remove optic from puncture needle Figure 28 Insert into the middle port PD_IFU_MicroPerc optic E_A 11 PD PN 0080 Rev A Date 19 03 2015 P au Figure 29 Affix Figure 30 Connect the 3 way stopcock Figure 31 Ability to flush M Figure 32 Connect the Tuohy Borst adapter to and for administration of contrast medium attach the laser fibre 4 5 Larger lumens If a larger lumen is needed in accordance Seldinger technique change from the 4 8F working shaft to the 8F working shaft Figure 33 Remove all instruments Figure 34 Enter Lunderquist guide wire incl optic from the 4 8F shaft under control then pull out 4 8F shaft Figure 35 Insert dilator in 8F shaft Figure 36 Insert 8F shaft with dilator using the guide wire then remove the
22. rvice in writing If damages are not immediately recognised they must be notified after recognition immedi ately and in writing to the parcel service or the transport company In addition notify the sending office in our company with the delivery note and the invoice num ber and put your complaint into the above mentioned documents 9 Classification CE This device complies with the requirements of Council Directive 93 42 EEC concerning medical devices Classification This product is in class IIa PoLvDrAGNOsT GmbH Am S ldnermoos 17 D 85399 Hallbergmoos Telephone 49 0 811 9987338 0 PD IFU MicroPerc optic E A 27 PD PN 0080 Rev A Date 19 03 2015
23. s of the disinfection sterilization Devices and accessories must be thoroughly cleaned before disinfection Thorough cleaning reduc es the number of microorganisms present removes organic materials and so supports the effec tiveness of the disinfection sterilization procedure Contact with patient secretions and reprocessing chemicals can affect your health Therefore always wear the prescribed protective equipment as specified in the hospital or national regulations when reprocessing the equipment Suitable protective equipment includes Eye protec tion glasses face masks moisture resistant protective clothing or gowns Note Contaminated gowns must be taken off before leaving the reprocessing area chemical resistant tight gloves which fit well and are sufficiently long Gloves should be changed and dis posed of regularly Make sure that the reprocessing area is adequately ventilated as set out in the hospi tal or national health and safety regulations Provide general ventilation at least eight to ten air changes per hour to reduce chemical vapours Rinse the channels thoroughly and carefully All internal channels must be thoroughly rinsed with sterile water to be free of disinfectants Do not use pressure greater than 50 kPa to dry or flush the channels with air or liquid otherwise the channels could be damaged PD_IFU_MicroPerc optic E_A 16 PD PN 0080 Rev A Date 19 03 2015 5 2 3 Pre cleaning Pre cleaning
24. se of the equipment is at the discretion of the physician 1 9 Repair replacement Repair of faulty equipment must be performed by persons authorized by the manufacturer and only with the use of original spare parts Do not make any unauthorized modification to the prod uct and do not attempt a repair This may result in equipment damage and thus a danger to pa tients staff Unauthorized changes or repairs release the manufacturer from any liability for the safety of the appliance Arbitrarily performed repairs performed during the warranty period may void any war ranty NOTE POLYDIAGNOST GmbH assumes no liability for damages and harm which occurs due to erroneous use of the device and non observance of this operating manual Changes which were not carried out by POLYDIAGNOST GmbH or through POLYDIAGNOST authorized professionals can lead to the loss of all warranty claims POLYDIAGNOST GmbH assumes no liability for injuries or damage which occur after changes which have not been undertaken by POLYDIAGNOST GmbH PD IFU MicroPerc optic E A PD PN 0080 Rev A Date 19 03 2015 5 2 MicROPERC Optic Specifications 10 000 pixel Optic 120 tem no PD PN 0080 Outer diameter 0 9 mm mage control system 10 000 pixels Viewing direction 0 direct view Field of View 120 Optical length 272 mm Standard light connection ACMI adapter Integrated fibre optic lighting Optic nitinol reinforced
25. the cleaning or disinfect ing agent must be strictly adhered to Use only sterile water for rinsing after disinfection One may only use freshly prepared cleaning disinfecting and rinsing solutions they may not be used more than once PD_IFU_MicroPerc optic E_A 17 PD PN 0080 Rev A Date 19 03 2015 The optical surfaces must not be treated with sharp objects In general endoscopes must be treated with special care in cleaning disinfection in order to avoid damage through use of great force hitting bending or dropping Do not use brushes or sponges made of metal for cleaning the surfaces and internal channels as this may lead to damage Semi rigid optic endoscopy accessories and other parts must not be placed in physio logical saline solution and should also not be cleaned in an ultrasonic bath Both meth ods lead directly to damage to the endoscope and its accessories Cleaning 1 Fill a basin with fresh cleaning solution 2 Put the optic with an attached protection tube Figure 40 or the accessories into the cleaning solution the optic accessories must be completely immersed Figure 40 Clean the outside surfaces with a soft cloth or sponge 4 Clean interior channels of the accessories with the respective suitable cleaning brushes within the cleaning bath The brush must always move from the proximal to distal end Ensure that the cleaning solution does not foam too much reduced cleaning action Rinse the
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