User`s Manual
Contents
1. After having a good view insert the LithoClast Probe Figure 62 5 6 LithoClast Master Probe If the use of LithoClast Master is scheduled the use of the 10 5 F working shaft is required Insert this like descriped under 5 4 on page 19 from the manual Figure 63a Figure 63b Figure 63c insert the optic incl shifter through the side port Figure 64 PH 01 2 Operating Manual PCNL Optic modular 22 PD PN 0080 Rev 004 Date June 06 2012 adapt the T piece with stopcock and Touhy Borst adapter at the straight channel Figure 65 now move the system inside the 10 5 F working shaft Figure 66a Figure 66b finally insert the LithoClast Master Probe through the Touhy Borst adapter Figure 67 PH 01 2 Operating Manual PCNL Optic modular 23 PD PN 0080 Rev 004 Date June 06 2012 6 Preparation for the use of the endoscopy system Carefully read the operating manual for every accessory device and prepare the device according to the respective specifications 6 1 3 joint arm 3 joint arm PD AC 0096 consisting of Table clamp PD AC 0101 Vario arm PD AC 0102 Camera support PD AC 0103 with mounting for ocular and mounting mechanism for light adapter POLYSCOPE Ocular mounting PD AC 0114 Figure 68 Assembly Turn lever A counter clockwise to attach the clamp to the device rack Turn lever A clockwise to tighten the clamp Loosen screw2. POLYDIAGNOST Operating Manual MICROPERC ALL SEEING NEEDLE 10 000 pixel semi rigid optic PD PN 0080 Modular semi rigid endoscopy system for Micro PCNL C Eoss PH 01 2 Operating Manual PCNL Optic modular 1 PD PN 0080 Rev 004 Date June 06 2012 All rights reserved This operating manual contains information that is protected by the manufac turer It is prohibited to copy this operating manual and to take sections of the text or duplicates without prior written permission by POLYDIAGNOST GmbH The manufacturer reserves the right to make changes and updates to the manual Due to the continued development of our products it is possible that technical specifications or images in this operating manual do not correspond to the current state of production As manufacturer of the endoscopes POLYDIAGNOST GmbH assumes no responsibility whatsoever for any damages to the devices nor for damages caused by the faulty use of the endoscope and by not adhering to this operating manual Service and repair work on the devices may only be carried out by the manufacturer or by a maintenance company authorized and appointed by POLYDIAGNOST GmbH Opening the instru ments or having repairs carried out by non authorized persons will void all safety and warranty claims POLYDIAGNOST GmbH POLYDIAGNOST Schafflerstr 13 Tel 49 84 41 80 60 0 Entwicklungs Produktions D 85276 Pfaffenhofen Ilm Fax 49 84 41 80 60 60 Vertriebs u
3. prod Vordermattenstrahe 2 79108 Freiburg development intind and distribution of opic j humen catheters has riodaced and app es a Quality Management System EN ISO 9001 mM d amp Gonns 45 Rev 004 Date June 06 2012
4. the work safety regulations the national and local hospital guidelines the operating manual the function of the endoscopy equipment the labeling of disinfectants PH 01 2 Operating Manual PCNL Optic modular 32 PD PN 0080 Rev 004 Date June 06 2012 9 2 2 Terminology Microorganisms Bacteria yeasts fungi and viruses Microorganisms may not be found on surgical instruments and endoscopes infection risk Cleaning Physical chemical elimination of impurities including organic substances Disinfection Reduction of the number of microorganisms with the objective of having as few microorganisms as possible survive low germ product of low microbiological contamination Sterilization Reduction of the number of microorganisms with the objective of having no microorganisms survive sterile product Sterile Absence of viable microorganisms very high certainty that less than one microorganism will survive on a million products 9 2 3 Causes of a faulty reconditioning Medical literature reports about patients infection and contamination with the following causes e Rushing the reconditioning procedure or aborting it altogether e Not adhering to mandatory prescribed concentrations and application times e Use of unsuitable chemicals e Incompatible cleaning and disinfectant solution e Misjudging the consequences that may occur as a result of improper reconditioning e Insufficiently reconditioned and prepared d
5. 27 PD PN 0080 Rev 004 Date June 06 2012 Adapter for products from other manufacturers are also available at POLYDIAGNOST These adapters are screwed onto the corresponding fixtures eee ee Adapter for light cable to light source Figure 80 Fuji PD LC 9002 pmm E Adapter for light cable to light source Figure 81 Pentax PD LC 9003 Adapter for light cable to light source Olympus and ACMI PD LC 9004 Figure 82 Adapter for light cable to light source Wolf PD LC 9005 Figure 83 z Adapter for light cable to light source Stryker PD LC 9006 Figure 84 Adapter for light cable to endoscope Wolf PD LC 9103 Figure 85 Adapter for optic body Wolf PD LC 9502 Is needed for use of PD LC 9103 Figure 86 PH 01 2 Operating Manual PCNL Optic modular 28 PD PN 0080 Rev 004 Date June 06 2012 Adapter for light cable to endoscope Storz PD LC 9104 Figure 87 Adapter for optic body Storz PD LC 9503 Is needed for use of PD LC 9104 Figure 88 Example Storz adapter set Consists of PD LC 9503 and PD LC 9104 Figure 89 6 5 The complete installed image transmission system A Camera head with TV adapter B Exchangeable ocular C Optic D Light cable E 3 joint arm Figure 90 Attention e The TV adapter can be placed in disinfectant solution e The camera head can not be placed in disinfectant solution It is held by the 3 joint arm and is thus outside of the possibly p
6. B 3 Push button C and slide the Vario arm into opening D Tighten screw B again The position of the 3 joint arm can be fixed with the help of the lever on the Vario arm Figure 69 Important Check the safe assembly of the 3 joint arm on the device rack or another safe location selected and checked by clinic personnel PH 01 2 Operating Manual PCNL Optic modular 24 PD PN 0080 Rev 004 Date June 06 2012 6 2 Exchangeable ocular The endoscope is supplied without an ocular Following exchangeable ocular is available Fix focus ocular black PD FS 4001 Figure 70 Fastening of the exchangeable ocular on the 3 joint arm Ocular mounting fixed on camera support Figure 71 Exchangeable ocular fixed in ocular mounting Figure 72 Important Make sure that both screws are fastened tightly Always mount the exchangeable ocular on the top of the camera support This reduces the danger of the ocular falling if the screws are not properly fixed PH 01 2 Operating Manual PCNL Optic modular 25 PD PN 0080 Rev 004 Date June 06 2012 6 3 Connection of ocular and camera The exchangeable oculars are connected to the TV adapter PD VC 1002 of the POLYDIAGNOST camera ENDOGNosT CS 207 PD VC 0210 or other medically permitted cameras The oculars have a standard ocular cup of 32 mm diameter and are connected to the CCD camera via the TV adapter with a 35 mm focal length as follows Connect the TV
7. or CE label the cleaning product is compatible with the used disinfectant and the used chemicals are compatible with the POLYDIAGNOST endoscopy devices and accessories Important The concentrations and application times indicated by the manufacturer of the cleaning product or disinfectant must be absolutely adhered to When irrigation after the disinfection only use sterile or low germ max 10 germs ml distilled or de ionized water PH 01 2 Operating Manual PCNL Optic modular 38 PD PN 0080 Rev 004 Date June 06 2012 Important Even when using machine cleaning and disinfection a manual pre cleaning must endoscope and endoscopic accessories must take place according to RKI guidelines For this follow steps 1 to 9 of the Cleaning section in chapter 9 3 5 Manual cleaning and disin fection Only once this is done should you proceed as follows 1 Place the disassembled POLYDIAGNOST endoscopy system into the disinfector using the steriliza tion tray Make sure that the devices are not damaged during this Sort instruments and acces sories properly on machine suitable instrument screens 2 Connect the operating and irrigation channels to the connecting tubes on the disinfection basket Start the program Note the indications by the manufacturer 4 Remove the endoscopy system once the program has finished If necessary allow the endoscopy system to continue to dry The fundamental suitability of the POLYD
8. H 01 2 Operating Manual PCNL Optic modular 16 PD PN 0080 Rev 004 Date June 06 2012 the stopcock for irrigation has to be connected at one sideport Touhy Borst adapter has to be connected with the other sideport Figure 42 Insert the laser fiber in the Touhy Borst adapter and keep the adapter so much closed that no irrigation solution flows out of it and the laser fiber can still become shiftet smoothly Figure 43 Laser fibers up to an outer diameter of 350um can be used PH 01 2 Operating Manual PCNL Optic modular 17 PD PN 0080 Rev 004 Date June 06 2012 5 3 Shock wave Lithotripsy If the use of LithoClast or a similar product is scheduled the 8 F working shaft must be used LithoClast Probe exterior diameter 1 mm Figure 44 8 F Working Shaft PD PN 0005 exterior diameter 2 65 mm Stopcock Figure 46 3 port LuerLock PD CA 0607 for the shaft of All Seeing Needle and 8 F working shaft Figure 47 Touhy Borst Adapter PD CA 0112 for fixation of the LithoClast Probe Figure 48 PH 01 2 Operating Manual PCNL Optic modular 18 PD PN 0080 Rev 004 Date June 06 2012 If the use of LithoClast Master or a similar product is scheduled the 10 5 F working shaft must be used LithoClast Master Probe exterior diameter 1 9 mm Figure 49 10 5 F Working Shaft PD PN 0020 exterior diameter 3 47 mm Figure 50 2 port Adapter for PCNL 10 5 F wo
9. IAGNOST endoscopy devices for effective machine cleaning and disinfection was verified by an independent test lab using the disinfector Hamo LS 2000 program no 89 50 C the cleaning product Korsolex Endo Cleaner concentration 150 ml 30 application time 5 min and the disinfectant Korsolex Endo Disinfectant concentration 300 ml 30 application time 10 min The procedure described above was taken into account dur ing this 1 Hamo AG Switzerland Bode Chemie GmbH Hamburg After cleaning disinfection rinsing and drying e Check for cleanliness and sound condition of the surfaces e g corrosion material quality and permeability of the interior channels possibly identification for the purpose of making a decision about a repeated reconditioning or disposal e Maintenance e Verification of the technical functional safety PH 01 2 Operating Manual PCNL Optic modular 39 PD PN 0080 Rev 004 Date June 06 2012 9 3 7 Sterilization Only previously cleaned disinfected and completely dried POLYDIAGNOST endoscopy devices and accessories may be sterilized The products must be placed in the sterilization tray before sterilization Care must be taken dur ing this that the products are not bent or damaged The sterilization tray is then to be packaged in a suitable sterilization packaging single use sterilization packaging for the intended sterilization procedure according to DIN EN 868 2 or DIN EN ISO 11607 1 T
10. Repairs or changes that were not carried out by PolyDiagnost lead to the voiding of all warranty claims POLYDIAGNOST assumes no warranty for the functionality of endoscopes devices or instruments whose repair was not carried out by POLYDIAGNOST POLYDIAGNOST assumes no liability for injuries or damages that occur after repair attempts that were not carried out by POLYDIAGNOST 8 2 Sending endoscope instrument in for repair Before sending in the endoscope or instrument please request a repair authorization number from our POLYDIAGNOST customer representative You can send the endoscope instrument in for repairs using this repair authorization number Please include a description of the error and the phone number of the contact person with the shipment Important Endoscopes instruments and devices must be thoroughly cleaned and disinfected sterilized before they are sent in for repair Include a written confirmation Insuffi ciently reconditioned devices represent an infection risk for anyone who comes into contact with them That is why we reserve the right not to accept contaminated en doscopes instruments and devices PH 01 2 Operating Manual PCNL Optic modular 31 PD PN 0080 Rev 004 Date June 06 2012 9 Instructions for reconditioning 9 1 General statement With regard to decontamination different requirements apply in different parts of the world One also has to be aware that in some countries the law
11. adapter including camera head to the exchangeable ocular Open the snap fixture Mounted TV adapter including camera head Figure 74 Adapting the ocular with the optic body Turn the opening ring of the ocular towards unlock Hold the ring in this position and push the optic body into the ocular Figure 75 Now turn the spring controlled ring of the ocular back towards lock Figure 76 PH 01 2 Operating Manual PCNL Optic modular 26 PD PN 0080 Rev 004 Date June 06 2012 6 4 Light connection The optic must be used with a certified Xenon light source see also POLYDIAGNOST ENDOGNosT Xenon light source operating manual The POLYDIAGNOST ENDOGNOsST light sources or similar certified products can be operated at full light intensity since the POLYDIAGNosT ENDOGNosT camera is equipped with a fast shutter THE POLYDIAGNOST standard light cable has a length of 1 800 mm and a diameter of 4 9 mm POLYDIAGNOST standard light cable with exchangeable adapters for light source and endoscope PD LC 3001 Light cable without adapter PD LC 2001 Figure 77 Adapter to the light source POLYDIAGNOST standard adapter Storz PD LC 9001 Adapter to the endoscope POLYDIAGNOST standard adapter ACMI PD LC 9101 Figure 78 The light cable is connected to the light connection of the optic body via the snap fixture of the ACMI adapter Figure 79 PH 01 2 Operating Manual PCNL Optic modular
12. cees tine eeeneeeeeeiee sea ee es 7 Product description caisiccscie ict cee cate cea cuenta cen eenaneee cate ces ean cate ea eeneneetiei nena 8 TECHNIC ace eg cig EE cnet gs cme igs cen eat cc eee eee 10 Camera SV SUSI Mice ct cacectcscecececececececececucecececucecucecucecucocucecucecucecucecucecucececesucecucecucececesuceee 10 DIGG ON DUNO eerie EEEIEE etd rinse arene eters EE EEEE EEEE EEEE 11 HNO SUNN Gl oder s earepectenrterate ives dereee tan adaiceice neuter avec wtetne duaeiennaneeaeraaeudeiossdeeeres eeaneeeceriasancanpiceesaat 12 Set up Of the system cece cece cece eee eee ee eee ee esas a esesa ea eeeeaeaesesaeaeeesanaeseeaees 13 Preparation of the MICROPERC system All Seeing Needle cccceeeeeeeeeeeeeeeeeeeeeeeeeens 13 Laser stone management through the working shaft of the All Seeing Needle 16 SHOCK Way LITMORMDSy iin 18 How to proceed with the 8 F or 10 5 F working Shaft cccccsccecseeeeeeeeeeeeeeeeeeessaeeeeaes 20 UROA PrOD ieia E EE E E sneer eeeseeeeease 21 LithoClast Master Prob cccccccccsscccccccsesssseeesseceecseecccceeeeseueeecseeeeceeeeeeeueeesesesessteeeess 22 Preparation for the use of the endoscopy System cccceceeseeeeeeeeeeeaeeaeaes 24 OMEN AED r ee cee eee eee eee eee 24 Exchangeable ocular ccccecceceeeeeeeeeeee eens eens eee e eens eens sen e SEA ASHES OES ESSA EERE Sa REESE a REESE SS 25 Connection of ocular ANG camera cece eee eee eee eee
13. ckaged products make sure that the sterile packaging is undamaged If the packaging is damaged the products may not be used 1 8 _ Repair exchange This endoscope contains no parts to be serviced by the user Do not make any changes to the endoscope or attempt to repair it as this can lead to putting the patient at risk or can damage the device See chapter Troubleshooting 1 9 Compatibility Our products may contain nickel and or latex Care must be taken in case of relevant allergies In such cases the use of the device is up to the doctor s judgment PH 01 2 Operating Manual PCNL Optic modular 6 PD PN 0080 Rev 004 Date June 06 2012 2 Specifications Figure 1 PCNL optic with protective tube for optic 10 000 pixel optic 120 Article number PD PN 0080 Exterior diameter 0 9mm Image control system 10 000 pixel Viewing direction 0 direct view Field of vision 120 Optic length 272 mm Standard light connection Aslan AET Integrated fiber optic lighting Reinforced nitinol optic Room temperature 10 40 C 50 104 F Operating conditions Rel humidity 30 85 Air pressure 700 1060 mbar PH 01 2 Operating Manual PCNL Optic modular 7 PD PN 0080 Rev 004 Date June 06 2012 3 3 1 The needed parts Product description The system consists out of 13 parts which all have to be placed at the table before examination Figure 2 Figur
14. cock b on T piece Figure 29 now insert the optic into the needle connect shifter with T piece with gentle twisting Figure 31 adapt irrigation tube at the stopcock Finally adjust the distal end of the optic to the cone end of the needle by using the shifter Figure 33b PH 01 2 Operating Manual PCNL Optic modular 14 PD PN 0080 Rev 004 Date June 06 2012 the stopcock allows irrigation Figure 34 and injection of contrast medium Figure 35 Important a Adjust up down position of the endoscopic picture on screen through rotating the camera head at the ocular b Irrigate the All Seeing Needle completely before placing into the patient Figure 36 Insertion of the All Seeing Needle under US Control PH 01 2 Operating Manual PCNL Optic modular 15 PD PN 0080 Rev 004 Date June 06 2012 5 2 Laser stone management through the working shaft of the All Seeing Needle remove stilett including optic out of the working shaft The working shaft remains inside the patient Figure 37 A move the optic out ofthe stilt Figure 38 now move the optic through the middle port of the 3 port adapter Figure 39 Very very important move finally the optic as far as possible out of the shifter and fix the optic with the screw a Figure 40 place the optic with the 3 port adapter in the working shaft and connect it with the rotating LuerLock Figure 41 P
15. contact with mucous membranes To contain the risk of a transfer of diseases as much as possible the endoscope must always be subjected to a thorough cleaning after every examination followed by a disinfection and or sterilization If the cleaning Is omitted then this undermines the effectiveness of disinfection and sterilization Endoscopes and accessories must be cleaned as thoroughly as possible before disinfection or steri lization Thorough cleaning reduces the number of microorganisms present eliminates organic materials and thus supports the effectiveness of the disinfection or sterilization procedure For the mechanical cleaning of openings and channels POLYDIAGNOST makes corresponding clean ing brushes available for the different channel diameters Contact your POLYDIAGNOST representative The contact with secretions of the patient and reconditioning chemicals can pose a danger to your health During reconditioning always wear the prescribed protection gear as specified in the hospital or national regulations Suitable protection gear is protective goggles face guard moisture resistant protective clothing or lab coat note soiled lab coats must be taken off before leaving the recondi tioning area chemical resistant water proof gloves that are the right size and sufficiently long Gloves must be exchanged and disposed of on a regular basis Irrigate the channels thoroughly and carefully To be free of disinfectants all i
16. e and adjust the white balance with the help of the corresponding switch on the camera Then hold the distal end of the optic at the same distance above a colorful graphic and adjust the focus with the adjustable ring on the TV adapter At the same time check the color fidelity PH 01 2 Operating Manual PCNL Optic modular 30 PD PN 0080 Rev 004 Date June 06 2012 If the image is cloudy clean the lens of the ocular with a cotton swab soaked in 70 alcohol ethanol or isopropanol If the endoscopic image disappears on the monitor during the examination there are three possi ble causes 1 The camera is defective or there is an operating error 2 The light source is defective or there is an operating error 3 If the diagnostic image disappears and instead a crystal structured image appears on the monitor this indicates a defect in the fiber optic system This does not pose a risk to the pa tient Remove the endoscope by slowly pulling it out Conclude the examination and inform the POLYDIAGNOST service 8 Troubleshooting 8 1 Occurrence of an error If the endoscope does not work perfectly check the endoscope as described in the chapter Operation of the endoscopy system If the problem can not be eliminated please consult your technician or your POLYDIAGNOST customer representative If the endoscope is obviously damaged please consult your POLYDIAGNOST customer representa tive ATTENTION
17. e 3 10 000 pixel Optic PD PN 0080 reusable Shifter 26 mm PD DS 1210 autoclavable All Seeing Needle 5 F PD PN 0015 exterior diameter 1 65 mm sterile single use T Piece 3 port PD CA 0205 for All Seeing Needle sterile single use 3 way Stopcock sterile single use Perfusion Tube PD CA 0201 sterile single use PH 01 2 Operating Manual PCNL Optic modular 8 Rev 004 Date June 06 2012 Figure 8 Figure 9 Figure 10 Figure 11 Figure 13 PD PN 0080 3 port LuerLock PD CA 0607 for the shaft of All Seeing Needle and 8 F working shaft sterile single use Touhy Borst Adapter PD CA 0112 for fixation of the laser fiber sterile single use 8 F Working Shaft PD PN 0005 exterior diameter 2 65 mm autoclavable 10 5 F Working Shaft PD PN 0020 exterior diameter 3 47 mm autoclavable 2 port Adapter for 10 5 F working shaft PD PN 0030 autoclavable Lunderquist Guide Wire PD PN 0010 sterile single use PH 01 2 Operating Manual PCNL Optic modular 9 Rev 004 Date June 06 2012 4 1 Camera system EndoGnost RA 100 The compact version of the POLYDIAGNOST endosco py tower includes Camera Xenon Ligthsource 15 Monitor Digital USB Stick Recorder video and pictures Figure 14 POLYDIAGNOST 3 Joint Arm It holds the camera outside the sterile area Figure 15 The ocular fix focus PD FS 4001 has to be fix
18. ed on the upper side of the 3 Joint Arm Figure 16 PH 01 2 Operating Manual PCNL Optic modular 10 PD PN 0080 Rev 004 Date June 06 2012 4 2 _ Irrigation pump POLYDIAGNOST Irrigation Pump IP 200 PD IP 0100 230 V PD IP 0110 110 V Figure 17 Irrigation Tube for IP 200 PD IP 0120 sterile single use Spike for the Irrigation Solution Bag PD IP 0121 sterile single use Figure 19 PH 01 2 Operating Manual PCNL Optic modular 11 PD PN 0080 Rev 004 Date June 06 2012 4 3 Labeling The respective serial number manufacturer and CE label are indicated on the body of the optic and the exchangeable oculars Serial number Manufacturer CE label Figure 20 Serial number and CE label Figure 21 Manufacturer Figure 22 PH 01 2 Operating Manual PCNL Optic modular 12 PD PN 0080 Rev 004 Date June 06 2012 5 Set up of the system 5 1 _ Preparation of the MICROPERC system All Seeing Needle MICROPERC system All Seeing Needle remove protection tube from the optic Figure 23 a o Figure 24 and move it with open screw over the optic Figure 25 The needle has to be placed in the shaft cone shaped connection Figure 26 and connected with slight twisting Figure 27 connect T piece a Figure 28 PH 01 2 Operating Manual PCNL Optic modular 13 PD PN 0080 Rev 004 Date June 06 2012 adapt stop
19. ept Extra N Ecolab GmbH e a N N Sekusept Forte Ecolab GmbH Sekusept Plus Ecolab GmbH Instru Plus Laboratorium Dr rer nat Deppe aooo Instru Star Laboratorium Dr rer nat Deppe Instru Zym Laboratorium Dr rer nat Deppe gigasept Sch lke amp Mayr GmbH N je N gigasept FF Sch lke amp Mayr GmbH PH 01 2 Operating Manual PCNL Optic modular 41 PD PN 0080 Rev 004 Date June 06 2012 Machine cleaning and disinfection sterilization Product name Manufacturer iye thermosept RKN zym Sch lke amp Mayr GmbH Attention When selecting the cleaning products and disinfectants please take care that they do not contain the chemicals listed here Iodine and iodine tincture Calcium hypochlorite Formic acid Copper II chloride Longer chain alcohols from 3C atoms Methanol PH 01 2 Operating Manual PCNL Optic modular 42 PD PN 0080 Rev 004 Date June 06 2012 Bromine water gt 1 Perchloric acid Hydrogen bromide Phenol solution Chlorine Mercury II chloride Chlorinated lime Nitric acid 10 Chloric acid Hydrochloric acid 10 Chlorosulfonic acid Sulfuric acid 10 and conc Chloroform Styrol Hydrogen peroxide 30 Formaline 30 Tin ammonium hexachloride 9 4 Storage of modular optic and accessories The storage space must be low germ low on dust dry and well ventilated Tempera
20. evices and or cleaning disinfectant solutions pay attention to holding times 9 3 Cleaning disinfection and sterilization 9 3 1 Basics Effective pre cleaning cleaning and disinfection are an indispensable prerequisite for an effective sterilization of POLYDIAGNOST endoscopes and accessories Make sure that only cleaning disinfection and sterilization procedures that are sufficiently vali dated with regard to devices and products are used and that the validated parameters are ad hered to in every cycle Also make sure that the regulations of the hospital and the manufacturer of the cleaning products and disinfectants the disinfectors and the sterilizers as well as the statutory provisions applicable in your country are adhered to This applies in particular for the different specifications with regard to an effective prion inactivation PH 01 2 Operating Manual PCNL Optic modular 33 PD PN 0080 Rev 004 Date June 06 2012 WARNING The endoscope was not sterilized or disinfected before delivery It must be cleaned and disinfected sterilized before every use ATTENTION In case of thermostable devices and instruments the autoclaving of gas sterilization is to be preferred 9 3 2 Precautionary measures ATTENTION If the endoscopic devices are not cleaned and disinfected or sterilized according to regulations then this can pose a risk to the safety of the patient During application the endoscope comes into
21. he original sterilization tray of the POLYDIAGNOST features holding brackets to avoid mechanical damage to unfixed devices For sterilization only the sterilization procedure listed below are to be used other sterilization pro cedures are not permissible Shifter PD DS 1210 8 F Shaft PD PN 0005 10 5 F Shaft PD PN 0020 2 port Adapter for PCNL Shaft PD PN 0030 PCNL optic semi rigid in the sterilization tray Ethylene oxide gas steriliza tion 55 C to max 60 C and formaldehyde gas sterilization STERRAD low temperature plasma sterilization Autoclave steam sterilization 121 C 20 minutes max 124 C Autoclave steam sterilization 132 134 C 5 minutes max 137 C t registered trademarks of the corresponding manufacturers X permissible ATTENTION Ethylene oxide EO gas sterilization Only use an ethylene oxide sterilizer that meets the specifications of DIN EN 1422 and a steriliza tion procedure that was validated according to DIN EN ISO 11135 1 The principal proof of the suitability of the endoscopes for an effective ethylene oxide sterilization was provided by an independent test lab using the Sterivit procedure by the company DMB Appa ratebau GmbH Wiesbaden The procedure indicated above was taken into account during this When determining the post run ventilation times you must follow the specifications of DIN EN ISO 10993 7 PH 01 2 Operating Manual PCNL Opt
22. ic modular 40 PD PN 0080 Rev 004 Date June 06 2012 The principal proof of a relatively low ethylene oxide residue of the used materials directly after the ethylene oxide sterilization was provided by an independent test lab using the Sterivit procedure of the company DMB Apparatebau GmbH Wiesbaden The procedure indicated above was taken into account during this Attention Repeated ethylene oxide sterilization can reduce the service life of the endoscope An effective and certified sterile packaging and suitable storage can prevent unnecessary repeated sterilizations Autoclaving steam sterilization Only use a steam sterilizer that meets the specifications of DIN EN 285 or DIN EN 13060 and a sterilization procedure fractionated vacuum procedure that was validated according to DIN EN ISO 17664 1 9 3 8 Material compatibility Due to continued advances in technical development it is not possible to guarantee that this list is complete That is why we recommend the tested and approved disinfectants type 1 and cleaning products type 2 in the following list Manual cleaning and disinfection sterilization Productname 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 l Aseptisol Bode Chemie GmbH Korsolex AF Bode Chemie GmbH a 41 Korsolex Plus Bode Chemie GmbH Sekus
23. infection disinfector Sterilization Material compatibility Storage of modular optic and accessories Service life Transporting the endoscope Transport inside the hospital Transport outside the hospital Transporting the endoscope by using a shipping company transport company Certificates PH 01 2 Operating Manual PCNL Optic modular 4 PD PN 0080 Rev 004 Date June 06 2012 1 Safety 1 1 Intended application For endoscopic therapy of kidney stones 1 2 Operating manual Before using the endoscope please thoroughly read the operating manual as well as the operating manuals of all other necessary devices that are to be used during the examination The different endoscopic procedures and the medical aspects of endoscopy are not a part of these instructions Keep the operating manual in a safe easily accessible place If you have questions or suggestions about the content of this operating manual please contact the company POLYDIAGNOST or its distribution partners 1 3 Compatibility with other devices The safe operation of endoscopy devices depends in large part on the correct selection of other devices The combination with any devices other than the recommended ones can lead to an im pairment of safety and performance 1 4 _ Important information The user has to check and decide whether the endoscope is the right model for the intended ex amination A prerequisite for the safety of patients is the proper hand
24. internal channels of the working shafts 2 port adapter for PCNL shafts and of the shifter with disinfectants 6 Clean the lens distal end of the PCNL optic by lightly rubbing it with a damp swab PH 01 2 Operating Manual PCNL Optic modular 35 PD PN 0080 Rev 004 Date June 06 2012 7 Place the optic protection tube onto the modular PCNL optic 8 Then irrigate with disinfectant solution see figure 92 Figure 92 The cleaning and disinfection must take place immediately after the application and the pre cleaning This is where different procedures can be used Machine procedure disinfector or Manual procedure placing device in cleaning products and disinfectants Note Due to the low reproducibility and effectiveness a manual cleaning and disinfecting should only take place if no disinfector is available 9 3 5 Manual cleaning and disinfection When selecting the cleaning products and disinfectants care must be taken that the disinfectant has a verified effectiveness e g DGHM OGHMP or FDA certification or CE label the cleaning product is compatible with the used disinfectant the used chemicals are compatible with the POLYDIAGNOST endoscopy devices and accessories Important The concentrations and application times indicated by the manufacturer of the cleaning product or disinfectant must be absolutely adhered to When irrigating after disinfection only use sterile or low germ max 10 germs ml dis
25. ling of the endoscope by the doctor and the medical personnel Examples of improper behavior e Using insufficiently prepared or wrongly stored devices increases the risk of infection of the patient and personnel e Forcing the endoscope forwards or backwards without a clear endoscopic view can lead to injury to the patient e The insertion and or use of endoscopic accessories without a clear endoscopic view can lead to injury to the patient 1 5 On receiving the modular PCNL optic Check the modular endoscope for damages and for proper functionality Do not use the modular endoscope if there are any visible damages and or if the functionality is not guaranteed If you notice any irregularities please contact your POLYDIAGNOST customer representative WARNING The endoscope was not sterilized or disinfected before delivery It must be cleaned and disinfected sterilized before every use as described in the corresponding chapter of the manual PH 01 2 Operating Manual PCNL Optic modular 5 PD PN 0080 Rev 004 Date June 06 2012 1 6 Reconditioning and storage After use recondition the endoscope and store it according to the general guidelines See chapter Instructions for reconditioning Insufficient reconditioning can create an infection risk and cause damage to the device Attention The optic is not autoclavable Autoclaving will damage the optic 1 7 Sterile packaged products When using sterile pa
26. n tray or a suitable storage tray The same goes for the accessories This reduces the risk of damages If you need to transport the de vice without a suitable tray hold the optic body and the optic in the protective tube in one hand and make sure that the light cable has a large radius to avoid kinks 10 2 Transport outside the hospital Transport the endoscope in the transport case Make sure that the endoscope is placed carefully in the cut outs in the case that are intended for this purpose and that this is not closed if the light cable juts out over the edge of the case ATTENTION The transport case can not be cleaned or disinfected Clean and disinfect or sterilize the endoscope before placing it in the transport case Before using the endoscope it must be disinfected or sterilized again 10 3 Transporting the endoscope by using a shipping company transport compan Important In case of any damage incurred during transport please pay careful attention to the following di rections since the insurance company covering the transport is not obligated to pay for any claims if these formal requirements are not adhered to If there are damages during transport it is in your interest to secure compensation claims by in volving representatives of the shipping company transport company in a timely manner to de termine the damages in the context of their relevant rules and regulations This means that if a loss or damage of the
27. nd Servicegesellschaft www polydiagnost com fur medizinelektronische info polydiagnost com Diagnostik und Therapiegerate mbH PH 01 2 Operating Manual PCNL Optic modular 2 PD PN 0080 Rev 004 Date June 06 2012 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 4 1 4 2 4 3 5 1 5 2 5 3 5 4 5 9 5 6 6 1 6 2 6 3 6 4 6 5 7 1 7 2 7 3 7 4 8 1 8 2 Table of Contents Page Safety ciriirninieinisini ninrin EAEN NEE Ea NENA 5 Intended application sssssnesenssnersnnsnnrnnnsnnrnnrrnnrnrnnnernrnrnnrnrnnnernrnnnnrnrnnnennrnnnnnnrnnnnnnne 5 Operating manual ssssessssssenssnsrnrrrrsrnrrsnnsrnrnrnnrnrnrnernrnrnnrnrnrnnrnrnnnnrnrnenennrnnnnrnnnennrnn nenne 5 Compatibility with other devices s ssssesesssnsrnnssnsrnrrsnsrnrnrnernrnrnnrnrnnnsrnrnrnsrnrrenernrnenne 5 Important information s ssssesssssnsrrnrsnnrnrrsnnrnrnrnnrnrnrrernrnnnnrnrnnnnrnrnnnnrnrnnnennrnnnennrnnnnnnne 5 On receiving the modular PCNL Optic cccscsccecsecrcecsecrcecnearcecuearseceearseseearseseearsnseeates 5 Reconditioning and StOragEsircserecnecienieiond ie a E aaa 6 Sterile packaged PrOCUCtS cccccceceeeeeeeeeeeeeeeeeeeeeeeeeeee eee eeeeaeeeeesaeeeseeaeeesaeaeaesasanaesesanes 6 REDA GXChe NOS vaceaneccseanecenvuaeveasacsuqenresnuautvecaudenmnanyaeeuasameenissncecaveanraaneacauaueseenwisavesas 6 OMI ernia ia ss caren enanua cea E A 6 SDSCILICACIONS sisisscssscsscssarsyecpranctnscanysieneraseiaievencvawenrecineciea
28. nena e eee eee eee eee ane a tensa ene 26 Ligth connection s ssssssesssnsrnnssnsrnrnrrsrnrnrnnrnrnrnnrnrnrnnnnrnrnennrnrnnnnrnnnrnnrnrnnnnrnrnnnnrnr nenne 27 The complete installed image transmission system ssesessesessensssnnnnunnnnnnnnnnnnnnnnnnrnnnns 29 Operation of the endoscopy System s ssesssssssrsrrsrsrrrrrnsrnrnrrsrnrnrnnrnrnenernrnennrnrnenennne 30 Preparation of the modular endoscope s sssesssssrssssrsnnrrrrsrnrnnnsnnrnnnrnnrnrnennrnrrennrnenenne 30 Inspection of the modular endoscope cccceceececeeeeeeeeeeeeeeeeeeeeeeeeeeeaeaeeesaeaesesenseseeaees 30 Ba CAUNO i ee ee 30 Checking the endoscopic IMAGE cccececeeeeceeeeeeeeeeeeeeeeeeeeeeeaeeeseeaeeeeaeaeeeeetaesesanaeseeaees 30 Troubleshooting cits ete wate srs cain a cede ene ew ence ee viene eeenetea en eaceeis aeqeas 31 Occurence of an GIO sieeve werent reece tence cere tet ee neete tetas ee ee cane be tecen eave EEEE ARETES 31 Sending endoscope instrument in for repair cecceeeeeeeceeeeeeeeeaeeeeeeaeeeeeeeeeeeetaeeeeaees 31 PH 01 2 Operating Manual PCNL Optic modular 3 PD PN 0080 Rev 004 Date June 06 2012 Instructions for reconditioning General statement Safety information Basics Terminology Causes of a faulty reconditioning Cleaning disinfection and sterilization Precautionary measures Reconditioning overview Pre cleaning immediately after the examination Manual cleaning and disinfection Machine cleaning and dis
29. ness 6 Irrigate all channels forcefully and thoroughly with cleaning solution at least five times single use syringe 7 Take the endoscopy system out of the cleaning bath as soon as the application time recom mended by the manufacturer of the cleaning product has passed 8 Next irrigate all channels at least five times using sterile or low germ distilled or de ionized water single use syringe Duration per irrigation cycle at least 1 minute 9 Next dry all channels by blowing medically clean compressed air through Disinfection 1 Fill a basin with the disinfectant solution 2 Place the disassembled POLYDIAGNOST endoscopy system into the disinfectant solution The endoscope must be completely submerged see also figure 93 3 Disinfect the exterior surfaces of the endoscopy system with a soft cloth or sponge Irrigate all channels thoroughly with disinfectant solution at least five times single use sy ringe Take the endoscopy system out of the disinfection bath as soon as the application time rec ommended by the manufacturer of the disinfection product has passed Next irrigate all channels at least five times using sterile or low germ distilled or de ionized water single use syringe Duration per irrigation cycle at least 1 minute Next dry all channels by blowing medically clean compressed air through PH 01 2 Operating Manual PCNL Optic modular 37 PD PN 0080 Rev 004 Date June 06 2012 The fundamen
30. nternal channels of the working shafts 2 port adapter for PCNL shafts and the shifter must be irrigated thoroughly with sterile or low germ distilled or de ionized water This prevents the next patient from being exposed to residues of disinfectants Make sure that the reconditioning area is sufficiently ventilated as specified in the hospital or national work safety regulations Sufficient ventilation at least eight to ten air changes per hour reduces chemical fumes For the drying or irrigation of the channels with air or liquid do not use pressures greater than 50 kPa otherwise the channels can be damaged PH 01 2 Operating Manual PCNL Optic modular 34 PD PN 0080 Rev 004 Date June 06 2012 9 3 3 Reconditioning overview after examination pre cleaning in examination room room 9 3 4 Pre cleaning immediately after the examination A pre cleaning has to take place immediately after the examination while the device is still in the examination room This is the only way to prevent the depositing of organic material can be prevented and to guaran tee successful sterilization 1 Remove all instruments valves and caps from the working channels 2 Dispose all of the disposables 3 Clean the exterior surfaces of the endoscopy system with a soft cloth or sponge soaked in disinfectant 4 Disassemble the modular endoscopy system into its individual parts optic shifter working shafts and adapter 5 Irrigate all
31. product is externally recognizable then the recipient has to demonstrate the loss or damage to the freight carrier no later than at the time the goods are delivered In case of transport by rail the railroad company must be asked for a state ment of the facts In case of a parcel shipment any damaged parcels must be recorded in writing by the shipping company before they are accepted PH 01 2 Operating Manual PCNL Optic modular 44 PD PN 0080 Rev 004 Date June 06 2012 In case of damages that are not immediately recognizable i e that are only discovered when unpacking the goods the shipping company or freight carrier must be notified in writing immediately The use of the following text is recommended for the required correspondence to the transporta tion company TOC GISPAIC CIC a ce ret eis eet essen beastie or to the post office the shipping company the transportation company the parcel service The Sh ipMent cuscersensceseececessecscessecessenecesassees indication of letter of consignment package signa ture OU eacacnucencusnecnenecsansneneenes sendet COvsarenccennccennecennnnnersneereneeness received OF acs eee Was accepted here without complaint since no externally recognizable dam ages were evident On opening the package however it turned out that the content was damaged and or lost during transport We hold you responsible for the damage that was incurred If you think it is necessary you can in
32. requires that all used endoscopes and instru ments must be guaranteed to be free of prions RKI guidelines The Robert Koch Institute RKI has published guidelines for the preparation of applied medical products All instructions for reconditioning published by the company POLYDIAGNOST are subject to the guidelines of the RKI First a brief overview of the required processing steps from the RKI guidelines e Proper preparation gathering possibly disassembling pre treating and pre cleaning of the used medical products and their transport to the location of the preparation safely enclosed and in a way that avoids damages e Cleaning disinfection irrigation and drying e Checking for cleanliness and sound condition of the surfaces e g corrosion material quality and possibly identification for the purpose of making a decision about a reconditioning e Care and maintenance e Verification of the technical functional safety e Labeling e Packaging and sterilization e Storage 9 2 Safety information 9 2 1 Basics This operating manual contains information that is necessary and unavoidable for the safe and effective reconditioning of the endoscope and its accessories Read this operating manual carefully and follow the instructions Keep all operating manuals in a safe easily accessible place All persons responsible for the recon ditioning must be trained thoroughly in the reconditioning procedures that are used
33. rescribed sterile area PH 01 2 Operating Manual PCNL Optic modular 29 PD PN 0080 Rev 004 Date June 06 2012 7 Operation of the endoscopy system Endoscopic procedures and the medical aspects of endoscopy are not a part of this operating manual 7 1 _ Preparation of the modular endoscope Make sure that the endoscope was cleaned disinfected and sterilized before use as described in the chapter Instructions for reconditioning 7 2 _ Inspection of the modular endoscope e Before every use check the endoscope for recognizable damages and functionality e Examine the device visually to make sure it is in perfect condition and check the image quality of the ocular together with the endoscope e Do not use the endoscope if you notice irregularities if there are any visible damages and or if the functionality is not guaranteed WARNING Monitor i EndoGnost RA 100 POLYDIAGNOST Video camera compact video tower Xenon light source USB Stick recorder Figure 91 Fe Carefully read the operating manual for every accessory device and prepare the device according to the respective specifications 7 4 Checking the endoscopic image Switch on the video camera light source and monitor and check the endoscopic image After switching on the entire system camera light source monitor switch the light source to the highest intensity Hold the distal end of the PCNL optic approx 5 cm above a white surfac
34. rking shaft PD PN 0030 T Piece 3 port PD CA 0205 for All Seeing Needle Figure 52 Touhy Borst Adapter PD CA 0112 for fixation of the LithoClast Master Probe Figure 53 LithoClast and LithoClast Master are registered tradenames of EMS Switzerland PH 01 2 Operating Manual PCNL Optic modular 19 PD PN 0080 Rev 004 Date June 06 2012 5 4 How to proceed with the 8 F or 10 5 F working shaft Take the Lunderquist Guide Wire and move it under X ray control into the working shaft of the All Seeing Needle which is placed inside the patient Figure 54 move then the needle out Figure 55 and move careful the 8 F or 10 5 F working shaft over the guide wire Figure 56 remove finally the obturator and guide wire Figure 57a Figure 57b PH 01 2 Operating Manual PCNL Optic modular 20 PD PN 0080 Rev 004 Date June 06 2012 5 5 LithoClast Probe Move the optic incl shifter through the side port of the 3 port adapter And take care that the optic is moved as far as possible backwards A Figure 58 adapt stopcock and perfusion tube Figure 59 now move the system inside the 8 F working shaft Figure 60 finally adapt the closed Touhy Borst adapter on the middle port Figure 61 PH 01 2 Operating Manual PCNL Optic modular 21 PD PN 0080 Rev 004 Date June 06 2012 Control the correct length of the optic distal end of the shaft on the screen
35. spect the extent of the damage in our company premises our storage facilities address Please also contact the department in our company that sent you the shipment specifying the letter of consignment and the invoice number and please enclose the mentioned documents with your complaint 11 Certificates Certification EC Certificate mdc medical device certification GmbH Nothed ogy O48 POLYDIAGNOS Po_yDiacnost GmbH Schafflerstrafe 13 85276 Pfaffenhofen endoscopic systems muti lumen catheters has introduced and apphes a Quality System for he desg wrwutactre and fra Spectr Annex Il excluding Section 4 of the Council Directive 93 42 EEC PD PN 0080 CE This device meets the requirements of the Council Direc tive 93 42 EEC regarding medical products This device is a product of class Ila Certificate mdc medical device certification GmbH POLYDIAGNOS POLYDIAGNOST GmbH Schafflerstrahe 13 85276 Pfaffenhofen Germany Veudeninatisncteabe 2 78108 Freiburg lor the scope development manufacturing and destribution of endoscopic systeens and mutt lumen catheters has r roduced ard apptes a Quality Management System WN cena oem aaa EN ISO 13485 Mecdical Geretcers Qualy manuegement systems yy purposes PH 01 2 Operating Manual PCNL Optic modular Certificate mdc medical device certification GmbH POLYDIAGNOS PoLyDiacnost GmbH Schafflerstrahe 13 85276 Pfaffenhofen Germany
36. tal suitability of the POLYDIAGNOST endoscopy devices for an effective manual clean ing and disinfection was verified by an independent test lab using the cleaning product CIDE ZYME application concentration 1 6 application time 5 min and the disinfectant CIDEX undi luted activated solution application time 30 min The procedure described above was taken into account during this 1 Johnson amp Johnson Medical GmbH Norderstedt 9 3 6 Machine cleaning and disinfection disinfector When selecting the disinfector care should be taken that the disinfector has a verified effectiveness e g DGHM OGHMP or FDA certification or CE label the disinfector has connections for the operating and irrigation channels of the POLYDIAGNOST endoscopy system only sterile or low germ max 10 germs ml distilled or de ionized water is used for irrigation that the disinfector is maintained and inspected on a regular basis When selecting the disinfection program care should be taken that for thermolabile products the corresponding program is selected the irrigation pressures used for the operating and irrigation channels are not too high see 9 3 2 Precautionary measures do not use pressures greater than 50 kPa the program contains sufficient irrigation cycles When selecting the used cleaning products and disinfectants care must be taken that the disinfectant has a verified effectiveness e g DGHM OGHMP or FDA certification
37. tilled or de ionized water PCNL optic endoscopy accessories and other parts should not be placed in physiological saline solution and should not be cleaned in ultrasonic bath This immediately leads to damages on the endoscope and its accessories Only freshly produced cleaning disinfection and irrigation solutions may be used and they may not be used more than once To clean the surfaces and internal channels do not use brushes or sponges made of metal as this can cause damages PH 01 2 Operating Manual PCNL Optic modular 36 PD PN 0080 Rev 004 Date June 06 2012 Cleaning 1 2 Fill a basin with the cleaning solution Place the disassembled POLYDIAGNOST endoscopy system into the cleaning solution The en doscope must be completely submerged Place PCNL optic with protective tube in place as depicted into cleaning solution A syringe filled with cleaning products or disinfectants is placed on the Luer Lock of the protective tube and the tube with optic inside is irrigated multiple times Figure 93 3 Clean the exterior surfaces of the endoscopy system with a soft cloth or sponge 4 Clean the internal channels of the working shafts 2 port adapter for PCNL shafts and shifter multiple times with the respectively suitable cleaning brushes inside the cleaning basin Always brush from the proximal end to the distal end 5 Make sure that the cleaning solution does not foam too much reduced cleaning effective
38. ture fluc tuations should be avoided Do not store the PCNL optic in the transport case Store the optic in the supplied protective tube and properly in the sterilization tray or a suitable storage tray The same goes for the accessories This reduces the risk of damages Before putting them away for storage thoroughly dry all parts of the modular PCNL optic and the accessories The workings shafts the 2 port adapter for PCNL shafts shifter and accessories are to be stored separately from the PCNL optic Storage in direct sunlight at high temperatures or where they are affected by X rays can dam age the POLYDIAGNOST optic or accessories or pose an infection risk PH 01 2 Operating Manual PCNL Optic modular 43 PD PN 0080 Rev 004 Date June 06 2012 9 5 Service life The service life of the products is not unlimited It is determined by the frequency of use and the quality of storage In case of proper storage usage cleaning disinfection and sterilization a service life of 3 years can be assumed Important note POLYDIAGNOST has made every effort to manufacture an endoscope with a maximum service life Still an unlimited durability can not be guaranteed The quality and service life of the device in large part depends on the careful handling and proper maintenance by a well trained team 10 Transporting the endoscope 10 1 Transport inside the hospital Transport the modular PCNL optic properly in the sterilizatio
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