User`s Manual - PolyDiagnost
Contents
1. Example A Next slide the optic including the shifter into the se lected channel of the handle in example A the middle entrance point and firmly connect it to the shifter using the Luer Lock of the handle Figure 10 Slide POLYSHAFT dental onto optic and connect it to the handle Figure 11 Length compensation of the optic using the shifter A Shifter B Fixing screw Figure 12 PH 01 2 Operating Manual Semi rigid Optic Dental 11 PD DS 1083 Rev 001 Date April 24 2012 If the optic sticks out of the POLYSHAFT dental the screw B figure 13 is loosened and the optic set exactly onto the distal end of the POLYSHAFT dental using the shifter This is checked using the monitor image Next the screw B is fixed again Figure 13 POLYSHAFT dental with the optic set to the distal end Figure 14 PH 01 2 Operating Manual Semi rigid Optic Dental 12 PD DS 1083 Rev 001 Date April 24 2012 4 3 Labeling The respective serial number manufacturer and CE label are indicated on the body of the optic and the modular ocular Serial number Manufacturer CE label Figure 15 Serial number and CE label Figure 16 Manufacturer Figure 17 The micro instruments developed by POLYDIAGNOST can be inserted through the working channel of the handle The diameter of the optic and instruments must be adjusted to the exterior or interior diameter of the POLYSHAFT Attention I2. POLYDIAGNOST Operating Manual Semi rigid optic 10 000 pixel PD DS 1083 Dental Modular Endoscope Modular semi rigid endoscopy system for Dental Procedures Root canal and dental implantology C Eoss PH 01 2 Operating Manual Semi rigid Optic modular Dental 1 PD DS 1083 Rev 001 Date April 24 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 Pfaffen
3. Sekusept Plus Ecolab GmbH Instru Plus Laboratorium Dr rer nat Deppe Instru Star Instru Zym Laboratorium Dr rer nat Deppe gigasept Sch lke amp Mayr GmbH gigasept FF Sch lke amp Mayr GmbH PH 01 2 Operating Manual Semi rigid Optic Dental 28 PD DS 1083 Rev 001 Date April 24 2012 Machine cleaning and disinfection sterilization Product name Manufacturer pe 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 Semi rigid Optic Dental 29 PD DS 1083 Rev 001 Date April 24 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 Dental Modular Endoscope and accessories The storage space must be low germ low on dust dry and well ventilated Temperature fluc tuations should be avoided Do not store the semi rigid endoscope in the transport case Store the endoscope in th
4. see figure 3 15 Operation of the endoscopy evetem ENNEN 16 Preparation of the dental modular endoscope E 16 Inspection of the modular endoscope ENEE 16 SG e n E EE 16 Checking the endoscopic Image 16 Troublechootimg NENNEN 17 Occurrence Of AN e WEEN 17 Sending endoscope instrument in Tor repair EEN 17 Instructions for reconditioning NENNEN 18 ESAE IT 18 Slide Eidel 18 BAC E 18 TU ON Le UE 19 Causes Of a faulty recondtionimg ENNEN 19 Cleaning disinfection and eteriltzaton EEN 19 DA Sizcc cececaetcececicacecteceanescaessadcaeactescececsaeeceescedecaesecicececectesececececesaecdceciccedcenessceetacet 19 PH 01 2 Operating Manual Semi rigid Optic Dental 3 PD DS 1083 Rev 001 Date April 24 2012 Precautionary measures Reconditioning overview Pre cleaning immediately after the examination Manual cleaning and disinfection Machine cleaning and disinfection disinfector Sterilization High Level Disinfection in Dental Clinics Material compatibility Storage of Dental Modular Endoscope 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 Semi rigid Optic Dental 4 PD DS 1083 Rev 001 Date April 24 2012 1 Safety 1 1 Intended application For endoscopic diagnosis and therapy of dental procedures e g root canal treatmen
5. protective tube STERRAD low temperature plasma sterilization with protective tube 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 Semi rigid Optic Dental 26 PD DS 1083 Rev 001 Date April 24 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
6. d E Gonns 32 Rev 001 Date April 24 2012
7. 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 Semi rigid Optic Dental 17 PD DS 1083 Rev 001 Date April 24 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 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
8. view can lead to injury to the patient 1 5 On receiving the Dental Modular Endoscope Check the endoscope for damages and for proper functionality Do not use the endoscope if there are any visible damages and or if the functionality is not guaranteed If you notice any irregulari ties 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 Semi rigid Optic Dental 5 PD DS 1083 Rev 001 Date April 24 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 packaged 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 Ou
9. Figure 26 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 distilled or de ionized water Semi rigid optic endoscopy accessories and other parts should not be placed in physiological sa line 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 chan
10. 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 critical for the safe and effective reconditioning of the endoscope and its accessories Read this operating manual carefully and fol low 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 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 Semi rigid Optic Dental 18 PD DS 1083 Rev 001 Date April 24 2012 9 2 2 Terminology Microorganisms Bacteria yeasts fu
11. 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 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
12. 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 High Level Disinfection in Dental Clinics The Dental Modular Endoscope is a heat sensitive device and incompatible with the traditional steam sterilization method available in dental clinics For this reason high level disinfection HLD is recommended for reprocessing the endoscope Before performing HLD on the endoscope the pre cleaning and cleaning instructions outlined in this chapter must be carried out High Level Disinfection HLD 1 Fill a basin with the HLD solution 2 Place the disassembled endoscope ie remove the POLYSHAFT dental dental handle and optic shifter from the endoscope in to the HLD solution The endoscope must be com pletely submerged The concentration and application soaking times indicated by the HLD manufacturer must be adhered to 3 Remove the endoscope from the HLD solution once the application soaking time recom mended by the HLD manufacture has passed 4 Immerse the endoscope in sterile or low germ distilled or de ionized water and then rinse the endoscope with sterile or low germ distilled or de ionized water three times 5 Dry the endoscope thoroughly
13. e 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 Semi rigid Optic Dental 31 PD DS 1083 Rev 001 Date April 24 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 TOTO GISPAICH CITC OT e sea tees estes ae E E E E EAR or to the post office the shipping company the transportation company the parcel service The ShipMent cusceceensceseecnceseescessesnceecenenensees indication of letter of consignment package signa ture OWN eacacnusencusnecnenecesseceseetes sender o 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 ls necessary you can inspect 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 sh
14. e 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 dental modular endos cope and the accessories The handle shifter and accessories are to be stored separately from endoscope Storage in direct sunlight at high temperatures or where they are affected by X rays can dam age the POLYDIAGNOST endoscope or accessories or pose an infection risk PH 01 2 Operating Manual Semi rigid Optic Dental 30 PD DS 1083 Rev 001 Date April 24 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 semi rigid optic properly in the sterilization tray or a suitable storage tray The same goes for the accessories This reduces the risk of damages If you need to transport the device w
15. east 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 27 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 Semi rigid Optic Dental 23 PD DS 1083 Rev 001 Date April 24 2012 The fundamental 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
16. hofen Um Fax 49 84 41 80 60 60 Vertriebs und Servicegesellschaft www polydiagnost com fur medizinelektronische info polydiagnost com Diagnostik und Therapiegerate mbH PH 01 2 Operating Manual Semi rigid Optic Dental 2 PD DS 1083 Rev 001 Date April 24 2012 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 6 1 7 1 7 2 7 3 7 4 8 1 8 2 9 1 9 2 9 2 1 9 2 2 9 2 3 9 3 9 3 1 Table of Contents Page SEENEN 5 Intended application ENNEN 5 Operating manual EN 5 Compatibility with other devices NENNEN 5 Important information ssssesssssnerenrsnnrnrrsnnrnnrrnnrnrnrrernrnnnnrnrnnnernrnnnnrnrnnnernrnnnennnnnnnnnne 5 On receiving the Dental Modular Endoecope NENNEN 5 Reconditioning and elle enee a aaa 6 Sterile packaged Droduch NENNEN 6 REDA le vaceaneccseanecenvuaeveasacsuqenresnuautvecaudenmnanyaeeuasameenissncecaveanraaneacauaueseenwisavesas 6 COND SODNI E 6 el tee EE 7 Product CSS eil e 8 VN accesses bec be ce oc bee oc ce os ee ne ge ig cg ecg ee eee 8 Individual description ccccccscsececnenecesnenseusnenecusnensensueueceseensenseeunerseseearsasuearsaseearsaseeatss 9 Functional EE ul 10 POLYDIAGNOST semi rigid modular optic 10 000 pixel Dental Modular Endoscope 10 Preparation of the Dental Modular Endoscope ANE 10 PMN n H 13 zg ln i ee PE E E E E E 13 Preparation for the use of the endoscopy evetem E 15 Preparation for use of endoscope system
17. ionized water PH 01 2 Operating Manual Semi rigid Optic Dental 24 PD DS 1083 Rev 001 Date April 24 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 POLYDIAGNOST 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 du
18. ipment 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 w lt and fra Spectr Annex Il excluding Section A of the Council Directive 93 42 EEC PD DS 1083 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 Teens 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 Rad oem aaa EN ISO 13485 Mecdical eer Qualy manuegement systems H yy purposes PH 01 2 Operating Manual Semi rigid Optic Dental Certificate mdc medical device certification GmbH POLYDIAGNOS PoLyDiacnost GmbH Schafflerstrahe 13 85276 Pfaffenhofen Germany e 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
19. ithout 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 product is externally recognizable then the recipient has to demonstrate the loss or damage to the freight carrier no later than at the time th
20. itioning 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 The use of a defective or imperfectly functioning endoscope can form a hazard to the safety of the patient Z Basic equipment X_ Video camera camera head with cable and TV adaptor XX Metal Halide or LED light source 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 semi rigid optic approx 5 cm above a white sur face 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 fo cus with the adjustable ring on the TV adapter At the same time check the color fidelity If the image is cloudy clean the lens of the ocular with a c
21. nels do not use brushes or sponges made of metal as this can cause damages PH 01 2 Operating Manual Semi rigid Optic Dental 22 PD DS 1083 Rev 001 Date April 24 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 semi rigid 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 27 3 Clean the exterior surfaces of the endoscopy system with a soft cloth or sponge 4 Clean the internal channels of the handle and shifter multiple times with the respectively suit able 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 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 l
22. ngi 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 devices 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 clea
23. ning 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 Semi rigid Optic Dental 19 PD DS 1083 Rev 001 Date April 24 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 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
24. nstruments that can be opened or closed must always be closed when they are inserted into or pulled out of the working channel The insertion and or use of endoscopic accessories without a clear endoscopic view can lead to injury to the patient Forced insertion of instruments into the working channel can damage the endoscope Please note that reconditioning is not permitted for the products marked single use PH 01 2 Operating Manual Semi rigid Optic Dental 13 PD DS 1083 Rev 001 Date April 24 2012 Figure 19 Figure 20 Figure 21 Figure 22 Sterilization tray PD AC 1013 Please note that only PolyDiagnost holders are permitted for the sterilization tray Shiftable irrigation suction catheter PD DS 0505 Exterior diameter 0 8 mm sterile single use Luer Lock cap set of 5 pieces PD CA 0609 disposable sterile packed cleaning brush for the optic shifter PD TD 0020 set of 5 pieces cleaning brush for the handle PD TD 0030 set of 5 pieces PH 01 2 Operating Manual Semi rigid Optic Dental PD DS 1083 14 Rev 001 Date April 24 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 Preparation for use of endoscope system see figure 3 e Once the optic has been cleaned disinfected sterilized and is ready for use remove the protection t
25. otton swab soaked in 70 alcohol ethanol or isopropanol PH 01 2 Operating Manual Semi rigid Optic Dental 16 PD DS 1083 Rev 001 Date April 24 2012 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 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
26. r 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 Semi rigid Optic Dental 25 PD DS 1083 Rev 001 Date April 24 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 The 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 Semi rigid optic Handles in the sterilization tra shifters Ethylene oxide gas steriliza tion 55 C to max 60 C and formaldehyde gas sterilization
27. r 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 Semi rigid Optic Dental 6 PD DS 1083 Rev 001 Date April 24 2012 2 Specifications Figure 1 Dental Modular Endoscope with protective tube for optic 10 000 pixel optic 120 Article number PD DS 1083 Exterior diameter 0 93 mm Image control system 10 000 pixel Viewing direction 0 direct view Field of vision 120 Optic length 151 mm Standard light connection ACMI acaptar 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 Semi rigid Optic Dental 7 PD DS 1083 Rev 001 Date April 24 2012 3 Product description 3 1 Overview POLYDIAGNOST S semi rigid optic system is a complete Dental Modular Endoscopy system A completely usable endoscopy system for dental procedures consisting of the following e 2 3 4 5 6 7 Modular optic 10 000 pixel PD DS 1083 with optic protection tube PD HS 0204 Dental handle PD DS 1310 Optic shifter 26 mm PD DS 1210 Modular ocular fix focus black PD FS 4001 POLYSHAFTS dental 2 3 mm root canal PD DS 1070 POLYSHAFTS dental 3 3 mm implant PD DS 1075 Optional sterilization
28. 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 internal channels of the handles 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
29. t and dental implantology as well as other dental related procedures 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 handling of the endoscope by the doctor and the medical personnel Examples of improper behavior Using insufficiently prepared or wrongly stored devices increases the risk of infection of the patient and personnel Forcing the endoscope forwards or backwards without a clear endoscopic view can lead to injury to the patient The insertion and or use of endoscopic accessories without a clear endoscopic
30. tray PD AC 1013 for preparation and storage Figure 2 PH 01 2 Operating Manual Semi rigid Optic Dental 8 PD DS 1083 Rev 001 Date April 24 2012 3 2 Individual description Modular optic 10 000 pixel Optic shifter 26 mm PD DS 1210 Dental handle PD DS 1310 PoLySHAFT 25 mm PoLySHarT 25 mm 2 30 mm 3 30 autoclavable autoclavable PD DS 1070 PD DS 1075 Application Application All dental procedures All dental procedures Root canal Root canal Dental implantology PH 01 2 Operating Manual Semi rigid Optic Dental 9 PD DS 1083 Rev 001 Date April 24 2012 4 Functional elements 4 1 POLYDIAGNOST semi rigid modular optic 10 000 pixel Dental Modular Endoscope Optic bod Modular ocular fix P Y focus 8 2 Light cable connection Handle dental gt S Irrigation channel y z W es Ki Kink Shifter Optic protection POLYSHAFT dental Working channel Figure 3 4 2 Preparation of the Dental Modular Endoscope A The sterilized endoscope with protective tube is put in place Kg Re mg The protective tube is removed oO 0 R mmg Figure 5 PH 01 2 Operating Manual Semi rigid Optic Dental 10 PD DS 1083 Rev 001 Date April 24 2012 Optic shifter autoclaved Figure 6 Dental handle autoclaved EE Figure 7 Selected POLYSHAFT dental The shifter is slid onto the optic and fixed on the proximal end using the screw
31. ube e Slide the optic shifter onto the optic and fix on the proximal end using the fixation screw e Slide the optic including the optic shifter into the middle channel of the handle e Slide the POLYSHAFT dental onto the optic and connect to the handle e If the optic protrudes out of the POLYSHAFT dental open the fixation screw on the optic shifter and adjust the optic to be exactly at the distal end of the POLYSHAFT dental e Irrigation devices are placed through the side ports of the handle e Attach the modular ocular to the optic body and tighten the ring of the ocular in place e Connect TV adaptor to the modular ocular e Connect the camera head to the TV adaptor e Attach the light cable to the light cable entrance on the optic body e The setup of the light source camera monitor should be according to the manufacturer s manual instructions i o Llight cable with exchangeable adapters for light source and en doscope Figure 23 TV adaptor Figure 24 Camera head and cable Figure 25 PH 01 2 Operating Manual Semi rigid Optic Dental 15 PD DS 1083 Rev 001 Date April 24 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 dental modular endoscope Make sure that the endoscope was cleaned disinfected and sterilized before use as described in the chapter Instructions for recond
32. with compressed air When using HLD solutions check the following The HLD solution is compatible to the cleaning products used The HLD has verified effectiveness The HLD chemicals are compatible to the PolyDiagnost endoscope device and accessories The concentration and application times indicated by the HLD manufacturer must be abso lutely adhered to Autoclave Steam Sterilization Accessories of the endoscope the dental handle POLYSHAFT dental optic shifter can undergo autocalve steam sterilization as mentioned in this chapter Prior to autoclave steam steriliza tion the pre cleaning cleaning and disinfection instructions outlined in this operating manual must be carried out PH 01 2 Operating Manual Semi rigid Optic Dental 27 PD DS 1083 Rev 001 Date April 24 2012 9 3 9 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 2 1 Cidex OPA Advanced Sterilization Products c o Johnson amp Johnson Medical GmbH Aseptisol Bode Chemie GmbH eo Korsolex AF Bode Chemie GmbH Korsolex Plus Bode Chemie GmbH Sekusept Forte Ecolab GmbH
33. 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 Semi rigid Optic Dental 20 PD DS 1083 Rev 001 Date April 24 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 Clean the exterior surfaces of the endoscopy system with a soft cloth or sponge soaked in disin fectant 3 Disassemble the modular endoscopy system into its individual parts optic handle and shifter 4 Irrigate all internal channels of the handle and of the shifter with disinfectants 5 Clean the lens distal end of the semi rigid optic by lightly rubbing it with a damp swab PH 01 2 Operating Manual Semi rigid Optic Dental 21 PD DS 1083 Rev 001 Date April 24 2012 6 Place the optic protection tube onto the modular semi rigid optic 7 Then irrigate with disinfectant solution see figure 26
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