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User`s Manual - PolyDiagnost

1. e PD IFU Semi rigid optics E A 20 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 5 3 Storage of optic and accessories The storage space must be low germ low dust dry and well ventilated Temperature fluctua tions must be avoided Do not store the semi rigid optic in the transport case Store the optic in the supplied protective tube and properly in the sterilisation tray or a suitable storage tray the same applies for the accessories This reduces the risk of damage Thoroughly dry all parts of the optic and the accessories before storing them The handle shifter and accessories must be stored separately from the semi rigid optic Storage in direct sunlight at a high temperature or where they are affected by X rays can damage the optic or accessories or pose an infection risk 6 Troubleshooting 6 1 Occurrence of a fault Fault No picture Possible causes No or inadequate connection fibre optic cable endoscope or light source ncorrect fibre optic cable adapter No or inadequate connection endoscope ocular Defective optic Light source and or camera and or monitor defective Configuration of monitor camera incorrect Mains power supply not connected or faulty Remedy Check the connections of the fibre optic cable and ocular Check the fibre optic cable Check the light source camera monitor Check the monitor camera configuration Check the mains power supply Return the
2. 1084 PD DS 1086 Rev A Date 19 03 2015 Note The disinfectant used must be approved by the manufacturer for disinfection of endoscopes Use cleaning friendly instrument trays for the endoscopes Avoid impacts and contact with other instruments Finally tap water or sterile water must be used for sufficient rinsing Cleaning and disinfection must be carried out immediately after use and precleaning This can be done with machine procedures disinfector or manual procedures insertion in cleaning agent and disinfectant 5 2 4 Manual cleaning and disinfection Important Ensure that the effectiveness of the cleaning agents and disinfectants has been verified That the cleaning agents are compatible with the used disinfectants The used agents are approved by the manufacturer for cleaning and disinfection of endoscopes The concentrations and application times specified by the manufacturer of the cleaning agent or disinfectant must be complied with Use only sterile water for irrigation after disinfection Only freshly produced cleaning disinfection and irrigation solutions may be used they may only be used once Sharp objects may not be used for handling optical surfaces In general endoscopes must be handled with great care during cleaning disinfection to avoid damage from application of excessive force knocks bending or being dropped Do not use brushes or metal sponges for cleaning the surfaces and internal channels as
3. RKI guidelines The Robert Koch Institut RKI has published guidelines for the preparation of used medical prod ucts An overview of the required preparation steps Proper preparation collection disassembly as required pretreatment and precleaning of the used medical products and their transport to the location of preparation safely enclosed and in a way that avoids damage Cleaning disinfection irrigation and drying Check for cleanliness and sound condition of surfaces Care and maintenance Verification of technical functional safety Labelling Packaging and sterilisation Storage 5 1 2 Important information All persons responsible for the reconditioning must be well trained in The reconditioning processes that are used Health and safety regulations National and local hospital guidelines The operating manual Function of endoscopy equipment Labelling of disinfectants 5 1 3 Terminology Microorganisms Bacteria yeasts fungi and viruses Microorganisms may not be found on surgical instruments and endoscopes risk of infection Cleaning Physical chemical elimination of impurities including organic substances Disinfection Reduction of the number of microorganisms with the objective that as few as possible viable microorganisms survive low germ product Sterilisation Reduction of the number of microorganisms with the objective that no viable microorganisms survive sterile product St
4. and sterilisation and that the validated parameters are complied with in every cycle The carrying out of the preparation processes lies in the responsibility of the user with regard to attainment of the desired disinfection cleaning and sterilisation effect Additionally comply with the regulations of the hospital and of the manufacturer of the cleaning agent and disinfectant disinfectors and sterilisers as well as the legal provisions applicable in your country PD_IFU_Semi rigid optics E_A 13 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 5 2 2 Precautionary measures ATTENTION The safety of the patient personnel may be endangered when the devices and corre sponding accessories are not properly cleaned and disinfected sterilised When cleaning is not carried out this endangers the effectiveness of disinfection sterilisation Devices and accessories must be cleaned as thoroughly as possible before disinfection Thorough cleaning reduces the number of microorganisms present eliminates organic materials and there fore supports the effectiveness of the disinfection sterilisation procedure Contact with secretions from the patient and reconditioning chemicals may endanger your health During reconditioning therefore always wear the prescribed protective equipment as specified in hospital or national regulations Suitable protective equipment are protective goggles face mask moisture res
5. medical aspects of endoscopy are not covered in this manual A prerequisite for the safety of the patient is the correct handling of the endoscope by the doctor and medical personnel The user must be trained on use of the device 1 3 A After receipt of the optic Check the optic for damage and operability Do not use the optic if it has visible damage and or its operability cannot be ensured Contact your customer service representative if you notice unusual behaviour or irregularities Damage during transportation must be reported immediately to the package service transport company WARNING The optic was not sterilised or disinfected before it was delivered It must be cleaned and disinfected sterilised every time before use as described in the corresponding chapter of the manual 1 4 J Environment Operation Comply with the operating conditions of the endoscope as well as the conditions for storage and transport The endoscope may become damaged or malfunction outside of the specified toleranc es Every time prior to use the optic and appropriate accessories must be examined for possible opti cal and mechanical damage in order to exclude risk of injury Endoscopes with damage or defec tive components may no longer be used During laser surgery and high frequency surgery comply with the instructions for use and the safety instructions of the used devices and accessories When the endoscope is used in conjunction
6. mm straight PD DS 1030 X Ophthalmology tear duct 0 9 mm 50 mm straight PD DS 1035 50 mm straight PD DS 1038 X Ophthalmology tear duct 1 1 mm Temporaman dibular joint 1 6 mm 50 mm straight PD DS 1042 arthroscopy Temporaman straight dibular joint 1 3 mm 50 mm sharp pointed PD DS 1065 arthrocentesis tip D Diagnosis T Therapy PD IFU Semi rigid optics E A 9 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 4 Functionality Figure 12 4 1 Assembly Figure 14 Insert into port of the handle and connect Figure 13 Slide shifter with open screw to shifter with LuerLock onto optic E Figure 16 Adjust optic exactly to the distal end l D Figure 15 Insert into de of the POLYSHAFT secure shifter screw connect handle and POLYSHAFT Figure 17 Join ocular to body and connect to camera PD IFU Semi rigid optics E A 10 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 4 2 Instruments Instruments can be inserted through the operating channel of the handle The diameters must be matched to the optic and the POLYSHAFT ATTENTION Instruments that can be opened or closed must always be closed when they are in serted into or pulled out of the operating channel Insertion and or use of accessories instruments without a clear endoscopic view may cause injuries to the patient Forced insertion of instruments into the operating channe
7. optic Fault Cloudy picture stripes streaks etc Possible causes Endoscope optical components are dirty Defective optic Remedy Clean carefully with swab or suitable cloths soaked in alcohol 70 ethanol Return the optic Fault High noise level due to light quantity being too low Possible causes Endoscope optical components are dirty Inadequate connection fibre optic cable endoscope or light source Inadequate connection endoscope ocular Defective fibre optic cable or defective optical fibre of the optic Remedy Clean carefully with cotton sticks or suitable cloths soaked in alcohol Check the connections of the fibre optic cable and ocular Replace the fibre optic cable Return the optic When faults cannot be rectified by simple measures please contact your technician or POLYDIAGNOST customer service representative PD IFU Semi rigid optics E A 21 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 7 Repair Warranty Disposal 1 Return for repair Repair of defective devices may only be carried out by persons authorised by the manufacturer Only original replacement parts may be used Do not make any unauthorised modifications to the device and do not attempt to carry out a repair as this may cause damage to the device and there fore also pose a risk to patients and personnel Unauthorised modifications or repairs release the manufacturer from any and all liability for the operab
8. they may cause damage The semi rigid optic endoscopy accessories and other parts may not be inserted in physiological saline solution and may also not be cleaned in an ultrasonic bath Dam age to the endoscope and its accessories is the consequence of both processes Cleaning 1 Fill a basin with fresh cleaning solution 2 Immerse the optic with fitted protective tube Figure 19 and the accessories into the cleaning solution the optic accessories must be completely submerged Figure 19 PD IFU Semi rigid optics E A 15 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 Clean the exterior surfaces with a soft cloth or sponge 4 Clean internal channels of the accessories in the cleaning basin by using suitable cleaning brushes 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 the optic thoroughly with cleaning solution at least five times disposable syringe see Figure 40 Also irrigate the accessories thoroughly with cleaning solution at least five times Remove the optic and accessories from the cleaning bath no earlier than after the application time recommended by the manufacturer of the cleaning agent 9 Afterwards irrigate all devices and accessories with sterile water at least five times disposable syringe Length of the irrigation cycle at least 1 minute 10 Finally
9. DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 Manual cleaning and disinfection sterilisation Productname Manufacturer 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 Korsolex AF Instru Zym Laboratorium Dr rer nat Deppe Machine cleaning and disinfection sterilisation Product name Manufacturer Type Dismoclean 24 Vario Bode Chemie GmbH MedsafeUK Md ooo 02 0 3E Zyme Medisafe UK Ltd thermosept ED Sch lke amp Mayr GmbH thermosept ER Sch lke amp Mayr GmbH thermosept RKN zym Sch lke amp Mayr GmbH PD IFU Semi rigid optics E A 19 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 When choosing cleaning agents and disinfectants please make sure that they do not contain the chemicals listed below Ethanol Potassium bifluoride Ethyl acetate Potassium hypochlorite Aluminium chloride Methyl chloride Benzine Sodium hypochlorite Sulphuric acid 1096 and conc Mi RR Chromic acid Turpentine Chromosulfuric acid Hydrogen tetrachloride Dimethylformamide Toluene Iron III chloride Trichlorethane Acetic acid 10 and conc Trichlorethylene Hydrogen fluoride Hydrogen peroxide 30 Hydrofluoric acid Xylene Formalin 30 Tin ammonium hexachloride
10. Do not make any unauthorised modifications to the device and do not attempt to carry out a repair as this may cause damage to the device and there fore also pose a risk to patients and personnel Unauthorised modifications or repairs release the manufacturer from any and all liability for the operational safety of the device Unauthorised repairs carried out during the warranty period will result in cancellation of any form of warranty ATTENTION POLYDIAGNOST GmbH does not accept any responsibility for injuries and damage that result from improper use of the device and from non compliance with this operating manual Modification not carried out by POLYDIAGNOST GmbH or specialists authorised by POLYDIAGNOST will lead to loss of any claims under warranty POLYDIAGNOST GmbH does not accept any liability for injuries or damage that occur af ter modifications that were not carried out by POLYDIAGNOST GmbH PD IFU Semi rigid optics E A 5 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 2 Semi rigid optic specifications Article number Exterior diameter Image control system Viewing direction Field of vision Optic length Standard light connection Article number Exterior diameter Image control system Viewing direction Field of vision Optic length Standard light connection Operating conditions Conditions for storage and transport 3 000 pixel optic 70 PD DS 1086 0 45 m
11. POLYDIAGNOST Operating Manual Semi rigid optics 3 000 pixel PD DS 1086 6 000 pixel PD DS 1084 10 000 pixel PD DS 1083 30 000 pixel PD DS 1080 C Eoss PD IFU Semi rigid optics E A 1 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 Table of Contents Page 1 Safety MSEC ONS METTE TOTO I RTL 4 1 1 TALC sU UTI 4 1 2 Operating manual oaseceveivxesiin virexn vr ek EX EK MAR ERU ET EMEN REP EOEFEREVDEEVEN EVEXEF EE assent FEE NEA VUE 4 1 3 After receipt of the OPtic cccecscscsecscscceceecrceceecrceceearseceearceceearseeeearseseearsaseearsasesarsaseeans 4 1 4 Environment Operation eseseseeeeenenee nennen nenne nennen nnns nnns sauna sese nnns 4 1 5 ReconglHoniig arieStOLdO Base era en cre eee aa tees ena TEC ERU HER YE FR DO TE ICIR RC KI ON 5 1 6 Sterile packaged NO CCS eu ssi pa HER ESRWRERV S IH aad SITE ER ERREUR VIX RE RIEN UR EET ELENA TLF DOOR UA 5 1 7 Compatibility and accessories sees nennen nennen nnn nenne nnn nnn 5 LS COMM AUDI e 5 1 9 Repair Replacement 1 eee nmn nnnm nnnm rn nnne nnne nenne 5 2 Semi rigid optic specifications isx sxuxeixksauxevkeusxvrkvE FE ER EXER ERR FEE TAE EDO REPRE ER Orc 6 3 Product HesScHDLOD seccaricnescatuipatecsaneesscannseancueswatnvenvuctncssncate NUMEN NUEVAS CINE ENUT IR REN NN nU MEE 7 Bele eM MeCN Gi ODU Ce soccer caenwencaeancesn casncesecienenencete
12. SA cucsesstesstessterssedstarstosetesesesetace tede E spes uode lass leer eds de DOE PE wececer cece ed 18 5 2 7 Compatibility of materials cessesseseeeeeen nennen nennen nnne nenne nnn nnn nnns 18 5 3 Storage of optic and ACCESSOSICS cccscseeeseesecesnenecesnenecuseenecusnenecuseenecesnenteeseestsuseententes 21 6 Uebsaesud uu m 21 6 1 Occurrence or a TAU is i252 ioi ei oir aee reso r eae eae a eae aeo o9 ego I9 OR PO ESPERTI Ese SED Y c Pe zwIS eS ec gu Ies CER Pe Srags s 21 PD IFU Semi rigid optics E A 2 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 Repair Warranty Disposal Return for repair Warranty Disposal Transportation of the optic Classification PD IFU Semi rigid optics E A 3 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 1 Safety instructions 1 1 Intended use The semi rigid optic is provided for the endoscopic diagnosis and therapy of the milk duct salivary duct tear duct temporamandibular joint and for arthroscopy of small joints 1 2 Operating manual Before using the optic thoroughly read the operating manual as well as the operating manuals of all other necessary devices that are used during the examination Follow the instructions All safety instructions must be complied with Keep the operating manual in a safe easily accessible place The different endoscopic procedures and the
13. avable Figure 6 Fixed focus ocular black PD FS 4001 Figure 7 Fixed focus ocular blue PD FS 4004 reusable reusable PD IFU Semi rigid optics E A 7 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 Figure 8 PoLySHAFT 90mm different diameters for Figure 9 PoLySHAFT 50mm different diameters for different applications different applications sterile disposable sterile disposable e Figure 10 Trocar pointed PD DS 1185 Figure 11 Obturator blunt PD DS 1195 autoclavable autoclavable 3 2 Overview of applications Optic Shifter 26 mm Shifter 48 mm Medium sized Short handle Short handle handle PolyShaft PolyShaft PolyShaft 50 mm 90 mm 50 mm Application Application Application Temporamandibul Milk duct ar joint Ophthalmology Salivary duct Arthroscopy Tear duct Arthrocentesis PD IFU Semi rigid optics E A 8 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 3 POLYSHAFT Exte uu Operating Shape Article number dia length UJ 3 000 pixel optic 6 000 pixel optic 10 000 pixel optic 30 000 pixel optic Application ee ee ce L UCE 0 75mm 90mm straight PD DS 1005 x x Salivary duct tice 0 9 mm 90 mm straight PD DS 1010 x x Salivary duct ee 115mm 90mm straight PD DS 1015 x x x x Salivary duct Salivary duct 2 0 mm 90 mm straight PD DS 1025 X X X X Ophthalmology AEG terdu 0 75 mm 50
14. dry all internal channels by blowing through with medically pure compressed air Disinfection 1 Fill a basin with disinfection solution 2 Immerse the optic with fitted protective tube and the accessories into the disinfection solution the optic accessories must be completely submerged Disinfect the exterior surfaces with a soft cloth or sponge 4 Irrigate the optic thoroughly with disinfection solution at least five times disposable syringe see Figure 40 Also irrigate the accessories thoroughly with disinfection solution at least five times Remove the optic and accessories from the disinfection bath no earlier than after the applica tion time recommended by the manufacturer of the disinfection solution 7 Afterwards irrigate all devices and accessories with sterile water at least five times disposable syringe Length of the irrigation cycle at least 1 minute 8 Finally dry all internal channels by blowing through with medically pure compressed air Dirt particles on optical surfaces can be post treated and removed with a swab soaked in alcohol 70 ethanol or with a neutral cleaner The fundamental suitability of the POLYDIAGNOST endoscopy devices for effective manual cleaning and disinfection has been verified by an independent testing laboratory by using the cleaning agent CIDEZYME application concentration 1 6 96 application time 5 min and the disinfectant CIDEX undiluted activated solution application tim
15. e 30 min The process described above was incorporated for this 1 Johnson amp Johnson Medical GmbH Norderstedt 5 2 5 Machine cleaning and disinfection disinfector Important Ensure that the effectiveness of the device has been verified The device has corresponding connections for the operation and irrigation channels That the cleaning agents are compatible with the used disinfectants The used agents are approved by the manufacturer for cleaning and disinfection of endoscopes Make sure that the appropriate program is selected for thermolabile products Excessive irrigation pressure is not used for the operation and irrigation channels see 5 2 2 Pre cautionary measures pressure not greater than 50 kPa PD IFU Semi rigid optics E A 16 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 The program has sufficient irrigation cycles When a thermal disinfector is used note that the temperature of over 100 C reached during dry ing means that only endoscopes devices labelled as being autoclavable may be disinfected Cleaning programs selected for thermolabile endoscopes must not exceed a temperature of 60 C The concentrations and application times specified by the manufacturer of the cleaning agent or disinfectant must be complied with Use only sterile water for irrigation after disinfection Only freshly produced cleaning disinfection and irrigation solutions may be used they may only be used
16. erile Absence of viable microorganisms very high safety less than one microor ganism may survive on one million products PD IFU Semi rigid optics E A 12 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 5 1 4 Causes of faulty reconditioning e Shortening or termination of the reconditioning process e Non compliance with mandatory prescribed concentrations and application times e Use of unsuitable chemicals e Incompatible cleaning and disinfection solution e Misjudgement of the consequences that may occur as the result of improper reconditioning e Insufficiently reconditioned and prepared devices and or cleaning disinfection solutions ad here to product lifetimes 5 2 Cleaning disinfection and sterilisation 5 2 1 Notes Effective precleaning cleaning and disinfection are a mandatory prerequisite for effective sterilisa tion of the optic and accessories Make sure that the solution fully wets all surfaces including any operating channels or cavities that may be present Comply with the instructions of the manufacturer of the cleaning agent and disinfectant with re gard to concentration and working time Be aware of the compatibility of the used solutions with each other and comply with manufacturer specifications e g with regard to concentration and application times Make sure that only adequately validated device specific and product specific procedures are used for cleaning disinfection
17. ical devices Classification This device is a Class IIa product POLYDIAGNOST GmbH Am Soldnermoos 17 D 85399 Hallbergmoos Phone 49 0 811 9987338 0 PD_IFU_Semi rigid optics E_A 23 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015
18. ility and operational safety of the device Unauthorised repairs carried out during the war ranty period will result in cancellation of any form of warranty Important A repair number must be requested from POLYDIAGNOST before returning the device You can return the device for repair using this repair number Please include a fault description and telephone number of the contact person with the shipment Devices must be thoroughly cleaned and disinfected before they are returned for re pair Include written confirmation that this has been done Insufficiently reconditioned devices represent an infection risk for all persons who come into contact with them Contaminated devices will not be accepted by POLYDIAGNOST 2 Warranty The warranty period is 12 months from the date of the invoice 3 Disposal The device is to be disposed of at the end of its working life in accordance with local regulations 8 X Transportation of the optic Transportation or disposal of the optic may only be carried out when it is in a disinfected state To reduce the risk of damage Transport the optic properly in the sterilisation tray or a suitable storage tray the same applies for the accessories Or transport the optic in the transport case Make sure that the optic is carefully placed in the cor rect recesses in the case and that the case is not closed if the optic cable protrudes over the edge of the case ATTENTION Important Please pa
19. istant protective clothing or lab coats note soiled lab coats must be taken off before leaving the reconditioning area chemical resistant water proof gloves that fit well and are sufficiently long Gloves must be exchanged and disposed of at regular intervals Make sure that the reconditioning area Is sufficiently ventilated as specified in the hospital or national health and safety regulations Sufficient ventilation at least eight to ten air changes per hour reduces chemical vapours Irrigate the channels thoroughly and carefully To be free of disinfectants all internal channels must be thoroughly irrigated with sterile water When drying or irrigated channels with air or liquid do not use a pressure greater than 50 kPa otherwise the channels may be damaged 5 2 3 Precleaning Precleaning must be carried out immediately after the examination This prevents blood protein or other substances from drying out Loosen remove all instruments valves caps and accessories from the optic Dispose of all disposable products Loosen the handle and shifter from the optic Irrigate internal channels of the accessories with disinfectant Carefully clean the lens distal end of the optic by lightly rubbing it with adamp swap Place the optic protection tube onto the optic Then irrigate with disinfection solution see Figure 18 gt Figure 18 PD_IFU_Semi rigid optics E_A 14 PD DS 1080 PD DS 1083 PD DS
20. l can damage the endoscope ATTENTION when laser devices are used When laser devices are used the optic must be protected from the effects of the laser The laser output power must only be activated when the tip of the laser fibre can be seen through the endoscope in order to prevent burns and or unwanted penetrations in the tissue surrounding the optic To prevent potential damage to eyes suitable protection must be worn when laser devices are used 4 3 Connecting to the endoscopy video system Connect the endoscope to the endoscopy video system with the ocular Connect the fibre optic cable to the endoscope 4 4 Checking the endoscopic image After you have switched on the endoscopy video system switch the light source to maximum in tensity Hold the distal end of the semi rigid optic approx 1 cm above a white surface and adjust the white balance with the corresponding switch Then hold the distal end of the optic at the same distance above a colourful graphic and adjust the focus by turning the adjusting ring on the TV adapter At the same time check the colour fideli ty Note The image quality depends to a great extent on an optimum illumination output To ensure this the light transition points of the endoscope and optical fibre must always be kept clean PD IFU Semi rigid optics E A 11 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 5 Reconditioning 5 1 General information 5 1 1
21. m 3 000 pixels 0 direct view 70 151 mm ACMI adapter Integrated fibre optic lighting Reinforced nitinol optic Reusable optic 10 000 pixel optic 120 PD DS 1083 0 9 mm 10 000 pixels 0 direct view 120 151 mm ACMI adapter Integrated fibre optic lighting Reinforced nitinol optic Reusable optic Room temperature Rel humidity Air pressure Temperature Rel humidity Air pressure PD_IFU_Semi rigid optics E_A PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 6 000 pixel optic 70 PD DS 1084 0 55 mm 6 000 pixels 0 direct view 70 151 mm ACMI adapter Integrated fibre optic lighting Reinforced nitinol optic Reusable optic 30 000 pixel optic 70 PD DS 1080 1 3 mm 30 000 pixels 0 direct view 70 151 mm ACMI adapter Integrated fibre optic lighting Reinforced nitinol optic Reusable optic 15 C to 35 C 30 9o to 60 760 to 1060 mbar 10 C to 45 C 10 to 85 760 to 1060 mbar 6 Rev A Date 19 03 2015 3 Product description 3 1 Semi rigid optic 1 Optic 2 Shifter 3 Handle 4 PoLySHAFT 5 Ocular 6 Optic protective tube Figure 1 c c Figure 2 Shifter 26 mm PD DS 1210 Figure 3 Shifter 48 mm PD DS 1220 autoclavable autoclavable a Figure 4 Medium sized handle PD DS 1315 Figure 5 Short handle PD DS 1320 with irrigation and operating channel with irrigation and operating channel autoclavable autocl
22. min The process described above was incorporated for this Hamo AG Schweiz Bode Chemie GmbH Hamburg After cleaning disinfection irrigation and drying e Check for cleanliness sound condition of surfaces e g corrosion material quality no sharp edges and dents and patency of internal channels possibly identification for the purpose of making a decision on repeated reconditioning preparation or disposal e Maintenance e Verification of technical functional safety PD IFU Semi rigid optics E A 17 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 5 2 6 Sterilisation Only previously cleaned disinfected and completely dried endoscopes and accessories may be sterilised The products must be placed in the sterilisation tray before sterilisation Care must be taken that the products are not bent or damaged The sterilisation tray must subsequently be packaged in suitable sterilisation packaging disposable sterilisation packaging for the intended sterilisation pro cedure according to DIN EN 868 2 or DIN EN ISO 11607 1 Retaining brackets are installed in POLYDIAGNOST original sterilisation trays that prevent mechanical damage to unfixed devices Only the sterilisation procedures listed below are to be used for sterilisation other sterilisation pro cedures are not permissible Semi rigid optic with protective tube in the Handles shifters sterilisation tray ETO gas sterilisation 55 C t
23. o max 60 C Low temperature plasma sterilisation STERRAD 100S Steam sterilisation autoclaving 121 C 20 min max 124 C Steam sterilisation autoclaving 132 134 C 5 min max 137 C X permissible Make sure that only adequately validated device specific and product specific procedures are used for sterilisation and that the validated parameters are complied with in every cycle Additionally comply with the regulations of the hospital and of the manufacturer of the sterilisers as well as the legal provisions applicable in your country The principal suitability of endoscopes for effective ETO gas sterilisation has been provided by an independent testing laboratory by using the Sterivit procedure of DMB Apparatebau GmbH Wies baden The process stated above was incorporated for this Note The carrying out of all quoted sterilisation processes lies in the responsibility of the user with re gard to attainment of the desired or required sterilisation effect Use of different sterilisation processes in an alternating sequence may result in early ageing of endoscopes If possible use solely one of the authorised processes 5 2 7 Compatibility of materials Due to constant technical advances in development it can not be guaranteed that this list is com plete We recommend the tested and approved disinfectants type 1 and cleaning agents type 2 listed below PD IFU Semi rigid optics E A 18 PD
24. once Note According to RKI guidelines endoscopes and endoscopy accessories must also be manually pre cleaned when machine cleaning and disinfection is used Follow steps 1 to 10 in the Cleaning section in chapter 5 2 4 Manual cleaning and disinfection Only after you have completed this continue as follows 1 Placed the disassembled endoscopy system into the disinfector by using the sterilisation tray Make sure that the devices are not damaged by this Sort instruments and accessories properly on machine suitable instrument screens 2 Connect the operation and irrigation channels to the connection tubes on the disinfection bas ket 3 Select the endoscopy cleaning program corresponding to the load and which is recommended by the manufacturer Start the program 4 Remove the endoscopy system once the program has finished If necessary let the endoscopy system dry out Dirt particles on optical surfaces can be post treated and removed with a swab soaked in alcohol 70 ethanol or with a neutral cleaner The fundamental suitability of the POLYDIAGNOST endoscopy devices for effective machine cleaning and disinfection has been verified by an independent testing laboratory by using the disinfector Hamo LS 2000 program no 89 50 C the cleaning agent Korsolex Endo Cleaner concentra tion 150 ml 30 I application time 5 min and the disinfectant Korsolex Endo Disinfectant concen tration 300 ml 30 application time 10
25. ueuncatyca ETN 7 3 2 Overview of applications ccceeeceeceeeeeecee eee eeee eee eeee ee nennen nenne nenne renun neas ne nennen 8 33 ro MAS ET zi REPRE 9 4 Functionality 10 kL AD EPEUMEMPERETEUUPITMBSTPUUTSM 10 T MSE TMCS Pm 11 4 3 Connecting to the endoscopy video system ssesssssssrerrsrsrnnrrnsrrnrennrnrnenernrrensrnrrensrnnnne 11 4 4 Checking the endoscopic image 1i eene enne nnns 11 5 R COMUNN ia 12 SE E a ENTIRATA E RTT E E A E 12 Sob RK Suidelln ssseiu ici SEE REREREEEREPERO E E AE 12 5 1 2 Important INFOMATION osssekvrsixrviverkkrEP vr ERE PER ERE ExERERER YET RERUvEER EFE Rn VERRE ET YET REPERI ER REY 12 5 1 3 Terminology d 12 5 1 4 Causes of faulty reconditioning eeeseeeeeeeeenn nennen nennen nenne nennen nnn nnn nnns 13 5 2 Cleaning disinfection and sterilisation eseeeseeeeeennen nmm 13 SNAM UI 13 5 2 2 Precautionary friedsllT6S ees ostro eser Eun r o EE rers EE Ea ne eser E ree Fo EE ree eoe Ea sees Es Ease serere es E Eas ET EE EEEs 14 3 2 5 BOCCONI naires steve RE A E A E A S aEKEER E EF IRE A 14 5 2 4 Manual cleaning and disinfection 1 eee eene nennen enne nnne nnne 15 5 2 5 Machine cleaning and disinfection disinfector cese 16 5 2 5 SEN
26. with electro medical devices make sure that the BF conditions insulated floating applied part are complied with Malfunction of a light source also used may cause hazards Therefore keep an operable replace ment light source available PD IFU Semi rigid optics E A 4 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 1 5 Reconditioning and storage After use recondition the optic and store it in accordance with general guidelines Insufficient re conditioning may create an infection risk and cause damage to the device ATTENTION The optic is not autoclavable Autoclaving can damage the optic 1 6 Sterile packaged products Check that the sterile packaging of sterile packaged products is undamaged Products may not be used when their packaging is damaged 1 7 Compatibility and accessories Combination with devices that are not recommended may result in impairment to safety and per formance Use only the accessories specified for the optic Use of incompatible accessories may cause mal function and or injuries to the user patient and third parties 1 8 Compatibility Our products may contain nickel and or latex Attention must be paid to corresponding allergies In such cases use of the device is at the discretion of the doctor 1 9 Repair Replacement Repair of defective devices may only be carried out by persons authorised by the manufacturer Only original replacement parts may be used
27. y careful attention to the information below in the event of damage during transportation as the transportation insurance company is not obliged to make reimbursements if these formali ties are not complied with In the event of damage during transportation it is in your interest to secure your claims for com pensation by consulting representatives of the package service transport company as early as possible for assessment of the damage in the context of their applicable regulations PD IFU Semi rigid optics E A 22 PD DS 1080 PD DS 1083 PD DS 1084 PD DS 1086 Rev A Date 19 03 2015 This means that if a loss of or damage to the goods is apparent the recipient must report the loss or damage to the shipper no later than when the goods are delivered In the case of transportation by rail a damage or loss report must also be requested from the rail company In the case of parcel shipments before damaged parcels are accepted the package service must certify in writing that the parcels are damaged In the event of damage not immediately apparent the package service or shipping compa ny must be informed in writing immediately after the damage has been ascertained Please also notify the dispatching department of our company quoting the number of the delivery note and invoice and include these documents with your complaint 9 Classification CE This device satisfies the requirements of Council Directive 93 42 EEC as regards med

User`s Manual - PolyDiagnost

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