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Pentax ECY-1575K [2/80] Contraindication
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Intended Use
The Video Cystoscope is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Urinary
Tract. The Urinary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Urethra and Bladder.
This instrument is introduced via the urethra when indications consistent with the need for the procedure are observed in adult
and pediatric patient populations.
Never use this endoscope for any purpose other than that for which it has been designed.
This video endoscope contained in this manual can only be used with PENTAX Video Processor, EPK-i series, EPK-p or EPK-
1000.
Notes
Read this owner’s manual before operating, and save the manual for future reference. Failure to read and thoroughly
understand the information presented in this manual, as well as those developed for ancillary endoscopic equipment and
accessories, may result in serious injury including infection by cross contamination to the patient and/or user. Furthermore,
failure to follow the instructions in this manual may result in damage to, and/or malfunction of, the equipment.
This manual describes the recommended procedures for inspecting and preparing the equipment prior to its use and for the
reprocessing and maintenance of the equipment after its use.
It does not describe how an actual procedure is to be performed, nor does it attempt to teach the beginner the proper technique
or any medical aspects regarding the use of the equipment.
It is the responsibility of each medical facility to ensure that only well educated and appropriately trained personnel, who are
competent and knowledgeable about the endoscopic equipment, antimicrobial agents/processes and hospital infection control
protocol be involved in the use and the reprocessing of these medical devices. Known risks and/or potential injuries associated
with flexible endoscopic procedures include, but are not limited to, the following: perforation, infection, hemorrhage, burns and
electric shock.
Current Infection control guidelines require that cystoscopes and other semi-critical medical devices, that normally come into
contact with intact mucous membranes, such as in the urinary tract, must at least be cleaned and high-level disinfected before
clinical use. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to each
clinical use. It must be recognized that infection control practices involve many complex and often controversial issues which are
constantly evolving. PENTAX strongly recommends that user remain informed of the latest federal and local regulations, and
encourages users to follow infection control guidelines developed by various organizations for health care professionals.
If you have any questions regarding any of the information in this manual or concerns pertaining to the safety and/or use of this
equipment, please contact your local PENTAX representative.
Sterility Statement
The instruments identified in this manual are reusable medical devices. Since they are packaged non-sterile, they must be
cleaned and either high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be
subjected to an appropriate cleaning and either high-level disinfection or sterilization process.
Contraindication
Please consult regional and national health authority recommendations and requirements regarding protocols to follow in order
to reprocess and/or destroy endoscopes that will be used or have been determined to have been used (post procedure) on
patients afflicted with Creutzfeldt-Jacob Disease (CJD or vCJD).
Do not use this product on a patient with untreated acute cystitis/urethritis. Doing so might result in an increase in inflammation
and possible permanent tissue damage.
Conventions
Throughout this manual, the following conventions will be used to indicate a potentially hazardous situation which, if not
avoided;
WARNING
: could result in death or serious injury.
CAUTION
: may result in minor or moderate injury or property-damage.
NOTE
:
may result in property-damage. Also, advises owner/operator about important information on the use of this
equipment.
Prescription Statement
Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical
professional.
Содержание
- Ecy 1575k 1
- Caution 2
- Contraindication 2
- Conventions 2
- Intended use 2
- Prescription statement 2
- Sterility statement 2
- Warning 2
- 1 general 5 3
- 1 inspection of the video processor 0 2 2 inspection of endoscope 2 2 3 preparation just before insertion of endoscope 5 3
- 1 pretreatment 7 3 2 insertion and withdrawal 7 3 3 biopsy 9 3 4 laser 0 3 5 electrosurgery 2 3
- 1 servicing 4 5 2 care and maintenance tips 6 3
- 1 video endoscope 1 2 accessories 1 3 video processors 3
- 2 cleaning disinfection sterilization procedures for endoscopes 9 3
- 3 endoscopic accessory instruments eais and endoscope components 2 3
- Care after use 5 3
- Caution 3
- Directions for use 7 3
- Important 3
- Nomenclature and function 3
- Post reprocessing 3 3
- Preparation and inspection for use 0 3
- Specifications 8 3
- Table of contents 3
- 1 video endoscope 4
- Nomenclature and function 4
- 1 cs c3s 6
- 1 flexible shaft 2 grip 3 handle 4 cups jaws 6
- 1 of b163 6
- 1 of b179 2 o ring of b181 6
- 1 white bristle 2 flexible shaft 3 handle 4 cs6015st cs6002sn 6
- 2 accessories 6
- Biopsy forceps 6
- Cleaning brush 6
- Irrigation control valve 6
- Suction control valve 6
- Suction cylinder cleaning brush 6
- 1 epk i series 8
- 3 video processors 8
- 2 epk 1000 9
- Warning replace the lamp cartridge if the indicator turns red and the image quality starts to deteriorate 9
- 1 inspection of the video processor 10
- Preparation and inspection for use 10
- 2 inspection of endoscope 12
- Before reprocessing and or immersion in any fluids pentax endoscopes should be tested for the loss of integrity in their watertight construction by using pentax brand leak testers for specific details on pentax recommended leak detection procedures please refer to the instructions supplied with pentax leak testers 12
- Inspection of the insertion tube a check the entire surface of the insertion tube for abnormal conditions such as dents crush marks wrinkles bumps buckles excessive bending protrusions peeling of outer sheath cuts holes or other irregularities any crush or indentation of the flexible shaft of the endoscopes can cause damage to the internal mechanisms of the endoscopes b similarly check the condition of the umbilical cable for outward signs of damage such as buckling crush marks etc 12
- Inspection of angulation controls slowly manipulate the angulation control lever to see that it functions smoothly be certain that a full and appropriate range of angulation is possible 18
- Inspection of irrigation mechanism a prior to use the irrigation control valve of b163 should be inspected remove the valve from the control body and make sure that the rubber portion is not damaged or worn 19
- E any accessory should be slowly inserted through the instrument channel inlet with the endoscope in a straight position there should be no resistance encountered if resistance is encountered do not attempt to introduce the accessory further the instrument channel may be damaged and the endoscope should not be used contact the pentax service department 23
- 3 preparation just before insertion of endoscope 25
- Gently clean the objective lens and the light guides with a cotton tip applicator moistened with 70 90 medical grade ethyl or isopropyl alcohol a lens cleaner anti fogging agent may also be applied via gauze or other applicator 3 check the endoscopic image and confirm that it is of acceptable quality for clinical use refer also to the owner s manual supplied with the pentax video processor for inspection of the image quality 4 apply a medical grade water soluble lubricant to the insertion tube do not use petroleum based lubricants 25
- If the endoscope has just recently been reprocessed has been prepared or stored properly and passed all pre procedure inspections the instrument should be ready to use if necessary the endoscope s insertion tube may be wiped down with a gauze dampened with 70 90 medical grade ethyl or isopropyl alcohol 25
- 1 pretreatment 27
- 2 insertion and withdrawal 27
- Adjust the intensity of the video processor to obtain a brightness level suitable for observation 27
- Begin flow of irrigant then insert the endoscope slowly under direct vision 27
- Directions for use 27
- The angulation control should be used as needed to position the endoscope angulation of the tip should be performed under direct vision in a gentle and deliberate manner should resistance be encountered never apply excessive force 27
- The patient should be prepared in your normal endoscopy regimen 27
- Image capture hard copy documentation video recording etc may be carried out as necessary 5 when attempting to withdraw the endoscope return the angulation control lever to its neutral position always withdraw the endoscope under direct visualization 28
- 3 biopsy 29
- 4 laser 30
- Should the distal tip of the endoscope be moved closer than 20 mm from the irradiated tissue surface the aiming beam may create a smear in the image as shown below if this smear affect becomes too severe and distorts the visual field the intensity of the aiming light should be decreased 31
- When activating the laser at high power about 100w for yag laser and 60w for diode laser and or if the endoscope tip comes to within 10 mm of the irradiated tissue flare may appear at the corners of the image as shown below 31
- 5 electrosurgery 32
- The operator and assistant s should wear rubber gloves and face masks to avoid burns during use of electrosurgical devices 2 the electrosurgical accessories should be introduced through the endoscope in the same manner as described for biopsy forceps in section 3 3 32
- 1 1 application 35
- 1 general 35
- As for accessories not listed above please refer to the manual supplied with each accessorry 35
- Care after use 35
- X available depending upon country and or local pentax distributor each pentax accessory may be an optional accessory 35
- 1 2 important instructions 36
- 1 3 internal channels of pentax endoscopes 38
- The following internal schematics have been provided as a service to help users better understand the intricate construction of pentax endoscopes please note that all solution entrance ports and flow pathways are illustrated below 38
- 2 1 pre cleaning 39
- 2 cleaning disinfection sterilization procedures for endoscopes 39
- 2 1 1 items required for pre cleaning 40
- 2 1 2 pre cleaning in a procedure room 41
- 2 2 leak testing 42
- Before reprocessing and or immersion in any fluids pentax endoscopes should be tested for the loss of integrity in their watertight construction by using pentax brand leak testers for specific details on pentax recommended leak detection procedures please refer to the instructions supplied with pentax leak testers 42
- Disconnect tubing from the endoscope irrigation nipple and attach the syringe filled to the endoscope irrigation nipple 15 place the distal end of the endoscope into the basin 16 using the syringe flush the 20 ml detergent solution or water into the irrigation channel 17 while the endoscope distal end still immersed in the basin using a 30 ml syringe flush air to purge detergent solution or water out of the endoscope irrigation channel 42
- Remove the endoscope pve connector from the video processor 19 carry the endoscope to a cleaning room 42
- Transport to the cleaning room 42
- 2 3 cleaning 43
- 2 3 1 items required for cleaning 44
- 2 3 2 preparatory procedure 44
- 2 3 3 external surfaces 44
- 2 3 4 channel cleaning with brushes 45
- Always immerse the endoscope during brushing 45
- Remove the rubber inlet seal of b190 this should be cleaned with the endoscope 45
- Still immersed in detergent solution wash the entire surfaces of the endoscope and the rubber inlet seal with clean gauze make sure that the recessed areas such as the endoscope distal tip channel opening valve cylinder etc should be cleaned thoroughly using the brushes provided open the cap when cleaning the rubber inlet seal 45
- 1 attach the cleaning cap of b155 2 attach the rubber inlet seal of b190 47
- 1 cs c3s 47
- 2 3 5 channel cleaning with detergent solution 47
- Alwaysimmersetheendoscopeduringflushingthedetergentsolutionintothe endoscope channel 47
- Attach 30 ml syringe to the suction irrigation nipple and flush detergent solution 47
- Caution 47
- Cylinder cleaning 47
- Ifresistanceisencounteredduringflushingthedetergentsolutionintothechannel never apply excessive forces to avoid damage to the endoscope do not use the endoscope and contact your local pentax service facility or sales representative 47
- Insert the specially designed cleaning brush cs c3s while rotating to scrub clean the surfaces inside the suction irrigation control valve receptacle on the control head do not insert the brush excessively 11 withdraw the brush while rotating clean the debris off the brush by rubbing with fingers 12 brush this cylinder at least 3 times and until it is visibly clean 47
- Install the instrument channel cleaning adapter of b155 as illustrated below figure 4 3 the rubber inlet seal of b190 should be in place 47
- Warning during flushing detergent solution avoid introduction of air the presence of air bubbles could prevent contact of the detergent solution with channel surfaces 47
- 2 3 6 immersion in the detergent 48
- 2 3 7 rinse 49
- 2 4 high level disinfection 50
- Before any attempt is made to disinfect the endoscope the complete cleaning procedure described elsewhere in this manual must have been completed prior to high level disinfection the end user should confirm the minimum effective concentration mec of reused disinfectant as per the manufacturer s instructions before complete immersion in any disinfecting solution the endoscope should have been leak tested as described elsewhere in this manual 50
- 2 4 1 items required for disinfection 51
- 2 4 2 preparatory procedure 51
- 2 4 3 channel disinfection with disinfecting solution 51
- 2 4 4 immersion in disinfecting solution 52
- 2 4 5 rinse 53
- 2 5 sterilization 54
- Attach a 30 ml syringe and flush the channel with air 30 ml or more to expel residual alcohol 13 ensure no alcohol exits the endoscope tip if any repeat the step 12 above 14 detach the cleaning cap of b155 and the rubber inlet seal of b190 from the endoscope 15 gently dry all external surfaces of the endoscope the cleaning cap of b155 and the rubber inlet seal of b190 with sterile gauze moistened with disinfectants for disinfection of environmental surfaces 54
- Drying of the channel 54
- 2 5 1 1 preparation 55
- 2 5 1 eto 55
- Ensure the cleaning cap of b155 and the rubber inlet seal of b190 are removed from the endoscope 55
- Ethylene oxide eto gas sterilization can be performed on these endoscopes provided the following special instructions are followed to ensure the proper performance of the instrument adhere to the sterilizer manufacturer s instructions and always use chemical and or biological indicator 55
- Remove the soaking cap oe c9 from the endoscope 3 attach the eto cap of c5 to the endoscope 55
- 2 5 1 2 wrap prior to the eto sterilization wrap the endoscope with sterilization wrap or pack 56
- 2 5 1 3 parameter 56
- 2 5 2 sterra 56
- Systems 50 100s nx 56
- The following parameters for ethylene oxide gas sterilization are proposed 56
- 2 5 3 other methods of sterilization 61
- 3 endoscopic accessory instruments eais and endoscope components 62
- Endoscopic accessory instruments eais and endoscope components can be subjected to the following cleaning and disinfection or sterilization for other items not listed below please refer to the manual supplied with those items 62
- Eto or sterra 62
- Not all manufacturers of automated endoscope reprocessors aers washer disinfectors wds make specific claims nor provide special instructions for reprocessing all of the removable endoscope components that are integral to the safe and effective operation of flexible endoscopes therefore should the aer wd manufacturer s instructions not specifically address reprocessing of any particular endoscope component suction irrigation valve inlet seal etc in the aer wd then those components must be reprocessed manually as described in pentax instructions labeling prior to use check with each aer wd manufacturer as to their specific claims with respect to reprocessing individual endoscope components 62
- Sterilization depending upon country and or local pentax distributor each pentax eai and component may be an optional accessory 62
- The soaking cap oe c9 should be attached to the endoscope during cleaning and disinfection the eto cap of c5 should be attached to the endoscope during the 62
- X available 62
- 3 1 1 items required for cleaning 63
- 3 1 2 cleaning procedure 63
- 3 1 cleaning 63
- 3 1 3 ultrasonic cleaning 65
- 3 1 4 rinse 65
- 3 2 high level disinfection 66
- Manipulate the biopsy forceps kw1811s in the basin 66
- Remove all the accessories and the components from the detergent solution 10 using a 10 ml syringe flush air into the lumen of the suction valve of b179 11 wipe all the surfaces of the accessories and the components gently with clean gauze 66
- 3 2 1 items required for disinfection 67
- 3 2 2 disinfecting procedure 67
- 3 2 3 rinse 67
- 3 3 1 eto 68
- 3 3 sterilization 68
- For the eto sterilization of the accessories and the components follow the instructions supplied with each item 68
- 3 3 1 1 wrap prior to the eto sterilization wrap the accessories and the components with sterilization wrap or pack 69
- 3 3 1 2 parameter 69
- 3 3 2 steam sterilization autoclaving 69
- For the steam sterilization of the accessories and the components follow the instructions supplied with each item 69
- 3 3 2 1 wrap prior to the steam sterilization wrap the accessories and the components with sterilization wrap or pack 70
- 3 3 2 2 parameter 70
- 3 3 3 sterra 70
- After the sterilization ensure that the package is intact if there are any signs of abnormalities such as stains tears or any other indications that the packaging has previously been damaged or opened repeat the sterilization with a new packaging 70
- Autoclave can be performed under the following conditions 70
- Caution 70
- Contact the manufacturer regarding directions for use of the wrap or pack 70
- For countries except usa 70
- For usa 70
- Note for usa 70
- Of b190 can be subjected to sterra 70
- Prior to sterilization clean and dry the components thoroughly failure to do so could result in ineffective or incomplete sterilization 70
- Sterilization 70
- Systems 50 100s nx 70
- The suction valve of b179 the irrigation valve of b163 and the rubber inlet seal 70
- Use chemical indicator ci and or biological indicator bi to control the sterilizationprocessandensuresterilizationefficacy 70
- Use the wrap suitable to steam sterilization 70
- Validation testing of these parameters was performed using kimberly clark wrap kc 600 70
- Warning 70
- Following reprocessing the endoscope may either be reused or placed in storage 2 prior to reuse ensure that instrument has been properly inspected and fully prepared for the next clinical procedure 3 prior to storage ensure that all internal channels endoscope components instrument surfaces and accessories are thoroughly dry 4 a cotton tipped applicator moistened with 70 90 medical grade ethyl or isopropyl alcohol may be used to carefully remove any films or residues left upon the lens surfaces such as the distal objective lens 5 the endoscope should be hung in a clean dry well ventilated storage cabinet at room temperature the insertion tube and light guide cable should be hung and kept as straight as possible during storage 73
- Post reprocessing 73
- 1 servicing 74
- 2 care and maintenance tips 76
- 1 light guide 2 objective lens 3 light guide 4 instrument channel 78
- Distal end 78
- Specifications 78
- Notice 80
- These instruments are used with class b medical equipment specified cispr11 and are intended for hospital or health care districts 80
- To avoid and resolve adverse electromagnetic effects do not operate these instruments near the rf energy equipment 80
- Together these endoscopes and the compatible processor comply with en 60601 1 2 for eu iec 60601 1 2 for other countries 80
- When used in clinical or residential areas near radio and tv receiver units these instruments may be subjected to radio interference 80
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