Pentax ECY-1575K [31/80] 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

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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