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Operating / Service

Manual

An Employee-Owned Company

IMPORTANT:

  Read all instructions before assembling or using this device.

  

 Instructions for Use

Laryngo-Nasopharyngoscope

49-5020  ENT-2L Pediatric (Ø2.1mm)

49-5030  ENT-3L Slim Line (Ø3.2mm)

49-5040  ENT-4L Standard (Ø4.2mm)

MACHIDA

Flexible Scope

Summary of Contents for MACHIDA

Page 1: ... Company IMPORTANT Read all instructions before assembling or using this device Instructions for Use Laryngo Nasopharyngoscope 49 5020 ENT 2L Pediatric Ø2 1mm 49 5030 ENT 3L Slim Line Ø3 2mm 49 5040 ENT 4L Standard Ø4 2mm MACHIDA Flexible Scope ...

Page 2: ...ss quality system has placed JEDMED as an industry leader As always our focus remains on you our valued customer Building rewarding and lasting relationships is the cornerstone of JEDMED s business philosophy JEDMED is committed to delivering reliable and cost effective solutions to medical professionals everywhere The employee owners of JEDMED would like to take this opportunity to thank you for ...

Page 3: ...t of Warnings 13 Functional Test Before Using 14 Ventilation Cap 15 Leak Testing 15 Cleaning Disinfection Sterilization 18 Maintenance Handling Transport Storage 22 Reorder Information 23 Specifications 24 Approved Detergents Disinfectants Sterilants 25 Section Page OPERATION SERVICE OPERATING Information 28 Troubleshooting 29 Returning Endoscopes for Service 30 Note Specifications subject to chan...

Page 4: ...en using fiberoptic light sources keep flammables away from light port fiberoptic cable ends and endoscope tip Disconnect from power before cleaning servicing or storing All cleaning and disinfecting should only be performed by appropriately trained individuals Do not allow liquid to enter any part of this device Safety Precautions general Alerts user to the possibility of PERSONAL INJURY WARNING ...

Page 5: ...ible fiberoptic endoscope designed for examining the larynx nasal cavity and nasopharynx These areas encompass the upper respiratory tract from the nasal passages to the vocal chords MACHIDA scopes are intended to be used by ENT physicians in an office setting for routine ENT procedures MACHIDA scopes are available in three sizes the 2 1mm pediatric insertion tube diameter ENT 2L the 3 2mm slim li...

Page 6: ...ptor included customer choice Waterproof leak leakage Testing Port EOG Port Light Guide Plug w Adaptor Light Guide LG Cord Angle Deflecting Section Distal Apical End Tip Insertion Tube Main Body Angle Lock Brake Lever Angle U D Deflection Knob Focus Adjustment Ring Eyepiece Illumination Window Observation Window ENT 2L Illumination Windows Observation Window ENT 3L ENT 4L ...

Page 7: ...ock Brake Lever Cam action lever which engages the brake Turning this lever to E engage will cause the deflection to be fixed at any desired position When the lever is moved to F free the deflection will no longer be fixed and the scope will return to the straight at rest position Main Body Plastic housing containing internal components Sealed to withstand soaking Insertion Tube Flexible protectiv...

Page 8: ...uer lock used for both waterproof testing and for aeration during sterilization using Ethylene Oxide Gas Light Guide Plug w Plug Sleeve Metal connector for attachment to light source The removable sleeves are designed for multiple types of light source adaptors including Karl Storz ACMI Olympus Wolf Dyonics Machida Pentax and Kay Light Guide Illumination Windows Termination point of the fiberoptic...

Page 9: ... adaptor Use only medical grade fiberoptic light sources to assure patient safety See page 12 13 Warning Light Port Adaptors Simply screw adaptors on or off by hand Fiberoptic Light Source medical grade Light Guide Adaptor must be of same type as Light Source Adaptor Light Source Adaptor must be of same type as Light Guide Adaptor 1 49 5102 Karl Storz adaptor 2 49 5104 Olympus ACMI adaptor 3 49 51...

Page 10: ...wearing glasses or contact lenses corrected vision Users who remove glasses or contact lenses uncorrected vision Rotate focus adjustment ring counter clockwise until it stops to align dot with line infinity focus Rotate focus adjustment ring clockwise to achieve sharpest image starting from infinity focus Focus settings will vary with each individual user NOTE Dot Line Focus Adjustment Ring ...

Page 11: ... pattern on the video monitor Moiré results from the pattern of the image fibers aligning with the pattern of pixels on the image chip of the camera To minimize moiré effects rotate endocoupler slightly on eyepiece of scope to un align fibers with pixels Slightly defocusing the image may also be effective Moiré All video cameras should be medical grade Standard eyepiece Endocoupler Angle U D Defle...

Page 12: ...y light source with the scope to determine that the tip temperature remains as cool as possible ideally under 41ºC 106ºF and that the emitted light does not cause excessive heating of tissue Tip temperatures exceeding 41ºC 106ºF may be allowable in some instances depending on location of viewing type of tissue contact and duration of use among others In all cases it is imperative to assure that ti...

Page 13: ...g or electrically isolated from any other equipment it is attached to In order to achieve this any fiberoptic light sources video cameras or other equipment attached to the scope MUST be medical grade and type BF floating or electrically isolated connections WARNING Before each use ALWAYS inspect outer surface of scope to ensure there are no unintended rough surfaces sharp edges or protrusions whi...

Page 14: ...l tip to verify both are smooth and unblemished 5 Test eyepiece focus adjustment 6 Place scope near representative anatomical target and verify colors observed by naked eye under ambient light appear consistent with those observed through scope using intended fiberoptic illumination 7 Verify high intensity light exiting distal tip windows is cool so as not to burn patient Scope is now ready for us...

Page 15: ...rproof testing port EOG port ADAPTORONLYFOREOGSTERILIZATIONPROCESS BESURETOREMOVEITWHENSCOPEISWASHEDORCLEANED ATTENTION ADAPTORONLYFOREOGSTERILIZATIONPROCESS BESURETOREMOVEITWHENSCOPEISWASHEDORCLEANED ATTENTION 1 2 3 DEVICE OPERATION Leak Testing The Leakage Tester is designed to check the airtightness of the endoscope by pressurizing the endoscope internally while the operator observes the gauge ...

Page 16: ...s above the scope Begin by slowly immersing the light guide cable and then the insertion tube If no bubbles are escaping air leaking from the immersed sections proceed to immersing the body Observe the scope for 1 minute if no bubbles are present the scope has passed the wet leak test If at anytime during the leak test bubbles are detected immediately remove the scope from the water and return the...

Page 17: ...ht guide cable first Immerse insertion tube next Immerse body last If pressure remains constant after 1 minute instrument passes wet leak test 2 Immerse Scope in Water and Observe DEVICE OPERATION Leak Testing continued 3 Disconnect Scope Air Exhaust Valve Leak Tester Connector Waterproof testing port EOG port Release Pressure Remove Leak Tester Squeeze bulb to pressurize ...

Page 18: ...acuation Set Point 0 088 MPa Post Exhaustive Vacuum 3 intervals Air Wash 20 minutes Aeration 12 hours Peracetic Acid S40 Sterilant Concentrate 23 minute cycle time Follow manufacturer s instructions CLEANING DISINFECTION STERILIZATION Under the medical device classification requirements the flexible endoscope is classified as a semi critical device By definition a semi critical device makes contac...

Page 19: ... to prevent the scope from touching the internal metal casing walls directly 3 Follow the manufacturer s recommendations along with the guidelines from page 18 4 Be sure to aerate the scope adequately after sterilization 5 Disconnect the EOG adaptor CLEANING DISINFECTION STERILIZATION continued Ventilation cap will allow fluids to enter scope Ventilation cap MUST be removed from scope before immer...

Page 20: ...fection 1 Perform leakage test to ensure scope seal has not been compromised refer to pages 15 17 or to leakage tester instruction manual for proper procedures 2 Prepare the high level disinfectant as recommended by the manufacturer along with the guidelines from page 18 3 Prepare the proper container for the high level disinfectant and pour the solution into it 4 Immerse the scope for the manufac...

Page 21: ...and gently dry Chemical High Level Disinfection Perform leakage test Soak flexible scope with disinfecting solution for the time period as specified by the manufacturer Thoroughly rinse flexible scope several times with sterile water Gently dry scope with sterile soft gauze Store scope Use scope Gas Sterilization Connect EOG adaptor to waterproof testing terminal Place flexible scope in EtO chambe...

Page 22: ...0 C Humidity 30 75 Atmospheric Pressure 10 2 15 4 PSI 0 07 0 106 MPa Transport Scope and accessories should be thoroughly cleaned disinfected and dried before storing Keep the instrument lying flat or hanging with the insertion tube and the angulation tip straight confirm angle lock lever is in F free position Store instrument in transport case or hanging with protection from dust and contact Ligh...

Page 23: ...T 3L Scope Ø3 2mm 49 5040 Standard ENT 4L Scope Ø4 2mm Light Source Adaptors 49 5102 Karl Storz Adaptor 49 5104 ACMI Olympus Adaptor 49 5106 R Wolf Dyonics Adaptor 49 5108 Machida Adaptor 49 5110 Pentax Adaptor 49 5112 Kay Elemetrics Pentax Adaptor Miscellaneous 49 4990 Carrying Case 49 5080 Leakage Tester 49 5085 EOG Adaptor RA01103 Ocular Cap For International Standard Ocular RA01017 EOG Aeratio...

Page 24: ...00mm Distal Tip Diameter ø2 0mm ø3 2mm ø4 2mm Flexible Part Diameter ø2 1mm ø3 2mm ø4 2mm Angle Deflection Up 130 130 130 Angle Deflection Down 100 100 100 Field of View 75 80 80 Depth of Focus Fixed 3 50mm 3 50mm 3 50mm Length of Light Guide 1 5m 1 5m 1 5m Weight use 7oz 7oz 7oz Weight Shipping 6 lbs 6 lbs 6 lbs Use Specifications Temperature 50 104 F 10 40 C Humidity 30 75 ...

Page 25: ...s instructions for either High Level Disinfection or Sterilization Steris S40 Sterilant Concentrate CIDEX OPA ü CIDEX Activated Glutaraldehyde Solution 2 4 glutaraldehyde ü ENZOL Enzymatic Detergent Solution ü ENZOL CIDEX and CIDEX OPA are registered trademarks of ADVANCED STERILIZATION PRODUCTS Division of Ethicon Inc a Johnson Johnson Company Steris is a registered trademark of STERIS Corporatio...

Page 26: ...MACHIDA Operating Service Manual 26 BLANK ...

Page 27: ...SERVICE INFORMATION ...

Page 28: ... parts l Before returning to JEDMED for service instrument must be cleaned disinfected and labelled accordingly If scope has failed leak testing and cannot be immersed for cleaning see page 30 for returning a soiled scope l Scope may be damaged if shipped incorrectly Refer to page 22 for transporting information SERVICE INFORMATION Always remove all electrical accessories before cleaning disinfect...

Page 29: ...beroptic cable not fully inserted into light source or scope connection Broken fibers in illumination bundle Debris or fingerprints on eyepiece Clean tip of scope Verify good connections Return to JEDMED for service Clean eyepiece Image observed through scope is dim Debris on scope tip covering light emitting window s Improper lamp in light source Improper heat filtering of fiberoptic light source...

Page 30: ...t information Return to JEDMED for service A protective plastic sheet is supplied for return of soiled flexible endoscopes 1 Returning Endoscopes for Service 552 IM003 Rev 0 02 2013 An Employee Owned Company COPYRIGHT 2013 JEDMED Instrument Company All rights reserved 2 3 4 folded sheet Normally all scopes should be cleaned disinfected and dried before returning to JEDMED for service If the scope ...

Page 31: ...NOTES ...

Page 32: ...5416 JEDMED Court St Louis MO 63129 314 845 3770 phone 314 845 3771 fax e mail info jedmed com website www JEDMED com ...

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