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Summary of Contents for Jedmed MACHIDA
- Page 1 Instructions for Use MACHIDA Flexible Scope 49-5020 ENT-2L Pediatric (Ø2.1mm) 49-5030 ENT-3L Slim Line (Ø3.2mm) 49-5040 ENT-4L Standard (Ø4.2mm) Operating / Service Manual IMPORTANT: Read all instructions before assembling or using this device. An Employee-Owned Company...
- Page 2 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 all your support. We are pleased and proud to serve the ever-changing medical community.
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Page 3: Table Of Contents
MACHIDA CONTENTS Operating / Service Manual CONTENTS Section Page OPERATION OPERATING Precautions (general) ............4 Description & Indications for Use ........5 Contents ................5 Parts Identification ..............6 Device Operation ..............7 Functions ............... 9 Connections Focusing ................Angulation & Video Cameras .......... -
Page 4: Precautions (General)
- All fiberoptic light sources should be medical-grade, electrically isolated, and not pose a heat risk to the patient. - MACHIDA fiberoptic bundles are fragile. Use care cleaning, handling and storing. - When using fiberoptic light sources, keep flammables away from light port, fiberoptic cable ends and endoscope tip. -
Page 5: Description & Indications For Use
These areas encompass video camera. the upper respiratory tract from the nasal A MACHIDA scope is a quality-designed passages to the vocal chords. MACHIDA scopes are intended to be used by ENT and manufactured medical device. Given... -
Page 6: Parts Identification
MACHIDA Operating / Service Manual PARTS IDENTIFICATION Package Contents Case Scope EOG Adaptor/ Light Source Ventilation Cap Adaptor (Actual case may be vary) (one adaptor included, customer choice) Features Waterproof (leak/leakage) Testing Port/EOG Port Light Guide Plug w/ Adaptor Light Guide (LG) Cord... -
Page 7: Device Operation
MACHIDA Operating / Service Manual DEVICE OPERATION - Functions Functions: Eyepiece Lens system used to enlarge and image the object in view. When looking through the eyepiece, a “V”-shaped pointer can be seen. This pointer indicates the “up” side of the scope and aids in the orientation of the viewed object. - Page 8 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 illumination bundle which produces the illumination field.
- Page 9 Basic Connections 1. Screw on light guide adaptor that is of the same type as the light source adaptor (Machida to Machida, K. Storz to K. Storz,...). 2. Connect light guide plug with adaptor to suitable fiberoptic light source. Do not use light guide plug without an adaptor.
- Page 10 MACHIDA Operating / Service Manual DEVICE OPERATION - Focusing WARNING Scope is not aseptic, as received. Scope MUST be cleaned and disinfected before initial use and between each patient. Line NOTE Focus settings will vary with each individual user.
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Page 11: Connections
MACHIDA Operating / Service Manual DEVICE OPERATION - Angulation WARNING Ensure angle lock lever is in the “F” (free) position. Always return the scope to the straight position with the angle lock lever in the “F” (free) position prior to removing the scope from the patient. - Page 12 In all cases, it is imperative to assure that tip heat flammable anesthetics! and/or emitted light does not cause an unacceptable risk to the patient or user. Due to the extreme nature of arc-lamps, JEDMED does not recommend using xenon-arc sources with this endoscope.
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Page 13: List Of Warnings
MACHIDA Operating / Service Manual DEVICE OPERATION - List of Warnings WARNING - Endoscope tip may become hot depending on the particular fiberoptic light source used. ALWAYS test tip temperature and heat emitted from scope tip before use. ALWAYS ensure either condition does not cause an unacceptable risk to the patient or user. - Page 14 MACHIDA Operating / Service Manual DEVICE OPERATION - Functional Test Before Using Before Use Leak test scope to verify no leaks (pages 15-17) Clean and disinfect scope (pages 18-21) Check Scope Functions 1. Connect scope to light source (pages 9, 12) 2.
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Page 15: Ventilation Cap
MACHIDA Operating / Service Manual DEVICE OPERATION - Ventilation Cap Overview An EOG adaptor/ventilation cap is used to open an airway to the inside of the scope. When the cap is connected to the scope, internal and external atmospheric pressures are allowed to equalize. - Page 16 JEDMED for service (see page 28). 7. Remove the scope from the water and carefully dry the entire scope. Pay particular attention to drying any water near the waterproof testing port/leak tester connection.
- Page 17 MACHIDA Operating / Service Manual DEVICE OPERATION - Leak Testing (continued) 1) Connect Tester to Scope and Pressurize Squeeze bulb to pressurize Air Exhaust Valve Leak Tester Connector Waterproof testing port/EOG port 2) Immerse Scope in Water and Observe Immerse light guide Immerse insertion tube Immerse body last.
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Page 18: Cleaning / Disinfection / Sterilization
Peracetic Acid ....S40™ Sterilant Concentrate ...23 minute cycle time Follow manufacturer’s instructions. * Machida flexible scopes have been tested and found compatible with Cidex ® glutaraldehyde. As recommended by the manufacturer, glutaraldehyde solutions that do not contain surfactants are more appropriate for flexible scopes. - Page 19 Follow all necessary procedures including the use of rubber gloves to ensure proper sterilization/high-level disinfection. NOTE Machida flexible scopes are designed to be highly reliable. With any delicate instrument proper care, cleaning, and maintenance will extend the life of the product and minimize repairs. Gas Sterilization...
- Page 20 MACHIDA Operating / Service Manual CLEANING / DISINFECTION / STERILIZATION (continued) Chemical Sterilization 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). Prepare the chemical sterilant as recommended by the manufacturer along with guidelines from the previous table.
- Page 21 MACHIDA Operating / Service Manual CLEANING / DISINFECTION / STERILIZATION (continued) Quick Reference: Cleaning, Disinfection and Sterilization Flowchart Withdraw scope from patient and immediately perform the following: Gently wipe all debris off insertion tube with a moistened gauze or disinfectant towelette.
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Page 22: Maintenance / Handling / Transport / Storage
This device is maintenance-free. Handling When handling a scope, handle as illustrated below: CAUTION Machida flexible scopes (and accessories) are constructed of precise and delicate components that they should be handled and operated in a manner which will not cause damage. -
Page 23: Reorder Information
RA01017 ..EOG Aeration Rubber Cap (Luer Cover) ..Endoscope Adaptor (Various Models Available, Contact JEDMED for information) Contact Information For additional information or to order replacement parts contact your Regional Sales Representative or JEDMED Technical Service. Refer to inside of back cover. -
Page 24: Specifications
MACHIDA Operating / Service Manual SPECIFICATIONS 49-5020 49-5030 49-5040 ENT-2L ENT-3L ENT-4L (Ø2.1mm) (Ø3.2mm) (Ø4.2mm) Total Length .........524mm ....... 534mm ....534mm Working Length ......310mm ....... 300mm ....300mm Distal Tip Diameter ..... ø2.0mm ...... ø3.2mm ....ø4.2mm Flexible Part Diameter ....ø2.1mm ...... ø3.2mm ....ø4.2mm Angle Deflection Up ....... -
Page 25: Approved Detergents, Disinfectants & Sterilants
MACHIDA Operating / Service Manual APPROVED DETERGENTS, DISINFECTANTS & STERILANTS High-Level Product Trade Name Detergent Disinfectant Sterilant ENZOL ® Enzymatic Detergent Solution ü CIDEX ® Activated Glutaraldehyde Solution (2.4% glutaraldehyde) ü ü CIDEX ® OPA ü ™ Steris ® S40 Sterilant Concentrate* ü... - Page 26 MACHIDA Operating / Service Manual BLANK...
- Page 27 SERVICE INFORMATION...
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Page 28: Information
Model and serial number are required when requesting service or replacement parts. 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. -
Page 29: Troubleshooting
Fiberoptic cable not fully inserted into Verify good connections. light source or scope connection. Image observed through scope is Broken fibers in illumination bundle. Return to JEDMED for service. dim. Debris or fingerprints on eyepiece. Clean eyepiece. Clean scope tip. -
Page 30: Returning Endoscopes For Service
An Employee-Owned Company Returning Endoscopes for Service Normally, all scopes should be cleaned, disinfected and dried before returning to JEDMED for service. If the scope presents a leak and cannot be submerged, please follow directions below. A protective plastic sheet is supplied for return of soiled flexible endoscopes. - 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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