Jedmed Ergo-Flex Instructions For Use Manual

Jedmed Ergo-Flex Instructions For Use Manual

Laryngo-nasopharyngoscope

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Instructions for Use
IMPORTANT: Read all instructions before assembling or using this device.
Ergo-Flex
49-4930
EF-N
49-4928
EF-N Slim
Operating / Service
Manual
An Employee-Owned Company
(Ø3.4mm)
(Ø2.8mm)

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Summary of Contents for Jedmed Ergo-Flex

  • Page 1 Instructions for Use Ergo-Flex 49-4930 EF-N (Ø3.4mm) 49-4928 EF-N Slim (Ø2.8mm) 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.
  • Page 3: Table Of Contents

    Ergo-Flex 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 Connections ........8 Focusing.........9 Angulation & Video Connection ......... 10 Light Source Risks.
  • Page 4: Precautions (General)

    - All fiberoptic light sources should be medical-grade, electrically isolated, and not pose a heat risk to the patient. - Ergo-Flex fiberoptic bundles are very 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

    Ergo-Flex scopes are intended to be used by field by attaching an optional video camera and endoscope coupler. Unsurpassed light...
  • Page 6: Parts Identification

    Ergo-Flex Operating / Service Manual PARTS IDENTIFICATION Package Contents Scope Leakage Ventilation Karl Storz Wolf Tester Adaptor Adaptor (attached to scope) (attached to scope) Features EF-N EF-N Slim Insertion tube with fiberoptic cable bendable distal tip image bundle Handle Leakage...
  • Page 7: Device Operation

    Operating / Service Manual DEVICE OPERATION - Connections Basic Connections 1. Connect suitable fiberoptic cable to Ergo-Flex. Scope will accept Karl Storz, Wolf or ACMI (see bottom of page) 2. Connect other end on fiberoptic cable to suitable fiberoptic light source.
  • Page 8: Focusing

    Ergo-Flex Operating / Service Manual DEVICE OPERATION - Focusing WARNING Scope is not aseptic, as received. Scope MUST be cleaned and disinfected before initial and every use. Note: Focus settings will vary with each, individual user. Users wearing glasses or contact lenses...
  • Page 9: Connections

    Ergo-Flex Operating / Service Manual DEVICE OPERATION - Angulation Angulation at distal end Hold scope comfortably in hand. Use thumb to gently rock articulation lever forward and backward. Observe corresponding angulation of the scope distal end. Movement should be smooth and symmetrical.
  • Page 10: Light Source Risks

    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.
  • Page 11: List Of Warnings

    Ergo-Flex 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 12: Functional Test Before Using

    7. Verify high-intensity light exiting distal tip windows is cool so as not to burn patient. Scope is now ready for use. Warning Ergo-Flex must be cleaned and disinfected before each use.
  • Page 13 Ergo-Flex Operating / Service Manual Blank...
  • Page 14: Ventilation Cap & Leak Testing

    Ergo-Flex Operating / Service Manual DEVICE OPERATION - Ventilation Cap Overview A 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 15 3. Observe gauge. If pressure reading drops more than 10 mmHg within 1 minute, DO NOT USE; scope must be returned to JEDMED for service (see page 25). If pressure remains constant after 1 minute, instrument passes leak test.
  • Page 16 Ergo-Flex Operating / Service Manual Blank...
  • Page 18 Blank...
  • Page 19: Maintenance / Storage / Transport

    Ergo-Flex Operating / Service Manual MAINTENANCE - STORAGE - TRANSPORT Maintenance This device is maintenance-free. Transport Instrument should be transported only in its original packaging. In the event of transporting via airlines, make sure to install the ventilation cap onto the connection port for the leak tester.
  • Page 20: Reorder Information

    Refer to the assembly drawings located at the back of this manual for replacement parts. 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 21: Specifications

    Ergo-Flex Operating / Service Manual SPECIFICATIONS EF-N Sheath Diameter 3.4mm Working Length 320mm Bend Angle (up/down) 130º Bending Radius Optical Field of View 80º Depth of Field 1 - 50mm Weight 230g (8 oz.) EF-N Slim Sheath Diameter 2.8mm Working Length...
  • Page 22: Approved Disinfectants & Detergents

    Ergo-Flex Operating / Service Manual APPROVED DISINFECTANTS & DETERGENTS High-Level Disinfectant Detergent Product Trade Name ENZOL ® Enzymatic Detergent Solution ü CIDEX ® Activated Dialdehyde Solution (2.4% glutaraldehyde) ü CIDEX ® OPA ü Steris ® S40 Sterilant Concentrate * ü...
  • Page 23: Service

    SERVICE INFORMATION...
  • Page 24: 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 next page for returning a soiled scope.
  • Page 25 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 fails leak testing and cannot be immersed, please follow directions below. A protective plastic sheet is supplied for return of soiled flexible endoscopes.
  • Page 26 Blank...
  • Page 27: Troubleshooting

    Check for broken or missing heat Improper heat filtering of fiberoptic light filter in fiberoptic light source. source. Return to JEDMED for service. Internal angulation mechanism is out- Angulation of tip is limited, not symmetrical, requires effort, or does of-adjustment.
  • Page 28 NOTES...
  • Page 29 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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Ef-nEf-n slim

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