Download
Share
Print this page
EvoEndo LE Instructions For Use Manual
  1. Manuals
  2. Brands
  3. EvoEndo Manuals
  4. Medical Equipment
  5. LE
  6. Instructions for use manual

EvoEndo LE Instructions For Use Manual

Hide thumbs

Advertisement

Quick Links

Download this manual
Instructions for Use
EvoEndo
Model LE
®
Single-Use Gastroscope
and EvoEndo
Controller (EE-C)
®
For use by trained physicians only. For in-hospital use.
EVOENDO
SINGLE-USE
®
ENDOSCOPY SYSTEM
EvoEndo
Inc.
®
EvoEndo
Inc.
®
12649 East Caley Avenue, Suite 116
Centennial, CO 80111
303.223.7445
www.evoendo.com
LBL-1 Rev. 4.0

Advertisement

loading
Need help?

Need help?

Do you have a question about the LE and is the answer not in the manual?

Questions and answers

Summary of Contents for EvoEndo LE

  • Page 1 Instructions for Use EvoEndo Model LE ® Single-Use Gastroscope and EvoEndo Controller (EE-C) ® For use by trained physicians only. For in-hospital use. EVOENDO SINGLE-USE ® ENDOSCOPY SYSTEM EvoEndo Inc. ® EvoEndo Inc. ® 12649 East Caley Avenue, Suite 116 Centennial, CO 80111 303.223.7445...
  • Page 2 Do not use if the product sterilization barrier or its Field of view (120 degrees) packaging is damaged Humidity limitation: relative humidity between 30 and Video connection for the EvoEndo® Scope 85% in operating environment Atmospheric pressure limitation: between 80 and 109 Direct current...

  • Page 3: Table Of Contents

    Scope 5. EvoEndo Scope Operation ® Controller 6. EvoEndo Controller (EE-C) Operation ® Cleaning 7. Cleaning and Disinfection of EvoEndo Controller ® Help 8. Troubleshooting Specs 9. Technical Specifications Appendix 1: Electromagnetic Compatibility Appendix 2. Standards Applied Appendix 3. Warranty and Replacement Program...

  • Page 4: Important Information - Read Before Use

    Copies of the current version are available on-line and upon request. WARNING Ev oEndo® Model LE Gastroscope is a single-use device and must be handled in a manner consistent with accepted medical practice to avoid contamination prior to insertion.
  • Page 5 Single-Use Endoscopy System. ® GENERAL NOTES Have a suitable backup system readily available for immediate use so the procedure can be continued if a malfunction should occur. EvoEndo is not ® responsible for any damage to the system or patient resulting from incorrect use.

  • Page 6: System Parts

    2. System Parts Before you install and use the system please ensure that the following EvoEndo items are available: ® - EvoEndo Model LE Single-Use Gastroscope - Part Number 1001 ® - EvoEndo Controller (EE-C) - Part Number 1002 ®...
  • Page 7 2.1.3 Handle Features Thumb lever Reset white-balance No function assigned Apply water Apply suction Parts Apply air Rotary dial 2mm working channel Supply tube umbilical Insertion tube (3.5mm OD) 2.1.4 Tip Steering Controls DOWN Thumb lever down = Tip up Rotary dial towards = Tip left Thumb lever up = Tip down Rotary dial away = Tip right...
  • Page 8 EvoEndo Controller (EE-C) ® The EvoEndo Controller (EE-C) processes the live image feed from the EvoEndo Scope. The device uses standard 110V wall ® ® power via the power supply included. It contains an HDMI port for direct output to a medical-grade monitor and a USB 3.0 port for connection to third-party software systems.

  • Page 9: Use Overview

    3. Use Overview 3.1. Unpack & inspect Device packaging not damaged? ‡ Device free from defects and not damaged during unpacking? ‡ Controller cleaned from previous use? ‡ Overview 3.2. Connect & test Can make appropriate electrical connections? ‡ Image quality sufficient? ‡...

  • Page 10: System Setup

    WARNING Do not use a knife or sharp instrument to open the pouch or cardboard box. CAUTION The EvoEndo Single-Use Endoscopy System consists of the parts ® described in section 2. They may only be replaced by EvoEndo authorized parts. ® Failure to comply with this may reduce safety and efficiency.
  • Page 11 Setup 4.4. Connect and Test EvoEndo Scope Supply Lines ® 4.4.1. Identify the water supply line on the EvoEndo Scope and connect via ® standard screw-top fitting to a standard 250ml (mimimum) single-use sterile water or saline bottle. NOTE Bottle must remain upright throughout the procedure.

  • Page 12: Evoendo ® Scope Operation

    EvoEndo Scope without touching the bending lever. ® WARNING Always observe the live endoscopic image while withdrawing the EvoEndo ® Scope. WARNING The temperature of the distal end of the endoscope may exceed 41 deg-C (106 deg-F) and reach up to 43 deg-C (110 deg-F) due to heating of the LEDs.
  • Page 13 Manipulating the Tip of the EvoEndo Scope ® DOWN The thumb control lever is used to flex and extend the tip of the EvoEndo ® Scope in the vertical plane. Moving the control lever downward will make the tip bend anteriorly (flexion).
  • Page 14 5.5. Aspiration Suction can be applied by pressing the suction button with the index finger. WARNING Ensure that the suction connector on the EvoEndo Single-Use Endoscopy System ® is only connected to a medical-grade suction apparatus.
  • Page 15 WARNING Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the EvoEndo Single-Use Endoscopy ® System, as this may result in patient injury or damage to EvoEndo Scope. ® WARNING To maintain patient safety and the safety of the end user, only medical approved accessories to be used.
  • Page 16 5.10. After Use 5.10.1. Remove the video connector cable to disconnect the EvoEndo Scope. ® 5.10.2. Disconnect all supply lines from the EvoEndo Scope. ® 5.10.3. Dispose of the EvoEndo Scope in accordance with local guidelines for collection of infected medical devices with electronic ®...

  • Page 17: Evoendo ® Controller (Ee-C) Operation

    6.2.7. Disconnect the HDMI cable. 6.2.8. Clean and disinfect the EvoEndo Controller as described in Section 7. ® WARNING Do not attempt to open or service the EvoEndo Controller; refer to Warranty ® statement in Appendix 3 and contact EvoEndo for a replacement.
  • Page 18 7.1. Cleaning 7.1.1. Ensuring the Controller is disconnected. 7.1.2. Use a standard cleaning detergent to clean and/or disinfect the EvoEndo Controller according to hospital policy. ® 7.1.3. After cleaning and/or disinfection, the EvoEndo Controller must be submitted to the pre-check procedure described in ®...

  • Page 19: Troubleshooting

    If problems occur with the system, please use this trouble-shooting guide to identify the cause and correct the error. 8.1. No live image Cause: Action: EvoEndo Scope not connected to EvoEndo Controller Check connections of EvoEndo Scope video connector to ® ®...

  • Page 20: Technical Specifications

    9. Technical Product Specifications 9.1. EvoEndo Model LE Single-Use Gastroscope Specifications ® Optical System Field of View 120° Diagonal 87.5 ° Horizontal Depth of Field 2.5mm - 25mm Illumination method Insertion portion Bending section 210° Up, 90° Down, 100° Left, 100° Right Insertion tube diameter 3.5 mm (0.14”)
  • Page 21 12V DC; 1.0A Operating environment Temperature 0 ~ 40° C (32 ~ 104° F) Storage Temperature -20 ~ 85°C (-4 ~ 185° F) Relative humidity 10 ~ 90% Plugs Between the power supply and EvoEndo -EE-C Ø5.5mm DC jack connector ®...
  • Page 22 Single-Use Endoscopy System requires special precautions to ensure ® electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC) the EvoEndo ® Single-Use Endoscopy System must be installed and operated according to the EMC information provided in this manual.
  • Page 23 The EvoEndo Single-Use Endoscopy System is intended for use in the electromagnetic environment specified below. The customer ® or the user of the EvoEndo Single-Use Endoscopy System shall ensure that it is used in such an environment. ® Immunity test...
  • Page 24 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the EvoEndo Single-Use Endoscopy System, including cables specified by the manufacturer. Otherwise, degradation of ®...
  • Page 25 The customer or the user of the EvoEndo Single-Use Endoscopy System can help prevent electromagnetic interference by maintaining a minimum ® distance between portable and mobile RF communications equipment (transmitters) and the EvoEndo Single-Use Endoscopy System as recommended ® below, according to the maximum output power of the communications equipment.
  • Page 26 - EN 60601-1-1 Medical electrical equipment - Part 1: General requirements for safety– Collateral standard: Electromagnetic compatibility - Requirements for test. Appendix 3. Warranty and Replacement Program The warranty period for the EvoEndo EE-C is three years from delivery to the customer. We agree to replace an EvoEndo EE-C free of ® ®...
  • Page 27 THIS PAGE IS INTENTIONALLY BLANK...
  • Page 28 Perform endoscopic procedure Withdraw, dispose & clean ‡ Remove any endoscopic accessories ‡ Discard Scope ‡ Recycle plastic packaging tray ‡ Clean and disinfect Controller ©2021 EvoEndo Inc. All rights reserved. EvoEndo is a Registered Trademark. International Patents Pending. ® ®...