Comen CVL-1 Manual

Video laryngoscope
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Manual for Video Laryngoscope
Copyright
Version: B00
Number: 046-00000415-00
Revision date: 11/2021
Product Name: Video Laryngoscope
Product Model: CVL-1/CVL-2/CVL-3/CVL-5
Address: Floor 10 - Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to
Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian
Sub-district, Guangming District, Shenzhen
Factory Address: Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building,
Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen
Name of registrant/manufacturer: Shenzhen Comen Medical Instruments Co., Ltd.
Statement
All rights reserved by Shenzhen Comen Medical Instruments Co., Ltd.
This manual contains confidential information. No part of this manual may be
reproduced, copied or translated into other languages in any form without written
permission of Comen.
This manual is only intended for users as a reference for operation, maintenance and
repair of Comen product CVL-1/CVL-2/CVL-3/CVL-5. No one shall disclose the
contents hereof to any other person.
I

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Summary of Contents for Comen CVL-1

  • Page 1 Comen. This manual is only intended for users as a reference for operation, maintenance and repair of Comen product CVL-1/CVL-2/CVL-3/CVL-5. No one shall disclose the contents hereof to any other person.
  • Page 2 This Manual does not imply the transfer of any proprietary right under patent law to any third party. Comen shall not be liable for any legal consequences arising out of breach of the patent law or infringement of any third-party rights.
  • Page 3: Table Of Contents

    Manual for Video Laryngoscope Contents Chapter 1 Safety ......................1-1 1.1 Safety Information ................... 1-1 1.2 Contraindications ..................... 1-7 1.3 Device Symbols ....................1-7 Chapter 2 Overview....................2-1 2.1 Product Introduction ..................2-1 2.1.1 Product Composition ................2-1 2.1.1.1 Disposable Laryngoscope Blade (Optional) ........2-2 2.1.2 Intended Use .....................
  • Page 4 Manual for Video Laryngoscope 3.5.6 File Transfer ..................... 3-9 3.5.7 Standby ON/OFF ..................3-9 3.6 Standby ......................3-10 3.7 Format ......................3-11 3.8 Power Off ...................... 3-11 Chapter 4 Maintenance ....................4-1 Chapter 5 Cleaning and Disinfection ................ 5-1 Chapter 6 Troubleshooting ..................6-1 Chapter 7 Warranty ....................
  • Page 5: Chapter 1 Safety

    Chapter 1 Safety 1.1 Safety Information Warning  Alerts you to situations that may result in serious consequences or adverse events or endanger personal safety. Failure to observe the warning information may cause severe injury or even death of user or patient. Caution ...
  • Page 6 Safety Note  Emphasizes important precautions provides instructions explanations for better use of the product. Warning  This product shall only be operated by trained doctors.  Do not use the video laryngoscope in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
  • Page 7 Avoid looking directly at the front light of the Video Laryngoscope.  The installation, maintenance and upgrade of the product shall be referred to the personnel approved or authorized by Comen.  If any technical problems happen, please contact Comen.
  • Page 8 Safety operation in the current configuration and the total leakage current should be in accordance with the requirement specified in IEC 60601-1.  If Video Laryngoscope malfunctions during use, place it in a neutral position and then slowly withdraw it. ...
  • Page 9 Power off the device after each use in order to maintain its service life.  Place the device on a stable and vibration-free table or in a well-ventilated cabinet.  Follow the User Manual to disinfect and clean the device.  Use the accessories and consumables approved by Comen only.
  • Page 10 Safety  DO NOT use it while charging.  Under the environment of 40 ℃, the working time of the equipment should not be more than 10 minutes, otherwise the temperature of the application part contacting the patient may be too high. ...
  • Page 11: Contraindications

    Safety Note  Carefully unpack it and take out the Video Laryngoscope and its accessories, and keep the packaging materials for future transportation and storage. Check the accessories against the packing list. In case of any mechanical damage upon unpacking, please contact our sales department or agent immediately.
  • Page 12 Safety USB port Power on/off button Environment-friendly Separate collection period electronic WEEE information products Serial number Manufacturing date Refer accompanied IPX0 IP Rating documentation This side up Stacking layer limit Fragile Keep dry Range of transport and Range of transport and storage storage environment environment temperature...
  • Page 13: Chapter 2 Overview

    Chapter 2 Overview 2.1 Product Introduction 2.1.1 Product Composition The video laryngoscope consists of a display, laryngoscope blade components (camera and LED light), charger components and accessories, as shown below:...
  • Page 14: Disposable Laryngoscope Blade (Optional)

    Overview (1). USB port (2). Power On/Off button (3). Light source(LED) (4). Camera (5). Handle components (6). Shaft components (7). Display screen (8).Disposable laryngoscope blade 2.1.1.1 Disposable Laryngoscope Blade (Optional) Fig. 2-1 Laryngoscope blade for Pediatric/Adult See "Appendix I Accessories" for details of the disposable laryngoscope blades that should be used together with the product.
  • Page 15: Intended Use

    Overview 2.1.2 Intended Use The device is equipped with disposable laryngoscope blades to take pictures that can be clearly displayed on the screen through HD camera and LED lights. It helps Medical personnel intubate accurately so as to reduce the damage to patients during intubation.
  • Page 16: Chapter 3 Installation & Usage

    Chapter 3 Installation & Usage 3.1 Power On Check all parts for any sign of mechanical damage before starting. Check whether the video laryngoscope can power on/off normally  Press the power button, and it will start the self-test. The indicator shall turn red and 1s later solid blue, and it will finally enter the main interface.
  • Page 17: Battery

    Charge the battery after transport or storage, as the video laryngoscope may not work properly in low battery. The charging temperature for battery is between 0 to 45° C.  Only use the power adapter provided by Comen to charge the battery.  The power adapter is non-medical device. ...
  • Page 18 Installation & Usage Comen.  When the product is not used for a long time, it is recommended to charge the battery every three months. It cannot be operated during charging. The blue indicator is solid on while charging, and is off when fully charged. When the battery level is below 20%, the red indicator and the battery icon will blink.
  • Page 19: Connecting Disposable Laryngoscope Blade

    Installation & Usage 3.3 Connecting Disposable Laryngoscope Blade Warning  Connect the disposable laryngoscope blade to the handle, and a "c“ick" ”ill be heard to indicate that it is in place, failure to do so may cause product malfunction or drop of the disposable laryngoscope blade. ...
  • Page 20: Usage

    Installation & Usage Buckle 3.4 Usage Warning  Follow the instructions in the manual to clean and disinfect the video laryngoscope before and after use.  That before each use or after a change of viewing modes / settings, the operator checked to ensure the view observed through the endoscope provides a live image (rather than a stored one) and has the correct image orientation...
  • Page 21 Installation & Usage Press the Power On/Off button, an image will appear on the screen, and the lamp will come on. Turning it on a few minutes in advance is recommended as it needs to preheat the main unit and the camera and then will be ready for use. Take out the disposable laryngoscope blade and insert the connecting parts of handle into the adapter sleeve of disposable laryngoscope blade .
  • Page 22: Settings

    Installation & Usage pushing the laryngoscope. You can also click the photograph button to take a picture when it is recording a video. When the glottis appears on the monitor and is open, lift the glottis with the disposable laryngoscope blade to see the tracheal ring. Push the endotracheal tube to a proper place in the trachea, then fix the endotracheal tube with one hand, and gently remove the Video Laryngoscope from the mouth.
  • Page 23: Languages

    Installation & Usage Select [Brightness] to set the screen brightness. 3.5.2 Languages Tap the display and select the icon to enter the [Menu] interface; Select [Languages] and then set the language. 3.5.3 Date Tap the display and select the icon to enter the [Menu] interface;...
  • Page 24: File

    Installation & Usage 3.5.5 File Tap the display and select the icon to enter the [Menu] interface; Select [Picture] or [Video] to view the pictures/videos. Then you can select a picture/video or all the pictures/videos, and tap the icon to delete them. 3.5.6 File Transfer File transfer through USB cable: Use the USB cable supplied to connect computer and USB port of Video...
  • Page 25: Standby

    Installation & Usage Select [Standby] and set it to [Open] or [Close]. 3.6 Standby If the user does not operate it for a certain period of time when the standby function is turned on, it will automatically enter the standby mode, and will shut down when it is in the standby mode for a long time.
  • Page 26: Format

    Installation & Usage 3.7 Format This feature will delete all the pictures and videos on the SD card and restore to the factory settings. Please use this function with caution. The steps are as follows: Tap the display and select the icon to enter the [Menu] interface;...
  • Page 27: Chapter 4 Maintenance

    Chapter 4 Maintenance Before using the Video Laryngoscope, or every 6-12 months or after each maintenance or upgrade, a complete check, (including functional safety check) of the equipment should be carried out by qualified technical maintenance personnel. The checks should include: Check if the operating environment of the equipment conform to relevant requirements.
  • Page 28 Upon request by the user, Comen will conditionally provide relevant circuit diagrams, component part lists, descriptions, calibration instructions to help the user to repair user-serviceable components of the equipment by appropriate and qualified technicians.
  • Page 29: Chapter 5 Cleaning And Disinfection

    Chapter 5 Cleaning and Disinfection The main unit of the video laryngoscope, charger and charging cable shall be cleaned regularly, and shall be cleaned more frequently in areas with severe pollution or heavy sandstorms. These are not waterproof parts, and shall not be immersed when cleaning them.
  • Page 30 Cleaning and Disinfection Warning  Turn device off before the cleaning and disinfection to prevent damage.  Device must be cleaned and disinfected before and after use.  The used disposable laryngoscope blades must be disposed in accordance with local laws and hospital regulations. ...
  • Page 31: Chapter 6 Troubleshooting

    Chapter 6 Troubleshooting Problem Solution The video laryngoscope fails to If it is in low battery, charge it for 5min, power on remove the USB cable, and then power it If the problem persists, contact the manufacturer. The power indicator is on, but no Check the surface of the camera and the image is shown on the screen.
  • Page 32: Chapter 7 Warranty

    The product will be repaired or replaced free of charge within the warranty period. After the warranty period, Comen will charge for the service and replacement parts. If the products need to be returned to Comen for service, the freight charges (including...
  • Page 33 Return If the products need to be returned to Comen, please contact Comen After-sales Service Department to acquire the right to return the goods. You must provide product serial number, which can be found on the product’s nameplate. If the serial number is illegible, your return request will be rejected.
  • Page 34 Warranty Fax: 0755-26431232 Customer Service Hotline: 4007009488...
  • Page 35: Appendix I Accessories

     Before using the equipment, check the accessories are compatible with the equipment. Incompatible accessories reduce the performance of the equipment. Dimensions (mm) Lifted Weight( Model Type weigh Unit: g) t (Kg) ≥6 CVL-1-1 Disposable 63.1 11.15 13.33 4.71...
  • Page 36 Accessories laryngoscope blade (for neonate) Disposable laryngoscope CVL-2-1 ≥6 86.27 15.02 20.63 9.13 blade (for Pediatric) Disposable ≥6 CVL-3-1 laryngoscope 107.77 16.7 22.15 8.76 blade(for Adult) Large disposable ≥6 CVL-5-1 laryngoscope 121.01 17.22 22.85 8.55 blade(for Adult) Note: The tolerance of all dimensions is ± 2mm.
  • Page 37 Accessories CVL-1-1diagram CVL-2-1/CVL-3-1/CVL-5-1diagram...
  • Page 38: Appendix Ii Product Specifications

    Appendix II Product Specifications Type of video laryngoscope Item Classification Electric shock Class II equipment powered by battery inside protection type Electric shock BF type equipment protection level Continuous operation equipment Work mode Mobility Level Handheld equipment Safety standard IEC60601-1 IEC60601-2-18 , IEC60601-1-2 Applied part...
  • Page 39 It should be stored at -20 ℃ ~ 55 ℃ , 0% ~ 93% RH (non-condensing), 50.0kPa ~ 106.0kPa, in a properly ventilated Storage environment free of corrosive gas. Battery ℃ ℃ charging temperature Main unit specifications Item Specifications 85x179x59 CVL-1:≤ 85x199x93 Dimension CVL-2:≤ 85x199x111 (mm) CVL-3:≤ 85x201x125 CVL-5:≤ II-2...
  • Page 40 Product Specifications CVL-1: ≤230g; CVL-2: ≤240g; CVL-3: ≤250g; CVL-5: ≤260g Weight 3.0 inch TFT display screen specification pixels Resolution: 640 × 480 Dimensions tolerance: ± 2mm, weight tolerance: ± 10g Remark Power specifications Item Specifications AC input voltage 100-240V~ of adapter.
  • Page 41 Product Specifications Working parameters ≥500lx, h=30mm Illuminance of light source LED light source Color temperature of light ≥5000K source ≥60°±15% Field angle (LCD Diagonal line) Camera Depth of field 5~80mm ≥6.35LP/mm Spatial resolution Forward and backward rotation angle of 0° ~130° ± 10° the displaying screen Left and right...
  • Page 42 Product Specifications Picture file JPG, resolution ≥640 × 480 format Video file MP4, resolution 640 × 480 format Digital video H.264 code format Store 30,000 pictures with a resolution of 640 * 480 in jpg format, or up to 4 hours 640 * 480 video recording in mp4 Store 60,000 pictures with a resolution of 640 * 480 in jpg format, or Storage up to8 hours 640 * 480 video recording in mp4...
  • Page 43: Appendix Iii Emc

    Appendix III EMC Warning  DO NOT stack the Video Laryngoscope on, under or have it close to any other equipment. If you need to use the video laryngoscope in such way, observe and verify that video laryngoscope works properly in such condition first.
  • Page 44  Please follow the EMC instructions in this User’s Manual to install and use the video laryngoscope.  Portable and mobile RF communication equipment may affect the performance of the video laryngoscope. To protect the video laryngoscope against strong electromagnetic interference, keep it away from mobile phones, microwave ovens, etc.
  • Page 45 interference to nearby electronic devices. CISPR 11 Class A RF emission The Video Laryngoscope can be used in IEC 61000-3-2 non-household facilities and all facilities Harmonic emission not directly connected to household public low-voltage supply network. IEC 61000-3-3 Voltage fluctuation / flicker emission Guide and Manufacturer’s Statement –...
  • Page 46 wooden, concrete or tile Contact discharge: Contact discharge: Electrostatic floor only. The ± 6kV ± 6kV discharge (ESD) RH should reach IEC 61000-4-2 Air discharge: ± 8kV Air discharge: ± 8kV 30% in case of composite floor. The mains power To power cord: Electrical fast supply should be...
  • Page 47 70% U , duration = 70% U , duration continuous 25 cycles = 25 cycles running of this sag = 30%) sag = 30%) product in case of <5% U , duration = <5% U , duration power = 5s interruption, you sag >95%) sag >95%)
  • Page 48 Electromagnetic Coincidence – Immunity Test IEC60601 Test Level Environment Level Guide working portable and mobile communication equipment closer to 3 Vrms RF conduction 3 Vrms part this 150 kHz to 80 MHz IEC 61000-4-6 product (including its cables) than recommended 3 V/m RF radiation isolation...
  • Page 49 MHz to 800 MHz 800 MHz to 2.5 GHz above formula: P – the transmitter’s maximum rated output power learnt from transmitter manufacturer; d – the recommended isolation distance (m). The field intensity of fixed RF transmitters measured surveying electromagnetic field and should be lower than the coincidence III-7...
  • Page 50 level either frequency range This product cause interference to the nearby equipment marked with following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency band applies. Note 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 51 Recommended Isolation Distance between Portable and Mobile RF Communication Equipment and This Product This product is intended to work in an electromagnetic environment with controlled RF radiation disturbance. You can prevent electromagnetic interference by maintaining the following recommended isolation distance between the portable and mobile RF communication equipment (transmitters) and this product, subject to the maximum rated output power of such communication equipment.
  • Page 52 In case of any maximum rated output power other than listed above, use the formula (“P” refers to the transmitter’s maximum rated output power (W) learnt from the transmitter manufacturer) in the relevant transmitter frequency column to calculate the recommended isolation distance “d” (m). Note 1: At 80 MHz and 800 MHz frequency points, the equation for the higher frequency band applies.

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