ZONE Medical MEDCAPTAIN NAVI-30 Operation Manual
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ZONE Medical MEDCAPTAIN NAVI-30 Operation Manual

Vein illuminator
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NAVI-30/NAVI-60
Vein Illuminator
Operation Manual
Before using the NAVI-30/NAVI-60 vein illuminator, please read
this Manual carefully and follow the safety precautions and
operating instructions contained herein.

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  • Page 1 NAVI-30/NAVI-60 Vein Illuminator Operation Manual Before using the NAVI-30/NAVI-60 vein illuminator, please read this Manual carefully and follow the safety precautions and operating instructions contained herein.
  • Page 2 Intellectual Property and Statement MEDICAL TECHNOLOGY CO., LTD. (hereinafter referred to as “MEDCAPTAIN”) owns the intellectual property rights to this Manual. © Copyright 2018-2019 MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. All rights reserved. No part of this Manual shall be reproduced, amended or translated by any individual or organization without the written permission of MEDCAPTAIN.
  • Page 3 Intellectual Property and Statement Illustrations  All the illustrations provided in this operation manual are for your reference only. The settings or data on the illustrations may differ from the actual settings or data of the product. Version Information V1.0 ...
  • Page 4 After-Sales Service Thanks for purchasing our vein illuminator.  MEDCAPTAIN provides limited warranty for the product. That is, we provide free after-sales services for the product within the warranty period. The specific warranty period is stipulated on the sales contract. For details, please contact your local distributor.

  • Page 5: Table Of Contents

    Contents Overview ............... 1 2 Safety ................ 3 3 Product Specifications ..........8 4 Product Description ..........10 5 Installation Description ......... 15 6 Operating Instructions .......... 18 7 Common Faults............24 8 Cleaning and Disinfection ........26 9 Maintenance ............30 Appendix A ..............

  • Page 6: Overview

    Overview 1 Overview 1.1 Intended Use The NAVI-30/NAVI-60 vein illuminator is used to observe and locate the superficial veins, and to assist medical personnel in venipuncture. 1.2 Contraindications Direct eye exposure to the light emitted by this product is forbidden. 1.3 Product Features As a portable professional medical device for vein imaging, the NAVI-30/NAVI-60 vein illuminator detects veins beneath skin by...
  • Page 7 Overview  Handheld device for medical personnel. Ergonomic design, comfortable to hold it.  Five projection colors are available for selection. The corresponding inverse color mode of each color can also be selected.  The projection brightness can be adjusted to adapt to different operation environments.

  • Page 8: Safety

    Safety 2 Safety 2.1 Warnings and Cautions In this Manual, the precautions are classified by importance into warnings and cautions as defined below: WARNING: The precautions related to safety and effectiveness. Failure to follow them may cause personal injuries. CAUTION: The precautions related to guidance and suggestions.
  • Page 9 Safety  The vein illuminator does not have a patient connection circuit. Prevent the patient from touching the vein illuminator.  This vein illuminator can only identify veins, and it cannot effectively evaluate arteries.  Do not use this product as diagnostic equipment or for any treatment purposes.
  • Page 10 Safety  Do not disassemble or try to repair the vein illuminator. Otherwise, serious hazards may be incurred. The manufacturer and distributor shall not be responsible for any vein illuminator that has been disassembled, modified or used for any purpose other than its intended purpose.
  • Page 11 Safety CAUTION:  Do not touch the display screen by using sharp objects. Otherwise, the display screen may get damaged.  Ensure that the vein illuminator is placed beyond the reach of the patient and other unauthorized persons.  Ensure that the battery is always installed in the vein illuminator during use.
  • Page 12 Safety Date of manufacture Direct current Authorized representative in the European Community Serial number Mark: conforms essential requirements Medical Device Directive 93/42/EEC DISPOSAL: Do not dispose of this product as unsorted municipal waste. Separate collection of such waste special treatment is necessary. Fragile, handle with care Keep away from sunlight Temperature limit...

  • Page 13: Product Specifications

    Product Specifications 3 Product Specifications Vein illuminator Name NAVI-30/NAVI-60 Model 224 (W) x 68 (H) x 64 (D) mm Dimensions About 0.5kg Weight Input: 100-240Vac 50/60Hz 1.5A Max Output: 12V 3.5A Power Adapter Model of the power adapter:LXCP52-012 Built-in lithium battery: 7.3V, 2750mAh Battery model: 18650-2S1P Continuous operation duration of the lithium battery: not shorter than 2.5 hours...
  • Page 14 Product Specifications Depth of Field of >30mm Imaging Infrared ≤0.6mW/m Radiation Energy Temperature: 5° C~40° C Operating Humidity: 20%~90% RH, non-condensing Conditions Pressure altitude: 70~106.0kPa Temperature: -20° C~+55° C Storage and Humidity: 10%~95% RH, non-condensing Shipping Pressure altitude: 61.7~107.4kPa Conditions 5 years Service Life 1.

  • Page 15: Product Description

    Product Description 4 Product Description 4.1 Structural Composition This product mainly consists of the infrared light source, image sensor (CCD), image processing chip, projection module, internal optical path module, power supply, and support. It does not come into contact with the patient during the use. 4.2 Operating Principles Compared with the superficial skin, the hemoglobin in veins has a stronger absorption of near-infrared light.
  • Page 16 Product Description 4.3.1 Front View 1 – Display screen 2 – Running indicator 3 – Battery indicator 4 – Power indicator 5 – Brightness button 6 – Size button 7 – Mode button 8 – Power button  Display screen (only NAVI-60 has a display screen): Displays various operation information like the remaining battery capacity, mode, color, and projection size.
  • Page 17 Product Description  When the device is connected to an external power supply and the battery is in charge state, the battery indicator is steady green. After the battery is fully charged, the battery indicator is extinguished.  When the battery is powering the device, the battery indicator is slowly blinking green.
  • Page 18 Product Description  Green light mode, red light mode, blue light mode, and light purple mode: The noise is weakened to accurately show the vein distribution.  Depth mode: The vein depth can be identified to assist medical personnel in inserting a needle. 4.3.2 Rear View 1–Projection...
  • Page 19 Product Description 4.3.3 Bottom View  Power interface: Used to connect to the power adapter. 4.4 Accessories Accessory Name AC power cable Power adapter Accuracy test card CAUTION:  All accessories of this device must be provided by the manufacturer. Otherwise, this device may be damaged, an electric shock may be caused, or the device may fail to reach specifications asserted in the operation manual.

  • Page 20: Installation Description

    Installation Description 5 Installation Description 5.1 Environment Requirements To ensure normal operation of the vein illuminator, please ensure that the installation environment meets the following requirements:  If a support is used, the installation workbench must be smooth and steady. ...
  • Page 21 Installation Description 2. Connect the AC power cable and power adapter. 3. Connect one end to the power interface at the bottom of the vein illuminator. 4. Connect the other end to a matching AC power socket. WARNING:  Do not touch the power plug with a wet hand. If any liquid or liquid residue exists on or around the power plug or power socket, remove this liquid or liquid residue before plugging in the device.
  • Page 22 Installation Description  Do not install the vein illuminator at a place where the power plug is difficult to be disconnected from the power socket. 5.4 Checking the Device Accuracy Since the vein illuminator is a precise device, before powering on it for the first time or after transporting it, the operator must check the accuracy of the device using an accuracy test card.

  • Page 23: Operating Instructions

    Operating Instructions 6 Operating Instructions 6.1 Powering On the Vein Illuminator After installing the vein illuminator, power on the vein illuminator according to the following steps: 1. Press the power button to power on the device. The running indicator is illuminated, and the device starts to project 6s later. 2.
  • Page 24 Operating Instructions Mode Image Remarks Basic The image is mode monochrome. Green light The image is green. mode light The image is red. mode 19/ 44...
  • Page 25 Operating Instructions Blue light The image is blue. mode Light The image is light purple purple. mode 1 bar of green light: Depth The vein depth is mode 0~2mm (shallow). 2 bars of green light: vein depth 2~4mm (relatively shallow). 20/ 44...
  • Page 26 Operating Instructions 3 bars of green light or none: The vein depth above (deep). Inverse In any mode except color depth mode, a user can press and hold the mode mode button and then release to switch to the inverse color mode of the current mode.
  • Page 27 Operating Instructions 6.3 Adjusting the Brightness Four levels of projection brightness are available for selection to match different use environments. A user can press the brightness button to adjust the brightness. See the following figures. Level 1 brightness (darkest) Level 2 brightness Level 3 brightness Level 4 brightness (brightest) 22/ 44...
  • Page 28 Operating Instructions 6.4 Adjusting the Size Three different sizes of projection image are designed to make the device be suitable for different groups of people, especially for children and infants. A user can press the size button to switch the size.

  • Page 29: Common Faults

    Common Faults 7 Common Faults  The device cannot be powered on after being connected to the power adapter. Possible cause: a. The device is not properly connected to the external power supply or the external power supply has no voltage. b.
  • Page 30 Common Faults Solution: Connect the device to the power adapter for charging the battery (the battery indicator is extinguished when the battery is fully charged), or directly use the external power supply to power the device. If the device still cannot be powered on, it may be abnormal.

  • Page 31: Cleaning And Disinfection

    Cleaning and Disinfection 8 Cleaning and Disinfection It is highly recommended that the materials and methods listed in this chapter be used for cleaning and disinfection of the device. If other materials or methods are used, the device may be damaged or its service life may be shortened.
  • Page 32 Cleaning and Disinfection 8.2 Cleaning WARNING:  Do not immerse the device in the detergent solution.  Prevent the solution from seeping into the device.  Do not use halogenated solvent, petroleum-based solvent, glass detergent, acetone, or other irritant detergents. ...
  • Page 33 Cleaning and Disinfection 8.3 Disinfection WARNING:  Do not immerse the device in the disinfectant solution.  Prevent the solution from seeping into the device.  Use the disinfectant according to its operation manual.  Do not autoclave the device. ...
  • Page 34 Cleaning and Disinfection The following table lists the disinfectants recommended for the device and the required contact time for the disinfection. Table 8-2 Recommended disinfectant solutions Disinfectant Solution Contact Time Disinfection Method Name 75% alcohol 3min Wipe 70% isopropanol 3min Wipe 3% hydrogen peroxide 30min...

  • Page 35: Maintenance

    Maintenance 9 Maintenance 9.1 Regular Maintenance To ensure safe use and lengthen the service life of the vein illuminator, please conduct regular maintenance and check. Table 9-1 lists the maintenance plan. Table 9-1 Maintenance plan Maintenance Item Frequency Maintenance Method Appearance check Before each use See section 9.1.1.
  • Page 36 Maintenance 9.1.3 Accuracy Check Check the device accuracy according to section 5.4. If the accuracy exceeds the reference range, contact the local distributor or the after-sales service department of MEDCAPTAIN for calibration of the device accuracy. 9.1.4 Electrical Safety Test To ensure safety, please conduct a dielectric strength test, leakage current test, and ground impedance test according to the method stipulated in IEC60601-1.
  • Page 37 Maintenance 9.2.2 Using the Battery  Before using the device for the first time or using the device after the device is not used for a long time Before using the vein illuminator for the first time, charge the built-in battery. Power off the vein illuminator and connect it to an external power supply for at least 10 hours until the battery is fully charged.
  • Page 38 Maintenance 2. Remove the retaining screws, and take down the battery compartment. 3. Take out the old battery, and install a new battery in the battery compartment. 4. Insert the battery plug into the socket in the direction shown in the following figure.
  • Page 39 Maintenance 9.3 Storage  Avoid water spill.  Do not store the vein illuminator in a hot and humid place.  Store the vein illuminator far away from excessive vibration, dust, and corrosive gas.  Store the vein illuminator out of direct sunlight and ultraviolet ray to avoid color fading.
  • Page 40 Appendix A Appendix A Electromagnetic Compatibility (EMC) CAUTION:  The NAVI-30/NAVI-60 vein illuminator complies with EMC standard IEC 60601-1-2:2014.  Users must install and use the NAVI-30/NAVI-60 vein illuminator based on the EMC information provided in the accompanying document.  Portable and mobile RF (Radio-Frequency) communication devices may affect the performance of the NAVI-30/NAVI-60 vein illuminator.
  • Page 41 Appendix A  After each maintenance, ensure that the internal structure, shielding system, and grounding system of the device remain complete and effective.  The Emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services.
  • Page 42 Appendix A closer than inches) part theNAVI-30/NAVI-60 vein illuminator, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Guidance and manufacturer’s declaration – electromagnetic emissions The NAVI-30/NAVI-60 vein illuminator is intended for use in the electromagnetic environment specified below.
  • Page 43 Appendix A Guidance and manufacturer’s declaration – electromagnetic immunity The NAVI-30/NAVI-60 vein illuminator is intended for use in the electromagnetic environment specified below. The customer or the user of the NAVI-30/NAVI-60 vein illuminator should assure that it is used in such an environment. IMMUNI IEC60601 test Compliance...
  • Page 44 Appendix A Line-to-ground kV,± 2 kV AC power cable Line-to-groun DC power cable(>3m) AC power ± 2 kV cable Line-to-ground SIP/SOP outdoor cable 0% 0.5 cycle 0% 0.5 cycle Mains power quality voltage At 0º , 45 º , 90 º , At 0º...
  • Page 45 Appendix A magnetic should be at levels fields characteristic (50/60Hz) typical location in a (PFMF) typical commercial or hospital environment 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration – electromagnetic immunity The NAVI-30/NAVI-60 vein illuminator is intended for use in the electromagnetic environment specified below.
  • Page 46 Appendix A 1 kHz Recommended separation distance Radiate 3 V/m 3 V/m  80 MHz – 80 MHz – 2.7 d RF  IEC610 2.7 GHz; GHz; 00-4-3 80% AM at 80% AM at 1  1 kHz 80M~800MHz 27V/m:380- 27V/m:380-39 ...
  • Page 47 Appendix A NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;...
  • Page 48 Appendix A Recommended separation distances between portable and mobile RF communications equipment and the NAVI-30/NAVI-60 vein illuminator The NAVI-30/NAVI-60 vein illuminator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NAVI-30/NAVI-60 vein illuminator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NAVI-30/NAVI-60 vein illuminator as...
  • Page 49 Appendix A NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz;...

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